Ramipril-2.5 Tablet

1. 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 ). • Ramipril capsules USP are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3 ). 1.1 Hypertension Ramipril capsules USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. …

• DOSAGE AND ADMINISTRATION • Hypertension: Initial dose is 2.5 mg to 20 mg once daily
• Adjust dosage according to blood pressure response after 2–4 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 . • Heart failure post-myocardial infarction: Starting dose of 2.5 mg twice daily
• If patient becomes hypotensive at this dose, decrease dosage to 1.25 mg twice daily
• Increase dose as tolerated toward a target dose of 5 mg twice daily, with dosage increases about 3 weeks apart . • Dosage adjustment: See respective sections pertaining to dosage adjustment in special situations
• Hypertension The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day
• Adjust dose according to blood pressure response
• The usual maintenance dosage range is 2.5 mg to 20 mg per day administered as a single dose or in two equally divided doses
• In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval
• In such patients, consider an increase in dosage or twice daily administration
• If blood pressure is not controlled with ramipril alone, a diuretic can be added
• Heart Failure Post-Myocardial Infarction
• For the treatment of post-myocardial infarction patients who have shown signs of congestive heart failure, the recommended starting dose of ramipril is 2.5 mg twice daily (5 mg per day)
• A patient who becomes hypotensive at this dose may be switched to 1.25 mg twice daily. …

3. DOSAGE FORMS AND STRENGTHS Capsule: 1.25 mg, 2.5 mg, 5 mg, 10 mg ( 3 ) Ramipril capsules USP are supplied as hard gelatin capsules containing 1.25 mg, 2.5 mg, 5 mg, and 10 mg of ramipril.

• Neonates with a history of in utero exposure to ramipril If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion
• Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function
• Ramipril, which crosses the placenta, can theoretically be removed from the neonatal circulation by these means, but limited experience has not shown that such removal is central to the treatment of these
• Infants
• Safety and effectiveness
• Pediatric patients have not been established. …

Of the total number of patients who received ramipril in U.S. clinical studies of ramipril, 11.0% were ≥65 years of age while 0.2% were ≥75 years of age. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be …

• PATIENT COUNSELING INFORMATION Angioedema Angioedema, including laryngeal edema, can occur rarely with treatment with ACE inhibitors, especially following the first dose
• Advise patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to take no more drug until they have consulted with the prescribing physician
• Neutropenia Advise patients to report promptly any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia. …

• CONTRAINDICATIONS Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema
• Ramipril is 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)

7. DRUG INTERACTIONS • Diuretics: Possibility of excessive hypotension ( 7.1 ). • Lithium: Use with caution ( 7.3 ). • Gold: Nitritoid reactions have been reported ( 7.4 ). • NSAIDS use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.5 ). 7.1 Diuretics Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with ramipril. The possibility of hypotensive effects with ramipril can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with ramipril. …

5. 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 ) 5.1 Anaphylactoid and Possibly Related Reactions Presumably because drugs that act directly on the renin-angiotensin-aldosterone system (e.g., ACE inhibitors) affect the metabolism of eicosanoids and p …

6. ADVERSE REACTIONS The most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Pregnancy Category D 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. …

10. OVERDOSAGE Single oral doses of ramipril in rats and mice of 10 g/kg to 11 g/kg resulted in significant lethality. In dogs, oral doses as high as 1 g/kg induced only mild gastrointestinal distress. Limited data on human overdosage are available. The most likely clinical manifestations would be symptoms attributable to hypotension. Laboratory determinations of serum levels of ramipril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of ramipril overdose. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.