Losartan Potassium And Hydrochlorothiazide

Losartan Potassium And Hydrochlorothiazide

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Questions & Answers

Side Effects & Adverse Reactions

Fetal Toxicity

Pregnancy Category D

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide as soon as possible. These adverse outcomes are usually associated with the use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the rennin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment.

If oligohydramnios is observed, discontinue losartan potassium and hydrochlorothiazide, unless it is considered life-saving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.

Closely observe infants with histories of in utero exposure to losartan potassium and hydrochlorothiazide for hypotension, oliguria, and hyperkalemia (see PRECAUTIONS, Pediatric Use).

There was no evidence of teratogenicity in rats or rabbits treated with a maximum losartan potassium dose of 10 mg/kg/day in combination with 2.5 mg/kg/day of hydrochlorothiazide. At these dosages, respective exposures (AUCs) of losartan, its active metabolite, and hydrochlorothiazide in rabbits were approximately 5, 1.5, and 1 times those achieved in humans with 100 mg losartan in combination with 25 mg hydrochlorothiazide. AUC values for losartan, its active metabolite and hydrochlorothiazide, extrapolated from data obtained with losartan administered to rats at a dose of 50 mg/kg/day in combination with 12.5 mg/kg/day of hydrochlorothiazide, were approximately 6, 2, and 2 times greater than those achieved in humans with 100 mg of losartan in combination with 25 mg of hydrochlorothiazide. Fetal toxicity in rats, as evidenced by a slight increase in supernumerary ribs, was observed when females were treated prior to and throughout gestation with 10 mg/kg/day losartan in combination with 2.5 mg/kg/day hydrochlorothiazide. As also observed in studies with losartan alone, adverse fetal and neonatal effects, including decreased body weight, renal toxicity, and mortality, occurred when pregnant rats were treated during late gestation and/or lactation with 50 mg/kg/day losartan in combination with 12.5 mg/kg/day hydrochlorothiazide. Respective AUCs for losartan, its active metabolite and hydrochlorothiazide at these dosages in rats were approximately 35, 10 and 10 times greater than those achieved in humans with the administration of 100 mg of losartan in combination with 25 mg hydrochlorothiazide. When hydrochlorothiazide was administered without losartan to pregnant mice and rats during their respective periods of major organogenesis, at doses up to 3000 and 1000 mg/kg/day, respectively, there was no evidence of harm to the fetus.

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Hypotension - Volume-Depleted Patients

In patients who are intravascularly volume-depleted (e.g., those treated with diuretics), symptomatic hypotension may occur after initiation of therapy with losartan potassium and hydrochlorothiazide. This condition should be corrected prior to administration of losartan potassium and hydrochlorothiazide (see DOSAGE AND ADMINISTRATION).

Impaired Hepatic Function
Losartan Potassium and Hydrochlorothiazide

Losartan potassium and hydrochlorothiazide is not recommended for patients with hepatic impairment who require titration with losartan. The lower starting dose of losartan recommended for use in patients with hepatic impairment cannot be given using losartan potassium and hydrochlorothiazide.

Hydrochlorothiazide

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Hypersensitivity Reaction

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.

Systemic Lupus Erythematosus

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Lithium Interaction

Lithium generally should not be given with thiazides. Monitor serum lithium levels in patients receiving lithium and hydrochlorothiazide (see PRECAUTIONS, Drug Interactions, Hydrochlorothiazide , Lithium).

Acute Myopia and Secondary Angle-Closure Glaucoma

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Hypertension

Losartan potassium and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, and DOSAGE AND ADMINISTRATION).

Hypertensive Patients with Left Ventricular Hypertrophy

Losartan potassium and hydrochlorothiazide tablets, USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients (see PRECAUTIONS, Race, CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke, Race, and DOSAGE AND ADMINISTRATION).

History

There is currently no drug history available for this drug.

Other Information

Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide 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-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is:


Losartan potassium structural formula

Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone.

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 structural formula

Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch (maize), and titanium dioxide. Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg also contain D&C yellow No. 10 aluminum lake.

Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide 100 mg/12.5 mg contains 8.48 mg (0.217 mEq) of potassium, and losartan potassium and hydrochlorothiazide 100 mg/25 mg contains 8.48 mg (0.217 mEq) of potassium.

Losartan Potassium And Hydrochlorothiazide Manufacturers


  • American Health Packaging
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [American Health Packaging]
  • Direct Rx
    Losartan Potassium And Hydrochlorothiazide Tablet [Direct Rx]
  • Proficient Rx Lp
    Losartan Potassium And Hydrochlorothiazide Tablet [Proficient Rx Lp]
  • Proficient Rx Lp
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Proficient Rx Lp]
  • Remedyrepack Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Direct Rx
    Losartan Potassium And Hydrochlorothiazide Tablet [Direct Rx]
  • Direct Rx
    Losartan Potassium And Hydrochlorothiazide Tablet [Direct Rx]
  • Sandoz Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Sandoz Inc.]
  • Watson Laboratories, Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Watson Laboratories, Inc.]
  • Physicians Total Care, Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Physicians Total Care, Inc.]
  • Rebel Distributors Corp
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Rebel Distributors Corp]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • Stat Rx Usa Llc
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Stat Rx Usa Llc]
  • Medvantx, Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Medvantx, Inc.]
  • Rebel Distributors Corp
    Losartan Potassium And Hydrochlorothiazide Tablet [Rebel Distributors Corp]
  • Dispensing Solutions, Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet [Dispensing Solutions, Inc.]
  • Dispensing Solutions, Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Dispensing Solutions, Inc.]
  • Mylan Pharmaceuticals Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Mylan Pharmaceuticals Inc.]
  • Legacy Pharmaceutical Packaging
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Legacy Pharmaceutical Packaging]
  • Lake Erie Medical Dba Quality Care Products Llc
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Remedyrepack Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Cadila Healthcare Limited
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Cadila Healthcare Limited]
  • Remedyrepack Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Bryant Ranch Prepack
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Bryant Ranch Prepack]
  • Macleods Pharmaceuticals Limited
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Macleods Pharmaceuticals Limited]
  • Remedyrepack Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Bryant Ranch Prepack
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Bryant Ranch Prepack]
  • Unit Dose Services
    Losartan Potassium And Hydrochlorothiazide Tablet [Unit Dose Services]
  • Unit Dose Services
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Unit Dose Services]
  • Unit Dose Services
    Losartan Potassium And Hydrochlorothiazide Tablet [Unit Dose Services]
  • Aidarex Pharmaceuticals Llc
    Losartan Potassium And Hydrochlorothiazide Tablet [Aidarex Pharmaceuticals Llc]
  • Aidarex Pharmaceuticals Llc
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Aidarex Pharmaceuticals Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Losartan Potassium And Hydrochlorothiazide (Losartan Potassium And Hydrochlorothiazide Tablets) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Teva Pharmaceuticals Usa Inc
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Teva Pharmaceuticals Usa Inc]
  • Aurobindo Pharma Limited
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Aurobindo Pharma Limited]
  • Apotex Corp.
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Apotex Corp.]
  • Sandoz Inc
    Losartan Potassium And Hydrochlorothiazide (Losartan Potassium And Hydrochlorothiazide Tablets) Tablet, Film Coated [Sandoz Inc]
  • Jubilant Cadista Pharmaceuticals Inc.
    Losartan Potassium And Hydrochlorothiazide (Losartan Potassium And Hydrochlorothiazide) Tablet, Film Coated [Jubilant Cadista Pharmaceuticals Inc.]
  • Bryant Ranch Prepack
    Losartan Potassium And Hydrochlorothiazide Tablet [Bryant Ranch Prepack]
  • Torrent Pharmaceuticals Limited
    Losartan Potassium And Hydrochlorothiazide Tablet [Torrent Pharmaceuticals Limited]
  • Northstar Rx Llc
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Northstar Rx Llc]
  • St Marys Medical Park Pharmacy
    Losartan Potassium And Hydrochlorothiazide (Losartan Potassium, Hydrochlorothiazide) Tablet, Film Coated [St Marys Medical Park Pharmacy]
  • Lupin Pharmaceuticals, Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet [Lupin Pharmaceuticals, Inc.]
  • American Health Packaging
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [American Health Packaging]
  • Qualitest Pharmaceuticals
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Qualitest Pharmaceuticals]
  • Roxane Laboratories, Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet [Roxane Laboratories, Inc.]
  • Avpak
    Losartan Potassium And Hydrochlorothiazide (Losartan Potassium And Hydrochlorothiazide) Tablet [Avpak]
  • Zydus Pharmaceuticals (Usa) Inc.
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Zydus Pharmaceuticals (Usa) Inc.]
  • Avkare, Inc.
    Losartan Potassium And Hydrochlorothiazide (Losartan Potassium And Hydrochlorothiazide) Tablet, Film Coated [Avkare, Inc.]
  • Medsource Pharmaceuticals
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Medsource Pharmaceuticals]
  • Proficient Rx Lp
    Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated [Proficient Rx Lp]

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