RAMIPRIL capsule
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
08-09-2011
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Active ingredient:
Ramipril (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G)
Available from:
Dr. Reddy's Laboratories Limited
INN (International Name):
Ramipril
Composition:
Ramipril 1.25 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Ramipril capsules are indicated for the treatment of hypertension. It 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 W a rnings 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% were ≥65 ye
Product summary:
Ramipril capsules, 1.25 mg are white to off-white powder filled in size ‘4’ hard gelatin capsule of opaque yellow colored cap and opaque white colored body imprinted with ‘RDY’ on cap and ‘438’ on body with black ink and are supplied in bottles of 30’s, 60’s, 90’s, 100’s, 500’s, 1000’s and Unit-dose packages 100 (10x10). Bottles of 30 NDC 55111-438-30 Bottles of 60 NDC 55111-438-60 Bottles of 90 NDC 55111-438-90 Bottles of 100 NDC 55111-438-01 Bottles of 500 NDC 55111-438-05 Bottles of 1000 NDC 55111-438-10 Unit-dose Packages 100 (10x10) NDC 55111-438-78 Ramipril capsules, 2.5 mg are white to off-white powder filled in size ‘4’ hard gelatin capsule of opaque orange colored cap and opaque white colored body imprinted with ‘RDY’ on cap and ‘439’ on body with black ink and are supplied in bottles of 30’s, 60’s, 90’s, 100’s, 500’s, 1000’s and Unit-dose packages 100 (10x10). Bottles of 30 NDC 55111-439-30 Bottles of 60 NDC 55111-439-60 Bottles of 90 NDC 55111-439-90 Bottles of 100 NDC 55111-439-01 Bottles of 500 NDC 55111-439-05 Bottles of 1000 NDC 55111-439-10 Unit-dose Packages 100 (10x10) NDC 55111-439-78 Ramipril capsules, 5 mg are white to off-white powder filled in size ‘4’ hard gelatin capsule of opaque swedish orange colored cap and opaque white colored body imprinted with ‘RDY’ on cap and ‘440’ on body with black ink and are supplied in bottles of 30’s, 60’s, 90’s 100’s, 500’s, 1000’s and Unit-dose packages 100 (10x10). Bottles of 30 NDC 55111-440-30 Bottles of 60 NDC 55111-440-60 Bottles of 90 NDC 55111-440-90 Bottles of 100 NDC 55111-440-01 Bottles of 500 NDC 55111-440-05 Bottles of 1000 NDC 55111-440-10 Unit-dose Packages 100 (10x10) NDC 55111-440-78 Ramipril capsules, 10 mg are white to off-white powder filled in size ‘4’ hard gelatin capsule of opaque light blue colored cap and opaque white colored body imprinted with ‘RDY’ on cap and ‘441’ on body with black ink and are supplied in bottles of 30’s, 60’s, 90’s, 100’s, 500’s, 1000’s and Unit-dose packages 100 (10x10). Bottles of 30 NDC 55111-441-30 Bottles of 60 NDC 55111-441-60 Bottles of 90 NDC 55111-441-90 Bottles of 100 NDC 55111-441-01 Bottles of 500 NDC 55111-441-05 Bottles of 1000 NDC 55111-441-10 Unit-dose Packages 100 (10x10) NDC 55111-441-78 Dispense in well-closed container with safety closure. Store at 20°-25°C (68°-77°F) excursions permitted to 15-30°C (59-86°F) (See USP Controlled Room Temperature).
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
RAMIPRIL- RAMIPRIL CAPSULE
DR. REDDY'S LABORATORIES LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RAMIPRIL CAPSULES SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR RAMIPRIL CAPSULES.
RAMIPRIL CAPSULES, ORAL
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 are indicated for the treatment of hypertension. It
may be used alone or in combination with thiazide
diuretics. (1.1). (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) (3)
CONTRAINDICATIONS
Angioedema related to previous treatment with an ACE inhibitor, or a
history of hereditary or idiopathic angioedema.(4).
(4)
(4)
WARNINGS AND PRECAUTIONS
ACE inhibitor use has been associated with the following: (5)
Angioedema, with increased risk in patients with a prior history (5.1)
Hypotension and hyperkalemia (5.5, 5.8)
impairment: monitor renal function during therapy (5.3)
Increased risk of renal impairment when combined with another blocker
of the rein-angiotensin-aldosterone system
(5.7)
Rare cholestatic jaundice and hepatic failure (5.2 )
Rare neutropenia and agranulocytosis (5.4)
(5)
ADVERSE REACTIONS
The most common adverse reactions in patients with hypertension
i
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