PROMETHAZINE

Antiemetic / Antihistamine

Brand names: Promethazine, Phenergan

Oral

Mechanism of Action

Other agent

Indications

INDICATIONS AND USAGE Promethazine hydrochloride tablets

USP are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild

uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions

as adjunctive therapy to epinephrine and other standard measures

after the acute manifestations have been controlled. Preoperative

postoperative

Contraindications

• CONTRAINDICATIONS Promethazine hydrochloride tablets
• USP are contraindicated for use in pediatric patients less than two years of age. Promethazine hydrochloride tablets
• USP are contraindicated in comatose states

FDA Warnings

WARNINGS WARNING: PROMETHAZINE HYDROCHLORIDE TABLETS, USP SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE TABLETS, USP IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE
Respiratory Depression Promethazine hydrochloride tablets, USP may lead to potentially fatal respiratory depression
Neuroleptic Malignant Syndrome A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine hydrochloride alone or in combination with antipsychotic drugs

Known Side Effects

11 documented side effects by frequency

Nausea

>10%

Vomiting

1-10%

Fatigue

1-10%

Diarrhea

1-10%

Headache

1-10%

Shortness of Breath

1-10%

Back Pain

0.1-1%

Anxiety

0.1-1%

Drug Not Working

0.1-1%

Weakness

0.1-1%

Joint Pain

0.1-1%

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Compare With

5 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral