Suprax Solutab, 400 mg 7 pcs

Pharmacotherapeutic group:

Cephalosporin antibiotic.

ATC code: [J01DD08]

Pharmacological properties

Pharmacodynamics:

Mechanism of action

A semi-synthetic oral cephalosporin III generation antibiotic. It has a bactericidal effect. The mechanism of action is related to inhibition of the synthesis of the bacterial cell wall. Cefixime is resistant to p-lactamases produced by many Gram-positive and Gram-negative bacteria.

The spectrum of antimicrobial activity

In clinical practice and in vitro the efficacy of cefixime has been confirmed in infections caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae.

Cefixime also has activity in vitro against Gram-positive -Streptococcus agalactiae and Gram-negative bacteria – Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp, Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus.

Pseudomonas spp., Enterococcus spp., Listeria monocytogenes, most strains of Enterobacter spp., Staphylococcus spp. (including methicillin-resistant strains), Bacteroides fragilis, Clostridium spp.

Pharmacokinetics:

Absorption

In oral administration bioavailability is 40-50% and does not depend on food intake. Maximal blood plasma concentration (Cmax) in adults is reached after 3-4 hours after an oral dose of 400 mg and is 2.5-4.9 µg/ml, after a dose of 200 mg – 1.49-3.25 µg/ml. Food intake has no significant effect on absorption of the drug from the gastrointestinal tract.

Distribution

The volume of distribution after administration of 200 mg of cefixime was 6.7 l, when reaching equilibrium concentration – 16.8 l. About 65% of cefixime binds to plasma proteins. The highest concentrations of cefixime are in urine and bile. Cefixime penetrates through the placenta. The concentration of cefixime in umbilical cord blood reached 1/6-1/2 of the drug concentration in maternal plasma; the drug was undetectable in breast milk.

Metabolism and excretion

The elimination half-life in adults and children is 3-4 h. Cefixime is not metabolized in the liver; 50-55% of the administered dose was excreted unchanged in the urine within 24 hours. About 10% of cefixime is excreted with the bile.

Pharmacokinetics in special clinical situations

In patients with renal insufficiency a longer half-life and correspondingly higher concentration of the drug in plasma and delayed elimination by the kidneys can be expected. In patients with creatinine clearance of 30 ml/min receiving cefixime 400 mg, the half-life period is increased up to 7-8 h, maximum concentration in plasma is on average 7.53 µg/ml, and excretion with urine – 5.5% within 24 hours. In patients with liver cirrhosis, the elimination half-life increases to 6.4 hours, the time to reach maximum concentration (TCmax) – 5.2 hours; simultaneously, the proportion of the drug eliminated by the kidneys increases. Cmax and area under the pharmacokinetic curve do not change.

Indications

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

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

Active ingredient

Composition

1 tablet contains:

The active ingredient:

cefixime – 400 mg (in the form of cefixime trihydrate 447.7 mg)

Excipients: Microcrystalline cellulose 44.5 mg, low-substituted hyprolose 40.0 mg, colloidal silica 5.0 mg, povidone 5.0 mg, magnesium stearate 10.0 mg, calcium saccharinate trisquihydrate 20.0 mg, strawberry flavoring FA 15757 5.0 mg, strawberry flavoring PV 4284) 2.5 mg, sunset yellow dye (E110) 0.3 mg.

How to take, the dosage

In adults and children with body weight over 50 kg the daily dose is 400 mg in 1 or 2 doses. In children with a body weight of 25-50 kg the drug is prescribed in a dose of 200 mg/day in 1 dose. The tablet can be swallowed with plenty of water or the resulting suspension can be dissolved in water and drunk immediately after preparation.

The drug can be taken regardless of meals. The duration of treatment depends on the nature of the course of the disease and the type of infection. After symptoms of infection and/or fever disappearance it is reasonable to continue taking the drug for at least 48-72 hours. The course of treatment for infections of the respiratory tract and ENT-organ is 7-14 days. In case of tonsillopharyngitis caused by Streptococcus pyogenes the duration of treatment shall be not less than 10 days.

In uncomplicated gonorrhea the drug is prescribed in a dose of 400 mg once. In uncomplicated lower urinary tract infections in women, the drug is prescribed for 3-7 days; in uncomplicated upper urinary tract infections in women – for 14 days. In case of uncomplicated upper and lower urinary tract infections in men the duration of treatment is 7-14 days.

Interaction

Special Instructions

Due to the possibility of cross-allergic reactions with penicillins, it is recommended that patient history be carefully evaluated. If an allergic reaction occurs, the drug should be discontinued immediately.

In case of toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, drug rash with eosinophilia and systemic manifestations, cefixime should be stopped and appropriate therapy should be given.

In case of anaphylactic shock the drug should be discontinued, epinephrine (adrenaline), systemic glucocorticosteroids and antihistamines should be administered.

In prolonged use of the drug it is possible to disrupt normal intestinal microflora, which may lead to excessive proliferation of Clostridium difficile and development of pseudomembranous colitis. When mild forms of antibiotic-associated diarrhea occur, it is usually sufficient to stop taking the drug. Corrective treatment (e.g., oral vancomycin 250 mg 4 times daily) is recommended for more severe forms. Antidiarrheals drugs that inhibit gastrointestinal motility are contraindicated in the development of pseudomembranous colitis.

Like other cephalosporins, cefixime may cause acute renal failure accompanied by tubulointerstitial nephritis. In case of acute renal failure, cefixime should be discontinued, appropriate measures taken and/or appropriate treatment administered.

In case of Suprax® Solutab® concomitantly with aminoglycosides, polymyxin B, colistimethate sodium, “loop” diuretics (furosemide, etacrynic acid) at high doses, renal function should be controlled. After long-term treatment with the drug Suprax® Solutab® the state of hematopoiesis function should be checked.

The dispersible tablets should be dissolved only in water. During treatment, a false-positive direct Coombs reaction and a false-positive urine glucose reaction are possible with some rapid diagnostic test systems.

Contraindications

– hypersensitivity to cefixime or components of the drug;

– hypersensitivity to cephalosporins or penicillins;

– not recommended for use in children with chronic renal impairment and in children with a body weight less than 25 kg in this dosage form

Elderly age, renal impairment, colitis (history), pregnancy.

Side effects

Side effects are classified according to the frequency of reported cases:
Very common: (>10%); common (1-10%); infrequent (0.1-1%); rare (0.01-0.1%); very rare (≤0.01%);

Blood and hematopoietic system disorders:
Very rare: transient leukopenia, agranulocytosis, pancytopenia, thrombocytopenia or eosinophilia. Individual cases of blood clotting disorders have been noted.
Frequency unknown: hemolytic anemia

Allergic reactions:
Rare: allergic reactions (e.g., urticaria, rash, erythema multiforme, skin itching).
Very rare: Lyell’s syndrome (toxic epidermal necrolysis); other allergic reactions associated with sensitization – drug fever, serum-like syndrome, hemolytic anemia and interstitial nephritis, Stevens-Johnson syndrome, anaphylactic shock. Some patients had cases of drug rash syndrome with eosinophilia and systemic manifestations.

Nervous system disorders:
Infrequent: headaches, dizziness, dysphoria, anxiety.

Respiratory system disorders:
Frequency unknown: dyspnea.

Digestive system reactions:
Often: abdominal pain, digestive disorders, nausea, vomiting and diarrhea.
Very rare: pseudomembranous colitis.

Hepatobiliary system disorders:
Rarely: increased activity of alkaline phosphatase and “hepatic” transaminases, increased concentration of bilirubin in the blood.
Very rare: isolated cases of hepatitis and cholestatic jaundice.

Urogenital system disorders:
Very rare: slight increase in concentration of creatinine and urea in blood, hematuria, possible development of acute renal failure accompanied with tubulointerstitial nephritis.

Overdose

Pregnancy use

The use of the drug Ceforal Solutab during pregnancy is possible when the expected benefits to the mother exceed the potential risk to the fetus.

Breast-feeding should be temporarily stopped if the drug has to be used during lactation.

Similarities