Colixtan Special Precautions

Hypotension in patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics) or with severe aortic stenosis, symptomatic hypotension may occur. Intravascular volume depletion should be corrected prior to administration of Losartan and Amlodipine, or a lower starting dose should be used. Because of the gradual onset of action, acute hypotension is unlikely.
Liver function impairment: A lower dose of Losartan should be considered for patients with a history of hepatic impairment. Because Amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t_1/2) is 56 hours in patients with impaired hepatic function, titrate slowly when administering Amlodipine to patients with severe hepatic impairment.
Losartan: Fetal Toxicity: Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Fixed-dose combination of Losartan and Amlodipine as soon as possible.
Hypersensitivity: Angioedema.
Electrolyte/Fluid Imbalance: Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia.
Renal Function Impairment: As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported in susceptible individuals; these changes in renal function may be reversible upon discontinuation of therapy. Other drugs that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Similar effects have been reported with Losartan; these changes in renal function may be reversible upon discontinuation of therapy.
Amlodipine: Increased Angina or Myocardial Infarction: Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Amlodipine, particularly in patients with severe obstructive coronary artery disease.
Use in Patients with Heart Failure: Amlodipine was associated with increased reports of pulmonary edema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Effects on ability to drive and use machines: No studies of the effects of FDC of Losartan and Amlodipine on the ability to drive and operate machines have been performed. However, certain side effects that have been reported with FDC of Losartan and Amlodipine may affect some patients' ability to drive or operate machinery. Individual responses to FDC of Losartan and Amlodipine may vary.