- Approval Id
- 6029b13e26d7287a
- Drug Name
- FLUVOXAMINE MALEATE TABLET 50 mg
- Product Name
- FLUVOXAMINE MALEATE TABLET 50 mg
- Approval Number
- SIN11823P
- Approval Date
- 2002-02-26
- Registrant
- PHARMLINE MARKETING PTE. LTD.
- Licence Holder
- PHARMLINE MARKETING PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **4.2 Posology and method of administration**
Posology
_Depression_
_Adults_
The recommended dose is 100 mg daily. Patients should start on 50 or 100 mg, given as a single dose, in the evening. It is recommended to increase the dose gradually until an effective dose is reached. The usual effective dose is 100mg per day and should be adjusted on individual patient responses. Although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 300mg a day (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Doses up to 150 mg can be given as a single dose, preferably in the evening. It is advisable that a total daily dose of more than 150 mg is given in two or three divided doses. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose.
Patients with depression should be treated for a sufficient period of at least six months to ensure that they are free from symptoms.
_Children/adolescents_
Fluvoxamine should not be used in children and adolescents under the age of 18 years for the treatment of major depressive episode. The efficacy and safety of fluvoxamine have not been established in the treatment of paediatric major depressive episode (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
_Obsessive Compulsive Disorder:_
_Adults_
The recommended dose is between 100 mg and 300 mg daily. Patients should start at 50 mg per day for 3 – 4 days. Although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to maximum of 300 mg a day (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Doses up to 150 mg can be given as a single dose, preferably in the evening. It is advisable that a total daily dose of more than 150 mg is given in two or three divided doses.
If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis. If no improvement is observed within 10 weeks, treatment with fluvoxamine should be reconsidered. While there are no systematic studies to answer the question of how long to continue fluvoxamine treatment, OCD is a chronic condition and it is reasonable to consider continuation beyond 10 weeks in responding patients. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose. The need for treatment should be reassessed periodically. Some clinicians advocate concomitant behavioural psychotherapy for patients who have done well on pharmacotherapy. Long-term efficacy (more than 24 weeks) has not been demonstrated in OCD.
_Children/adolescents_
In children over eight years and adolescents there is limited data on a dose of up to 100 mg twice a day for 10 weeks. The starting dose is 25 mg per day. Increase every 4–7 days in 25 mg increments, as tolerated until an effective dose is achieved. The maximum dose in children should not exceed 200 mg/day. (For further details see sections 5.1 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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.
_Hepatic or renal insufficiency_
Patients suffering from hepatic or renal insufficiency should start on a low dose and be carefully monitored.
_Method of administration_
Fluvoxamine tablets should be swallowed with water and 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 sections 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
- Major depressive episode.
- Obsessive Compulsive Disorder (OCD).
- Contraindications
- **4.3 Contraindications**
Fluvoxamine tablets are contraindicated in combination with tizanidine and monoamine oxidase inhibitors (MAOIs) (see sections 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Treatment with fluvoxamine can be initiated:
- two weeks after discontinuation of an irreversible MAOI, or
- the following day after discontinuation of a reversible MAOI (e.g. moclobemide).
At least one week should elapse between discontinuation of fluvoxamine and initiation of therapy with any MAOI.
Hypersensitivity to the active substance or to any of the excipients mentioned in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Atc Code
- N06AB08
- Atc Item Name
- fluvoxamine
- Pharma Manufacturer Name
- PHARMLINE MARKETING PTE. LTD.
- Company Detail Path
- /organization/pharmline-marketing-pte-ltd
