ATROPINE SULFATE injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Hikma Pharmaceuticals USA Inc.

Laluan pentadbiran:

ENDOTRACHEAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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. 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 pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of atropine on the fetus. Data Human Data No adequate and well-controlled studies are available regarding use of atropine in pregnant women. In a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformation. In a surveillance study, 381 newborns were exposed to atropine during the first trimester; 18 major birth defects were observed when 16 were expected. No specific pattern of major birth defects was identified. In another surveillance study of 50 pregnancies in the first trimester, atropine use was not associated with an increased risk of malformations. Methodological limitations of these observational studies including the inability to control for the dosage and timing of atropine exposure, underlying maternal disease, or concomitant maternal drug use, cannot definitively establish or exclude any drug- associated risk during pregnancy. Risk Summary Trace amounts of atropine have been reported in human milk after oral intake. There are no available data on atropine levels in human milk after intravenous injection, the effects on the breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of atropine to an infant during lactation. Clinical Considerations Minimizing exposure The elimination half-life of atropine is more than doubled in children less than 2 years of age [see Clinical Pharmacology (12.3)]. To minimize potential infant exposure to Atropine Sulfate Injection, a woman may pump and discard her milk for 24 hours after use before resuming to breastfeed her infant. 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.

Ringkasan produk:

Atropine Sulfate Injection, USP is a non-pyrogenic, isotonic, clear solution and is supplied as follows: Presentation Single Vial 10 Vial Pack NDC# 0641-6251-01 0641-6251-10 Description 8 mg per 20 mL (0.4 mg per mL) Multiple-dose vial 20 mL multiple-dose vial, packaged in a carton containing 10 vials. 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

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ATROPINE SULFATE- ATROPINE SULFATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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, 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)
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)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity (5.1)
Worsening of Ischemic Heart Disease (5.2)
Acute Glaucoma (5.3)
Pyloric obstruction (5.4)
Complete urinary retention (5.5)
Viscid plugs (5.6)
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)
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.
DRUG INTERACTIONS
_Mexiletine_: Decreases rate of mexiletine absorption. (7.1)
REVISED: 1/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Administration
2.2 Adult Dosage
2.3 Pediatric Dosage
2.4 Dosing in Patients with Ischemic Heart Disease
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
5.2 Worsening of Ischemic Heart Disease
5.3 Acute Glaucoma
5.4 Pyloric Obstruction
5.5 Compl