Rolacin 500 Tablet
Clarithromycin
500mg
Beximco Pharmaceuticals Ltd.
| Pack size | |
|---|---|
| Unite Price | 40.00 BDT |
Indications
Rolacin 500 Tablet is used for:
Respiratory tract infections, Skin and soft tissue infections, Leprosy, peptic ulcer disease, pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia, legionellosis, Helicobacter pylori, lyme disease, Community-Acquired Pneumonia.
Adult Dose
Oral
Acute Exacerbation of Chronic Bronchitis
250-500 mg PO q12hr for 7-14 days
Extended release: 1000 mg PO once daily for 7 days
Mycobacterial Infection
Prophylaxis and treatment
500 mg PO q12hr for 7-14 days
Use with antimycobacterial drugs such as rifampin and ethambutol
Peptic Ulcer Disease
500 mg PO q8-12hr for 10-14 days
Administer as part of 2- or 3-drug combination regimen with bismuth subsalicylate, amoxicillin, H2 receptor antagonist, or proton pump inhibitor
Pharyngitis, Tonsillitis
250 mg PO q12hr for 10 days
Community-Acquired Pneumonia, Skin/Skin Structure Infection
250 mg PO q12hr for 7-14 days
Extended release: 1000 mg PO once daily for 7 days
Endocarditis
Prophylaxis
500 mg PO 30-60 minutes before surgical procedure
Intravenous
Respiratory tract infections; Skin and soft tissue infections ; Susceptible infections
Adult: 500 mg bid for 2-5 days. Infuse over 60 min using a 0.2% soln. Revert to oral therapy whenever possible.
Child Dose
Child: PO 15 mg/kg/day, max 1 g/day q12h
Renal Dose
Renal impairment:
CrCl (ml/min)
<30 Half the dosage or double dosing interval.
Administration
Standard release tab & oral susp: May be taken with or without food.
XL & MR tab: Should be taken with food. Swallow whole, do not chew/crush.
Contra Indications
Hypersensitivity. Patients receiving terfenadine, astemizole, pimozide, cisapride and ergot derivatives. Pregnancy; history of acute porphyria.
Precautions
Renal and hepatic impairment; macrolide cross-resistance; lactation, children.
Lactation: Drug is excreted in breast milk; use with caution
Pregnancy-Lactation
Pregnancy Category: B
Lactation: enters breast milk/not recommended
Interactions
Reduced efficacy w/ CYP3A inducers (e.g. phenytoin, carbamazepine). Strong inducers of CYP450 system (e.g. efavirenz, rifampicin) may accelerate metabolism, thus lower plasma levels of clarithromycin. Inhibition of metabolism w/ ritonavir. Torsades de pointes may result from concomitant quinidine or disopyramide. Increased phosphodiesterase inhibitor exposure w/ sildenafil, tadalafil or vardenafil. Increased risk of digoxin toxicity. Decreased concentration of zidovudine.
Concomitant use w/ atazanavir, itraconazole or saquinavir may result to bi-directional drug interactions. Hypotension, bradyarrhythmias, and lactic acidosis may result when taken w/ verapamil. Increased risk of myopathy, including rhabdomyolysis w/ HMG-CoA reductase inhibitors. Increased risk of hypoglycaemia w/ oral hypoglycaemic drugs (e.g. pioglitazone) and insulin. Risk of serious haemorrhage and elevation of INR and prothrombin time w/ oral anticoagulants. Increased ototoxicity w/ aminoglycosides. Increased and prolonged sedation w/ triabenzodiazepines (e.g. midazolam).
Potentially Fatal: Concurrent use w/ ergot alkaloids (e.g. ergotamine or dihydroergotamine) is associated w/ acute ergot toxicity characterised by vasospasm and ischaemia of the extremities. Concomitant use w/ astemizole, cisapride, pimozide and terfenadine may result in QT prolongation or ventricular cardiac arrhythmia.
Side Effects
Side effects of Clarithromycin :
>10%
Gastrointestinal (GI) effects, general (13%)
1-10%
Abnormal taste (adults, 3-7%), Diarrhea (3-6%), Nausea (adults, 3-6%), Vomiting (adults, 1%; children, 6%), Elevated blood urea nitrogen (BUN; 4%), Abdominal pain (adults, 2%; children, 3%), Rash (children, 3%), Dyspepsia (2%), Heartburn (adults, 2%), Headache (2%), Elevated prothrombin time (PT; 1%)
<1%
Anaphylaxis, Anorexia, Anxiety, Clostridium difficile colitis, Dizziness, Dyspnea, Elevated liver function tests, Glossitis, Hallucinations, Hepatic dysfunction, Hepatitis, Hypoglycemia, Increased alkaline phosphatase, Increased aspartate aminotransferase, Increased bilirubin, Increased serum creatinine, Jaundice, Leukopenia, Manic behavior, Neuromuscular blockade, Neutropenia, Pancreatitis, Psychosis, QT prolongation, Seizures, Stevens-Johnson syndrome, Thrombocytopenia
Potentially Fatal: Pseudomembranous colitis, anaphylaxis, Stevens-Johnson syndrome.
Mode of Action
Clarithromycin inhibits protein synthesis by binding to 50s ribosomal subunits of susceptible organisms. It has activity against susceptible streptococci and staphylococci as well as other species including B. catarrhalis, L. spp, C. trachomatis and U. urealyticum.
Note
Rolacin 500 500mg Tablet generic name is Clarithromycin. Rolacin 500 500mg Tablet is manufactured by Beximco Pharmaceuticals Ltd.Rolacin 500 is availble in all over Bangladesh.
Mes BD drug index information on Rolacin 500 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.