Sefrad125 mg/5 ml

Respiratory Tract Infections

Sefrad 125 mg/5 ml 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; Sefrad 125 mg/5 ml is an alternative for patients who cannot take a penicillin for reasons other than immediate/severe (anaphylactic-type) hypersensitivity.

Skin and Skin Structure Infections

Sefrad 125 mg/5 ml is an established treatment for uncomplicated skin and soft tissue infections caused by susceptible staphylococci and streptococci.

Urinary Tract Infections

Sefrad 125 mg/5 ml 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

Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml 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.

Sefrad 125 mg/5 ml 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.

Sefrad 125 mg/5 ml 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.

Sefrad 125 mg/5 ml is a semisynthetic, first-generation cephalosporin antibiotic belonging to the beta-lactam class of medicines. Sefrad 125 mg/5 ml is bactericidal, meaning it kills susceptible bacteria rather than merely stopping their growth, by interfering with the formation of the bacterial cell wall. Sefrad 125 mg/5 ml 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. Sefrad 125 mg/5 ml does not treat viral infections such as the common cold or flu, and Sefrad 125 mg/5 ml should be taken exactly as prescribed by a qualified healthcare professional.

Sefrad 125 mg/5 ml belongs to the therapeutic class of first-generation cephalosporin antibiotics (beta-lactam class).

Sefrad 125 mg/5 ml is a bactericidal, semisynthetic first-generation cephalosporin. Sefrad 125 mg/5 ml 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. Sefrad 125 mg/5 ml 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.

Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml requires adjustment in patients with reduced kidney function (see Use in Special Populations).

• Sefrad 125 mg/5 ml capsules may be taken with or without food; taking Sefrad 125 mg/5 ml with food may help reduce stomach upset.
• Shake the reconstituted oral suspension of Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml is given by a healthcare professional as a deep intramuscular injection or by slow intravenous injection/infusion; it is not for self-administration.
• Take Sefrad 125 mg/5 ml at evenly spaced intervals as directed, and complete the full prescribed course.
• Take Sefrad 125 mg/5 ml exactly as prescribed by your physician; do not stop, extend, skip doses, or share Sefrad 125 mg/5 ml with others without medical advice.

• Probenecid: probenecid reduces renal tubular secretion of Sefrad 125 mg/5 ml, resulting in higher and more prolonged blood levels of Sefrad 125 mg/5 ml; 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 Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml; concurrent use is generally avoided unless specifically directed by a physician.
• Live attenuated bacterial vaccines (e.g., oral live typhoid vaccine): Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml.
• Laboratory test interference: Sefrad 125 mg/5 ml 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

Sefrad 125 mg/5 ml 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. Sefrad 125 mg/5 ml, 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 Sefrad 125 mg/5 ml 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

Sefrad 125 mg/5 ml is excreted in breast milk in small amounts. Although serious effects in breastfed infants are not well documented, Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml while breastfeeding.

• Penicillin cross-reactivity: patients with a history of penicillin allergy may also be allergic to Sefrad 125 mg/5 ml and other cephalosporins because of structural similarity; use Sefrad 125 mg/5 ml 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, Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml. Seek medical advice for persistent or severe diarrhea, and do not treat it with anti-peristaltic agents without medical advice.
• Renal impairment: because Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml may result in overgrowth of non-susceptible organisms, including fungi; report new or worsening symptoms during treatment with Sefrad 125 mg/5 ml to a healthcare professional.
• Laboratory test interference: Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml if tests are being performed.
• Antibiotic stewardship: take Sefrad 125 mg/5 ml exactly as prescribed by your physician; do not stop, extend, skip doses, or share Sefrad 125 mg/5 ml with others without medical advice, as inappropriate use of Sefrad 125 mg/5 ml contributes to antibiotic resistance and may not adequately treat the infection.
• Not effective against viral infections: Sefrad 125 mg/5 ml treats bacterial infections only and has no effect on viruses such as those causing the common cold or influenza.

Reported effects of Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml overdose. If an overdose of Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml from the body in cases of significant renal impairment or severe overdose.

Store Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml solutions have a much shorter stability and should be used promptly as directed by the healthcare provider preparing them. Do not use Sefrad 125 mg/5 ml beyond its expiry date.

Children

Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml in infants under 9 months of age are not available, so Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml adjusted accordingly if renal impairment is present.

Renal Impairment

Because Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml individualized by their nephrologist/physician in relation to dialysis sessions.

Hepatic Impairment

Sefrad 125 mg/5 ml is eliminated mainly by the kidneys rather than the liver, and specific dose adjustment for hepatic impairment alone is not well established; Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml in this population.

The duration of treatment with Sefrad 125 mg/5 ml is set by the prescriber and depends on the indication and clinical response. As a general guide, Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml is limited to a short course around the time of surgery rather than prolonged treatment. Patients should take Sefrad 125 mg/5 ml for exactly as long as prescribed and should not stop, extend, or repeat a course of Sefrad 125 mg/5 ml without medical advice.

Powder for oral suspension of Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml). Once reconstituted, store the suspension of Sefrad 125 mg/5 ml as directed (see Storage Conditions) and shake well before each dose. Injectable Sefrad 125 mg/5 ml 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).

Sefrad 125 mg/5 ml is bactericidal. Sefrad 125 mg/5 ml 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. Sefrad 125 mg/5 ml 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

Sefrad 125 mg/5 ml is approved for use in infants over 9 months of age and older children. Standard pediatric dosing of Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml 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; Sefrad 125 mg/5 ml 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 Sefrad 125 mg/5 ml should be completed in children, and antibiotic stewardship principles apply equally to pediatric use.