ATROPINE SULFATE injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Medical Purchasing Solutions, LLC

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. None. Risk Summary There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see Clinical Considerations) . Available data from published observational studies on atropine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . Animal reproduction studies have not been conducted with atropine. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy

Resumen del producto:

Atropine Sulfate Injection, USP 0.4 and 1 mg/mL are supplied in 1 mL, single-dose glass vials as follows: Table 2: How Supplied Concentration (mg/mL) Package Size NDC # 0.4 mg/mL 1 Vial 16729-525-63 10 Vials 16729-525-03 25 Vials 16729-525-08 1 mg/mL 1 Vial 16729-526-63 10 Vials 16729-526-03 25 Vials 16729-526-08 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.] 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 4020 0 602817

Estado de Autorización:

New Drug Application

Ficha técnica

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
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 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
For intravenous administration ( 2.1)
Titrate according to heart rate, PR interval, blood pressure and
symptoms ( 2.1)
Adult dosage
Antisialagogue or for antivagal effects: Initial single dose of 0.5 to
1 mg ( 2.2)
Antidote for organophosphorus or muscarinic mushroom poisoning:
Initial single dose of 2 to 3 mg,
repeated every 20-30 minutes ( 2.2)
Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3-5 minutes
if asystole persists ( 2.2)
Patients with Coronary Artery Disease: Limit the total dose to 0.03 to
0.04 mg/kg ( 2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 0.4 or 1 mg/mL as a clear, colorless solution in a
single-dose vial.
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Tachycardia ( 5.1)
Glaucoma ( 5.2)
Pyloric obstruction ( 5.3)
Worsening urinary retention ( 5.4)
Viscid bronchial plugs ( 5.5)
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: 9/2020
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