Diphenoxylate Hydrochloride and Atropine Sulfate (Page 3 of 3)

OVERDOSAGE

Diagnosis

Overdosage can be life-threatening. Symptoms of overdosage may include opioid and/or anticholinergic effects including respiratory depression, coma, delirium, lethargy, dryness of the skin and mucous membranes, mydriasis or miosis, flushing, hyperthermia, tachycardia, hypotonia, tachypnea, toxic encephalopathy, seizures and incoherent speech.

Respiratory depression has been reported up to 30 hours after ingestion and may recur despite an initial response to narcotic antagonists.

Treat all possible diphenoxylate hydrochloride and atropine sulfate overdosages as serious and maintain medical observation/hospitalization until patients become asymptomatic without naloxone use.

Treatment

A pure narcotic antagonist (e.g., naloxone) should be used in the treatment of respiratory depression caused by diphenoxylate hydrochloride and atropine sulfate. Refer to the prescribing information for naloxone. Consider diphenoxylate hydrochloride and atropine sulfate toxicity even in settings of negative toxicology tests.

Following initial improvement of respiratory function, repeated doses of naloxone hydrochloride may be required to counteract recurrent respiratory depression.

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information of the management of poisoning or overdosage.

DOSAGE AND ADMINISTRATION

Management of Diarrhea in Patients 13 Years of Age and Older

Diphenoxylate hydrochloride and atropine sulfate tablets are recommended as adjunctive therapy for the management of diarrhea in patients 13 years of age and older. Consider the nutritional status and degree of dehydration in patients prior to initiating therapy with diphenoxylate hydrochloride and atropine sulfate. The use of this product should be accompanied by appropriate fluid and electrolyte therapy, when indicated. If severe dehydration or electrolyte imbalance is present, do not administer diphenoxylate hydrochloride and atropine sulfate tablets until appropriate corrective therapy has been indicated (see WARNINGS).

Initial and Maximum Recommended Dosage in Patients 13 Years of Age and Older

The initial adult dosage is two diphenoxylate hydrochloride and atropine sulfate tablets four times daily (maximum total daily dose of 20 mg per day of diphenoxylate hydrochloride). Most patients will require this dosage until initial control of diarrhea has been achieved. Clinical improvement of acute diarrhea is usually observed within 48 hours.

Dosage After Initial Control of Diarrhea

After initial control has been achieved, the diphenoxylate hydrochloride and atropine sulfate dosage may be reduced to meet individual requirements. Control may often be maintained with as little as two diphenoxylate hydrochloride and atropine sulfate tablets daily.

Duration of Treatment

If clinical improvement of chronic diarrhea after treatment with the maximum recommended daily dosage is not observed within 10 days, discontinue diphenoxylate hydrochloride and atropine sulfate tablets as symptoms are unlikely to be controlled by further administration.

HOW SUPPLIED

Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP are available as round white tablets debossed ‘490’ on one side and plain on the other side. Each tablet contains 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate and are supplied as:

NDC NumberSize

62559-490-01 Bottle of 100 tablets

62559-490-10 Bottle of 1,000 tablets

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].

Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
http://medlibrary.org/lib/images-rx/diphenoxylate-hydrochloride-and-atropine-sulfate-36/ani.jpg

9981 Rev 03/18

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV
2.5 mg/0.025 mg
NDC 62559-490-01
Rx only
100 Tablets

Label
(click image for full-size original)

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
diphenoxylate hydrochloride and atropine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-490
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENOXYLATE HYDROCHLORIDE (DIPHENOXYLATE) DIPHENOXYLATE HYDROCHLORIDE 2.5 mg
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 0.025 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
SUCROSE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 490
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-490-01 100 TABLET in 1 BOTTLE None
2 NDC:62559-490-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086727 07/07/2017
Labeler — ANI Pharmaceuticals, Inc. (145588013)
Registrant — ANI Pharmaceuticals, Inc. (145588013)

Revised: 10/2019 ANI Pharmaceuticals, Inc.

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