diazepam injection, USP - CARPUJECT How Supplied/Storage and Handling | Pfizer Medical Information - US

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HOW SUPPLIED

Carpuject™ Sterile Cartridge Unit with Luer Lock

Unit of Sale	Concentration
NDC 0409-1273-32 Carton of 10 2 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System	10 mg/2 mL (5 mg/mL)

Instructions for Use of the Syringe Systems

Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02.

Do not use if solution is darker than slightly yellow or contains a precipitate.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand.

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

diazepam injection, USP - CARPUJECT Quick Finder

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WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

•: Concomitant use of benzodiazepines and opioids may result in profound sedation,...

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INDICATIONS AND USAGE

Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not...

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DOSAGE AND ADMINISTRATION

Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg intramuscular or intravenous, depending on the...

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CONTRAINDICATIONS

Diazepam Injection is contraindicated in patients with a known hypersensitivity to this drug; acute narrow angle glaucoma; and open angle glaucoma unless patients are receiving appropriate therapy.

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WARNINGS

Risks from Concomitant Use with Opioids

Concomitant use of benzodiazepines, including diazepam, and opioids may result in profound sedation, respiratory...

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ADVERSE REACTIONS

Side effects most commonly reported were drowsiness, fatigue, and ataxia; venous thrombosis and phlebitis at the site of injection. Other adverse reactions less frequently reported include:

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DRUG ABUSE AND DEPENDENCE

Controlled Substance

Diazepam Injection is a schedule IV controlled substance.

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OVERDOSAGE

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy,...

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DESCRIPTION

Diazepam Injection, USP is a sterile, nonpyrogenic solution intended for intramuscular or intravenous administration. Each milliliter (mL) contains 5 mg diazepam; 40% propylene glycol; 10% alcohol; 5% sodium...

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CLINICAL PHARMACOLOGY

In animals, diazepam appears to act on parts of the limbic system, the thalamus and hypothalamus, and induces calming effects. Diazepam, unlike chlorpromazine and reserpine, has no demonstrable...

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ANIMAL PHARMACOLOGY

Oral LD50 of diazepam is 720 mg/kg in mice and 1,240 mg/kg in rats. Intraperitoneal administration of 400 mg/kg to a monkey resulted in death on the sixth day.

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HOW SUPPLIED

Carpuject™ Sterile Cartridge Unit with Luer Lock

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CIV

Rx only

This product's labeling may...

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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.