Diamode

Loperamide slows the rhythm of digestion so that the small intestines have more time to absorb fluid and nutrients from the foods you eat.

Loperamide is used to treat diarrhea. Loperamide is also used to reduce the amount of stool in people who have an ileostomy (re-routing of the bowel through a surgical opening in the stomach).

Loperamide may also be used for purposes not listed in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

For adults, loperamide is usually taken as a single dose of 4 milligrams (mg) at the first sign of diarrhea, and again at a dose of 2 mg if diarrhea comes back. For children, the correct dose depends on the child's age.

Do not take more than the recommended dose of this medicine. Misuse of loperamide can cause serious heart problems that could be fatal. Follow all dosing instructions very carefully.

If you take loperamide without a prescription (over-the-counter), do not take more 8 mg in 24 hours. If your doctor has prescribed loperamide, do not take more than 16 mg per day.

The loperamide chewable tablet must be chewed before swallowing.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Take loperamide with a full glass of water. Drink plenty of liquids while you are taking loperamide, to keep from getting dehydrated.

Imodium A-D Liquid and New Imodium A-D Liquid contain two different strengths of loperamide. If you switch from using one brand to using the other, follow the dosing instructions carefully. Imodium A-D Liquid also contains a small amount of alcohol, but New Imodium A-D Liquid does not.

Call your doctor if your symptoms do not improve after 2 days of treatment, or if you also have stomach bloating.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking loperamide and call your doctor at once if you have:

• headache with chest pain and severe dizziness;

• a light-headed feeling, like you might pass out;

• fast or pounding heartbeats;

• stomach pain or bloating;

• ongoing or worsening diarrhea;

• diarrhea that is watery or bloody; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• dizziness, drowsiness;

• dry mouth;

• constipation;

• stomach discomfort; or

• nausea and vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• gemfibrozil, ritonavir; or

• stomach acid reducers--cimetidine, ranitidine.

Loperamide can cause a serious heart problem, especially if you use certain medicines at the same time. Ask a doctor or pharmacist if it is safe for you to use loperamide if you are also using any of the following drugs, especially:

• anagrelide, cilostazol, donepezil, fluconazole, methadone, ondansetron;

• an antibiotic or antifungal medicine--azithromycin, ciprofloxacin, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, levofloxacin, moxifloxacin, pentamidine, telithromycin;

• cancer medicine--arsenic trioxide, oxaliplatin, vandetanib;

• an antidepressant--citalopram, escitalopram;

• anti-malaria medication--chloroquine, halofantrine, quinine;

• heart rhythm medicine--amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, quinidine, sotalol; or

• medicine to treat a psychiatric disorder--chlorpromazine, droperidol, haloperidol, pimozide, thioridazine.

These lists are not complete. Other drugs may interact with loperamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Loperamide is a medicine used along with other measures to treat diarrhea. Loperamide helps stop diarrhea by slowing down the movements of the intestines.

In the U.S., loperamide capsules are available only with your doctor's prescription.

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 under 6 years of age unless directed by a doctor. Children, especially very young children, are very sensitive to the effects of loperamide. This may increase the chance of side effects during treatment. Also, the fluid loss caused by diarrhea may result in a serious health problem (dehydration). Loperamide may hide the symptoms of dehydration. For these reasons, do not give medicine for diarrhea to children without first checking with their doctor. If you have any questions about this, check with your health care professional.

Geriatric

The fluid loss caused by diarrhea may result in a serious health problem (dehydration). Loperamide may hide the symptoms of dehydration. For this reason, elderly persons with diarrhea, in addition to using medicine for diarrhea, must receive a sufficient amount of liquids to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 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.

• Eliglustat
• Saquinavir
• Simeprevir

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.

• Gemfibrozil

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:

• Colitis (severe)—A more serious problem of the colon may develop if you use loperamide

• Dysentery—This condition may get worse; a different kind of treatment may be needed

• Liver disease—The chance of severe central nervous system (CNS) side effects may be greater in patients with liver disease

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

Do not use loperamide to treat your diarrhea if you have a fever or if there is blood or mucus in your stools. Contact your doctor.

For safe and effective use of this medicine:

• Follow your doctor's instructions if this medicine was prescribed.
• Follow the manufacturer's package directions if you are treating yourself.

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Importance of diet and fluid intake 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 (dehydration) 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 lightheadedness
  • 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 diarrhea:
  • For oral dosage form (capsules):
    • Adults and teenagers—The usual dose is 4 milligrams (mg) (2 capsules) after the first loose bowel movement, and 2 mg (1 capsule) after each loose bowel movement after the first dose has been taken. No more than 16 mg (8 capsules) should be taken in any twenty-four-hour period.
    • Children 8 to 12 years of age—The usual dose is 2 mg (1 capsule) three times a day.
    • Children 6 to 8 years of age—The usual dose is 2 mg (1 capsule) two times a day.
    • Children up to 6 years of age—Use is not recommended unless directed by your doctor.
  • For oral dosage form (oral solution):
    • Adults and teenagers—The usual dose is 4 teaspoonfuls (4 mg) after the first loose bowel movement, and 2 teaspoonfuls (2 mg) after each loose bowel movement after the first dose has been taken. No more than 8 teaspoonfuls (8 mg) should be taken in any twenty-four-hour period.
    • Children 9 to 11 years of age—The usual dose is 2 teaspoonfuls (2 mg) after the first loose bowel movement, and 1 teaspoonful (1 mg) after each loose bowel movement after the first dose has been taken. No more than 6 teaspoonfuls (6 mg) should be taken in any twenty-four-hour period.
    • Children 6 to 8 years of age—The usual dose is 2 teaspoonfuls (2 mg) after the first loose bowel movement, and 1 teaspoonful (1 mg) after each loose bowel movement after the first dose has been taken. No more than 4 teaspoonfuls (4 mg) should be taken in any twenty-four-hour period.
    • Children up to 6 years of age—Use is not recommended unless directed by your doctor.
  • For oral dosage form (tablets):
    • Adults and teenagers—The usual dose is 4 mg (2 tablets) after the first loose bowel movement, and 2 mg (1 tablet) after each loose bowel movement after the first dose has been taken. No more than 8 mg (4 tablets) should be taken in any twenty-four-hour period.
    • Children 9 to 11 years of age—The usual dose is 2 mg (1 tablet) after the first loose bowel movement, and 1 mg (½ tablet) after each loose bowel movement after the first dose has been taken. No more than 6 mg (3 tablets) should be taken in any twenty-four-hour period.
    • Children 6 to 8 years of age—The usual dose is 2 mg (1 tablet) after the first loose bowel movement, and 1 mg (½ tablet) after each loose bowel movement after the first dose has been taken. No more than 4 mg (2 tablets) should be taken in any twenty-four-hour period.
    • Children up to 6 years of age—Use is not recommended unless directed by your doctor.

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.

Applies to loperamide: oral capsule, oral capsule liquid filled, oral liquid, oral solution, oral suspension, oral tablet, oral tablet chewable

Along with its needed effects, loperamide (the active ingredient contained in Diamode) 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 while taking loperamide:

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

Check with your doctor as soon as possible if any of the following side effects occur while taking loperamide:

• Skin rash

Some side effects of loperamide 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:

• Dizziness or drowsiness
• dryness of mouth