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Zartan-S

Zartan-S

losartan

Manufacturer:

Hizon

Distributor:

Sigma Medical Solution Trading
Full Prescribing Info
Contents
Losartan potassium.
Description
Each film-coated tablet contains: Losartan potassium 50 mg/100 mg.
50 mg: White to off-white, oblong, biconvex, film-coated tablet.
100 mg: White to off-white, oval, biconvex, film-coated tablet, plain on both sides.
Action
Angiotensin II Receptor Blocker.
Pharmacology: Pharmacodynamics: Losartan Potassium is an angiotensin II receptor antagonist with antihypertensive activity due mainly to selective blockade AT1 receptors and the consequent reduced pressor effect of angiotensin II.
Pharmacokinetics: Losartan Potassium is readily absorbed from the gastrointestinal tract following oral administration, with an oral bioavailability of about 33%. It undergoes first-pass metabolism to form an active carboxylic acid metabolite E-3174 (EXP-3174), which has greater pharmacological activity than losartan, and some inactive metabolites. Metabolism is primarily by cytochrome P450 isoenzymes CYP2C9 and CYP3A4. Peak plasma concentrations of losartan and E-3174 occur about 1 hour and 3 to 4 hours, respectively, after an oral dose. Both losartan and E-3174 are more than 98% bound to plasma proteins. Losartan is excreted in the urine and in the feces via bile, as unchanged drug and metabolites. Following oral dosing, about 35% of the dose is excreted in the urine and about 60% in the feces. The terminal elimination half-lives of losartan and E-3174 are about 1.5 to 2.5 hours and 3 to 9 hours respectively.
Indications/Uses
For the management of hypertension, particularly in patients who develop cough with ACE inhibitors; for the treatment of diabetic nephropathy.
Dosage/Direction for Use
Usual dose is 50 mg once daily.
The dose may be increased, if necessary, to 100 mg daily as a single dose or in two divided doses. An initial dose of 25 mg once daily may be used in the elderly over 75 years, and for patients with moderate to severe renal impairment (creatinine clearance less than 20 mL per minute), or intravascular fluid depletion.
A reduced dose should also be considered for patients with hepatic impairment.
Or as prescribed by the physician.
Contraindications
Losartan Potassium is contraindicated in pregnancy.
Special Precautions
Losartan Potassium should be used with care, if at all, during breastfeeding. It should be used with caution in patients with renal artery stenosis. Reduced doses may be required in patients with renal or hepatic impairment. Patients with volume depletion may experience hypotension.
Use In Pregnancy & Lactation
Losartan is contraindicated in pregnancy because it has been associated with fetal toxicity.
Adverse Reactions
Adverse effects include dizziness and dose-related orthostatic hypotension. Hypotension may occur particularly in patients with volume depletion (for example those who have received high-dose diuretics). Losartan Potassium may cause hyperkalaemia in patients with renal disease. Other adverse effects that have been reported with angiotensin II receptor antagonist include respiratory tract disorder, back pain, gastrointestinal disturbances, fatigue, and neutropenia.
ADR Reporting: Patient should seek medical attention immediately at the first sign of any adverse drug reaction.
Drug Interactions
The antihypertensive effects of losartan may be potentiated by drugs or other agents that lower blood pressure. Additive hyperkalaemic effect is possible with potassium supplements, potassium-sparing diuretics, or other drugs that can cause hyperkalaemia; losartan and potassium-sparing diuretics should not generally be given together. NSAIDs should be used with caution in patients taking losartan as the risk of renal impairment may be increased, particularly in those who are inadequately hydrated; use of NSAIDs may also attenuate the hypotensive effect of losartan.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA01 - losartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Zartan-S FC tab 100 mg
Packing/Price
100's
Form
Zartan-S FC tab 50 mg
Packing/Price
100's
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