Clarithromycin Stella 500mg Treatment of infection (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Clarithromycin
Ingredient Upper respiratory tract infection, chronic bronchitis, H.pylori infection (HP), pneumonia

Ingredient

Composition information	Content
Clarithromycin	500mg

Uses

Indications

Clarithromycin is indicated for treatment in cases of infections caused by sensitive bacteria such as:

Lower respiratory infections such as acute, chronic bronchitis and pneumonia. Figure. Clarithromycin at a more neutral pH at acid pH. It is resistant to many aerobic, anaerobic, gram -positive and gram -negative bacteria. The minimum inhibitory concentration (mic) of clarithromycin is lower than the mic of erythromycin twice.

Clarithromycin's 14-hydroxy metabolites also have antibacterial activity. The mic of this metabolite is equal to or twice as higher than that of the initial drug mic, except for the effect on H. Influenzae The activity of the 14-hydroxy metabolic substance is twice as higher than the original drug.

Macrolid antibiotic antibiotic mechanism is often associated with changes in the destination position associated with antibiotics, based on changes and/or active pushing antibiotics of bacteria.

The development of drug resistance can be intermediaries or plasmid. Macrolid -resistant bacteria produce enzymes that make adenin methylation remaining in RNA of ribosom and eventually inhibit antibiotics attached to ribosom.

Macrolid -resistant bacteria are usually cross -resistant to lincosamid and streptogramin B based on methylation at the position attached to ribosom. Clarithromycin is also classified as these strong enzyme inhibitors. Moreover, macrolid has a bactericidal effect by inhibiting the ribosom peptidyl transferase.

There is a completely cross -outing between clarithromycin, erythromycin and azithromycin. Staphylococcus resistant to methicillin and streptococcus pneumonia resistant penicillin is also resistant to macrolid like clarithromycin.

The threshold values: The following threshold values for clarithromycin, separating sensitive bacteria from anti-drug microorganisms, have been set up by the European Commission on antibiotic sensitivity test (EUCAST) 2010-04-27 (v1.1).

a. The threshold values that are not related to the bacteria have been determined mainly on the PK/PD database and independently of the mic distribution of specialized species. They are only used for bacterial strains not mentioned in the table or notes. However, the pharmaceutical data for the results of calculating threshold values are not related to the bacterial strain of the macrolid, lincosamin and streptogramin group, which is IE.

b. Erythromycin can be used to determine the sensitivity of bacteria listed for other macrolids (azithromycin, clarithromycin and Roxithromycin).

c. Clarithromycin is used to eradicate H. pylori (mic ≤ 0.25mg/l for wild type).

d. The correlation between mic values of macrolid towards H. Influenzae and clinical results is unknown. Therefore, threshold values for macrolid and related antibiotics have been established to classify H. Influenzae wild bacteria as intermediate bacteria. Clarithromycin is used to eradicate H. pylori, the minimum inhibitory concentration (mic) ≤ 0.25µg/ml has been established as the sensitive threshold value by the Clinical Standards and Testing Institute (CLSI). The infected drug resistance ratio may vary by geographic area and over time for selected bacteria strains and should have information about local drug resistance, especially when treating severe infections. When needed, experts should be consulted if the local drug resistance rate for the use of drugs on at least some infections is still unclear.

Sensitivity: The infected drug resistance ratio may vary by geographical area and over time for selected bacterial strains and vomiting with information about local drug resistance, especially when treating severe infections. When needed, experts should be consulted if the local drug resistance rate for the use of drugs on at least some infectious diseases is still unclear 210% of the drug resistance in at least one country in the European Union.

The common sensitive bacteria strains

corynebacterium diptheriae

Moraxella catrhalis

Pasteurella Multocida

Legionella spp.

Unlike C. Difficile.

chlamydia trachomatis

Clamydophila Pneumoniae

Clamydophilapsitacci

mycobacterium spp.

streptococcus group B

Streptococcus Viridans

Enterococcus spp+

Staphylococcus aureus, sensitive to methicillin and resistance to methicillin+

streptococcus pneumoniae *+

Staphylococcus epidermidis+

helicobacter pylori

peptococcus/peptostreptococcus spp.

The strains of bacteria are available for drug resistance

acinetobacter

Entembacteriacea

Anaerobic bacteria fusobacterium spp. Europe.

* The strains of bacteria against the effectiveness of the drug have been proven in clinical research (if sensitive).

Show high -resistance bacterial strains (> 50%) that have been observed in one or more regions/countries/regions of Europe.

§ The threshold values for macrolid antibiotics and related antibiotics have been established to classify H. Influenzae wild bacteria as intermediate bacteria.

Other information:

Sensitivity and resistance to Clarithromycin of Streptococcus Pneumoniae and Streptococcus spp. Can be predicted by Erythromycin test.

Most clinical experiences obtained from controlled randomized clinical trials show that the use of clarithromycin 500mg x 2 times/day in combination with other antibiotics such as Amoxicillin or Metronidazol and Omeprazol (used in the allowable dose) in 7 days of reaching H. Pylori 80% in patients with stomach ulcers - duodenum.

As expected, the rate of except is significantly lower in patients with H. pylori -resistant strains of metronidazol resistance. Therefore, the information about the local drug resistance and the treatment guidance should be considered when choosing the appropriate coordination treatment regime to eradicate H. pylori.

Moreover, in persistent patients with infections, secondary drug resistance (in patients infected with primary sensitivity strains) with antibacterial drugs should be reminded for a new re -treatment regime.

pharmacokinetics

Clarithromycin is quickly absorbed through the gastrointestinal tract and first metabolized, bioavailability of the mother medicine reaches about 55%. The level of absorption is almost no affected by food.

Clarithromycin's peak concentration and main metabolites 14-hydroxyclarithromycin are about 1 and 0.6mcg/ml respectively after taking single dose 250mg; In a stable state, when using the same dose every 12 hours, the peak concentration of clarithromycin is about 2mcg/ml and of 14-hydroxyclarithromycin about 0.7mcg/ml.The pharmacokinetics of Clarithromycin are not linear and depends on the dose, high doses can create the peak concentration of the mother drug that does not increase in proportion due to the saturated drug metabolism.

Clarithromycin and main metabolites are widely distributed, the concentration of tissue is surpassed the serum concentration, partly due to intracellular absorption.

Clarithromycin has been found in breast milk. Clarithromycin is strongly metabolized in the liver and is eliminated into the stool. 5 - 10% of the drug in constant form is found in the feces, in a stable state, about 20% and 30% corresponding to the 250mg and 500mg tablet dose are eliminated in urine in the form of unchanged. 14 -Hydroxyclarithromycin as well as other metabolites are also eliminated in urine about 10-15% of the dose.

Clarithromycin and 14 -hydroxyclarithromycin are about 3-4 hours and 5 - 6 hours respectively in patients using 250mg doses every 12 hours and about 5-7 hours and 7 - 9 hours in patients taking 500mg every 8-12 hours. Prolonged sale time in patients with renal failure.

Before taking Clarithromycin Stella 500mg Treatment of infection (4 blisters x 7 tablets)

How to use

Clarithromycin 500mg is used by oral and is not affected by food.

Dosage

Dosage for patients with respiratory infections/Skin infections and soft tissue

Adults and children over 12 years: The usual dose is 250mg twice a day can increase to 500mg twice a day in case of severe infection.

Treatment time is about 14 days.

Do not use Clarithromycin for children under 12 years old.

Dosage to treat Helicobacter pylori in patients with duodenal ulcer (adults and elderly)

Treatment time is about 14 days.

3 drug regimen: Clarithromycin (500mg) twice a day, Lansoprazol 30mg twice a day and amoxycillin 1000mg twice a day.

3 drug regimen: Clarithromycin (500mg) twice a day, Lansoprazol 30mg twice a day and Metronidazol 400mg twice a day.

3 drug regimen: Clarithromycin (500mg) twice a day, Omeprazol 20mg twice a day, combined with Amoxycillin 1000mg twice a day or Metronidazol 400mg 2 times a day.

3 drug regimen: Clarithromycin (500mg) twice a day, amoxycillin 1000mg twice a day and Omeprazol 20mg twice a day.

Dosage for patients with renal failure

Patients with renal impairment with creatinine clearance less than 30ml/min should reduce the dose half, 250mg once a day or 250mg twice a day if the infection is severe. Do not treat more than 14 days.

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?

Unwanted effects when overdose need to be treated by immediately eliminating unprocessed drugs and supportive treatment. Like other macrolid antibiotics, the serum concentration of clarithromycin cannot be excluded by the method of hemolysis or abdominal fertilizer.

What to do when forgetting a 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 Clarithromycin 500mg, you may experience unwanted effects (ADR).

Common

The most unwanted effect is digestive disorders, especially in young people with a frequency of 5%. The allergic reaction is different from urticaria to anaphylaxis and Stevens -Johnson syndrome. There may also be fake fake colitis from mild to life -threatening.

Body: Hypersensitivity reactions such as itching, urticaria, skin rash, stimulation.

rarely

Digestive: Symptoms of biliary stasis (upper abdominal pain, sometimes a lot of pain), nausea, vomiting.

Liver: abnormal liver function values, serum bilirubin increased and often accompanied by jaundice, rash and eosinophilia.

hearing: deaf (if high doses) of the sensory nerves can recover.

When encountering side effects of Clarithromycin 500mg, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using Clarithromycin 500mg, you need to read the user manual carefully and refer to the information below.

Contraindicated

Clarithromycin 500mg contraindicated drug in the following cases:

Patients with hypersensitivity to clarithromycin, erythromycin or any other macrolide antibiotics or any ingredients of the drug.

Contrain to use Clarithromycin with some drugs such as Terfenadin, Astemizol, Cisaprid and Pimozid because it can significantly increase the concentration of these drugs in plasma and toxicity on the heart serious and/or life -threatening.

Concentrated with naked alkaloids (Ergotamin, dihydroergotamine) is also contraindicated because of the ability to cause serious toxicity.

Do not use clarithromycin for patients with a history of prolonged QT or ventricular arrhythmia with vertex.

Do not use Clarithromycin simultaneously with HMG-CoA Reductase inhibitors (Statin) are metabolized by most CYP3A4 (lovastatin or simvastatin) because of the increased risk of muscle diseases including muscle pattern. Clarithromycin should be discontinued during treatment with the above drugs.

Do not use clarithromycin for patients with hypokalemia (risk of extension of QT).

Do not use clarithromycin for patients with severe liver failure.

Be cautious when using

indicate clarithromycin when knowing that there is no infection or suspected infection or to prevent, it does not bring benefits to patients but also increases the risk of developing many resistance bacteria.

Clarithromycin is eliminated mainly through the liver and kidneys. Clarithromycin can be used without adjusting the dose for patients with liver failure with normal kidney function.

However, if the kidney failure is severe or not accompanied by liver failure, the dose should be reduced or prolonged the dosage.

Unsacrined Clarithromycin and Ranitidin Bismuth Citrate for patients with creatinine clearance under 25ml/minute and should not be used for patients with a history of acute porphyrin metabolic disorders.

Like other antibacterial drugs, clarithromycin can cause excessive growth of non -sensitive bacteria or fungi. If superinfection occurs, replaced with appropriate therapy.

Effects on the liver:

Increase the concentration of ALT (SGPT), AST (SGOT), γ-glutamyltransferase (γ-glutamyl transpeptidase, GGT, GGTP), alkaline phosphatase, LDH, and/or the total amount of serum bilirubin that has been reported (less than 1% of patients) in patients with separate clarithromycin or combined treatment Omeprazol.

Liver and abnormalities of liver function (such as cholestasis, or no jaundice) have also been reported in patients taking drugs. This liver function abnormal may be serious but often recovered. However, liver failure leads to necrosis that has been reported rare, mainly above but patients with severe liver failure and/or use of drugs combined with treatment.

The ability to drive and operate machinery

There is no data on the influence of clarithromycin on the ability to drive and operate machinery. The possibility of dizziness, dizziness, confusion and disorientation may occur when taking the drug, so pay attention before driving and operating machinery.

Pregnancy and nursing mothers

Pregnant women: There is no complete and controlled research on pregnant women. Clarithromycin should only be used during pregnancy when considering the benefits and risks for the fetus.

Lactating women: Be careful when using Clarithromycin for nursing women.

Drug interaction

The drugs metabolized by enzymes in the liver:

Concentrated with clarithromycin increases the serum concentration of these drugs, so closely monitor the serum concentration of the drugs used simultaneously.

Carbamazepin: Be careful when used with Clarithromycin. Carbamazepine and/or monitoring carbamazepine levels should be reduced.

cisaprid: Contrain to use with Clarithromycin. The simultaneous use of clarithromycin and/or erythromycin with cisaprid extends the QT interval and causes heavy arrhythmia (ventricular tachycardia, ventricular vibration, torsion), has a death report.

darifenacin: Darifenacin's dose should not exceed 7.5mg/day when used simultaneously with CYP3A4 inhibitors including clarithromycin.

Disopyramid: When using simultaneously with clarithromycin should monitor the electrocardiogram and serum disopyramid concentration. Verification, extending the QT range and increasing the disposal time of disopyramid (40 hours) has been reported in a patient taking Disopyramid maintenance dose (200mg twice a day) and Clarithromycin (250mg 2 times a day), Metronidazol (400mg 2 times a day) in H. Pylori treatment causes chronic duodenal ulcers. There has been a climax report when sharing clarithromycin with disopyramid.

erlotinib: Be cautious when used with CYP3A4 inhibitors, including clarithromycin and consider reducing the dose of erlotinib if the unwanted effect occurs.

Eszopiclon : Reduce the dose of Eszopiclon when used simultaneously with CYP3A4 inhibitors including clarithromycin. At the beginning of treatment, the dose of Eszopiclon should not exceed 1mg but may increase to 2mg if clinical indications.

Hydroxymethylglutaryl-coa inhibitors (HMG-COA) Reductase: Clarithromycin increases the serum concentration of these drugs (lovastatin, simvastatin) due to inhibition of metabolism by isoenzyme cytocrom P-450. The pattern is sometimes accompanied by secondary acute renal failure with myoglobin urine rare when treated individually or in combination with macrol -group antibiotics.

pimozid : Contrain to use with macrolid antibiotics, including clarithromycin. Macrolid antibiotics such as azithromycin, clarithromycin and erythromycin inhibit the metabolism of pimozid, increasing serum pimozid concentration. Because pimozid causes a QT range, increasing serum levels can increase the risk of serious heart disease such as a critical ventricular arrhythmia. There have been at least two deaths in patients treated simultaneously clarithromycin with pimozid.

rifabutin or rifampin: increase clarithromycin metabolism when used simultaneously.

terfenadin and Astemizol: Extend the Unusual QT, ST-U range and ventricular tachycardia, including vertices that have been reported in some patients using Terfenadin and Erythromycin simultaneously.

anticoagulant drugs:

When used simultaneously, Clarithromycin can increase the effects of oral anticoagulants.

antiviral drugs:

Atazanavir: Use Clarithromycin (500mg twice a day) with Atazanavir (400mg once a day) increases the peak concentration in plasma and AUC of Clarithromycin, reduces the peak of plasma and AUC of 14-Hydrocithromycin, and increases the peak of plasma and AUC of Atazanavir. Increasing the concentration of clarithromycin can cause a distance of QT.

Delavirdin: Use Clarithromycin (500mg twice a day in 15 days) with Delavirdin (300mg 3 times a day in 30 days) increasing 100% AUC of Clarithromycin but does not have a significant effect on Delavirdin's pharmacokinetics.

Efavirenz: Using Clarithromycin (500mg every 12 hours) and Efavirenz (400mg per day for 7 days) reduces the peak concentration in plasma and AUC of Clarithromycin 26% and 39% corresponding, increasing the peak concentration in plasma and AUC of 14-Hydroxclarithromycin 49% and 34% respectively. Efavirenz's AUC is not affected.

This clinical pharmacokinetic interaction is not known. In drug interactive studies, 46% of patients use Clarithromycin and Efavirenz. Due to the pharmacokinetic interactive reports between Clarithromycin and Efavirenz and the high rash rate in users simultaneously these drugs or clarithromycin replacement drugs (such as azithromycin) should consider using patients using Efavirenz. If using the drug and at the same time need to monitor the effectiveness of macrolid.

indinavir : Use Clarithromycin (500mg every 12 hours) with indinavir (800mg 3 times) increases both indinavir and clarithromycin levels.

Lopinavir: Using Clarithromycin with combinations of Lopinavir and Ritonavir may increase Clarithromycin levels.

Nevirapin: Concomitance with clarithromycin reduces plasma and AUC concentrations of clarithromycin, increases plasma and AUC concentrations of its main metabolites (14-hydroxyclarithromycin) and increases nevirapine levels.

ritonavir: When Clarithromycin is used in patients using ritonavir, it is not necessary to change the dose of clarithromycin commonly used in people with normal kidney function: However, clarithromycin should be reduced by 50% in patients with Creatinin liquidity of 30 to 60ml/min and 75% reduced in patients with crustininomina 30ml/minute.

Saquinavir : simultaneous use of clarithromycin and saquinavir may increase the concentration of plasma of both drugs.

Zidovudin: Concentrated with clarithromycin in adults infected with HIV, reduces the peak concentration of zidovudin about 41% but does not significantly affect the pharmacokinetics of clarithromycin, in some adults infected with HIV, using Clarithromycin (500mg 2 times a day) reduces the AUC stability state of Zidovudin medium medium 12%.

Take Clarithromycin before taking Zidovudin 2 - 4 hours as a stable state of the peak concentration in the serum of zidovudin doubled but AUC is not affected.

Benzodiazepin: The impact on the central nervous system (such as drowsiness, confusion) has been reported when using clarithromycin simultaneously with Triazolam.

Colchicin: There has been a report on colchicin toxicity when clarithromycin is used simultaneously with colchicin, especially in older patients and/or in patients with renal impairment.

digoxin: Increased serum concentration of digoxin.

Ergot alkaloids: Contrain to use Clarithromycin and Ergot alkaloids (ergotamin, dihydroergotamine). Simultaneous use Clarithromycin and ergotamine or dihydroergotamine toxic Ergot toxic, characterized by vasoconstriction and ischemia at other limbs and tissues, including the central nervous system.

Fluconazole: In healthy people drink 500mg Clarithromycin twice a day simultaneously with fluconazole 200mg per day, stable stability of the bottom serum level and area under the serum concentration curve over time (AUC) of Clarithromycin increases an average of 33% and 18%.

omeprazol: Used with clarithromycin that changes pharmacokinetics (such as increased concentration in stomach tissue and/or serum) of clarithromycin, 14-hydroxyclarithromycin, and omeprazol.

quinidine: The vertex has been reported rare in patients using clarithromycin with quinidine. If clarithromycin and quinidine are used simultaneously, serum quinidine concentration should be monitored.

Ranitidin: simultaneously use ranitidin bismuth citrate with clarithromycin increases the plasma concentration of ranitidin (57%), bismuth plasma concentrations (48%) and plasma concentrations of 14-hydroxyclarithromycin (31%).

Sildenafil: Concomitance to Erythromycin has been reported as an increase in AUC of Sildenafil. Because interactions can occur with clarithromycin, it is advisable to consider reducing the dose of sildenafil.

Theophylllin: simultaneously using clarithromycin for patients who are taking theophylllin may be related to the increase of theophylllin concentration in serum due to the decrease of the liver and/or the clearance of theophylllin.

Storage

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

To be out of reach of children.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.