Normetec

Normetec

Manufacturer:

Pfizer
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. Replacement therapy: Patient receiving olmesartan medoxomil & amlodipine from separate tab may instead receive Normetec containing the same component doses. Add-on therapy: Patients whose BP is not adequately controlled on olmesartan medomoxil or amlodipine monotherapy. Should not be used as initial therapy.
Dosage/Direction for Use
Adult Usual dose: 1 tab daily. Treatment should not be initiated w/ this combination. Titration of dosage is recommended. Elderly & mild to moderate renal impairment Max dose: Olmesartan medoxomil 20 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to dihydropyridines. Severe renal impairment, severe hepatic impairment or biliary obstruction. Cardiogenic shock, acute MI (w/in 1st 4 wk), unstable angina pectoris. Do not co-administer aliskiren w/ Normetec in patients w/ diabetes. Pregnancy & lactation.
Special Precautions
Vol &/or Na depletion; severe CHF or underlying renal disease including renal artery stenosis; renovascular HTN, electrolyte imbalance, sprue-like enteropathy; recent kidney transplantation; mild to moderate hepatic impairment; aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy; primary aldosteronism; increased angina &/or MI; CHF; ethnic differences; concomitant use of ACE inhibitors or angiotensin receptor antagonist & anti-inflammatory drugs & thiazide diuretics, lithium; ischaemic heart or cerebrovascular disease. May impair ability to drive or operate machinery. Hepatic impairment. Pregnancy & lactation. Childn & adolescent <18 yr.
Adverse Reactions
Peripheral oedema, oedema, fatigue, pitting oedema, nervous system disorders, dizziness, headache, vascular disorders, HTN, GI disorders, nausea, palpitations, tachycardia, vertigo, vomiting, dyspepsia, diarrhea, constipation, dry mouth, upper abdominal pain, asthenia, face oedema, drug hypersensitivity, decreased blood K, increased blood creatinine & uric acid, increased γ-glutamyl transferase, hyperkalemia, muscle spasm, pain in extremity & back pain, postural dizziness, lethargy, paraesthesia, hypoaesthesia, syncope, decreased libido, pollakiuria, erectile dysfunction, dyspnoea, cough, rash, urticaria, hypotension, orthostatic hypotension. Angina pectoris, bronchitis, cough, pharyngitis, rhinitis, abdominal pain, gastroenteritis, arthritis, skeletal pain, haematuria, UTI, chest pain, influenza-like symptoms, pain, flushing.
Drug Interactions
Aliskiren, colesevelam HCl, K supplements, K-sparing diuretics, salt substitute containing K, heparin, ACE inhibitors, lithium, other hypertensives (eg, α-blockers, diuretics), NSAIDs including COX-2 inhibitors & acetylsalicylic acid. CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir), CYP3A4 inducers (eg, rifampicin, Hypericum perforatum), cimetidine, Al/Mg, sildenafil, atorvastatin, digoxin, ethanol, warfarin, tacrolimus, cyclosporin.
MIMS Class
Angiotensin II Antagonists / Calcium Antagonists / Anti-Anginal Drugs
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.
Presentation/Packing
Form
Normetec FC tab 10 mg/40 mg
Packing/Price
30's (Rp322,489/pak)
Form
Normetec FC tab 5 mg/20 mg
Packing/Price
30's (Rp322,489/pak)
Form
Normetec FC tab 5 mg/40 mg
Packing/Price
30's (Rp322,489/pak)
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