Motofen

Name: Motofen

Manufacturer

  • Valeant Pharmaceuticals International

  • Valeant Pharmaceuticals North America LLC

Uses For Motofen

Difenoxin and atropine combination medicine is used along with other measures to treat severe diarrhea in adults. Difenoxin helps stop diarrhea by slowing down the movements of the intestines.

Since difenoxin is chemically related to some narcotics, it may be habit-forming if taken in doses that are larger than prescribed. To help prevent possible abuse, atropine (an anticholinergic) has been added. If higher-than-normal doses of the combination are taken, the atropine will cause unpleasant effects, making it unlikely that such doses will be taken again.

Difenoxin and atropine combination medicine should not be used in children. Children with diarrhea should be given solutions of carbohydrates (sugars) and electrolytes (important salts) to replace the water and important salts that are lost from the body during diarrhea.

This medicine is available only with your doctor's prescription.

Before Using Motofen

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine should not be used in children. Children, especially very young children, are very sensitive to the effects of difenoxin and atropine. This may increase the chance of side effects during treatment. Also, the fluid loss caused by diarrhea may result in a severe condition. For this reason, it is very important that a sufficient amount of liquids be given to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Geriatric

Shortness of breath or difficulty in breathing may be more likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of difenoxin. Also, the fluid loss caused by diarrhea may result in a severe condition. For this reason, elderly persons should not take this medicine without first checking with their doctor. It is also very important that a sufficient amount of liquids be taken to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Ambenonium
  • Nalmefene
  • Naltrexone
  • Potassium
  • Safinamide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Amphetamine
  • Benzphetamine
  • Bromazepam
  • Bromopride
  • Buprenorphine
  • Bupropion
  • Butorphanol
  • Carbinoxamine
  • Codeine
  • Desmopressin
  • Dextroamphetamine
  • Dihydrocodeine
  • Donepezil
  • Doxylamine
  • Fentanyl
  • Flibanserin
  • Furazolidone
  • Hydrocodone
  • Hydromorphone
  • Iproniazid
  • Isocarboxazid
  • Levorphanol
  • Linezolid
  • Lisdexamfetamine
  • Lorazepam
  • Meclizine
  • Meperidine
  • Methadone
  • Methamphetamine
  • Methylene Blue
  • Moclobemide
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Oxycodone
  • Oxymorphone
  • Pentazocine
  • Periciazine
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Remifentanil
  • Selegiline
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Tiotropium
  • Tramadol
  • Tranylcypromine
  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Arbutamine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse (or history of) or
  • Drug abuse (history of)—There is a greater chance that this medicine may become habit-forming
  • Colitis (severe)—A more serious problem of the colon may develop if you use this medicine
  • Down's syndrome—Side effects may be more likely and severe in these patients
  • Dysentery—This condition may get worse; a different kind of treatment may be needed
  • Emphysema, asthma, bronchitis, or other chronic lung disease—There is a greater chance that this medicine may cause breathing problems in patients who have any of these conditions
  • Enlarged prostate or
  • Urinary tract blockage or difficult urination—Problems with urination may develop with the use of this medicine
  • Gallbladder disease or gallstones—Use of this medicine may cause spasms of the biliary tract and make the condition worse
  • Glaucoma—Severe pain in the eye may occur with the use of this medicine; however, the chance of this happening is low
  • Heart disease—This medicine may have some effects on the heart, which may make the condition worse
  • Hiatal hernia—The atropine in this medicine may make this condition worse; however, the chance of this happening is low
  • High blood pressure (hypertension)—The atropine in this medicine may cause an increase in blood pressure; however, the chance of this happening is low
  • Intestinal blockage—This medicine may make the condition worse
  • Kidney disease—The atropine in this medicine may build up in the body and cause side effects
  • Liver disease—The chance of central nervous system (CNS) side effects, including coma, may be greater in patients who have this condition
  • Myasthenia gravis—This medicine may make the condition worse
  • Overactive or underactive thyroid—Unwanted effects on breathing and heart rate may occur
  • Overflow incontinence—This medicine may make the condition worse

Indications and Usage for Motofen

Motofen® is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.

Motofen Dosage and Administration

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.

-200-10 Bottle Label

Motofen 
difenoxin and atropine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54766-200
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 0.025 mg
DIFENOXIN HYDROCHLORIDE (DIFENOXIN) DIFENOXIN 1 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE  
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
ANHYDROUS LACTOSE  
Product Characteristics
Color white Score 2 pieces
Shape PENTAGON (5 sided) Size 7mm
Flavor Imprint Code 0200;M
Contains     
Packaging
# Item Code Package Description
1 NDC:54766-200-10 100 TABLET in 1 BOTTLE
2 NDC:54766-200-04 4 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017744 04/11/2017
Labeler - Sebela Pharmaceuticals Inc. (079104574)
Establishment
Name Address ID/FEI Operations
Alcami Carolinas Corporation 832395235 manufacture(54766-200)
Revised: 04/2017   Sebela Pharmaceuticals Inc.
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