Instructions for Cefixime-Vista film-coated tablets 400 mg No. 10
Composition
active ingredient: cefixime;
1 film-coated tablet contains 400 mg of cefixime (as cefixime trihydrate);
Excipients: microcrystalline cellulose; pregelatinized starch; dibasic calcium phosphate, dihydrate, unground; dibasic calcium phosphate, dihydrate, powder; magnesium stearate.
film coating: Opadry AMB White OY-B-28920 or equivalent; polyvinyl alcohol; titanium dioxide (E 171); talc; lecithin; xanthan gum.
Dosage form
Film-coated tablets.
Main physicochemical properties: oblong tablets, film-coated, white in color, with a break line on both sides and embossed with F on one side and P1 on the other.
Pharmacotherapeutic group
Antibiotic of the 3rd generation cephalosporin group. ATX code J01D D08.
Pharmacological properties
Pharmacodynamics
Cefixime is a third-generation cephalosporin antibiotic for internal use. In vitro, 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 pathogens, including Streptococcus pneumoniae, Streptococcus pyogenes, E. coli, Proteus Mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. Has a high degree of stability in the presence of beta-lactamases. Most strains of enterococci (Streptococcus faecalis, group D Streptococci) 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.
Pharmacokinetics
Absorption. The absolute bioavailability of cefixime after oral administration is 22-54%. Since the presence of food does not significantly affect absorption, cefixime can be administered without regard to food intake. Peak serum levels after administration of recommended doses for adults or children range from 1.5 to 3 mcg/mL. There is little or no accumulation of cefixime with repeated administration.
Distribution: Cefixime is almost completely bound to albumin, with an average free fraction of approximately 30%.
Metabolism: Metabolites of cefixime have not been identified in human serum or urine. Excretion: Cefixime is excreted mainly unchanged in the urine. The main mechanism is glomerular filtration.
There is no data on the penetration of cefixime into breast milk.
Indication
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
upper respiratory tract infections (including otitis media, sinusitis, pharyngitis, tonsillitis of bacterial etiology) in case of known or suspected resistance of the pathogen to other commonly used antibiotics or if there is a 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 pathogens, including Streptococcus pneumoniae, Streptococcus pyogenes, E. coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. Has a high degree of stability in the presence of beta-lactamases.
Most strains of enterococci (Streptococcus faecalis, group D Streptococci) 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.
Contraindication
Confirmed hypersensitivity to cephalosporin antibiotics or to other components of the drug.
Hypersensitivity to penicillins; porphyria.
Interaction with other medicinal products and other types of interactions
Probenecid (and other tubular secretion blockers) increases the maximum concentration of cefixime in the blood, slowing down the excretion of cefixime by the kidneys, which may lead to symptoms of overdose.
Salicylic acid increases the concentration of free cefixime by 50% due to displacement of cefixime from protein binding sites; this effect is concentration-dependent.
Carbamazepine may cause an increase in cefixime plasma concentrations, therefore it is advisable to monitor its plasma levels.
Nifedipine increases the bioavailability of cefixime.
Furosemide, aminoglycosides increase the nephrotoxicity of the drug.
As with other antibiotics, cefixime may reduce estrogen reabsorption and reduce the effectiveness of combined oral contraceptives.
Coumarin-type anticoagulants.
Other forms of interactions: the use of cephalosporins may cause a false-positive reaction when determining glucose in the urine using Benedict's, Fehling's solutions or when using "Clinitest" tablets. During the use of cefixime, the direct Coombs test may give a false-positive result.
Application features
Encephalopathy.
When using beta-lactam antibiotics, including Cefixime-Vista, the risk of encephalopathy (which may manifest as convulsions, confusion and impaired consciousness, and movement disorders) increases, especially in case of overdose or in patients with existing renal impairment.
Severe skin reactions.
Serious skin adverse reactions, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and drug rash with eosinophilia and systemic symptoms (DRESS), have been observed in some patients treated with cefixime. In cases of serious skin adverse reactions, cefixime should be discontinued and appropriate treatment and/or precautions should be taken.
Hypersensitivity reactions.
Before using cefixime, careful inquiry should be made regarding the patient's history of hypersensitivity reactions to penicillins and cephalosporins or to other drugs.
Cefixime-Vista should be used with caution in patients with allergic reactions to penicillins. In both in vivo (in humans) and in vitro studies, evidence of cross-allergic reactions between penicillins and cephalosporins has been found. Such cases have been reported rarely. Reactions have been of the anaphylactic type, especially after parenteral administration.
Antibiotics should be used with caution in patients with a history of any form of hypersensitivity reactions, especially after the use of drugs. If an allergic reaction occurs, the use of the drug should be discontinued immediately.
Anemia.
Cases of hemolytic anemia, including severe cases with fatal outcome, have been reported following the use of cephalosporins. Recurrent cases of hemolytic anemia following the use of cephalosporins have also been reported in patients who previously experienced hemolytic anemia following initial administration of cephalosporins, including cefixime.
Acute renal failure.
As with other cephalosporins, Cefixime-Vista can cause acute renal failure, including tubulointerstitial nephritis as the underlying pathological condition. If acute renal failure occurs, Cefixime should be discontinued and appropriate therapy and/or measures should be taken.
Kidney failure.
For patients with severe renal insufficiency and for patients undergoing hemodialysis or peritoneal dialysis, the dose of Cefixime-Vista should be reduced accordingly (see section "Method of administration and dosage").
Changes in intestinal microflora.
Prolonged use of antibacterial drugs may result in the growth of non-susceptible microorganisms and disruption of the normal intestinal flora, which may lead to overgrowth of Clostridium difficile and the development of pseudomembranous colitis. In mild cases of pseudomembranous colitis caused by the use of antibiotics, discontinuation of the drug may be sufficient. If the symptoms of colitis do not improve after discontinuation, oral vancomycin, which is the antibiotic of choice in the event of pseudomembranous colitis, should be prescribed.
In case of moderate or severe colitis, electrolytes and protein solutions should be added to the treatment. Concomitant use of drugs that reduce intestinal peristalsis should be avoided. Broad-spectrum antibiotics should be prescribed with caution to patients with a history of gastrointestinal diseases, especially colitis.
Laboratory research data.
When using the drug Cefixime-Vista, reversible changes in liver, kidney and blood function indicators (thrombocytopenia, leukopenia and eosinophilia) may occur.
Cephalosporins increase the toxicity of alcohol, so it is not recommended to drink alcoholic beverages during treatment with cefixime.
Use during pregnancy or breastfeeding
There is no data on the use of the drug during pregnancy. Cefixime crosses the placenta. The drug should not be used during pregnancy or breastfeeding - use is possible only as prescribed by a doctor in case of extreme necessity.
Ability to influence reaction speed when driving vehicles or other mechanisms
The use of the drug Cefixime-Vista does not affect the speed of reaction when driving or operating other mechanisms. In case of dizziness, driving or operating other mechanisms should be avoided.
Method of administration and doses
The medicine can be taken regardless of meals.
To prevent complications, cefixime is usually continued for 5–10 days for upper respiratory tract or urinary tract infections, and for 10–14 days for lower respiratory tract infections.
Treatment for middle ear inflammation usually lasts 10–14 days.
In infections caused by group A beta-hemolytic streptococcus, in order to prevent the occurrence of late complications (acute articular rheumatism, glomerulonephritis), treatment should last at least 10 days.
For uncomplicated lower urinary tract infections in women, the drug can be used for 1–3 days.
The drug should be administered with caution to patients with renal insufficiency; with creatinine clearance ≤ 20 ml/min, the daily dose of the drug should be reduced to 200 mg. There are no age-related dosage recommendations for elderly patients.
Children
The drug Cefixime-Vista is used in children over 12 years of age.
Overdose
There is a risk of encephalopathy with the use of beta-lactam antibiotics, including Cefixime-Vista, especially in case of overdose or in patients with pre-existing renal impairment.
No cases of drug overdose were observed. Adverse reactions observed when using the drug in doses up to 2 g in healthy study participants did not differ from adverse reactions observed in patients who took the drug in recommended doses.
Symptoms: increased manifestation of adverse reactions.
Treatment: Gastric lavage, symptomatic and supportive therapy. There is no specific antidote. Hemodialysis or peritoneal dialysis only slightly contribute to the removal of cefixime from the body.
Adverse reactions
When using cephalosporins, gastrointestinal disorders are most often observed, hypersensitivity reactions are rare.
Hypersensitivity reactions are more common in patients who have previously had hypersensitivity reactions and in patients with a history of allergy, hay fever, urticaria, or bronchial asthma with an allergic component.
The following adverse reactions have rarely occurred with the use of cefixime:
Gastrointestinal: glossitis, nausea, vomiting, heartburn, abdominal pain, diarrhea, indigestion, dyspepsia, oral candidiasis, stomatitis, flatulence. Switching to 200 mg 2 times a day may relieve diarrhea. Severe, prolonged diarrhea is associated with the use of some classes of antibiotics and may be a sign of pseudomembranous colitis - in this case, a diagnosis should be made. If such a diagnosis is confirmed by colonoscopy, the use of any antibiotics should be immediately discontinued and oral vancomycin should be prescribed. It is contraindicated to use drugs that reduce intestinal peristalsis; from the immune system: reactions resembling serum sickness, anaphylaxis, arthralgia and drug fever, interstitial nephritis, angioedema;
From the blood system: transient leukopenia, agranulocytosis, pancytopenia, transient neutropenia, granulocytopenia, thrombocytopenia, thrombocytosis, eosinophilia. Cases of hemolytic anemia have also been reported in patients taking cephalosporins. Isolated cases of blood clotting disorders are known;
Liver: jaundice, transient increase in transaminase levels [aspartate aminotransferase (AST), alanine aminotransferase (ALT)], alkaline phosphatase, total bilirubin, isolated cases of hepatitis;
Urinary system: transient increase in serum urea and creatinine levels; acute renal failure, including tubulointerstitial nephritis;
Respiratory: shortness of breath;
Skin: urticaria, skin rash, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS);
Nervous system: headache, dizziness, dysphoria; Cases of convulsions have been reported with the use of cephalosporins, including cefixime (frequency unknown);
When using beta-lactam antibiotics, including Cefixime-Vista, the risk of encephalopathy (which may manifest as convulsions, confusion and impaired consciousness, and movement disorders) increases, especially in case of overdose or in patients with existing renal impairment (frequency unknown).
From the side of the organs of hearing and vestibular apparatus: hearing loss;
general disorders: increased body temperature, facial swelling;
others: anorexia, vaginitis caused by Candida, genital itching.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the marketing authorisation of a medicinal product is an important procedure. It allows for continued monitoring of the benefit-risk balance of the medicinal product in question. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
5 tablets in a blister; 1 or 2 blisters in a cardboard box.
Vacation category
Producer
ACS DOBFAR S.P.A.
Location of the manufacturer and address of its place of business
V. LAURENTINA KM 24,730, POMEZIA (RM), 00071, Italy
