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LOSARTAN BOSTON 50

COMPOSITION:
Each film-coated tablet contains:
Active ingredient: Losartan potassium……………………..50 mg
Excipients: Avicel, Lactose, Prejel, HPC, Magnesium stearate, HPMC, PEG 6000, Titanium dioxide, Carnauba wax, Ethanol 96%, Purified water q.s for one film-coated tablet.

 

Rx PRESCRIPTION ONLY MEDICINE
COMPOSITION:

Each film-coated tablet contains:
Active ingredient: Losartan potassium……………………..50 mg
Excipients: Avicel, Lactose, Prejel, HPC, Magnesium stearate, HPMC, PEG 6000, Titanium dioxide, Carnauba wax, Ethanol 96%, Purified water q.s for one film-coated tablet.
PHARMACODYNAMICS:
Losartan is an angiotensin II receptor antagonist with antihypertensive activity. It and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g., vascular smooth muscle, adrenal gland).
Losartan is a reversible, competitive inhibitor of the AT1 receptor. The active metabolite is 10 to 40 times more potent by weight than losartan and appears to be a reversible, non-competitive inhibitor of the AT1 receptor.
Neither losartan nor its active metabolite inhibits ACE (kininase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin). Therefore, it appears less likely than ACE inhibitors to cause cough.
PHARMACOKINETICS:
Losartan is readily absorbed from the gastrointestinal tract after oral doses, but undergoes substantial first-pass metabolism by cytochrome P450 enzymes; the systemic bioavailability of losartan is about 33%. About 14% of an orally-administered dose of losartan is converted to an active carboxylic acid metabolite; some inactive metabolites are also formed.
Peak plasma concentrations of losartan and its active metabolite occur about 1 hour and 3 to 4 hours, respectively. Both losartan and its active metabolite are more than 98% bound to plasma proteins.
Losartan is excreted in the urine, and in the faeces, as unchanged drug and metabolites. About 4% of an oral dose is excreted unchanged in urine and about 6% is excreted in urine as the active metabolite. Following oral 14 C-labeled losartan, about 35% of radioactivity is recovered in the urine and about 60% in the feces.
The terminal half-life of losartan is about 2 hours and of the metabolite is about 6 - 9 hours.
In patients with mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of losartan and its active metabolite were more than respectively about 5 times and 1.7 times in young male volunteers.
INDICATIONS:
For treatment of hypertension, particularly in patients who develop cough with ACE inhibitors or to reduce the risk of stroke in patients with left ventricular hypertrophy. It may be used alone or in combination with other antihypertensive agents.
For renal protection in type 2 diabetic patients with nephropathy.
DOSAGE AND ADMINISTRATION:
Administration: Losartan BOSTON 50 is administered orally without regard to meals.
Dosage:
Adult hypertensive patients:
The usual starting dose is 50 mg once daily.
In patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) and patients with a history of hepatic impairment: 25 mg once daily.
This drug can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.
No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis.
Hypertensive Patients with Left Ventricular Hypertrophy
The usual starting dose is 50 mg once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of losartan should be increased to 100 mg once daily based on blood pressure response.
Nephropathy in Type 2 Diabetic Patients
The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response. Losartan may be administered with insulin and other commonly used hypoglycemic agents (e.g., sulfonylureas, glitazones and glucosidase inhibitors).
CONTRAINDICATIONS:
Known hypersensitivity to losartan or any ingredient of the drug.
PRECAUTIONS:
It should be used with caution in patients with renal artery stenosis and in patients with hepatic impairment.
    In patients with unilateral or bilateral renal artery stenosis taking losartan,  increased serum creatinine or blood urea nitrogen (BUN) have been reported. These effects were reversible upon discontinuation of therapy.
Patients with volume depletion (for example those who have received high-dose diuretic therapy) may experience hypotension; volume depletion should be corrected before starting therapy, or a low initial dose should be used.
Since hyperkalaemia may occur, serum potassium concentrations should be monitored, especially in the elderly and patients with renal impairment. The concomitant use of potassium-sparing diuretics should generally be avoided.
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function have been reported in susceptible individuals treated with losartan; these changes in renal function were reversible upon discontinuation of therapy.
Safety and effectiveness in children have not been established.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
None reported.
DRUG INTERACTIONS:
No significant drug-drug pharmacokinetic interactions have been found in interaction studies with hydrochlorothiazide, digoxine, warfarin, cimetidine and phenobarbital. Rifampin, an inducer of drug metabolism, decreased the concentrations of losartan and its active metabolite.
Concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.
The antihypertensive effect of losartan may be decreased by the non-steroidal anti-inflammatory drug, indomethacin.
ADVERSE EFFECT:
Adverse effects of losartan have been reported to be usually mild and transient, and include dizziness, headache, and dose-related orthostatic hypotension. Hyperkalaemia, myalgia, and arthralgia have been reported.
Hypotension may occur particularly in patients with volume depletion (for example those who have received high-dose diuretics).
Losartan appears less likely than ACE inhibitors to cause cough.
Other adverse effects that have been reported with angiotensin II receptor antagonists include respiratory-tract disorders, back pain, gastrointestinal disturbances.
Notify your physicians if you should experience any of adverse effects.
PREGNACY AND LACTATION:
Pregnancy: When used in pregnant women during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, losartan should be discontinued as soon as possible.
Lactation: It is not known whether losartan is excreted in human milk. Because of the potential for adverse 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.
OVERDOSAGE:
Symptoms: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation.
Treatment: If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its active metabolite can be removed by hemodialysis.
STORAGE: In a dry place, below 30oC, protect from light.
SHELF LIFE: 36 months from the manufacturing date. Do not use after expiry date.
PACKAGING: Box of 4 blisters x 15 film-coated tablets.    
SPECIFICATION: Manufacturer’s specification.
KEEP OUT OF REACH OF CHILDREN.
USE ONLY AS DIRECTED BY YOUR PHYSICIAN.
CAREFULLY READ THE PACKAGE INSERT BEFORE USE.
FOR FURTHER INFORMATION, DO NOT HESISTATE TO ASK YOUR PHYSICIANS.
Manufactured at:
BOSTON VIETNAM PHARMACEUTICAL JOINT STOCK COMPANY
No. 43, Street no. 8, VSIP, Thuan An, Binh Duong, Vietnam
Tel: 0650 769 606 - Fax: 0650 769 601
                                                                               
   

 


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