Drugs Details

Drugs Info of Keflex, Panixine
Drugs Details
  • Drugs Type  : FDA
  • Date : 12th Jan 2015 04:37 am
  • Brand Name : Keflex, Panixine
  • Generic Name : cephalexin (Pronunciation: sef a LEX in)
Descriptions

Keflex® Capsules (Cephalexin, USP) is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S•H2O and the molecular weight is 365.41.

Cephalexin has the following structural formula:

 

KEFLEX® (Cephalexin) Structural Formula Illustration

The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.

The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.

Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg or 750 mg of cephalexin. The capsules also contain cellulose, D & C Yellow No. 10, F D & C Blue No. 1, F D & C Yellow No. 6, gelatin, magnesium stearate, silicone, titanium dioxide, and other inactive ingredients.

What are the possible side effects of cephalexin (Keflex, Panixine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • seizure (convulsions);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • easy bruising or bleeding, unusual weakness;
  • confusion, agitation,...

Read All Potential Side Effects and See Pictures of Keflex »

What are the precautions when taking cephalexin (Keflex)?

Before taking cephalexin, tell your doctor or pharmacist if you are allergic to it; or to penicillins or other cephalosporins (such as cefpodoxime); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, stomach/intestinal disease (such as colitis).

The liquid form of this product may contain sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription...

Read All Potential Precautions of Keflex »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Keflex (cephalexin) is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Keflex (cephalexin) is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Keflex (cephalexin) in the subsequent prevention of rheumatic fever are not available at present.)

Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis

Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes

Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis

Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae

Note — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Keflex (cephalexin) and other antibacterial drugs, Keflex (cephalexin) 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.

Dosage Administration

Keflex (cephalexin) is administered orally.

Adults — The adult dosage ranges from 1 to 4 g daily in divided doses. The 333 mg and 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Keflex (cephalexin) greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

Pediatric Patients — The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

In severe infections, the dosage may be doubled.

In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.

In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of Keflex (cephalexin) should be administered for at least 10 days.

How Supplied

Keflex® Capsules (Cephalexin, USP), are available in:

The 250 mg capsules are a white powder filled into size 2 capsules (opaque white and opaque dark green) that are imprinted with Keflex (cephalexin) 250 mg on the white body in edible black ink. They are available as follows:

Bottles of 20 NDC 11042-112-97
Bottles of 100 NDC 11042-112-96

The 333 mg capsules are a white powder filled into size 1 capsules (opaque light green and opaque light green) that are imprinted Keflex (cephalexin) 333 mg on the light green body in edible black ink. They are available as follows:

Bottles of 50 NDC 11042-114-40

The 500 mg capsules are a white powder filled into size 0 capsules (opaque light green and opaque dark green) that are imprinted with Keflex (cephalexin) 500 mg on the light green body in edible black ink. They are available as follows:

Bottles of 20NDC 11042-113-97
Bottles of 100 NDC 11042-113-96

The 750 mg capsules are a white powder filled into elongated size 00 capsules (opaque dark green and opaque dark green) that are imprinted Keflex (cephalexin) 750 mg on the dark green body in edible white ink. They are available as follows:

Bottles of 50 NDC 11042-115-40

Display box of 10 cartons each containing 1 blister card of 1 capsule as a sample package (Not For ReSale) NDC 11042-115-01

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Literature revised October 26, 2006. Manufactured by: CEPH International Corporation, Carolina, PR 00985 for MIDDLEBROOK PHARMACEUTICALS, INC., Germantown, Maryland 20876, USA. Revision Date: 06/07. FDA revision date: 9/16/2008

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Gastrointestinal — Onset of pseudomembranous colitis may occur during or after antibacterial treatment. (see WARNINGS.) Nausea and vomiting have been reported rarely. The most frequent side effect has been diarrhea. It was very rarely severe enough to warrant cessation of therapy. Dyspepsia, gastritis, and abdominal pain have also occurred. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.

Hypersensitivity — Allergic reactions in the form of rash, urticaria, angioedema, and, rarely, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been observed. These reactions usually subsided upon discontinuation of the drug. In some of these reactions, supportive therapy may be necessary. Anaphylaxis has also been reported.

Other reactions have included genital and anal pruritus, genital moniliasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported rarely. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in AST and ALT have been reported.

In addition to the adverse reactions listed above that have been observed in patients treated with Keflex (cephalexin) , the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics:

Adverse Reactions — Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see INDICATIONS AND USAGE and PRECAUTIONS, General). If seizures associated with drug therapy should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Altered Laboratory Tests — Prolonged prothrombin time, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated LDH, pancytopenia, leukopenia, and agranulocytosis.

Read the Keflex (cephalexin) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Metformin — In healthy subjects given single 500 mg doses of cephalexin and metformin, plasma metformin mean Cmax and AUC increased by an average of 34% and 24%, respectively, and metformin mean renal clearance decreased by 14%. No information is available about the interaction of cephalexin and metformin following multiple doses of either drug. Although not observed in this study, adverse effects could potentially arise from co-administration of cephalexin and metformin by inhibition of tubular secretion via organic cationic transporter systems. Accordingly, careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin.

Probenecid — As with other β-lactams, the renal excretion of cephalexin is inhibited by probenecid.

Drug / Laboratory Test Interactions

As a result of administration of Keflex (cephalexin) , a false-positive reaction for glucose in the urine may occur. This has been observed with Benedict's and Fehling's solutions and also with Clinitest® tablets.

Read the Keflex Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

BEFORE THERAPY WITH CEPHALEXIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALEXIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEPHALEXIN OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.

Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. No exception should be made with regard to Keflex (cephalexin) .

Clostridium difficileassociated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Keflex (cephalexin) , 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.

Precautions

General

Prescribing Keflex (cephalexin) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected. If an allergic reaction to Keflex (cephalexin) occurs, the drug should be discontinued and the patient treated with the usual agents (e.g., epinephrine or other pressor amines, antihistamines, or corticosteroids).

Prolonged use of Keflex (cephalexin) 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. Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs' test may be due to the drug.

Keflex (cephalexin) should be administered with caution in the presence of markedly impaired renal function. Under such conditions, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended.

Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male and female rats, fertility and reproductive performance were not affected by cephalexin oral doses up to 1.5 times the highest recommended human dose based upon mg/m².

Pregnancy

Teratogenic effects — Pregnancy Category B — Reproduction studies have been performed on mice and rats using oral doses of cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon mg/m², and have revealed no harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

The excretion of cephalexin in human milk increased up to 4 hours after a 500-mg dose; the drug reached a maximum level of 4 μg/mL, then decreased gradually, and had disappeared 8 hours after administration. Caution should be exercised when Keflex (cephalexin) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Keflex (cephalexin) in pediatric patients was established in clinical trials for the dosages described in the DOSAGE AND ADMINISTRATION section. In these trials, pediatric patients may have received Keflex (cephalexin) capsules or Keflex (cephalexin) for Oral Suspension. Keflex (cephalexin) capsules should only be used in children and adolescents capable of ingesting the capsule.

Geriatric Use

Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS, General).

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Signs and Symptoms — Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. If other symptoms are present, it is probably secondary to an underlying disease state, an allergic reaction, or toxicity due to ingestion of a second medication.

Treatment — To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

Unless 5 to 10 times the normal dose of cephalexin has been ingested, gastrointestinal decontamination should not be necessary.

Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin; however, it would be extremely unlikely that one of these procedures would be indicated. The oral median lethal dose of cephalexin in rats is > 5000 mg/kg.

ContrainDications

Keflex (cephalexin) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Human Pharmacology

Keflex (cephalexin) is acid stable and may be given without regard to meals. It is rapidly absorbed after oral administration. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 μg/mL respectively were obtained at 1 hour. Measurable levels were present 6 hours after administration. Cephalexin is excreted in the urine by glomerular filtration and tubular secretion. Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. During this period, peak urine concentrations following the 250-mg, 500-mg, and 1-g doses were approximately 1000, 2200, and 5000 μg/mL respectively.

Microbiology

In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis. Cephalexin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Aerobes, Gram-positive:

Staphylococcus aureus (including penicillinase-producing strains)
Streptococcus pneumoniae (penicillin-susceptible strains)
Streptococcus pyogenes

Aerobes, Gram-negative:

Escherichia coli
Haemophilus influenzae
Klebsiella pneumoniae
Moraxella (Branhamella) catarrhalis
Proteus mirabilis

Note — Methicillin-resistant staphylococci and most strains of enterococci (Enterococcus faecalis [formerly Streptococcus faecalis]) are resistant to cephalosporins, including cephalexin. It is not active against most strains of Enterobacter spp., Morganella morganii, and Proteus vulgaris. It has no activity against Pseudomonas spp. or Acinetobacter calcoaceticus. Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibiotics.

Susceptibility Tests

Dilution techniques — Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MIC's). These MIC's provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC's should be determined using a standardized procedure. Standardized procedures are based on a dilution method1-3 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of cephalothin powder. The MIC values should be interpreted according to the following criteria:

 

MIC (μg/mL) Interpretation
≤ 8 Susceptible (S)
16 Intermediate (I)
≥ 32 Resistant (R)

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard cephalothin powder should provide the following MIC values:

 

Microorganism MIC (μg/mL)
E. coliATCC 25922 4-16
S. aureus ATCC 29213 0.12-0.5

Diffusion techniques — Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2,3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30-μg cephalothin to test the susceptibility of microorganisms to cephalexin.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30-μg cephalothin disk should be interpreted according to the following criteria:

 

Zone Diameter (mm) Interpretation
≥ 18 Susceptible (S)
15-17 Intermediate (I)
≤ 14 Resistant (R)

Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for cephalexin.

As with standard dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30-μg cephalothin disk should provide the following zone diameters in these laboratory test quality control strains:

 

Microorganism Zone Diameter (mm)
E. coli ATCC 25922 15-21
S. aureus ATCC 25923 29-37

REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically — Fourth Edition. Approved Standard NCCLS Document M7-A4, Vol. 17, No. 2, NCCLS, Wayne, PA, January, 1997.

2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests — Sixth Edition. Approved Standard NCCLS Document M2-A6, Vol. 17, No. 1, NCCLS, Wayne, PA, January, 1997.

3. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing — Eighth Informational Supplement. Approved Standard NCCLS Document M100-S8, Vol. 18, No. 1, NCCLS, Wayne, PA, January, 1998.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients should be counseled that antibacterial drugs including Keflex (cephalexin) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Keflex (cephalexin) is prescribed to treat a bacterial infection, patients should be told 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 (cephalexin) or other antibacterial drugs in the future.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

CEPHALEXIN - ORAL

 

(sef-a-LEX-in)

 

COMMON BRAND NAME(S): Keflex

 

USES: This medication is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria.

This medication will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

 

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used before dental procedures in patients with certain heart conditions (such as artificial heart valves) to help prevent serious infection of the heart (bacterial endocarditis).

 

HOW TO USE: Take this medication by mouth as directed by your doctor, usually every 6 to 12 hours with or without food.

If you are using the suspension, shake the bottle well before each dose. Measure the dose carefully using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition and response to treatment. In children, the dose is also based on weight.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.

Tell your doctor if your condition persists or worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Diarrhea may occur. If diarrhea persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Keflex (cephalexin) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking cephalexin, tell your doctor or pharmacist if you are allergic to it; or to penicillins or other cephalosporins (such as cefpodoxime); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, stomach/intestinal disease (such as colitis).

The liquid form of this product may contain sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: vaccines that contain live bacteria (such as typhoid, BCG).

Although most antibiotics probably do not affect hormonal birth control such as pills, patch or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This medication may interfere with certain laboratory tests (including Coombs' test, certain urine glucose tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe/persistent vomiting, blood in the urine, seizures.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

Laboratory and/or medical tests (such as kidney function, cultures) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store the capsules and tablets at room temperature away from light and moisture. Do not store in the bathroom.

Store the suspension in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze. Keep the container tightly closed. Discard any unused portion after 14 days.

Different brands of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using.

Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Keflex, Panixine

Generic Name: cephalexin (Pronunciation: sef a LEX in)

  • What is cephalexin (Keflex)?
  • What are the possible side effects of cephalexin (Keflex)?
  • What is the most important information I should know about cephalexin (Keflex)?
  • What should I discuss with my healthcare provider before taking cephalexin (Keflex)?
  • How should I take cephalexin (Keflex)?
  • What happens if I miss a dose (Keflex)?
  • What happens if I overdose (Keflex)?
  • What should I avoid while taking cephalexin (Keflex)?
  • What other drugs will affect cephalexin (Keflex)?
  • Where can I get more information?

What is cephalexin (Keflex)?

Cephalexin is in a group of drugs called cephalosporin antibiotics. Cephalexin fights bacteria in the body.

Cephalexin is used to treat infections caused by bacteria, including upper respiratory infections, ear infections, skin infections, and urinary tract infections.

Cephalexin may also be used for other purposes not listed in this medication guide.

Cephalexin 250 mg Tab-TEV

oval, white, imprinted with 22 38, TEVA

What are the possible side effects of cephalexin (Keflex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • seizure (convulsions);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • easy bruising or bleeding, unusual weakness;
  • confusion, agitation, hallucinations (seeing things that are not there); or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea;
  • dizziness, tired feeling;
  • joint pain; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the Keflex (cephalexin) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about cephalexin (Keflex)?

Do not use this medication if you are allergic to cephalexin, or to similar antibiotics, such as Ceclor, Ceftin, Cefzil, Duricef, Fortaz, Omnicef, Spectracef, Suprax, and others.

Before using cephalexin, tell your doctor if you are allergic to any drugs (especially penicillins), 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. Cephalexin will not treat a viral infection such as the common cold or flu.

Side Effects Centers
  • Keflex

Patient Detailed How Take

What should I discuss with my healthcare provider before taking cephalexin (Keflex)?

Do not use this medication if you are allergic to cephalexin, or to other cephalosporin antibiotics, such as:

  • cefaclor (Ceclor);
  • cefadroxil (Duricef);
  • cefdinir (Omnicef);
  • cefditoren (Spectracef);
  • cefixime (Suprax);
  • cefprozil (Cefzil);
  • ceftazidime (Fortaz); or
  • cefuroxime (Ceftin).

Before using cephalexin, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have:

  • kidney disease;
  • liver disease;
  • a stomach or intestinal disorder such as colitis;
  • diabetes; or
  • if you are malnourished.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take cephalexin.

The oral suspension (liquid) form of cephalexin may contain sugar. This may affect you if you have diabetes.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Cephalexin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take cephalexin (Keflex)?

Take the medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Take cephalexin with a full glass of water.

Dissolve the cephalexin dispersible tablet in a small amount of water, about 2 teaspoonfuls. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away. Do not swallow or chew a dispersible tablet.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

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

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using cephalexin.

Store the tablets and capsules at room temperature away from moisture and heat.

Store the liquid medicine in the refrigerator. Throw away any unused medication after 14 days.

Side Effects Centers
  • Keflex

Patient Detailed Avoid Taking

What happens if I miss a dose (Keflex)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Keflex)?

Seek emergency medical attention if you think you have used too much of this medicine.

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

What should I avoid while taking cephalexin (Keflex)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What other drugs will affect cephalexin (Keflex)?

Before using cephalexin, tell your doctor if you are using any of the following drugs:

  • a blood thinner such as warfarin (Coumadin);
  • metformin (Fortamet, Glucophage, Riomet, Actoplus, Avandamet, Metaglip); or
  • probenecid (Benemid).

This list is not complete and there may be other drugs that can interact with cephalexin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about cephalexin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 7.04. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers
  • Keflex

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI