Cefexta Forte250 mg/5 ml

Respiratory Tract Infections

Cefexta Forte is an FDA-approved, established treatment for community-acquired pneumonia of mild to moderate severity and for acute bacterial exacerbations of chronic bronchitis, caused by susceptible organisms such as Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, and Moraxella catarrhalis.

Ear, Nose, and Throat Infections

Cefexta Forte is an established treatment for acute bacterial otitis media in pediatric patients and for acute maxillary sinusitis and pharyngitis/tonsillitis in both adults and children caused by susceptible strains of Streptococcus pyogenes (Group A beta-hemolytic streptococcus), S. pneumoniae, H. influenzae, and M. catarrhalis. For streptococcal pharyngitis/tonsillitis, Cefexta Forte is a guideline-supported alternative for patients who cannot use first-line penicillin therapy.

Skin and Skin Structure Infections

Cefexta Forte is an established treatment for uncomplicated skin and skin structure infections, such as mild to moderate cellulitis, wound infections, and abscesses, caused by susceptible strains of Staphylococcus aureus (methicillin-susceptible only) and S. pyogenes.

Penicillin-Allergic Patients

Because Cefexta Forte is a cephalosporin rather than a penicillin, it is sometimes used as an alternative agent for patients with a documented penicillin allergy who require treatment for one of the infections above; however, patients with a history of severe or anaphylactic penicillin allergy should generally avoid all beta-lactam antibiotics, including Cefexta Forte, given the possibility of cross-reactivity (see Contraindications and Precautions and Warnings).

Cefexta Forte is not effective against methicillin-resistant Staphylococcus aureus (MRSA), atypical respiratory pathogens such as Mycoplasma or Chlamydophila species, or viral infections, and should be reserved for infections proven or strongly suspected to be due to susceptible bacteria.

Each capsule contains Cefdinir 300 mg. Each 5 mL of reconstituted oral suspension contains Cefdinir 125 mg or Cefdinir 250 mg, depending on the marketed strength.

Cefexta Forte is a semi-synthetic, third-generation oral cephalosporin antibiotic used to treat a range of bacterial infections. Cefexta Forte works by interfering with the construction of the bacterial cell wall, which causes susceptible bacteria to die. Cefexta Forte is commonly prescribed for respiratory tract infections such as community-acquired pneumonia and bronchitis, ear infections in children, sinus infections, throat infections, and uncomplicated skin infections. Cefexta Forte is available as capsules and as a powder that a pharmacist reconstitutes into an oral suspension for children and patients who cannot swallow capsules. Cefexta Forte does not treat viral infections such as the common cold or influenza, and Cefexta Forte should be taken exactly as prescribed by a qualified healthcare professional, for the full length of the prescribed course.

Antibiotic — Third-generation Cephalosporin (oral)

Cefdinir is absorbed after oral administration, though absolute bioavailability is lower with the capsule (about 16-21%) than with the suspension (about 25%); a high-fat meal does not significantly change extent of absorption of the capsule but delays absorption of the suspension. Cefdinir is minimally metabolized; the small fraction that is metabolized is converted to an inactive metabolite. Cefdinir is not appreciably bound by tissue and is eliminated primarily unchanged via the kidneys, with a mean elimination half-life of approximately 1.7 hours in adults with normal renal function. Because clearance of Cefdinir depends on renal function, patients with reduced creatinine clearance accumulate the drug and require dose adjustment (see Dosage and Administration and Use in Special Populations). Cefdinir is not significantly removed by peritoneal dialysis, but hemodialysis does remove a substantial fraction of the drug.

• Cefexta Forte capsules may be taken without regard to meals.
• Cefexta Forte oral suspension may be taken without regard to meals; shake the bottle well before each dose.
• Swallow Cefexta Forte capsules whole with water; do not open or crush them unless directed by a physician or pharmacist.
• Use the measuring device provided with Cefexta Forte oral suspension for accurate dosing — do not use a household spoon.
• Separate Cefexta Forte from antacids containing aluminum or magnesium, and from iron supplements or iron-fortified foods, by at least 2 hours before or after dosing, as these can reduce absorption of Cefexta Forte (iron-fortified infant formula does not require separation).
• Take Cefexta Forte exactly as prescribed by the physician; do not stop, extend, skip doses, or share Cefexta Forte with others without medical advice, even if symptoms improve before the full course is completed.
• Reddish or rust-colored stools can occur during Cefexta Forte therapy, particularly in children also taking iron; this discoloration is harmless and is not blood (see FAQ), but persistent diarrhea or abdominal pain should be reported to a physician.

• Antacids (aluminum- or magnesium-containing): reduce absorption of Cefexta Forte by approximately 40%; separate dosing of Cefexta Forte from antacids by at least 2 hours.
• Iron supplements: reduce absorption of Cefexta Forte by 31-80% depending on the iron dose; separate dosing of Cefexta Forte from iron supplements by at least 2 hours. Iron-fortified infant formula does not significantly affect absorption of Cefexta Forte.
• Probenecid: inhibits renal tubular secretion of Cefexta Forte, roughly doubling systemic exposure to Cefexta Forte and increasing peak concentrations; concurrent use requires caution.
• Warfarin and other vitamin K antagonists: as with other cephalosporins, concurrent use of Cefexta Forte with warfarin has rarely been associated with increased anticoagulant effect; monitor coagulation parameters closely if Cefexta Forte is co-administered with warfarin.

Common Side Effects

• Diarrhea (most common; higher rate in young children)
• Nausea and vomiting
• Headache
• Abdominal pain
• Vaginal moniliasis (yeast infection) in women
• Skin rash, more frequent in young children and often related to diaper area
• Reddish/rust-colored stool discoloration (harmless; not blood — see FAQ)

Serious Side Effects (Seek Medical Attention)

• Severe, watery, or bloody diarrhea that does not improve, which may indicate Clostridioides difficile-associated colitis
• Signs of a severe allergic reaction such as swelling of the face, lips, or throat, difficulty breathing, or hives
• Severe skin reactions such as blistering, peeling, or widespread rash (possible Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Yellowing of the skin or eyes, dark urine, or unusual tiredness, which may indicate liver problems
• Unusual bleeding, bruising, or persistent sore throat/fever, which may rarely indicate a blood disorder
• Seizures (reported rarely, particularly with high doses in patients with renal impairment)

Pregnancy

Animal reproduction studies with Cefexta Forte have not shown evidence of harm to the fetus, but adequate and well-controlled studies in pregnant women are lacking. Because animal reproduction studies are not always predictive of human response, Cefexta Forte should be used during pregnancy only if clearly needed, and the potential benefit should justify the potential risk to the fetus. Any use of Cefexta Forte during pregnancy should be individually assessed and supervised by a qualified physician.

Breastfeeding

Cefexta Forte was not detected in human breast milk following a single 600 mg dose in lactating women, but data remain limited. Caution should still be exercised, and a physician should be consulted before using Cefexta Forte while breastfeeding, so that the infant can be monitored for possible effects such as diarrhea or thrush.

• Antibiotic stewardship: Take Cefexta Forte exactly as prescribed by your physician; do not stop, extend, skip doses, or share Cefexta Forte with others without medical advice, even if you feel better before finishing the course.
• Penicillin cross-reactivity: Patients with a history of penicillin allergy may also react to Cefexta Forte, since cephalosporins and penicillins share a similar chemical structure (partial cross-reactivity); use Cefexta Forte with caution in penicillin-allergic patients and avoid it in those with a history of severe or immediate-type (anaphylactic) penicillin reactions.
• Clostridioides difficile-associated diarrhea (CDAD): as with nearly all antibiotics, Cefexta Forte can allow overgrowth of C. difficile in the gut, causing diarrhea or colitis ranging from mild to life-threatening; this can occur during treatment or up to two months after stopping Cefexta Forte. Seek medical advice for persistent or severe diarrhea.
• Renal impairment: Cefexta Forte is cleared by the kidneys and accumulates in patients with reduced kidney function; dose reduction is required when creatinine clearance is below 30 mL/min (see Dosage and Administration).
• Reddish stool discoloration: Cefexta Forte, especially when taken with iron-containing products, can cause harmless reddish or rust-colored stools that may resemble blood; this is a benign, non-hemorrhagic phenomenon caused by an interaction between Cefexta Forte (or its breakdown products) and iron, not gastrointestinal bleeding (see FAQ).
• Superinfection: prolonged use of Cefexta Forte may result in overgrowth of non-susceptible organisms, including fungi; monitor for new signs of infection.
• Not effective against viral infections: Cefexta Forte treats bacterial infections only and has no effect on viruses such as those causing the common cold or influenza; using Cefexta Forte when not needed contributes to the development of drug-resistant bacteria.
• False-positive tests: Cefexta Forte, like other cephalosporins, may cause a false-positive reaction for ketones in urine and may cause a false-positive result for glucose with copper-reduction tests (e.g., Clinitest); glucose-oxidase tests are not affected.

Limited information is available on Cefexta Forte overdose in humans. Based on the known effects of Cefexta Forte and other cephalosporins, overdose may be expected to cause an extension of common side effects such as nausea, vomiting, and diarrhea, and could theoretically increase the risk of seizures, particularly in patients with reduced kidney function. There is no specific antidote for Cefexta Forte overdose. If an overdose of Cefexta Forte is suspected, seek immediate medical attention or contact a poison control center right away; treatment is generally supportive and symptomatic. Hemodialysis can remove Cefexta Forte from the body and may be considered in cases of serious toxicity, particularly if kidney function is impaired.

Store Cefexta Forte capsules at room temperature (below 30°C), away from light and moisture, in a tightly closed container. Once the oral suspension of Cefexta Forte has been reconstituted by the pharmacist, it may be stored at room temperature and must be used within 10 days; discard any unused suspension after that time. Keep Cefexta Forte out of the reach and sight of children.

Children

Cefexta Forte is approved for use in children 6 months of age and older for acute bacterial otitis media, acute maxillary sinusitis, pharyngitis/tonsillitis, and uncomplicated skin infections, using weight-based dosing (see Dosage). Safety and efficacy of Cefexta Forte in children younger than 6 months have not been established. Diarrhea and rash occur more frequently in young children, particularly those 2 years of age and younger, than in older children and adults.

Elderly

Clinical studies of Cefexta Forte did not identify differences in response between elderly and younger patients, but elderly patients are more likely to have age-related decreased renal function; dose selection should take kidney function into account, and dose adjustment may be needed (see Dosage and Administration).

Renal Impairment

Cefexta Forte is eliminated primarily by the kidneys. In patients with creatinine clearance below 30 mL/min, the dose of Cefexta Forte must be reduced (see Dosage and Administration); dosage adjustment is also required for patients on hemodialysis.

Hepatic Impairment

Because Cefexta Forte is eliminated mainly by the kidneys and undergoes minimal hepatic metabolism, no dosage adjustment of Cefexta Forte is routinely required in patients with hepatic impairment alone, though clinical judgment should still be used.

Pregnant and Breastfeeding Women

See the Pregnancy and Lactation section above for detailed guidance on the use of Cefexta Forte in this population.

The duration of treatment with Cefexta Forte is set by the prescriber and depends on the indication: typically 10 days for community-acquired pneumonia, skin/skin structure infections, acute otitis media, and acute maxillary sinusitis, and 5 to 10 days for acute exacerbation of chronic bronchitis and pharyngitis/tonsillitis. Patients should complete the full prescribed course of Cefexta Forte exactly as directed and should not stop, extend, or repeat a course of Cefexta Forte without medical advice, even if symptoms improve earlier.

Cefexta Forte for oral suspension is supplied as a powder that a pharmacist reconstitutes with water before dispensing. To prepare the 125 mg/5 mL or 250 mg/5 mL suspension, water is added to the powder in two portions, shaking well after each addition, to make a final volume of 60 mL or 100 mL depending on the pack size. After reconstitution, the suspension should be shaken well before each use and can be stored at room temperature for up to 10 days, after which any unused portion should be discarded.

Third-generation Cephalosporin antibiotic (oral)

Cefdinir is a bactericidal antibiotic. Like other beta-lactam antibiotics, Cefdinir works by binding to penicillin-binding proteins located inside the bacterial cell wall, which inhibits the final step of bacterial cell wall synthesis (transpeptidation/cross-linking of peptidoglycan). This weakens the cell wall of susceptible bacteria, causing the cell to lyse (burst) and die. Cefdinir is stable in the presence of some, but not all, bacterial beta-lactamase enzymes, which affects its spectrum of activity against certain resistant organisms.

Category B (FDA legacy pregnancy category)

Cefexta Forte is approved for use in pediatric patients 6 months through 12 years of age for acute bacterial otitis media, acute maxillary sinusitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections, dosed at 7 mg/kg every 12 hours or 14 mg/kg once daily (maximum 600 mg per day) using the oral suspension. Safety and efficacy of Cefexta Forte in infants younger than 6 months have not been established. Diarrhea and skin rash (often in the diaper area) occur more frequently in young children, especially those 2 years of age or younger, than in older patients. Reddish or rust-colored stool can occur in children taking Cefexta Forte, particularly those also receiving iron-containing products or iron-fortified formula; this is a harmless discoloration and not blood (see FAQ), but persistent gastrointestinal symptoms should be reported to the child's physician. Any pediatric use of Cefexta Forte should be guided by a pediatrician or qualified healthcare professional.