Butapenem injection powder 500 HQ Pharma Treatment of infection (10 vials)

Dosage form Box of 10 vials
Specifications Doripenem
Ingredient Central Pharmaceutical Joint Stock Company 2

Ingredient

Composition information	Content
Doripenem	500mg

Uses

Indications

Butapenem injection powder for cases of infections caused by bacteria sensitive to drugs, including: complex infections in the abdominal cavity, complex urinary tract infections, respiratory infections including infected pneumonia in hospitals and including patients with mechanical breathing pneumonia) and pneumonia in cyst patients.

Pharmacology

Doripenem is a Carbapenem synthesis antibiotic, structured and reasonably active as Imipenem. Doripenem is durable with the hydrolysis effect of Dehydropeptidase-I (DHP-1) in the microphone of the nearby tubular cell of the kidneys than the imipenem, so it does not need to be used with the DHP-1 inhibitor like Cilastatin.

Doripenem inhibits the synthesis of bacterial cell walls by attaching penicillin bonding proteins (PBP) to activate these proteins, thereby killing bactericidal effects. The drug has the strongest affinity with PBP 2 and PBP 3 of Pseudomonas Aeruginosa and PBP 2 of Escherichia Coli.

In vitro, Doripenem has the ability to inhibit or be inhibited mainly by other antibacterial drugs. The drug has a plus or weak effect with amikacin and levofloxacin for pseudomonas aegurinosa, with daptomycin, linezolid levofloxacin and vancomycin for gram -positive bacteria.

Doripenem has a broad spectrum, on many types of gram -negative bacteria, aerobic grams and some anaerobic bacteria. The spectrum of doripenem is similar to Meropenem and Imipenem, but Doripenem is somewhat stronger than other carbapenems on Enterobacteriaceae and Pseudomonas Aeruginosa.

Doripenem has a Vitro and clinical effect on gram -positive bacteria when arbitrary, including Streptococus Intermedius and Streptococcus Constellatus. The drug also works in vitro for Staphylococcus aureus (including sensitive strains with oxacilin/methicillin). S. Epidermidis. S. Agalactiae (Streptococci Group B) and S. Pyogenes (Streptococci groups of hemolytic groups).

Doripenem has a Vitro and Clinical effect on gram -negative bacteria when arbitrary, including Escherichia Coli, Klebsiella Pneumoniae. Proteus Mirabilis, Pseudomonas Aeruginosa and Acinetobacter baumannii. The drug also has in vitro effects on citrobacter freundii, Enerobacter Clocae. E. Derogenes, K. Oxytoca, Morganella Morganii, Serratia Marcescens and some Burkhoderia Cepacia strains.

Doripenem has a Vitro and clinical effect on many anaerobic bacteria, including Bacteroides Fragilis. B caccae, b thetaio-taomicron. B Uniformis. B vulgatus, and peptostreptococcus micros.

Bacterial resistance mechanism for doripenem includes inactivated drugs by carbapenem hydrolysis enzymes (metallo-dama-lactamase), mutant PBP or obtained reduction Doripenem is sustainable with most beta-lactamase including penicillinase and cephalosporinase caused by Gram-positive and grams of bacteria, but it is not durable with the hydrolysis effect of carbapenem hydrolysis lactamase. Staphylococcus anti -meticillin staphylococcus is always considered antipenem resistance.

Dynamic pharmacokinetics

Dynamic pharmacokinetics of linear doripenem during intravenous doses of 0.5 - 1g. After a 500 mg of doripenem intravenous infusion for 1 hour, the maximum measured concentration in plasma is 23 micrograms/ml, reduced to 10 micrograms/ml after 1.5 hours and 1 microgram/ml after 6 hours. Doripenem is linked to a plasma protein below 10% and is widely distributed to the body's tissue and fluid, including organizations in the abdomen, abdominal leaking, bile, gallbladder and urine. The distribution of the equilibrium state in healthy adults is 16.8 liters (ranging from 8.09 - 55.5 liters). Doripenem metabolizes partially into an open -ring open metabolitus (Doripenem M1), mainly thanks to Dehydropeptidase.

In vitro research shows that the drug is not metabolized by cytochrom P450 liver enzymes. Doripenem excreted mainly in the form of unchanged by the kidneys, thanks to the excretion in the renal tubules and the filter through the glomerular. After taking a single dose of 500 mg doripenem, 75% of the initial dose is constant and 15% of the initial dose in the form of metabolites found in the urine within 48 hours less than 1% of the dose of elimination in feces. Doripenem is not accumulated when using repeated dose mode in people with normal kidney function. Half life eliminates the serum of the drug about 1 hour longer in kidney failure. The drug is excluded by hemorrhage.

Pharmacokinetics/pharmacokinetics related to

Preparatory studies have shown that, like other antibiotics Beta-lactam, the time with doripenem concentration in plasma is higher than the minimum inhibitory concentration (MIC) is the best correlation parameters with efficiency. Similar to other time antibiotics, Doripenem has a bactericidal effect when the time has a higher plasma concentration than the mic (T> Mic) less than 40% and has a bactericidal effect when T> Mic is over 40%. Prolonging drug transmission time (up to 4 hours) is effective to increase T> mic over 40% to 81%, so it is advisable to transmit medicine for 4 hours for patients with pneumonia sufficient pneumonia at the hospital, including pneumonia when they have to be assisted.

In patients with severe infections or immunodeficiency, 4 -hour transmission will be more suitable because Doripenem's mic for pathogenic bacteria in these cases has been identified or suspected to be greater than 0.5 mg/ml. The dose of 500 mg doripenem is transmitted for 4 hours, every 8 hours is given priority in patients with normal renal function and infected with pathogenic bacteria with mic with doripenem ≤ 4 mg/liter.

Before taking Butapenem injection powder 500 HQ Pharma Treatment of infection (10 vials)

How to use

doripenem is infused in 1 hour or 4 hours.

Perfect: Add 10 ml of distilled water injected or 0.9% sodium chlorid injection solution to 500 mg of doripenem, shaking gently to create a mixture of 50 mg/ml. This epidemic must be diluted before infusion to the patient.

Dilute before transmitting: The mixture after reconciliation is diluted by pumping to the infusion of 100 ml of 0.9% sodium chlorid solution or 5% glucose solution, shaking it to create a transparent solution.

Dosage

Dosage for adults:

Doripenem is used in the form of monohydrates but the dose is recommended by an anhydrous doripenem of 1.04 g of doripenem monohydrate, equivalent to about 1 g of anhydrous donipenem.

The usual dose of Doripenem is 500mg, every 8 hours, intravenously in 1 hour. In cases of very severe infections or caused by less sensitive bacteria strains, it is necessary to transmit medicine for 4 hours. The duration of the treatment may be 5-14 days depending on the site of infection, the severity and response of the patient clinically. After at least 3 days of treatment with intravenous doripenem, depending on the clinical response of the patient, it can switch to appropriate oral antibiotic.

Dosage in children:

Do not use Doripenem for children under 18 years of age due to the safety and effectiveness of the drug has not been determined.

Patients with renal failure:

Need to reduce the dose of doripenem when used for patients with ClCr

Doripenem is eliminated during the separation, but there is not enough data to recommend adjusting the dose in patients with hematuria, so avoiding drugs for these subjects.

Patients with liver failure: There is no parameters of pharmacokinetics of Doripenem in patients with liver failure. Because Doripenem does not metabolize through the liver, liver function will not affect the pharmacokinetics of the drug.

Elderly: No need to adjust the dospenem dose in patients over 65 years old with normal kidney function. However, careful dosage should be selected because elderly patients often have a reduced renal function or increased blood nitrogen before the kidneys compared to young people.

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 to do when overdose?

Handling: Doripenem overdose should stop taking the drug and treat symptoms until the drug is excreted through the kidneys. Dorpenem may be eliminated by hemorrhage but there is no appropriate information about the conduct of hemorrhage when overdose Doripenem.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

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

In phase studies 2 and 3, when using Doripenem at a dose of 500mg every 8 hours, the rate of ADR is 32%. The proportion of patients using Doripenem must stop the drug because ADR is 0.1%.

Very common, ADR> 1/10:

TKTW: headache.

digest nausea, diarrhea.

Bacterial infection: Candida infection in the mouth, vaginal yeast infection. Kidney.

digestive: colitis caused by C. Difficile.

If the hypersensitivity reaction occurs in patients using Doripenem, it is necessary to stop the drug and apply appropriate treatments (e.g. epinephrine, corticosteroids, infusion, antihistamine transmission, hypertension amines, oxygen breathing and airway maintenance).

If the patient has diarrhea during or after treatment with Doripenem, it is necessary to monitor and have appropriate diagnosis and treatment. Some cases of diarrhea and fake colitis may end when stopping the drug, but in severe cases, need for infusion and electrolytes, supplements for protein and use drugs that work for D. Difficile (metronidazole oral or vancomycin).

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Butapenem drugs are contraindicated in the following cases:

Hypersensitivity to doripenem or other drugs in the same carbapenem group.

There is a history of anaphylactic reaction when using beta - lactam.

Be cautious when using

do not use doripenem in the inhaler because it can cause pneumonia.

Be cautious when used for other hypersensitivity patients with carbapenem, penicillin or cephalosporin, due to increased risk of anaphylactic reaction.

Patients with a history of hypersensitivity to many different allergens also increases the risk of being life -threatening reaction to beta - lactam.

Do not use doripenem simultaneously with probenecid. Be cautious when used simultaneously with Valproic acid, it is necessary to monitor the serum valproic acid level.

Needs to reduce the dose when used for patients with medium and severe renal failure, and regularly monitor patients.

Convulsions and adverse reactions on TKTW have been reported when using other carbapenem (imipenem, ertapenem, meropenem), the risk of increased risk in people with diseases in the TKTW system (such as brain damage, epilepsy history) or renal function failure. There have been reports on patients with convulsions when using Doripenem, but the causal relationship has not been determined.

Using antibiotics can cause superinfection of fungi and bacteria that are not sensitive, including diarrhea caused by C. differentiation and fake colitis. Therefore, it is necessary to monitor and have appropriate diagnosis if the patient has secondary diarrhea when treated with Doripenem.

To limit the development of anti -drug bacteria and maintain the effectiveness of Doripenem, as well as other antibiotics, only use Doripenem for diagnosed cases or doubt is certainly infections caused by sensitive bacteria with drugs. It is necessary to base on bacterial tests (if any) when choosing antibiotics.

Monitor patients carefully during treatment, if superinfection occurs, appropriate intervention is needed. Avoid using doripenem for a long time.

Indicators to be monitored during treatment. Manifestations of anaphylactic reaction when using the first dose, periodic monitoring of kidney function, consider monitoring hematology indicators if used for prolonged use.

Use drugs for women during pregnancy and lactation

for pregnant women:

In animal studies, Doripenem does not have any adverse effects on the fetus. No control studies have been performed in pregnant women and it is unclear whether the drug is harmful to the fetus or not when using Defipenem for pregnant women after careful consideration, seeing superior benefits.

For breastfeeding:

It is not clear whether the drug will excrete in breast milk or not. Mouse research shows that Doripenem and metabolites are excreted in milk. Consider the benefits of feeding children or stop breastfeeding when using Doripenem for breastfeeding women.

The effect of the drug on driving and operating machinery

has not recorded.

Drug interaction

Valproic acid: Doripenem reduces the level of valproic acid to the desired treatment limit, can increase the risk of seizures, need to be cautious when used in combination. The interactive mechanism is not known, but the carbapenem can inhibit the hydrolysis of glucuronid of Valproic acid.

Probenecid: Probenecid reduces the excretion of doripenem through the renal tubules, increasing blood concentration in the blood and prolonging the time to eliminate drugs. Should avoid simultaneous use.

Other antibiotics: In vitro research shows that it is less likely to have antagonistic doripenem or antibiotic -acting by other antibiotics (such as amikacin, co - trimoxazol, daptomycin, levofloxacin, linezolid, vancomycin).

Medications affect or metabolize by liver microsom enzyme. In vitro research shows that it is not likely to occur.

Metabolic drugs by Uridin Diphosphate - Glucuronosyl - Transferase 1A1 (UGT 1A1).

In vitro research shows that Doripenem does not cause UGT 1A1.

Cavalry:

In addition to 0.9% sodium chloride solution or 5% glucose, do not mix doripenem with any other drug.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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