Cefixim EXPRESS Dispersible pills 400mg, 7pcs

Composition

Active ingredient:

• cefixime trihydrate – 447.7 mg in terms of cefixime-400.0 mg

Auxiliary substances:

• microcrystalline cellulose 102,
• low-substituted hyprolose (low-substituted hydroxypropylcellulose),
• colloidal silicon dioxide (aerosil),
• povidone K 30,
• magnesium stearate, saccharin,
• strawberry flavor*,
• dye sunset yellow (E 110).

* Flavor composition: natural flavoring agents, maltodextrin, gum arabic (E 414), triacetin (E 1518),1,2-propylene glycol (E 1520), acetic acid (E 260) or natural aromatics, propylene glycol (E 1520), ethanol.

Pharmacological action

Pharmacodynamics

Cefixime is a semi-synthetic broad-spectrum antibiotic from the group of cephalosporins of the third generation for oral use. It has a bactericidal effect. The mechanism of action is associated with inhibition of bacterial cell wall synthesis. Cefixime is resistant to beta-lactamases produced by many gram-positive and gram-negative bacteria.

Antimicrobial activity spectrum

In clinical practice and in vitro, the effectiveness of cefixime has been confirmed in infections caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae.

Cefixime also has in vitro activity against gram-positive-Streptococcus agalactiae and Gram-negative bacteria-Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp.. Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus.

Pseudomonas spp., Enterococcus spp., Listeria monocytogenes, most strains of Enterobacter spp., Staphylococcus spp. are resistant to the drug. (including methicillin-resistant strains), Bacteroides fragilis, Clostridium spp.

Pharmacokinetics

Absorption rate

When taken orally, the bioavailability is 40-50% and does not depend on food intake. The maximum concentration in blood plasma (Cmax) in adults after oral use at a dose of 400 mg is reached in 3-4 hours and is 2.5-4.9 mcg / ml, after use at a dose of 200 mg-1.49-3.25 mcg/ml. Food intake does not significantly affect the absorption of the drug from the gastrointestinal tract (GIT).

Distribution

The volume of distribution after use of 200 mg of cefixime was 6.7 liters, when the equilibrium concentration was reached-16.8 liters. About 65% of cefixime binds to plasma proteins. Cefixime produces the highest concentrations in the urine and bile. Cefixime passes through the placenta. The concentration of cefixime in the blood of the umbilical cord reached 1/6-1/2 of the concentration of the drug in the mother’s blood plasma; the drug is not detected in breast milk.

Metabolism and elimination

The half-life in adults and children is 3-4 hours. Cefixime is not metabolized in the liver; 50-55% of the dose taken is excreted unchanged in the urine within 24 hours. About 10% of cefixime is excreted in the bile.

Pharmacokinetics in special clinical situations

If the patient has renal insufficiency, you can expect an increase in the half-life and, accordingly, a higher concentration of the drug in plasma and a slowdown in its elimination by the kidneys. In patients with a creatinine clearance of 30 ml / min when taking 400 mg of cefixime, the half-life increases to 7-8 hours, the maximum plasma concentration is on average 7.53 mcg / ml, and urinary excretion in 24 hours is 5.5%.

In patients with cirrhosis of the liver, the half – life increases to 6.4 hours, the time to reach the maximum concentration (TCmax) – 5.2 hours; at the same time, the proportion of the drug eliminated by the kidneys increases. Cmax and area under the pharmacokinetic curve do not change.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• streptococcal tonsillitis and pharyngitis;
• sinusitis;
• acute bronchitis;
• exacerbation of chronic bronchitis;
• acute otitis media;
• uncomplicated urinary tract infections;
• uncomplicated gonorrhea;
• shigellosis.

Use during pregnancy and lactation

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

Contraindications

• Hypersensitivity to cefixime or components of the drug;
• hypersensitivity to cephalosporins or penicillins;
• not recommended for use in children with chronic renal failure and in children weighing less than 25 kg in this dosage form.

With caution

Advanced age, kidney failure, colitis (in the anamnesis), pregnancy.

Side effects

Side effects are classified according to the frequency of reported cases: very common (>10%); common (1-10%); infrequent (0.1-1%); rare (0.01-0.1%); very rare (≤0.01%). From the side of the blood system and hematopoietic organs: Very rare:  transient leukopenia, agranulocytosis, pancytopenia, thrombocytopenia, or eosinophilia. There were isolated cases of blood clotting disorders. Frequency unknown:  hemolytic anemia. Allergic reactions: Rarely:  allergic reactions (for example: urticaria, rash, erythema multiforme, pruritus). Very rare:  Lyell’s syndrome (toxic epidermal necrolysis); other allergic reactions associated with sensitization – drug fever, serum sickness-like syndrome, hemolytic anemia and interstitial nephritis, Stevens-Johnson syndrome, anaphylactic shock. Drug rash syndrome with eosinophilia and systemic manifestations has been reported in some patients. Nervous system disorders: Infrequently:  headaches, dizziness, dysphoria, anxiety. Respiratory system disorders: Frequency unknown:  dyspnoea. Reactions from the digestive system: Often:  abdominal pain, digestive disorders, nausea, vomiting and diarrhea. Very rare:  pseudomembranous colitis. From the side of the hepatobiliary system: Rarely:  increased activity of alkaline phosphatase and “hepatic” transaminases, increased concentration of bilirubin in the blood. Very rare:  isolated cases of hepatitis and cholestatic jaundice. From the genitourinary system: Very rare:  a slight increase in the concentration of creatinine and urea in the blood, hematuria, may develop acute renal failure, accompanied by tubulointerstitial nephritis.

Interaction

Tubular secretion blockers (probenecid, etc. ) slow the excretion of cefixime through the kidneys, which can lead to symptoms of overdose. Cefixime reduces the prothrombin index, enhances the effect of indirect anticoagulants. When cefixime was co-administered with carbamazepine, an increase in the concentration of the latter in plasma was observed; in such cases, therapeutic drug monitoring is advisable.

How to take, course of use and dosage

For adults and children with a body weight of more than 50 kg, the daily dose is 400 mg in one or two doses. For children with a body weight of 25-50 kg, the drug is prescribed at a dose of 200 mg per day in one dose. The tablet can be swallowed with a sufficient amount of water, or diluted in water and drink the resulting suspension immediately after cooking. The drug can be taken regardless of food intake. The duration of treatment depends on the nature of the course of the disease and the type of infection. After the symptoms of infection and/or fever disappear, it is advisable to continue taking the drug for at least 48-72 hours. The course of treatment for respiratory tract and ENT infections is 7-14 days. For tonsillopharyngitis caused by Streptococcus pyogenes, the duration of treatment should be at least 10 days. In uncomplicated gonorrhea, the drug is prescribed at a dose of 400 mg once. For uncomplicated lower urinary tract infections in women, the drug can be prescribed for 3-7 days, for uncomplicated upper urinary tract infections in women-14 days. For uncomplicated upper and lower urinary tract infections in men, the duration of treatment is 7-14 days. In case of impaired renal function, the dose is set depending on the indicator of creatinine clearance in the blood serum. When creatinine clearance is 21-60 ml/min or in patients undergoing hemodialysis, it is recommended to use other dosage forms of the drug due to the need to reduce the daily dose by 25%. If creatinine clearance is 20 ml / min or less or in patients undergoing peritoneal dialysis, the daily dose should be reduced by 2 times.

Overdose

When taken at a dose exceeding the maximum daily dose, the frequency of the dose-dependent side effects described above may increase. Treatment: gastric lavage; perform symptomatic and supportive therapy. Hemodialysis and peritoneal dialysis are not effective.

Special instructions

Due to the possibility of cross-allergic reactions with penicillins, it is recommended to carefully evaluate the patient’s medical history. If an allergic reaction occurs, the drug should be discontinued immediately.

If toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, drug rash syndrome with eosinophilia and systemic manifestations occur, cefixime should be discontinued and the necessary therapy should be performed.

If anaphylactic shock develops, the drug should be discontinued, epinephrine (epinephrine), systemic glucocorticosteroids and antihistamines should be administered.

With prolonged use of the drug, it is possible to disrupt the normal intestinal microflora, which can lead to excessive reproduction of Clostridium difficile and the development of pseudomembranous colitis. If mild forms of antioiotic – associated diarrhea occur, it is usually sufficient to stop taking the drug. For more severe forms, corrective treatment is recommended (for example, oral use of vancomycin 250 mg 4 times a day).

Antidiarrheal drugs that inhibit gastrointestinal motility are contraindicated in the development of pseudomembranous colitis.

Like other cephalosporins, cefixime can cause acute renal failure accompanied by tubulointerstitial nephritis. In case of acute renal failure, cefixime should be discontinued, appropriate measures should be taken and/or appropriate treatment should be prescribed.

If Cefixime EXPRESS is used simultaneously with aminoglycosides, polymyxin B, sodium colistimethate, or loop diuretics (furosemide, etacric acid) in high doses, renal function should be monitored. After long-term treatment with Cefixime EXPRESS, the state of hematopoiesis function should be checked.

Dispersible tablets should only be dissolved in water. During treatment, a false positive direct Coombs reaction and a false positive reaction of urine to glucose are possible when using some test systems for rapid diagnosis.

Influence on the ability to drive vehicles and mechanisms

Studies of the effect of the drug Cefixime EXPRESS on the ability to drive vehicles and mechanisms have not been conducted. Due to possible adverse effects (such as dizziness), caution should be exercised.

Storage conditions

At a temperature not exceeding 25 °C in the original packaging (in a cardboard pack). Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Cefixime

Conditions of release from pharmacies

By prescription

Dosage form

tablets soluble