DYNACIRC SRO Modified release capsule Ref.[8732] Active ingredients: Isradipine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: Novartis New Zealand Limited, 109 Carlton Gore Road, Newmarket, Auckland 1023, PO Box 99102, Newmarket, Auckland 1149, Telephone: 0800 354 335

Therapeutic indications

Treatment of hypertension.

Posology and method of administration

The recommended dosage in mild to moderate hypertension is one 5 mg SRO capsule once a day.

Dynacirc SRO capsules must be swallowed whole.

If one 5 mg SRO capsule once a day is not sufficiently effective after at least 4 weeks of treatment, the addition of another antihypertensive agent is recommended (preferably a thiazide diuretic, ACE inhibitor or beta-blocker).

Dynacirc SRO can also be added to existing antihypertensive treatment.

When Dynacirc SRO is given concurrently with cimetidine, the dose of Dynacirc SRO should be reduced by 50% (see section 4.5 Interactions with other medicines and other forms of interaction).

Special Populations

Geriatrics, renal impairment and hepatic impairment

In elderly patients or in patients with impaired hepatic or renal function, a more suitable starting dose is one 2.5 mg SRO capsule once a day.

Paediatrics

Well designed clinical trials of calcium channel blockers in children have not been performed. Although limited retrospective data are available in the paediatric population, Dynacirc is not recommended in these patients.

Overdose

Signs and Symptoms

Experience with Dynacirc SRO overdosage is limited. The available data suggests that overdosage might result in marked and prolonged hypotension.

Treatment

Patients should be admitted to hospital and generally should be managed in an intensive care setting, with continuous monitoring of cardiac function, blood gases, and blood biochemistry. Emergency supportive measures such as artificial ventilation or cardiac pacing should be instituted if appropriate.

In the event of a potentially life-threatening oral overdose, use induction of vomiting or gastric lavage and/or activated charcoal to remove the drug from the gastrointestinal tract (only if presented within 1 hour after ingestion of Dynacirc).

Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care.

For advice on the management of overdose please contact the National Poisons Centre 0800 POISON (0800 764766).

Shelf life

3 years.

Special precautions for storage

Store below 30°C.

Dynacirc SRO must be kept out of the reach and sight of children.

Nature and contents of container

Alu/PVC/PVDC blister pack containing 10 or 30 capsules.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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