Indicated 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, or Obstetric Sedation

• Prevention and Control of Nausea and Vomiting Associated with Certain Types of Anesthesia and Surgery

• Therapy Adjunctive to Meperidine or other Analgesics for Control of Postoperative Pain

• Sedation in Both Children and Adults, as well as Relief of Apprehension and Production of Light Sleep from Which the Patient can be Easily Aroused

• Active and Prophylactic Treatment of Motion Sickness

• Antiemetic Therapy in Postoperative Patients

Phenergan Tablets and Suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines

Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.

Promethazine HCI should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression.

Use of Promethazine HCl tablets in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.

Promethazine HCl tablets may lead to potentially fatal respiratory depression.

Promethazine HCl tablets may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.

Promethazine HCl tablets should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow toxic agents.

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs.

Antiemetics are not recommended for treatment of uncomplicated vomiting in pediatric patients, and their use should be limited to prolonged vomiting of known etiology. the extrapyramidal symptoms which can occur secondary to promethazine hcl tablets administration may be confused with the cns signs of undiagnosed primary disease, e.g., encephalopathy or reye’s syndrome. the use of promethazine hcl tablets should be avoided in pediatric patients whose signs and symptoms may suggest reye’s syndrome or other hepatic diseases.

Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine hydrochloride.

Administration of promethazine HCl has been associated with reported cholestatic jaundice.

Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction.

Promethazine HCl tablets should be used cautiously in persons with cardiovascular disease or with impairment of liver function.

An increase in blood glucose has been reported in patients receiving promethazine hydrochloride.

Excessively large doses of antihistamines, including promethazine hydrochloride tablets, USP in pediatric patients may cause sudden death. Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine hydrochloride.

Epinephrine should NOT be used to treat hypotension associated with promethazine HCl tablets overdose.

Promethazine hydrochloride tablets, USP may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence of promethazine hydrochloride.

Promethazine hydrochloride tablets, USP may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine hydrochloride. When given concomitantly with promethazine hydrochloride tablets, USP the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half.

Concomitant use of other agents with anticholinergic properties should be undertaken with caution.

Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.

Promethazine hydrochloride tablets, USP administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.

There are no adequate and well-controlled studies of promethazine hydrochloride tablets, USP in pregnant women. Animal studies: fetal mortality.

It is not known whether promethazine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from promethazine hydrochloride tablets, USP a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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• Morning sickness. GoToSource

• Acute gastroenteritis. GoToSource

• Acute migraine. GoToSource  

• Use with haloperidol to treat psychosis induced agitation/aggression. GoToSource

• Vestibular neuritis. GoToSource 

• Use in patients under 2 years of age. GoToSource

Neuroleptic malignant syndrome (life-threatening neurological disorder). GoToSource

Blurred vision, tinnitus (noise or ringing in the ears), extrapyramidal symptoms (movement disorders),  tachycardia (fast heart rate), urinary retention, constipation and worsening of glaucoma. GoToSource

Liver injury, hypotension (low blood pressure), bone marrow suppression and depression of the thermoregulatory mechanism resulting in hypothermia/hyperthermia. GoToSource

Apnea (sleep disorder). GoToSource

Respiratory depression and sudden death, seizures, photosensitivity and rash, hyperexcitability, thrombocytopenia (deficiency of platelets in blood and agranulocytosis (low white blood cell count). GoToSource

Necrosis (cell or tissue death) caused by intra-arterial injection of promethazine. GoToSource

Lawsuits filed for severe tissue injury including gangrene.