Source: FDA, National Drug Code (US) Revision Year: 2020
PHENERGAN Injection is contraindicated for use in pediatric patients less than two years of age due to the risk of respiratory depression (see WARNINGS – Respiratory Depression).
PHENERGAN Injection is contraindicated in comatose states.
Under no circumstances should PHENERGAN Injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see WARNINGS – Severe Tissue Injury, Including Gangrene).
PHENERGAN Injection should not be given by the subcutaneous route because evidence of chemical irritation has been noted, and necrotic lesions have resulted following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscular injection.
PHENERGAN Injection is contraindicated in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine or other phenothiazines.
PHENERGAN Injection 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 in pediatric patients less than 2 years of age. A wide range of weight-based doses of PHENERGAN Injection have resulted in respiratory depression in these patients.
Caution should be exercised when administering PHENERGAN Injection to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of PHENERGAN Injection be used in pediatric patients 2 years of age and older. Avoid concomitant administration of other drugs with respiratory depressant effects because of an association with respiratory depression, and sometimes death, in pediatric patients.
Because of the risk of potentially fatal respiratory depression, use of PHENERGAN Injection in patients with compromised respiratory function or patients at risk for respiratory failure (e.g. COPD, sleep apnea) should be avoided.
PHENERGAN Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. 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.
Because of the risks of intravenous injection, the preferred route of administration of PHENERGAN Injection is deep intramuscular injection (see DOSAGE AND ADMINISTRATION). Subcutaneous injection is contraindicated. Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or unintentional intra-arterial injection as pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Aspiration of dark blood does not preclude intra-arterial needle placement because blood is discolored upon contact with PHENERGAN Injection. Use of syringes with rigid plungers or of small-bore needles might obscure typical arterial backflow if this is relied upon alone.
In the event that a patient complains of pain during intravenous injection of Phenergan 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.
PHENERGAN Injection 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, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, 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).
PHENERGAN Injection may lower seizure threshold and 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.
PHENERGAN Injection should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine hydrochloride 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 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 Injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthma episodes, in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
This product is light sensitive and should be inspected before use and discarded if either color or particulate is observed.
Administration of promethazine has been associated with reported cholestatic jaundice.
PHENERGAN Injection is contraindicated in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression. PHENERGAN Injection should be used with caution in pediatric patients 2 years of age and older (see WARNINGS – Respiratory Depression).
PHENERGAN Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse reactions 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 (see WARNINGS – Severe Tissue Injury, Including Gangrene; and DOSAGE AND ADMINISTRATION).
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.
Increased or decreased blood pressure, tachycardia, bradycardia, faintness.
Dermatitis, photosensitivity, urticaria.
Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.
Dry mouth, nausea, vomiting, jaundice.
Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS – Respiratory Depression.)
Angioneurotic edema. Neuroleptic Malignant Syndrome (potentially fatal) has also been reported. (See WARNINGS – Neuroleptic Malignant Syndrome.)
Hyperexcitability and abnormal movements have been reported in patients following a single administration of PHENERGAN Injection. Consideration should be given to the discontinuation of PHENERGAN Injection 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.
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 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 WARNINGS – Respiratory Depression).
Patients should be advised of the risk of severe tissue injury, including gangrene (see WARNINGS – Severe Tissue Injury, Including Gangrene). Patients should be advised to immediately report persistent or worsening pain or burning at the injection site.
PHENERGAN 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 WARNINGS – CNS Depression and PRECAUTIONS – Drug Interactions).
Patients should be advised to report any involuntary muscle movements (see ADVERSE REACTIONS – Paradoxical Reactions).
Patients should be advised to avoid prolonged exposure to the sun (see ADVERSE REACTIONS – Dermatologic).
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PHENERGAN Injection may increase, prolong, or intensify the sedative action of central-nervous-system depressants, such as alcohol, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine hydrochloride. When given concomitantly with PHENERGAN Injection, 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. Dosage must be individualized. Excessive amounts of PHENERGAN Injection relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.
Because of the potential for promethazine hydrochloride to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with PHENERGAN Injection overdose.
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 MAO Inhibitors and phenothiazines are used concomitantly. This possibility should be considered with PHENERGAN Injection.
Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg (approximately 2.1 and 4.2 times the maximum recommended human daily dose) of PHENERGAN Injection. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.
There are no adequate and well-controlled studies of PHENERGAN Injection in pregnant women. Because animal reproduction studies are not always predictive of human response, PHENERGAN Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Adequate studies to determine the action of the drug on parturition, lactation and development of the animal neonate have not been conducted.
PHENERGAN Injection administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.
PHENERGAN Injection may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). Limited data suggest that use of PHENERGAN Injection during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect on later growth and development of the newborn is unknown. (See also Pregnancy – Nonteratogenic Effects.)
It is not known whether PHENERGAN Injection 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 PHENERGAN Injection, 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.
PHENERGAN Injection is contraindicated for use in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression. PHENERGAN Injection should be used with caution in pediatric patients 2 years of age and older (see WARNINGS – Respiratory Depression).
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 Injection administration may be confused with the CNS signs of undiagnosed primary disease, e.g. encephalopathy or Reye’s syndrome. The use of PHENERGAN 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 Injection, in pediatric patients may cause sudden death (see OVERDOSAGE). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of PHENERGAN 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 Injection.
(patients approximately 60 years or older)
Since therapeutic requirements for sedative drugs tend to be less in geriatric patients, the dosage should be reduced for these patients.
The following laboratory tests may be affected in patients who are receiving therapy with PHENERGAN Injection:
Pregnancy Tests:
Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.
Glucose Tolerance Test:
An increase in blood glucose has been reported in patients receiving promethazine hydrochloride.
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