Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
Ramipril (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G)
Dr. Reddy's Laboratories Limited
Ramipril
Ramipril 1.25 mg
ORAL
PRESCRIPTION DRUG
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
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).
Abbreviated New Drug Application
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 Прочетете целия документ