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| Isoptin ® 240 mg SR Tablets |
For The Medical Profession
Only
Isoptin ®
240 mg SR Tablets
Active drug substance : Verapamil hydrochloride
Calcium antagonist for the treatment of hypertension and
secondary prevention after acute myocardial infarction.
Composition: I Film coated tablet contains: 240 mg of verapamil hydrochloride Mode o( action: The calcium antagonist verapa.mil inhibits the transmembranous influx of calcium ions into the heart and vascular smooth muscle cell. The antihypertensive effect of Isoptin stems from a decrease in peripheral vascular resistance without an incrcasc in heart rate as a reflex response.
As early as the first day of treatment blood pressure falls; the effect is found to persist aLso in long-term therapy. [soptin is suitable for the treatment of all types of hypertension: for monotherapy in mild to moderate hypertension combined with other antihypertensives-in particular with diuretics and according to more recent findings, with ACE inhibitors in more severe types of hypertension.
Due to the calcium-antagonistic effect on the vascular smooth muscles of the coronaries, Isoptin enhances myocardial blood flow, even in poststenotic areas and relieves coronary spasms. JbSOtfl has a marked antiarrhythmic effect, particularly in supraventricular arrhythmias. It delays impulse conduction in the AV node and decreases ventricular rate.
Indications: Hypertension
Secondary prevention after acute myocardial infarction
Dosage and mode ofadmlnistratlon:The doses ofisoptin SR 240-mg, individualized according to the seventy of the disease are to be taken regularly as prescribed by the physician. The film coated tablets are to be swallowed whole with some liquid, preferably with or shortly after meals. Unless otherwise instructed, the daily dose is I film coated tablet in the morning (patients requiring particularly gradual blood pressure lowering should be started on half a tablet taken in the morning). If after about 2 weeks of ireatment a dose increase is found to be necessary the dose can be raised to a maximum of 2 film coated tablets daily. On long-term treatment a daily dose of 480 mg should not be exceeded. Short - term dose increases are possible only when directed by the physician. In patients with impaired hepatic function the effect of verapamil is intensified and prolonged depending on the severity of the liver disease due to diminished drug metabolism. In these cases dosage should be adjusted with special care starting with the lowest possible dose.
Cootraindications: Isoptin SR 240 mg should not be given in the following cases: Cardiovascular shock, complicated acute myocardial infarction (brdycardia, marked hypotension, left ventricular failure), severe conduction disorders (2 and 3 degree AV block) and sick sinus syndrome (bradycardia, tachycardia syndrome).
Side effects: Particularly when given in high doses or in the presence of previous damage some cardiovascular effects of verapamil may occasionally be greater than therapeutically desired:
bradycardiac arrhythmias such as sinus bradycardia. sinus arrest with asystole,2 and 3rd &gree AV block or bradyerrhythmia in atrial fibrillation, hypotension, development or aggrevation of heart failure. Constipation has been reported frequently. In rare cases nausea, vertigo or dizziness, headache, flushing, fatigue, nervousness, ankle oe&ma. erythromelalgia and paraesthcsia may occur. In very rare cases there may be myalgia and arthraLgia. Single cases of allergic skin reactions (exanthema, pruritus, urticaria, Quinckes oedema, Stevens-Johnson syndrome ) have been reported in addition to a reversible increase of transaminases and/or alkaline phosphatase which is probably a sign of allergic hepatitis. In very rare cases gynaccomastia, which so far has been fully reversible in all cases following discontinuation of the drug, has been observed in elderly patients under long - term treatment Rises in prolactin levels have been reported. On extremely rare occasions gingival hyperplasia, which is fully reversible when the drug is discontinued, may occur under long-term treatment.
Interactlons:The simultaneous administration of Isoptin SR 240 mg and cardioactive drugs (e.g. betareceptor blockers, antiarrhythtnics) of inhalation anaesthctics may Lead to a mutual enhancement of the cardiovascuFr effects (AV blockade, bradycardia. hypotension heart failure). When given in combination with quinidine ü patients with hypertrophic obstructive cardiomyopathy, single cases of hypotension and pulmonary edema were observed. Intravenous betareceptor blockers should not be given to patients under treatment with Isoptin SR 240 mg. Isoptin SR 240 mg may intensify the blood pressure-lowering effect of other antihypertensives. Rises in digoxin plasma levels under concomitant administration of verapamil have been reported. Physicians should be alert for symptoms of possible digoxin toxicity. The digitalis level should be determined and the glycoside dose reduced, if required. There have also been occasional reports on interactions with carbamazepine ( potentiated by verapamil, neurotoxic side effects), lithium (attenuated by verapamil, enhanced neurotoxicity), cyclosporin, theophylline (rise of plasma level be verapaniil ), rifampicin, phenytoin and phenobarbital ( reduced plasma level and effects of verapamil attenuated ). Verapamil plasma levels may be increased under concomitant administration of cimetidine. The effect of muscle relaxants may be potentiated. Precautions:When treating hypertension with Isoptin SR 240 mg, blood pressure monitoring at regular intervals is required. Depending on individual susceptibility, the patient’s ability to drive a vehicle or operate machinery may be impaired. This is particularly true in the initial stages of tzeatment,when changing over from another drug, and also with respect to the consumpaon of alcohol.
Careshould be taken In:lst degree AV block, bradycardia < 50 beats/mm, hypotension <90 mm Hg systolic pressure, athal fibrillation I flutter and simultaneous preexcitation syndrome C. g., WPW syndrome (risk of inducing ventricular tachycardia), heart failure (compensation with cardiac glycosides, for example before, initiating treatment).
Isoptin SR 240 mg should not be given during pregnancy (esecia1!y in the first trimester) and lactation unless,in the physician’s judgement, it is essential for the patient’s we1lbeing. Expiry date: Do not use beyond the expiry date indicated on the carton.
Presentation: Trade packs containing 2 strips x 10 film coated scored tablets. Other forms: Trade packs containing 3 strips,each of 10 tablets of Isoptin 80 mg. Trade packs containing 5 ampoules, each containing 5 mg. of verapamil hydrochloride /2 ml. Store the drug carefully
Keep out of reach of children. P.220A
Produced in Egypt byKahira Pharm. & Chem. md. Co. ABBOTT Under Licence from Abbott Laboratories
Isoptin ®
240 mg SR Tablets
Active drug substance : Verapamil hydrochloride
Calcium antagonist for the treatment of hypertension and
secondary prevention after acute myocardial infarction.
Composition: I Film coated tablet contains: 240 mg of verapamil hydrochloride Mode o( action: The calcium antagonist verapa.mil inhibits the transmembranous influx of calcium ions into the heart and vascular smooth muscle cell. The antihypertensive effect of Isoptin stems from a decrease in peripheral vascular resistance without an incrcasc in heart rate as a reflex response.
As early as the first day of treatment blood pressure falls; the effect is found to persist aLso in long-term therapy. [soptin is suitable for the treatment of all types of hypertension: for monotherapy in mild to moderate hypertension combined with other antihypertensives-in particular with diuretics and according to more recent findings, with ACE inhibitors in more severe types of hypertension.
Due to the calcium-antagonistic effect on the vascular smooth muscles of the coronaries, Isoptin enhances myocardial blood flow, even in poststenotic areas and relieves coronary spasms. JbSOtfl has a marked antiarrhythmic effect, particularly in supraventricular arrhythmias. It delays impulse conduction in the AV node and decreases ventricular rate.
Indications: Hypertension
Secondary prevention after acute myocardial infarction
Dosage and mode ofadmlnistratlon:The doses ofisoptin SR 240-mg, individualized according to the seventy of the disease are to be taken regularly as prescribed by the physician. The film coated tablets are to be swallowed whole with some liquid, preferably with or shortly after meals. Unless otherwise instructed, the daily dose is I film coated tablet in the morning (patients requiring particularly gradual blood pressure lowering should be started on half a tablet taken in the morning). If after about 2 weeks of ireatment a dose increase is found to be necessary the dose can be raised to a maximum of 2 film coated tablets daily. On long-term treatment a daily dose of 480 mg should not be exceeded. Short - term dose increases are possible only when directed by the physician. In patients with impaired hepatic function the effect of verapamil is intensified and prolonged depending on the severity of the liver disease due to diminished drug metabolism. In these cases dosage should be adjusted with special care starting with the lowest possible dose.
Cootraindications: Isoptin SR 240 mg should not be given in the following cases: Cardiovascular shock, complicated acute myocardial infarction (brdycardia, marked hypotension, left ventricular failure), severe conduction disorders (2 and 3 degree AV block) and sick sinus syndrome (bradycardia, tachycardia syndrome).
Side effects: Particularly when given in high doses or in the presence of previous damage some cardiovascular effects of verapamil may occasionally be greater than therapeutically desired:
bradycardiac arrhythmias such as sinus bradycardia. sinus arrest with asystole,2 and 3rd &gree AV block or bradyerrhythmia in atrial fibrillation, hypotension, development or aggrevation of heart failure. Constipation has been reported frequently. In rare cases nausea, vertigo or dizziness, headache, flushing, fatigue, nervousness, ankle oe&ma. erythromelalgia and paraesthcsia may occur. In very rare cases there may be myalgia and arthraLgia. Single cases of allergic skin reactions (exanthema, pruritus, urticaria, Quinckes oedema, Stevens-Johnson syndrome ) have been reported in addition to a reversible increase of transaminases and/or alkaline phosphatase which is probably a sign of allergic hepatitis. In very rare cases gynaccomastia, which so far has been fully reversible in all cases following discontinuation of the drug, has been observed in elderly patients under long - term treatment Rises in prolactin levels have been reported. On extremely rare occasions gingival hyperplasia, which is fully reversible when the drug is discontinued, may occur under long-term treatment.
Interactlons:The simultaneous administration of Isoptin SR 240 mg and cardioactive drugs (e.g. betareceptor blockers, antiarrhythtnics) of inhalation anaesthctics may Lead to a mutual enhancement of the cardiovascuFr effects (AV blockade, bradycardia. hypotension heart failure). When given in combination with quinidine ü patients with hypertrophic obstructive cardiomyopathy, single cases of hypotension and pulmonary edema were observed. Intravenous betareceptor blockers should not be given to patients under treatment with Isoptin SR 240 mg. Isoptin SR 240 mg may intensify the blood pressure-lowering effect of other antihypertensives. Rises in digoxin plasma levels under concomitant administration of verapamil have been reported. Physicians should be alert for symptoms of possible digoxin toxicity. The digitalis level should be determined and the glycoside dose reduced, if required. There have also been occasional reports on interactions with carbamazepine ( potentiated by verapamil, neurotoxic side effects), lithium (attenuated by verapamil, enhanced neurotoxicity), cyclosporin, theophylline (rise of plasma level be verapaniil ), rifampicin, phenytoin and phenobarbital ( reduced plasma level and effects of verapamil attenuated ). Verapamil plasma levels may be increased under concomitant administration of cimetidine. The effect of muscle relaxants may be potentiated. Precautions:When treating hypertension with Isoptin SR 240 mg, blood pressure monitoring at regular intervals is required. Depending on individual susceptibility, the patient’s ability to drive a vehicle or operate machinery may be impaired. This is particularly true in the initial stages of tzeatment,when changing over from another drug, and also with respect to the consumpaon of alcohol.
Careshould be taken In:lst degree AV block, bradycardia < 50 beats/mm, hypotension <90 mm Hg systolic pressure, athal fibrillation I flutter and simultaneous preexcitation syndrome C. g., WPW syndrome (risk of inducing ventricular tachycardia), heart failure (compensation with cardiac glycosides, for example before, initiating treatment).
Isoptin SR 240 mg should not be given during pregnancy (esecia1!y in the first trimester) and lactation unless,in the physician’s judgement, it is essential for the patient’s we1lbeing. Expiry date: Do not use beyond the expiry date indicated on the carton.
Presentation: Trade packs containing 2 strips x 10 film coated scored tablets. Other forms: Trade packs containing 3 strips,each of 10 tablets of Isoptin 80 mg. Trade packs containing 5 ampoules, each containing 5 mg. of verapamil hydrochloride /2 ml. Store the drug carefully
Keep out of reach of children. P.220A
Produced in Egypt byKahira Pharm. & Chem. md. Co. ABBOTT Under Licence from Abbott Laboratories
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