Folbiol Tablet

Folbiol tablet is a pharmaceutical preparation containing folic acid (vitamin B9) as its active ingredient, primarily marketed in Turkey. This medication plays a crucial role in various physiological processes and is prescribed for both therapeutic and preventive purposes. This comprehensive overview examines Folbiol’s composition, mechanism of action, clinical applications, dosage guidelines, and safety profile to provide healthcare professionals and patients with essential information about this important medication.

Composition and Pharmaceutical Properties

Folbiol is available as a yellow, round tablet with one side scored, containing 5 mg of folic acid as the active pharmaceutical ingredient. The excipients include lactose monohydrate (of bovine milk origin), corn starch, primojel, talc, and magnesium stearate. These inactive components assist in the tablet’s stability, disintegration, and absorption characteristics. The medication is typically dispensed in blister packages containing 50 tablets and requires proper storage conditions to maintain its efficacy.

Pharmacological Mechanism of Action

Folic acid, the active component in Folbiol, functions as a crucial vitamin that undergoes conversion in the body to its biologically active forms-tetrahydrofolic acid and methyltetrahydrofolate-through the enzymatic action of dihydrofolate reductase. These metabolically active derivatives serve as essential cofactors in single-carbon transfer reactions within the human body, contributing significantly to several biochemical processes.

The primary biochemical functions of folic acid include facilitating the synthesis of purines and thymidylate, which are integral components of DNA and RNA synthesis. This role makes folic acid indispensable for nucleoprotein formation and effective erythropoiesis (red blood cell production). Additionally, folic acid facilitates the interconversion of amino acids, supports the methylation of transfer RNA (tRNA), and assists in the generation and utilization of formate, a key intermediate in cellular metabolism7. These metabolic activities establish Folbiol as a critical component in maintaining normal blood cell production, especially under conditions of folate deficiency.

Therapeutic Indications

Treatment of Megaloblastic Anemia

Folbiol tablet is primarily indicated for the treatment of megaloblastic anemia resulting from folic acid deficiency. This condition is characterized by the production of abnormally large, structurally altered red blood cells due to impaired DNA synthesis. By correcting the underlying folate deficiency, Folbiol helps restore normal erythropoiesis and reverses the hematological abnormalities associated with this type of anemia.

Nutritional Deficiencies and Malabsorption Syndromes

The medication is effective in addressing folate deficiencies stemming from nutritional inadequacies or malabsorption syndromes. It is specifically indicated for conditions like tropical or non-tropical sprue (celiac disease), where intestinal absorption of nutrients, including folate, is compromised. In these cases, Folbiol helps overcome the absorption deficit by providing a pharmaceutical-grade source of folic acid.

Prenatal and Perinatal Care

Perhaps one of the most critical applications of Folbiol tablet is in prenatal care. Adequate folate levels are essential during pregnancy, particularly in the early stages, to prevent neural tube defects in the developing fetus. Healthcare providers often recommend folic acid supplementation for women of childbearing age who are planning pregnancy, ideally starting three months before conception and continuing through the first trimester.

Supportive Therapy in Chronic Conditions

Folbiol serves as an important adjunctive therapy in chronic hemolytic states such as thalassemia major or sickle cell anemia. In these conditions, the accelerated destruction of red blood cells creates an increased demand for folate to support enhanced erythropoiesis, making supplementation necessary to prevent secondary folate deficiency.

Dosage Guidelines and Administration

The dosage of Folbiol varies according to the specific clinical indication and individual patient requirements. For the treatment of megaloblastic anemia due to folate deficiency, the standard adult dosage is 5 mg (one tablet) daily for a period of 4 months. In cases of severe deficiency or malabsorption syndromes, the dosage may be increased up to 15 mg (three tablets) daily.

For prophylaxis in chronic hemolytic states such as thalassemia or sickle cell anemia, a dosage of 5 mg daily or weekly may be prescribed, depending on the severity of the condition and individual needs. In prenatal care for the prevention of neural tube defects, the recommended regimen typically involves starting supplementation at least three months before conception and continuing through the first 12 weeks of pregnancy.

The medication is administered orally and can be taken with or without food, although taking it with meals may help mitigate potential gastrointestinal discomfort. For pediatric patients, dosage adjustments are made based on age:

• Infants: 0.1 mg daily

• Children under 4 years: 0.3 mg daily

• Children 4 years and older: 0.4 mg daily

Side Effects

While Folbiol is generally well-tolerated, certain adverse effects may occur, particularly at higher doses. Common side effects include gastrointestinal disturbances such as nausea, loss of appetite, bloating, gas, and stomach pain. Some patients may experience a bitter or unpleasant taste in the mouth. Neurological effects, though less common, may include confusion or trouble concentrating, sleep problems, and mood changes such as depression or excitement.

Serious Adverse Reactions

Serious adverse reactions to Folbiol tablet are rare but warrant immediate medical attention. Allergic reactions may manifest as hives, rash, itching, skin redness, wheezing, difficulty breathing, or swelling of the face, lips, tongue, or throat. Folic acid supplementation may increase the risk of seizures in some patients with epilepsy who are receiving anticonvulsant medications such as phenobarbital, primidone, or diphenylhydantoin.

An important consideration is that prolonged high-dose folic acid therapy may mask the hematological manifestations of vitamin B12 deficiency while allowing neurological damage to progress unchecked. Therefore, it is essential to rule out vitamin B12 deficiency before initiating folate therapy for megaloblastic anemia.

Contraindications and Precautions

Folbiol is contraindicated in individuals with known hypersensitivity to folic acid or any of the excipients in the formulation. It should not be used in untreated cobalamin (vitamin B12) deficiency, as folic acid supplementation can mask the hematological manifestations of B12 deficiency while allowing neurological complications to progress.

Caution is advised when administering Folbiol to patients with epilepsy, as it may lower seizure thresholds in some individuals. Additionally, the medication should be used with caution in patients potentially harboring folate-dependent tumors, as there are theoretical concerns about stimulating tumor growth.

Since Folbiol contains lactose, patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should exercise caution when using this medication.

Drug Interactions

Several medications may interact with Folbiol, potentially affecting its efficacy or metabolism. Phenytoin, methotrexate, sulfasalazine, and trimethoprim may interact with folic acid, potentially reducing its effectiveness or altering drug metabolism7. Similarly, chloramphenicol and co-trimoxazole can reduce the efficacy of Folbiol.

Patients receiving anticonvulsant therapy should be monitored closely when starting folic acid supplementation, as it may affect seizure control. Healthcare providers should conduct a comprehensive review of all concurrent medications before initiating Folbiol tablet therapy to minimize the risk of adverse interactions.

Key Information

Conclusion

Folbiol represents an important pharmaceutical intervention for addressing folate deficiency and its clinical manifestations. Its primary active ingredient, folic acid, plays a crucial role in cellular metabolism, DNA synthesis, and erythropoiesis. The medication is particularly valuable in treating megaloblastic anemia, supporting patients with malabsorption syndromes, and preventing congenital neural tube defects when used appropriately during pregnancy.

While generally safe and well-tolerated, Folbiol should be prescribed with attention to potential contraindications, drug interactions, and individual patient factors. Healthcare providers should ensure appropriate diagnosis before initiating therapy and monitor patients during treatment to optimize outcomes and minimize adverse effects. As with all medications, patient education regarding proper usage, potential side effects, and the importance of adherence to the prescribed regimen is essential for achieving optimal therapeutic benefits from Folbiol.