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

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.

Adverse Effects That May Mimic Natural Diseases or Disorders

Liver toxicity may resemble acute gallbladder disease or viral hepatitis.

Possible Effects on Laboratory Tests

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.

CAUTION

  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.

Advisability of Use During Pregnancy

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.

Advisability of Use if Breast-Feeding

Presence of this drug in breast milk: Yes.

Monitor nursing infant closely and discontinue drug or nursing if ad­verse effects develop.

Habit-Forming Potential: None.

Effects of Overdosage: Possible nausea, vomiting, diarrhea and abdominal discomfort.

Possible Effects of Long-Term Use: Superinfections.

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

discretion) Liver function tests if the estolate form is used.

While Taking This Drug, Observe the Following

Foods: No restrictions.

Beverages: Avoid fruit juices and carbonated beverages for hour after tak­ing any nonenteric-coated preparation. May be taken with milk.

Alcohol: Avoid if you have impaired liver function or are taking the estolate form of this drug.

Tobacco Smoking: No interactions expected.

Other Drugs Erythromycin may increase the effects of

  • carbamazepine (Tegretol), and cause toxicity.

  • digoxin (Lanoxin), and cause toxicity.

  • ergotamine (Cafergot, Ergostat, etc.), and cause impaired circulation to extremities.

  • methylprednisolone (Medrol), and cause excess steroid effects.

  • theophylline (aminophylline, Theo-Dur, etc.), and cause toxicity.

  • warfarin (Coumadin), and increase the risk of bleeding. Erythromycin may decrease the effects of

  • clindamycin.

  • lincomycin.

  • penicillins.

Driving, Hazardous Activities: This drug may cause nausea and/or diarrhea. 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.

Special Storage Instructions: Keep liquid forms refrigerated.

Observe the Following Expiration Times: Freshly mixed oral suspension— 14 days. Premixed oral suspension—18 months. Ask pharmacist for guidance.

TEXT 14. Read the following text and find out information when this drug should not be taken.

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