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

Description:Capsules of size "0" with a violet lid and a white casing, the contents of the capsule are a yellowish-white mixture of powder and fine granules. On the capsules with food ink code H808.

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 th in 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 spp., Enterococcus (Streptococcus) gray groups D, Listeria monocytogenes, Staphylococcus spp., including methicilin-resistant strains. Enterobacter spp., Bacteroides fragilis, Clostridium spp. are stable to action cefixime.

Pharmacokinetics:

The ingestion bioavailability of cefixime is from 40 to 50% regardless of the poor, but the maximum concentration in serum cefixime achieved faster by 0.8 h while taking the drug with meals.

When receiving the capsule in the serum maximum concentration is achieved after 4 hours and 3.5 ug / ml.

The connection with plasma proteins, mainly with albumins, is 65%.The half-life period depends on the dose and is from 3 to 4 hours.

About 50% is excreted by the kidneys in unchanged form, about 10% is excreted with bile. If renal function is impaired (creatinine clearance 20-40 ml / min), the elimination half-life increases to 6.4 hours, with creatinine clearance of 5-10 ml / min 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 penicillins, children under 12 years of age, renal dysfunction with KK less than 60 ml / min.

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:

Inside.In the average daily dose for adults and children over 12 years with a body weight of more than 50 kg - 400 mg once a day. The average duration of the course of treatment is 7-10 days. In diseases caused by Streptococcus pyogenes, the course of treatment is at least 10 days. With uncomplicated gonorrhea - 400 mg once.

In case of renal dysfunction with QC less than 60 ml / min, patients who are on hemodialysis or peritoneal dialysis, it is recommended to take Supraks ® as a suspension for oral administration.

Side effects:

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

From the nervous system: headache, dizziness, tinnitus, convulsions. From the digestive system: dry mouth, anorexia, nausea, vomiting, diarrhea, constipation, flatulence, abdominal pain, dysbiosis, impaired liver function, cholestasis, cholestatic jaundice, candidiasis, stomatitis, glossitis, pseudomembranous colitis.

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

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

On the part of the reproductive system: vaginitis, itching of the genitals.

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

Other: Candidiasis, dyspnea, development of hypovitaminosis B.

Overdose:

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

Treatment: gastric lavage, symptomatic and maintenance therapy, which, if necessary, includes the use of antihistamines, glucocorticosteroids, epinephrine, norepinephrine, dopamine, oxygen therapy, transfusion of infusion solutions, artificial ventilation. 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 its concentration in the blood plasma. With the simultaneous use of cefixin and carbamazepine, the concentration of carbamazepine 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, so the drug should be used 1-2 hours before or 4 hours after taking the above medicines.

Special instructions:

Patients who had a history of allergic reactions to penicillins, may have increased sensitivity to cephalosporin antibiotics. With prolonged use of the drug, a normal microflora of the intestinal can be disturbed, which can lead to the growth of Clostridium difficile and cause severe diarrhea and pseudomembranous colitis.

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

Impact on the ability to drive vehicles and engage in other potentially hazardous activities.

Patients receiving cefixime, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require a high concentration of attention and speed of psychomotor reactions, taking into account the profile of side effects.

Form release / dosage:

Capsules 400 mg

Packaging:Primary: 6 capsules per blister of PVC / PVDC / aluminum foil.

Secondary: 1 blister with instructions for use in a cardboard box.

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 of the period indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N013023 / 01

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®)