ATROPINE SULFATE injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

HF Acquisition Co LLC, DBA HealthFirst

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Atropine sulfate is given parenterally as a preanesthetic medication to decrease salivation and bronchial secretions. It is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, atropine sulfate given with morphine may be indicated. Atropine sulfate is indicated for relaxation of the upper gastrointestinal tract and colon during hypotonic radiography. Atropine is used as an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of aminata and in poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare “nerve gases”. Large doses relieve the muscarine-like symptoms and some of the central nervous system manifestations. Conditions at which inhibition of postganglionic cholinergic nerves are undesirable, such as glaucoma and tachycardia. Also contraindicated in asthma, because the parenteral dose which might relieve asthma would have an excessive drying effect

Rezumat produs:

ATROPINE SULFATE INJECTION, USP is supplied in the following dosage forms: NDC 51662-1311-1 ATROPINE SULFATE INJECTION, USP 8mg/20mL (0.4mg/mL) 20mL VIAL NDC 51662-1311-2 - 1 Pouch of ATROPINE SULFATE INJECTION, USP 8mg/20mL (0.4mg/mL) 20mL VIAL NDC 51662-1311-3 - Case of 25 pouches of ATROPINE SULFATE INJECTION, USP 8mg/20mL (0.4mg/mL) 20mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Atropine Sulfate Injection, USP is available in the following: 0.4 mg/mL 20 mL multiple dose vial packaged in 10s (NDC 0641-6006-10) Use only if solution is clear and seal intact. Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: WEST-WARD PHARMACEUTICALS Eatontown, NJ 07724 USA Revised June 2011 462-416-01

Statutul autorizaţiei:

unapproved drug other

Caracteristicilor produsului

ATROPINE SULFATE- ATROPINE SULFATE INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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ATROPINE SULFATE INJECTION, USP 8MG/20ML (0.4MG/ML) 20ML VIAL
SPL UNCLASSIFIED
FOR IM, IV OR SC USE
RX only
DESCRIPTION
Atropine Sulfate Injection, USP is a sterile solution of atropine
sulfate in Water for Injection. Each mL
contains Atropine Sulfate 0.4 mg; Sodium Chloride 9 mg; Benzyl Alcohol
9 mg; Water for Injection qs;
pH may be adjusted with Sulfuric Acid if necessary. pH 3.0-6.5.
Atropine Sulfate Injection, USP may be given intramuscularly,
intravenously or subcutaneously.
Atropine is a white crystalline alkaloid which may be extracted from
belladonna root or may be
produced synthetically. It is used as atropine sulfate because this
compound has much greater solubility.
Atropine sulfate is an anticholinergic drug. The empirical formula of
atropine sulfate is
(C17H23NO3)2•H2SO4•H2O.
The structural formula is:
CLINICAL PHARMACOLOGY
The most important therapeutic action of atropine is the inhibition of
smooth muscle and glands
innervated by postganglionic cholinergic nerves. It also has central
nervous system activity, which may
be stimulating or depressing depending upon the dose.
Following the administration of usual clinical doses, atropine
produces stimulation of the medulla and
higher cerebral centers. This effect is manifested by mild central
vagal excitation and moderate
respiratory stimulation. Atropine sulfate also acts peripherally as a
competitive antagonist of the
muscarinic actions of acetylcholine. It does not prevent the release
of acetylcholine but antagonizes the
effect of acetylcholine on the effector cells.
These actions include vasodilation, drying of the mouth, an increase
in the pulse rate, inhibition of
contractions of the gastrointestinal tract, ureter, and bladder, and
reduction of salivary, bronchial,
g