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Abecab 5mg+20mg

Tablet
Amlodipine + Olmesartan Medoxomil
ACI Pharmaceuticals

Other Strength:
- Abecab 5mg+40mg

Alternative:
- Bizoran 5mg+20mg
- Orbapin 5mg+20mg
- Camlosart™ 5mg+20mg
- Olmevas AM 5mg+20mg
- Tenivasc 5mg+20mg
- Duoblock 5mg+20mg



Abecab
Description
Abecab®is a combination preparation ofAmlodipineBesylate& Olmesartan Medoxomil.Amlodipine is a calcium channel blockerthat acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Olmesartan blocks the 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.

Indications
Abecab® is indicated for the treatment of hypertension, alone or with other antihypertensive agents. Abecab®may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Dosage and administration
General considerations
Maximum antihypertensive effects are attained within 2 weeks. Abecab®may be taken with or without food. Abecab®may be administered with other antihypertensive agents. Dosage may be increased after 2 weeks. The maximum recommended dose of Abecab®is 2 tablets (10/40 mg) once daily.

Initial therapy
The usual starting dose of Abecab®is one tablet (5/20 mg) once daily. Depending on the blood pressure response, the dose may be titrated at intervals of 1-2 weeks to two tablets of Abecab®(10/40 mg)once daily.

Replacement therapy
Abecab® may be substituted for its individually titrated components. When substituting for individual components, the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.

Add-on Therapy
Abecab®may be used to provide additional blood pressure lowering for patients not adequately controlled with Amlodipine(or another dihydropyridine calcium channel blocker) alone or with OlmesartanMedoxomil (or another Angiotensin receptor blocker) alone.

Elderlypatients
No dosage adjustment is necessary in elderly patients≥ 65 years age.

Patients with hepatic impairment
Initial therapy with Abecab®is not recommended in patient’s ≥75 years and in patients with hepatic impairment.

Children
The safety and effectiveness of Abecab®in pediatric patients have not been established.

Use in pregnancy and lactation
Olmesartan medoxomil: Pregnancy Categories C (first trimester) and D (second and third trimesters).

Amlodipine:There are no adequate and well-controlled studies in pregnant women. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When pregnancy is detected, discontinue this Amlodipine and Olmesartan combination as soon as possible.It is not known whether the Amlodipineor OlmesartanMedoxomilisexcreted in human milk.

Sideeffects
The overall incidence of side effects on therapy with Amlodipine and Olmesartan combinationwas similar to that seen with corresponding doses of the individual components and to placebo. The common side effects includeedema, hypotension, orthostatichypotension, rash, pruritus, palpitation, urinary frequency, and nocturia.

Contraindications
Combination of Amlodipine and Olmesartan iscontraindicated in patients who arehypersensitive to any component of this product orto any of its ingredients.

Precautions
Caution should be exercised in patients with volume or salt depletion, severe aortic stenosis,severe obstructive coronary artery disease, congestive heart failure, impaired renal function, and hepatic impairment.No initial dosage adjustment is recommended for patients with moderate to marked renal impairment (Creatinine clearance <40 mL/min).Combination of Amlodipine and Olmesartanis not recommended below Creatinine Clearance <20 mL/min.

Drug Interactions
In vitro data indicate that Amlodipinehas no effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin.No significant drug interactions were reportedwhenOlmesartan wasco-administered with digoxin or warfarin.

Overdosage
If massive overdose occurs, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential and treatment should be supportive.

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

Presentation
Abecab® tablet: Eachcoated tablet containsAmlodipine Besylate BP equivalent to 5mg Amlodipine and Olmesartan medoxomil INN 20mg.

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

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