OLZOX AM
Composition OLMESARTAN 20mg + AMLODIPINE 5 mg
Indication For management of Hypertension
Mechanism of Action

Olmesartan is a selective and competitive angiotensin II Type 1 (AT1) receptor antagonist that blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II. As a result, Olmesartan relaxes blood vessels, hence lowering BP and increases blood supply and oxygen to the heart.

AMLODIPINE:

Amlodipine relaxes peripheral and coronary vascular smooth muscle. It produces coronary vasodilation by inhibiting the entry of Ca ions into the slow channels or select voltage-sensitive channels of the vascular smooth muscle and myocardium during depolarisation. It also increases myocardial oxygen delivery in patients w/ vasospastic angina.

Pharmacokinetic’s

OLMESARTAN

Absorption: Bioavailability: Approx. 26%. Time to peak plasma concentration: Approx. 1-2 hr.

Distribution: Volume of distribution: 17 L. Plasma protein binding: ≤99%.

Metabolism: Olmesartan medoxomil undergoes ester hydrolysis in the GI tract to active form Olmesartan.

Excretion: Via faeces (50-65%) and urine (35-50%) both as Olmesartan. Terminal half-life: Approx. 10-15 hr.

AMLODIPINE

Adult: Initially, 5 mg once daily increased to 10 mg once daily if necessary.

Child: 6-17 yr Initially, 2.5 mg once daily, increased to 5 mg once daily if necessary.

Elderly: Initially, 2.5 mg once daily.

Hepatic impairment: Initially, 2.5 mg once daily.

Side effects

OLMESARTAN

Potentially Fatal: Acute renal failure.

May cause sprue-like enteropathy (Symptoms: Severe, chronic diarrhoea with substantial wt. loss). Dizziness, headache, abdominal pain, dyspepsia, diarrhoea, gastroenteritis, nausea, bronchitis, pharyngitis, rhinitis, arthritis, back pain, skeletal pain, fatigue, flu-like symptoms, angioedema, peripheral oedema, haematuria, UTI, hyperkalaemia, hypertriglyceridemia, hyperuricaemia, hyperglycaemia, elevated liver enzymes.

AMLODIPINE:

Somnolence, dizziness, headache, ankle swelling, oedema, flushing, fatigue, palpitations, abdominal pain, nausea. Rarely, confusion, rash, gingival hyperplasia, muscle cramps, dyspnoea.

Precaution

OLMESARTAN

Patients with aortic or mitral valve stenosis, renal artery stenosis; at risk for hypotension (e.g. patients with volume or salt depletion); history of angioedema; at risk for hyperkalaemia (e.g. patients w/ DM). Severe renal and hepatic impairment. Lactation. Monitoring Parameters Monitor BP, serum creatinine and K levels periodically.

AMLODIPINE:

Patients with cardiac failure. Hepatic and renal impairment. Elderly. Pregnancy and lactation. Patient Counselling May impair ability to drive and operate machinery. Monitoring Parameters Monitor BP and heart rate.

Dosage

OLMESARTAN

Adult: Initial: 10-20 mg once daily may then be increased up to max 40 mg once daily if needed.

Child: 6-16 yr. <35 kg: 10 mg once daily; ≥35 kg: 20 mg once daily. Doses may be doubled once if necessary after 2 wk.

Elderly: No dosage adjustment needed.

Renal impairment: Mild to moderate (Circle: 20-60 mL/min): Max: 20 mg once daily.

Hepatic impairment:

Moderate: Initial: 10 mg once daily may increase up to max 20 mg once daily.

AMLODIPINE:

Hypertension

Adult: Initially, 5 mg once daily increased to 10 mg once daily if necessary.

Child: 6-17 yr Initially, 2.5 mg once daily, increased to 5 mg once daily if necessary.

Elderly: Initially, 2.5 mg once daily.

Hepatic impairment: Initially, 2.5 mg once daily.