In the U.S.—

In Canada—

• Antidiarrheal (antiperistaltic)

Diphenoxylate and atropine (dye-fen-OX-i-late and A-troe-peen) is a combination medicine used along with other measures to treat severe diarrhea in adults. Diphenoxylate helps stop diarrhea by slowing down the movements of the intestines.

Since diphenoxylate 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.

Diphenoxylate and atropine combination medicine should not be used in children. Children with diarrhea should be given solutions of carbohydrates (sugars) and important salts (electrolytes) to replace the water, sugars, and important salts that are lost from the body during diarrhea. For more information on these solutions, see the Carbohydrates and Electrolytes (Systemic) monograph.

This medicine is available only with your doctor's prescription in the following dosage forms:

Oral
• Oral solution (U.S.)
• Tablets (U.S. and Canada)

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 diphenoxylate and atropine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to diphenoxylate or atropine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in humans. In animal studies this medicine given in larger doses than the usual human dose has not been shown to cause birth defects. However, some studies in rats have shown that this medicine reduces the weight gain of the pregnant rat and lessens the chance of conceiving or becoming pregnant when given in doses many times the usual human dose.

Breast-feeding—Although both diphenoxylate and atropine pass into the breast milk, this medicine has not been shown to cause problems in nursing babies.

Children—This medicine should not be used in children. Children, especially very young children, are very sensitive to the effects of diphenoxylate 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.

Older adults—Shortness of breath or difficulty in breathing may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of diphenoxylate. 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.

Other 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 diphenoxylate and atropine, it is especially important that your health care professional know if you are taking any of the following:

• Antibiotics, such as cephalosporins (e.g., Ceftin, Keflex), clindamycin (e.g., Cleocin), erythromycins (e.g., E.E.S., PCE), tetracyclines (e.g., Achromycin, Doryx)—These antibiotics may cause diarrhea. Diphenoxylate and atropine may make the diarrhea caused by antibiotics worse or make it last longer

• Central nervous system (CNS) depressants (medicines that cause drowsiness)—Effects, such as drowsiness, of CNS depressants or of diphenoxylate and atropine may become greater

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking diphenoxylate and atropine while you are taking or within 2 weeks of taking MAO inhibitors may cause severe side effects; these medicines should not be used together

• Opioid (narcotic) antagonists (naltrexone [e.g., ReVia])—Withdrawal side effects may occur in patients who have become addicted to the diphenoxylate in this combination medicine; also, naltrexone will make this medicine less effective against diarrhea

• Other anticholinergics (medicine to help reduce stomach acid and abdominal or stomach spasms or cramps)—Use of other anticholinergics with this combination medicine may increase the effects of the atropine in this combination; however, this is not likely to happen with the usual doses of diphenoxylate and atropine

• Alcohol abuse (or history of) or
• Drug abuse (history of)—There is a greater chance that this medicine will 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 serious breathing problems in patients who have any of these conditions

• Enlarged prostate or
• Urinary tract blockage or difficult urination—Severe 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 small

• 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 small

• High blood pressure (hypertension)—The atropine in this medicine may cause an increase in blood pressure; however, the chance of this happening is small

• 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

If this medicine upsets your stomach, your doctor may want you to take it with food.

Take this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.

For patients taking the liquid form of this medicine:

• This medicine is to be taken by mouth even if it comes in a dropper bottle. The amount to be taken is to be measured with the specially marked dropper.

Importance of diet and fluids while treating diarrhea :

• In addition to using medicine for diarrhea, it is very important that you replace the fluid lost by the body and follow a proper diet. For the first 24 hours you should eat gelatin and drink plenty of caffeine-free clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, and broth. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, caffeine, and alcoholic beverages may make the condition worse.
• If too much fluid has been lost by the body due to the diarrhea a serious condition may develop. Check with your doctor as soon as possible if any of the following signs or symptoms of too much fluid loss occur:
  • Decreased urination
  • Dizziness and light-headedness
  • Dryness of mouth
  • Increased thirst
  • Wrinkled skin

Dosing—

The dose of diphenoxylate and atropine combination medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of diphenoxylate and atropine combination. If your dose is different, do not change it unless your doctor tells you to do so.

• For severe diarrhea:
  • For oral dosage form (oral solution):
    • Adults and teenagers—At first, the dose is 5 milligrams (mg) (2 teaspoonfuls) three or four times a day. Then, the dose is usually 5 mg (2 teaspoonfuls) once a day, as needed.
    • Children up to 12 years of age—Use is not recommended.
  • For oral dosage form (tablets):
    • Adults and teenagers—At first, the dose is 5 mg (2 tablets) three or four times a day. Then, the dose is usually 5 mg (2 tablets) once a day, as needed.
    • Children up to 12 years of age—Use is not recommended.

Missed dose—

If you are taking this medicine on a regular schedule and you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children since overdose is especially dangerous in children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Your doctor should check your progress at regular visits if you will be taking this medicine regularly for a long time.

Check with your doctor if your diarrhea does not stop after two days or if you develop a fever.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

If you think you or anyone else may have taken an overdose, get emergency help at once. Taking an overdose of this medicine may lead to unconsciousness and possibly death. Signs or symptoms of overdose include severe drowsiness; shortness of breath or troubled breathing; fast heartbeat; and unusual warmth, dryness, and flushing of the skin.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

When this medicine is used for short periods of time at low doses, side effects usually are rare. However, check with your doctor immediately if any of the following side effects are severe and occur suddenly, since they may be signs of a more severe and dangerous problem with your bowels:

• Bloating;  constipation;  loss of appetite;  stomach pain (severe) with nausea and vomiting 

Check with your doctor immediately also if the following effects occur, since they may be signs of an overdose of this medicine:

• Blurred vision (continuing) or changes in near vision;  drowsiness (severe);  dryness of mouth, nose, and throat (severe);  fast heartbeat;  shortness of breath or troubled breathing (severe);  unusual excitement, nervousness, restlessness, or irritability ;  unusual warmth, dryness, and flushing of the skin  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue, worsen, or are bothersome:

• Less common or rare
  • Blurred vision;  confusion;  difficult urination;  dizziness or light-headedness ;  drowsiness;  dryness of skin and mouth;  fever;  headache;  increased body temperature;  mental depression;  numbness of hands or feet;  skin rash or itching;  swelling of the gums 
  
  

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this time check with your doctor if you notice any of the following side effects:

• Rare
  • Increased sweating;  muscle cramps;  nausea or vomiting;  shivering or trembling ;  stomach cramps 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.