Faxtin-10 Tablet
Fluoxetine
10mg
Panas Pharmaceutical Pvt. Ltd.
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Available as:
Indications
Faxtin-10 Tablet is used for:
Panic disorder, Obsessive compulsive disorder, Trichotillomania, Premenstrual dysphoric disorder, Major depression, Post-traumatic stress disorder, Bulimia nervosa, Body dysmorphic disorder, Binge eating disorder
Adult Dose
Oral
Depression
Adult: Initially, 20 mg once daily. May gradually increase up to max 80 mg daily in 2 divided doses, if no clinical response after several wk.
Bulimia nervosa
Adult: 60 mg daily as a single or in divided doses.
Hepatic impairment: Reduce dose and/or dosing frequency.
Obsessive compulsive disorder
Adult: Initially, 20 mg once daily, increased up to 60 mg daily if no clinical response after several wk. Max: 80 mg daily in 2 divided doses.
Premenstrual dysphoric disorder
Adult: 20 mg daily continuously. Alternatively, 20 mg daily to be started 14 days before menstruation and continued until 1st day of menses; repeat w/ each cycle.
Panic disorder
Adult: Initially, 10 mg once daily, increase to 20 mg daily after a wk. May further increase to 60 mg daily, if no clinical response after several wk.
Elderly: Max: 60 mg daily.
Hepatic impairment: Reduce dose and/or dosing frequency.
Child Dose
Oral
Depression
Child: >8 yr Initially, 10 mg daily, may increase to 20 mg daily after 1-2 wk.
Low wt childn: Initially, 10 mg daily, may increase to 20 mg daily after several wk, only if clinical response is insufficient.
Obsessive compulsive disorder
Child: >7 yr Initially, 10 mg daily, may increase to 20 mg daily after 2 wk; increase further up to 60 mg daily after several wk as necessary.
Low-wt childn: Initially, 10 mg daily, may increase to 20-30 mg daily after several wk, if required.
Renal Dose
Renal impairment: Use caution; drug accumulation may occur with severe renal impairment
Administration
May be taken with or without food.
Contra Indications
Severe renal or hepatic failure; hypersensitivity; lactation; concomitant MAOIs or within 2 wk of MAOI withdrawal.
Precautions
Unstable epilepsy, liver and renal impairment, cardiac disease, diabetes, electroconvulsive therapy, bleeding disorders, closed-angle glaucoma; pregnancy. May impair performace of skilled tasks; withdraw gradually. Close monitoring of clinical worsening and behavioural changes during the 1st few mth of treatment or when there are dose changes.
Lactation
Excreted in milk; avoid (AAP states effect on nursing infants is unknown but may be of concern)
Pregnancy-Lactation
Interactions
May cause transient shift in plasma conc of tightly protein bound drugs e.g. warfarin and digoxin, resulting in adverse effects. T1/2 of diazepam is prolonged. Avoid concurrent use with clopidogrel.
Potentially Fatal: Serious reactions when combined with MAOIs; at least 14 days should elapse after MAOIs withdrawal before starting fluoxetine treatment or at least 5 wk should elapse after fluoxetine treatment before starting MAOIs therapy. Two-fold increase in plasma levels of other antidepressants when combined with fluoxetine. Monitor lithium levels when combined.
Adverse Effects
Side effects of Fluoxetine :
>10%
Headache (20-25%),Nausea (12-29%),Insomnia (10-33%),Anorexia (4-17%),Anxiety (6-15%),Asthenia (10-15%),Diarrhea (8-18%),Nervousness (8-14%),Somnolence (5-17%),Tremor (3-13%),Weakness (7-21%)
1-10%
Dizziness (9%),Dry mouth (6-10%),Dyspepsia (6-10%),Sweating (5-10%),Decreased libido (2-5%),Abnormal taste (>1%),Agitation (>1%),Chest pain (>1%),Chills (>1%),Confusion (>1%),Ear pain (>1%),Hypertension (>1%),Increased appetite (>1%),Palpitation (>1%),Sleep disorder (>1%),Tinnitus (>1%),Urinary frequency (>1%),Vomiting (>1%),Weight gain (>1%)
Frequency Not Defined
Dysglycemia in patients with DM
Risk of seizure with concomitant electroconvulsive therapy (rare)
Potentially Fatal: Rarely, systemic events possibly related to vasculitis have been reported in patients with rash but may be serious involving lungs, kidney and liver.
Mechanism of Action
Fluoxetine is a potent and highly selective inhibitor of serotonin (5-HT) re-uptake. No affinity for adrenoceptors or histamine, GABA-B, or muscarinic receptors.
Note
Faxtin-10 10mg Tablet manufactured by Panas Pharmaceutical Pvt. Ltd.. Its generic name is Fluoxetine. Faxtin-10 is availble in Nepal.
Farmaco Nepal drug index information on Faxtin-10 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.