Bio-Cef

In the U.S.

• Bio-Cef
• Keflex
• Panixine DisperDose

In Canada

• Novo-Lexin

Available Dosage Forms:

• Tablet
• Capsule
• Tablet for Suspension
• Powder for Suspension

Therapeutic Class: Antibiotic

Pharmacologic Class: 1st Generation Cephalosporin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cephalexin in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cephalexin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving cephalexin.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cholera Vaccine, Live
• Probenecid
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cholestyramine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Colitis (inflammation in gut), history of or
• Diarrhea, severe, history of or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Applies to cephalexin: oral capsule, oral powder for reconstitution, oral tablet, oral tablet dispersible

General

The most commonly reported side effects included diarrhea, dyspepsia, gastritis, nausea, and vomiting.[Ref]

Gastrointestinal

Frequency not reported: Diarrhea, nausea, vomiting, dyspepsia, gastritis, abdominal pain, anal pruritus, Clostridium difficile-associated diarrhea/colitis/pseudomembranous colitis
Postmarketing reports: Colitis[Ref]

Hematologic

Frequency not reported: Direct Coombs' test seroconversion, decreased prothrombin activity/prolonged prothrombin time, eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia
Postmarketing reports: Aplastic anemia, pancytopenia, leukopenia, agranulocytosis[Ref]

Dermatologic

Frequency not reported: Urticaria, rash, erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis/exanthematic necrolysis[Ref]

Hepatic

Frequency not reported: Transient hepatitis, cholestatic jaundice, AST and ALT elevations
Postmarketing reports: Increased bilirubin[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity/allergic reactions, angioedema, anaphylaxis[Ref]

Allergic reactions (including urticaria and angioedema) usually subsided upon treatment discontinuation.[Ref]

Genitourinary

Frequency not reported: Genital pruritus, genital candidiasis, vulvovaginitis/vaginitis and vaginal discharge[Ref]

Nervous system

Frequency not reported: Seizure, dizziness, headache[Ref]

Psychiatric

Frequency not reported: Agitation, confusion, hallucinations[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, arthritis, joint disorder[Ref]

Renal

Frequency not reported: Reversible interstitial nephritis
Postmarketing reports: Renal dysfunction, toxic nephropathy, increased blood urea nitrogen, increased creatinine[Ref]

Other

Frequency not reported: Fatigue
Postmarketing reports: Fever[Ref]

Immunologic

Frequency not reported: Development of drug-resistant bacteria development[Ref]

Metabolic

Postmarketing reports: Increased alkaline phosphatase, increased lactate dehydrogenase (LDH)[Ref]

Cardiovascular

Postmarketing reports: Hemorrhage[Ref]

Some side effects of Biocef may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

15 years and older: 250 to 333 mg orally every 6 hours OR 500 mg orally every 12 hours
-Maximum dose: 4 g per day
-Duration of therapy: 7 to 14 days

Use: Treatment of bone infections caused by susceptible S aureus and P mirabilis

15 years and older: 250 to 333 mg orally every 6 hours OR 500 mg orally every 12 hours
-Maximum dose: 4 g per day
-Duration of therapy: 7 to 14 days

Use: Treatment of genitourinary tract infections caused by susceptible E coli, P mirabilis, and K pneumoniae

AHA and IDSA Recommendations: 50 mg/kg orally as a single dose 30 to 60 minutes before the procedure

Use: Prevention of infective endocarditis in patients allergic to penicillins/ampicillins undergoing a dental procedure (except in immediate hypersensitivity)

Data not available

Administration advice:
-This drug may be taken with or without food.
-Tablets and capsules should be taken with a full glass of water.

Storage requirements:
-Capsules: Protect from light and moisture.
-Oral suspension: Store in the refrigerator (2 to 8C) when not in use.

General:
-Limitation of use: This drug should not be used to treat patients with severe systemic infections during the acute phase.
-This drug may be preferred to other antibiotics in pediatric patients due to increased tolerability and palatability.

Monitoring:
-Hematologic: Prothrombin time (especially in patients at risk of prolonged prothrombin time)
-Renal: Renal function (especially in patients with renal dysfunction)

Patient advice:
-Patients should be told to report any unusual or severe side effects.
-Patients should be instructed to report signs/symptoms of Clostridium difficile (e.g., watery/bloody stools, stomach cramps, fever), for up to 2 months after stopping treatment.
-Patients should be directed to take the full course of treatment, even if they feel better.
-Patients receiving the oral suspension/syrup formulations should be told to discard any remaining drug at the end of the duration of therapy.

Summary of Use during Lactation

Limited information indicates that maternal doses of cephalexin up to 1 gram produce low levels in milk that are usually not expected to cause adverse effects in breastfed infants. Cephalexin is an alternative for the treatment of mastitis.[1][2] Occasionally disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush have been reported with cephalosporins, but these effects have not been adequately evaluated.

Drug Levels

Maternal Levels. After a single 1 gram oral dose of cephalexin in 6 women who were 2 days postpartum, peak milk levels occurred 4 to 5 hours after the dose and averaged 0.51 mg/L (range 0.24 to 0.85 mg/L).[3]

After a single 500 mg oral dose of cephalexin in 2 women (time postpartum not stated), peak milk levels of 0.7 mg/L occurred 4 hours after the dose.[4]

A woman who was 28 days postpartum had been taking oral cephalexin 500 mg plus probenecid 500 mg 4 times daily for 16 days collected 12 fore-and hindmilk samples over a 16-hour period. Milk cephalexin levels ranged from about 0.4 to 1 mg/L over the milk collection period with little correlation to the times of the doses. The authors calculated that an exclusively breastfed infant would receive 112 mcg/kg daily which is much less than the recommended infant dosage of 25 to 100 mg/kg daily. The infant dosage in milk corresponds to about 0.5% of the maternal weight-adjusted dosage which is higher than in previous reports.[5] The higher milk levels in this patient may have been a result of the concurrent probenecid use.

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

Effects in Breastfed Infants

In a prospective follow-up study, 7 nursing mothers reported taking cephalexin (dosage not specified). Two mothers reported diarrhea in their infants. No rashes or candidiasis were reported among the exposed infants.[6]

A prospective, controlled study asked mothers who called an information service about adverse reactions experience by their breastfed infants. One of 11 cephalexin-exposed infants reportedly developed diarrhea during maternal cephalexin therapy.[7]

A woman received intravenous cephalothin 1 g every 6 hours for 3 days. Her breastfed infant had a green liquid stool, severe diarrhea, discomfort and crying. The mother's drug regimen was then changed to oral cephalexin 500 mg plus oral probenecid 500 mg 4 times daily for another 16 days. The infant continued to have diarrhea during this time. The authors rated the diarrhea as probably related to cephalexin in milk.[5]

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

(Mastitis) Dicloxacillin, (Methicillin-resistant Staph. aureus) Doxycycline, Linezolid, Minocycline, Trimethoprim-Sulfamethoxazole, Vancomycin

References

1. Amir LH. ABM clinical protocol #4: Mastitis, revised March 2014. Breastfeed Med. 2014;9:239-43. PMID: 24911394

2. Berens PD. Breast pain: Engorgement, nipple pain, and mastitis. Clin Obstet Gynecol. 2016;58:902-14. PMID: 26512442

3. Kafetzis DA, Siafas CA, Georgakopoulos PA et al. Passage of cephalosporins and amoxicillin into the breast milk. Acta Paediatr Scand. 1981;70:285-8. PMID: 7246123

4. Matsuda S. Transfer of antibiotics into maternal milk. Biol Res Pregnancy. 1984;5:57-60. PMID: 6743732

5. Ilett KF, Hackett LP, Ingle B et al. Transfer of probenecid and cephalexin into breast milk. Ann Pharmacother. 2006;40:986-9. PMID: 16551765

6. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID: 8498418

7. Benyamini L, Merlob P, Stahl B et al. The safety of amoxicillin/clavulanic acid and cefuroxime during lactation. Ther Drug Monit. 2005;27:499-502. PMID: 16044108

LactMed Record Number

60

Last Revision Date

20170601

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.