Wockhardt Usa, Inc.
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Wockhardt Usa, Inc. Drugs
Promethazine HCl Injection is contraindicated for use in pediatric patients less than 2 years of age.
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.
UNINTENTIONAL INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY (see CONTRAINDICATIONS, WARNINGS-Injection Site Reactions). SUBCUTANEOUS INJECTION IS CONTRAINDICATED, AS IT MAY RESULT IN TISSUE NECROSIS (see CONTRAINDICATIONS, WARNINGS-Injection Site Reactions, and ADVERSE REACTIONS).
Injection into or near a nerve may result in permanent tissue damage (see ADVERSE REACTIONS).
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.
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.
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.
Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS–Use in Pediatric Patients).
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.
Promethazine HCl is contraindicated for use in pediatric patients less than two years of age.
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.
Promethazine HCl Injection is contraindicated for use in pediatric patients less than 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients). Caution should be exercised when administering promethazine HCl 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-Black Box Warning and 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.
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.Usual Dose: Teaspoonfuls (5 mL) Adults and children 12 years and older 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls (40 mL) in 24 hours. Children 6 to under 12 years 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours. Children 2 to under 6 years ½ teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours.
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