Irbesartan
Irbesartan Tablets USP Rx only
61b60f94-35e6-b90b-08ce-fbb2fe011f34
HUMAN PRESCRIPTION DRUG LABEL
Aug 8, 2023
AvPAK
DUNS: 832926666
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
WARNINGS SECTION
WARNINGS
5.1 Fetal Toxicity
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. Potential neonatal
adverse effects include skull hypoplasia, anuria, hypotension, renal failure,
and death. When
pregnancy is detected, discontinue irbesartan tablets as soon as possible [see Use in Specific Populations (8.1)].
5.2 Hypotension in Volume- or Salt-Depleted Patients
In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g. those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with irbesartan. Correct volume or salt depletion prior to administration of irbesartan or use a lower starting dose [see Dosage and Administration (2.4)].
DOSAGE & ADMINISTRATION SECTION
DOSAGE & ADMINISTRATION
2.1 General Considerations
Irbesartan tablets may be administered with other antihypertensive agents and
with or without food.
2.2 Hypertension
The recommended initial dose of irbesartan tablets is 150 mg once daily. The
dosage can be increased to a maximum dose of 300 mg once daily as needed to
control blood pressure [see Clinical Studies (14.1)].
2.3 Nephropathy in Type 2 Diabetic Patients
The recommended dose is 300 mg once daily [see Clinical Studies (14.2)].
2.4 Dose Adjustment in Volume- and Salt-Depleted Patients
The recommended initial dose is 75 mg once daily in patients with depletion of
intravascular volume or salt (e.g., patients treated vigorously with diuretics
or on hemodialysis) [see Warnings and Precautions (5.2)].
Dosage Forms and Strengths
Irbesartan Tablets USP, 75 mg are white to off white, capsule shaped, biconvex
tablets debossed with '158' on one side and 'H' on the other side.
Irbesartan Tablets USP, 150 mg are white to off white, capsule shaped,
biconvex tablets debossed with '159' on one side and 'H' on the other side.
Irbesartan Tablets USP, 300 mg are white to off white, capsule shaped,
biconvex tablets debossed with '160' on one side and 'H' on the other side.