국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)
Henry Schein, Inc.
ENDOTRACHEAL
PRESCRIPTION DRUG
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. 8.1 Pregnancy 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 pr
Atropine Sulfate Injection, USP is a non-pyrogenic, isotonic, clear solution and is supplied as follows: 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
Abbreviated New Drug Application
ATROPINE SULFATE- ATROPINE SULFATE INJECTION INJECTION HENRY SCHEIN, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATIONTHESE 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) (2) 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) (4) CONTRAINDICATIONS None. (4) (5) WARNINGS AND PRECAUTIONS Hypersensitivity (5.1) (6) Worsening of Ischemic Heart Disease (5.2) (6) Acute Glaucoma (5.3) (6) Pyloric obstruction (5.4) (6) Complete urinary retention (5.5) (6) Viscid plugs (5.6) (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) (7) 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. (7) DRUG INTERACTIONS Mexiletine: Decreases rate of mexiletine absorption. (7.1) (8) Revised: 12/2021 (8) REVISED: 11/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 6 ADVERSE REACTIONS 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 13 NO 전체 문서 읽기