Cravit Tab 750mg Interthai Pharm medicine for mild, medium and severe infections (1 blister x 5 tablets)
Dosage form Box of 1 blister x 5 tablets
Specifications Levofloxacin
Ingredient Interthai Pharm
Ingredient
| Composition information | Content |
| Levofloxacin | 750mg |
Uses
Indications
Cravit tablets are indicated for mild, medium and severe infections in adults (≥ 18 years old) due to sensitive bacterial strains in the following cases:
Having pneumonia in the community due to Staphylococcus aureus, Streptococcus Pneumoniae (including resistance strains with penicillin), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella cimxella, chlamydia, chlamydia Pneumoniae, Legionella Pneumophila or Mycoplasma Pneumonia.
Pneumonia is acquired at Hospital due to Staphylococcus aureus sensitive to methicillin, Pseudomonas Aeruginosa, Serratia Marcescens, Escherichia Coli, Klebsiella Pneumoniae, Haemophilus Influenzae or Streptococcus Pneumoniae. Need to use a complementary regimen when clinical indications. In the case of a pathogenic or predictive or predictable a Pseudomanas Aeruginosa, Cravit is recommended to use in combination with an antibiotic β-lactam resistant to Pseudomonas.
Skin infections and non -complicated skin structure (mild to medium) including abscess, cellular inflammation, pimples, impetigo, purulent dermatitis, staphylococcus aureus and streptococcus pyogenes.
Skin infections and complex skin structure (light to medium) due to Staphylococcus aureus sensitive to methicillin, Enterococcus Faecalis, Streptococcus Pyogenes or Proteus Mirabilis.
Chronic prostatitis caused by bacteria Escherichia coli, Enterococcus Faecalis or Staphylococ- CuS Epidermidis.
nephritis - pyelonephritis (light to medium) due to Escherichia coli.
Non -complicated urinary tract infections (Urinary tract infections - Mild to medium) caused by Enterococcus Faecalis, Entobacter Clacae, Escherichia Coli, Klebsiella Pneumoniae, Proteus Mirabilis, Pseudomonas Aeruginosa or Staphylococcus Saprophyticus.
Due to Fluoroquinolon antibiotics, including cravit tablets related to serious harmful reactions (see warning and caution) and non -complicated urinary tract infections in some patients who can go away on their own, only use Cravit tablets for patients without other treatment options instead.
Acute bacterial infections of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae or moraxella catarrhalis.
Due to Fluoroquinolon antibiotics, including cravit tablets related to serious harmful reactions (see warning and caution) and acute bacterial infections of chronic bronchitis in some patients who can go away on their own, should only use cravit tablets for patients without other treatment options instead.
Bacterial sinusitis: streptococcus pneumoniae, Haemophilus influenzae or Moraxella catrhalis.Due to Fluoroquinolon antibiotics, including tablets, cravit is related to serious harmful reactions (see warning and caution) and acute sinusitis caused by bacteria that some patients can go away on their own, only use cravit tablets for patients without other replacement treatment options.
Pharmacokic
levofloxacin is the L's isomers of Racemic mixture, ofloxacin - an antibiotic of Quinolon group. Ofloxacin's antibacterial activity is mainly due to l.
This isomers are 2 times stronger than ofloxacin.
The mechanism of action of levofloxacin and other Fluoroquinolon antibiotics related to the ability to inhibit the Topoisomerase IV and DNA Gyrase of bacteria (both of these enzymes belong to Topoismase Enzyme II), these enzymes are essential for DNA duplication, copy, repair and recombinant. Levofloxacin has antibacterial effect in vitro on many strains of Gram -negative and gram -positive bacteria. Levofloxacin usually has a bactericidal effect at a concentration of or a bit higher than the inhibitory concentration.
Fluoroquinolones include levofloxacin, chemical structure and mechanisms of action different from aminoglycosides, macrolid and ß-lactam, including penicillins. Therefore fluoroquinolones may be active on bacteria that have been resistant to the antibiotics above. Resistance to levofloxacin due to spontaneous mutations in vitro is very rare (about 10-9 to 10-10). Despite the decimal resistance between levofloxacin and other fluoroquinolones, some other bacteria that have been resistant to fluoroquinolones may still be sensitive to levofloxacin. Levofloxacin shows the antibacterial activity on most of the bacteria strains below in both in vitro and clinically with the infections described in the specified section and usage:
Gram -positive aerobic bacteria:
Enterococcus Faecalis, Staphylococcus aureus, Staphylococcus saprophyticus, Streptococcus pneumoniae (including penicillin strains), Streptococcus pyogenes.
Gram -negative aerobic bacteria:
En
Other bacteria:
chlamydia pneumoniae, Mycoplasma pneumoniae.
The following data has been proven in vitro but the clinical significance has not been set.
Gram -positive aerobic bacteria:
Staphylococcus epidermidis, Streptococcus (group C/F), Streptococcus (Group G), Streptococcus Agalactiae, Streptococcus Milleri, Streptococcus Viridan group.
Gram -negative aerobic bacteria:
acinetobacter baumannii, acinetobacter lwoffii, bordetella pertussis, citrobacter (diversus) koseri, citrobacter freundii, enterobacter aerogenes, enterobacter Sakazakii, Klebsella Oxytoca, Morganella Morganiiiiiiiiiiiiiiiiiii, MorganiII (Entobacter) Agglomerans, Proteus vulgaris, Providencia Rettgeri, Providencia Stuartii, Pseudomonas Fluorescens, Serratia Marcescens.
Gram -positive anaerobic bacteria:
Clostridium perfringens.
Dynamic pharmacokinetics
absorption and drug concentration in plasma:
levofloxacin is absorbed quickly and almost completely after oral use. The drug achieves the peak concentration in plasma after taking 1 to 2 hours. The absolute bioavailability of a 500 mg tablet is approximately 99%, showing the ability to completely absorb oral by levofloxacin. Levofloxacin levofloxacin pharmacokinetics and can be predicted after single dose and oral repetition dose. The average value ± SD of the peak concentration and the bottom concentration is achieved after using the dose mode once a day by oral route is 5.7 ± 1.4 and 0.5 ± 0.2 µg/ml respectively with the dose of 500 mg and 8.6 ± 1.9 and 1.1 ± 0.4 µg/ml at a dose of 750 mg.
distribution:
Levofloxacin's distribution volume is about 74 to 112 l after single dose and repeated dose of 500 mg or 750 mg, showing the wide distribution capacity of the drug in the body's tissues. The peak concentration of levofloxacin in the skin tissue and water polish on healthy people achieved for about 3 hours after drinking. AUC ratio in plasma biopsy/AUC skin tissue is approximately 2 and AUC ratio of plasma water/AUC is approximately 1 when using the dose repeated Levofloxacin 500 mg and 750 mg once a day on healthy people. Levofloxacin also penetrates well into the lung tissue. The drug concentration in the lung tissue is 2 to 5 times higher than the plasma concentration and ranges from 2.4 to 11.3 µg/g within 24 hours when taking a single dose of 500 mg oral.
In vitro, within the concentration of levofloxacin in serum/ plasma has clinical significance (1 to 10 µg/ ml), the link ratio of levofloxacin with serum protein of all research animals, determined by the equilibrium separation method is about 24 to 38%. On the body, levofloxacin is mainly linked to plasma albumin. Link of levofloxacin with serum protein does not depend on the concentration of the drug.
transformation:
levofloxacin stabilizes stereoscopic structure in plasma and urine, is not converted into its optical isomer D-Ofloxacin. Levofloxacin is very small and eliminated mainly in the form of intact through the urine. After oral use, about 87% of the dose is restored intact in the urine after 48 hours, on the contrary, only less than 4% of the dose is found in the feces after 72 hours. Under 5% of the dose found in urine in the form of Desmethyl and N-OXID metabolites, two single metabolites are determined on humans. The pharmacological effect of these metabolites is less meaningful.
Excretion:
levofloxacin is excreted in large amounts in the form of intact through the urine. Half of the lifetime of levofloxacin in plasma is about 6 to 8 hours after taking single dose levofloxacin and oral repetition. The average of the total apparent clearance and kidney clearance is 144 to 226 ml/min and 96 to 142 ml/min. The renal clearance is greater than the glomerular filtration rate proves that there is a positive excretion in the renal tubules of levofloxacin and the filtration mechanism in the glomerular. Simultaneous use of levofloxacin with cimetidine or probenecid reduces the kidney clearance of levofloxacin, respectively, 24% and 35%, showing the excretion of Levofloxacin, respectively, occurs in the near -edge tube. Levofloxacin crystals are not found in any urine samples collected from levofloxacin objects.
Before taking Cravit Tab 750mg Interthai Pharm medicine for mild, medium and severe infections (1 blister x 5 tablets)
How to use
oral tablets. Take the tablet with a glass of water.
Dosage
Patients with normal kidney function:
Patients with normal renal function (ClCr> 50ml/minute).
B: Semular therapy (from intravenous to drinking) can be conducted under a doctor's decision.
c: Due to methicillin sensitive bacteria such as Staphylococcus aureus, Streptococcus Pneumoniae (Including Multi-Drug-Resistant Isolates [MDRSP])), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae Moraxella catrhalis, Chlamydophila Pneumoniae, Legionella Pneumophila, or Mycoplasma Pneumoniae.
D: Due to Streptococcus Pneumoniae (excluding multi-drug resistance- MDRSP), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or chlamydophila pneumoniae.
E: This regimen is indicated for complex urinary tract infections (cuti) caused by Escherichia Coli, Klebsiella Pneumoniae, Proteus Mirabilis and acute nephritis (AP) caused by E. Coli, including cases of simultaneously infection.
F: This regimen is indicated for complicated urinary tract infections (cuti) caused by Enterococcus Faecalis, Enterococcus Clacoce, Escherichia Coli, Klebsiella Pneumoniae, Proteus Nirabilis, Pseudomonas Aeruginosa; And for acute nephritis (AP) by E. Coli.
Patients with renal function:
CLCR from 20 to 49 ml/min.
CLCR is from 10 to 9 ml/min.
Hemodialysis.
Peritonics continuously outpatient.
No need to adjust the dose
500 mg
500 mg
500 mg
500 mg
250 mg every 24 hours
250 mg every 48 hours
250 mg every 48 hours
250 mg every 48 hours
CLCR from 20 to 49 ml/min.
CLCR is from 10 to 19 ml/minute.
Hemodialysis.
Peritonics continuously outpatient.
No need to adjust the dose
750 mg
750 mg
750 mg
750 mg
750 mg every 48 hours
500 mg every 48 hours
500 mg every 48 hours
500 mg every 48 hours
CLCR is from 10 to 19 ml/minute.
No need to adjust the dose
250 mg
Men:
Creatinine clearance (ml/min) = [weight (kg) x (140 - age)]/[72 x Serum creatinine concentration (mg/dl)]
Women: 0.85 x The value is calculated according to the above formula.
Serum creatinine levels should be measured in a stable renal function state.
Patients with liver failure:
No need to adjust the dose due to levofloxacin is excreted mainly through the kidneys, almost no metabolized through the liver.
Elderly:
No need to adjust the dose in the elderly, but need to note the patient's kidney function.
What to do when overdose?In case of an overdose, it is necessary to remove the stomach empty. Antacid can be used to protect the stomach lining. There is no specific antidote. Patients need to be monitored and compensated appropriately. Hematomopiatric or peritoneal jurisdiction is not effective in eliminating levofloxacin.
What to do when you forget 1 dose?
Side Effects
The following harmful reactions have been recorded in clinical studies and post -commercial monitoring activities. The frequency of the following harmful reactions is determined when using Levofloxacin 500 mg over a total of 1930 patients in phase 3 and 4 clinical trials (including 1582 patients in phase 3 clinical studies conducted in Japan (337 patients) and in China (1245 patients) and 348 patients in clinical clinical tests in the stage of Japan in a Japanese stage. If the ratio of a harmful reaction has a difference between the two sources (i.e. ratio from other clinical trials with the ratio of post -commercial research), the higher rate will be selected.
Classification of the frequency of harmful reactions according to CIOMS:
Very popular: 10% ≤ ratio
Common: 1% ≤ ratio
Less: 0.1% ≤ ratio
Rare: 0.01% ≤ ratio
Very rare: ratio
*: See the "warning" section
Hematological disorders and lymphatic systems:
Very rare:
Unknown frequency:
Anemia
platelet reduction*
Reducing all bloody hematoma*, loss of granulocytes*,
Hemolytic anemia with urinary hemoglobin*.
Unknown frequency:
anorexia.
Hypoglycemic blood glucose (may appear coma due to hypoglycemia)*, hyperglycemia*.
Unknown frequency:
Insomnia.
Symptoms of mental disorders such as confusion*, delirium*, depression*, hallucinations.
Less:
Rare:
Very rare:
Unknown frequency:
Dizziness, headache.
Sleeping chicken, numbness, tremor, dementia, disorder.
Cognitive disorders.
convulsions*, loss of taste.
Peripheral neuropathy, extracurricular disorders, smells of smell, smell disorders.
rare:
visual disorders.
Unknown frequency:
tinnitus.
deaf.
Unknown frequency:
Brushing the chest.
ventricular tachycard (including nails)*, extending the QT*, tachycardia.
Very rare:
Unknown frequency:
shock*.
Hypotension.
Unknown frequency:
dry throat.
interstitial pneumonia*, Eosin hypernage pneumonia*.
Less:
Rare:
Very rare:
Unknown frequency:
Nausea, vomiting, diarrhea, stomach.
Abdominal pain, indigestion, flatulence, constipation.
stomatitis.
Tongue inflammation.
Colitis with blood stools, such as fake colitis*.
Unknown frequency:
Liver dysfunction.
Hepatitis*, jaundice*.
Rare:
Very rare:
Unknown frequency:
Itching, rash.
Increase sweating, urticaria.
Increase light sensitivity.
Poisoned epidermal necrosis (ten)*, corneal - skin - mucous ulcer syndrome (Stevens -Johnson syndrome)*, atopic vascular inflammation*.
Rare:
Unknown frequency:
joint pain, limb pain, back pain, muscle weakness.
joint disease, muscle pain.
muscle pattern*, tendon disease such as Achill tendonitis or tendon -breaking*, worsen myasthenia gravis*, muscle tear.
Rare:
Unknown frequency:
Bloody.
Multiurian, diuretic, acute renal failure*.
interstitial nephritis*, anaturia, urination, urinary retention.
Very rare:
Unknown frequency:
thirst, chest tightness, discomfort, hot feeling, edema.
Fever.
Chest pain.
Less:
Rare:
Very rare:
Increase AST, increase ALT, increase LDH, reduce leukocytes, eosinophilia.
Increased creatinine, positive protein, alkaline phosphatase, increased γ-giP, hyperlirubin blood bilirubin, decreased lymphocytes, neutropenia, increased CPK, positive urinary glucose, blood glucose, thrombocytopenia.
Reduce bun, reduce urine accumulation.
Hyperlepse hyperka.
Warnings
Contraindicated
contraindicated levofloxacin in the following cases:
Caution when using
cautious
Cravit tab should be used carefully in the following patients:
Warning
use drugs for children:
Safety and efficiency on children and children under 18 have not been set up. Quinolon, including levofloxacin, causes joint disease and cartilage bone in some animals in the development period.
Use medicine for the elderly:
Levofloxacin pharmacokinetics characteristics in young adults and the elderly have no significant differences when considering changes in creatinine clearance. However, due to the main discharge of the drug is excreted through the kidneys, the risk of harmful reactions of this drug may increase above patients with impaired renal function.
On the other hand, the renal function of the elderly often decreases, need to be cautious in choosing the dose and may need to monitor the patient's kidney function.The effect of the drug on the ability to drive and operate machinery
Unwanted effects on the central nervous system such as dizziness/ dizziness and sleeping chicken may appear. Therefore, patients need to be recommended unwanted effects on the nerves that can impair concentration, reflexes and can be dangerous in situations where these possibilities are especially important to patients (for example, working on high, driving or operating machinery).
Using drugs for women during pregnancy and lactation
Using drugs during pregnancy:
levofloxacin does not affect fertility on rats at oral dose 360 mg/kg/day. Levofloxacin does not cause fetal defects on rats at a dose of 810 mg/kg/day orally or a dose of up to 160 mg/kg/day intravenously. Do not record fetal defects on rabbits at a dose of 50 mg/kg/day orally.
Due to the lack of human data and fluoroquinolones, there is a risk of experimental damage to the supporting cartilage of developing organizations, levofloxacin is not used for pregnant women or pregnant women (see the contraindications section).
Use drugs during breastfeeding:
Due to the lack of human data and fluoroquinolones, there is a risk of experimental damage to supporting cartilage of developing organizations, levofloxacin is not used for breastfeeding women (see contraindications).
Interactive drug
antacids, sucralfate, metal cation, multivitamine:
While the complexity with the 2 cerematic cations occurs with other quinolones, with Cravit 500 is different: combining cravit 500 tablets with antacids containing magnesium, aluminum or sucralfate, metal cations such as iron and multivitamine preparations with zinc will interact with the absorption of levofloxacin in the digestive tract desire. Therefore, these drugs should only be taken 2 hours before or 2 hours after using levofloxacin.
Theophyllin:
There is no meaning of cravit's meaning to plasma concentrations, under the curve and other distribution parameters of theophyllin discovered in clinical trials in healthy volunteers. Similarly, there is no clear influence of theophyllin to the distribution and absorption of levofloxacin recorded. However, the simultaneous use of fluoroquinolon is different from theophyllin that leads to the extension of the disposal time, increasing theophyllin level in plasma, leading to an increase in the risk of side effects due to theophylllin in these patients. Therefore, theophyllin concentration needs to be closely monitored and adjust the dose appropriately when used simultaneously with cravit. Side effects, including convulsions may occur when there is an increase or no increase in theophyllin level in plasma.
fenbufen or similar nonsteroidal anti -inflammatory drugs (NSAIDs):
Pharmacological interactivity (may increase the risk of stimulating the central nervous system and convulsions). Animal studies have shown that this risk may be less than other fluoroquinolone and that risk varies depending on each specific NSAID. When fenbufen, the level of levofloxacin is about 13% higher than when not in use.
Diabetes treatment:
Blood disorders, including hyperglycemia and hypoglycemia, have been reported in patients treated simultaneously with fluoroquinolones and a diabetes drug. Therefore, careful monitoring of blood sugar when combining these drugs.
Warfarin:
Used with warfarin has been reported to increase the effectiveness of warfarin (metabolic warfarin in the liver is inhibited, or free warfarin can increase by replacing competition for protein bonding position) and thus prolonging prothrombin time.
Anti -arrhythmia IA and Group III:
Levofloxacin is carefully used for patients who are using IA anti -arrhythmic drugs (such as Quinidine Sulfate or Procainamide Hydrochloride) and Group III anti -arrhyths (such as Amiodarone Hydrochloride and Sotalol Hydrochloride). The QT range may be prolonged.
cyclosporine:
In clinical studies in healthy volunteers, do not record a significant effect of cravit to the concentration of nails in plasma, area under curves and other dynamic parameters of Cyclosporin. However, plasma cyclosporin concentrations have increased when used simultaneously with other fluoroquinolones. In other studies without the same drug, CMAX and Ke of Levofloxacin are a bit lower while the time TMAX and T ages are slightly longer in the presence of cyclosporin. However, this difference has no clinical significance. Therefore, no need to adjust the dose of cravit or cyclosporin when using two medications simultaneously.
Probenecid and Cimetidine:
Probenecid and cimetidine have a statistical significant impact on cravit excretion. Levofloxacin's kidney clearance decreased by 24% due to cimetidine and 34% due to probenecid. Because both drugs have the ability to prevent the excretion in the renal tubules of levofloxacin. However, in the test dosage in the study, the difference in dynamics seems to be unrelated to clinical.
Be careful when using cravit along with excreted drugs such as probenecid and cimetidine, especially in patients with renal failure.
digoxin:
In a clinical study related to healthy volunteers, there is no significant effect of cravit on plasma concentrations, AUC and other orientation parameters for digoxin. The absorption and dynamics of levofloxacin is similar to each other when there is or without Digoxin. Therefore, there is no need to adjust the dosage for cravit or digoxin when using these two drugs.
Interactions with diagnostic tests:
Some fluoroquinolones, including levofloxacin, can give false positive results with urine screening results with opiates using the existing immune test kit. It may be necessary to check the positive opiate results by more accurate methods.
Storage
Store in a dry place, below 30 ° C.
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