Imogen (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, which helps 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 your doctor's prescription.

If you are taking this medicine for chronic diarrhea, it is very important for your doctor to check you regularly for any problems or side effects that might arise from this medicine. If you are taking this medicine for acute diarrhea, do not use it for more than 2 days unless your doctor instructs you to.

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

This medicine may cause heart rhythm issues (for example, torsades de pointes, ventricular arrhythmias). Contact your doctor immediately if you or your child experience chest pain or discomfort, a fast, slow, or irregular heartbeat, fainting, or difficulty breathing.

Loperamide may increase your risk of stomach or bowel issues. Contact your doctor immediately if you experience 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 care. Contact your doctor immediately if you have a rash, itching, hoarseness, difficulty breathing, trouble swallowing, or swelling of your hands, face, or mouth while using this medicine.

This medicine may cause some people to feel dizzy, drowsy, or tired. Make sure you know how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are not alert.

Do not take other medicines unless you have discussed them 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 of taking it compared to the benefits it may provide. Here are some important things to think about:

Allergies

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

Pediatric

There have not been appropriate studies on the effects of loperamide in children. Its safety and effectiveness have not been established. This medicine should not be given to children younger than 2 years old.

Geriatric

Current studies have not shown any specific problems that would limit the effectiveness of loperamide in older adults. However, older patients are more likely to experience heart rhythm problems, which may require caution when using loperamide.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together despite the possibility of an interaction. If you are taking this medicine, it is crucial for your healthcare professional to know if you are also taking any of the medicines listed below. The following interactions have been chosen based on 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 necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency for 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 course of action for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Gemfibrozil

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

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

• HIV or AIDS—Use with caution. Side effects may become more severe.

• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

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

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical attention.

Check with your doctor right away if you have any of these side effects:

Rare

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

Incidence not known

• Blistering, peeling, or 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, or 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. Your health care professional may also know ways to prevent or reduce some of these side effects. Check with your health care professional if any of these side effects continue, 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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