Promethazine HCl Injection
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Promethazine HCl Injection
Promethazine hydrochloride (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.
DOSAGE AND ADMINISTRATION
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 (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.
Important Notes on Administration
The preferred parenteral route of administration for promethazine hydrochloride (promethazine hydrochloride 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 hydrochloride (promethazine hydrochloride injection) should be given in 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 hydrochloride (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 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 promethazine hydrochloride (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.
Promethazine hydrochloride (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 (promethazine hydrochloride injection) may be given intramuscularly or intravenously with an appropriately reduced dose of any desired narcotic. If necessary, promethazine hydrochloride (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 (promethazine hydrochloride injection) may be administered during a 24-hour period to patients in labor.
Promethazine hydrochloride (promethazine hydrochloride injection) tablets and promethazine hydrochloride (promethazine hydrochloride injection) rectal suppositories are 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).
Promethazine Hydrochloride (promethazine hydrochloride injection) Injection, USP is available as follows:
|0703-2191-04||25 mg/mL||1 mL fill in a 2 mL vial
25 vial per shelf tray
|0703-2201-04||50 mg/mL|| 1 mL fill in a 2 mL vial
25 vial per shelf tray
Store at room temperature 15°-30°C (59°-86°F).
Protect from light. Keep covered in carton until time of use.
Do not use if solution has developed color or contains a precipitate.
Issued: July 2004
SICOR Pharmaceuticals, Inc., Irvine, CA 92618
FDA rev date: 6/1/2004
Last reviewed on RxList: 6/21/2007
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