Rasalet
Generic Name
Aliskiren
Manufacturer
Acme Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rasalet 1 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Rasalet 1 mg Tablet contains Aliskiren, a direct renin inhibitor, used to treat essential hypertension (high blood pressure). It helps to lower blood pressure by blocking the activity of renin, an enzyme that plays a key role in regulating blood pressure.
Uses & Indications
Dosage
Adults
Initial dose for Aliskiren is typically 150 mg once daily, may be increased to a maximum of 300 mg once daily. (Note: 1 mg is not a standard therapeutic dose for hypertension.)
Elderly
No specific dose adjustment required for elderly patients based on age alone, but caution with renal impairment is advised.
Renal_impairment
Initiate with 150 mg once daily. Avoid in severe renal impairment (eGFR < 30 mL/min/1.73 m²) or in combination with ARBs/ACE inhibitors in such patients.
How to Take
Take orally once daily, preferably at the same time each day. It can be taken with or without food, but consistency in relation to food intake is recommended.
Mechanism of Action
Aliskiren directly binds to the active site of renin, an enzyme that initiates the Renin-Angiotensin-Aldosterone System (RAAS) cascade. By inhibiting renin, it prevents the conversion of angiotensinogen to angiotensin I, thereby reducing the formation of angiotensin II, a potent vasoconstrictor, and aldosterone, which promotes sodium and water retention. This leads to vasodilation and reduced fluid volume, resulting in lower blood pressure.
Pharmacokinetics
Onset
Antihypertensive effect within 2 weeks, full effect in 4 weeks.
Excretion
Primarily unchanged in feces (approx. 78%), renal excretion is minor (approx. 1.4%).
Half life
Approximately 24 hours.
Absorption
Low oral bioavailability (approx. 2.5%), peak plasma levels reached in 1-3 hours.
Metabolism
Primarily by CYP3A4, but minimal metabolism.
Side Effects
Contraindications
- Hypersensitivity to Aliskiren or any component
- Concomitant use with ACE inhibitors or Angiotensin Receptor Blockers (ARBs) in patients with diabetes or moderate-to-severe renal impairment (eGFR < 60 mL/min/1.73 m²)
- Pregnancy (second and third trimesters)
Drug Interactions
NSAIDs
May reduce the antihypertensive effect and increase the risk of renal impairment, especially in dehydrated or elderly patients.
Cyclosporine
Significant increase in Aliskiren plasma concentrations. Concomitant use is contraindicated.
Itraconazole
Significant increase in Aliskiren plasma concentrations. Concomitant use is contraindicated.
ACE Inhibitors/ARBs
Increased risk of hypotension, hyperkalemia, and renal impairment, especially in patients with diabetes or renal impairment. Concomitant use is contraindicated.
Potassium-sparing diuretics/Potassium supplements
Increased risk of hyperkalemia.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
The most likely manifestation of overdose is hypotension. Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage and/or activated charcoal may be considered. Hemodialysis is not effective.
Pregnancy & Lactation
Pregnancy Category D (2nd and 3rd trimesters). Discontinue Rasalet immediately if pregnancy is detected due to risk of fetal injury and death. Not recommended during lactation as it is unknown if Aliskiren is excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to Aliskiren or any component
- Concomitant use with ACE inhibitors or Angiotensin Receptor Blockers (ARBs) in patients with diabetes or moderate-to-severe renal impairment (eGFR < 60 mL/min/1.73 m²)
- Pregnancy (second and third trimesters)
Drug Interactions
NSAIDs
May reduce the antihypertensive effect and increase the risk of renal impairment, especially in dehydrated or elderly patients.
Cyclosporine
Significant increase in Aliskiren plasma concentrations. Concomitant use is contraindicated.
Itraconazole
Significant increase in Aliskiren plasma concentrations. Concomitant use is contraindicated.
ACE Inhibitors/ARBs
Increased risk of hypotension, hyperkalemia, and renal impairment, especially in patients with diabetes or renal impairment. Concomitant use is contraindicated.
Potassium-sparing diuretics/Potassium supplements
Increased risk of hyperkalemia.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
The most likely manifestation of overdose is hypotension. Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage and/or activated charcoal may be considered. Hemodialysis is not effective.
Pregnancy & Lactation
Pregnancy Category D (2nd and 3rd trimesters). Discontinue Rasalet immediately if pregnancy is detected due to risk of fetal injury and death. Not recommended during lactation as it is unknown if Aliskiren is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date, refer to package insert for exact expiry.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Patent Expired (molecule), brand specific patents may vary
Clinical Trials
Aliskiren has undergone extensive clinical trials demonstrating its efficacy and safety in the treatment of hypertension, both as monotherapy and in combination with other antihypertensive agents. Studies like ASPIRE HIGHER and ASTRONAUT have investigated its role and outcomes.
Lab Monitoring
- Serum creatinine
- Serum potassium
- Blood pressure
Doctor Notes
- Monitor blood pressure, renal function (creatinine, eGFR), and serum potassium levels regularly.
- Counsel patients on the importance of consistent intake and reporting adverse effects, especially angioedema.
- Avoid use in pregnant patients and those planning pregnancy.
- Strictly contraindicated with ACEIs/ARBs in diabetics or patients with moderate-to-severe renal impairment.
Patient Guidelines
- Take consistently as prescribed.
- Do not stop taking without consulting your doctor.
- Monitor blood pressure regularly at home.
- Report any signs of angioedema (swelling of face, lips, tongue, throat).
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next 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.
Driving Precautions
May cause dizziness or fatigue. Patients should be cautioned about operating machinery or driving until they know how Rasalet affects them.
Lifestyle Advice
- Follow a low-sodium diet.
- Engage in regular physical activity.
- Avoid smoking and excessive alcohol consumption.
- Maintain a healthy weight.
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