Suprax - instructions for use, dose, side effects, contraindications

Description:From almost white to cream color small granules. After mixing, a suspension is formed from almost white to cream-colored with sweet strawberry flavors.

Pharmacotherapeutic group:Antibiotic-cephalosporin.

ATX: & nbsp

J.01.D.D.08 Cefixim

Pharmacodynamics:

Cefixime is a semi-synthetic cephalosporin antibiotic of the third generation of a broad spectrum of action. Cefixim acts bactericidal, inhibiting the synthesis of the cell membrane, is resistant to the action of beta-lactamases produced by most gram-positive and gram-negative bacteria. In vitro and in conditions of clinical practice cefixime is usually effective against the following microorganisms:

gram-positive: Streptococcus pneumoniae, Streptococcus pyogenes;

gram-negative: Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Escherichia coli, Proteus mirabilis. Neisseria gonorrhoeae.

In vitro cefixime is usually effective against the following microorganisms:

gram-positive: Streptococcus agalactiae;

gram-negative: Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus, Serratia marcescens.

Note: Pseudomonas species, Enterococcus (Streptococcus) serogroup D. Listeria monocytogenes, most staphylococci, including methicillin-resistant strains. Enterobacter spp., Bacteroides fragilis, Clostridium spp. resistant to the action of cefixime.

Pharmacokinetics:

When administered inside the bioavailability of the drug is 40 to 50% regardless of food intake, but the maximum concentration of cefimax in the serum is achieved faster by 0.8 h when taking the drug with food.

When the suspension is taken, the maximum concentration in the blood serum is reached after 4 hours and is 2.8 μg / ml (with the intake of 200 mg) and 4.4 μg / ml (with 400 mg of the drug).

The connection with plasma proteins, mainly with atbumins, is 65%.

About 50% of the dose is excreted by the kidneys unchanged for 24 hours, about 10% of the dose

is excreted with bile.

The half-life period depends on the dose and ranges from 3 to 4 hours. If the renal function is impaired, creatinine clearance (CC) of 20-40 ml / min increases the half-life to 6.4 hours, with creatinine clearance of 5-10 ml / min - up to 11 , 5 hours

Indications:

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

-pharyngitis, tonsillitis, sinusitis;

- Acute and chronic bronchitis;

- Middle otitis media;

uncomplicated urinary tract infections;

uncomplicated gonorrhea.

Contraindications:Hypersensitivity, to cephalosporins and to penicillins, children's age (up to 6 months.).

Carefully:

elderly age, chronic renal failure, pseudomembranous colitis (in the anamnesis).

Pregnancy and lactation:

The use of the drug during pregnancy is possible if the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Children aged 6 months to 12 years are prescribed as a suspension at a dose of 8 mg / kg / day once or in 2 divided doses of 4 mg / kg every 12 hours.For children aged 5-11 years, the daily dose of the suspension is 6-10 ml, at the age of 2-4 years - 5 ml, at the age from 6 months to 1 year - 2.5-4 ml.

For adults and children over 12 years of age with a body weight of more than 50 kg - 400 mg once a day or 200 mg 2 times a day.

The average duration of treatment is 7-10 days.

In diseases caused by Streptococcus pyogenes, the course of treatment is at least 10 days. If the kidney function is disrupted, the dose is set depending on the KK value: with KK 21-60 ml / min or in patients on hemodialysis, the daily dose should be reduced by 25%. With CC 20 ml / min or less, or in patients on peritoneal dialysis, the daily dose should be halved.

Method of preparation of the suspension: turn the vial and shake the contents of the vial. Add 40 ml of cooled boiled water in 2 stages and shake until a homogeneous suspension forms, allow the suspension to settle for 5 minutes to ensure complete dissolution of the powder. Before use, the prepared suspension must be shaken well.

Use the suspension for 14 days from the time of preparation, subject to storage conditions from 15 to 25 ° C.

Side effects:

Allergic reactions: urticaria, skin hyperemia, skin itching, eosinophilia. fever, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic shock.

From the nervous system: headache, dizziness, tinnitus.

From the digestive system: dry mouth, anorexia, nausea, vomiting, diarrhea, constipation, flatulence, abdominal pain, dysbiosis, impaired liver function, cholestasis, cholestatic jaundice, candidiasis, rarely - stomatitis, glossitis, pseudomembranous enterocolitis.

From the hematopoiesis: pancytopenia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, bleeding.

From the urinary system: interstitial nephritis, impaired renal function.

From the genitourinary system: vaginitis.

Laboratory indicators: increased activity of "hepatic" transaminases and alkaline phosphatase, hyperbilirubinemia, increased urea nitrogen, hypercreatininaemia, increased prothrombin time.

Other: candidamycosis, reactions that resemble serum sickness, convulsions, acute renal failure, itching of the vagina, dyspnea.

Overdose:

Symptoms: increased adverse reactions, especially on the part of the digestive tract, except for allergic reactions.

Treatment: gastric lavage, symptomatic and supportive therapy. Cefixim is not excreted in large quantities from circulating blood by hemo-or peritoneal dialysis.

Interaction:

The tubular secretion blockers, allopurinol, diuretics delay the excretion of cefixin by the kidneys, which can lead to an increase in the concentration of the drug in the blood plasma.

With simultaneous use with carbamazepine, its concentration in the blood plasma increases.

Reduces the prothrombin index, increases the effect of indirect anticoagulants. Antacids containing magnesium or aluminum hydroxide, slow the absorption of the drug.

Special instructions:

Patients who had a history of allergic reactions to penicillins, may have increased sensitivity to cephalosporin antibiotics.

With prolonged intake of the drug, a normal intestinal microflora disorder may occur, which can lead to the growth of Clostridia difficile, cause severe diarrhea and pseudomembranous colitis.

During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible.

Patients with diabetes should take into account that the preparation contains sucrose 15 g in 20 ml (400 mg).

Effect on the ability to drive transp. cf. and fur:

Form release / dosage:

Granules for oral suspension, 100 mg / 5 ml

Packaging:

in bottles of dark glass with a screw-on plastic lid from 30.3 to 35.0 g (equivalent to 1.2 g of cefixime + 4% re-laying).

For 1 bottle with instructions for use and a plastic dispensing spoon with a volume of 10 ml or 5 ml in a cardboard bundle.

Storage conditions:At a temperature of 15 ° C to 25 ° C. Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N013023 / 02

Date of registration:09.06.2009

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

Manufacturer: & nbsp

Jazeera Pharmaceutical Industries Saudi Arabia

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

Information update date: & nbsp14.01.2016

Illustrated instructions

Instructions

Supraks® (Suprax®)