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| Isoptin ® 80 mg Tablets |
For The Medical Profession OnIy
Isoptin ®
80 mg Tablets
Active drug substance : Verapamil hydrochloride
Calcium antagonist for the treatment of coronary insufficiency. hypertension and cardiac arrhythmia.
Composition: I tablet contains: 80 rng of verapamil hydrochloride
Mode of action:Verapamil inhibits the transmembrane influx of calcium ions into the heart and vascular smooth muscle cell., The myocardial oxygen demand is lowered directly as a result of the effect on the energy consuming metabolic processes of the myocardial cell and indirectly due to a reduction of the after load.
Due to the calcium-antagonistic effect on the smooth vascular muscles of the coronaries, Isoptin enhances myocardial blood flow, even in post-stenotic areas, and relieves coronary spasms.
These properties contribute to the antiischemic and antianginal efficacy of Isoptin in all
types of coronary artery disease. The antihypertensive effect of Isoptin stems from a decrease in peripheral vascular resistance - without an increase 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. Isoptin 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. Its effect on normal blood pressure is negligible.
Isoptin has a marked antiarrhythmic effect, particularly in supraventncular arrhythmias. It delays impulse conduction in the AV node. Owing to this, ventricular rate is normalized. Normal heart rate is either not affected or only lowered.
Indications :Chronic coronary insufficiency and long-term treatment of chronic stable and unstable angina - angina at rest including vasâspastic angina, angina pectons after myocardial infarction. Hypertension.
Tachyarrhy thmias, such as paroxysmal supraventricular tachycardia, atrial fibrillation/flutter with rapid ventricular response (except in WPW syndrome. see precautions), premature
ventricular beats.
Dosage and mode of administration :The doses of Isoptin 80 mg, individualized according to the severity of the disease, are to be taken regularly as prescribed by the physician. The tablets are to be swallowed whole with some liquid, preferably with or shortly after meals. Unless otherwise instructed, the dose is I tablet of Isoptin 80 mg, 3-4 times a day. 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. depending on the severity of the liver disease, the effect of verapamil is intensified and
prolonged due to diminished drug metabolism. In these cases dosage should be adjusted with special care.
Contraindications :Isoptin 80 mg should not be given in the following cases Cardiovascular shock complicated acute rnyocardial infarction (bradycardia, marked hypotension, left ventricular failure), severe conduction disorders (2nd 3 degree AV block, sinoatrial 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 therapeuica1ly desired: bradycardias. such as sinus bradycardia. sinus arrests with asystole, 2nd and 3rd degree AV block or bradyarrhythmia in atrial fibrillation. hypotension, development or aggravation of heart failure. Constipation has been reported frequently. In rare cases: nausea. vertigo or dizziness, headache, flushing, fatigue, nervousness, ankle edema, erythromelalgia and paraesthesia may occur. In very rare cases, there may be myalgia and arthralgia. Single cases of allergic skin reactions (exanthema, pruritus,urticaria,Quinckes’s edemaStevensjohnson syndrome) have been reported, in addition to a reversible increase to transaminases and/ or alkaline phosphatase, which is probably a sign of allergic hepatitis. In very rare cases ‘ynaecomastia, which so far has been fully reversible in all cases following discontinuation o 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.
Interactions:The Simultaneous administration of Isoptin 80 mg and other cardioactive drugs (e. g. beta-receptor blockers. antiarrhythmics ) or inhalation anaesthetic may lead to a mutual enhancement of the cardiovascular effects (AV bockade, bradycardia. hypotension, heart failure) . When given in combination with quinidine to patients with hypertrophic obstructive cardiomyopathy, single cases of hypotension and pulmonary edema were observed. Intravenous beta-receptor blockers should not be given to patients under treatment with isoptin 80 mg. Isoptin 80 mg may intensify the blood pressure-lowenng effect of other antihypertensives. Rises in digoxin plasma levels under concomitant administration of verapamil have been reported
Physicians should be on the alert for symptoms of possible digoxin toxicity. The digitalis level should be determined and the lycoside dose reduced, if required. There have also been occasionaireports on interaction with carbamazepine (potentiated by verapamil, neurotoxicity), cyclosporin, theophylline, (increase of plasma level by verapamil), 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:Under therapy with isoptin 80 mg. monitoring of the patient’s blood pressure, 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 treatment. when changing over from another drug and also with respect to the consumption of alcohol.
Care should be taken in: degree AV block, bradycardia < 50 beats/mm, hypotension <90 mm Hg systolic pressure, atrial fibrillation/flutter and simultaneous pre-excitation syndrome, e.g. WPW syndrome (risk of inducing ventricular tachycardia ), heart failure (compensation with cardiac glycosides, for example, before initiating treatment). Isoptin 80 mg should not be çiven during pregnancy (especially in the first trimester) and lactation unless, in the physician’s judgment. it is essential for the patient’s well-being.
Expiry date:Do not use beyond the expiry—date indicated on the carton
Presentation:Trade packs containing three strips each of 10 tablets of Isoptin 80 mg. Other forms:Trade packs conIainng strips of 10 film coated scored tablets of Isoptin SR 240 mg Trade packs containing 5 ampoules, each containing S mg. of verapamil hydrochloride I 2 ml. Store the drug carefully.
Keep out of reach of children. P.221 A
Produced in Egypt by:tahira Pharm. & Chem. md. Co. ABBOTT Under Licence from Abbott Laboratories
Isoptin ®
80 mg Tablets
Active drug substance : Verapamil hydrochloride
Calcium antagonist for the treatment of coronary insufficiency. hypertension and cardiac arrhythmia.
Composition: I tablet contains: 80 rng of verapamil hydrochloride
Mode of action:Verapamil inhibits the transmembrane influx of calcium ions into the heart and vascular smooth muscle cell., The myocardial oxygen demand is lowered directly as a result of the effect on the energy consuming metabolic processes of the myocardial cell and indirectly due to a reduction of the after load.
Due to the calcium-antagonistic effect on the smooth vascular muscles of the coronaries, Isoptin enhances myocardial blood flow, even in post-stenotic areas, and relieves coronary spasms.
These properties contribute to the antiischemic and antianginal efficacy of Isoptin in all
types of coronary artery disease. The antihypertensive effect of Isoptin stems from a decrease in peripheral vascular resistance - without an increase 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. Isoptin 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. Its effect on normal blood pressure is negligible.
Isoptin has a marked antiarrhythmic effect, particularly in supraventncular arrhythmias. It delays impulse conduction in the AV node. Owing to this, ventricular rate is normalized. Normal heart rate is either not affected or only lowered.
Indications :Chronic coronary insufficiency and long-term treatment of chronic stable and unstable angina - angina at rest including vasâspastic angina, angina pectons after myocardial infarction. Hypertension.
Tachyarrhy thmias, such as paroxysmal supraventricular tachycardia, atrial fibrillation/flutter with rapid ventricular response (except in WPW syndrome. see precautions), premature
ventricular beats.
Dosage and mode of administration :The doses of Isoptin 80 mg, individualized according to the severity of the disease, are to be taken regularly as prescribed by the physician. The tablets are to be swallowed whole with some liquid, preferably with or shortly after meals. Unless otherwise instructed, the dose is I tablet of Isoptin 80 mg, 3-4 times a day. 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. depending on the severity of the liver disease, the effect of verapamil is intensified and
prolonged due to diminished drug metabolism. In these cases dosage should be adjusted with special care.
Contraindications :Isoptin 80 mg should not be given in the following cases Cardiovascular shock complicated acute rnyocardial infarction (bradycardia, marked hypotension, left ventricular failure), severe conduction disorders (2nd 3 degree AV block, sinoatrial 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 therapeuica1ly desired: bradycardias. such as sinus bradycardia. sinus arrests with asystole, 2nd and 3rd degree AV block or bradyarrhythmia in atrial fibrillation. hypotension, development or aggravation of heart failure. Constipation has been reported frequently. In rare cases: nausea. vertigo or dizziness, headache, flushing, fatigue, nervousness, ankle edema, erythromelalgia and paraesthesia may occur. In very rare cases, there may be myalgia and arthralgia. Single cases of allergic skin reactions (exanthema, pruritus,urticaria,Quinckes’s edemaStevensjohnson syndrome) have been reported, in addition to a reversible increase to transaminases and/ or alkaline phosphatase, which is probably a sign of allergic hepatitis. In very rare cases ‘ynaecomastia, which so far has been fully reversible in all cases following discontinuation o 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.
Interactions:The Simultaneous administration of Isoptin 80 mg and other cardioactive drugs (e. g. beta-receptor blockers. antiarrhythmics ) or inhalation anaesthetic may lead to a mutual enhancement of the cardiovascular effects (AV bockade, bradycardia. hypotension, heart failure) . When given in combination with quinidine to patients with hypertrophic obstructive cardiomyopathy, single cases of hypotension and pulmonary edema were observed. Intravenous beta-receptor blockers should not be given to patients under treatment with isoptin 80 mg. Isoptin 80 mg may intensify the blood pressure-lowenng effect of other antihypertensives. Rises in digoxin plasma levels under concomitant administration of verapamil have been reported
Physicians should be on the alert for symptoms of possible digoxin toxicity. The digitalis level should be determined and the lycoside dose reduced, if required. There have also been occasionaireports on interaction with carbamazepine (potentiated by verapamil, neurotoxicity), cyclosporin, theophylline, (increase of plasma level by verapamil), 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:Under therapy with isoptin 80 mg. monitoring of the patient’s blood pressure, 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 treatment. when changing over from another drug and also with respect to the consumption of alcohol.
Care should be taken in: degree AV block, bradycardia < 50 beats/mm, hypotension <90 mm Hg systolic pressure, atrial fibrillation/flutter and simultaneous pre-excitation syndrome, e.g. WPW syndrome (risk of inducing ventricular tachycardia ), heart failure (compensation with cardiac glycosides, for example, before initiating treatment). Isoptin 80 mg should not be çiven during pregnancy (especially in the first trimester) and lactation unless, in the physician’s judgment. it is essential for the patient’s well-being.
Expiry date:Do not use beyond the expiry—date indicated on the carton
Presentation:Trade packs containing three strips each of 10 tablets of Isoptin 80 mg. Other forms:Trade packs conIainng strips of 10 film coated scored tablets of Isoptin SR 240 mg Trade packs containing 5 ampoules, each containing S mg. of verapamil hydrochloride I 2 ml. Store the drug carefully.
Keep out of reach of children. P.221 A
Produced in Egypt by:tahira Pharm. & Chem. md. Co. ABBOTT Under Licence from Abbott Laboratories
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