Amlodipine Besilate + Valsartan
Indications
Amlodipine and Valsartan combination is
indicated for the treatment of hypertension. This fixed combination drug
is not indicated for the initial therapy of hypertension.
Pharmacology
Amlodipine is a dihydropyridine calcium
channel blocker that inhibits the transmembrane influx of calcium ions
into vascular smooth muscle and cardiac muscle. Valsartan blocks the
vasoconstrictor and aldosterone-secreting effects of Angiotensin II by
selectively blocking the binding of Angiotensin II to the AT1 receptor
in many tissues, such as vascular smooth muscle and the adrenal gland.
Its action is therefore independent of the pathways for Angiotensin II
synthesis. Amlodipine and Valsartan have been shown to be effective in
lowering blood pressure. Both Amlodipine and Valsartan lower blood
pressure by reducing peripheral resistance, but calcium influx blockade
and reduction of Angiotensin II vasoconstriction are complementary
mechanisms.
Dosage & Administration
Treatment of hypertension:
Amlodipine is an effective treatment of hypertension in once daily
doses of 2.5 mg - 10 mg while Valsartan is effective in doses of 80
mg-320 mg. In clinical trials with Amlodipine and Valsartan, using
amlodipine doses of 5 mg-10 mg and Valsartan doses of 160 mg-320 mg, the
antihypertensive effects increased with increasing doses. The majority
of the antihypertensive effect is attained within 2 weeks after
initiation of therapy or a change in dose. The dosage can be increased
after 1 to 2 weeks of therapy to a maximum of 10/320 mg once daily as
needed to control blood pressure. This combination may be administered
with or without food. This combination may be administered with other
antihypertensive agents. A patient whose blood pressure is not
adequately controlled with Amlodipine alone or with Valsartan alone may
be switched to this combination therapy.
Elderly patients: Because of decreased clearance of Amlodipine, therapy should usually be initiated at 2.5 mg.
Renal Impairment: No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.
Hepatic Impairment: No initial dosage adjustment is required for patients with mild or moderate liver insufficiency. Titrate slowly in patients with hepatic impairment.
Elderly patients: Because of decreased clearance of Amlodipine, therapy should usually be initiated at 2.5 mg.
Renal Impairment: No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.
Hepatic Impairment: No initial dosage adjustment is required for patients with mild or moderate liver insufficiency. Titrate slowly in patients with hepatic impairment.
Interaction
No drug interaction studies have been
conducted with Amlodipine and Valsartan combination, although studies
have been conducted with the individual components.
Contraindications
This combination product is contraindicated in patients who are hypersensitive to any components of this product.
Side Effects
Generally been mild and transient in
nature. The most common side effects include peripheral edema, nasal
congestion, sore throat and discomfort when swallowing, upper
respiratory tract infection, dizziness etc.
Pregnancy & Lactation
Pregnancy Category D. It is not known
whether Amlodipine or Valsartan is excreted in human milk. Because of
the potential for adverse effects on the nursing infant, a decision
should be made whether to discontinue nursing or discontinue the drug,
taking into account the importance of the drug to the mother.
Precautions & Warnings
Avoid fetal or neonatal exposure, assess
for hypotension, warn patients with severe obstructive coronary artery
disease about the risk of myocardial infarction or increased angina,
titrate slowly in patients with impaired hepatic or severely impaired
renal function.
Use in Special Populations
Safety and effectiveness in paediatric patients have not been established.
Therapeutic Class
Combined antihypertensive preparations
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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