Regulatory Information
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Therapeutic
Prescription Only
Formulation Information
TABLET
**DOSAGE AND ADMINISTRATION** **For oral use only.** - **Adults:** Supraventricular arrhythmias: the recommended starting dosage is 50mg twice daily and most patients will be controlled at this dose. If required the dose may be increased to a maximum of 300mg daily. Ventricular arrhythmias: the recommended starting dosage is 100mg twice daily. The maximum daily dose is 400mg and this is normally reserved for patients of large build or where rapid control of the arrhythmia is required. After 3–5 days it is recommended that the dosage be progressively adjusted to the lowest level which maintains control of the arrhythmia. It may be possible to reduce dosage during long-term treatment. - **Children:** Tambocor is not recommended in children under 12, as there is insufficient evidence of its use in this age group. - **Elderly Patients:** The rate of flecainide elimination from plasma may be reduced in elderly people. This should be taken into consideration when making dose adjustments. - **Plasma Levels:** Based on PVC suppression, it appears that plasma levels of 200–1000 ng/mL may be needed to obtain the maximum therapeutic effect. Plasma levels about 700–1000 ng/mL are associated with increased likelihood of adverse experience. - **Dosage in Impaired Renal Function:** In patients with significant renal impairment (creatinine clearance of 35 mL/ min/1.73sq.m. or less) the maximum initial dosage should be 100mg daily (or 50mg twice daily). When used in such patients, frequent plasma level monitoring is strongly recommended.
ORAL
Medical Information
**INDICATIONS** Tambocor tablets are indicated for: 1. AV nodal reciprocating tachycardia; Arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways. 2. Paroxysmal atrial fibrillation in patients with disabling symptoms. Arrhythmias of recent onset will respond more readily. 3. Symptomatic sustained ventricular tachycardia. 4. Premature ventricular contractions and/or non-sustained ventricular tachycardia which are causing disabling symptoms, where these are resistant to other therapy or when other treatment has not been tolerated. Tambocor tablets can be used for the maintenance of normal rhythm following conversion by other means.
**CONTRAINDICATIONS** Tambocor is contraindicated in cardiac failure, and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics or nonsustained ventricular tachycardia. It is also contraindicated in patients with long standing atrial fibrillation in whom there has been no attempt to convert to sinus rhythm and in patients with haemodynamically significant valvular heart disease. Unless pacing rescue is available, Tambocor should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrioventricular block, bundle branch block or distal block.
C01BC04
flecainide
Manufacturer Information
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Unique Pharmaceutical Laboratories, (A Division of J.B. Chemicals & Pharmaceuticals Limited)
Active Ingredients
Documents
Package Inserts
Tambocor Tablet PI.pdf
Approved: September 18, 2020