Methscopolamine (Page 2 of 2)

OVERDOSAGE

The symptoms of overdosage with methscopolamine bromide tablets USP, 2.5 mg and 5mg progress from intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis and coma.

Measures to be taken are (1) induction of emesis and (2) injection of physostigmine 0.5 to 2 mg intravenously, and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (alcohol sponging, ice packs). Excitement of a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

The oral LD50 in rats is 1,352 to 2,617 mg/kg. No data is available on the dialyzability of methscopolamine bromide.

DOSAGE AND ADMINISTRATION

The average dosage of methscopolamine bromide tablets USP is 2.5 mg one-half hour before meals and 2.5 to 5mg at bedtime. A starting dose of 12.5 mg daily will be clinically effective in most patients without the production of appreciable side effects.

If the patient is having severe symptoms which demand prompt relief, the drug may be started on a daily dosage of 20 mg, administered in doses of 5mg one-half hour before meals and at bedtime. If very unpleasant side effects develop promptly, the daily dosage should be reduced. If neither symptomatic relief nor side effects appear, the daily dosage may be increased. Some patients have tolerated 30 mg daily with no unpleasant reactions.

Patients whose dosage has been reduced to eliminate or modify side effects often continue to show adequate response both subjectively in relief of symptoms and objectively as measured by antisecretory effects.

The ultimate aim of therapy is to arrive at a dosage which provides maximal clinical effectiveness with a minimum of unpleasant side effects. Many patients report no side effects on a dosage which gives complete relief of symptoms. On the other hand, some patients have reported severe side effects without appreciable symptomatic relief. Such patients must be considered unsuited for this therapy. Usually they have been or will prove to be similarly intolerant to other anticholinergic drugs. If methscopolamine bromide is to be used in a patient who gives a history of such intolerance, it should be started at a low dosage.

HOW SUPPLIED

Methscopolamine Bromide Tablets USP, 2.5 mg tablets are available as white, round tablets, debossed with “BOCA” on one side, debossed “603″ on opposite:

Bottles of 100 (NDC 60429-177-01)

Methscopolamine Bromide Tablets USP, 5 mg are available as white, oval-shaped tablets, debossed with “BOCA” on one side, debossed “604″ on opposite:

Bottles of 60 (NDC 60429-251-60) Bottles of 100 (NDC 60429-251-01)

Store at 20°-25°C (6r-77°F) (See USP Controlled Room Temperature).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

REFERENCES

  1. The Pharmacological Basis of Therapeutics , Gilman and Goodman, MacMillan Publ. Co., New York, 6th Ed., 1980.
  2. American Hospital Formulary Service , American Society of Hospital Pharmacists, Bethesda, Maryland.
  3. Domino, E.F., Corasen, G.: Central and Peripheral Effects of Muscarinic Cholinergic Blocking Agents in Man. Anesthesiology 28:568-574 (1967).
  4. Mogensen, L. and Orinius, E.: Arrhythmic Complications after Parasympathetic Treatment of Bradyarrhythmias in a Coronary Care Unit, Acta Med. Scand. 190:495-498 (1971).
  5. Neeld, J.B., at al: Cardiac Rate and Rhythm Changes with Atropine and Methscopolamine, Clin. Pharmacol. Ther. 17(3):290-295 (March) 1975.

Rx Only

Call your doctor far medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by: Sovereign 7590 Sand Street Ft. Worth, TX 76118
Manufactured for: Boca Pharmacal, Inc. Coral Springs, FL 33065
www.bocapharmacalcom 1-800-354-8460
Marketed/Packaged by: GSMS Inc. Camarillo, CA 93012

500158 Rev. 08/2009

PRINCIPAL DISPLAY PANEL — 5 mg

Label Graphic -- 5 mg
(click image for full-size original)

METHSCOPOLAMINE
methscopolamine bromide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-251(NDC:64376-604)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHSCOPOLAMINE BROMIDE (METHSCOPOLAMINE) METHSCOPOLAMINE BROMIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code BOCA;604
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-251-60 60 TABLET in 1 BOTTLE None
2 NDC:60429-251-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040624 12/28/2006
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 REPACK (60429-251), RELABEL (60429-251)

Revised: 07/2011 Golden State Medical Supply, Inc.

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