ATROPINE SULFATE injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

General Injectables & Vaccines, Inc

INN (Nome Internazionale):

ATROPINE SULFATE

Composizione:

ATROPINE SULFATE 1 mg in 1 mL

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

- In the treatment of parkinsonism. Rigidity and tremor relieved by the apparently selective depressant action. - In the gastrointestinal tract to relieve pylorospasm, hypertonicity of the small intestine and the hypermotility of the colon. - To relieve hypertonicity of the uterine muscle. - To relax the spasm of biliary and uretered colic and bronchial spasm. - To diminish the tone of the detrusor muscle of the urinary bladder in the treatment of urinary tract disorders. - To control the crying and laughing episodes in patients with brain lesions. - 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. - In the management of peptic ulcer. - In anesthesia to control excessive salivation and bronchial secretions. - To control rhinorrhea of acute rhinitis or hay fever. - As an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of Aminata and

Dettagli prodotto:

Product No.                    Concentration          Vial/Ampule Size NDC 0517-0805-25         0.4 mg/0.5 mL           0.5 mL Ampule packed in boxes of 25 NDC 0517-0101-25         1.0 mg/1 mL              1 mL Ampule packed in boxes of 25 NDC 0517-0401-25         0.4 mg/1 mL              1 mL Single Dose Vial packed in boxes of 25 NDC 0517-1010-25         1.0 mg/1 mL              1 mL Single Dose Vial packed in boxes of 25 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

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

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 INJECTION, USP
RX ONLY
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:
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 bronchial
secretions.
10. To control rhinorrhea of ac