Prothiazine Tablets and Syrup

/ CTS

Route of administration: Oral.
Not for use in children under the age of 2 years.
For treatment of allergies:
Children aged 2-5 years:
5-15 ml of syrup in one dose, to be taken at night or 5 ml two to three times a day. Do not administer more than 15 ml per day.
Children aged 6-12 years:
10-25 ml of syrup in one dose to be taken at night, or 10 ml twice a day. Do not administer more than 25 ml per day.
Children above the age of 12 and adults:
Begin treatment by taking one tablet at night. The dosage can be increased to a maximum of one tablet twice a day, as required.
For treatment and prevention of nausea and vomiting:
Children aged 2-5 years:
5 ml of syrup every 4-6 hours up to a maximum of 15 ml per day.
Children aged 6-12 years:
A dose of 10 ml of syrup; wait 4-6 hours before administering another dose. Up to two doses per day can be administered (a total of 20 ml per day).
Children above the age of 12 and adults:
One tablet every 4-6 hours, up to a maximum of 4 tablets per day.
For short-term use as a sedative, with the doctor’s instruction only:
Children aged 2-5 years:
5-15 ml of syrup as a single dose to be taken at night, at bedtime.
Children aged 6-12 years:
10-20 ml of syrup as a single dose to be taken at night, at bedtime.
Children above the age of 12 and adults:
One to three tablets as a single dose, to be taken at night, at bedtime.

Antihistaminic, Antiemetic, Sedative.

Should not be used in patients in coma or suffering from CNS depression of any cause.
Hypersensitivity to the active substance or to any of the excipients.
Contraindicated for use in children less than two years of age because of the potential for fatal respiratory depression.
Should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.

Caution should be used in patients with:
Asthma, bronchitis or bronchiectasis, Prothiazine may thicken or dry lung secretions and impair expectoration. Severe coronary artery disease, Narrow angle glaucoma, Epilepsy, Hepatic and renal insufficiency, Bladder neck or pyloro-duodenal obstruction.
Ototoxicity
Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.
QT prolongation
Phenothiazine derivatives may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalaemia, and acquired (i.e. drug induced) QT prolongation. If the clinical situation permits, medical and laboratory evaluations should be performed to rule out possible risk factors before initiating treatment with a phenothiazine derivative and as deemed necessary during treatment.
Photosensitivity reactions
Due to the risk of photosensitivity, exposure to strong sunlight or ultraviolet light should be avoided during or shortly after treatment.
Paediatric population
The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s Syndrome.
See prescribing information for full details.

See prescribing information for full details

* The drug will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic.
* Alcohol should be avoided during treatment, Combination with alcohol enhances the sedative effects of H1 antihistamines.
* The drug may interfere with immunological urine pregnancy tests to produce false positive or false-negative results.
* The drug should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false negative results.
* Special caution is required when promethazine is used concurrently with drugs known to cause QT prolongation (such as antiarrhythmics, antimicrobials, antidepressants, antipsychotics) to avoid exacerbation of risk of QT prolongation.
See prescribing information for full details.

Pregnancy: Should not be used in pregnancy unless the physician considers it essential. The use is not recommended 2 weeks prior to delivery in view of the risk of irritability and excitement in the neonate.
Lactation: The drug is excreted in breast milk. There are risks of neonatal irritability and excitement. This medical product is not recommended for use in breast-feeding.

Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children: coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. High doses (supratherapeutic doses) can cause ventricular arrhythmias including QT prolongation and torsade de pointes. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic effect of promethazine; alternatively, gastric lavage may be used.
Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.

Storage: Store below 25°C
Shelf life: Prothiazine syrup after first opening- 22 days.