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Scopolamine (Scopolamine Hydrobromide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Scopolamine Hydrobromide Injection, USP is indicated as a sedative and tranquilizing depressant to the central nervous system.  In its peripheral actions, scopolamine differs from atropine in that it is a stronger blocking agent for the iris, ciliary body and salivary, bronchial and sweat glands but is weaker in its action on the heart (in which it is incapable of exerting actions in tolerated doses), the intestinal tract and bronchial musculature.

In addition to the usual uses for antimuscarinic drugs, scopolamine is employed for its central depressant actions as a sedative.  Frequently it is given as a preanesthetic medicament for both its sedative-tranquilizing and antisecretory actions.  It is an effective antiemetic.  It is used in maniacal states, in delirium tremens and in obstetrics.  As a mydriatic and cycloplegic, it has a somewhat shorter duration (3 to 7 days) and intraocular pressure is affected less markedly than with atropine.

DOSAGE AND ADMINISTRATION

Adult

For obstetric amnesia or preoperative sedation, 0.32 to 0.65 mg (320 to 650 mcg).

For sedation or tranquilization, 0.6 mg (600 mcg) 3 or 4 times a day.

Subcutaneous, as an antiemetic, 0.6 to 1 mg.

Pediatric

Age 6 mo. to 3 yr., 0.1 to 0.15 mg (100 to 150 mcg).  Age 3 to 6 yr., 0.2 to 0.3 mg (200 to 300 mcg).

Subcutaneous, as antiemetic, 0.006 mg (6 mcg) per kg.

 

              Dosage Equivalents

1 mg (1000 mcg)/mL

1     mg

      (1000 mcg)        

1    mL

0.8  mg

(800 mcg)

0.8  mL

0.6  mg

(600 mcg)

0.6  mL

0.5  mg

(500 mcg)

0.5  mL

0.4  mg

(400 mcg)

0.4  mL

0.3  mg

(300 mcg)

0.3  mL

0.2  mg

(200 mcg)

0.2  mL

0.1  mg

(100 mcg)

0.1  mL

0.4 mg (400 mcg)/mL

0.4  mg

(400 mcg)

1    mL

0.3  mg

(300 mcg)

   0.75 mL  

   0.25 mg  

(250 mcg)

0.63 mL

0.2  mg

(200 mcg)

0.50 mL

0.15 mg

(150 mcg)

0.38 mL

Belladonna alkaloids provide a therapeutic effect in about 1 or 2 hours with a duration of about 4 hours.

Geriatric and debilitated patients may respond to the usual doses with excitement, agitation, drowsiness or confusion; lower doses may be required in such patients.

Close supervision is recommended for infants, blondes, mongoloids and children with spastic paralysis or brain damage, since an increased responsiveness to belladonna alkaloids has been reported in these patients and dosage adjustments are often required.

Administration of belladonna alkaloids and barbiturates 30 to 60 minutes before meals is recommended to maximize absorption and, when issued for reducing stomach acid formation, to allow its effect to coincide better with antacid administration following the meal.

Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit.

HOW 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

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