Osaka, Japan – August 28, 2019 – Sawai Pharmaceutical Co., Ltd. (Head office: Osaka, Japan,
President: Mitsuo Sawai) today received approval of its partial change application by the Ministry of
Health, Labour and Welfare (MHLW) for CANDESARTAN Tablets 2 mg, 4 mg, 8 mg and 12 mg
[SAWAI], and CANDESARTAN OD Tablets 2 mg, 4 mg, 8 mg and 12 mg [SAWAI]*
.
This approval expands the indications of CANDESARTAN products to include the same uses as their
brand equivalents.
* Brand products: BLOPRESS® (Candesartan Cilexetil) Tablets 2 mg, 4 mg, 8 mg and 12 mg
“Indications and Usage” and “Dosage and Administration” approvals are described below (New approval is underlined);
Indications and Usage
Tablets 2 mg, 4 mg, 8 mg and 12 mg, and OD Tablets 2 mg, 4 mg, 8 mg and 12 mg
1.Hypertension
2.Renal parenchymal hypertension
Tablets 2 mg, 4 mg, and 8 mg, and OD Tablets 2 mg, 4 mg, and 8 mg
3.Chronic cardiac failure (mild to moderate) for which administration of angiotensin converting enzyme inhibitors is not appropriate
Dosage and Administration
Tablets 2 mg, 4 mg, 8 mg and 12 mg, and OD Tablets 2 mg, 4 mg, 8 mg and 12 mg
1.Hypertension
Adults
The usual adult dose for oral use is 4 to 8 mg of candesartan cilexetil once daily, increased to 12 mg
if necessary. The initial dose for patients with hypertension associated with renal impairment is 2 mg
once daily, increased to 8 mg if necessary.
Children
The usual dose for children ≧ 1 year and < 6 years of age is 0.05 to 0.3 mg/kg as candesartan
cilexetil orally administered once daily.
The usual dose for children ≧ 6 years of age is 2 to 8 mg as candesartan cilexetil orally administered
once daily, increased to 12 mg if necessary. Start with a low dose for patients with hypertension
associated with renal impairment and increase the dose to 8 mg if necessary.
2.Renal parenchymal hypertension
The usual initial adult dose for oral use is 2 mg of candesartan cilexetil once daily, increased to 8 mg if necessary
Tablets 2 mg, 4 mg, and 8 mg, and OD Tablets 2 mg, 4 mg, and 8 mg
3.Chronic cardiac failure (mild to moderate) for which administration of angiotensin converting enzyme inhibitors is not appropriate
The usual adult dose for oral use is 4 mg of candesartan cilexetil once daily, increased to 8 mg if necessary. In principle, background therapy other than angiotensin converting enzyme inhibitors should be continued.
The products announced in this press release are not approved by the Food & Drug Administration for sale and distribution in the United States.