Abetis Plus 40mg+12.5mg

Tablet
Olmesartan Medoxomil + Hydrochlorothiazide
ACI Pharmaceuticals

Other Strength:
- Abetis 40mg
- Abetis 10mg
- Abetis 20mg

Alternative:
- Rezor Plus 40mg+12.5mg



Abetis Plus
Description
Abetis Plus® is a combination preparation of Olmesartan Medoxomil and Hydrochlorothiazide, where Olmesartan is an Angiotensin II receptorantagonist (AT1subtype), and Hydrochlorothiazide is a thiazide diuretic. Olmesartan blocksthe vasoconstrictor effects of AngiotensinII by selectively blocking the binding of AngiotensinII to the AT1receptor in vascular smooth muscle. Its action is, therefore, independent of the pathways for AngiotensinII synthesis. Hydrochlorothiazide affects the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. Co-administration of an Angiotensin II receptor antagonist(like -Olmesartan Medoxomil)tends to reverse the potassium loss associated with these diuretics(like –Hydrochlorothiazide).

Indications
Abetis Plus®is indicated for the treatment of hypertension. Thiscombinationpreparationis indicated in patients whose blood pressure is not adequately controlled on Olmesartan alone.It is not indicated for initial therapy.

Dosage and administration
Dosage must be individualized. Abetis Plus®can be taken with or without food.

Adults
The usual recommended starting dose is one tablet of Abetis Plus®(20/12.5) once daily. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks to two tablets of Abetis Plus®(40/25) once daily.

Elderly and renalimpairment
In elderly patients the same dosage of the combination is recommended as for adults.No dosage adjustment is necessary in patients with mild to moderate renal impairment (Creatinine clearance is30 ml/min, < 60 ml/min). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Abetis Plus®is not recommended.

Children and adolescents
Abetis Plus®is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.

Use in pregnancy and lactation
Pregnancy Categories C (first trimester) and D (second and third trimesters).It is not known whether Olmesartan is excreted in human milk, butOlmesartanwasexcreted in the milk of lactating rats. Thiazidesappear 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
Treatment with Olmesartan -hydrochlorothiazide was well tolerated, with an incidence of adverse events similar to placebo. Events generally were mild, transient and had no relationship to the dose of Olmesartan -hydrochlorothiazide, such as vertigo, coughing, back pain, rash, weakness, transient blurred vision, diarrhea, headache, and urinary tract infection.

Contraindications
This combination preparationiscontraindicated in patients who are hypersensitiveto the active substances, to any of the excipients or to other sulfonamide-derived substances (since Hydrochlorothiazide is a sulfonamide-derived medicinal product).

Precautions
All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis and hypokalemia. Hypokalemia may develop, especially with rapid diuresis, when severe cirrhosis is present, or after prolonged therapy. As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with Olmesartan.

Drug Interactions
No significant drug interactions were reported whenOlmesartan wasco-administered with Hydrochlorothiazide, Digoxin or Warfarin in healthy volunteers. The bioavailability of Olmesartan was not significantly altered by the co-administration of antacids [Al(OH)3/Mg(OH)2]. Olmesartan isnot metabolized by the Cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce or are metabolized by those enzymes are not expected. Hydrochlorothiazide may causeorthostatic hypotension when administered concurrently with Alcohol, Barbiturates or Narcotics. Lithium should not generally be given with diuretics. NSAIDs can reduce the diuretic, natriuretic and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.

Overdosage
Only limited information is available regarding Overdosagein humansalthough the most likely effect of overdosageishypotension. If Overdosageis occurred, the patient should be carefully monitored and treatment should be symptomatic and supportive. The most common signs and symptoms of Hydrochlorothiazide overdose is electrolyte depletion i.e. –hypokalemia, hypochloremia, hyponatremia. Dehydration may also occur from excessive diuresis.

Pharmaceutical precautions
Store in a cool and dry place. Protect from light.

Presentation
AbetisPlus®tablet:Eachcoated tablet contains OlmesartanMedoxomil INN 20mgand Hydrochlorothiazide BP 12.5 mg.

Package quantities
AbetisPlus®tablet:Carton of 30 tabletsin Alu-PVC blister.

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