DailyMed Label: Promethazine Hydrochloride

DailyMed Label: Promethazine Hydrochloride

2023

DailyMed Prescription

Promethazine Hydrochloride

Promethazine Hydrochloride

Henry Schein, Inc.

NDC: 0404-9941

NDC: 0404-9941

Promethazine hydrochloride injection, USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10H-Phenothiazine-10-ethanamine,N,N,a-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. 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. Formula1.jpg

Promethazine hydrochloride 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.

Important Notes on Administration Promethazine hydrochloride 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 (see WARNINGS - Severe Tissue Injury, Including Gangrene ). The preferred parenteral route of administration for promethazine hydrochloride injection is by deep intramuscular injection. Under no circumstances should promethazine hydrochloride 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 ). Subcutaneous injection is contraindicated as it may result in tissue necrosis. When administered intravenously, promethazine hydrochloride injection should be given in a concentration no greater than 25 mg per mL and at a rate not to exceed 25 mg per minute. It is preferable to inject through the tubing of an intravenous infusion set that is known to be functioning satisfactorily. In the event that a patient complains of pain during intravenous injection of promethazine hydrochloride injection, the injection should be stopped immediately to evaluate for possible arterial injection or perivascular extravasation. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use promethazine hydrochloride 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. 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 promethazine hydrochloride 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 promethazine hydrochloride 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 ). Promethazine hydrochloride is contraindicated for use in pediatric patients less than two years of age. Obstetrics Promethazine hydrochloride 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) promethazine hydrochloride injection may be given with an appropriately reduced dose of any desired narcotic (see PRECAUTIONS - Drug Interactions ). If necessary, promethazine hydrochloride 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 promethazine hydrochloride injection may be administered during a 24-hour period to patients in labor. Pediatric Patients Promethazine hydrochloride 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.

Children Less Than 2 Years of Age Promethazine hydrochloride 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 ). Comatose State Promethazine hydrochloride injection is contraindicated in comatose states. Intra-Arterial Injection Under no circumstances should promethazine hydrochloride 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 ). Subcutaneous Injection Promethazine hydrochloride 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. Idiosyncratic Reaction or Hypersensitivity Promethazine hydrochloride injection is contraindicated in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine or other phenothiazines.

General 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. Promethazine hydrochloride injection should be used cautiously in persons with cardiovascular disease or impairment of liver function. Information for Patients 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. Promethazine hydrochloride 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 ). Drug Interactions CNS Depressants Promethazine hydrochloride 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 promethazine hydrochloride 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 promethazine hydrochloride 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 promethazine hydrochloride 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 promethazine hydrochloride injection. Drug/Laboratory Test Interactions The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride 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. Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine hydrochloride injection, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility. Promethazine hydrochloride injection was nonmutagenic in the Salmonella test system of Ames. Pregnancy Teratogenic Effects—Pregnancy Category C 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 promethazine hydrochloride 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 promethazine hydrochloride injection in pregnant women. Because animal reproduction studies are not always predictive of human response, promethazine hydrochloride 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. Nonteratogenic Effects Promethazine hydrochloride injection administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Labor and Delivery Promethazine hydrochloride injection may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION ). Limited data suggest that use of promethazine hydrochloride 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.) Nursing Mothers It is not known whether promethazine hydrochloride 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 promethazine hydrochloride 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. Pediatric Use Promethazine hydrochloride injection is contraindicated for use in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression. Promethazine hydrochloride 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 promethazine hydrochloride injection administration may be confused with the CNS signs of undiagnosed primary disease, e.g. encephalopathy or Reye's syndrome. The use of promethazine hydrochloride 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 promethazine hydrochloride injection, in pediatric patients may cause sudden death (see OVERDOSAGE ). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride 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 promethazine hydrochloride injection. Geriatric Use (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.

Promethazine Hydrochloride Injection, USP is available as follows: 25 mg/mL 1 mL ampuls packaged in 25s (NDC 0641-1495-35) 50 mg/mL 1 mL ampuls packaged in 25s (NDC 0641-1496-35) Storage Store at 20°-25°C (68°-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 West-Ward Pharmaceutical Corp. 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  Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit  NDC 0641-1495-35 1 mL ampuls packaged in 25s NDC 0404-9941-01 1 1 mL ampuls vial in a bag (Ampul bears NDC 0641-1495-31) 25 mg/mL NDC 0641-1496-35 1 mL ampuls packaged in 25s NDC 0404-9942-01 1 1 mL ampuls vial in a bag (Ampul bears NDC 0641-1496-31) 50 mg/mL Manufactured by: HIKMA FARMACEUTICA (PORTUGAL), S.A. Estrada do Rio da Mo, 8, 8A e 8B - Fervenca - 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkley Heights, NJ 07922 Revised September 2020 462-638-02 PIN292-WES/3

Promethazine hydrochloride is a phenothiazine derivative which possesses antihistaminic, sedative, antimotion-sickness, antiemetic, and anticholinergic effects. Promethazine is a competitive H1 receptor antagonist, but does not block the release of histamine. Structural differences from the neuroleptic phenothiazines result in its relative lack (1/10 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.

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