Kenzar Plus

Kenzar Plus

losartan + hydrochlorothiazide

Manufacturer:

ACME

Distributor:

Bell-Kenz Pharma

Marketer:

Euro Generics
Full Prescribing Info
Contents
Losartan potassium, hydrochlorothiazide.
Description
Each film-coated tablet contains: Losartan potassium 50 mg, Hydrochlorothiazide 12.5 mg.
Action
Pharmacology: Pharmacokinetics: Losartan potassium: It 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 faeces 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 faeces. The terminal elimination half-lives of losartan and E-3174 are about 1.5 to 2.5 hours and 3 to 9 hours, respectively.
Hydrochlorothiazide: It is fairly rapidly absorbed from the gastrointestinal tract. It is reported to have a bioavailability of about 65 to 70%. It has been estimated to have a plasma half-life of between about 5 and 15 hours and appears to be preferentially bound to red blood cells. It is excreted mainly unchanged in the urine. It crosses the placental barrier and is distributed into breast milk.
Indications/Uses
Losartan Potassium + Hydrochlorothiazide (Kenzar Plus) is indicated for the treatment of hypertension, for patients in whom combination therapy is appropriate.
Dosage/Direction for Use
The usual starting dose of Losartan Potassium + Hydrochlorothiazide (Kenzar Plus) is 1 tablet once daily. If blood pressure remains uncontrolled after 3 weeks of therapy, the dose may be increased to 2 tablets once daily. The maximum dose is 2 tablets of Losartan Potassium + Hydrochlorothiazide (Kenzar Plus) once daily. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy. No initial dosage adjustment of this tablet is necessary for elderly patients, but maximum dose should not be used as initial therapy in elderly patients. Losartan Potassium + Hydrochlorothiazide (Kenzar Plus) may be administered with or without food.
Or as directed by physician.
Overdosage
Losartan potassium: 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. If symptomatic hypotension should occur, supportive treatment should be instituted.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
Contraindications
It is contraindicated in: patients who are hypersensitive to any component of this product; patients with anuria; patients who are hypersensitive to other sulfonamide-derived drugs.
Special Precautions
Hypersensitivity: angioedema.
Hydrochlorothiazide therapy is associated with electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis and hypokalemia. Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
Hyperglycemia may occur with thiazide diuretics. In diabetic patients, dosage adjustments of insulin or oral hypoglycemic agents may be required.
Impaired renal function.
Symptomatic hypotension.
Use In Pregnancy & Lactation
Pregnancy: When used in pregnancy during the second or third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is suspected, Losartan Potassium + Hydrochlorothiazide (Kenzar Plus) should be discontinued as soon as possible.
Nursing Mothers: It is not known whether losartan is excreted in human milk. Thiazides appear 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.
Side Effects
The combination of Losartan potassium and Hydrochlorothiazide is generally well tolerated. However, few side effects including: abdominal pain, edema/swelling, palpitation, back pain, dizziness, cough, sinusitis, upper respiratory tract infection, rashes.
Drug Interactions
Losartan: No significant drug-drug pharmacokinetic interactions have been found in interaction studies 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 salt substitutes containing potassium may lead to increase in serum potassium.
As with other antihypertensive agents, the antihypertensive effects of Losartan may be blunted by the non-steroidal inflammatory drug Indomethacin.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with thiazide diuretics: Alcohol, Barbiturates or narcotics: potentiation of orthostatic hypotension may occur.
Anti-diabetic drugs (oral agents and insulin): dosage adjustment of the antidiabetic drug may be requested.
Other antihypertensive drug: additive effect.
Skeletal muscle relaxants: possible increased responsiveness to the muscle relaxant.
NSAIDs: in some patients, it can reduce the antihypertensive effects of thiazide diuretics.
Storage
Store at temperature not exceeding 30°C. Protect from light.
MIMS Class
Angiotensin II Antagonists / Diuretics
ATC Classification
C09DA01 - losartan and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Kenzar Plus FC tab
Packing/Price
30's (P17.5/film-coated tab, P525/pack)
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