Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)
Accord Healthcare Inc.
INTRAVENOUS
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. 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 clinicall
Atropine Sulfate Injection, USP is a non-pyrogenic, isotonic, clear solution and is supplied as follows: NDC on 8 mg per 20 mL (0.4 mg per mL) Multiple-dose vial: 16729-512-05 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. After initial use, store between 20°C to 25°C (68°F to 77°F) and discard within 24 hours Manufactured For: Accord Healthcare, Inc., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA. Manufactured By: Intas Pharmaceuticals Limited, Plot No.: 457, 458, Village – Matoda, Bavla Road, Ta. - Sanand, Dist.- Ahmedabad – 382 210. India. 10 3619 0 696327 Revised: December 2019
Abbreviated New Drug Application
ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION ACCORD HEALTHCARE INC. ---------- 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 ACCORD HEALTHCARE INC. AT 1-866-941- 7875 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_. DRUG INTERACTIONS _Mexiletine_: Decreases rate of mexiletine absorption. ( 7.1) REVISED: 12/2019 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 Complete Urinary Retentio Citiți documentul complet