Medication info

PERNOB Injection 100 milligrams (Polynate Calcium)

Prescription medication경구 · 정맥Approval withdrawn
Ingredient · strength
Calcium Folinate›106.7mg / 1 ampoule
Manufacturer / importer
삼진제약(주)
Appearance
A clear injectable solution that is colorless to light yellow, contained in a brown ampule
Packaging
10 mL - 10 ampules per box
Approval status
Approval withdrawn

MFDS item code 199001320 · Notified 1990.12.04

This product's status changed to Approval withdrawn on 2025.01.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of toxicity due to folate metabolism inhibitors and efficacy in treating metastatic colon cancer
Who uses it
Adults
Adult dosage
1. Standard methotrexate therapy: Inject 6-12 mg of Polynate intramuscularly every 6 hours for a total of 4 times a day. 2. Rescue therapy with methotrexate and Polynate: Starting 3 hours after stopping methotrexate, administer 15 mg of Polynate intravenously every 3 hours for a total of 9 doses, followed by intravenous or intramuscular injections every 6 hours for a total of 8 doses. 3. In combination with 5-Fluorouracil (5-FU) for metastatic colon cancer

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Reduction of toxicity due to folate metabolism inhibitors and efficacy in treating metastatic colon cancer

View approved original text

This medication is used to reduce toxicity caused by folate metabolism inhibitors. Additionally, it helps enhance the efficacy of treatment for metastatic colon cancer when used in combination with 5-Fluorouracil (5-FU). It is administered in both injection and tablet forms and is effective for alleviating toxicity related to folate metabolism inhibitors and for colon cancer treatment.

Dosage and Administration

Adult dosage

1. Standard methotrexate therapy: Inject 6-12 mg of Polynate intramuscularly every 6 hours for a total of 4 times a day. 2. Rescue therapy with methotrexate and Polynate: Starting 3 hours after stopping methotrexate, administer 15 mg of Polynate intravenously every 3 hours for a total of 9 doses, followed by intravenous or intramuscular injections every 6 hours for a total of 8 doses. 3. In combination with 5-Fluorouracil (5-FU) for metastatic colon cancer

Precautions

This medication is not suitable for treating malignant anemia or megaloblastic anemia caused by vitamin B12 deficiency. Caution is required, as blood conditions may improve even while neurological symptoms are progressing. When using the injectable form, care must be taken to avoid glass shards if the ampule is broken, especially when administering to children or the elderly. Women who are pregnant or breastfeeding should not receive this medication in combination with 5-FU. Caution is necessary when this medication is used by pregnant or breastfeeding women for the purpose of reducing toxicity of folate antagonists. This medication may cause allergic reactions, hives, injection site pain, fever, central nervous system symptoms (such as paralysis, agitation, depression), and other side effects. When used in combination with 5-FU, diarrhea, skin reactions, stomatitis, and hematological toxicity may occur, so if severe symptoms arise, dosage adjustment of 5-FU may be required. This medication must be used under the direction of a physician experienced in chemotherapy, in conjunction with methotrexate, and the treatment duration and dosage should be determined by monitoring plasma methotrexate levels. If there is ascites, renal function impairment, or abnormal fluid status, drug elimination may be delayed, and high doses should be administered intravenously. This medication uses a transporter similar to methotrexate, so effectiveness may diminish in cases of resistance. If the patient is poorly absorbing the medication or experiencing severe vomiting, it is preferable to administer it via injection instead of orally. In patients with central nervous system tumors, repeated administration may lead to drug accumulation and decreased antitumor effectiveness, so overdose should be avoided. This medication is not used for the treatment of erythrocytosis due to specific DNA synthesis inhibitors. It is ineffective against some side effects such as nephrotoxicity caused by methotrexate. This drug increases metabolism in the liver, which may reduce blood levels of certain anticonvulsants, so monitoring and dosage adjustment are necessary. There is a need for caution in combining it with 5-FU as it may increase the effectiveness and side effects of 5-FU. Consideration for the risks and benefits to the fetus is necessary when administering to pregnant women, and caution is also needed when administering to breastfeeding women. Elderly or frail patients are at higher risk of gastrointestinal toxicity and should be treated with particular caution. This medication should not be administered intrathecally, and due to its calcium content, the intravenous administration rate must be limited.

Side effects and when to seek care immediately

Serious side effects

Hives, anaphylactic reactions (including severe swelling, chest tightness, difficulty breathing, cold sweat, and pallor)

Mild side effects

Vascular pain, transient pain, fever, agitation, depression, diarrhea, skin reactions, dry skin, stomatitis, conjunctivitis, mucositis, mild hematological toxicity, leukopenia, central nervous system disorders (excluding paralysis disorders), hypersensitivity, hives

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light, so it should be stored in a light-resistant container. Additionally, avoid storing it in excessively hot or cold places; it is advisable to store it at room temperature.

Appearance and packaging

Appearance

A clear injectable solution that is colorless to light yellow, contained in a brown ampule

Package unit

10 mL - 10 ampules per box

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.