Telmisartan/Amlodipine Plus Tablets 40/5/10 Milligrams

Adult dose

Take 1 tablet once daily with or without food. It is recommended to take it at the same time each day (e.g., in the morning). The dosage of telmisartan/amlodipine combination should be individualized based on blood pressure control status. - 40/5 milligrams: Administer to patients whose blood pressure is not adequately controlled with 5 milligrams of amlodipine or 40 milligrams of telmisartan. - 80/5 milligrams: Administer to patients whose blood pressure is not adequately controlled with 5 milligrams of amlodipine or this drug 40/5 milligrams. - 40/10 milligrams: Administer to patients whose blood pressure is not adequately controlled with 10 milligrams of amlodipine. - 80/10 milligrams: Administer to patients whose blood pressure is not adequately controlled with 10 milligrams of amlodipine or this drug 40/10 milligrams. ◦ For patients with renal impairment: No dosage adjustment is needed for mild to moderate renal impairment; however, for severe renal impairment, it is recommended to start with a lower dose and titrate gradually. Routine monitoring of serum potassium and creatinine levels is recommended. ◦ For patients with liver impairment: The daily dosage of telmisartan for patients with mild to moderate liver impairment should not exceed 40 milligrams. ◦ For the elderly: In patients aged 75 years and older, as the clearance of amlodipine is reduced, treatment should be started at a lower dose and titrated gradually. ○ Rosuvastatin 1. Primary hypercholesterolemia (including heterozygous familial hypercholesterolemia type IIa), mixed dyslipidemia (type IIb), primary dysbetalipoproteinemia (type III), and homozygous familial hypercholesterolemia: Patients taking rosuvastatin should maintain a standard cholesterol-lowering diet before and during treatment. Rosuvastatin can be administered at any time during the day, with no dietary restrictions. The initial dose is 5 milligrams once daily, and if greater LDL cholesterol reduction is needed, it can be adjusted to a maintenance dose. A maintenance dose of 10 milligrams once daily is appropriate for most patients at this dosage. The maintenance dose should be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with an upper limit of 20 milligrams per day. 2. For the elderly: Dosage adjustment is not required. 3. For patients with renal failure: There is no need for dosage adjustment in patients with mild to moderate renal failure. It should not be administered to patients with severe renal failure. Caution is advised when administering rosuvastatin 20 mg to patients with moderate renal failure. 4. For patients with liver failure: Those with a Child-Pugh score of 7 or less did not show increased systemic exposure to rosuvastatin, but patient with a Child-Pugh score of 8 or 9 did. Renal function tests should be considered for these patients. There is no experience in administering to patients with a Child-Pugh score over 9. Rosuvastatin should not be given to patients with active liver disease. 5. Regarding race: Asian patients may have increased systemic exposure to rosuvastatin; hence, the recommended initial dose is 5 milligrams. A dose of 40 milligrams is contraindicated. 6. For patients prone to myopathy: The recommended initial dose for patients prone to myopathy is 5 milligrams. For some of these patients, a dose of 40 milligrams of rosuvastatin is contraindicated. The drug interaction study of the active ingredients telmisartan/amlodipine 80/10 mg and rosuvastatin 20 mg showed that in the presence of telmisartan/amlodipine, the Cmax of rosuvastatin increased approximately 2.1 times, and AUC increased approximately 1.2 times. Therefore, the potential risks due to the increase in Cmax of rosuvastatin should be evaluated, and patients should be closely monitored.

This drug may cause serious harm to the fetus and newborn during pregnancy; therefore, if pregnancy is confirmed, use should be discontinued immediately. This drug should not be used if there is an allergy to its ingredients or similar drugs. It is safer not to administer this drug to patients with severely impaired liver or kidney function, certain heart diseases, or certain muscular disorders. Special caution should be exercised when using this drug in elderly patients, patients with very low blood pressure, or those with high serum potassium levels. If symptoms such as muscle pain, muscle weakness, or related symptoms occur, consult a doctor immediately, and if necessary, serum muscle enzyme levels should be checked, and the medication may need to be discontinued if abnormalities are found. This drug may affect liver function; therefore, regular liver function tests should be carried out before and during treatment. Since drug interactions may occur when taken with other medications, it is crucial to inform the doctor or pharmacist if other medications are being taken. This drug is generally not used during breastfeeding; if it must be taken, breastfeeding should be stopped. Safety and efficacy in children have not been sufficiently verified, so its use is not recommended. In case of overdose, symptoms may include hypotension, dizziness, and arrhythmia; necessary medical attention should be sought immediately.

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, anaphylactic reaction, thrombocytopenia, atrial fibrillation, congestive heart failure, myocardial infarction, acute renal failure, jaundice, severe adverse skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms), acute severe conditions (sepsis, hypotension, major surgeries, wounds, severe metabolic/endocrine/electrolyte disturbances)

Mild side effects

• Dyspepsia
• dizziness
• frequent bowel movements
• diabetes
• dry vesicular sounds
• urticaria
• nail fungus
• lumbar spinal stenosis
• ear wax
• vertigo

This drug is sensitive to light and should be stored in a light-resistant container. It is recommended to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness for a longer period.

Appearance

Oval-shaped bilayer tablet consisting of a white layer and a light blue layer

Package unit

30 tablets/box [10 tablets/PTP*3]