Losartan and hydrochlorothiazide

Name: Losartan and hydrochlorothiazide

Losartan and Hydrochlorothiazide Overview

Losartan and hydrochlorothiazide is a prescription medication used to treat high blood pressure. It is also used to reduce the risk of stroke in patients with high blood pressure and left ventricular hypertrophy.

It is a single product containing 2 medications: losartan and hydrochlorothiazide. Losartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. Hydrochlorothiazide is in a class of medications called diuretics, or "water pills." It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine.

This medication comes in tablet form and is taken up to twice a day with or without food.

Common side effects of losartan and hydrochlorothiazide include upper respiratory infection, back pain, and rash. It can also cause dizziness. Do not drive or operate heavy machinery until you know how losartan and hydrochlorothiazide affects you.

Losartan and Hydrochlorothiazide Precautions

Serious side effects have been reported with losartan and hydrochlorothiazide including the following:

  • Injury or death of unborn babies
  • Allergic Reaction. Symptoms of an allergic reaction are swelling of the face, lips, throat, or tongue. Get emergency medical help right away and stop taking losartan and hydrochlorothiazide.
  • Low blood pressure (hypotension). Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy.  Call your doctor right away.  
  • A new or worsening condition called systemic lupus erythematosus.
  • If you have kidney problems, you may see a worsening in how well your kidneys work. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain.
  • If you have liver problems, you may see a worsening in how well your liver works. Call your doctor if you get nausea, pain in the right upper stomach area (abdomen), yellow eyes or skin (which can be itchy).
  • Eye problems. One of the medicines in losartan and hydrochlorothiazide can cause eye problems that, if left untreated, may lead to vision loss.  Symptoms of eye problems can happen within hours to weeks of starting losartan and hydrochlorothiazide. Tell your doctor right away if you have:
    • decrease in vision
    • eye pain

Do not take losartan and hydrochlorothiazide if you:

  • are allergic to losartan and hydrochlorothiazide or to any of its ingredients
  • are allergic to any sulfonamide-containing medicines ("sulfa"). Ask your doctor if you are not sure what "sulfa" medicines are
  • are not passing urine
  • have diabetes and are taking a medicine called aliskiren to reduce blood pressure

Losartan and Hydrochlorothiazide Overdose

If you take too much losartan and hydrochlorothiazide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

If losartan and hydrochlorothiazide is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur.  However, if overdose is suspected, seek emergency medical attention.

Losartan and Hydrochlorothiazide FDA Warning

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 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 renin-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 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.

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.

Proper Use of losartan and hydrochlorothiazide

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these is most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that losartan and hydrochlorothiazide will not cure your high blood pressure but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

losartan and hydrochlorothiazide may be taken with or without food.

losartan and hydrochlorothiazide comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you also use cholestyramine or colestipol, take these at least 4 hours after you take losartan and hydrochlorothiazide.

Dosing

The dose of losartan and hydrochlorothiazide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of losartan and hydrochlorothiazide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For high blood pressure:
      • Adults—At first, one tablet once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 100 mg of losartan and 25 mg of hydrochlorothiazide per day.
      • Children—Use and dose must be determined by your doctor.
    • For lowering risk of stroke in patients with high blood pressure and enlargement of the heart:
      • Adults—At first, one tablet once a day. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of losartan and hydrochlorothiazide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using losartan and hydrochlorothiazide

It is very important that your doctor check your progress at regular visits to make sure that losartan and hydrochlorothiazide is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using losartan and hydrochlorothiazide while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using losartan and hydrochlorothiazide, tell your doctor right away.

losartan and hydrochlorothiazide may cause dizziness, lightheadedness, or fainting, especially when you get up suddenly from a lying or sitting position. Make sure you know how you react to losartan and hydrochlorothiazide before you drive, use machines, or do anything else that could be dangerous if you are dizzy. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you become sick while taking losartan and hydrochlorothiazide, especially if you have severe or continuing nausea or vomiting, or diarrhea that does not stop. These conditions may cause you to lose too much water and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Check with your doctor immediately if blurred vision, difficulty reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor may want an eye doctor to check your eyes.

losartan and hydrochlorothiazide may affect blood sugar levels. Diabetic patients may notice a change in the results of blood or urine glucose tests. Talk to your doctor if you have any questions.

Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

Drinking alcohol or taking narcotic pain relievers or sleeping pills with losartan and hydrochlorothiazide may intensify feeling lightheaded, dizzy, or faint. Tell your doctor if you are drinking alcohol or using pain relievers or sleeping pills.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

losartan and hydrochlorothiazide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
  • Black, tarry stools
  • blood in the urine or stools
  • cough or hoarseness accompanied by chills or fever, lower back or side pain, or painful or difficult urination
  • fainting
  • pinpoint red spots on the skin
  • pounding heartbeat
  • severe stomach pain, nausea, and vomiting
  • skin rash
  • swelling of the feet or lower legs
  • unusual bleeding or bruising
Incidence not known
  • Coma
  • confusion
  • dark-colored urine
  • decreased urine output
  • dry mouth
  • fast or irregular heartbeat
  • fever
  • increased thirst
  • irritability
  • large, flat, blue, or purplish patches in the skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • muscle cramps or pain
  • muscle spasms
  • muscle stiffness
  • muscle twitching
  • nausea or vomiting
  • painful knees and ankles
  • raised red swellings on the skin, the buttocks, legs, or ankles
  • restlessness
  • seizures
  • shortness of breath
  • swelling of the face, ankles, or hands
  • upper right abdominal or stomach pain
  • unusual tiredness or weakness
  • weak or irregular heartbeat
  • yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Cold or flu-like symptoms
  • dizziness
  • headache
  • increased sensitivity of the skin to sunlight
  • sore throat
  • stomach pain
Rare
  • Dry cough
  • sinus problems

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, oral: 50/12.5: Losartan potassium 50 mg and hydrochlorothiazide 12.5 mg; 100/12.5: Losartan potassium 100 mg and hydrochlorothiazide 12.5 mg; 100/25: Losartan potassium 100 mg and hydrochlorothiazide 25 mg

Hyzaar 50/12.5: Losartan potassium 50 mg and hydrochlorothiazide 12.5 mg [contains potassium 4.24 mg (0.108 mEq)]

Hyzaar 100/12.5: Losartan potassium 100 mg and hydrochlorothiazide 12.5 mg [contains potassium 8.48 mg (0.216 mEq)]

Hyzaar 100/25: Losartan potassium 100 mg and hydrochlorothiazide 25 mg [contains potassium 8.48 mg (0.216 mEq)]

Brand Names U.S.

  • Hyzaar

Warnings/Precautions

Concerns related to adverse effects:

• Angioedema: Angioedema has been reported rarely with some angiotensin II receptor antagonists (ARBs) and may occur at any time during treatment (especially following first dose). It may involve the head and neck (potentially compromising airway) or the intestine (presenting with abdominal pain). Patients with idiopathic or hereditary angioedema or previous angioedema associated with ACE-inhibitor therapy may be at an increased risk. Prolonged frequent monitoring may be required, especially if tongue, glottis, or larynx are involved, as they are associated with airway obstruction. Patients with a history of airway surgery may have a higher risk of airway obstruction. Discontinue therapy immediately if angioedema occurs. Aggressive early management is critical. Intramuscular (IM) administration of epinephrine may be necessary. Do not readminister to patients who have had angioedema with ARBs.

• Electrolyte disturbances: Hyperkalemia may occur with losartan; risk factors include renal dysfunction, diabetes mellitus, and concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salts. Use cautiously, if at all, with these agents and monitor potassium closely. Thiazide diuretics may cause hypokalemia, hypochloremic alkalosis, hypomagnesemia, and hyponatremia.

• Hypersensitivity reactions: Hypersensitivity reactions may occur with hydrochlorothiazide. Risk is increased in patients with a history of allergy or bronchial asthma.

• Hypotension: Symptomatic hypotension may occur upon initiation in patients who are salt- or volume-depleted (eg, those treated with high-dose diuretics); correct volume depletion prior to administration. This transient hypotensive response is not a contraindication to further treatment with losartan/hydrochlorothiazide.

• Ocular effects: Hydrochlorothiazide may cause acute transient myopia and acute angle-closure glaucoma, typically occurring within hours to weeks following initiation; discontinue therapy immediately in patients with acute decreases in visual acuity or ocular pain. Additional treatments may be needed if uncontrolled intraocular pressure persists. Risk factors may include a history of sulfonamide or penicillin allergy.

• Photosensitivity: Photosensitization may occur with use of hydrochlorothiazide.

• Renal function deterioration: May be associated with deterioration of renal function and/or increases in serum creatinine, particularly in patients with low renal blood flow (eg, renal artery stenosis, heart failure) whose glomerular filtration rate (GFR) is dependent on efferent arteriolar vasoconstriction by angiotensin II; deterioration may result in oliguria, acute renal failure, and progressive azotemia. Small increases in serum creatinine may occur following initiation; consider discontinuation only in patients with progressive and/or significant deterioration in renal function.

• Sulfonamide (“sulfa”) allergy: The product labeling for many medications containing a sulfonamide chemical group includes a broad contraindication in patients with a prior allergic reaction to sulfonamides. There is a potential for cross-reactivity between members of a specific class (eg, two antibiotic sulfonamides). However, concerns for cross-reactivity have previously extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur or at the very least this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides. T-cell-mediated (type IV) reactions (eg, maculopapular rash) are less well understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.

Disease-related concerns:

• Aortic/mitral stenosis: Use losartan with caution in patients with significant aortic/mitral stenosis.

• Diabetes: Use hydrochlorothiazide with caution in patients with prediabetes or diabetes mellitus; may see a change in glucose control.

• Gout: In certain patients with a history of gout, a familial predisposition to gout, or chronic renal failure, gout can be precipitated by hydrochlorothiazide. This risk may be increased with doses ≥25 mg (Gurwitz 1997).

• Hepatic impairment: Use is not recommended for initial therapy in patients with hepatic impairment. Use with caution in hepatic impairment or progressive hepatic disease; avoid electrolyte and acid/base imbalances that might lead to hepatic encephalopathy/coma.

• Hypercalcemia: Thiazide diuretics may decrease renal calcium excretion; consider avoiding use in patients with hypercalcemia.

• Hypercholesterolemia: Use with caution in patients with moderate or high cholesterol concentrations; increased cholesterol and triglyceride levels have been reported with thiazides.

• Parathyroid disease: Thiazide diuretics reduce calcium excretion; pathologic changes in the parathyroid glands with hypercalcemia and hypophosphatemia have been observed with prolonged use; should be discontinued prior to testing for parathyroid function.

• Renal artery stenosis: Use losartan with caution in patients with unstented unilateral/bilateral renal artery stenosis. When unstented bilateral renal artery stenosis is present, use is generally avoided due to the elevated risk of deterioration in renal function unless possible benefits outweigh risks.

• Renal impairment: Use losartan with caution with preexisting renal insufficiency. Avoid hydrochlorothiazide in severe renal disease (ineffective); may precipitate azotemia; discontinue or consider withholding if renal impairment occurs. Contraindicated in patients with anuria.

• Systemic lupus erythematosus (SLE): Hydrochlorothiazide can cause SLE exacerbation or activation.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Black patients: When used to reduce the risk of stroke in patients with HTN and LVH, may not be effective in the black population.

• Pregnancy: [US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected.

• Surgical patients: In patients on chronic angiotensin receptor blocker (ARB) therapy, intraoperative hypotension may occur with induction and maintenance of general anesthesia; however, discontinuation of therapy prior to surgery is controversial. If continued preoperatively, avoidance of hypotensive agents during surgery is prudent (Hillis, 2011).

Other warnings/precautions:

• Appropriate use: Not indicated for initial therapy of hypertension, except in severe hypertension where the benefit of a prompt blood pressure reduction exceeds the risk of initiating combination therapy. Do not use as initial therapy in patients with intravascular volume depletion; correct prior to use.

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