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INNOLACT 100MG TABLETS

Spirinolactone USP

FDA/SD.175-7459 Spirinolactone USP 100mg

What it does

Spironolactone is a medication that helps the body get rid of excess fluid and can also help balance certain hormones.

Commonly used for: heart failure, high blood pressure (hypertension), swelling (oedema), certain hormone-related conditions

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.175-7459
Registration date
2022-09-06
Expiry date
2027-09-01
Status
Valid
Active ingredient
Spirinolactone USP
Dosage form
Spirinolactone USP
Strength
100mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Oa & J Pharmaceuticals
Country of origin
-

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:01 · updated 2026-09-25 04:00:08

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Spironolactone is a medication that helps the body get rid of excess fluid and can also help balance certain hormones.

What it treats

  • heart failure
  • high blood pressure (hypertension)
  • swelling (oedema)
  • certain hormone-related conditions

How it works

It works by blocking a hormone that causes the body to retain salt and water, which helps lower blood pressure and reduces swelling.

Who it's for

It is usually prescribed for adults who have conditions related to fluid retention, high blood pressure, or hormonal imbalances.

Cautions

  • • May cause increased potassium levels in the blood.
  • • Should be used with care in patients with kidney problems.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: spirinolactone

Spironolactone is a potassium-sparing diuretic that acts primarily on the distal convoluted tubule and collecting duct of the nephron. It is commonly used for its ability to promote diuresis while conserving potassium, making it useful in various clinical settings such as hypertension, heart failure, and edema associated with liver cirrhosis or nephrotic syndrome. Spironolactone is also known for its anti-androgenic properties, which can be beneficial in conditions like hirsutism and acne.

Indications

  • Hypertension
  • Heart failure
  • Edema associated with liver cirrhosis
  • Nephrotic syndrome
  • Hirsutism
  • Acne

Dosage

Children: Refer to the BNF

Adults: Refer to the BNF for specific dosing guidelines based on the condition being treated.

Mechanism of action

Spironolactone is an aldosterone antagonist that works by competitively inhibiting the action of aldosterone at mineralocorticoid receptors in the renal tubules. This leads to increased excretion of sodium and water while retaining potassium. Additionally, its anti-androgen effects result from inhibition of androgen receptors and reduction of testosterone synthesis, contributing to its use in treating androgen-related disorders.

Pharmacodynamics

Spironolactone's diuretic effect results from its ability to block the reabsorption of sodium in exchange for potassium in the kidney, leading to increased urinary sodium and water excretion. The onset of action typically occurs within 24 to 48 hours of oral administration, with peak effects observed after several days of treatment. Its anti-androgenic effects can reduce symptoms associated with hyperandrogenism, such as acne and hirsutism.

Pharmacokinetics

Spironolactone is well absorbed from the gastrointestinal tract, with peak plasma concentrations reached within 1 to 3 hours after oral administration. It has a high volume of distribution and is extensively metabolized in the liver to active metabolites, including canrenone. The elimination half-life varies, generally ranging from 1.5 to 2 hours for spironolactone and 16 to 20 hours for its active metabolites. Excretion occurs primarily via the urine, with about 30% of the drug eliminated unchanged.

Contra-indications

  • Anuria
  • Acute renal insufficiency
  • Hyperkalemia
  • Hypersensitivity to spironolactone or any excipients
  • Pregnancy (unless specifically indicated)

Adverse effects

  • Hyperkalemia
  • Hypotension
  • Dizziness
  • Gastrointestinal disturbances (nausea, vomiting, diarrhea)
  • Gynecomastia
  • Menstrual irregularities
  • Rash
  • Fatigue

Interactions

  • Potassium-sparing diuretics (increased risk of hyperkalemia)
  • ACE inhibitors (increased risk of hyperkalemia)
  • Angiotensin II receptor antagonists (increased risk of hyperkalemia)
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) may reduce the diuretic effect
  • Digoxin (spironolactone may enhance the effects of digoxin)

Precautions

  • Monitor renal function and serum potassium levels regularly
  • Caution in patients with hepatic impairment
  • Use with caution in patients with diabetes mellitus
  • May cause electrocardiographic changes in patients with hyperkalemia

Pregnancy

Spironolactone is contraindicated in pregnancy unless specifically indicated for certain conditions, such as primary hyperaldosteronism.

Breast-feeding

Spironolactone is excreted in breast milk; use with caution and consider the benefits and risks.

Storage

Store at room temperature, away from moisture and heat. Protect from light.

Formulations

  • Tablets
  • Oral suspension

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.