ORBAPIN \n(Amlodipine and Olmesartan Medoxomil) \nTablet \n \nDescription \nORBAPIN is a combination of two antihypertensive drugs \ncontaining Amlodipine, a dihydropyridine calcium channel \nblocker and Olmesartan Medoxomil, an angiotensin II receptor \nantagonist. Amlodipine inhibits the transmembrane influx of \ncalcium ions into vascular smooth & cardiac muscle. Amlodipine \nis a peripheral arterial vasodilator that acts directly on vascular \nsmooth muscle to cause a reduction in peripheral vascular \nresistance and a reduction in blood pressure. Olmesartan is an \nangiotensin II receptor antagonist that acts on AT1 subtype by \nblocking the action of angiotensin II receptor. Olmesartan dilates \nblood vessels and reduces blood pressure without affecting \npulse rate. \n \nComposition \nORBAPIN 5/20: Each film-coated tablet contains Amlodipine \nBesilate BP equivalent to Amlodipine 5 mg and Olmesartan \nMedoxomil BP 20 mg. \nORBAPIN 5/40: Each film-coated tablet contains Amlodipine \nBesilate BP equivalent to Amlodipine 5 mg and Olmesartan \nMedoxomil BP 40 mg. \nIndication \n \nORBAPIN is indicated for the treatment of hypertension, alone or \nwith other antihypertensive agents. ORBAPIN may also be used \nas initial therapy in patients who are likely to need multiple \nantihypertensive agents to achieve their blood pressure goals. \nDosage & Administration \n \nInitial therapy \nThe usual starting dose of ORBAPIN is one tablet (5/20 mg) \nonce daily. The starting dosage can be increased after 1 to 2 \nweeks of therapy to a maximum dose of two tablets of ORBAPIN \n(5/20 mg) once daily as needed to control blood pressure. \nORBAPIN 5/40 may be administered in patients whose blood \npressure is not adequately controlled by ORBAPIN 5/20. \nMaximum antihypertensive effects are attained within 2 weeks \nafter a change in dose. ORBAPIN may be taken with or without \nfood. ORBAPIN may be administered with other antihypertensive \nagents. Initial therapy with this combination is not recommended \nin patient?s ?75 years old or with hepatic impairment. No initial \ndose adjustment is recommended for patients with moderate to \nmarked renal impairment (Creatinine clearance < 40 mL/min). \nCombination of Amlodipine and Olmesartan is not recommended \nbelow Creatinine clearance < 20 mL/min. \n \nReplacement therapy \nORBAPIN may be substituted for its individual titrated \ncomponents. When substituting for individual components, the \ndose of one or both of the components can be increased if blood \npressure control has not been satisfactory. \n \nAdd-on therapy \nORBAPIN may be used to provide additional blood pressure \nlowering for patients not adequately control with Amlodipine (or \nanother dihydropyridine calcium channel blocker) alone or with \nOlmesartan Medoxomil (or another angiotensin II receptor \nblocker) alone. \n \nOR, AS DIRECTED BY PHYSICIAN. \n \nSide Effects \nThe reported side effects were generally mild and seldom led to \ndiscontinuation of treatment. The most common side effects \ninclude peripherial edema, flushing, palpitations, dizziness. Other \nside effects that occurred in placebo-controlled clinical trials are \northostatic hypotension, diarrhea, rash, abdominal pain, fatigue, \nback pain, pruritus, rhabdomyolysis. \n \nContraindication \nHypersensitivity to any of the component of this combination \nproduct. \nPrecautions \n07 1353 / 01 \n \nHypotension in Volume or Salt-Depleted patients: \nSymptomatic hypotension may occur initiation of treatment. \nVasodilation: Cautions should be exercised when administering \nthe drug, particularly in patients with severe aortic stenosis. \nPatients with Severe Obstructive Coronary Artery Disease: \nPatients may develop increased frequency, duration, or severity \nof angina or acute myocardial infarction on starting calcium \nchannel blocker therapy or at the time of dosage increase. \nPatients with Congestive Heart Failure: Calcium channel \nblockers should be used with caution in patients with heart \nfailure. Patient with impaired Renal Function: Caution should \nbe exercised when administering the drug to patients with renal \nimpairment. Patients with Hepatic Impairment: Caution should \nbe exercised when administering the drug to patients with severe \nhepatic impairment. \nUse in pregnancy & Lactation \nPregnancy: When pregnancy is detected, discontinue this \ncombination product as soon as possible. When used in \npregnancy during the second and third trimesters, drugs that act \ndirectly on the renin-angiotensin system can cause injury and \neven death to the developing fetus. \nLactation: Because of the potential for adverse effects on the \nnursing infant, a decision should be made whether to discontinue \nnursing or discontinue the drug. \nPaediatric Use \nThe safety and effectiveness of Amlodipine & Olmesartan \ncombination in paediatric patients have not been established. \nDrug Interactions \nIn clinical trials, Amlodipine has been safely administered with \nthiazide diuretic, beta blockers, angiotensin converting enzyme \ninhibitors, long acting nitrates, sublingual nitroglycerin, digoxin, \nwarfarin, NSAID?s, antibiotic and oral hypoglycemic drugs. No \nsignificant drug interactions were reported in studies in which \nOlmesartan Medoximil was co-administered with digoxin or \nwarfarin, antacids. Olmesartan Medoxomil is not metabolized by \nthe cytochrome P450 system and has no effects on P450 \nenzymes. \nOver dose \nThere is no information on over dose with Amlodipine and \nOlmesartan Medoxomil in human. \nSupply \nORBAPIN 5/20 : Each box contains 3x10 tablets in Alu-Alu \nblister strips. \nORBAPIN 5/40 : Each box contains 3x10 tablets in Alu-Alu \nblister strips. \nKeep all medicines out of reach of children. \nStore in a cool & dry place, protected from light. \n* Further information is available on request. \nFOR HEALTH, VIGOUR AND HAPPINESS \nDHAMRAI, DHAKA, BANGLADESH.