Spiromide Tablet (10 Tab)

SPIROMIDE TABLET

Name: Spiromide Tablet (Brand name)

Composition: Each film-coated tablet contains:

• Spironolactone: 50 mg
• Furosemide: 20 mg

Uses: Spiromide Tablet is a combination medication primarily used to manage fluid retention (oedema) and high blood pressure. It is prescribed for:

• Oedema associated with congestive heart failure
• Oedema and ascites associated with liver cirrhosis
• Oedema in kidney disorders, including nephrotic syndrome
• Mild to moderate essential hypertension (high blood pressure)
• Resistant oedema where it is associated with secondary hyperaldosteronism

Dosage and Administration: Spiromide Tablet is for oral administration. The dose must be the lowest sufficient to achieve the desired effect.

• Adults: Typically, 1-4 tablets daily.
• Tablets are best taken at breakfast and/or lunch with a generous amount of liquid.
• An evening dose is generally not recommended, especially during initial treatment, to avoid increased nocturnal urination.
• Take the whole tablet without chewing or crushing.
• Take with or immediately after meals to minimize stomach irritation.
• Children: The product is not suitable for use in children.

Side Effects: Common side effects may include:

• Dizziness, lightheadedness, or headache
• Nausea, vomiting, diarrhea, or stomach upset
• Increased urination
• Dehydration and electrolyte disturbances (e.g., hyperkalemia, hyponatremia, hypochloremic alkalosis)
• Low blood pressure (hypotension)
• Muscle cramps or weakness
• Elevated blood urea, hyperuricemia (which can precipitate gout), and hyperglycemia
• Gynecomastia (in males), and vocal changes (hoarseness, deepening of voice in women, increase in pitch in men)
• Tinnitus, hearing loss (temporary, rarely irreversible)

Precautions:

• Contraindications: Do not use in patients with hypovolemia or dehydration, impaired renal function (creatinine clearance below 30ml/min), anuria, renal failure not responding to furosemide, hyperkalemia, severe hypokalemia, severe hyponatremia, Addison's disease, or hypersensitivity to furosemide, spironolactone, or sulfonamide derivatives. Not recommended during pregnancy and breastfeeding.
• Monitoring: Regular monitoring of serum electrolytes (potassium, sodium), blood pressure, kidney function, and blood glucose levels is essential.
• Drug Interactions: Exercise caution with potassium supplements or other potassium-sparing agents, ACE inhibitors, Angiotensin II receptor antagonists, NSAIDs, cardiac glycosides, lithium, sucralfate, aminoglycosides, and cisplatin, as these can lead to adverse interactions.
• Alcohol: Avoid alcohol consumption due to increased risk of low blood pressure.
• Specific Conditions: Use with caution in patients with hepatic cirrhosis (risk of encephalopathy), hypoproteinemia, diabetes, prostatic hypertrophy, or conditions where vocal changes are particularly important (e.g., actors, singers).
• Driving/Operating Machinery: May cause dizziness or sleepiness; avoid driving or operating heavy machinery until you know how it affects you.

Storage:

• Store in a cool and dry place, away from direct sunlight.
• Keep out of sight and reach of children.
• Typically stored below 25°C or 30°C.
• Protect from moisture and freezing.

What is Spiromide Tablet used for?

Spiromide Tablet is primarily used to manage fluid retention, also known as oedema or swelling, which is associated with conditions like congestive heart failure, liver cirrhosis (fluid build-up in the abdomen, known as ascites), and certain kidney disorders such as nephrotic syndrome. It may also be prescribed as an add-on treatment for mild to moderate essential hypertension (high blood pressure).

How does Spiromide Tablet work?

Spiromide Tablet contains two active ingredients: Furosemide and Spironolactone. Furosemide is a loop diuretic that works by inhibiting the reabsorption of sodium and chloride in the kidneys, leading to increased urine production and the removal of excess water and electrolytes from the body. Spironolactone is a potassium-sparing diuretic and an aldosterone antagonist. It blocks the action of aldosterone, a hormone that causes the body to retain sodium and water, thereby promoting sodium and water excretion while helping to prevent the excessive loss of potassium that can occur with Furosemide alone. This dual action helps to efficiently reduce fluid overload and maintain electrolyte balance.

What is the usual dosage of Spiromide Tablet?

For adults, the typical dosage of Spiromide Tablet ranges from 1 to 4 tablets daily, as determined by a healthcare provider based on the individual's condition and response to treatment. It is recommended to take the tablets with a generous amount of liquid at breakfast and/or lunch. Taking an evening dose is generally not advised, especially during initial treatment, to minimize nocturnal urination.

What are the possible side effects of Spiromide Tablet?

Common side effects may include increased urination, dizziness, headache, dehydration, low blood pressure (hypotension), and gastrointestinal disturbances such as nausea, diarrhea, or vomiting. It can also lead to electrolyte imbalances like high potassium levels (hyperkalaemia) or low sodium levels (hyponatremia). Less common but possible side effects include elevated blood urea, high uric acid levels (which can trigger gout), increased blood sugar, tinnitus (ringing in the ears), and temporary hearing loss. In males, gynecomastia (breast enlargement) has been reported. If you experience any persistent or severe side effects, consult your doctor.

Is Spiromide Tablet safe during pregnancy or breastfeeding?

Spiromide Tablet is generally not recommended during pregnancy and is contraindicated unless there are compelling medical reasons, as it may pose risks to the developing baby. Treatment during pregnancy requires monitoring of fetal growth. For breastfeeding mothers, Furosemide passes into breast milk and may inhibit lactation, and a metabolite of Spironolactone (canrenone) also appears in breast milk. Therefore, Spiromide Tablet must not be used by breastfeeding mothers. Always consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Can Spiromide Tablet be taken with other medications?

Spiromide Tablet can interact with various medications, potentially altering their effects or increasing the risk of side effects. It is crucial to inform your doctor about all other medications you are taking, including:

• Potassium supplements or other potassium-sparing agents: Concurrent use is not recommended as it can lead to severe hyperkalaemia (high potassium levels).
• NSAIDs (Non-Steroidal Anti-inflammatory Drugs) like ibuprofen: These can reduce the diuretic effect and increase the risk of kidney problems.
• ACE inhibitors or Angiotensin II Receptor Antagonists: Concomitant use can lead to a marked fall in blood pressure and deterioration in renal function.
• Lithium: Spiromide can increase serum lithium levels, leading to increased toxicity.
• Cardiac glycosides (e.g., Digoxin): Electrolyte disturbances caused by Spiromide can increase the toxicity of cardiac glycosides.
• Aminoglycosides and certain cephalosporins: Increased risk of ototoxicity (hearing damage) and nephrotoxicity (kidney damage).
• Sucralfate: May decrease the absorption of furosemide, reducing its effect; avoid taking within two hours of each other.
• Corticosteroids: May enhance potassium loss.

Dosage adjustments for concurrently administered cardiac glycosides, diuretics, and antihypertensive agents may be necessary.

What precautions should be taken while using Spiromide Tablet?

Several precautions should be observed when taking Spiromide Tablet:

• Contraindications: Do not use if you have known allergies to Furosemide, Spironolactone, sulfonamides, or any other components of the tablet. It is also contraindicated in patients with severe kidney impairment (creatinine clearance below 30ml/min), anuria (inability to produce urine), hyperkalaemia, severe hypokalaemia or hyponatremia, hypovolemia, dehydration, or Addison's disease.
• Medical Conditions: Use with caution if you have liver disease (especially severe cirrhosis), kidney disease, diabetes, hypotension (low blood pressure), or hypoproteinemia (low protein levels in the blood).
• Monitoring: Regular monitoring of kidney function, blood pressure, and electrolyte levels (especially potassium, sodium, calcium, and magnesium) is essential during treatment.
• Alcohol: Avoid consuming alcohol as it can increase the risk of low blood pressure and dizziness.
• Driving and operating machinery: Spiromide Tablet may cause dizziness, lightheadedness, or reduced mental alertness, so avoid driving or operating dangerous machinery until you know how it affects you.
• Diet: Avoid potassium-rich foods or potassium supplements unless specifically advised by your doctor, as Spironolactone helps to retain potassium. Reducing salt intake can also help manage fluid retention.
• Vocal changes: Spironolactone may cause vocal changes, which should be considered, especially for individuals whose voice is important for their profession (e.g., actors, singers, teachers).

What happens if a dose of Spiromide Tablet is missed?

If you miss a dose of Spiromide Tablet, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should Spiromide Tablet be stored?

Spiromide Tablet should be stored at room temperature, in a cool and dry place. Keep it away from direct sunlight, moisture, and excessive heat. Always ensure the medication is kept out of the reach of children.