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

Logo TERFLURAZINE-1 TABLETS
TERFLURAZINE-2 TABLETS
TERFLURAZINE-5 TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

TERFLURAZINE-1 TABLETS
TERFLURAZINE-2 TABLETS
TERFLURAZINE-5 TABLETS

COMPOSITION:
Tablets containing 1 mg, 2 mg or 5 mg
Trifluoperazine as the hydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
A 2.6.1 Phenothiazines and Derivatives.

PHARMACOLOGICAL ACTION:
Terflurazine is a tranquilliser belonging to the piperazine subgroup of substituted phenothiazines. Its onset of action is rapid and its effects are long lasting. It possesses effective antipsychotic and anti-emetic activity but lacks sedative properties and has only mild adrenolytic, antihistaminic and antispasmodic action.

INDICATIONS:
Acute and chronic schizophrenia, acute mania and delirium tremens.

CONTRA-INDICATIONS:
Contra-indicated in persons suffering from blood, bone marrow and liver diseases. Like all medicines, it should be administered with caution to pregnant women during the first trimester. Terflurazine is also contra-indicated in patients with central nervous system depression or in those who are comatose.

DOSAGE AND DIRECTIONS FOR USE:
The dosage for psychotic patients must be adjusted to the severity of the condition and response of the patient. The usual starting dose is 5 mg twice daily. Within 2 or 3 weeks after starting therapy most patients will show optimum response on 5 mg three times daily, or 10 mg twice daily a few may, need 40 mg a day or even more.
When the maximum response is achieved, the dose should be reduced to a satisfactory maintenance level.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects include drowsiness, dryness of the mouth, pallor of the skin, postural hypotension, weakness, lowering of body temperature (occasionally pyrexia), tachycardia, arrhythmias, agitation, insomnia, depression or sometimes agitation, photosensitivity and skin rashes.
Sensitivity reactions include urticaria, photosensitisation and on occasions exfoliative dermatitis.
Terflurazine may alter endocrine function. Patients have experienced amenorrhoea galactorrhoea, gynaecomastia, and mass gain and there have been reports of raised serum-cholesterol concentrations.
Extrapyramidal dysfunction with symptoms such as akathisia dystonia and Parkinsonism may occur. Muscles of the face and shoulder girdle maybe selectively involved. Spasm of the neck muscles, extensor rigidity of the back muscles, carpopedal spasm, oculogyric crises, trismus and swallowing difficulty may be observed. Excitement and increased suggestibility are occasionally encountered. The extrapyramidal symptoms are reversible and usually subside within 24 to 48 hours after lowering dosage or temporarily discontinuing the drug, or by simultaneous administration of an anti-Parkinsonian drug. However, persistent tardive dyskinesia has occurred and may be irreversible.
Other side-effects include temporary stimulation or jitteriness, transient drowsiness dizziness, muscular weakness, anorexia, dryness of the mouth, rash, lactation and blurred vision, jaundice, allergic purpura, agranulocytosis, leucopenia, and thrombocytopenia have been reported occasionally.
If sore throat, fever and weakness develop, the drug should be withdrawn immediately and white blood cell and differential counts should be made. If evidence of bilirubinuria and icterus appear, the drug should likewise be discontinued, and liver function tests should be made.
Although the hypotensive activity of Terflurazine is minor, patients with impaired cardiovascular systems should not receive large doses of Terflurazine. As Terflurazine may potentiate the action of antihypotensive agents, as well as that of general anaesthetics, hypnotics, alcohol, and other central nervous system depressants, caution should be observed in concomitant use of any of these drugs with Terflurazine. If use of a vasopressor should be necessary to counteract hypotension induced by an antihypertensive drug given simultaneously, epinephrine should not be employed because Terflurazine may reverse its action and cause profound hypotension; levarterenol however, may be given. The antiemetic action of Terflurazine may mask signs of overdosage of toxic drugs or may obscure diagnosis of intestinal obstruction and brain tumour.
Phenothiazines have important effects on the heat regulatory mechanism and patients receiving them are prone to hypothermia and hyperpyrexia may occur under certain conditions.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Extrapyramidal dysfunction with symptoms such as akathisia, dystonia and parkinsonism. Muscles of the face, neck and shoulder-girdle may be selectively involved; extensor rigidity of the back muscles, carpopedal spasm, oculogyric crisis, trismus, and difficulty in swallowing may occur.
Empty stomach by aspiration and lavage. The severe extrapyramidal reactions may be controlled with anticholinergic anti-Parkinsonian agents.

CONDITIONS OF REGISTRATION:
May be advertised to the professions only.

IDENTIFICATION:
Blue sugar-coated tablets.

PRESENTATION:
Packs of 50 and 250 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
1 mg –L/2.6.1/222.
2 mg –L/2.6.1/223.
5 mg –L/2.6.1/224.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13.7.78. M899
  Tradepak PE

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