Normetec Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Per 5 mg/20 mg FC tab Amlodipine besylate 5 mg, olmesartan medoxomil 20 mg. Per 5 mg/40 mg FC tab Amlodipine besylate 5 mg, olmesartan medoxomil 40 mg. Per 10 mg/40 mg FC tab Amlodipine besylate 10 mg, olmesartan medoxomil 40 mg

Indications/Uses

Essential HTN in patients inadequately controlled by olmesartan medoxomil or amlodipine monotherapy.

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Dosage/Direction for Use

1 tab/day.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity to dihydropyridine derivatives. Severe hepatic insufficiency & biliary obstruction. Cardiogenic shock, acute MI (w/in 1st 4 wk), unstable angina pectoris. Pregnancy & lactation.

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Special Precautions

Renal & hepatic impairment; correct hypovolaemia or Na depletion prior to administration. Severe CHF or underlying renal disease including renal artery stenosis. Renovascular HTN, recent kidney transplantation. Monitor serum K & creatinine. Aortic or mitral valve stenosis; obstructive hypertrophic cardiomyopathy. Primary aldosteronism. Ischaemic heart or cerebrovascular disease. May impair ability to drive or operate machinery. Childn & adolescent <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dizziness, headache, peripheral oedema, oedema, pitting oedema, fatigue, angina pectoris, bronchitis, pharyngitis, rhinitis, abdominal pain, gastroenteritis, arthritis, skeletal pain, haematuria, UTI, chest pain, flu-like symptoms, pain, flushing.

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Drug Interactions

K supplements, K-sparing diuretics, salt substitute containing K, heparin, ACE inhibitors, lithium, other hypertensives (eg, α-blockers, diuretics), NSAIDs including COX-2 inhibitors, ASA & nonselective NSAIDs, antacid (Al-Mg hydroxide), diltiazem, ketoconazole, itraconazole, ritonavir, carbamazepine, phenobarb, phenytoin, fosphenytoin, primidone, rifampicin, Hypericum perforatum, sildenafil.

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Storage

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Description

View Normetec description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Angiotensin II Antagonists / Anti-Anginal Drugs / Calcium Antagonists

ATC Classification

C09DB02 - olmesartan medoxomil and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.

Thai FDA Category

Presentation/Packing

Form

Normetec FC tab 10 mg/40 mg

Packing/Price

30's

Form

Normetec FC tab 5 mg/20 mg

Packing/Price

30's

Form

Normetec FC tab 5 mg/40 mg

Packing/Price

30's

Normetec

olmesartan + amlodipine

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma