Medication info
Acellex Tablet 2 mg (Palbociclib)

Acellex Tablet 2 mg (Palbociclib)

Prescription medicationTabletOral
Ingredient · strength
Polmacoxib›2mg / 1 tablet
Manufacturer / importer
CGN Bio Co., Ltd.
Appearance
Blue, rounded triangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201907587 · Approved 2019.10.30 · Insurance code 050100020

Summary

Main use
Relief of symptoms of osteoarthritis (degenerative arthritis)
Who takes it
Adults
Adult dose
Before administering this medicine, consider the potential risks and benefits of this medicine and other alternative treatments. Cardiovascular risk increases with higher doses and longer exposure; therefore, use this medicine for the shortest possible duration. The efficacy of this medicine for more than 6 weeks and the safety of long-term use for more than 6 months have not been established. Adverse reactions such as hypertension, angina, and edema may occur during treatment. Therefore, during treatment with this medicine, regularly reassess the patient's symptom relief, whether treatment should continue, and response to treatment at least monthly. Adults: The recommended dose is 2mg once daily, taken after a meal. Do not exceed a daily dose of 2mg. If there is no therapeutic benefit at the recommended dose, discontinue this medicine and consider an appropriate alternative treatment. Patients with hepatic or renal impairment: Do not administer this medicine because there is no experience with its use in these patients.

Ingredients

Manufacturer
CGN Bio Co., Ltd.

Efficacy & effects

Relief of symptoms of osteoarthritis (degenerative arthritis)

  • Osteoarthritis
  • degenerative arthritis
View approved original text

This medication is used to alleviate symptoms or signs of osteoarthritis, also known as degenerative arthritis. When treating, it acts as a selective COX-2 inhibitor, and it is important to carefully evaluate each patient's overall health and risks before administering the medication. This will help safely improve osteoarthritis symptoms.

How to take

Adult dose

Before administering this medicine, consider the potential risks and benefits of this medicine and other alternative treatments. Cardiovascular risk increases with higher doses and longer exposure; therefore, use this medicine for the shortest possible duration. The efficacy of this medicine for more than 6 weeks and the safety of long-term use for more than 6 months have not been established. Adverse reactions such as hypertension, angina, and edema may occur during treatment. Therefore, during treatment with this medicine, regularly reassess the patient's symptom relief, whether treatment should continue, and response to treatment at least monthly. Adults: The recommended dose is 2mg once daily, taken after a meal. Do not exceed a daily dose of 2mg. If there is no therapeutic benefit at the recommended dose, discontinue this medicine and consider an appropriate alternative treatment. Patients with hepatic or renal impairment: Do not administer this medicine because there is no experience with its use in these patients.

Precautions

This medication may increase the risk of gastrointestinal bleeding in individuals who regularly consume more than three alcoholic beverages daily, so it is essential to consult a doctor or pharmacist before use. This medication may affect the cardiovascular system and could potentially increase the risk of myocardial infarction or stroke; therefore, it should be used only at the lowest effective dose and for the shortest duration. Serious gastrointestinal complications such as gastrointestinal bleeding, ulcers, or perforation may occur, and if symptoms appear, immediate medical attention should be sought. This medication is not to be administered to individuals with specific allergies, uncontrolled hypertension, poor liver or kidney function, pregnant or breastfeeding women, or those with heart disease. Patients with asthma, heart failure, hypertension, or diabetes should use this medication with particular caution and under medical supervision. During treatment, symptoms such as headache, dyspepsia, upper abdominal pain, elevated blood pressure, swelling, and shortness of breath may occur, and any unusual symptoms should be reported immediately. This medication can affect liver and kidney function, so regular blood tests and liver function tests are required, and if abnormalities are detected, the medication should be discontinued. This medication may interact with other drugs, especially antihypertensive agents, diuretics, anticoagulants, lithium, and methotrexate; it is crucial to consult a doctor before concurrent use. Women who are pregnant or planning to become pregnant should avoid using this medication and, if breastfeeding, should either stop breastfeeding or discontinue the medication. This medication has not established safety and efficacy in children under the age of 18 and should not be used in this population. Elderly patients may have reduced kidney and liver functions, and special attention and monitoring are required when administering this medication. In cases of overdose, symptoms such as nausea, vomiting, drowsiness, and upper abdominal pain may manifest, and immediate medical treatment is necessary. This medication should be stored in a safe place away from children's reach and should not be transferred to other containers.

Side effects

Gastrointestinal bleeding, serious cardiovascular thrombotic events, myocardial infarction, stroke, upper abdominal pain, dyspepsia, nasopharyngitis, pneumonia, tinea capitis, bronchitis, soft tissue infection, abscess, herpes zoster, influenza, syphilis, urinary tract infection, nail fungus, colon adenoma, anemia, skin papilloma, eosinophilia, hypersensitivity reaction, chemical allergy, diabetes, hypercholesterolemia, hyperkalemia, depressed mood, major depressive disorder, headache, insomnia, paresthesia, conscious depressive state, dizziness, drowsiness, lethargy, Alzheimer's type dementia, tremors, eyelid edema, eyelid swelling, blepharitis, eyelid spasm, dry eyes, keratitis, macular hole, ear discomfort, positional dizziness, palpitations, angina pectoris, myocardial ischemia, hypertension, arrhythmia, high blood pressure, facial flushing, abnormal blood pressure, cough, dyspnea, asthma, runny nose, oropharyngeal pain, productive cough, rhinitis, allergic rhinitis, upper abdominal pain, diarrhea, nausea, abdominal pain, vomiting, bowel motility disorder, irritable bowel syndrome, stool discoloration, food poisoning, peptic ulcer, gingivitis, dental disorder, dry mouth, enteritis, upper abdominal discomfort, gastritis, abdominal discomfort, lower abdominal pain, aphthous stomatitis, constipation, gastroesophageal reflux disease, colon polyp, esophagitis, hyperbilirubinemia, facial swelling, urticaria, erythema, neurodermatitis, itching, generalized itching, xerotic eczema, arthralgia, back pain, flat feet, joint swelling, neck pain, limb pain, plantar fasciitis, musculoskeletal pain, intervertebral disc herniation, muscle cramps, frequent urination, chronic kidney disease, microalbuminuria, urinary stones, breast pain, chest discomfort, facial edema, edema, peripheral edema, fatigue, generalized edema, influenza-like illness, weight gain, asthenia, thirst, contusion, abrasion, laceration, traffic accident, spinal compression fracture, chills, fever, insect bite, concussion, ligament rupture, ligament sprain, wound, wrist fracture, heat sensation, drug overdose, neutrophilia, decreased unsaturated iron binding capacity, prolonged prothrombin time, decreased hemoglobin, increased alanine aminotransferase, increased aspartate aminotransferase, increased creatine phosphokinase, increased serum creatinine, stroke, sensory disturbances, sensory loss, rash, drug rash, skin erosion, tachycardia, conjunctival injection, gastrointestinal disturbance, abdominal distension, decreased appetite, daydreaming, dysuria, lethargy, somnolence, nausea, vomiting, hypertension, acute renal failure, respiratory depression, coma, exfoliative dermatitis, mucocutaneous syndrome, toxic epidermal necrolysis, skin rash, mucosal lesions, blisters, fever, itching, severe bronchospasm

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

Storage

This medication should be stored in a sealed container to prevent air or moisture ingress. The storage temperature should be maintained between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Blue, rounded triangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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

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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.