Pocco Lisinopril Dihydrate Tablets

POCCO LISINOPRIL 10 mg
(Lisinopril Tablets USP)

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory.

 

COMPOSITION

Each tablet contains:

Lisinopril Dihydrate USP

Equivalent to Anhydrous Lisinopril 10 mg

Also contains mannitol.

 

CLINICAL PHARMACOLOGY

PHARMACOLOGICAL 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, angiotensinII. 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.

 

INDICATIONS AND USAGE

Hypertension: Treatment of hypertension.

Heart failure: Treatment of symptomatic heart failure.

Acute myocardial infarction: Short-term (6 weeks) treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction.

 

CONTRAINDICATIONS

Hypersensitivity to lisinopril, to any of the excipients or any other angiotensin converting enzyme (ACE) inhibitor.

History of angioedema associated with previous ACE inhibitor therapy.

Hereditary or idiopathic angioedema.

 

DRUG INTERACTIONS

In general, lisinopril should not be taken with potassium supplements or diuretics that conserve potassium, for example, hydrochlorothiazide/ triamterene (Dyazide), since blood potassium levels may rise to dangerous levels.

There have been reports that aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Advil, Children’s Advil/Motrin, Medipren, Motrin, Nuprin, PediaCare Fever, and many others), indomethacin (Indocin, Indocin-SR), and naproxen (Anaprox, Naprelan, Naprosyn, Aleve) may reduce the effects of ACE inhibitors.

 

WARNING

Pregnancy

FDA pregnancy category D: Use of lisinopril is contraindicated (see Black Box Warning). Animal and human data have revealed evidence of embryolethality and teratogenicity associated with angiotensin converting enzyme (ACE) inhibitors. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible.

Lactation

A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes ACE inhibitors have the potential to adversely affect a nursing infant.

 

PRECAUTION

Tell your doctor and pharmacist if you are allergic to lisinopril, enalapril (Vasotec), benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), moexipril (Univase), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik), or any other medications.

Tell your doctor if you have or have ever had heart or kidney disease; diabetes; lupus; scleroderma; or angioedema, a condition that causes difficulty swallowing or breathing and painful swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs.

Tell your doctor if you plan to become pregnant or are breast-feeding.

 

ADVERSE REACTION

Get emergency medical help if you have any of these signs of an allergic reaction to lisinopril: hives; severe stomach pain, difficult breathing; swelling of your face, lips, tongue, or throat.

A light-headed feeling, like you might pass out, little or no urinating, swelling, rapid weight gain, fever, chills, body aches, flu symptom, tired feeling, muscle weakness, and pounding or uneven heartbeats, psoriasis (raised, silvery flaking of the skin), chest pain, high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

 

DRUG ABUSE AND DEPENDENCE

None.

 

SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

Limited data are available for overdose in humans. Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.

 

DOSAGE AND ADMINISTRATION

Lisinopril should be administered orally in a single daily dose. As with all other medication taken once daily, lisinopril should be taken at approximately the same time each day. The absorption of lisinopril tablets is not affected by food.

Hypertension
Lisinopril may be used as monotherapy or in combination with other classes of antihypertensive medicinal products.

Starting dose is 10mg and effective maintenance dosage is 20mg administered in a single daily dose.

Heart failure

In patients with symptomatic heart failure, lisinopril should be used as adjunctive therapy to diuretics and, where appropriate, digitalis or beta-blockers. Lisinopril may be initiated at a starting dose of 2.5mg once a day, which should be administered under medical supervision to determine the initial effect on the blood pressure.

 

Presentation

14 x 2 Calendar Pack Tablets

 

Storage Instructions

Store at a temperature not exceeding 30°C in a dry place, protected from light.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

 

Manufactured by

Scott-Edil Pharmacia Ltd.

56, E.P.I.P., Phase-I, Jharmajri – 173 205, Distt. Solan, INDIA.

 

Imported and Distributed by

First J POCCO PHARM LTD.

89, DENIS OSADEBE WAY, ASABA,

DELTA STATE, NIGERIA.

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