ATROPINE SULFATE injection

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

HF Acquisition Co LLC, DBA HealthFirst

Адміністрація маршрут:

INTRAVENOUS

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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. 8.1 Pregnancy 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. 8.3 Nursing Mothers Trace amounts of atropine was found in breast milk. The clinical impact of this is not known. 8.4 Pediatric Use Recommendations for use in pediatric patients are not based on clinical trials. 8.5 Geriatric Use 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.

Огляд продуктів:

Atropine Sulfate Injection, USP, 1 mg/10 mL (0.1 mg/mL), is supplied in single-dose syringes as follows: In unit-use packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Rx Only INTERNATIONAL MEDICATION SYSTEMS, LIMITED So. El Monte, CA 91733, U.S.A. An Amphastar Pharmaceuticals Company Rev. 10-20 © INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2020 6933390J Atropine Sulfate Injection, USP, 1 mg/10 mL (0.1 mg/mL), is supplied in single-dose syringes as follows: In unit-use packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe. (CASE OF 10) Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Rx Only INTERNATIONAL MEDICATION SYSTEMS, LIMITED So. El Monte, CA 91733, U.S.A. An Amphastar Pharmaceuticals Company Rev. 10-20 © INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2020 6933390J

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

ATROPINE SULFATE- ATROPINE SULFATE INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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ATROPINE SULFATE INJECTION, USP 1MG/10ML (0.1MG/ML) 10ML SYR
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 ( 2.1)
- 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)
DOSAGE FORMS AND STRENGTHS
0.1 mg/mL injection in 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 Amphastar
Pharmaceuticals, Inc.
at 1-800-423-4136, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (
6)
DRUG INTERACTIONS
Mexiletine: Decreases rate of mexiletine absorption. ( 7.1)
Revised: 2/2021
TABEL OF CONTENTS
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Gen