Ambicef (Powder) Instructions for Use

Marketing Authorization Holder

Pharmasintez, JSC (Russia)

ATC Code

J01DC01 (Cefoxitin)

Active Substance

Cefoxitin (Rec.INN registered by WHO)

Dosage Forms

	Ambicef	Powder for preparation of solution for intravenous and intramuscular administration 0.5 g: vials 1, 5, 10, 15, 25, 50 or 100 pcs.
		Powder for preparation of solution for intravenous and intramuscular administration 1 g: vials 1, 5, 10, 15, 25, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint.

0.5 g – vials (1) – cardboard packs.
0.5 g – vials (5) – cardboard packs.
0.5 g – vials (10) – cardboard packs.
0.5 g – vials (15) – cardboard packs.
0.5 g – vials (25) – cardboard packs.
0.5 g – vials (50) – cardboard packs.
0.5 g – vials (100) – cardboard packs.

Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint.

1 g – vials (1) – cardboard packs.
1 g – vials (5) – cardboard packs.
1 g – vials (10) – cardboard packs.
1 g – vials (15) – cardboard packs.
1 g – vials (25) – cardboard packs.
1 g – vials (50) – cardboard packs.
1 g – vials (100) – cardboard packs.

Clinical-Pharmacological Group

Second generation cephalosporin

Pharmacotherapeutic Group

Systemic antibacterial agents; other beta-lactam antibacterial agents; second-generation cephalosporins

Pharmacological Action

Cephalosporin antibiotic of the second generation with a broad spectrum of action. It has a bactericidal effect.

It is highly active against gram-negative bacteria: Haemophilus influenzae, Escherichia coli, Salmonella spp., Shigella spp., Enterobacter spp., Proteus mirabilis, Neisseria gonorrhoeae; gram-positive bacteria: Staphylococcus spp., Streptococcus spp.; anaerobic bacteria: Bacteroides spp.

It is not active against Pseudomonas spp., most strains of Enterococcus spp., many strains of Enterobacter cloacae, methicillin-resistant strains of Staphylococcus spp. and Listeria monocytogenes.

It is resistant to the action of beta-lactamases.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to cefoxitin, including abdominal and gynecological infections, sepsis, endocarditis, urinary tract infections, respiratory tract infections, bone and joint infections, skin and soft tissue infections.

Mixed infections caused by sensitive strains of aerobic and anaerobic bacteria. Prevention of postoperative infectious complications.

ICD codes

Dosage Regimen

The dosage is set individually, taking into account the severity and localization of the infection, and the sensitivity of the pathogen. It is administered intramuscularly or intravenously (bolus or drip).

The average dose for adults is 1-2 g every 8 hours. For severe infections, the daily dose can be increased to 200 mg/kg (but not more than 12 g). In case of impaired renal excretory function, the first dose is 1-2 g, and subsequently the single dose should be reduced and the intervals between administrations increased.

For children, a single dose is 20-40 mg/kg; the interval between administrations for premature infants weighing 1500 g and newborns of the first week of life is 12 hours, for newborns 1-4 weeks of life – 8 hours, over 1 month – 6-8 hours.

For the prevention of postoperative infections, adults are administered 2 g intramuscularly or intravenously 0.5-1 hour before the start of surgery; after surgery – 2 g every 6 hours during the first day. Children are administered 30-40 mg/kg with the same intervals, however, for newborns, the 2nd and 3rd doses are administered after 8-12 hours. During a caesarean section, 2 g is administered intravenously as a single dose after clamping the umbilical cord.

Adverse Reactions

With prolonged use in high doses : nausea, vomiting, dry mouth, loss of appetite, diarrhea, skin allergic reactions, arterial hypotension may occur; rarely – pseudomembranous colitis, changes in peripheral blood picture (leukopenia, neutropenia, thrombocytopenia), anemia (including hemolytic), transient increase in the concentration of liver enzymes in the blood, impaired renal function.

Contraindications

Hypersensitivity to cephalosporins.

Use in Pregnancy and Lactation

Use during pregnancy and lactation is possible only in cases of extreme necessity, when the intended benefit to the mother outweighs the potential risk to the fetus or child.

Use in Hepatic Impairment

Use with caution in severe hepatic impairment.

Use in Renal Impairment

Use with caution in severe renal impairment.

Pediatric Use

Use is possible according to the dosage regimen.

Special Precautions

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

Cefoxitin is not recommended for the treatment of meningitis.

Use with caution in severe impairment of renal and/or hepatic function.

During treatment, a positive direct Coombs test is possible.

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.