Under the category of the OTC/Nutraceutical products are listed the products which are sold without prescription. Members of Farmavita.net are invited to publish their out-license offers in this Category.

Description

Farmavita.Net member have readily available Lisinopril, tablets 5-10-20 mg, bulk supply with license for use of EU CTD Dossier.

Offer is valid subject to confirmation, country by country. Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.

 INDICATIONS AND USAGE
Hypertension

Lisinopril is indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.

Heart Failure

Lisinopril is indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis.

Acute Myocardial Infarction

Lisinopril is indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers.

In using Lisinopril, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that Lisinopril does not have a similar risk.

CLINICAL PHARMACOLOGY
Mechanism of Action

Lisinopril inhibits angiotensin converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of lisinopril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium. In hypertensive patients with normal renal function treated with PRINIVIL alone for up to 24 weeks, the mean increase in serum potassium was approximately 0.1 mEq/L; however, approximately 15 percent of patients had increases greater than 0.5 mEq/L and approximately six percent had a decrease greater than 0.5 mEq/L. In the same study, patients treated with PRINIVIL and hydrochlorothiazide for up to 24 weeks had a mean decrease in serum potassium of 0.1 mEq/L; approximately 4 percent of patients had increases greater than 0.5 mEq/L and approximately 12 percent had a decrease greater than 0.5 mEq/L. Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity.

More info at http://www.rxlist.com/cgi/generic/lisinop.htm

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Pharma licensing Out-licensing (offer)

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