ATEDIO combination tablet
Cilnidipine 10 mg/Valsartan 80 mg
DESCRIPTION
ATEDIO combination tablets is a pale-yellow elliptic film-coated tablet formulation containing per tablet 80 mg of valsartan and 10 mg of cilnidipine.
COMPOSITION
ATEDIO combination tablets contain magnesium aluminometasilicate, microcrystalline cellulose, lactose hydrate, macrogol 400, croscarmellose sodium, hydroxypropyl cellulose, hypromellose phthalate ester, hydrous silicon dioxide, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide, yellow iron sesquioxide, and carnauba wax as additives.
INDICATIONS
Hypertension
DOSAGE AND ADMINISTRATION
Dosage The adult dose of ATEDIO combination tablet is one tablet once daily (80 mg as valsartan and 10 mg as cilnidipine) administered orally after breakfast. Do not use ATEDIO combination tablet as the first-line drug for hypertensive therapy.
ADVERSE REACTIONS
Japanese clinical studies that had been conducted by date of approval reported adverse reactions, including laboratory abnormalities in 55 of 459 patients (120%). The main adverse reactions were hyperuricemia in 6 patients (1.3%) and increased ALT (GPT) in 5 patients (1.1%). Clinically significant adverse reaction such as angioedema, hepatitis, hepatic dysfunction, jaundice, renal failure, hyperkalemia, shock, syncope, loss of consciousness, agranulocytosis, decreased white blood cells, decreased platelets, interstitial pneumonia, hypoglycemia, rhabdomyolysis, toxic epidermal necrolysis (TEN), oculomucocutaneous syndrome (Stevens-Johnson syndrome), erythema multiforme, pemphigus, pemphigoid were frequently unknown. Other adverse reactions were if any of the following adverse reactions occur, appropriate measures should be taken depending on the symptoms: abnormal hepatic function, increased ALT (GPT), increased AST (GOT), hyperuricemia, headache, facial flushing (hot flashes), constipation, increased blood potassium, hyperlipidemia (increased blood cholesterol, increased triglycerides).
CONTRAINDICATIONS
Do not administer ATEDIO combination tablet to the following patients: 1. Patients with a history of hypersensitivity to any of the ingredients of ATEDIO combination tablet. 2. Pregnant women or women having possibilities of being pregnant (see the section “Use During Pregnancy, Delivery, or lactation”). 3. Patients with diabetes mellitus who are receiving aliskiren (except patients with extremely poor blood pressure control with other hypotensive therapies) (An increase in the risks of nonfatal stroke, renal dysfunction, hyperkalemia, and hypotension has been reported).
PRECAUTIONS
(Precautions related to Indications) Do not use ATEDIO combination tablet as the first-line drug because it may cause an excessive decrease in blood pressure. (Precautions related to Dosage and Administration) 1. The use of ATEDIO combination tablet should be considered patient by patient on the basis of the following dosages and administrations of valsartan and cilnidipine: Valsartan: The usual adult dose is 40 to 80 mg as valsartan administered orally once daily. The dose should be adjusted appropriately depending on age and symptoms and may be increased up to 160 mg daily. Cilnidipine: Usually, for adults, 5 to 10 mg is administered as cilnidipine for orally once a day after breakfast. The dosage may be adjusted according to the patient’s age and symptoms. The dose can be increased up to 20 mg once a day, if a sufficient response does not appear. For adults with severe hypertension, ATELEC tablet should be administered 10 to 20 mg once a day for oral use after breakfast. 2. In principle, consider switching to ATEDIO combination tablet in cases in which the patient has a combination of valsartan 80 mg and cilnidipine 10 mg or blood pressure control is inadequate with either of these drugs.
Use during Pregnancy, Delivery, or Lactation (1) ATEDIO combination tablet should not be administered to pregnant women or women having possibilities of being pregnant. Discontinue administration immediately if the patient is found to be pregnant during treatment. (It has been reported that angiotensin II receptor antagonists and angiotensin converting enzyme inhibitors including valsartan caused fetal and neonatal death, oligohydramnios, fetal and neonatal hypotension, renal failure, hyperkalemia, cranial aplasia, extremity contracture presumed to be due to oligohydramnios, brain and craniofacial malformation, and hypoplasia and aplasia of the lungs in patients who received those drugs during the second to third trimester pregnancy. In addition, a retrospective epidemiological study of angiotensin converting enzyme inhibitors conducted overseas has reported that the relative risk of fetal malformation was higher in the patient group that received angiotensin converting enzyme inhibitors during the first trimester than in the patient group that received no antihypertensive drug. In addition, it has been reported that cilnidipine prolongs the gestation period and delivery time in animal experiments in rats. (2). It is advisable to avoid the administration of ATEDIO combination tablet to nursing mothers.
OVERDOSES AND TREATMENT
1. Signs and Symptoms: No information is available about an overdose of ATEDIO combination tablet. The overdose of valsartan, a component of ATEDIO combination tablet, may cause a marked decrease in blood pressure, leading to a depressed level of consciousness and circulatory collapse.
2. Treatments The following treatments should generally be taken: (1) Forced emesis and administration of activated charcoal (2) In the case of marked hypotension, immediately take appropriate measures, such as intravenous injection of physiological saline with the patient in the supine position. Note: Valsartan cannot be removed by hemodialysis because 93% or more of valsartan is bound to plasma protein.
PACKAGING
Box of 10 blisters x 10 tablets
STORAGE
Store below 30°C
SHELF-LIFE
36 months from manufacturing date.