Cephalexin Suspension – FDA prescribing info, unwanted side effects and makes use of

What You Need to Know
December 7, 2020 0 Comments

Dosage Kind: powder for oral suspension

Medically reviewed by Medicine.com. Final up to date on Apr 1, 2019.


INDICATIONS & USAGE

Respiratory Tract Infections

Cephalexin is indicated for the therapy of respiratory tract infections attributable to prone isolates of Streptococcus pneumoniae and Streptococcus pyogenes.

Otitis Media

Cephalexin is indicated for the therapy of otitis media attributable to prone isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.

Pores and skin and Pores and skin Construction Infections

Cephalexin is indicated for the therapy of pores and skin and pores and skin construction infections attributable to prone isolates of the next Gram-positive micro organism: Staphylococcus aureus and Streptococcus pyogenes.

Bone Infections

Cephalexin is indicated for the therapy of bone infections attributable to prone isolates of Staphylococcus aureus and Proteus mirabilis.

Genitourinary Tract Infections

Cephalexin is indicated for the therapy of genitourinary tract infections, together with acute prostatitis, attributable to prone isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.

Utilization

To scale back the event of drug-resistant micro organism and preserve the effectiveness of cephalexin and different antibacterial medicine, cephalexin must be used solely to deal with infections which are confirmed or strongly suspected to be attributable to prone micro organism. When tradition and susceptibility info is accessible, this info must be thought-about in choosing or modifying antibacterial remedy. Within the absence of such knowledge, native epidemiology and susceptibility patterns could contribute to the empiric choice of remedy.

DOSAGE & ADMINISTRATION

Adults and Pediatric Sufferers at Least 15 Years of Age

The same old dose of oral cephalexin is 250 mg each 6 hours, however a dose of 500 mg each 12 hours could also be administered. Therapy is run for 7 to 14 days.

For extra extreme infections bigger doses of oral cephalexin could also be wanted, as much as 4 grams day by day in two to 4 equally divided doses.

Pediatric Sufferers (over 1 12 months of age)

The really useful whole day by day dose of oral cephalexin for pediatric sufferers is 25 to 50 mg/kg given in equally divided doses for 7 to 14 days. Within the therapy of β-hemolytic streptococcal infections, length of not less than 10 days is really useful. In extreme infections, a complete day by day dose of fifty to 100 mg/kg could also be administered in equally divided doses.

For the therapy of otitis media, the really useful day by day dose is 75 to 100 mg/kg given in equally divided doses.

Weight
10 kg (22 lb)
20 kg (44 lb)
40 kg (88 lb)
Cephalexin Suspension 125mg/5mL
½ to 1 tsp q.i.d.
1 to 2 tsp q.i.d.
2 to 4 tsp q.i.d.
250mg/5mL
¼ to ½ tsp q.i.d.
½ to 1 tsp q.i.d.
1 to 2 tsp q.i.d.
Weight
10 kg (22 lb)
20 kg (44 lb)
40 kg (88 lb)
125mg/5mL
1 to 2 tsp b.i.d.
2 to 4 tsp b.i.d.
4 to eight tsp b.i.d.
250mg/5mL
½ to 1 tsp b.i.d
1 to 2 tsp b.i.d.
2 to 4 tsp b.i.d.

Instructions for Mixing

125 mg per 5 mL (100 mL when combined): Put together suspension time at meting out. Add to the bottle a complete of 67 mL of water. For ease in preparation, faucet bottle to loosen powder, add the water in 2 parts, shaking effectively after every addition. The ensuing suspension will include cephalexin monohydrate equal to 125 mg cephalexin in every 5 mL (teaspoonful).

125 mg per 5 mL (200 mL when combined): Put together suspension time at meting out. Add to the bottle a complete of 134 mL of water. For ease in preparation, faucet bottle to loosen powder, add the water in 2 parts, shaking effectively after every addition. The ensuing suspension will include cephalexin monohydrate equal to 125 mg cephalexin in every 5 mL (teaspoonful).

250 mg per 5 mL (100 mL when combined): Put together suspension time at meting out. Add to the bottle a complete of 67 mL of water. For ease in preparation, faucet bottle to loosen powder, add the water in 2 parts, shaking effectively after every addition. The ensuing suspension will include cephalexin monohydrate equal to 250 mg cephalexin in every 5 mL (teaspoonful).

250 mg per 5 mL (200 mL when combined): Put together suspension time at meting out. Add to the bottle a complete of 134 mL of water. For ease in preparation, faucet bottle to loosen powder, add the water in 2 parts, shaking effectively after every addition. The ensuing suspension will include cephalexin monohydrate equal to 250 mg cephalexin in every 5 mL (teaspoonful).

*After mixing, retailer in fridge. Could also be saved for 14 days with out important lack of efficiency.

Dosage Changes in Grownup and Pediatric Sufferers at Least 15 Years of Age with Renal Impairment

Administer the next dosing regimens for cephalexin to sufferers with impaired renal perform [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6)].

Desk 1. Really helpful Dose Routine for Sufferers with Renal Impairment

Renal perform Dose routine suggestion
Creatinine clearance ≥60 mL/min No dose adjustment
Creatinine clearance 30 to 59 mL/min No dose adjustment; most day by day dose mustn’t exceed 1 g
Creatinine clearance 15 to 29 mL/min 250 mg, each 8 hours or each 12 hours
Creatinine clearance 5 to 14 mL/min not but on dialysis* 250 mg, each 24 hours
Creatinine clearance 1 to 4 mL/min not but on dialysis* 250 mg, each 48 hours or each 60 hours

*There may be inadequate info to make dose adjustment suggestions in sufferers on hemodialysis.

DOSAGE FORMS & STRENGTHS

Cephalexin For Oral Suspension USP

125 mg/5mL and 250 mg/5mL

Contraindications

Cephalexin is contraindicated in sufferers with recognized hypersensitivity to cephalexin or different members of the cephalosporin class of antibacterial medicine.

Warnings and Precautions

Hypersensitivity Reactions

Allergic reactions within the type of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or poisonous epidermal necrolysis have been reported with using cephalexin. Earlier than remedy with cephalexin is instituted, inquire whether or not the affected person has a historical past of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or different medicine. Cross-hypersensitivity amongst beta-lactam antibacterial medicine could happen in as much as 10% of sufferers with a historical past of penicillin allergy.

If an allergic response to cephalexin happens, discontinue the drug and institute acceptable therapy.

Clostridium difficile-Related Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of practically all antibacterial brokers, together with cephalexin, and should vary in severity from delicate diarrhea to deadly colitis. Therapy with antibacterial brokers alters the conventional flora of the colon resulting in overgrowth of C. difficile.

C. difficile produces toxins A and B, which contribute to the event of CDAD. Hypertoxin-producing strains of C. difficile trigger elevated morbidity and mortality, as these infections may be refractory to antimicrobial remedy and should require colectomy. CDAD should be thought-about in all sufferers who current with diarrhea following antibiotic use. Cautious medical historical past is critical since CDAD has been reported to happen over two months after the administration of antibacterial brokers.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed towards C. difficile could should be discontinued. Acceptable fluid and electrolyte administration, protein supplementation, antibiotic therapy of C. difficile, and surgical analysis must be instituted as clinically indicated.

Direct Coombs’ Take a look at Seroconversion

Constructive direct Coombs’ exams have been reported throughout therapy with the cephalosporin antibacterial medicine together with cephalexin. Acute intravascular hemolysis induced by cephalexin remedy has been reported. If anemia develops throughout or after cephalexin remedy, carry out a diagnostic work-up for drug-induced hemolytic anemia, discontinue cephalexin and institute acceptable remedy.

Seizure Potential

A number of cephalosporins have been implicated in triggering seizures, significantly in sufferers with renal impairment when the dosage was not decreased. If seizures happen, discontinue cephalexin. Anticonvulsant remedy may be given if clinically indicated.

Extended Prothrombin Time

Cephalosporins could also be related to extended prothrombin time. These in danger embrace sufferers with renal or hepatic impairment, or poor dietary state, in addition to sufferers receiving a protracted course of antibacterial remedy, and sufferers receiving anticoagulant remedy. Monitor prothrombin time in sufferers in danger and handle as indicated.

Improvement of Drug-Resistant Micro organism

Prescribing cephalexin within the absence of a confirmed or strongly suspected bacterial an infection is unlikely to offer profit to the affected person and will increase the danger of the event of drug-resistant micro organism.

Extended use of cephalexin could end result within the overgrowth of nonsusceptible organisms. Cautious commentary of the affected person is important. If superinfection happens throughout remedy, acceptable measures must be taken.

Opposed Reactions

The next severe occasions are described in better element within the Warning and Precautions part:
• Hypersensitivity reactions [see Warning and Precautions (5.1)]
• Clostridium difficile-associated diarrhea [see Warnings and Precautions (5.2)]
• Direct Coombs’ Take a look at Seroconversion [see Warnings and Precautions (5.3)]
• Seizure Potential [see Warnings and Precautions (5.4)]
• Impact on Prothrombin Exercise [see Warnings and Precautions (5.5)]
• Improvement of Drug-Resistant Micro organism [see Warnings and Precautions (5.6)]

Scientific Trials Expertise

As a result of scientific trials are performed beneath broadly various situations, hostile response charges noticed within the scientific trials of a drug can’t be straight in comparison with charges within the scientific trials of one other drug and should not replicate the charges noticed in apply.

In scientific trials, essentially the most frequent hostile response was diarrhea. Nausea and vomiting, dyspepsia, gastritis, and belly ache have additionally occurred. As with penicillins and different cephalosporins, transient hepatitis and cholestatic jaundice have been reported.

Different reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint dysfunction. Reversible interstitial nephritis has been reported. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in aspartate transaminase (AST) and alanine transaminase (ALT) have been reported.

Along with the hostile reactions listed above which were noticed in sufferers handled with cephalexin, the next hostile reactions and different altered laboratory exams have been reported for cephalosporin class antibacterial medicine:

Different Opposed Reactions: Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and poisonous nephropathy.

Altered Laboratory Checks: Extended prothrombin time, elevated blood urea nitrogen (BUN), elevated creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (LDH), pancytopenia, leukopenia, and agranulocytosis.

Drug Interactions

Metformin

Administration of cephalexin with metformin leads to elevated plasma metformin concentrations and decreased renal clearance of metformin.

Cautious affected person monitoring and dose adjustment of metformin is really useful in sufferers concomitantly taking cephalexin and metformin [see Clinical Pharmacology (12.2)].

Probenecid

The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin will not be really useful.

Interplay with Laboratory or Diagnostic Testing

A false-positive response could happen when testing for the presence of glucose within the urine utilizing Benedict’s resolution or Fehling’s resolution.

USE IN SPECIFIC POPULATIONS

Being pregnant

Being pregnant Class B

There are not any satisfactory and well-controlled research in pregnant girls. As a result of animal replica research should not at all times predictive of human response, this drug must be used throughout being pregnant provided that clearly wanted.

Copy research have been carried out on mice and rats utilizing oral doses of cephalexin monohydrate 0.6 and 1.5 instances the utmost day by day human dose (66 mg/kg/day) based mostly upon physique floor space foundation, and have revealed no proof of impaired fertility or hurt to the fetus.

Nursing Moms

Cephalexin is excreted in human milk. Warning must be exercised when cephalexin is run to a nursing girl.

Pediatric Use

The security and effectiveness of cephalexin in pediatric sufferers was established in scientific trials for the dosages described within the dosage and administration part [see Dosage and Administration (2.2)].

Geriatric Use

Of the 701 topics in 3 printed scientific research of cephalexin, 433 (62%) had been 65 and over. No general variations in security or effectiveness had been noticed between these topics and youthful topics, and different reported scientific expertise has not recognized variations in responses between the aged and youthful sufferers.

This drug is considerably excreted by the kidney, and the danger of poisonous reactions to this drug could also be better in sufferers with impaired renal perform. As a result of aged sufferers usually tend to have decreased renal perform, care must be taken in dose choice [see Warnings and Precautions (5.4)].

Renal Impairment

Cephalexin must be administered with warning within the presence of impaired renal perform (creatinine clearance < 30 mL/min, with or with out dialysis). Beneath such situations, cautious scientific commentary and laboratory research renal perform monitoring must be performed as a result of secure dosage could also be decrease than that often really useful [see Dosage and Administration (2.3)].

Overdosage

Signs of oral overdose could embrace nausea, vomiting, epigastric misery, diarrhea, and hematuria. Within the occasion of an overdose, institute basic supportive measures.

Compelled diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion haven’t been established as helpful for an overdose of cephalexin.

Cephalexin Suspension Description

Cephalexin oral suspension, USP is a semisynthetic cephalosporin antibacterial drug meant for oral administration. It’s 7-(D-α- Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formulation C16H17N3O4S•H2O and the molecular weight is 365.41.

Cephalexin has the next structural formulation:

Inactive Components: Colloidal silicon dioxide, FD&C Crimson # 40, methyl cellulose (15 premium LV), methyl cellulose (4AC premium), sodium benzoate, strawberry taste, sucrose, xanthan gum.

Cephalexin Suspension – Scientific Pharmacology

Mechanism of Motion

Cephalexin is a cephalosporin antibacterial drug [see Microbiology (12.4)].

Pharmacokinetics

Absorption:

Cephalexin is acid steady and could also be given with out regard to meals. Following doses of 250 mg, 500 mg, and 1 g, common peak serum ranges of roughly 9, 18, and 32 mcg/mL, respectively, had been obtained at 1 hour. Serum ranges had been detectable 6 hours after administration (at a degree of detection of 0.2 mcg/mL).

Distribution:

Cephalexin is roughly 10% to fifteen% sure to plasma proteins.

Excretion:

Cephalexin is excreted within the urine by glomerular filtration and tubular secretion. Research confirmed that over 90% of the drug was excreted unchanged within the urine inside 8 hours. Throughout this era, peak urine concentrations following the 250 mg, 500 mg, and 1 g doses had been roughly 1,000, 2,200, and 5,000 mcg/mL respectively.

Drug Interactions:

In wholesome topics given single 500 mg doses of cephalexin and metformin, plasma metformin imply Cmax and AUC elevated by a mean of 34% and 24%, respectively, and metformin imply renal clearance decreased by 14%. No info is accessible concerning the interplay of cephalexin and metformin following a number of doses of both drug.

Microbiology

Mechanism of Motion

Cephalexin is a bactericidal agent that acts by the inhibition of bacterial cell-wall synthesis.

Resistance
Methicillin-resistant staphylococci and most isolates of enterococci are proof against cephalexin. Cephalexin will not be lively towards most isolates of Enterobacter spp., Morganella morganii, and Proteus vulgaris. Cephalexin has no exercise towards Pseudomonas spp., or Acinetobacter calcoaceticus. Penicillin-resistant Streptococcus pneumoniae is often cross-resistant to beta-lactam antibacterial medicine.

Antimicrobial Exercise

Cephalexin has been proven to be lively towards most isolates of the next micro organism each in vitro and in scientific infections [see Indications and Usage (1)].

Gram-positive micro organism

Staphylococcus aureus (methicillin-susceptible isolates solely) Streptococcus pneumoniae (penicillin-susceptible isolates) Streptococcus pyogenes

Gram-negative micro organism Escherichia coli Haemophilus influenzae Klebsiella pneumoniae Moraxella catarrhalis Proteus mirabilis

SusceptibilityTesting

For particular info concerning susceptibility take a look at interpretive standards and related take a look at strategies and high quality management requirements acknowledged by FDA for this drug, please see: https://www.fda.gov/STIC.

Nonclinical Toxicology

Carcinogenesis & Mutagenesis & Impairment Of Fertility

Lifetime research in animals haven’t been carried out to judge the carcinogenic potential of cephalexin. Checks to find out the mutagenic potential of cephalexin haven’t been carried out. In female and male rats, fertility and reproductive efficiency weren’t affected by cephalexin oral doses as much as 1.5 instances the best really useful human dose based mostly upon physique floor space.

How Provided/Storage and Dealing with

Cephalexin for oral suspension* USP (a strawberry flavored formulation) is equipped as follows:

125 mg/5 mL:

Bottles of 100 mL (NDC 67877-544-88)

Bottles of 200 mL (NDC 67877-544-68)

250 mg/5 mL:

Bottles of 100 mL (NDC 67877-545-88)

Bottles of 200 mL (NDC 67877-545-68)

Instructions for mixing are included on the label.

Retailer at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature].

Shake effectively earlier than utilizing. Hold tightly closed.

*After mixing, retailer in fridge. Could also be saved for 14 days with out important lack of efficiency.

Affected person Counseling Info

  • Advise sufferers that allergic reactions, together with severe allergic reactions, may happen and that severe reactions require quick therapy. Ask the affected person about any earlier hypersensitivity reactions to cephalexin, different beta-lactams (together with cephalosporins) or different allergens (5.1)
  • Advise sufferers that diarrhea is a standard drawback attributable to antibacterial medicine and often resolves when the drug is discontinued. Generally, frequent watery or bloody diarrhea could happen and could also be an indication of a extra severe intestinal an infection. If extreme watery or bloody diarrhea develops, advise sufferers to contact their healthcare supplier.
  • Counsel sufferers that antibacterial medicine together with cephalexin, ought to solely be used to deal with bacterial infections. They don’t deal with viral infections (e.g., the widespread chilly). When cephalexin is prescribed to deal with a bacterial an infection, inform sufferers that though it’s common to really feel higher early in the middle of remedy, the remedy must be taken precisely as directed. Skipping doses or not finishing the total course of remedy could (1) lower the effectiveness of the quick therapy and (2) enhance the chance that micro organism will develop resistance and won’t be treatable by cephalexin or different antibacterial medicine sooner or later.

Manufactured in India by:
Alkem Laboratories Ltd.,
Mumbai – 400013, INDIA.

Distributed by:

Ascend Laboratories, LLC
Parsippany, NJ 07054

Revised: December, 2018
PT 2851

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67877-544-88
Cephalexin for Oral Suspension, USP 125 mg per 5 mL
when reconstituted in line with instructions.
Standard Pediatric Dose: 25 to 50 mg per kg a day in 4 divided doses. For extra extreme an infection, dose could also be doubled. See accompanying literature.
Rx solely
For Oral Use solely
100 mL (when combined)
Ascend Laboratories, LLC

NDC 67877-545-88
Cephalexin for Oral Suspension, USP 250 mg per 5 mL
when reconstituted in line with instructions.
Standard Pediatric Dose: 25 to 50 mg per kg a day in 4 divided doses. For extra extreme an infection, dose could also be doubled.
See accompanying literature.
Rx solely
For Oral Use solely
100 mL (when combined)
Ascend Laboratories, LLC

CEPHALEXIN
cephalexin for suspension
Product Info
Product Sort HUMAN PRESCRIPTION DRUG LABEL Merchandise Code (Supply) NDC:67877-544
Route of Administration ORAL DEA Schedule
Lively Ingredient/Lively Moiety
Ingredient Identify Foundation of Energy Energy
CEPHALEXIN (CEPHALEXIN ANHYDROUS) CEPHALEXIN ANHYDROUS 125 mg in 5 mL
Inactive Components
Ingredient Identify Energy
SUCROSE
METHYLCELLULOSE (15 MPA.S)
METHYLCELLULOSE (400 MPA.S)
SODIUM BENZOATE
XANTHAN GUM
SILICON DIOXIDE
STRAWBERRY
FD&C RED NO. 40
Product Traits
Colour YELLOW (Pale Yellow) Rating
Form Measurement
Taste STRAWBERRY Imprint Code
Incorporates
Packaging
# Merchandise Code Package deal Description
1 NDC:67877-544-88 100 mL in 1 BOTTLE
2 NDC:67877-544-68 200 mL in 1 BOTTLE
Advertising Info
Advertising Class Software Quantity or Monograph Quotation Advertising Begin Date Advertising Finish Date
ANDA ANDA210221 03/28/2019
CEPHALEXIN
cephalexin for suspension
Product Info
Product Sort HUMAN PRESCRIPTION DRUG LABEL Merchandise Code (Supply) NDC:67877-545
Route of Administration ORAL DEA Schedule
Lively Ingredient/Lively Moiety
Ingredient Identify Foundation of Energy Energy
CEPHALEXIN (CEPHALEXIN ANHYDROUS) CEPHALEXIN ANHYDROUS 250 mg in 5 mL
Inactive Components
Ingredient Identify Energy
SUCROSE
METHYLCELLULOSE (15 MPA.S)
METHYLCELLULOSE (400 MPA.S)
SODIUM BENZOATE
XANTHAN GUM
SILICON DIOXIDE
STRAWBERRY
FD&C RED NO. 40
Product Traits
Colour YELLOW (Pale Yellow) Rating
Form Measurement
Taste STRAWBERRY Imprint Code
Incorporates
Packaging
# Merchandise Code Package deal Description
1 NDC:67877-545-88 100 mL in 1 BOTTLE
2 NDC:67877-545-68 200 mL in 1 BOTTLE
Advertising Info
Advertising Class Software Quantity or Monograph Quotation Advertising Begin Date Advertising Finish Date
ANDA ANDA210221 03/28/2019
Labeler – Ascend Laboratories, LLC (141250469)
Institution
Identify Tackle ID/FEI Operations
Alkem Laboratories Restricted 915628612 MANUFACTURE(67877-544, 67877-545)

Ascend Laboratories, LLC

Ceaselessly Requested Questions

Extra about cephalexin

Shopper sources

Skilled sources

Different manufacturers: Keflex, Daxbia, Panixine

Associated therapy guides

Leave a Reply

Your email address will not be published. Required fields are marked *