Pronunciation: (ROE-zi-GLI-ta-zone MAL-ee-ate/met-FOR-min HYE-droe-KLOR-ide)
Class: Antidiabetic combination

Trade Names:
Avandamet
- Tablets rosiglitazone 2 mg/metformin 500 mg
- Tablets rosiglitazone 2 mg/metformin 1,000 mg
- Tablets rosiglitazone 4 mg/metformin 500 mg
- Tablets rosiglitazone 4 mg/metformin 1,000 mg

Pharmacology

Rosiglitazone

Increases insulin sensitivity.

Metformin

Decreases blood glucose by reducing hepatic glucose production, increases peripheral glucose uptake and utilization, and decreases intestinal absorption of glucose.

Pharmacokinetics

Special Populations

Renal Function Impairment

Plasma and blood half-life of metformin is prolonged and the renal Cl is decreased in proportion to the decrease in CrCl.

Hepatic Function Impairment

Cl of rosiglitzone was significantly lower in patients with moderate to severe liver disease and C _max and AUC _0-∞ were increased 2- and 3-fold, respectively.

Indications and Usage

As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with combination rosiglitazone and metformin is appropriate.

Contraindications

Patients with renal disease or renal function impairment that may also result from conditions such as CV collapse, acute MI, and septicemia; acute or chronic metabolic acidosis, with or without coma; known hypersensitivity to any component of the product; established New York Heart Association class III or IV heart failure; temporarily suspend treatment in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials.

Dosage and Administration

Base dosage selection of rosiglitazone and metformin on the patient’s current doses of rosiglitazone or metformin (max daily dose, rosiglitazone 8 mg/metformin 2,000 mg).

Patients Inadequately Controlled on Metformin Monotherapy
Adults

PO Start with rosiglitazone 4 mg daily plus the metformin dose already being taken. If prior therapy consists of metformin 1,000 mg/day, start with 2 mg/500 mg and administer 1 tablet twice daily. If prior therapy consists of metformin 2,000 mg/day, start with 2 mg/1,000 mg and administer 1 tablet twice daily.

Patients Inadequately Controlled on Rosiglitazone Monotherapy
Adults

PO Start with metformin 1,000 mg daily plus the rosiglitazone dose already being taken. If prior therapy consists of rosiglitazone 4 mg/day, start with 2 mg/500 mg and administer 1 tablet twice daily. If prior therapy consists of rosiglitazone 8 mg/day, start with 4 mg/500 mg and administer 1 tablet twice daily.

Switching from Separate Doses of Rosiglitazone and Metformin to Combination Therapy
Adults

PO Start with the doses of rosiglitazone and metformin already being taken. Increase the dose in increments of rosiglitazone 4 mg and/or metformin 500 mg up to the max recommended total daily dose of 8 mg/2,000 mg.

Drug-Naive Patients
Adults

PO Start with 2 mg/500 mg once or twice daily. Consider a starting dosage of 2 mg/500 mg twice daily for patients with glycosylated hemoglobin (HbA _1c ) more than 11% or fasting plasma glucose more than 270 mg/dL. Increase dose in increments of 2 mg/500 mg per day in divided doses if patient is not adequately controlled after 4 wk (max, 8 mg/2,000 mg per day).

Renal Function Impairment
Adults

PO Dosage adjustments should be based on careful assessment of renal function.

Hepatic Function Impairment
Adults

PO Do not initiate treatment in patients exhibiting evidence of active liver disease or increased serum transaminase levels (ALT more than 2.5 × ULN at the start of therapy).

Storage/Stability

Store at 59° to 86°F. Protect from light.

Drug Interactions

Alcohol

The effects of metformin on lactate metabolism may be potentiated.

Cationic drugs (eg, amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin)

Use with caution; may interact with metformin by competing for common renal tubular transport systems.

Cimetidine

Increased metformin plasma levels.

CYP2C8 inducers (eg, rifampin)

Rosiglitazone plasma concentrations may be reduced, decreasing the efficacy.

CYP2C8 inhibitors (eg, azole antifungal agents [ketoconazole], fluvoxamine, gemfibrozil, trimethoprim)

May elevate rosiglitazone plasma levels, increasing the pharmacologic effects and adverse reactions.

Drugs that cause hyperglycemia (eg, calcium channel blockers, corticosteroids, diuretics, estrogens, isoniazid, nicotinic acid, oral contraceptives, phenothiazines, phenytoin, sympathomimetics, thyroid products)

May lead to loss of glycemic control.

Drugs that cause hypoglycemia (eg, beta-adrenergic blockers, chloramphenicol, fluconazole, MAOIs, NSAIDs, probenecid, salicylates, sulfinpyrazone, sulfonamides, urine acidifiers)

May lead to loss of glycemic control.

Furosemide

Metformin plasma levels may be elevated while furosemide levels may be decreased.

Insulin

Risk of edema may be increased, even after several months of therapy.

Iodinated contrast material

May cause acute renal failure and has been associated with lactic acidosis in patients receiving metformin.

Nevirapine

Nevirapine plasma concentrations may be reduced, decreasing efficacy.

Nifedipine

Metformin plasma levels may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

CHF (postmarketing).

CNS

Headache (11%); dizziness (8%); fatigue (6%).

Dermatologic

Pruritus, rash, Stevens-Johnson syndrome, urticaria (postmarketing).

EENT

Nasopharyngitis (6%); decreased visual acuity, diabetic macular edema (postmarketing).

GI

Nausea/vomiting (16%); diarrhea (14%); dyspepsia (10%); abdominal pain, constipation, loose stools (5%).

Hematologic-Lymphatic

Anemia (7%); decreased Hgb and Hct.

Hepatic

Hepatic failure, hepatitis and hepatic enzyme elevations (postmarketing).

Metabolic-Nutritional

Hypoglycemia (12%); edema (6%).

Musculoskeletal

Arthralgia, back pain (5%).

Respiratory

Upper respiratory tract infection (16%); sinusitis (6%); pulmonary edema, pulmonary effusions (postmarketing).

Miscellaneous

Injury (8%); viral infection (5%); anaphylactic reaction, angioedema (postmarketing).

Precautions

Warnings CHF May occur or be exacerbated. Observe patients for signs and symptoms of heart failure after starting therapy or increasing the dose. Manage heart failure according to current standards of care. Consider discontinuation or dose reduction if signs or symptoms develop. Use of drug is not recommended in patients with symptomatic heart failure. Lactic acidosis Lactic acidosis is a rare but serious metabolic complication that can occur because of metformin accumulation during treatment with rosiglitazone/metformin. It is fatal in approximately 50% of cases. Myocardial ischemia Rosiglitazone is associated with an increased risk of myocardial ischemic events (eg, angina, MI). However, available data on the risk of myocardial ischemia are inconclusive.

Monitor Monitor all patients, especially those receiving rosiglitazone concurrently with a sulfonylurea or insulin and those at risk of heart failure or with mild to moderate heart failure, for signs and symptoms relating to fluid retention, including heart failure. Because the risk of metformin accumulation and lactic acidosis increases with the degree of renal function impairment, assess renal function before starting therapy and at least annually thereafter. Discontinue rosiglitazone/metformin if there is evidence of renal function impairment. Measure fasting blood glucose and HbA 1c periodically to monitor therapeutic response. Initial and periodic monitoring of liver enzymes, hematologic parameters, and renal function is recommended.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

In general, elderly patients are not titrated to the max dose because of age-related decreases in renal function.

Renal Function

Decreased renal function results in decreased renal Cl and prolongation of the metformin half-life. Concomitant medications that affect renal function may result in hemodynamic changes or interfere with disposition of metformin (eg, cationic drugs); use with caution. Avoid metformin in patients whose serum creatinine levels exceed the ULN for their age.

Hepatic Function

Avoid metformin in patients with clinical or laboratory evidence of hepatic disease.

Do not initiate therapy in patients with clinical evidence of active liver disease or baseline ALT more than 2.5 × ULN. Initiation or continuation of therapy in patients with ALT less than 2.5 × ULN should proceed with caution; discontinue therapy in these patients if ALT increases to more than 3 × ULN and persists.

Special Risk Patients

Do not titrate elderly, debilitated, and malnourished patients to the max dose. Use with caution in patients with edema; avoid use in patients with type 1 diabetes.

Bone fractures

Increased incidence of bone fractures has been noted in women taking rosiglitazone, but not men.

Change in clinical status

Promptly evaluate patients who develop laboratory abnormalities or clinical illness for evidence of ketoacidosis or lactic acidosis. Evaluate serum electrolytes and ketones, blood glucose, and, if indicated, blood pH, lactate, pyruvate, and metformin concentrations.

Coadministration with insulin

The addition of rosiglitazone to insulin therapy increased the risk of CHF and myocardial ischemia. Coadministration is not recommended.

Edema

Rosiglitazone may cause fluid retention; use with caution in patients with edema or those who are at risk of heart failure.

Hematologic

Dose-related decreases in HgB and Hct have been reported in patients taking rosiglitazone.

Hypoglycemia

Risk may be increased when used in combination with other hypoglycemic agents, necessitating dose reduction of concomitant therapy.

Hypoxic states

Immediately discontinue therapy in any condition characterized by hypoxemia (eg, acute CHF, MI).

Iodinated contrast materials

Withhold metformin therapy at the time of or prior to parenteral contrast studies with iodinated materials. Reinstitute therapy 48 h after the study and after renal function has been determined to be healthy.

Lactic acidosis

Can occur as a result of metformin accumulation (eg, renal function impairment) or in pathophysiologic conditions associated with tissue hypoperfusion and hypoxia. The risk of lactic acidosis increases with the degree of renal function impairment and the age of the patient.

Macular edema

Has been reported in postmarketing experience in patients taking rosiglitazone.

Ovulation

Rosiglitazone therapy may result in ovulation in some premenopausal anovulatory women, increasing the risk of pregnancy.

Surgical procedures

Treatment should be temporarily suspended for any surgical procedure, except minor procedures not associated with restricted intake of food and fluids, and should not be restarted until oral intake has resumed and renal function has been evaluated as normal.

Type 1 diabetes

Not indicated for use in patients with type 1 diabetes.

Vitamin B ₁₂ levels

Metformin may decrease vitamin B ₁₂ levels.

Weight gain

Dose-related weight gain was seen with rosiglitazone.

Overdosage

Symptoms

Lactic acidosis.

Patient Information

• Educate patient regarding diabetes and its management, including target ranges for blood sugar control. Instruct patient that medication is not a substitute for diet and exercise, and to continue to follow prescribed regimens.
• Educate patient or caregiver regarding potential long-term complications of diabetes and the need for regular physical and eye examinations.
• Advise patient to read patient information leaflet before starting therapy and with each refill.
• Advise patient to take dose once or twice daily, as prescribed, and to take with food to decrease GI distress.
• Advise patient that dose may be gradually increased every 2 wk until max benefit is obtained, but that it can take up to 2 to 3 mo for full benefit to be noted.
• Advise patient not to stop taking or change the dose unless advised by health care provider.
• Ensure that patient understands how to use home glucose monitor and has a plan for monitoring and recording blood sugar measurements (eg, log). Advise patient to take log to each visit with health care provider.
• Educate patient regarding value of periodic HbA _1c testing to confirm level of glucose control.
• Advise patient to discuss with health care provider a plan for managing each of the following situations: medication dosing during intercurrent conditions (eg, infection, sick days, stress, trauma, vomiting), accidental administration of too little or too much medication, missed dose, inadequate food intake or a skipped meal, travel across time zones, change in physical activity.
• Advise patient to carry medical identification (eg, bracelet, card) of diabetes.
• Caution patient to avoid excessive alcohol intake to reduce risk of metabolic acidosis.
• Instruct patient to report any of the following to health care provider immediately: abdominal pain, anorexia, dark urine, general body discomfort, fatigue, muscle aches, nausea, rapid weight gain, unexplained drowsiness, unexplained rapid breathing or shortness of breath, vomiting, yellowing of the skin or eyes.
• Review symptoms of hypoglycemia and hyperglycemia, and action plans to undertake in the event either occurs.
• Instruct patient to notify health care provider if experiencing hypoglycemic episodes or if measured blood sugar is outside target range.
• Caution premenopausal women that drug can cause resumption of ovulation in premenopausal anovulatory women with insulin resistance. Advise such women to discuss adequate contraceptive measures with health care provider.

Copyright © 2009 Wolters Kluwer Health.

Rosiglitazone/

Metformin

Generic Name: Rosiglitazone/Metformin (ROE-zi-GLI-ta-zone/met-FOR-min)
Brand Name: Avandamet

Rosiglitazone/Metformin is used for:

Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Rosiglitazone/Metformin is a thiazolidinedione and biguanide antidiabetic combination. It works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.

Do NOT use Rosiglitazone/Metformin if:

• you are allergic to any ingredient in Rosiglitazone/Metformin
• you have type 1 diabetes
• you have moderate to severe heart failure
• you have had a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (eg, diabetic ketoacidosis), or a type of diabetic eye problem (macular edema), or you are severely dehydrated
• you have had a stroke or a recent heart attack, or you are in shock
• you are 80 years old or more and have not had a kidney function test
• you will be having surgery or certain lab procedures
• you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone
• you are taking a nitrate (eg, nitroglycerin) or using insulin

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

Before using Rosiglitazone/Metformin:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of heart problems (eg, heart failure), abnormal liver function tests, lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, eye or vision problems, or lactic acidosis
• if you have fluid retention or swelling problems, vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B₁₂ levels, or anemia, or you are dehydrated
• if you have an infection, fever, recent injury, or moderate to severe burns
• if you drink alcohol or have a history of alcohol abuse
• if you will be having surgery or certain lab procedures
• if you are taking a beta-blocker (eg, propranolol)

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

• Insulin or nitrates (eg, nitroglycerin) because the risk of heart problems may be increased
• Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, nicotinic acid, oral antidiabetics (eg, glipizide), phenothiazines (eg, chlorpromazine), phenytoin, sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high or low blood sugar may be increased
• Amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin because they may increase the risk of Rosiglitazone/Metformin’s side effects
• Gemfibrozil because it may increase the risk of Rosiglitazone/Metformin’s side effects
• Rifampin because it may decrease Rosiglitazone/Metformin’s effectiveness, resulting in high blood sugar
• Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by Rosiglitazone/Metformin

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

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

• Rosiglitazone/Metformin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Rosiglitazone/Metformin refilled.
• Take Rosiglitazone/Metformin by mouth with meals.
• Take Rosiglitazone/Metformin on a regular schedule to get the most benefit from it. Taking Rosiglitazone/Metformin at the same time each day will help you remember to take it.
• Continue to take Rosiglitazone/Metformin even if you feel well. Do not miss any doses.
• If you miss a dose of Rosiglitazone/Metformin, 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 Rosiglitazone/Metformin.

Important safety information:

• Rosiglitazone/Metformin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Rosiglitazone/Metformin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Follow the diet and exercise program given to you by your health care provider.
• Talk to your doctor or health care provider before you drink alcohol while you use Rosiglitazone/Metformin.
• Tell your doctor or dentist that you take Rosiglitazone/Metformin before you receive any medical or dental care, emergency care, or surgery.
• Do NOT take more than the recommended dose without checking with your doctor.
• Be careful not to become dehydrated, especially during hot weather, while you are being active, or if you have vomiting or diarrhea. Dehydration may increase your risk of side effects from Rosiglitazone/Metformin.
• Rosiglitazone/Metformin may cause ovulation in women who have not reached menopause but do not ovulate. Women who wish to avoid pregnancy should be sure to use an effective form of birth control while using Rosiglitazone/Metformin.
• Carry an ID card at all times that says you have diabetes. Check your blood sugar levels regularly as directed by your doctor. If they are often higher or lower than they should be and you take Rosiglitazone/Metformin exactly as prescribed, tell your doctor.
• Rosiglitazone/Metformin does not usually cause low blood sugar. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take Rosiglitazone/Metformin along with certain other medicines for diabetes (eg, sulfonylureas, insulin). 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.
• Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar closely and tell your doctor right away.
• Rosiglitazone/Metformin may commonly cause upset stomach, indigestion, nausea, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis.
• An increased incidence of bone fracture has been reported in women who take Rosiglitazone/Metformin. Tell your doctor if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis). Tell your doctor right away if you experience any unusual bone pain.
• Lab tests, including fasting blood sugar, hemoglobin A_1c, eye examinations, and liver function, may be performed while you use Rosiglitazone/Metformin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Rosiglitazone/Metformin with caution in the ELDERLY; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in the elderly.
• Rosiglitazone/Metformin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rosiglitazone/Metformin while you are pregnant. It is not known if Rosiglitazone/Metformin is found in breast milk. Do not breast-feed while taking Rosiglitazone/Metformin.

Possible side effects of Rosiglitazone/Metformin:

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:

Cold symptoms; diarrhea; headache; indigestion; mild weight gain; nausea; stomach upset.

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); blurred vision or other vision changes; bone pain; chest pain or discomfort; dark urine; dizziness or lightheadedness; fainting; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; muscle pain or weakness; numbness of an arm or leg; pale stools; persistent loss of appetite; red, swollen, blistered, or peeling skin; severe or persistent nausea or vomiting; shortness of breath; slow or irregular heartbeat; sudden severe headache, dizziness, or vomiting; sudden unexplained weight gain; swelling of the hands, ankles, or feet; unusual bone pain; unusual drowsiness; unusual stomach pain or discomfort; unusual tiredness or weakness; yellowing of the eyes or skin.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include dizziness or lightheadedness; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or tenderness; slow or irregular heartbeat; unusual drowsiness; unusual stomach discomfort; unusual weakness or tiredness.

Proper storage of Rosiglitazone/Metformin:

Store Rosiglitazone/Metformin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in bathroom. Keep Rosiglitazone/Metformin out of the reach of children and away from pets.

General information:

• If you have any questions about Rosiglitazone/Metformin, please talk with your doctor, pharmacist, or other health care provider.
• Rosiglitazone/Metformin 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.
• If using Rosiglitazone/Metformin for an extended period of time, obtain refills before your supply runs out.

This information is a summary only. It does not contain all information about Rosiglitazone/Metformin. 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.

Generic Name: sodium sulfacetamide-sulfur topical (SO dee um sull fah SEH tah mide-SULL fer TAH pih kal)
Brand Names: Novacet, Plexion, Plexion SCT, Plexion TS, Rosanil Cleanser, Rosula, Rosula Cleanser, Sulfacet-R, Zetacet Wash

What is Rosula (sodium sulfacetamide-sulfur topical)?

Sodium sulfacetamide is an antibacterial agent. Sodium sulfacetamide interferes with the growth of bacteria on the skin. Sulfur may also inhibit the growth of bacteria on the skin and it may cause drying of the skin.

Sodium sulfacetamide-sulfur topical is used in the treatment of acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sodium sulfacetamide-sulfur topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Rosula (sodium sulfacetamide-sulfur topical)?

Stop using sodium sulfacetamide-sulfur topical and contact your healthcare provider if you develop new or worsening signs of a skin rash, soreness of the joints, fever, or sores in the mouth. Do not use other topical products on the same area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide-sulfur topical. Do not cover the area after applying sodium sulfacetamide-sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

What should I discuss with my healthcare provider before using Rosula (sodium sulfacetamide-sulfur topical)?

Do not use sodium sulfacetamide-sulfur topical without first talking to your doctor if you have an allergy to sulfa products. You may not be able to use sodium sulfacetamide-sulfur topical, or you may require special monitoring during treatment.

Do not apply sodium sulfacetamide-sulfur topical to large areas of open, broken, burned, or infected skin without first talking to your doctor. Large areas of damaged skin may allow more medicine to be absorbed by the body, possibly resulting in side effects.

Sodium sulfacetamide-sulfur topical is in the FDA pregnancy category C. This means that it is not known whether sodium sulfacetamide-sulfur topical will be harmful to an unborn baby. Do not use sodium sulfacetamide-sulfur topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether sodium sulfacetamide passes into breast milk. Do not use sodium sulfacetamide-sulfur topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Rosula (sodium sulfacetamide-sulfur topical)?

Use sodium sulfacetamide-sulfur topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after applying the medication.

Clean and dry the affected area. Apply a thin film of the medication. Avoid application of the medication to the eyes, the inside of the nose and mouth, the lips, and areas where the skin is broken. If medication gets on any of these areas, rinse it off with water. Do not cover the affected area after applying sodium sulfacetamide-sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

It is important to use sodium sulfacetamide regularly to get the most benefit. It may take several weeks or more to see the effects of this drug.

Store sodium sulfacetamide-sulfur topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and apply only the next regularly scheduled dose.

What happens if I overdose?

An overdose of sodium sulfacetamide-sulfur topical is unlikely to threaten life. If an overdose is suspected or if the medication has been ingested, call a poison control center or an emergency room for advice.

What should I avoid while using Rosula (sodium sulfacetamide-sulfur topical)?

Do not use other topical products on the same area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide-sulfur topical. Do not cover the area after applying sodium sulfacetamide-sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

Rosula (sodium sulfacetamide-sulfur topical) side effects

Serious side effects are not likely to occur with the use of sodium sulfacetamide-sulfur topical. Stop using sodium sulfacetamide-sulfur topical and seek emergency medical attention or contact your doctor immediately if you experience

• an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives);

• new or worsening signs of a skin rash;

• soreness of the joints;

• fever; or

• sores in the mouth.

More commonly, you may experience some redness, warmth, swelling, itching, stinging, burning, or irritation of the treated area. If these side effects are excessive, notify your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rosula (sodium sulfacetamide-sulfur topical)?

Do not use other topical products on the same area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide-sulfur topical.

Drugs other than those listed here may also interact with sodium sulfacetamide-sulfur topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

• Your pharmacist has additional information about sodium sulfacetamide-sulfur topical written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:42:24 PM.

roe-zi-GLI-ta-zone

Commonly used brand name(s):

In the U.S.

• Avandia

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidiabetic

Chemical Class: Thiazolidinedione

Uses For rosiglitazone

Rosiglitazone is used to treat high blood sugar levels that are caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future. Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Rosiglitazone helps your body use the insulin better and it reduces the amount of insulin in your body. It may be used alone or with another type of diabetes medicine, such as metformin, a sulfonylurea, or a sulfonylurea plus metformin .

rosiglitazone is available only with your doctor’s prescription.

Before Using rosiglitazone

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 rosiglitazone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to rosiglitazone 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 rosiglitazone in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of rosiglitazone in the elderly .

Pregnancy

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

Breast Feeding

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

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

• Bitter Melon
• Fenugreek
• Gemfibrozil
• Glucomannan
• Guar Gum
• Psyllium
• Rifampin
• St John’s Wort
• Trimethoprim

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Diabetic ketoacidosis (ketones in the blood) or
• Lactic acidosis (lactic acid in the blood) or
• Metabolic acidosis (extra acids in the blood) or
• Type 1 diabetes—Patients with any of these conditions should not use rosiglitazone .

• Diabetic macular edema (swelling of the back of the eye) or
• Edema or
• Jaundice or
• Liver disease—Rosiglitazone may make these conditions worse .

• Fragile bones (especially women)—Use with caution. rosiglitazone may increase the risk of fractures .

• Heart disease or
• Heart surgery in the past or
• History of heart attacks or
• Other heart problems—rosiglitazone may increase the risk of heart attacks and make these conditions worse

• Heart failure, severe —rosiglitazone should not be used in patients with this condition .

Proper Use of rosiglitazone

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Rosiglitazone may be taken with or without food.

Dosing

The dose of rosiglitazone 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 rosiglitazone. 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 type 2 diabetes:
    • Rosiglitazone alone:
      • Adults—At first, the dose is 4 milligrams (mg) once a day or 2 mg twice a day. After 8 to 12 weeks, the dose may be increased to 8 mg once a day or 4 mg twice a day.
      • Children—Use and dose must be determined by your doctor.
    • Rosiglitazone with metformin:
      • Adults—At first, the dose is 4 milligrams (mg) once a day or 2 mg twice a day. Any changes in dose will be determined by your doctor .
      • Children—Use and dose must be determined by your doctor.
    • Rosiglitazone with a sulfonylurea:
      • Adults—4 milligrams (mg) once a day or 2 mg twice a day. Any changes in the dose will be determined by your doctor.
      • Children—Use and dose must be determined by your doctor.
    • Rosiglitazone with sulfonylurea plus metformin:
      • Adults—4 milligrams (mg) once a day or 2 mg twice a day. Any changes in the dose will be determined by your doctor .
      • Children—Use and dose must be determined by your doctor .

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using rosiglitazone

It is very important that your doctor check your progress at regular visits to make sure that rosiglitazone is working properly. Blood tests may be needed to check for unwanted effects .

If you experience abdominal or stomach pain, dark urine, loss of appetite, nausea or vomiting, unusual tiredness or weakness, or yellow eyes or skin, check with your doctor immediately. These may be symptoms of liver problems.

Seek medical attention immediately if you experience chest pain or discomfort; nausea; pain or discomfort in arms, jaw, back or neck; shortness of breath; sweating; or vomiting. These may be symptoms of a heart attack.

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

If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

Rosiglitazone may increase the chance of a premenopausal woman with type 2 diabetes getting pregnant. Reliable birth control is recommended. Talk to your health care professional about choices, risks, and benefits.

Make sure your doctor knows if you are using insulin or nitrate medicines (e.g., Isordil®, Imdur®, or Sorbitrate®) before you start taking rosiglitazone. Using any of them together with rosiglitazone may increase your risk of having serious side effects .

It is very important to carefully follow any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are taking rosiglitazone unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

rosiglitazone does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take rosiglitazone with another type of diabetes medicine. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and amount); ketones in urine; loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

It is important to tell your healthcare professional that you are taking rosiglitazone if you are going to have any medical procedures or surgical procedures.

rosiglitazone 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:

Less common

• Abdominal or stomach pain
• blurred vision
• chest pain or discomfort
• decrease in amount of urine
• dry mouth
• fatigue
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• irregular heartbeat
• nausea
• noisy, rattling breathing
• pain in the shoulders, arms, jaw, or neck
• pale skin
• shortness of breath
• sweating
• swelling of fingers, hands, feet, or lower legs
• trouble breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• weight gain, rapid or unusual

Rare

• Anxiety
• chills
• cold sweats
• coma
• confusion
• dark urine
• depression
• dizziness
• fast heartbeat
• headache
• loss of appetite
• nervousness
• nightmares
• seizures
• shakiness
• slurred speech

Incidence not known

• Blue lips and fingernails
• changes in vision
• coughing that sometimes produces a pink frothy sputum
• hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• itching
• light-colored stools
• redness of skin
• skin rash
• wheezing
• yellow eyes or skin

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

More common

• Ear congestion
• fever
• general feeling of discomfort or illness
• hoarseness or other voice changes
• injury
• joint pain
• muscle aches and pains
• runny or stuffy nose
• shivering
• sneezing
• sore throat
• trouble sleeping

Less common

• Back pain
• cough
• diarrhea
• light-headedness
• pain or tenderness around the eyes and cheekbones

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.

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Generic Name: Sulfacetamide/Sulfur (sul-fa-SEE-ta-mide/SULL-fer)
Brand Name: Rosac

Rosac Cream is used for:

Treating acne. It may also be used for other conditions as determined by your doctor.

Rosac Cream is a sulfonamide antibiotic, drying agent, and sunscreen combination. It works by killing bacteria and gently drying the skin to help treat acne. The sunscreen protects the skin from irritation due to sunburn.

Do NOT use Rosac Cream if:

• you are allergic to any ingredient in Rosac Cream
• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide

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

Before using Rosac Cream:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of lupus

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

• Silver-containing products (eg, silver sulfadiazine) because they may decrease Rosac Cream’s effectiveness
• Methenamine because it may increase the risk of Rosac Cream’s side effects

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

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

• Rosac Cream is for use on the skin only. Rosac Cream may stain clothing and the skin if too much is used.
• Wash your hands before and immediately after using Rosac Cream. Gently wash the affected area and pat dry. Apply a thin film of medicine to the affected area. Avoid getting Rosac Cream in your eyes, nose, or mouth.
• To clear up your infection completely, use Rosac Cream for the full course of treatment. Keep using it even if you feel better in a few days.
• Rosac Cream works best if it is used at the same time each day.
• Continue to use Rosac Cream even if you feel well. Do not miss any doses.
• If you miss a dose of Rosac Cream, use 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 use 2 doses at once.

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

Important safety information:

• It may take several days for Rosac Cream to work fully.
• Avoid getting Rosac Cream in your eyes, nose, or mouth.
• Talk with your doctor before you use any other medicines or cleansers on your skin.
• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Rosac Cream only works against bacteria; it does not treat viral infections.
• Be sure to use Rosac Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Rosac Cream may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• If you use topical products too often, your condition may become worse.
• Rosac Cream should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rosac Cream while you are pregnant. It is not known if Rosac Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use Rosac Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Rosac Cream:

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:

Irritation, stinging, or burning of the skin.

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); bloody diarrhea; fever; joint pain; red, swollen, or blistered skin; severe diarrhea; sores in the mouth; stomach cramps/pain.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Rosac Cream may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.

Proper storage of Rosac Cream:

Store Rosac Cream 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. Do not freeze. Keep Rosac Cream out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Rosac Cream. 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.

Generic Name: Sulfacetamide Sodium/Sulfur with Cleanser (SUL-fa-SET-a-mide SOE-dee-um/SUL-fur)
Brand Name: Rosanil

Rosanil is used for:

Treating acne, rosacea, and seborrhea. It may also be used for other conditions as determined by your doctor.

Rosanil is a combination sulfonamide antibiotic and keratolytic. It is packaged with a skin cleanser. It works by killing bacteria and shedding the top layer of skin to help treat acne

Do NOT use Rosanil if:

• you are allergic to any ingredient in Rosanil
• you have had a severe allergic reaction (eg, difficulty breathing, dizziness, hives, severe rash) to any other sulfonamide medicine (eg, sulfamethoxazole)
• you have kidney disease

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

Before using Rosanil:

Some medical conditions may interact with Rosanil. 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 eczema or a history of lupus

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

• Silver-containing products (eg, silver sulfadiazine) because they may decrease Rosanil’s effectiveness

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

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

• Gently wash the affected area using the provided skin cleanser, then dry.
• Wet the skin and apply a generous amount of medicine to the affected area. Massage gently into the skin for 10 to 20 seconds, working into a full lather. Rinse well and pat dry.
• Wash your hands right after using Rosanil.
• If dry skin occurs, you may rinse the medicine off the skin sooner or use the medicine less often, as directed by your doctor.
• Rosanil works best if it is used at the same time(s) each day.
• Continue to use Rosanil even if your condition improves. Do not miss any doses.
• If you miss a dose of Rosanil, use 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 use 2 doses at once.

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

Important safety information:

• Rosanil is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool tap water.
• Talk with your doctor before you use any other medicines or cleansers on your skin.
• Do not apply Rosanil to open wounds or to damaged or burned skin without first checking with your doctor.
• If you use topical products too often, your condition may become worse.
• Rosanil should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rosanil while you are pregnant. It is not known if Rosanil is found in breast milk after topical use. If you are or will be breast-feeding while you use Rosanil, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Rosanil:

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:

Mild dryness, irritation, redness, scaling, stinging, or burning of the skin.

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); cracked or extremely dry skin; fever; joint pain; severe diarrhea; severe skin irritation, redness, or scaling; sores in the mouth; swollen or blistered skin; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Rosanil may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.

Proper storage of Rosanil:

Store Rosanil at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Keep the container tightly closed. Store away from heat and light. Do not freeze. Keep Rosanil out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Rosanil. 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.

Generic Name: sodium sulfacetamide-sulfur topical (SO dee um sull fah SEH tah mide-SULL fer TAH pih kal)
Brand Names: Novacet, Plexion, Plexion SCT, Plexion TS, Rosanil Cleanser, Rosula, Rosula Cleanser, Sulfacet-R, Zetacet Wash

What is Rosanil Cleanser (sodium sulfacetamide-sulfur topical)?

Sodium sulfacetamide is an antibacterial agent. Sodium sulfacetamide interferes with the growth of bacteria on the skin. Sulfur may also inhibit the growth of bacteria on the skin and it may cause drying of the skin.

Sodium sulfacetamide-sulfur topical is used in the treatment of acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sodium sulfacetamide-sulfur topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Rosanil Cleanser (sodium sulfacetamide-sulfur topical)?

Stop using sodium sulfacetamide-sulfur topical and contact your healthcare provider if you develop new or worsening signs of a skin rash, soreness of the joints, fever, or sores in the mouth. Do not use other topical products on the same area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide-sulfur topical. Do not cover the area after applying sodium sulfacetamide-sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

What should I discuss with my healthcare provider before using Rosanil Cleanser (sodium sulfacetamide-sulfur topical)?

Do not use sodium sulfacetamide-sulfur topical without first talking to your doctor if you have an allergy to sulfa products. You may not be able to use sodium sulfacetamide-sulfur topical, or you may require special monitoring during treatment.

Do not apply sodium sulfacetamide-sulfur topical to large areas of open, broken, burned, or infected skin without first talking to your doctor. Large areas of damaged skin may allow more medicine to be absorbed by the body, possibly resulting in side effects.

Sodium sulfacetamide-sulfur topical is in the FDA pregnancy category C. This means that it is not known whether sodium sulfacetamide-sulfur topical will be harmful to an unborn baby. Do not use sodium sulfacetamide-sulfur topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether sodium sulfacetamide passes into breast milk. Do not use sodium sulfacetamide-sulfur topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Rosanil Cleanser (sodium sulfacetamide-sulfur topical)?

Use sodium sulfacetamide-sulfur topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after applying the medication.

Clean and dry the affected area. Apply a thin film of the medication. Avoid application of the medication to the eyes, the inside of the nose and mouth, the lips, and areas where the skin is broken. If medication gets on any of these areas, rinse it off with water. Do not cover the affected area after applying sodium sulfacetamide-sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

It is important to use sodium sulfacetamide regularly to get the most benefit. It may take several weeks or more to see the effects of this drug.

Store sodium sulfacetamide-sulfur topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and apply only the next regularly scheduled dose.

What happens if I overdose?

An overdose of sodium sulfacetamide-sulfur topical is unlikely to threaten life. If an overdose is suspected or if the medication has been ingested, call a poison control center or an emergency room for advice.

What should I avoid while using Rosanil Cleanser (sodium sulfacetamide-sulfur topical)?

Do not use other topical products on the same area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide-sulfur topical. Do not cover the area after applying sodium sulfacetamide-sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

Rosanil Cleanser (sodium sulfacetamide-sulfur topical) side effects

Serious side effects are not likely to occur with the use of sodium sulfacetamide-sulfur topical. Stop using sodium sulfacetamide-sulfur topical and seek emergency medical attention or contact your doctor immediately if you experience

• an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives);

• new or worsening signs of a skin rash;

• soreness of the joints;

• fever; or

• sores in the mouth.

More commonly, you may experience some redness, warmth, swelling, itching, stinging, burning, or irritation of the treated area. If these side effects are excessive, notify your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rosanil Cleanser (sodium sulfacetamide-sulfur topical)?

Do not use other topical products on the same area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide-sulfur topical.

Drugs other than those listed here may also interact with sodium sulfacetamide-sulfur topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

• Your pharmacist has additional information about sodium sulfacetamide-sulfur topical written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:42:24 PM.

Generic Name: rosiglitazone (oral) (row zi GLI ta zone)
Brand Names: Avandia

What is rosiglitazone?

Rosiglitazone is an oral diabetes medicine that helps control blood sugar levels.

Rosiglitazone is for people with type 2 (non-insulin-dependent) diabetes. Rosiglitazone is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.

Rosiglitazone is not recommended for use with insulin.

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

What is the most important information I should know about rosiglitazone?

Do not use rosiglitazone if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking rosiglitazone, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them, including hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar. Some women using rosiglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control. Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking rosiglitazone. Talk with your doctor if you are concerned about this possibility. Taking certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with rosiglitazone.

What should I discuss with my healthcare provider before taking rosiglitazone?

Do not use rosiglitazone if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking rosiglitazone, tell your doctor if you have:

• congestive heart failure or heart disease;

• a history of heart attack or stroke;

• liver disease; or

• eye problems caused by diabetes.

Taking certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with rosiglitazone. Some women using rosiglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control. Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking rosiglitazone. Talk with your doctor if you are concerned about this possibility. FDA pregnancy category C. It is not known whether rosiglitazone will harm an unborn baby. Before you use this medicine, tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether rosiglitazone passes into breast milk or if it could harm a nursing baby. Do not take rosiglitazone without first talking to your doctor if you are breast-feeding a baby.

How should I take rosiglitazone?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Rosiglitazone is usually taken in the morning and evening. You may take the medicine with or without food.

Rosiglitazone is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your doctor may also recommend other medicines to treat your diabetes.

It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested, and you may need regular eye exams. It is important that you not miss any scheduled visits to your doctor.

Your medication needs may change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. Your doctor may want you to stop taking rosiglitazone for a short time if any of these situations affect you.

Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them:

• hunger, headache, confusion, irritability;

• drowsiness, weakness, dizziness, tremors;

• sweating, fast heartbeat;

• seizure (convulsions); or

• fainting, coma (severe hypoglycemia can be fatal).

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Store rosiglitazone at room temperature away from moisture, heat, and light.

See also: Rosiglitazone dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 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. You may have signs of low blood sugar, such as hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma.

What should I avoid while taking rosiglitazone?

Avoid drinking alcohol while taking rosiglitazone. Alcohol lowers blood sugar and may increase the risk of hypoglycemia while you are taking this medicine.

Rosiglitazone 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. Stop using rosiglitazone and call your doctor at once if you have any of these serious side effects:

• feeling short of breath, even with mild exertion;

• swelling or rapid weight gain;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• blurred vision;

• increased thirst or hunger, urinating more than usual; or

• pale skin, easy bruising or bleeding, weakness.

Less serious side effects may include:

• sneezing, runny nose, cough or other signs of a cold;

• headache;

• gradual weight gain;

• mild diarrhea; or

• back pain.

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.

Rosiglitazone Dosing Information

Usual Adult Dose for Diabetes Mellitus Type II:

Initial dose: 4 mg/day orally as a single daily dose or in two divided doses. Doses may be taken without regard to meals.

Maintenance dose: The dose may be increased to 8 mg daily in patients who fail to respond adequately following 12 weeks of initial therapy.

What other drugs will affect rosiglitazone?

You may be more likely to have hyperglycemia (high blood sugar) if you are taking rosiglitazone with other drugs that raise blood sugar. Drugs that can raise blood sugar include:

• isoniazid;

• diuretics (water pills);

• steroids (prednisone and others);

• phenothiazines (Compazine and others);

• thyroid medicine (Synthroid and others);

• birth control pills and other hormones;

• seizure medicines (Dilantin and others); and

• diet pills or medicines to treat asthma, colds or allergies.

You may be more likely to have hypoglycemia (low blood sugar) if you are taking rosiglitazone with other drugs that lower blood sugar. Drugs that can lower blood sugar include:

• nonsteroidal anti-inflammatory drugs (NSAIDs);

• aspirin or other salicylates (including Pepto-Bismol);

• sulfa drugs (Bactrim and others);

• a monoamine oxidase inhibitor (MAOI);

• beta-blockers (Tenormin and others); or

• probenecid (Benemid).

Some medications may interact with rosiglitazone. Tell your doctor if you are using any of the following drugs:

• gemfibrozil (Gemcor);

• rifampin (Rifater, Rifadin, Rimactane); or

• a nitrate drug for chest pain or heart problems, such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), or isosorbide mononitrate (Imdur, ISMO, Monoket).

This list is not complete and there may be other drugs that can interact with rosiglitazone. 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.

Where can I get more information?

• Your pharmacist has additional information about rosiglitazone written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 9.04. Revision Date: 05/17/2010 3:56:46 PM.

Generic Name: Ropinirole (roe-PIN-i-ROLE)
Brand Name: Requip XL

Ropinirole Extended-Release Tablets are used for:

Treating Parkinson disease. It may also be used for other conditions as determined by your doctor.

Ropinirole Extended-Release Tablets are a dopamine agonist. It works in certain areas of the brain to reduce the symptoms of Parkinson disease.

Do NOT use Ropinirole Extended-Release Tablets if:

• you are allergic to any ingredient in Ropinirole Extended-Release Tablets

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

Before using Ropinirole Extended-Release Tablets:

Some medical conditions may interact with Ropinirole Extended-Release Tablets. 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 heart problems, high or low blood pressure, liver disease, mental or mood problems, or a sleep disorder
• if you smoke, drink alcohol, or have a personal or family history of addiction (eg, alcohol, gambling)

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

• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
• Entacapone or levodopa because the risk of hallucinations may be increased
• Benzodiazepines (eg, diazepam), medicines for mental or mood problems (eg, antidepressants, antipsychotics), or medicines for sleep (eg, zolpidem) because the risk of severe drowsiness may be increased
• Estrogens (eg, estradiol), fluvoxamine, or quinolones (eg, ciprofloxacin) because they may increase the risk of Ropinirole Extended-Release Tablets’s side effects
• Butyrophenones (eg, haloperidol), metoclopramide, omeprazole, phenothiazines (eg, chlorpromazine), or thioxanthenes (eg, thiothixene) because they may decrease Ropinirole Extended-Release Tablets’s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ropinirole Extended-Release Tablets 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 Ropinirole Extended-Release Tablets:

Use Ropinirole Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Ropinirole Extended-Release Tablets. Talk to your pharmacist if you have questions about this information.
• Take Ropinirole Extended-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow Ropinirole Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Do not suddenly stop taking Ropinirole Extended-Release Tablets or change your dose without checking with your doctor. Certain severe side effects (eg, abnormal thinking, confusion, fever, stiff muscles) may occur. If you need to stop Ropinirole Extended-Release Tablets or add a new medicine, your doctor will gradually lower your dose.
• Take Ropinirole Extended-Release Tablets on a regular schedule to get the most benefit from it. Taking Ropinirole Extended-Release Tablets at the same time each day will help you remember to take it.
• If you miss a dose of Ropinirole Extended-Release Tablets, 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. If you miss several doses of Ropinirole Extended-Release Tablets, contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use Ropinirole Extended-Release Tablets.

Important safety information:

• Ropinirole Extended-Release Tablets may cause dizziness, drowsiness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Ropinirole Extended-Release Tablets 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 or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ropinirole Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Ropinirole Extended-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Some people who use Ropinirole Extended-Release Tablets may experience sudden onset of severe drowsiness or may even fall asleep during normal daily activities (eg, driving, eating, talking). This could occur without warning. If this happens, do not drive, operate machinery, or perform other possibly unsafe tasks while you use Ropinirole Extended-Release Tablets. Tell your doctor right away.
• Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using Ropinirole Extended-Release Tablets. Tell your doctor right away if you notice such effects.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if Ropinirole Extended-Release Tablets also increases the risk of melanoma. You may need to have skin exams while you are using Ropinirole Extended-Release Tablets. Discuss any questions or concerns with your doctor.
• Use Ropinirole Extended-Release Tablets with caution in ELDERLY patients with Parkinson disease; they may be more sensitive to its effects, especially hallucinations.
• Ropinirole Extended-Release Tablets should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ropinirole Extended-Release Tablets while you are pregnant. It is not known if Ropinirole Extended-Release Tablets are found in breast milk. Ropinirole Extended-Release Tablets may decrease breast milk production. Do not breast-feed while taking Ropinirole Extended-Release Tablets.

Possible side effects of Ropinirole Extended-Release Tablets:

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

Constipation; dizziness; drowsiness; fatigue; headache; increased sweating; lightheadedness; loss of appetite; nausea; sore throat or flu-like symptoms; stomach pain or upset; tiredness; vomiting; weakness.

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); anxiety; blood in the urine; blurred vision; chest pain; confusion; decreased coordination; fainting; falling asleep during the daytime or normal daily activities (eg, conversations, eating); fast, slow, or irregular heartbeat; hallucinations; impotence; joint stiffness or pain; nightmares; numbness or tingling of the skin; severe or persistent headache or dizziness; shortness of breath; swelling of the arms or legs; uncontrolled muscle movements; unusual skin growths or change in the appearance of a mole.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include agitation; chest pain; confusion; decreased coordination; fainting; hallucinations; severe or persistent dizziness or drowsiness; uncontrolled muscle movements (eg, of the arms, legs, face); vomiting.

Proper storage of Ropinirole Extended-Release Tablets:

Store Ropinirole Extended-Release Tablets at 77 degrees F (25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Ropinirole Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Ropinirole Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Ropinirole Extended-Release Tablets are 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.

This information is a summary only. It does not contain all information about Ropinirole Extended-Release Tablets. 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.

Brand names: Requip

Why is Ropinirole hydrochloride prescribed?

Requip helps relieve the signs and symptoms of Parkinson’s disease. Caused by a deficit of dopamine (one of the brain’s chief chemical messengers), this disorder is marked by progressive muscle stiffness, tremor, and fatigue. Requip is also used to relieve symptoms of restless legs syndrome. It works by stimulating dopamine receptors in the brain, thus promoting better, easier movement.

Requip can be taken with or without levodopa, another drug used to treat the symptoms of Parkinson’s disease.

Most important fact about Ropinirole hydrochloride

Requip is not a cure for Parkinson’s disease. However, it does alleviate symptoms of the disease, and it can shorten the “off” periods of immobility that patients on long-term levodopa therapy often begin to experience.

How should you take Ropinirole hydrochloride?

Take 3 doses a day, with or without food. If the drug upsets your stomach, combining it with food may relieve the problem. If you are also taking levodopa, its dosage may be gradually decreased when you start therapy with Requip.

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

• Storage instructions…
  Store at room temperature away from light.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Requip.

• Side effects may include:
  Abdominal pain, abnormal dreaming, abnormal muscle movements, abnormal vision, amnesia, anxiety, arthritis, bronchitis, chest pain, confusion, constipation, decreased muscle movements, diarrhea, difficulty breathing, dizziness, drowsiness, dry mouth, eye problems, fainting, falling, fatigue, hallucinations, headache, hot flashes, increased sweating, increase/decrease in blood pressure, indigestion, joint pain, leg swelling, muscle spasms, nausea, nervousness, pain, paralysis, respiratory tract infection, runny nose, sinus inflammation, skin tingling, sore throat, stomach discomfort, swelling, toothache, tremor, urinary tract infection, viral infections, vomiting, weakness

Why should Ropinirole hydrochloride not be prescribed?

If Requip gives you an allergic reaction, you will not be able to continue using it.

Special warnings about Ropinirole hydrochloride

At the start of Requip therapy and whenever the dose is increased, you face a slightly increased risk of a fainting spell or other symptoms of low blood pressure such as dizziness, nausea, sweating, and light-headedness, particularly when you get up suddenly after sitting or reclining for a prolonged period. To avoid such symptoms, be careful to stand up slowly.

If you are taking Requip to treat Parkinson’s disease, you may be at a higher risk for developing skin cancer (melanoma). Be sure to see your doctor regularly for screenings.

There have been some reports of symptoms getting worse during therapy for restless legs syndrome. Contact your doctor if this occurs.

A few patients—especially older ones—also develop hallucinations. Let your doctor know if this occurs. You may have to stop Requip therapy.

Use Requip with caution if you have heart disease. There is also a slight chance of developing respiratory difficulties or problems with your eyesight. If you find it hard to breathe, have any swelling, or develop problems with your vision, alert your doctor at once.

If you are taking Sinemet with Requip, you may experience jerking muscle movements. Tell your doctor. He will need to decrease your dose of Sinemet.

With other Parkinson’s medications, a sudden dose reduction has been known to cause high fever, muscle stiffness, and loss of consciousness. Although this has not happened with Requip, be alert for such problems and contact your doctor immediately if they occur.

Requip may cause drowsiness, and some people have reported falling asleep without warning during their daily activities. Do not drive a car or operate machinery until you know how the drug affects you. If you find that Requip makes you sleepy or that you’re suddenly falling asleep in the middle of routine activities, tell your doctor; he will probably discontinue the drug.

Requip may also cause darkening of your skin and eye color. Tell your doctor if you notice any change.

Possible food and drug interactions when taking Ropinirole hydrochloride

If Requip is taken with certain other drugs, the effects of either can be increased, decreased, or altered. It is especially important to check with your doctor before combining Requip with the following:

Alcohol
Benzodiazepines such as alprazolam
Certain antidepressants
Ciprofloxacin
Drugs that contain levodopa
Estrogen medications such as ethinyl estradiol
Metoclopramide
Tranquilizers

Special information if you are pregnant or breastfeeding

Although the effects of Requip during pregnancy have not been adequately studied in humans, birth defects have occurred in animals. If you are pregnant or plan to become pregnant, inform your doctor immediately.

Requip may inhibit production of breast milk. There is also a possibility that it will appear in breast milk and affect the nursing infant. If Ropinirole hydrochloride is essential to your health, your doctor may advise you to discontinue breastfeeding.

Recommended dosage for Ropinirole hydrochloride

ADULTS

Parkinson’s disease

Requip is taken 3 times a day. During the first week of therapy, each dose is 0.25 milligram. During the second week, the amount rises to 0.5 milligram. In the third week, it increases to 0.75 milligram, and in the fourth week reaches 1 milligram (3 milligrams daily). If necessary, your doctor will gradually increase the dosage further, up to a maximum of 24 milligrams per day.

If you need to stop Requip therapy, the doctor will discontinue the drug gradually over a 7-day period, reducing the number of doses from 3 to 2 per day for the first 4 days, then to once a day for the remaining 3 days.

Restless legs syndrome

The usual starting dose is 0.25 milligrams taken 1 to 3 hours before bedtime. Depending on your response, the doctor may increase your dose in small increments up to a maximum of 4 milligrams daily.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical treatment immediately.

• Symptoms of Requip overdose may include:
  Agitation, chest pain, confusion, drowsiness, facial muscle movements, fainting, grogginess, increased jerkiness of movement, rapid heartbeat, symptoms of low blood pressure (dizziness, light-headedness) upon standing, nausea, vomiting