Oxampicine (Capsules, Powder) Instructions for Use

ATC Code

J01CR50 (Penicillin combinations)

Active Substances

Oxacillin (Rec.INN registered by WHO)

Ampicillin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Broad-spectrum penicillin antibiotic, resistant to penicillinase

Pharmacotherapeutic Group

Combined antibiotic (semisynthetic penicillins)

Pharmacological Action

A combined antibiotic that unites the spectrum of action of ampicillin and oxacillin.

Ampicillin is a semisynthetic penicillin that acts bactericidally and is acid-resistant. It is active against gram-positive, non-penicillinase-producing microorganisms ( Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae), and gram-negative microorganisms ( Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Salmonella spp., Shigella spp., Proteus mirabilis, Haemophilus influenzae).

Oxacillin is a penicillinase-resistant semisynthetic antibiotic from the penicillin group, acid-resistant; it has a bactericidal effect against gram-positive microorganisms ( Staphylococcus spp., Streptococcus spp., including Streptococcus pneumoniae, Actinimyces spp., Bacillus anthracis, Corynebacterium diphtheriae, anaerobic spore-forming bacilli, including Clostridium), gram-negative cocci ( Neisseria gonorrhoeae, Neisseria meningitidis), Escherichia coli, Proteus mirabilis, Haemophilus influenzae, Klebsiella pneumoniae, Actinomyces spp., Treponema spp.

Pseudomonas aeruginosa and other non-fermenting gram-negative bacteria, most strains of Proteus vulgaris, Providencia rettgeri, Morganella morganii are resistant to the action of the combination.

Pharmacokinetics

T_Cmax of both antibiotics in the blood is 0.5-1 h after intramuscular administration.

Both antibiotics are excreted by the kidneys, partially with bile. They do not accumulate upon repeated administration.

Indications

Bacterial infections caused by susceptible pathogens, including sinusitis, tonsillitis, otitis media; bronchitis, pneumonia; cholangitis, cholecystitis; pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, cervicitis; infections of the skin and soft tissues: erysipelas, impetigo, secondarily infected dermatoses.

Prophylaxis of postoperative complications during surgical interventions (including against the background of immunodeficiency), infections in newborns (infection of amniotic fluid; neonatal respiratory distress requiring resuscitation measures; risk of aspiration pneumonia).

Severe infections (sepsis, endocarditis, meningitis, postpartum infection).

ICD codes

Dosage Regimen

Powder

The dosage is established individually, depending on the indications, clinical situation, and patient’s age.

For intramuscular administration, the daily dose for adults and children over 14 years is 3-6 g; for newborns, premature infants, and children under 1 year – 100-200 mg/kg; 1-6 years – 100 mg/kg; 7-14 years – 100 mg/kg. The daily dose is administered in 3-4 doses, with an interval of 6-8 hours. If necessary, these doses can be increased by 1.5-2 times.

Capsules

The dosage regimen is established individually, depending on the indications, clinical situation, and patient’s age.

For oral administration, a single dose for adults and children over 14 years is 0.5-1 g, the daily dose is 2-4 g. Children 3-7 years are prescribed 100 mg/kg/day, 7-14 years – 50 mg/kg/day. The duration of treatment is from 5-7 days to 2 weeks. The daily dose is divided into 4-6 doses.

Adverse Reactions

Allergic reactions: urticaria, skin hyperemia, angioedema, rhinitis, conjunctivitis; fever, arthralgia, eosinophilia, in rare cases – anaphylactic shock;

From the digestive system: taste alteration, nausea, vomiting, diarrhea, rarely – pseudomembranous enterocolitis.

From the hematopoietic system: leukopenia, neutropenia, anemia.

General reactions: superinfection, dysbacteriosis.

Local reactions: infiltration at the injection site, pain.

Contraindications

Hypersensitivity to the components of the drug; infectious mononucleosis; lymphocytic leukemia.

With caution

Chronic renal failure; children born to mothers with hypersensitivity to penicillins.

Use in Pregnancy and Lactation

Use during pregnancy is possible according to indications, in recommended doses and regimens.

It is excreted in breast milk in low concentrations. If it is necessary to use the drug during lactation, the issue of discontinuing breastfeeding should be considered.

Use in Hepatic Impairment

During course treatment, it is necessary to monitor the state of liver function.

Use in Renal Impairment

Should be used with caution in chronic renal failure. When used in high doses in patients with renal failure, toxic effects on the CNS are possible. During course treatment, it is necessary to monitor the state of kidney function.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and regimens. Use with caution in children born to mothers with hypersensitivity to penicillins.

Special Precautions

During course treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver, and kidneys.

The possibility of developing superinfection (due to the growth of flora insensitive to it) requires an appropriate change in antibacterial therapy.

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

When used in high doses in patients with renal failure, toxic effects on the CNS are possible.

Drug Interactions

Antacids, glucosamine, laxatives, food, aminoglycosides (when taken orally) slow down and reduce absorption; ascorbic acid increases absorption.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) – synergism of action; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) – antagonism of action.

Increases the effectiveness of indirect anticoagulants (by suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index); reduces the effectiveness of oral contraceptives, drugs in the process of metabolism of which PABA is formed, ethinylestradiol – risk of “breakthrough” bleeding.

Diuretics, allopurinol, tubular secretion blockers, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of the drug components in plasma, which increases the risk of toxic effects.

Allopurinol – increased risk of skin rash.

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.