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 ;
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 ; Sedation and treatment of insomnia in adults; As an adjunct in preoperative sedation in surgery and obstetrics; As a paediatric sedative.
Dosage and Administration
Usage:I.M.
Posology
Adults: The usual dose is 25 – 50 mg. Maximum parenteral dose 100 mg.
Elderly: No specific dosage recommendations.
Paediatric population: 6.25 – 12.5 mg for children from 5 – 10 years by deep intramuscular injection. Not for use in children under 2 years of age.
Precautions & Warning:
1.Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported with Promethazine use.
2.Caution must be exercised when using H1-antihistamines such as Promethazine due to the risk of sedation.
3.Intravenous injection should be performed with extreme care to avoid extravasation or inadvertent intra-arterial injection, which could lead to necrosis and peripheral gangrene.
4.Ototoxicity; QT prolongation; Photosensitivity reactions; Paediatric population; Excipient with known effect
Contraindications:
1. Promethazine should not be given to patients with a known hypersensitivity to promethazine, other phenothiazines, or to 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 two years of age because of the potential for fatal respiratory depression.
4. Promethazine should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.
Adverse Reactions:
1. Immune system disorders: Allergic reactions, including anaphylactic reaction, urticaria, angioedema.
2. Skin and subcutaneous tissue disorders: Rash, photosensitivity reaction.
3. Nervous system disorders: Sedation or somnolence
4. Psychiatric disorders: Agitation, confusional state, anxiety.
5. Eye disorders: Blurred vision
6. Gastrointestinal disorders: Epigastric irritation/discomfort, dry mouth
7. Renal and urinary disorders: Urinary retention
8. Metabolism and nutrition disorders Decreased appetite
Drug interactions:
1. Promethazine will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic.
2. Alcohol should be avoided during treatment.
3.Promethazine may cause hypotension, and dosage adjustment of antihypertensive therapy may therefore be required.
4. Promethazine may lower the convulsive threshold, and dosage adjustment of anticonvulsant medication may therefore be required.
5. Promethazine may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results.
6. Promethazine 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.
Storage instructions:
Store in the original carton in order to protect from light.