Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Neon Healthcare Limited, 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom
Amias is indicated for the:
The recommended initial dose and usual maintenance dose of Amias is 8 mg once daily. Most of the antihypertensive effect is attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 16 mg once daily and to a maximum of 32 mg once daily. Therapy should be adjusted according to blood pressure response.
Amias may also be administered with other antihypertensive agents – (see sections 4.3, 4.4, 4.5 and 5.1). Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Amias.
No initial dose adjustment is necessary in elderly patients.
An initial dose of 4 mg may be considered in patients at risk for hypotension, such as patients with possible volume depletion (see section 4.4).
The starting dose is 4 mg in patients with renal impairment, including patients on haemodialysis. The dose should be titrated according to response. There is limited experience in patients with very severe or end-stage renal impairment (Cl creatinine <15 ml/min) (see section 4.4).
An initial dose of 4 mg once daily is recommended in patients with mild to moderate hepatic impairment. The dose may be adjusted according to response. Amias is contraindicated in patients with severe hepatic impairment and/or cholestasis (see sections 4.3 and 5.2).
The antihypertensive effect of candesartan is less pronounced in black patients than in non-black patients. Consequently, uptitration of Amias and concomitant therapy may be more frequently needed for blood pressure control in black patients than in non-black patients (see section 5.1).
The recommended starting dose is 4 mg once daily.
For patients weighing <50 kg: In patients whose blood pressure is not adequately controlled, the dose can be increased to a maximum of 8 mg once daily.
For patients weighing ≥50 kg: In patients whose blood pressure is not adequately controlled, the dose can be increased to 8 mg once daily and then to 16 mg once daily if needed (see section 5.1).
Doses above 32 mg have not been studied in paediatric patients.
Most of the antihypertensive effect is attained within 4 weeks.
For children with possible intravascular volume depletion (e.g. patients treated with diuretics, particularly those with impaired renal function), Amias treatment should be initiated under close medical supervision and a lower starting dose than the general starting dose above should be considered (see section 4.4).
Amias has not been studied in children with glomerular filtration rate less than 30 ml/min/1.73m² (see section 4.4).
The antihypertensive effect of candesartan is less pronounced in black patients than in non-black patients (see section 5.1).
The safety and efficacy in children aged 1 to <6 years of age has not been established. Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Amias is contraindicated in children aged below 1 year (see section 4.3).
The usual recommended initial dose of Amias is 4 mg once daily. Up-titration to the target dose of 32 mg once daily (maximum dose) or the highest tolerated dose is done by doubling the dose at intervals of at least 2 weeks (see section 4.4). Evaluation of patients with heart failure should always comprise assessment of renal function including monitoring of serum creatinine and potassium. Amias can be administered with other heart failure treatment, including ACE inhibitors, beta-blockers, diuretics and digitalis or a combination of these medicinal products. Amias may be co-administered with an ACE-inhibitor in patients with symptomatic heart failure despite optimal standard heart failure therapy when mineralocorticoid receptor antagonists are not tolerated. The combination of an ACE inhibitor, a potassium-sparing diuretic (e.g. spironolactone) and Amias is not recommended and should be considered only after careful evaluation of the potential benefits and risks (see sections 4.4, 4.8 and 5.1).
No initial dose adjustment is necessary for elderly patients or in patients with intravascular volume depletion or renal impairment or mild to moderate hepatic impairment.
The safety and efficacy of Amias in children aged between birth and 18 years have not been established in the treatment of heart failure. No data are available.
Oral use.
Amias should be taken once daily with or without food. The bioavailability of candesartan is not affected by food.
Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness. In individual case reports of overdose (of up to 672 mg candesartan cilexetil) in an adult, patient recovery was uneventful.
If symptomatic hypotension should occur, symptomatic treatment should be instituted and vital signs monitored. The patient should be placed supine with the legs elevated. If this is not sufficient, plasma volume should be increased by infusion of, for example, isotonic saline solution. Sympathomimetic medicinal products may be administered if the above-mentioned measures are not sufficient.
Candesartan is not removed by haemodialysis.
3 years.
Do not store above 30°C.
Polypropylene blisters (7, 10 or 14 tablets/blister).
2 mg tablets: Blister packs of 7 and 14 tablets.
4 mg, 8 mg and 16 mg tablets: Blister packs of 7, 14, 20, 28, 50, 56, 98, 98x1 (single dose unit), 100 or 300 tablets.
32 mg tablets: Blister packs of 7, 10, 14, 20, 28, 50, 56, 98, 100 or 300 tablets. PVC/PVDC/Alu blister
4mg Tablets: Blister packs of 14, 28, 30, 56, 84, 90, 91, 98, 140 or 280 tablets.
8 mg Tablets: Blister packs of 14, 28, 30, 56, 84, 90, 91, 98, 140 or 280 tablets.
16 mg Tablets: Blister packs of 14, 28, 30, 56, 84, 90, 91, 98, 140 or 280 tablets.
32 mg Tablets: Blister packs of 7, 14, 20, 28, 30, 50, 56, 84, 90, 91, 98, 100, 140, 280 or 300 tablets.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
