ATROPINE SULFATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)

Available from:

Hikma Pharmaceuticals USA Inc.

Administration route:

ENDOTRACHEAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia. None. Risk Summary Limited available data with Atropine Sulfate Injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes (see Data) . There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see Clinical Considerations) . Animal reproduction studies have not been conducted with Atropine Sulfate Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 t

Product summary:

Atropine Sulfate Injection, USP is a non-pyrogenic, isotonic, clear solution and is supplied as follows: Presentation Single Vial 10 Vial Pack NDC# 0641-6251-01 0641-6251-10 Description 8 mg per 20 mL (0.4 mg per mL) Multiple-dose vial 20 mL multiple-dose vial, packaged in a carton containing 10 vials. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. After initial use, store between 20° to 25°C (68° to 77°F) and discard within 24 hours. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: December 2021 462-917-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATROPINE SULFATE- ATROPINE SULFATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATROPINE SULFATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ATROPINE SULFATE
INJECTION. ATROPINE SULFATE INJECTION, FOR INTRAVENOUS, INTRAMUSCULAR,
SUBCUTANEOUS, INTRAOSSEOUS
OR ENDOTRACHEAL USE. INITIAL U.S. APPROVAL: 1960
INDICATIONS AND USAGE
Atropine is a muscarinic antagonist indicated for temporary blockade
of severe or life threatening
muscarinic effects. (1)
DOSAGE AND ADMINISTRATION
Dosage is individualized by use, refer to the full prescribing
information for recommended adult and
pediatric dosages (2.2, 2.3).
Patients with Ischemic Heart Disease: Do not exceed 0.04 mg/kg. (2.4,
5.2)
DOSAGE FORMS AND STRENGTHS
Injection: 8 mg per 20 mL (0.4 mg per mL) multiple dose glass vial (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity (5.1)
Worsening of Ischemic Heart Disease (5.2)
Acute Glaucoma (5.3)
Pyloric obstruction (5.4)
Complete urinary retention (5.5)
Viscid plugs (5.6)
ADVERSE REACTIONS
Most adverse reactions are directly related to atropine’s
antimuscarinic action. Dryness of the mouth,
blurred vision, photophobia and tachycardia commonly occur with
chronic administration of therapeutic
doses. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT 1-
877-845-0689 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
_Mexiletine_: Decreases rate of mexiletine absorption. (7.1)
REVISED: 12/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Administration
2.2 Adult Dosage
2.3 Pediatric Dosage
2.4 Dosing in Patients with Ischemic Heart Disease
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
5.2 Worsening of Ischemic Heart Disease
5.3 Acute Glaucoma
5.4 Pyloric Obstruction
5.5 Comp