MedCallyLooking up the FDA label…
Looking up the FDA label…
Angiotensin Converting Enzyme Inhibitor
FDA boxed warning
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning • When pregnancy is detected, discontinue ramipril as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue ramipril as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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.. • Ramipril capsules USP are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction. 1.1 Hypertension Ramipril capsules USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. 1.3 Heart Failure Post-Myocardial Infarction Ramipril capsules USP are indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of ramipril to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure.
17. PATIENT COUNSELING INFORMATION 17.1 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. 17.2 Neutropenia Advise patients to report promptly any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia. 17.3 Symptomatic Hypotension Inform patients that light-headedness can occur, especially during the first days of therapy, and it should be reported. Advise patients to discontinue ramipril if syncope (fainting) occurs, and to follow up with their health care providers. Inform patients that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting while taking ramipril can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. 17.4 Pregnancy Female patients of childbearing age should be told about the consequences of exposure to ramipril during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible. 17.5 Hyperkalemia Advise patients not to use salt substitutes containing potassium without consulting their physician. Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Goa - 403 722 INDIA. Revised: February 15, 2013 ID#: 231272 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320
6. ADVERSE REACTIONS The most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough. 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 dr…
Having one of these?
A doctor will tell you whether it matters and what to do about it. Written answer, a week of free follow-ups.
Ask a doctor — $19.994. 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).
2. 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,…
7. DRUG INTERACTIONS • Diuretics: Possibility of excessive hypotension. • Lithium: Use with caution. • Gold: Nitritoid reactions have been reported. • NSAIDS use may lead to increased risk of renal impairment and loss of antihypertensive effect. 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 b…
Taking something else alongside it?
Interaction warnings are written per drug, not for your particular combination. A doctor can check yours.
Ask about my combinationWorks in a similar way — ace inhibitors
These are different medicines in the same family, not swaps for each other. Which one suits you is a prescribing decision.