Micardis HCT 25 mg/1

telmisartan and hydrochlorothiazide · TABLET · Boehringer Ingelheim Pharmaceuticals, Inc.

No Recall History

Plain English

Micardis HCT is a tablet containing telmisartan and hydrochlorothiazide at 25 mg/1, taken oral. Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..

Key Facts

Brand Name: Micardis HCT
Generic Name: telmisartan and hydrochlorothiazide
NDC Code (Product): 0597-0042
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Strength: 25 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA021162
Drug Class: Thiazide Diuretic [EPC]; Angiotensin 2 Receptor Blocker [EPC]
Marketing Start: 12/01/2000

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dizziness151 reports

drug ineffective120 reports

nausea116 reports

fatigue108 reports

headache108 reports

blood pressure increased102 reports

diarrhoea94 reports

dyspnoea93 reports

hypotension83 reports

hypertension82 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE MICARDIS HCT (telmisartan and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with MICARDIS HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different …

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Usual starting dose is 80 mg/12.5 mg once daily ( 2.1 ) Titrate up to 160 mg/25 mg as needed ( 2.1 ) Initiate patients with biliary obstructive disorders or hepatic insufficiency at 40 mg/12.5 mg ( 2.2 ) 2.1 Dosing Information Initiate a patient whose blood pressure is not adequately controlled with telmisartan monotherapy 80 mg on MICARDIS HCT, 80 mg/12.5 mg orally once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary. Initiate a patient whose blood pressure is not adequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen on MICARDIS HCT 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary. Patients titrated to the individual components (telmisartan and hydrochlorothiazide) may instead receive the corresponding dose of MICARDIS HCT. MICARDIS HCT may be administered with other antihypertensive drugs. 2.2 Dose Adjustment for Hepatic Impairment Initiate patients with biliary obstructive disorders or hepatic insufficiency under close medical supervision using the 40 mg/12.5 mg combination. MICARDIS HCT table…

Contraindications

4 CONTRAINDICATIONS MICARDIS HCT is contraindicated: In patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.5) ]. In patients with anuria. For co-administration with aliskiren in patients with diabetes [see Drug Interactions (7.4) ]. Hypersensitivity to telmisartan or any component ( 4 ) Anuria ( 4 ) Co-Administration with aliskiren in patients with diabetes ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Lithium: Risk of lithium toxicity ( 7.2 ) Non-steroidal anti-inflammatory drugs (NSAIDs): Reduced diuretic, natriuretic, and antihypertensive effects; increased risk of renal impairment ( 7.3 ) Dual blockade of renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.4 ) Antidiabetic drugs: Dosage adjustment may be required ( 7.6 ) Cholestyramine and colestipol: Reduced absorption of thiazides ( 7.7 ) 7.1 Agents Increasing Serum Potassium Co-administration of telmisartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of thiazide diuretics or angiotensin II receptor antagonists, including telmisartan. Monitor lithium levels in patients receiving MICARDIS HCT and lithium. 7.3 Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors Telmisartan Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those o…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in labeling: Hypotension [see Warnings and Precautions (5.2) ] Renal Impairment [see Warnings and Precautions (5.3) ] Electrolytes and Metabolic Disorders [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥2% of patients) were upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. MICARDIS HCT has been evaluated for safety in more than 1700 patients, including 716 treated for hypertension for longer than 6 months and 420 for more than 1 year. Adverse reactions have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide. Adverse…

Frequently Asked Questions

What is Micardis HCT used for?

Micardis HCT contains telmisartan and hydrochlorothiazide. It is a tablet taken oral. Consult your doctor for specific uses.

Is Micardis HCT a controlled substance?

Micardis HCT is not classified as a controlled substance by the DEA.

What is the generic name for Micardis HCT?

The generic name for Micardis HCT is telmisartan and hydrochlorothiazide. There are 11 other brand versions of telmisartan and hydrochlorothiazide.

What is the NDC code for Micardis HCT 25 mg/1?

The NDC (National Drug Code) for Micardis HCT 25 mg/1 is 0597-0042, listed by Boehringer Ingelheim Pharmaceuticals, Inc..

Product NDC

0597-0042

Package NDC

0597-0042-37

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