Meronem

Meronem – antibacterial drug of a broad spectrum of activity.

Form of release and structure

Meronem release in the form of powder for preparation of solution for intravenous (in/in) introductions: from white till light yellow color (on 500 mg in glass bottles with a capacity of 10 and 20 ml, on 10 bottles in cardboard packs with control of the first opening; on 1000 mg in glass bottles with a capacity of 30 ml, on 10 bottles in cardboard packs with control of the first opening).

Active ingredient: a meropenema trihydrate, in 1 bottle in terms of anhydrous meropeny – 500 or 1000 mg.

Auxiliary component: anhydrous carbonate of sodium.

Indications to use

To adults and children Meronem is more senior than 3 months appoint for treatment of infectious and inflammatory diseases (as monodrug or in a combination with other antimicrobic means):

• Infections of an abdominal cavity;
• Infections of an urinary system;
• Infectious and inflammatory diseases of bodies of a small pelvis, including an endometritis;
• Septicaemia;
• Meningitis;
• Infections of skin and its structures.

As monodrug or in a combination with antifungal/antiviral means Meronem appoint for empirical therapy by the adult with the estimated infection which is followed by symptoms of a febrile neutropenia.

Contraindications

Absolute:

• Children's age up to 3 months;
• The expressed hypersensitivity (heavy skin or anaphylactic reactions) to any antibacterial drug with a beta laktamnoy structure, i.e. to cephalosporins and/or penicillin;
• Instructions in the anamnesis on hypersensitivity to meropeny or to other means from group of karbapenem.

Relative (it is necessary to observe extra care in connection with risk of development of complications):

• Existence of complaints from digestive tract (for example, diarrheas), especially at the patients having colitis;
• Simultaneous use of potentially nefrotoksichny drugs.

During a pregnancy/lactation Meronem can be appointed only if the expected advantage of therapy exceeds possible risks for the fruit/child.

Route of administration and dosage

Meronem is entered intravenously in the form of a bolyusny injection within at least 5 minutes or in the form of infusion within 15-30 minutes.

For bolyusny in/in injections Meronem part with sterile injection water (on 250 mg of a meropenem – 5 ml of water).

For in/in infusions Meronem part from one of the following infusional liquids (in number of 50-200 ml): 5 or 10% solution of a dextrose, 2,5 or 10% solution of Mannitolum, 0,9% solution of sodium of chloride, 5% dextrose solution from 0,225% solution of sodium of chloride, 5% dextrose solution from 0,9% solution of sodium of chloride, 5% dextrose solution from 0,02% solution of Natrii hydrocarbonas, 5% dextrose solution from 0,15% chloride potassium solution.

At cultivation it is necessary to follow standard rules of an asepsis, before introduction – to stir up divorced solution. Meronem it is impossible to speshivat or add to other drugs. All bottles are intended for single use.

Doses and duration of treatment are established individually depending on a type of the activator, weight of a course of a disease and the general condition of the patient.

The recommended doses for adults:

• Pneumonia, gynecologic infections, infections of urinary tract, skin and its structures: on 500 mg intravenously each 8 hours;
• Peritonitis, septicaemia, nozokomialny pneumonia, suspicion of a bacterial infection at patients with neutropenia symptoms: on 1000 mg intravenously each 8 hours;
• Meningitis: on 2000 mg each 8 hours.

The recommended doses for adult patients with renal failures depending on the clearance of creatinine (CC):

• KK 26-50: 1 dose each 12 hours;
• KK 10-25: ½ doses each 12 hours;
• KK of less than 10: ½ doses each 24 hours.

Active ingredient of Meronem is removed at a hemodialysis. For this reason in case of prolonged treatment, for recovery of effective concentration of a meropenem in a blood plasma it is recommended to enter the dose appointed by the doctor at the end of the procedure of a hemodialysis.

Experience of use of Meronem at treatment of the patients who are on peritoneal dialysis no.

To children aged from 3 months up to 12 years the drug is administered intravenously by each 8 hours in a dose of 10-20 mg/kg depending on a condition of the child, type of an infection, sensitivity of the activator and weight of a course of a disease.

To children with body weight more than 50 kg appoint doses for adults.

The recommended dose at meningitis makes 40 mg on kilogram of body weight each 8 hours.

There is no experience of use of Meronem for children with renal failures and a liver.

Side effects

In general drug is transferred by patients well, therapy cancellations demand side effects seldom.

Possible undesirable reactions:

• System of a hemopoiesis: often – a thrombocytosis; infrequently – thrombocytopenia, an eosinophilia; seldom – an agranulocytosis, a neutropenia, a leukopenia; very seldom – hemolitic anemia;
• Digestive tract: often – increase in activity of hepatic transaminases, diarrhea, nausea and/or vomiting, increase in concentration of bilirubin in blood serum, an alkaline phosphatase and a lactate dehydrogenase; infrequently – a lock * and cholestatic hepatitis *; very seldom – pseudomembranous colitis;
• Nervous system: infrequently – paresthesia, a headache, sleeplessness *, a hyperexcitability *, uneasiness *, a syncope *, a depression *, hallucinations *; seldom – spasms;
• Immune system: very seldom – displays of an anaphylaxis, a Quincke's disease;
• Cardiovascular system: infrequently – a thromboembolism of branches of a pulmonary artery *, bradycardia *, tachycardia *, decrease or increase in arterial pressure *, heart failure *, a myocardial infarction *, a cardiac standstill *;
• Kidneys and urinary system: infrequently – increase in concentration of urea and creatinine in blood;
• Skin and hypodermic cellulose: infrequently – a skin itch, rash and a small tortoiseshell; very seldom – Stephens-Johnson's syndrome, a multiformny erythema, a toxic epidermal necrolysis;
• Respiratory system: infrequently – диспноэ *;
• Others: often – local reactions (pain, an inflammation, thrombophlebitis in a drug injection site); seldom – candidiasis of a mucous membrane of an oral cavity, vaginal candidiasis.

* Relationship of cause and effect of these side effects using Meronem is not established.

Special instructions

Experience of use of Meronem for children with primary/secondary immunodeficience, and also a neutropenia is absent.

Treatment of patients with diseases of a liver should be carried out under careful control of concentration of bilirubin and activity of transaminases.

Due to the probability of excess growth of insensitive microorganisms during therapy observation of a condition of the patient is necessary.

At Meronem's use as monodrug at treatment of the patients who are in a critical state at whom it is revealed or the lower respiratory tract infection caused by Pseudomonas aeruginosa is suspected, it is recommended to carry out sensitivity tests regularly.

In rare instances Meronem promotes development of pseudomembranous colitis which on weight of a current can vary from easy to a life-threatening form. It is important to remember risk of developing of pseudomembranous colitis at emergence of diarrhea against the background of administration of drug.

It is necessary to consider probability of development of cross allergic reactions between Meronem and cephalosporins, penicillin, beta лактамными antibiotics. There are messages on exceptional cases of development of serious reactions of hypersensitivity to meropeny, including with a fatal outcome. For this reason before purpose of this drug it is necessary to collect the careful anamnesis of the patient, having paid special attention to reactions of hypersensitivity to a beta laktamnym to antibacterial agents. In case of existence of such data in the history of a disease Meronem apply with extra care if there is an allergic reaction, cancel drug and undertake the appropriate measures.

Meronem is not recommended to apply at the infectious diseases caused Methicillinum - resistant staphylococcus.

Influence of drug on the speed of reactions of the person and his ability to concentration of attention was not studied. However it is necessary to consider probability of development of such side effects as paresthesias, a headache, spasms.

Medicinal interaction

Meronem is not recommended to apply along with valproic acid drugs.

Terms and storage conditions

To store at a temperature to 30ºС in the place unavailable to children. Not to freeze.

Period of validity – 4 years.

Divorced Meronem also some time keeps the efficiency.

Solvent type: storage time in the refrigerator (4ºC)/storage time at the room temperature (15-25ºС):

• Water for injections: 8 hours / 24 hour;
• 0,9% chloride sodium solution: 8 hours / 48 hours;
• 5% dextrose solution: 3 hours / 14 hours;
• 10% dextrose solution: 2 hours / 8 hours;
• 5% solution of a dextrose and 0,225% chloride sodium solution: 3 hours / 14 hours;
• 5% solution of a dextrose and 0,15% chloride potassium solution: 3 hours / 14 hours;
• 5% solution of a dextrose and 0,02% Natrii hydrocarbonas solution: 2 hours / 8 hours;
• 5% solution of a dextrose and 0,9% chloride sodium solution: 3 hours / 14 hours;
• 2,5 or 10% Mannitolum solution: 3 hours / 14 hours.