Bisocam 2.5/5 Tablet

Bisocam 2.5/5 Tablet is used for: Hypertension, Chronic stable angina pectoris

Oral Indicated in patients whose blood pressure is not adequately controlled with bisoprolol or amlodipine alone. Tablet The recommended daily dose is 1 tablet once daily of the given strength.

Renal impairment No dosage adjustment is required for patients with mild to moderate renal impairment. In case of severe renal impairment (creatinine clearance < 20 mL/min), the daily dose of the bisoprolol component of Bisoprolol + Amlodipine must not exceed 10 mg.

May be taken with or without food: Take in the morning w/ or w/o food.

Hypersensitivity to amlodipine, dihydropyridine derivatives & bisoprolol. Amlodipine: Severe hypotension, shock including cardiogenic shock, left ventricle outflow tract obstruction (eg, high grade aortic stenosis) & haemodynamically unstable heart failure after acute MI. Bisoprolol: Acute heart failure or during episodes of heart failure requiring IV inotropic therapy, cardiogenic shock, 2nd or 3rd degree AV block w/o pacemaker, sick sinus syndrome, SA block, symptomatic bradycardia & hypotension, severe bronchial asthma, severe forms of peripheral arterial occlusive disease & Raynaud's syndrome; untreated phaeochromocytoma, metabolic acidosis.

Avoid abrupt discontinuation especially in patients w/ ischaemic heart disease. May affect ability to drive & use machines. Hepatic &/or renal impairment. Not recommended during pregnancy & lactation. Childn & adolescents <18 yr. Elderly. Amlodipine: Hypertensive crisis, severe heart failure (NYHA class III & IV), CHF. Bisoprolol: Ischaemic heart disease, HTN or angina associated w/ heart failure, DM, 1st degree AV block, Prinzmetal's angina, peripheral arterial occlusive disease, psoriasis or history of psoriasis, phaeochromocytoma, bronchial asthma or other chronic obstructive lung diseases. May masked symptoms of hyperthyreosis. Strict fasting/diet. Patients undergoing general anaesth. Concomitant desensitisation therapy.

Pregnancy: Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the fetus/newborn. In general, beta-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, spontaneous abortion and early labor. Adverse effects (e.g. hypoglycemia and bradycardia) may occur in the fetus and newborn infant. If treatment with beta-adrenoceptor blockers is necessary, beta1-selective adrenoceptor blockers are preferable. The safety of amlodipine in human pregnancy has not been established. Reproductive studies in rats have shown no toxicity of amlodipine except for delayed date of delivery and prolonged duration of labor at dosages 50 times greater than the maximum recommended dosage for humans. Bisoprolol + Amlodipine is not recommended during pregnancy unless clearly necessary. If treatment with Bisoprolol + Amlodipine is considered necessary, the uteroplacental blood flow and the fetal growth should be closely monitored. In case of harmful effects on pregnancy or the fetus, alternative treatment should be considered. The newborn infant must be closely monitored. Symptoms of hypoglycemia and bradycardia are generally to be expected within the first 3 days. Lactation: It is not known whether bisoprolol is excreted in human milk. Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 - 7%, with a maximum of 15%. The effect of amlodipine on infants is unknown. Therefore, administration of Bisoprolol + Amlodipine is not recommended during breastfeeding. Fertility: No human data on fertility are known for the combination product. Reversible biochemical changes in spermatozoa have been reported in some patients treated by calcium channel blockers. However, clinical data are insufficient regarding the potential effect of amlodipine on fertility. Bisoprolol had no influence on fertility or on general reproduction performance in animal studies, while amlodipine showed in a published investigation adverse effects on male fertility parameters.

Amlodipine: Increased risk of hypotension w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides, verapamil, diltiazem. Different plasma conc w/ CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Increased BP-lowering effects w/ grapefruit or grapefruit juice. Lethal ventricular fibrillation & CV collapse associated w/ hyperkalemia w/ verapamil & IV dantrolene. Increased tacrolimus blood levels. Monitor cyclosporine levels in renal transplant patients. Increased exposure to simvastatin. Bisoprolol: Negative influence in contractility, AV conduction & BP w/ verapamil- & diltiazem-type Ca antagonists. Reduced heart rate, cardiac output & vasodilation w/ centrally-acting antihypertensive drugs eg, clonidine, methyldopa, moxonodine, rilmenidine. Increased risk of hypotension & deterioration of ventricular pump function w/ dihydropyridine-type Ca antagonists eg, nifedipine.

Side effects of Bisoprolol + Amlodipine : Dizziness, headache; nausea, altered bowel habits eg, diarrhoea, constipation; fatigue. Amlodipine: Oedema. Somnolence; visual disturbances eg, diplopia; palpitations; flushing; dyspnoea; abdominal pain, dyspepsia; ankle swelling, muscle cramps; asthenia. Bisoprolol: Feeling of coldness & numbness in extremities; vomiting. Blood and lymphatic system disorders: Very rare: Leukopenia, thrombocytopenia. Immune system disorders: Rare: Allergic reactions, mainly affecting the skin. Metabolism and nutrition disorders: Very rare: Hyperglycemia. Psychiatric disorders: Uncommon: Insomnia, mood changes (including anxiety), depression, sleep disorder. Rare: Nightmare, hallucination, confusion. Nervous system disorders: Common: Dizziness, headache, somnolence. Uncommon: Hypesthesia, paresthesia, dysgeusia, tremor. Very rare: Peripheral neuropathy. Eye disorders: Uncommon: Visual disturbance (including diplopia). Rare: Decreased tear secretion (to be considered if the patient uses contact lenses). Very rare: Conjunctivitis. Ear and labyrinth disorders: Uncommon: Tinnitus. Rare: Hearing disorders. Cardiac disorders: Common: Palpitations, bradycardia*. Uncommon: Atrioventricular-conduction disturbances, worsening of pre-existing heart failure, bradycardia**. Very rare: Myocardial infarction, arrhythmia. ascular disorders: Common: Flushing, feeling of coldness and numbness in the extremities. Uncommon: Hypotension, syncope. Very rare: Vasculitis. Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnea, bronchospasm in patients with bronchial asthma or a history of obstructive pulmonary disease, rhinitis. Rare: Allergic rhinitis. Very rare: Cough. Gastrointestinal disorders: Common: Gastrointestinal complaints such as nausea, vomiting, diarrhea, constipation, abdominal pain. Uncommon: Dyspepsia, dry mouth. Very rare: Gastritis, gingival hyperplasia, pancreatitis. Hepatobiliary disorders: Rare: Hepatitis. Very rare: Jaundice. Skin and subcutaneous tissue disorders: Uncommon: Alopecia, discolorations on the skin, hyperhydrosis, pruritus, exanthema. Very rare: Angio-edema, urticaria, exfoliative dermatitis, psoriasis (psoriasis-like skin disorders or aggravated psoriasis), erythema multiforme, Stevens-Johnson syndrome, photosensitivity. Not known: Toxic epidermal necrolysis. Musculoskeletal and connective tissue disorders: Uncommon: Arthralgia, myalgia, muscular weakness, muscle cramps, back pain. Very rare: Muscular hypertonia. Renal and urinary disorders: Uncommon: pollakiuria, micturition disorder, nocturia. Reproductive system and breast disorders: Uncommon: Erectile dysfunction, gynecomastia. General disorders: Common: Edema (e.g. ankle edema), fatigue. Uncommon: Asthenia, chest pain, pain, malaise.

Bisoprolol: Bisoprolol is a beta1-selective adrenoceptor-blocking agent lacking intrinsic stimulating and relevant membrane stabilizing activity. It only shows very low affinity to the beta2-receptor of the smooth muscles of bronchi and vessels as well as to the beta2-receptors concerned with metabolic regulation. Therefore, bisoprolol is generally not to be expected to influence the airway resistance and beta2-mediated metabolic effects. Its beta1-selectivity extends beyond the therapeutic dose range. Bisoprolol has no pronounced negative inotropic effect. Bisoprolol reaches its maximal effect 3-4 hours after oral administration. The plasma elimination half-life (10-12 hours) provides 24 hours efficacy following a once daily dosage. The maximal antihypertensive effect of bisoprolol treatment is generally reached after 2 weeks. In acute administration in patients with coronary heart disease without chronic heart failure, bisoprolol reduces the heart rate and stroke volume and thus the cardiac output and oxygen consumption. In chronic administration, the initially elevated peripheral resistance decreases. Among others, the depression of plasma renin activity is discussed as a mechanism of action underlying the antihypertensive effect of beta-blockers. Amlodipine: Amlodipine inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle (slow channel blocker or calcium ion antagonist). The mechanism of its antihypertensive action is due to a direct relaxant effect on vascular smooth muscle causing reduction in peripheral vascular resistance. The precise mechanism by which it relieves angina has not been fully determined, it may have the following two actions: It dilates peripheral arterioles and thus, reduces the total peripheral resistance (afterload). Since it does not cause reflex tachycardia, myocardial energy consumption and oxygen requirement will be reduced. By means of dilatation of the main coronary arteries and coronary arterioles, both in normal and ischemic regions, it improves oxygen supply. By the previously mentioned mechanism, it increases myocardial oxygen delivery even in case of coronary artery spasm (Prinzmetal's or variant angina). Bisoprolol and Amlodipine Combination: This combination allows to increase the antihypertensive and anti-anginal efficacy by complementary mechanism of actions of the two active compounds: vasoselective effect of the calcium channel blocker amlodipine (decrease of peripheral resistance) and cardioselective beta-blocker bisoprolol (decrease of cardiac output).

Bisocam 2.5/5 2.5mg + 5mg Tablet manufactured by Square Pharmaceuticals PLC.. Its generic name is Bisoprolol + Amlodipine. Bisocam 2.5/5 is availble in Bangladesh. Farmaco BD drug index information on Bisocam 2.5/5 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.