Indications  

As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins; As an antiemetic. For short term use.; Treatment of insomnia in adults; As a paediatric sedative.

Dosage and Administration

Usage:Oral.

Paediatric population: Not for use in children under the age of 6 years.

As an antihistamine in allergy:

1. Children 6 – 10 years: 25 mg as a single dose*.Maximum daily dose 25 mg.

2. Children over 10 years and adults (including elderly):25 mg as a single dose*.

Increasing to a maximum of 25 mg twice a day as required.

*Single doses are best taken at night.

As an antiemetic:

1.Children 6 – 10 years: The use of promethazine tablet is recommended.

2.Children over 10 years and adults (including elderly): 25 mg to be taken the night before the journey. To be repeated after 6 – 8 hours as required.

As a paediatric sedative for short term use and for short term treatment of insomnia in adults:

1.Children 6 – 10 years: 25 mg as a single night time dose.

2.Children over 10 years and adults (including elderly): 25 mg or 50 mg as a single night time dose.

Precautions & Warning:

1.Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported with promethazine use. In case of allergic reaction, treatment with promethazine must be discontinued and appropriate symptomatic treatment initiated .

2.promethazine should be avoided in patients with liver or renal dysfunction, Parkinson's disease, hypothyroidism, cardiac failure, pheochromocytoma, myasthenia gravis, or prostate hypertrophy, or in patients with a history of narrow angle glaucoma or agranulocytosis.

3.Caution must be exercised when using H1-antihistamines such as promethazine due to the risk of sedation. Combined use with other sedative medicinal products is not recommended .

4.Ototoxicity, QT prolongation, Photosensitivity reactions, Paediatric population, Excipient(s) with known effect.

Contraindications:

1. Promethazine should not be given to patients with a known hypersensitivity to promethazine, other phenothiazines, or to any other ingredients in the formulation of promethazine.

2. Promethazine should not be used in patients in coma or suffering from CNS depression of any cause.

3. Promethazine is contraindicated for use in children less than 6 years of age.

4. Promethazine should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.

Adverse Reactions:

Immune system disorders: Allergic reactions, including anaphylactic reaction, urticaria, angioedema.

Skin and subcutaneous tissue disorders: Rash, photosensitivity reaction.

Nervous system disorders: Sedation or somnolence Dizziness, headaches, extrapyramidal effects including restless legs syndrome, muscle spasms and tic-like movements of the head and face.

Psychiatric disorders: Agitation, confusional state, anxiety.

Eye disorders: Blurred vision

Gastrointestinal disorders: Epigastric irritation/discomfort, dry mouth

Renal and urinary disorders: Urinary retention

Metabolism and nutrition disorders: Decreased appetite

Drug interactions:

promethazine will enhance the action of any anticholinergic agent, tricyclic ;antidepressant, sedative or hypnotic.; Alcohol should be avoided during treatment; monamine oxidase inhibitors; Seizure threshold-lowering drugs;

Storage instructions:

Store below 30℃. Store in the original carton in order to protect from light.