Imotil (Oral)

Loperamide is used to manage and ease the symptoms of acute diarrhea. It is also used to treat chronic diarrhea in patients with inflammatory bowel disease. Loperamide works by slowing down the movements of the intestines to help stop diarrhea.

Loperamide is also used to reduce the amount of drainage in patients who have ileostomies.

Loperamide capsules can be bought over-the-counter or with a prescription from your doctor.

If you will be taking this medicine for chronic diarrhea, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. If you will be taking this medicine for acute diarrhea, you should not use it for more than 2 days, unless directed by your doctor.

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

This medicine may cause heart rhythm problems (eg, torsades de pointes, ventricular arrhythmias). Check with your doctor right away if you or your child have chest pain or discomfort, fast, slow, or irregular heartbeat, fainting, or trouble breathing.

Loperamide may increase your risk for stomach or bowel problems. Check with your doctor right away if you have bloating, blood in the stools, constipation, fever, loss of appetite, nausea or vomiting, or stomach pain.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause some people to become dizzy, or drowsy, or tired. 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 not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, the following points should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, be sure to read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how loperamide affects children. Its safety and effectiveness have not been established. This medicine should not be used in children younger than 2 years of age.

Geriatric

Currently, there are no studies showing specific problems in elderly patients that would limit the use of loperamide. However, older adults are more likely to have heart rhythm issues, which may require caution when using loperamide.

Breast Feeding

There are no sufficient studies on the effects of this medication when used by breastfeeding women. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be combined even if an interaction might occur. In these cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant, but not an exhaustive list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Abiraterone Acetate
• Adagrasib
• Capmatinib
• Itraconazole
• Saquinavir
• Simeprevir
• Venetoclax

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Gemfibrozil

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Consuming alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Heart rhythm problems, history of—Use with caution. This may worsen your condition.

• HIV or AIDS—Use with caution. This may worsen side effects.

• Liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

• Stomach or bowel problems (e.g., dysentery, bacterial enterocolitis, pseudomembranous colitis, stomach pain without diarrhea, ulcerative colitis)—Should not be used in patients with these conditions.

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

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

Rare

• Bloating
• constipation
• loss of appetite
• nausea
• stomach pain
• vomiting

Incidence not known

• Blistering, peeling, loosening of skin
• chest pain or discomfort
• chills
• cough
• decrease in urine volume
• decrease in frequency of urination
• difficulty in passing urine
• diarrhea
• fainting
• fast, pounding, or irregular heartbeat or pulse
• hives or welts, itching, rash
• irregular or slow heartbeat
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• no blood pressure or pulse
• painful urination
• palpitations
• red irritated eyes
• redness of the skin
• red skin lesions, often with a purple center
• sores, ulcers, or white spots in the mouth or on the lips
• sore throat
• stopping of heart
• unconsciousness
• unusual tiredness or weakness

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:

Rare

• Acid or sour stomach
• belching
• dizziness
• drowsiness
• dryness of mouth
• excess air or gas in the stomach or bowels
• full feeling
• heartburn
• indigestion
• passing gas
• stomach upset

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.

In the U.S.

• Diamode
• Imodium
• Imodium A-D
• Imogen
• Imotil
• Imperim
• Kaodene A-D
• Kao-Paverin Caps

Available Dosage Forms:

• Capsule, Liquid Filled
• Solution
• Tablet
• Capsule
• Suspension
• Liquid

Therapeutic Class: Antidiarrheal

Take this medicine exactly 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. To do so may increase the chance of side effects.

Swallow the capsule whole. Do not crush, break, or chew it.

Drink plenty of water while using this medicine.

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 acute diarrhea: For oral dosage form (capsules): Adults and children 13 years of age and older—At first, 4 milligrams (mg) (2 capsules) after the first loose bowel movement, then 2 mg (1 capsule) after each loose bowel movement after the first dose has been taken. However, dose is usually not more than 16 mg (8 capsules). Children 8 to 12 years of age weighing more than 30 kilograms (kg)—2 mg (1 capsule) 3 times a day. Children 6 to 8 years of age weighing 20 to 30 kg—2 mg (1 capsule) 2 times a day. Children 2 to 5 years of age weighing 20 kg or less—Use the oral solution. Children younger than 2 years of age—Use is not recommended. For oral dosage form (oral solution): Children 8 to 12 years of age weighing more than 30 kilograms (kg)—2 teaspoonfuls (2 mg) 3 times a day. Children 6 to 8 years of age weighing 20 to 30 kg—2 teaspoonfuls (2 mg) 3 times a day. Children 2 to 5 years of age weighing 13 to 20 kg—1 teaspoonful (1 mg) 3 times a day. Children younger than 2 years of age—Use is not recommended. 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 24-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 24-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 24-hour period. Children up to 6 years of age—Use is not recommended unless directed by your doctor.
• For chronic diarrhea: For oral dosage form (capsules): Adults—At first, 4 milligrams (mg) (2 capsules) after the first loose bowel movement, then 2 mg (1 capsule) after each loose bowel movement after the first dose has been taken. Your doctor may adjust your dose as needed. However, dose is usually not more than 16 mg (8 capsules) per day. Children 2 years of age and older—Use and dose must be determined by your doctor. Children younger than 2 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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