MSD injection powder treated cases of infection (20 ml)
Dosage form Box x 20ml
Specifications Imipenem, cilastatin
Ingredient
| Composition information | Content |
| Imipenem | 500mg |
| Cilastatin | 500mg |
Uses
Indications
MSD 20 ml vials are used to treat infections caused by bacteria sensitive to drugs in the following cases:
Tienam is a strong inhibitor of bacterial cell wall synthesis and has bactericidal effects on a broad spectrum of pathogens, both grams and grams, both aerobic and anaerobic.
Along with the new generation cephalosporin and penicillin, Tienam has a wide -spectrum anti -gram -negative bacteria but is the only drug that remains highly active in Gram -positive bacteria. Previously, this activity was only available in the Beta-Lactam antibiotics of the narrow spectrum of the first generations. The activity of Tienam includes Pseudomonas Aeruginosa, Staphylococcus aureus, Enterococcus Faecalis and Bacteroides Fragilis, a group of many pathological factors that are difficult to solve, often resistant to other antibiotics.
Tienam avoids being descended by bacterial beta-lactamase enzymes. This makes the drug effective against a high percentage of microorganisms such as Pseudomonas Aeruginosa, Serratia spp., And Enterobacter spp.
pharmacokinetics
imipenem
On a healthy volunteer, Tienam intravenously for 20 minutes. The imipenem concentration in plasma reaches a maximum of about 12 - 20 mcg/ml at a dose of 250 mg, 21 - 58 mcg/ml at a dose of 500 mg, and 41 - 83 mcg/ml at a dose of 1,000 mg. The maximum maximum plasma levels of Imipenem with doses of 250 mg, 500 mg and 1,000 mg are 17.39 and 66 mcg/ml. In these doses, the plasma level of imipenem antibiotic activity drops below 1 mcg/ml or lower for 4 to 6 hours after transmission.
The half -life of the plasma of imipenem is 1 hour. Approximately 70% of antibiotics collected intact in the urine within 10 hours, and no longer detects the excretion of medicine through the urine. Imipenem concentration in the urine exceeds 10 mcg/ml until 8 hours after using the dose of 500 mg Tienam.
The rest of the antibiotic dose obtained in the urine in the form of non -activated antibacterial metabolites, and basically there is no Imipenem elimination through feces.
There is no cumulative imipenem in plasma or urine with tienam dose modes used every 6 hours in patients with normal kidney function. Simultaneous use of Tienam with Probenecid increases negligible plasma and half -numbered plasma time of imipenem. The rate of collection in urine of the active (non -metabolic) Imipenem decreases to approximately 60% of the dosage when using Tienam along with Probenecid.
When used alone, imipenem is metabolized in the kidney by dehydropeptidase-i. The collection rate in urine in individuals is about 5-40%, the average receiving level is 15-20% of many studies. Imipenem bonding ratio to plasma proteins is approximately 20%.
cilastatin
cilastatin is a specific inhibitor of enzyme dehydropeptidase-i, and has the effect of effectively inhibiting the IMIPENEM metabolism. Therefore, simultaneous use of imipenem and cilastatin allows to achieve effective bacterial resistance levels in terms of urine and plasma.
The maximum plasma cilastatin level is achieved after 20 minutes of venous transmission between 21 - 26 mcg/ml at a dose of 250 mg, from 21 - 55 mcg/ml at a dose of 500 mg, and 56 - 88 mcg/ml at the dose of 1,000 mg. Maximum plasma levels of cilastatin after doses of 250 mg, 500 mg and 1,000 mg are 22, 42 and 72 mcg/ml.
The semi -cancellation time in Cilastatin's plasma is approximately 1 hour. About 70 - 80% of the dose of cilastatin received unchanged in the urine in the form of mother medicine for 10 hours after using Tienam. After that, there was no longer a cilastatin appearance in the urine.
approximately 10% found in the form of n-acetyl metabolites with inhibitory activity for dehydropeptidase is equivalent to this activity of the mother medicine. Dehydropeptidase activity in the kidneys quickly returns to normal after eliminating cilastatin from the circulatory system.
Simultaneous use of Tienam and Probenecid doubled the plasma and semi -cancellation time of cilastatin, but did not have any impact on the recovery rate of cilastatin in urine.
Cilastatin's connection with plasma protein is approximately 40%.
Before taking MSD injection powder treated cases of infection (20 ml)
How to use
for intravenous injection.
Dosage
adults
Total daily doses and lines of Tienam are based on the nature or severity of bacterial infections; and are divided into equal doses based on assessing the sensitivity level of pathogenic bacteria, kidney function and weight.
Most of the infections respond to a dose of 1-2 g per day, divided into 3-4 times.
To treat medium infections, 1 g x 2 times a day. With bacterial infections due to less sensitive bacteria, tienam dose of intravenous daily can be increased to a maximum of 4 g/day or 50 mg/kg/day depending on which dose is lower. Each dose of 500 mg of tienam intravenous intravenously must be intravenous for 20-30 minutes. Each dose> 500 mg must be transmitted in 40 - 60 minutes.
In patients with nausea, when transmission, the transmission speed may be slower. The maximum dosage of the day should not exceed 50 mg/kg/day or 4 g/day, depending on which dose is lower. However, patients with cystic fibrosis with normal kidney function have been treated with tienam to the dose of 90 mg/kg/day, divided into many times but not more than 4 g/day.
Need to reduce the dosage of Tienam for patients with creatinine purification 70ml/min/1.73m2 and/or weight
Do not allow patients with creatinine purification concentration of 5 ml/min/1.73 m2 to use intravenously, unless the hemolysis will be conducted for 48 hours. There is no enough data to recommend using tienam intravenously for patients with abdominal fertilizer.
Children
Children weighing 40 kg
Should use the dose of people.
Children and newborns weighs
For children from 3 months of age and older, the recommended dose for cases of bacterial infections outside the central nervous system is 15 - 25 mg/kg/dose for each distance every 6 hours. For patients under 3 months of age (weight of 1,500 g), recommended dose for cases of infection outside the central nervous system as follows:
4 weeks - 3 months of age: 25 mg/kg for every 6 hours.
Doses of 500 mg or less should be intravenous from 15 to 30 minutes. The dose of over 500 mg should be intravenous from 40 to 60 minutes. Do not use Tienam for pediatric patients who can respect less than 60 kg with renal function because there is no clinical data for these cases. Tienam is not recommended in the treatment of meningitis.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do
do when overdose? Imipenem-cilastatin sodium can be fertilized. However, the benefits of this procedure in case of overdose are still unclear. What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
When using 20 ml of MSD vials, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Kidney: Distant/Uria.
Neurological: Like other beta-lactam antibiotics, adultery effects on the central nervous system such as muscle contraction, psychological disorders, including hallucinations, confusion state or body convulsions have been recorded in the form of dosage for intravenous injection. For people with leukemia: when treated with tienam, nausea and/or vomiting related to common drugs in patients with leukemia rather than in patients without leukopenia. Uncommon, 1/1000 Rare, 1/10000 Instructions on how to handle ADR When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Tienam bottle of 20 ml of MSD is contraindicated in cases of hypersensitivity to any component of the product.
Be cautious when using
There are some clinical evidence and in the laboratory of cross-allergy partially between Tienam and other antibiotics belonging to other beta-lactam groups, penicillin and cephalosporin. Before treatment with Tienam, it is advisable to carefully learn about previous hypersensitivity reactions with beta-lactam antibiotics. If allergic reactions to Tienam occur, the drug must be stopped and properly handled.
Cases of reporting in literature show that the use of carbapenems includes imipenem for patients who are using Valproic acid or Divalproex sodium has reduced Valproic acid levels. It is not recommended to use Imipenem at the same time as Valproic acid/divalproex sodium. If you need to use Tienam, you should consider supplementing with anti -convulsions/epilepsy drugs.
fake colitis has been recorded with most antibiotics and mild to life -threatening levels. Therefore, antibiotics must be carefully used in patients with a history of gastrointestinal pipes, especially colitis. It is necessary to think about diagnosing fake colitis in patients with diarrhea when using antibiotics. Although many studies show that a toxin produced by Clostridium difficile is the first cause of colitis due to antibiotic use, but other causes must also think of.
with children
Do not use tienam for children with central neuropathy because of the risk of convulsions. Do not use money for children 2 mg/dL) because there is no clinical data for this object.
The central nervous system as well as other beta-lactam antibiotics. Adultery effects on the central nervous system such as muscle contraction, confusion state, convulsions have been recorded, especially when exceeding the recommended dose based on kidney function and body weight. These effects are most commonly recorded in patients with diseases in the central nervous system (for example, brain damage or epilepsy history) and/or kidney function that has caused the drug to accumulate. Therefore, it is advisable to follow the recommended dosage regimen, especially in the above objects.
Continue to use anti -convulsions in patients with epilepsy. If local tremor occurs, muscle contraction and convulsions, patients must be examined and treat convulsions immediately if not yet treated before. If the symptoms of the central nervous system continue to reduce the dose or stop Tienam. Patients with creatinine purification 5 ml/min/1.73m2 should not use Tienam, unless the blood decomposes will be used. Tienam is only recommended to use when considering the benefits of treatment beyond the risk of hidden seizures.
The ability to drive and operate machinery
No information.
Pregnancy
The use of Tienam in pregnancy has not been fully and thoroughly studied. Therefore, you should only use Tienam during pregnancy if the benefit for the mother is over the risk of the fetus.
The period of breastfeeding
Imipenem was found in breast milk. If the use of Tienam is really necessary for the mother, the mother should stop breastfeeding.
Drug interaction
Epilepsy has been recorded in patients using Ganciclovir and Tienam. Do not coordinate these drugs unless the benefits are more than the risk.
Cases of reporting in literature show that the use of carbapenem includes imipenem for patients who are using Valproic acid. Valproic acid levels may decrease below the treatment level due to the results of this drug interaction, thus increasing the risk of epilepsy/epilepsy.Although it is unclear this drug interaction mechanism, data from in vitro studies and animal research suggests carbapenem perhaps inhibiting the hydrolysis of glucoronide metabolism of valproic acid, thus reducing serum valproic acid levels.
Storage
Store dry powder under 25 ° C.
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