Advisability of Use During Pregnancy

Pregnancy Category: С (tentative). See Pregnancy Code inside back cover.

Animal studies: No drug-induced birth defects found in rats; drug-in­duced embryo and fetal toxicity were demonstrated in rats and rabbits.

Human studies: Information from adequate studies of pregnant women is not available.

Avoid use if possible. Use only if clearly necessary and for the shortest possible time.

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:

pain, nausea.

Possible drowsiness, dizziness, lethargy, abdominal.

Possible Effects of Long-Term Use: Some long-term (2 year) studies in rats revealed the development of drug-induced carcinoid tumors in the stomach. To date, long-term use of this drug (more than 5 years) in humans has not revealed any drug-induced tumor potential. Pending more studies of long-term human use, it is advisable to limit the use of this drug to the shortest duration possible to obtain optimal results.

Suggested Periodic Examinations While Taking This Drug

(at physician's discretion) Complete blood cell counts.

While Taking This Drug, Observe the Following

Foods: No restrictions.

Beverages: No restrictions. May be taken with milk.

Alcohol: No interactions expected. However, alcohol is best avoided; it

stimulates the secretion of stomach acid. Tobacco Smoking: No interactions expected. However, smoking is best

avoided; it may stimulate the secretion of stomach acid. Other Drugs Omeprazole may increase the effects of

• anticoagulants (warfarin, etc.) and increase the risk of bleeding.

• diazepam (Valium) and cause excessive sedation.

• phenytoin (Dilantin, etc.) and cause phenytoin toxicity.
Omeprazole may decrease the effects of

• ampicillin.

• iron preparations.

• ketoconazole (Nizoral).

Driving, Hazardous Activities: This drug may cause drowsiness and dizziness. Restrict activities as necessary.

Aviation Note: The use of this drug may be a disqualification for piloting. Consult a designated Aviation Medical Examiner.

Exposure to Sun: No restrictions.

Discontinuation: Follow your physician's instructions. The duration of use will vary according to the condition under treatment and individual patient response. Premature discontinuation could result in incomplete healing or prompt recurrence of symptoms.

TEXT 8. Read the following text and find out the information about possible effects of long-term use.