Losartan Potassium Hydrochlorothiazide Drug Facts

Losartan Potassium / Hydrochlorothiazide

Trade Names:
Hyzaar
- Tablets 12.5 mg hydrochlorothiazide/50 mg losartan potassium
- Tablets 12.5 mg hydrochlorothiazide/100 mg losartan potassium
- Tablets 25 mg hydrochlorothiazide/100 mg losartan potassium

Pharmacology

Losartan antagonizes the effect of angiotensin II (vasoconstriction and aldosterone secretion) by blocking the angiotensin II receptor (AT1 receptor) in vascular smooth muscle and the adrenal gland, producing decreased BP; hydrochlorothiazide inhibits reabsorption of sodium and chloride in ascending loop of Henle and early distal tubules.

Indications and Usage

Hypertension.

Contraindications

Anuria; hypersensitivity to other sulfonamide-derivatives or any component of product.

Dosage and Administration

PO 50 mg losartan/12.5 mg hydrochlorothiazide once daily is usual dose (max, 100 mg losartan/25 mg hydrochlorothiazide daily).

General Advice

Administer once daily in the morning, with or without food. Administer with food if GI upset occurs.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F). Keep container tightly closed. Protect from light.

Drug Interactions

Losartan plasma levels may be elevated, increasing the antihypertensive and adverse effects.

Plasma levels of lithium may be elevated, increasing the pharmacologic and adverse effects.

Losartan plasma levels may be reduced, decreasing the antihypertensive effects.

May lead to increased serum potassium.

Increased risk of orthostatic hypotension.

Dose adjustments of antidiabetic agent may be needed.

Actions of other antihypertensive agents may be potentiated.

Absorption of hydrochlorothiazide may be impaired.

Increased risk of electrolyte depletion (eg, hypokalemia).

Decreased response to pressor amine.

Responsiveness to muscle relaxant may be increased.

Plasma levels of lithium may be elevated, increasing the risk of toxicity.

Antihypertensive, diuretic, and natriuretic effects of hydrochlorothiazide may be reduced.

Laboratory Test Interactions

Serum levels of protein-bound iodine may be decreased without signs of thyroid dysfunction.

Adverse Reactions

Cardiovascular

Palpitations; orthostatic effects, angina pectoris, arrhythmias (eg, atrial fibrillation, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation), CVA, hypotension, MI, second-degree AV block (losartan); orthostatic hypotension (hydrochlorothiazide).

CNS

Dizziness; syncope, anxiety, ataxia, confusion, depression, dream abnormality, hyperesthesia, insomnia, decreased libido, memory impairment, migraine, nervousness, panic disorder, paresthesia, peripheral neuropathy, sleep disorder, somnolence, tremor, vertigo (losartan); restlessness (hydrochlorothiazide).

Dermatologic

Rash; alopecia, dermatitis, dry skin, ecchymosis, erythema, flushing, photosensitivity, pruritus, sweating, urticaria (losartan); photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), erythema multiforme (eg, Stevens-Johnson syndrome), exfoliative dermatitis (eg, toxic epidermal necrolysis), purpura (hydrochlorothiazide).

EENT

Sinusitis; cough; nasal congestion, angioedema, pharyngeal discomfort, rhinitis, blurred vision, burning/stinging in the eyes, conjunctivitis, decreased visual acuity, taste perversion, tinnitus (losartan); transient blurred vision, xanthopsia (hydrochlorothiazide).

GI

Abdominal pain; anorexia, constipation, dental pain, dry mouth, dyspepsia, flatulence, gastritis, vomiting (losartan); pancreatitis, sialadenitis, cramping, gastric irritation (hydrochlorothiazide).

Genitourinary

Impotence, nocturia, urinary frequency, UTI (losartan); glucosuria, renal failure, renal dysfunction, interstitial nephritis (hydrochlorothiazide).

Hematologic

Anemia (losartan); aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia (hydrochlorothiazide).

Hepatic

Jaundice (intrahepatic cholestatic jaundice) (hydrochlorothiazide).

Metabolic

Edema; gout (losartan); hyperglycemia, hyperuricemia (hydrochlorothiazide).

Respiratory

Upper respiratory tract infection; dyspnea, epistaxis, respiratory congestion (losartan); respiratory distress (eg, pneumonitis, pulmonary edema) (hydrochlorothiazide).

Miscellaneous

Back pain; chest pain, facial edema, arm pain, arthralgia, arthritis, fibromyalgia, hip pain, joint swelling, knee pain, leg pain, muscle cramps, muscle weakness, musculoskeletal pain, myalgia, shoulder pain, stiffness (losartan); weakness, fever, muscle spasm (hydrochlorothiazide).

Precautions

Pregnancy

Category C (first trimester); Category D (second and third trimester).

Lactation

Undetermined (losartan); excreted in breast milk (hydrochlorothiazide).

Children

Safety and efficacy not established.

Hypersensitivity

May occur in patients with or without history of allergy or bronchial asthma; cross-sensitivity with sulfonamides may also occur.

Renal Function

Use with caution.

Hepatic Function

Do not use.

Hypotension, volume-depleted patients

Correct condition before using drug.

Systemic lupus erythematosus

Exacerbation or activation may occur with thiazide diuretics.

Overdosage

Symptoms

Hypotension, tachycardia, bradycardia, electrolyte depletion (eg, hypokalemia), dehydration.

Patient Information

• Advise patient to take every day as prescribed, without regard to meals.
• Advise patient to try to take at the same time each day.
• Inform patient that drug controls, but not does cure, hypertension and to continue taking drug as prescribed even when BP is not elevated.
• Caution patient not to change the dose or stop taking unless advised to do so by health care provider.
• Instruct patient to continue taking other BP medications as prescribed by health care provider.
• Instruct patient in BP and pulse measurement skills.
• Advise patient to monitor and record BP and pulse at home and to inform health care provider should abnormal measurements be noted. Also advise patient to take record of BP and pulse to each follow-up visit.
• Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
• Instruct patient to lie or sit down if they experience dizziness or lightheadedness when standing.
• Caution patient that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to excessive fall in BP resulting in lightheadedness or fainting.
• Instruct diabetic patient to monitor blood glucose more frequently when drug is started or dose is changed and to inform health care provider of significant changes in readings.
• Caution patient to avoid unnecessary exposure to UV light (eg, sunlight, tanning booths) and to use sunscreen and wear protective clothing when exposed to UV light to avoid photosensitivity reaction.
• Emphasize to hypertensive patient importance of other modalities on BP: weight control, regular exercise, smoking cessation, and moderate intake of alcohol and salt.
• Instruct patient to stop taking drug and immediately report any of the following symptoms to health care provider: fainting or swelling of the face, lips, eyelids or tongue.
• Caution patient to not take any prescription or OTC medications, salt substitutes, or dietary supplements unless advised to do so by health care provider.