Rosiglitazonediabetes medicine that help control blood sugar levels for people with type 2 diabetes mellitus or non-insulin dependent diabetes mellitus (NIDDM). Type 2 diabetes mellitus do not use daily insulin injections. This medication is not for treating type 1 diabetes.
Special precautions: Do not use rosiglitazone if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (DKA); treatment with insulin is needed in these cases. Before taking this medication, 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.
This medication may be harmful to an unborn baby (FDA pregnancy category C). 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; pregnant or planning to get pregnant. Avoid drinking alcohol while taking rosiglitazone. Alcohol lowers blood sugar and may increase the risk of hypoglycemia.
This drug is only part of a complete program of treatment that also includes diet, exercise, and weight control. Fasting blood sugar will be tested on regular basis for proper monitoring of blood sugar control. Your liver function may also need to be tested, and you may need regular eye exams. Your medication needs may also change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. 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, or taking extra medicine to make up the missed dose.
The signs of low blood sugar (hypoglycemia) are the following:
• 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 hypoglycemia. 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. Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms are the same as the signs of hypoglycemia listed above.
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
• feeling short of breath, even with mild exertion;
• swelling or rapid weight gain;
• chest pain, 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.
Continue taking this medication and talk to your doctor if you have any of these less serious side effects:
• sneezing, runny nose, cough or other signs of a cold;
• gradual weight gain;
• mild diarrhea; or
• back pain.
Talk to your doctor about any other side effect that seems unusual or bothersome.
Drugs that can raise blood sugar:
• 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.
Drugs that can lower blood sugar:
• 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);
• probenecid (Benemid); or
• a blood thinner (warfarin, Coumadin and others).
Some other medications may interact with rosiglitazone:
• gemfibrozil (Gemcor); or rifampin (Rifater, Rifadin, Rimactane).
If you are using any of these drugs, you may not be able to take rosiglitazone, or you
may require a dosage adjustment or special monitoring. There may be other drugs not listed that can affect 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.
The molecular formula is C18H19N3O3S· C4H4O4. Rosiglitazone maleate is a white to off-white solid with a melting point range of 122°to 123°C. The pKa values of rosiglitazone maleate are 6.8 and 6.1. It is readily soluble in ethanol and a buffered aqueous solution with pH of 2.3; solubility decreases with increasing pH in the physiological range. TILTAB tablet contains rosiglitazone maleate equivalent to rosiglitazone, 2 mg, 4 mg, or 8 mg, for oral administration. Inactive ingredients are: Hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, sodium starch glycolate, titanium dioxide, triacetin, and 1 or more of the following: Synthetic red and yellow iron oxides and talc.
Rosiglitazone has the following structural formula: