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| Antiepileptic, Antidiabetic, Antianginal, Antifungal |
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Rosiglitazone
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INFORMATION FOR USE OF A MEDICAL PRACTITIONER, HOSPITAL OR LABORATORY |
| Each film coated tablet contains: Rosiglitazone Maleate eq. to Rosiglitazone 2 mg |
Each film coated tablet contains: Rosiglitazone Maleate eq. to Rosiglitazone 4 mg |
Each film coated tablet contains: Rosiglitazone Maleate eq. to Rosiglitazone 8 mg |
WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA ● Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients. After initiation of ROZIT, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of ROZIT must be considered. ● ROZIT is not recommended in patients with symptomatic heart failure. Initiation of ROZIT in patients with established NYHA Class III or IV heart failure is contraindicated. |
PHARMACOLOGICAL CLASSIFICATION |
ROZIT (Rosiglitazone), a member of the thiazolidinedione class of antidiabetic agents, improves glycemic control by improving insulin sensitivity. Rosiglitazone is a highly selective and potent agonist for the peroxisome proliferator-activated receptor-gamma (PPARγ). In humans, PPAR receptors are found in key target tissues for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPARγ nuclear receptors regulates the transcription of insulin-responsive genes involved in the control of glucose production, transport, and utilization. In addition, PPARγ-responsive genes also participate in the regulation of fatty acid metabolism. The absolute bioavailability of rosiglitazone is 99%. Peak plasma concentrations are observed about 1 hour after dosing. Administration of rosiglitazone with food resulted in no change in overall exposure (AUC). The mean (CV %) oral volume of distribution (Vss/F) of rosiglitazone is approximately 17.6 (30%) liters, based on a population pharmacokinetic analysis. Rosiglitazone is approximately 99.8% bound to plasma proteins, primarily albumin. Rosiglitazone is extensively metabolized with no unchanged drug excreted in the urine. The major routes of metabolism were N-demethylation and hydroxylation, followed by conjugation with sulfate and glucuronic acid. All the circulating metabolites are considerably less potent than parent and, therefore, are not expected to contribute to the insulin-sensitizing activity of rosiglitazone. Following oral or intravenous administration of [14C]rosiglitazone maleate, approximately 64% and 23% of the dose was eliminated in the urine and in the feces, respectively. The plasma half-life of [14C] related material ranged from 103 to 158 hours. ROZIT is indicated for the treatment of: |
| ROZIT is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. |
Make sure you have told your doctor if you: |
· Are pregnant, trying for a baby or breast-feeding · Suffer from heart failure or heart disease. · Suffer from acute coronary syndrome (symptoms suggestive of a heart attack). · Suffer from peripheral arterial disease (fatty patches cause narrowing of arteries which results in less blood getting to the legs, causing leg pain)· Suffer from liver or kidney problems. · Are due to have any surgery in the near future · Use insulin |
You must take your medicine as the doctor tells you. It is important to take ROZIT Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness. ROZIT may be administered at a starting dose of 4 mg either as a single daily dose or in 2 divided doses. For patients who respond inadequately following 8 to 12 weeks of treatment, as determined by reduction in fasting plasma glucose (FPG), the dose may be increased to 8 mg daily as monotherapy or in combination with metformin, sulfonylurea, or sulfonylurea plus metformin. Take the missed dose as soon as you remember it. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your doses as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist. Do not take a double dose to make up for the dose that you missed. WHAT TO DO IF AN OVERDOSE IS TAKEN |
In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning. Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription, your doctor may wish to alter your dose of ROZIT if you are taking any drug: · Gemfibrozil · Montelukast· Rifampin |
Like all medicines, ROZIT can cause side effects. Some common side effects include: | Fluid retention cough, chest infection weight gain |
- a small reduction in red blood cell count (anaemia) and white blood cell count
- Low blood sugar levels (hypoglycaemia). This occurs more often when ROZIT is taken with sulphonylureas or insulin.
- heart failure or fluid in the lungs (pulmonary oedema)
- heart problems such as angina or heart attack
- Headache
- visual disorders
- Broken bones, usually in the hand, upper arm or foot.
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You must tell your doctor immediately if you develop any of the following: - rapid increase in weight
- shortness of breath
- swelling of legs and feet
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| · Keep all medicines out of the reach of children. · Store in a cool, dry place, away from direct heat and light. |
| Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice. |
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