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Exforge HCT
Angiotensin II antagonists combinations plain (valsartan) with
dihydropyridine derivatives (amlodipine) and thiazide diuretics (HCTZ)
COMPOSITION AND PHARMACEUTICAL
FORM
Active substances:
Amlodipine besylate:
3-Ethyl-5-methyl(±)-2-[(2-minoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate,mono-benzenesulphonate.
Valsartan: (S)-N-valeryl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-valine.
Hydrochlorothiazide:
6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide.
Five strengths are available. One
tablet of Exforge HCT contains:
- 5 mg of amlodipine ( equivalent
to 6.94 mg amlodipine besylate), 160 mg of valsartan and 12.5 mg
hydrochlorothiazide
- 10 mg of amlodipine (
equivalent to 13.87 mg amlodipine besylate), 160 mg of valsartan and 12.5 mg
hydrochlorothiazide
- 5 mg of amlodipine ( equivalent
to 6.94 mg amlodipine besylate), 160 mg of valsartan and 25 mg
hydrochlorothiazide
- 10 mg of amlodipine (
equivalent to 13.87 mg amlodipine besylate), 160 mg of valsartan and 25 mg
hydrochlorothiazide
- 10 mg of amlodipine (
equivalent to 13.87 mg amlodipine besylate), 320 mg of valsartan and 25 mg
hydrochlorothiazide
For a full list of excipients,
see section EXCIPIENTS.
Certain dosage strengths and
dosage forms may not be available in all countries.
Exforge HCT 5/160/12.5mg: White,
biconvex, ovaloid film-coated tablet with bevelled edge, debossed with "NVR"
on one side and "VCL on the other side.
Exforge HCT 10/160/12.5mg: Pale
yellow, biconvex, ovaloid film-coated tablet with bevelled edge, debossed
with "NVR" on one side and "VDL on the other side.
Exforge HCT 5/160/25mg: Yellow,
biconvex, ovaloid film-coated tablet with bevelled edge, debossed with "NVR"
on one side and "VEL on the other side.
Exforge HCT 10/160/25mg:
Brown-yellow, biconvex, ovaloid film-coated tablet with bevelled edge,
debossed with "NVR" on one side and "VHL on the other side.
Exforge HCT 10/320/25mg:
Brown-yellow, biconvex, ovaloid film-coated tablet with bevelled edge,
debossed with "NVR" on one side and "VFL on the other side.
INDICATIONS
Treatment of essential
hypertension.
This fixed combination drug is
not indicated for the initial therapy of hypertension ( See section DOSAGE
AND ADMINISTRATION ).
DOSAGE AND ADMINISTRATION
The recommended dose is one
tablet per day ( the 5 strengths are listed in section COMPOSITION AND
PHARMACEUTICAL FORM ).
A patient whose blood pressure is
not adequately controlled on dual therapy may be directly switched to
combination therapy with Exforge HCT.
For convenience, patients
receiving valsartan, amlodipine and HCTZ from separate tablets may be
switched to Exforge HCT containing the same component doses. A patient who
experiences dose limiting adverse reactions on any dual combination of the
components of Exforge HCT may be switched to Exforge HCT containing a lower
dose of that component to achieve similar blood pressure reductions.
Dosage may be increased after two
weeks. The maximum antihypertensive effect of Exforge HCT is reached within
two weeks after a change in dose. The maximum recommended dose of Exforge
HCT is 10/320/25mg.
Exforge HCT can be taken with or
without food. It is recommended to take Exforge HCT with some water.
In Elderly
No adjustment of the initial dose
is required for elderly patients ( See section PHARMACOKINETICS ).
Children and adolescents (
below 18 years )
Exforge HCT is not recommended
for use in patients aged below 18 years due to a lack of data on safety and
eficacy.
Renal and hepatic impairment
No dosage adjustment is required
for patients with mild to moderate renal impariment but caution should be
exercised when administering Exforge HCT to patients with hepatic impairment
or biliary obstructive disoders ( see section SPECIAL WARNINGS AND
PRECAUTIONS FOR USE ). Due to the hydrochlorothiazide component, Exforge HCT
is not recommended in patients with severe renal impairment ( creatinine
clearance < 30 mL/min ) and in patients with severe hepatic impariment (
See
section CONTRAINDICATIONS and section PHARMACOKINETICS ).
CONTRAINDICATIONS
Hypersensitivity to amlodipine,
valsartan, HCTZ, other sulfonamides or to any of the excipients.
Exforge HCT is contraindicated in
pregnancy ( see section PREGNANCY AND LACTATION ). Because of
hydrochlorothiazide, Exforge HCT is contraindicated in patients with severe
hepatic impairment, severe renal impairment ( creatinine clearance < 30 mL/min
), anuria, refractory hypokalaemia, hyponatraemia, hypercalcaemia, and
symptomatic hyperuricaemia.
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