Prefolic 50 mg/3ml. (6 ampoules)

Composition and Presentation

The medicine is a homogeneous, finely crystalline powder. It is contained in a dark-glass vial sealed with a plastic stopper and an aluminium cap. The cardboard box also contains ampoules of solvent (water for injection) and instructions for the treatment.

Action

It replenishes folic acid deficiency in the body, restores the production of nucleic acids, and blocks the toxic effects of folic acid antagonists.

The active ingredient is a coenzyme involved in many biochemical processes in the body. It is important for amino acid metabolism, the biosynthesis of purine and pyrimidine bases, the production of blood cells, and the stimulation of embryogenesis.

After the solution is administered by injection, the active ingredient is broken down to form methyltetrahydrofolate, an organic substance and the most biologically active form of folic acid. It then produces the following pharmacological effects:

• methyl groups needed for the functioning of various enzymes and biologically active substances are synthesised;
• the production of enzymes, purines, and nucleic acids needed for cell replication, proper function of the gastrointestinal tract, endocrine glands, and cardiovascular system, and immune protection is initiated.

The use of the medicine also helps restore disrupted DNA, RNA, and protein synthesis.

Indications

The solution for injection is used as part of the combined treatment of patients with folate-deficiency anaemia caused by impaired blood formation in the bone marrow due to a lack of folic acid. It is prescribed to patients in cases of excessive exposure to methotrexate and aminopterin. These folic acid antagonists are used to treat a variety of conditions, including cancer. However, when they accumulate excessively in tissues, toxic effects begin to appear, and the medicine counteracts them.

The list of contraindications includes factors associated with a high risk of developing and worsening serious cardiovascular diseases. The vitamin preparation is also used as part of combined treatment for anaemia and leukopenia arising during treatment with certain medicines or radiation therapy. It has also shown good results as part of combined treatment for chronic gastroenteritis and intestinal tuberculosis.

Contraindications

An absolute contraindication is individual intolerance to any component of the solution for injection. This may be either the active ingredient or an excipient.

Possible Side Effects

The vitamin preparation is generally well tolerated. Adverse reactions are fairly rare and may include:

• local allergic symptoms, such as itchy rashes, swelling, and skin irritation;
• a slight increase in body temperature;
• a rapid heartbeat;
• low blood pressure;
• anaphylaxis.

Any adverse symptoms should be reported immediately to the doctor who prescribed the medicine. The doctor will provide appropriate treatment and choose a different therapeutic approach.

Interactions

Concomitant use with medicines in the anticonvulsant drug class is not recommended. In such combinations, megaloblasts are produced in insufficient quantities, which may lead to a seizure.

No other drug combinations that alter pharmacological effects, including mutual effects, have been reported. To prevent such an outcome, it is recommended that injectable medicines be administered with a short interval between them.

The package leaflet provides no information about compatibility with alcohol. However, ethyl alcohol is highly toxic to all the body's systems. It is therefore recommended to avoid alcohol throughout the course of treatment.

Method of Administration and Dosage

The solution prepared by mixing the powder with water for injection is administered slowly by intravenous injection. The dosing regimen depends on the type of condition. The standard daily dose is 15 mg, and the next injection is given two days later. Treatment continues until the desired clinical response is achieved: stable remission and the resolution of all symptoms of folic acid deficiency in organs and tissues.

When used as an antidote, the medicine is given at a dose of 50 to 100 mg. To bind folic acid antagonists, it is administered every three to eight hours. Treatment ends after all toxic substances have been eliminated.

Overdose is unlikely. Any excess active ingredient will be utilised by the body in the production of important biologically active substances.

Prescription and Storage

Available on prescription.

Store the package in a dark place at a temperature of 25°C or lower.

Use in Specific Patient Groups

Patients in these groups may be prescribed the medicine for either treatment or prevention. The doctor will first weigh the benefit to the woman against the potential risks to the child.

These activities are permitted provided the medicine is well tolerated.

If the patient has pernicious anaemia, vitamin B12 must be used at the same time.

• folate-deficiency anaemia
• folic acid deficiency
• treatment of folate-deficiency anaemia