Rocef125 mg/5 ml

Respiratory Tract Infections

Rocef is an established treatment for susceptible upper and lower respiratory tract infections, including pharyngitis, tonsillitis, otitis media, and lobar pneumonia caused by susceptible strains of Streptococcus pneumoniae, Streptococcus pyogenes (Group A beta-hemolytic streptococci), Staphylococcus aureus (including penicillinase-producing strains), and Haemophilus influenzae. For streptococcal pharyngitis/tonsillitis, penicillin or amoxicillin remain the guideline-preferred first-line agents; Rocef is an alternative for patients who cannot take a penicillin for reasons other than immediate/severe (anaphylactic-type) hypersensitivity.

Skin and Skin Structure Infections

Rocef is an established treatment for uncomplicated skin and soft tissue infections caused by susceptible staphylococci and streptococci.

Urinary Tract Infections

Rocef is an established treatment for uncomplicated and, at higher doses, complicated urinary tract infections, including cystitis and prostatitis, caused by susceptible organisms such as Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.

Bone and Joint Infections

Rocef has guideline- and practice-supported use as a treatment option for susceptible bone and joint infections, generally as a narrower-spectrum alternative once causative organism and susceptibility are known; it is not typically first-line empiric therapy for serious bone/joint infection.

Perioperative (Surgical) Prophylaxis

The injectable form of Rocef is used as an adjunct, short-course perioperative antibiotic to reduce the risk of postoperative infection in contaminated or potentially contaminated surgery; it is given as prophylaxis around the time of surgery rather than as prolonged treatment, consistent with antibiotic stewardship principles.

Rocef is not effective against methicillin-resistant staphylococci, Pseudomonas aeruginosa, most Enterococcus species, or viral, fungal, or parasitic infections, and should be reserved for infections known or strongly suspected to be caused by susceptible bacteria.

Cephradine is available in several strengths and dosage forms, including capsules (250 mg and 500 mg), oral suspension (125 mg/5 mL and 250 mg/5 mL after reconstitution), pediatric oral drops, and injectable powder for reconstitution (250 mg, 500 mg, and 1 g vials), depending on the manufacturer and market.

Rocef is a semisynthetic, first-generation cephalosporin antibiotic belonging to the beta-lactam class of medicines. Rocef is bactericidal, meaning it kills susceptible bacteria rather than merely stopping their growth, by interfering with the formation of the bacterial cell wall. Rocef is commonly prescribed for respiratory tract infections, skin and soft tissue infections, urinary tract infections, and certain bone and joint infections caused by susceptible organisms. Rocef does not treat viral infections such as the common cold or flu, and Rocef should be taken exactly as prescribed by a qualified healthcare professional.

Rocef belongs to the therapeutic class of first-generation cephalosporin antibiotics (beta-lactam class).

Cephradine is a bactericidal, semisynthetic first-generation cephalosporin. Cephradine acts by binding to penicillin-binding proteins (PBPs) located on the bacterial cell membrane, thereby inhibiting the transpeptidation (cross-linking) step of bacterial cell wall (peptidoglycan) synthesis. This weakens the cell wall, leading to cell lysis and death of susceptible, actively dividing bacteria. Cephradine retains activity against many penicillinase-producing strains of Staphylococcus aureus because of relative stability to certain staphylococcal beta-lactamases, although it is not stable against many broader-spectrum beta-lactamases produced by gram-negative organisms.

Cephradine is well absorbed after oral administration, is widely distributed in body tissues and fluids, undergoes minimal metabolism, and is eliminated primarily unchanged by the kidneys through glomerular filtration and tubular secretion. Because renal elimination is the major route of clearance, dosing of Cephradine requires adjustment in patients with reduced kidney function (see Use in Special Populations).

• Rocef capsules may be taken with or without food; taking Rocef with food may help reduce stomach upset.
• Shake the reconstituted oral suspension of Rocef well before each use to ensure an even dose, and use an accurate measuring device/spoon rather than a household spoon.
• The injectable form of Rocef is given by a healthcare professional as a deep intramuscular injection or by slow intravenous injection/infusion; it is not for self-administration.
• Take Rocef at evenly spaced intervals as directed, and complete the full prescribed course.
• Take Rocef exactly as prescribed by your physician; do not stop, extend, skip doses, or share Rocef with others without medical advice.

• Probenecid: probenecid reduces renal tubular secretion of Rocef, resulting in higher and more prolonged blood levels of Rocef; this combination is sometimes used deliberately under medical supervision but otherwise requires awareness of increased exposure.
• Aminoglycosides and loop diuretics (e.g., furosemide): concurrent use with Rocef may increase the risk of nephrotoxicity, particularly in patients with pre-existing renal impairment; renal function should be monitored.
• Bacteriostatic antibiotics (e.g., chloramphenicol, tetracyclines): concurrent use may theoretically antagonize the bactericidal action of Rocef; concurrent use is generally avoided unless specifically directed by a physician.
• Live attenuated bacterial vaccines (e.g., oral live typhoid vaccine): Rocef and other antibacterials can reduce the effectiveness of live bacterial vaccines; where possible, live bacterial vaccination should be delayed until after completing a course of Rocef.
• Laboratory test interference: Rocef can cause false-positive results in urine glucose tests that use copper-reduction methods (e.g., Benedict's or Fehling's solution, Clinitest); glucose-oxidase based tests are not affected.

Common Side Effects

• Nausea, vomiting, diarrhea, and other gastrointestinal disturbances
• Abdominal discomfort or loss of appetite
• Mild skin rash, itching, or urticaria
• Vaginal itching or discharge (candidal vaginitis)

Less Common Side Effects

• Glossitis (tongue inflammation) and oral thrush
• Headache or dizziness
• Mild, transient changes in blood counts (e.g., eosinophilia, leukopenia)

Serious Side Effects (Seek Medical Attention)

• Severe or persistent watery or bloody diarrhea, which may indicate Clostridioides difficile-associated diarrhea or colitis — see Precautions and Warnings
• Signs of a severe allergic reaction such as swelling of the face, lips, or throat, difficulty breathing, or widespread hives — see Precautions and Warnings
• Yellowing of the skin or eyes, dark urine, or unusual tiredness, which may indicate liver involvement
• Unusual bruising, bleeding, persistent sore throat, fever, or pallor, which may rarely indicate a blood disorder
• Signs of kidney problems such as decreased urination or swelling, particularly with prolonged or high-dose use

Pregnancy

Rocef is classified in FDA legacy Pregnancy Category B: animal reproduction studies have not shown evidence of fetal harm, but there are no adequate and well-controlled studies in pregnant women. Rocef, like other cephalosporins, is generally considered an acceptable option in pregnancy when a penicillin cannot be used and treatment of a bacterial infection is clearly needed, but Rocef should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under the direct guidance of a qualified healthcare professional.

Breastfeeding

Rocef is excreted in breast milk in small amounts. Although serious effects in breastfed infants are not well documented, Rocef should be used with caution during breastfeeding, and the infant should be monitored for possible effects such as diarrhea, diaper rash, or oral thrush from disturbance of normal gut flora. A physician should be consulted before using Rocef while breastfeeding.

• Penicillin cross-reactivity: patients with a history of penicillin allergy may also be allergic to Rocef and other cephalosporins because of structural similarity; use Rocef with caution in penicillin-allergic patients, and avoid it in those with a history of severe or immediate (anaphylactic-type) penicillin hypersensitivity.
• Clostridioides difficile-associated diarrhea and colitis: as with almost any antibacterial agent, Rocef can disturb normal gut flora and permit overgrowth of C. difficile, ranging from mild diarrhea to severe, potentially life-threatening colitis; this can occur during or even weeks after stopping Rocef. Seek medical advice for persistent or severe diarrhea, and do not treat it with anti-peristaltic agents without medical advice.
• Renal impairment: because Rocef is eliminated mainly by the kidneys, dosing must be reduced in patients with impaired renal function to avoid drug accumulation and toxicity; see Use in Special Populations.
• Superinfection: prolonged or repeated use of Rocef may result in overgrowth of non-susceptible organisms, including fungi; report new or worsening symptoms during treatment with Rocef to a healthcare professional.
• Laboratory test interference: Rocef may cause false-positive results on copper-reduction urine glucose tests and, rarely, a false-positive direct Coombs test; inform laboratory staff that you are taking Rocef if tests are being performed.
• Antibiotic stewardship: take Rocef exactly as prescribed by your physician; do not stop, extend, skip doses, or share Rocef with others without medical advice, as inappropriate use of Rocef contributes to antibiotic resistance and may not adequately treat the infection.
• Not effective against viral infections: Rocef treats bacterial infections only and has no effect on viruses such as those causing the common cold or influenza.

Reported effects of Rocef overdose are generally an extension of its common side effects, particularly nausea, vomiting, diarrhea, and other gastric upset; neuromuscular excitability or seizures could theoretically occur with very large doses, especially in patients with renal impairment, as with other beta-lactam antibiotics. There is no specific antidote for Rocef overdose. If an overdose of Rocef is suspected, seek immediate medical attention or contact a poison control center; gastric lavage may be considered by medical staff soon after a large recent ingestion. Management is otherwise supportive and symptomatic, and hemodialysis can help remove Rocef from the body in cases of significant renal impairment or severe overdose.

Store Rocef capsules and unreconstituted powder at room temperature (below 30°C), away from direct light and moisture, in the original container, and out of the reach and sight of children. Once the oral suspension of Rocef has been reconstituted with water, it should be kept tightly closed and used within 7 days if stored at room temperature or within 14 days if refrigerated (2–8°C); shake well before each use and discard any unused portion after this time. Reconstituted injectable Rocef solutions have a much shorter stability and should be used promptly as directed by the healthcare provider preparing them. Do not use Rocef beyond its expiry date.

Children

Rocef is approved for use in infants over 9 months of age and older children, dosed on a weight basis (see Pediatric Uses). Adequate data supporting twice-daily dosing regimens of Rocef in infants under 9 months of age are not available, so Rocef should be used with particular caution, and generally more frequent dosing, in this younger age group under close medical supervision.

Elderly

No specific dose adjustment of Rocef is required for older adults on the basis of age alone, but because renal function commonly declines with age, elderly patients should have their kidney function assessed, and the dose of Rocef adjusted accordingly if renal impairment is present.

Renal Impairment

Because Rocef is cleared mainly by the kidneys, the dosing interval and/or dose must be reduced in renal impairment to avoid accumulation:

Patients on hemodialysis should have the dose and timing of Rocef individualized by their nephrologist/physician in relation to dialysis sessions.

Hepatic Impairment

Rocef is eliminated mainly by the kidneys rather than the liver, and specific dose adjustment for hepatic impairment alone is not well established; Rocef can generally be used at standard doses in patients with liver impairment and normal renal function, under medical supervision.

Pregnant and Breastfeeding Women

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

The duration of treatment with Rocef is set by the prescriber and depends on the indication and clinical response. As a general guide, Rocef is continued for at least 48–72 hours after the patient becomes asymptomatic or there is evidence the infection has resolved. An important exception is streptococcal (Group A beta-hemolytic streptococcus) pharyngitis/tonsillitis, for which Rocef should be given for a minimum of 10 days to reduce the risk of rheumatic fever and post-streptococcal glomerulonephritis, even though symptoms often improve earlier. Perioperative prophylactic use of Rocef is limited to a short course around the time of surgery rather than prolonged treatment. Patients should take Rocef for exactly as long as prescribed and should not stop, extend, or repeat a course of Rocef without medical advice.

Powder for oral suspension of Rocef must be reconstituted before use: add the amount of water specified on the product label in two portions, shaking well after each addition, to obtain a uniform suspension (typically providing 125 mg/5 mL or 250 mg/5 mL of Rocef). Once reconstituted, store the suspension of Rocef as directed (see Storage Conditions) and shake well before each dose. Injectable Rocef powder for solution is reconstituted by a healthcare professional with sterile water for injection or another appropriate diluent, according to the vial strength and route (intramuscular or intravenous) directed by the prescriber, and should be used promptly after reconstitution.

First-generation cephalosporin antibiotic (beta-lactam class).

Cephradine is bactericidal. Cephradine binds to penicillin-binding proteins (PBPs) in the bacterial cell membrane and inhibits the transpeptidation (cross-linking) reaction required for bacterial cell wall (peptidoglycan) synthesis. Without an intact cell wall, susceptible bacteria are unable to withstand osmotic pressure, leading to cell lysis and death. Cephradine is relatively stable against certain penicillinases produced by staphylococci, which allows it to remain active against many penicillin-resistant staphylococcal strains, though it is not active against methicillin-resistant staphylococci or organisms producing broader-spectrum beta-lactamases.

B

Rocef is approved for use in infants over 9 months of age and older children. Standard pediatric dosing of Rocef for respiratory tract, skin/soft tissue, and urinary tract infections is 25–50 mg/kg/day given in divided doses every 6 to 12 hours. For otitis media caused by Haemophilus influenzae, a higher dose of 75–100 mg/kg/day in divided doses every 6 to 12 hours is used, not exceeding 4 g/day. For more severe infections requiring the injectable form, doses of 50–100 mg/kg/day (up to 300 mg/kg/day in severe, life-threatening infection) may be used under close medical supervision. Adequate data supporting twice-daily dosing of Rocef in infants younger than 9 months are not available, and safety and efficacy of such regimens in this younger age group have not been established; Rocef should be used in infants under 9 months only when a physician judges it necessary, with appropriate monitoring. As with adults, a full prescribed course of Rocef should be completed in children, and antibiotic stewardship principles apply equally to pediatric use.