Votrient

Generic Name: pazopanib (Oral route)

paz-OH-pa-nib

Oral route(Tablet)

Severe and fatal hepatotoxicity has been observed in clinical studies. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended .

Commonly used brand name(s)

In the U.S.

• Votrient

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For Votrient

Pazopanib is an anticancer medicine that is used to treat adults with kidney cancer (advanced renal cell carcinoma).

Pazopanib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by pazopanib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with pazopanib, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

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

Before Using Votrient

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 pazopanib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pazopanib in the elderly. However, elderly patients may be more sensitive to the effects of pazopanib than younger adults, and are more likely to have age-related liver problems, which may require caution for patients receiving pazopanib.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 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.

• Cisapride


• Dronedarone


• Mesoridazine


• Pimozide


• Posaconazole


• Sparfloxacin


• Thioridazine

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.

• Alfentanil


• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Atazanavir


• Azithromycin


• Carbamazepine


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Cyclosporine


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Ergotamine


• Erythromycin


• Fentanyl


• Flecainide


• Fluconazole


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Indinavir


• Itraconazole


• Ketoconazole


• Lapatinib


• Levofloxacin


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nefazodone


• Nelfinavir


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paclitaxel


• Paliperidone


• Perflutren Lipid Microsphere


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Rifampin


• Ritonavir


• Salmeterol


• Saquinavir


• Sirolimus


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Tacrolimus


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trazodone


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone

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.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• food


• Grapefruit Juice

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:

• Angina (severe chest pain), history of or


• Gilbert's syndrome (a genetic liver disease) or


• Heart attack, history of or


• Heart disease or


• Heart rhythm problems (e.g., QT prolongation), history of or


• Hypertension (high blood pressure) or


• Hypothyroidism (underactive thyroid) or


• Stomach or bowel problems (e.g., fistula, perforation, tear) or


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

• Bleeding problems or


• Hemoptysis (coughing up of blood), history of or


• Stomach bleeding (last 6 months)—It is not known if pazopanib will work in patients with these conditions.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Votrient

Take this medicine only as directed by your doctor to benefit your condition as much as possible. 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.

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

It is best to take this medicine on an empty stomach, at least one hour before or 2 hours after a meal.

Swallow the tablets whole. Do not break, crush, or chew it.

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 form (tablets):
  
  • For late-stage kidney cancer:
    
    • Adults—800 milligrams (mg) once a day.
    
    
    • Children—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.

If you miss a dose or forget to use it, and it is less than 12 hours since your last dose, wait and take your next dose at the normal time. Do not use extra medicine to make up for a 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 Votrient

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal or stomach pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

You will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

This medicine may increase your chance of bleeding. To help with this problem, stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Check with your doctor right away if you start having severe abdominal or stomach burning, cramps, or pains; bloody or black, tarry stools; trouble breathing; heartburn; indigestion; nausea; or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

This medicine may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Grapefruits and grapefruit juice may increase the effects of pazopanib by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you taking 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.

Votrient 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 or tenderness


• black, tarry stools


• bleeding gums


• blood in the urine or stools


• blurred vision


• chest pain


• chills


• clay colored stools


• cloudy urine


• constipation


• cough


• coughing up blood


• dark urine


• decreased appetite


• depressed mood


• difficulty with breathing or swallowing


• dizziness


• dry skin and hair


• feeling cold


• fever


• hair loss


• headache


• hoarseness or husky voice


• increased menstrual flow or vaginal bleeding


• itching


• loss of appetite


• lower back or side pain


• muscle cramps and stiffness


• nausea and vomiting


• nervousness


• nosebleeds


• painful or difficult urination


• pale skin


• paralysis


• pinpoint red spots on the skin


• pounding in the ears


• prolonged bleeding from cuts


• red or black, tarry stools


• red or dark brown urine


• redness, swelling, or pain of the skin


• scaling of the skin on the hands and feet


• shortness of breath


• skin rash


• slow or fast heartbeat


• sore throat


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


• swelling of the feet or lower legs


• swollen glands


• tingling of the hands and feet


• ulceration of the skin


• unusual bleeding or bruising


• unusual tiredness or weakness


• weight gain


• yellow eyes or skin

Less common

• Bleeding from rectum or bloody stools


• blood in the urine


• bloody nose


• chest pain or discomfort


• confusion


• coughing or spitting up blood


• fainting


• irregular heartbeat


• irregular or slow heart rate


• numbness or tingling in the face, arms, or legs


• pain or discomfort in the shoulders, arms, jaw, back, or neck


• sweating


• swelling or puffiness of the face


• trouble speaking, thinking, or walking

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

• Change in hair color


• change in taste


• decreased weight


• diarrhea


• hair loss


• lack or loss of strength


• loss of taste


• thinning of the hair


• weight loss

Less common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• stomach discomfort, upset, or pain

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: Votrient side effects (in more detail)

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More Votrient resources

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

• Votrient Prescribing Information (FDA)


• Votrient Consumer Overview


• Votrient Monograph (AHFS DI)


• Votrient MedFacts Consumer Leaflet (Wolters Kluwer)


• Pazopanib Professional Patient Advice (Wolters Kluwer)

Compare Votrient with other medications

• Renal Cell Carcinoma

Glucotrol

Pronunciation: GLIP-i-zide
Generic Name: Glipizide
Brand Name: Glucotrol

Glucotrol is used for:

Treating type 2 diabetes in patients who cannot control blood sugar levels by diet and exercise alone. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Glucotrol is a sulfonylurea antidiabetic medicine. It works by causing the pancreas to release insulin, which helps to lower blood sugar.

Do NOT use Glucotrol if:

• you are allergic to any ingredient in Glucotrol


• you have certain severe problems associated with diabetes (eg, diabetic ketoacidosis, diabetic coma)


• you have very high blood acid levels (acidosis)


• you have type 1 diabetes


• you are pregnant and are within 1 month of the expected delivery date

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

Before using Glucotrol:

Some medical conditions may interact with Glucotrol. 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 had a severe allergic reaction (eg, a severe rash, hives, breathing difficulties, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), probenecid, sulfamethoxazole, valdecoxib, or zonisamide


• if you have a history of liver, kidney, thyroid, or heart problems; high blood acid levels (acidosis) or diabetic ketoacidosis; certain hormonal problems (eg, adrenal or pituitary problems, syndrome of inappropriate antidiuretic hormone secretion [SIADH]); or low blood sodium levels


• if you have stomach or bowel problems (eg, stomach or bowel narrowing or blockage, stomach paralysis), or you drink alcohol or have a history of alcohol abuse


• if you have poor health or nutrition, fever, an infection, moderate to severe burns, a recent injury, or severe diarrhea


• if you or a family member have a condition called glucose-6-phosphate dehydrogenase (G6PD) deficiency


• if you will be having surgery

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

• Beta-blockers (eg, propranolol) because the risk of low blood sugar may be increased. They may also hide certain signs of low blood sugar and make it more difficult to notice


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), azole antifungals (eg, miconazole, ketoconazole), chloramphenicol, clofibrate, fenfluramine, insulin, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), phenylbutazone, probenecid, quinolone antibiotics (eg, ciprofloxacin), salicylates (eg, aspirin), or sulfonamides (eg, sulfamethoxazole) because the risk of low blood sugar may be increased


• Calcium channel blockers (eg, diltiazem), corticosteroids (eg, prednisone), decongestants (eg, pseudoephedrine), diazoxide, diuretics (eg, furosemide, hydrochlorothiazide), estrogens, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, promethazine), phenytoin, rifamycins (eg, rifampin), sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid supplements (eg, levothyroxine) because they may decrease Glucotrol's effectiveness, resulting in high blood sugar


• Gemfibrozil because blood sugar may be increased or decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Glucotrol 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 Glucotrol:

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

• Take Glucotrol by mouth 30 minutes before a meal as directed by your doctor.


• If you are taking 1 dose daily, take Glucotrol 30 minutes before breakfast or the first main meal of the day unless your doctor tells you otherwise.


• Glucotrol works best if it is taken at the same time each day.


• Continue to take Glucotrol even if you feel well. Do not miss any doses.


• If you miss a dose of Glucotrol, 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 Glucotrol.

Important safety information:

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


• Check with your doctor before you drink alcohol while you are taking Glucotrol. Alcohol may increase the risk of low blood sugar. Rarely, alcohol may interact with Glucotrol and cause a serious reaction with symptoms such as flushing, nausea, vomiting, dizziness, or stomach pain. Discuss any questions or concerns with your doctor.


• Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Glucotrol exactly as prescribed, tell your doctor.


• Proper diet, regular exercise, and regular blood sugar testing are important for best results with Glucotrol. Follow the diet and exercise program given to you by your health care provider.


• It may be harder to control your blood sugar during times of stress, such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.


• Glucotrol may cause low blood sugar levels. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.


• Risk of low blood sugar may be increased by severe or prolonged exercise, drinking alcohol, or skipping meals.


• Glucotrol is a sulfonylurea. It may increase the risk of death from heart disease. Talk with your doctor about the benefits and risks of this or other therapies to treat your condition.


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


• Glucotrol should not be used by itself to treat type 1 diabetes. If you have questions about using Glucotrol to treat type 1 diabetes, talk with your doctor.


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


• Lab tests, including fasting blood glucose, hemoglobin A_1c, and liver function, may be performed while you take Glucotrol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Glucotrol with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sugar levels. Low blood sugar levels may also be more difficult to recognize in the elderly.


• Glucotrol 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 taking Glucotrol while you are pregnant. Glucotrol should not be taken if you are within 1 month of the expected delivery date because it may cause low blood sugar in the baby. It is not known if Glucotrol is found in breast milk. Do not breast-feed while taking Glucotrol.

When used for long periods of time, Glucotrol may not work as well. If your blood sugar has been under control and then becomes hard to manage, contact your doctor. Do not change the dose of your medicine without checking with your doctor.

Possible side effects of Glucotrol:

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:

Diarrhea; dizziness; drowsiness; headache; nausea.

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; skin redness; dizziness); confusion; fainting; fever, chills, or persistent sore throat; irregular heartbeat; low blood sugar symptoms (eg, anxiety; fast heartbeat; light-headedness; severe or persistent dizziness, drowsiness, or headache; tremors; unusual sweating; weakness); severe or persistent blurred vision or other vision problems; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the eyes or skin); unusual bruising or bleeding; unusual stomach or back pain; unusual tiredness or 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: Glucotrol 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 coma; confusion; fainting; fast heartbeat; lethargy; light-headedness; seizures; severe dizziness or drowsiness; tremor; unusual sweating.

Proper storage of Glucotrol:

Store Glucotrol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Glucotrol out of the reach of children and away from pets.

General information:

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


• Glucotrol 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 Glucotrol. 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 Glucotrol resources

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

• Glucotrol Consumer Overview


• Glucotrol Prescribing Information (FDA)


• Glucotrol Advanced Consumer (Micromedex) - Includes Dosage Information


• Glipizide Prescribing Information (FDA)


• Glipizide Professional Patient Advice (Wolters Kluwer)


• Glipizide Monograph (AHFS DI)


• Glipizide XL Prescribing Information (FDA)


• Glucotrol XL Prescribing Information (FDA)

Compare Glucotrol with other medications

• Diabetes, Type 2

Alomide Allergy 0.1% eye drops, Solution

1. Name Of The Medicinal Product

Alomide Allergy 0.1% Eye Drops, Solution

2. Qualitative And Quantitative Composition

Each ml contains 0.1% w/v lodoxamide (as 0.178% w/v lodoxamide trometamol)

For excipients, see section 6.1

3. Pharmaceutical Form

Eye Drops, Solution

A clear, colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

ALOMIDE is indicated in the treatment of the ocular signs and symptoms of allergic conjunctivitis

4.2 Posology And Method Of Administration

Adults and children (4 years and above): one or two drops in each eye four times a day at regular intervals.

ALOMIDE therapy is dependent upon its administration at regular intervals, as directed.

ALOMIDE therapy should not be used for more than 4 weeks without seeking medical advice.

Improvements in signs and symptoms in response to ALOMIDE therapy (decreased discomfort, itching, foreign body sensation, photophobia, acute ocular pain, tearing, discharge, erythema/swelling, conjunctival redness, limbal reaction, epithelial disease, ptosis) are usually evident within a few days, but longer treatment for up to four weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

Instillation of eye drops in allergic conjunctivitis may cause discomfort initially and that this will decline with improvement of the disease (see 4.8 Undesirable Effects).

Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.

Children less than 4 years: The safety and effectiveness of ALOMIDE in children below the age of four years have not been established.

Elderly: There are no special precautions to be followed in prescribing ALOMIDE for the elderly.

If required, corticosteroids may be used concomitantly with ALOMIDE.

4.3 Contraindications

ALOMIDE is contraindicated in those persons who have a known hypersensitivity to lodoxamide or any of the excipients.

4.4 Special Warnings And Precautions For Use

• ALOMIDE is not for injection.

• The recommended frequency of administration should not be exceeded.

• Patients should be advised that instillation of eye drops may initially cause discomfort or transient burning or stinging (see section 4.8). Should these symptoms persist, the patient should be advised to contact the prescribing physician

• ALOMIDE contains benzalkonium chloride, a preservative that may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of ALOMIDE and wait at least 15 minutes before reinsertion.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

4.6 Pregnancy And Lactation

Pregnancy

There are no or limited amount of data from the use of ALOMIDE in pregnant-women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of ALOMIDE during pregnancy.

Lactation

It is not known whether lodoxamide is excreted in human milk. There is insufficient information on the excretion of lodoxamide from ALOMIDE in animal milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ALOMIDE therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

4.7 Effects On Ability To Drive And Use Machines

Lodoxamide has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision or visual disturbances occur, the patient must wait until the vision is clear before driving or using machinery.

4.8 Undesirable Effects

a. Summary of the safety profile

In clinical trials, the most common adverse reaction was ocular discomfort.

b. Tabulated list of adverse reactions

The following adverse reactions are classified according to the following convention: very common (

System Organ Classification	MedDRA Preferred Term (v.12.1)
Nervous system disorders	Uncommon: dizziness, headache Rare: somnolence, dysgeusia
Eye disorders	Very common: ocular discomfort Common: vision blurred, dry eye, eye pruritus, lacrimation increased, ocular hyperaemia Uncommon: eye pain, eye oedema, asthenopia, corneal deposits, conjunctival oedema, abnormal sensation in eye, foreign body sensation in eyes, eye discharge, eye irritation Rare: corneal erosion, corneal scar, corneal abrasion, anterior chamber cell, corneal epithelium defect, keratitis, blepharitis, eye allergy, visual impairment, eyelid oedema, conjunctival disorder
Cardiac disorders	Not known: palpitations
Respiratory, thoracic and mediastinal disorders	Rare: nasal dryness, sneezing
Gastrointestinal disorders	Uncommon: nausea Rare: abdominal discomfort
Skin and subcutaneous tissue disorders	Uncommon: eyelid exfoliation Rare: rash
General disorders and administration site conditions	Uncommon: feeling hot

4.9 Overdose

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product.

In the event of a topical overdose, flush from the eye with lukewarm water. .

In case of accidental ingestion of doses of 0.1 mg to 10.0 mg of lodoxamide, the following side adverse effects may occur: feeling of warmth, flushing, nausea, vomiting, diaphoresis and abdominal cramping. Transient elevations of systolic and diastolic blood pressure have been noted with doses of 3.0 and 10.0 mg of oral lodoxamide, but they resolve spontaneously after a short time. Other possible adverse effects after an oral overdose are: headache, dizziness, fatigue and loose stools.

If accidentally ingested, efforts to decrease further absorption may be appropriate.

Lavage, if the overdose has been taken within 1 hour or treatment with activated charcoal should be considered.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Lodoxamide, a mast cell stabiliser inhibits the in vivo Type I immediate hypersensitivity reaction in animals and man.

In vitro studies have demonstrated the ability of lodoxamide to stabilise mast cells and prevent the antigen specific induced release of histamine. In addition, lodoxamide prevents the release of other mast cell inflammatory mediators (i.e. SRS-A, slow reacting substances of anaphylaxis also known as the peptido-leukotrienes). Lodoxamide inhibits histamine release in vitro by preventing the movement of calcium into the mast cell after stimulation.

5.2 Pharmacokinetic Properties

The oral bioavailability of ¹⁴C-lodoxamide in man is 71%, approximately 87% of the absorbed drug undergoes bio transformation. The metabolic transformation of lodoxamide results from stepwise hydrolysis of the oxylamide groups to form the monoxamate and the diamine. The diamine undergoes further hydroxylation followed by conjugation to either the O-glucuronide or O-sulphate. The O-glucuronide and O-sulphate metabolites account for 79% of the biotransformed lodoxamide, with the monoxamate and diamine accounting for 5% and 3% of the excreted metabolites. Only 2.7% of the absorbed dose is recovered as unchanged drug in the urine

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which were additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium chloride

Mannitol

Hypromellose

Sodium citrate

Citric acid

Disodium edetate;

Tyloxapol

Sodium hydroxide for pH adjustment and/or

Hydrochloric acid for pH adjustment

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

The contents and bottle should be discarded one month after opening the container for the first time.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

ALOMIDE is supplied in 5 mL, natural, low-density polyethylene bottles with natural, low density polyethylene dispensing plugs and tamper evident polypropylene screw caps.

6.6 Special Precautions For Disposal And Other Handling

The dispensing tip should not be touched with the fingers or by the conjunctiva when drops are instilled. The container should be kept tightly closed.

7. Marketing Authorisation Holder

Alcon Laboratories (UK) Ltd

Pentagon Park

Boundary Way

Hemel Hempstead

Herts

HP2 7UD

United Kingdom

8. Marketing Authorisation Number(S)

PL 00649/0159

9. Date Of First Authorisation/Renewal Of The Authorisation

12/10/2006

10. Date Of Revision Of The Text

8 November 2010

Salbutamol Tablets 2mg

Due to technical difficulties in printing the label-leaflet format, please find the relevant text below. Text is representative of the leaflet portion of label-leaflet spec no 50404943.

Salbutamol 2mg tablets

Salbutamol sulphate

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Index

• 1. What Salbutamol tablets are and what they are used for


• 2. Before you take


• 3. How to take


• 4. Possible side effects


• 5. How to store


• 6. Further information

What Salbutamol tablets are and what they are used for

Salbutamol tablets belong to a group of medicines called selective beta-2-androgenic agonists, which can be used to relax the muscles of the airways and womb. Salbutamol tablets may be used in:

• asthma, to relieve the narrowing of the airways


• chronic bronchitis


• emphysema


• the prevention of premature labour.

Before you take

Do not take Salbutamol tablets and tell your doctor if you:

• are allergic (hypersensitive) to salbutamol or any other ingredients in Salbutamol tablets (see section 6)


• have threatened abortion (potential miscarriage) during the first six months of pregnancy


• are taking beta-blockers such as propranolol

Check with your doctor or pharmacist before taking Salbutamol tablets if you have:

• an overactive thyroid gland (thyrotoxicosis).


• diabetes.


• a history of heart disease, irregular heart rhythm or angina.
  
  
  Although it is not known exactly how often this happens, some people occasionally experience chest pain (due to heart problems such as angina). Tell your doctor/midwife if you develop these symptoms whilst receiving treatment with salbutamol, but do not stop using this medicine unless told to do so.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

• guanethidine, reserpine or methyldopa (to treat high blood pressure)


• monoamine oxidase inhibitors e.g. tranylcypromine (for depression)


• tricyclic antidepressants e.g. amitriptyline (for depression)


• beta-blockers such as propranolol


• corticosteroids


• theophylline (for breathing problems).

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding tell your doctor or pharmacist before taking this medicine.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a sugar called lactose.

Ingredients warning

Salbutamol tablets contain carmoisine (EI22) which may cause allergic reactions.

Tests

If you have severe asthma, your doctor may monitor you more closely by carrying out certain tests.

How to take

Always take Salbutamol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with water

If you notice the tablets are not working as well as before, contact your doctor for advice.

• Adults:
  
  
  Usual dose is 4mg three or four times a day. Your doctor may increase this gradually up to a maximum of 8mg three or four times a day. Some patients may be treated successfully with 2mg three or four times a day.



• Elderly or patients known to be sensitive to this product or other similar drugs:
  
  
  Initially 2mg three or four times a day should be given.



• Children 2-6 years:
  
  
  1-2mg three or four times a day.



• Children 6-12 years:
  
  
  2mg three or four times a day.



• Children over 12 years:
  
  
  2-4mg three or four times a day.



• Children under 2 years:
  
  
  Not recommended.



• Premature labour:
  
  
  The maintenance dose is 4mg three or four times a day.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include low levels of potassium in the blood which may cause muscle twitching or weakness and an irregular heart beat.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

Possible side effects

Like all medicines, Salbutamol tablets can cause side effects, although not everybody gets them.

Tell your doctor if you notice any of the following effects, they get worse or if you notice any not listed:

• an allergic reaction (hypersensitivity): swelling of the face, lips, throat or tongue, pale or red irregular raised patches with severe itching (hives), difficulty breathing, low blood pressure, collapse.


• increased lactic acid in the body: rapid breathing, being sick, stomach pain.


• low blood potassium: muscle twitching or weakness, an irregular heart beat.


• other: headaches, increased blood sugar levels, slight shaking (usually of the hands), a tense feeling, widening of blood vessels which can cause an increase in heart function and heart rate, an irregular heart beat, muscle spasm, fluid on the lungs. An increase in the amount of acid in the body (ketoacidosis) may occur in diabetics.

How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place.

Do not use Salbutamol tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Salbutamol tablets contain

• The active substance (the ingredient that makes the tablets work) is salbutamol sulphate. Each tablet contains 2.4mg of the active ingredient equivalent to 2mg salbutamol.



• The other ingredients are maize starch, lactose monohydrate, dispersed pink (erythrosine (E127), carmoisine (E122), titanium dioxide (E171), sodium starch glycollate, talc, magnesium stearate.

What Salbutamol tablets look like and contents of the pack

Salbutamol tablets are pink, circular, flat bevelled edge, uncoated tablets.

Pack size is 28.

Marketing Authorisation Holder and Manufacturer

Actavis

Barnstaple

EX32 8NS

UK

This leaflet was last revised in April 2010.

procaine penicillin

Generic Name: procaine penicillin (PRO kane PEN i SIL in)

Brand Names: Wycillin

What is procaine penicillin ?

Procaine penicillin is an antibiotic that fights bacteria in your body.

Procaine penicillin is used to treat many different types of infections caused by bacteria, including syphilis (a sexually transmitted disease).

Do not use this medication for any other infection that has not been checked by your doctor.

Procaine penicillin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about procaine penicillin ?

You should not use this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceftin, Cefzil, Omnicef, Keflex, and others.

Before using procaine penicillin, tell your doctor if you have asthma or a history of allergies, or kidney disease.

Do not inject this medication into a vein or life-threatening side effects may result.

Use this medication for the full prescribed length of time. Call your doctor if your infection does not improve, or if it gets worse while using procaine penicillin.

Tell your doctor about all other medications you use, especially gout medication, a blood thinner, a diuretic, a tetracycline antibiotic, or a non-steroidal anti-inflammatory drug (NSAID).

Procaine penicillin can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using procaine penicillin. Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

After you have finished your treatment with procaine penicillin, your doctor may want to do tests to make sure your infection has completely cleared up.

What should I discuss with my health care provider before using procaine penicillin ?

You should not use this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceclor, Ceftin, Duricef, Keflex, Lorabid, Omnicef, Spectracef, and others.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use procaine penicillin:

• 
  

  asthma or a history of allergies; or

  
  


• kidney disease.

FDA pregnancy category B. Procaine penicillin is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Procaine penicillin can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using procaine penicillin. Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Procaine penicillin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use procaine penicillin?

Procaine penicillin is given as an injection into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Procaine penicillin must be injected slowly into a muscle of the buttock or upper thigh.

Do not inject the medication into a vein or life-threatening side effects could result.

Your procaine penicillin injections should be given at evenly spaced intervals.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Procaine penicillin will not treat a viral infection such as the common cold or flu.

Call your doctor if your infection does not improve, or if it gets worse while using procaine penicillin.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

This medication can cause you to have unusual results with certain lab tests, including tests to check for glucose (sugar) in the urine. Tell any doctor who treats you that you are using procaine penicillin.

After you have finished your treatment with procaine penicillin, your doctor may want to do tests to make sure your infection has completely cleared up.

Store this medication in the refrigerator. Do not freeze. Do not use the mixed medication if it has changed colors or has any particles in it.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include mood changes, agitation, confusion, and seizure (convulsions).

What should I avoid while using procaine penicillin?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, stop using this medication and call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Do not receive a "live" vaccine such as typhoid vaccine, cholera vaccine, or BCG (Bacillus Calmette and Guérin) vaccine.

Procaine penicillin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  diarrhea that is watery or bloody;

  
  


• 
  

  peeling skin , severe pain, or changes in skin color where the medicine was injected;

  
  


• 
  

  dizziness, joint or muscle pain;

  
  


• 
  

  fast or pounding heartbeats;

  
  


• 
  

  numbness, tingling, pain, swelling, or redness in your arms or legs;

  
  


• 
  

  confusion, agitation, depression, unusual thoughts or behavior;

  
  


• 
  

  chest pain, problems with vision or speech;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  fever, chills, dizziness, muscle pain, rapid breathing or heart rate;

  
  


• 
  

  uncontrolled muscle movements, problems with balance or walking;

  
  


• 
  

  pale skin, easy bruising or bleeding, unusual weakness;

  
  


• 
  

  sore throat, flu symptoms;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  rash or itching with swollen glands, joint pain, or general ill feeling; or

  
  


• 
  

  slow heart rate, weak pulse, fainting, slow breathing.

  
  

Less serious side effects may include:

• 
  

  pain where the injection was given;

  
  


• 
  

  vaginal itching or discharge;

  
  


• 
  

  white patches in your mouth or throat;

  
  


• 
  

  nausea, vomiting;

  
  


• 
  

  blurred vision, ringing in your ears;

  
  


• 
  

  headache, dizziness; or

  
  


• 
  

  mild skin rash,

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Procaine penicillin Dosing Information

Usual Adult Dose for Skin or Soft Tissue Infection:

Moderately severe to severe infections due to susceptible group A streptococci: 600,000 to 1,000,000 units/day IM for at least 10 days

Usual Adult Dose for Upper Respiratory Tract Infection:

Moderately severe to severe infections due to susceptible group A streptococci: 600,000 to 1,000,000 units/day IM for at least 10 days

Usual Adult Dose for Tonsillitis/Pharyngitis:

Moderately severe to severe infections due to susceptible group A streptococci: 600,000 to 1,000,000 units/day IM for at least 10 days

Usual Adult Dose for Streptococcal Infection:

Erysipelas, scarlet fever:
Moderately severe to severe infections due to susceptible group A streptococci: 600,000 to 1,000,000 units/day IM for at least 10 days

Usual Adult Dose for Pneumonia:

Moderately severe (uncomplicated) infections due to susceptible pneumococci: 600,000 to 1,000,000 units/day IM

Usual Adult Dose for Bacterial Infection:

Moderately severe to severe infections due to susceptible staphylococci and uncomplicated infections due to Erysipelothrix rhusiopathiae: 600,000 to 1,000,000 units/day IM

Bejel, pinta, and yaws: The usual treatment is the same as for syphilis in the corresponding stage of disease.

Usual Adult Dose for Anthrax Prophylaxis:

1.2 million units IM every 12 hours

Duration: Anthrax prophylaxis should continue for 60 days. Safety of procaine penicillin has not been established for more than 2 weeks of use. Consider an alternate treatment beyond 2 weeks.

Usual Adult Dose for Cutaneous Bacillus anthracis:

600,000 to 1,000,000 units/day IM

Although 5 to 10 days of treatment may be adequate for mild, uncomplicated cutaneous anthrax (naturally occurring or endemic exposures), the Centers for Disease Control and Prevention (CDC) recommend continuing therapy for 60 days if cutaneous anthrax occurs as a result of exposure to aerosolized Bacillus anthracis spores.

Usual Adult Dose for Neurosyphilis:

600,000 units/day IM for 10 to 15 days
Total dose: 6 to 9 million units

If compliance can be ensured, the CDC recommends: Procaine penicillin 2.4 million units IM once a day plus probenecid 500 mg orally 4 times a day for 10 to 14 days; may follow with penicillin G benzathine 2.4 million units IM once a week for up to 3 weeks

IV penicillin G is the recommended regimen for the treatment of neurosyphilis. All patients should undergo clinical and serological testing every 6 months for 2 to 3 years.

Usual Adult Dose for Tertiary Syphilis:

600,000 units/day IM for 10 to 15 days
Total dose: 6 to 9 million units

All patients should undergo clinical and serological testing every 6 months for 2 to 3 years.

Usual Adult Dose for Syphilis -- Latent:

Latent with a negative spinal fluid: 600,000 units/day IM for 8 days
Total dose: 4,800,000 units

Latent with positive or no spinal fluid examination: 600,000 units/day IM for 10 to 15 days
Total dose: 6 to 9 million units

The CDC recommends penicillin G benzathine as the drug of choice for the treatment of latent syphilis. All patients should undergo clinical and serological testing every 6 months for 2 to 3 years.

Usual Adult Dose for Syphilis -- Early:

Primary and secondary: 600,000 units/day IM for 8 days
Total dose: 4,800,000 units

The CDC recommends penicillin G benzathine as the drug of choice for the treatment of primary or secondary syphilis. All patients should undergo clinical and serological testing every 6 months for 2 to 3 years.

Usual Adult Dose for Diphtheria:

Adjunctive therapy with antitoxin: 300,000 to 600,000 units/day IM for 14 days; the CDC recommends 300,000 units/day IM for patients weighing 10 kg or less and 600,000 units/day IM for patients weighing more than 10 kg

Patients usually are not contagious 48 hours after starting therapy. Two consecutive negative cultures after treatment is completed should be obtained to confirm eradication of the organism.

Carrier state: 300,000 units/day IM

Follow-up cultures at least 2 weeks after treatment is completed are recommended. If positive, erythromycin and additional follow-up cultures are recommended.

Usual Adult Dose for Fusospirochetosis:

600,000 to 1,000,000 units/day IM

Usual Adult Dose for Rat-bite Fever:

600,000 to 1,000,000 units/day IM

Usual Adult Dose for Endocarditis:

Only in extremely sensitive infections: 600,000 to 1,000,000 units/day IM

Usual Pediatric Dose for Bacterial Infection:

The American Academy of Pediatrics (AAP) recommends 50,000 units/kg IM once a day for neonates and 25,000 to 50,000 units/kg/day IM in 1 or 2 divided doses (maximum adult dose 4.8 million units/day) for children older than 1 month of age.

Moderately severe to severe infections due to susceptible staphylococci in patients weighing less than 27 kg: 300,000 units/day IM

Usual Pediatric Dose for Streptococcal Infection:

Moderately severe to severe infections due to susceptible group A streptococci in patients weighing less than 27 kg: 300,000 units/day IM

Usual Pediatric Dose for Pneumonia:

Moderately severe (uncomplicated) infections due to susceptible pneumococci in patients weighing less than 27 kg: 300,000 units/day IM

Usual Pediatric Dose for Anthrax Prophylaxis:

25,000 units/kg IM every 12 hours

Duration: Anthrax prophylaxis should continue for 60 days. Safety of procaine penicillin has not been established for more than 2 weeks of use. Consider an alternate treatment beyond 2 weeks.

Usual Pediatric Dose for Congenital Syphilis:

Less than 32 kg: 50,000 units/day IM for 10 days

The CDC and AAP recommend readministration of the entire course of therapy if more than 1 day is missed.

Usual Pediatric Dose for Neurosyphilis:

Greater than 12 years: 600,000 units/day IM for 10 to 15 days
Total dose: 6 to 9 million units

If compliance can be ensured, the CDC recommends: Procaine penicillin 2.4 million units IM once a day plus probenecid 500 mg orally 4 times a day for 10 to 14 days; may follow with penicillin G benzathine 2.4 million units IM once a week for up to 3 weeks

IV penicillin G is the recommended regimen for the treatment of neurosyphilis. All patients should undergo clinical and serological testing every 6 months for 2 to 3 years.

Usual Pediatric Dose for Tertiary Syphilis:

Greater than 12 years: 600,000 units/day IM for 10 to 15 days
Total dose: 6 to 9 million units

All patients should undergo clinical and serological testing every 6 months for 2 to 3 years.

Usual Pediatric Dose for Syphilis -- Latent:

Greater than 12 years:
Latent with a negative spinal fluid: 600,000 units/day IM for 8 days
Total dose: 4,800,000 units

Latent with positive or no spinal fluid examination: 600,000 units/day IM for 10 to 15 days
Total dose: 6 to 9 million units

The CDC recommends penicillin G benzathine as the drug of choice for the treatment of latent syphilis. All patients should undergo clinical and serological testing every 6 months for 2 to 3 years.

Usual Pediatric Dose for Syphilis -- Early:

Greater than 12 years:
Primary and secondary: 600,000 units/day IM for 8 days
Total dose: 4,800,000 units

The CDC recommends penicillin G benzathine as the drug of choice for the treatment of primary or secondary syphilis. All patients should undergo clinical and serological testing every 6 months for 2 to 3 years.

Usual Pediatric Dose for Diphtheria:

Adjunctive therapy with antitoxin: The CDC recommends 300,000 units/day IM for patients weighing 10 kg or less and 600,000 units/day IM for patients weighing more than 10 kg. The AAP recommends 25,000 to 50,000 units/kg/day in 2 divided for 14 days with a maximum dose of 1.2 million units per day.

Patients usually are not contagious 48 hours after starting therapy. Two consecutive negative cultures after treatment is completed should be obtained to confirm eradication of the organism.

What other drugs will affect procaine penicillin?

Tell your doctor about all other medications you use, especially:

• 
  

  probenecid (Benemid);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor HCT, Vasoretic, Zestoretic), and others;

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  a tetracycline antibiotic, such as demeclocycline (Declomycin, Ledermycin), doxycycline (Adoxa, Doryx, Vibramycin, Periostat), minocycline (Minocin), or tetracycline (Broadspec, Panmycin, Sumycin); or

  
  


• 
  

  NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), naproxen (Aleve, Naprosyn), meloxicam (Mobic), piroxicam (Feldene), and others.

  
  

This list is not complete and there may be other drugs that can interact with procaine penicillin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More procaine penicillin resources

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

Compare procaine penicillin with other medications

• Anthrax Prophylaxis
• Bacterial Infection
• Congenital Syphilis
• Cutaneous Bacillus anthracis
• Diphtheria
• Endocarditis
• Fusospirochetosis, Trench Mouth
• Neurosyphilis
• Pneumonia
• Rat-bite Fever
• Skin Infection
• Streptococcal Infection
• Syphilis, Early
• Syphilis, Latent
• Tertiary Syphilis
• Tonsillitis/Pharyngitis
• Upper Respiratory Tract Infection

Where can I get more information?

• Your doctor or pharmacist can provide more information about procaine penicillin.

See also: procaine penicillin side effects (in more detail)

Diurexan 20mg Tablets

Diurexan 20 mg tablets

Xipamide

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.



• If you have any further questions, ask your doctor or pharmacist.



• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In this leaflet:

• 1. What Diurexan is for



• 2. Before you take Diurexan



• 3. How to take Diurexan



• 4. Possible side effects



• 5. How to store Diurexan



• 6. Further information

What Diurexan is for

Diurexan belongs to the group of medicines known as diuretics. Diuretics are often referred to as water tablets.

Diurexan removes excess water from the body by increasing how often you urinate. It is used to treat high blood pressure (hypertension) and too much fluid in the body (oedema), often caused by heart failure or problems with your liver or kidneys.

Before you use Diurexan

Do not take Diurexan if:

• You are allergic to Xipamide



• You are allergic to any of the other ingredients of Diurexan (listed in section 6)



• You have low levels of salts in your blood sometimes caused by severe vomiting or diarrhoea



• You have liver disease that is causing you to become unconscious



• You have severe kidney disease



• You have untreated Addison’s disease – a condition in which your adrenal glands do not produce sufficient levels of natural steroid in the blood



• You are less than 4 months’ pregnant.

If any of the above applies to you, talk to your doctor or pharmacist.

Check with your doctor before taking Diurexan if:

• You have gout or have too much uric acid in your urine



• You have diabetes



• You have kidney or liver disease



• You have an enlarged prostate gland or trouble urinating



• You suffer with coronary or cerebral arteriosclerosis (narrowing of the arteries in the heart or brain)



• Your body produces too much aldosterone, a hormone which controls salt and water balance (hyperaldosteronism)



• You have diarrhoea



• You are malnourished (a severe lack of food)



• You are being sick



• You are over 65 years of age.

Tell your doctor if you are taking any of the following medicines:

• Medicines for high blood pressure



• Medicines called cardiac glycosides such as digoxin for heart problems



• Insulin or tablets for diabetes



• Lithium.

Taking these Diurexan at the same time as these medicines may lead to your doctor adjusting the dose you require.

Also tell your doctor if you are taking:

• Steroids used to treat many conditions including asthma, arthritis, eczema and dermatitis



• ACTH which is mainly used to test if your pituitary gland is working properly



• Carbenoxolone used to treat stomach ulcers and inflammation of the oesophagus



• Amphotericin used to treat fungal and bacterial infections



• Laxatives.

These medicines may cause the level of potassium in your blood to fall when used at the same time as Diurexan.

Tell your doctor or pharmacist if you are taking any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breastfeeding ask your doctor or pharmacist for advice before taking Diurexan.

How to take Diurexan

Always take Diurexan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.

For high blood pressure:

The usual dose is one tablet per day, taken early in the morning.

For excessive fluid retention:

The usual starting dose is two tablets per day, taken early in the morning.

Once your doctor has seen how the medicine is working, they may change your dose. They may reduce it to one tablet per day. If the medicine is not having much effect, your doctor may increase your dose to 3 or 4 tablets per day.

Medical check-ups

Taking Diurexan for a long time can cause you to lose potassium from your blood. Your doctor will check for this and may prescribe you extra potassium especially if you are elderly or getting little potassium in your diet.

If you take more Diurexan than you should

If you accidentally take too much Diurexan immediately go to the nearest hospital casaulty department or your doctor. An overdose may cause the loss of too much fluid from your body.

This can cause hypotension, making you feel faint and change the make-up of your blood.

You may have your stomach washed out and an infusion into your vein to replace lost fluids.

If you forget to take Diurexan

Do not take a double dose to make up for a missed dose. Simply take your dose as planned.

If you have any further questions on the use of this product, ask your doctor or pharmacist

Possible side effects

Like all medicines, Diurexan can cause side effects, although not everybody gets them.

These may include:

• Slight dizziness



• Effects on your stomach or intestine such as stomach pain, constipation and diarrhoea



• Low potassium and sodium levels in blood (hypokalaemia and hyponatraemia respectively) which may cause headaches, muscle cramps and weakness.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Diurexan

Keep out of the reach and sight of children.

Do not use Diurexan after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

Further information

What Diurexan contains

The active substance is xipamide. Each tablet contains 20 mg of xipamide.

The other ingredients are maize starch, mannitol, cellulose powder, colloidal silicon dioxide, magnesium stearate and purified water.

What Diurexan looks like

Diurexan tablets are white and round with a notch on one side and an "A" on the other. They are about 6 mm in diameter. They come in blister strips strips of 14 tablets with 10 blister strips in a box.

Marketing Authorisation Holder is:

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford

CM22 6PU

United Kingdom

Manufacturer is:

Sidefarma, S.A.

Rua da Guiné, n^º 26

2689-514 Prior Velho

PORTUGAL

This leaflet was last updated on September 2008

If this leaflet is difficult to see or read and you would like it in a different format, please contact

Meda Pharmaceuticals

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford

CM22 6PU

United Kingdom

Metanium Nappy Rash Ointment

1. Name Of The Medicinal Product

Metanium Ointment

Metanium Nappy Rash Ointment

2. Qualitative And Quantitative Composition

Titanium Dioxide	20.0% w/w
Titanium Peroxide	5.0% w/w
Titanium Salicylate	3.0% w/w

3. Pharmaceutical Form

Ointment for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

As a treatment for nappy rash

4.2 Posology And Method Of Administration

Posology:

Topical.

Adults:

Not applicable.

Elderly:

Not applicable.

Children:

Dab a small amount of Metanium over the sore area. Spread the ointment thinly so the skin texture can be clearly seen through it. Repeat at each nappy change.

4.3 Contraindications

Hypersensitivity to the drug formulation.

4.4 Special Warnings And Precautions For Use

If no response occurs, or the condition worsens, consult your doctor.

For external use only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not known.

4.6 Pregnancy And Lactation

Not known.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Rarely: skin irritations.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The combination of titanium salts with a water repellent siliconised base forms a tenacious non-occlusive film on the skin which protects against irritation and repeated hydration.

5.2 Pharmacokinetic Properties

Metanium is indicated for topical use and has an action similar to zinc oxide preparations.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Dimethicone 350

Light Liquid Paraffin

Tincture of Benzoin

White Soft Paraffin.

6.2 Incompatibilities

Not known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium collapsible tube with membrane seal and spiked polypropylene cap.

Pack sizes: 25 g, 30 g.

6.6 Special Precautions For Disposal And Other Handling

No special precautions necessary.

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0366

9. Date Of First Authorisation/Renewal Of The Authorisation

30/04/02.

10. Date Of Revision Of The Text

8^th April 2010