ATROPINE SULFATE- atropine sulfate injection injection

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Henry Schein, Inc.

Manustamisviis:

ENDOTRACHEAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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. 8.1 Pregnancy 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 clinically recognized pr

Toote kokkuvõte:

Atropine Sulfate Injection, USP is a non-pyrogenic, isotonic, clear solution and is supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. After initial use, store between 20° to 25°C (68° to 77°F) and discard within 24 hours. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: December 2021 462-917-00

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

ATROPINE SULFATE- ATROPINE SULFATE INJECTION INJECTION
HENRY SCHEIN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATIONTHESE 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) (2)
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)
(4)
CONTRAINDICATIONS
None. (4) (5)
WARNINGS AND PRECAUTIONS
Hypersensitivity (5.1) (6)
Worsening of Ischemic Heart Disease (5.2) (6)
Acute Glaucoma (5.3) (6)
Pyloric obstruction (5.4) (6)
Complete urinary retention (5.5) (6)
Viscid plugs (5.6) (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) (7)
To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals
USA Inc. at 1-877-845-0689
or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH. (7)
DRUG INTERACTIONS
Mexiletine: Decreases rate of mexiletine absorption. (7.1) (8)
Revised: 12/2021 (8)
REVISED: 11/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
13 NO