Lomotil

Generic Name: diphenoxylate and atropine (Oral route)

dye-fen-OX-i-late hye-droe-KLOR-ide, AT-roe-peen SUL-fate

Commonly used brand name(s):

In the U.S.

• Lomocot
• Lomotil
• Lonox
• Vi-Atro

Available Dosage Forms:

• Solution
• Tablet

Therapeutic Class: Antidiarrheal

Pharmacologic Class: Atropine

Chemical Class: Diphenoxylate

Uses For Lomotil

Diphenoxylate and atropine 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.

Before Using Lomotil

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 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.

Geriatric

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.

Pregnancy

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

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
• Potassium Chloride

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.

• Clorgyline
• Digoxin
• Furazolidone
• Iproniazid
• Isocarboxazid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Selegiline
• Tapentadol
• Toloxatone
• Tranylcypromine

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 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

Proper Use of diphenoxylate and atropine

This section provides information on the proper use of a number of products that contain diphenoxylate and atropine. It may not be specific to Lomotil. Please read with care.

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 this 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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 miss a dose of this medicine, 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Lomotil

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.

Lomotil Side Effects

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.

Check with your doctor immediately if any of the following side effects occur:

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

Check with your doctor immediately if any of the following side effects occur:

• 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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• 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, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

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

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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