cephalexin

Active material: Cephalexin
When ATH: J01DB01
CCF: I generation Cephalosporin
When CSF: 06.02.01
Manufacturer: HEMOFARM A.D. (Serbia)

Pharmaceutical form, composition and packaging

Granules for suspension for oral orange-yellow; adding water in a suspension of yellow-orange color with a characteristic fruity odor.

Excipients: sodium saccharin, citric acid anhydride, dye iron oxide yellow (E172), guar gum, Sodium benzoate, simethicone S 184, sucrose, strawberry flavor, apple flavor, raspberry flavor, flavoring “tutti frutti”.

40 g (for the preparation of 100 ml suspension) – vials of dark glass (1) complete with a measured spoon in volume 5 ml and the risks to the volume 2.5 ml – packs cardboard.

Capsules gelatin, size №2, a case and a lid light green color; contents of capsules – granulated powder from white to yellowish.

Excipients: magnesium stearate, microcrystalline cellulose PH 102.

Ingredients of the capsule shell: Titanium dioxide (E171), dye iron oxide yellow (E172), indigokarmin (I Indigotin) (E132), gelatin.

8 PC. – blisters (2) – packs cardboard.

Capsules gelatin, size №0, with a cap of dark green color and the body of a greenish-yellow color; contents of capsules – granulated powder from white to yellowish.

Excipients: magnesium stearate, microcrystalline cellulose PH 102.

Ingredients of the capsule shell: Titanium dioxide (E171), dye iron oxide yellow (E172), dye iron oxide black (E172), indigokarmin (I Indigotin) (E132), gelatin.

8 PC. – blisters (2) – packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCES

Pharmacological action

I generation cephalosporin antibiotic broad spectrum. It has bactericidal activity.

Active against gram-positive bacteria: Staphylococcus spp. (strains, producing and not producing penicillinase), Streptococcus spp. (incl. Streptococcus pneumoniae), Corynebacterium diphtheriae; Gram negative bacteria: Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., Escherichia coli.

Not against Haemophilus influenzae, Proteus spp. (indole-positive strains), Mycobacterium tuberculosis, anaerobes.

Pharmacokinetics

After ingestion well absorbed from the gastrointestinal tract. Absorption sostavlyaet 90%. cephalexin is acid, meal slows absorption, but does not affect its fullness. Bioavailability is 95%. C_max achieved through the - 1-2 no. Once inside 250 mg, 500 mg, 1 г C_max is equal to 9, 18, and 32 ug / ml, respectively. Relatively uniformly distributed in various tissues and body fluids: light, bronchial mucosa, liver, heart, kidney. Do not cross the BBB, It crosses the placental barrier, in a small amount is excreted in breast milk. V_d – 0.26 l / kg. Plasma protein binding – 5-15%. T_1/2 – 0.9-1.5 no. 90% excreted by the kidneys in unchanged form (2/3 – by glomerular filtration, 1/3 – by tubular secretion); the bile – 0.5%. Total clearance – 380 ml / min, renal clearance – 210 ml / min. C_max in urine after oral administration 250 mg, 500 mg, 1 g respectively – 1000, 2200, 5000 ug / ml. In case of violation of renal function in blood concentration increases, and the time of withdrawal is extended. T_1/2 – 20-40 no.

Testimony

Infectious-inflammatory diseases, caused by susceptible microorganisms to cephalexin, incl. diseases of the upper and lower respiratory tract, urinary tract, skin and soft tissue; otitis media, osteomyelitis, endometritis, gonorrhea.

Dosage regimen

Establish individually, taking into account the severity and localization of infection, susceptibility. If ingestion average dose for adults – by 250-500 mg every 6-12 no. If necessary, the daily dose was increased to 4-6 g. The duration of treatment 7-14 days. In children with a body weight less than 40 kg average daily dose is 25-50 mg / kg, the multiplicity of reception 4 times / day. In severe infections daily dose may be increased to 100 mg / kg, and receiving frequency – to 6 time / day. When infections, caused by beta-hemolytic streptococcus group A, the minimum duration of treatment is 10 days.

Side effect

CNS: weakness, excitation, hallucinations, convulsions, headache, dizziness, drowsiness, in a few cases – hallucinations.

From the urinary system: interstitial nephritis.

On the part of the reproductive system: vaginitis, vaginal discharge, candidiasis genitals.

From the digestive system: nausea, vomiting, dry mouth, loss of appetite, diarrhea, abdominal pains, dyspepsia, intestinal candidiasis, oral; rarely – pseudomembranous enterocolitis; in a few cases – cholestatic jaundice, hepatitis.

From the hematopoietic system: in a few cases – changes in the peripheral blood picture (reversible leukopenia, neutropenia, thrombocytopenia).

From the laboratory parameters: increase in liver transaminases and alkaline phosphatase, increased prothrombin time.

Allergic reactions: hives, эritema, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylaxis, arthritis, eozinofilija, itching genitals and anus, skin rash, itch, dermatitis, eozinofilija; rarely – angioedema, artralgii.

Contraindications

Hypersensitivity to cephalosporins.

Pregnancy and lactation

Pregnancy and lactation (breast-feeding) It is possible only in cases, when the intended benefits to the mother outweighs the potential risk to the fetus or child.

Cautions

To use caution in patients with renal insufficiency, pseudomembranous colitis in history.

In patients with hypersensitivity to penicillin allergic reaction to cephalosporin antibiotics.

During treatment possible positive direct Coombs' test, as well as the false positive reaction of urine for sugar.

During therapy should not drink alcohol.

Used with caution in children under the age of 6 months.

Drug Interactions

With simultaneous application of cephalexin enhances the effect of anticoagulants.

With simultaneous use of aminoglycoside nephrotoxicity increases cephalexin, polymyxins, fenilʙutazona, furosemida.

Salicylates and indomethacin slow excretion of cephalexin.