ile of the individual components amlodipine, valsartan and hydrochlorothiazide.
Information on Exforge HCT
The safety of Exforge HCT has been eva luated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide. Adverse reactions were generally mild and transient in nature and only infrequently required discontinuation of therapy. In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Exforge HCT were dizziness and hypotension (0.7%).
In the 8-week controlled clinical study, no significant new or unexpected adverse reactions were observed with triple therapy treatment compared to the known effects of the monotherapy or dual therapy components.
In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Exforge HCT were minor and consistent with the pharmacological mechanism of action of the monotherapy agents. The presence of valsartan in the triple combination attenuated the hypokalaemic effect of hydrochlorothiazide.
The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Exforge HCT (amlodipine/valsartan/HCT) and amlodipine, valsartan and HCT individually.
Very common: 1/10; common: 1/100 to <1/10; uncommon: 1/1,000 to <1/100; rare: 1/10,000 to <1/1,000; very rare: <1/10,000, not known (cannot be estimated from the available data).
MedDRA System Organ Class
Adverse reactions
Frequency
Exforge HCT
Amlodipine
Valsartan
HCT
Blood and lymphatic system disorders
Agranulocytosis, bone marrow depression
--
--
Very rare
Decrease in haemoglobin and in haematocrit
--
--
Not known
--
Haemolytic anaemia
--
--
--
Very rare
Leukopenia
--
Very rare
--
Very rare
Neutropenia
--
--
Not known
--
Thrombocytopenia
--
Very rare
Not known
Rare
Immune system disorders
Hypersensitivity
--
Very rare
Not known
Very rare
Metabolism and nutrition disorders
Anorexia
Uncommon
--
--
--
Hypercalcaemia
Uncommon
--
--
Rare
Hyperglycaemia
--
Very rare
--
Rare
Hyperlipidaemia
Uncommon
--
--
--
Hyperuricaemia
Uncommon
--
--
Uncommon
Hypochloraemic alkalosis
--
--
--
Very rare
Hypokalaemia
Common
--
--
Common
Hypomagnesaemia
--
--
--
Uncommon
Hyponatraemia
Uncommon
--
--
Uncommon
Psychiatric disorders
Depression
--
--
--
Rare
Insomnia/sleep disturbances
Uncommon
Uncommon
--
Rare
Mood swings
--
Uncommon
--
Nervous system disorders
Coordination abnormal
Uncommon
--
--
--
Dizziness
Common
Common
& |
