ATROPINE SULFATE injection, solution

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:

1. In the treatment of parkinsonism. Rigidity and tremor relieved by the apparently selective depressant action. 2. In the gastrointestinal tract to relieve pylorospasm, hypertonicity of the small intestine and the hypermotility of the colon. 3. To relieve hypertonicity of the uterine muscle. 4. To relax the spasm of biliary and uretered colic and bronchial spasm. 5. To diminish the tone of the detrusor muscle of the urinary bladder in the treatment of urinary tract disorders. 6. To control the crying and laughing episodes in patients with brain lesions. 7. In cases of closed head injuries which cause acetylcholine to be released or to be present in cerebrospinal fluid which in turn causes abnormal EEG patterns, stupor and neurological signs. 8. In the management of peptic ulcer. 9. In anesthesia to control excessive salivation and bronchial secretions. 10. To control rhinorrhea of acute rhinitis or hay fever. 11. As an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain

Product summary:

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). IN1010 Rev. 1/09 MG #7603 AMERICAN REGENT, INC. SHIRLEY, NY 11967

Authorization status:

unapproved drug other

Summary of Product characteristics

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
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 0.4 MG/ML INJECTION, USP 1 ML SINGLE DOSE VIAL
DESCRIPTION
Atropine Sulfate Injection, USP is a sterile, isotonic solution of
Atropine Sulfate in Water
for Injection q.s. Sodium Chloride added for isotonicity. pH adjusted
with Sulfuric Acid.
Preservative free. Atropine is a white crystalline alkaloid which may
be extracted from
belladonna root and hyoscyamine or may be produced synthetically. It
is used in the
form of atropine sulfate because this compound has much greater
solubility in water.
The structural formula of Atropine is as follows:
Molecular Formula Molecular Weight
C17H23NO3 289.37
CLINICAL PHARMACOLOGY
Atropine has two actions. The most important therapeutic action is the
inhibition of
smooth muscle and glands innervated by postganglionic cholinergic
nerves. Atropine
also has central-nervous system activity, which may be stimulating or
depressing
depending upon the dose.
INDICATIONS AND USAGE
1. In the treatment of parkinsonism. Rigidity and tremor relieved by
the apparently
selective depressant action.
2. In the gastrointestinal tract to relieve pylorospasm, hypertonicity
of the small intestine
and the hypermotility of the colon.
3. To relieve hypertonicity of the uterine muscle.
4. To relax the spasm of biliary and uretered colic and bronchial
spasm.
5. To diminish the tone of the detrusor muscle of the urinary bladder
in the treatment of
urinary tract disorders.
6. To control the crying and laughing episodes in patients with brain
lesions.
7. In cases of closed head injuries which cause acetylcholine to be
released or to be
present in cerebrospinal fluid which in turn causes abnormal EEG
patterns, stupor and
neurological signs.
8. In the management of peptic ulcer.
9. In anesthesia to control exc