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