DESCRIPTION
id: dc2baef4-5f02-4b22-b57f-1677444fdc09
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, colloidal silicon dioxide, glyceryl monostearate, hard fat, and white wax. Promethazine HCl Suppositories, USP are for rectal administration only.
Promethazine HCl is a racemic compound; the empirical formula is C17H20N2S∙HCl and its molecular weight is 320.88.
Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine, 10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)- with the following structural formula:
Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder, which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol.
CLINICAL PHARMACOLOGY
id: c91bdb2a-a8ed-4849-813d-6040e8764256
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties.
Promethazine is an H1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects.
Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.
INDICATIONS AND USAGE
id: 1436f63b-0698-420c-9a39-5d552220e887
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Promethazine HCl Suppositories, 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, 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.
CONTRAINDICATIONS
id: 607fa52d-c5d8-4a56-968a-b6a52e03da8a
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age.
Promethazine HCl 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.
ADVERSE REACTIONS
id: d61685af-1f26-4142-aae2-c0b3da508cae
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Central Nervous System
Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.
Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness.
Dermatologic – Dermatitis, photosensitivity, urticaria.
Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.
Gastrointestinal – Dry mouth, nausea, vomiting, jaundice.
Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See
WARNINGS–Respiratory Depression
).
Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported (See
WARNINGS–Neuroleptic Malignant Syndrome
).
Paradoxical Reactions
Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.
To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
OVERDOSAGE
id: 155916b2-8a82-43c7-8c54-6be3e2645bd7
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, and unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex).
Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.
Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur.
DOSAGE AND ADMINISTRATION
id: ef635e19-55c5-4584-9a6e-0ea839d63e83
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (see
WARNINGS–Black Box Warning and Use in Pediatric Patients).
Promethazine HCl Suppositories are for rectal administration only.
HOW SUPPLIED
id: 06b33cff-228b-4aa7-b9b7-ad47ea642240
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Promethazine HCl Rectal Suppositories, USP are available in boxes of 12 as follows:
| 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. |
Box of 12 |
NDC 51672-5296-1 |
| 25 mg, white, bullet-shaped suppository wrapped in silver foil. |
Box of 12 |
NDC 51672-5297-1 |
PRINCIPAL DISPLAY PANEL – 12.5 mg Blister Pack Carton
id: 4195dc9a-fcb4-481c-82f2-c7c59997203e
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 51672-5296-1
12
Suppositories
Promethazine HCl
Suppositories USP,
12.5 mg
For Rectal Administration
Rx only
TARO
PRINCIPAL DISPLAY PANEL – 25 mg Blister Pack Carton
id: f834498c-45b0-4197-8ad6-f71407fcef9b
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 51672-5297-1
12
Suppositories
Promethazine HCl
Suppositories USP,
25 mg
For Rectal Administration
Rx only
TARO
