Anafranil

Anafranil

clomipramine

Manufacturer:

Sandoz

Distributor:

Zuellig
Concise Prescribing Info
Contents
Clomipramine HCl
Indications/Uses
Adult Treatment of depressive states of varying aetiology & symptomatology: Endogenous, reactive, neurotic, organic, masked & involutional depression; depression associated w/ schizophrenia & psychopathy; depressive syndromes due to presenility or senility, chronic painful conditions & chronic somatic diseases; depressive mood disorders of a reactive, neurotic or psychopathic nature. Phobias & panic attacks, obsessive-compulsive syndromes, cataplexy accompanying narcolepsy, chronic painful conditions (cancer pain, neuropathic pain & idiopathic pain syndrome). Childn & adolescent (≥6 yr) Obsessive-compulsive syndromes: Nocturnal enuresis once organic causes have been ruled out.
Dosage/Direction for Use
Adult Depression, obsessive-compulsive syndromes & phobias Initially one 25 mg tab bd-tds or 75 mg once daily (preferably in the evening). Increase stepwise during 1st week of treatment, depending on tolerability, to 4-6 tab of 25 mg or two 75 mg tab daily. Max: 250 mg/day. Maintenance dose: 2-4 tab of 25 mg or one 75 mg tab daily. Panic attacks, agoraphobia Initially 10 mg daily. Dose range: 25-100 mg, max of 150 mg. Cataplexy accompanying narcolepsy 25-75 mg/day. Chronic painful conditions Individualised dosage: 10-150 mg/day. Childn & adolescent Obsessive-compulsive syndromes Initially 25 mg/day should be increased to max of 3 mg/kg or 100 mg daily during the 1st 2 wk. May be gradually increased to 3 mg/kg or 200 mg in following wk. Nocturnal enuresis Childn >12 yr 1-3 tab of 25 mg. Childn 9-12 yr 1-2 tab of 25 mg. Childn 6-8 yr 2-3 tab of 10 mg.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to clomipramine. Cross-sensitivity to TCAs of the dibenzazepine group. In combination, or w/in 14 days before or after treatment, w/ a MAOI; concomitant treatment w/ selective, reversible MAO-A inhibitors eg, moclobemide. Recent MI. Congenital long QT syndrome.
Special Precautions
Worsening of depression &/or suicidality or other psychiatric symptoms. Patients w/ panic disorder; schizophrenia & cyclic affective disorders receiving TCAs; CV disorders especially patients w/ CV insufficiency, conduction disorders (eg, AV block grades I to III) or arrhythmias. Monitor cardiac function & ECG. Co-medication w/ SSRIs or serotonin & noradrenergic reuptake inhibitors (SNaRIs); risk of serotonergic toxicity. Patients w/ epilepsy & other predisposing factors eg, brain damage of varying aetiology, concomitant use of neuroleptics, w/drawal from alcohol or drugs w/ anticonvulsive properties (eg, benzodiazepines). Patients w/ history of increased IOP, narrow-angle glaucoma or urinary retention (eg, diseases of the prostate); contact lenses wearer. Patients w/ severe hepatic disease & tumours of adrenal medulla (eg, phaeochromocytoma, neuroblastoma); hyperthyroidism or patients receiving thyroid prep; hepatic & renal disease; chronic constipation. Regular dental check-ups during long-term treatment. Perform periodic WBC counts & monitor for symptoms eg, fever & sore throat particularly during the 1st few mth of therapy & during prolonged treatment. General or local anaesth. Abrupt w/drawal should be avoided. Rare hereditary problems of galactose intolerance, fructose intolerance, severe lactase deficiency, sucrase-isomaltase insufficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Pregnancy & lactation. Elderly. Childn & adolescent <18 yr.
Adverse Reactions
Accomodation disorder, blurred vision; nausea, dry mouth, constipation; fatigue; increased wt; increased appetite; dizziness, tremor, headache, myoclonus, somnolence; restlessness; micturition disorder; libido disorder, erectile dysfunction; hyperhidrosis. Sinus tachycardia, palpitation, orthostatic hypotension, clinically irrelevant ECG changes (eg, ST & T changes) in patients of normal cardiac status; tinnitus; mydriasis; vomiting, abdominal disorders, diarrhoea; increased transaminases; decreased appetite; muscular weakness; speech disorder, paraesthesias, muscle hypertonia, dysgeusia, memory impairment, disturbance in attention; confusional state, disorientation, hallucinations (particularly in elderly patients & patients w/ Parkinson's disease), anxiety, agitation, sleep disorder, mania, hypomania, aggression, depersonalisation, aggravation of depression, insomnia, nightmares, delirium; galactorrhoea, breast enlargement; yawning; dermatitis allergic (skin rash, urticaria), photosensitivity reaction, pruritus; hot flush.
Drug Interactions
Risk of serotonin syndrome w/ MAOIs. Increased plasma conc w/ antiarrhythmics. Increased risk of QTc prolongation & torsades de pointes. Possible serotonin syndrome w/ SSRIs, SNaRIs, TCAs or lithium. Increased conc w/ terbinafine, cimetidine, antipsychotics (eg, phenothiazines), methylphenidate, valproate, grapefruit, grapefruit juice or cranberry juice. Monitor therapeutic response of TCAs at high dose estrogen regimens. Decreased conc w/ rifampicin, anticonvulsants (eg, barbiturates, carbamazepine, phenobarb & phenytoin), cigarette smoking (nicotine), colestipol & cholestyramine, St John's wort. Potentiated effects of anticholinergic agents (eg, phenothiazine, antiparkinsonian agents, antihistamines, atropine, biperiden). Diminished or abolished antihypertensive effect of guanethidine, betanidine, reserpine, clonidine & α-methyldopa. Potentiated effects of alcohol & other CNS depressant (eg, barbiturates, benzodiazepines or general anaesth). Potentiated CV effect of adrenaline, noradrenaline, isoprenaline, ephedrine & phenylephrine (local anaesth). Potentiated anticoagulant effect of coumarin (eg, warfarin).
MIMS Class
Antidepressants
ATC Classification
N06AA04 - clomipramine ; Belongs to the class of non-selective monoamine reuptake inhibitors. Used in the management of depression.
Presentation/Packing
Form
Anafranil tab 10 mg
Packing/Price
30's
Form
Anafranil tab 25 mg
Packing/Price
200's
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