LUVOX Tablet Ref.[50292] Active ingredients: Fluvoxamine

Depression

The recommended starting dose of fluvoxamine is 50 mg per day for one week, given as a single dose in the evening. Doses should be gradually increased (by 50 mg per week) until an effective dose is reached, with a maximum of 300 mg per day (the usually effective dose is 100 mg/day). Doses up to 150 mg can be given as a single dose. It is recommended that total daily doses of greater than 150 mg be given in 2 or 3 divided doses.

If no improvement is observed within 6 weeks of initiation of therapy, treatment with fluvoxamine should be reconsidered. It is important to ascertain that an adequate therapeutic dose has been maintained throughout this period.

In agreement with the consensus statement of the WHO, antidepressant medication should be continued for at least 6 months after recovery from a depressive episode.

Obsessive Compulsive Disorder

Adults

The recommended starting dose of fluvoxamine is 50 mg per day for 3 to 4 days. The dosage should be increased gradually (i.e. by 50 mg every 4 to 6 days) until an effective dose is achieved, with a maximum of 300 mg per day. (The usually effective dose is in the range of 100-300 mg/day.) Doses up to 150 mg per day can be given as a single dose, preferably in the evening. It is recommended that a total daily dose of more than 150 mg is given in 2 or 3 divided doses.

Children and adolescents (8-17 years)

The recommended starting dose of fluvoxamine in paediatric populations (ages 8-17 years) is 25 mg administered as a single daily dose at bedtime. In a controlled clinical trial establishing the effectiveness of LUVOX in OCD, paediatric patients (ages 8-17) were titrated within a dose range of 50 to 200 mg/day. The dose should be increased in 25 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved. Physicians should consider age and gender differences when dosing paediatric patients. The maximum dose should not exceed 200 mg/day. Therapeutic effect in female children may be achieved with lower doses. It is advisable that a total daily dose of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.

If a good therapeutic response is achieved, treatment can be continued at the required dosage. There are no systematic studies which address the issue of the length of treatment. However, since obsessive compulsive disorder (OCD) is a chronic condition, it is reasonable to consider continuation beyond 10 weeks in responding patients. Data from the long-term (up to two years) open-extension phase of the placebo-controlled study in children supports sustained efficacy of the medicine. Dosage adjustments should be made carefully, on an individual patient basis, throughout therapy to maintain the patient at the lowest effective dose. The need for treatment should be reassessed periodically.

Some clinicians advocate concomitant behavioural psychotherapy in conjunction with pharmacotherapy.

If no improvement is observed within 10 weeks of initiation of therapy, treatment with fluvoxamine should be reconsidered. It is important to ascertain that an adequate therapeutic dose has been maintained throughout this period.

Administration

LUVOX (fluvoxamine maleate) tablets should be swallowed with water, without chewing.

Withdrawal symptoms seen on discontinuation of fluvoxamine

Abrupt discontinuation should be avoided. When stopping treatment with fluvoxamine, the dose should be gradually reduced over a period of at least one or two weeks in order to reduce the risk of withdrawal reactions (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and Section 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Symptoms

The most common symptoms of overdose include gastrointestinal complaints (nausea, vomiting and diarrhoea). Somnolence and dizziness, cardiac events (tachycardia, bradycardia, hypotension), liver function disturbances, convulsions and coma have also been reported.

More than 300 cases of deliberate overdosage with fluvoxamine have been reported to date.

The highest documented dose of fluvoxamine ingested by a patient is 12 grams. This patient recovered completely.

Occasionally, more serious complications have been observed in cases of deliberate overdosage of fluvoxamine in combination with other drugs. Six deaths due to an overdose of fluvoxamine alone have been reported.

Treatment

There is no specific antidote to fluvoxamine. Treatment should consist of general measures employed in the management of overdose along with general symptomatic and supportive measures.

For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

Store below 25oC. Keep out of reach of children.

LUVOX tablets are available in blister packs (PVC/PVDC/Al).

50 mg tablets: packs of 60^*^, 30 and 10 (sample pack).

100 mg tablets: packs of 30 and 10 (sample pack).

^* Not distributed in Australia

Australian Register of Therapeutic Goods (ARTG)

AUST R 57632 – LUVOX fluvoxamine maleate 50mg tablet blister pack.

AUST R 57633 – LUVOX fluvoxamine maleate 100mg tablet blister pack.

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.