LUVOX 100 tablets
(and dosage form):
LUVOX 100 tablets
Each Luvox 100 tablet contains fluvoxamine maleate (5-methoxy-4'-(trifluoromethyl)valerophenone(E)-O-(2-aminoethyl)oxime maleate (1:1)) 100 mg.
A. 1.2 Psychoanaleptics (antidepressants).
Luvox is a psychotropic substance. Its mechanism of action is thought to be related to its specific serotonin re-uptake inhibition in brain neurones, whilst there is minimum interference with noradrenergic processes.
Fluvoxamine maleate is variably absorbed after oral administration.
The plasma half-life is approximately 15 hours after a single dose and 22 hours after multiple doses of 100 mg given orally.
Fluvoxamine maleate is transformed in the liver into pharmacologically inactive metabolites which are excreted by the kidney. Steady state levels are attained within two weeks of treatment with a constant dose. The pharmacokinetic profile in elderly volunteers (over 60 years of age) did not differ substantially from that in a population with ages ranging from 20 to 35 years.
Luvox is indicated for the treatment of major depressive episodes and for the short-term treatment of severe, disabling obsessive-compulsive disorder, where the obsessions or compulsions cause marked distress, are time-consuming or significantly interfere with social or occupational functioning.
Sensitivity to fluvoxamine maleate. Pregnancy and lactation. Safety and efficacy have not been established in children. Safety in patients with liver dysfunction and moderate to pronounced renal function impairment has not been established. Safety has not been established in epileptics.
Patients should not receive Luvox together with or within 2 weeks of terminating treatment with monoamineoxidase inhibitors. At least one week should elapse between discontinuation of Luvox and initiation of therapy with a monoamineoxidase inhibitor.
DOSAGE AND DIRECTIONS FOR USE
Major depressive episodes
The effective daily dose usually varies between 100 mg and 200 mg and should be adjusted to the individual response of the patient up to a maximum of 300 mg. The minimum recommended starting dose is 100 mg per day and 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 2 or 3 divided doses.
The effective dosage usually lies between 100 mg and 200 mg, with some patients requiring up to 300 mg per day. The recommended starting dose is 50 mg per day for 3-4 days. The dosage should be increased gradually until the effective dosage is achieved, with a maximum of 300 mg per day. If no improvement is observed within 10 weeks, treatment with fluvoxamine should be reconsidered.
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.
Luvox tablets should be swallowed with water and without chewing.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Nausea with or without vomiting is the most frequently seen symptom associated with fluvoxamine treatment. This may diminish within the first two weeks of treatment. The most common side effects seen during clinical studies with Luvox were somnolence, constipation, agitation, anorexia, tremor, dry mouth, headache, insomnia, asthenia, drowsiness, dizziness, sweating, decreased libido, dyspepsia, nervousness, mass gain, vision disturbance, diarrhoea, dyskinesia, rash, anxiety and abnormal (delayed) ejaculation.
Patients suffering from mildly impaired hepatic or renal function should start on a low dose and be carefully monitored.
Treatment with Luvox may be associated with an increase in hepatic enzymes, mostly accompanied by symptoms. Treatment should be discontinued in these patients.
Sedation may occur in some patients. Therefore patients should be cautioned about participating in activities where impaired decision-making may lead to accidents, until it is certain that Luvox does not cause sedation.
There have been reports of extrapyramidal symptoms associated with the use of SSRIs and of aggravation of Parkinsons disease in patients taking SSRIs. Luvox should therefore be avoided in patients with extrapyramidal disorders.
It is recommended to decrease the dose gradually when discontinuing treatment with Luvox as this may decrease the possible occurrence of withdrawal symptoms.
An increase in previously stable plasma levels of tricyclic antidepressants when used together with Luvox, has been reported. The combination of Luvox with these drugs is not recommended.
Lithium (and possibly tryptophan) enhances the serotonergic effects of fluvoxamine and the combination should therefore be used with caution.
The serotonergic effects may also be enhanced when fluvoxamine is used in combination with other serotonergic agents (including sumatriptin and SSRIs). On occasions this may result in a serotonergic syndrome.
Fluvoxamine can prolong the elimination of medicines metabolised by oxidation in the liver. A clinically significant interaction is possible with medicine with a narrow therapeutic index (eg warfarin, phenytoin, theophylline, clozapine and carbamazepine). The plasma levels of oxidatively metabolised benzodiazepines are likely to be increased during co-administration of fluvoxamine. In interaction studies increased plasma levels of propranolol and warfarin were seen during concurrent administration of Luvox. It may therefore be advisable to lower the dose of these medicines when prescribing Luvox.
No interactions were seen with digoxin and atenolol.
Alcohol should not be used concomitantly with Luvox, as psychomotor impairment may be increased.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
There is no specific antidote to Luvox.
In cases of overdosage the stomach should be emptied as soon as possible after tablet ingestion and symptomatic and supportive treatment should be given.
Oval, biconvex, white, film-coated, breakable tablets, inscribed with Son the one side and 313on the other.
Blister packs of 30 tablets.
Store below 30°C in original packs, protected from direct sunlight. For shelf-life please refer to the imprint on the pack. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/09072/07)
106 Sixteenth Road
P O Box 5278
Halfway House 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT
14 October 1995
Solvay Pharmaceuticals BV Weesp The Netherlands
Schering (Pty) Ltd
(Reg No: 1964/09072/07)
Updated on this site: December 2000
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