Ceftriaxon 2 g
Ceftriaxon 2 g
WHAT Ceftriaxon-MIR AND WHAT IT IS USED
Ceftriaxon-MIP is a cephalosporin antibiotic for intravenous administration for the treatment of infections caused by microorganisms susceptible to ceftriaxon:
Septicemia (blood poisoning);
Borreliosis (particularly II and stage III);
Abdominal infections (peritonitis, infections of the biliary tract and gastrointestinal tract);
Infections of the bones and joints;
Infections of skin and soft tissue, including infected wounds;
Infections of the kidney and urinary tract;
Respiratory tract infections, particularly pneumonia, and ear, nose and throat infections;
Genital infections, including gonorrhea;
Infection and the prevention of infections in patients with weakened immune defenses;
Prophylaxis before and after surgery in the event of an increased risk of infection.
2 BEFORE USING Ceftriaxon-MIR
Do not use Ceftriaxon-MIR:
if you are allergic (hypersensitive) to ceftriaxon or other cephalosporin antibiotics.
Take special care with Ceftriaxon-MIR
You should tell your doctor:
If you are hypersensitive to penicillin or other antibiotics such as chemically bonded other ?-lactam antibiotics. It is possible to events and hypersensitivity to ceftriaxon (cross-allergy);
If you have other allergies (eg. Hay fever, asthma). Then the risk of severe hypersensitivity reactions is increased.
In case of severe renal impairment have special dosage recommendations (see section 3 'Dosage in case of renal impairment ").
If you experience symptoms of pseudomembranous enterocolitis (a serious complication occurring with inflammation of the gastrointestinal tract), your doctor will discontinue therapy with ceftriaxon-MIP and appropriate therapy initiated.
Lidocaine-containing solution used for intramuscular injection should not be used in cases of cardiac conduction or acute decompensated heart failure and in cases of hypersensitivity to local anesthetics of amidoatsiden type and during pregnancy and lactation (see information manufacturer lidocaine solution).
Any use of antibiotics may result in the expansion of non-susceptible organisms. Please note the symptoms of secondary infection with these organisms (eg. Colonization of mucous membranes with mushrooms accompanied with redness and white films). Secondary infections should be treated appropriately.
In patients concomitantly treated with medications or prior, potentially damaging the kidneys (eg. Aminoglycoside antibiotics), renal function should be monitored because of the possibility of increased kidney damaging effects.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
There are the following interactions:
Ceftriaxon / other antibiotics
Ceftriaxon should not be combined with bacteriostatic antibiotics, because the light of the antibacterial efficacy may occur antagonistic effect. Synergism between ceftriaxon and aminoglycosides for many Gram (-) bacteria have been experimentally demonstrated. Since increased efficacy of this combination may not always safe to predict, it should be considered in cases of severe life-threatening infections caused by microorganisms such as Pseudomonas aeruginosa. Both drugs must be administered separately for chemical and physical incompatibility.
Ceftriaxon / probenecid
The application of a high oral dose of probenecid (1 to 2 g per day) can partially reduce the secretion of ceftriaxon in the bile, but this does not result in increased serum levels.
Ceftriaxon / hormonal contraceptives
Security of the contraceptive effect of oral contraceptives is questionable in the case of co-administration with ceftriaxon. Therefore, you must apply on other contraceptive measures during treatment with Ceftriaxon-MIR.
Effects on laboratory parameters
During treatment with ceftriaxon, Coombs test in rare cases may give false positive results.
The determination of glucose in urine may give a false positive or false negative results depending on the method used. This can be prevented by using enzymatic methods.
Ceftriaxon can cause false positive test for galactosemia.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Ceftriaxon crosses the placenta. There are no adequate data on the use of ceftriaxon in pregnant women. Therefore, ceftriaxon should be used during pregnancy, especially during the first three months only after rigorous assessment of the benefit / risk ratio.
Small amounts of ceftriaxon are excreted in human milk. Therefore, ceftriaxon should be used during lactation only after rigorous assessment of the benefit / risk and taking account of possible adverse effects on the infant.
Driving and using machines
In general, there is no evidence that ceftriaxon affects the ability to drive and use machines. However, rare side effects such as low blood pressure or dizziness may pose a potential risk when driving or operating machinery.
Important information about some of the ingredients of Ceftriaxon-MIR
1 vial of Ceftriaxon-MIP 2 g contains 166 mg (7,2 mmol) of sodium. Please keep this in mind if you're on a diet, limiting salt.
3 HOW TO USE Ceftriaxon-MIR
Ceftriaxon-MIP is always used by medical personnel. The reconstituted solution is administered intravenously as an intravenous injection or infusion, intra-arterial infusion or by intramuscular injection. Your doctor will inform you regarding the necessary duration and frequency of administration of Ceftriaxon-MIP.
Use in children
Studies have shown that ceftriaxon can displace the product from the breakdown of hemoglobin (bilirubin) from binding to plasma proteins. Ceftriaxon should not be used in infants and particularly in premature infants, which show an increased concentration of bilirubin in the blood, due to the possibility of the occurrence of cerebral disorders caused by bilirubin (bilirubin encephalopathy) in these patients;
For the treatment of nevroborelioza and severe infections such as sepsis and meningitis, as well as in children under 2 years old, ceftriaxon should be administered intramuscularly.
Dosage and route of administration should be selected depending on the severity of infection, susceptibility of the organism, age, weight and renal function of the patient. Your doctor will inform the appropriate dose and duration of treatment with Ceftriaxon-MIP.
Adults and adolescents (12 - 18 years, body weight> 50 kg)
1-2 g ceftriaxon once daily. In case of severe, life-threatening infections such as septicemia, nazokomialna pneumonia, bacterial meningitis, and the like, and in the case of moderately sensitive bacteria, the dose may be increased to 4 g daily.
Infants of two weeks, infants (28 days - 23 months) and children (2-11 years)
20 to 80 mg per kg of body weight / day, depending on the severity of the infection. For children weighing more than 50 kg should be used with the usual adult dose.
Premature or newborn to 2 weeks
From 20 to 50 mg per kg of body weight / day.
A dose of 50 mg per kg of body weight / day is considered sufficient even in cases of severe infections such as meningitis.
When the elderly are valid doses in adults.
Patients with impaired renal function
Dose reduction is not necessary in patients with impaired renal function, provided that liver function is normal. Only in patients with creatinine clearance <10 ml / min, the daily dose should not exceed 2 g.
Patients with hepatic impairment
In patients with hepatic impairment do not require dose reduction provided that renal function is preserved.
In patients with severe renal impairment accompanied by hepatic insufficiency, plasma concentrations of ceftriaxon should be monitored regularly in order to adjust the dose if necessary.
Haemo or peritoneal dialysis
Dialysis patients need no further dose of ceftriaxon after dialysis. However, plasma levels should be monitored for the purpose of dose adjustment when necessary, as in these patients the elimination rate can be reduced.
Special dosage recommendations
Adults, adolescents over 12 years of age and children weighing more than> 50 kg, treatment should be initiated at a dose of 100 mg / kg body weight for 24 hours per day but should not exceed a maximum dose of 4 g daily.
In bacterial meningitis in infants and children, treatment should be initiated at a dose of between 50 and 100 mg / kg body weight once daily. Must not exceed the maximum daily dose of 2 g. In premature infants, and the daily dose is 50 mg / kg body weight.
After identifying the pathogen and defining its sensitivity, the dose may be reduced accordingly.
The duration of treatment depends on the progress of the disease. Usually sufficient one to two weeks.
For the treatment of uncomplicated gonorrhea in adolescents and adults are recommended single dose of ceftriaxon 250 mg administered intramuscularly. Before starting treatment should be ruled out syphilis.
Premature and newborn to two weeks received intravenously a single dose of 25 to 50 mg / kg body weight for the prophylaxis and treatment of infections caused by the gonococci. A daily dose of 125 mg should not be exceeded.
Borreliosis (II and III stage)
Adults and adolescents (12-18 years) received 2 g of ceftriaxon once daily at least 14 days. In severe, refractory cases reported doses of up to 4 g per day.
In children up to 11 years old, a dose of 50 to 100 mg / kg body weight once daily, up to a maximum daily dose of 2 g and the duration of treatment not less than 14 days.
For perioperative prophylaxis single dose ceftriaxon should be administered 30-90 min before surgery. In general, the dose corresponds to the therapeutic unit dose. Before colorectal surgery ceftriaxon has to be administered in combination with an antibiotic coating anaerobic bacterial spectrum.
Duration of treatment
The duration of treatment depends on the severity of the infection and the clinical and bacteriological course.
If you take more than the amount of Ceftriaxon-MIP
Typical symptoms of overdose have not yet been observed. Suspected of taking more than the prescribed dose seek medical attention immediately.
If you forget to take Ceftriaxon-MIP
You should not apply a double dose to make up the missed dose. The missed dose should be administered before the next scheduled dose only if the time between applications is still long enough.
If treatment with Ceftriaxon-MIP is interrupted or delayed wound
Lowest dose irregular application or premature discontinuation of treatment may worsen the outcome of treatment or lead to a recurrence whose treatment is more difficult. Please follow your doctor's instructions.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 POSSIBLE SIDE EFFECTS
Like all medicines, Tsefgriakson-MIP can cause side effects, although not everybody gets them.
To assess the incidence of adverse drug reactions commonly use the following classification:
Very common: More than 1 in 10 patients treated;
Common: More than 1 in 100 patients treated;
Uncommon: More than 1 in 1000 patients treated;
Rare: More than 1 in 10,000 patients treated;
Extremely rare case 1 or less per 10,000 treated patients, including isolated reports.
Infections and infestations:
Uncommon: Mycosis of the genital tract (colonize the mucous membranes of the genitals with mushrooms accompanied with redness and white films).
Blood and lymphatic system disorders:
Rare: Minimum prolongation of prothrombin time (clinical study of the rate of blood clotting), and increased bleeding tendency in both cephalosporins with N-methyl-thiotetrazolyl- chain is not reported. Leukopenia, granulocytopenia (neutropenia), and eosinophilia (disorders of white blood cells in the blood);
Very rare: thrombocytopenia (decreased number of platelets in the blood) and agranulocytosis <500 / mm3 (greatly reducing the number of granular white blood cells in the blood), late, often after treatment of 10 days and a total dose of> 20 g of ceftriaxon. Hemolytic anemia (pronounced destruction of red blood cells).
Immune system disorders:
Common Drug fever or chills. Allergic skin reactions;
Rare: Severe acute hypersensitivity reactions (anaphylaxis and anaphylactoid reactions). Severe skin reactions.
Nervous system disorders:
Uncommon: Headache and dizziness.
Uncommon: Stomatitis (inflammation of the oral mucosa), glossitis (sore throat) and gastro-intestinal disorders in the form of lack of appetite, nausea, vomiting, abdominal pain, loose stools or diarrhea. These side effects are very mild and usually disappear after discontinuation of therapy;
Very rare: pseudomembranous colitis (see below for details), most commonly caused by Clostridium difficile.
Very common: Children: precipitates of calcium salt of ceftriaxon in the gallbladder or bile ducts that look like shadows on ultrasound and disappear after termination or completion of treatment;
Common: Elevations of liver enzymes in serum (SGOT, SGPT, alkaline phosphatase);
Rare: Adults: precipitates of calcium salt of ceftriaxon in the gallbladder or bile ducts, most often after administration of higher than recommended doses of ceftriaxon. Pancreatitis with the possibility of biliary obstruction. Can not be ruled out pancreatitis have been caused by ceftriaxon acting in the gallbladder as a cofactor or activator. In the rare cases in which pancreatitis is accompanied by clinical symptoms, eg. pain, symptomatic measures are recommended. It should also be borne in mind discontinuation.
Skin and subcutaneous tissue disorders:
Common: Allergic skin reactions such as dermatitis (skin inflammation), urticaria (raised skin rash extensive), exanthema (rash), itching, swelling of the skin and joints;
Rare: Erythema multiforme syndrome, Stevens-Johnson syndrome and Lyell / toxic dermal necrosis (severe skin reactions requiring immediate treatment).
Renal and urinary disorders:
Uncommon: Increased serum creatinine and oliguria (decreased urine output);
Rare: precipitates of ceftriaxon in the kidney, the most commonly in children 3 years of age, or treated with high dose (e. 80 mg / kg body weight or more), or a total dose of 10 g, and having other risk factors (e.g., . dehydration, immobilization, etc..). This phenomenon may not be accompanied by discomfort, but may also cause discomfort and renal disorders. These symptoms disappear after cessation of treatment with ceftriaxon.
General disorders and administration site conditions:
Common: Inflammatory disorders of the venous wall (thrombophlebitis) and pain at the injection site after intravenous injection. During the rapid intravenous injection may occur nausea and rash. This can be prevented by slow injection (for 2 to 4 min). Intramuscular injection of ceftriaxon is painful and therefore should be done in combination with the solutions of local anesthetic (1% lidocaine solution pa).
Herxheimer Reaction in the treatment of Spirochaetosis as borreliosis, in the form of fever, chills, headache and joint pain. This is due to the antibacterial effect of ceftriaxon against borrelia. Patients should be informed of the fact that this is occurring frequently and usually result from antibiotic treatment of borreliosis. After long continued treatment with ceftriaxon borreliosis were described symptoms such as skin reactions, itching, fever, leukopenia (reduction in the number of leukocytes in the blood), elevated liver enzymes, shortness of breath and joint pain. This corresponds to a partial discomfort symptoms borreliosis.
Measures to counter:
These rarely occurring adverse reactions (for a detailed description of these events see above) under certain conditions can be life threatening. Therefore, the doctor should be informed immediately if any of these occur or develop with unexpected force.
Treatment induced by antibiotic associated colitis (pseudomembranous colitis):
During antibiotic treatment or within 3 weeks after its completion may occur caused by antibiotic treatment inflammatory bowel disease. It is characterized by watery or loose stools strongly throughout the day, fever and severe abdominal cramps, which may be accompanied by loss of blood, and pieces of the intestinal mucosa. The doctor decides on the termination of the use of Ceftriaxon and if necessary immediately initiate appropriate treatment.
Drugs that inhibit peristalsis are contraindicated.