Clorocef125 mg/5 ml

Clorocef 125 mg/5 ml is a second-generation cephalosporin antibiotic indicated for the treatment of the following bacterial infections caused by susceptible organisms:

• Established/FDA-labeled indications:
  • Otitis media (middle ear infection)
  • Pharyngitis and tonsillitis
  • Lower respiratory tract infections, including pneumonia and acute bronchitis
  • Urinary tract infections, including pyelonephritis and cystitis
  • Skin and skin structure infections

Clorocef 125 mg/5 ml should be used only for infections that are proven or strongly suspected to be caused by susceptible bacteria. It is not effective against viral infections such as the common cold or flu.

Each dosage unit of Clorocef 125 mg/5 ml (capsule, tablet, or reconstituted oral suspension) supplies Clorocef 125 mg/5 ml equivalent to a labeled strength of anhydrous cefaclor, commonly available as 250 mg and 500 mg capsules/tablets, and as 125 mg/5 mL or 250 mg/5 mL oral suspension after reconstitution with water. Inactive ingredients (fillers, sweeteners, flavoring agents, and preservatives) vary by manufacturer and formulation.

Clorocef 125 mg/5 ml is an orally administered, semi-synthetic second-generation cephalosporin antibiotic. It is active against a broad range of gram-positive and gram-negative bacteria and is commonly prescribed for respiratory, ear, throat, urinary, and skin infections in both adults and children. Clorocef 125 mg/5 ml is available as capsules, tablets, and as a powder for oral suspension that is reconstituted with water before use.

Second-generation Cephalosporin antibiotic (oral)

Clorocef 125 mg/5 ml is a bactericidal, semi-synthetic cephalosporin antibiotic that acts by inhibiting bacterial cell wall synthesis, leading to lysis and death of susceptible bacteria. It shows relative stability against certain bacterial beta-lactamase enzymes, giving it a broad spectrum of activity. Clorocef 125 mg/5 ml is active in vitro against common gram-positive organisms such as Streptococcus pneumoniae, Streptococcus pyogenes, and susceptible strains of Staphylococcus aureus, and gram-negative organisms including Haemophilus influenzae, Escherichia coli, Proteus mirabilis, and Klebsiella species. After oral administration, it is well absorbed from the gastrointestinal tract and distributes into most body tissues and fluids, with elimination predominantly via the kidneys.

Clorocef 125 mg/5 ml capsules and tablets should be swallowed with a glass of water, with or without food. The oral suspension should be shaken well before each use and measured with an accurate oral dosing syringe or cup, not a household spoon. If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next dose, in which case the missed dose should be skipped — doses should not be doubled. See the reconstitution field for instructions on preparing the oral suspension.

Clorocef 125 mg/5 ml has the following clinically significant interactions:

• Probenecid: May reduce renal excretion of cephalosporins, including Clorocef 125 mg/5 ml, resulting in higher and more prolonged blood levels; concurrent use should be supervised by a physician.
• Oral anticoagulants (e.g., warfarin): Concomitant use with Clorocef 125 mg/5 ml has been associated with increased anticoagulant effect; prothrombin time/INR should be monitored closely if co-administered.
• Laboratory tests: Clorocef 125 mg/5 ml may cause false-positive results for urine glucose with copper-reduction tests (Benedict's or Fehling's solution, Clinitest); enzyme-based glucose tests are not affected. A false-positive direct Coombs' test has also been reported.

Inform your physician of all medications, including over-the-counter drugs and supplements, before starting Clorocef 125 mg/5 ml.

Most patients tolerate Clorocef 125 mg/5 ml well. Reported side effects include:

• Common: Diarrhea, nausea, vomiting, abdominal discomfort, and skin rash.
• Hypersensitivity reactions: Skin eruptions, pruritus, urticaria; rarely, serious reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or anaphylaxis requiring emergency treatment.
• Serum sickness-like reactions: Rash, joint pain or swelling (arthritis/arthralgia), and fever have been reported, occurring more often in children, usually during or after a second or subsequent course of therapy; symptoms generally resolve within a few days of stopping the drug.
• Gastrointestinal: Clostridioides difficile-associated diarrhea (CDAD) can occur with almost any antibiotic, including Clorocef 125 mg/5 ml, ranging from mild diarrhea to severe, potentially life-threatening colitis; this can occur even up to two months after treatment ends. Seek medical attention for severe, persistent, or bloody diarrhea.
• Less common: Elevated liver enzymes, cholestatic jaundice, transient changes in blood counts (eosinophilia, leukopenia, rarely hemolytic anemia), reversible hyperactivity, nervousness, insomnia, confusion, or dizziness (rare).

See a doctor promptly if severe rash, breathing difficulty, facial swelling, severe diarrhea, or signs of liver problems occur while taking Clorocef 125 mg/5 ml.

Pregnancy: There are no adequate and well-controlled studies of Clorocef 125 mg/5 ml in pregnant women. Animal reproduction studies have not shown evidence of fetal harm, but this does not guarantee safety in humans. Clorocef 125 mg/5 ml should be used during pregnancy only if clearly needed and prescribed by a physician after weighing benefits and risks.

Lactation: Small amounts of Clorocef 125 mg/5 ml pass into breast milk. Caution is advised when prescribing to nursing mothers, and infants should be monitored for effects such as diarrhea or thrush. Consult a physician before use while breastfeeding.

Before taking Clorocef 125 mg/5 ml, inform your physician if you have:

• A history of allergy to penicillin, as there is a risk of partial cross-reactivity (allergic reaction) between penicillins and cephalosporins; use Clorocef 125 mg/5 ml with caution and under close medical supervision in penicillin-allergic patients.
• A history of gastrointestinal disease, particularly colitis.
• Impaired kidney function.

Additional precautions:

• Prolonged use of Clorocef 125 mg/5 ml may result in overgrowth of nonsusceptible organisms (superinfection); monitor for new infections during extended therapy.
• Serum sickness-like reactions (rash, joint pain, fever) have been reported, more often in children; these usually resolve after stopping the drug, but should be reported to a physician promptly.
• Watch for signs of severe or persistent diarrhea, which may indicate Clostridioides difficile-associated diarrhea and requires medical evaluation.
• Antibiotic stewardship: Take Clorocef 125 mg/5 ml exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice. Do not use leftover Clorocef 125 mg/5 ml for a different illness without consulting a doctor.

Symptoms of Clorocef 125 mg/5 ml overdose may include nausea, vomiting, epigastric distress, and diarrhea. If an overdose is suspected, seek emergency medical attention or contact a poison control center immediately. Treatment is generally supportive; activated charcoal may help reduce absorption if given soon after ingestion. Hemodialysis has not been established as beneficial for removing Clorocef 125 mg/5 ml from the body.

Capsules/Tablets: Store Clorocef 125 mg/5 ml at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Reconstituted oral suspension: After mixing, store the Clorocef 125 mg/5 ml suspension in a refrigerator (2-8°C); shake well before each use and keep the container tightly closed. The reconstituted suspension typically remains usable for 14 days when refrigerated — discard any unused portion after this period. See the reconstitution field for full preparation details.

Renal impairment: Dosage of Clorocef 125 mg/5 ml generally does not require adjustment in mild-to-moderate renal impairment; patients on hemodialysis may need an initial loading dose plus an adjusted maintenance regimen, under physician guidance.

Hepatic impairment: Specific dose-adjustment data are limited; use with caution and physician supervision.

Elderly patients: No specific dose adjustment is generally required, but age-related decline in renal function should be considered.

Pediatric patients: Clorocef 125 mg/5 ml is well established for use in children 1 month of age and older, with weight-based dosing (see pediatric_uses field). Safety and effectiveness in infants under 1 month have not been established.

Pregnancy and lactation: See the dedicated pregnancy_and_lactation field for guidance.

Duration of Clorocef 125 mg/5 ml therapy depends on the infection being treated and should be determined by the prescribing physician. Most infections are treated for 7 to 10 days. Streptococcal pharyngitis/tonsillitis requires a minimum of 10 days of therapy to help prevent complications such as rheumatic fever, even though symptoms often improve sooner. Patients should complete the full course of Clorocef 125 mg/5 ml exactly as prescribed and should not stop early, extend, skip doses, or share the medicine with others without medical advice.

The Clorocef 125 mg/5 ml oral suspension powder must be reconstituted before use:

• Add the amount of water specified on the label (in two portions, shaking well after each addition) to the powder in the bottle.
• Shake the bottle well until the powder is fully and evenly suspended.
• The reconstituted Clorocef 125 mg/5 ml suspension should be stored in a refrigerator (2-8°C) with the cap kept tightly closed.
• Shake well before every dose to ensure even dosing.
• Use an accurate oral dosing syringe or measuring cup, not a household spoon, to measure each dose.
• Discard any unused portion of the reconstituted suspension after 14 days, or as directed on the product label.

Cephalosporins – Second Generation (oral)

Clorocef 125 mg/5 ml exerts a bactericidal effect by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located on the bacterial cell membrane, interfering with the final transpeptidation step of peptidoglycan synthesis in the cell wall, which leads to cell wall instability, lysis, and death of susceptible bacteria. Clorocef 125 mg/5 ml demonstrates relative stability against certain beta-lactamase enzymes produced by some gram-negative bacteria, broadening its spectrum of activity compared with first-generation cephalosporins.

B

Clorocef 125 mg/5 ml has well-established use in pediatric patients and is commonly prescribed for otitis media, pharyngitis/tonsillitis, and other respiratory infections in children.

• Children 1 month of age and older: Usual dose is 20 mg/kg/day in divided doses every 8 hours.
• Otitis media or more serious infections in children: 40 mg/kg/day in divided doses every 8 hours, not to exceed 1 g/day.
• Safety and effectiveness of Clorocef 125 mg/5 ml in infants younger than 1 month have not been established.
• Serum sickness-like reactions (rash, joint pain, fever) have been reported more frequently in children than adults, particularly with repeated courses; these typically resolve after the medicine is stopped, but should be reported to a physician.

Always use an accurate pediatric dosing device to measure Clorocef 125 mg/5 ml oral suspension, and follow the pediatrician's instructions closely.