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PROTHIADEN 25 mg : Capsules
PROTHIADEN 75 mg: Tablets
SCHEDULING STATUS
Schedule 5
PROPRIETARY NAME
(and dosage form)
PROTHIADEN 25 mg : Capsules
PROTHIADEN 75 mg: Tablets
COMPOSITION
25 mg Capsule: Each gelatin capsule contains 25 mg Dothiepin hydrochloride.
75 mg Tablet: Each sugar-coated tablet contains 75 mg Dothiepin hydrochloride.
PHARMACOLOGICAL CLASSIFICATION
A 1.2 Psychoanaleptics (antidepressants).
PHARMACOLOGICAL ACTION
Dothiepin Hydrochloride is a tricyclic antidepressant which has anxiolytic properties. The descriptive chemical name is 3-(6H-
dibenzo(b,e)-thiepin-11-ylidene)propyldimethylamine hydrochloride.
Dothiepin is readily absorbed from the gastro-intestinal tract, and extensively demethylated by first pass metabolism in the liver to its
primary active metabolite, northiaden.
Dothiepin is excreted in the urine, mainly in the form of metabolites; small amounts are also excreted in the faeces. Dothiepin and its
metabolites have a half-life of 19-33 hours. Dothiepin is also excreted in breast-milk.
INDICATIONS
Treatment of major depressive disorders in adults and in depression associated with anxiety.
CONTRA-INDICATIONS
Safety in pregnancy and lactation has not been established.
PROTHIADEN should not be given concurrently or within 14 days of treatment with MAO inhibitory medicine.
It is inadvisable to use catecholamine-containing local anaesthetics in patients receiving PROTHIADEN.
It is inadvisable to give PROTHIADEN to patients with recent myocardial infarction or a cardiac arrhythmia.
WARNINGS:
Patients with heart block.
This medicine should at all times be kept out of reach of children as even small doses may be fatal to them.
At the time of initiation of therapy patients should be advised not to drive a motor vehicle, climb dangerous heights or operate
dangerous machinery, for at least several days. In these situations impaired decision making could lead to accidents.
Adults:
Dosage may vary widely depending on the individual patients and conditions. It is preferable to use the smaller dose for the first few
days. In certain circumstances, i.e. in hospital use, PROTHIADEN has been given at dosages up to 225 mg daily. The usual dosage
range is 75 mg to 150 mg daily.
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PROTHIADEN 25 mg : Capsules; PROTHIADEN 75 mg: Tablets http://www.mentalmeds.org/prescription_meds/Prothiaden.html
Elderly:
The recommended initial dose for the elderly is 50 - 75 mg daily. Half the normal maintenance dose may be adequate.
Note:
Elderly patients are more prone to all these effects and therapy should be initiated at lower than standard doses in the elderly.
Special Precautions:
(a) Psychosis may be activated in schizophrenic patients.
(b) Caution should be observed with patients suffering from a depressive phase of manic depressive psychosis, as occasionally
hypomania or mania can be precipitated in such patients. Use is not recommended in mania. Patients with suicidal tendencies
should be carefully supervised during treatment.
(c) In elderly male patients suffering from prostatism urinary retention may be precipitated.
(d) In patients suffering from cardiac disease special caution should be observed because of the occasional problems of tachycardia,
dysrhythmias, orthostatic hypotension and other unwanted effects on blood pressure, aggravation of conduction disturbances, and
electrocardiographic abnormalities. Regular cardiological and electrocardiographic examination is advised.
(e) Epilepsy may be aggravated.
(f) The medicine should usually not be given to patients receiving other central nervous system depressants, e.g. barbiturates and to
patients receiving monoamine oxidase inhibitors only after a suitable interval (the drugs may be given together if the dosages are
carefully controlled, preferably in hospital). The pressor effects of the direct acting sympathomimetic agents, adrenaline and
noradrenaline, are enhanced, and the use of local anaesthetics containing these vasoconstrictors should be avoided as
hypertensive reactions may occur. The simultaneous administration of anticholinergic agents may be dangerous. The hypotensive
effect of certain antihypertensive agents may be reduced.
(g) Narrow-angle glaucoma may be aggravated.
(h) Withdraw treatment if allergic skin reactions appear.
(i) Should be used with caution in patients with hyperthyroidism or with impaired liver function or a history of urinary retention or
constipation.
(j) Blood sugar concentrations may be altered in diabetic patients.
(k) The effects of Prothiaden are influenced by drugs that affect their metabolism. Barbiturates and other enzyme inducers such as
anti-epileptics increase their metabolism while neuroleptics, cimetidine, methylphenidate and possibly oestrogens and oral
contraceptives reduce it.
(l) It is recommended that antidepressants should be withdrawn gradually.
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PROTHIADEN 25 mg : Capsules; PROTHIADEN 75 mg: Tablets http://www.mentalmeds.org/prescription_meds/Prothiaden.html
hyperreflexia, hypotension and respiratory and cardiac depression. Cardiac arrhythmias may be life-threatening, and may recur some
days after apparent recovery.
There are no specific antidotes for PROTHIADEN and other analogous antidepressants so that the immediate treatment for
overdosage should be physical induction of emesis in conscious patients, followed in all cases by general support of respiration and
blood circulation. If the overdose is known to have been taken within the previous four hours gastric lavage and aspirations should be
undertaken; in unconscious patients with no cough reflex the lungs should be protected with a cuffed endotracheal tube.
Haemodialysis is not recommended as this type of antidepressant is largely protein-bound. Within 18 hours there should be signs of
recovery as the patient metabolizes the drug. Sinus tachycardia may be observed but unless a specific dysrhythmia occurs no treatment
is necessary.
Hyperexcitability may lead to convulsions which could overload the myocardium.
During recovery the patient should rest quietly until any cardiac abnormalities have resolved.
IDENTIFICATION
25 mg A red/brown capsule overprinted P 25 in white for sale in pharmacy.
Capsule: A red/brown capsule which may or may not be overprinted will be available in Government institutions only.
75 mg Tablet: A round, biconvex, polished tablet with a red sugar coat overprinted P 75 in white for sale in pharmacy.
A round, biconvex, polished tablet with a red sugar coat which may or may not be overprinted will be available in
Government institutions only.
PRESENTATION
25 mg Capsules: Amber glass bottle containing 100 capsules.
75 mg Tablets: Calendar Pack: Cartons containing 28 blister packed tablets.
STORAGE INSTRUCTIONS
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBERS
PROTHIADEN 25 mg Capsules: F/1.2/161
PROTHIADEN 75 mg Tablets: K/1.2/3
989832
Davbar Dbn.
Updated on this site: October 1999
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