displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Promethazine HCl Injection USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine HCl (10H-phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula:
C17H21ClN2S MW = 320.89
Each mL contains: Promethazine HCl 25 mg or 50 mg, Edetate Disodium 0.1 mg, Calcium Chloride 0.04 mg, Sodium Metabisulfite 0.25 mg, with Phenol 5 mg as preservative, in Water for Injection, q.s. Buffered with Glacial Acetic Acid and Sodium Acetate, Trihydrate. The pH range is 4.0 to 5.5. Sealed under Nitrogen.Promethazine HCl 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.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Promethazine HCl 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 results in its relative lack (1/10) of dopamine antagonist properties. In therapeutic doses, promethazine HCl produces no significant effects on the cardiovascular system. 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 HCl 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.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Promethazine HCl 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.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Promethazine HCl Injection is contraindicated in comatose states and in patients who have demonstrated an idiosyncrasy or hypersensitivity to promethazine or other phenothiazines.Under no circumstances should Promethazine HCl Injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see “WARNINGS – Inadvertent Intra-arterial Injection”).Promethazine HCl Injection should not be given by the subcutaneous route; evidence of chemical irritation has been noted, and necrotic lesions have resulted on rare occasions following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscular injection.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Signs and symptoms of overdosage range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, and unconsciousness.Stimulation may be evident, especially in pediatric patients and geriatric patients. Convulsions may rarely occur. A paradoxical 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.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.Do not use Promethazine HCl 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.Important Notes on Administration: The preferred parenteral route of administration for Promethazine HCl Injection is by deep intramuscular injection. The proper intravenous administration of this product is well-tolerated, but use of this route is not without some hazard. Not for subcutaneous administration.INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY (see “WARNINGS – Inadvertent Intra-arterial Injection”). SUBCUTANEOUS INJECTION IS CONTRAINDICATED, AS IT MAY RESULT IN TISSUE NECROSIS (see “CONTRAINDICATIONS”).Injection into or near a nerve may result in permanent tissue damage.When used intravenously, Promethazine HCl Injection should be given in a concentration no greater than 25 mg/mL 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.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 HCl 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 medication may be administered either intramuscularly or intravenously and dosage of analgesics and barbiturates reduced accordingly.Preoperative and Postoperative Use:As an adjunct to preoperative or postoperative medication, 25 to 50 mg of Promethazine HCl 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.Obstetrics:Promethazine HCl 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 HCl Injection may be given intramuscularly or intravenously with an appropriately reduced dose of any desired narcotic. If necessary, Promethazine HCl 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 HCl Injection may be administered during a 24-hour period to patients in labor.Pediatric Patients:Promethazine HCl Injection is contraindicated for children under 2 years of age (see “WARNINGS – Use in Pediatric Patients”).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 0.5 mg per lb. of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Antiemetics should not be used in vomiting of unknown etiology in pediatric patients (see “WARNINGS – Use in Pediatric Patients”).
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Promethazine HCl Injection USP is available as follows:
25 mg/mL, 1 mL ampules, cartons of 25
50 mg/mL, 1 mL ampules, cartons of 25Store at controlled room temperature 15º-30ºC (59º – 86ºF).Protect from light. Keep covered in carton until time of use.Do not use if solution has developed color or contains a precipitate.Literature revised: June 2004Product Nos.: 1107-81, 0259-81Watson Laboratories, Inc.
Corona, CA 92880 USA695302590591*B1