PHENERGAN Solution for injection (2020)

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REMEDYREPACK INC.

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1. Description

PHENERGAN Injection (promethazine hydrochloride injection, USP), is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10 H-Phenothiazine-10-ethanamine, ...

2. Clinical Pharmacology

Promethazine hydrochloride is a phenothiazine derivative which possesses antihistaminic, sedative, antimotion-sickness, antiemetic, and anticholinergic effects. Promethazine is a competitive H1 ...

3. Indications and Usage

PHENERGAN 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 ...

4. Contraindications

Children Less Than 2 Years of Age PHENERGAN 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). ...

5. Warnings

Respiratory Depression Pediatrics PHENERGAN Injection should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases ...

6.1. 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. ...

6.2. 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 ...

6.4. Drug Interactions

CNS Depressants PHENERGAN Injection may increase, prolong, or intensify the sedative action of central-nervous-system depressants, such as alcohol, sedative/hypnotics (including barbiturates), general ...

6.5. Drug/Laboratory Test Interactions

The following laboratory tests may be affected in patients who are receiving therapy with PHENERGAN Injection: Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to assess the carcinogenic potential of PHENERGAN Injection, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment ...

6.7. 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 ...

6.8. Labor and Delivery

PHENERGAN Injection may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). Limited data suggest that use of PHENERGAN Injection during labor and delivery ...

6.9. Nursing Mothers

It is not known whether PHENERGAN 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 ...

6.10. Pediatric Use

PHENERGAN Injection is contraindicated for use in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression. PHENERGAN Injection should be used with caution ...

6.11. 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.

7. Adverse Reactions

Respiratory Depression PHENERGAN Injection is contraindicated in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression. PHENERGAN Injection should be used ...

9. Overdosage

Signs and symptoms of overdosage range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness and sudden death. Other ...

10. Dosage and Administration

Important Notes on Administration PHENERGAN Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Irritation and damage can result from ...

11. How Supplied

PHENERGAN Injection (promethazine hydrochloride injection, USP) is available as follows: 25 mg/Ml NDC: 70518-2656-00 PACKAGING: 25 in 1 CARTON NDC: 70518-2656-01 PACKAGING: 1 mL in 1 VIAL TYPE 0 Repackaged ...

12. Storage and Handling

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. ...

BOXED WARNING SECTION

Respiratory Depression – Pediatrics PHENERGAN Injection should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing ...