ATROPINE SULFATE- 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:

International Medication Systems, Limited

INN (International Name):

Atropine Sulfate

Composition:

Atropine Sulfate 0.1 mg in 1 mL

Administration route:

PARENTERAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atropine Sulfate Injection, USP, may be given parenterally as a pre-anesthetic medication in surgical patients to reduce salivation and bronchial secretions. It may also be used to suppress vagal activity associated with the use of halogenated hydrocarbons during inhalation anesthesia and reflex excitation arising from mechanical stimulation during surgery. The antispasmodic action of atropine is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, atropine concomitantly with morphine may be indicated. Atropine relaxes the upper GI tract and colon during hypotonic radiography. In poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases, large doses of atropine relieve the muscarine-like symptoms and some of the central nervous system manifestations. It is also used as an antidote for mushroom poisoning due to muscarine in certain species such as Amanita muscaria . Atropine Sulfate

Product summary:

ATROPINE SULFATE INJECTION, USP. In unit-use packages containing the Luer-Jet Luer-Lock Prefilled Syringe. Ten cartons per package. Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Store at controlled room temperature 15° to 30°C (59° to 86°F). Rx Only INTERNATIONAL MEDICATION SYSTEMS, LIMITED So. El Monte, CA 91733, U.S.A. An Amphastar Pharmaceuticals Company                                Rev. 2-13 © INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2013

Authorization status:

unapproved drug other

Summary of Product characteristics

ATROPINE SULFATE - ATROPINE SULFATE INJECTION
INTERNATIONAL MEDICATION SYSTEMS, LIMITED
_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
DESCRIPTION
Atropine is chemically 1 α H, 5 α H - Tropan-3 α-ol (±) -tropate
(ester), with the following structural
formula:
Atropine rarely occurs as such in any of the plants and has been
prepared by synthesis. It is usually
employed in the form of atropine sulfate (the sulfate [2:1]
monohydrate salt of atropine), which has much
greater solubility in water.
Atropine Sulfate Injection, USP, is a sterile aqueous solution of
atropine sulfate. Each mL contains
atropine sulfate, 0.1 mg; sodium chloride, 8.8 mg, for isotonicity;
citric acid, 0.63 mg, and sodium
citrate, 0.29 mg, as buffers. May contain additional citric acid
and/or sodium citrate for pH adjustment
(3.0-6.5). The air above the liquid in the container has been
displaced by nitrogen gas.
CLLNICAL PHARMACOLOGY
Atropine inhibits the muscarinic actions of acetylcholine at
postganglionic parasympathetic
neuroeffector sites including smooth muscle, secretory glands and CNS
sites. Large doses may block
nicotinic receptors at the autonomic ganglia and at the neuromuscular
junction.
Specific anticholinergic responses are dose-related. Small doses of
atropine inhibit salivary and
bronchial secretions and sweating; moderate doses dilate the pupil,
inhibit accommodation and increase
the heart rate (vagolytic effect); larger doses will decrease motility
of the GI and urinary tracts; very
large doses will inhibit gastric acid secretion.
INDICATIONS AND USAGE
Atropine Sulfate Injection, USP, may be given parenterally as a
pre-anesthetic medication in surgical
patients to reduce salivation and bronchial secretions. It may also be
used to suppress vagal activity
associated with the use of halogenated hydrocarbons during inhalation
anesthesia and reflex e