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:

Cardinal Health

INN (International Name):

Atropine Sulfate

Composition:

Atropine Sulfate 0.4 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
CARDINAL HEALTH
_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
DES CRIPTION
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 excessive salivation and