Advisability of Use During Pregnancy. Possible Effects on Laboratory Tests

Precautions for Use

CAUTION

Possible Effects on Laboratory Tests

Adverse Effects That May Mimic Natural Diseases or Disorders

Possible Effects on Sexual Function

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

Possible Adverse Effects

Possible Side-Effects

Inform Your Physician Before Taking This Drug If

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

• you have a history of any type of bone marrow or blood cell disorder,
especially one that is drug-induced.

• you are currently taking any anticoagulant medication, diazepam
(Valium) or phenytoin (Dilantin, etc.).

(natural, expected and unavoidable drug actions) None reported.

(unusual, unexpected and infrequent reactions)

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.

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.

Persistent infection or bruising may reflect bone marrow depression;

blood counts advisable. Liver reactions may suggest viral hepatitis.

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.

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

2. Report promptly any indications of infection.

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

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.

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.

Дата добавления: 2015-06-25