Kubitsin lyophilisate d / pr-r for intravenous injection. 350 mg vial 1 pc. (daptomycin)

Packaging

1 bottle

Indications

Complicated infections of the skin and soft tissues in adults

bacteremia caused by Staphylococcus aureus, including established or suspected infectious endocarditis in adults.

Contraindications

Hypersensitivity to daptomycin or excipients.

Caution:

impaired renal function (Cl creatinine <80 ml / min)

obesity

severe impaired liver function (> 9 on the Child-Pough scale)

patients older than 65 years.

severe renal impairment (creatinine Cl <30 ml / min) - the drug should be prescribed only in cases where the expected benefits of the therapy outweigh the potential risk.

Use during pregnancy and lactation

The use of the drug Kubitsin in pregnant women has not been studied. In experimental studies, daptomycin does not adversely affect the course of pregnancy, embryonic / fetal development, childbirth and postnatal development. Prescribe the drug during pregnancy should only be in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

It is not known whether daptomycin with breast milk is excreted in humans. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Composition

Xeroform 0.1 g, belladonna bellflower extract) thick 0.02 g, zinc sulfate 0.05 g distilled glycerin 0.12 g solution for infusion 1 fl.

daptomycin 350 mg

500 mg

component composition without the amount of

excipients: sodium hydroxide ZN solution

Dosage and administration of

IV, in the form of infusion, for at least 30 minutes.

Complicated infections of the skin and soft tissues

The recommended dose for adults is 4 mg / kg once a day for 7-14 days or until the infection disappears. With the development of bacteremia caused by Staphylococcus aureus, 6 mg / kg of the drug is prescribed once a day.

Bacteremia caused by Staphylococcus aureus, including established or suspected infectious endocarditis

The recommended dose for adults is 6 mg / kg 1 time in knocking for 2-6 weeks at the discretion of the attending physician.

Patients with impaired renal function. In patients with Cl creatinine ≥30 ml / min, dose adjustment of the drug is not required.

In patients with Cl creatinine <30 ml / min or patients receiving hemodialysis or continuous ambulatory peritoneal dialysis, the interval between injections of the drug Kubitsin should be increased to 48 hours (this correction of the dosage interval has not been studied in clinical studies and is based on pharmacokinetic modeling data )

In patients with end-stage kidney disease, Cubicin should be given on the same day after hemodialysis.

Patients with impaired liver function. In patients with mild to moderate impaired liver function (<8 points on the Child-Pough scale), dose adjustment is not required.

Since in patients with severely impaired liver function (> 9 points on the Child-Pough scale), the efficacy and safety of daptomycin have not been studied, caution should be exercised when prescribing the drug Cubicin in this category of patients.

Patients older than 65 years. Patients older than 65 years with a lack of severe renal impairment, the drug is prescribed with caution in a dose of 4 or 6 mg / kg once a day.

Since the experience of using the drug Kubitsin in patients over 65 years of age is limited, caution must be exercised when using the drug in this category of patients.

Children and adolescents (under 18 years old). Since the effectiveness and safety of the drug Kubitsin in children and adolescents has not been established, the drug is not recommended for use in this category of patients.

Rules for the preparation and administration of a solution of the drug Cubicin

1. To obtain a solution for iv administration with a concentration of daptomycin 50 mg / ml: - 350 mg of lyophilisate should be dissolved in 7.0 ml 0, 9% solution of sodium chloride or sterile water for injection

- 500 mg of lyophilisate should be dissolved in 10.0 ml of a 0.9% solution of sodium chloride or sterile water for injection.

Preparation of a solution of the drug cubicin is carried out under aseptic conditions. The polypropylene “flip off” cap must be removed to detect the central part of the rubber plug. 7 or 10 ml of a 0.9% solution of sodium chloride or sterile water for injection is introduced into the vial through the center of the rubber stopper, directing the needle to the wall of the vial. The bottle must be carefully rotated to ensure complete dissolution of the drug, after which it should be left for 10 minutes. The vial should then be gently shaken for 5 minutes until the desired clear reconstituted solution is obtained. In order to avoid foaming of the drug, the vial should not be shaken vigorously. Complete dissolution of the lyophilisate usually occurs within 15 minutes.

Prior to the administration of the drug Kubitsin, visually check the quality of dissolution of the drug and the color of the solution. The solution of the drug Kubitsin should be from pale yellow to light brown. When the color changes or the appearance of insoluble visible particles, the drug can not be used.

The chemical and physical stability of the dissolved drug in the vial is maintained for 4 hours at temperatures up to 30 ° C for 12 hours at temperatures up to 25 ° C for 48 hours at 2–8 ° C.

2. The resulting solution of the drug Kubitsin should be diluted with 50 ml of 0.9% sodium chloride solution and injected intravenously for 30 minutes.

The chemical and physical stability of the diluted solution in infusion bags is maintained for 12 hours at temperatures up to 25 ° C or 24 hours at 2–8 ° C. From a microbiological point of view, a diluted solution of the drug for iv administration should be used immediately after preparation. If the prepared infusion solution is not used immediately, the storage time should not exceed 24 hours at a temperature of 2–8 ° C.

The total shelf life of the daptomycin solution in the vial and the diluted drug solution in the infusion bag should not exceed 12 hours at 25 ° C or 24 hours at 2–8 ° C.

3. After a single injection of the drug Kubitsin, the unused solution of the drug remaining in the vial cannot be reused.

4. After using the product, all materials should be disposed of properly.

Do not mix Cubicin with glucose-containing solutions.

Side effects of

In clinical trials, more than 1,500 people received treatment with Cubicin (for 7-14 days).

The most common adverse reactions were headache, nausea, vomiting, diarrhea, fungal infections, rash, reactions at the injection site, increased activity of CPK and liver enzymes - ALT, ACT and alkaline phosphatase.

During clinical trials, the following adverse events were noted, listed below on organs and systems with an indication of their frequency of occurrence: often ( 1/100, <1/10) sometimes ( 1/1000, <1/100) rarely ( 1 / 10000, <1/1000), very rarely ( 1/10000), incl. individual messages. In each group, adverse events are presented in decreasing order of severity.

Infectious diseases: often - fungal infections, sometimes - urinary tract infections.

From the hemopoietic system: sometimes - thrombocythemia, anemia, eosinophilia.

Disorders of metabolism and nutrition: sometimes - anorexia, hyperglycemia.

Mental disorders: sometimes - anxiety, insomnia.

From the nervous system and sensory organs: often - headache sometimes - dizziness, paresthesia, taste disturbances.

From the cardiovascular system: sometimes - supraventricular tachycardia, extrasystole, flushing of the face, increase or decrease in blood pressure.

From the digestive system: often - nausea, vomiting, diarrhea sometimes - constipation, abdominal pain, dyspepsia, glossitis.

From the liver and biliary tract: sometimes - jaundice.

From the skin and subcutaneous tissue: often - rash sometimes - itching, urticaria.

From the musculoskeletal system: sometimes - myositis, muscle weakness, myalgia, arthralgia.

From the urinary system: sometimes - impaired renal function.

From the reproductive and endocrine system: sometimes - vaginitis.

On the part of the body as a whole, local reactions: often - reactions at the injection site, sometimes - fever, weakness, fatigue, pain.

Change in laboratory results: often - violation of laboratory parameters of liver function (increased activity of ACT, ALT and alkaline phosphatase), increased activity of CPK, sometimes - violation of electrolyte balance, increased plasma levels of creatinine, myoglobin, increased activity of LDH.

When using the drug Kubitsin in clinical practice, the following adverse events were noted: on the part of the immune system: very rarely - hypersensitivity (individual spontaneous messages), including pulmonary eosinophilia, vesicular-bullous rash involving mucous membranes and sensation of oropharyngeal edema, anaphylaxis, post-infusion reactions including tachycardia, wheezing, fever, chills, systemic hyperemia, dizziness, fainting, metallic taste in the mouth.

From the musculoskeletal system: very rarely - rhabdomyolysis. In approximately 50% of cases, rhabdomyolysis was observed in patients with preexisting renal failure or with the simultaneous use of the drug Kubitsin with drugs that cause rhabdomyolysis.

Change in laboratory results: in some cases, myopathy, manifested by muscle symptoms and increased activity of CPK, was accompanied by an increase in transaminases. The increased activity of transaminases was probably associated with the effect of the drug on skeletal muscle. In most cases, an increase in the activity of transaminases of 1-3 degrees was observed, disappearing after the cessation of therapy with the drug Kubitsin.

Drug Interaction

Daptomycin is not metabolised or slightly metabolized with the involvement of the cytochrome P450 isoenzyme system (CYP450).

Since in vitro studies do not have a clinically relevant inducing or inhibiting effect on the CYP450 isoenzyme system (1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4), the development of CYP450-dependent interactions in humans is unlikely.

Experience with concomitant use of daptomycin with drugs that may be accompanied by myopathy is limited. However, there have been several cases of increased CPK activity and the development of rhabdomyolysis in patients taking Kubicin along with myopathy-inducing drugs. To prescribe the drug Kubicin together with drugs that cause myopathy, should only be when the benefits of therapy outweigh the possible risk.

When using the drug Kubicin together with drugs that can cause myopathy, it is necessary to monitor the activity of CPK more than once a week and to monitor patients in order to timely identify any symptoms that indicate the development of myopathy.

Because daptomycin is eliminated mainly by renal filtration, its plasma concentration may increase when used concurrently with drugs that reduce renal filtration (including NSAIDs, including selective COX-2 inhibitors). In addition, the use of daptomycin with these drugs may develop pharmacodynamic interaction due to the additive effect on renal function.

It should be used with caution Kubicin together with potentially nephrotoxic drugs, providing additional regular monitoring of kidney function in all patients (regardless of the initial state of renal function).

Clinical practice has identified cases of interaction of daptomycin with the specific reagent used in the determination of PV / INR. This interaction led to a pronounced lengthening of the PV and an increase in MHO. In the detection of PV / INR deviation in patients, receiving treatment with the drug Kubicin, the possibility of interaction of daptomycin in vitro with a laboratory reagent should be considered. The probability of an error in the determination of PV or MHO can be minimized if blood is drawn at the lowest possible concentration of daptomycin in the blood plasma.

If necessary, the drug can be used (injected into / in) together with aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.

Incompatibility. It is impossible to mix the drug Kubicin with glucose-containing solutions, as well as other drugs, except for the above.

Overdose

Treatment: symptomatic therapy and medical follow-up. Daptomycin is slowly excreted by hemodialysis (about 15% of the administered dose is excreted after 4 h) or by peritoneal dialysis (about 11% of the administered dose is removed after 48 h).

Storage conditions

At 2–8 ° C.

Keep out of the reach of children.

Expiration

3 years.

Deystvuyuschee substances

daptomycin

Dosage form

dosage form

infusion solution



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