Sorcef (cefixime) granules for oral suspension 100 mg/5 ml. 100 ml. vial

Description

Sorcef (cefixime) granules for oral suspension 100 mg/5 ml. 100 ml. vial

Composition

active ingredient: cefixime;

5 ml of suspension contain cefixime (in the form of cefixime trihydrate) 100 mg;

excipients: sodium benzoate (E 211), sucrose, xanthan gum, orange flavor.

Dosage form

Granules for oral suspension.

Basic physical and chemical properties:

granules: a mixture of yellow to almost yellow granules and colorless crystals with a pleasant orange odour;

suspension: viscous liquid from white to cream color with a pleasant orange smell.

Pharmacological group

Antibacterial agents for systemic use. Beta-lactam antibiotics. 3rd generation cephalosporins.
Code ATX J01D D08.

Pharmacological properties

It is a third generation antibiotic cephalosporin. Its bactericidal activity (the ability to kill bacteria) is due to the inhibition of the production of cell membrane components. It is active against most Gram (+) and Gram (-) microorganisms. This drug is characterized by high resistance to penicillinases, cephalosporinases (β-lactamases) of bacteria. Is active against the following organisms: Streptococcus pneumonіae, Streptococcus pyogenes, Haemophіlus influenzae, Moraxella catarrhalіs, Escherichia coli, Proteus mirabіlis, Neisserіa gonorrhoeae, Streptococcus agalactiae, Haemophilus paraіnfluenzae, Proteus vulgarіs, Klebsiella pneumonіae, Klebsіella oxytoca, Pasteurella multocіda, Providencіa spp, Salmonella spp. ., Shigella spp., Citrobacter amalonatіcus, Citrobacter dversus. Enterococcus spp., Lіsteria monocytogenes, Pseudomonas spp., Most strains of Enterobacter spp., Staphylococcus spp., Bacteroides fragilis, Clostridium spp. Are resistant to this antibiotic.

Indications

Sorcef suspension is prescribed for infections caused by microorganisms that are sensitive to it:

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

Contraindications

You can not use Sorcef suspension:

• with allergies to cephalosporins, penicillins;
• with allergies to cefixime, intolerance to auxiliary components;
• children under 6 months of age;
• with porphyria.

Sorcef is used with caution in renal failure, colitis (in the past), in the elderly, pregnant women.

Application during pregnancy and lactation

Use is allowed only when prescribed by a doctor, when the intended benefit to the mother outweighs the risk to the fetus. If necessary, use during lactation, feeding should be discontinued.

Method of administration and dosage

Sorcef suspension is applied inside.

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

For children aged 6 months to 10 years weighing up to 50 kg: the recommended dose is 8 mg / kg per day once or 4 mg / kg every 12 hours, depending on the severity of the disease.

Adults and children over 10 years of age (or weighing over 50 kg): The recommended dose is 400 mg once a day or 200 mg every 12 hours, depending on the severity of the disease.

Elderly patients: administer the drug at the recommended adult dose. Renal function should be monitored and the dose adjusted in severe renal insufficiency (see “Dosage in Renal Insufficiency”).

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 recommended to reduce the daily dose by 50%. This also applies to patients who are on continuous ambulatory peritoneal dialysis or hemodialysis.

Suspension preparation method

For internal use only.

• For 60 ml suspension (100 mg / 5 ml): before dilution, shake the bottle several times, add 40 ml of purified water in 2 doses using a measuring cup and shake until a homogeneous suspension is formed.
• For 100 ml suspension (100 mg / 5 ml): before dilution, shake the bottle several times, add 66 ml of purified water in 2 doses using a measuring cup and shake until a homogeneous suspension is formed.

Before use, the finished suspension should be shaken well.

Dose the suspension with a measuring spoon.

Children

The drug is used for children from 6 months. The safety and efficacy of cefixime in children under 6 months of age have not been established, so the use of cefixime in this category of patients is not recommended.

Overdose

When taken in a dose exceeding the maximum daily dose, side effects may increase.
Overdose treatment: gastric lavage, symptomatic, supportive therapy.

Side effects:

• Blood test changes: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, eosinophilia, blood clotting disorder.
• Genitourinary disorders: increased concentration of creatinine in the blood, hematuria.
• Allergic reactions: urticaria, pruritus, Lyell’s syndrome, drug fever, hemolytic anemia, interstitial nephritis, serum-like syndrome, anaphylactic shock.
• Digestive disorders: abdominal pain, diarrhea, digestive disorders, nausea, pseudomembranous colitis.
• Neurological disorders: headaches, dizziness, dysphoria.
• Hepatobiliary disorders: increased levels of alkaline phosphatase, transaminases, hepatitis, cholestatic jaundice.