AVAPRO Film-coated tablet (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Sanofi-Aventis U.S. LLC

Λέξεις κλειδιά

0024-5850 0024-5851 0024-5852

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BOXED WARNING SECTION

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue AVAPRO as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Drugs that ...

1. Indications and Usage

1.1 Hypertension AVAPRO is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes ...

2. Dosage and Administration

2.1 General Considerations AVAPRO may be administered with other antihypertensive agents and with or without food. 2.2 Hypertension The recommended initial dose of AVAPRO is 150 mg once daily. The dosage ...

3. Dosage Forms and Strengths

AVAPRO 75 mg is a white to off-white, biconvex oval, film-coated, tablet debossed with a heart on one side and 2871 on the other. AVAPRO 150 mg is a white to off-white, biconvex oval, film-coated, tablet ...

4. Contraindications

AVAPRO is contraindicated in patients who are hypersensitive to any component of this product. Do not coadminister aliskiren with AVAPRO in patients with diabetes.

5. Warnings and Precautions

5.1 Fetal Toxicity AVAPRO can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal ...

6. Adverse Reactions

The following important adverse reactions are described elsewhere in the labeling: Hypotension in Volume or Salt-depleted Patients [see Warnings and Precautions (5.2)] Impaired Renal Function ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of AVAPRO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to ...

7. Drug Interactions

7.1 Agents Increasing Serum Potassium Coadministration of AVAPRO with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe. Monitor serum potassium in such patients. ...

8.1. Pregnancy

Risk Summary AVAPRO can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal ...

8.2. Lactation

There are no available data on the presence of irbesartan in human milk, effects on milk production, or the breastfed infant. Irbesartan or some metabolite of irbesartan is secreted in the milk of lactating ...

8.4. Pediatric Use

Irbesartan, in a study at a dose of up to 4.5 mg/kg/day, once daily, did not appear to lower blood pressure effectively in pediatric patients ages 6 to 16 years. AVAPRO has not been studied in pediatric ...

8.5. Geriatric Use

Of 4925 subjects receiving AVAPRO in controlled clinical studies of hypertension, 911 (18.5%) were 65 years and over, while 150 (3.0%) were 75 years and over. No overall differences in effectiveness or ...

10. Overdosage

No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well-tolerated. The most likely manifestations of overdosage are expected to be hypotension and ...

11. Description

AVAPRO (irbesartan) is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. ...

12.1. Mechanism of Action

Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the primary vasoactive hormone of the ...

12.2. Pharmacodynamics

In healthy subjects, single oral irbesartan doses of up to 300 mg produced dose-dependent inhibition of the pressor effect of angiotensin II infusions. Inhibition was complete (100%) 4 hours following ...

12.3. Pharmacokinetics

Absorption The oral absorption of irbesartan is rapid and complete with an average absolute bioavailability of 60% to 80%. Following oral administration of AVAPRO, peak plasma concentrations of irbesartan ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of carcinogenicity was observed when irbesartan was administered at dosages of up to 500/1000 mg/kg/day (males/females, respectively) in rats and 1000 mg/kg/day in mice for up to 2 years. For ...

14. Clinical Studies

14.1 Hypertension The antihypertensive effects of AVAPRO were examined in 7 placebo-controlled 8- to 12-week trials in patients with baseline diastolic blood pressures of 95 to 110 mmHg. Doses of 1 to ...

16.1. How Supplied

AVAPRO (irbesartan) is available as white to off-white, biconvex oval, film-coated tablets, debossed with a heart shape on one side and a code on the other (see Table below). Unit-of-use bottles contain ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Pregnancy Advise female patients of childbearing age about the consequences of exposure to AVAPRO during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be ...