Unitrexate 50Mg/2Ml 50Mg 5 Injections

Unitrexate 50Mg/2Ml 50Mg 5 Injections

Description:

Unitrexate 50 mg/2 ml injections contain methotrexate, a potent antimetabolite and antifolate medicine used as a chemotherapy and immunosuppressive agent. It is indicated for the treatment of various cancers and certain severe autoimmune diseases under strict medical supervision. Each pack contains 5 injectable vials designed for intramuscular (i.m.) or intravenous (i.v.) administration in hospital or specialized clinical settings.

Indications:

• Treatment of certain cancers such as acute lymphoblastic leukemia (ALL), choriocarcinoma, Burkitt's lymphoma, non‑metastatic osteosarcoma, lymphosarcoma, meningeal leukemia, mycosis fungoides, and hydatidiform mole (as part of approved protocols).
• Management of severe, active rheumatoid arthritis in adults who have not responded adequately to other disease‑modifying antirheumatic drugs (DMARDs), as prescribed by a specialist.
• Treatment of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy and only under specialist supervision.
• May be used in certain cases of corticosteroid‑dependent severe asthma and other autoimmune conditions as per specialist oncology/rheumatology protocols.
• Used as an antineoplastic and immunosuppressant agent to inhibit abnormal cell proliferation and modulate immune activity.

Active Ingredients / Key Components:

• Methotrexate – 50 mg per 2 ml vial (concentration: 25 mg/ml).
• Excipients: The full list of inactive ingredients (such as solvents, stabilizers, or preservatives) is not provided in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.). Please refer to the official package insert for complete excipient details.

Dosage & Administration / How to Use:

• Unitrexate is for parenteral use only and must be administered by, or under the direct supervision of, an experienced physician familiar with methotrexate therapy.
• Routes of administration: intramuscular (i.m.) or intravenous (i.v.) injection, depending on the indication, dose, and treatment protocol.
• Dosage: The dose, frequency, and duration vary widely according to the disease being treated (oncology vs. autoimmune), patient age, body surface area or weight, organ function, and concomitant therapies. Typical regimens for cancer are much higher and may be given as single or divided doses; autoimmune disease regimens usually involve low weekly doses. Exact dosing must follow specialized treatment protocols and the prescribing physician’s instructions.
• Methotrexate for autoimmune diseases (e.g., rheumatoid arthritis, psoriasis) is generally given once weekly, not daily. Incorrect daily dosing can lead to severe toxicity or death.
• Folic acid or folinic acid (leucovorin) supplementation may be prescribed to reduce certain toxicities, especially in high‑dose regimens or long‑term therapy, as directed by the physician.
• Regular monitoring of complete blood count, liver function tests, renal function, and, when indicated, chest imaging is mandatory before and during treatment.
• Do not self‑inject or adjust the dose on your own. Always follow the exact schedule and instructions provided by your oncologist or rheumatologist.

Clinical Benefits:

• Provides effective antineoplastic activity by inhibiting DNA, RNA, and protein synthesis in rapidly dividing malignant cells, helping to control and reduce tumor burden in sensitive cancers.
• Acts as a powerful immunosuppressant and disease‑modifying agent in severe rheumatoid arthritis, helping to reduce joint inflammation, pain, and long‑term joint damage.
• Improves severe, treatment‑resistant psoriasis by slowing down excessive skin cell proliferation and modulating immune responses.
• Supports combination chemotherapy protocols in hematologic malignancies and solid tumors, enhancing overall treatment efficacy when used according to established guidelines.

Warnings & Contraindications:

• Methotrexate is a high‑risk medicine with a narrow therapeutic index and can cause serious, sometimes fatal, toxicity. It must only be used under strict medical supervision with appropriate monitoring.
• Contraindicated in pregnancy due to strong teratogenic and abortifacient effects. Women of childbearing potential and men must use effective contraception during treatment and for a recommended period after the last dose, as advised by their doctor.
• Contraindicated during breastfeeding, as methotrexate passes into breast milk and may harm the infant.
• Contraindicated in patients with severe hepatic impairment, significant renal impairment (unless dose is adjusted under specialist care), severe bone marrow suppression, or pre‑existing blood dyscrasias (e.g., severe anemia, leukopenia, thrombocytopenia).
• Use with extreme caution in patients with liver disease (including chronic alcohol use), kidney disease, active or chronic infections, peptic ulcer disease, or pre‑existing lung disease.
• Concomitant use with other hepatotoxic, nephrotoxic, or myelosuppressive drugs, high‑dose NSAIDs, or certain antibiotics (e.g., trimethoprim‑sulfamethoxazole) may increase toxicity and must be carefully evaluated by the physician.
• Avoid live vaccines during treatment and for a period after therapy, as methotrexate suppresses the immune system and may increase the risk of infection or vaccine‑related complications.
• Alcohol consumption should be avoided or strictly limited due to increased risk of liver toxicity.
• Consult your doctor before use if you have liver disease, kidney disease, blood disorders, lung problems, active infections, diabetes, or are taking any other prescription, over‑the‑counter, or herbal medicines.
• Keep out of reach of children. Accidental ingestion or incorrect dosing can be life‑threatening.

Side Effects:

• Common side effects may include nausea, vomiting, loss of appetite, abdominal discomfort, mouth ulcers (stomatitis), fatigue, headache, and mild hair thinning.
• Hematologic effects such as anemia, leukopenia, and thrombocytopenia can occur, increasing the risk of infections, bleeding, and fatigue.
• Hepatotoxicity (elevated liver enzymes, hepatitis, fibrosis, or cirrhosis) may develop, especially with long‑term use or in patients with additional risk factors (e.g., alcohol use, pre‑existing liver disease).
• Renal toxicity, particularly with high doses, may occur and can be worsened by dehydration or interacting medicines.
• Serious pulmonary toxicity (methotrexate‑induced pneumonitis) may present with dry cough, shortness of breath, fever, and chest pain; this requires immediate medical evaluation and discontinuation of the drug.
• Severe skin reactions, photosensitivity, rash, or exfoliative dermatitis may occur in rare cases.
• Seek urgent medical attention if you experience signs of severe infection (fever, chills, sore throat), unusual bruising or bleeding, severe or persistent vomiting or diarrhea, yellowing of skin or eyes, dark urine, difficulty breathing, chest pain, or severe skin reactions.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children. Do not use after the expiry date stated on the package. Do not freeze unless the official product insert specifically allows it. Dispose of unused or expired vials according to local regulations or as instructed by your pharmacist or healthcare provider.

Specifications:

• Product type: Prescription antineoplastic and immunosuppressant medicine (methotrexate injection).
• Strength: 50 mg methotrexate per 2 ml vial (25 mg/ml).
• Form: Injectable solution for intramuscular (i.m.) or intravenous (i.v.) administration.
• Pack size: 5 vials per pack.
• Intended use: Hospital and specialist clinic use under supervision of an oncologist, rheumatologist, or other qualified specialist.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.