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Ramipril (Ramipril)

Trade Name : Ramipril

West-Ward Pharmaceuticals Corp.

CAPSULE

Strength 1.25 mg/1

RAMIPRIL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ramipril (Ramipril) which is also known as Ramipril and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 1.25 mg/1 per ml. Read more

Ramipril (Ramipril) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 ().
  • Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ().
  • Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ().
  • 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 dose ().
  • 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. ().
  • Ramipril Capsules USP are supplied as hard gelatin capsules containing 1.25 mg, 2.5 mg, 5 mg and 10 mg of ramipril USP.
  • Capsule: 1.25 mg, 2.5 mg, 5 mg, 10 mg ()
  • 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).
  • Ramipril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ramipril within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor n
  • Do not co-administer ramipril with aliskiren:
  • Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema ().
  • Ramipril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ramipril within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor ().
  • Do not co-administer aliskiren with ramipril in patients with diabetes ().
  • Angioedema: increased risk in patients with a prior history ()
  • Hypotension and hyperkalemia (, )
  • Renal impairment: monitor renal function during therapy ()
  • Avoid concomitant use of an ACE inhibitor and angiotensin blocker ()
  • Rare cholestatic jaundice and hepatic failure ()
  • Rare neutropenia and agranulocytosis ()
  • The most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough ().
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or the FDA at 1-800-FDA-1088 or .
  • 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 ().
  • mTOR inhibitor or neprilysin inhibitor use may increase angioedema risk ()
  • Pregnancy: Discontinue drug if pregnancy is detected (, ).
  • Nursing Mothers: Ramipril use is not recommended in nursing mothers ().
  • 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.
  • No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of ramipril and its metabolites. Similarly, it is not known which, if any, of these substances can be effectively removed from the body by hemodialysis.
  • Angiotensin II could presumably serve as a specific antagonistu2011antidote in the setting of ramipril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of ramipril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat ramipril overdose by infusion of normal saline solution.
  • Ramipril USP is a 2u2011azau2011bicyclo [3.3.0]u2011octaneu20113u2011carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105u00b0C to 112u00b0C.
  • The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (23a6a)u20111-[()u2011u2011[()u20111-Carboxyu20113u2011phenylpropyl]alanyl]octahydrocyclopenta[]pyrroleu20112u2011carboxylic acid, 1u2011ethyl ester.
  • Ramipril Capsules USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1.
  • The structural formula for ramipril is:
  • Its molecular formula is CHNO, and its molecular weight is 416.51.
  • Ramiprilat, the diacid metabolite of ramipril, is a nonu2011sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.
  • No data
  • No evidence of a tumorigenic effect was found when ramipril was given by gavage to rats for up to 24 months at doses of up to 500 mg/kg/day or to mice for up to 18 months at doses of up to 1000 mg/kg/day. (For either species, these doses are about 200 times the maximum recommended human dose when compared on the basis of body surface area.) No mutagenic activity was detected in the Ames test in bacteria, the micronucleus test in mice, unscheduled DNA synthesis in a human cell line, or a forward geneu2011mutation assay in a Chinese hamster ovary cell line. Several metabolites and degradation products of ramipril were also negative in the Ames test. A study in rats with dosages as great as 500 mg/kg/day did not produce adverse effects on fertility.
  • No teratogenic effects of ramipril were seen in studies of pregnant rats, rabbits, and cynomologus monkeys. On a body surface area basis, the doses used were up to approximately 400 times (in rats and monkeys) and 2 times (in rabbits) the recommended human dose.
  • No data
  • Ramipril Capsules USP
  • 1.25 mg capsules are supplied as yellow, opaque capsules with u201c54 328u201d printed in black ink on the cap and body, containing a white to off-white powder.
  • NDC 0054-0106-25: Bottle of 100 Capsules
  • 2.5 mg capsules are supplied as orange, opaque capsules with u201c54 794u201d printed in black ink on the cap and body, containing a white to off-white powder.
  • NDC 0054-0107-25: Bottle of 100 Capsules
  • NDC 0054-0107-29: Bottle of 500 Capsules
  • NDC 0054-0107-20: 10x10 Unit-Dose
  • 5 mg capsules are supplied as red, opaque capsules with u201c54 145u201d printed in black ink on the cap and body, containing a white to off-white powder.
  • NDC 0054-0108-25: Bottle of 100 Capsules
  • NDC 0054-0108-29: Bottle of 500 Capsules
  • NDC 0054-0108-20: 10x10 Unit-Dose
  • 10 mg capsules are supplied as blue, opaque capsules with u201c54 602u201d printed in black ink on the cap and body, containing a white to off-white powder.
  • NDC 0054-0109-25: Bottle of 100 Capsules
  • NDC 0054-0109-29: Bottle of 500 Capsules
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF.
  • Angioedema:
  • Angioedema, including laryngeal edema, can occur rarely with treatment with ACE inhibitors, especially following the first dose. Advise patients to immediately report any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to temporarily discontinue drug until they have consulted with the prescribing physician.
  • Neutropenia:
  • Advise patients to promptly report any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia.
  • Symptomatic Hypotension:
  • Inform patients that lightheadedness 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.
  • Pregnancy:
  • Tell female patients of childbearing age about the consequences of exposure to ramipril during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physicians as soon as possible.
  • Hyperkalemia:
  • Advise patients not to use salt substitutes containing potassium without consulting their physician.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10004223/11
  • Revised December 2019
  • Ramipril Capsules USP, 1.25 mg
  • NDC 0054-0106-25
  • Rx only
  • Ramipril Capsules USP, 2.5 mg
  • NDC 0054-0107-25
  • Rx only
  • Ramipril Capsules USP, 5 mg
  • NDC 0054-0108-25
  • Rx only
  • Ramipril Capsules USP, 10 mg
  • NDC 0054-0109-25
  • Rx only

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