ATROPINE SULFATE injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Hospira, Inc.

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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. Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. Trace amounts of atropine was found in breast milk. The clinical impact of this is not known. Recommendations for use in pediatric patients are not based on clinical trials. An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disea

Обзор продуктов:

Atropine Sulfate Injection, USP is supplied in single-dose syringes as follows: Syringes Concentration (mg/mL) Fill Volume Total Atropine Content NDC# (Unit of Sale) Ansyr™ Plastic Syringe 0.1 mg/mL 10 mL 1 mg 0409-1630-10 (Bundle of 10) Ansyr™ Plastic Syringe 0.05 mg/mL 5 mL 0.25 mg 0409-9630-05 (Bundle of 10) LifeShield™ Abboject™ Glass Syringe 0.1 mg/mL 5 mL 0.5 mg 0409-4910-34 (Bundle of 10) LifeShield™ Abboject™ Glass Syringe 0.1 mg/mL 10 mL 1 mg 0409-4911-34 (Bundle of 10) 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.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                          Abboject™ is a trademark of the Abbott group of companies. LifeShield™ is the trademark of ICU Medical, Inc. and is used under license. LAB-1041-4.0

Статус Авторизация:

New Drug Application

Характеристики продукта

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
HOSPIRA, INC.
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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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
•
•
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 HOSPIRA, INC. AT
1-800-441-4100, OR FDA
AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
_Mexiletine:_ Decreases rate of mexiletine absorption. (7.1)
REVISED: 6/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 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 mg
to 1 mg (2.2)
Antidote for organophosphorus or muscarinic mushroom poisoning:
Initial single dose of 2 mg 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
mg/kg to 0.04 mg/kg (2.4)
0.05 mg/mL injection in Ansyr™ Plastic Syringe (3)
0.1 mg/mL injection in Ansyr™ Plastic Syringe (3)
0.1 mg/mL injection in LifeShield™ Abboject™ Glass Syringe (3)