Terramycin

Local irritation may be present after intramuscular injection. The injection should be deep, with care taken not to injure the sciatic nerve nor inject intravascularly.

Gastrointestinal:  anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. These reactions have been caused by both the oral and parenteral administration of tetracyclines.

Skin:  maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See " WARNINGS ").

Renal toxicity:  Rise in BUN has been reported and is apparently dose related. (See " Warnings ").

Hypersensitivity reactions:  Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, and exacerbation of systemic lupus erythematosus.

Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving full therapeutic dosages. These conditions disappeared rapidly when the drug was discontinued.

Blood:  Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function studies are known to occur.

Read the entire FDA prescribing information for Terramycin (Oxytetracycline)

• Pfizer Animal Health

• Pfizer Labs

• Pfizer U.S. Pharmaceuticals Group

Summary of Use during Lactation

A number of reviews have stated that tetracyclines are contraindicated during breastfeeding because of possible staining of infants' dental enamel or bone deposition of tetracyclines. However, a close examination of available literature indicates that there is not likely to be harm in short-term use of oxytetracycline during lactation because milk levels are low and absorption by the infant is inhibited by the calcium in breastmilk. Short-term use of oxytetracycline is acceptable in nursing mothers. As a theoretical precaution, avoid prolonged or repeat courses during nursing. Monitor the infant for rash and for possible effects on the gastrointestinal flora, such as diarrhea or candidiasis (thrush, diaper rash).

Drug Levels

Maternal Levels. In an old study using a microbiologic assay, 5 women in the first week postpartum were given oxytetracycline in dosages ranging from 2 to 4 grams daily in single or divided doses. Oxytetracycline generally did not appear in milk for the first 24 hours. Concentrations then ranged from 0.25 to 1 mg/L until about a day following discontinuation of the drug.[1]

In another old study using a microbiologic assay, milk oxytetracycline levels were in an unspecified number of nursing mothers at 9 am after various dosages of oxytetracycline during the previous days. Whether they had mastitis and the time postpartum were not stated. Milk levels increased to as high as 3 mg/L after a daily dose of 1.5 grams orally for 3 days. Milk levels increased to 3 mg/L after a daily dose of 2 grams orally for 3 days.[2]

Two women were given 1.5 grams daily of oral oxytetracycline. Milk levels ranged from 0.7 to 1.1 mg/L with the peak occurring 7 hours after the dose. The authors estimated that a breastfed infant would receive 300 mcg daily of oxytetracycline in milk.[3]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

No adverse effects were noted in an unspecified number of breastfed infants whose mothers were taking oral oxytetracycline 1.5 or 2 g daily for 3 days. Ages of the infants and extent of breastfeeding were not stated.[2]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Doxycycline, Tetracycline

References

1. Ottolenghi-Preti GF, Massironi A. [Terramycin in lactation; specific method of determination]. Ann Ostet Ginecol. 1952;74:746-58. PMID: 13031337

2. Gruner JM. [The excretion of terramycin and tetracycline in human milk]. Geburtshilfe Frauenheilkd. 1955;15:354-60. PMID: 14380696

3. Borderon E, Soutoul JH et al. [Excretion of antibiotics in human milk]. Med Mal Infect. 1975;5:373-6.