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

Logo RECEPTOZINE 10 mg TABLETS
RECEPTOZINE 25 mg TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

RECEPTOZINE 10 mg TABLETS
RECEPTOZINE 25 mg TABLETS

COMPOSITION:
Each tablet contains:
Promethazine hydrochloride        10 mg or 25 mg
Sugar        30 mg

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.1 Antihistamines

PHARMACOLOGICAL ACTION:
Promethazine is a phenothiazine which is a competitive antagonist of histamine at the H
1-receptors.

INDICATIONS:
Promethazine hydrochloride is indicated in disorders known to respond to antihistamine therapy, for example, hay fever, vasomotor rhinorrhoea, urticaria, and sensitisation reactions to drugs and other substances. It may be of symptomatic value in relieving pruritus.

CONTRA-INDICATIONS:
Receptozine is contra-indicated in comatose patients, particularly those under the influence of alcohol; barbiturates; narcotics, or other central nervous system depressants, if used in conjunction with any of these agents it should be given in much reduced dosages as it enhances their actions. Its use is inadvisable in patients with tachycardia or cardiac insufficiency and in patients with liver disfunction or with a history of jaundice. Bone-marrow depression, first trimester of pregnancy.
Caution in epilepsy as number of attacks may increase.

WARNING:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents.
Patients should be warned against taking care of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.

INTERACTIONS:
Receptozine may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. The effect of anticholinergics such as atropine and tricyclic antidepressants may be enhanced by the concomitant administration of those antihistamines which possess similar action.

DOSAGE AND DIRECTIONS FOR USE:
Children from 6 to 12 years: 10 mg - 25 mg per day in divided doses. If two doses are given in 24 hours the lower dose should be used.
Adults: 20 mg to 50 mg per day in divided doses.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effects is sedation varying from slight drowsiness to deep sleep and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and incoordination. Other side-effects include increase in blood pressure, gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation, colic and epigastric pain. Promethazine may also produce headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands. Symptoms of stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Allergy and dermatological reactions may occur. Blood disorders, including agranulocytosis, haemolytic anaemia and leucopenia have been reported. Jaundice and photosensitivity reactions may have been reported.
Promethazine hydrochloride must be administered with caution to patients with hepatic disorders.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage in children may include convulsions and hyperpyrexia. Extrapyramidal reactions may occur in adults. Large doses of promethazine may precipitate fits in epileptics. If the medicine has been taken by mouth recently, the stomach should be emptied by aspiration and lavage. The treatment for overdosage should be symptomatic, supportive and may include gastric lavage (where applicable).

IDENTIFICATION:
Receptozine 10 mg tablets: Blue to greenish-blue sugar coated, round biconvex tablets.
Receptozine 25 mg tablets: Blue to greenish-blue sugar coated, round biconvex tablets.

PRESENTATION:
Amber PVC containers of 500 and 5000 tablets.
White HDPE bottles of 1000 tablets.
Patient ready packs of different pack sizes.

STORAGE INSTRUCTIONS:
Store in a cool dry place, below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION:
Receptozine 10 mg Tablet R/5.7.1/154
Receptozine 25 mg Tablet R/5.7.1/155

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
BE-TABS PHARMACEUTICALS (PTY) LTD,
14 Lautre Road
Stormill, Ext. 1
Roodepoort 1724
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 December 1983

CODE: IBTZ/7
JETPRINT 5/03

New addition to this site: April 2005
Source: Hospital Pharmacy

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