LEUCOVORIN INJ 50MG (CALCIUM FOLINATE)

Calcium folinate, also known as leucovorin, acts as a reduced form of folic acid and is essential in the mechanism of action of CALCIUM FOLINATE Injection. It serves as a cofactor in various enzymatic reactions involved in DNA synthesis and methylation. By providing an active form of folate, calcium folinate aids in the conversion of toxic metabolites produced by certain chemotherapy agents, such as methotrexate, into non-toxic forms. This process helps protect healthy cells from the harmful effects of chemotherapy, particularly targeting rapidly dividing cells like cancerous ones. Calcium folinate's mechanism of action is crucial in enhancing the effectiveness of specific cancer treatments and reducing the toxicity associated with high-dose chemotherapy regimens.

CALCIUM FOLINATE

Antifolic (antimetabolite) drug.

Injection

The following are the uses of CALCIUM FOLINATE Injection:

• Used for treating folate deficiency, especially in megaloblastic and macrocytic anemias
• Used for reducing side effects in methotrexate chemotherapy
• Used for preventing neural tube defects during pregnancy
• Used for managing high homocysteine levels
• Used for improving fertility in males with low sperm count
• Used for supporting cardiovascular health by lowering homocysteine
• Used for treating certain types of depression and cognitive decline
• Used for aiding in the absorption of certain nutrients

In the case of an overdose of CALCIUM FOLINATE Injection, immediate medical intervention is required. Symptoms may include nausea, vomiting, diarrhea, and skin reactions. It is important to monitor the patient's vital signs and seek emergency medical care to manage the potential complications. Treatment should focus on supportive care and addressing any specific symptoms that arise due to the overdose.

In the case of a missed dose of CALCIUM FOLINATE Injection, it is important to act promptly. If you realize you have missed a dose, administer it as soon as possible, but avoid taking a double dose to make up for the missed one. Consult your healthcare professional for specific guidance, as they may advise you to skip the missed dose and continue with the next scheduled dose. They will provide instructions tailored to your medical condition and treatment plan.

To administer the CALCIUM FOLINATE Injection, carefully draw the prescribed dose into a syringe and inject it slowly into the muscle or intravenous infusion, as directed by your healthcare professional, ensuring proper aseptic technique and following the recommended dosage guidelines.

Following are the conditions when CALCIUM FOLINATE Injection should not be used:

• Must not be used in patients with a known hypersensitivity or severe allergic reaction to folinic acid or any of its excipients.
• Contraindicated in patients with pernicious anemia, as it is not effective in treating this condition.
• Should not be administered when a patient has experienced a previous severe allergic reaction to folic acid.
• Not recommended for use as a sole treatment for acute lymphoblastic leukemia.
• Avoid in patients with severe renal impairment or undergoing renal dialysis, as dosage adjustments may be required.
• Not suitable for the prevention of fetal neural tube defects; folic acid is preferred for this purpose.

The side effects of CALCIUM FOLINATE Injection may include:

• Nausea and vomiting
• Diarrhea
• Loss of appetite
• Skin reactions, such as rash, itching, or redness
• Mouth sores or ulcers
• Allergic reactions, including hives and swelling
• Difficulty breathing or swallowing
• Fatigue and weakness

Following are the precautions and warnings for CALCIUM FOLINATE Injection:

• This medication should not be used in patients with known hypersensitivity or allergy to calcium folinate or any of its excipients.
• It is crucial to monitor for signs of anaphylaxis or severe allergic reactions, especially in patients with a history of allergies.
• Patients with impaired renal function or kidney disease may require dosage adjustments, as the drug is primarily eliminated through the kidneys.
• Caution is advised in individuals with a history of asthma, as it may trigger bronchospasm.
• Elderly patients may be more susceptible to the side effects, particularly gastrointestinal issues and bone marrow suppression.
• Folic acid or its derivatives should be used with caution in patients with pernicious anemia, as it may mask the underlying vitamin B12 deficiency.
• Pregnant and breastfeeding women should only use this medication under medical supervision, as the safety during these periods has not been fully established.

Following are the drug interactions for Calcium Folinate Injection:

• Calcium Folinate may interact with certain chemotherapy drugs like methotrexate, enhancing its effects and potentially reducing the toxicity of methotrexate in normal cells. However, it may also reduce methotrexate's therapeutic effect in high-dose therapy.
• When used with 5-fluorouracil (5-FU), Calcium Folinate can enhance its efficacy, making the combination beneficial in certain cancer treatments, such as colorectal cancer.
• Calcium Folinate may interact with phenytoin, a medication used for seizures, potentially leading to decreased phenytoin effectiveness. Monitoring blood levels is recommended when used together.
• Concurrent use with other folate antagonists, such as trimethoprim or pyrimethamine, may reduce the therapeutic effects of Calcium Folinate, requiring dose adjustments.
• It may interact with certain antifolate drugs, like sulfasalazine, by reducing their efficacy in treating infections or inflammatory conditions.
• Calcium Folinate may increase the toxicity of certain drugs, such as fluorouracil (5-FU), when used in combination with them, so careful monitoring is necessary.
• The use of Calcium Folinate with anticoagulants like warfarin may interfere with the anticoagulant's effect, requiring regular monitoring of prothrombin time (PT) or International Normalized Ratio (INR).
• If Calcium Folinate is used with anticonvulsants like carbamazepine or phenobarbital, there could be an increased risk of vitamin D deficiency, requiring supplementation.
• In patients receiving methotrexate for high-dose therapy, Calcium Folinate is used to “rescue” normal cells from toxicity, but this combination should be carefully monitored to ensure optimal therapeutic outcomes.

Following are the food interactions for Calcium Folinate Injection:

• Alcohol consumption should be avoided as it may interfere with the absorption of folinic acid, leading to reduced effectiveness.
• Grapefruit and its juice should be consumed cautiously as they can affect the metabolism of folinic acid, potentially altering its therapeutic effect.
• High-protein foods like meat, fish, and eggs can enhance the absorption of folinic acid, ensuring better utilization.
• Leafy green vegetables, legumes, and citrus fruits, rich in natural folates, can complement the therapy by providing additional folate sources.
• Fortified cereals and grains can contribute to overall folate intake, supporting the therapeutic effect.
• Avoid excessive intake of foods fortified with folic acid, as high doses can mask the symptoms of vitamin B12 deficiency.
• Ensure a balanced diet with a variety of foods to optimize the benefits of Calcium Folinate Injection.

CALCIUM FOLINATE Injection should be stored properly in a controlled environment, preferably in a cool and dry place, away from direct sunlight and moisture. It is crucial to maintain a temperature range between 20°C to 25°C (68°F to 77°F) to ensure the integrity of the medication. Keep the injection in its original packaging, tightly sealed, to prevent contamination. Disposal of unused or expired injections should be done responsibly, avoiding any environmental hazards. Do not throw away the medication in regular trash or pour it down the drain; instead, follow local guidelines or consult healthcare professionals for appropriate disposal methods. Keep the medication out of children's reach to prevent accidental exposure.

Following are the quick tips for CALCIUM FOLINATE Injection:

• Administer the injection under medical supervision for the treatment of folate deficiency.
• Ensure the injection is prepared and administered by a healthcare professional.
• Follow the prescribed dosage and schedule provided by your doctor.
• Do not inject intravenously; it should be given deep intramuscularly or slowly intravenously.
• Store the injection as directed on the packaging to maintain its potency.
• Inform your doctor if you are pregnant, breastfeeding, or have any known allergies.
• Report any side effects or unusual symptoms to your healthcare provider promptly.