INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo THADEN(TM) - 25 capsules
THADEN(TM) - 75 tablets

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

THADEN(TM) - 25 capsules
THADEN(TM) - 75 tablets

COMPOSITION:
Each THADEN (TM) - 25 capsule contains 25 mg
dothiepin hydrochloride.
Each THADEN(TM) - 75 tablet contains 75 mg dothiepin hydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
A 1.2 Psychoanaleptics (antidepressants)

PHARMACOLOGICAL ACTION:
Thaden (dothiepin hydrochloride) is a tricyclic antidepressant.

INDICATIONS:
For the treatment of depression in adults.

CONTRA-INDICATIONS:
The acute phase of myocardial infarction, and in patients with heart block. Administration is not advised during the first trimester of pregnancy.

WARNINGS:
Use of Thaden is generally considered to be unsafe in porphyria. 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 seven days. In these situations impaired decision making could lead to accidents.

SPECIAL WARNING:
This medicine should at all times be kept out of the reach of children, as even small doses may be fatal to them.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
Dosage may vary widely depending on the individual patient and conditions. It is preferable to use the smaller dose for the first few days.
In the treatment of depression, Thaden is given in doses of 25 mg three times daily initially, gradually increased to 50 mg three times daily if necessary; alternatively, 75 or 150 mg may be given as a single night-time dose. Higher doses of up to 225 mg daily have been given in severely depressed patients. The recommended initial dose for the elderly is 50 to 75 mg daily. Half the normal maintenance dose may be adequate in the elderly.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Many side-effects are caused by its anti-muscarinic actions. These include dry mouth, sour or metallic taste, constipation which can lead to paralytic ileus, urinary retention, blurred vision and disturbances in accommodation, palpitations, tachycardia, and impotence. When anticholinergic effects are severe the medicine should be discontinued or reduced. Other adverse effects include drowsiness (but nervousness and insomnia may occur), headache, peripheral neuropathy, tremor, orthostatic hypotension, hypertension, dizziness, sweating, weakness and fatigue, ataxia, epileptiform seizures, extrapyramidal symptoms including speech difficulties, tinnitus, stomatitis and gastric irritation with nausea and vomiting. Confusion or delirium may occur, particularly in the elderly. Anorexia with weighs loss, or weight gain, sometimes with inappropriate appetite (carbohydrate craving) may occur. Allergic skin reactions and photosensitisation have been reported, as well as cholestatic jaundice and blood disorders, including eosinophilia, bone-marrow depression, thrombocytopenia, leucopenia, and agranulocytosis. The tricyclic antidepressants have an adverse effect on the myocardium and can cause conduction defects and cardiac arrhythmias; an increased risk of sudden death has been suspected in cardiac patients receiving tricyclic antidepressants. Endocrine effects associated with tricyclic antidepressant therapy include changes in libido, interference with sexual function, gynaecomastia and breast enlargement, and galactorrhoea. Changes in blood sugar concentrations may also occur, as well as inappropriate secretion of antidiuretic hormone.

NOTE: Elderly patients are more prone to all these effects, and therapy should be initiated at lower standard doses in the elderly.

Special Precautions:
a) 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. Withdraw the drug if the depression turns into a manic phase. Patients with suicidal tendencies should be carefully supervised during treatment.
b) In elderly male patients suffering from prostatism, urinary retention may be precipitated.
c) 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 electro-cardiograph abnormalities. Regular cardiological and electrocardiographic examination is advised.
d) Use with caution in patients with hyperthyroidism or with impaired liver function and in those with a history of epilepsy, untreated narrow-angle glaucoma, urinary retention, prostatic hypertrophy or constipation.
e) The medicine should not usually be given to patients receiving other central nervous system depressants, e.g. barbiturates. It should not be given to patients receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment. The pressor effects of the direct acting sympathomimetic agents, adrenaline or 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. The effects of tricyclic antidepressants, 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. Hyperthyroid patients or those taking thyroid preparations may show an enhanced response to tricyclic antidepressants. The effects of bethanidine, debrisoquine, guanethidine and possibly of clonidine are reduced by tricyclic antidepressants.
f) In diabetic patients, as blood sugar concentrations may be altered.
g) Withdraw the drug if allergic skin reactions appear.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage and poisoning may be characterised by central nervous system depression or excitation, severe anti-cholinergic effects and cardiotoxicity. The following symptoms and signs are characteristic of acute overdosage: drowsiness, restlessness, ataxia, stupor, coma, pyrexia, palpitations, tachycardia, cardiac arrhythmias, hypotension and in severe cases, respiratory depression. Epileptiform seizures may occur. The stomach should be emptied by emesis or aspiration and lavage. In particular, the patient should be monitored for cardiac arrhythmias and anti-arrhythmic measures instituted if cardiac output is jeopardised.

IDENTIFICATION:
THADEN(TM) - 25: A white powder, encapsulated in an opaque no. 3 capsule with a red body and red cap, imprinted in white ink with the Lennon Logo.
THADEN(TM) - 75: A round, red, film-coated, biconvex tablet.

PRESENTATION:
THADEN(TM) - 25: Securitainers containing 100 capsules
THADEN(TM) - 75: Blister calendar packs of 28 tablets.

STORAGE INSTRUCTIONS:
THADEN(TM) - 25: Store below 25°C. Protect from light.
THADEN(TM) - 75: Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS:
THADEN(TM) - 25: Z/1.2/171;
THADEN(TM) - 75: Z/1.2/301.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited, 7 Fairclough Road, PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13/02/1992.

        D832
                A & S PRINTERS

Updated on this site: June 2003
Current: February 2005
Source: Community Pharmacy

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