Maxiktam-AF powder for the preparation of intravenous solution 1g+1g fl


"Dona" is an effective drug containing glucosamine. Used to treat osteochondrosis, osteoarthritis. Promotes the restoration of cartilage and bone tissue, improves the permeability of joint capsules. Many patients (more than 80%) note the cessation of pain after several months of use. The course of therapy is long, you must first consult a doctor.

“Dona” stimulates tissue repair (elimination of damage). The active ingredient is glucosamine. Performs the functions of an analgesic and anti-inflammatory agent. Has a complex effect on joints:

  • increased permeability of the joint capsule;
  • replenishment of glucosamine deficiency;
  • increased proteoglycan synthesis;
  • increased synthesis of hyaluronic acid, which is contained in synovial fluid;
  • restoration of metabolism in articular cartilage and synovial membranes;
  • stimulation of chondroitinsulfuric acid synthesis;
  • improving calcium absorption by bones;
  • preventing the destruction of joints and bones;
  • reduction of joint pain.

The drug is almost completely (90%) absorbed from the gastrointestinal tract, which ensures a biavailability level of 25%.

The product is produced in the form of tablets weighing 750 mg each and powder (1500 mg). Sold in pharmacies, dispensed without a prescription. Should be stored at room temperature (up to 25 degrees) for a total shelf life of 3 years from the date of production.

Indications and contraindications for the use of Dona tablets

The drug is used for osteochondrosis of any parts of the spine and other joints, as well as for the treatment of osteoarthritis of peripheral joints and the spine.

In some cases, use is contraindicated:

  • high sensitivity to glucosamine or auxiliary components of the drug;
  • severe chronic kidney failure.

With caution, the drug is given to children under 12 years of age inclusive and to women during pregnancy and lactation. It is important to understand that no studies have been conducted on the effect of the drug, so using the medicine on your own is not recommended. You must first coordinate its appointment with your doctor.

Also, tablets are used with caution by patients with diabetes and bronchial asthma. If glucose tolerance is impaired, there are problems with the liver and kidneys, use is allowed only under medical supervision. This is especially important when long-term therapy is planned.

In some cases, side effects from the use of Dona tablets and powder are observed, for example:

  • flatulence;
  • bloating;
  • stool disorders (diarrhea);
  • headaches;
  • increased drowsiness;
  • nausea;
  • manifestations of allergies (itching, urticaria, erythema).

Buy Dona powder for oral solution 1500 mg No. 20 in pharmacies

Trade name of the drug:

Dona®

International nonproprietary name:

glucosamine

Dosage form:

powder for the preparation of solution for oral administration.

Compound:

One sachet contains:

active substance: crystalline glucosamine sulfate 1884 mg (contains glucosamine sulfate 1500 mg and sodium chloride 384 mg); excipients: aspartame, sorbitol, carbowax 4000 (macrogol 4000), citric acid.

Description

White crystalline powder.

Pharmacotherapeutic group:

tissue repair stimulator.

Pharmacological properties

Dona has an anti-inflammatory and analgesic effect, replenishes endogenous glucosamine deficiency, stimulates the synthesis of proteoglycans and hyaluronic acid in synovial fluid; increases the permeability of the joint capsule, restores enzymatic processes in the cells of the synovial membrane and articular cartilage. Promotes fixation of sulfur during the synthesis of chondroitinsulfuric acid, facilitates normal calcium deposition in bone tissue, inhibits the development of degenerative processes in joints, restores their function, reducing joint pain.

Pharmacokinetics

Absorption in the gastrointestinal tract is 90%, bioavailability is 26%, half-life is 70 hours.

Indications for use

Primary and secondary osteoarthritis, osteochondrosis, spondyloarthrosis.

Contraindications

Individual hypersensitivity to glucosamine sulfate, aspartame and other components of the drug. Due to the aspartame content, it is contraindicated in patients with phenylketonuria.

It is not recommended to prescribe the drug during pregnancy and lactation, as well as in childhood (up to 12 years) due to the lack of scientific clinical data in this category of patients.

Carefully

Caution should be exercised in patients with allergies to seafood (shrimp, shellfish).

Directions for use and doses

Inside. The contents of one sachet are dissolved in 200 ml of water and taken orally once a day. The symptomatic effect occurs 2-3 weeks after using the drug. The duration and regimen of treatment is prescribed by the attending physician. The minimum course of therapy is 6 weeks.

Side effect

The drug is well tolerated, in some cases the following are possible: gastralgia, flatulence, diarrhea, constipation, allergic reactions - urticaria, itching.

Overdose

Cases of overdose are unknown. Treatment: gastric lavage, symptomatic therapy.

Interaction with other drugs

Compatible with non-steroidal anti-inflammatory drugs, paracetamol and glucocorticosteroids. Increases the absorption of tetracyclines, reduces the absorption of semisynthetic penicillins, chloramphenicol.

special instructions

When using the drug in patients with impaired glucose tolerance, with severe liver and kidney failure, medical supervision is necessary.

Release form

3950 mg (1500 mg of glucosamine sulfate) in sachets of three-layer material made of paper, polyethylene, thermally sealed together on four sides. The plastic film is in direct contact with the contents of the bag.

20 or 30 sachets along with instructions for use are placed in a cardboard box.

Best before date

3 years. Do not use after the expiration date indicated on the packaging.

Storage conditions

Store at a temperature not exceeding 25 ºC. Keep out of the reach of children

Vacation conditions

Available without a prescription.

"Dona": instructions for use

The drug is taken 1 tablet orally in the morning and evening, preferably during a meal, with a sufficient amount of water. In the first days the effect is unnoticeable, which is normal. The first results appear after a 2-3 week continuous course. In this case, the minimum duration of therapy is from 4 to 6 weeks; tablets are often taken for several months.

After this, a break is taken for 1.5-2 months, then the cycle is repeated. The dosage, as well as the duration of therapy and the general regimen depend on the age, condition of the patient, chronic diseases and other factors.

In the case of powder, the contents of 1 sachet must be dissolved in 1 glass of water (200-250 ml) and drunk with meals. Reception is carried out only once a day. In this case, the total duration of the course is determined by the same rules as in the case of tablets.

Overdose and drug interactions

No cases of overdose have been identified. If the dose is violated, immediate gastric lavage and treatment are indicated depending on the symptoms that arise. The drug should be used with caution in patients who are allergic to various types of seafood. If the patient is on a sodium diet, he needs to follow the dosage, since one Dona tablet contains 75 mg of pure sodium.

The product is compatible with various drugs:

  • glucorticosteroids;
  • non-steroidal anti-inflammatory drugs;
  • paracetamol and drugs based on it.

Parallel use with antibiotics leads to an increase in the therapeutic effect of drugs of the tetracycline group and a weakening of semisynthetic penicillin, as well as chloramphenicol. It is also possible to enhance the effect of coumarin anticoagulants.

Maxiktam-AF powder for the preparation of intravenous solution 1g+1g fl

pharmachologic effect

Combined broad-spectrum antibiotic.

Cefepime is an antibiotic from the group of IV generation cephalosporins. It acts bactericidal, disrupting the synthesis of the cell wall of microorganisms. The targets of cefepime are penicillin-binding proteins (PBPs), the antibiotic shows the greatest affinity for PBP3, slightly less for PBP2 and moderate affinity for PBP1a and PBP1b of gram-negative bacteria. It has a wide spectrum of action against gram-positive and gram-negative microorganisms; there is no cross-resistance with antibiotics of other groups.

Sulbactam is an irreversible inhibitor of a number of widespread beta-lactamases; it does not have clinically significant antibacterial activity (with the exception of Neisseria spp. and Acinetobacter spp.). The ability of sulbactam to prevent the destruction of penicillins and cephalosporins by resistant microorganisms was confirmed in studies using resistant strains of microorganisms, for which sulbactam had pronounced synergism with penicillins and cephalosporins. In addition, sulbactam interacts with some penicillin-binding proteins, so the combination of cefepime + sulbactam often has a more pronounced effect on sensitive strains of microorganisms than the use of cefepime alone. The combination of sulbactam and cefepime is active against all microorganisms sensitive to cefepime, as well as a number of microorganisms resistant to it.

Cefepime + sulbactam is active against gram-positive aerobic microorganisms: Staphylococcus aureus (including strains producing beta-lactamases); Staphylococcus epidermidis (including beta-lactamase producing strains); other strains of Staphylococcus spp., including Staphylococcus hominis, Staphylococcus saprophyticus; Streptococcus pyogenes (group A streptococci); Streptococcus agalactiae (group B streptococci); Streptococcus pneumoniae (including strains with intermediate resistance to penicillin - minimum inhibitory concentration from 0.1 to 1 μg/ml); other beta-hemolytic Streptococcus spp. (groups C, G, F), Streptococcus hovis (group D), Streptococcus spp. Viridans groups; gram-negative aerobic microorganisms: Acinetobacter calcoaceticus (substrains anitratus, lwofii)/Acinetobacter baumannii, Aeromonas hydrophila; Capnocytophaga spp.; Cilrobacter spp., including Citrobacter diversus, Citrobacter freundii, Campylobacter jejuni; Enterobacter spp. (including Enterobacter cloacae, Enterobacter aerogenes, Enterobacter sakazakii), Escherichia coli; Gardnerella vaginalis, Haemophilus ducreyi; Haemophilus influenzae (including beta-lactamase producing strains), Haemophilus parainfluenzae, Hafnia alvei, Klebsiella spp. (including Klebsiella pneumoniae, Klebsiella oxytoca, Klebsiella ozaenae), Legionella spp., Morganella morganii, Moraxella catarrhalis (Branhamella catarrhalis) (including strains producing beta-lactamases), Neisseria gonorrhoeae (including strains producing beta-lactamases), Neisseria meningitidis, Pantoea agglomerans (formerly known as Enterobacter agglomerans), Proteus spp. (including Proteus mirabilis, Proteus vulgaris), Providencia spp., including Providencia rettgeri, Providencia Stuartii; Pseudomonas spp. (including Pseudomonas aeruginosa, Pseudomonas putida, Pseudomonas stutzeri), Salmonella spp.; Serratia spp., including Serratia marcescens, Serratia liquefaciens; Shigella spp., Yersinia enterocolitica; anaerobic microorganisms: Bacteroides spp., Clostridium perfringens, Fusobacterium spp., Mobiluncus spp., Peptostreptococcus spp., Prevotella melaninogenica (known as Bacteroides melaninogenicus), Veillonella spp.

Cefepime is inactive against Bacteroides fragilis and Clostridium difficile; against many strains of Stenotrophomonas maltophilia, formerly known as Xanthomonas maltophilia and Pseudomonas maltophilia.

Enterococcus spp. and methicillin-resistant staphylococci are resistant to most cephalosporin antibiotics, including cefepime.

Pharmacokinetics

Cefepime

The bioavailability of cefepime is 100%. The time to reach Cmax of cefepime after IV and IM administration is at the end of the infusion and 1-2 hours, respectively. Cmax with intramuscular administration in doses of 500 mg, 1 g and 2 g - 13.9, 29.6 and 57.5 μg/ml, respectively; with intravenous administration in doses of 500 mg, 1 g and 2 g - 39.1, 81.7 and 163.9 mcg/ml, respectively. Therapeutic concentrations of cefepime are found in the following fluids and tissues: urine, bile, peritoneal fluid, bullous fluid, bronchial mucosa, sputum, prostate, appendix and gall bladder. The binding of cefepime to plasma proteins averages 16.4% and does not depend on the concentration of cefepime in the blood plasma. Cefepime is metabolized to N-methylpyrrolidine, which is rapidly converted to N-methylpyrrolidine oxide. Cefepime is excreted primarily by the kidneys, by glomerular filtration (renal clearance averages 110 ml/min). Approximately 85% of the administered dose of unchanged cefepime, less than 1% N-methylpyrrolidine, about 6.8% N-methylpyrrolidine oxide and about 2.5% cefepime epimer are found in urine. After administration of doses from 250 mg to 2 g, T1/2 of cefepime from the body averages about 2 hours. The total clearance averages 120 ml/min. When cefepime was administered intravenously to healthy volunteers at a dose of 2 g every 8 hours for 9 days, no accumulation was observed. T1/2 of cefepime increases in renal failure, and a linear relationship is observed between total clearance and CC. In severe renal impairment requiring dialysis sessions, T1/2 averages 13 hours with hemodialysis and 19 hours with continuous peritoneal dialysis. After a single intravenous administration of 1 g of cefepime to healthy volunteers over 65 years of age, an increase in AUC and a decrease in renal clearance were observed compared with young volunteers.

Sulbactam

Cmax of sulbactam after intravenous administration of 1 g was 236.8 mcg/ml; after intramuscular administration of 500 mg - 19 mcg/ml. Sulbactam is well distributed in various tissues and fluids, including bile, gallbladder, skin, appendix, fallopian tubes, ovaries, and uterus. Approximately 84% of a sulbactam dose is excreted by the kidneys. T1/2 of sulbactam averages about 1 hour. In case of renal dysfunction, a high correlation has been revealed between the total clearance of sulbactam from the body and the calculated creatinine clearance. In patients with end-stage renal failure, a significant prolongation of T1/2 of sulbactam was detected (up to 9.7 hours). Hemodialysis caused significant changes in T1/2, total clearance and Vd of sulbactam. Compared with healthy volunteers, elderly people showed a prolongation of T1/2, a decrease in clearance and an increase in Vd of sulbactam.

Indications of the active substances of the drug Maxiktam®-AF

Infectious and inflammatory diseases in adults caused by microorganisms sensitive to the combination of cefepime + sulbactam: lower respiratory tract infections, including pneumonia and bronchitis; urinary tract infections, both complicated, including pyelonephritis, and uncomplicated; skin and soft tissue infections; abdominal infections, including peritonitis and biliary tract infections; inflammatory diseases of the pelvic organs; septicemia; febrile neutropenia.

Prevention of surgical site infections during abdominal surgery.

Infectious and inflammatory diseases in children over 2 months of age caused by microorganisms sensitive to the combination of cefepime + sulbactam: pneumonia; urinary tract infections, both complicated, including pyelonephritis, and uncomplicated; skin and soft tissue infections; septicemia; febrile neutropenia; bacterial meningitis.

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.

Administer intravenously (bolus or infusion) or intramuscularly. Doses and route of administration depend on the sensitivity of the pathogens, the severity of the infection, the state of renal function, general condition, body weight and age of the patient.

IV administration is recommended for patients with severe or life-threatening infections, especially those at risk of septic shock.

Side effect

Infections: candidiasis of the oral mucosa, vaginal infections, candidiasis.

Allergic reactions: skin rash, erythema, urticaria, itching, anaphylactic reactions, anaphylactic shock, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, angioedema.

From the nervous system: headache, convulsions, paresthesia, dysgeusia, dizziness; Post-marketing experience: encephalopathy (impaired consciousness, including confusion, hallucinations, stupor and coma), myoclonus, seizures and non-convulsive status epilepticus. Although most cases were observed in patients with renal impairment who received cefepime at doses higher than recommended, some cases of neurotoxicity were observed in patients who received dose adjustments based on the degree of renal impairment.

Vascular disorders: vasodilation, bleeding.

From the respiratory system: shortness of breath.

From the digestive system: diarrhea, nausea, vomiting, colitis (including pseudomembranous colitis), abdominal pain, constipation, digestive disorders, increased activity of ALT, AST, alkaline phosphatase, total bilirubin.

From the urinary system: renal failure, toxic nephropathy, increased serum creatinine, increased urea nitrogen in the blood.

From the hematopoietic system: anemia, eosinophilia, thrombocytopenia, leukopenia and neutropenia, aplastic anemia, hemolytic anemia, agranulocytosis.

From the blood coagulation system: increased prothrombin time or APTT.

General reactions and reactions at the injection site: phlebitis at the injection site, pain at the injection site, fever and inflammation at the injection site, chills.

Other: genital itching, change in taste, vaginitis, erythema, false-positive Coombs test without hemolysis.

Contraindications for use

Hypersensitivity to cefepime, as well as to other cephalosporins, penicillins, other beta-lactam antibiotics, arginine, sulbactam; children up to 2 months old.

Carefully

History of gastrointestinal diseases (especially colitis), renal failure.

Use during pregnancy and breastfeeding

Adequate and controlled clinical studies have not been conducted in pregnant women. During pregnancy, use is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Cefepime and sulbactam are excreted in breast milk. If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be decided.

special instructions

In the presence of factors that can cause renal impairment, dose adjustment of cefepime and sulbactam is required to compensate for the reduced rate of excretion of the drug by the kidneys. The dosage regimen depends on the degree of renal failure, the severity of the infection and the sensitivity of microorganisms. For mild or moderate renal impairment, the initial dose of the drug is the same as for normal renal function. The risk of developing toxic reactions is especially increased in elderly patients with impaired renal function.

As with the use of other representatives of cephalosporins, in the practice of using cefepime, there have been cases of development in patients of encephalopathy (usually reversible) (confusion, hallucinations, stupor, coma), myoclonus, seizures (including non-convulsive status epilepticus) and/or renal insufficiency. Most cases were observed in patients with renal failure who were prescribed doses higher than recommended. Typically, symptoms of neurotoxicity disappeared after interruption of treatment and/or after hemodialysis, but sometimes they were fatal. In patients with impaired renal function or in the presence of other factors that may lead to a slower elimination of cefepime, its dose should be adjusted.

Before starting treatment, it is necessary to establish whether the patient has a history of allergic reactions to cefepime, sulbactam, other cephalosporin antibiotics, penicillins and other beta-lactam antibiotics, as well as other forms of allergies. When using all types of beta-lactam antibiotics, cases of severe hypersensitivity reactions, sometimes fatal, have been reported. If an allergic reaction develops, treatment with the drug should be stopped and appropriate measures taken. If a severe allergic reaction (eg, anaphylactic reaction) occurs immediately during administration, epinephrine and other supportive care may be required.

Antibiotics of the cephalosporin group can cause a false-positive reaction to glucose in urine in tests based on the reduction of copper ions (with Benedict's or Fehling's solutions or with Klinintest tablets), but not in enzyme tests (with glucose oxidase). In this regard, it is recommended to use enzyme tests with glucose oxidase to determine glucose in urine.

When prescribing empirical treatment, it is necessary to take into account data on the acquired resistance of pathogenic microorganisms. The level of resistance of microorganisms may change over time and vary in individual geographic regions. To identify the causative microorganism and determine sensitivity to cefepime + sulbactam, appropriate tests should be performed. The drug can be used as monotherapy even before identification of the causative microorganism, since it has a wide spectrum of antibacterial action against gram-positive and gram-positive microorganisms. If there is a risk of mixed aerobic/anaerobic infection (especially when microorganisms insensitive to cefepime + sulbactam may be present), treatment with the drug in combination with another drug that acts on anaerobes can be started before identifying the pathogen.

After identifying the pathogen and determining antibiotic sensitivity, treatment should be carried out in accordance with the test results.

As with the use of other antibacterial drugs, treatment with cefepime + sulbactam can lead to the colonization of insensitive microflora. If superinfections develop during treatment, appropriate measures must be taken.

When using almost all broad-spectrum antibacterial drugs, Clostridium difficile-associated diarrhea (CDAD-Clostridium difficile-associated diarrhea) may occur, which can be either mild or severe, even fatal. If diarrhea occurs during treatment with a drug containing this combination, the diagnosis of CDAD should be confirmed. The patient should be closely monitored for the development of CDAD, as cases of its occurrence have been reported more than two months after stopping the use of antibacterial drugs. If a diagnosis of CDAD is suspected or confirmed, use of antibacterial drugs other than those prescribed to suppress Clostridium difficile should be discontinued. The use of drugs that inhibit intestinal motility is contraindicated in this situation.

Impact on the ability to drive vehicles and machinery

During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, taking into account the possibility of developing side effects from the central nervous system.

Drug interactions

Concomitant use with bacteriostatic antibacterial drugs may reduce the effect of the beta-lactam antibiotic.

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