Freevox

Uses

Obsessive-Compulsive Disorder: Freevox Maleate are used for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.

Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.

Freevox is also used to associated treatment for these conditions: Bulimia Nervosa, Major Depressive Disorder (MDD), Obsessive Compulsive Disorder (OCD)

How Freevox works

The exact mechanism of action of fluvoxamine has not been fully determined, but appears to be linked to its inhibition of CNS neuronal uptake of serotonin . Freevox blocks the reuptake of serotonin at the serotonin reuptake pump of the neuronal membrane, enhancing the actions of serotonin on 5HT_1A autoreceptors . Studies have also demonstrated that fluvoxamine has virtually no affinity for α₁- or α₂-adrenergic, β-adrenergic, muscarinic, dopamine D₂, histamine H₁, GABA-benzodiazepine, opiate, 5-HT₁, or 5-HT₂ receptors, despite having an affinity for binding to σ1 receptors .

Dosage

Freevox dosage

Adults: The recommended starting dose for Freevox Maleate Tablets in adult patients is 50 mg, administered as a single daily dose at bedtime. In the controlled clinical trials establishing the effectiveness of Freevox Maleate Tablets in OCD, patients were titrated within a dose range of 100 to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved, not to exceed 300 mg per day. It is advisable that a total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.

Pediatric Population (children and adolescents): The recommended starting dose for Freevox Maleate Tablets in pediatric 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 Freevox Maleate Tablets in OCD, pediatric patients (ages 8-17) were titrated within a dose range of 50 to 200 mg/day. Physicians should consider age and gender differences when dosing pediatric patients. The maximum dose in children up to age 11 should not exceed 200 mg/day. Therapeutic effect in female children may be achieved with lower doses. Dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit. The dose should be increased in 25 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved. 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.

Elderly Or Hepatically Impaired Patients: Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to modify the initial dose and the subsequent dose titration for these patient groups.

Side Effects

Nausea, vomiting, asthenia, headache, malaise, palpitations/tachycardia, abdominal pain, anorexia, constipation, diarrhoea, dry mouth, dyspepsia, agitation, anxiety, dizziness, insomnia, nervousness, somnolence, tremor, sweating.

Toxicity

Freevox is a member of antidepressants that possess an increased risk compared to placebo of suicidal thinking and behaviour (suicidality) in children, adolescents, and young adults (ages including and and below 24) in short-term studies of major depressive disorder and other psychiatric disorders .

Freevox maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) .

Side effects include anorexia, constipation, dry mouth, headache, nausea, nervousness, skin rash, sleep problems, somnolence, liver toxicity, mania, increase urination, seizures, sweating increase, tremors, or Tourette's syndrome .

Precaution

History of mania or seizures; liver dysfunction; presence of depressive symptoms; smokers. Treatment with MAOI should only be started at least 2 wk after stopping fluvoxamine treatment. Increased risk of suicidal ideation and behaviour when used in children, adolescents and young adults <24 yr. Pregnancy, elderly; operating hazardous machinery; withdraw gradually. Monitor prothrombin time in patients who are taking oral anticoagulants concurrently.

Interaction

Co-admin with fluvoxamine may increase carbamazepine toxicity and serum levels of theophylline. Lithium enhances the serotonergic effects of fluvoxamine. Anticoagulants may require dosage adjustments. Diltiazem with fluvoxamine may lead to bradycardia. Avoid alcohol.

Potentially Fatal: Freevox should not be used in combination with MAOIs, or within 14 days of discontinuing treatment with MAOIs.

Food Interaction

• Avoid alcohol.
• Avoid grapefruit products.
• Limit caffeine intake.
• Take with or without food. The absorption is unaffected by food.

[Moderate] GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents.

Use in combination may result in additive central nervous system depression and
MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol.

Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.

Freevox Drug Interaction

Major: amphetamine / dextroamphetamine, amphetamine / dextroamphetamine, lisdexamfetamine, lisdexamfetamineModerate: aripiprazole, aripiprazole, lamotrigine, lamotrigine, quetiapine, quetiapine, alprazolam, alprazolamUnknown: omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol

Freevox Disease Interaction

Major: depressionModerate: hyponatremia, liver disease, mania, platelet function, seizure disorders, SIADHMinor: smoking, weight loss

Volume of Distribution

• 25 L/kg .

Elimination Route

Well absorbed, bioavailability of fluvoxamine maleate is 53% .

Half Life

15.6 hours .

Elimination Route

Nine metabolites were identified following a 5 mg radio labelled dose of fluvoxamine maleate, constituting approximately 85% of the urinary excretion products of fluvoxamine . The main human metabolite was fluvoxamine acid which, together with its N-acetylated analog, accounted for about 60% of the urinary excretion products . Approximately 2% of fluvoxamine was excreted in urine unchanged . Following a 14C-labelled oral dose of fluvoxamine maleate (5 mg), an average of 94% of drug-related products was recovered in the urine within 71 hours .

Pregnancy & Breastfeeding use

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Contraindication

Hypersensitivity. Not to be used with thioridazine, terfenadine, astemizole, cisapride, pimozide, aloestron, tizanidine. Lactation.

Special Warning

Elderly Or Hepatically Impaired Patients: Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to modify the initial dose and the subsequent dose titration for these patient groups.

Pregnant Women During The Third Trimester: Neonates exposed to Freevox Maleate Tablets and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding and may be at risk for persistent pulmonary hypertension of the newborn (PPHN). When treating pregnant women with Freevox Maleate Tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

Storage Condition

Store Freevox Maleate Tablets at room temperature between 15°C to 30°C. Keep Freevox Maleate Tablets away from high humidity.

Innovators Monograph

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