Loperamide

(loh PER a mide)

Introduced: 1977

Class: Antidiarrheal

Prescription: USA: Yes Canada: No

Controlled Drug: USA: No Canada: No

Available as Generic: No

Brand Names: Imodium, Imodium AD

Principal Uses

As a Single Drug Product: Used primarily for the control of cramping and diarrhea associated with acute gastroenteritis and chronic enteritis and colitis. Also used to reduce the volume of discharge from ileostomies.

How This Drug Works: Not completely established. It is thought that this drug acts directly on the nerve supply of the gastrointestinal tract to reduce its motility and propulsive contractions, thus relieving cramp­ing and diarrhea.

Available Dosage Forms and Strengths

Capsules — 2 mg

Liquid — 1 mg per 5-ml teaspoonful (alcohol 5.25%)

Tablets — 2 mg

Usual Adult Dosage Range: For acute diarrhea: 4 mg initially, then 2 mg after each unformed stool until diarrhea is controlled. For chronic diarrhea: 4 to 8 mg/day in divided doses, taken 8 to 12 hours apart. The total daily dosage should not exceed 16 mg. Note: Actual dosage and administration schedule must be determined by the physician for each patient individually.

Dosing Instructions: May be taken on an empty stomach or with food if stomach irritation occurs. The capsule may be opened for administra­tion.

Usual Duration of Use: Continual use on a regular schedule for 48 hours is usually necessary to determine this drug's effectiveness in controlling acute diarrhea; continual use for 10 days may be needed to evaluate its effectiveness in controlling chronic diarrhea. If diarrhea persists, con­sult your physician.

This Drug Should Not Be Taken If

• you have had an allergic reaction to it previously.

• it is prescribed for a child under 2 years of age.

Inform Your Physician Before Taking This Drug If

• you have a history of liver disease or impaired liver function.

• you have regional enteritis or ulcerative colitis.

Possible Side-Effects (natural, expected and unavoidable drug actions) Drowsiness, constipation.

Possible Adverse Effects (unusual, unexpected and infrequent reactions) If any of the following develop, consult your physician promptly for guidance.

Mild Adverse Effects

Allergic Reaction: Skin rash.

Fatigue, dizziness.

Reduced appetite, dry mouth, nausea, vomiting, stomach pain, bloating. Serious Adverse Effects

"Toxic megacolon" (distended, immobile colon with fluid retention) may develop while treating acute ulcerative colitis.

Possible Effects on Sexual Function: None reported.

Possible Effects on Laboratory Tests

None reported.

CAUTION

1. Do not exceed recommended doses.

2. If used to treat chronic diarrhea, report promptly any development of bloating, abdominal distension, nausea, vomiting, constipation or abdominal pain.

Precautions for Use

By Infants and Children: Do not use in those under 2 years of age. Follow physician's instructions exactly regarding dosage. Observe for drowsi­ness, irritability, personality changes and altered behavior.

By Those over 60 Years of Age: Start treatment with small doses. You may be more sensitive to the sedative and constipating effects of this drug.

Advisability of Use During Pregnancy

Pregnancy Category: В (tentative). See Pregnancy Code inside back cover. Animal studies: No birth defects found in rat and rabbit studies. Human studies: Information from adequate studies of pregnant women

is not available. Use sparingly and only if clearly needed. Ask physician for guidance.

Advisability of Use if Breast-Feeding

Presence of this drug in breast milk: Unknown. Avoid drug or refrain from nursing.

Habit-Forming Potential: None.

Effects of Overdosage: Drowsiness, lethargy, depression, dry mouth.

Possible Effects of Long-Term Use: None identified.

Suggested Periodic Examinations While Taking This Drug (at physician's

discretion) None required.

While Taking This Drug, Observe the Following

Foods: No restrictions. Follow prescribed diet. Beverages: No restrictions. May be taken with milk.

Alcohol: Use with caution until combined effects have been determined.

This drug may increase the depressant action of alcohol on the brain. Tobacco Smoking: No interactions expected.

Other Drugs: No significant drug interactions reported.

Driving, Hazardous Activities: This drug may cause drowsiness or dizziness.

Restrict activities as necessary. Aviation Note: The use of this drug is a disqualification for piloting.

Consult a designated Aviation Medical Examiner. Exposure to Sun: No restrictions.

TEXT 15. Read the following text and make up a dialogue using the information from the text.