ATROPINE SULFATE injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Accord Healthcare, Inc.,

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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.

Termék összefoglaló:

Atropine Sulfate Injection, USP is supplied in single-dose syringes as follows: The Glass syringe is presented in a tray with polypropylene plunger rod. 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., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA. Manufactured By: Intas Pharmaceuticals Limited, Ahmedabad-380 054, India. 10 5231 3 6026793 Issued November 2023

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

ATROPINE SULFATE- ATROPINE SULFATE INJECTION
ACCORD HEALTHCARE, INC.,
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATROPINE SULFATE
INJECTIONSAFELY 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 20-30 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
0.05 mg/mL injection in Glass Syringe ( 3)
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
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, CONTACTACCORD HEALTHCARE INC.
AT 1-866-941-
7875OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
_Mexiletine:_Decreases rate of mexiletine absorption. ( 7.1)
REVISED: 11/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Administration
INSTRUCTIONS FOR USE:
2.2 Adult Dosage
2.3 Pediatric