Medication info

Ronoksin Injection (Piroxicam) PRIME-PIROCAMInj.

Prescription medicationOral · Intramuscular injectionApproval withdrawn
Ingredient · strength
Piroxicam›20mg / 1mL
Manufacturer / importer
Korea Prime Pharmaceutical Co., Ltd.
Appearance
For domestic use: A brown ampoule containing a pale yellow liquid or a glass vial (part of a prefilled syringe system) sealed with a rubber cap that contains a pale yellow liquid. For export: Contains a light yellow liquid.
Packaging
1mL/ampoule X 50
Approval status
Approval withdrawn

MFDS item code 200203476 · Notified 2002.02.14

This product's status changed to Approval withdrawn on 2024.12.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of chronic pain (e.g., back pain) and joint disorders (e.g., rheumatoid arthritis)
Who uses it
Adults
Adult dosage
(Oral) Adults: Administer piroxicam 20 mg orally once daily. The maximum recommended daily dose is 20 mg of piroxicam. To reduce the risk of adverse reactions, use the lowest effective dose for the shortest duration possible. Therapeutic effect and tolerability should be reviewed within 14 days after starting this drug. If continued treatment is considered necessary, more frequent reviews should be conducted. (Injection) Adults: Administer piroxicam 20 mg by intramuscular injection once daily. The maximum recommended daily dose is 20 mg of piroxicam. To reduce the risk of adverse reactions, use the lowest effective dose for the shortest duration possible. Therapeutic effect and tolerability should be reviewed within 14 days after starting this drug. If continued treatment is considered necessary, more frequent reviews should be conducted. The oral or suppository formulation of this drug may be administered concomitantly, but the total daily dose across both routes must not exceed the maximum recommended daily dose.

Ingredients

Manufacturer
Korea Prime Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of chronic pain (e.g., back pain) and joint disorders (e.g., rheumatoid arthritis)

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • low back pain
  • adhesive capsulitis of the shoulder
  • cervical radiculopathy
View approved original text

This medication is administered when there is a lack of response or insufficient effect from nonsteroidal anti-inflammatory drugs. It is primarily used for chronic inflammatory conditions such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It is also effective for chronic pain symptoms like low back pain, adhesive capsulitis of the shoulder, and cervical radiculopathy. In these cases, this medication can help improve symptoms.

Dosage and Administration

Adult dosage

(Oral) Adults: Administer piroxicam 20 mg orally once daily. The maximum recommended daily dose is 20 mg of piroxicam. To reduce the risk of adverse reactions, use the lowest effective dose for the shortest duration possible. Therapeutic effect and tolerability should be reviewed within 14 days after starting this drug. If continued treatment is considered necessary, more frequent reviews should be conducted. (Injection) Adults: Administer piroxicam 20 mg by intramuscular injection once daily. The maximum recommended daily dose is 20 mg of piroxicam. To reduce the risk of adverse reactions, use the lowest effective dose for the shortest duration possible. Therapeutic effect and tolerability should be reviewed within 14 days after starting this drug. If continued treatment is considered necessary, more frequent reviews should be conducted. The oral or suppository formulation of this drug may be administered concomitantly, but the total daily dose across both routes must not exceed the maximum recommended daily dose.

Precautions

Careful consultation with a physician or pharmacist is essential for those who regularly consume more than three glasses of alcohol per day, as this medication may increase the risk of gastrointestinal bleeding. This medication may increase the risk of myocardial infarction and stroke in patients with a history of cardiovascular issues or risk factors, so caution is required. Cardiovascular symptoms should be closely monitored during treatment, and if any symptoms arise, they should be reported immediately. This medication can cause serious gastrointestinal side effects such as gastrointestinal bleeding, ulcers, and perforation, particularly in elderly patients or those with a history of gastrointestinal disorders. The risk of gastrointestinal side effects increases with prolonged use; therefore, the drug should be used at the minimum effective dose for the shortest duration possible. If gastrointestinal symptoms or bleeding occur, discontinue use immediately and consult a physician. Serious skin adverse reactions can occur, so if skin rashes or allergic symptoms develop, use should be discontinued immediately. There is a risk of glass fragments when using ampoule injections, so caution is needed while breaking them, particularly for children and the elderly. Patients with gastrointestinal ulcers, bleeding, inflammatory bowel disease, severe liver or kidney impairment, severe heart disease, or hypertension should not take this medication. Patients with a history of allergy to aspirin or other nonsteroidal anti-inflammatory drugs should also avoid taking this medication. This medication should not be administered to pregnant or breastfeeding women, children, or elderly patients over 80 years old. Patients with a history of peptic ulcers, liver or kidney function decline, hypertension, or asthma should use this medication cautiously and under a doctor's guidance. Those on long-term treatment should regularly undergo blood tests and liver and kidney function tests to check for abnormalities. This medication is not an effective treatment for infectious inflammation and should be used with appropriate antibiotics when infections are present. This medication can prolong bleeding time, so caution is needed for patients at risk of bleeding. There may be interactions with other medications, so inform the physician of any current medications, especially when used with anticoagulants, diuretics, lithium, or methotrexate. Overdose may result in drowsiness, nausea, vomiting, gastrointestinal bleeding, and immediate medical attention should be sought. Keep out of reach of children and do not transfer to other containers for safety.

Side effects

Gastrointestinal bleeding, peptic ulcer, hematemesis, melena, epigastric pain, abdominal discomfort, loss of appetite, nausea, vomiting, diarrhea, watery stools, stomatitis, dyspepsia, abdominal bloating, constipation, glossitis, shock, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome, Lyell's syndrome, photosensitive reactions, onycholysis, abnormal nail growth, hair loss, vesiculopustular reactions, anemia, granulocytopenia, thrombocytopenia, aplastic anemia, bone marrow suppression, purpura, leukopenia, pancytopenia, eosinophilia, hypertension, congestive heart failure, acute heart disease, jaundice, hepatitis, elevated AST/ALT, elevated ALP, elevated LDH, acute renal failure, fluid retention, oliguria, hematuria, proteinuria, elevated BUN, elevated serum creatinine, hyperkalemia, rash, pruritus, bronchospasm, urticaria, angioedema, vasculitis, serum sickness, drowsiness, dizziness, headache, tinnitus, numbness in hands and feet, depression, irritability, hallucinations, mood changes, mental confusion, allergic swelling of face and hands, dry mouth, generalized malaise, blurred vision, eye irritation, shoulder stiffness, fever, palpitations, shortness of breath

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

Storage

This medication is sensitive to light and should be stored in a tightly sealed container that prevents light exposure. It is recommended to keep it at room temperature between 1°C and 30°C. Proper storage helps maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

For domestic use: A brown ampoule containing a pale yellow liquid or a glass vial (part of a prefilled syringe system) sealed with a rubber cap that contains a pale yellow liquid. For export: Contains a light yellow liquid.

Package unit

1mL/ampoule X 50

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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.