Folinex 5mg Tablet 10pcs

✔️ Each Folinex tablet contains the following:

• Calcium Folinate Hydrate BP equivalent to:
  • 5 mg of Folinic Acid (for one formulation).
  • 15 mg of Folinic Acid (for another formulation).

✔️ Common side effects of Folinex include:

• Mucositis (inflammation of mucous membranes).
• Stomatitis (mouth sores).
• Leukopenia (reduction in white blood cell count).
• Diarrhea, which may limit dosing.

✔️ Dosage and Administration

Folinic Acid Rescue Therapy (Methotrexate Toxicity):

• Timing: Begin treatment as soon as possible after a suspected overdose and within 24 hours of methotrexate administration.
• Indications for Rescue Therapy: Necessary when methotrexate is administered at doses exceeding 500 mg/m².
• General Dosage:
  • Administer 15 mg (approximately 10 mg/m²) every 6 hours for 10 doses.
  • Treatment should start approximately 24 hours after methotrexate infusion.

Managing Toxicity of Less Potent Folic Acid Antagonists:

• For drugs such as trimethoprim or pyrimethamine:
  • Dosage ranges between 5 mg to 15 mg of Folinic Acid daily.

Neutralizing Immediate Methotrexate Toxicity:

• If methotrexate overdose is suspected:
  • Administer folinate at a dose equal to or greater than the dose of methotrexate.
  • Folinate must be given within 1 hour of methotrexate administration for efficacy.

Megaloblastic Anemia:

• Recommended dosage: 5 mg to 15 mg of Folinic Acid daily.

Use in Children and Adolescents:

• The safety and efficacy of Folinex for pediatric and adolescent patients have not yet been fully established.

Note: Medication should be taken strictly under the guidance of a qualified medical professional.

✔️ Overdose Effects

• No significant adverse effects have been reported following excessive calcium folinate intake.
• However, high doses may reduce the therapeutic efficacy of folic acid antagonists.
• No specific antidote exists for folinate overdose; supportive care is recommended in such cases.

✔️ Drug Interactions

1. Antiepileptic Medications (Phenobarbital, Phenytoin, Primidone):
   • High doses of folinate may counteract the antiepileptic effects of these drugs, potentially increasing seizure frequency in susceptible individuals.
2. Concurrent Use with Fluoropyrimidines:
   • Combining calcium folinate with fluoropyrimidines, such as 5-fluorouracil (5-FU), has been associated with seizures and syncope. Caution is advised.

✔️ Contraindications

• Hypersensitivity to calcium folinate or any components of the product.
• Pernicious anemia or other megaloblastic anemias due to vitamin B12 deficiency.
• Individuals with rare hereditary disorders such as:
  • Galactose intolerance.
  • Lapp lactase deficiency.
  • Glucose-galactose malabsorption.

✔️ Pregnancy and Lactation

• Pregnancy:
  • There is insufficient clinical evidence to confirm the safety of calcium folinate use in pregnant women. It should only be prescribed if the potential benefit outweighs the risks to the fetus.
• Lactation:
  • It is not confirmed whether calcium folinate is excreted in breast milk. Caution should be exercised when administering to nursing mothers.

✔️ Precautions and Warnings

• Folinex should only be administered alongside methotrexate or 5-FU under the supervision of an experienced clinician.
• In cases of folic acid antagonist overdose:
  • Folinate must be administered as soon as possible (preferably within 4 hours). Delayed administration may reduce its efficacy.
• Avoid simultaneous administration of Folinex and folic acid antagonists (e.g., methotrexate) unless intended for toxicity management.
• Folinex does not affect their antibacterial efficacy when used concurrently with pyrimethamine or trimethoprim.

✔️ Additional Recommendations for Methotrexate Therapy:

• Ensure prompt methotrexate excretion through:
  • Alkalinization of urine to achieve a urinary pH >7.0 before methotrexate infusion.
  • Adequate hydration to maintain a urine output of 1800-2000 cc/m²/day on days 2, 3, and 4 post-treatment.
  • Monitoring of plasma methotrexate concentration, blood urea nitrogen (BUN), and creatinine levels on days 2, 3, and 4 until plasma methotrexate levels drop below 10⁻⁷ molar.

✔️ Storage:

• Store below 30°C.
• Protect from light.
• Keep out of reach of children.