Supraks Solutab - instructions for use, dose, side effects, contraindications

microcrystalline cellulose, low-substituted giprolase, silicon dioxide colloid, povidone, magnesium stearate, calcium saccharinate trisesquihydrate, strawberry flavor (FA 15757 and PV 4284), yellow sunset sunset (E110).

Description:An oblong pill of pale orange color with a risk on both sides, with the smell of strawberry.

Pharmacotherapeutic group:Antibiotic-cephalosporin

ATX: & nbsp

J.01.D.D.08 Cefixim

Pharmacodynamics:

Mechanism of action

Semisynthetic antibiotic from the group of cephalosporins of the third generation for oral administration. Has a bactericidal effect. The mechanism of action is associated with the inhibition of bacterial cell wall synthesis. Cefixim is resistant to the action of β-lactamases produced by many gram-positive and gram-negative bacteria.

Spectrum of antimicrobial activity

In clinical practice and in vitro the efficacy of cefifim has been confirmed in infections caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae.

Cefixime also has activity in vitro against gram-positive - Streptococcus agalactiae and Gram-negative bacteria - Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus.

TO drug are stable Pseudomonas spp., Enterococcus spp., Listeria monocytogenes, most strains Enterobacter spp., Staphylococcus spp. (including methicillin-resistant strains), Bacteroides fragilis, Clostridium spp.

Pharmacokinetics:

Absorption

When administered, the bioavailability is 40-50% and does not depend on food intake. The maximum concentration in the blood plasma (C_m_Oh) in adults after oral administration in a dose of 400 mg is achieved after 3-4 hours and is 2.5-4.9 μg / ml, after taking a dose of 200 mg - 1.49-3.25 μg / ml. Taking food to absorb the drug from the digestive tract does not have a significant effect.

Distribution

The volume of distribution with the introduction of 200 mg of cefixime was 6.7 liters, with an equilibrium concentration of 16.8 liters. With plasma proteins, about 65% cefixime. The highest concentrations cefixime creates in the urine and bile. Cefixim penetrates the placenta. The concentration of cefixime in the blood of the umbilical cord reached 1 / 6-1 / 2 of the concentration of the drug in the mother's blood plasma; in breast milk the drug is not determined.

Metabolism and excretion

The half-life in adults and children is 3-4 hours. Cefixim not metabolized in the liver; 50-55% of the accepted dose is excreted in the urine unchanged for 24 hours. About 10% of cefixime is excreted with bile.

Pharmacokinetics in special clinical situations

If the patient has renal insufficiency, one can expect an increase in the half-life and, accordingly, a higher concentration of the drug in the plasma and a slower elimination of its elimination by the kidneys. In patients with creatinine clearance of 30 ml / min with 400 mg of cefixime, the elimination half-life increases to 7-8 hours, the maximum plasma concentration is on average 7.53 μg / ml, and excretion in urine in 24 hours is 5.5%. In patients with cirrhosis of the liver, the half-life increases to 6.4 hours, the time to reach the maximum concentration (TC_m_Oh) - 5.2 hours; At the same time, the proportion of the drug eliminated by the kidneys increases. FROM_m_Oh and the area under the pharmacokinetic curve does not change.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- Streptococcal tonsillitis and pharyngitis;

- sinusitis;

- acute bronchitis;

- exacerbation of chronic bronchitis;

acute otitis media;

uncomplicated urinary tract infections;

uncomplicated gonorrhea;

- shigellosis.

Contraindications:

- Hypersensitivity to cefixime or the components of the drug;

- hypersensitivity to cephalosporins or penicillins;

- is not recommended for use in children with chronic renal failure and in children weighing less than 25 kg in this dosage form.

Carefully:Elderly age, renal failure, colitis (in history), pregnancy.

Pregnancy and lactation:The use of SupraX® Solutab® in pregnancy is possible when the intended benefit to the mother exceeds the potential risk to the fetus. If you need to use the drug during lactation, breastfeeding should be discontinued.

Dosing and Administration:

For adults and children weighing more than 50 kg, the daily dose is 400 mg in one or two doses.

Children with a body weight of 25-50 kg of the drug is administered at a dose of 200 mg per day in one session.

The tablet can be swallowed by washing with a sufficient amount of water, or diluted in water and drunk the resulting suspension immediately after preparation. The drug can be taken regardless of food intake.

The duration of treatment depends on the nature of the course of the disease and the type of infection. After the symptoms of infection and / or fever disappear, it is advisable to continue taking the drug for at least 48-72 hours.

The course of treatment for respiratory infections and JIOP-organs is 7-14 days.

With tonsillofaringitis caused by Streptococcus pyogenes, the duration of treatment should be at least 10 days.

With uncomplicated gonorrhea, the drug is prescribed at a dose of 400 mg once.

In uncomplicated infections of the lower urinary tract in women, the drug can be administered within 3-7 days, with uncomplicated upper urinary tract infections in women - 14 days.

In uncomplicated infections of the upper and lower urinary tract in men, the duration of treatment is 7-14 days.

If the renal function is impaired, the dose is set depending on the creatinine clearance in the blood serum.

With creatinine clearance of 21-60 ml / min or in patients on hemodialysis, it is recommended to use other dosage forms of the drug in connection with the need to reduce the daily dose by 25%.

With a creatinine clearance of 20 ml / min or less, or in patients on peritoneal dialysis, the daily dose should be reduced by a factor of 2.

Side effects:

Side effects are classified by frequency of reported cases: Very often: (> 10%); often (1-10%); infrequently (0.1-1%); rarely (0.01-0.1%); rarely (<0,01%);

On the part of the blood system and hemopoiesis:

Rarely: transient leukopenia, agranulocytosis, pancytopenia, thrombocytopenia or eosinophilia. There were isolated cases of blood clotting disorders.

Frequency unknown: hemolytic anemia.

Allergic reactions:

Rarely: allergic reactions (for example, urticaria, rash, erythema multiforme, itchy skin).

Rarely: Lyell's syndrome (toxic epidermal necrolysis); other allergic reactions associated with sensitization - drug fever, a syndrome similar to serum sickness, hemolytic anemia and interstitial nephritis, Stevens-Johnson syndrome, anaphylactic shock.In some patients cases of the syndrome of drug rash with eosinophilia and systemic manifestations were noted.

From the nervous system:

Infrequently: headaches, dizziness, dysphoria, anxiety.

From the respiratory system:

Frequency unknown: dyspnoea.

Reactions from the digestive system.

Often: abdominal pain, digestive disorders, nausea, vomiting and diarrhea.

Rarely: pseudomembranous colitis.

From the hepatobiliary system:

Rarely: an increase in the activity of alkaline phosphatase and "liver" transaminases, an increase in the concentration of bilirubin in the blood.

Rarely: isolated cases of hepatitis and cholestatic jaundice.

From the genitourinary system:

Rarely: a slight increase in the concentration of creatinine and urea in the blood, hematuria, possibly the development of acute renal failure, accompanied by tubulointerstitial nephritis.

Overdose:

When taken in a dose exceeding the maximum daily, it is possible to increase the frequency of the above described dose-dependent side effects.

Treatment: gastric lavage; conduct symptomatic and supportive therapy.Hemodialysis and peritoneal dialysis are not effective.

Interaction:

The tubular secretion blockers (probenecid, etc.) slow the excretion of cefixime through the kidneys, which can lead to overdose symptoms.

Cefixim reduces the prothrombin index, increases the effect of indirect anticoagulants.

With the simultaneous use of cefixime with carbamazepine, an increase in plasma concentration was observed; in such cases it is advisable to carry out therapeutic drug monitoring.

Special instructions:

In connection with the possibility of the occurrence of cross-allergic reactions with penicillins, it is recommended to carefully evaluate the patient's history. If an allergic reaction occurs, the drug should be discontinued immediately. In the event of toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, drug rash syndrome with eosinophilia and systemic manifestations, cefixime reception should be discontinued and the necessary therapy should be performed.

With the development of anaphylactic shock, the drug should be stopped, epinephrine (adrenaline), systemic glucocorticosteroids and antihistamines.

With prolonged use of the drug, it is possible to disrupt the normal intestinal microflora, which can lead to excessive reproduction of Clostridium difficile and the development of pseudomembranous colitis. When light forms of antibiotic-associated diarrhea appear, it is usually enough to stop taking the drug. In more severe forms, a corrective treatment is recommended (for example, the administration of vancomycin by 250 mg 4 times a day). Antidiarrhoeal drugs that inhibit gastrointestinal motility are contraindicated in the development of pseudomembranous colitis.

Like other cephalosporins, cefixime can cause acute kidney failure, accompanied by tubulointerstitial nephritis. In the case of acute renal failure, cephalaxis should be stopped, appropriate measures taken and / or appropriate treatment should be prescribed.

In the case of the use of SupraX® Solutab® concomitantly with aminoglycosides, polymyxin B, sodium colistimetate, "loop" diuretics (furosemide, ethacrynic acid) in high doses, it is necessary to monitor kidney function. After prolonged treatment with SupraX® Solutab®, the status of the hematopoietic function should be checked.

Dispersible tablets should be dissolved only in water. During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible with some test systems for express diagnostics.

Effect on the ability to drive transp. cf. and fur:Studies of the effect of Ceforal Solutab on the ability to drive vehicles and mechanisms have not been carried out. Due to possible adverse effects (eg, dizziness), care should be taken.

Form release / dosage:

Tablets are dispersible 400 mg.

Packaging:

1, 5, 7 tablets in the blister of PVDC / PVC film and aluminum foil.

1 blister for 1, 5, 7 tablets or 2 blisters for 5 tablets together with instructions for use in a cardboard bundle.

Storage conditions:Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-005995/10

Date of registration:06/25/2010 / LSR-005995/10

Expiration Date:Unlimited

The owner of the registration certificate:Astellas Farma Europe BVAstellas Farma Europe BV Netherlands

Manufacturer: & nbsp

A.MENARINI Manufacturing Logistics and Servicer Italy

Representation: & nbspASTELLAS PHARMA YUROP BV ASTELLAS PHARMA YUROP BV Netherlands

Information update date: & nbsp14.01.2016

Illustrated instructions

Instructions

Suprax® Solutab® (Suprax® Solutab®)