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RAMIPRIL | RAMIPRIL [DirectRX] | BioPortfolio

13:32 EST 27th January 2019 | BioPortfolio
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Ramipril capsules are supplied as hard gelatin capsules containing 2.5 mg, 5 mg, and 10 mg of ramipril

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).

Do not coadminister ramipril capsules with aliskiren: in patients with diabetes

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 antagonist-antidote 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 is a 2-aza-bicyclo[3.3.0]-octane-3-carboxylic acid derivative. It is a white or almost white crystalline powder soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C and 112°C.

The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)-1[(S)-N-[(S)-1-carboxy-3-phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid, 1-ethyl ester; its structural formula is:

Chemical structure for ramipril

C23H32N2O5 M.W. 416.5

Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.

Ramipril is supplied as hard shell capsules for oral administration containing 2.5 mg, 5 mg, and 10 mg of ramipril. The inactive ingredients are black iron oxide, gelatin, lactose anhydrous, pregelatinized starch, propylene glycol, shellac, sodium stearyl fumarate, and titanium dioxide. The imprinting ink may contain potassium hydroxide. Additionally, the 2.5 mg capsule shell contains yellow iron oxide and red iron oxide, the 5 mg capsule shell contains red iron oxide, and the 10 mg capsule shell contains FD&C Blue #2.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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 gene-mutation 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 cynomolgus 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

Manufacturer

DirectRX

Active Ingredients

Source

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Ramipril [direct rx]

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Clinical Trials [86 Associated Clinical Trials listed on BioPortfolio]

Higher Dose of Ramipril Versus Addition of Telmisartan-Ramipril in Hypertension and Diabetes

The purpose of this study is to determine if a dose of ramipril combined with a normal dose of telmisartan 80 mg will be more effective than ramipril 20 mg in reducing microalbuminuria in ...

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The objective is to investigate the safety of ramipril 10 mg/day used in prevention of cardiovascular events in high-risk patients, including the criteria of the HOPE study.

Testing Ramipril to Prevent Memory Loss in People With Glioblastoma

This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chem...

Pharmacodynamic Equivalence of Ramipril 10 mg and Atorvastatin 40 mg Administered as a Cardiovascular (CV) Polypill Acetylsalicylic Acid-Atorvastatin-Ramipril (AAR) as Compared to Monotherapy

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Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension

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PubMed Articles [3 Associated PubMed Articles listed on BioPortfolio]

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