Suprax (gran. for priming suspension. 100 mg/5 ml from 30.3 g to 35 g)


Suprax®

Absorption:

According to the results of studies involving healthy volunteers, after oral administration of cefixime, maximum serum concentrations are usually achieved after 3-4 hours. Following single doses of 50, 100, and 200 mg, mean maximum serum concentrations were 1.02, 1.46, and 2.63 mg/L, respectively, in 12 healthy Caucasians, and 0.69, 1.13, and 1.95 mg/l, respectively, in 12 healthy Japanese subjects.

Children's population:

After single doses of 1.5, 3.0, and 6.0 mg/kg cefixime were administered to Japanese pediatric patients, peak serum concentrations after 3 to 4 hours were 1.14, 2.01, and 3.97 mg/L, respectively.

Distribution:

In human plasma, cefixime is approximately 70% protein bound, with the level of binding independent of concentration in the range of 0.5-30 mg/l. Cefixime is distributed, reaching concentrations in organs/tissues and biological fluids, such as saliva, tonsils, mucous membrane of the maxillary sinuses, middle ear discharge, bile, lung tissue and gall bladder.

Metabolism and excretion:

Biologically active metabolites of cefixime were not detected in the plasma or urine of healthy volunteers after oral administration of the drug. Approximately 20% of a 200 mg dose of cefixime in healthy volunteers is excreted unchanged by the kidneys. The half-life is 2-4 hours.

Kidney failure:

The pharmacokinetics of a single 400 mg oral dose were studied in studies involving patients with varying degrees of renal impairment. Based on the results of studies, half-life, total clearance (CL/F), renal clearance and area under the pharmacokinetic curve (AUC) in patients with severe renal impairment (creatinine clearance < 20 ml/min), patients on hemodialysis or on continuous ambulatory peritoneal dialysis (CAPD) differed from the corresponding indicators of healthy volunteers.

Pharmacokinetic characteristics (mean values) of cefixime in healthy volunteers and patients with varying degrees of severity of renal dysfunction

Study group CLCr

(ml/mnn/1.73 m2)

Cmax

(mg/l)

Tmax

(h)

T1/2β

(h)

AUC

(mgh/l)

CL/F

(ml/kg/h)

Renal clearance

(ml/kg/h)

Healthy Volunteers 111 4,9 4,9 3,2 40 141 22
Severity of renal dysfunction
Very light 71 5,8 4,0 4,7 57 127 22
Light 51 7,6 4,5 7,0 90 70 10
Moderate 28 7,5 3,5 7,2 100 80 3,7
Heavy 9,8 9,6 6,0 11,5# 188# 41# 2,1#
Hemodialysis 1,3 6,2 4,8 8,2 94 73 0,4#
CAPD 3,0 10,2 5,0 14,9# 220# 42# 0,5#

The discrepancy is statistically significant compared to the values ​​of healthy volunteers.

Abbreviations: CLCr - creatinine clearance, Cmax - maximum concentration, Tmax - time to reach maximum concentration, T1/2β - half-life, CL/F - total clearance, CAPD - continuous ambulatory peritoneal dialysis, AUC - area under the pharmacokinetic curve # p < 0 .05 compared to healthy volunteers

Suprax (gran. for priming suspension. 100 mg/5 ml from 30.3 g to 35 g)

A country

Italy
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Active substance

Cefixime

Compound

The active substance is Cefixime.

pharmachologic effect

Antimicrobial, antibacterial (bactericidal). Inhibits the synthesis of peptidoglycan, the main structural component of the bacterial cell wall. Resistant to beta-lactamase. Active against many gram-positive and gram-negative microorganisms: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, E.coli, Proteus mirabilis, Proteus vulgaris, N. gonorrhoeae, Klebsiella pneumoniae, Klebsiella oxy toca, Pasteurella multocida , Providencia species, Salmonella spp., Shigella spp., Citrobacter diversus, Serratia marcescens, etc. Rapidly absorbed from the gastrointestinal tract. In the blood, more than half is bound to proteins (albumin). It is excreted in the urine mainly unchanged and in bile.

Indications for use

Urinary tract infections, otitis media, pharyngitis, tonsillitis, sinusitis, acute and chronic bronchitis, uncomplicated gonorrhea of ​​the urethra and cervix.

Mode of application

As prescribed by a doctor.

Interaction

No information available.

Side effect

From the digestive system: dry mouth, anorexia, nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, transient increase in the activity of liver transaminases and alkaline phosphatase, hyperbilirubinemia, jaundice, gastrointestinal candidiasis, dysbacteriosis; rarely - stomatitis, glossitis, pseudomembranous enterocolitis. From the hematopoietic system: leukopenia, thrombocytopenia, neutropenia, hemolytic anemia, pancytopenia, aplastic anemia, bleeding. From the side of the central nervous system: dizziness, headache. From the urinary system: interstitial nephritis, impaired renal function, acute renal failure. Allergic reactions: skin itching, urticaria, skin hyperemia, eosinophilia, fever, erythema multiforme, toxic epidermal necrolysis, anaphylactic shock. Other: candidiasis, shortness of breath, development of hypovitaminosis B.

Contraindications

Hypersensitivity, pregnancy, breastfeeding (stop during treatment), children under 6 months of age.

Overdose

Symptoms: increased adverse reactions, especially from the gastrointestinal tract. Treatment: gastric lavage, prescription of antihistamines and glucocorticoids.

special instructions

Prescribe with caution to patients with gastrointestinal diseases, especially colitis. In case of impaired renal function or in patients on hemodialysis, the daily dose is reduced by 25%. When creatinine clearance is less than 20 ml/min, the dose is reduced by 2 times.

Dispensing conditions in pharmacies

On prescription

How to take Suprax

According to the instructions for use, Suprax is taken orally once a day, regardless of food intake.

How to drink Suprax correctly

Capsules for oral administration

  • children from 6 months to 12 years: 8 mg/kg body weight 1 time/day. or 4 mg/kg every 12 hours;
  • children over 12 years of age weighing more than 50 kg and adults: 400 mg 1 time / day.

Oral suspension

  • children from 6 months to 1 year: 2.5-4 ml/day;
  • children 2-4 years old: 5 ml/day;
  • children 5-11 years old: 6-10 ml/day.

To properly prepare the suspension, shake the granules in the bottle, gradually pour 40 ml of cool water into it, shaking thoroughly each time until a homogeneous suspension is formed. If cooking in a bottle is not possible, then you should use glass or enamel containers. To completely dissolve the granules, you should let the resulting solution stand for about five minutes. Suprax suspension does not need to be stored in the refrigerator.

The duration of the course of therapy depends on the diagnosis, the severity of the disease, the presence of complications and the characteristics of the patient’s body. It is determined by the attending physician. On average, treatment lasts 7-10 days.

  • for gonorrhea – 1 day;
  • for mild forms of genitourinary infection – from 3 to 7 days;
  • for angina, Suprax is prescribed in a course of 7-14 days (for angina in children, the daily dose is reduced).

It is worth noting that with prolonged use of Suprax, the patient may experience chronic diarrhea and the subsequent development of severe colitis.

Also, while taking the drug, dizziness or attacks of severe headache may occur. It is better to refrain from driving a car or using complex equipment that requires immediate response or concentration.

Suprax's analogs

Do you know why Suprax is better than its analogues? It is used to treat aggressive pathogens, and is quite effective. And all this is outpatient! The drug can also be used gradually, that is, the doctor has the opportunity to prescribe step-by-step therapy. This is necessary in fairly serious cases. Treatment begins with parenteral forms of 3rd generation cephalosporins, and after 2-3 days, when the patient’s condition has improved, they switch to oral administration of Suprax.

Suprax's analogs

The following drugs have a similar therapeutic effect with Suprax capsules:

  • Amoxicillin;
  • Amoxiclav;
  • Flemoxin;
  • Cefatoxime;
  • Ceftriaxone;
  • Sumamed;

Synonyms (drugs containing the same active substance) are:

  • Ixim lupine;
  • Pantsef;

Remember that only the attending physician can replace one drug with another, who takes into account not only the severity of the patient’s condition, the nature of the disease, but also contraindications and possible side effects.

Suprax/Pancef

These antibiotics are based on the same active substance. If you rely on patient reviews, then when taking Pancef, the body is less likely to show negative reactions in the form of side effects.

Suprax/Sumamed

Sumamed basically contains azithromycin, which has a broader antimicrobial effect. Sumamed is prescribed to children; it causes fewer side effects and the course duration is shorter.

Suprax/Amoxiclav

Unlike Amoxiclav, Suprax is better tolerated and less likely to cause dysbiosis and other gastrointestinal disorders.

Suprax granules for suspension 100mg/5ml

Active substance: cefixime Dosage form

The drug is available with a prescription

Granules for preparation. susp. for oral administration 100 mg/5 ml: vial. 30.3-35.0 g Release form, packaging and composition of the drug Suprax®

Granules for the preparation of suspension for oral administration from almost white to cream color, small; Once mixed, it produces an off-white to cream-colored slurry with a sweet strawberry aroma.

1 fl. 5 ml of ready-made suspension.

cefixime trihydrate (micronized) 1.402 g 100 mg

 (equivalent to 1.2 g cefixime + 4% refill)

Excipients: sodium benzoate - 0.03 g, sucrose - 30.225 g, xanthan gum - 0.155 g, strawberry flavor - 0.048 g. Pharmacological action

Semisynthetic cephalosporin antibiotic of the third generation for oral administration with a broad spectrum of action. Acts bactericidal. The mechanism of action is due to inhibition of the synthesis of the pathogen's cell membrane. Cefixime is resistant to the action of β-lactamases produced by most gram-positive and gram-negative bacteria.

In vitro, cefixime is active against gram-positive bacteria: Streptococcus agalactiae; gram-negative bacteria: Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus, Serratia marcescens.

In vitro and in clinical practice, cefixime is active against gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes; gram-negative bacteria: Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae.

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

Pharmacokinetics

When taken orally, the bioavailability of cefixime is 40-50%, regardless of food intake, however, the Cmax of cefixime in serum is achieved faster by 0.8 hours when taking the drug with food. Binding to plasma proteins, mainly albumin, is 65%. About 50% of the dose is excreted unchanged in the urine within 24 hours, about 10% of the dose is excreted in bile. T1/2 depends on the dose and is 3-4 hours. In patients with impaired renal function with CC from 20 to 40 ml/min, T1/2 increases to 6.4 hours, with CC 5-10 ml/min - up to 11.5 hours.

Indications of the active substances of the drug Suprax®

Infectious and inflammatory diseases caused by sensitive microorganisms: pharyngitis, tonsillitis, sinusitis, acute and chronic bronchitis, otitis media, uncomplicated urinary tract infections, uncomplicated gonorrhea. Dosage regimen

The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. The compliance of the dosage form of a particular drug with the indications for use and dosage regimen should be strictly observed.

For adults and children over 12 years of age weighing more than 50 kg, the daily dose is 400 mg (1 time/day or 200 mg 2 times/day). The duration of treatment is 7-10 days. For uncomplicated gonorrhea - 400 mg once.

Children under 12 years of age - 8 mg/kg body weight 1 time/day or 4 mg/kg every 12 hours.

For infections caused by Streptococcus pyogenes, the course of treatment should be at least 10 days.

In case of impaired renal function (with CC from 21 to 60 ml/min) or in patients on hemodialysis, the daily dose should be reduced by 25%.

With CC≤20 ml/min or in patients on peritoneal dialysis, the daily dose should be reduced by 2 times.

Side effect

From the digestive system: dry mouth, anorexia, diarrhea, nausea, vomiting, abdominal pain, flatulence, transient increase in the activity of liver transaminases and alkaline phosphatase, hyperbilirubinemia, jaundice, gastrointestinal candidiasis, dysbacteriosis; rarely - stomatitis, glossitis, pseudomembranous enterocolitis.

From the hematopoietic system: leukopenia, thrombocytopenia, neutropenia, hemolytic anemia.

From the side of the central nervous system: dizziness, headache.

From the urinary system: interstitial nephritis.

Allergic reactions: skin itching, urticaria, skin hyperemia, eosinophilia, fever.

Contraindications for use

Hypersensitivity to cephalosporins and penicillins.

Use during pregnancy and breastfeeding

Use during pregnancy is possible only when the expected benefit to the mother outweighs the potential risk to the fetus.

If necessary, use during lactation should stop breastfeeding.

Use for renal impairment

In case of impaired renal function (with CC from 21 to 60 ml/min) or in patients on hemodialysis, the daily dose should be reduced by 25%. With CC≤20 ml/min, the daily dose should be reduced by 2 times.

Use in children

Use with caution in children under 6 months of age.

Use in elderly patients

Use with caution in elderly patients.

special instructions

Use with caution in elderly patients, patients with chronic renal failure or pseudomembranous colitis (history), and in children under 6 months of age.

With long-term use, normal intestinal microflora may be disrupted, which can lead to the growth of Clostridium difficile and cause the development of severe diarrhea and pseudomembranous colitis.

In patients with a history of allergic reactions to penicillins, manifestations of hypersensitivity to cephalosporin antibiotics are possible.

During treatment, a positive direct Coombs test and a false positive urine test for glucose are possible.

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