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Promethazine HCl Injection

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Promethazine HCl Injection

WARNINGS

PROMETHAZINE HYDROCHLORIDE (promethazine hydrochloride 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 HYDROCHLORIDE (promethazine hydrochloride injection) IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE (promethazine hydrochloride injection) HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE (promethazine hydrochloride injection) TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE (promethazine hydrochloride injection) BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

Sulfite Sensitivity

Promethazine hydrochloride (promethazine hydrochloride 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.

CNS Depression

Promethazine hydrochloride (promethazine hydrochloride injection) may impair the mental and 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, tranquilizers, etc. (See PRECAUTIONS, Information for Patients.)

Lower Seizure Threshold

Promethazine hydrochloride (promethazine hydrochloride 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

Promethazine hydrochloride (promethazine hydrochloride injection) should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine has been used in association with other known marrow-toxic agents.

Use in Pediatric Patients

PROMETHAZINE HYDROCHLORIDE (promethazine hydrochloride injection) TABLETS AND SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE (promethazine hydrochloride injection) TABLETS AND SUPPOSITORIES TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND NOT FIRMLY WEIGHT-RELATED, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION OF INDIVIDUALIZED DOSING. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.

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 (promethazine hydrochloride injection) TABLETS AND SUPPOSITORIES ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE'S SYNDROME. THE USE OF PROMETHAZINE HYDROCHLORIDE (promethazine hydrochloride injection) TABLETS AND SUPPOSITORIES 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 (promethazine hydrochloride injection) , in pediatric patients may cause hallucinations, convulsions, and sudden death. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine hydrochloride (promethazine hydrochloride injection) .

Inadvertent Intra-arterial Injection

Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection of promethazine hydrochloride (promethazine hydrochloride injection) , usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Intravenous injection was intended in all the cases reported but perivascular extravasation or arterial placement of the needle is now suspect. There is no proven successful management of this condition after it occurs, although sympathetic block and heparinization are commonly employed during the acute management because of the results of animal experiments with other known arteriolar irritants. Aspiration of dark blood does not preclude intra-arterial needle placement, because blood is discolored upon contact with promethazine hydrochloride (promethazine hydrochloride injection) . Use of syringes with rigid plungers or of small bore needles might obscure typical arterial backflow if this is relied upon alone.

When used intravenously, promethazine hydrochloride (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. When administering any irritant drug intravenously, it is usually preferable to inject it 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 intended intravenous injection of promethazine hydrochloride (promethazine hydrochloride injection) , the injection should be stopped immediately to provide for evaluation of possible arterial placement or perivascular extravasation.

Visual Inspection

This product is light sensitive and should be inspected before use and discarded if either color or particulate is observed.

Other Considerations

Sedative drugs or CNS depressants should be avoided in patients with a history of sleep apnea.

Administration of promethazine has been associated with reported cholestatic jaundice.

PRECAUTIONS

General

Drugs having anticholingeric 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 (promethazine hydrochloride injection) should be used cautiously in persons with cardiovascular disease or impairment of liver function.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long term animal studies have not been performed to assess the carcinogenic potential of promethazine hydrochloride (promethazine hydrochloride injection) , nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility. Promethazine hydrochloride was nonmutagenic in the Ames Salmonella test system.

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 (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 (promethazine hydrochloride injection) in pregnant women. Because animal reproduction studies are not always predictive of human response, promethazine hydrochloride (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 (promethazine hydrochloride injection) received within two weeks of delivery may inhibit platelet aggregation in the newborn.

Labor and Delivery

Promethazine hydrochloride (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 (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 Nonteratogenic Effects.)

Nursing Mothers

It is not known whether promethazine hydrochloride (promethazine hydrochloride injection) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when promethazine hydrochloride (promethazine hydrochloride injection) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients under 2 years of age have not been established.

Promethazine hydrochloride (promethazine hydrochloride injection) should be used with caution in pediatric patients 2 years of age and older. (See WARNINGS, Use in Pediatric Patients.)

Use in Geriatric 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.

Last reviewed on RxList: 6/21/2007
This monograph has been modified to include the generic and brand name in many instances.

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