Betasporina (Powder) Instructions for Use

Marketing Authorization Holder

Laboratorios Atral, S.A. (Portugal)

ATC Code

J01DD04 (Ceftriaxone)

Active Substance

Ceftriaxone (Rec.INN registered by WHO)

Dosage Form

Betasporina

Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 or 50 pcs.

Dosage Form, Packaging, and Composition

1 g – vials (50) – cardboard boxes.
1 g – 10 ml vials (1) – cardboard packs.
1 g – 10 ml vials (50) – cardboard packs.

Clinical-Pharmacological Group

Third generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

Ceftriaxone is a broad-spectrum third-generation cephalosporin antibiotic. It exerts a bactericidal effect by inhibiting bacterial cell wall synthesis. Ceftriaxone acetylates membrane-bound transpeptidases, thereby disrupting the cross-linking of peptidoglycans necessary for providing strength and rigidity to the cell wall.

It is active against aerobic, anaerobic, gram-positive and gram-negative bacteria.

It is resistant to the action of beta-lactamases.

Pharmacokinetics

Plasma protein binding is 85-95%. Ceftriaxone is widely distributed in body tissues and fluids. Therapeutic concentrations are achieved in the cerebrospinal fluid in meningitis. High concentrations are achieved in bile. It crosses the placental barrier and is excreted in breast milk in small amounts. About 40-65% of ceftriaxone is excreted unchanged in the urine. The remainder is excreted in bile and feces.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to ceftriaxone, including peritonitis, sepsis, meningitis, cholangitis, gallbladder empyema, shigellosis, salmonella carriage, pneumonia, lung abscess, pleural empyema, pyelonephritis, infections of bones, joints, skin and soft tissues, genital organs, infected wounds and burns.

Prevention of postoperative infection.

ICD codes

Dosage Regimen

Individual. Administered intramuscularly or intravenously at 1-2 g every 24 hours or 0.5-1 g every 12 hours. Depending on the etiology of the disease, it can be administered intramuscularly at a dose of 250 mg as a single dose. The daily dose for newborns is 20-50 mg/kg; for children aged 2 months to 12 years – 20-100 mg/kg; frequency of administration is once a day. The duration of the course is determined individually. In patients with impaired renal function, adjustment of the dosage regimen is required, taking into account the creatinine clearance values.

Maximum daily doses for adults – 4 g, for children – 2 g.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea, transient increase in the activity of hepatic transaminases, cholestatic jaundice, hepatitis, pseudomembranous colitis.

Allergic reactions: skin rash, itching, eosinophilia; rarely – angioedema.

From the hematopoietic system: with prolonged use in high doses, changes in the peripheral blood picture are possible (leukopenia, neutropenia, thrombocytopenia, hemolytic anemia).

From the blood coagulation system: hypoprothrombinemia.

From the urinary system: interstitial nephritis.

Effects due to chemotherapeutic action: candidiasis.

Local reactions: phlebitis (with intravenous administration), pain at the injection site (with intramuscular administration).

Contraindications

Hypersensitivity to ceftriaxone and other cephalosporins.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies on the safety of ceftriaxone during pregnancy have not been conducted.

The use of ceftriaxone during pregnancy and lactation is possible in cases where the intended therapeutic benefit for the mother outweighs the potential risk to the fetus.

Ceftriaxone is excreted in breast milk in low concentrations.

In experimental studies in animals, no teratogenic or embryotoxic effects of ceftriaxone were found.

Use in Renal Impairment

In patients with impaired renal function, adjustment of the dosage regimen is required, taking into account the creatinine clearance values.

Use with caution in severe renal impairment.

Pediatric Use

In newborns with hyperbilirubinemia, especially premature infants, use is possible under strict medical supervision.

Special Precautions

In patients with hypersensitivity to penicillins, allergic reactions to cephalosporin antibiotics are possible.

Use with caution in severe renal impairment.

Ceftriaxone solutions should not be mixed or administered simultaneously with other antimicrobial drugs or solutions.

In newborns with hyperbilirubinemia, especially premature infants, use is possible under strict medical supervision.

Drug Interactions

Ceftriaxone, by suppressing the intestinal flora, interferes with the synthesis of vitamin K. Therefore, with simultaneous use with drugs that reduce platelet aggregation (NSAIDs, salicylates, sulfinpyrazone), the risk of bleeding increases. For the same reason, with simultaneous use with anticoagulants, an enhancement of the anticoagulant effect is noted.

With simultaneous use with “loop” diuretics, the risk of nephrotoxic effects increases.

Storage Conditions

Store at 15°C (59°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.