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Composition
Fluvoxamine maleate.
 
Indications
Treatment of symptoms of depressive illness.
 
Contraindications
Fluvoxamine tablets are contraindicated in combination with monoamine oxidase inhibitors. At least two weeks should elapse between discontinuation of a reversible MAOI and initiation of treatment with fluvoxamine.
At least one week should elapse between discontinuation of fluvoxamine and therapy with any MAOI. Furthermore fluvoxamine is contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate or one of the excipients of the tablets.
 
Precautions / Warnings
Patients should not receive faverin®/luvox® together with or within 2 weeks of terminating treatment with monoamine oxidase inhibitors. Patients suffering from hepatic insufficiency should start a low dose and be carefully monitored. Rarely, treatment with faverin®/luvox® has been associated with an increase in hepatic enzymes mostly accompanied by symptoms. Although there is some experience in children, faverin®/luvox® is not yet recommended in this age group.
faverin®/luvox® alone has no effect on psychomotor skills associated with driving and operating machinery. However in combination with alcohol some impairment may be seen. Although faverin®/luvox® has itself no proven proconvulsive properties, caution is recommended in epileptics.
 
Pregnancy & Lactation
Reproduction studies in animals at high doses revealed no evidence of impaired fertility reproductive performance or teratogenic effects in the offspring. Nevertheless, the usual precautions concerning the administration of any drug during pregnancy should be observed. Since fluvoxamine is almost certainly excreted via human milk, faverin®/luvox® should not be used by lactating women.
 
Side Effects
Depressed patients often display vegetative symptoms, e.g. blurred vision and dry mouth. Nausea sometimes accompanied by vomiting are the most frequently seen symptoms associated with fluvoxamine treatment. This usually diminishes within the first two weeks of treatment. For further information see package insert.
 
Dosage and Administration
The effective daily dose usually varies between 100 mg and 200 mg and should be adjusted to the individual response of the patient to a maximum of 300 mg. It is recommended to increase the dose gradually until the effective dose is reached. The dose of 100 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 2 or 3 divided doses.
 

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Download luvox® PIL in PDF format  

 


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