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:

Amneal Pharmaceuticals LLC

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Atropine sulfate injection 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 disease or other drug therapy.

Обзор продуктов:

Atropine Sulfate Injection USP, 0.5 mg/5 mL (0.1 mg/mL) is available as a sterile, clear, colorless solution for intravenous administration and supplied in 5 mL single-dose glass syringe as follows: Strength (Concentration) NDC# Unit of Sale Each Atropine Sulfate Injection, USP 0.5 mg/5 mL (0.1 mg/mL) NDC 70121-1705-7 (package of 10, 5 mL single-dose glass syringes) NDC 70121-1705-1 (1 syringe in 1 carton) Atropine Sulfate Injection USP, 1 mg/10 mL (0.1 mg/mL) is available as a sterile, clear, colorless solution for intravenous administration and supplied in 10 mL single-dose glass syringe as follows: Strength (Concentration) NDC# Unit of Sale Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL) NDC 70121-1706-1 (1, 10 mL single-dose glass syringe in 1 carton) NDC 70121-1706-2 (10, 10 mL single-dose glass syringes in 1 carton) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 01-2024-01

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
AMNEAL PHARMACEUTICALS 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
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 to 30 minutes. (2.2)
- Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3 to 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)
DOSAGE FORMS AND STRENGTHS
0.5 mg/5 mL (0.1 mg/mL) injection in 5 mL single-dose glass syringe.
(3)
1 mg/10 mL (0.1 mg/mL) injection in 10 mL single-dose glass syringe.
(3)
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 AMNEAL PHARMACEUTICALS
AT 1-877-835-
5472 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
_Mexiletine:_ Decreases rate of mexiletine absorption. (7.1)
REVISED: 1/2024
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Ad