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difenoxin and atropine sulfate
Overview
What is Motofen?
Each five-sided dye free MOTOFEN® tablet contains: 1 mg of difenoxin (equivalent to 1.09 mg of difenoxin hydrochloride) and 0.025 mg of atropine sulfate (equivalent to 0.01 mg of atropine).
The structural formula is:
Atropine sulfate is present to discourage deliberate overdose.
Atropine sulfate, an anticholinergic, is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, endo-(±)-, (2:1) (salt), monohydrate and has the following structural formula:
Inactive Ingredients: calcium stearate, cellulose, lactose, corn starch.
What does Motofen look like?
What are the available doses of Motofen?
Sorry No records found.
What should I talk to my health care provider before I take Motofen?
Sorry No records found
How should I use Motofen?
MOTOFEN® is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
The recommended starting dose of MOTOFEN® tablets in adults is 2 tablets then 1 tablet after each loose stool or 1 tablet every 3 to 4 hours as needed, but the total dosage during any 24-hour treatment period should not exceed 8 tablets. In the treatment of diarrhea, if clinical improvement is not observed in 48 hours, continued administration of this type of medication is not recommended. For acute diarrheas and acute exacerbations of functional diarrhea, treatment beyond 48 hours is usually not necessary.
Studies in children below the age of 12 have been inadequate to evaluate the safety and effectiveness of MOTOFEN® in this age group. MOTOFEN® is contraindicated in children under 2 years of age.
What interacts with Motofen?
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What are the warnings of Motofen?
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What are the precautions of Motofen?
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What are the side effects of Motofen?
Sorry No records found
What should I look out for while using Motofen?
MOTOFEN® is contraindicated in patients with diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic
species,
) and pseudomembranous colitis associated with broad spectrum antibiotics. Antiperistaltic agents should not be used in the conditions because they may prolong and/or worsen diarrhea.
MOTOFEN® is
because of the decreased margin of safety of drugs in this class in younger age groups.
MOTOFEN® is contraindicated in patients with a known hypersensitivity to difenoxin, atropine, or any of the inactive ingredients, and in patients who are jaundiced.
MOTOFEN® IS NOT AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO. MOTOFEN® IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEE
). THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN.
FLUID AND ELECTROLYTE BALANCE
IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS MANIFESTED, MOTOFEN® SHOULD BE WITHHELD UNTIL APPROPRIATE CORRECTIVE THERAPY HAS BEEN INITIATED.
Ulcerative Colitis
Liver and Kidney Disease
Atropine
What might happen if I take too much Motofen?
In the event of overdosage (initial signs may include dryness of the skin and mucous membranes, flushing, hyperthermia and tachycardia followed by lethargy or coma, hypotonic reflexes, nystagmus, pinpoint pupils and respiratory depression) gastric lavage, establishment of a patent airway and possibly mechanically assisted respiration are advised.
The narcotic antagonist naloxone may be used in the treatment of respiratory depression caused by narcotic analgesics of pharmacologically related compounds such as MOTOFEN® tablets. When naloxone is administered intravenously, the onset of action is generally apparent within two minutes. Naloxone may be administered subcutaneously or intramuscularly providing a slightly less rapid onset of action but a more prolonged effect.
To counteract respiratory depression caused by MOTOFEN® overdosage, the following dosage schedule for naloxone should be followed:
Adult Dosage:
function does not adequately improve after the initial dose, the same IV dose may be repeated at two-to-three minute
intervals.
Children:
Since the duration of action of difenoxin hydrochloride is longer than that of naloxone, improvement of respiration following administration may be followed by recurrent respiratory depression. Consequently, continuous observation is necessary until the effect of difenoxin hydrochloride on respiration (which effect may persist for many hours) has passed. Supplemental
intramuscular doses of naloxone may be utilized to produce a longer lasting effect. TREAT ALL POSSIBLE MOTOFEN® OVERDOSAGES AS SERIOUS AND MAINTAIN MEDICAL OBSERVATION FOR AT LEAST 48 HOURS, PREFERABLY UNDER CONTINUOUS HOSPITAL CARE.
Although signs of overdosage and respiratory depression may not be evident soon after ingestion of difenoxin
hydrochloride, respiratory depression may occur from 12 to 30 hours later.
How should I store and handle Motofen?
Store in a dry place protected from light. Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]MOTOFEN® is available as a white, dye-free, five-sided, scored tablet with “0200” on the scored side and "M" on the other side. Each tablet contains 1 mg difenoxin and 0.025 mg atropine sulfate. Supplied in bottles of 100 tablets (NDC 54766-200-10). Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Animal studies have shown that difenoxin hydrochloride manifests its antidiarrheal effect by slowing intestinal motility. The mechanism of action is by a local effect on the gastrointestinal wall.
Difenoxin is the principal active metabolite of diphenoxylate.
Following oral administration of MOTOFEN®, difenoxin is rapidly and extensively absorbed. Mean peak plasma levels of approximately 160 ng/mL occurred within 40 to 60 minutes in most patients following an oral dose of 2 mg. Plasma levels decline to less than 10% of their peak values within 24 hours and to less than 1% of their peak values within 72 hours. This decline parallels the appearance of difenoxin and its metabolites in the urine. Difenoxin is metabolized to an inactive hydroxylated metabolite. Both the drug and its metabolites are excreted, mainly as conjugates, in urine and feces.
Non-Clinical Toxicology
MOTOFEN® is contraindicated in patients with diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic species, ) and pseudomembranous colitis associated with broad spectrum antibiotics. Antiperistaltic agents should not be used in the conditions because they may prolong and/or worsen diarrhea.MOTOFEN® is because of the decreased margin of safety of drugs in this class in younger age groups.
MOTOFEN® is contraindicated in patients with a known hypersensitivity to difenoxin, atropine, or any of the inactive ingredients, and in patients who are jaundiced.
MOTOFEN® IS NOT AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO. MOTOFEN® IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEE ). THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN.
FLUID AND ELECTROLYTE BALANCE
IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS MANIFESTED, MOTOFEN® SHOULD BE WITHHELD UNTIL APPROPRIATE CORRECTIVE THERAPY HAS BEEN INITIATED.
Ulcerative Colitis
Liver and Kidney Disease
Atropine
In view of the small amount of atropine present (0.025 mg/tablet), such effects such as dryness of the skin and mucous membranes, flushing, hyperthermia, tachycardia and urinary retention are very unlikely to occur, except perhaps in children. Many of the adverse effects reported during clinical investigation of MOTOFEN® are difficult to distinguish from symptoms associated with the diarrheal syndrome. However, the following events were reported at the stated frequencies:
Gastrointestinal:
Central Nervous System:
Other less frequent reactions:
THIS MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT CONTAINER AND OUT OF THE REACH OF CHILDREN SINCE AN OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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