Prilas 5 and 10 Lisinopril Tablets

Prilas® – 5 Lisinopril Tablets USP 5mg and Prilas® – 10 Lisinopril Tablets USP 10mg

Generic name, Composition, Pharmaceutical form, Therapeutic indications, Posology and Method of administration, Starting dose, Maintenance dose, Dosage adjustment, Paediatric use, Use in the elderly, Use in kidney transplant patients, Contraindications, Interactions, Pregnancy and Lactation uses, Effects on ability to drive and use machines, Undesirable effects, Overdose, Dosage, Presentation, Storage, Warning, NAFDAC Registration No., Manufacturer and Marketer of Prilas Tablet for Hypertension.

 

 Composition

Each uncoated tablet contains:

Lisinopril USP equivalent to Lisinopril (Anhydrous) 5mg

Lisinopril USP equivalent to Lisinopril (Anhydrous) 10mg

 

Pharmaceutical form

Round tablets

 

Therapeutic indications

 

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.

 

Renal complications of diabetes mellitus

In normotensive insulin-dependent and hypertensive non-insulin-dependent diabetes mellitus patients who have incipient nephropathy characterized by microalbuminuria, Prilas reduces urinary albumin excretion rate.

 

Posology and method of administration

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

The dose should be individualized according to patient profile and blood pressure response (see Special warnings and precautions for use).

 

Hypertension

Prilas may be used as monotherapy or in combination with other classes of antihypertensive therapy.

 

Starting dose

In patients with hypertension the usual recommended starting dose is 10mg. patients with a strongly activated rennin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or colume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 2.5 – 5.0mg is recommended in such patients and the initiation of treatment should take place under medical supervision. A lower starting dose is required in the presence of renal impairment (see Table 1).

 

Maintenance dose

The usual effective maintenance dosage is 20mg administered in a single daily dose.

 

Diuretic-treated patients

Symptomatic hypotension may occur following initiation of therapy with Prilas. This is more likely in patients who are being treated currently with diuretics. Caution is recommended, therefore, since these patients may be volume and/or salt depleted. If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with Prilas. In hypertensive patients in whom the diuretic cannot be discontinued, therapy with Prilas should be initiated with a 5mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of Prilas should be adjusted according to blood pressure response. If required, diuretic therapy may be resumed (see Special warnings and precautions for use and interactions).

 

Dosage adjustment in renal impairment

Dosage in patients with renal impairment should be based on creatinine clearance as outlined in Table 1 below.

 

Table 1 Dosage adjustment in renal impairment

Creatinine Clearance (ml/min) Starting Dose (mg/day)
Less than 10 ml/min (including patients on dialysis) 2.5mg*
10 – 30 ml/min 2.5 – 5.0mg
31 – 70 ml/min 5.0 – 10.0mg

*Dosage and/or frequency of administration should be adjusted depending on the blood pressure response.

The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40mg daily.

 

Heart failure

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

 

Acute myocardial infraction

Patients should receive, as appropriate, the standard recommended treatmenst such as thrombolytics, aspirin, and blockers. Intravenous or transdermal glyceryl trinitrate may be used together with Prilas.

 

Starting dose (first 3 days after infraction)

Treatment with Prilas may be started within 24 hours of the onset of symptoms. Treatment should not be started if systolic blood pressure is lower than 100mmHg. The first dose od Prilas is 5mg given orally, followed by 5mg after 24 hours, 10mg after 48 hours and then 10mg once daily. Patients with a low systolic blood pressure (120mmHg or less) when treatment is started or during the first 3 days after the infarction should be given a lower dose 2.5mg orally.

 

Maintenance dose

The maintenance dose is 10mg once daily. If prolonged hypotension occurs (systolic blood pressure less than 90mmHg for more than 1 hour) Prilas should be withdrawn.

 

Renal complications of diabetes mellitus

In normotensive insulin-dependent diabetes mellitus patients, the daily dose is 10mg once daily which can be increased to 20mg once again.

 

Paediatric use

Use in children is not recommended.

 

Use in the elderly

The dosage should be adjusted according to the blood pressure response.

 

Use in kidney transplant patients

Treatment with Prilas is therefore not recommended

 

Contraindications

  • Hypersensitivity to Prilas, 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.
  • Second or third trimesters of pregnancy (see Pregnancy and lactation).

 

Interactions

Diuretics

When a diuretic is added to the therapy of a patient receiving Prilas the antihypertensive effect is usually additive.

 

Potassium supplements, potassium-sparing diuretics or potassium-containing salt substitutes

The use of potassium supplements, potassium-sparing diuretics or potassium-containing salt substitutes, particularly in patients with impaired renal function, may lead to a significant increase in serum potassium.

 

Lithium

Reversible increase in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.

 

Non steroidal anti-inflammatory drugs (NSAIDs) including acetyisalicylic acid>3g/day

Chronic administration of NSAIDs may reduce the antihypertensive effect of an ACE inhibitor.

 

Other antihypertensive agents

Concomitant use of these agents may increase the hypotensive effects of Prilas.

 

Tricylic antidepressants/Antipsychotics/Anaesthetics

Concomitant use of certain anaesthetic medicinal products, Tricylic antidepressants and antipsychotics with ACE inhibitors may result further reduction of blood pressure.

 

Sympathomimetics

Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.

 

Antidiabetics

Epidemiological studies have suggested that concomitant administration of ACE inhibitors and antidiabetic medicines (insulins, oral hypoglycaemic agents) may cause an increased blood glucose lowering effect with risk of hypoglycaemia.

 

Acetyisalicylic acid, thrombolytics, beta-blockers, nitrates

Prilas may be used concomitantly, with acetyisalicylic acid (at cardiologic doses), thrombolytics, beta-blockers and/or nitrates.

 

Pregnancy and lactation

Pregnancy

Prilas is contraindicated during pregnancy.

 

Lactation

The use of Prilas is not recommended in women who are breast – feeding.

 

Effects on ability to drive and use machines

When driving vehicles or operating machines it should be taken into account that occasionally dizziness or tiredness may occur.

 

Undesirable effects

The following undesirable effects have been observed and reported durin treatment with Prilas and other ACE inhibitors with the following frequencies: Very common (> 10%), common (> 1%, < 10%), uncommon (> 0.1%, < 1%), very rare (< 0.01%) including isolated reports.

 

Blood and the lymphatic system disorders

Rare: decreases in haemoglobin, decrease in haenatocrit.

Very rare: bone marrow depression, anaemia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis, haemolytic anaemia, lymphadenopathy, autoimmune disease.

 

Metabolism and nutrition disorders

Very rare: hypoglycaemia.

 

Nervous system and psychiatric disorders

Common: dizziness, headache.

Uncommon: mood alterations, paraesthesia, vertigo, taste disturbance, sleep disturbance.

Rare: mental confusion.

 

Cardiac and vascular disorders

Common: orthostatic effects (including hypertension)

Uncommon: myocardial infarction ot cerebrovascular accident, possibly secondary to excessive hypertension in high risk patients, palpitations, tachycardia. Raynaud’s phenomenon.

 

Respiratory, thoratic and mediastinal disorders

Common: cough

Uncommon: rhinitis.

Very rare: bronchospasm, sinusitis. Allergic alveolitis/eosinophilic pneumonia.

 

Gastrointestinal disorders

Common: diarrhea, vomiting.

Uncommon: nausea, abdominal pain and indigestion.

Rare: dry mouth.

Very rare: pancreatitis, intestinal angioedema, hepatitis either hepatocellular or cholestatic, jaundice and hepatic failure.

 

Skin and subcutaneous tissue disorder

Uncommon: rash, pruritus.

Rare: hypersensitivity/angioneurotic cedema: angioneurotic oedema of the face, lips, tongue, urticaria, alopecia, psoriasis.

Very rare: diaphoresis, toxic epidermal necrolysis, Steven-Johnson syndrome.

 

Renal and urinary disorders

Common: renal dysfunction.

Rare: uraemia, acute renal failure.

Very rare: oliguria.

 

Overdose

Limited data are available for overdose in humans.

 

Dosage

As directed by the physician.

 

Presentation

Carton of 2 x 14 Tablets.

 

Storage

Store in a cool and dry place, below 25oC.

 

Warning

Keep all medicines away from children.

 

NAFDAC Registration No. A4-3335

 

Manufactured by

Osaka Pharmaceuticals Pvt. Ltd.

Old National Highway No. 8, Sankarda – 391 350,

Dist. Vadodara, Gujarat, India.

 

Marketed by

Seagreen Pharmaceuticals Ltd.

3, Okunfolami Street, Anthony Village,

Lagos, Nigeria.

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