Орфикс

General characteristics. Structure:

Active ingredient: 200 mg of a tsefiksim.

Excipients: calcium phosphate, cellulose microcrystallic, starch prezhelatinizirovanny, sodium lauryl sulfate, magnesium stearate.

Structure of a cover: copper of chlorophyllin, titanium dioxide, propylparaben, methylparaben.

Pharmacological properties:

Pharmacodynamics. Tsefalosporinovy antibiotic of the III generation. Has bactericidal effect at the expense of inhibition of synthesis of mukopeptid of a wall of a bacterial cell that leads to lysis and death of a bacterium.

It is highly active concerning gram-positive microorganisms: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae; gram-negative microorganisms: Escherichia coli, Haemophilus influenzae (including the strains producing β-lactamelements), Maraxella catarrhalis (including on the majority of the strains producing β-lactamelements), Proteus mirabilis, Neisseria gonorrhoeae (including the strains producing a penicillinase), Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus, Serratia marcescens.

Pharmacokinetics. Absorption and distribution. At intake about 40-50% of drug are soaked up. At administration of drug in a dose of 200 mg of Cmax in serum makes about 2 mkg/ml (from 1 to 4 mkg/ml). Drug Tmax in serum makes 3–4 h. Time of the maximum absorption of drug at inclusion in time of food increases approximately by 0.8 h.

Linkng with proteins of plasma - about 65%.

Metabolism and removal. Drug is not metabolized in an organism. T1/2 of a tsefiksim averages 3–4 h, however can reach 9 h. About 50% of drug are removed with urine in not changed look in 24 h.

Pharmacokinetics in special clinical cases. At patients with a renal failure of moderate severity (KK from 20 to 40 ml/min.) T1/2 of drug increases to 6.4 h. At patients with a renal failure of heavy degree (KK from 5 to 20 ml/min.) T1/2 of drug increases to 11,5 h.

Indications to use:

The infectious and inflammatory diseases caused by microorganisms, sensitive to drug:

— acute and chronic pharyngitis, tonsillitis, sinusitis, bronchitis;

— average otitis;

— uncomplicated infections of urinogenital system (including gonorrhea).

Route of administration and doses:

At adults and children 12 years are aged more senior (with body weight more than 50 kg) the daily dose of drug makes 400 mg (1 times/days or on 200 mg of 2 times/days).

At children aged from 6 years up to 12 years the daily dose of drug makes 8 mg/kg/days or on 4 mg/kg each 12 h.

Duration of a course of treatment depends on disease severity and is established individually. Average courses of treatment and doses are presented in the table:

Infection	Dose	Therapy duration
Uncomplicated infections of urinary tract or upper parts of respiratory tracts	400 mg once or on 200 mg each 12 h	5–10 days
Infections of lower parts of respiratory tracts	400 mg once or on 200 mg each 12 h	10-14 days
Average otitis	400 mg once or on 200 mg each 12 h	10–14 days
The infections caused by a β-hemolitic streptococcus of group A	400 mg once or on 200 mg each 12 h	10 days
Uncomplicated gonorrhea of an urethra and neck of uterus	400 mg	Single dose

The recommended mode of use of drug for patients with a renal failure is presented in the table:

Clearance of creatinine	Daily dose
≥60 ml/min.	400 mg
21–60 ml/min. or hemodialysis	300 mg
≤20 ml/min. or long out-patient peritoneal dialysis	200 mg

Features of use:

Use at pregnancy and feeding by a breast. Use of drug at pregnancy and in the period of a lactation perhaps only in that case when the estimated advantage for mother surpasses potential risk for a fruit and the child.

In need of appointment in the period of a lactation it is necessary to stop breastfeeding.

Use at renal failures. At patients with a renal failure drug T1/2 increases.

Special instructions. It is necessary to use with care drug at hypersensitivity to cephalosporins and other medicines, in particular, to penicillin.

At some patients against the background of administration of drug false positive reaction of urine to ketones when using Sodium nitroprussidum, but not is possible when using nitroferricyanide.

Against the background of administration of drug false positive reaction of urine to glucose with Benedict or Fellinga's reactant is possible.

Against the background of reception of tsefalosporinovy antibiotics false positive direct test of Koombs is possible.

Use in pediatrics. Safety and efficiency of use of a tsefiksim for children aged up to 6 months is unknown. Children under 6 years are not recommended to use drug in a dosage form of the capsule.

Influence on ability to driving of motor transport and to control of mechanisms. It is necessary to be careful during the driving of motor transport and control of mechanisms.

Side effects:

From the alimentary system: diarrhea, soft and frequent chair, abdominal pains, dyspepsia, nausea and vomiting, meteorism.

From TsNS: headache, dizziness.

From a reproductive system: genital itch, vaginitis, candidiasis.

From system of a hemopoiesis: passing thrombocytopenia, leukopenia and eosinophilia.

From coagulant system of blood: seldom - increase in a prothrombin time.

From a metabolism: short-term increase in hepatic tests and ShchF, short-term increase in total quantity of nitrogen in blood or creatinine.

Allergic reactions: skin rash, small tortoiseshell, medicinal fever, itch, Stephens-Johnson's syndrome, mnogoformny erythema, arthralgia.

Interaction with other medicines:

At simultaneous use of a tsefiksim and warfarin, and also other anticoagulants the increase in a prothrombin time sometimes leading to bleeding is noted.

The combined use of a tsefiksim with carbamazepine leads to increase in level of carbamazepine.

It is necessary to appoint with care tsefiksy with the above-stated drugs.

Contraindications:

Hypersensitivity to antibiotics of a tsefalosporinovy and penicillinic row.

Overdose:

Symptoms: strengthening of side reactions.

Treatment: a gastric lavage, carry out symptomatic and supporting therapy, an oxygenotherapy, IVL. At haemo - or peritoneal dialysis the insignificant quantity of a tsefiksim is removed. The specific antidote is unknown.

Storage conditions:

Drug should be stored in the unavailable to children, dry, protected from light place at a temperature not above 25 °C. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

10 pieces - strips (1) - boxes cardboard.
10 pieces - strips (5) - boxes cardboard.