Description
Abecab® is a combination preparation of Amlodipine Besylate & Olmesartan
Medoxomil.Amlodipine is a calcium channel blocker that 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 Angiotensin II by
selectively blocking the binding of Angiotensin II to the AT1 receptor in vascular
smooth muscle. Its action is, therefore, independent of the pathways for Angiotensin
II 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 Olmesartan Medoxomil (or another Angiotensin receptor
blocker) alone.
Elderly patients
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 Amlodipine or Olmesartan Medoxomil is excreted in
human milk.
Side effects
The overall incidence of side effects on therapy with Amlodipine and Olmesartan
combination was similar to that seen with corresponding doses of the individual
components and to placebo. The common side effects include edema, hypotension,
orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, and nocturia.
Contraindications
Combination of Amlodipine and Olmesartan is contraindicated in patients who are
hypersensitive to any component of this product or to 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 Olmesartan is not
recommended below Creatinine Clearance <20 mL/min.
Drug Interactions
In vitro data indicate that Amlodipine has no effect on the human plasma protein
binding of digoxin, phenytoin, warfarin, and indomethacin. No significant drug
interactions were reported when Olmesartan was co-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: Each coated tablet contains Amlodipine Besylate BP equivalent to 5
mg Amlodipine and Olmesartan medoxomil INN 20 mg.
Package quantities
Abecab® tablet: Carton of 30 tablets in Alu-PVC blister.