Suprax granules for suspension 100mg/5ml

Composition and release form

in a blister pack 6 pcs.; in a cardboard pack 1 package.

in dark glass bottles of 60 ml; in a cardboard pack 1 bottle complete with a dosing spoon.

Description of the dosage form

200 mg capsules with a yellow cap and a white body, containing a mixture of powder and small granules of a yellowish-white color.

400 mg capsules with a purple cap and a white body, containing a mixture of powder and small granules of a yellowish-white color. The code H808 is marked on the capsule.

Granules for the preparation of suspension for oral administration: small granules from white to cream color. After dilution, the suspension is almost white to cream in color with a sweet strawberry aroma.

Pharmacodynamics

Inhibits the synthesis of the pathogen's cell membrane. Cefixime is resistant to beta-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, E.coli, Proteus mirabilis, Neisseria gonorrhoeae.

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

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.

Pharmacokinetics

When taken orally, the bioavailability of cefixime is 40–50%, regardless of food intake, however, the Cmax of cefixime in serum is achieved 0.8 hours faster when taking the drug with food.

When taking the drug in capsule form at a dose of 200 mg, Cmax in serum is achieved after 4 hours and is 2 mcg/ml, when taken at a dose of 400 mg - 3.5 mcg/ml. When taking the drug in the form of a suspension at a dose of 200 mg, Cmax in serum is achieved after 4 hours and is 2.8 mcg/ml, when taken at a dose of 400 mg - 4.4 mcg/ml. 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 a creatinine Cl of 20-40 ml/min, T1/2 increases to 6.4 hours, with a creatinine Cl of 5-10 ml/min - up to 11.5 hours.

Side effects

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

From the digestive system: dry mouth, anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain, dysbiosis, liver dysfunction (increased activity of liver transaminases, alkaline phosphatase, hyperbilirubinemia, jaundice), gastrointestinal candidiasis; rarely - stomatitis, glossitis, pseudomembranous enterocolitis.

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

From the urinary system: interstitial nephritis.

From the nervous system: dizziness, headache.

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

A country

Italy
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

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

Directions for use and doses

Inside. For adults and children over 12 years of age weighing more than 50 kg, the average daily dose is 400 mg (once a day or 200 mg 2 times a day). The average duration of treatment is 7–10 days.

For uncomplicated gonorrhea - 400 mg once a day.

Children under 12 years of age are prescribed as a suspension at a dose of 8 mg/kg once or in 2 doses (4 mg/kg every 12 hours). For children aged 6 months to 1 year, the daily dose of the suspension is 2.5-4 ml, for children aged 2-4 years - 5 ml, for children aged 5-11 years - 6-10 ml. For diseases caused by Streptococcus pyogenes, the course of treatment is at least 10 days.

In case of impaired renal function, the dose is set depending on the serum creatinine clearance: with creatinine Cl 21–60 ml/min or in patients on hemodialysis, the daily dose should be reduced by 25%. When Cl creatinine is less than or equal to 20 ml/min or in patients on peritoneal dialysis, the daily dose should be reduced by 2 times.

Method for preparing the suspension: turn the bottle over and shake the powder. Add 40 ml of boiled water cooled to room temperature in 2 stages and shake after each addition until a homogeneous suspension is formed. After this, it is necessary to allow the suspension to stand for 5 minutes to ensure complete dissolution of the powder. The prepared suspension should be shaken before use.

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.