Micardis Telmisartan Tablets

Brand Name: 美卡素®(Micardis®)
Generic Name: Telmisartan
Strength: 80 mg per tablet, 7 tablets per box
Manufacturer: Boehringer Ingelheim Hellas Single Member S.A.(original overseas manufacturer); Shanghai Boehringer Ingelheim Pharmaceutical Co., Ltd.(domestic repackaging enterprise)
Marketing Authorization Holder: Boehringer Ingelheim International GmbH
Approval Date in China: April 16, 2007 (initial approval)
Registration Number: 国药准字HJ20171003
Storage: Seal tightly, store in a cool dry place away from sunlight and moisture; keep out of children’s reach, follow detailed storage rules written on the package insert

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1. Indications and Usage
Hypertension: Treatment of essential hypertension.
Cardiovascular Risk Reduction: Treatment of patients aged 55 years and older at high risk for major cardiovascular events who are unable to take ACE inhibitors.
2. Dosage and Administration
Hypertension: The usual recommended dosage is 40 mg once daily, which may be increased to 80 mg once daily.
Cardiovascular Risk Reduction: The recommended dosage is 80 mg once daily.
Special Populations: In patients with mild to moderate renal impairment, no dosage adjustment is necessary. For patients with mild to moderate hepatic impairment, the maximum dosage should not exceed 40 mg once daily.
Administration: Can be taken with or without food.
3. Mechanism of Action
Angiotensin II Receptor Blockade: Telmisartan selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle and adrenal glands.
Physiological Effects: This inhibition prevents vasoconstriction and aldosterone secretion, leading to decreased peripheral vascular resistance and reduced blood pressure without affecting heart rate.
4. Safety and Warnings
Renal Artery Stenosis: Use with caution in patients with bilateral renal artery stenosis or stenosis of a single functioning kidney due to the risk of severe hypotension and acute renal failure.
Pregnancy and Lactation: Contraindicated during the second and third trimesters of pregnancy due to potential fetal toxicity (e.g., renal failure, skull hypoplasia).
Hypovolemia: Symptomatic hypotension may occur in patients with volume or salt depletion (e.g., those on high-dose diuretics).
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Dizziness, abdominal pain, diarrhea, back pain, influenza-like symptoms, and hyperkalemia.
Clinical Research: Pivotal cardiovascular outcome trials (e.g., ONTARGET) have demonstrated its efficacy in reducing cardiovascular mortality and morbidity compared to placebo.
6. Drug Interactions
ACE Inhibitors: Concomitant use is not recommended due to increased risks of hypotension, hyperkalemia, and renal dysfunction.
Potassium-Sparing Diuretics and Potassium Supplements: May increase the risk of hyperkalemia; serum potassium levels should be monitored.
NSAIDs: Non-steroidal anti-inflammatory drugs may attenuate the antihypertensive effect and worsen renal function.
Lithium: Concomitant use may increase serum lithium levels and toxicity.
7. Pharmaceutical Information
Active Ingredient: Telmisartan.
Excipients: Hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, iron oxide.
Appearance: White to off-white oval film-coated tablets.
Storage: Store below 30°C in a dry place.

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