TAXI 10s About 200 mg coated tablets

The instruction for use
of medicine for experts

of TAKSIM-O
of TAXIM-O

the Trade name
of Taksim-O

the International unlicensed


name Tsefiksim Lekarstvennaya
the Tablet form, coated 200 mg
of the Granule for preparation of oral suspension of 50 mg / 5 ml

Structure
One coated tablet contains
active agent – tsefiksy 200 mg (in the form of a tsefiksim of trihydrate),
excipients: the sulfate, aerosil, talc purified of magnesium stearate, a hydroksipropilmetiltsellyuloz, the titan dioxide, propylene glycol aviset 200, sodium a lauryl.

5 ml of ready suspension contain
active agent – tsefiksy 50 mg (in the form of a tsefiksim of trihydrate),
excipients: sugar, xanthan gum, silicon colloidal anhydrous, Natrium benzoicum, fragrance pineapple.

Description
of the Tablet: biconvex round tablets, coated white color.
Suspension: almost white granules placed in a glass bottle of orange color, granules at preparation forms suspension of almost white color with a characteristic smell of pineapple of 30 ml.

Pharmacotherapeutic group
Antimicrobial drugs for system use. Cephalosporins.
Code of automatic telephone exchange J01DA23

Pharmacological

Pharmacokinetics Absorption properties and distribution: at intake the bioavailability of a tsefiksim is 40-50% irrespective of meal, however the maximum concentration of a tsefiksim in serum is reached 0.8 h quicker at administration of drug together with food.
At administration of drug in the form of tablets in a dose of 200 mg the maximum concentration in blood serum is reached in 4 h and makes 2 mkg/ml, at reception in a dose of 400 mg – 3.5 mkg/ml.
At administration of drug in the form of suspension in a dose of 200 mg the maximum concentration in blood serum is reached in 4 h and makes 2.8 mkg/ml, at reception in a dose of 400 mg – 4.4 mkg/ml.
Linking with proteins of plasma, mainly with albumine, makes 65%.
Removal: about 50% of a dose are removed with urine in an invariable look during 24 h, about 10% of a dose are removed with bile. Elimination half-life depends on a dose and makes 3-4 h.
At patients with renal failures at clearance of creatinine of 20-40 ml/min. the elimination half-life increases to 6.4 h, at clearance of creatinine of 5-10 ml/min. – to 11.5 h.
A pharmacodynamics
the Semi-synthetic tsefalosporinovy antibiotic of the III generation for intake of a broad spectrum of activity. Works bakteritsidno. The mechanism of action is caused by oppression of synthesis of a cellular membrane of the activator. Tsefiksim is resistant to action beta laktamaz, the gram-positive and gram-negative bacteria produced by the majority.
Tsefiksim is active concerning gram-positive bacteria: Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, gram-negative bacteria: Haemophilus parainfluenzae, Haemophilus influenzae, Escherichia coli, Moraxella (Branhamella) catarrhalis, Proteus mirabilis, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus, Serratia marcescens, Neisseria gonorrhoeae.
Pseudomonas spp., Enterococcus (Streptococcus) of a serogroup of D, Listeria monocytogenes, the majority of Staphylococcus spp are resistant to drug. (including metitsilin-resistant strains), Enterobacter spp., Bacteroides fragilis, Clostridium spp.

Indications
the Infectious and inflammatory diseases caused by microorganisms, sensitive to drug:
- pharyngitis
- tonsillitis
- sinusitis
- acute and chronic bronchitis
- average otitis
- uncomplicated infections of urinary tract
- a gonococcal infection.

The route of administration and doses
For adults and children are more senior than 12 years with body weight more than 50 kg a daily dose makes 400 mg (1 time a day or on 200 mg 2 times a day). Duration of a course of treatment - 7-10 days.
To children aged from 6 months up to 12 years drug each 12 h appoint in the form of suspension in a dose 8 mg/kg of body weight of 1 times a day or on 4 mg/kg. (to children at the age of 5-12 years the daily dose makes 6-10 ml, at the age of 2-4 years - 5 ml, aged from 6 months till 1 year – 2.5-4 ml).
In uncomplicated gonorrhea appoint 400 mg once.
In the infections caused by Streptococcus pyogenes, the course of treatment has to make not less than 10 days.
In renal failures (at clearance of creatinine of 21-60 ml/min.) or at the patients who are on a hemodialysis, the daily dose should be reduced by 25%. At clearance of creatinine of smaller or equal 20 ml/min. or at the patients who are on peritoneal dialysis, the daily dose should be reduced twice.
Rules of preparation of suspension
to Turn a bottle and to stir up granules. To add about 30 ml of the boiled water cooled to room temperature to 2 stages and to shake up after each addition before formation of homogeneous suspension (the volume of suspension should not exceed tags on a large bottle). After that it is necessary to let suspension stand within 5 minutes for ensuring full suspending of granules. Before use ready suspension should be shaken up.

Side effects
- dryness in a mouth, anorexia, diarrhea, nausea, vomiting, an abdominal pain, a meteorism, tranzitorny increase in activity of hepatic transaminases and alkaline phosphatase, a hyperbilirubinemia, jaundice, digestive tract candidiasis, dysbacteriosis, it is rare - stomatitis, a glossitis, pseudomembranous colitis
- a leukopenia, thrombocytopenia, a neutropenia, hemolytic anemia
- dizziness, a headache
- interstitial nephrite
- a skin itching, a small tortoiseshell, a dermahemia, an eosinophilia, fever.

Contraindications
- hypersensitivity to cephalosporins and penicillin
- presence of bleedings in the anamnesis
- pregnancy
- children's age up to 6 months.

Medicinal interactions
are not established.

Special instructions
With care it is necessary to appoint Taksim-O to patients of advanced age, patients with chronic kidney disease or pseudomembranous colitis (in the anamnesis).
At long administration of drug the disturbance of normal intestinal microflora is possible that can lead to growth of Clostridium difficile and cause development of heavy diarrhea and pseudomembranous colitis.
The patients having allergic reactions to penicillin in the anamnesis can show hypersensitivity to tsefalosporinovy antibiotics.
During treatment the positive forward reaction of Koombs and false positive reaction of urine to glucose is possible.
At use of the drug Taksim-0 C the danger of development of neurotoxicity exists piperidic acid.
Pregnancy and a lactation
In need of use of Taksima-O in the period of a lactation it is necessary to stop breastfeeding.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms


the Overdose
Symptoms does not influence: neurotoxic syndrome (nystagmus, behavior disorder, hallucinations, spasms) and strengthening of other side effects.
Treatment: gastric lavage, carry out symptomatic and maintenance therapy which if necessary includes use of antihistaminic drugs, glucocorticoids, pressor amines, oxygenotherapy, transfusion of infusion solutions, artificial ventilation of the lungs.
The hemodialysis and peritoneal dialysis are inefficient.

A release form
On 10 tablets in the blister. On 1 blister together with the instruction for use are placed in a cardboard box.
On 15 g of dry granules in the large bottles of dark glass corked by the screwed cover with control of the first opening. On 1 butylyu together with the instruction for use place in a box cardboard.


To Store storage conditions in the dry place at a temperature from +15 to +25 wasps.
To store out of children's reach!


The Tablet expiration date – 2 years
Suspension – 1.5 years (18 months)
to use Ready suspension within 7 days.
Not to use after an expiration date.

Release order from drugstores
According to the prescription



Alkem Laboratories Limited Producer Alkem House Devashish, Senapati Bapat Marg, Lower Parel, Mumbai – 400,013