Klabid 500mg

Tablet
Clarithromycin
Unimed Unihealth MFG. Ltd

Other Strength:
- Klabid 250mg
- Klabid ER 500mg

Alternative:
- Remac 500mg
- Claricin 500 500mg



Klabid
Presentation
Klabid 250 Tablet: Yellow, oval-shaped film coated tablet; each tablet contains Clarithromycin BP 250mg.
Klabid 500 Tablet: Yellow, oval-shaped film coated tablet; each tablet contains Clarithromycin BP 500mg.
Klabid 70ml Suspension: White mixed fruit-flavoured granules; each 5ml contains Clarithromycin BP 125mg.

Indications
Klabid 250 and 500 Tablets: Klabid 250mg & 500mg Tablets are indicated in adults and children 12 years and older. Clarithromycin is indicated for treatment of infections caused by susceptible organisms. Indications include: Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia. Upper respiratory tract infections for example, sinusitis and pharyngitis. Clarithromycin is appropriate for initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atypical respiratory pathogens as listed in the microbiology section. Clarithromycin is also indicated in skin and soft tissue infections of mild to moderate severity for example folliculitis, cellulitis and erysipelas. Clarithromycin in the presence of acid suppression effected by omeprazole or lansoprazole is also indicated for the eradication of H. pylori in patients with duodenal ulcers. Klabid 125mg/5ml granules for paediatric suspension: Clarithromycin Paediatric Suspension or Clarithromycin 125mg/5ml Granules for Oral Suspension is indicated in children 6 months to 12 years. Clarithromycin Paediatric Suspension or Clarithromycin 125mg/5ml Granules for Oral Suspension is indicated for the treatment of infections caused by susceptible organisms.
Indications include: Lower respiratory tract infections. Upper respiratory tract infections. Skin and skin structure infections. Acute otitis media.

Dosage and administration
Klabid 250 & 500 Tablets: Patients with respiratory tract/skin and soft tissue infections: Adults: The usual dose is 250mg twice daily although this may be increased to 500mg twice daily in severe infections. The usual duration of treatment is 6 to 14 days. Children older than 12 years: As for adults. Eradication of H. pylori in patients with duodenal ulcers: Adults: The usual duration of treatment is 6 to 14 days. 1. Triple Therapy: Clarithromycin (500mg) twice daily and lansoprazole 30mg twice daily should be given with amoxycillin 1000mg twice daily. 2. Triple Therapy: Clarithromycin (500mg) twice daily and lansoprazole 30mg twice daily should be given with metronidazole 400mg twice daily. 3. Triple Therapy: Clarithromycin (500mg) twice daily and omeprazole 40mg daily should be given with amoxycillin 1000mg twice daily or metronidazole 400mg twice daily. 4. Triple Therapy: Clarithromycin (500mg) twice daily should be given with amoxycillin 1000mg twice daily and omeprazole 20mg daily. 5. Dual Therapy: The usual dose of Clarithromycin is 500mg three times daily for 14 days. Clarithromycin should be administered with oral omeprazole 40mg once daily. The pivotal study was conducted with omeprazole 40mg once daily for 28 days. Supportive studies have been conducted with omeprazole 40mg once daily for 14 days. Clarithromycin may be given without regard to meals as food does not affect the extent of bioavailability.

In patients with renal impairment with creatinine clearance less than 30ml/min, the dosage of clarithromycin should be reduced by one-half, i.e. 250mg once daily, or 250mg twice daily in more severe infections. Treatment should not be continued beyond 14 days in these patients. Klabid 125mg/5ml granules for paediatric suspension: Children younger than 12 years: Use of Clarithromycin 250mg Tablets are not recommended for children younger than 12 years. Clinical trials have been conducted using clarithromycin paediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin paediatric suspension (granules for oral suspension). The usual duration of treatment is for 5 to 10 days depending on the pathogen involved and the severity of the condition. The recommended daily dosage of Clarithromycin Paediatric Suspension or Clarithromycin 125mg/5ml Granules for Oral Suspension in children is given in the following table and is based on a 7.5mg/kg b.i.d. dosing

Dosage Based on Body Weight (kg)
Weight*(kg) Approx Age (yrs) Dosage (ml)
bid Dosage per 5ml
teaspoonful twice daily
8-11 1-2 2.50 1/2
12-19 3-6 5.00 1
20-29 7-9 7.50 1 1/2
30-40 10-12 7.50 2
* Children < 8 kg should be dosed on a per kg basis (approx. 7.5 mg/kg bid)

Preparation for use:
70ml bottle: 45ml of water is to be added to the granules in the bottle and shaken to yield 70ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125mg per 5ml.

Contraindications, Special warnings and precautions for use:
Contraindications: Clarithromycin is contra-indicated in patients with known hypersensitivity to macrolide antibiotic drugs or to any of its excipients. Concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated, as this may result in ergot toxicity. Concomitant administration of clarithromycin and any of the following drugs is contraindicated: astemizole, cisapride, pimozide and terfenadine as this may result in QT prolongation and cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, and torsades de pointe.Clarithromycin should not be given to patients with history of QT prolongation or ventricular cardiac arrhythmia, including torsades de pointe. Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins), lovastatin or simvastatin, due to the risk of rhabdomyolysis. Treatment with these agents should be discontinued during clarithromycin treatment. Clarithromycin should not be given to patients with hypokalaemia (risk of prolongation of QT-time). Clarithromycin should not be used in patients who suffer from severe hepatic failure in combination with renal impairment. Special warnings and precautions: Caution is advised in patients with severe renal insufficiency. Clarithromycin is principally excreted by the liver. Therefore, caution should be exercised in administering this antibiotic to patients with impaired hepatic function. Caution should also be exercised when administering clarithromycin to patients with moderate to severe renal impairment. Cases of fatal hepatic failure have been reported. Some patients may have had preexisting hepatic disease or may have been taking other hepatotoxic medicinal products. Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop, such as anorexia, jaundice, dark urine, pruritus, or tender abdomen. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-threatening. Clostridium difficile – associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents including clarithromycin, and may range in severity from mild diarrhoea to fatal colitis. Drugs inhibiting peristalsis should be avoided. Exacerbation of symptoms of myasthenia gravis has been reported in patients receiving clarithromycin therapy. There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly,
some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients. If concomitant administration of colchicine and clarithromycin is necessary, patients should be monitored for clinical symptoms of colchicine toxicity. Caution is advised regarding concomitant administration of clarithromycin and triazolobenzodiazepines, such as triazolam, and midazolam. Caution is advised regarding concomitant administration of clarithromycin with other ototoxic drugs, especially with aminoglycosides. Monitoring of vestibular and auditory function should be carried out during and after treatment. Due to the risk

for QT prolongation, clarithromycin should be used with caution in patients with coronary artery disease, severe cardiac insufficiency, hypomagnesaemia, bradycardia (<50 bpm), or when coadministered with other medicinal products associated with QT prolongation. Clarithromycin must not be used in patients with congenital or documented acquired QT prolongation or history of ventricular arrhythmia. Pneumonia: In view of the emerging resistance of Streptococcus pneumoniae to macrolides, it is important that sensitivity testing be performed when prescribing clarithromycin for community-acquired pneumonia. In hospital-acquired pneumonia, clarithromycin should be used in combination with additional appropriate antibiotics. Skin and soft tissue infections of mild to moderate severity: These infections are most often caused by Staphylococcus aureus and Streptococcus pyogenes, both of which may be resistant to macrolides. Therefore, it is important that sensitivity testing be performed. In cases where betalactam
antibiotics cannot be used (e.g. allergy), other antibiotics, such as clindamycin, may be the drug of first choice. Currently, macrolides are only considered to play a role in some skin and soft tissue infections, such as those caused by Corynebacterium minutissimum (erythrasma), acne vulgaris, and erysipelas and in situations where penicillin treatment cannot be used. In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, clarithromycin therapy should be discontinued immediately and appropriate treatment should be urgently initiated. Clarithromycin should be used with caution when administered concurrently with medications that induce the cytochrome CYP3A4 enzyme. HMG-CoA reductase inhibitors: Concomitant use of clarithromycin with lovastatin or simvastatinis contraindicated . As with other macrolides, clarithromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors. Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly. Patients should be monitored for signs and symptoms of myopathy. Rare reports of rhabdomyolysis have also been reported in patients taking atorvastatin or rosuvastatin concomitantly with clarithromycin. When used with clarithromycin, atorvastatin or rosuvastatin should be administered in the lowest possible doses.
Adjustment of the statin dose or use of a statin that is not dependent on CYP3A metabolism (e.g. fluvastatin or pravastatin) should be considered. Oral hypoglycaemic agents/Insulin: The concomitant use of clarithromycin and oral hypoglycaemic agents and/or insulin can result in significant hypoglycaemia. With certain hypoglycaemic drugs such as nateglinide, pioglitazone, repaglinide and rosiglitazone, inhibition of CYP3A enzyme by clarithromycin may be involved and could cause hypolgycemia when used concomitantly. Careful monitoring of glucose is recommended. Oral anticoagulants: There is a risk of serious haemorrhage and significant elevations in International Normalized Ratio (INR) and prothrombin time when clarithromycin is co-administered with warfarin. INR and prothrombin times should be frequently monitored while patients are receiving clarithromycin and oral anticoagulants concurrently. Use of any antimicrobial therapy, such as clarithromycin, to treat H. pylori infection may select for drugresistant organisms. Long-term use may, as with other antibiotics, result in colonisation with increased numbers of non-susceptible bacteria and fungi. If superinfections occur, appropriate therapy should be instituted. Attention should also be paid to the possibility of cross resistance between clarithromycin and other macrolide drugs, as well as lincomycin and clindamycin.

Pregnancy & Lactation: Pregnancy: The safety of clarithromycin during pregnancy and breast feeding of infants has not been established. Based on variable results obtained from studies in mice, rats, rabbits and monkeys, the possibility of adverse effects on embryofoetal development cannot be excluded. Therefore, use during pregnancy is not advised without carefully weighing
the benefits against risk. Clarithromycin is excreted into human breast milk.

Side effects: The most frequent and common adverse reactions related to clarithromycin therapy for both adult and peadiatric populations are abdominal pain, diarrhoea, nausea, vomiting and taste perversion. These adverse reactions are usually mild in intensity and are consistent with the known safety profile of macrolide antibiotics. There was no significant difference in the incidence
of these gastrointestinal adverse reactions during clinical trials between the patient population with or without pre-existing mycobacterial infections.

Infections and infestations: Uncommon: Cellulitis, candidiasis, gastroenteritis, infection, vaginal infection. Blood and lymphatic system: Uncommon: Leukopenia, neutropenia , thrombocythaemia, eosinophilia. Immune system disorders: Uncommon: Anaphylactoid reaction, hypersensitivity. Metabolism and nutrition disorders: Uncommon: Anorexia, decreased appetite. Psychiatric disorders: Common: Insomnia, Uncommon: Anxiety, nervousness, screaming. Nervous system disorders: Common: Dysgeusia, headache, taste perversion, Uncommon: Loss of consciousness, dyskinesia, dizziness, somnolence, tremor. Ear and labyrinth disorders: Uncommon: Vertigo, hearing impaired, tinnitus. Cardiac disorders: Common: Vasodilation, Respiratory, thoracic and mediastinal disorder: Uncommon: Asthma, epistaxis, pulmonary embolism. Gastrointestinal disorders: Common: Diarrhoea, vomiting, dyspepsia, nausea, abdominal pain, Uncommon: Oesophagitis, gastrooesophageal reflux disease, gastritis, proctalgia, stomatitis, glossitis, abdominal distension, constipation, dry mouth, eructation, flatulence. Hepatobiliary disorders: Common: Liver function test abnormal, Uncommon: Cholestasis, hepatitis, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased. Skin and subcutaneous tissue disorders: Common: Rash, hyperhidrosis, Uncommon: Dermatitis bullous, pruritus, urticaria, rash maculo-papular. Musculoskeletal and connective tissue disorders: Uncommon: Muscle spasms, musculoskeletal stiffness, myalgia. Renal and urinary disorders: Uncommon: Blood creatinine increased, blood urea increased. Investigations: Uncommon: Albumin globulin ratio abnormal, blood alkaline phosphatase increased, blood lactate dehydrogenase increased.

Drug Interaction: Effects of Other Medicinal Products on Clarithromycin: Drugs that are inducers of CYP3A (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital, St John’s wort) may induce the metabolism of clarithromycin. This may result in sub-therapeutic levels of clarithromycin leading to reduced efficacy. Furthermore, it might be necessary to monitor the plasma levels of the CYP3A inducer, which could be increased owing to the inhibition of CYP3A by clarithromycin. Concomitant administration of rifabutin and clarithromycin resulted in an increase in rifabutin, and decrease in clarithromycin serum levels together with an increased risk of uveitis. The following drugs are known or suspected to affect circulating concentrations of clarithromycin; clarithromycin dosage adjustment or consideration of alternative treatments may be required. Efavirenz, nevirapine, rifampicin, rifabutin and rifapentin: Strong inducers of the cytochrome P450 metabolism system such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine may accelerate the metabolism of clarithromycin and thus lower the plasma levels of clarithromycin, while increasing those of 14-OH-clarithromycin, a metabolite that is also microbiologically active. Since the microbiological activities of clarithromycin and 14-OH-clarithromycin are different for different bacteria, the intended therapeutic effect could be impaired during concomitant administration of clarithromycin and enzyme inducers. Fluconazole: Concomitant administration of fluconazole 200 mg daily and clarithromycin 500 mg twice daily to 21 healthy volunteers led to increases in the mean steady-state minimum clarithromycin concentration (Cmin) and area under the curve (AUC) of 33% and 18% respectively. No clarithromycin dose adjustment is necessary. Ritonavir: A pharmacokinetic study demonstrated that the concomitant administration of ritonavir 200 mg every eight hours and clarithromycin 500 mg every 12 hours resulted in a marked inhibition of the metabolism of clarithromycin. The clarithromycin Cmax increased by 31%, Cmin increased 182% and AUC increased by 77% with concomitant administration of
ritonavir. Because of the large therapeutic window for clarithromycin, no dosage reduction should be necessary in patients with normal renal function. However, for patients with renal impairment, the following dosage adjustments should be considered: For patients with CLCR 30 to 60 mL/min the dose of clarithromycin should be reduced by 50%. For patients with CLCR <30 mL/min the dose of clarithromycin should be decreased by 75%. Doses of clarithromycin greater than 1 gm/day should not be co-administered with ritonavir. Similar dose adjustments should be considered in patients with reduced renal function when ritonavir is used as a pharmacokinetic enhancer with other HIV protease inhibitors including atazanavir and saquinavir. Sildenafil, tadalafil and vardenafil: Each of these phosphodiesterase inhibitors is metabolised, at least in part, by CYP3A, and CYP3A may be inhibited by concomitantly administered clarithromycin. Co-administration of clarithromycin with sildenafil, tadalafil or vardenafil would likely result in increased phosphodiesterase inhibitor exposure. Reduction of sildenafil, tadalafil and vardenafil dosages should be considered when these drugs are co-administered with clarithromycin. Theophylline, carbamazepine: Results of clinical studies indicate that there was a modest but statistically significant increase of circulating theophylline or carbamazepine levels when either of these drugs were administered concomitantly with clarithromycin. Tolterodine: A reduction in tolterodine dosage may be necessary in the presence of CYP3A inhibitors, such asclarithromycin in the CYP2D6 poor metaboliser population. Digoxin: Digoxin is thought to be a substrate for the efflux transporter, P-glycoprotein (Pgp). Clarithromycin is known to inhibit Pgp. When clarithromycin and digoxin are administered together, inhibition of Pgp by clarithromycin may lead to increased exposure to digoxin. Elevated digoxin serum concentrations in patients receiving clarithromycin and digoxin concomitantly have also been reported in post marketing surveillance. Some patients have shown clinical signs consistent with digoxin toxicity, including potentially fatal arrhythmias. Serum digoxin concentrations should be carefully monitored while patients are receiving digoxin and clarithromycin simultaneously. Zidovudine: Simultaneous oral administration of clarithromycin tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine concentrations.

Overdose: Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Pharmaceutical precautions
Store in a cool and dry place, protected from light.

Packaging quantities
Klabid 250 Tablet: Each box contains 14 tablets in Alu-PVDC blister.
Klabid 500 Tablet: Each box contains 14 tablets in Alu-PVDC blister.
Klabid 70ml Suspension: Bottles containing granules to produce 70ml Suspension when reconstituted.


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