ATROPINE SULFATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Atropine Sulfate (UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I)

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

Atropine Sulfate

Composition:

Atropine Sulfate 0.4 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 July 2011    462-416-01

Authorization status:

unapproved drug other

Summary of Product characteristics

ATROPINE SULFATE- ATROPINE SULFATE INJECTION
GENERAL INJECTABLES & VACCINES, INC
_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 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 acetycholine.
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, gastric and sweat gland
secretions. Following clinica