Inwanz
Invanz: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Invanz
ATX code: J01DH03
Active ingredient: Ertapenem (Ertapenem)
Manufacturer: LABORATOIRES MERCK SHARP & DOHME-SHIBRET (France); Representative office: MSD (USA)
Description and photo update: 18.10.2018
Prices in pharmacies: from 2300 rubles.
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Invanz is an antibacterial drug of the carbapenem group.
Release form and composition
Dosage form Invanza is a lyophilisate for preparing a solution for injection: a porous mass or powder of almost white or white color (glass vials without color with a volume of 20 ml, in a cardboard box 1 bottle).
1 bottle contains:
- active substance: ertapenem sodium - 1.213 g, which is equivalent to 1 g of ertapenem;
- auxiliary components: sodium hydroxide, sodium bicarbonate.
Pharmacological properties
Pharmacodynamics
The antibiotic Invanz is active against a wide range of gram-positive and gram-negative aerobic and anaerobic bacteria.
Ertapenem - 1-β-methylcarbapenem, a long-acting beta-lactam antibiotic, its bactericidal activity is due to the ability to inhibit cell wall synthesis and bind to penicillin-binding proteins. It exhibits significant resistance to hydrolysis by beta-lactamases of most classes, except for metallo-beta-lactamase.
In a clinical setting, the drug is effective against most strains of the following microorganisms in vitro:
- aerobic and facultative anaerobic gram-positive microorganisms: Staphylococcus aureus (except methicillin-resistant staphylococci), Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus agalactiae;
- aerobic and facultative anaerobic gram-negative microorganisms: Klebsiella pneumoniae, Escherichia coli, Haemophilus influenzae (including beta-lactamase-producing strains), Proteus mirabilis, Moraxella catarrhalis;
- anaerobic microorganisms: Eubacterium, Bacteroides fragilis, Porphyromonas asaccharolytica, Clostridium (except C. difficile microorganisms), Prevotella, Peptostreptococcus.
Many strains of Enterococcus faecalis and Enterococcus faecium are resistant to the drug.
Pharmacokinetics
Absorption of 1 g of ertapenem, dissolved in 1% lidocaine solution (without epinephrine), after i / m administration is well absorbed, its bioavailability reaches approximately 92%. After about 2 hours, the maximum plasma concentration is reached.
The degree of binding of ertapenem to human plasma proteins decreases with an increase in its concentration in blood plasma.
Cumulation of the drug against the background of repeated use in adult patients in the recommended doses does not occur.
According to the results of clinical studies, the concentration of ertapenem in the breast milk of a woman taking 1 g of the drug by intravenous injection for 5 days is less than 0.38 μg / ml, 5 days after discontinuation of the drug, the level of the active substance was below the detection limit. or ertapenem was found in trace amounts.
The main metabolite of ertapenem after intravenous administration is an open-ring derivative formed by hydrolysis of the beta-lactam ring.
The drug is excreted mainly by the kidneys. The half-life from blood plasma in adults is about 4 hours, children - about 2.5 hours. According to the research results, after intravenous administration of 1 g of ertapenem, about 80% is excreted by the kidneys (of which 38% - unchanged and about 37% - in the form of a metabolite with an open beta-lactam ring), 10% - by the intestine.
The average concentration of ertapenem in urine within 2 hours after intravenous administration of 1 g of the drug in adult patients exceeds 984 μg / ml, and in the period from 12 to 24 hours - 52 μg / ml.
In men and women, the plasma concentration of ertapenem is comparable.
After intravenous administration of 1 g of the drug, the concentration of ertapenem in blood plasma in adults and children 13–17 years old is comparable, in patients over 65 years old - slightly higher than in patients under the age of 65 years (excess does not require dose adjustment).
In hepatic impairment, the pharmacokinetics of ertapenem have not been studied. But since the intensity of metabolism of the drug in the liver is insignificant, the impairment of its function should not have a clinically significant effect on the pharmacokinetics of ertapenem.
In renal failure, the total concentration of ertapenem in blood plasma depends on the severity of the disease and creatinine clearance (CC):
- mild degree, CC 60–90 ml / min per 1.73 m 2: comparable to that in healthy patients;
- moderate degree, CC 31–59 ml / min per 1.73 m 2: increased by about 1.5 times;
- severe degree, CC 5-30 ml / min per 1.73 m 2: increased by about 2.6 times;
- end-stage renal failure, CC is less than 10 ml / min per 1.73 m 2: increased by about 2.9 times compared with healthy volunteers. With intravenous administration of the drug immediately before a hemodialysis session, about 30% of the administered dose is determined in the dialysate.
There is no information on the use of the drug for renal failure in children.
Indications for use
According to the instructions, Inwanz is indicated for the treatment of moderate and severe infectious and inflammatory diseases caused by sensitive strains of microorganisms:
- community-acquired pneumonia;
- infectious pathologies of the skin and subcutaneous tissue, including infections of the legs in diabetes mellitus (diabetic foot);
- intra-abdominal infections;
- pyelonephritis and other urinary tract infections;
- postpartum endomyometritis, postoperative gynecological infections, septic abortion and other acute forms of infections of the pelvic organs;
- bacterial septicemia.
In addition, the drug is prescribed for empirical starting antibiotic therapy until the causative agent of the disease is identified.
Contraindications
- the use of lidocaine hydrochloride to dissolve the lyophilisate with i / m administration of the drug in patients with established intolerance to local amide anesthetics, impaired intracardiac conduction, severe arterial hypotension;
- age up to three months of life;
- hypersensitivity to beta-lactam antibiotics;
- established intolerance to the components of the drug.
Invanz should be prescribed with caution during pregnancy and breastfeeding.
Instructions for the use of Invanza: method and dosage
The ready-made Invanza solution is intended for intravenous (iv) drip and intramuscular (i / m) administration. IM administration is an alternative to intravenous infusion.
The duration of the infusion is 0.5 hours.
A solution for intravenous administration begins with dissolution of the lyophilisate. The following solvents can be used to dissolve the lyophilisate: 0.9% sodium chloride solution for injection, bacteriostatic water for injection or water for injection.
After adding 10 ml of solvent to the contents of the bottle, shake it well. The resulting solution must be immediately mixed with a previously prepared 0.9% sodium chloride solution for infusion. For adults, its volume should be 50 ml. When treating children, the dose prescribed for the child is taken from the vial with the drug with a syringe and transferred to a container with 0.9% sodium chloride solution for infusion. The concentration of the finished solution for children should not exceed 0.02 g per 1 ml.
The reconstituted solution for infusion is suitable for use within 6 hours at a storage temperature not exceeding 25 ° C. If necessary, it can be stored for 24 hours in the refrigerator (not allowed to freeze) and, after removing from the refrigerator, used within 4 hours.
Infusion should be carried out in isolation, without mixing the solution with other drugs.
It is contraindicated to use diluents containing dextrose (glucose).
To prepare a solution for intramuscular injection, the contents of the vial (1 g of lyophilisate) are dissolved in 3.2 ml of 1% or 2% lidocaine hydrochloride solution for injection (without epinephrine). To completely dissolve the lyophilisate, the bottle should be shaken thoroughly. At the dose prescribed by your doctor, the ready-to-use solution must be immediately deeply injected into a large muscle, such as the gluteus muscles or the lateral muscles of the thigh.
The solution for i / m administration is suitable for use within 1 hour.
Do not use solution for intramuscular injection for intravenous administration.
The reconstituted Inwanza solution should be in the color range from colorless to light yellow.
Before the introduction of each of the solutions, they should be visually inspected for discoloration or the presence of suspended particles.
The recommended dosage of Inwanza has age restrictions:
- patients aged 13 years and older: 1 g once a day;
- children from 3 months to 12 years old: at the rate of 0.015 g per 1 kg of weight 2 times a day (but not more than 1 g).
The duration of treatment depends on the severity of the disease and the type of infection, usually it is 3-14 days. Possible subsequent transfer of the patient to oral antibiotic therapy.
If liver function is impaired, dose adjustment is not required.
In renal failure in adult patients with creatinine clearance (CC) more than 30 ml / min by 1.73 m 2, the dose of the drug should not be reduced.
In case of severe renal dysfunction (CC 30 ml / min per 1.73 m 2 and below) in adults, including patients on hemodialysis, it is recommended to use the drug in a daily dose of 0.5 g.
Adult patients on hemodialysis should be additionally administered 0.15 g of the drug after a hemodialysis session, if the administration of the prescribed dose (0.5 g) was made within the next 6 hours before hemodialysis. If the drug is administered more than 6 hours before the hemodialysis session, then an additional dose is not required.
There is no experience of using Invanza in children with renal failure or on hemodialysis.
Side effects
Adverse events identified during clinical trials in the treatment of adult patients:
- from the central nervous system (CNS): often - headache; infrequently - perversion of taste, dizziness, drowsiness, confusion, convulsive seizure, insomnia; rarely - anxiety, agitation, tremor, fainting, depression; frequency unknown - hallucinations, mental disorders (including delirium, aggressiveness, change in mental status, disorientation), dyskinesia, gait disturbance, myoclonus;
- from the immune system: rarely - allergic reactions; frequency unknown - anaphylactoid reactions, anaphylaxis;
- parasitic and infectious pathologies: infrequently - candidiasis of the oral mucosa, fungal infection, candidiasis, vaginitis, pseudomembranous colitis; rarely - dermatomycosis, pneumonia, urinary tract infections, wound infection after surgery;
- on the part of the cardiovascular system: often - sinus bradycardia, venous complications after infusion (thrombophlebitis, phlebitis); infrequently - a decrease in blood pressure (BP); rarely - tachycardia, bleeding, arrhythmia, increased blood pressure;
- from the side of metabolism: rarely - hypoglycemia;
- from the respiratory system: infrequently - an unpleasant sensation in the throat, dyspnea; rarely - wheezing, nasal congestion, shortness of breath, nosebleeds;
- from the hematopoietic system: rarely - thrombocytopenia, neutropenia;
- from the digestive system: often - nausea, vomiting, diarrhea; infrequently - belching with sour contents, abdominal pain, constipation, dyspepsia, dry mouth; rarely - fecal incontinence, dysphagia, pelvic peritonitis, jaundice, cholecystitis, liver damage;
- on the part of the organ of vision: rarely - disorders of the sclera;
- dermatological reactions: often - itching, rash; infrequently - urticaria, erythema; rarely - peeling of the skin, dermatitis; frequency unknown - drug rash with systemic symptoms and eosinophilia (DRESS syndrome);
- from the urinary system: rarely - renal failure, including acute renal failure;
- from the genital organs: genital bleeding;
- from the musculoskeletal system: rarely - pain in the shoulder, muscle spasms; frequency unknown - muscle weakness;
- laboratory parameters: often - an increase in the number of platelets (3%), an increase in the activity of aspartate aminotransferase (4.6%), alanine aminotransferase (4.6%), alkaline phosphatase (3.8%); infrequently - an increase in the concentration of creatinine, indirect and direct bilirubin, glucose and urea, a decrease in the number of segmented neutrophils, leukocytes, platelets, hemoglobin and hematocrit, an increase in the content of eosinophils, an increase in activated partial thromboplastin time (APTT) and an increase in the number of prothrombin time, leukocyte time, segmented neutrophils, the content of bacteria, epithelial cells, erythrocytes and leukocytes in the urine, a positive reaction to the Clostridium difficile toxin, candiduria; rarely - an increase in the activity of lactate dehydrogenase, a decrease in the concentration of creatinine, bicarbonates, potassium,an increase in the content of potassium and phosphorus, the concentration of urobilinogen, a decrease in the number of lymphocytes, an increase in the number of stab neutrophils, myelocytes, monocytes, atypical lymphocytes;
- on the part of the organism as a whole and local reactions: infrequently - weakness, fatigue, extravasation, fever, anorexia, chest pain; rarely - malaise, induration at the injection site.
In children, against the background of the use of the antibiotic Inwanz, in addition to the most frequently occurring undesirable effects (diarrhea and pain at the injection site), the following side effects may develop:
- from the side of the central nervous system: infrequently - headache; frequency unknown - mental disorder (including aggressiveness), hallucinations;
- from the digestive system: often - diarrhea; infrequently - melena, fecal discoloration;
- on the part of the cardiovascular system: infrequently - increased blood pressure, rush of blood;
- dermatological reactions: often - diaper dermatitis; infrequently - rash, petechiae, erythema;
- laboratory parameters: often - neutropenia (3%), increased activity of alanine aminotransferase (2.9%), aspartate aminotransferase (2.8%); infrequently - a decrease in hemoglobin, an increase in prothrombin time, aPTT, platelet count;
- local reactions: often - pain at the injection site; infrequently - a burning sensation and warmth at the injection site, itching, erythema.
Overdose
The specific symptoms of Inwanza overdose have not been established.
The drug does not cause the development of clinically significant toxic reactions with an accidental single administration of an increased daily dose: adults - up to 3 g, children - up to 2 g.
Treatment: drug withdrawal, general supportive therapy. It is possible to use hemodialysis, but there is no exact information about the effectiveness of this procedure for treating an overdose.
special instructions
With prolonged use of Invanza, the appearance of microorganisms insensitive to the drug and their excessive growth is possible. If superinfection develops, adequate measures are required.
Since against the background of the use of ertapenem, there is a risk of developing pseudomembranous colitis (the main reason for its appearance is the toxin produced by Clostridium difficile), in the event of severe diarrhea in a patient, the possibility of this complication should be taken into account. The severity of pseudomembranous colitis can range from mild to life-threatening.
Accidental injection of Invanza into a blood vessel during intramuscular injection should not be allowed.
Influence on the ability to drive vehicles and complex mechanisms
During the period of treatment with the drug, care should be taken when driving vehicles and mechanisms, as it is possible to develop undesirable reactions in the form of dizziness and drowsiness.
Application during pregnancy and lactation
During pregnancy, the use of Invanza is indicated only in an exceptional case, when, according to the doctor, the expected clinical effect of therapy for the mother exceeds the potential threat to the fetus.
During lactation, the drug should be prescribed with caution, since ertapenem is excreted in breast milk.
Pediatric use
It is not recommended to use Invanz for the treatment of infants under three months of age.
The effectiveness and safety of the drug in children is comparable to that in adult patients.
For children from 3 months to 12 years old, the drug is prescribed at the rate of 0.015 g per 1 kg of the child's weight 2 times a day. The maximum daily dose is 1 g.
With impaired renal function
Do not reduce the dose of Invanza in adult patients with renal failure with CC more than 30 ml / min per 1.73 m 2.
In case of severe renal dysfunction (CC 30 ml / min per 1.73 m 2 and below) in adults, including patients on hemodialysis, it is recommended to use the drug in a daily dose of 0.5 g.
Adult patients on hemodialysis should be additionally administered 0.15 g of the drug after a hemodialysis session, if the administration of the prescribed dose (0.5 g) was made within the next 6 hours before hemodialysis. If the drug is administered more than 6 hours before the hemodialysis session, then an additional dose is not required.
There is no experience of using Invanza in children with renal failure or on hemodialysis.
For violations of liver function
In case of impaired liver function, dose adjustment of Inwanza is not required.
Use in the elderly
According to clinical studies, the safety and efficacy of the drug in the treatment of patients over the age of 65 years is comparable to that in patients of younger age.
No dose adjustment is required.
Drug interactions
When used simultaneously with probenecid and other drugs that block tubular secretion, correction of the Invanza dosing regimen is not required.
Ertapenem does not inhibit the metabolism of drugs, which is mediated by the following cytochrome P450 isoenzymes - 1A2, 3A4, 2D6, 2C9, 2C19, 2E1. Clinically significant drug interactions due to changes in the intensity of microsomal oxidation, inhibition of tubular secretion, or impaired binding to P-glycoprotein are not expected.
Since carbapenems, including ertapenem, when combined with valproic acid or sodium divalproate, lower the concentration of valproic acid in blood plasma, this combination is not recommended.
Analogs
Analogs of Invanza are: Europenem, Inemplus, Lastin, Mepenam, Meromek, Merospin, Merobotsid, Prepenem, Ronem, Sinerpen, Tienam.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Invanza
Reviews about Inwanza are mostly positive.
Price for Invanz in pharmacies
The price for Invanz for 1 bottle is from 2365 rubles.
Inwanz: prices in online pharmacies
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Drug name Price Pharmacy |
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Invanz 1 g lyophilisate for preparation of solution for injection 20 ml 1 pc. RUB 2300 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
