Amlosafe LS (5+5) Tablet

Uses of Amlosafe LS (5+5) Tablet

Antihypertensive

Side Effects of Amlosafe LS (5+5) Tablet

Nausea, headache, dizziness, cough, diarrhoea, fatigue, rash, oedema, flushing, palpitation, chest pain, asthenia, dry mouth; elevations in BUN, serum creatinine and potassium may occur. Potentially Fatal: Angioneurotic oedema reported with ACE inhibitors.

Drug Interactions

There is an increased risk of hypotension with concurrent use of antihypertensives with alprostadil. Amlodipine: Increased risk of hypotension with concurrent use with alprostadil, non-nucleoside reverse trancriptase inhibitors and cytochrome P450 inhibitors such as protease inhibitors (such as ritonovir), quinupristin/dalfopristin, azole antifungals (such as itraconazole and ketoconazole). Reduced effect of amlodipine with cytochrome P450 inducers such as phenobarbital, primidone, rifampicin and St John's Wort. Lisinopril: It reduces potassium loss caused by thiazides. Patients on diuretics may experience increased reduction in BP. Hyperkalaemia with concomitant use of potassium-sparing diuretics/potassium supplements may occur. Lisinopril may increase serum lithium levels; monitoring of serum lithium levels is recommended. Concurrent use with NSAIDs may further worsen renal function in patients with renal impairment; may also reduce the antihypertensive effect of lisinopril.

Contraindications

Hypersensitivity to either component, history of angioedema related to ACE inhibitor, patients with hereditary or idiopathic angioedema. Pregnancy & lactation.

Mechanism of Action

Amlodipine is a dihydropyridine calcium channel blocker that inhibits transmembrane influx of calcium ions into the vascular smooth muscle and cardiac muscle. Lisinopril is an angiotension-converting enzyme inhibitor that reduces BP, mainly by suppressing the renin-angiotensin-aldosterone system. Absorption: Amlodipine: Plasma levels peak between 6-12 hr after oral admin; absolute bioavailability is about 64-90%. Lisinopril: Serum levels peak at approx 7 hr after oral admin. Distribution: Amlodipine: Volume of distribution: 21L/kg; protein-binding: 93 to 98%. Lisinopril: Protein-binding: 25% Metabolism: Amlodipine: About 90% converted to inactive metabolites by the liver. Lisinopril: Does not undergo metabolism. Excretion: Amlodipine: 10% of the parent drug and 60% of the metabolites are removed in the urine; terminal elimination half-life of about 30-50 hr. Lisinopril: Excreted unchanged entirely in the urine; elimination half-life: 11-12 hr.

Special Precautions

Renal impairment, hepatic impairment and heart failure. Caution when used in patients with severe obstructive coronary artery disease due to risk of increased frequency, duration and/or severity of angina or acute MI. Safety and efficacy have not been established in children.

How to Use

Take orally with food and water, as directed by your physician.

How to Store

Keep in a cool, dry place away from sunlight and moisture.

Safety Concerns

• Alcohol: Avoid during treatment.
• Breastfeeding: Not recommended.
• Pregnancy: Contraindicated.
• Liver/Kidney: Use with caution.

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