SUPRAKS

Active material: Cefixime
When ATH: J01DD08
CCF: III generation cephalosporins
ICD-10 codes (testimony): A54, H66, J01, J02, J03, J04, J20, J31, J32, J35.0, J37, J42, N10, N11, N30, N34, N41
When CSF: 06.02.03
Manufacturer: HIKMA PHARMACEUTICALS (Jordan)

Pharmaceutical form, composition and packaging

Capsules yellow cap and white body; contents of capsules – yellowish-white powder and a mixture of fine granules.

Excipients: colloidal silicon dioxide, magnesium stearate, carboxymethyl cellulose.

The composition of the shell capsules: Titanium dioxide, dye D&C yellow 10, dye FD&C yellow 6, gelatin.

6 PC. – blisters (1) – packs cardboard.

Capsules with a purple cap and white body, Coated code “N808”; contents of capsules – yellowish-white powder and a mixture of fine granules.

Excipients: colloidal silicon dioxide, magnesium stearate, carboxymethyl cellulose.

The composition of the shell capsules: Titanium dioxide, azoruʙin, dye FD&C Blue 2, gelatin.

6 PC. – blisters (1) – packs cardboard.

Granules for oral suspension from almost white to cream-colored; A suspension from almost white to cream color with a sweet aroma of strawberries.

Excipients: Sodium benzoate, sucrose, yellow resin, Strawberry flavor.

Dark glass bottles capacity 60 ml (1) complete with a dosing spoon – packs cardboard.

Pharmacological action

Semisynthetic cephalosporin antibiotic broad spectrum of III generation oral. Effective bactericidal. The mechanism of action is due to inhibition of the synthesis of the cell membrane of the pathogen. Cefixime is resistant to β-lactamases, produced by most gram-positive and gram-negative bacteria.

In vitro cefixime active against gram-positive bacteria: Streptococcus agalactiae; Gram negative bacteria: Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter different, Serratia wilting.

In vitro and in clinical practice cefixime active against gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes; Gram negative bacteria: Haemophilus influenzae, Moraxella (Branham) catarrhalis, Escherichia coli, Proteus is wonderful, Neisseria gonorrhoeae.

C drug resistant Pseudomonas spp., Enterococcus (Streptococcus) serogroup D, Listeria monocytogenes, most Staphylococcus spp.. (including methicillin-resistant strains), Enterobacter spp., Bacteroides fragilis, Clostridium spp.

Pharmacokinetics

Absorption and distribution

When ingestion bioavailability of cefixime 40-50% regardless of the meal, However, C_max cefixime serum achieved faster on 0.8 h while taking the drug with meals.

Before the drug in capsule form at a dose 200 mg C_max of serum is reached after 4 h and is 2 ug / ml, upon receiving a dose 400 mg – 3.5 ug / ml.

Before the drug in suspension at a dose 200 mg C_max of serum is reached after 4 h and is 2.8 ug / ml, upon receiving a dose 400 mg – 4.4 ug / ml.

Plasma protein binding, mainly albumin, is 65%.

Deduction

About 50% the dose is excreted in the urine unchanged within 24 no, about 10% the dose is excreted in the bile.

T_1/2 dose-dependent and is 3-4 no.

Pharmacokinetics in special clinical situations

Patients with impaired renal function in QA by 20 to 40 ml / min T_1/2 increases to 6.4 no, at CC 5-10 ml / min - to 11.5 no.

Testimony

Infectious-inflammatory diseases, caused by susceptible to malaria infections:

- Pharyngitis;

- Tonsillitis;

- Sinusitis;

- Acute and chronic bronchitis;

- Otitis media;

- Uncomplicated urinary tract infections;

- Neoslojnennaya gonorrhea.

Dosage regimen

To adults and children over 12 years old with a body weight more 50 kg daily dose is 400 mg (1 time / day or 200 mg 2 times / day). The duration of treatment – 7-10 days.

At uncomplicated gonorrhea appointed 400 mg dose.

Children under 12 years drug administered as a suspension in a dose of 8 mg / kg body weight 1 time / day or 4 mg / kg every 12 no.

For children 5-11 years daily dose is 6-10 ml suspension, aged 2-4 years – 5 ml, aged 6 Months before 1 year – 2.5-4 ml.

At infections, caused by Streptococcus pyogenes, treatment should be at least 10 days.

At renal impairment (in KK from 21 to 60 ml / min) or patients, hemodialysis, the daily dose should be reduced by 25%.

At QC ≤20 mL / min or patients, on peritoneal dialysis, the daily dose should be reduced 2 times.

Rules suspension

Turn the bottle and shake the pellets. Add 40 mL, cooled to room temperature, boiled in water 2 phase and after each addition, stir until a homogeneous suspension. Thereafter, the slurry must be given to stand for 5 minutes to ensure complete disintegration of granules. Before applying the prepared suspension should be shaken.

Side effect

From the digestive system: dry mouth, anorexia, diarrhea, nausea, vomiting, stomach ache, flatulence, transient increase in liver transaminases and alkaline phosphatase, giperʙiliruʙinemija, jaundice, gastrointestinal candidiasis, dysbiosis; rarely – stomatitis, glossitis, pseudomembranous enterocolitis.

From the hematopoietic system: leukopenia, thrombocytopenia, neutropenia, gemoliticheskaya anemia.

CNS: dizziness, headache.

From the urinary system: interstitial nephritis.

Allergic reactions: itching, hives, dermahemia, eozinofilija, fever.

Contraindications

- Hypersensitivity to penicillins and cephalosporins.

FROM caution should be used in elderly patients Supraks, patients with chronic renal failure, or pseudomembranous colitis (history), children under the age of 6 Months.

Pregnancy and lactation

Application Supraksa during pregnancy is possible only in case, when the intended benefits to the mother outweighs the potential risk to the fetus.

If necessary, use Supraksa during lactation should stop breastfeeding.

Cautions

Chronic administration of the drug may impair the normal intestinal microflora, that can lead to growth Clostridium difficile and cause the development of severe diarrhea and pseudomembranous colitis.

Patients, with a history of allergic reaction to penicillin, may exhibit increased sensitivity to cephalosporin antibiotics.

During treatment possible positive direct Coombs' test and false positive reaction to urinary glucose.

Overdose

Symptoms: increasing incidence described side effects.

Treatment: gastric lavage; symptomatic and supportive therapy, which, if necessary, includes the use of antihistamines, GCS, pressor amines, oksigenoterapiю, transfusion of infusion solutions, IVL. Hemodialysis and peritoneal dialysis are ineffective.

Drug Interactions

Blockers tubular secretion (allopurinol, Diuretic) cefixime delayed excretion by the kidneys, which may lead to increased toxicity.

Cefixime reduces prothrombin index, It increases the effect of indirect anticoagulants.

Antacids, containing magnesium or aluminum hydroxide, slow down the absorption of cefixime.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children at temperature from 15 ° to 25 ° C. Shelf life – 3 year.

The obtained suspension should be used within 14 days after preparation when stored (15-25° C).