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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 26.06.2023

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Diphenoxylate Hydrochloride and Atropine Sulfate Mylan is indicated as an adjunct to rehydration in acute
diarrhea. It is used as a symptomatic treatment in chronic
mild ulcerative colitis.
Diphenoxylate Hydrochloride and Atropine Sulfate Mylan is used also for the control of stool formation
after colostomy or ileostomy.
Diphenoxylate Hydrochloride and Atropine Sulfate Mylan affects the body in many different ways, such as reducing spasms in the bladder, stomach, and intestines.
Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) is an antidiarrheal medication.
The combination of Diphenoxylate Hydrochloride and Atropine Sulfate Mylan and Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) is used to treat diarrhea.
Diphenoxylate Hydrochloride and Atropine Sulfate Mylan and Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) may also be used for other purposes not listed in this medication guide.
DO NOT EXCEED RECOMMENDED DOSAGE.
Adults: The recommended initial dosage is two Diphenoxylate Hydrochloride and Atropine Sulfate Mylan tablets four times daily or 10 ml (two regular teaspoonfuls) of Diphenoxylate Hydrochloride and Atropine Sulfate Mylan liquid four times daily (20 mg per day). Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (two tablets or 10 ml of liquid) daily.
Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration.
Children: Diphenoxylate Hydrochloride and Atropine Sulfate Mylan is not recommended in children under 2 years of age and should be used with special caution in young children. The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use Diphenoxylate Hydrochloride and Atropine Sulfate Mylan liquid. Do not use Diphenoxylate Hydrochloride and Atropine Sulfate Mylan tablets for this age group.
Only the plastic dropper should be used when measuring Diphenoxylate Hydrochloride and Atropine Sulfate Mylan liquid for administration to children.
Dosage schedule for children: The recommended initial total daily dosage of Diphenoxylate Hydrochloride and Atropine Sulfate Mylan liquid for children is 0.3 to 0.4 mg/kg, administered in four divided doses. The following table provides an approximate initial daily dosage recommendation for children.
These pediatric schedules are the best approximation of an average dose recommendation which may be adjusted downward according to the overall nutritional status and degree of dehydration encountered in the sick child. Reduction of dosage may be made as soon as initial control of symptoms has been achieved. Maintenance dosage may be as low as one-fourth of the initial daily dosage. If no response occurs within 48 hours, Diphenoxylate Hydrochloride and Atropine Sulfate Mylan is unlikely to be effective.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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What is the most important information I should know about Diphenoxylate Hydrochloride and Atropine Sulfate Mylan?
Diphenoxylate Hydrochloride and Atropine Sulfate Mylan is contraindicated in patients with
- Known hypersensitivity to Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) or Diphenoxylate Hydrochloride and Atropine Sulfate Mylan.
- Obstructive jaundice.
- Diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria.
Use Diphenoxylate Hydrochloride and Atropine Sulfate Mylan solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Diphenoxylate Hydrochloride and Atropine Sulfate Mylan solution by mouth with or without food.
- Use the dropper than comes with Diphenoxylate Hydrochloride and Atropine Sulfate Mylan solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
- If you miss a dose of Diphenoxylate Hydrochloride and Atropine Sulfate Mylan solution and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Diphenoxylate Hydrochloride and Atropine Sulfate Mylan solution.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Diarrhea, adjunct therapy: Adjunctive management of diarrhea in patients ≥13 years of age.
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What other drugs will affect Diphenoxylate Hydrochloride and Atropine Sulfate Mylan?
Known drug interactions include barbiturates, tranquilizers, and alcohol. Diphenoxylate Hydrochloride and Atropine Sulfate Mylan may interact with MAO inhibitors.
In studies with male rats, Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) hydrochloride was found to inhibit the hepatic microsomal enzyme system at a dose of 2 mg/kg/day. Therefore, Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) has the potential to prolong the biological half-lives of drugs for which the rate of elimination is dependent on the microsomal drug metabolizing enzyme system.
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What are the possible side effects of Diphenoxylate Hydrochloride and Atropine Sulfate Mylan?
At therapeutic doses, the following have been reported; they are listed in decreasing order of severity, but not of frequency:
Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache.
Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus.
Gastrointestinal system: toxic megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort.
The following Diphenoxylate Hydrochloride and Atropine Sulfate Mylan sulfate effects are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes. These effects may occur, especially in children.
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.
Drug Abuse And Dependence
Controlled Substance
Diphenoxylate Hydrochloride and Atropine Sulfate Mylan is classified as a Schedule V controlled substance by federal regulation. Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) hydrochloride is chemically related to the narcotic analgesic meperidine.
Drug Abuse And Dependence
In doses used for the treatment of diarrhea, whether acute or chronic, Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) has not produced addiction.
Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. At high doses it exhibits codeine-like subjective effects. The dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects. The insolubility of Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) hydrochloride in commonly available aqueous media precludes intravenous selfadministration. A dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets, administered to humans for 40 to 70 days, produced opiate withdrawal symptoms. Since addiction to Diphenoxylate (Diphenoxylate Hydrochloride and Diphenoxylate Hydrochloride and Atropine Sulfate Mylan Sulfate Mylan) hydrochloride is possible at high doses, the recommended dosage should not be exceeded.