Velosef

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Velosef and other antibacterial drugs, Velosef should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Velosef (Cephradine) Capsules and Velosef for Oral Suspension are indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

RESPIRATORY TRACT INFECTIONS (e.g., tonsillitis, pharyngitis, and lobar pneumonia) caused by group A beta-hemolytic streptococci and S. pneumoniae (formerly D. pneumonia).

(Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Velosef is generally effective in the eradication of streptococci from the nasopharynx; substantial data establishing the efficacy of Velosef in the subsequent prevention of rheumatic fever are not available at present.)

OTITIS MEDIA caused by group A beta-hemolytic streptococci, S. pneumoniae (formerly D. pneumoniae), H. influenzae, and staphylococci.

SKIN AND SKIN STRUCTURE INFECTIONS caused by staphylococci (penicillin-susceptible and penicillin-resistant) and beta-hemolytic streptococci.

URINARY TRACT INFECTIONS, including prostatitis, caused by E. coli, P. mirabilis, Klebsiella species, and enterococci (S. faecalis). The high concentrations of cephradine achievable in the urinary tract will be effective against many strains of enterococci for which disc susceptibility studies indicate relative resistance. It is to be noted that among beta-lactam antibiotics, ampicillin is the drug of choice for enterococcal urinary tract (S. faecalis) infection.

NoteCulture and susceptibility tests should be initiated prior to and during therapy.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Velosef and other antibacterial drugs, Velosef should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Following clinical improvement achieved with parenteral therapy, oral cephradine may be utilized for continuation of treatment of persistent or severe conditions where prolonged therapy is indicated.

Cephradine is contraindicated in patients with known hypersensitivity to the cephalosporin group of antibiotics.

Velosef Capsules (Cephradine Capsules USP)

Storage

Velosef CapsulesKeep tightly closed. Do not store above 86° F.

Velosef for Oral SuspensionPrior to constitution, store at room temperature; avoid excessive heat. After constitution, when stored at room temperature, discard unused portion after seven days; when stored in refrigerator, discard unused portion after 14 days. Keep tightly closed.

Bristol-Myers Squibb Company
Princeton, NJ 08543

February 2004

There are no case reports of adverse effects of cephradine on the fetus. Data reveal that cephradine is more likely to produce significant and therapeutic fetal levels after 15 weeks gestation. In the first and second trimesters, intravenously or orally administered cephradine produces amniotic fluid levels of 1 mcg/mL or less. A 1 gram intravenous dose between weeks 15 and 30, however, produces amniotic fluid levels ranging from 3 to 15 mcg/mL within 50 minutes of administration. The Michigan Medicaid surveillance study showed a possible association between cephradine and congenital defects. This report is a summary of information from two studies, one in which 239 of 104,000 pregnant women from 1980 to 1983, and one in which 339 of 229,000 pregnant women from 1985 to 1992 received cephradine. In the first study 20 total defects (3 cardiovascular defects) were observed (14 and 2 were expected, respectively). In the second study, 27 total defects (9 cardiovascular defects) were observed (14 and 3 were expected, respectively). Cleft palate was not observed in either study. These data support an association between cephradine and congenital defects, although other causes, such as the underlying disease(s) of the mother and concomitant drug therapy are unaccounted for.

Cephradine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Cephradine should only be given during pregnancy when need has been clearly established.

Cephradine is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely. Other cephalosporins have been classified as compatible with breast-feeding by the American Academy of Pediatrics.

No reports of adverse effects in the nursing infant are reported. After cephradine 500 mg orally every 6 hours for 48 hours, human milk levels of 0.6 mcg/mL are reported. The average milk to maternal serum level ratio is 0.2. While this level and ratio are extremely low, some experts warn of unknown direct effects on the nursing infant, modification of neonatal bowel flora, and difficulty in the interpretation of culture results in the evaluation of a suspected infection.

Summary of Use during Lactation

Cephradine is acceptable to use during breastfeeding. Limited information indicates that maternal doses of oral cephradine up to 2 grams daily produce low levels in milk that are not expected to cause adverse effects in breastfed infants. Occasionally, disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush, has been reported with cephalosporins, but these effects have not been adequately evaluated.

Drug Levels

Maternal Levels. Six women were given cephradine 500 mg orally every 6 hours for 9 doses. Milk levels after the last dose were essentially constant for the 6 hours following the dose with a range of 0.62 to 0.68 mg/L.[1][2]

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

Effects in Breastfed Infants

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

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

Cephalexin

References

1. Mischler TW, Corson SL, Bolognese RJ et al. Presence of cephradine in body fluids of lactating and pregnant women. Clin Pharmacol Ther. 1972;15:214. Abstract.

2. Mischler TW, Corson SL, Larranaga A et al. Cephradine and epicillin in body fluids of lactating and pregnant women. J Reprod Med. 1978;21:130-6. PMID: 569206

LactMed Record Number

61

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.