Promethazine Hydrochloride 25 MG Oral Tablet
Generic Name: PROMETHAZINE HYDROCHLORIDE
Brand Name: PROMETHAZINE HYDROCHLORIDE
- Substance Name(s):
- PROMETHAZINE HYDROCHLORIDE
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.
A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE TABLETS, USP HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TABLETS, USP TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER.
IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE TABLETS, USP BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
CNS Depression 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 (see PRECAUTIONS- Information for Patients and Drug Interactions ).
Respiratory Depression Promethazine hydrochloride tablets, USP may lead to potentially fatal respiratory depression.
Use of promethazine hydrochloride tablets, USP in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.
Lower Seizure Threshold Promethazine hydrochloride tablets, USP 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.
Bone-Marrow Depression Promethazine hydrochloride tablets, USP should be used with caution in patients with bone-marrow depression.
Leukopenia and agranulocytosis have been reported, usually when promethazine hydrochloride tablets, USP have been used in association with other known marrow-toxic agents.
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.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).
The diagnostic evaluation of patients with this syndrome is complicated.
In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g.
pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS).
Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include 1) immediate discontinuation of promethazine hydrochloride, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available.
There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.
Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered.
Use in Pediatric Patients PROMETHAZINE HYDROCHLORIDE TABLETS, USP ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TABLETS, USP TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.
RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION.
CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.
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 HYDROCHLORIDE TABLETS, USP ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE’S SYNDROME.
THE USE OF PROMETHAZINE HYDROCHLORIDE TABLETS, USP SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE’S SYNDROME OR OTHER HEPATIC DISEASES.
Excessively large dosages of antihistamines, including promethazine hydrochloride tablets, USP, in pediatric patients may cause sudden death (see OVERDOSAGE ).
Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride tablets, USP 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.
Other Considerations Administration of promethazine hydrochloride has been associated with reported cholestatic jaundice.
OVERDOSAGE
Signs and symptoms of overdosage with promethazine hydrochloride range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death.
Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensorplantar 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.
Treatment Treatment of overdosage is essentially symptomatic and supportive.
Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored.
Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic.
Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation.
Diazepam may be used to control convulsions.
Acidosis and electrolyte losses should be corrected.
Note that any depressant effects of promethazine hydrochloride are not reversed by naloxone.
Avoid analeptics which may cause convulsions.
The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated.
In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered.
EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure.
Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates.
Oxygen may also be administered.
Limited experience with dialysis indicates that it is not helpful.
DESCRIPTION
Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride.
Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride.
Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride.
Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose.
In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6.
Promethazine hydrochloride is a racemic compound; the empirical formula is C17H20N2S•HCl and its molecular weight is 320.88.
Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula: Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air.
It is freely soluble in water and soluble in alcohol.
HOW SUPPLIED
Promethazine hydrochloride tablets, USP are available as follows: Promethazine hydrochloride tablets, USP 12.5 mg are supplied as orange colored, round shaped, biconvex tablets, debossed “K” on left and “2” on right of bisect, on one side and plain on the other side.
Promethazine hydrochloride tablets, USP 25 mg are supplied as white colored, round shaped, flat face bevel edge tablets, debossed “K 3” on one side and quadrisected on the other side.
Promethazine hydrochloride tablets, USP 50 mg are supplied as pink colored, round shaped, biconvex tablets, debossed “K 4” on one side and plain on the other side.
Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Protect from light.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Manufactured by: KVK-TECH, INC.
110 Terry Drive Newtown, PA 18940-1850 Item ID # 006025/01 05/07 Manufacturer’s Code: 10702
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, 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 post-operative 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.
DOSAGE AND ADMINISTRATION
Promethazine hydrochloride tablets, USP are contraindicated for children under 2 years of age (see WARNINGS – Black Box Warning and Use in Pediatric Patients ).
Promethazine hydrochloride tablets, USP are for oral administration only.
Allergy The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary.
Single 25 mg doses at bedtime or 6.25 mg to 12.5 mg taken three times daily will usually suffice.
After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms.
The administration of promethazine hydrochloride in 25 mg doses will control minor transfusion reactions of an allergic nature.
Motion Sickness The average adult dose is 25 mg taken twice daily.
The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary.
On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal.
For children, promethazine hydrochloride tablets, USP 12.5 mg to 25 mg, twice daily, may be administered.
Nausea and Vomiting Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS – Use in Pediatric Patients ).
The average effective dose of promethazine hydrochloride tablets, USP for the active therapy of nausea and vomiting in children or adults is 25 mg.
12.5 to 25 mg doses may be repeated, as necessary, at 4 to 6 hour intervals.
For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.
For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4 to 6 hour intervals, as necessary.
Sedation This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused.
Administration of 12.5 to 25 mg promethazine hydrochloride orally at bedtime will provide sedation in children.
Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.
Pre- and Postoperative Use Promethazine hydrochloride tablets, USP in 12.5 to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.
For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug.
Usual adult dosage is 50 mg promethazine hydrochloride tablets, USP with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.
Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25 to 50 mg doses in adults.
Promethazine hydrochloride tablets, USP are contraindicated for children under 2 years of age.