Hydrochlorothiazide and irbesartan

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Hydrochlorothiazide and irbesartan

Generic name: hydrochlorothiazide and irbesartan (HYE droe KLOR oh THYE a zide and ir be SAR tan)
Brand name: Avalide
Dosage forms: oral tablet (12.5 mg-150 mg; 12.5 mg-300 mg)
Drug class: Angiotensin II inhibitors with thiazides






What is hydrochlorothiazide and irbesartan?

Hydrochlorothiazide is a diuretic (water pill). Irbesartan is an angiotensin II receptor blocker (sometimes called an ARB blocker).

Hydrochlorothiazide and irbesartan is a combination medicine used to treat high blood pressure (hypertension).

Hydrochlorothiazide and irbesartan may also be used for purposes not listed in this medication guide

Irbesartan and hydrochlorothiazide Uses

  • Hypertension:

    • It is indicated primarily for the treatment of hypertension.

Irbesartan and hydrochlorothiazide (Avalide, Coaprovel) Dose in the treatment of Hypertension: Oral:

Note:

  • The maximum antihypertensive effect of the drug is achieved after 2 – 4 weeks of the treatment, however, dosage titration may be done after one week with careful titration.
  • The treatment dose must be individualized.
  • Add-on therapy:

    • The combination therapy is indicated in patients with uncontrolled hypertension despite single agent or in whom edema is concerning.
  • Initial therapy:

    • Treatment is initiated at a dose of Irbesartan 150 mg/hydrochlorothiazide 12.5 mg once a day.
    • The dose may be titrated after a week or two if the initial response to treatment is inadequate.
    • The maximum daily dose is Irbesartan 300 mg/hydrochlorothiazide 25 mg.

 

Dose in Children:

It is not indicated for use in children.

 

Pregnancy Risk Factor D

        • [US Boxed Warning] Irbesartan can cause severe fetal harm. It can cause the death of the foetus.
        • Stop taking the medication as soon as you are certain that your pregnancy has been confirmed.

    Use of irrisartan or hydrochlorothiazide during breastfeeding

      • It is unknown whether irbesartan is excreted into breastmilk. Breastmilk is often contaminated with Thiazide Diuretics.
      • The manufacturer suggests discontinuing the drug or breastfeeding, depending on how important the drug therapy is to the mother.

 

Dose in Kidney Disease:

  • CrCl >30 mL/minute:
    • Adjustment in the dose is not necessary. Use with caution.
  • CrCl ≤30 mL/minute:
    • Avoid irbesartan in advanced kidney disease.
    • Hydrochlorothiazide is not effective in advanced kidney disease.

 

Dose in Liver Disease:

Adjustment in the dose is not necessary.

Use with caution in patients with advanced liver disease.

 

Side Effects of Irbesartan and hydrochlorothiazide (Avalide, Coaprovel):

  • Cardiovascular:

    • Edema
    • Chest Pain
    • Decreased Blood Pressure
    • Tachycardia
  • Central Nervous System:

    • Dizziness
    • Fatigue
  • Endocrine:

    • Hypokalemia
  • Gastrointestinal:

    • Nausea And Vomiting
    • Dyspepsia
    • Heartburn
    • Abdominal Pain
  • Genitourinary:

    • Difficulty In Micturition
  • Neuromuscular & Skeletal:

    • Musculoskeletal Pain
  • Renal:

    • Increased Blood Urea Nitrogen
    • Increased Serum Creatinine
  • Miscellaneous:

    • Flu-Like Symptoms

 

Contraindications to Irbesartan and hydrochlorothiazide (Avalide, Coaprovel):

  • Allergies to hydrochlorothiazide or sulfonamides-derived drugs (or any component of the formulation)
  • Concomitant use of the drug with aliskiren (for the reduction of proteinuria in patients with diabetes mellitus)
  • Anuria

Canadian labeling: Additional contraindications not in US labeling

  • Concomitant use with aliskiren in patients with a GFR <60 mL/minute/1.73 m2;
  • Use ACE inhibitors in conjunction with it (for the treatment of diabetic nephropathy patients who have high levels of proteinuria).
  • pregnancy;
  • Breastfeeding
  • Rare hereditary issues of glucose-galactose malabsorption or galactose intolerance are rare.

Warnings and precautions

  • Angioedema

    • Angioedema tends to be more common when angiotensin converting inhibitors (ACE-inhibitors) are used. However, it is rarer when angiotensin II receptor blocking agents are used.
    • Angioedema can occur after any treatment, especially after the first dose.
    • It can manifest as facial swelling, which may lead to obstruction of the airway or abdominal pain.
    • Edema is more common in patients who have a history of idiopathic edema or hereditary edema, and those who have had angioedema caused by ACE-inhibitors.
    • Patients with these conditions may need to be monitored for a long time.
    • Patients who have had a history of neck and head surgery must stop receiving treatment if angioedema develops. This is because the risk of obstruction to the airways in these patients can be high.
    • Patients must be aggressively managed and may require urgent airway care or intramuscular administration of epinephrine.
    • Patients who have angioedema to ARBs are not recommended for re-administration.
  • Electrolyte disturbances:

    • Angiotensin receptor blocking drugs can increase the risk of hyperkalemia.
    • Hyperkalemia is a risk for patients who are:
      • Patients with kidney dysfunction
      • Diabetes mellitus and
      • Use potassium-containing salts, potassium sparing diet diuretics or potassium supplements
    • Patients at high risk of hyperkalemia should not use it. A close monitoring of potassium levels is recommended.
    • Hypokalemia, hyponatremia and hypomagnesemia can be caused by Thiazide Diuretics.
  • Gout

    • Hydrochlorothiazide can trigger gout in people with kidney dysfunction, who have had gout in the past, and those who are prone to it in their families.
  • Hypersensitivity reactions

    • Hydrochlorothiazide may cause allergic reactions in some patients. Patients with a history or bronchial asthma and allergy are at high risk.
  • Hypotension

    • Hypotension can occur in patients with low blood volume, such as those who are being treated with high dose diuretics.
    • Before treatment can be initiated, volume depletion must first be rectified.
    • A combination pill can be used to treat hypotension, even if it is transient or initial.
  • Ocular effects

    • Myopia and acute angle-closure blindness have been linked to hydrochlorothiazide. Ocular symptoms may occur within hours or weeks after treatment is initiated.
    • Temporarily discontinuing the drug may be possible for patients who experience severe visual impairment. If the pain continues, additional treatment may be required to reduce ocular pain or ocular pressure.
    • Patients with penicillin allergies or a history of allergic reactions to sulfonamides are more likely to experience ocular symptoms.
  • Photosensitivity

    • Patients may develop Photosensitivity.
  • Renal function deterioration:

    • Use of ARBs may lead to impaired renal function and high creatinine.
    • Patients with low renal blood flow, such as those with heart failure or renal artery stenosis, may experience renal dysfunction. These patients have a reduced GFR due to efferent arterial vasoconstriction via angiotensin 2.
    • Oliguria, acute renal dysfunction, progressive azotemia, or both may be symptoms.
    • Although small deterioration can occur, it is possible to stop treatment if there is clinically significant impairment of renal function.
  • Allergy to sulfonamide (“sulfa”)

    • FDA-approved product labels for medications that contain a sulfonamide chemical groups include a wide contraindication for patients who have had an allergic reaction to sulfonamides in the past.
    • Cross-reactivity is possible between members of one class (eg two antibiotic sulfonamides).
    • Cross-reactivity concerns have been raised previously for all compounds with the sulfonamide structural (SO NH).
    • A better understanding of allergy mechanisms suggests that there are very few cross-reactivity opportunities between antibiotic sulfonamides, and nonantibiotic.
    • Cross-reactions due to antibody production (anaphylaxis) are less likely with non-antibiotic sulfuramides.
    • T-cell-mediated (type IV), reactions (eg maculopapular skin rash) are less understood. It is difficult to exclude this possibility based on current knowledge.
    • For severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, these drugs should not be used.
  • Mitral and aortic stenosis:

    • Patients with severe mitral or aortic valve obstruction should not use it.
  • Bariatric surgery

    • Dehydration
      • In the immediate aftermath of bariatric surgery, hydrochlorothiazide must be avoided as it can cause electrolyte disturbances or dehydration.
      • Once the patient has started drinking enough fluid, Thiazide or other diuretics can be resumed.
  • Diabetes:

    • Patients with diabetes and prediabetes should not use hydrochlorothiazide as it can cause impaired glucose metabolism.
  • Hepatic impairment

    • Patients suffering from severe hepatic impairment must be advised to avoid the drug.
    • It can lead to electrolyte imbalances and precipitate hepatic Encephalopathy.
    • Patients with advanced liver disease may be at risk from hepatorenal syndrome due to ARBs.
  • Hypercalcemia:

    • Thiazide diuretics cause hypercalcemia. Patients suffering from hypercalcemia should be cautious when taking thiazide diuretics.
  • Hypercholesterolemia:

    • Thiazide diuretics can cause an increase in cholesterol and triglyceride levels. Patients with high or moderate cholesterol should not use it.
  • Parathyroid disease

    • Hypercalcemia can be caused by Thiazide diuretics, which reduce renal calcium excretion.
    • Long-term use of the drug can cause pathologic changes to the parathyroid gland.
    • Patients who are being tested for parathyroid disease should also stop taking it.
  • Renal artery stenosis

    • Patients with bilateral renal arterial stenosis need to be advised ARBs with caution. Due to the increased risk of renal function impairment, ARBs should be avoided in patients with unstented bilateral renal arteriosis.
  • Renal impairment

    • ARBs should be used with caution in patients with preexisting renal disease. Preexisting azotemia may be worsened by hydrochlorothiazide.
  • Systemic lupus erythematosus (SLE):

    • Hydrochlorothiazide can activate or exacerebate SLE.

 

Monitoring Parameters:

  • Monitor Blood pressure;
  • serum electrolytes,
  • BUN and  creatinine

 

How to administer Irbesartan and hydrochlorothiazide (Avalide, Coaprovel)?

It is administered orally with or without food.

 

Mechanism of action of Irbesartan and hydrochlorothiazide (Avalide, Coaprovel):

Irbesartan:

      • It acts as an antagonist to angiotensin II receptors and causes the release aldosterone.
      • Aldosterone releases sodium and water into the kidneys, resulting in high blood pressure.
      • Irbesartan binds with the AT1 angiotensin I receptors, preventing angiotensin I from binding to its receptors.
      • It inhibits the vasoconstriction, and causes water and sodium depletion through its aldosterone inhibitoring effects.

Hydrochlorothiazide:

    • It is located in the distal renal tubules and inhibits the reabsorption sodium, water, potassium, or hydrogen ions.


 What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

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

Overdose symptoms may include fast or slow heartbeat, feeling light-headed, or fainting.



International Brand Names of Irbesartan and hydrochlorothiazide:

  • Avalide
  • ACT Irbesartan/HCT
  • Apo-Irbesartan/HCTZ
  • Avalide
  • Irbesartan-HCT
  • Irbesartan-HCTZ
  • JAMPIrbesartan and Hydrochlorothiazide
  • Mint-Irbesartan/HCTZ
  • PMS-Irbesartan HCTZ
  • Ran-Irbesartan HCTZ
  • ratio-Irbesartan HCTZ
  • Sandoz-Irbesartan HCT
  • Teva-Irbesartan HCTZ
  • Andaran HTC
  • Aprozide
  • Arbitan PLUS
  • Avalide
  • Avapro HCT
  • CoAprovel
  • Co-Besartin
  • Co-Irvebal
  • Co-Ivyzar
  • CoApprovel
  • Coaprovel
  • CoAprovel
  • Corycardon
  • Ibef
  • Ifirmacombi
  • Ihybes-G
  • Irbemed PLus
  • Irbeprex H
  • Irbezyd-H
  • Irbis-HT
  • Irovel-H
  • Irtan Plus
  • Karvezide
  • KoIrbesso
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