Scopolamine Injection

Name: Scopolamine Injection

Uses of Scopolamine Injection

  • It is used during surgery.

How do I store and/or throw out Scopolamine Injection?

  • If you need to store scopolamine injection at home, talk with your doctor, nurse, or pharmacist about how to store it.

Scopolamine Injection - Clinical Pharmacology

Scopolamine hydrobromide is one of the major antimuscarinic agents that inhibit the action of acetylcholine (ACh) on autonomic effectors innervated by postganglionic cholinergic nerves as well as on smooth muscles that lack cholinergic innervation.  It exerts little effects on the actions of ACh at nicotinic receptor sites such as autonomic ganglia.  The major action of this antimuscarinic agent is a surmountable antagonism to ACh and other muscarinic agents.

As compared with atropine, scopolamine differs only quantitatively in antimuscarinic actions.  Scopolamine has a stronger action on the iris, ciliary body and certain secretory glands such as salivary, bronchial and sweat.  Scopolamine, in therapeutic doses, normally causes drowsiness, euphoria, amnesia, fatigue and dreamless sleep with a reduction in rapid-eye-movement sleep.  However, the same doses occasionally cause excitement, restlessness, hallucinations or delirium, especially in the presence of severe pain.  Scopolamine depresses the EEG arousal response to photostimulation.  It is more potent than atropine on the antitremor activity (parkinsonism) in animals induced by surgical lesions.  Scopolamine is effective in preventing motion sickness by acting on the maculae of the utricle and saccule.

Scopolamine, although less potent than atropine, has been used frequently in preanesthetic medication for the purpose of inhibiting the secretions of the nose, mouth, pharynx and bronchi and reduces the occurrence of laryngospasm during general anesthesia.  Scopolamine is less potent in the decrease of cardiac rate, but not in the changes of blood pressure or cardiac output.  Like other antimuscarinic agents, scopolamine has been used widely in the treatment of peptic ulcers and as an antispasmodic agent for G.I. disorders.  This is due to the fact that scopolamine reduces salivary secretion, the gastric secretion (both the volume and acid content), and also it inhibits the motor activity of the stomach, duodenum, jejunum, ileum and colon, characterized by a decrease in tone, amplitude and frequency of peristaltic contractions.

Precautions

General

If there is mydriasis and photophobia, dark glasses should be worn.  Appropriate dosage precautions must be taken with infants, children, persons with mongolism, brain damage, spasticity, or light irides.  Elevated intraocular pressure, urinary difficulty and retention and constipation are more probable in elderly persons.  Men with prostatic hypertrophy should especially be monitored for urinary function.  Because of the tachycardic effects of the drugs, care must be exercised when tachycardia, other tachyarrhythmias, coronary heart disease, congestive heart disease or hyperthyroidism preexist.  Persons with hypertension may experience both exaggerated orthostatic hypotension and tachycardia.  Similarly, autonomic neuropathy requires caution.  Persons with a history of allergies or bronchial asthma will show a higher than normal incidence of hypersensitivity reactions.

Laboratory Tests

Barbiturates may increase Bromosulfonphthalein (BSP) levels; administration is not recommended during the 24 hours preceding the test.

Drug Interactions

Other drugs, such as phenothiazines, tricyclic antidepressants, certain antihistamines, meperidine, etc., which have weak antimuscarinic activity, may considerably intensify the effects of antimuscarinic drugs.  Aluminum- and magnesium trisilicate-containing antacids have been shown to decrease the absorption of some antimuscarinic drugs and may possibly do so with all of them.

Pregnancy Category C

Scopolamine hydrobromide can pass the placental barrier; the threat to the fetus in utero is unknown, but use during pregnancy may cause respiratory depression in the neonate and may contribute to neonatal hemorrhage due to reduction in Vitamin K-dependent clotting factors in the neonate.

Scopolamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Problems in humans have not been documented; however, risk-benefit must be considered since barbiturates and belladonna alkaloids are excreted in breast milk.

Overdosage

Serious systemic intoxication can occur even from topical ophthalmologic application, especially in children, since both local absorption and nasolacrimal drainage into the gut can deliver considerable amounts to the circulation.  In serious intoxication, hyperpyrexia, flushing, nausea, vomiting, drowsiness, disorientation, stupor, hallucinations, leukocytosis, nonallergenic rashes, circulatory or respiratory collapse, even death, in addition to all aforenamed effects, may occur.  Children, especially infants and children with mongolism, spastic paralysis or brain damage, are more sensitive than adults to the toxic effects.

If marked excitement is present and more specific treatment is not available, diazepam is most suitable for sedation and for control of convulsions.  Large doses should be avoided because the central depressant action may coincide with the depression occurring late in belladonna poisoning.  Phenothiazines should not be used because their antimuscuranic action is likely to intensify toxicity and may plunge the patient into coma.  Artificial respiration with oxygen may be necessary.  Ice bags and alcohol sponges help to reduce fever, especially in children.

How is Scopolamine Injection Supplied

Scopolamine Hydrobromide Injection, USP is supplied as:

Product

No.

NDC

No.

Strength


26801

63323-268-01     

0.4 mg/mL      

1 mL in a 2 mL multiple dose vial, in packages of 25.

27001

63323-270-01

1 mg/mL

1 mL in a 2 mL multiple dose vial, in packages of 25.

PROTECT FROM LIGHT.

Use only if solution is clear and seal intact.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

45818C

Revised: April 2008

PACKAGE LABEL - PRINCIPAL DISPLAY - Scopolamine 1 mL Multiple Dose Vial Label

NDC 63323-268-01

26801

Scopolamine Hydrobromide Injection, USP

0.4 mg/mL

For IM, IV or SC Use

1 mL Multiple Dose Vial

Usual Dosage: See insert.

Protect From Light.

 

 

PACKAGE LABEL - PRINCIPAL DISPLAY - Scopolamine 1 mL Multiple Dose Vial Tray Label

NDC 63323-268-01

26801

Scopolamine Hydrobromide Injection, USP

0.4 mg/mL

For IM, IV or SC Use

1 mL Multiple Dose Vial

Rx only


 

 

 

SCOPOLAMINE HYDROBROMIDE 
scopolamine hydrobromide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63323-268
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SCOPOLAMINE HYDROBROMIDE (SCOPOLAMINE) SCOPOLAMINE HYDROBROMIDE 0.4 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN  
PROPYLPARABEN  
HYDROBROMIC ACID  
Packaging
# Item Code Package Description
1 NDC:63323-268-01 25 VIAL, MULTI-DOSE (25 VIAL) in 1 TRAY
1 1 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/18/2000
Labeler - APP Pharmaceuticals, LLC (608775388)
Establishment
Name Address ID/FEI Operations
APP Pharmaceuticals, LLC 840771732 MANUFACTURE(63323-268)
Revised: 08/2012   APP Pharmaceuticals, LLC

Interactions

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

No monograph available at this time.

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

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