Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED PHENERGAN Injection (promethazine hydrochloride injection, USP) is available as follows: 25 mg/mL 1 mL vials packaged in 25s (NDC 0641-6084-25) 50 mg/mL 1 mL vials packaged in 25s (NDC 0641-6085-25) Storage Store at 20 ° to 25 °C (68 ° to 77 °F) [See USP Controlled Room Temperature]. Protect from light. Keep covered in carton until time of use. Do not use if solution has developed color or contains a precipitate. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Phenergan is a registered trademark of Wyeth and is used under license. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised December 2023 462-024-07; PRINCIPAL DISPLAY PANEL NDC 0641- 6084 -01 Rx only Phenergan Injection (Promethazine HCl Inj., USP) 25 mg/mL Deep IM Use Preferred Must Dilute for IV Use Protect from light 1 mL Vial NDC 0641- 6084 -25 Rx only Phenergan Injection (Promethazine HCl Inj., USP) 25 mg/mL Deep Intramuscular Use Preferred Must be Diluted Prior to Intravenous Use 25 x 1 mL Vials 25 mg mL vial 25 mg mL shelfpack; PRINCIPAL DISPLAY PANEL NDC 0641- 6085 -01 Rx only Phenergan Injection (Promethazine HCl Inj., USP) 50 mg/mL Deep IM Use Preferred Must Dilute for IV Use Protect from light 1 mL Vial NDC 0641- 6085 -25 Rx only Phenergan Injection (Promethazine HCl Inj., USP) 50 mg/mL Deep Intramuscular Use Preferred Must be Diluted Prior to Intravenous Use 25 x 1 mL Vials 50 mg mL vial 50 mg mL shelfpack
- HOW SUPPLIED PHENERGAN Injection (promethazine hydrochloride injection, USP) is available as follows: 25 mg/mL 1 mL vials packaged in 25s (NDC 0641-6084-25) 50 mg/mL 1 mL vials packaged in 25s (NDC 0641-6085-25) Storage Store at 20 ° to 25 °C (68 ° to 77 °F) [See USP Controlled Room Temperature]. Protect from light. Keep covered in carton until time of use. Do not use if solution has developed color or contains a precipitate. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Phenergan is a registered trademark of Wyeth and is used under license. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised December 2023 462-024-07
- PRINCIPAL DISPLAY PANEL NDC 0641- 6084 -01 Rx only Phenergan Injection (Promethazine HCl Inj., USP) 25 mg/mL Deep IM Use Preferred Must Dilute for IV Use Protect from light 1 mL Vial NDC 0641- 6084 -25 Rx only Phenergan Injection (Promethazine HCl Inj., USP) 25 mg/mL Deep Intramuscular Use Preferred Must be Diluted Prior to Intravenous Use 25 x 1 mL Vials 25 mg mL vial 25 mg mL shelfpack
- PRINCIPAL DISPLAY PANEL NDC 0641- 6085 -01 Rx only Phenergan Injection (Promethazine HCl Inj., USP) 50 mg/mL Deep IM Use Preferred Must Dilute for IV Use Protect from light 1 mL Vial NDC 0641- 6085 -25 Rx only Phenergan Injection (Promethazine HCl Inj., USP) 50 mg/mL Deep Intramuscular Use Preferred Must be Diluted Prior to Intravenous Use 25 x 1 mL Vials 50 mg mL vial 50 mg mL shelfpack
Overview
PHENERGAN Injection (promethazine hydrochloride injection, USP) is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10 H -Phenothiazine-10-ethanamine, N,N,α -trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula: C 17 H 21 ClN 2 S MW 320.88 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 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. chemical structure
Indications & Usage
PHENERGAN Injection is indicated for the following conditions: Amelioration of allergic reactions to blood or plasma. In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused. Active treatment of motion sickness. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. As an adjunct to analgesics for the control of postoperative pain. Preoperative, postoperative, and obstetric (during labor) sedation. Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.
Dosage & Administration
Important Administration Information for Adult and Pediatric Patients 2 Years of Age and Older The preferred route of administration of PHENERGAN Injection is by deep intramuscular administration (see WARNINGS - Severe Tissue Injury, Including Gangrene ). PHENERGAN Injection may be administered intravenously after dilution as recommended below (see Preparation and Administration ). If pain occurs at the injection site during intravenous infusion, immediately discontinue the infusion, and evaluate for possible arterial injection or perivascular extravasation. Allergic Conditions The average adult dose is 25 mg. This dose may be repeated within two hours if necessary, but continued therapy, if indicated, should be via the oral route as soon as existing circumstances permit. After initiation of treatment, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The average adult dose for amelioration of allergic reactions to blood or plasma is 25 mg. Sedation In hospitalized adult patients, nighttime sedation may be achieved by a dose of 25 to 50 mg of PHENERGAN Injection. Nausea and Vomiting 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 PRECAUTIONS - Drug Interactions ). Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see PRECAUTIONS - Pediatric Use ). Preoperative and Postoperative Use As an adjunct to preoperative or postoperative medication, 25 to 50 mg of PHENERGAN 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 PRECAUTIONS - Drug Interactions ). PHENERGAN Injection is contraindicated for use in pediatric patients less than two years of age. Obstetrics PHENERGAN Injection in doses of 50 mg will provide sedation and relieve apprehension in the early stages of labor. When labor is definitely established, 25 to 75 mg (average dose, 50 mg) PHENERGAN Injection may be given with an appropriately reduced dose of any desired narcotic (see PRECAUTIONS - Drug Interactions ). If necessary, PHENERGAN Injection with a reduced dose of analgesic may be repeated once or twice at four-hour intervals in the course of a normal labor. A maximum total dose of 100 mg of PHENERGAN Injection may be administered during a 24-hour period to patients in labor. Pediatric Patients PHENERGAN Injection is contraindicated for use in pediatric patients less than 2 years of age (see WARNINGS - Respiratory Depression ). Caution should be exercised when administering promethazine hydrochloride to pediatric patients 2 years of age or older. It is recommended that the lowest effective dose of promethazine hydrochloride be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided (see WARNINGS - Respiratory Depression ). 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 PRECAUTIONS - Drug Interactions ). Antiemetics should not be used in vomiting of unknown etiology in pediatric patients. Preparation and Administration Instructions for Diluted Intravenous Infusion in Adults Inspect the solution for particulate matter and discoloration, before dilution, after dilution, and before administration. Discard the vial, ampule, or bag if particulates and/or discoloration are observed. 1. Determine the recommended dose of promethazine hydrochloride injection. 2. Aseptically withdraw the required volume from the vial or ampule and transfer it into an infusion bag. Use a filter needle when withdrawing promethazine hydrochloride injection from the ampule. 3. Dilute with the recommended volume of 0.9% Sodium Chloride Injection, see Table 1. Avoid mixing and/or diluting with any other drugs or solutions other than 0.9% Sodium Chloride Injection. 4. Gently invert the infusion bag. 5. Check patency of the access site before administration. 6. Administer the diluted solution through an intravenous catheter, inserted in a large vein (preferably through a central venous catheter), over 20 to 40 minutes; for maximum infusion rates, see Table 1. Do NOT administer via an intravenous catheter in the hand or wrist. 7. If pain occurs at the injection site during intravenous infusion, immediately discontinue the infusion and evaluate for possible arterial injection or perivascular extravasation. Table 1. Preparation and Infusion Information by Adult Dose of PHENERGAN Injection Dose of PHENERGAN Injection Volume of 0.9% Sodium Chloride Injection for Dilution Maximum Concentration of the Diluted PHENERGAN Injection Solution Maximum Rate of Infusion 12.5 mg 50 mL 1 mg/mL 2.5 mL/minute 25 mg 50 mL 2.5 mL/minute 50 mg 50 mL 2.5 mL/minute 75 mg 100 mL 5 mL/minute Preparation and Administration Instructions for Diluted Intravenous Infusion to Pediatric Patients 2 Years of Age and Older Inspect the solution for particulate matter and discoloration, before dilution, after dilution, and before administration. Discard the vial, ampule, syringe or bag if particulates and/or discoloration are observed. 1. Determine the recommended dose of promethazine hydrochloride injection for pediatric patients 2 years of age and older. 2. Aseptically withdraw the required volume from the vial or ampule and transfer it into an appropriately sized syringe or bag for use with an infusion pump. Use a filter needle when withdrawing promethazine hydrochloride injection from the ampule. 3. Dilute with the recommended volume of 0.9% Sodium Chloride Injection, see Table 2. Avoid mixing and/or diluting with any other drugs or solutions other than 0.9% Sodium Chloride Injection. 4. Gently invert the syringe or bag. 5. Check patency of the access site before administration. 6. Administer the diluted solution through an intravenous catheter, inserted in a large vein (preferably through a central venous catheter) with a maximum infusion rate of 1.25 mL/minute. Do NOT administer via an intravenous catheter in the hand or wrist. 7. If pain occurs at the injection site during intravenous infusion, immediately discontinue the infusion and evaluate for possible arterial injection or perivascular extravasation. Table 2. Preparation and Infusion Information by Pediatric Dose of PHENERGAN Injection Avoid mixing and/or diluting with any other drugs or solutions besides 0.9% Sodium Chloride Injection Dose of PHENERGAN Injection Volume of 0.9% Sodium Chloride Injection for Dilution Maximum Concentration of the Diluted PHENERGAN Injection Solution Maximum Rate of Infusion Up to 25 mg 25 mL 1 mg/mL 1.25 mL/minute 25 mg to 50 mg 50 mL Storage of Diluted PHENERGAN Injection Diluted solution may be stored up to 4 hours at room temperature, 20°C to 25°C (68°F to 77°F), or refrigerated at 2°C to 8°C (36° to 46°F), up to 24 hours.
Warnings & Precautions
WARNINGS Respiratory Depression Pediatrics 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. Other 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. Severe Tissue Injury, Including Gangrene PHENERGAN Injection has been reported to cause severe chemical irritation and damage to tissues, including gangrene, regardless of the route of parenteral administration. Intra-arterial and subcutaneous administration have resulted in more significant complications. The use of PHENERGAN Injection by intravenous injection at concentrations greater than 1 mg/mL, intra- arterial injection, or subcutaneous injection is contraindicated (see CONTRAINDICATIONS ). Irritation and damage can result from perivascular extravasation, intra- arterial injection, and intraneuronal or perineuronal infiltration. Inadvertent intra-arterial injection can cause severe arteriospasm. Other reported adverse reactions included 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. The preferred route of administration of PHENERGAN Injection is by deep intramuscular administration. PHENERGAN Injection may be administered intravenously after dilution through an intravenous catheter inserted in a large vein. Preferably through a central venous catheter (see DOSAGE AND ADMINISTRATION ). If pain occurs at the injection site during intravenous infusion, immediately discontinue the infusion, evaluate for possible arterial injection or perivascular extravasation, and initiate appropriate medical management. CNS Depression 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 ). Lower Seizure Threshold 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. Bone-Marrow Depression 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. 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. Sulfite Sensitivity 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. Visual Inspection This product is light sensitive and should be inspected before use and discarded if either color or particulate is observed. Cholestatic Jaundice Administration of promethazine has been associated with reported cholestatic jaundice.
Boxed Warning
RESPIRATORY DEPRESSION IN PEDIATRICS AND SEVERE TISSUE INJURY, INCLUDING GANGRENE Respiratory Depression – Pediatrics 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. Caution should be exercised when administering PHENERGAN Injection to pediatric patients 2 years of age and older (See Warning – Respiratory Depression ) Severe Tissue Injury, Including Gangrene Severe chemical irritation and damage to tissues regardless of the route of parenteral administration has been reported in patients treated with PHENERGAN Injection including gangrene, tissue necrosis, and thrombophlebitis; and in some cases, surgical intervention including fasciotomy, skin graft, and/or amputation have been required (see WARNINGS – Severe Tissue Injury, Including Gangrene .). The use of promethazine hydrochloride injection by the following routes of administration is CONTRAINDICATED: Intravenous injection at concentrations greater than 1 mg/mL Intra-arterial injection Subcutaneous injection (see CONTRAINDICATIONS ). The preferred route of administration is by deep intramuscular administration. PHENERGAN Injection may be administered intravenously after dilution through an intravenous catheter inserted in a large vein. Preferably through a central venous catheter (see DOSAGE AND ADMINISTRATION ). If pain occurs at the injection site during intravenous infusion, immediately discontinue the infusion and evaluate for possible arterial injection or perivascular extravasation, and initiate appropriate medical management.
Contraindications
The use of PHENERGAN Injection is contraindicated: In pediatric patients less than 2 years of age due to the risk of respiratory depression (see WARNINGS – Respiratory Depression ). For use as an intravenous injection at concentrations greater than 1 mg/mL due to the risk of perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration (see WARNINGS - Severe Tissue Injury, Including Gangrene and DOSAGE AND ADMINISTRATION ). For use as an intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see WARNINGS - Severe Tissue Injury, Including Gangrene ). For use as a subcutaneous injection because chemical irritation and necrotic lesions have been reported (see WARNINGS - Severe Tissue Injury, Including Gangrene ). In patients in a comatose state. In patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine hydrochloride or other phenothiazines.
Adverse Reactions
Respiratory Depression 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 ). Severe Tissue Injury, Including Gangrene PHENERGAN Injection has been reported to cause severe chemical irritation and damage to tissues, including gangrene, regardless of the route of parenteral administration . Intra-arterial and subcutaneous injection have resulted in more significant complications (see CONTRAINDICATIONS ). Reported adverse reactions included burning, pain, erythema, swelling, sensory loss, palsies, paralysis, severe spasm of distal vessels, thrombophlebitis, venous thrombosis, phlebitis, abscesses, tissue necrosis, and gangrene (see WARNINGS - Severe Tissue Injury, Including Gangrene ). 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 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.
Drug Interactions
CNS Depressants 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. Epinephrine 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. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase (MAO) Inhibitors 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.
Storage & Handling
Storage Store at 20 ° to 25 °C (68 ° to 77 °F) [See USP Controlled Room Temperature]. Protect from light. Keep covered in carton until time of use. Do not use if solution has developed color or contains a precipitate. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Phenergan is a registered trademark of Wyeth and is used under license. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised December 2023 462-024-07
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