Advisability of Use During Pregnancy. Possible Effects on Laboratory Tests

Precautions for Use

Possible Effects on Laboratory Tests

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

Inform Your Physician Before Taking This Drug If

This Drug Should Not Be Taken If

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.

Available Dosage Forms and Strengths

Capsules — 2 mg

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

Tablets — 2 mg

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.

• you have had an allergic reaction to it previously.

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

• 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.

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.

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.

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.

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.

Дата добавления: 2015-06-25