Normetec

Normetec

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 5 mg/20 mg FC tab Amlodipine besilate 5 mg, olmesartan medoxomil 20 mg. Per 5 mg/40 mg FC tab Amlodipine besilate 5 mg, olmesartan medoxomil 40 mg. Per 10 mg/40 mg FC tab Amlodipine besilate 10 mg, olmesartan medoxomil 40 mg
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to amlodipine, olmesartan or dihydropyridine derivatives. Co-administration w/ aliskiren in patients w/ diabetes. Pregnancy.
Special Precautions
Symptomatic hypotension in patients w/ vol- &/or Na-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea, or vomiting. Patients w/ severe CHF or underlying renal disease including renal artery stenosis. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Patients suffering from aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy. Mild to moderate hepatic & renal impairment. Not recommended in severe renal (CrCl <20 mL/min) & hepatic impairment. Lactation. Not recommended in childn & adolescents <18 yr. Olmesartan: Sprue-line enteropathy. May cause hyperkalemia. Periodically monitor serum electrolytes.
Adverse Reactions
Dizziness, headache, edema, fatigue. Amlodipine: Facial flushing, palpitation.
Drug Interactions
Increased BP lowering effect w/ α-blockers, diuretics. Amlodipine: May increase plasma conc w/ potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). May decrease plasma conc w/ CYP3A4 inducers [eg, anticonvulsants (eg, carbamazepine, phenobarb, phenytoin, fosphenytoin, primidone), rifampicin, Hypericum perforatum]. Increased exposure to simvastatin, tacrolimus & cyclosporine. Olmesartan: Increased serum conc & toxicity of lithium. Increased risk of hypotension, hyperkalemia & changes in renal function including acute renal failure w/ angiotensin receptor antagonists, ACE inhibitors or aliskiren. May increase the worsening of renal function w/ NSAIDs. May attenuate antihypertensive effect w/ NSAIDs including COX-2 inhibitors. Reduced systemic exposure & peak plasma conc w/ colesevelam HCl.
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 5 mg/20 mg FC tab
Packing/Price
28's (P1,749.3/pack)
Form
Normetec 5 mg/40 mg FC tab
Packing/Price
28's (P2,228.52/pack)
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