Composition


Each tablet contains: Promethazine HCI 10 mg or 25 mg.
Each 5 ml of the syrup contains: Promethazine HCI 5 mg.


Indications

  • Perennial and seasonal allergic rhinitis.
  • Vasomotor rhinitis.
  • Allergic conjunctivitis.
  • Mild, uncomplicated allergic skin mani­festations of urticaria and angioedema.
  • Amelioration of allergic reactions to blood or plasma.
  • Common cold, for the relief of sneezing and rhinorrhea.
  • Motion sickness for the prevention and treatment of nausea, vomiting, and dizzi­ness.

Contraindications

In patients with lower respiratory tract symptoms including asthma, in comatose patients and in individuals known to be hypersensitive to it.

Side Effects


Infrequently, drowsiness, dryness of mouth, headache, and tiredness may occur.
Extrapyramidal adverse reactions have rarely been reported, especially after high doses.


Precautions


May cause drowsiness. Avoid alcoholic beverages.
Caution in patients with cardiovascular dis­eases, acute asthma, prostatic hypertro­phy, urinary retention, glaucoma, or liver dysfunction.
Avoid the exposure of skin to excessive sunlight.
Discontinue its use before taking allergy skin tests due to possible false positive results.
Contains sodium disulfite as an inactive ingredient, which may cause allergic type reactions including anaphylactic symptoms in susceptible patients, mostly in those having a history of asthma. If any signs of
hypersensitivity reactions occur, discontin­ue immediately and consult a physician.

Pregnancy, Lactation, Overdosage

(seeinsert leaflet).

Drug Interactions


Co-administering promethazine with CNS depressants, alcohol, or MAOI may poten­tiate its sedative effect.

Dosage and Administration


Adults and Children Above 10 Years
Tablets: 25 mg at bedtime increased to
25 mg twice daily if necessary or 10-20 mg
2-3 times daily before meals.
Children Up to 10 Years
Syrup
5-10 years: 10-25 mg daily in 1-2 divided doses.
2-5 years: 5-15 mg daily in 1-2 divided doses.
Below 2 years: Not recommended.
Take the dose at bedtime or as directed by the physician.
Higher doses are used in pre-operative sedative effects.
Do not exceed the stated dose.


Packaging


t: 20
sy: 100 ml.