If any of the following develop, consult your physician promptly for guidance.

Mild Adverse Effects

Allergic Reactions: Skin rash (1.5%), itching. Headache (6.9%), dizziness (1.5%), drowsiness, weakness (1.1%).Indigestion (2.4%), nausea (2.2%), vomiting (1.5%), diarrhea (3%), con­stipation (1.1%). Serious Adverse Effects

Rare bone marrow depression : fatigue, weakness, fever, sore throat, infections, abnormal bleeding or bruising.

Rare liver damage with jaundice.

Urinary tract infection: painful urination, cloudy or bloody urine.

Possible Effects on Sexual Function

One case of drug-induced male breast enlargement and tenderness (gyne­comastia) has been reported; this occurred on two separate occasions in association with the use of this drug.

Adverse Effects That May Mimic Natural Diseases or Disorders

Persistent infection or bruising may reflect bone marrow depression;

blood counts advisable. Liver reactions may suggest viral hepatitis.

Possible Effects on Laboratory Tests

Complete blood cell counts: decreased red cells, hemoglobin, white cells

and platelets.

Blood glucose level: decreased. Liver function tests: increased liver enzymes (ALT/GPT, AST/GOT and

alkaline phosphatase), increased bilirubin.

CAUTION

1. Follow your physician's instructions exactly regarding the length of time you take this drug. Do not extend its use without his guidance.

1. Report promptly any indications of infection.

2. Inform your physician if you plan to take any other medications (prescription or over-the-counter) while taking omeprazole.

Precautions for Use

By Infants and Children

: Safety and effectiveness for use by those under 12 years of age have not

been established. By Those over 60 Years of Age: Slower elimination of this drug makes it

possible to achieve satisfactory response with smaller doses; this

reduces the risk of adverse effects. Limit the daily dose to 20 mg if

possible.

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.

CLINDAMYCIN

(klin da MI sin)

Introduced: 1973

Class: Antibiotic

Prescription: USA: Yes

Controlled Drug: USA: No Canada: Yes

Available as Generic: USA: Yes Canada: No

Brand Names: Cleocin, Cleocin T, Dalacin С

Principal Uses

As a Single Drug Product

Used primarily to treat serious and unusual infections of the lungs and bronchial tubes, organs and tissues within the abdominal cavity, the genital tract and pelvic organs in women, the skin and soft tissue structures and generalized infections involving the bloodstream. A more recent use has been the prevention and treatment of pneumocystis carinii pneumonia, a frequent infection associated with AIDS.

How This Drug Works: By interfering with the formation of proteins necessary for cell growth and reproduction, this drug (in low concentrations) arrests the multiplication of bacteria and (in high concentrations) destroys bacteria.

Available Dosage Forms and Strengths

Capsules — 75 mg, 150 mg, 300 mg Injection — 150 mg per ml Oral solution — 75 mg per 5-ml teaspoonful Topical solution — 10 mg per ml

Usual Adult Dosage Range: For infections of average severity: 150 to 300 mg/6 hours; for more severe infections: 300 to 450 mg/6 hours. The total daily dosage should not exceed 1800 mg. Note: Actual dosage and administration schedule must be determined by the physician for each patient individually.

Dosing Instructions: Take the capsule with a full glass of water or with food

to prevent irritation of the esophagus. The capsule may be opened and the contents mixed with food for administration. Shake the oral solution well before measuring the dose. Do not refrigerate the oral solution; chilling can cause it to thicken, making administration difficult.

Usual Duration of Use: Continual use on a regular schedule for 3 to 5 days is usually necessary to determine this drug's effectiveness in control­ling responsive infections. The duration of use should not exceed the time required to eliminate the infection.

Possible Advantages of This Drug: Bacterial sensitivity testing may show this drug to be more effective than commonly used antibiotics in treat­ing some severe and unusual infections.

Currently a "Drug of Choice"

for preventing and treating pneumonia due to pneumocystis carinii, a frequent complication of AIDS.

This Drug Should Not Be Taken If

• you are allergic to either clindamycin or lincomycin.

• it is prescribed for a mild or trivial infection such as a cold, sore throat or "flu-like" illness.

• you have a history of Crohn's disease or ulcerative colitis.