LOSARTAN-ELSaad 25
-
Chemical Name:
Losartan Potassium -
Therapeutic Category:
Cardiovascular drugs -
Pharmacologic Category:
Angiotensin II Receptor Blocker -
Pharmaceutical Form:
Tablets -
Composition:
Losartan Potassium 25mg
LOSARTAN ELSaad
Film Coated Tablets
Losartan Potassium
Antihypertensive
1.PHARMACOLOGY:
Losartan is an angiotensin II receptor antagonist with antihypertensive activity mainly due to selective blocked of AT1.
Neither Losartan nor its potent active metabolite inhibits ACE (Kininase II), the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin, nor do they bind to or block other hormon receptors or ion channels known to be important in cardiovascular regulation.
2.PHARMACOKINETICS:
Losartan is well absorbed. The bioavailability is approximately 33 %. About 14 % of an orally administered dose of Losartan is converted to the active metabolite.
Mean peak concentrations of Losartan and its active metabolite are reached in 1 hour (Losartan) and 3-4 hours (its active metabolite).
The terminal half-life of Losartan is about 2 hours and of the metabolite is about 6-9 hours.
3.INDICATIONS:
LOSARTAN ELSaad is indicated for the treatment of hypertension.
LOSARTAN ELSaad may be used alone or in combination with other antihypertensive agents.
4.CONTRAINDICATIONS:
Hypersensitivity to any component of this product.
5.PRECAUTIONS:
- Care should be taken in patients whose renal function may depend on the activity of the renin-angiotensin- aldosterone system.
- In case of impaired hepatic function, a lower dose should be considered.
- Care should be taken in patients with severe congestive heart failure because of possible hypotension or in patients who are intravascularly volume-depleted (e.g., those treated with diuretics).
- Care should be taken in patients previously experienced angioedema.
- A patient should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.
- Pregnancy and lactation: Pregnancy categories: C (first trimester) and D (second and third trimesters). Nonetheless, when patients become pregnant, physicians should have the patient discontinue the use of Losartan as soon as possible.
Because of the effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
6.SIDE EFFECTS:
In general, treatment with Losartan is well - tolerated.
It may rarely cause diarrhea, dyspepsia, muscle cramp, dizziness, insomnia and cough.
7.DRUG INTERACTIONS:
- There is no significant drug-drug pharmacokinetic interactions with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital.
- As with other drugs that block Angiotensin II or its effects, concomitant use of potassium sparing diuretics (e.g. spironolactone, triamterene, amiloride), potassium supplements, or oral substitutes containing potassium may lead to increase in serum potassium.
- Potent inhibitors of cytochrome (ketoconazole, gestodene, sulfaphenazole) show significant inhibition of the formation of the active metabolite.
8.DOSAGE & ADMINISTRATION:
Usual starting dose: 50 mg once daily.
LOSARTAN ELSaad can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.
In patients with possible depletion of intravascular volume (e.g. patients treated with diuretics): 25 mg .
LOSARTAN ELSaad may be administered with other antihypertensive agents.
LOSARTAN ELSaad may be administered with or without food.
9.PACKAGING & COMPOSITION:
- LOSARTAN ELSaad 25 – F.C.Tablets: A pack of 20 f.c.tablets in blister. Each film coated tablet contains Losartan Potassium 25 mg.
- LOSARTAN ELSaad 50 – F.C.Tablets: A pack of 20 f.c.tablets in blister. Each film coated tablet contains Losartan Potassium 50 mg.
- LOSARTAN ELSaad 100 – F.C.Tablets: A pack of 10 or 20 f.c.tablets in blister. Each film coated tablet contains Losartan Potassium 100 mg.
10.STORAGE CONDITIONS:
Store LOSARTAN ELSaad – F.C.Tablets at temperature between (15-30)°C. Protect from light.
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