ISOPTIN SR TABLET 240 MG [SIN00344P]

Product Info

ISOPTIN SR TABLET 240 MG

[SIN00344P]

Therapeutic Indications
Hypertension

Posology and method of administration
The doses of Isoptin® SR 240mg, 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 fluid, preferably with or shortly after meals. Unless otherwise instructed, the daily dose for adults is 1 film coated tablet in the morning (patients requiring particularly gradual blood pressure lowering should be started on half tablet taken in the morning). If after about 2 weeks of treatment a dose increase is found to be necessary the dose can be raised to a maximum of 2 film coated tablets daily (additionally 1 half to 1 film coated tablet in the evening after an interval of about 12 hours). On long-term treatment a daily dose of 480mg should not be exceeded; short-term dose increases are possible only when directed by the physician. For children and adults requiring smaller doses of verapamil, Isoptin® 40mg and 80mg are available. In patients with impaired hepatic function the effect of verapamil is intensified and prolonged depending on the severity of the liver disease due to the diminished drug metabolism. In these cases dosage should be adjusted with special care starting with low doses (eg. in patients with hepatic cirrhosis with 1 tablet 40mg 2–3 times daily).

Special Population

Renal Impairment
Current available data are described in Special Warnings and Precautions for Use Section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Verapamil hydrochloride should be used cautiously and with close monitoring in patients with impaired renal function.

Liver Impairment
In patients with impaired liver function, metabolism of the drug is delayed to a greater or lesser extent depending on the severity of hepatic dysfunction, thus potentiating and prolonging the effects of verapamil hydrochloride. Therefore, the dosage needs to be adjusted with special caution in patients with impaired liver function and low doses should be given initially (see Special Warnings and Precautions for Use Section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
For oral use only.
Tablets should be taken without sucking or chewing, with sufficient liquid, preferably with or shortly after meals.

Contraindications

• Hypersensitivity to verapamil hydrochloride or to any of the inactive ingredients

• Cardiogenic shock

• Second or third degree AV block (except in patients with a functioning artificial pacemaker)

• Sick sinus syndrome (except in patients with a functioning artificial pacemaker)

• Congestive heart failure and/or severe left ventricular dysfunction (e.g. reduced ejection fraction of less than 35%, and/or pulmonary wedge pressure above 20 mmHg), unless secondary to a supraventricular tachycardia amenable to verapamil therapy.

• Atrial fibrillation/flutter in the presence of an accessory bypass tract (e.g. Wolff-Parkinson-White, Lown-Ganong-Levine syndromes). These patients are at risk to develop ventricular tachyarrhythmia including ventricular fibrillation if verapamil hydrochloride is administered.

• Acute myocardial infarction with complications (bradycardia, marked hypotension, left ventricular failure) and sinoatrial block

• Combination with Ivabradine (See Interaction with other medicinal products and other forms of interaction section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)