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Advisability of Use if Breast-Feeding




Advisability of Use During Pregnancy

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.

Mild Adverse Effects

Allergic Reactions: Skin rash; swelling of face, hands or feet; fever.

Lost or altered taste, mouth or tongue sores.Rapid heart rate, palpitation. Serious Adverse Effects

Bone marrow depression—fatigue, weakness, fever, sore throat, abnormal bleeding or bruising.

Kidney damage—water retention (edema).

Liver damage—with or without jaundice.

Possible Effects on Sexual Function: Decreased male libido (20% to 30%)

with recommended dosage.

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

and platelets; increased eosinophils. Blood antinuclear antibodies (ANA): increased. Blood cholesterol and triglycerides: no effects. Blood sodium level: decreased. Blood urea nitrogen level (BUN): increased. Liver function tests: increased liver enzymes (alkaline phosphatase, AST/GOT, LDH), increased bilirubin. Urine ketone tests: false positive results with Keto-diastix and Chemstrip-6.

CAUTION:

1. If possible, it is advisable to discontinue all other antihypertensive drugs (especially diuretics) for 1 week before starting captopril.

2. Report promptly any indications of infection (fever, sore throat), and any indications of water retention (weight gain, puffiness, swollen feet or ankles).

3. Do not use a salt substitute without your physician's knowledge and approval. (Many salt substitutes contain potassium.)

4. It is advisable to obtain blood cell counts and urine analyses before starting this drug.

By Infants and Children: Safety and effectiveness for use by those in this age group have not been established.

By Those over 60 Years of Age: Small doses are advisable until tolerance has been determined. Sudden and excessive lowering of blood pressure can predispose to stroke or heart attack in those with impaired brain circu­lation or coronary artery heart disease.

Pregnancy Category: С (tentative). See Pregnancy Code inside back cover. Animal studies: No birth defects found in rat, rabbit or hamster studies.

However, this drug was shown to be toxic to the embryo and newborn. Human studies: Information from adequate studies of pregnant women

is not available. Avoid during first 3 months if possible. Use only if clearly needed during

last 6 months.

Presence of this drug in breast milk: Yes, in small amounts. Monitor nursing infant closely and discontinue drug or nursing if adverse effects develop.

Habit-Forming Potential: None.

Effects of Overdosage: Excessive drop in blood pressure lightheadedness, dizziness, fainting.

Possible Effects of Long-Term Use: Gradual increase in blood potassium level.

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

discretion)

Before starting drug: Complete blood cell counts; urine analysis with measurement of protein content, blood potassium level. During use of drug: Blood cell counts every 2 weeks during the first 3 months of treatment, then periodically for duration of use. Urine protein measurements every month during the first 9 months of treatment, then periodically for duration of use. Periodic measurements of blood potassium.




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