Klacid MR 500mg Abbott tablets for respiratory infections (1 blister x 5 tablets)
Dosage form Box of 1 blister x 5 tablets
Specifications Clarithromycin
Ingredient
| Composition information | Content |
| Clarithromycin | 500mg |
Uses
indications
Klacid MR 500 mg drug is indicated in the following cases:
Treatment of lower respiratory tract infections: For example, acute and chronic bronchitis, Mycoplasma pneumoniae and Legionella, diphtheria, the early stages of the pertussis, the chance of the opportunity due to mycobacterium.
Upper respiratory infections such as sinusitis and pharyngitis, otitis media. Klacid MR 500 mg is also indicated in the treatment of skin infections and soft tissue from mild to moderate, such as folliculitis, cellular inflammation and circles. Treatment of tooth infections.
Pharmacokology
Clarithromycin is a semi -synthetic derivative of erythromycin A. The drug has antibacterial activity by combining with the ribosome 50S unit of sensitive bacteria and protein synthesis inhibitors. The drug is highly effective against many Gram -positive and Gram -negative bacteria and anaerobic. The minimum inhibitory concentration (MICS) of Clarithromycin is generally lower than that of Erythromycin's mics.
Clarithromycin metabolic metabolites also have antibacterial activity. The microphone of this metabolic substance is equal to or twice higher than the mother of the mother complex, except for H.influenzae in which the metabolic 14 - hydroxy is twice as higher than the mother complex.
In In vitro, Klacid is often active against the following bacteria:
Found less accumulation or abnormal accumulation and the tendency to transform unchanged in any type after using many doses. Based on the detection of this equivalent absorption, the following Vivo and Vitro in Vitro data can be used for the type of evaluation of evaluation.
Distribution, biological changes and elimination
In vitro: The result of in vitro studies shows the cohesion of clarithromycin with protein in human plasma on average about 70% at concentrations of 0.45 - 4.5mcg/ml. The decrease in the cohesion rate to 41% at a concentration of 45 mcg/ml suggests that the cohesion positions may be saturated, but this only occurs at concentrations higher than the concentration of treatment.
In vivo: Clarithromycin concentration in all tissues, except for the central nervous system, many times higher than the concentration of drugs in the circulatory system. The highest drug concentration is seen in the lung and liver tissue, where the ratio between the drug concentration in the tissue is from 10 to 20.
Normal objects
In patients using Clarithromycin 500 mg released once daily, the peak of plasma peaks in the stable state of clarithromycin is 1.3 mcg/ml and 14-hydroxy clarithromycin is 0.48 mg/mL.
When the dose increases to 1000 mg (2 x 500 mg) used once daily, the maximum concentration in the stable state of Clarithromycin is 2.4 mcg/ml and of the metabolitus is 0.67 mcg/ml. Clarithromycin's excretion half -time at 1000 mg is about 5.8 hours, while 14 - OH - Clarithromycin is about 8.9 hours. The maximum time achieved for a dose of 500 mg - 1000 mg at about 6 hours.
In a stable state, the concentration of 14 - OH - Clarithromycin does not increase corresponding to the dose of clarithromycin. The semi -cancellation time of both clarithromycin and metabolites tends to be longer at higher doses. The non -linear pharmacokinetics of Clarithromycin along with the reduction of the formation of products of the process 14 - Hydroxylation and N - Demethylation high doses show that the non -linear metabolism of Clarithromycin becomes more pronounced at high doses. Excretion in urine accounts for about 40% of clarithromycin dose. Elimination through stool accounts for about 30%.
Patient
Clarithromycin and metabolites 14 - OH easily distribute into the body's tissues and fluids. The limited data obtained from a small amount of patients shows that clarithromycin does not achieve significant concentrations in the cerebrospinal fluid after oral dosage (meaning only 1 to 2% of serum concentration in cerebrospinal fluid in patients with normal cerebrospinal fence-cerebrospinal fluids). The concentration in tissues is usually several times higher than the serum concentration.
Hepatic failure
In a study comparison between a healthy group of people with a group of patients with liver dysfunction, 250 mg Clarithromycin released immediately twice a day for 2 days and a single dose of 250 mg at the 3rd day, plasma concentrations in stable state and Clarithromycin elimination have no significant differences between the two groups. In contrast, the concentration in the stable state of metabolites 14 - OH is noticeably lower in the group of patients with liver failure.
The reduction of parent compound elimination by 14 - hydroxylation is somewhat compensated by the increase in the elimination of the mother medicine through the kidney, so the concentration of the mother medicine in a stable state between the two groups is equivalent. This result shows no need to adjust the dose in people who fail the level from medium to severe but have normal kidney function.
kidney failure
A study was conducted to evaluate and compare pharmacokinetic data when using clarithromycin to release oral doses of 500 mg in people with normal kidney function and those with reduced renal function. A plasma concentration, sale time, maximum concentration (cmax) and minimum concentration (cmin) of both clarithromycin and metabolites 14 - OH are higher and under the concentration curve (AUC) larger in patients with renal impairment.
KELIM (KELIM) and lower urine excretion. The difference of these parameters is related to the level of renal failure, the greater the degree of difference.
Elderly
A study was also conducted to evaluate and compare safety as well as pharmacokinetic data when using multiple doses of Clarithromycin 500 mg fast -release oral release in healthy elderly men and women compared to healthy men and young women. In the elderly group, higher plasma circulation concentration and slower renal elimination than the young group with both clarithromycin and metabolites 14 - OH.
However, there is no difference between the two groups when the clearance through urine is correlated with the clearinine clearance. This shows that any effect on clarithromycin metabolism is related to the function of the kidneys and has nothing to do with age.
Before taking Klacid MR 500mg Abbott tablets for respiratory infections (1 blister x 5 tablets)
How to use
take the tablet with a glass of water.
Dosage
Adults
The recommended dose for Klacid MR in adults and children over 12 years old is 1 tablet 500 mg daily, drink while eating. In more severe infections, the dose may increase to 2 tablets of 500 mg daily. The usual treatment time is 5-14 days, except for the treatment of pneumonia in the community and sinusitis requires 6-14 days of treatment.
Teeth infection
In the treatment of tooth infections, the common dose used Klacid MR is 1 tablet of 500 mg daily, used for 5 days.
No crushing or chewing klacid tablets mr.
Patients with renal failure
In patients with severe renal failure (creatinine clearance
Children
The use of Klacid MR has not been studied in children under 12 years old.
Use Klacid in the form of children.
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?
Symptoms
Reports show that large digestion of clarithromycin can cause digestive symptoms. A patient with a history of bipolar disorder has digested 8 g clarithromycin and shows that mental change, paranoid attitude, reduced potassium and blood oxygen.
Handling
Should treat allergic reactions that come with an overdose by gastrointestinal and supportive treatment. Like other macrolide, the concentration of Clarithromycin in serum is not affected by dialysis or peritoneal fertilizer.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
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 the drug, you may experience unwanted effects (ADR).
The common adverse effects related to the treatment of clarithromycin are abdominal pain, diarrhea, nausea, vomiting and taste disorders. These adverse reactions are often mild and known as the adverse effects of macrolide drugs.
In clinical studies, there is no significant difference in the adverse effect rate on the gastrointestinal tract in patients with or non -contaminated with Mycobacterial before.
The table below raises the adverse effects reported in patients using clarithromycin in clinical studies and reports after bringing drugs to the market. These adverse effects are arranged according to the body's system and the frequency of appearance, conventions are as follows: Very common (≥1/10), common (≥1/100 - sensory, pain First, feeling Light senses mouth * Because these reactions are volunteered from the community with unknown sample size, unable to accurately estimate the frequency or establish a human-free relationship with the drug used. ** In a number of reports on Ly Van, Clarithromycin has been used simultaneously with other drugs that are known to be related to mechanical prizes such as statins, fibrats, colchicin or allopurinol. 1 adverse reaction is reported only to the form of powder preparation. 2 adverse reactions are reported only to the form of transformed release border. 3 adverse reactions are reported only to the form of preparation of oral phase nuggets. 4 adverse reactions are reported only to the form of tablet preparation. Patients with immunodeficiency impairment In AIDS patients and other immunodeficiency patients who are treated with mycobacterium infection with high doses of clarithromycin for a long time, often difficult to distinguish unwanted effects due to the use of clarithromycin or symptoms of HIV or current disease. In patients who are adults, most of unwanted effects are recorded in patients treated at daily dose 1000 mg Clarithromycin are: nausea, vomiting, taste change, abdominal pain, diarrhea, rash, bloating, headache, hearing disorders, increased metabolism of concentration in the server of glutamic oxaloacetic transaminase Transaminase (SGPT). Unwanted effects with low frequency include shortness of breath, insomnia and dry mouth. In these immunodeficiency patients, the evaluation of the value of the laboratory parameters is done by analyzing abnormal values (for example, the highest limit or lowest). When implementing these criteria, about 2-3% of patients use 1000 mg of clarithromycin per day, with high concentrations of SGOT and SGPT abnormally high, and the number of erythrocytes and platelets is abnormally low. A small percentage of patients with high bun concentrations. Instructions for handling 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
contraindicated drugs in the following cases:
Be cautious when using
should not prescribe Clarithromycin for pregnant women before careful consideration of benefits and risks, especially in the first 3 months of pregnancy.
Like other antibiotics, the use of long -term clarithromycin can cause fungal proliferation and non -sensitive bacteria. If superinfection occurs, appropriate treatment should be conducted.
Be careful when used for patients with severe renal impairment.
There have been reports on liver dysfunction, including liver enzyme, liver cell inflammation and/or cholestatic hepatitis, with or without jaundice when using Clarithromycin. Liver dysfunction may be serious and often recovered. In some cases, there has been a report of death from liver failure often associated with serious diseases available and/or medications used simultaneously. Stop using clarithromycin if signs and symptoms of hepatitis, such as anorexia, jaundice, dark urine itchy, or abdominal pain.The fake colitis has been reported to most antibacterial drugs, including macrolids, and mild to life -threatening condition. Diarrhea is associated with Clostridium Difficile (CDAD) reported when used with most antibiotics including clarithromycin, and the degree of mild diarrhea to death.
Antibiotic treatment changes the normal bacteria of the intestine, which can lead to overexoration of C. Difficile. CDAD must be concerned in all patients with diarrhea after antibiotics. Careful medical records are necessary because there is a report on the appearance of CDAD for 2 months after antibiotic use.
colchicine
There have been reports after the drug to the market for colchicine poisoning when using clarithromycin and colchicine, especially in the elderly, some occur in patients with renal impairment. Died in some cases. Contrain to use Colchicine and Clarithromycin simultaneously.
Be careful when using Clarithromycin with triazolobenzodiazepine drugs, such as triazolam and midazolam intramuscularly.
Cardiovascular events
The phenomenon of extending the process of the heart and the QT interval, resulting in the risk of developing arrhythmia and peak twisted when treated with macrolid drugs including Clarithromycin (see unwanted effect section).
Therefore, the following cases can lead to an increase in the risk of ventricular arrhythmia (including torsion), should be cautious when using clarithromycin in the following patients:
Patients with coronary artery disease, severe heart failure, conduction disorders or slow heartbeat are clinically significant
Patients with electrolytes such as blood magnesium reduced. Do not use clarithromycin for patients with hypotension (see the control section)
Patients are using simultaneously with other drugs that extend other QT (see drug interactions)
Contrain to use Clarithromycin with Astemizole, Cisapride, Dimozide and Terfenadine (see the control item)
Epidemiological studies investigate the risk of cardiovascular disadvantages with macrolide has shown different results. A number of observation studies have determined a rare short -term risk of arrhythmia, myocardial infarction and cardiovascular death related to macrolide including Clarithromycin. These risks should be considered to consider the benefits of treatment when prescribing Clarithromycin.
pneumonia
Due to the increasing streptococcus pneumoniae's macrolid drug resistance, the implementation of antibiotics is important when prescribing Clarithromycin for patients with pneumonia with community. Clarithromycin should be used in combination with other appropriate antibiotics in the treatment of pneumonia.
Skin and soft tissue infections from light to medium
Most of the skin infections are usually caused by Staphylococcus aureus and Streptococcus pyogenes, both bacteria can be resistant to macrolide drugs. Therefore, antibiotics are very important. In the absence of beta-lactam antibiotics (for example, allergies), other antibiotics, such as clindamycin, may be the first choice. Currently, macrolid drugs are only considered for the treatment of skin and soft tissue infections, such as bacterial infections caused by coryneebacterium minutissimum, acne, skin infections causing high -grade fever and cases that cannot be used penicillin.
In the case of acute and severe hypersensitivity reactions, such as Stevens - Jonhnson syndrome, anaphylactic shock, poisoned epidermal necrosis and dress, immediately stop using clarithromycin and urgently treat appropriate treatment.
Be cautious when using Clarithromycin along with drugs irritating the enzyme system CYP3A4.
Should pay attention to the diagonal resistance between Clarithromycin and other macrolid drugs, as well as with Lincomycin and Clindamycin.
HMG-CoA Reductase inhibitors (Statin drugs)
Contraindicated use Clarithromycin with lovastatin or simvastatin. Be careful when prescribing Clarithromycin along with other statins. There have been reports on Ly Co Van in patients using Clarithromycin simultaneously with statin drugs. Patients should be monitored on signs and symptoms of muscle diseases.
In case of being forced to use clarithromycin and statin medications, the lowest dosage recommendations are registered by statin. Consider using statin drugs regardless of CYP3A metabolism (such as fluvastatin).
Oral hypoglycemic medications/lnsulin
Simultaneous use Clarithromycin and oral hypoglycemic drugs and/or insulin may significantly reduce blood sugar. Need strict control of blood sugar.
Oral anticoagulants
Concomitance Clarithromycin and warfarin are at risk of serious bleeding, increasing the Inr (International Normalized Ratio) and prothrombin time. Regular tests of Inr and prothrombin must be checked when the patient takes and clarithromycin and anticoagulants.
excipients
Clarithromycin Change of Liberation Tablets contains lactose. Patients with rare genetics are not tolerated with galatose, deficiency of lactase or malposure of glucose-galatose should not use this form of preparation.
affects the ability to drive and operate machinery
There has been no report on the impact of the drug while driving and operating machinery.
It is recommended that patients with the risk of dizziness, confusion, and disorientation may occur when using the drug.
pregnancy and lactation
Clarithromycin's safety during pregnancy and breastfeeding has not been verified. Therefore, KLACID should not be used during pregnancy or breastfeeding unless the benefits are more than the risk.
Clarithromycin's safety during breastfeeding has not been studied. Clarithromycin is determined in breast milk.
Drug interaction
cisapride, pimozide, astemizole and terfenadine
Increased Cisapride concentration has been reported in patients with simultaneous use of cisapride and clarithromycin. This can cause extension of QT and arrhythmias including ventricular tachycardia, ventricular vibration and torsion. Similar manifestations were seen when using simultaneously pimozide and clarithromycin.
Macrolide disrupts the metabolism of terfenadin, E increases the concentration of terfenadine, sometimes leading to arrhythmia such as extending the QT distance, ventricular tachycardia, ventricular vibration and torsion (see contraindicated). In a study of 14 healthy volunteers, simultaneously using clarithromycin and terfenadine increased by 2-3 times the concentration in serum metabolic metabolites of terfenadine and extended the QT range but did not detect any clinical manifestations. Similar manifestations are seen when using simultaneously Astemizole and other macrolids.
Alkaloid fungus
Market reports show that the use of Clarithromycin at the same time with ergotamine or dihydroergotamine is related to the toxicity of the fungus of the fungus typical by vasoconstriction, ischemia at the limbs and other tissues including the central nervous system. Contraindicated use at the same time Clarithromycin with mushroom alkaloids.
HMG-CoA Reductase inhibitors (Statin drugs)
Do not simultaneously use clarithromycin with lovastatin or simvastatin because these statins are metabolized largely by CYP3A4, increasing plasma medication concentration when used with clarithromycin, leading to an increase in muscle disease risk, including muscle prize. There have been reports on the muscular awards in patients using clarithromycin along with these statins. If necessary, Clarithromycin is needed, lovastatin or simvastatin must be stopped during this treatment.
Be careful when prescribing Clarithromycin with statin medications. In cases where clarithromycin must be used and statin drugs, the lowest dosage recommendations are registered by statin. Consider using statin drugs regardless of the metabolism of CYP3A (such as fluvastatin). Patients should be monitored on signs and symptoms of muscle diseases.
The impact of other drugs on Clarithromycin
The drugs irritating the CYP3A enzyme system (for example, Rifampicin, Phenytoin, Carbamazepine, Phenobarbital, St John’s Wort) can increase the metabolism of Clarithromycin. This can cause low clarithromycin levels below the treatment threshold, reducing the effectiveness of the drug's treatment. Moreover, it may be necessary to monitor the plasma concentration of drugs that irritate the CYP3A system, which can be increased by Clarithromycin inhibit the CYP3A system.
Use Clarithromycin and Rifabutin at the same time increase rifabutin levels and reduce the levels of serum clarithromycin, along with increased risk of grape vein inflammation.
The following drugs are known or suspected to affect Clarithromycin's circulatory concentration; Adjust the clarithromycin dose or choose the alternative treatment should be considered.
Efavirenz, Nevirapine, Rifampicin, Rifabutin and Rifapentine
Cytochrome P450 metabolic drugs such as Efavirenz, Nevirapine, Rifampicin, Rifabutin and Rifapentine may increase the metabolism of clarithromycin, thus reducing the concentration of clarithromycin in plasma. Meanwhile, the concentration of 14-oh-clarithromycin increases, which also has antibacterial activity. Due to the antibacterial activity of Clarithromycin and 14-OH-Clarithromycin different for different bacteria, the effectiveness of treatment may be affected if used at the same time Clarithromycin with enzyme induction substances.
Eravirine
Clarithromycin's concentration is reduced by Etravirin, however, the concentration of active metabolites, 14-oh-clarithromycin increases. Because metabolites have 14-oh-clarithromycin activity that reduces the activity of mycobacterium avium complex (Mac) complex, the common activity for pathogens may be changed. Therefore, it is necessary to consider replacing clarithromycin with other drugs when treating Mac in patients with Etravirine.
fluconazole
Use Fluconazole 200 mg at the same time and Clarithromycin 500 mg twice a day for 21 healthy volunteers to increase the minimum concentration (cmin) in the stable state of Clarithromycin to 33% and the area under the curve (AUC) to 18%. The concentration in the stable state of metabolites is active 14-oh-clarithromycin is not affected when used simultaneously with fluconazole. No dose adjustment of clarithromycin.
ritonavir
A pharmacokinetic study proves that simultaneous use of ritonavir 200 mg every 8 hours and Clarithromycin 500 mg every 12 hours inhibit the metabolism of Clarithromycin. Clarithromycin's CMAX increased by 31%, CMIN increased by 182% and AUC increased by 77% when used with ritonavir. Found the complete inhibition of 14-oh-clarithromycin.
Because Clarithromycin has a large treatment range, it is not necessary to reduce the dose in patients with normal renal function. However, for patients with renal impairment, the dose adjustment should be as follows: For patients with creatinine clearance from 30 - 60 ml/min, reduce clarithromycin dose by 50%. For patients with creatinine clearance
Consider adjusting the dose in patients with renal impairment when using Ritonavir in combination with enzyme inhibitors including Atazanavir and Saquinavir.
The effect of clarithromycin on other drugs
anti -arrhyths
There have been reports after bringing the drug to the market to occur when using Clarithromycin at the same time with quinidine or disopyramide. Electrolyte test should be checked for about QT length during use at the same time clarithromycin with these drugs. Need to monitor the serum concentration of these drugs while taking clarithromycin.
There have been after -sales reports on hypoglycemia when using clarithromycin with disopyramide. Therefore, it is necessary to monitor blood sugar when using clarithromycin simultaneously with disopyramide.
Oral hypoglycemic drugs/insulin
Clarithromycin inhibits CYP3A and may be related to or causes hypoglycemia when used simultaneously with some hypoglycemic drugs such as Nateganide and Repaglinide. Need strict control of blood sugar.
interactions via CYP3A4
Simultaneously used Clarithromycin, known as a CYP3A4 inhibitor, with a major metabolic drug through CYP3A4 may be related to the increase in the concentration of the drug, which may increase or prolong both the treatment and adverse effects of the same drug.
Be cautious when using Clarithromycin in patients treated with drugs known as the substrate of the CYP3A4 enzyme, especially if the CYP3A4 substrate has a narrow safety (eg carbamazepine) and the substrate is mainly metabolized by this enzyme. Adjusting the dose can be considered and when possible, the serum concentration of the drugs metabolized mainly by CYP3A4 should be closely checked in patients using Clarithromycin simultaneously.
The following drugs or groups of drugs are known to be metabolized by ISOzyme CYP3A4: Alprazolam, Estemizole, Carbamazepine, Cilostazol, Cisapride, Cyclosporine, Disopyramide, alkaloids of chicken fungus, Lovastatin, methylprednisolone, Midazolam, Midazolam, Midazolam, Midazolam, Midazolam, Midazolam, Midylprednisolone Omeprazole, oral anticoagulants (eg Warfarin), Pimozide, Quinldine, Rifabutin, Sildenafil, Simvastatin, Tacrolimus, Terfenadine, Triazolam and Vinblastine, but this list is not complete. Drug interactions with similar mechanisms through other isozymes in the cytochrome P450 system include phenytoin, theophyllline and valproate.omeprazole
Use Clarithromycin (500 mg every 8 hours) along with omeprazole (40 mg/day) on healthy adults. Plasma concentrations in the stable state of Omeprazole increased (CMAX increased by 30%, ACU 0-24 increased by 89%and the sale time increased by 34%) when used at the same time as Clarithromycin. The average 24 -hour gastric pH is 5.2 when using omeprazole alone and 5.7 when sharing Omeprazole with clarithromycin.
Sildenafil, Tadalafil and Vardenafil
Each phosphodiesterase enzyme inhibitor is metabolized, at least in part, because CYP3A4, and CYP3A4 can be inhibited when used simultaneously Clarithromycin.
Use these drugs at the same time with Clarithromycin will be able to increase the exposure of phosphodiesterase inhibitors. The dose of these drugs should be reduced when used simultaneously with clarithromycin.
Theophyllin, carbamezapine
The results of clinical studies show that, although increasing at a modest level, statistically significance (P ≤ 0.05) concentration of theophylline or carbamazepine during the circulation when they share one of these drugs with clarithromycin.
Tolterodine
The main metabolic path of Tolterodine is through 2D6 ISOform of Cytochrome P450 (CYP2D6). However, in people who do not have CYP2D6, the identified transformation line is through CYP3A4. In these people, the inhibition of CYP3A4 will significantly increase the concentration of serum tolterodine. The decrease of the tolterodine dose may be necessary when there are CYP3A4 inhibitors as clarithromycin.
triazolobenzodiazepine (for example: Alprazolam, Midazolam, Triazolam)
When using Midazolam at the same time with Clarithromycin (500 mg, 2 times/day), Midazolam's AUC increased by 2.7 times when used injecting and increased 7 times when used orally. Therefore, avoid using clarithromycin with oral midazolam at the same time. If using midazolam injected at the same time as Clarithromycin, you should closely monitor patients to be able to adjust the dose. The same note for other benzodiazepine transformed through CYP3A4, including triazolam and alprazolam.
For benzodiazepine, the elimination does not depend on CYP3A4 (Temazepam, Nitrazepam, Lorazepam), important important interactions are almost no occurrence when used with Clarithromycin. There have been reports after bringing the drug to the market for drug interactions and the effects on the central nervous system (for example, drowsiness and confusion) when using Clarithromycin at the same time with Triazolam. Should monitor the effect on the central nervous system in patients taking drugs.
Other drug interactions
colchicine
Colchicine is a substrate for both CYP3A4 and P-Glycoproteln (PGP). Clarithromycin and other macrolides inhibit CYP3A4 and PGP. When using Clarithromycin at the same time as Colchicine, the inhibition of CYP3A4 and/or PGP due to clarithromycin can lead to increased exposure to colchicine. It is necessary to check the patient on clinical symptoms due to colchicine poisoning. Colchicine dose should be reduced when used simultaneously with clarithromycin in patients with normal renal and liver function. Convincidation simultaneously clarithromycin and colchicine in patients with renal failure or liver failure.
digoxin
Digoxin is a substrate for P-Glycoprotein transportation (PGP). Clarithromycin inhibits PGP. When shared with clarithromycin and digoxin, PGP inhibitors by clarithromycin may increase the exposure of digoxin. There has been a report on the increase in serum Digoxin concentration in patients using Digoxin and Clarithromycin at the same time. Some patients have clinical signs of Digoxin poisoning, including death -causing arrhythmia. Should closely monitor serum digoxin concentrations in patients using clarithromycin and digoxin at the same time.
zidovudine
Take Clarithromycin at the same time quickly release and zidovudine in adults infected with HIV -infected people can lead to a decrease in zidovudine levels in a stable state. Because clarithromycin affects zidovudine's absorption at the same time, it is possible to avoid this interaction by using clarithromycin and zidovudine at time apart. This interaction does not occur in HIV -infected children using chaos clarithromycin with zidovudine or dideoxylnosine. Similar drug interactive studies with clarithromycin tablets are adjusted with zidovudine that have not been done.
phenytoin and valproate
There have been spontaneous or published reports on interaction of CYP3A4 inhibitors, including clarithromycin with drugs that are not metabolized by CYP3A (eg phenytoin and valproate). The serum concentration of these drugs should be determined with Clarithromycin. There have been reports on increased plasma concentrations of the above drugs.
Two -way drug interaction
Atazanavir
both Clarithromycin and Atazanavir are the substrate and inhibitors of CYP3A4, and there is evidence of a two -way drug interaction. Use Clarithromycin at the same time (500 mg x 2 times/day) with Atazanavir (400 mg once a day) increasing the exposure to clarithromycin twice and reducing 70% of exposure to 14-oh-clarithromycin, an increase of 28% AUC of Atazanavir.
Because Clarithromycin has a wide range of treatment, the decrease in clarithromycin is not necessary in patients with normal renal function. In patients with average renal impairment (the clearing of Creatinin 30 to 60 ml/min), the dose of clarithromycin should be reduced by 50%.
For patients with creatinine clearance less than 30 ml/min, clarithromycin should be reduced by 75% and should use a reasonable form of drugs. Clarithromycin should not be used at the same time ≥1000 mg/day with protease inhibitors.
Calcium blockers
Be cautious when using Clarithromycin simultaneously with calcium blockers metabolized through CYP3A4 (such as Verapamil, Amlodipine, Diltiazem) due to the risk of hypotension. Clarithromycin's plasma concentrations and calcium blockers have an increase in drug interaction. Observed hypotension, slow arrhythmia and lactic acid infection in patients using Clarithromycin and Verapamil.
iTraconazole
both Clarithromycin and Itraconazole are the substrates and CYP3A4 inhibitors, resulting in a two -way drug interaction. Clarithromycin may increase the plasma concentration of otraconazole, while iTraconazole may increase the plasma concentration of clarithromycin. Patients who are using Clarithromycin and Itraconazole should be closely monitored by these signs or symptoms due to this prolonged or prolonged pharmacological effect.
saquinavir
both Clarithromycin and Saquinavir are the substrate and inhibitors of CYP3A4, and there has been evidence of two -way interaction. Use a combination of clarithromycin (500 mg x 2 times/day) and Saquinavir (soft gelatin capsule, 1200 mg x 3 times/day) for 12 healthy volunteers to increase AUC in a stable state to 177% and CMAX to 187% compared to saquinavir. Clarithromycin's AUC and CMAX values are about 40% higher than using clarithromycin.
No need to adjust the dose when using these two drugs at the same time in a certain period of dose/form of research. Observations from studies on drug interactions using soft gelatin capsules may not be the same as when using hard gelatin capsules of Saquinavir. Observations from drug interactive studies performed with Saquinavir may not be the same as the effects visible when treated with Saquinavir/Ritonavir. When using Saquinavir and Ritonavir, it is recommended to note the hidden effect of ritonavir on clarithromycin.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
To be out of reach of children.
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