Edarbyclor

Name: Edarbyclor

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Aliskiren

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Acetyldigoxin
  • Amtolmetin Guacil
  • Arsenic Trioxide
  • Aspirin
  • Benazepril
  • Bepridil
  • Bromfenac
  • Bufexamac
  • Captopril
  • Celecoxib
  • Ceritinib
  • Choline Salicylate
  • Clonixin
  • Deslanoside
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Digitalis
  • Digitoxin
  • Digoxin
  • Dipyrone
  • Dofetilide
  • Droperidol
  • Droxicam
  • Enalapril
  • Enalaprilat
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Flecainide
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Flurbiprofen
  • Fosinopril
  • Ibuprofen
  • Indomethacin
  • Ketanserin
  • Ketoprofen
  • Ketorolac
  • Levomethadyl
  • Lisinopril
  • Lithium
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Metildigoxin
  • Moexipril
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Perindopril
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Quinapril
  • Ramipril
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sotalol
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Trandolapril
  • Trimethoprim
  • Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Amtolmetin Guacil
  • Bromfenac
  • Bufexamac
  • Celecoxib
  • Choline Salicylate
  • Clonixin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Droxicam
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Gossypol
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Licorice
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Proglumetacin
  • Propionic Acid
  • Propyphenazone
  • Proquazone
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib
  • Warfarin

What should I discuss with my healthcare provider before taking azilsartan and chlorthalidone?

You should not use this medicine if you are allergic to azilsartan or chlorthalidone, or if you are unable to urinate.

If you have diabetes, do not use azilsartan and chlorthalidone together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

You may also need to avoid taking azilsartan and chlorthalidone with aliskiren if you have kidney disease.

To make sure this medicine is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • gout;

  • an electrolyte imbalance (such as low levels of potassium in your blood);

  • a history of heart disease or stroke; or

  • if you are dehydrated.

FDA pregnancy category D. Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Azilsartan and chlorthalidone can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

It is not known whether azilsartan and chlorthalidone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medicine.

Azilsartan and chlorthalidone is not approved for use by anyone younger than 18 years old.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Azilsartan and chlorthalidone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • feeling like you might pass out;

  • urinating less than usual or not at all;

  • drowsiness, confusion, mood changes, increased thirst, loss of appetite;

  • swelling, weight gain, feeling short of breath; or

  • signs of electrolyte imbalance--dry mouth, extreme thirst, weakness, drowsiness, restless feeling, confusion, increased or decreased urination, nausea and vomiting, constipation, muscle pain or weakness, fast heart rate, or seizure (convulsions).

Common side effects may include:

  • dizziness; or

  • feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store and/or throw out Edarbyclor?

  • Store in the original container at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Contraindications

  • Edarbyclor is contraindicated in patients with anuria [see Warnings and Precautions (5.3)].
  • Do not coadminister aliskiren-containing products with Edarbyclor in patients with diabetes [see Drug Interactions (7)].

Warnings and Precautions

Fetal Toxicity

Azilsartan medoxomil

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal 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 Edarbyclor as soon as possible [see Use in Specific Populations (8.1)].

Chlorthalidone

Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia.

Hypotension in Volume- or Salt-Depleted Patients

In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with Edarbyclor. Such patients are probably not good candidates to start therapy with more than one drug; therefore, correct volume prior to administration of Edarbyclor. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Impaired Renal Function

Edarbyclor

Monitor for worsening renal function in patients with renal impairment. Consider withholding or discontinuing Edarbyclor if progressive renal impairment becomes evident.

Azilsartan medoxomil

As a consequence of inhibiting the renin-angiotensin system, changes in renal function may be anticipated in susceptible individuals treated with Edarbyclor. In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g., patients with severe congestive heart failure, renal artery stenosis, or volume depletion), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. Similar results may be anticipated in patients treated with Edarbyclor [see Drug Interactions (7), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported. There has been no long-term use of azilsartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results are expected.

Chlorthalidone

In patients with renal disease, chlorthalidone may precipitate azotemia. If progressive renal impairment becomes evident, as indicated by increased blood urea nitrogen, consider withholding or discontinuing diuretic therapy.

Serum Electrolyte Imbalances

Thiazide diuretics can cause hyponatremia and hypokalemia. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone. Co-administration of digitalis may exacerbate the adverse effects of hypokalemia. Monitor serum electrolytes periodically.

Edarbyclor attenuates chlorthalidone-associated hypokalemia. In patients with normal potassium levels at baseline, 1.7% of Edarbyclor-treated patients, 0.9% of azilsartan medoxomil-treated patients, and 13.4% of chlorthalidone-treated patients shifted to low potassium values (less than 3.4 mmol/L).

Hyperuricemia

Chlorthalidone

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics.

Important information

You should not use Edarbyclor if you are unable to urinate.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant. Edarbyclor can cause injury or death to an unborn baby.

If you have diabetes, do not use Edarbyclor together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

Before taking this medicine

You should not use Edarbyclor if you are allergic to azilsartan or chlorthalidone, or if you are unable to urinate.

If you have diabetes, do not use Edarbyclor together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

You may also need to avoid taking Edarbyclor with aliskiren if you have kidney disease.

To make sure this medicine is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • gout;

  • an electrolyte imbalance (such as low levels of potassium in your blood);

  • a history of heart disease or stroke; or

  • if you are dehydrated.

FDA pregnancy category D. Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Edarbyclor can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

It is not known whether azilsartan and chlorthalidonepasses into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medicine.

Edarbyclor is not approved for use by anyone younger than 18 years old.

What other drugs will affect Edarbyclor?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Edarbyclor, especially:

  • digoxin;

  • lithium;

  • a diuretic or "water pill"; or

  • other heart or blood pressure medicines.

This list is not complete. Other drugs may interact with azilsartan and chlorthalidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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