Suprax: instructions for use. Suprax® Solutab® dispersible tablets Suprax suspension 400 mg

Probably, every person at least once in his life has come across a condition that requires the use of antibiotics. There are just a huge number of antibacterial drugs. One of them is Suprax (400 mg). Instructions for the use of this drug, as well as its dosage, indications, contraindications, release form, analogues and opinions of patients and doctors about it, you can read about it in this article. Therefore, carefully read the information provided in order to arm and protect yourself as much as possible.

A few words about the composition and form of release

The instructions for use for "Suprax" (400 mg) describe this agent as a semisynthetic antibiotic intended for oral administration. The tool has three forms of release: tablets, capsules and special granules for preparing a suspension. Each form of release contains a similar active ingredient - cefixime, as well as auxiliary components that give the drug the desired form, and also help the drug to be absorbed by the body as quickly and better as possible. So, let's take a closer look at each form of release.

Tablets "Suprax" (400 mg) instructions for use describe as a drug intended for resorption. Each pill has an oblong shape and is colored orange. The drug has a rather pleasant strawberry taste, so it will not be difficult to take it. The tablets are sold in packs, each of which can contain one, five, seven, or ten pills.

The product is also available in capsule form for internal use. They have an elongated cylindrical shape and a whitish-yellow tint. Each capsule contains granular contents. Each package contains six capsules.

The preparation "Suprax" (400 mg) is also described by the instructions for use as a product produced in the form of granules for preparing a suspension. Each granule is a small ball with a white-cream color. The ready-made liquid for use will have a pale shade and a pleasant strawberry smell.

The granules are placed in a glass darkened bottle, which will also include a measuring spoon. Each bottle contains about thirty-five grams of the substance, with the help of which a solution for oral administration will be prepared in the future.

Any form of release has the same active substance content. Therefore, you can choose the most appropriate form of application for yourself.

Pharmacological features

"Suprax" (400 mg) instructions for use characterizes as a very effective antibiotic with a fairly wide range of applications. The agent has an effect due to the fact that under its influence the formation of bacterial cell walls is suspended. The tool has proven itself perfectly in the elimination of both gram-positive and gram-negative bacteria. These include various types of streptococci, Escherichia coli, Salmonella, Proteus, and many others.

The drug has high bioavailability. At the same time, food intake does not significantly affect the effectiveness of the drug. The tool is very convenient to use, as it only needs to be taken once a day. The drug very well and quickly penetrates the focus of infection, begins to fight against pathological microorganisms. The agent is able to penetrate very quickly into the urinary tract, tonsils, ears, lungs, and also into the nasal cavity. At the same time, the medication has a significantly less negative effect on the digestive system.

In what cases can you apply

Tablets "Suprax" (400 mg) instructions for use recommend using in the presence of diseases caused by bacteria that are sensitive to the active ingredients that make up the drug. Most often, this remedy is prescribed by doctors in the presence of diseases of the respiratory and genitourinary system. The remedy is able to cope with sinusitis, bronchitis, pharyngitis, laryngitis, otitis media, as well as with a mild form of gonorrhea.

Medicine "Suprax" (400 mg): instructions for use

In order for the product to have a good healing effect and not lead to side effects, it is very important to use it correctly. Tablets and capsules are usually prescribed for adults, as well as for children over the age of twelve. The tool is recommended to be taken once a day, one tablet. Most often, the total duration of treatment is about seven to ten days, but in some cases it can be extended to two weeks. With a mild form of gonorrhea, it will be sufficient to take the medication once.

Usually, for patients suffering from serious pathologies of the liver and kidneys, doctors recommend using the agent in the form of a granule release to prepare a suspension. Also, the suspension is prescribed by doctors and children from the age of six months.

Babies aged from six months to twelve years old, the suspension needs to be prepared, taking into account the weight of the baby. Children aged six to twelve months are advised to take a dose of 3-4 ml of the prepared solution. For babies under the age of four, a single dosage of 5 ml of the substance is suitable. But for older children, you can increase the dosage to ten milligrams of the prepared liquid.

Adults are advised to take the drug at a dosage of 400 mg once a day, breaking this amount of the active substance into two applications. The usual duration of suspension treatment is about one to two weeks. However, if the disease is caused by streptococci, then the course of treatment should be extended.

Instructions for use for "Suprax Solutab" (400 mg) recommends halving the dosage of the active substance for those patients who suffer from serious kidney and liver diseases.

Suspension preparation features

It is very important to prepare the slurry correctly. Only in this case will it bring health benefits. First, you need to turn the glass bottle upside down, shake it thoroughly. Now add forty milligrams of chilled boiled water to it.

It is best to infuse the liquid in two steps. After each of them, the suspension must be shaken thoroughly. The result should be a homogeneous, homogeneous suspension. Now let it sit for five minutes. This must be done so that the granules are completely dissolved. Be sure to shake the suspension well each time before using it so that the active substances are evenly distributed in the liquid.

Contraindications for use

The drug "Suprax Solutab" (400 mg) instructions for use strongly recommends using with extreme caution, carefully following all the doctor's recommendations, as well as constantly monitoring your health indicators. It should be borne in mind that this drug can not be used in all cases. Consider the main contraindications to the use of this medication:

• it is forbidden to use the product for people who have hypersensitivity to any of the components that make up this medication;
• also, the remedy is contraindicated in patients with serious kidney pathologies, in some cases, the medicine can still be prescribed by doctors in the presence of such diseases, however, treatment should be carried out only under strict supervision;
• capsules and tablets cannot be used by children under twelve years of age, but granules for preparing a suspension will come to the rescue.

Is the development of undesirable effects possible

Instructions for use for the drug "Suprax" (400 mg) indicate that this drug can lead to just a huge number of side effects, so you need to take the medication with extreme caution. Let's consider what undesirable reactions develop most often:

1. Quite often, patients notice the development of allergic reactions against the background of the use of the drug "Suprax" (400 mg). They usually manifest themselves in the form of a rash all over the body, hives, itching and fever.
2. Also, often there are negative phenomena from the central nervous system and digestive organs. Patients complained of headaches, dizziness, increased fatigue and drowsiness. Also, such phenomena as nausea, pain in the abdominal cavity developed, dysbacteriosis, diarrhea occurred, sometimes the appetite completely disappeared.
3. Often there were diseases of the hematopoietic organs, as well as the excretory system. Some patients complained of severe kidney failure.
4. Also, against the background of the use of the drug, women noticed the development of various diseases of the genitourinary system.

If you have any side effects while using the drug "Suprax" (400 mg), the description, instructions for the use of which are given in this article, immediately contact the hospital. Perhaps these drugs simply do not suit you, so the doctor must choose the most optimal drug.

What happens in case of an overdose

The drug (400 mg) "Suprax" (analogues of the drug, instructions for use - this is very important information that every patient should familiarize himself with before starting a course of treatment) is capable of causing overdose symptoms. Therefore, take the remedy in a dosage clearly established by the doctor, in no case self-medicate.

Very often, an increase in side effects, especially on the part of the digestive system, indicates the symptoms of an overdose. If you notice that your condition has worsened, go to the hospital immediately.

The hospital will give you gastric lavage and prescribe supportive and symptomatic treatment. In no case, do not ignore the therapy prescribed by the doctor, otherwise it will not be so easy to get rid of the symptoms of an overdose.

Use by pregnant and lactating women

Instructions for use, description and composition of "Suprax" (400 mg) allow you to study all the features of this drug, to understand the nuances of its use. The medication is prohibited for use by women during pregnancy and lactation. The substances that make up the product are capable of penetrating through they can harm the child. Therefore, the medicine should be taken only if the benefits from it to the mother significantly exceed the harm to the unborn baby.

It should also be borne in mind that the ingredients of the medicine also pass into breast milk, so it is not recommended to take the medicine for lactating women. If there is still an urgent need for this, then it means that it makes sense to transfer the child to artificial feeding.

It is very important to read the instructions for use for "Suprax" (400 mg) before starting treatment. The composition of this product is not entirely safe, so it should be taken very carefully. Be prepared for the fact that against the background of the use of this remedy, you may develop dysbiosis, therefore it is best to combine this medication with preparations containing lactobacilli.

If you have a hypersensitivity to antibiotics made on the basis of penicillins, you may also be hypersensitive to Suprax. Therefore, in this case, it is better not to risk it, but to choose a more suitable antibiotic.

"Suprax" (400 mg): analogues

Instructions for use for this medication indicate that it is far from always possible to take it. In this case, it is worth figuring out whether there are other medicines that can replace it. In fact, there are a lot of such drugs. It is necessary not to self-medicate, but to trust experienced doctors. Most often, doctors prescribe to their patients such substitutes for "Suprax" (400 mg) as:

• "Cefspan";
• "Pancef";
• Ixim Lupine;
• Betasporin;
• "Ificef";
• "Dardum", and many others.

Produced in various forms. It is a 3 generation semi-synthetic cephalosporin antibiotic. It inhibits the synthesis of the cell membrane, is resistant to the action of lactamases, which are produced by most bacteria.

Composition, release form, packaging

Capsules with a yellow cap and a former body of 200 mg contain a mixture of granules and powder. The 400 mg capsules have a purple lid and a white body. The latter is marked with the H808 code.

The auxiliary substances are: silicon dioxide, magnesium, azorubin and carboxymethyl cellulose. The casing is made from titanium dioxide, dyes and gelatin. One carton contains 6 capsules placed in a cellular contour packaging.

The suspension granules contain 100 mg of active ingredient. Excipients are sodium benzonate, sucrose, flavor, yellow resin. Granules are produced for preparation of suspension in 60 ml dark glass vials.

The set includes a dosage spoon. After dilution, the suspension is almost white with a sweet strawberry flavor. In all forms, cefixime is the main antibacterial agent.

Manufacturer

Antibiotic is produced in Jordan by GEDEON RICHTER

Indications for use

Suprax is prescribed for diseases caused by a bacterial infection. With its help, you can effectively cure:

• pharyngitis,
• sinusitis,
• sinusitis,
• and the flu,
• tonsillitis,
• bronchitis.

The drug is suitable for the treatment of the genitourinary system. Effectively combats uncomplicated forms of diseases. The effectiveness of the active component becomes higher if bacterial inoculation on the microflora is carried out in advance.

Contraindications

The main group of contraindications includes an increased sensitivity of the body to drugs of the cephalosporin and penicillin groups. With extreme caution, it is prescribed for babies up to 6 months old, elderly citizens, people with pseudomembranous colitis, etc. For capsules, contraindications are children under 12 years of age.

Mechanism of action

• multiforme exudative.

Reactions from other systems are also possible: vaginitis, dysfunction of the urinary system, dysbiosis, jaundice, anemia, thrombocytopenia. On the part of laboratory parameters, there is an increase in the activity of hepatic transaminases, an increase in urea nitrogen, an increase in prothrombin time.

Other side effects include the development of hypovitaminosis B, the appearance of shortness of breath, etc.

Overdose

With an increase in the dose, side effects may be enhanced, especially from the gastrointestinal tract. Treatment is carried out by flushing, supportive therapy. It should be borne in mind that peritoneal dialysis and hemodialysis are ineffective.

If necessary, glucocorticoids, pressor amines and transfusion of infusion solutions may be prescribed.

special instructions

Capsules and suspensions should only be used when the intended benefit to the mother is higher than the risk to which the fetus may be exposed. During the period of taking the medicine, it is recommended to interrupt breastfeeding.

People who have allergic reactions to penicillins have an increased sensitivity to Suprax. Experts warn that taking the drug may disrupt the balance of normal microflora. The result is the growth of Clostridium difficile. This leads to diarrhea and pseudomembraneous colitis.

Drug interactions

Allopurinol, diuretics delay the excretion of cefixime by the kidneys. This increases the toxicity of the drug. Suprax reduces the prothrombin index and leads to an increase in the action of indirect anticoagulants. Preparations that contain magnesium, aluminum hydroxide can slow down the absorption of the drug.

In case of impaired renal function or in people on hemodialysis, the daily dose is reduced by 25%.

The active ingredient (INN) is cefixime.

List of analogues with the same active substance. The approximate prices of online pharmacies are shown in brackets:

• Pancef (600 rubles for 10 tab.);
• Pancef in the form of a suspension has a children's dosage;
• Ceforal Solutab (currently absent);
• Ixim Lupine (500 r for 5 servings, children's dosage).

In general, the antibiotic cefixime cannot be classified as a cheap drug. But in many cases, you can pick up another drug that will cost much less, for example: List of antibiotics for furunculosis.

Price

Average online price *, 806 p. (caps 400mg No. 6)

Where can one buy:

Instructions for use

(when the picture opens, click the button at the bottom of the screen)

Suprax is an antibacterial drug from the group of 3rd generation cephalosporins. The drug is widely used in the treatment of diseases of infectious and inflammatory origin.

The antibiotic Suprax has a pronounced bactericidal effect, belongs to drugs of a wide spectrum of action, which allows it to have an effect on almost all pathogenic microorganisms.

What is the difference

The drug is produced in two forms:

• water-soluble tablets (Suprax Solutab);
• capsules (Suprax).

Both forms of the antibiotic contain 400 mg of cefixime, which forms the basis of the drug. There are slight differences in excipients. Both are for oral administration. Currently produced by the same manufacturer.

Solutab dissolves and absorbs faster, it can be chewed and has a strawberry flavor. It is believed to be better absorbed.

Solutab is available in 7 tablets per package, ordinary Suprax - 6 capsules.

Indications

The drug Suprax is widely used in various fields of medicine. It is often used to treat the following conditions:

• acute or exacerbation of chronic pharyngitis;
• sinusitis;
• sinusitis of varying degrees;
• sore throats;
• complications after influenza or viral infection;
• otitis;
• acute or chronic bronchitis;
• pneumonia;
• pyelonephritis;
• pyoderma and severe furunculosis;
• cystitis;
• uncomplicated gonorrheal urethritis.

The drug can be prescribed for infections of the skin and connective tissue, as well as other inflammatory diseases that are caused by microorganisms and bacteria that are sensitive to the drug.

Method of administration and dosage

The drug Suprax should be prescribed by a doctor individually for each patient, based on the diagnosis, body weight, and body characteristics.

Pills

The dose of Suprax Solutab for adults and children over 18 years of age is 1 tablet (400 mg) per day. Sometimes, as directed by a doctor, a single dose is divided into 2 doses, 200 mg each. Drink with water.

If for any reason the patient cannot swallow the pill whole, it can be dissolved in 100 ml of warm water. In this case, it is also better to drink it with water.

Capsules

Adults and children who have reached 12 years of age are prescribed 400 mg once a day or 200 mg twice a day.

When diagnosed with "uncomplicated gonorrhea", a single dose of 400 mg (1 capsule) is prescribed.

If a person has a history of severe kidney disease or the patient is on hemodialysis, the daily dose is reduced by 25%.

Capsules should be taken whole with plenty of water. Doctors recommend taking the drug at the same time every day.

Before or after meals

All forms of Suprax can be taken both before, after, and during meals, in other words, regardless of the meal.

Duration

With infections of the ENT organs and the respiratory system, the duration of the drug intake is 6-14 days. If such diseases proceed with complications, then the therapeutic course will be up to 14 days.

In uncomplicated form of gonorrhea, the drug is taken once in a dose of 400 mg.

If after 3 days of taking the drug there is no improvement, you need to inform the doctor who can adjust the dose of the drug or choose another antibacterial drug. In the process of taking Suprax, you need to take probiotics that can protect the intestinal microflora from dysbiosis.

Contraindications

Suprax in the form of capsules or tablets has several contraindications, including:

1. Individual intolerance to drugs from the cephalosporin group or penicillins.
2. Renal failure
3. Children's age of a child body weight, which is less than 25 kg.

This drug should be used with caution by persons over 60 years of age, as well as those who have a history of severe kidney and cardiovascular diseases.

Use during pregnancy and breastfeeding

The drug is contraindicated at all periods, except in cases where the intended benefit to the mother outweighs the risk to the child.

Alcohol compatibility

There is no evidence of a direct interaction of Suprax with alcohol, but one must take into account the double burden on the liver and the fact that alcohol aggravates any infectious diseases.

In addition, alcohol accelerates the elimination of antibiotics from the body, thus it is possible to "interrupt" the course of treatment, which should be continuous.

Side effects

The following symptoms are possible:

1. Hyperemia of the skin, pruritus.
2. Headache.
3. Noise in ears.
4. Nausea, vomiting.
5. Digestive disorders.
6. Dysbacteriosis.
7. Anemia.

The appearance of the above symptoms is a reason to seek medical help.

Overdose

With a slight intensity of symptoms, it is recommended to flush the stomach, take a sorbent preparation. In more severe cases, the patient must be hospitalized.

Composition

As part of Suprax, cefixime trihydrate at a dose of 400 mg acts as an active substance.

Auxiliary substances Suprax Solutab: microcrystalline cellulose, low-substituted hyprolose, colloidal silicon dioxide, povidone, magnesium stearate, calcium saccharinate trisesquihydrate, strawberry flavor (FA 15757 and PV 4284), sunset yellow dye (E110).

Excipients of Suprax capsules: colloidal silicon dioxide, magnesium stearate, calcium carmellose. The composition of the capsule shell: titanium dioxide, dye Azorubin (E122), dye Indigocarmine (E132), gelatin.

You can buy the drug in the form of capsules in a cardboard box containing blister No. 6.

Suprax Solutab tablets are sold in blisters of 7 tablets.

Storage conditions

Store the Suprax antibiotic in a dark place out of the reach of children at temperatures up to 25 ° C. The shelf life is no more than 3 years from the date of issue.

In pharmacies, the drug is available on prescription.

Excipients: colloidal silicon dioxide, magnesium stearate, calcium carmellose.

Capsule shell composition: titanium dioxide, dye Azorubin (E122), dye Indigocarmine (E132), gelatin.

Food ink composition: shellac, ethanol, isopropanol, butanol, propylene glycol, sodium hydroxide povidone, titanium dioxide.

6 pcs. - blisters (1) - cardboard packs.

Granules for preparation of oral suspension almost white to cream color; off-white to cream-colored ready-to-use suspension with a sweet strawberry aroma.

Excipients: sodium benzoate, sucrose, yellow resin, strawberry flavor.

60 ml dark glass bottles (1) complete with a dosing spoon - cardboard packs.

Clinical and pharmacological group

Generation III cephalosporin

pharmachologic effect

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

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

In vitro cefixime 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.

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

Pharmacokinetics

Absorption and distribution

When taken orally, the bioavailability of cefixime is 40-50% regardless of food intake, however, the C max of cefixime in serum is reached 0.8 h faster when taking the drug with food.

When taking the drug in the form of capsules, C max in serum is reached after 4 hours and is 2 μg / ml, when taken at a dose of 400 mg - 3.5 μg / ml.

When the drug is taken in the form of a suspension at a dose of 200 mg, serum C max is reached after 4 hours and is 2.8 μg / ml, when taken at a dose of 400 mg - 4.4 μg / ml.

Plasma protein binding, mainly albumin, is 65%.

Withdrawal

About 50% of the dose is excreted in the urine unchanged within 24 hours, about 10% of the dose is excreted in the bile.

T 1/2 depends on the dose and is 3-4 hours.

Pharmacokinetics in special clinical situations

In patients with impaired renal function with CC from 20 to 40 ml / min, T 1/2 increases to 6.4 h, with CC 5-10 ml / min - up to 11.5 h.

Indications for the use of the drug

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

- pharyngitis;

- tonsillitis;

- sinusitis;

- acute and chronic bronchitis;

- otitis media;

- uncomplicated urinary tract infections;

- uncomplicated gonorrhea.

Dosage regimen

For adults and children over 12 years old weighing more than 50 kg the daily dose is 400 mg 1 time / day. The duration of the course of treatment is 7-10 days.

When uncomplicated gonorrheaappoint 400 mg once.

Children under the age of 12 the drug is prescribed in the form of a suspension at a dose of 8 mg / kg of body weight 1 time / day or 4 mg / kg every 12 hours.

Children aged 5-11 the daily dose is 6-10 ml of suspension, at the age of 2-4 years - 5 ml, at the age of 6 months to 1 year - 2.5-4 ml.

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

With or at

When QC ≤20 ml / min or at

For patients with impaired renal function with CC less than 60 ml / min, who are on hemodialysis or peritoneal dialysis, the drug should be prescribed in the form of a suspension.

Suspension preparation rules

Invert the bottle and shake the granules. Add 40 ml of boiled water cooled to room temperature in 2 steps and shake after each addition until a homogeneous suspension is formed. After that, it is necessary to allow the suspension to settle for 5 minutes to ensure complete disintegration of the granules. Shake the finished suspension before use.

Side effect

From the digestive system: dry mouth, anorexia, nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, transient increase in the activity of hepatic transaminases and alkaline phosphatase, hyperbilirubinemia, jaundice, gastrointestinal candidiasis, dysbiosis; 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: pruritus, urticaria, skin hyperemia, eosinophilia, fever, erythema multiforme exudative, toxic epidermal necrolysis, anaphylactic shock.

On the part of laboratory parameters: increased urea nitrogen, hypercreatininemia, increased prothrombin time.

Others: candidiasis, shortness of breath, development of hypovitaminosis B.

Contraindications to the use of the drug

- impaired renal function with CC less than 60 ml / min (for capsules);

- children under 12 years of age (for capsules);

- hypersensitivity to cephalosporins and penicillins.

WITH caution Suprax should be prescribed to elderly patients, patients with chronic renal failure or pseudomembranous colitis (in history), in the form of granules for the preparation of a suspension - to children under 6 months of age.

Use of the drug during pregnancy and breastfeeding

The use of Suprax during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If necessary, the use of Suprax during lactation should stop breastfeeding.

Application for impaired renal function

WITH caution Suprax should be prescribed to patients with chronic renal failure.

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

When QC≤20 ml / min or at patients on peritoneal dialysis, the daily dose should be halved.

special instructions

With prolonged use of the drug, a violation of the normal intestinal microflora is possible, which can lead to the growth of Clostridium difficile and cause the development of severe diarrhea and pseudomembranous colitis.

Patients with a history of allergic reactions to penicillins may be hypersensitive to cephalosporin antibiotics.

During treatment, a positive direct Coombs' reaction and a false positive urine glucose reaction are possible.

Influence on the ability to drive vehicles and use mechanisms

Patients taking cefixime should be careful when driving and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, taking into account the profile of side effects.

Overdose

Symptoms: increased manifestations of the described side effects, with the exception of allergic reactions.

Treatment: gastric lavage; carry out symptomatic and supportive therapy, which, if necessary, includes the use of antihistamines, GCS, epinephrine, norepinephrine, dopamine, oxygen therapy, transfusion of infusion solutions, mechanical ventilation. Cefixime is not excreted in large quantities from the circulating blood by hemo - or peritoneal dialysis.

Drug interactions

Tubular secretion blockers (allopurinol, diuretics) delay the excretion of cefixime by the kidneys, which can lead to an increase in the concentration of the drug in the blood plasma.

With the simultaneous use of cefixime and carbamazepine, the concentration of carbamazepine in the blood plasma increases.

Reduces the prothrombin index, enhances the effect of indirect anticoagulants.

Terms of dispensing from pharmacies

The drug is available by prescription.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature of 15 ° to 25 ° C. The shelf life is 3 years.

The prepared suspension should be used within 14 days from the date of preparation, subject to storage conditions (15-25 ° C).

Composition

1 tablet contains:
Active substance:
cefixime - 400 mg (as cefixime trihydrate 447.7 mg)
Excipients:
microcrystalline cellulose 44.5 mg, low-substituted hyprolose 40.0 mg, colloidal silicon dioxide 5.0 mg, povidone 5.0 mg, magnesium stearate 10.0 mg, calcium saccharinate trisesquihydrate 20.0 mg, strawberry flavor FA 15757 5.0 mg, strawberry flavor PV 4284 2.5 mg, dye "sunset yellow" (E110) 0.3 mg.

Description

Oblong tablet of pale orange color with a scribble on both sides, with a strawberry scent.

Pharmacotherapeutic group

Antibacterial agents for systemic use. 3rd generation cephalosporins.
ATX code:

Pharmacological properties

Pharmacodynamics
Mechanism of action
Semisynthetic antibiotic from the group of III generation cephalosporins for oral administration. Has a bactericidal effect. The mechanism of action is associated with inhibition of the synthesis of the bacterial cell wall. Cefixime is resistant to β-lactamases produced by many gram-positive and gram-negative bacteria.
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 in vitro activity 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.
Resistant to the drug Pseudomonas spp., Enterococcus spp., Listeria monocytogenes, most strains Enterobacter spp., Staphylococcus spp.(including methicillin-resistant strains), Bacteroides fragilis, Clostridium spp.
Pharmacokinetics
Absorption
When taken orally, bioavailability is 50% and does not depend on food intake. The maximum plasma concentration (C max) after oral administration at a dose of 400 mg is achieved in 3-4 hours and is 3.5-4.0 μg / ml, after administration at a dose of 200 mg - 3.0 μg / ml. Food intake does not have a significant effect on the absorption of the drug from the gastrointestinal tract, slowing down the time of the onset of the peak concentration by 1 hour.
Distribution
The volume of distribution with the introduction of 200 mg when the equilibrium concentration is reached is 17 liters. About 70% of cefixime binds to plasma proteins (mainly albumin).
Metabolism and excretion
The half-life in adults and children is 3-4 hours. 16-25% of the dose taken is excreted in the urine or bile unchanged.
Pharmacokinetics in special clinical situations
In patients with severe renal impairment (creatinine clearance<20 мл/мин) замедляется выведение цефиксима почками, удлиняется период полувыведения и повышается пиковая сывороточная концентрация, что требует снижения суточной дозы с 400 мг до 200 мг в сутки.
In patients with liver damage, clearance decreases, and the half-life increases to 6.4 hours, which, however, does not require correction of the daily dose.
In elderly patients, plasma concentration, bioavailability and the amount of excreted drug slightly increase (15-25%), which, however, does not require an adjustment of the daily dose.

Indications for use

The drug is used for infectious and inflammatory diseases caused by microorganisms sensitive to cefixime:
- upper respiratory tract infections (tonsillitis, pharyngitis);
- lower respiratory tract infections (pneumonia, bronchitis);
- infections of the ENT organs (otitis media, etc.);
- kidney and urinary tract infections;
- uncomplicated gonorrhea.

Contraindications

Hypersensitivity to cefixime or drug components;
- hypersensitivity to cephalosporins or penicillins.
In this dosage form, the drug is not recommended for children weighing less than 25 kg.

Pregnancy and lactation

The use of Suprax® Solutab® during pregnancy is possible when the intended benefit to the mother outweighs the potential risk to the fetus, under the supervision of medical personnel. Despite the fact that no embryotoxic effects were found, Suprax® Solutab® should not be prescribed during the first trimester of pregnancy. It is not known whether cefixime is excreted into breast milk, therefore, if it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Method of administration and dosage

The Suprax® Solutab® tablet can be swallowed whole with a sufficient amount of water, or dissolved in water and the resulting suspension can be drunk immediately after preparation. The drug can be taken with or without food.
For adults and children weighing more than 50 kg, the daily dose is 400 mg once a day. For children weighing 25-50 kg, the daily dose is 8 mg / kg of body weight per day. The daily dose can be divided into 2 doses: 4 mg / kg every 12 hours. It is recommended that such children also use Suprax® in the form of a powder for preparing a suspension, which allows for a more accurate dosage of the drug.
The duration of treatment depends on the nature of the course of the disease and the type of infection. Based on the data of clinical trials, it has been established that 7-day therapy of Suprax® Solutab® is sufficient to treat most infections. However, in especially severe cases, the course can be extended up to 14 days. The course of treatment for infections of the respiratory tract and ENT organs is 7-14 days.
Acute otitis media: it is recommended to use the drug in the form of a suspension, as clinical trials have shown higher peak concentrations of cefixime in the blood when using a suspension than tablets at the same dose.
With tonsillopharyngitis caused by Streptococcus pyogenes, the duration of treatment should be at least 10 days.
In uncomplicated gonorrhea, the drug is prescribed in a dose of 400 mg once.
For uncomplicated infections of the lower urinary tract in women, the drug can be prescribed for 3-7 days, for uncomplicated infections of the upper urinary tract in women - 14 days.
In uncomplicated infections of the upper and lower urinary tract in men, the duration of treatment is 7-14 days.
After the symptoms of infection and / or fever have disappeared, it is advisable to continue taking the drug for at least the next 2-3 days.
In case of impaired renal function: in patients with creatinine clearance ≤ 20 ml / min, who are on outpatient peritoneal or hemodialysis, the recommended daily dose is 200 mg. No dose adjustment is required in patients with creatinine clearance\u003e 20 ml / min, elderly patients and patients with impaired liver function.
If you miss the next dose of the drug, you should take the missed dose as soon as the patient remembered it, or, if the time for the next dose is already approaching, just skip this dose. In the future, you should continue taking the drug Suprax® Solutab® after 24 hours in accordance with the previously prescribed dosage.

Side effect

With the use of cephalosporins, gastrointestinal disorders are most often noted; hypersensitivity reactions were occasionally noted.
Hypersensitivity reactions are more common in patients who have already experienced hypersensitivity reactions, and in patients with a history of allergies, hay fever, urticaria, asthma with an allergic component.
When taking cefixime, the following adverse reactions rarely occurred:
- from the gastrointestinal tract: anorexia, glossitis, nausea, vomiting, heartburn, abdominal pain, diarrhea and dyspepsia. Switching to 200 mg 2 times a day can relieve diarrhea. Severe, prolonged diarrhea has been associated with the use of certain classes of antibiotics. In this case, a diagnosis of pseudomembranous colitis should be carried out. If this diagnosis is confirmed by colonoscopy, any antibiotic should be discontinued immediately and oral vancomycin given. The use of drugs that reduce intestinal peristalsis is contraindicated.
- hypersensitivity reactions: reactions resembling serum sickness, anaphylaxis, arthralgia and drug fever, angioedema, anaphylactic / anaphylactoid reactions.
- reactions from the blood and lymphatic system:changes in laboratory parameters: pancytopenia, leukocytopenia, transient neutropenia, granulocytopenia, thrombocytopenia, agranulocytosis and eosinophilia. There have also been isolated cases of hemolytic anemia in patients treated with cephalosporin antibiotics.
- from the liver and biliary tract: jaundice, transient increase in the concentration of transaminases (AST, ALT), alkaline phosphatase and total serum bilirubin, hepatitis.
- from the urinary system: a transient increase in the concentration of urea and creatinine in the serum.
- on the part of the respiratory system: dyspnea.
- on the skin side: urticaria, skin rash, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash syndrome with eosinophilia and systemic manifestations (DRESS).
- from the side of the central nervous system:headaches, dizziness, convulsions.
- general violations: fever, swelling of the face.
- others:candidal vaginitis.
If any of the listed adverse reactions occur, as well as reactions not listed in these instructions for use, you should immediately consult a doctor.

Overdose

With an increase in the daily dose to 2 g in healthy volunteers in comparison with the intake in a therapeutic dose, there was no increase in the frequency of adverse reactions. However, when taken in a dose exceeding the maximum daily, an increase in the frequency of the dose-dependent side effects described above is possible.
Treatment: gastric lavage; carry out symptomatic and supportive therapy. Hemodialysis and peritoneal dialysis are ineffective.

Interaction with other medicinal products and other forms of interaction

Indirect anticoagulants
Cefixime should be used with caution in patients receiving indirect anticoagulants such as warfarin. Since cefixime can enhance the effect of anticoagulants, there may be an increase in prothrombin time with or without bleeding.
Carbamazepine
With the simultaneous use of cefixime with carbamazepine, an increase in the concentration of carbamazepine in the blood plasma was observed. In such cases, it is advisable to carry out drug monitoring of the concentration of carbamazepine in the blood plasma.
Other forms of interaction
Taking cephalosporins can interfere with the results of some laboratory tests, causing false-positive reactions for the presence of glucose in the urine, using solutions of Benedict, Fehling or Clinitest (except for enzyme methods). Taking cephalosporins can also cause a positive (sometimes false positive) Coombs' test.

Precautionary measures

Severe skin reactions.
There have been reports of serious skin adverse reactions, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, drug rash syndrome with eosinophilia and systemic manifestations (DRESS syndrome), in some patients treated with cefixime. If severe skin reactions occur, cefixime should be discontinued and appropriate therapy and / or other necessary measures should be taken.
Hypersensitivity reactions.
Before taking the drug Suprax® Solutab®, it is necessary to carefully determine the presence of a history of hypersensitivity reactions to cephalosporins, penicillins or other drugs.
It is necessary to take the drug Suprax® Solutab® with caution in patients with allergy to penicillins. There is evidence of cross-allergic reactions of penicillins with cephalosporins, both in vivo and in vitro. There have been rare reports of cases of anaphylactic reactions after parenteral administration of cefixime.
Antibiotics should be used with caution in patients with a history of allergic reactions, especially to drugs. If an allergic reaction occurs, the use of Suprax® Solutab® should be discontinued immediately.
Changes in the intestinal microflora.
With prolonged use of antibacterial drugs, it is possible to develop resistant microorganisms, and disrupt the normal intestinal microflora, which can lead to excessive reproduction Clostridium difficile and the development of pseudomembranous colitis. In milder forms of antibiotic-induced pseudomembranous colitis, it may be sufficient to stop taking the drug. If withdrawal of the drug does not help, it is recommended to prescribe vancomycin by mouth - the antibiotic of choice in the treatment of pseudomembranous colitis.
In moderate and severe forms of pseudomembranous colitis, solutions of electrolytes and proteins are added to the treatment.
Simultaneous administration of antiperistaltic drugs should be avoided.
Broad-spectrum antibiotics should be used with caution in patients with a history of gastrointestinal disease, especially colitis.
Effect on coagulation
The use of cephalosporins, including cefixime, may be associated with a decrease in prothrombin activity. The risk group consists of patients with renal or hepatic insufficiency, undernutrition, as well as patients receiving a long course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. In such patients, prothrombin time should be monitored and, if necessary, exogenous vitamin K.
Laboratory tests.
The use of the drug Suprax® Solutab® can cause moderate, reversible changes in parameters characterizing the function of the liver and kidneys, as well as indicators of a general blood test ”(thrombocytopenia, leukopenia, and eosinophilia).
Renal failure
In patients with severe renal failure and those on hemodialysis or peritoneal dialysis, it is necessary to reduce the dose (see section "Dosage and Administration").
Anemia.
There are reports of cases of the development of hemolytic anemia (including with fatal outcomes) in patients treated with cephalosporins. Patients who have previously experienced anemia while taking cephalosporins, including cefixime, may have repeated episodes of hemolytic anemia.
Suprax® Solutab® contains azo dye E 110, which can cause allergic reactions.