Amlife Plus

Amlife Plus

Manufacturer:

Therapharma

Distributor:

United Lab
Full Prescribing Info
Contents
Losartan potassium, amlodipine besilate, hydrochlorothiazide.
Description
50 mg/5 mg/12.5 mg FC tab: Each film-coated tablet contains: Losartan potassium 50 mg, Amlodipine (as besilate) equivalent to Amlodipine 5 mg, Hydrochlorothiazide 12.5mg.
100 mg/5 mg/12.5 mg FC tab: Each film-coated tablet contains: Losartan potassium 100 mg, Amlodipine (as besilate) equivalent to Amlodipine 5 mg, Hydrochlorothiazide 12.5 mg.
100 mg/10 mg/12.5 mg FC tab: Each film-coated tablet contains: Losartan potassium 100 mg, Amlodipine (as besilate) equivalent to Amlodipine to Amlodipine 10 mg, Hydrochlorothiazide 12.5 mg.
Indications/Uses
Losartan plus Amlodipine plus Hydrochlorothiazide is indicated for the treatment of mild to moderate hypertension. It is also indicated in hypertension not responding to monotherapy with calcium antagonists or angiotensin II receptor antagonists.
Dosage/Direction for Use
Losartan: Dosing must be individualized. The usual starting dose of Losartan is 50mg once daily, with 25mg recommended for patients with intravascular volume depletion and patients with a history of hepatic impairment. Losartan can be administered once or twice daily at total daily doses of 25 to 100mg.
Amlodipine: The usual initial antihypertensive oral dose of Amlodipine is 5mg once daily with a maximum dose of 10mg once daily.
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5mg once daily and this dose may be used when adding Amlodipine to other hypertensive therapy.
Adjust dosage according to patient's need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient's response to each dose level.
The recommended dose for chronic stable or vasospastic angina is 5-10mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10mg for adequate effect.
The recommended dose range for patients with coronary artery disease is 5-10mg once daily.
Hydrochlorothiazide: Hydrochlorothiazide is effective in doses of 12.5 to 50mg once daily and can be given at doses of 12.5 to 25mg.
Contraindications
The combination is contraindicated in patients who are hypersensitive to any component of this product.
Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
Special Precautions
Hypersensitivity: Angioedema.
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis.
In patients who are intravascularly volume-depleted (e.g., those treated with diuretics), symptomatic hypotension may occur after initiation of therapy. This condition should be corrected prior to administration.
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Amlodipine, particularly in patients with severe obstructive coronary artery disease.
Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
Lithium generally should not be given with thiazides.
All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance.
Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.
Used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women; discontinue the drug when pregnancy is detected.
Use In Pregnancy & Lactation
Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women; discontinue the drug when pregnancy is detected.
Adverse Reactions
The combination of Losartan, Amlodipine and Hydrochlorothiazide is well tolerated. Side effects include nausea, headache, dizziness, abdominal pain, fatigue, flushing, palpitation and asthenia.
Drug Interactions
Losartan: Cimetidine, Phenobarbital, rifampicin, Fluconazole.
Amlodipine: Diltiazem, Erythromycin, Ketoconazole, Itraconazole, Ritonavir.
Hydrochlorothiazide: Insulin, oral diabetes medication, other blood pressure medicine, alcohol; Barbiturates, such as: (Amobarbital, Butabarbital, Phenobarbital, Primidone Pentobarbital, Thiopental); Narcotics, such as codeine, morphine, oxycodone, and hydrocodone; Cholestyramine, Colestipol; Corticosteroids, such as prednisone, hydrocortisone, dexamethasone; Norepinephrine, Corticotropin; Muscle relaxants, such as tubocurarine; Lithium; Non-steroidal Anti-inflammatory Drugs (NSAIDs).
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
C09DX - Angiotensin II receptor blockers (ARBs), other combinations ; Used in the treatment of cardiovascular disease.
Presentation/Packing
50 mg/5 mg/12.5 mg FC tab 50's. 100 mg/5 mg/12.5 mg FC tab 50's. 100 mg/10 mg/12.5 mg FC tab 50's.
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