Sorcef (cefixime) coated tablets 400 mg. №10

Description

Sorcef (cefixime) coated tablets 400 mg. №10

Composition

active ingredient: cefixime;

1 film-coated tablet contains 400 mg cefixime (in the form of 447.630 mg cefixime trihydrate);

excipients: gelatin; calcium hydrophosphate, dihydrate; corn starch; pregelatinized starch; magnesium stearate; sodium lauryl sulfate; cellulose microcrystalline; hypromelosis; macrogol 4000; titanium dioxide (E 171).

Dosage form

Film-coated tablets.

Basic physical and chemical properties: oblong biconvex tablets, film-coated creamy-white color, with a break line on one side.

Pharmacological group

Antibacterial agents for systemic use. Beta-lactam antibiotics. Third generation cephalosporins.
Code ATX J01D D08.

Pharmacological properties

Cefixime is an antibiotic of the third generation cephalosporin group for oral administration. Under in vitro conditions, it exhibits significant bactericidal activity against a wide range of gram-positive and gram-negative microorganisms.
Clinically effective in the treatment of infections caused by the most common pathogenic microorganisms, including Streptococcus pneumoniae, Streptococcus pyogenes, E. coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamases – positive and negative), Branhamella catarrhalis (beta-lactamases and negative) and Enterobacter species. Has a high degree of stability in the presence of beta-lactamases.
Most strains of enterococci (Streptococcus faecalis, Streptococci group D) and Staphylococci (including coagulase-positive, coagulase-negative and methicillin-resistant strains) are resistant to cefixime. In addition, most strains of Pseudomonas, Bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to cefixime.

Indications

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

• upper respiratory tract infections (including otitis media) and other upper respiratory tract infections (sinusitis, pharyngitis, tonsillitis of bacterial etiology) in case of known or suspected resistance of the pathogen to other commonly used antibiotics, or in case of risk of treatment failure;
• lower respiratory tract infections (including acute bronchitis and exacerbation of chronic bronchitis);
• urinary tract infections (including cystitis, cystourethritis, uncomplicated pyelonephritis).

Clinically effective in the treatment of infections caused by the most common pathogenic microorganisms, including Streptococcus pneumoniae, Streptococcus pyogenes, E. coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamases – positive and negative), Branhamella catarrhalis (beta-lactamases and negative) and Enterobacter species. Has a high degree of stability in the presence of beta-lactamases.
Most strains of enterococci (Streptococcus faecalis, Streptococci group D) and Staphylococci (including coagulase-positive, coagulase-negative and methicillin-resistant strains) are resistant to cefixime. In addition, most strains of Pseudomonas, Bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to cefixime.

Contraindications

Confirmed hypersensitivity to antibiotics of the cephalosporin group or to other components of the drug; hypersensitivity to penicillins; porphyria.

Application during pregnancy or lactation

In the study of reproduction in mice and rats when the animals were administered doses that are almost 400 times higher than the dose for humans, there were no cases of effects on fertility or disturbances in the fetus in connection with the use of cefixime. In the rabbit, at doses up to 4 times the human dose, there was no evidence of a teratogenic effect; revealed a high incidence of abortion and maternal mortality, which are the expected consequence of the known sensitivity of rabbits to changes in the intestinal microflora population caused by antibiotics.
There is no data on the use of the drug during pregnancy. Cefixime crosses the placenta.
Do not use the drug during pregnancy or lactation, unless absolutely necessary as directed by a doctor.

Method of administration and dosage

Eating does not affect the absorption of cefixime. Usually the course of treatment Sorcef tablets is 7 days, if necessary – up to 14 days. In the treatment of uncomplicated cystitis, the course of treatment is 3 days.

Adults and children over 12 years old weighing more than 50 kg: the recommended dose is 400 mg (one tablet) once a day or 200 mg (half a tablet) every 12 hours, depending on the severity of the disease.

Elderly patients: administer the drug Sorcef tablets at the recommended adult dose. Renal function should be monitored and dose adjusted in severe renal impairment.

Dosage in Renal Insufficiency: Cefixime may be used in patients with impaired renal function. For patients with a creatinine clearance of 20 ml/min or greater, use the usual dose and dosage regimen. For patients with creatinine clearance below 20 ml / min, it is not recommended to exceed 200 mg (half a tablet) 1 time per day. This also applies to patients who are on continuous ambulatory peritoneal dialysis or hemodialysis.

Children

Children under the age of 12 are advised to use the drug in a different dosage form.

Overdose

No cases of drug overdose were observed. Adverse reactions observed with the use of the drug in doses up to 2 g in healthy study participants did not differ from the adverse reactions observed in patients taking the drug at the recommended doses.
Symptoms: increased manifestation of adverse reactions.
Treatment. Gastric lavage, prescribe symptomatic and supportive therapy. There is no specific antidote. Hemodialysis or peritoneal dialysis only slightly promotes the elimination of cefixime from the body.

Side effects:

• On the part of the blood and lymphatic system: eosinophilia, hypereosinophilia, agranulocytosis, leukopenia, neutropenia, granulocytopenia, hemolytic anemia, thrombocytopenia, thrombocytosis, hypoprothrombinemia, thrombophlebitis, increased thrombin and prothrombin time (bleeding and bruising)
• From the digestive system: stomach cramps, abdominal pain, diarrhea, dyspepsia, nausea, vomiting, flatulence, dysbiosis, candidiasis of the oral mucosa, stomatitis, glossitis.
• From the liver and biliary tract: jaundice, hepatitis, cholestasis.
• Infectious and parasitic diseases: pseudomembranous colitis.
• On the part of laboratory parameters: an increase in aspartate aminotransferase, an increase in alanine aminotransferase, an increase in bilirubin in the blood, an increase in blood urea, an increase in serum creatinine.
• From the side of metabolism and nutrition: anorexia (loss of appetite).
• From the nervous system: headache, dizziness, dysphoria, hyperactivity.
• From the side of the hearing organs: hearing loss.
• From the respiratory system, chest and mediastinal organs: dyspnea.
• From the side of the kidneys and urinary tract: acute renal failure, including tubulointerstitial nephritis as the main pathological condition, hematuria.
• From the immune system and from the skin and subcutaneous tissue: anaphylactic reaction; serum sickness-like reactions; drug rash with eosinophilia and systemic manifestations; fever; swelling of the face; hypersensitivity reactions in the form of rash, pruritus, drug fever and arthralgia, including rare cases of urticaria or angioedema. These reactions usually disappeared after discontinuation of therapy; exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).
• Reproductive system and mammary glands: genital itching, vaginitis / moniliasis.
• General disorders: weakness, fatigue, increased sweating, inflammation of the mucous membranes.