Clarithid XL Extended Release Tablet 500 mg (Clarithromycin)

Adult dose

(Tablets) ○ Adults: The usual dose is 250mg (potency) of clarithromycin per dose, twice daily. For severe infections, administer 500mg (potency) per dose, twice daily. The usual treatment duration is 7～14 days. In patients with renal failure whose creatinine clearance is 30mL/min or less, the dose should be reduced by half. That is, administer 250mg (potency) once daily, or, for severe infections, 250mg (potency) per dose twice daily. Do not administer this medicine to these patients for more than 14 days. ○ Mycobacterial infections: Administer 500mg (potency) of this medicine per dose, twice daily. In this case, it should be administered in combination with other antimycobacterial agents such as ethambutol, clofazimine, and rifampin. ○ Eradication of Helicobacter pylori in patients with duodenal ulcers: Administer 500mg (potency) of this medicine 3 times daily for 14 days in combination with omeprazole 40mg once daily, followed by omeprazole 40mg once daily for 14 consecutive days. That is, administer clarithromycin 500mg (potency) per dose 3 times daily for 14 days (days 1～14), and administer omeprazole 40mg once daily for 28 days (days 1～28). (Extended-release tablets) The usual adult dose of clarithromycin is 1 tablet [500mg (potency)] once daily; for severe infections, take 2 tablets [1000mg (potency)] once daily with food (do not chew). The usual treatment duration is 7～14 days. ○ Patients with renal impairment whose creatinine clearance is less than 30mL/min: Administer clarithromycin 250mg once daily. Since extended-release tablets cannot be crushed or divided, use the tablet formulation in this case. For severe infections, take 1 tablet [500mg (potency)] once daily with food. No dose adjustment is necessary for patients with moderate renal impairment whose creatinine clearance is 30mL/min or more and less than 60mL/min.

Child dose

○ Pediatric patients aged 12 years and older (tablets): Same as adults. The usual dose is 250mg (potency) twice daily; for severe infections, administer 500mg (potency) twice daily. The usual treatment duration is 7～14 days. For mycobacterial infections, administer 500mg (potency) twice daily. For Helicobacter pylori eradication in patients with duodenal ulcers, administer 500mg (potency) three times daily for 14 days (days 1～14). ○ Pediatric patients under 12 years: Use clarithromycin dry syrup. ○ Pediatric patients aged 12 years and older (extended-release tablets): Same as adults. The usual dose is 1 tablet [500mg (potency)] once daily; for severe infections, take 2 tablets [1000mg (potency)] once daily with food (do not chew). The usual treatment duration is 7～14 days. ○ Pediatric patients aged 12 years and younger: Use clarithromycin dry syrup.

This medication should not be administered to patients with allergies to certain components. Patients who have had hypersensitivity reactions to clarithromycin or similar antibiotics should also avoid use. It may be dangerous to take it in conjunction with certain medications that can affect heart rhythm; therefore, patients taking such medications should inform their healthcare provider. It is advisable to avoid using this drug in patients with severe heart disease or severe liver dysfunction, pregnant or nursing women. Patients with reduced kidney function, the elderly, and those taking other specific medications should use this drug cautiously. This medication contains lactose and is not suitable for patients with lactose intolerance. While taking this drug, patients should be aware that allergic reactions or serious side effects may occur, and should inform their healthcare provider immediately if unusual symptoms arise. Particularly, if there are abnormalities in heart rhythm, liver function, severe skin rash, or difficulty in breathing, treatment should be stopped immediately and appropriate care should be obtained. This drug interacts with many other medications; thus, patients who are currently taking other medications must inform their healthcare provider and take it as directed. Pregnant or nursing women should not take this drug unless absolutely necessary and should consult a specialist beforehand. The tablet form may not be suitable for children; age-appropriate formulations should be used. Caution should be observed while driving or operating machinery during treatment, as dizziness or confusion may occur. In the case of overdose, gastrointestinal disturbances or neurological symptoms may occur, so prescribed dosages must be adhered to. This medication should be stored under appropriate conditions, kept in a tightly sealed container away from air and light, and stored at room temperature away from direct sunlight.

Shock, anaphylactic symptoms, respiratory distress, convulsions, erythema, rashes, itching, hives, skin erythema, angioedema, joint swelling, drug eruption, abdominal distension, nausea, vomiting, dyspepsia, abdominal pain, discomfort, flatulence, diarrhea, oral mucosal ulceration, upper abdominal pain, thirst, transient tooth discoloration, pancreatitis, increased amylase, dysgeusia, anorexia, constipation, stool discoloration, pseudomembranous colitis, hemorrhagic colitis, fever, cough, eosinophilia, eosinophilic lung infiltrates, interstitial pneumonia, chronic bronchitis, acute maxillary sinusitis, eosinophilia, thrombocytopenia, pancytopenia, hemolytic anemia, leukopenia, agranulocytosis, dizziness, depression, taste loss, smell loss, anxiety, insomnia, nightmares, tinnitus, confusion, disorientation, hallucinations, psychosis, depersonalization, convulsions, tremors, numbness, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic purpura, drug rash (DRESS), jaundice, hepatocellular hepatitis, cholestatic hepatitis, increased liver enzymes, liver dysfunction, liver failure, fulminant hepatitis, elevated AST, elevated ALT, elevated γ-GTP, elevated LDH, elevated ALP, increased total bilirubin, elevated serum creatinine, elevated BUN, interstitial nephritis, renal failure, rhabdomyolysis, glossitis, stomatitis, oral candidiasis, QT prolongation, ventricular tachycardia, Torsades de Pointes, malaise, headache, taste distortion, hearing loss, paresthesia, arthralgia, myalgia, olfactory disorder, tinnitus, auditory impairment, hypoglycemia, purpuric rash, acute generalized exanthematous pustulosis (AGEP), muscle cramps, musculoskeletal stiffness, myopathy, elevated serum creatinine, elevated blood urea, nephritis, injection site phlebitis, injection site pain, injection site inflammation, fever, weakness, chest pain, chills, fatigue, abnormal albumin-globulin ratio, elevated serum alkaline phosphatase, elevated serum lactate dehydrogenase, increased INR, prolonged prothrombin time, urine discoloration, vasodilation, cardiac arrest, atrial fibrillation, ectopic beats, palpitations, asthma, epistaxis, pulmonary embolism, esophagitis, gastroesophageal reflux disease, gastritis, rectal pain, belching, bloating

This medication should be stored in a tightly sealed container to protect it from air and light. It is recommended to store it at a room temperature between 1 to 30 degrees Celsius.

Appearance

Yellow oval extended-release tablet

Package unit

14 tablets/box [14 tablets (7 tablets/PTP x 2)]