Sofasin (Tablets) Instructions for Use

Marketing Authorization Holder

Faran Laboratories, S.A. (Greece)

ATC Code

J01MA06 (Norfloxacin)

Active Substance

Norfloxacin (Rec.INN registered by WHO)

Dosage Form

Sofasin

Film-coated tablets, 400 mg: 14 pcs.

Dosage Form, Packaging, and Composition

14 pcs. – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug of the fluoroquinolone group

Pharmacotherapeutic Group

Antimicrobial agent – fluoroquinolone

Pharmacological Action

A broad-spectrum antimicrobial synthetic agent of the fluoroquinolone group. It has a bactericidal effect. By suppressing DNA gyrase, it disrupts the DNA supercoiling process.

It is highly active against most gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Pseudomonas aeruginosa, Neisseria gonorrhoeae, Neisseria meningitidis.

It is active against some gram-positive bacteria (including Staphylococcus aureus).

Anaerobic bacteria are resistant to norfloxacin, while Enterococcus spp. and Acinetobacter spp. have low sensitivity.

It is resistant to the action of β-lactamases.

Pharmacokinetics

When taken orally, about 30-40% is absorbed; food intake reduces the rate of absorption. Plasma protein binding is 14%. Norfloxacin is well distributed in the tissues of the urogenital system. It crosses the placental barrier. About 30% is excreted unchanged in the urine.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to norfloxacin, including diseases of the urinary tract, prostate gland, gastrointestinal tract, gonorrhea, prevention of recurrences of urinary tract infections, bacterial infections in patients with granulocytopenia, “traveler’s diarrhea”.

ICD codes

Dosage Regimen

Administer the dosage individually, based on the type and severity of the infection.

For uncomplicated urinary tract infections, take 400 mg twice daily for 7-10 days.

For complicated urinary tract infections, take 400 mg twice daily for 10-21 days.

For bacterial prostatitis, take 400 mg twice daily for 28 days

For uncomplicated gonorrhea, administer a single 800 mg dose.

For gastrointestinal infections, including “traveler’s diarrhea,” take 400 mg twice daily for 3-5 days.

For prophylaxis of recurrent urinary tract infections, take 200 mg once daily at bedtime.

For patients with renal impairment, adjust the dosage: for creatinine clearance 30 mL/min/1.73 m² or higher, use the standard regimen; for clearance below 30 mL/min/1.73 m², administer 400 mg once daily.

Take tablets orally with a full glass of water.

Take the dose at least 2 hours before or 2 hours after consuming antacids or products containing iron, zinc, magnesium, or calcium.

Complete the full prescribed course of therapy, even if symptoms improve.

Adverse Reactions

From the digestive system nausea, heartburn, anorexia, diarrhea, abdominal pain.

From the CNS headache, dizziness, feeling of fatigue, sleep disorders, irritability, feeling of anxiety.

Allergic reactions skin rash, itching, angioedema.

From the urinary system interstitial nephritis.

Contraindications

Pregnancy, lactation (breastfeeding), childhood and adolescence (up to 15 years), glucose-6-phosphate dehydrogenase deficiency, hypersensitivity to norfloxacin and other quinolone drugs.

Use in Pregnancy and Lactation

Norfloxacin is contraindicated during pregnancy and lactation (breastfeeding), since experimental studies have established that it causes arthropathy.

Use in Hepatic Impairment

Should be used with caution in patients with severe liver dysfunction.

Use in Renal Impairment

Should be used with caution in patients with severe renal impairment.

Pediatric Use

Contraindicated in childhood and adolescence (up to 15 years).

Special Precautions

Should be used with caution in patients with epilepsy, convulsive syndrome of other etiology, and with severe impairment of renal and liver function. During treatment, patients should receive a sufficient amount of fluid (under diuresis control).

Norfloxacin should be taken at least 2 hours before or 2 hours after taking antacids or preparations containing iron, zinc, magnesium, calcium, or sucralfate.

Drug Interactions

With simultaneous use of norfloxacin with warfarin, the anticoagulant effect of the latter is enhanced.

With simultaneous use of norfloxacin with cyclosporine, an increase in the concentration of the latter in the blood plasma is noted.

With simultaneous administration of norfloxacin and antacids or preparations containing iron, zinc, magnesium, calcium, or sucralfate, the absorption of norfloxacin is reduced due to the formation of chelates with metal ions (the interval between their intake should be at least 4 hours).

With simultaneous administration, Norfloxacin reduces the clearance of theophylline by 25%, therefore, when used concomitantly, the dose of theophylline should be reduced.

Simultaneous administration of norfloxacin with drugs that have a potential ability to reduce blood pressure can cause a sharp decrease in it. In this regard, in such cases, as well as with simultaneous administration of barbiturates and anesthetic agents, heart rate, blood pressure, and ECG parameters should be monitored. Simultaneous use with drugs that lower the epileptic threshold can lead to the development of epileptiform seizures.

Reduces the effect of nitrofurans.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.