Telmisartan And Hydrochlorothiazide
Generic Name: telmisartan and hydrochlorothiazide
Brand Names:
Telmisartan And Hydrochlorothiazide
11 DESCRIPTION Telmisartan and Hydrochlorothiazide Tablets, USP are a combination of telmisartan, USP an orally active angiotensin II antagonist acting on the AT 1 receptor subtype, and hydrochlorothiazide, USP a thiazide diuretic. Telmisartan, USP a non-peptide molecule, is chemically described as 4’-[[4-methyl- 6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl] methyl]-2-biphenylcarboxylic acid.
Overview
11 DESCRIPTION Telmisartan and Hydrochlorothiazide Tablets, USP are a combination of telmisartan, USP an orally active angiotensin II antagonist acting on the AT 1 receptor subtype, and hydrochlorothiazide, USP a thiazide diuretic. Telmisartan, USP a non-peptide molecule, is chemically described as 4’-[[4-methyl- 6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl] methyl]-2-biphenylcarboxylic acid.
Uses
1 INDICATIONS AND USAGE Telmisartan and hydrochlorothiazide tablets are 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 telmisartan and hydrochlorothiazide tablets.
Dosage
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 telmisartan and hydrochlorothiazide tablets, 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 telmisartan and hydrochlorothiazide tablets 80 mg/12.5 mg once daily.
Side Effects
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 AvKARE at 1-855-361-3993, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Warnings
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. 5 WARNINGS AND PRECAUTIONS Avoid fetal or neonatal exposure ( 5.1 ) Correct volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 ) Observe for clinical signs of fluid or electrolyte imbalance ( 5.4 ) Hypersensitivity Reaction ( 5.5 ) Acute Myopia and Secondary Angle-Closure Glaucoma ( 5.6 ) 5.1 Fetal Toxicity Telmisartan Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. 4 CONTRAINDICATIONS Telmisartan and hydrochlorothiazide tablets are contraindicated: In patients who are hypersensitive to any component of this product [see Warnings and Precautions ( 5.5 )]. In patients with anuria.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Telmisartan and Hydrochlorothiazide Tablets, USP are available in three strengths as 40 mg/12.5 mg, 80 mg/12.5 mg and 80 mg/25 mg. 40 mg/12.5 mg: Biconvex, two-layered, capsule shaped uncoated tablets wherein, the hydrochlorothiazide layer is white to off-white, debossed with “423” and the telmisartan layer is mottled orange to reddish brown without debossing.
Frequently Asked Questions
What is Telmisartan And Hydrochlorothiazide used for?▼
1 INDICATIONS AND USAGE Telmisartan and hydrochlorothiazide tablets are 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 telmisartan and hydrochlorothiazide tablets.
What are the side effects of Telmisartan And Hydrochlorothiazide?▼
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 AvKARE at 1-855-361-3993, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the important warnings for Telmisartan And Hydrochlorothiazide?▼
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. 5 WARNINGS AND PRECAUTIONS Avoid fetal or neonatal exposure ( 5.1 ) Correct volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 ) Observe for clinical signs of fluid or electrolyte imbalance ( 5.4 ) Hypersensitivity Reaction ( 5.5 ) Acute Myopia and Secondary Angle-Closure Glaucoma ( 5.6 ) 5.1 Fetal Toxicity Telmisartan Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. 4 CONTRAINDICATIONS Telmisartan and hydrochlorothiazide tablets are contraindicated: In patients who are hypersensitive to any component of this product [see Warnings and Precautions ( 5.5 )]. In patients with anuria.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.