Exforge HCT

Exforge HCT Adverse Reactions




Full Prescribing Info
Adverse Reactions
The presentation of the safety profile of Exforge HCT is based on the experience with Exforge HCT and the individual components.
Information on Exforge HCT: The safety of Exforge HCT has been evaluated at its maximum dose of 10/320/25 mg for safety in one controlled clinical study with 2271 patients, 582 of whom received valsartan in combination with amlodipine and HCTZ. There were no new adverse reactions which occurred specifically with Exforge HCT in addition to those known to be associated with the individual monotherapies. No additional risks other than those previously identified were observed with long-term treatment. Exforge HCT was generally well-tolerated regardless of gender, age, or race. Changes in laboratory parameters observed with the combination of Exforge HCT were minor and consistent with the pharmacologic mechanism of action of the monotherapy agents. The presence of valsartan in both the triple combination and the dual combination with HCTZ attenuated the hypokalemic effect of HCTZ.
Additional information on individual components: Adverse reactions previously reported with one of the individual components may occur with Exforge HCT even if not observed in the pivotal clinical trial.
Amlodipine: Because amlodipine clinical trials were conducted under widely varying conditions, adverse experience rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse experiences reported with amlodipine monotherapy, irrespective of their causal association with the study drug, were as follows: (see Table 1).

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Valsartan: Adverse Drug Reactions (ADRs) reported in the hypertension indication from clinical studies, post-marketing experience and laboratory findings are listed as follows according to system organ class.
For all the ADRs reported from post-marketing experience and laboratory findings, it is not possible to apply any ADR frequency and therefore they are mentioned with a "not known" frequency. (See Table 2.)

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The following events have also been observed during clinical trials in hypertensive patients irrespective of their causal association with the study drug: Insomnia, libido decrease, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral infections.
Hydrochlorothiazide: Hydrochlorothiazide has been extensively prescribed for many years, frequently in higher doses than those contained in Exforge HCT. The following additional adverse reactions have been reported in patients treated with thiazide diuretics alone, including hydrochlorothiazide: (see Table 3).

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Description of selected adverse reactions: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed.
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