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Hyzaar

[Losartan/HCTZ]

Hypersensitivity

purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema;

Metabolic

Text Continues Below



hyperglycemia, glycosuria, hyperuricemia;

Musculoskeletal

muscle spasm;

Nervous System/ Psychiatric

restlessness;

Renal

renal failure, renal dysfunction, interstitial nephritis;

Skin

erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis;

Special Senses

transient blurred vision, xanthopsia.

Persistent dry cough (with an incidence of a few percent) has been associated with ACE inhibitor use and in practice can be a cause of discontinuation of ACE inhibitor therapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of losartan on the incidence of cough in hypertensive patients who had experienced cough while receiving ACE inhibitor therapy. Patients who had typical ACE inhibitor cough when challenged with lisinopril, whose cough disappeared on placebo, were randomized to losartan 50 mg, lisinopril 20 mg, or either placebo (one study, n= 97) or 25 mg hydrochlorothiazide (n= 135). The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown below.
Study 1 * HCTZ Losartan Lisinopril
Cough 25% 17% 69%

Study 2 ** Placebo Losartan Lisinopril
Cough 35% 29% 62%

* Demographics = (89% caucasian, 64% female)
** Demographics = (90% caucasian, 51% female)

These studies demonstrate that the incidence of cough associated with losartan therapy, in a population that all had cough associated with ACE inhibitor therapy, is similar to that associated with hydrochlorothiazide or placebo therapy. Cases of cough, including positive re-challenges, have been reported with the use of losartan in post-marketing experience.

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