Normetec Special Precautions




Zuellig Pharma
Full Prescribing Info
Special Precautions
Patients with Hypovolaemia or Sodium Depletion: Symptomatic hypotension may occur in patients who are volume- and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting, especially after the 1st dose. Correction of this condition prior to administration of Normetec or close medical supervision at the start of the treatment is recommended.
Other Conditions with Stimulation of the Renin-Angiotensin-Aldosterone System: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (eg, patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with other medicinal products that affect this system eg, angiotensin II receptor antagonists, has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.
Renovascular Hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Renal Impairment and Kidney Transplantation: When Normetec is used in patients with impaired renal function, periodic monitoring of serum potassium and creatinine levels is recommended. Use of Normetec is not recommended in patients with severe renal impairment (CrCl <20 mL/min) (see Pharmacokinetics under Actions and Dosage & Administration). There is no experience of the administration of Normetec in patients with a recent kidney transplant or in patients with end-stage renal impairment (ie, CrCl <12 mL/min).
Hepatic Impairment: Exposure to amlodipine and olmesartan medoxomil is increased in patients with hepatic impairment (see Pharmacokinetics under Actions). Care should be taken when Normetec is administered in patients with mild to moderate hepatic impairment. In moderately impaired patients, the dose of olmesartan medoxomil should not exceed 20 mg (see Dosage & Administration). Use of Normetec in patients with severe hepatic impairment is contraindicated (see Contraindications).
Hyperkalaemia: As with other angiotensin II antagonists and ACE inhibitors, hyperkalaemia may occur during treatment, especially in the presence of renal impairment and/or heart failure (see Interactions). Close monitoring of serum potassium levels in patients at risk is recommended.
Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium or other medicinal products that may increase potassium levels (heparin, etc) should be undertaken with caution and with frequent monitoring of potassium levels.
Lithium: As with other angiotensin II receptor antagonists, the concomitant use of Normetec and lithium is not recommended (see Interactions).
Aortic or Mitral Valve Stenosis, Obstructive Hypertrophic Cardiomyopathy: Due to the amlodipine component of Normetec, as with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Primary Aldosteronism: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore, the use of Normetec is not recommended in such patients.
Heart Failure: As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death.
In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo (see Pharmacology: Pharmacodynamics under Actions).
Ethnic Differences: As with all other angiotensin II antagonists, the BP lowering effect of Normetec can be somewhat less in Black patients than in non-Black patients, possibly because of a higher prevalence of low-renin status in the Black hypertensive population.
Pregnancy: Angiotensin II antagonists should not be initiated during pregnancy. Unless continued angiotensin II antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see Use in pregnancy under Contraindications).
Other: As with any antihypertensive agent, excessive BP decrease in patients with ischaemic heart disease or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.
Effects on the Ability to Drive or Operate Machinery: No studies on the effects on the ability to drive and use machines have been performed. However, it should be borne in mind that dizziness or fatigue may occasionally occur in patients taking antihypertensive therapy.
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