Important information, read carefully! ISOPTIN 40 mg...Important information, read carefully! Active...
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Important information, read carefully! Active drug substance: verapamil hydrochloride Film coated tablets Calcium antagonist for the treatment of coronary insufficiency, hypertension and cardiac arrhythmia Composition 1 film coated tablet contains 40 mg 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 afterload. Due to the calcium-antagonistic effect on the smooth vascular muscles of the coronaries, Isoptin ® enhances myocardial blood flow, even in poststenotic areas, and relieves coronary spasms. These properties contribute to the anti-ischemic and anti-anginal 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 day 1 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 anti-arrhythmic effect, particularly in supraventricular arrhythmias. It delays impulse conduction in the AV node. Owing to this, sinus rhythm is restored and/or ventricular rate is normalized, depending on the type of arrhythmia. Normal heart rate is either not affected or only minimally lowered. Indications Chronic coronary insufficiency and long-term treatment of angina pectoris, coronary spasms – vasospastic angina. Angina pectoris after myocardial infarction. Hypertension. Tachyarrhythmia, 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 40 mg, individualized according to the severity 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 dose for adults is 1–2 film coated tablets of Isoptin 40 mg, 3–4 times a day. If higher doses or fewer administrations are necessary, Isoptin 80 mg, Isoptin 120 mg and slow-release Isoptin are recommended alternatives. 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. The following doses are recommended for the treatment of tachyarrhythmia in children: Older pre-school children aged up to 6 years are given 1 film coated tablet of Isoptin 40 mg 2–3 times daily; school children take 1–3 film coated tablets of Isoptin 40 mg 2–3 times daily (maximum daily dose 360 mg). 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 starting with low doses (e.g. in patients with hepatic cirrhosis with 1 film coated tablet of Isoptin 40 mg twice daily). Isoptin 40 mg is particularly useful when titrating these patients. Contraindications Isoptin 40 mg should not be given in the following cases: Cardiovascular shock, complicated acute myocardial infarction (bradycardia, marked hypotension, left ventricular failure); severe conduction disorders (2 nd and 3 rd 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 therapeutically desired: bradycardic arrhythmias, such as sinus bradycardia, sinus arrest with asystole, 2 nd and 3 rd 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 oedemas, erythromelalgia and paraesthesia may occur. In very rare cases, there may be myalgia and arthralgia. Single cases of allergic skin reactions (exanthema, pruritus, urticaria, angioneurotic 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 gynaecomastia, 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. Interactions The simultaneous administration of Isoptin 40 mg and other cardioactive drugs (e.g. betareceptor blockers, anti-arrhythmics) or inhalation anaesthetics may lead to a mutual enhancement of the cardiovascular effects (AV blockade, bradycardia, hypotension, heart failure). When given in combination with quinidine to patients with hypertrophic obstructive cardiomyopathy, single cases of hypotension and pulmonary oedema were observed. Intravenous betareceptor blockers should not be given to patients under treatment with Isoptin 40 mg. Isoptin 40 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 on the 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 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 When treating hypertension with Isoptin 40 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: 1 st degree AV block, bradycardia < 50 beats/min, 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 40 mg should not be given during pregnancy (especially in the first trimester) and lactation unless, in the physician’s judgement, it is essential for the patient’s well-being. Expiry date Do not use beyond the expiry date indicated on the carton. Trade packs 20 film coated tablets Store the drug carefully! Keep out of the reach of children! Abbott GmbH & Co. KG · D-67008 Ludwigshafen · Germany 2 4236 103 · SA · 5203 schw. 000 1 215 ISOPTIN ® 40 mg ABBOTT 24236103 SA 1 10.12.2002, 12:33 Uhr 1
Transcript of Important information, read carefully! ISOPTIN 40 mg...Important information, read carefully! Active...
Important information, read carefully!
Active drug substance: verapamil hydrochloride
Film coated tablets
Calcium antagonist for the treatment of coronary insufficiency, hypertension and cardiac arrhythmia
Composition1 film coated tablet contains 40 mg of verapamil hydrochloride.
Mode of actionVerapamil inhibits the transmembrane influx of calcium ions into the heart and vascular smooth muscle cell. The myocardialoxygen demand is lowered directly as a result of the effect on the energy consuming metabolic processes of the myocardial celland indirectly due to a reduction of the afterload.Due to the calcium-antagonistic effect on the smooth vascular muscles of the coronaries, Isoptin® enhances myocardial bloodflow, even in poststenotic areas, and relieves coronary spasms.These properties contribute to the anti-ischemic and anti-anginal 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 rateas a reflex response. As early as day 1 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 withother antihypertensives – in particular with diuretics and, according to more recent findings, with ACE inhibitors – in more severetypes of hypertension. Its effect on normal blood pressure is negligible.Isoptin has a marked anti-arrhythmic effect, particularly in supraventricular arrhythmias. It delays impulse conduction in the AVnode. Owing to this, sinus rhythm is restored and/or ventricular rate is normalized, depending on the type of arrhythmia. Normalheart rate is either not affected or only minimally lowered.
IndicationsChronic coronary insufficiency and long-term treatment of angina pectoris, coronary spasms – vasospastic angina.Angina pectoris after myocardial infarction.Hypertension.Tachyarrhythmia, such as paroxysmal supraventricular tachycardia, atrial fibrillation/flutter with rapid ventricular response (exceptin WPW syndrome, see precautions), premature ventricular beats.
Dosage and mode of administrationThe doses of Isoptin 40 mg, individualized according to the severity of the disease, are to be taken regularly as prescribed by thephysician. The film coated tablets are to be swallowed whole with some liquid, preferably with or shortly after meals.Unless otherwise instructed, the dose for adults is 1–2 film coated tablets of Isoptin 40 mg, 3–4 times a day. If higher doses orfewer administrations are necessary, Isoptin 80 mg, Isoptin 120 mg and slow-release Isoptin are recommended alternatives. Onlong-term treatment a daily dose of 480 mg should not be exceeded; short-term dose increases are possible only when directedby the physician.The following doses are recommended for the treatment of tachyarrhythmia in children:Older pre-school children aged up to 6 years are given 1 film coated tablet of Isoptin 40 mg 2–3 times daily; school children take1–3 film coated tablets of Isoptin 40 mg 2–3 times daily (maximum daily dose 360 mg).In patients with impaired hepatic function, depending on the severity of the liver disease, the effect of verapamil is intensified andprolonged due to diminished drug metabolism. In these cases dosage should be adjusted with special care starting with lowdoses (e.g. in patients with hepatic cirrhosis with 1 film coated tablet of Isoptin 40 mg twice daily). Isoptin 40 mg is particularlyuseful when titrating these patients.
ContraindicationsIsoptin 40 mg should not be given in the following cases:Cardiovascular shock, complicated acute myocardial infarction (bradycardia, marked hypotension, left ventricular failure); severeconduction disorders (2nd and 3rd degree AV block, sinoatrial block) and sick sinus syndrome (bradycardia-tachycardia syndrome).
Side effectsParticularly when given in high doses or in the presence of previous damage, some cardiovascular effects of verapamil mayoccasionally be greater than therapeutically desired: bradycardic arrhythmias, such as sinus bradycardia, sinus arrest 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 oedemas, erythromelalgia and paraesthesia may occur. In very rare cases, there may be myalgia and arthralgia.Single cases of allergic skin reactions (exanthema, pruritus, urticaria, angioneurotic oedema, Stevens-Johnson syndrome) havebeen reported, in addition to a reversible increase of transaminases and/or alkaline phosphatase, which is probably a sign ofallergic hepatitis.In very rare cases gynaecomastia, which so far has been fully reversible in all cases following discontinuation of the drug, has beenobserved 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.
InteractionsThe simultaneous administration of Isoptin 40 mg and other cardioactive drugs (e.g. betareceptor blockers, anti-arrhythmics) orinhalation anaesthetics may lead to a mutual enhancement of the cardiovascular effects (AV blockade, bradycardia, hypotension,heart failure). When given in combination with quinidine to patients with hypertrophic obstructive cardiomyopathy, single cases ofhypotension and pulmonary oedema were observed. Intravenous betareceptor blockers should not be given to patients undertreatment with Isoptin 40 mg.Isoptin 40 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 on thealert 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 by verapamil), rifampicin,phenytoin and phenobarbital (reduced plasma level and effects of verapamil attenuated). Verapamil plasma levels may be increasedunder concomitant administration of cimetidine. The effect of muscle relaxants may be potentiated.
PrecautionsWhen treating hypertension with Isoptin 40 mg, monitoring of the patient’s blood pressure at regular intervals is required. Dependingon individual susceptibility, the patient’s ability to drive a vehicle or operate machinery may be impaired. This is particularly true inthe initial stages of treatment, when changing over from another drug, and also with respect to the consumption of alcohol.Care should be taken in:1st degree AV block, bradycardia < 50 beats/min, hypotension < 90 mm Hg systolic pressure, atrial fibrillation/ flutter and simultaneouspre-excitation syndrome, e.g. WPW syndrome (risk of inducing ventricular tachycardia), heart failure (compensation with cardiacglycosides, for example, before initiating treatment).Isoptin 40 mg should not be given during pregnancy (especially in the first trimester) and lactation unless, in the physician’sjudgement, it is essential for the patient’s well-being.
Expiry dateDo not use beyond the expiry date indicated on the carton.
Trade packs20 film coated tablets
Store the drug carefully!
Keep out of the reach of children!
Abbott GmbH & Co. KG · D-67008 Ludwigshafen · Germany
2 4236 103 · SA · 5203 schw. 000 1 215
ISOPTIN® 40 mg
ABBOTT
24236103 SA 1 10.12.2002, 12:33 Uhr1
6500
Sommer
Abbott GmbH & Co. KG · D-67008 Ludwigshafen · Germany
ABBOTT
24236103 SA 1 10.12.2002, 12:33 Uhr2
