Azilsartan-Chlorthalidone

Azilsartan-Chlorthalidone is a combination medication used for the treatment of hypertension (high blood pressure) in patients not adequately controlled with monotherapy.

• Azilsartan-Chlorthalidone is available under the following different brand names: Edarbyclor

Common side effects of Azilsartan-Chlorthalidone include:

• dizziness
• fatigue
• weakness
• tiredness
• skin rash
• diarrhea
• nausea
• upset stomach
• cough

Serious side effects of Azilsartan-Chlorthalidone include:

• lightheadedness
• urinating less than usual or not at all
• drowsiness
• confusion
• mood changes
• increased thirst
• loss of appetite
• swelling
• weight gain
• feeling short of breath
• electrolyte imbalance (dry mouth, extreme thirst, drowsiness, restless feeling, confusion, increased or decreased urination, constipation, muscle pain or weakness, fast heart rate, or seizures/convulsions)

Rare side effects of Azilsartan-Chlorthalidone include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 40 mg/12.5 mg
• 40 mg/25 mg

Hypertension

Adult dosage

• 40 mg/12.5 mg orally every day initially; may increase to 40 mg/25 mg after 2–4 weeks as needed to achieve blood pressure goals; not to exceed 40 mg/25 mg daily
• Switching from ARB or diuretic monotherapy: Initiate with 40 mg/12.5 mg orally every day

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Azilsartan-Chlorthalidone has severe interactions with the following drugs:
  • aliskiren
  • sparsentan
• Azilsartan-Chlorthalidone has serious interactions with the following drugs:
  • aliskiren
  • aminolevulinic acid oral
  • aminolevulinic acid topical
  • benazepril
  • captopril
  • enalapril
  • fosinopril
  • isocarboxazid
  • lisinopril
  • lithium
  • lofexidine
  • methyl aminolevulinate
  • moexipril
  • perindopril
  • potassium phosphates, IV
  • quinapril
  • ramipril
  • squill
  • trandolapril
  • tretinoin
• Azilsartan-Chlorthalidone has moderate interactions with at least 177 drugs
• Azilsartan-Chlorthalidone has minor interactions with at least 108 drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions, or concerns.

Contraindications

• Anuria
• Coadministration with aliskiren-containing products in patients with diabetes

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Azilsartan-Chlorthalidone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Azilsartan-Chlorthalidone?”

Cautions

• Hyperuricemia
  • Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics
• Fetal toxicity
  • 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
  • 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, symptomatic hypotension may occur after initiation of treatment; such patients are probably not good candidates to start therapy with more than one drug
  • Correct volume prior to administration; if hypotension does occur, place the patient in a supine position and, if necessary, give an IV infusion of normal saline
  • Transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized
• Electrolytes
  • Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone; Edarbyclor attenuates chlorthalidone-associated hypokalemia
  • Coadministration of digitalis may exacerbate adverse effects of hypokalemia
  • Thiazide diuretics can cause hyponatremia and hypokalemia; drugs that inhibit the renin-angiotensin system can cause hyperkalemia; monitor serum electrolytes periodically
• Impaired renal function
  • Monitor for worsening renal function in patients with renal impairment; consider withholding or discontinuing if progressive renal impairment becomes evident
  • May cause renal failure in patients with renal artery stenosis
• Azilsartan:
  • Dual blockade of the renin-angiotensin system with ARBs, ACE inhibitors, or aliskiren is associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy
  • As a consequence of inhibiting the renin-angiotensin system, changes in renal function may be anticipated in susceptible individuals receiving therapy
  • In patients whose renal function may depend on the activity of the renin-angiotensin system (eg, 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 receiving therapy
• 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

Pregnancy and Lactation

• Drugs can cause fetal harm when administered to a pregnant woman; 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; 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; when pregnancy is detected, discontinue drug as soon as possible
• Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section and post-partum hemorrhage); hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly
• Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters can result in reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death
• Perform serial ultrasound examinations to assess the intra-amniotic environment; closely observe infants with histories of in-utero exposure to the drug for hypotension, oliguria, and hyperkalemia; in neonates with a history of in-utero exposure to the drug, if oliguria or hypotension occurs, support blood pressure and renal perfusion; exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function
• Thiazides cross the placenta; use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possible other adverse reactions that have occurred in adults
• Lactation
  • There is limited information regarding the presence of azilsartan in human milk, its effects on breastfed infants, or on milk production; azilsartan is present in rat milk; thiazide-like diuretics like chlorthalidone are excreted in human milk; because of its potential for adverse effects on the nursing infant, advise a nursing woman that breastfeeding is not recommended during therapy