Phenergan Information
Phenergan (Promethazine) Description
Phenergan (Promethazine) (promethazine hydrochloride) Injection, is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10-Phenothiazine-10-ethanamine,α-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula:
Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate.
Phenergan (Promethazine) (promethazine hydrochloride) Injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.
Phenergan (Promethazine) Clinical Pharmacology
Promethazine hydrochloride is a phenothiazine derivative which possesses antihistaminic, sedative, antimotion-sickness, antiemetic, and anticholinergic effects. Promethazine is a competitive H receptor antagonist, but does not block the release of histamine. Structural differences from the neuroleptic phenothiazines result in its relative lack (110 that of chlorpromazine) of dopamine antagonist properties. Clinical effects are generally apparent within 5 minutes of an intravenous injection and within 20 minutes of an intramuscular injection. Duration of action is four to six hours, although effects may persist up to 12 hours. Promethazine hydrochloride is metabolized in the liver, with the sulfoxides of promethazine and N-desmethylpromethazine being the predominant metabolites appearing in the urine. Following intravenous administration in healthy volunteers, the plasma half-life for promethazine has been reported to range from 9 to 16 hours. The mean plasma half-life for promethazine after intramuscular administration in healthy volunteers has been reported to be 9.8 ± 3.4 hours.
Phenergan (Promethazine) Indications And Usage
Phenergan (Promethazine) Injection is indicated for the following conditions:
Phenergan (Promethazine) Warnings
Phenergan (Promethazine) Injection can cause severe chemical irritation and . Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse event reports include burning, pain, erythema, swelling, sensory loss, palsies, paralysis, severe spasm of distal vessels, thrombophlebitis, venous thrombosis, phlebitis, abscesses, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required.
DOSAGE AND ADMINISTRATION
In the event that a patient complains of pain during intravenous injection of Phenergan (Promethazine) Injection, the injection should be stopped immediately to evaluate for possible arterial injection or perivascular extravasation.
There is no proven successful management of unintentional intra-arterial injection or perivascular extravasation after it occurs. Sympathetic block and heparinization have been employed during the acute management of unintentional intra-arterial injection, because of the results of animal experiments with other known arteriolar irritants.
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.
Phenergan (Promethazine) Precautions
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.
Phenergan (Promethazine) Injection should be used cautiously in persons with cardiovascular disease or impairment of liver function.
Patients should be advised of the risk of respiratory depression, including potentially fatal respiratory depression in children less than 2 years of age (see ).
Patients should be advised of the risk of severe tissue injury, including gangrene (see ). Patients should be advised to immediately report persistent or worsening pain or burning at the injection site.
Phenergan (Promethazine) Injection may cause marked drowsiness or impair the mental or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers may enhance impairment (see and ).
Patients should be advised to report any involuntary muscle movements (see ).
Patients should be advised to avoid prolonged exposure to the sun (see ).
Phenergan (Promethazine) Injection is contraindicated for use in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression. Phenergan (Promethazine) Injection should be used with caution in pediatric patients 2 years of age and older (see ).
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 Phenergan (Promethazine) Injection administration may be confused with the CNS signs of undiagnosed primary disease, e.g. encephalopathy or Reye's syndrome. The use of Phenergan (Promethazine) Injection 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 Phenergan (Promethazine) Injection, in pediatric patients may cause sudden death (see ). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of Phenergan (Promethazine) Injection in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of Phenergan (Promethazine) Injection.
Phenergan (Promethazine) Overdosage
Signs and symptoms of overdosage 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 extensor-plantar reflexes (Babinski reflex).
Stimulation may be evident, especially in pediatric patients and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in pediatric patients 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; etc., as well as gastrointestinal symptoms, may occur.
Phenergan (Promethazine) Dosage And Administration
Phenergan (Promethazine) Injection can cause severe chemical irritation and . Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration (see ).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not use Phenergan (Promethazine) Injection if solution has developed color or contains precipitate.
To avoid the possibility of physical and/or chemical incompatibility, consult specialized literature before diluting with any injectable solution or combining with any other medication. Do not use if there is a precipitate or any sign of incompatibility.
For control of nausea and vomiting, the usual adult dose is 12.5 to 25 mg, not to be repeated more frequently than every four hours. When used for control of postoperative nausea and vomiting, the dosage of analgesics and barbiturates should be reduced accordingly (see ).
Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see ).
As an adjunct to preoperative or postoperative medication, 25 to 50 mg of Phenergan (Promethazine) Injection in adults may be combined with appropriately reduced doses of analgesics and atropine-like drugs as desired. Dosage of concomitant analgesic or hypnotic medication should be reduced accordingly (see ).
Phenergan (Promethazine) is contraindicated for use in pediatric patients less than two years of age.
In pediatric patients 2 years of age and older, the dosage should not exceed half that of the suggested adult dose. As an adjunct to premedication, the suggested dose is 1.1 mg per kg of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug (see ). Antiemetics should not be used in vomiting of unknown etiology in pediatric patients.
Phenergan (Promethazine) How Supplied
Phenergan (Promethazine) (promethazine hydrochloride) Injection is available as follows:
25 mg/mL
50 mg/mL
Phenergan (Promethazine) Package Label - Principal Display Panel
NDC 60977-001-44
1 mL Vial
462-366-02
NDC 60977-001-03
25 x 1 mL Vials
Manufactured by Deerfield, IL 60015 USA
462-367-01
Each mL contains promethazine hydrochloride25 mg, edetate disodium 0.1 mg,calcium chloride 0.04 mg, sodium metabisulfite0.25 mg and phenol 5 mg inWater for Injection. pH 4.0-5.5; bufferedwith acetic acid-sodium acetate.
NDC 60977-001-43
Rx only
1 mL Ampul
Manufactured by
462-020-01
NDC 60977-001-01
25 x 1 mL Ampuls
Each mL contains promethazine hydrochloride 25 mg, edetate disodium 0.1 mg,calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg inWater for Injection. pH 4.0-5.5; buffered with acetic acid-sodium acetate.
To open ampuls, ignore color line; break at constriction.
Manufactured by Deerfield, IL 60015 USA
462-021-02
