Finorex 10mg Tablet 10pcs

Composition

Finerenone

Uses of Finorex 10mg Tablet

Treatment of Chronic kidney disease (CKD)

Side Effects of Finorex 10mg Tablet

• High potassium level (hyperkalemia; signs include weakness or tiredness, nausea, numbness in the hands and lips, muscle cramps, and slow pulse rate)
• Low sodium level (hyponatremia; signs include nausea, tiredness, headache, confusion, muscle cramps)
• High uric acid level (hyperuricaemia)
• Low blood pressure causes dizziness and fainting
• Low hemoglobin (Hb) levels

How does Finorex 10mg Tablet work?

Finerenone blocks aldosterone, a hormone that causes salt and water retention, which can increase blood pressure and stress the kidneys. By inhibiting aldosterone, finerenone reduces salt and water retention, lowers blood pressure, and eases kidney strain, helping to slow kidney damage in people with diabetes and chronic kidney disease.

Quick Suggestions:

• For patients who are unable to swallow whole tablets, Finerenone may be crushed and mixed with water or soft foods, before taking it.
• Inform your doctor if you are taking potassium supplements or any other medications for high blood pressure or heart disease.
• Women of childbearing potential should use effective contraception during the treatment to avoid getting pregnant.
• Avoid breastfeeding at the time of treatment with Finerenone and for one day after treatment.
• Finerenone contains lactose; inform your doctor if you have lactose intolerance.

Indications of Finorex 10mg Tablet

Finerenone is used to prevent chronic kidney disease.

Pharmacology

• Mechanism: Finerenone is a nonsteroidal, selective mineralocorticoid receptor (MR) antagonist. It blocks MR activation by aldosterone and cortisol, reducing sodium reabsorption and preventing MR overactivation in tissues like the kidneys, heart, and blood vessels. This helps mitigate fibrosis and inflammation.
• Effects on Blood Pressure: In patients, finerenone reduces mean systolic blood pressure by 3 mmHg and diastolic blood pressure by 1-2 mmHg within a month, with these effects remaining stable thereafter.
• QT Interval: Even at 4 times the maximum recommended dose, finerenone does not significantly prolong the QT interval.
• Absorption: Fully absorbed after oral administration, with an absolute bioavailability of 44%. Peak plasma concentration (Cmax) is reached within 0.5 to 1.25 hours.
• Steady State: Achieved after 2 days, with a steady-state Cmax of 160 µg/L and an AUCt of 686 µg.h/L at a 20 mg dose.
• Distribution: The volume of distribution at steady state is 52.6 L, with 92% plasma protein binding (primarily to serum albumin).
• Elimination: Terminal half-life is 2-3 hours, with systemic clearance of 25 L/h.
• Metabolism: Finerenone is primarily metabolized by CYP3A4 (90%) and CYP2C8 (10%) to inactive metabolites. About 80% of the dose is excreted in urine.

Finerenone Dosage and Administration

Starting Dosage:

• eGFR ≥60 mL/min/1.73 m²: 20 mg once daily
• eGFR ≥25 to <60 mL/min/1.73 m²: 10 mg once daily
• eGFR <25 mL/min/1.73 m²: Not recommended

Dosage Adjustment:

• Increase to 20 mg once daily after 4 weeks, based on eGFR and serum potassium levels.
• For those who cannot swallow tablets, they can be crushed and mixed with water or soft foods.

Monitoring and Dose Adjustment:

• Measure serum potassium 4 weeks after starting treatment. If levels are >4.8 to 5.0 mEq/L, consider treatment initiation with additional monitoring.
• Monitor serum potassium 4 weeks after any dose adjustments and throughout treatment, adjusting the dose as necessary.

Missed Dose:

• Take the missed dose as soon as possible on the same day. If it’s too late, skip the missed dose and resume the regular dosing schedule.

Overdose:

• Likely to cause hyperkalemia. Discontinue treatment and manage hyperkalemia accordingly. Hemodialysis is unlikely to remove Finerenone effectively due to high protein binding.

Interaction

Drug-Drug Interactions for Finorex 10mg Tablet

Inform your doctor if you are taking any of the following:

• Antifungal Agents: Itraconazole, ketoconazole
• Anti-HIV Agents: Ritonavir, nelfinavir, cobicistat
• Antibacterial Agents: Clarithromycin, telithromycin, erythromycin
• Diuretics: Amiloride, triamterene
• Other MR Antagonists: Eplerenone, esaxerenone, spironolactone, canrenone
• Trimethoprim or a combination of trimethoprim + sulfamethoxazole
• Potassium Supplements
• Cardiac Drugs: Verapamil
• Rifampicin (for TB)
• Antiepileptics: Carbamazepine, phenytoin, phenobarbital
• Antidepressants: St. John’s Wort, fluvoxamine, nefazodone
• Blood Pressure Lowering Agents: Atenolol, amlodipine, enalapril, telmisartan, olmesartan

Drug-Food Interaction:

• Avoid Grapefruit: Do not consume grapefruit or grapefruit juice while taking Finorex 10mg Tablet, as it may cause adverse effects due to increased finerenone levels.

Contraindications of Finerenone

• Allergy to the Finerenone of any other ingredients of this medicine
• Concomitant treatment with strong inhibitors of CYP3A4 enzymes, e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone
• Addison's disease (A disorder in which the adrenal glands don't produce enough hormones)

Pregnancy and Breastfeeding Information for Finorex 10

Pregnancy:

• There are no data on Finorex 10’s use during pregnancy to assess risks of major birth defects, miscarriage, or adverse outcomes. Animal studies show developmental toxicity at exposures approximately 4 times higher than human levels. The clinical significance is unclear. The general risk of birth defects and miscarriage in the U.S. population is 2-4% and 15-20%, respectively. Avoid Finorex 10 during pregnancy unless deemed necessary by a healthcare provider.

Breastfeeding:

• There is no data on the presence of finerenone in human milk or its effects on breastfed infants. Animal studies suggest that finerenone is present in rat milk and may be in human milk as well. Due to potential risks to the infant, avoid breastfeeding during treatment and for 1 day after finishing Finorex 10.

Precautions & Warnings

• Inform your doctor about any history of heart, liver, or kidney issues.
• Mention all medications you are taking, especially diuretics, antibacterial agents, and potassium supplements.
• Do not take Finerenone if you are allergic to any of its components; consult your healthcare provider if unsure.
• Avoid strong CYP3A4 inhibitors and grapefruit or grapefruit juice while on Finerenone.
• Use Finerenone during pregnancy only if necessary and advised by your doctor.
• Do not breastfeed while taking Finerenone as it may harm your child.
• Finerenone is not recommended for children or teenagers under 18 due to unknown safety and efficacy in this age group.

Storage:

Store Finorex 10 in a cool and dry place, protected from direct sunlight, moisture, and heat. Keep it away from children and pets. Discard any unused, expired medicine properly. Do not flush the medicine