Duowell Dosage/Direction for Use

This drug is administered only to adults, and the dose should be individualized to each patient based on the effectiveness and tolerability of telmisartan/rosuvastatin.
This drug can be taken once daily in the regular time (e.g. morning) if possible.
The fixed-dose combination is not suitable for initial therapy.
If the patient is taking both telmisartan and rosuvastatin, switch to this combination product having the same content of each active ingredient for convenience.
If a dosage adjustment is necessary, titration should be done with the individual components.
Patients with essential hypertension: Adults: The usually effective dose is telmisartan 40 mg once daily. Some patients may already benefit at a daily dose of telmisartan 20 mg. In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination with thiazide type diuretics such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan. When considering raising the dose of telmisartan, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment.
Patients with cardiovascular disease: Adults: The recommended dose is telmisartan 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity. When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.
Patients with hepatic impairment: This drug should be used with caution in patients with moderate hepatic impairment, and the posology should not exceed telmisartan 40 mg once daily.
Patients with hyperlipidemia and hypercholesterolemia: Applies to patients with primary hypercholesterolemia (Type IIa including heterozygous familial hypercholesterolemia) and combined hyperlipidemia (Type IIb), primary dysbetalipoproteinemia (Type III) and homozygous familiar hypercholesterolemia.
Prior to and during administration of rosuvastatin, patients should have a standard low-cholesterol diet and it must be maintained during the period of treatment. The initial dose is rosuvastatin 5 mg once a day, and if further reduction of LDL-cholesterol level is required, it can be adjusted to the maintenance dose and administered. The maintenance dose is rosuvastatin 10 mg once a day, and almost all patients are controlled in this dose. The maintenance dose should be adjusted properly according to LDL-cholesterol level, treatment target and patient's response with an interval of 4 weeks or longer, and can be increased to the maximum of rosuvastatin 20 mg a day.
Patients with renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Rosuvastatin is contraindicated in patients with severe renal impairment. The use of rosuvastatin 20 mg for the patients with moderate renal impairment should be carefully considered.
Patients with hepatic impairment: There was no increase in systemic exposure to rosuvastatin in subjects with Child-Pugh scores of 7 or below. However, increased systemic exposure has been observed in subjects with Child-Pugh scores of 8 and 9. In these patients an assessment of renal function should be considered. There is no experience in subjects with Child-Pugh scores above 9. Rosuvastatin is contraindicated in patients with active liver disease.
Patients with pre-disposing factors to myopathy: The recommended start dose is rosuvastatin 5 mg in patients with predisposing factors to myopathy. The rosuvastatin 40 mg dose is contraindicated in patients with pre-disposing factors for myopathy.
Use in patients of Asian ancestry: Increased systemic exposure of rosuvastatin has been seen in Asian subjects. The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry. The dose of rosuvastatin 40 mg is contraindicated.
Use in the elderly: Excessive hypotension is generally not desirable for the elderly (cerebral infarction may occur). When administered to the elderly, this medicine should be administered with caution while observing the patient's condition.
Others: As a result of the pharmacokinetic drug-drug interaction study between telmisartan 80 mg and rosuvastatin 20 mg, Cmax and AUC of telmisartan in the effect of rosuvastatin increased 1.35-fold and 1.17-fold, respectively, and Cmax and AUC of rosuvastatin in the effect of telmisartan increased 2-fold and 1.18-fold, respectively. Therefore, when this drug is administered, the potential risk caused by increased Cmax of rosuvastatin should be evaluated, and patient should be carefully monitored.
Route of Administration: For oral administration only.