Aldactazide (Hydrochlorothiazide and spironolactone) is a combination pill of hydrochlorothiazide and spironolactone. Both are diuretics and helps in treating hypertensive patients with fluid retention or congestive cardiac failure.

Hydrochlorothiazide and spironolactone Uses:

• Edema:

  • It is used to treat edoema in cirrhosis of the liver, nephrotic syndrome, and congestive cardiac failure (CCF).

• Hypertension:

  • Mild to moderate hypertension is treated with it.

Hydrochlorothiazide and spironolactone (Aldactazide) Dose in Adults

Hydrochlorothiazide and spironolactone (Aldactazide) Dose in the treatment of Edema:

• Oral: Hydrochlorothiazide 25 - 200 mg per day and spironolactone 25 - 200 mg per day in single or divided doses

Hydrochlorothiazide and spironolactone (Aldactazide Dose in the treatment of Hypertension: Oral:

• Standard dosages of spironolactone and hydrochlorothiazide are 50 to 100 mg and 50 to 100 mg, respectively, per day.

• Alternate recommendations:

  • Hydrochlorothiazide's intended dose range is 25–100 mg given in one or two split doses (JNC 8)
  • Spironolactone 25–50 mg daily and hydrochlorothiazide 12.5–50 mg daily are the typical dosing ranges.

Hydrochlorothiazide and spironolactone (Aldactazide) Dose in Children

Note: The term "product" refers to a predetermined mixture of components in defined milligramme ratios, such as hydrochlorothiazide and spironolactone.

Hydrochlorothiazide and spironolactone (Aldactazide) Dose in the treatment of Bronchopulmonary dysplasia (BPD):

Few data are available, and efficacy outcomes can vary. Diuretics are employed in clinical practise because to their many advantages in the management of BPD, including the best length of treatment and influence on pulmonary endpoints.

• Infants:

  • Oral: 1.5 mg/kg/dose every 12 hours

Hydrochlorothiazide and spironolactone (Aldactazide) Dose in the treatment of Edema and Hypertension: 

• Infants, Children, and Adolescents:

  • Oral: Initial: 1 mg/kg/day in divided doses once or twice a day;
  • It can be titrated up to the maximum daily dose, which is 100 mg per day or 3 to 3.3 mg/kg/day.

Pregnancy Risk Category: C

• This product has not been used in animal reproduction studies.
• Contraindications in pregnancy can be made by individual agents.

Use of spironolactone and hydrochlorothiazide during breastfeeding

• Breastmilk contains the active metabolite (canrenone), and the thiazide diuretics.
• Breastfeeding can lead to serious adverse reactions in infants.
• US labeling suggests that you consider the importance of the mother's treatment.
• It should be decided whether to cease nursing or stop taking the medication.
• Talk to individual agents.

Hydrochlorothiazide and spironolactone (Aldactazide) Dose in Kidney Disease:

• No dose adjustments listed in the manufacturer’s labeling
• With CrCl below 30 mL/min, hydrochlorothiazide has limited efficacy; it should not be used in individuals who have major renal abnormalities including anuria, acute renal insufficiency, or significant renal excretory function impairment.
• For additional considerations, see individual drugs.

Dose in Liver disease:

• No dose adjustments listed in manufacturer’s labelling.
• Contraindicated in acute or severe liver failure.

Side effects of Aldactazide (Hydrochlorothiazide and spironolactone):

See individuals agents: Spironolactone and hydrochlorothiazide.

Contraindications to Hydrochlorothiazide and spironolactone (Aldactazide):

• Hypersensitivity to thiazides and sulphonamide-derived medications
• Anuria, acute renal insufficiency; renal decompensation; significant impairments of renal excretory function
• Hypercalcemia
• Hyperkalemia
• Addison's Disease
• Hepatic impairment, acute or severe

Canadian labeling: Additional contraindications not in US labeling

• Hypersensitivity to spironolactone and any component of the formulation
• Use eplerenone, low molecular weight Heparin and heparin in conjunction
• Pregnancy;
• Breastfeeding

Notice: 

• The FDA-approved product labelling states that this medication should not be taken with other sulphonamide-containing drug classes, but the validity of this claim has been questioned.
• See "Warnings/Precautions" for more detail.

Warnings and precautions

• CNS effects

  • There have been reports of dizziness and somnolence as a result of the use
  • These side effects, especially somnolence or dizziness, should be discussed with patients.
  • Patients should also be advised to exercise caution while operating machinery or driving until the initial treatment is completed.

• Electrolyte disturbances:

  • SpironolactoneHyperkalemia can occur; risk factors
    • • Renal dysfunction
      • diabetes mellitus
      • Use of potassium-depleting diuretics, potassium supplements, or potassium-containing sodium salts concurrently
  • When utilising these substances, exercise caution. Keep a tight eye on potassium levels as well.
  • Hypokalemia, hypochloremic acidosis, hypomagnesemia and hyponatremia can be caused by Thiazide diuretics.

• Gout

  • Hydrochlorothiazide can cause gout in some patients who have gout history, chronic renal failure, or a family predisposition.
  • Higher risk is associated with doses >=25mg

• Gynecomastia

  • spironolactone therapy (Related both to dose and duration).
  • After therapy is stopped, the condition is typically reversible, however it might not always recur.

• Hyperkalemia:

  • Hyperkalemia is a possibility. Be aware that serum potassium levels increase in a dose-related manner. Hyperkalemia rates rise as renal function declines.
  • Combining stronger ACE inhibitor dosages (such as lisinopril >= 10 mg per day in adults) raises the risk of hyperkalemia.
  • Hyperkalemia may require dose reductions or discontinuation of therapy.
  • Hyperkalemia patients should not be given this medicine.
  • Hyperkalemia can be dangerous.

• Hypersensitivity reactions

  • Hydrochlorothiazide can cause hypersensitivity reactions.
  • Patients with bronchial or allergy history are at greater risk.

• Ocular effects

  • Patients with acute transient myopia or acute angle-closure vision loss may experience hydrochlorothiazide.
  • Stop using it immediately if you have severe visual impairments or pain.
  • If intraocular pressure is not under control, more treatments can be needed.
  • A risk factor could be a history of sulfonamide or penicillin allergies.

• Photosensitivity

  • Photosensitization may occur.

• Allergy to sulfonamide ("sulfa")

  • For drugs that have experienced an allergic reaction and contain a sulphonamide chemical group, FDA-approved product labelling is available.
  • It is conceivable for members of one particular class to exhibit cross-reactivity (eg two antibiotic sulphonamides).
  • A deeper understanding of allergy mechanisms has shown that cross-reactivity between non-antibiotic sulfonamides or antibiotic sulfonamides is very unlikely. It may not happen.
  • T-cell-mediated reactions (type IV hypersensitivity) (eg, maculopapular skin rash) are less well understood. It is impossible to exclude this possibility based on current knowledge.
  • Some clinicians avoid these classes because of severe reactions such as Stevens-Johnson syndrome/TEN.

• Tumorigenic:

  • When administered for a longer time, Spironolactone was found to be tumorigenic in animal experiments.
  • Avoid unnecessary use

• Diabetes:

  • Hydrochlorothiazide should be used with caution in patients suffering from prediabetes and diabetes mellitus.
  • This might alter how your body controls your blood sugar.

• Hepatic impairment

  • Treatment of patients with mild to moderate hepatic impairment should be cautious.
  • Contraindicated for severe or acute hepatic impairment
  • Hepatic encephalopathy/coma can occur in progressive/severe liver diseases.

• Hypercalcemia:

  • The excretion of calcium from the kidneys may be decreased by Thiazide diuretics
  • Hypercalcemia patients should be advised not to take this medication.

• Hypercholesterolemia:

  • Patients with high or moderate cholesterol levels should be cautious.
  • Thiazide can increase cholesterol and triglyceride levels.

• Parathyroid disease

  • Thiazide diuretics reduce calcium excretion
  • Long-term use can cause parathyroid gland pathologic changes with hypophosphatemia and hypercalcemia.
  • Do not discontinue testing for parathyroid function.

• Renal impairment

  • Patients with impaired renal function may experience cumulative effects, such as azotemia.
  • Hydrochlorothiazide is not effective in severe renal disease.
  • Spironolactone may produce hyperkalemia in patients with renal impairment; the risk is raised with deteriorating renal function and when it is used in conjunction with higher doses of ACE inhibitors, such as lisinopril >= 10 mg/day.
    caution should be exercised in patients with minor renal impairment.
  • Anuria, acute renal failure, renal decompensation, or substantial abnormalities in renal excretory function are contraindicated.

• Systemic lupus erythematosus (SLE):

  • SLE activation or exacerbation may be caused by hydrochlorothiazide.

Monitoring parameters:

• Blood pressure
• Serum electrolytes
• Input & Output ratios
• Renal function

How to administer Aldactazide (Hydrochlorothiazide and spironolactone)?

Oral:

• With or without food, it can be taken in single or split dosages.

Mechanism of action of Aldactazide (Hydrochlorothiazide and spironolactone):

See individual agents (Hydrochlorothiazide and Spironolactone)

International Brand Names of Hydrochlorothiazide and spironolactone:

• Aldactazide
• Aldactazide 25
• Aldactazide 50
• Teva-Spironolactone/HCTZ
• Adactazida
• Aldactazide
• Aldazida
• Ondolen
• Slosat
• Spironothiazid
• Spirozide

Hydrochlorothiazide and spironolactone Brand Names in Pakistan: