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Advisability of Use During Pregnancy. Possible Effects on Laboratory Tests




CAUTION

Possible Effects on Laboratory Tests

Adverse Effects That May Mimic Natural Diseases or Disorders

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

Inform Your Physician Before Taking This Drug If

• you have a history of a previous "reaction" to erythromycin.

• you are allergic by nature: hay fever, asthma, hives, eczema.

• you have taken the estolate form of erythromycin previously.

Possible Side-Effects (natural, expected and unavoidable drug actions) Superinfections (see Glossary).

Possible Adverse Effects (unusual, unexpected and infrequent reactions)

Mild Adverse Effects

Allergic Reactions: Skin rash, hives, itching. Nausea, vomiting, diarrhea, abdominal cramping. Serious Adverse Effects

Allergic Reaction: Rare anaphylactic reaction.Idiosyncratic Reactions: Liver reaction—nausea, vomiting, fever, jaundice (usually but not exclusively associated with erythromycin estolate). Drug-induced colitis, transient loss of hearing.

Possible Effects on Sexual Function: None reported.

Liver toxicity may resemble acute gallbladder disease or viral hepatitis.

Complete blood cell counts: white cells may increase or decrease; eosino­phils increased (allergic reaction); platelets decreased.

Prothrombin time: increased (drug taken concurrently with warfarin).

Liver function tests: liver enzymes increased (ALT/GPT, AST/GOT and alkaline phosphatase), increased bilirubin.

1. Take the full dosage prescribed to prevent the possible emergence of
resistant bacterial strains.

2. If you have a history of liver disease or impaired liver function, avoid
any form of erythromycin estolate.

3. If diarrhea develops and continues for more than 24 hours, consult
your physician promptly.

Precautions for Use

By Infants and Children: Observe allergic children closely for indications of developing allergy to this drug. Observe also for evidence of gastrointestinal irritation.

By Those over 60 Years of Age: Observe for indications of itching reactions in the genital and anal regions, often due to yeast superinfections. Observe also for evidence of hearing loss. Report such developments promptly.

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

Animal studies: Studies of rats are inconclusive.

Human studies: No increase in birth defects reported in 230 exposures. Information from adequate studies of pregnant women is not availa­ble.

Generally thought to be safe during entire pregnancy, except for erythro­mycin estolate; this form of erythromycin can cause toxic liver reac­tions during pregnancy and should be avoided.




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