Unipril
Generic Name
Fosinopril Sodium
Manufacturer
Hypothetical Pharma Co.
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| unipril 125 mg tablet | ৳ 2.51 | ৳ 25.10 |
Description
Overview of the medicine
Unipril 125 mg tablet (Fosinopril Sodium) is an angiotensin-converting enzyme (ACE) inhibitor used primarily for the treatment of hypertension and congestive heart failure. Please note that 125 mg is an unusually high strength for Fosinopril and typically requires extreme caution and specific clinical justification.
Uses & Indications
Dosage
Adults
The usual therapeutic range for Fosinopril Sodium is 10-40 mg once daily. A 125 mg dose is significantly higher than typically recommended and would only be considered in highly exceptional circumstances under strict medical supervision due to increased risk of severe adverse effects such as profound hypotension, renal failure, and hyperkalemia. It is generally not a standard or recommended dose.
Elderly
No specific dose adjustment is usually required for elderly patients, but lower starting doses may be considered. A 125 mg dose is not appropriate for the elderly.
Renal_impairment
In patients with renal impairment, initial dosage may be reduced. Fosinopril has a balanced elimination pathway, so dosage adjustment may be less critical than for other ACEIs, but monitoring is essential. A 125 mg dose is extremely high for renal impairment patients and contraindicated.
How to Take
Take orally, once daily, with or without food. It is best taken at the same time each day.
Mechanism of Action
Fosinopril is a prodrug that is hydrolyzed to fosinoprilat, which inhibits ACE. This inhibition prevents the conversion of angiotensin I to angiotensin II (a potent vasoconstrictor and aldosterone secretor), leading to vasodilation, reduced peripheral resistance, and decreased blood pressure. It also reduces aldosterone secretion, leading to decreased sodium and water retention.
Pharmacokinetics
Onset
Onset of action typically occurs within 1 hour, with peak effect at 2-6 hours.
Excretion
Approximately half of the absorbed fosinoprilat is excreted in urine and half in feces, suggesting a balanced elimination pathway.
Half life
Effective half-life for fosinoprilat is approximately 11.5 hours.
Absorption
Approximately 36% of an oral dose of fosinopril sodium is absorbed. Absorption is not affected by food.
Metabolism
Fosinopril is metabolized in the liver to fosinoprilat, the active metabolite.
Side Effects
Contraindications
- History of angioedema related to previous ACE inhibitor treatment
- Hereditary or idiopathic angioedema
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m²)
- Pregnancy (second and third trimesters)
Drug Interactions
Lithium
Increased serum lithium levels and lithium toxicity. Monitor lithium levels.
Aliskiren
Concomitant use is contraindicated in patients with diabetes or renal impairment due to increased risk of hypotension, hyperkalemia, and renal dysfunction.
Diuretics
Increased hypotensive effect, risk of acute renal failure. Dose adjustment may be necessary.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the hypotensive effect of ACE inhibitors and increase the risk of renal impairment.
Potassium-sparing diuretics/Potassium supplements
Increased risk of hyperkalemia.
Storage
Store at room temperature (20°C to 25°C), away from moisture and direct light. Keep out of reach of children.
Overdose
Symptoms of overdose include severe hypotension. Treatment is supportive, including intravenous saline infusion to restore blood pressure. Hemodialysis may be considered.
Pregnancy & Lactation
Fosinopril is contraindicated during the second and third trimesters of pregnancy due to fetal toxicity. Discontinue immediately if pregnancy is detected. Use with caution during lactation; consult a doctor.
Side Effects
Contraindications
- History of angioedema related to previous ACE inhibitor treatment
- Hereditary or idiopathic angioedema
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m²)
- Pregnancy (second and third trimesters)
Drug Interactions
Lithium
Increased serum lithium levels and lithium toxicity. Monitor lithium levels.
Aliskiren
Concomitant use is contraindicated in patients with diabetes or renal impairment due to increased risk of hypotension, hyperkalemia, and renal dysfunction.
Diuretics
Increased hypotensive effect, risk of acute renal failure. Dose adjustment may be necessary.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the hypotensive effect of ACE inhibitors and increase the risk of renal impairment.
Potassium-sparing diuretics/Potassium supplements
Increased risk of hyperkalemia.
Storage
Store at room temperature (20°C to 25°C), away from moisture and direct light. Keep out of reach of children.
Overdose
Symptoms of overdose include severe hypotension. Treatment is supportive, including intravenous saline infusion to restore blood pressure. Hemodialysis may be considered.
Pregnancy & Lactation
Fosinopril is contraindicated during the second and third trimesters of pregnancy due to fetal toxicity. Discontinue immediately if pregnancy is detected. Use with caution during lactation; consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date.
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Patent expired
Clinical Trials
Fosinopril has undergone extensive clinical trials demonstrating its efficacy and safety for hypertension and heart failure at standard therapeutic doses (10-40 mg). No specific trials supporting a 125 mg dose are publicly available.
Lab Monitoring
- Serum creatinine and blood urea nitrogen (BUN) to monitor renal function
- Serum potassium levels to check for hyperkalemia
- Liver function tests periodically
Doctor Notes
- Emphasize patient education on adherence and potential side effects, particularly cough and angioedema.
- Regular monitoring of renal function and serum potassium is crucial, especially when initiating treatment or adjusting dosage.
- 125 mg of Fosinopril is a significantly supra-therapeutic dose; extreme caution, close monitoring for adverse effects, and clear justification are paramount if such a dose is ever considered. It is generally not advisable.
Patient Guidelines
- Take medication regularly as prescribed.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Report any swelling of the face, lips, tongue, or throat immediately.
- Avoid potassium supplements or salt substitutes containing potassium without medical advice.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
May cause dizziness, especially at the start of treatment or when changing doses. Avoid driving or operating machinery until you know how it affects you.
Lifestyle Advice
- Maintain a healthy diet low in sodium.
- Engage in regular physical activity.
- Avoid smoking and excessive alcohol consumption.
- Monitor blood pressure regularly at home.
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