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Indications/Uses
Treatment of mild to moderate hypertension in case of inadequate control with monotherapy.
Dosage/Direction for Use
Usual Initial Dose: 1 tablet daily. May be increased to 2 tablets daily. Similar doses are given in the treatment of stable angina and Prinzmetal's angina.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients with cardiogenic shock, recent myocardial infarction, acute unstable angina and chronic stable angina attack.
Use in pregnancy: Losartan is contraindicated in pregnancy.
Use in pregnancy: Losartan is contraindicated in pregnancy.
Special Precautions
Patients w/ renal artery stenosis; renal & hepatic impairment; hypotension; vol depletion or those on high-dose diuretic therapy; poor cardiac reserve, heart failure; severe aortic stenosis. Monitor serum K conc especially in the elderly & those w/ renal impairment & avoid concomitant use w/ K-sparing diuretics. Abrupt w/drawal. Discontinue use if ischemic pain occurs. Lactation.
Use In Pregnancy & Lactation
Use in pregnancy: Losartan is contraindicated in pregnancy.
Use in lactation: Losartan should be used cautiously at all, during breastfeeding.
Use in lactation: Losartan should be used cautiously at all, during breastfeeding.
Adverse Reactions
Dizziness, flushing, headache, hypotension, peripheral edema, tachycardia & palpitations. Nausea & other GI disturbances, increased micturition frequency, lethargy, eye pain & mental depression; paradoxical increase in ischemic chest pain (start of treatment), excessive fall in BP leading to cerebral or myocardial ischemia or transient blindness. Rashes (including erythema multiforme), fever & abnormalities in liver function including cholestasis; myalgia, tremor; impotence.
Drug Interactions
May enhance antihypertensive effects of β-blockers, aldesleukin, antipsychotics, quinidine, carbamazepine, phenytoin, rifampicin, cimetidine & erythromycin.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacokinetics: Losartan 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 hr and 3-4 hrs, respectively, after an oral dose. Both losartan and E-3174 are >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 if excreted in the urine and about 60% in the feces. The terminal elimination half-lives (t½) of losartan and E-3174 are about 1.5-2.5 hrs and 3-9 hrs, respectively.
Amlodipine is well-absorbed following oral administration with peak blood concentrations occurring after 6-12 hrs. The bioavailability is about 60-65%. Amlodipine is reported to be about 97.5% bound to plasma proteins. It has a prolonged terminal t½ of 35-50 hrs and steady-state plasma concentrations are not achieved until after 7-8 days of administration. Amlodipine is extensively metabolized in the liver; metabolite are mostly excreted in the urine together with <10% of a dose as unchanged drug.
Amlodipine is well-absorbed following oral administration with peak blood concentrations occurring after 6-12 hrs. The bioavailability is about 60-65%. Amlodipine is reported to be about 97.5% bound to plasma proteins. It has a prolonged terminal t½ of 35-50 hrs and steady-state plasma concentrations are not achieved until after 7-8 days of administration. Amlodipine is extensively metabolized in the liver; metabolite are mostly excreted in the urine together with <10% of a dose as unchanged drug.
MedsGo Class
Angiotensin II Antagonists / Calcium Antagonists / Anti-Anginal Drugs
Features
Dosage
5 mg / 50 mg
Ingredients
- Amlodipine
- Losartan Potassium
Packaging
Film-Coated Tablet 30's
Generic Name
Amlodipine Besilate / Losartan Potassium
Registration Number
DRP-5685-08
Classification
Prescription Drug (RX)
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