Imodium

Fluid and electrolyte depletion often occur in patients who have diarrhea. In such cases, administration of appropriate fluid and electrolytes is very important. The use of IMODIUM® (loperamide hcl) does not preclude the need for appropriate fluid and electrolyte therapy.

In general, IMODIUM (loperamide hcl) should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. IMODIUM (loperamide hcl) must be discontinued promptly when constipation, abdominal distention or ileus develop.

Treatment of diarrhea with IMODIUM (loperamide hcl) is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated).

Patients with AIDS treated with IMODIUM (loperamide hcl) for diarrhea should have therapy stopped at the earliest signs of abdominal distention. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride. {ref EDMS-PSDB-2564186, pg 12}

IMODIUM® (loperamide hcl) should be used with special caution in young children because of the greater variability of response in this age group. Dehydration, particularly in younger children, may further influence the variability of response to IMODIUM® (loperamide hcl) .

Imodium is part of the drug class:

• ANTIPROPULSIVES

You should not use this medication if you are allergic to loperamide, or if you have:

• stools that are bloody, black, or tarry; or
• if you have diarrhea that is caused by taking an antibiotic.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• a fever;
• mucus in your stools;
• a history of liver disease; or
• if you are taking an antibiotic.

FDA pregnancy category C. It is not known whether loperamide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Loperamide can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using loperamide.

Do not give this medicine to a child without medical advice.

Loperamide may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you are taking an antibiotic and you have diarrhea that is watery or has blood in it, call your doctor. Do not use loperamide to stop the diarrhea unless your doctor has told you to.

Clinical Trial Data

The adverse effects reported during clinical investigations of IMODIUM® (loperamide hydrochloride) are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with IMODIUM® (loperamide hcl) were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea.

The adverse events reported are summarized irrespective of the causality assessment of the investigators.

1) Adverse events from 4 placebo-controlled studies in patients with acute diarrhea The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented in the table below.

The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride, were: dry mouth, flatulence, abdominal cramp and colic.

2) Adverse events from 20 placebo-controlled studies in patients with chronic diarrhea

The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented below in the table below.

The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride were: nausea, vomiting, headache, meteorism, abdominal pain, abdominal cramp and colic.

3) Adverse events from seventy-six controlled and uncontrolled studies in patients with acute or chronic diarrhea

The adverse events with an incidence of 1.0% or greater in patients from all studies are given in the table below.

Post -marketing experience

The following adverse events have been reported:

Rash, pruritus, urticaria, angioedema, and extremely rare cases of bullous eruption including erythema multiforme, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with use of IMODIUM (loperamide hcl) .

Isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions have been reported with the use of IMODIUM (loperamide hcl) .

Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon, including toxic megacolon (see CONTRAINDICATIONS and WARNINGS).

Urinary retention

Drowsiness, dizziness

Tiredness

A number of the adverse events reported during the clinical investigations and post- marketing experience with loperamide are frequent symptoms of the underlying diarrheal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence). These symptoms are often difficult to distinguish from undesirable drug effects.

Drug Abuse And Dependence

A specific clinical study designed to assess the abuse potential of loperamide at high doses resulted in a finding of extremely low abuse potential.

Studies in morphine-dependent monkeys demonstrated that loperamide hydrochloride at doses above those recommended for humans prevented signs of morphine withdrawal. However, in humans, the naloxone challenge pupil test, which when positive indicates opiate-like effects, performed after a single high dose, or after more than two years of therapeutic use of IMODIUM® (loperamide hydrochloride), was negative. Orally administered IMODIUM® (loperamide hcl) (loperamide formulated with magnesium stearate) is both highly insoluble and penetrates the CNS poorly.

Read the entire FDA prescribing information for Imodium (Loperamide Hcl)

(1 capsule = 2 mg)
Patients should receive appropriate fluid and electrolyte replacement as needed.

Acute Diarrhea

Adults: The recommended initial dose is 4mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. Daily dose should not exceed 16mg (eight capsules). Clinical improvement is usually observed within 48 hours.

Children: In children 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation (Imodium® A-D 1 mg/7.5 mL) should be used; for ages 6 to 12, either Imodium® Capsules or Imodium® A-D Liquid may be used. For children 2 to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements:

Recommended First Day Dosage Schedule
Two to five years: 1 mg t.i.d. (3mg daily dose) (13 to 20 kg)
Six to eight years: 2 mg b.i.d. (4mg daily dose) (20 to 30 kg)
Eight to twelve years: 2mg t.i.d. (6mg daily dose) (greater than 30 kg)

Recommended Subsequent Daily Dosage
Following the first treatment day, it is recommended that subsequent Imodium® doses (1 mg/10 kg body weight) be administered only after a loose stool. Total daily dosage should not exceed recommended dosages for the first day.

Chronic Diarrhea

Children: Although Imodium® has been studied in a limited number of children with chronic diarrhea; the therapeutic dose for the treatment of chronic diarrhea in a pediatric population has not been established.

Adults: The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of Imodium® should be reduced to meet individual requirements. When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses.

The average daily maintenance dosage in clinical trials was 4 to 8 mg (two to four capsules). A dosage of 16 mg (eight capsules) was rarely exceeded. If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. Imodium® administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment.

Children under 2 Years

The use of Imodium in children under 2 years is not recommended. There have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with very young children less than two years of age.

Elderly

No formal pharmacokinetic studies were conducted in elderly subjects. However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dosage adjustment is required in the elderly.

Renal Impairment

No pharmacokinetic data are available in patients with renal impairment. Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment (see PRECAUTIONS section).

Hepatic Impairment

Although no pharmacokinetic data are available in patients with hepatic impairment, Imodium should be used with caution in such patients because of reduced first pass metabolism. (see Precautions).

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

The Imodium 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 Imodium with a full glass of water. Drink plenty of liquids while you are taking this medicine, 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.

Usual Adult Dose for Diarrhea -- Acute:

Tablets, capsules, and liquid:
Initial: 4 mg orally after the first loose stool, then
Maintenance: 2 mg after each loose stool, not to exceed 16 mg in any 24-hour period. Clinical improvement is usually observed within 48 hours.
Chewable tablets:
Initial: 4 mg after the first loose stool, then
Maintenance: 2 mg after each subsequent loose stool, but not exceeding 8 mg in 24 hours.

Usual Adult Dose for Diarrhea -- Chronic:

Tablets, capsules, and liquid:
Initial: 4 mg orally once followed by 2 mg orally after each loose stool, not to exceed 16 mg in any 24-hour period.
Maintenance: The average daily maintenance dosage is 4 to 8 mg. Clinical improvement is usually observed within 10 days. If clinical improvement is not observed at a maximum dosage of 16 mg for duration of 10 days, symptoms are unlikely to be controlled by further administration.

Usual Pediatric Dose for Diarrhea -- Acute:

2 to 6 years (13 to 20 kg):
Liquid formulation only to be used in this age group.
Initial: 1 mg orally 3 times a day for the first day, then
Maintenance: 0.1 mg/kg/dose after each loose stool, but not exceeding initial dose.

6 to 8 years (20 to 30 kg):
Tablets, capsules, and liquid:
Initial: 2 mg orally twice a day for the first day, then
Maintenance: 0.1 mg/kg/dose after each loose stool, but not exceeding initial dose.
Chewable tablets:
Initial: 2 mg orally after the first loose stool, then
Maintenance: 1 mg orally after each subsequent loose stool, but not exceeding 4 mg in 24 hours.

8 to 12 years (greater than 30 kg):
Tablets, capsules, and liquid:
Initial: 2 mg orally 3 times a day for the first day, then
Maintenance: 0.1 mg/kg/dose after each loose stool, but not exceeding initial dose.
Chewable tablets:
Initial: 2 mg orally after the first loose stool, then
Maintenance: 1 mg orally after each subsequent loose stool, but not exceeding 6 mg in 24 hours.

12 to 18 years:
Tablets, chewable tablets, capsules, and liquid:
Initial: 4 mg after the first loose stool, then
Maintenance: 2 mg after each subsequent loose stool, but not exceeding 8 mg in 24 hours.

Usual Pediatric Dose for Diarrhea -- Chronic:

less than 2 years:
Therapeutic dose for the treatment of chronic diarrhea has not been established for this patient population.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dizziness, drowsiness, little or no urination, severe stomach cramps, or constipation.

Avoid drinking tonic water. It can interact with loperamide and may cause serious heart problems.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink.

Imodium may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you are taking an antibiotic and you have diarrhea that is watery or has blood in it, call your doctor. Do not use Imodium to stop the diarrhea unless your doctor has told you to.

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 Imodium 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.