Spironolactone (Hairos)25mg Tablets

Certainly! Here's the detailed information for Spironolactone (Hairos) 25mg Tablets:

Product Description:

Spironolactone (Hairos) is a potassium-sparing diuretic and aldosterone antagonist. It works by blocking the action of aldosterone, a hormone that regulates sodium and potassium balance. By inhibiting aldosterone, Spironolactone helps the kidneys remove excess sodium and water from the body, while retaining potassium. This action makes it useful in treating conditions related to fluid retention (edema) and high blood pressure.

Each Spironolactone (Hairos) 25mg tablet contains 25 mg of Spironolactone. It is commonly used in the treatment of hypertension, edema, heart failure, and certain hormonal conditions like hyperaldosteronism and hirsutism.

Indications:

Spironolactone (Hairos) is indicated for the following conditions:

1. Hypertension (High Blood Pressure):

   • Spironolactone can be used alone or in combination with other antihypertensive medications to manage high blood pressure.

2. Heart Failure:

   • Used to treat congestive heart failure (CHF), particularly in cases with fluid retention or edema, and it helps to reduce hospitalizations and improve survival.

3. Edema:

   • Effective in treating edema associated with conditions such as liver cirrhosis, nephrotic syndrome, or kidney disease, where the body accumulates excessive fluid.

4. Primary Hyperaldosteronism:

   • Used for the treatment of primary hyperaldosteronism, a condition where there is an overproduction of aldosterone, leading to high blood pressure and low potassium levels.

5. Hirsutism (Excessive Hair Growth):

   • Often prescribed off-label for hirsutism in women, as it works by reducing the effects of male hormones (androgens) that cause excessive hair growth.

6. Acne and Polycystic Ovary Syndrome (PCOS) (off-label use):

   • Sometimes used to treat acne and other symptoms associated with PCOS, particularly when hormonal imbalances are involved.

Dosages:

The dosage of Spironolactone (Hairos) varies depending on the condition being treated. Below are typical dosages:

• For Hypertension:

  • Initial Dose: 25 mg to 50 mg once daily, typically in the morning.

  • Maintenance Dose: The dose can be increased up to 100 mg per day if necessary, depending on the response and tolerance.

• For Edema (Fluid Retention):

  • Initial Dose: 25 mg to 100 mg daily, usually taken in a single dose or divided into two doses.

  • Maintenance Dose: The dose can be adjusted based on the severity of the edema. In severe cases, the dose can be increased to 200 mg per day.

• For Heart Failure:

  • Initial Dose: Typically starts at 25 mg to 50 mg once daily.

  • Maintenance Dose: The dose can be gradually increased based on clinical response, up to 100 mg to 200 mg per day, but should be monitored carefully.

• For Primary Hyperaldosteronism:

  • Initial Dose: 100 mg daily, taken in divided doses (morning and evening).

  • Maintenance Dose: The dose may be adjusted to 200 mg per day, depending on the patient's condition.

• For Hirsutism and PCOS (Off-label use):

  • Initial Dose: Typically 25 mg to 50 mg daily.

  • Maintenance Dose: This can be gradually increased if necessary.

Note: Always follow the exact dosage prescribed by your healthcare provider. The dosage may vary depending on individual needs and medical conditions.

Side Effects:

While Spironolactone (Hairos) is generally well tolerated, it can cause side effects. Common and serious side effects may include:

1. Common Side Effects:

   • Hyperkalemia (high potassium levels): Symptoms can include muscle weakness, irregular heartbeat, and fatigue.

   • Dizziness or lightheadedness, especially when standing up quickly.

   • Fatigue or feeling unusually tired.

   • Headache.

   • Gastrointestinal upset (nausea, vomiting, or diarrhea).

   • Menstrual irregularities (in women).

2. Serious Side Effects:

   • Hyperkalemia: High potassium levels can lead to serious heart issues, including arrhythmias. Symptoms of hyperkalemia include muscle weakness, slow or irregular heart rate, and numbness or tingling.

   • Gynecomastia (enlarged breasts in men): Spironolactone can cause breast enlargement in male patients, which may be reversible if the medication is stopped.

   • Severe allergic reactions: Rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.

   • Renal dysfunction: Can cause or worsen kidney problems in some patients. Kidney function should be monitored during treatment.

   • Jaundice (yellowing of the skin or eyes) or other signs of liver dysfunction.

3. Rare but Serious Side Effects:

   • Hypotension (low blood pressure): Especially when starting treatment or after an increase in dosage.

   • Confusion or mood changes, especially in elderly patients.

Contraindications:

Spironolactone (Hairos) should not be used in the following conditions:

1. Hypersensitivity:

   • Contraindicated in individuals with known allergy to Spironolactone or any of its components.

2. Hyperkalemia:

   • Spironolactone is contraindicated in patients with high potassium levels (hyperkalemia), as it may exacerbate this condition.

3. Severe Renal Impairment:

   • Should not be used in patients with severe renal dysfunction or acute renal failure, as the medication can worsen kidney function.

4. Anuria:

   • Contraindicated in patients who are unable to produce urine (anuria) or have severe renal insufficiency.

5. Addison’s Disease:

   • Contraindicated in patients with Addison's disease (a condition where the adrenal glands do not produce sufficient steroid hormones), as Spironolactone may exacerbate this condition.

6. Pregnancy:

   • Should be used with caution during pregnancy, especially in the first trimester. It is classified as Category C (risk cannot be ruled out), so it should only be used if clearly needed and prescribed by a healthcare provider.

7. Breastfeeding:

   • Should be used with caution while breastfeeding, as Spironolactone may pass into breast milk.

Warnings and Precautions:

1. Electrolyte Imbalances:

   • Spironolactone can cause hyperkalemia (high potassium levels), which can be dangerous. Regular monitoring of potassium levels is essential during treatment, especially in patients with kidney problems or those on potassium supplements.

2. Kidney Function:

   • Kidney function should be closely monitored, particularly during the first few weeks of treatment, as Spironolactone can cause or worsen renal impairment in some patients.

3. Elderly Patients:

   • Elderly patients may be more sensitive to Spironolactone, particularly with respect to its effects on kidney function and potassium levels.

4. Menstrual Irregularities:

   • Women may experience menstrual changes, including irregular periods or amenorrhea (absence of menstruation).

5. Breast Enlargement in Men (Gynecomastia):

   • Men may experience gynecomastia (enlargement of breast tissue), which can be bothersome but is often reversible if the medication is discontinued.

6. Drug Interactions:

   • Potassium supplements or salt substitutes containing potassium should be used with caution as they can increase the risk of hyperkalemia.

   • ACE inhibitors, ARBs, NSAIDs, and other diuretics may interact with Spironolactone and increase the risk of kidney dysfunction or electrolyte imbalances.

7. Caution in Hepatic Disease:

   • Use with caution in patients with liver disease, as Spironolactone can exacerbate liver-related fluid retention issues and may cause hepatic encephalopathy in severe cases.

Storage:

• Store Spironolactone (Hairos) at room temperature (20°C to 25°C), away from heat, moisture, and light.

• Keep out of the reach of children.

Important Note: Always follow your healthcare provider's instructions on how to take Spironolactone (Hairos) and attend regular follow-up appointments to monitor its effectiveness and any potential side effects. If you experience severe side effects or any signs of allergic reactions, seek medical attention immediately.