Spilac-F
Generic Name
Spironolactone and Furosemide
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| spilac f 20 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Spilac-F is a combination diuretic containing Spironolactone and Furosemide. It is used to treat fluid retention (edema) and high blood pressure (hypertension), especially when there is a risk of potassium loss with other diuretics.
Uses & Indications
Dosage
Adults
Typical initial dose: 1 tablet (Spironolactone 50 mg + Furosemide 20 mg) once daily. Dosage may be adjusted based on patient response and clinical condition.
Elderly
Initiate with a lower dose and monitor renal function and electrolytes closely. Dosage should be individualized.
Renal_impairment
Use with caution. Contraindicated in anuria and acute renal failure. Dosage adjustment may be required in moderate impairment; regular monitoring of electrolytes and renal function is essential. Not recommended in severe impairment.
How to Take
Administer orally, preferably in the morning to avoid nocturnal diuresis. Can be taken with or without food. Swallow the tablet whole with water.
Mechanism of Action
Furosemide is a loop diuretic that inhibits the reabsorption of sodium and chloride in the loop of Henle, leading to increased excretion of water, sodium, chloride, and potassium. Spironolactone is an aldosterone antagonist that competitively binds to aldosterone receptors in the distal renal tubules, increasing sodium and water excretion while conserving potassium. The combination helps to prevent potassium loss caused by furosemide.
Pharmacokinetics
Onset
Furosemide: 30-60 minutes (oral), Spironolactone: Gradual, full effect may take several days.
Excretion
Furosemide: Primarily renal (60-80% unchanged), some biliary/fecal. Spironolactone: Primarily renal (as metabolites), some biliary/fecal.
Half life
Furosemide: 1-1.5 hours. Spironolactone: Active metabolites (e.g., canrenone) have longer half-lives (13-24 hours).
Absorption
Furosemide is rapidly absorbed from the GI tract (oral bioavailability 60-70%). Spironolactone is well absorbed and extensively metabolized.
Metabolism
Furosemide: Hepatic (some renal metabolism). Spironolactone: Extensively metabolized in the liver to active and inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Spironolactone, Furosemide, or any component of the formulation.
- Anuria (absence of urine production).
- Acute renal failure.
- Hyperkalemia (high blood potassium levels).
- Severe hepatic impairment, especially with encephalopathy.
- Addison's disease or other conditions associated with hyperkalemia.
Drug Interactions
Lithium
Increased risk of lithium toxicity.
Other antihypertensives
Potentiated hypotensive effect.
Aminoglycoside antibiotics
Increased risk of ototoxicity (hearing damage).
Corticosteroids, ACTH, Amphotericin B
Enhanced electrolyte depletion, particularly hypokalemia (though spironolactone counteracts this).
ACE inhibitors, ARBs, Potassium supplements, NSAIDs, Trimethoprim
Increased risk of hyperkalemia.
Storage
Store below 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include dehydration, electrolyte imbalance (e.g., hyperkalemia, hyponatremia), hypotension, and gastrointestinal disturbances. Management involves supportive care, correction of electrolyte and fluid imbalances, and discontinuation of the drug. Hemodialysis is not effective for spironolactone.
Pregnancy & Lactation
Pregnancy Category C for both Spironolactone and Furosemide. Use only if potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding as both drugs are excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to Spironolactone, Furosemide, or any component of the formulation.
- Anuria (absence of urine production).
- Acute renal failure.
- Hyperkalemia (high blood potassium levels).
- Severe hepatic impairment, especially with encephalopathy.
- Addison's disease or other conditions associated with hyperkalemia.
Drug Interactions
Lithium
Increased risk of lithium toxicity.
Other antihypertensives
Potentiated hypotensive effect.
Aminoglycoside antibiotics
Increased risk of ototoxicity (hearing damage).
Corticosteroids, ACTH, Amphotericin B
Enhanced electrolyte depletion, particularly hypokalemia (though spironolactone counteracts this).
ACE inhibitors, ARBs, Potassium supplements, NSAIDs, Trimethoprim
Increased risk of hyperkalemia.
Storage
Store below 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include dehydration, electrolyte imbalance (e.g., hyperkalemia, hyponatremia), hypotension, and gastrointestinal disturbances. Management involves supportive care, correction of electrolyte and fluid imbalances, and discontinuation of the drug. Hemodialysis is not effective for spironolactone.
Pregnancy & Lactation
Pregnancy Category C for both Spironolactone and Furosemide. Use only if potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding as both drugs are excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, check product packaging for exact expiry.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of both Spironolactone and Furosemide individually and in combination for their indicated uses.
Lab Monitoring
- Serum electrolytes (potassium, sodium, chloride, magnesium, calcium) at baseline and regularly during treatment.
- Renal function tests (creatinine, BUN) at baseline and regularly.
- Liver function tests, especially in patients with pre-existing hepatic impairment.
- Blood pressure monitoring.
Doctor Notes
- Emphasize regular monitoring of serum electrolytes (especially potassium) and renal function, particularly in elderly patients and those with existing cardiac, hepatic, or renal conditions.
- Advise patients on symptoms of hyperkalemia and hypovolemia.
- Counsel male patients about the potential for gynaecomastia with spironolactone use.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking it without consulting your doctor, even if you feel better.
- Monitor your fluid intake and report any signs of excessive fluid loss or electrolyte imbalance.
- Avoid rapid changes in position to prevent dizziness due to reduced blood pressure.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness or lightheadedness, especially at the start of treatment. Avoid driving or operating machinery until you know how it affects you.
Lifestyle Advice
- Maintain adequate hydration.
- Limit high-sodium foods.
- Monitor your blood pressure and weight regularly.
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