Instructions Cefinac powder for oral suspension 100 mg/5 ml bottle 50 ml
Composition
active ingredient: cefixime;
5 ml of suspension contains cefixime trihydrate equivalent to cefixime 100 mg;
excipients: sucrose, xanthan gum, sodium benzoate (E 211), colloidal anhydrous silicon dioxide, strawberry-guarana flavoring 586997 AP0551.
Dosage form
Powder for oral suspension.
Main physicochemical properties:
for dry powder: granular powder from almost white to light yellow in color with a specific odor;
for the reconstituted suspension: light yellow suspension with a specific odor.
Pharmacotherapeutic group
Antibacterials for systemic use. Other β-lactam antibiotics. Third-generation cephalosporins. 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 meals. The maximum serum level after taking the recommended doses for adults or children is 1.5 to 3 μg/ml. With repeated administration, there is little or no accumulation of cefixime.
Distribution: Cefixime is almost completely bound to albumin, with an average free fraction of approximately 30%.
Metabolism: Metabolites of cefixime have not been isolated from human serum or urine.
Excretion: Cefixime is excreted mainly unchanged in the urine. The predominant 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 inflammation of the middle ear (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 ineffectiveness of their use);
– lower respiratory tract infections (including acute bronchitis and exacerbation of chronic bronchitis);
– urinary tract infections (including cystitis, cystourethritis, uncomplicated pyelonephritis).
Contraindication
Hypersensitivity to cefixime or other components of the drug, other cephalosporins or penicillins (see section "Special instructions"). Porphyria.
Interaction with other medicinal products and other types of interactions
Blockers of tubular secretion (allopurinol, probenecid, diuretics, etc.) increase the maximum concentration of cefixime in the blood serum, slowing down the excretion of cefixime by the kidneys, which can lead to overdose.
Salicylic acid increases the concentration of free cefixime by 50% due to displacement of cefixime from protein binding sites; this fact is concentration-dependent.
Concomitant use with carbamazepine may increase its plasma concentration, therefore it is advisable to monitor the level of carbamazepine in the blood plasma.
The combined use of cefixime with potentially nephrotoxic substances (aminoglycosides, colistin, polymyxin, viomycin) or potent diuretics (ethacrynic acid, furosemide) increases the risk of developing renal failure.
Nifedipine increases bioavailability, but clinical interactions have not been determined.
Antacids containing magnesium or aluminum hydroxide slow down the absorption of the drug.
Potentially, like other antibiotics, the use of the drug may reduce estrogen reabsorption and reduce the effectiveness of combined oral contraceptives.
As with other cephalosporins, increases in prothrombin time have been reported in some patients, therefore caution should be exercised in patients receiving anticoagulant therapy.
During treatment with cefixime, a false-positive direct Coombs test and a false-positive reaction to glucose in the urine when using copper sulfate tablets, Benedict's or Fehling's solutions are possible. It is recommended to use a glucose oxidase test to determine glucose in the urine.
Application features
Severe cutaneous adverse reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in some patients with cefixime. If severe cutaneous adverse reactions occur, cefixime should be discontinued and appropriate treatment should be initiated.
Cefixime should be administered with caution to patients who have had hypersensitivity reactions to other drugs.
As with other cephalosporins, cefixime should be administered with caution to patients with a history of hypersensitivity reactions to penicillins due to the possibility of cross-hypersensitivity to penicillins and cephalosporins. Severe reactions (including anaphylactic shock) have been reported to both classes of drugs. If an allergic reaction to cefixime develops, the drug should be discontinued and appropriate therapy instituted.
Cases of drug-induced hemolytic anemia, including severe and fatal cases, have been reported with cephalosporins. Hemolytic anemia has also been reported following repeated use of cephalosporins (including cefixime).
Cefixime should be used with caution in patients with significant renal impairment (see Dosage in renal impairment).
As with other cephalosporins, cefixime may 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. Caution should be exercised when prescribing the drug in patients with a history of bleeding, gastrointestinal diseases, especially ulcerative colitis, regional enteritis or colitis on the background of use, as well as in cases of impaired liver function.
The safety of cefixime in premature infants or neonates has not been established.
Treatment with broad-spectrum antibiotics may disrupt the normal intestinal flora, which can lead to overgrowth of toxin-producing Clostridium difficile, a major cause of antibiotic-associated diarrhea. Pseudomembranous colitis has been associated with the use of broad-spectrum antibiotics (including macrolides, semisynthetic penicillins, lincosamides, and cephalosporins). Therefore, it is important to consider the diagnosis in patients who develop diarrhea during or after antibiotic use. Symptoms of pseudomembranous colitis may develop during or after antibiotic treatment is discontinued.
Treatment of pseudomembranous colitis should include sigmoidoscopy, appropriate bacteriological studies, and fluid, electrolyte, and protein supplementation. If the condition does not improve after discontinuation of the drug or symptoms become severe, oral vancomycin should be administered. Vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis (caused by C. difficile). Other causes of colitis should be excluded.
In case of simultaneous use of cefixime with aminoglycosides, polymyxin B, colistin, loop diuretics (furosemide, ethacrynic acid) in high doses, it is necessary to carefully monitor renal function. After prolonged use of cefixime, it is necessary to check the state of hematopoiesis function.
Cephalosporins increase the toxicity of alcohol, so it is not recommended to drink alcoholic beverages during treatment with cefixime.
Important information about some of the components of the drug.
5 ml of the diluted suspension contains 2.338 g of sucrose. Use with caution in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not be prescribed the drug. This drug may be harmful to the teeth. It is recommended to rinse the mouth with water after use, and for children - to drink plenty of water.
Use during pregnancy or breastfeeding
There are no data on the use of the drug during pregnancy. Cefixime crosses the placenta.
The drug should not be used during pregnancy or breastfeeding, except when prescribed by a doctor in case of urgent need.
Ability to influence reaction speed when driving vehicles or other mechanisms
The use of the drug Cefinac 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
For children aged 6 months to 10 years with a body weight of up to 50 kg, the recommended dose is 8 mg/kg per day as a single dose or 4 mg/kg every 12 hours, depending on the severity of the disease.
For adults and children aged 10 years and over (or weighing more than 50 kg), the recommended dose is 400 mg per day as a single dose or 200 mg every 12 hours, depending on the severity of the disease.
Elderly patients should be given the recommended adult dose. Renal function should be monitored and the dose adjusted in severe renal impairment (see Dosage in renal impairment).
Cefixime can be used in renal failure.
For patients with creatinine clearance of 20 ml/min or higher, the usual dose and dosing regimen should be used. For patients with creatinine clearance below 20 ml/min, a 50% reduction in the daily dose is recommended. This also applies to patients on continuous ambulatory peritoneal dialysis or hemodialysis.
Method of preparing the suspension.
For internal use only.
Before preparation, the bottle must be inverted and shaken to loosen the powder, and boiled cold water must be added (see table).
| Cefinac, powder for oral suspension | Release form | Breeding conditions |
| 100 mg/ 5 ml | 50 ml | Add 35 ml of water to the powder vial in 2 doses, shaking the contents of the vial each time until a homogeneous suspension is formed. |
| 100 ml | Add 69 ml of water to the powder vial in 2 doses, shaking the contents of the vial each time until a homogeneous suspension is formed. | |
After dilution, store the suspension in a refrigerator for 14 days. Do not freeze. Keep the bottle tightly closed.
Before each administration, the prepared suspension should be thoroughly shaken by shaking the bottle.
Children.
The drug should be used in children aged 6 months and older. The safety and efficacy of cefixime in children under 6 months of age have not been established, therefore the use of cefixime in this category of patients is not recommended.
Overdose
No cases of overdose were observed. Adverse reactions observed when using the drug in doses up to 2 g in healthy volunteers did not differ from adverse reactions observed in patients taking 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
From the blood and lymphatic system: eosinophilia, hypereosinophilia, agranulocytosis, leukopenia, neutropenia, granulocytopenia, hemolytic anemia, thrombocytopenia, thrombocytosis, hypoprothrombinemia, thrombophlebitis, prolongation of thrombin and prothrombin time (bleeding and bruising without apparent cause), purpura.
On the part of the digestive tract: stomach cramps, abdominal pain, diarrhea*, dyspepsia, nausea, vomiting, flatulence, dysbacteriosis, candidiasis of the oral mucosa, stomatitis, glossitis.
Liver and biliary tract: jaundice, hepatitis, cholestasis.
Infectious and parasitic diseases: pseudomembranous colitis.
Laboratory parameters: increased aspartate aminotransferase, increased alanine aminotransferase, increased bilirubin in the blood, increased blood urea, increased serum creatinine.
Metabolism and nutrition disorders: anorexia (loss of appetite).
From the nervous system: headache, dizziness, dysphoria, hyperactivity.
Hearing disorders: hearing loss.
From the respiratory system: dyspnea.
Renal and urinary disorders: acute renal failure, including tubulointerstitial nephritis as the underlying pathological condition, hematuria.
Immune system and skin and subcutaneous tissue disorders: anaphylactic reaction; serum sickness-like reactions; drug rash with eosinophilia and systemic symptoms (DRESS); fever; facial swelling, hypersensitivity reactions in the form of rash, itching, drug fever and arthralgia, including rare cases of urticaria or angioedema. These reactions usually disappeared after discontinuation of therapy; erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).
Reproductive system and breast disorders: genital itching, vaginitis/moniliasis.
General disorders: weakness, fatigue, increased sweating, inflammation of the mucous membranes.
* Diarrhea is usually associated with higher doses. Moderate to severe diarrhea has been reported; discontinuation of therapy is warranted. Cefixime should be discontinued if severe diarrhea occurs.
Expiration date
For dry powder (until reconstitution) – 3 years.
For the prepared suspension (after reconstitution) – 14 days.
Storage conditions
For dry powder (before reconstitution).
Store at a temperature not exceeding 30 °C in the original packaging.
Keep out of reach of children.
For the prepared suspension (after reconstitution).
Store in the refrigerator (do not freeze).
Keep out of reach of children.
Packaging
1 bottle with powder for preparation of 50 ml suspension or 1 bottle with powder for preparation of 100 ml suspension. 1 bottle with a measuring cup and a measuring spoon in a cardboard box.
Vacation category
According to the recipe.
Producer
Nectar Life Sciences Limited-Unit VI.
Location of the manufacturer and address of its place of business
Bhatolikalan Village, Near Jharmajri, E.P.I.P., P.V. Barotiwala, Tehsil Baddi, District Solan, Himachal Pradesh, 174103, India.
