Prolert 20 mg/5 ml (Oral Suspension)

Indications

• Depressive illness
• Bulimia nervosa
• Obsessive compulsive disorder

Pharmacology

• Selective inhibition of serotonin reuptake
• Increased synaptic concentration of serotonin in the CNS
• Enhanced serotonergic neurotransmission

Dosage & Administration

• Initial treatment with 20 mg/day of Fluoxetine
• Dose increase after several weeks if no clinical improvement
• Maximum dose of 80 mg/day
• Maintenance treatment for several months or longer
• Use in children not recommended

Interaction

• Serious fatal reactions reported with MAO inhibitors
• Greater than two fold increases of stable plasma levels of other antidepressants
• Reports of increased or decreased lithium levels
• Elevation of blood levels of haloperidol and clozapine
• Elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity
• Caution advised with concomitant administration of CNS active drugs

Contraindications

• Hypersensitivity to Fluoxetine
• Combination with monoamine oxidase inhibitors (MAOIs)
• Use within 14 days of discontinuing therapy with MAOI

Side Effects

• Gastrointestinal effects: nausea, vomiting, dyspepsia, dry mouth, diarrhea
• Neurological effects: anxiety, nervousness, insomnia, drowsiness, fatigue
• Others: excessive sweating, pruritus, skin rashes associated with liver, kidney and lung involvement

Pregnancy & Lactation

• No teratogenicity or harmful effects found in animal studies
• Use in pregnancy only if clearly needed
• Caution in nursing women

Precautions & Warnings

• Use with caution and in reduced doses in patients with impaired hepatic or renal function
• Caution in patients with epilepsy or a history of such disorders
• Caution in diabetic subjects
• Depressed patients with suicidal tendencies should be carefully supervised during treatment
• Not considered suitable for the depressive component of bipolar (manic depressive) illness

Therapeutic Class

• Phenothiazine related drugs

Storage Conditions

• Protect from light & moisture
• Store below 30°C
• Keep in cool & dry place
• Keep out of the reach of children

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