Ceforal Solutab 400 - Instructions For Use, Price, Analogues, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ceforal Solutab

Ceforal Solutab: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Ceforal Solutab

ATX code: J01DD08

Active ingredient: cefixime (Cefixime)

Manufacturer: A. Menarini Manufacturing Logistics and Services S.r.l. (A. Menarini Manufacturing Logistics and Services SrL) (Italy)

Description and photo updated: 2018-29-11

Ceforal Solutab is a third generation cephalosporin antibiotic with a broad spectrum of bactericidal action.

Release form and composition

Dosage form - dispersible tablets: pale orange, oblong, scored on both sides, with a characteristic strawberry odor (in a cardboard box 1 blister of 1 or 7 tablets; 1 or 2 blisters of 5 tablets and instructions for use Ceforal Solutab 400 mg).

Composition of 1 tablet:

• active substance: cefixime - 400 mg (cefixime trihydrate - 447.7 mg);
• auxiliary components: povidone, colloidal silicon dioxide, trisesquihydrate of calcium saccharinate, magnesium stearate, microcrystalline cellulose, low-substituted hyprolose, sunset yellow dye (E110), strawberry flavor.

Pharmacological properties

Pharmacodynamics

Cefixime is a semi-synthetic cephalosporin antibiotic of the third generation with a wide spectrum of action, intended for oral administration. The mechanism of bactericidal action is associated with inhibition of the synthesis of the cell membrane of the pathogen. The substance is resistant to the effects of β-lactamases, which are produced by most gram-positive and gram-negative bacteria.

Cefixime is active against the following bacteria:

• gram-positive: Streptococcus agalactiae;
• gram-negative: Salmonella spp., Serratia marcescens, Citrobacter amalonaticus, Shigella spp., Citrobacter diversus, Providencia spp., Proteus vulgaris, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida.

In clinical practice, the activity of the substance has been confirmed in relation to the following bacteria:

• gram-positive: Streptococcus pyogenes, Streptococcus pneumoniae;
• Gram negative: Neisseria gonorrhoeae, Proteus mirabilis, Moraxella (Branhamella) catarrhalis, Haemophilus influenzae, Escherichia coli.

Resistant to cefixime: Listeria monocytogenes, Pseudomonas spp., Enterococcus (Streptococcus) serogroup D, Bacteroides fragilis, Enterobacter spp., Clostridium spp., Most Staphylococcus spp. (including methicillin-resistant strains).

Pharmacokinetics

The bioavailability of cefixime when taken orally is 40-50%, the value of this indicator does not depend on food intake, however, the time to reach C _max (maximum concentration) of cefixime in serum when taking the drug with food decreases by 0.8 hours.

Cefixime binds to plasma proteins, mainly albumin, at a level of 65%. Approximately 50% of the dose is excreted unchanged in the urine within 24 hours, and approximately 10% of the dose is excreted in the bile.

T _1/2 (half-life) is 3-4 hours and depends on the dose taken.

In patients with creatinine clearance of 20-40 ml / min, T _1/2 increases to 6.4 hours, with creatinine clearance in the range from 5 to 10 ml / min - up to 11.5 hours.

Indications for use

Ceforal Solutab is prescribed for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the action of cefixime:

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

Contraindications

Absolute:

• chronic renal failure in children;
• weight less than 25 kg;
• lactation period;
• individual intolerance to the components of the drug, as well as cephalosporins or penicillins.

Relative (Ceforal Solutab tablets 400 mg are prescribed under medical supervision):

• renal failure;
• burdened history of colitis;
• elderly age;
• pregnancy.

Ceforal Solutab, instructions for use: method and dosage

Ceforal Solutab tablets are taken orally, regardless of food intake.

The drug can be used in one of two ways: swallow the tablet whole with a sufficient amount of water, or dilute in water to a suspension, which must be drunk immediately after preparation.

The daily dose for adults and children weighing 50 kg and more is 400 mg, it can be taken once or divided by 2 times.

For children weighing from 25 to 50 kg Ceforal Solutab is prescribed in a daily dose of 200 mg at one time.

In the treatment of uncomplicated gonorrhea, a single dose of 400 mg of Ceforal Solutab is indicated.

The duration of the course is determined individually, depending on the nature of the course of the disease and the type of pathogen. After the symptoms of infection and / or fever disappear, it is recommended to continue therapy for at least 2-3 days.

Average course duration:

• diseases of the ENT organs and respiratory tract, complicated infections of the lower and upper urinary tract in men: 7-14 days;
• streptococcal (Streptococcus pyogenes) tonsillopharyngitis: at least 10 days;
• uncomplicated infections of the lower and upper urinary tract in women: 3-7 or 14 days, respectively.

For patients with impaired renal function, the dose of Ceforal Solutab is set individually, depending on the value of creatinine clearance:

• 20 ml / min and less, as well as in patients on peritoneal dialysis: the daily dose is halved;
• 21-60 ml / min, as well as in patients on hemodialysis: the daily dose is reduced by 25%, in connection with which this group of patients is recommended to use other dosage forms of the drug.

Side effects

Possible adverse reactions (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):

• genitourinary system: very rarely - hematuria, a slight increase in the level of creatinine in the blood;
• nervous system: infrequently - dizziness, headaches, dysphoria;
• hepatobiliary system: rarely - an increase in the level of transaminases and alkaline phosphatase; very rarely - hepatitis, cholestatic jaundice;
• digestive system: infrequently - diarrhea, digestive disorders, abdominal pain, nausea, vomiting; very rarely - pseudomembranous colitis;
• blood and hematopoietic organs: very rarely - agranulocytosis, transient leukopenia, pancytopenia, eosinophilia, thrombocytopenia; in some cases - blood clotting disorders;
• immune system: rarely - hypersensitivity reactions (in the form of urticaria, pruritus); very rarely - Lyell's syndrome (patients should stop taking Ceforal Solutab immediately), other allergic reactions that are associated with sensitization - interstitial nephritis, drug fever, hemolytic anemia, a syndrome resembling serum sickness; in cases of anaphylactic shock, the administration of epinephrine, systemic glucocorticoids and antihistamines is indicated.

Overdose

The main symptoms: an increase in the frequency of dose-dependent adverse reactions.

Therapy: gastric lavage; symptomatic and supportive treatment.

In case of overdose, hemodialysis and peritoneal dialysis are ineffective.

special instructions

The tablets should only be dissolved in water.

Before prescribing Ceforal Solutab, the patient's history should be carefully analyzed, which is associated with the existing likelihood of developing cross-allergic reactions with penicillins. In cases of an allergic reaction, the drug should be discontinued immediately.

During a long course of therapy, a violation of the normal intestinal microflora is possible. This can cause excessive multiplication of Clostridium difficile and, as a result, the development of pseudomembranous colitis.

If antibiotic-associated diarrhea is mild, it is usually sufficient to cancel Ceforal Solutab. In severe forms, corrective therapy is carried out (for example, vancomycin is administered orally 4 times a day, 250 mg). Medicines that have an antidiarrheal, inhibitory effect on gastrointestinal motility are contraindicated.

Careful monitoring of renal function is necessary in cases of using Ceforal Solutab simultaneously with high doses of aminoglycosides, polymyxin B, sodium colistimethate, loop diuretics (furosemide, ethacrynic acid).

After a long course of taking Ceforal Solutab, the state of the hematopoiesis function is assessed.

It is required to take into account that against the background of the treatment, when using some test systems for express diagnostics, a false-positive direct Coombs reaction and a false-positive urine reaction to glucose are possible.

Influence on the ability to drive vehicles and complex mechanisms

Patients during the period of therapy should take into account the likelihood of developing adverse reactions that negatively affect the ability to drive vehicles (in particular, dizziness) and be careful.

Application during pregnancy and lactation

• pregnancy: Ceforal Solutab can be prescribed only in cases where the expected benefit is higher than the possible harm;
• lactation period: at the time of taking the drug, breastfeeding should be interrupted.

Pediatric use

Ceforal Solutab is not prescribed for children weighing less than 25 kg.

With impaired renal function

Patients with renal insufficiency require caution during therapy.

Use in the elderly

For elderly patients, Ceforal Solutab is prescribed with caution.

Drug interactions

• tubular secretion blockers (for example, probenecid): excretion of cefixime through the kidneys is slowed down, which can lead to the development of symptoms of an overdose;
• indirect anticoagulants: their effect is enhanced, while the prothrombin index decreases;
• carbamazepine: an increase in its plasma concentration is likely; if combined use is necessary, therapeutic drug monitoring is indicated.

Analogs

Analogs of Ceforal Solutab are: Suprax Solutab, Suprax, Pantsef, Cefspan, Ixim Lupin, Tsemidexor, etc.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Ceforal Solutab

Reviews about Ceforal Solutab are mostly positive. It is used for many indications, and in almost all cases it is highly effective. In rare cases, the development of adverse reactions is reported.

Price for Ceforal Solutab in pharmacies

The approximate price for Ceforal Solutab (10 tablets) is 623-712 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!