RAMIPRIL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRIL - UNII:L35JN3I7SJ)

Available from:

Camber Pharmaceuticals

INN (International Name):

RAMIPRIL

Composition:

RAMIPRIL 1.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ramipril Capsules, USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Ramipril capsules are contraindicated in patients who are hypersensitive to this product or any other ACE inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Pregnancy Categories C (first trimester) and D (second and third trimesters) [see Warnings and Precautions ( 5.6 ) ]. Ingestion of a single 10 mg oral dose of ramipril resulted in undetectable amounts of ramipril and its metabolites in breast milk. However, because multiple doses may produce low milk concentrations that are not predictable from a single dose, do not use ramipril in nursing mothers. Safety and effectiveness in pediatric patients have not been established. Irreversible kidney damage has been observed in very young rats given a single dose of ramipril. Of the total number of patients who received ramipril in U.S. clinical studies of ramipril, 11.0% wer

Product summary:

Ramipril capsules, USP are available as 1.25 mg, 2.5 mg, 5 mg, and 10 mg in hard gelatin capsules. Ramipril 1.25 mg capsules are hard gelatin capsules size "4", yellow opaque body with yellow opaque cap imprinted with IG271 on cap and 1.25 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 31722-271-01), 500 (31722-271-05) and 1000 (NDC 31722-271-10). Ramipril 2.5 mg capsules are hard gelatin capsules size "4", orange opaque body with orange opaque cap imprinted with IG272 on cap and 2.5 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 31722-272-01), 500 (NDC 31722-272-05) and 1000 (NDC 31722-272-10). Ramipril 5 mg capsules are hard gelatin capsules size "4", red opaque body with red opaque cap imprinted with IG273 on cap and 5 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 31722-273-01), 500 (NDC 31722-273-05) and 1000 (NDC 31722-273-10). Ramipril 10 mg capsules are hard gelatin capsules size "4", blue opaque body with blue opaque cap imprinted with IG274 on cap and 10 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 31722-274-01), 500 (NDC 31722-274-05) and 1000 (NDC 31722-274-10). Dispense in well-closed container with safety closure. Store at controlled room temperature between 20° and 25°C (68° and 77°F) (See USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RAMIPRIL - RAMIPRIL CAPSULE
CAMBER PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
RAMIPRIL CAPSULES, USP, ORAL
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RAMIPRIL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RAMIPRIL.
RAMIPRIL (RAMIPRIL) CAPSULE FOR ORAL USE.
INITIAL U.S. APPROVAL: 1991
WARNING: AVOID USE IN PREGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ WHEN
USED IN PREGNANCY, ACE INHIBITORS CAN
CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. WHEN PREGNANCY IS
DETECTED, DISCONTINUE RAMIPRIL AS SOON
AS POSSIBLE (5.6).
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS
Dual Blockade of the Renin-Angiotensin- Aldosterone System:
Telmisartan (5.7) 10/2010
INDICATIONS AND USAGE
Ramipril capsules, USP are indicated for the treatment of
hypertension. It may be used alone or in combination with
thiazide diuretics. (1.1).
DOSAGE AND ADMINISTRATION
Hypertension: Initial dose is 2.5 mg to 20 mg once daily. Adjust
dosage according to blood pressure response after 2 to
4 weeks of treatment. The usual maintenance dose following titration
is 2.5 mg to 20 mg daily as a single dose or
equally divided doses (2.1).
Dosage adjustment: See respective sections pertaining to dosage
adjustment in special situations (2.5).
DOSAGE FORMS AND STRENGTHS
Capsule: 1.25 mg, 2.5 mg, 5 mg, 10 mg (3)
CONTRAINDICATIONS
Angioedema related to previous treatment with an ACE inhibitor, or a
history of hereditary or idiopathic angioedema.(4).
WARNINGS AND PRECAUTIONS
ACE inhibitor use has been associated with the following:
Angioedema, with increased risk in patients with a prior history (5.1)
Hypotension and hyperkalemia (5.5, 5.8)
Renal impairment: monitor renal function during therapy (5.3)
Increased risk of renal impairment when combined with another blocker
of the renin-angiotensin-aldosterone
system (5.7)
Rare cholestatic jaundice and hepatic failure (5.2)
Rare neutropenia and agranulocytosis (5.4)
ADVERSE REACTIONS
The most common adverse reactions in patients with hype