Description

Prefolic Ampoules 50 mg, 3 ml, #6 Solution

Composition

Each ampoule contains 50 mg of folic acid dissolved in 3 ml of sterile solution for injection. Excipients may include sodium chloride and water for injection. Packaged in a set of 6 ampoules.

Description

Prefolic is a sterile injectable form of folic acid (vitamin B9), a water-soluble vitamin essential for DNA synthesis, erythropoiesis, and fetal neural tube development. The preparation is designed for intramuscular or intravenous administration in clinical situations requiring rapid folate correction.

Pharmacological Classification

Vitamin B-complex group. Hematinic and nutritional therapeutic agent.

Mechanism of Action

Folic acid functions as a coenzyme in the synthesis of nucleic acids (DNA and RNA) and amino acids. It plays a pivotal role in cellular division, especially in rapidly dividing tissues like bone marrow. It also reduces homocysteine levels, thereby supporting cardiovascular health and neurodevelopment during gestation.

Indications

• Megaloblastic anemia due to folic acid deficiency
• Folate deficiency in pregnancy or lactation
• Malabsorption syndromes (e.g., celiac disease, tropical sprue)
• Supportive therapy during long-term anticonvulsant or methotrexate treatment
• Hemolytic anemia or chronic alcoholism
• Prevention of neural tube defects in preconception and early pregnancy

Pharmacokinetics

After parenteral administration, folic acid is rapidly distributed in body tissues and converted in the liver to its active metabolite, tetrahydrofolate. Peak plasma levels are achieved within 30–60 minutes. It is stored primarily in the liver. Folic acid is excreted unchanged or as metabolites via the kidneys. Elimination half-life is approximately 3–4 hours.

Dosage and Administration

• Standard adult dose: 1 ampoule (50 mg/3 ml) daily via IM or slow IV injection
• In pregnancy: as prescribed for prophylactic use
• In renal or hepatic impairment: dose adjustment may be required
• Always administer under medical supervision

Contraindications

• Known hypersensitivity to folic acid or formulation components
• Untreated vitamin B12 deficiency (pernicious anemia)
• Cancer patients undergoing chemotherapy with antifolate agents (unless co-administered appropriately)

Warnings and Precautions

• Monitor hematological response; folate therapy can mask vitamin B12 deficiency
• Caution in renal or hepatic dysfunction
• May require concurrent B12 supplementation in certain patient populations

Adverse Reactions

• Common: nausea, abdominal cramps, injection site irritation
• Rare: allergic reactions including rash, pruritus, bronchospasm, or anaphylaxis
• Neurological: possible worsening of neurologic symptoms in unrecognized B12 deficiency

Drug Interactions

• Antagonized by folate-depleting drugs: methotrexate, trimethoprim, pyrimethamine
• May decrease effectiveness of certain anticonvulsants (e.g., phenytoin, phenobarbital)
• Consult with physician if used with cytotoxic agents or antimalarials

Use in Pregnancy and Lactation

Folic acid is essential during pregnancy and lactation. High-dose injectable folate is commonly used in high-risk pregnancies to prevent neural tube defects. Safety is well established when used as directed.

Overdose

Acute overdose is rare and generally non-toxic. Symptoms may include gastrointestinal discomfort or insomnia. In massive overdoses, supportive care is indicated. No specific antidote exists.

Storage

• Store at 15–25°C (59–77°F) in a dry, light-protected place
• Do not freeze
• Keep out of reach of children

Packaging

6 ampoules per box, each containing 3 ml of 50 mg folic acid solution

Scientific References

• Folate deficiency and clinical implications – PubMed
• Folic Acid – StatPearls, NCBI