Prescription Drug Name:
Losartan Potassium and Hydrochlorothiazide Tablets, USP
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
tablets 50 mg/ 12.5 mg and losartan potassium and hydrochlorothiazide
tablets 100 mg/ 25 mg combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide.
USP is a white or practically white, practically odorless crystalline
powder with a molecular weight of 297.74. It is slightly soluble in
water; freely soluble in sodium hydroxide solution, in n-butylamine,
and in dimethylformamide, sparingly soluble in methanol; insoluble in
ether, in chloroform, and in dilute mineral acids.
potassium and hydrochlorothiazide tablet intended for oral
administration contains losartan potassium, 50 mg or 100 mg and
hydrochlorothiazide, 12.5 mg or 25 mg. In addition, each tablet also
contains the following inactive ingredients: colloidal silica
anhydrous, hydroxypropyl cellulose (low substituted), hydroxypropyl
methylcellulose, lactose monohydrate, magnesium stearate, maize starch,
microcrystalline cellulose, polyethylene glycol, sodium starch
glycolate, talc and titanium dioxide.
hydrochlorothiazide tablet 50 mg/ 12.5 mg contains 4.24 mg (0.108 mEq)
of potassium and losartan potassium and hydrochlorothiazide tablet 100
mg/ 25 mg contains 8.48 mg (0.216 mEq) of potassium.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
tablets are contraindicated in patients who are hypersensitive to any
component of this product.
component, this product is contraindicated in patients with anuria or
hypersensitivity to other sulfonamide-derived drugs.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
has been evaluated for safety in 858 patients treated for essential
hypertension and 3889 patients treated for hypertension and left
ventricular hypertrophy. In clinical trials with losartan potassium and
hydrochlorothiazide, no adverse experiences peculiar to this
combination have been observed. Adverse experiences have been limited
to those that were reported previously with losartan potassium and/or
hydrochlorothiazide. The overall incidence of adverse experiences
reported with the combination was comparable to placebo.
general, treatment with losartan potassium and hydrochlorothiazide was
well tolerated. For the most part, adverse experiences have been mild
and transient in nature and have not required discontinuation of
therapy. In controlled clinical trials, discontinuation of therapy due
to clinical adverse experiences was required in only 2.8% and 2.3% of
patients treated with the combination and placebo, respectively.
these double-blind controlled clinical trials, the following adverse
experiences reported with losartan-hydrochlorothiazide occurred in ≥1
percent of patients, and more often on drug than placebo, regardless of
following adverse events were also reported at a rate of 1 % or
greater, but were as, or more, common in the placebo group in studies
of essential hypertension: asthenia/fatigue, diarrhea, nausea,
headache, bronchitis, pharyngitis.
about the same rates in men and women. Adverse events were somewhat
more frequent in the elderly compared to non-elderly patients and
somewhat more frequent in Blacks compared to non-Blacks for both the
losartan and hydrochlorothiazide and the control groups.
patient with known hypersensitivity to aspirin and penicillin, when
treated with losartan potassium, was withdrawn from study due to
swelling of the lips and eyelids and facial rash, reported as
angioedema, which returned to normal 5 days after therapy was
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Tablets, USP 50 mg/ 12.5 mg, are white to off-white, capsule-shaped,
film-coated tablets debossed with “ZD18” on one side and plain on other
side and are supplied as follows:
Potassium and Hydrochlorothiazide Tablets, USP 100 mg/ 25 mg, are white
to off-white, capsule-shaped, film-coated tablets debossed with “ZD19”
on one side and plain on other side and are supplied as follows:
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4