Keflex

Common side effects of Keflex include:

• upset stomach
• diarrhea
• vomiting
• stomach cramps
• fever
• mild skin rash

This is not a complete list of Keflex side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Keflex . See “Drug Precautions” section.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medications you take including prescription and non-prescription medications, vitamins, and herbal supplements. Especially tell your doctor if you take:

• metformin (Glucophage)
• probenecid (Benemid)

This is not a complete list of Keflex drug interactions.  Ask your doctor or pharmacist for more information.

Before taking Keflex, tell your doctor about all your medical conditions.  Especially tell your doctor if you:

• have had an allergic reaction to Keflex, or other cephalosporins
• have had an allergic reaction to penicillin antibiotics
• have decreased kidney function
• have decreased liver function
• have a history of gastrointestinal (digestive tract) diseases
• have been treated with anticoagulant therapies, or blood thinners
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Keflex falls into category B.  Studies in animals have failed to demonstrate a risk to the unborn baby and there are no well-controlled studies in pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.  The active ingredient of Keflex is excreted in human breast milk.  The effect of Keflex on the nursing infant is not known.

• Store Keflex oral suspension in the refrigerator for up to 14 days.
• Store Keflex tablets and capsules at room temperature between 68° and 77°F (20° and 25°C).
• Keep this and all medicines out of the reach of children.

Adults and Pediatric Patients At Least 15 years of age

The usual dose of oral Keflex is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days.

For more severe infections larger doses of oral Keflex may be needed, up to 4 grams daily in two to four equally divided doses.

Pediatric Patients (over 1 year of age)

The recommended total daily dose of oral Keflex for pediatric patients is 25 to 50 mg/kg given in equally divided doses for 7 to 14 days. In the treatment of β-hemolytic streptococcal infections, duration of at least 10 days is recommended. In severe infections, a total daily dose of 50 to 100 mg/kg may be administered in equally divided doses.

For the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg given in equally divided doses.

Dosage Adjustments in Adult and Pediatric Patients At Least 15 years of Age with Renal Impairment

Administer the following dosing regimens for Keflex to patients with impaired renal function [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6)].

Hypersensitivity Reactions

Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of Keflex. Before therapy with Keflex is instituted, inquire whether the patient has a history of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy.

If an allergic reaction to Keflex occurs, discontinue the drug and institute appropriate treatment.

Clostridium difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Keflex, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Direct Coombs' Test Seroconversion

Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibacterial drugs including cephalexin. Acute intravascular hemolysis induced by cephalexin therapy has been reported. If anemia develops during or after cephalexin therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue cephalexin and institute appropriate therapy.

Seizure Potential

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures occur, discontinue Keflex. Anticonvulsant therapy can be given if clinically indicated.

Prolonged Prothrombin Time

Cephalosporins may be associated with prolonged prothrombin time. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy, and patients receiving anticoagulant therapy. Monitor prothrombin time in patients at risk and manage as indicated.

Development of Drug-Resistant Bacteria

Prescribing Keflex in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Prolonged use of Keflex may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Metformin

Administration of Keflex with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin.

Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking Keflex and metformin [see Clinical Pharmacology (12.2)].

Probenecid

The renal excretion of Keflex is inhibited by probenecid. Co-administration of probenecid with Keflex is not recommended.

Interaction with Laboratory or Diagnostic Testing

A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict's solution or Fehling's solution.

• Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to Keflex, other beta-lactams (including cephalosporins) or other allergens (5.1)
• Advise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, advise patients to contact their healthcare provider.
• Counsel patients that antibacterial drugs including Keflex, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Keflex is prescribed to treat a bacterial infection, tell patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Keflex or other antibacterial drugs in the future.

Manufactured in Austria for:
Pragma Pharmaceuticals, LLC
Distributed by: Fera Pharmaceuticals, LLC
Locust Valley, N.Y. 11560

Pragma™

PPI-011
Rev. 0416

Principal Display Panel - 250 mg Bottle Label

NDC 58463-011-01

Keflex®

Cephalexin Capsules, USP

250 mg

100 Capsules

Rx only

PragmaTM

Principal Display Panel - 500 mg Bottle Label

NDC 58463-012-01

Keflex®

Cephalexin Capsules, USP

500 mg

100 Capsules

Rx only

PragmaTM

Principal Display Panel - 750 mg Bottle Label

NDC 58463-013-50

Keflex®

Cephalexin Capsules, USP

750 mg

50 Capsules

Rx only

PragmaTM

You should not use Keflex if you are allergic to cephalexin or to similar antibiotics, such as Ceftin, Cefzil, Omnicef, and others. Tell your doctor if you are allergic to any drugs, especially penicillins or other antibiotics, or if you have kidney or liver disease, a stomach or intestinal disorder such as colitis, diabetes, or if you are malnourished.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Keflex will not treat a viral infection such as the common cold or flu.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, and blood in your urine.