Losartan Potassium and Hydrochlorothiazide Tablets, USP

/Losartan Potassium and Hydrochlorothiazide Tablets, USP
Losartan Potassium and Hydrochlorothiazide Tablets, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Losartan Potassium and Hydrochlorothiazide Tablets, USP

ID:

17c70627-857f-40ad-836e-2b15336bd8d6

Code:

34391-3

DESCRIPTION


id: 661633b6-00d8-4e39-b254-f62227ffdc01
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Losartan potassium and hydrochlorothiazide
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.
Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is: Losartan potassium, USP is off-white to creamish-yellow powder with a molecular weight of 461.01. It is soluble in water. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is: 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.
Each losartan
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.
Losartan potassium and
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.

CONTRAINDICATIONS


id: d7a83b30-10ab-4ed2-8543-e11a672d3fe4
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Losartan potassium and hydrochlorothiazide
tablets are contraindicated in patients who are hypersensitive to any
component of this product.
Because of the hydrochlorothiazide
component, this product is contraindicated in patients with anuria or
hypersensitivity to other sulfonamide-derived drugs.

ADVERSE REACTIONS


id: 1f8e4cd2-d4c1-4014-b253-e06b6510bf05
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Losartan potassium and hydrochlorothiazide
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.
In
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.
In
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
drug relationship:

Losartan 
Potassium 
and 
Hydrochlorothiazide


(
n
=
858
)

Placebo



(
n
=
173
)

Body 
as 

Whole 

    Abdominal pain 
    Edema/swelling

1.2
1.3
0.6
1.2
Cardiovascular 

    Palpitation

1.4 0.0
Musculoskeletal  

    Back pain

2.1 0.6
Nervous
/
Psychiatric 

    Dizziness

5.7 2.9
Respiratory 

    Cough 
    Sinusitis 
    Upper respiratory 
       infection

2.6
1.2
6.1
2.3
0.6
4.6
Skin 

    Rash

1.4 0.0
The
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.
Adverse events occurred at
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.
A
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
discontinued.
Superficial peeling of palms and hemolysis were reported in one subject treated with losartan potassium.

HOW SUPPLIED


id: a6d86d12-578a-4def-8805-c3e20cd180f3
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Losartan Potassium and Hydrochlorothiazide
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:
NDC 68382-142-06 in bottle of 30 tablets NDC 68382-142-16 in bottle of 90 tablets NDC 68382-142-10 in bottle of 1000 tablets NDC 68382-142-40 in bottle of 5000 tablets Losartan
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:
NDC 68382-143-06 in bottle of 30 tablets NDC 68382-143-16 in bottle of 90 tablets NDC 68382-143-10 in bottle of 1000 tablets NDC 68382-143-23 in bottle of 4000 tablets

PRINCIPAL DISPLAY PANEL


id: 6a6b3119-282f-4bdf-ae54-40c59fc45f7f
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 68258-6040-XX
NDC 68258-6040-03
NDC 68258-6040-09