terbinafine

TER-bin-a-feen

Commonly used brand name(s)

In the U.S.

• Lamisil


• Terbinex

Available Dosage Forms:

• Packet


• Tablet

Therapeutic Class: Antifungal

Chemical Class: Allylamine

Uses For terbinafine

Terbinafine belongs to the group of medicines called antifungals. It is used to treat fungus infections of the scalp, body, groin (jock itch), feet (athlete's foot), fingernails, and toenails.

terbinafine is available only with your doctor's prescription.

Before Using terbinafine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For terbinafine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to terbinafine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of terbinafine oral granules in children younger than 4 years of age with fungal infections of the scalp. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of terbinafine tablets in children with fungal infections of the fingernails or toenails. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of terbinafine oral granules have not been performed in the geriatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of terbinafine tablets in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving terbinafine tablets.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking terbinafine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using terbinafine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clozapine

Using terbinafine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine


• Metoprolol


• Nortriptyline


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of terbinafine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems (e.g., neutropenia) or


• Systemic lupus erythematosus or SLE or


• Weakened immune system—Use with caution. May make these conditions worse.

• Liver disease, active or chronic—Use is not recommended in patients with this condition.

Proper Use of terbinafine

Take terbinafine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

terbinafine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

Terbinafine tablets may be taken with food or on an empty stomach. However, it is best to take terbinafine oral granules with food.

To help clear up your infection completely, it is very important that you keep using terbinafine for the full time of treatment, even if your symptoms begin to clear up or you begin to feel better after a few days. Since fungal infections may be very slow to clear up, you may need to take terbinafine for several weeks or months. If you stop taking terbinafine too soon, your symptoms may return.

terbinafine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at the same times every day. If you need help in planning the best time to take your medicine, check with your doctor.

If you are using the oral granules, you may sprinkle the contents on a spoonful of pudding or other soft, non-acidic food such as mashed potatoes. This mixture must be swallowed immediately without chewing. Do not use applesauce or fruit-based foods. If you will need two packets of oral granules with each dose, you may sprinkle the content of both packets on one spoonful or two spoonfuls of non-acidic food.

Avoid caffeine (coffee, soda, chocolate) while you are using terbinafine. Terbinafine may cause caffeine to stay in your body longer than usual.

Dosing

The dose of terbinafine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of terbinafine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (granules):
  
  • For tinea capitis (fungus infections of the scalp):
    
    • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 250 milligrams (mg) once a day for 6 weeks.
    
    
    • Children 4 years of age and older and weighing over 35 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 250 milligrams (mg) once a day for 6 weeks.
    
    
    • Children 4 years of age and older and weighing less than 25 kg to 35 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 125 to 187.5 mg once a day for 6 weeks.
    
    
    • Children younger than 4 years of age—Use and dose must be determined by the doctor.
    
    
  
  


• For oral dosage form (tablets):
  
  • For onychomycosis (fungus infections of the fingernails):
    
    • Adults—250 milligrams (mg) once a day for 6 weeks.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  
  • For onychomycosis (fungus infections of the toenails):
    
    • Adults—250 milligrams (mg) once a day for 12 weeks.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  
  • For tinea corporis (ringworm of the body):
    
    • Adults and teenagers—250 milligrams (mg) once a day for 2 to 4 weeks.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  
  • For tinea cruris (ringworm of the groin; jock itch):
    
    • Adults and teenagers—250 milligrams (mg) once a day for 2 to 4 weeks.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  
  • For tinea pedis (ringworm of the foot; athlete's foot):
    
    • Adults and teenagers—250 milligrams (mg) once a day for 2 to 6 weeks.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  

Missed Dose

If you miss a dose of terbinafine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of terbinafine tablets, take it as soon as you can. If your next regular dose is less than 4 hours away, wait until then to use the medicine and skip the missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using terbinafine

It is important that your doctor check the progress of you or your child at regular visits to make sure that terbinafine is working properly. Blood tests may be needed to check for any unwanted effects.

If your or your child's symptoms do not improve, or if they become worse, check with your doctor. You may need to take terbinafine for several weeks or months before your infection gets better.

terbinafine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking terbinafine and call your doctor right away if you have a skin rash, itching, hives, trouble with breathing or swallowing, or any swelling of your hands, face, or mouth while you or your child are using terbinafine.

terbinafine may cause serious liver problems, including liver failure. Stop taking terbinafine and check with your doctor right away if you start having nausea or vomiting, dark urine, light-colored stools, stomach pain, or yellow eyes or skin while you or your child are using terbinafine.

terbinafine may cause problems with your sense of taste or smell. Stop taking terbinafine and tell your doctor if you or your child have change or loss of sense of smell, change in taste or loss of taste, poor appetite, or weight loss.

You may become depressed when taking terbinafine. Tell your doctor right away if you or your child thinks terbinafine is causing changes in your mood or behavior. Other symptoms include feeling very sad or empty, irritable, lack of appetite, loss of interest or pleasure, restlessness, trouble concentrating, or trouble sleeping.

Liver problems may be more likely to occur if you drink alcoholic beverages while you are taking terbinafine. You should not drink alcoholic beverages while you are taking terbinafine.

Serious skin reactions can occur with terbinafine. Stop using terbinafine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you or your child are using terbinafine.

terbinafine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you or your child get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Stop taking terbinafine and tell your doctor right away if you or your child have a red, scaly, skin rash or unusual sensitivity of the skin to the sun that can lead to a rash.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

terbinafine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Fever

Less common

• Body aches or pain


• chills


• cough


• diarrhea


• difficulty with breathing


• ear congestion


• general feeling of discomfort or illness


• headache


• joint pain


• loss of appetite


• loss of voice


• nasal congestion


• nausea


• runny nose


• shivering


• skin rash or itching


• sneezing


• sore throat


• sweating


• trouble with sleeping


• unusual tiredness or weakness


• upper abdominal or stomach pain


• vomiting

Rare

• Dark urine


• difficulty with swallowing


• pale skin


• pale stools


• redness, blistering, peeling, or loosening of the skin


• stomach pain


• unusual bleeding or bruising


• yellow skin or eyes

Incidence not known

• Black, tarry, stools


• bleeding gums


• bloating


• blood in the urine or stools


• chest pain


• constipation


• cough or hoarseness


• dizziness


• fast heartbeat


• feeling of discomfort


• flu-like symptoms


• general feeling of tiredness or weakness


• hair loss


• high fever


• hives


• indigestion


• inflammation of the joints


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• light-colored stools


• lower back or side pain


• muscle aches


• painful or difficult urination


• pains in the stomach, side, or abdomen, possibly radiating to the back


• persistent loss of appetite


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


• red, scaling, or crusted skin


• shortness of breath or troubled breathing


• sores, ulcers, or white spots on the lips or in the mouth


• sores, welting, or blisters


• stomach pain, continuing


• swollen glands


• swollen lymph glands


• tightness in the chest


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unexplained bleeding or bruising


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Stomach pain (mild)


• stuffy nose

Less common

• Acid or sour stomach


• bad, unusual, or unpleasant (after) taste


• belching


• change of taste or loss of taste


• heartburn


• toothache

Incidence not known

• Decreased vision


• difficulty with moving


• discouragement


• feeling sad or empty


• irritability


• lack of appetite


• loss of interest or pleasure


• loss of sense of smell


• muscle cramps or spasms


• muscle stiffness


• tiredness


• trouble concentrating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More terbinafine resources

• Terbinafine Use in Pregnancy & Breastfeeding
• Drug Images
• Terbinafine Drug Interactions
• Terbinafine Support Group
• 45 Reviews for Terbinafine - Add your own review/rating

• Terbinafine Professional Patient Advice (Wolters Kluwer)


• Terbinafine Prescribing Information (FDA)


• Terbinafine MedFacts Consumer Leaflet (Wolters Kluwer)


• Lamisil Prescribing Information (FDA)


• Lamisil Monograph (AHFS DI)


• Lamisil Consumer Overview

Compare terbinafine with other medications

• Cutaneous Candidiasis
• Onychomycosis, Fingernail
• Onychomycosis, Toenail
• Tinea Capitis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Prohist LQ Liquid

Pronunciation: FEN-il-EF-rin/trye-PROE-li-deen
Generic Name: Phenylephrine/Triprolidine
Brand Name: Prohist LQ

Prohist LQ Liquid is used for:

Temporarily relieving symptoms of hay fever, allergies, or the common cold, including nasal congestion, runny nose, sneezing, itching of the nose and throat, and itchy or watery eyes. It may also be used for other conditions as determined by your doctor.

Prohist LQ Liquid is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.

Do NOT use Prohist LQ Liquid if:

• you are allergic to any ingredient in Prohist LQ Liquid


• you have severe or uncontrolled high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prohist LQ Liquid:

Some medical conditions may interact with Prohist LQ Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of an adrenal gland problem (eg, adrenal gland tumor); a heart problem (eg, cor pulmonale; fast, slow, or irregular heartbeat; heart disease); high blood pressure; diabetes; a blood vessel problem; a stroke; glaucoma or increased pressure in the eye; seizures; or a thyroid problem


• if you have a history of asthma or other breathing problems, chronic cough, lung problems (eg, chronic bronchitis, emphysema), chronic obstructive pulmonary disease (COPD), or trouble breathing when you sleep (sleep apnea)


• if you have a blockage of your bladder, stomach, or bowels; ulcers; trouble sleeping; trouble urinating; an enlarged prostate or other prostate problems; or the blood disease porphyria

Some MEDICINES MAY INTERACT with Prohist LQ Liquid. Tell your health care provider if you are taking any other medicines, especially if any of the following apply to you:

• Digoxin or droxidopa because the risk of irregular heartbeat or a heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, linezolid, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Prohist LQ Liquid's side effects


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Prohist LQ Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Prohist LQ Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prohist LQ Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prohist LQ Liquid:

Use Prohist LQ Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take medicine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Prohist LQ Liquid and are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prohist LQ Liquid.

Important safety information:

• Prohist LQ Liquid may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Prohist LQ Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Prohist LQ Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not drink alcohol while you are using Prohist LQ Liquid.


• Diabetes patients - Prohist LQ Liquid may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Prohist LQ Liquid has a decongestant/antihistamine in it. Before you start any new medicine, check the label to see if it has a decongestant or antihistamine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not take diet or appetite control medicines while you are taking Prohist LQ Liquid without checking with your doctor.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days, if they get worse, if they occur along with a fever, or if new symptoms occur, check with your doctor.


• If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take Prohist LQ Liquid.


• Prohist LQ Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Prohist LQ Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Prohist LQ Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Prohist LQ Liquid for a few days before the tests.


• Tell your doctor or dentist that you take Prohist LQ Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Prohist LQ Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Prohist LQ Liquid is not recommended for use in CHILDREN younger than 6 years without first checking with the child's doctor.


• Caution is advised when using Prohist LQ Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.


• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss with your doctor the benefits and risks of taking Prohist LQ Liquid while you are pregnant. Prohist LQ Liquid is found in breast milk. If you are or will be breast-feeding while you take Prohist LQ Liquid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Prohist LQ Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability (especially in children); headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; confusion; decreased coordination; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes; persistent trouble sleeping; restlessness; seizure; severe dizziness, drowsiness, light-headedness, or headache; severe nervousness or anxiety; tremors; unusual weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Prohist LQ side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish colored skin; blurred vision; confusion; dilated pupils; fever; flushing; hallucinations; mental or mood changes; ringing in the ears; seizures; severe drowsiness, dizziness, light-headedness, or headache; severe excitability; sweating; tremors; unusually fast, slow, or irregular breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Prohist LQ Liquid:

Store Prohist LQ Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prohist LQ Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Prohist LQ Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Prohist LQ Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prohist LQ Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Prohist LQ resources

• Prohist LQ Side Effects (in more detail)
• Prohist LQ Use in Pregnancy & Breastfeeding
• Prohist LQ Drug Interactions
• 0 Reviews · Be the first to review/rate this drug

Tolectin 600

Generic Name: tolmetin (Oral route)

TOLE-met-in

Oral route(Tablet;Capsule)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Tolmetin is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Tolectin 600


• Tolectin DS

Available Dosage Forms:

• Tablet


• Capsule

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For Tolectin 600

Tolmetin is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Before Using Tolectin 600

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tolmetin in children below 2 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of tolmetin in geriatric patients. However, elderly patients may be more sensitive to the effects of tolmetin than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving tolmetin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Pentoxifylline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Acenocoumarol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dicumarol


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Phenprocoumon


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or


• Bleeding problems or


• Blood clots or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• Hypertension (high blood pressure) or


• Kidney disease or


• Liver disease (e.g., hepatitis) or


• Stomach or intestinal ulcers or bleeding, history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or


• Aspirin sensitivity, history of—This medicine should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG])—This medicine should not be used to relieve pain right before or after the surgery.

Proper Use of tolmetin

This section provides information on the proper use of a number of products that contain tolmetin. It may not be specific to Tolectin 600. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

It is best to take this medicine on an empty stomach. However, if it upsets your stomach, you may take this medicine with an antacid that does not contain sodium bicarbonate.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or tablets):
  
  • For osteoarthritis and rheumatoid arthritis:
    
    • Adults—At first, 400 milligrams (mg) three times a day. Your doctor may increase your dose as needed up to a total dose of 1800 mg per day.
    
    
    • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. At first, 20 milligrams (mg) per kilogram (kg) of body weight per day, divided into smaller amounts that are taken three or four times a day. Your doctor may increase your dose as needed up to 30 mg per kg of body weight per day.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Tolectin 600

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in the mouth or on the lips, or unusual tiredness or weakness.

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs; severe stomach pain; black, tarry stools; vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Tolectin 600 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• diarrhea


• dizziness


• headache


• nausea


• numbness or tingling in the arms or legs


• swelling


• trouble thinking, speaking, or walking


• vomiting


• weakness


• weight gain

Less common

• Black, tarry stools


• bladder pain


• blood in the vomit


• bloody or cloudy urine


• blurred or loss of vision


• burning feeling in the chest or stomach


• burning, itching, redness, or stinging of the skin


• chest pain


• difficult, burning, or painful urination


• disturbed color perception


• double vision


• frequent urge to urinate


• halos around lights


• indigestion


• lower back or side pain


• night blindness


• overbright appearance of lights


• severe or continuing stomach pain


• stomach upset


• tenderness in the stomach area


• tunnel vision

Rare

• Back or leg pains


• bleeding gums


• blistering, peeling, or loosening of the skin


• chills


• constipation


• cough or hoarseness


• dark urine


• decreased urine output


• difficulty with breathing


• difficulty with swallowing


• dilated neck veins


• extreme fatigue


• fast, irregular heartbeat


• feeling of discomfort


• fever


• general body swelling


• heartburn


• hives or welts


• increased thirst


• inflammation of the joints


• irregular breathing


• joint or muscle pain


• light-colored stools


• loss of appetite


• muscle aches


• nosebleeds


• pale skin


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


• severe and continuing nausea


• shortness of breath


• skin rash


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swelling of the face, fingers, feet, or lower legs


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• tightness in the chest


• trouble with breathing


• unusual bleeding or bruising


• unusual tiredness or weakness


• upper right abdominal pain


• wheezing


• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• bloated full feeling


• excess air or gas in the stomach or intestines


• lack or loss of strength


• passing gas


• stomach discomfort


• weight loss

Less common

• Continuing ringing or buzzing or other unexplained noise in the ears


• discouragement


• feeling sad or empty


• hearing loss


• irritability


• loss of interest or pleasure


• sleepiness


• tiredness


• trouble with concentrating


• trouble with sleeping

Rare

• Redness, swelling, or soreness of the tongue


• swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tolectin 600 side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Tolectin 600 resources

• Tolectin 600 Side Effects (in more detail)
• Tolectin 600 Use in Pregnancy & Breastfeeding
• Drug Images
• Tolectin 600 Drug Interactions
• Tolectin 600 Support Group
• 0 Reviews for Tolectin 600 - Add your own review/rating

• Tolectin 600 MedFacts Consumer Leaflet (Wolters Kluwer)


• Tolmetin Prescribing Information (FDA)


• Tolectin Monograph (AHFS DI)


• Tolectin Concise Consumer Information (Cerner Multum)

Compare Tolectin 600 with other medications

• Back Pain
• Gout, Acute
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Trandate Tablets

Pronunciation: la-BAYT-a-lol
Generic Name: Labetalol
Brand Name: Trandate

Trandate is used for:

Treating high blood pressure. It may be used alone or in combination with other medicines, such as diuretics. It may also be used for other conditions as determined by your doctor.

Trandate is an adrenergic receptor blocker. It works by blocking both alpha and beta receptors in the body, which lowers blood pressure.

Do NOT use Trandate if:

• you are allergic to any ingredient in Trandate


• you have second- or third-degree (complete) heart block, moderate to severe first-degree heart block after a heart attack, heart failure, a certain abnormal electrocardiogram (ECG) (prolonged QT interval), or shock caused by serious heart problems


• you have asthma, obstructive airway disease, or other breathing disorders


• you have severe slow heartbeat or severe low blood pressure

Contact your doctor or health care provider right away if any of these apply to you.

Before using Trandate:

Some medical conditions may interact with Trandate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diabetes, an adrenal gland tumor (pheochromocytoma), lung or breathing problems (eg, bronchitis, chronic obstructive pulmonary disease [COPD], emphysema), kidney problems, liver problems, or thyroid problems


• if you have heart problems (eg, first-degree heart block, slow heartbeat, irregular heartbeat, Wolff-Parkinson-White syndrome, sick sinus syndrome), low blood pressure, a history of heart failure, or you have had a recent heart attack


• if you are scheduled to have surgery, including cataract surgery, or have recently had surgery

Some MEDICINES MAY INTERACT with Trandate. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Calcium channel blockers (eg, verapamil), cimetidine, or digoxin because they may increase the risk of Trandate's side effects


• General anesthetics (eg, halothane), nitroglycerin, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Trandate


• Beta-agonists (eg, albuterol) because their effectiveness may be decreased by Trandate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trandate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Trandate:

Use Trandate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Trandate by mouth with or without food.


• If you miss a dose of Trandate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Trandate.

Important safety information:

• Trandate may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Trandate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Trandate may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Do not suddenly stop taking Trandate without first checking with your doctor. Suddenly stopping Trandate may result in chest pain or temporary symptoms such as shaking, sweating, headache, irregular heartbeat, and general unwell feeling. If your doctor decides that you should stop taking Trandate, your dosage should be reduced over a period of 1 to 2 weeks and you should be carefully monitored.


• Tell your doctor or dentist that you take Trandate before you receive any medical or dental care, emergency care, or surgery.


• If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are taking Trandate.


• Trandate may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Trandate.


• If your doctor has instructed you to check your blood pressure and heart rate regularly, be sure to do so.


• Diabetes patients - Trandate may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Diabetes patients - Trandate may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including liver function, may be performed while you use Trandate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Trandate with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness, lightheadedness, or fainting.


• Trandate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Trandate while you are pregnant. Trandate is found in breast milk. If you are or will be breast-feeding while you use Trandate, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Trandate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; indigestion; lightheadedness; nausea; stuffy nose; temporary tingling of the scalp; unusual tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; dark urine; decreased sexual ability; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, depression); muscle pain or tenderness; pale stools; persistent cough; persistent loss of appetite; right upper stomach pain; severe or persistent dizziness; shortness of breath; swelling of the hands or feet; unexplained or sudden weight gain; unusual bruising or bleeding; weakness; wheezing; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Trandate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; seizures; severe dizziness or lightheadedness, especially when standing; shortness of breath; slow heartbeat.

Proper storage of Trandate:

Store Trandate between 36 and 86 degrees F (2 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Trandate out of the reach of children and away from pets.

General information:

• If you have any questions about Trandate, please talk with your doctor, pharmacist, or other health care provider.


• Trandate is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Trandate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Trandate resources

• Trandate Side Effects (in more detail)
• Trandate Dosage
• Trandate Use in Pregnancy & Breastfeeding
• Drug Images
• Trandate Drug Interactions
• Trandate Support Group
• 0 Reviews for Trandate - Add your own review/rating

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Monodox

Dosage Form: capsule
Monodox ® Doxycycline Monohydrate Capsules

Revised: January 2012

Rx only

191158-2

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Monodox and other antibacterial drugs, Monodox should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION

Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. Monodox 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline.

Structural formula:

C22H24N2O8 • H2O      M.W. = 462.45

Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.

Inert ingredients: colloidal silicon dioxide; magnesium stearate; microcrystalline cellulose; sodium starch glycolate; and a hard gelatin capsule which contains black iron oxide, red iron oxide, titanium dioxide, and yellow iron oxide for the 100 mg and 75 mg strengths, titanium dioxide and yellow iron oxide for the 50 mg strength. The capsules are printed with edible ink containing black iron oxide, red iron oxide, and yellow iron oxide for the 50 mg and 100 mg strengths and black iron oxide, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1, and D&C Yellow No. 10 for the 75 mg strength.

CLINICAL PHARMACOLOGY

Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Doxycycline is virtually completely absorbed after oral administration.

Following a 200 mg dose of doxycycline monohydrate, 24 normal adult volunteers averaged the following serum concentration values:

Time (hr):	0.5	1.0	1.5	2.0	3.0	4.0	8.0	12.0	24.0	48.0	72.0
Conc.	1.02	2.26	2.67	3.01	3.16	3.03	2.03	1.62	0.95	0.37	0.15 (μg/mL)

Average Observed Values

Maximum Concentration	3.61 μg/mL (± 0.9 sd)
Time of Maximum Concentration	2.60 hr (± 1.10 sd)
Elimination Rate Constant	0.049 per hr (± 0.030 sd)
Half-Life	16.33 hr (± 4.53 sd)

Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 mL/min). This percentage excretion may fall as low as 1-5%/72 hours in individuals with severe renal insufficiency (creatinine clearance below 10 mL/min). Studies have shown no significant difference in serum half-life of doxycycline (range 18-22 hours) in individuals with normal and severely impaired renal function.

Hemodialysis does not alter serum half-life.

Microbiology: The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including doxycycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative microorganisms. Cross-resistance of these microorganisms to tetracyclines is common.

Doxycycline has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Aerobic Gram-Positive Microorganisms:

Because many strains of the following groups of gram-positive microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended.

Bacillus anthracis

Listeria monocytogenes

Staphylococcus aureus*

*Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection.

Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used to treat streptococcal infections unless the microorganism has been demonstrated to be susceptible.

Streptococcus pneumoniae

Aerobic Gram-Negative Microorganisms:

Bartonella bacilliformis	Haemophilus ducreyi
Brucella species	Haemophilus influenzae
Calymmatobacterium granulomatis	Neisseria gonorrhoeae
Campylobacter fetus	Vibrio cholerae
Francisella tularensis	Yersinia pestis

Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended:

Acinetobacter species	Klebsiella species
Enterobacter aerogenes	Shigella species
Escherichia coli

Anaerobic Microorganisms:

Actinomyces israelii	Fusobacterium fusiforme
Clostridium species

Other Microorganisms:

Borrelia recurrentis	Rickettsiae
Chlamydia psittaci	Treponema pallidum
Chlamydia trachomatis	Treponema pertenue
Mycoplasma pneumoniae

Susceptibility Tests:

Dilution Techniques:

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MIC’s). These MIC’s provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC’s should be determined using a standardized procedure. Standardized procedures are based on a dilution method1,3 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of tetracycline powder. The MIC values should be interpreted according to the following criteria:

Interpretive criteria for Enterobacteriaceae, Staphylococcus aureus and Acinetobacter spp.
Microorganism	MIC Interpretive Standard (μg/mL)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Enterobacteriaceae	≤ 4	8	≥ 16
Staphylococcus aureus
Acinetobacter spp.

Microorganisms that are susceptible to tetracycline are generally susceptible to doxycycline.

Interpretive Criteria for Haemophilus spp.
Microorganism	MIC Interpretive Standard (μg/mL)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Haemophilus spp.	≤ 2	4	≥ 8

Interpretive criteria for Haemophilus spp. are applicable only to tests performed by broth microdilution method using Haemophilus Test Medium (HTM).1,3


Microorganisms that are susceptible to tetracycline are generally susceptible to doxycycline.

Interpretive Criteria for Neisseria gonorrhoeae
Microorganism	MIC Interpretive Standard (μg/mL)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Neisseria gonorrhoeae	≤ 0.25	0.5 - 1	≥ 2

Interpretive criteria for Neisseria gonorrhoeae are applicable only to tests performed by agar dilution method using GC agar base with 1% defined growth supplement.1,3


Microorganisms that are susceptible to tetracycline are generally susceptible to doxycycline.

Interpretive Criteria for Streptococcus pneumoniae
Microorganism	MIC Interpretive Standard (μg/mL)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Streptococcus pneumoniae	≤ 2	4	≥ 8

Interpretive criteria for Streptococcus pneumoniae are applicable only to tests performed by broth microdilution method using Cation-Adjusted Mueller-Hinton broth with 2.5% - 5% lysed horse blood.1,3


Microoganisms that are susceptible to tetracycline are generally susceptible to doxycycline.

Interpretive Criteria for Bacillus anthracis and Brucella spp.
Microorganism	MIC Interpretive Standard (μg/mL)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Bacillus anthracis	≤ 1	-	-
Brucella spp.

Broth Microdilution performed in unsupplemented Brucella broth pH adjusted to 7.1 ± 0.1 for Brucella spp.5


For some organism/antimicrobial agent combinations, the absence or rare occurrence of resistant strains precludes defining results for categories other than “susceptible.”  For strains yielding results suggestive of a “nonsusceptible” category, organism identification and antimicrobial susceptibility test results should be confirmed.5

Incubation in 5% CO2 may be required for growth of some strains of Brucella spp. especially B. abortus. 

Incubation broth MIC tests in CO2 may decrease the MIC of tetracyclines, usually by one doubling dilution.5


Microorganisms that are susceptible to tetracycline are generally susceptible to doxycycline.

Interpretive Criteria for Burkholderia mallei, Burkholderia pseudomallei and Yersinia pestis
Microorganism	MIC Interpretive Standard (μg/mL)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Burkholderia mallei	≤ 4	8	≥ 16
Burkholderia pseudomallei
Yersinia pestis

Microorganisms that are susceptible to tetracycline are generally susceptible to doxycycline.

Interpretive Criteria for Franciscella tularensis
Microorganism	MIC Interpretive Standard (μg/mL)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Franciscella tularensis	≤ 4	-	-

Broth Microdilutions performed in Cation-Adjusted Mueller-Hinton broth with 2% defined growth supplement for Franciscella tularensis5

For some organism/antimicrobial agent combinations, the absence or rare occurrence of resistant strains precludes defining results for categories other than “susceptible.”  For strains yielding results suggestive of a “nonsusceptible” category, organism identification and antimicrobial susceptibility test results should be confirmed.5

Microorganisms that are susceptible to tetracycline are generally susceptible to doxycycline.

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard tetracycline powder should provide the following MIC values:

Quality Control Ranges for MIC Broth Dilution Method

* Range applicable only to tests performed by broth microdilution method using Haemophilus Test Medium (HTM).1,3 † Range applicable only to tests performed by agar dilution method using GC agar base with 1% defined growth supplement.1,3 ‡ Range applicable only to tests performed by broth microdilution method using Cation-Adjusted Mueller-Hinton broth with 2.5% to 5% lysed horse blood.1,3
Microorganism	ATCC Number	Cation-Adjusted Mueller-Hinton (CAMHB) MIC (μg/mL)
Escherichia coli	25922	0.5 - 2
Haemophilus influenzae	49247	4 - 32*
Neisseria gonorrhoeae	49226	0.25 - 1†
Pseudomonas aeruginosa	27853	8 - 32
Staphylococcus aureus	29213	0.12 - 1
Streptococcus pneumoniae	49619	0.06 - 0.5‡

Diffusion Techniques:

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2,3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30-μg tetracycline or 30-μg doxycycline to test the susceptibility of microorganisms to doxycycline.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30-μg tetracycline-class disk or the 30-μg doxycycline disk should be interpreted according to the following criteria:

Interpretive Zone Diameters for Staphylococcus aureus
Antimicrobial Agent	Zone Diameter (nearest whole mm)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Tetracycline	≥ 19	15 - 18	≤ 14
Doxycycline	≥ 16	13 - 15	≤ 12

Interpretive Zone Diameters for Enterobacteriaceae.
Antimicrobial Agent	Zone Diameter (nearest whole mm)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Tetracycline	≥ 15	12 - 14	≤ 11
Doxycycline	≥ 14	11 - 13	≤ 10
Minocycline	≥ 16	13 - 15	≤ 12

Interpretive Zone Diameters for Acinetobactor spp.
Antimicrobial Agent	Zone Diameter (nearest whole mm)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Tetracycline	≥ 15	12 - 14	≤ 11
Doxycycline	≥ 13	10 - 12	≤ 9
Minocycline	≥ 16	13 - 15	≤ 12

 

Interpretive Zone Diameters for Haemophilus spp.
Antimicrobial Agent	Zone Diameter (nearest whole mm)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Tetracycline	≥ 29	26 - 28	≤ 25

Interpretive criteria applicable only to tests performed by disk diffusion method using a 30-μg tetracycline-class disk and using Haemophilus Test Medium (HTM).2,3


Microorganisms that are susceptible to tetracycline are generally susceptible to doxycycline.

Interpretive Zone Diameters for Neisseria gonorrhoeae
Antimicrobial Agent	Zone Diameter (nearest whole mm)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Tetracycline	≥ 38	31 - 37	≤ 30

Interpretive criteria applicable only to tests performed by disk diffusion method using a 30-μg tetracycline-class disk and using GC agar base with 1% defined growth supplement.2,3

Zone diameters ≤ 19 mm may indicate a plasmid-mediated tetracycline-resistant Neisseria gonorrhoeae (TRNG) isolate. These TRNG strains should be confirmed by the dilution test (MIC ≥ 16 μg/mL).


Microorganisms that are susceptible to tetracycline are generally susceptible to doxycycline.

Interpretive Zone Diameters for Streptococcus pneumoniae
Antimicrobial Agent	Zone Diameter (nearest whole mm)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Tetracycline	≥ 23	19 - 22	≤ 18

Interpretative criteria applicable only to tests performed by disk diffusion method using a 30-μg tetracycline-class disk and using Mueller-Hinton agar with 5% defibrinated sheep blood and incubated in 5% CO2.2,3


Microorganisms that are susceptible to tetracycline are generally susceptible to doxycycline.

Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for tetracycline or doxycycline, respectively.

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30-μg tetracycline-class disk or the 30-μg doxycycline disk should provide the following zone diameters in these laboratory test quality control strains:

Quality Control Zone Diameters for Disk Diffusion Method

* Range applicable only to tests performed by disk diffusion method using a 30-μg tetracycline-class disk and using Haemophilus Test Medium (HTM).2,3 † Range applicable only to tests performed by disk diffusion method using a 30-μg tetracycline-class disk and using GC agar base with 1% defined growth supplement.2,3 ‡ Range applicable only to tests performed by disk diffusion method using a 30-μg tetracycline-class disk and using Mueller-Hinton agar with 5% defibrinated sheep blood and incubated in 5% CO2. 2,3
Microorganism	ATCC Number	Zone Diameter (mm)
		Tetracycline		Doxycycline		Minocycline
Escherichia coli	25922	18 - 25		18 - 24		19 - 25
Haemophilus influenzae	49247	14 - 22*		-		-
Neisseria gonorrhoeae	49226	30 - 42†		-		-
Staphylococcus aureus	25923	24 - 30		23 - 29		25 - 30
Streptococcus pneumoniae	49619	27 - 31‡		-		-

Anaerobic Techniques:

For anaerobic bacteria, the susceptibility to tetracycline as MIC’s can be determined by standardized test methods.3,4 The MIC values obtained should be interpreted according to the following criteria:

Agar Dilution Interpretive Criteria for Anaerobes

Microorganism	MIC Interpretive Standard (μg/mL)
	Susceptible (S)	Intermediate (I)	Resistant (R)
Anaerobes	≤ 4	8	≥ 16

Microorganisms that are susceptible to tetracycline are generally susceptible to doxycycline.


Interpretation is identical to that stated above for results using dilution techniques.

As with other susceptibility techniques, the use of laboratory control microorganisms is required to control the technical aspects of the laboratory standardized procedures. Standardized tetracycline powder should provide the following MIC values:

Quality Control Ranges for MIC Agar Dilution Method

Microorganism	ATCC Number	MIC (μg/mL)
Bacteroides fragilis	25285	0.125 - 0.5
Bacteroides thetaiotamicron	29741	8 - 32

Range applicable only to tests performed by the reference agar dilution method.

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain effectiveness of Monodox and other antibacterial drugs, Monodox should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Doxycycline is indicated for the treatment of the following infections:

     Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.

     Respiratory tract infections caused by Mycoplasma pneumoniae.

     Lymphogranuloma venereum caused by Chlamydia trachomatis.

     Psittacosis (ornithosis) caused by Chlamydia psittaci.

     Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.

     Inclusion conjunctivitis caused by Chlamydia trachomatis.

     Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.

     Nongonococcal urethritis caused by Ureaplasma urealyticum.

     Relapsing fever due to Borrelia recurrentis.

Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:

     Chancroid caused by Haemophilus ducreyi.

     Plague due to Yersinia pestis (formerly Pasteurella pestis).

     Tularemia due to Francisella tularensis (formerly Pasteurella tularensis).

     Cholera caused by Vibrio cholerae (formerly Vibrio comma).

     Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus).

     Brucellosis due to Brucella species (in conjunction with streptomycin).

     Bartonellosis due to Bartonella bacilliformis.

     Granuloma inguinale caused by Calymmatobacterium granulomatis.

Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.

Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

     Escherichia coli

     Enterobacter aerogenes (formerly Aerobacter aerogenes)

     Shigella species

     Acinetobacter species (formerly Mima species and Herellea species)

     Respiratory tract infections caused by Haemophilus influenzae.

     Respiratory tract and urinary tract infections caused by Klebsiella species.

Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:

    Upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae).

    Skin and skin structure infections caused by Staphylococcus aureus.

    Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infections.

When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:

     Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.

     Syphilis caused by Treponema pallidum.

     Yaws caused by Treponema pertenue.

     Listeriosis due to Listeria monocytogenes.

     Vincent’s infection caused by Fusobacterium fusiforme.

     Actinomycosis caused by Actinomyces israelii.

     Infections caused by Clostridium species.

In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.

In severe acne, doxycycline may be useful adjunctive therapy.

CONTRAINDICATIONS

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

WARNINGS

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Monodox, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryo toxicity has been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus.

The antianabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.

PRECAUTIONS

General:

As with other antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.

Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving tetracyclines. These conditions disappeared when the drug was discontinued.

Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated.

Prescribing Monodox in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information for Patients:

All patients taking doxycycline should be advised:

–to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (e.g., skin eruptions, etc.) occurs. Sunscreen or sunblock should be considered. (See WARNINGS.)

–to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.)

–that the absorption of tetracyclines is reduced when taken with foods, especially those which contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. (See Drug Interactions.)

–that the absorption of tetracyclines is reduced when taking bismuth subsalicylate. (See Drug Interactions.)

–not to use outdated or poorly stored doxycycline.

–that the use of doxycycline might increase the incidence of vaginal candidiasis.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Patients should be counseled that antibacterial drugs including Monodox should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Monodox is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Monodox or other antibacterial drugs in the future.

Laboratory Tests:

In venereal disease when coexistent syphilis is suspected, a dark-field examination should be done before treatment is started and the blood serology repeated monthly for at least four months.

In long-term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.

Drug Interactions:

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Concurrent use of tetracycline may render oral contraceptives less effective.

Drug/Laboratory Test Interactions:

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals to evaluate the carcinogenic potential of doxycycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with related antibiotics, oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors). Likewise, although mutagenicity studies of doxycycline have not been conducted, positive results in in vitro mammalian cell assays have been reported for related antibiotics (tetracycline, oxytetracycline). Doxycycline administered orally at dosage levels as high as 250 mg/kg/day had no apparent effect on the fertility of female rats. Effect on male fertility has not been studied.

Pregnancy:

Teratogenic Effects.

Pregnancy Category D:

There are no adequate and well-controlled studies on the use of doxycycline in pregnant short-term, first trimester exposure. There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women such as that proposed for treatment of anthrax exposure. An expert review of published data on experiences with doxycycline use during pregnancy by TERIS - the Teratogen Information System - concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity and quality of data were assessed as limited to fair), but the data are insufficient to state that there is no risk.6

A case-control study (18,515 mothers of infants with congenital anomalies and 32,804 mothers of infants with no congenital anomalies) shows a weak but marginally statistically significant association with total malformations and use of doxycycline anytime during pregnancy. (Sixty-three [0.19%] of the controls and 56 [0.30%] of the cases were treated with doxycycline.) This association was not seen when the analysis was confined to maternal treatment during the period of organogenesis (i.e., in the second and third months of gestation) with the exception of a marginal relationship with neural tube defect based on only two exposed cases.7

A small prospective study of 81 pregnancies describes 43 pregnant women treated for 10 days with doxycycline during early first trimester. All mothers reported their exposed infants were normal at 1 year of age.8

Labor and Delivery:

The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers:

Tetracyclines are excreted in human milk, however, the extent of absorption of tetracyclines, including doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not necessarily contraindicated; however, the effects of prolonged exposure to doxycycline in breast milk are unknown.9 Because of the potential for adverse reactions in nursing infants from doxycycline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. (See WARNINGS.)

Pediatric Use:

See WARNINGS and DOSAGE AND ADMINISTRATION sections.

ADVERSE REACTIONS

Due to oral doxycycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines.

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See DOSAGE AND ADMINISTRATION.)

Skin: Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS.)

Renal Toxicity: Rise in BUN has been reported and is apparently dose related. (See WARNINGS.)

Hypersensitivity Reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and