Sefin250 mg/vial

Sefin 250 mg/vial is indicated for the treatment of bacterial infections caused by susceptible Gram-positive and Gram-negative microorganisms. It is effective across a broad range of infection types, including respiratory, urinary, and skin-related conditions.

Upper Respiratory Tract Infections (URTI)

• Sinusitis
• Pharyngitis
• Tonsillitis
• Laryngo-tracheo-bronchitis
• Otitis media (middle ear infection)

Lower Respiratory Tract Infections (LRTI)

• Acute and chronic bronchitis
• Lobar pneumonia
• Bronchopneumonia

Urinary Tract Infections (UTI)

• Cystitis (bladder infection)
• Urethritis (urethral infection)
• Pyelonephritis (kidney infection)

Skin & Soft Tissue Infections (SSTI)

• Abscess
• Cellulitis
• Furunculosis (boils/furuncles)
• Impetigo

Susceptible Microorganisms

The following organisms are susceptible to Sefin 250 mg/vial in vitro:

Gram-positive: Staphylococci (including penicillin-sensitive, resistant, and penicillinase-producing strains), Streptococci, Streptococcus pyogenes (beta-haemolytic), Streptococcus pneumoniae.

Gram-negative: Escherichia coli, Klebsiella spp., Proteus mirabilis, Haemophilus influenzae, Shigella spp., Salmonella spp. (including Salmonella typhi), Neisseria spp.

Note: Many strains of E. coli and Staphylococcus aureus that produce penicillinase — and are therefore ampicillin-resistant — remain susceptible to Sefin 250 mg/vial, as the drug is unaffected by this enzyme.

First-Generation Cephalosporins

Sefin 250 mg/vial is a semisynthetic, broad-spectrum bactericidal antibiotic belonging to the first-generation cephalosporin class. It is active against both Gram-positive and Gram-negative bacteria, including penicillinase-producing and non-producing staphylococci.

Mechanism of Action

The primary site of action of Sefin 250 mg/vial is the bacterial cell wall. The cell walls of susceptible organisms contain a structural polymer called peptidoglycan. Sefin 250 mg/vial inhibits the cross-linking (transpeptidation) process required for peptidoglycan synthesis. As a result, a structurally defective, porous cell wall is formed. The bacterium subsequently undergoes lysis (cell rupture) due to external osmotic pressure, leading to bacterial cell death.

Key Pharmacological Properties

• Bactericidal (kills bacteria rather than merely inhibiting growth)
• Stable against penicillinase enzymes, making it effective against many ampicillin-resistant strains
• Well absorbed following oral administration
• Also available as an injectable formulation for severe or systemic infections requiring rapid coverage

The following drug combinations with Sefin 250 mg/vial require careful clinical monitoring due to the risk of additive or enhanced toxicity:

Aminoglycosides (e.g., gentamicin, amikacin): Concurrent use may increase the risk of nephrotoxicity (kidney damage). Renal function should be monitored closely if co-administration is necessary.

Loop Diuretics (e.g., furosemide, ethacrynic acid): Concomitant use enhances the possibility of renal toxicity. Use with caution and monitor kidney function.

Probenecid: Reduces the renal tubular secretion of Sefin 250 mg/vial, leading to elevated serum drug levels and an increased risk of renal toxicity. Avoid concurrent use where possible.

Adverse reactions to Sefin 250 mg/vial are generally limited to gastrointestinal disturbances and occasional hypersensitivity phenomena. Individuals with a prior history of allergy, asthma, hay fever, or urticaria are at greater risk of hypersensitivity reactions.

Common / General

• Nausea, vomiting, diarrhoea, abdominal pain, heartburn, glossitis
• Dizziness, tightness in the chest
• Vaginitis, Candida overgrowth (secondary to antibiotic use)

Skin & Hypersensitivity Reactions

• Urticaria, skin rashes, joint pains, oedema
• Fever, serum sickness-like reactions, anaphylaxis

Blood & Lymphatic System Disorders (frequency unknown)

• Thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia

Psychiatric Disorders (frequency unknown)

• Confusion, sleep disturbances

Nervous System Disorders (frequency unknown / rare)

• Hyperactivity, hypertonia, dizziness, nervousness; rarely headache

Hepatobiliary Disorders (frequency unknown)

• Liver enzyme disturbances, transient hepatitis, cholestatic jaundice

Renal & Urinary Disorders (frequency unknown)

• Reversible interstitial nephritis

Laboratory / Investigations (frequency unknown)

• Elevated blood urea nitrogen (BUN), serum creatinine, ALT, AST, total bilirubin, and alkaline phosphatase

Pregnancy: Although animal studies have not demonstrated any teratogenic effects, the safety of Sefin 250 mg/vial in human pregnancy has not been formally established. It should only be used during pregnancy when the potential benefit clearly justifies the potential risk to the fetus. Physician supervision is essential.

Lactation: Sefin 250 mg/vial is excreted in breast milk and should be used with caution in breastfeeding (lactating) mothers. The potential risk to the nursing infant should be carefully considered before prescribing.

Effect on Ability to Drive: Since Sefin 250 mg/vial may cause dizziness, patients should be advised to exercise caution when operating hazardous machinery or driving motor vehicles during treatment.

• Superinfection: Prolonged use of Sefin 250 mg/vial may result in overgrowth of non-susceptible organisms (e.g., Candida spp.), leading to secondary (superimposed) infections. Monitor patients accordingly.
• Cross-sensitivity with Penicillins: Administer with care in patients with known penicillin hypersensitivity, due to the risk of cross-reactivity between beta-lactam antibiotics.
• Coombs Test Interference: Cephalosporin antibiotics may cause a false-positive result in Coombs' testing. In neonates whose mothers received cephalosporins prior to delivery, a positive Coombs result may be drug-induced and should be interpreted clinically.
• False-Positive Urine Glucose: Sefin 250 mg/vial may produce a false-positive urine glucose result when tested with Benedict's solution, Fehling's solution, or Clinitest tablets. This interference does not occur with enzyme-based tests such as Clinistix or Diastix.
• Renal Impairment: Dosage adjustment is required in patients with reduced renal function. Refer to the Use in Special Populations section for specific dose recommendations.
• Lactose-Containing Formulations: Patients with hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not use Sefin 250 mg/vial formulations containing lactose.

Symptoms of Sefin 250 mg/vial overdose are non-specific and primarily gastrointestinal, including nausea, vomiting, diarrhoea, and general gastric upset.

Management: Treatment is mainly supportive and symptomatic. Gastric lavage should be performed if a large amount has been ingested. Adequate hydration should be maintained and renal function monitored. Seek medical attention immediately in cases of suspected overdose.

Renal Impairment — Dose Adjustment

The following doses are recommended for patients not on haemodialysis (based on a standard 500 mg every 6 hours regimen):

Patients on Chronic Intermittent Haemodialysis:

• 250 mg at the start of haemodialysis
• 250 mg 6–12 hours after the start of haemodialysis
• 250 mg 36–48 hours after the start of haemodialysis
• 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose

Additional Notes for All Patients:

• Higher doses of up to 1 g four times daily (QID) may be required for severe or chronic infections, regardless of patient age or weight.
• Paediatric doses must not exceed the adult maximum, regardless of infection severity.
• For persistent infections, several weeks of continued Sefin 250 mg/vial therapy may be necessary.
• Patients may be transferred from IM/IV to oral Sefin 250 mg/vial at the same dosage level.

First generation Cephalosporins

Sefin 250 mg/vial is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Sefin 250 mg/vial. The main site of action of Sefin 250 mg/vial is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Sefin 250 mg/vial inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Sefin 250 mg/vial is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis: CrCl: >20 ml/min: 500 mg every 6 hours CrCl: 5-20 ml/min: 250 mg every 6 hours CrCl: <5 ml/min: 250 mg every 50-70 hours. Recommendations for patients on chronic, intermittent haemodialysis: 250 mg at the start of haemodialysis 250 mg 6 to 12 hours after the start 250 mg 36 to 48 hours after the start 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose. Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required. Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Sefin 250 mg/vial therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Sefin 250 mg/vial therapy to oral treatment at the same dosage level.