Medication info
Aselex Capsule 2 mg (Fomasaprevir)

Aselex Capsule 2 mg (Fomasaprevir)

Prescription medicationHard capsuleOral
Ingredient · strength
Polmacoxib›2mg / 1 capsule
Manufacturer / importer
CGN Biotech Co., Ltd.
Appearance
Hard capsules in white and light yellow powder.
Packaging
For domestic use - 30 capsules/bottle, for domestic use - 100 capsules/bottle, for export - 10 capsules/bottle, for export - 30 capsules/bottle
Approval status
Active

MFDS item code 201500622 · Approved 2015.02.05 · Insurance code 050100010

Summary

Main use
Relief of signs and 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. As cardiovascular risk increases with the dose and duration of exposure, administer this medicine for the shortest possible duration. Efficacy for more than 6 weeks and safety with long-term administration for more than 6 months have not been established. Adverse reactions such as hypertension, angina, and edema may occur during treatment. Therefore, during treatment, reassess at least monthly whether to continue treatment based on symptom relief and the patient's response to treatment. 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, as there is no experience with its use in these patients.

Ingredients

Manufacturer
CGN Biotech Co., Ltd.

Efficacy & effects

Relief of signs and symptoms of osteoarthritis (degenerative arthritis)

  • Symptoms and signs of osteoarthritis
  • degenerative arthritis
View approved original text

This medication is used to relieve pain and inflammation caused by osteoarthritis. Osteoarthritis mainly occurs due to degenerative changes in the joints, and the selective COX-2 inhibitory action of this medication helps reduce pain and improve joint function. A thorough assessment of the overall health status and risk factors of each patient must be conducted before administering the medication. This ensures safe therapeutic effects can be expected. It is effectively used for the relief of osteoarthritis symptoms.

How to take

Adult dose

Before administering this medicine, consider the potential risks and benefits of this medicine and other alternative treatments. As cardiovascular risk increases with the dose and duration of exposure, administer this medicine for the shortest possible duration. Efficacy for more than 6 weeks and safety with long-term administration for more than 6 months have not been established. Adverse reactions such as hypertension, angina, and edema may occur during treatment. Therefore, during treatment, reassess at least monthly whether to continue treatment based on symptom relief and the patient's response to treatment. 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, as there is no experience with its use in these patients.

Precautions

Patients who regularly consume more than three alcoholic beverages a day should consult their doctor or pharmacist before taking this medication. This is because there is a risk of gastrointestinal bleeding. Moreover, this medication may affect the cardiovascular system and increase the risk of severe thrombotic reactions such as myocardial infarction or stroke. Therefore, individuals with cardiovascular diseases or risk factors should use the lowest dose for the shortest duration, and if symptoms like chest pain, shortness of breath, weakness, or slurred speech occur, they should consult a healthcare professional immediately. This medication may also affect the gastrointestinal system, possibly leading to serious issues like gastrointestinal bleeding, ulcers, or perforations. Elderly patients or those with a history of gastrointestinal diseases should exercise increased caution, and if symptoms like epigastric pain, dyspepsia, black stools, or vomiting blood occur, they should visit a hospital promptly. Individuals with hypersensitivity or allergies, those with uncontrolled hypertension, liver or kidney impairment, active gastric ulcers or inflammatory bowel diseases, congestive heart failure, or ischemic heart disease, as well as pregnant or lactating women, should not use this medication. Those with specific diseases or conditions such as bronchial asthma, heart failure, hypertension, edema, dehydration, elderly individuals, or diabetes need special precautions when using this medication, and should take it cautiously under the guidance of a physician. During use, various adverse reactions may occur, including upper abdominal pain, dyspepsia, headache, increased blood pressure, respiratory distress, skin rash, edema, and fatigue; if such symptoms persist or worsen, immediate consultation with a healthcare professional is necessary. This medication may affect liver and kidney function, so regular blood tests and liver and kidney function assessments are necessary, and if symptoms of liver dysfunction or decreased kidney function appear, usage should be discontinued. This medication can interact with other drugs; thus, consultation with a physician is mandatory when taken with drugs metabolized in the liver, antihypertensive drugs, diuretics, anticoagulants, lithium, methotrexate, etc. Pregnant women or those planning to become pregnant should not take this medication, and if breastfeeding, it is advisable to avoid taking it or to discontinue breastfeeding. The safety of this medication in children and adolescents under 18 has not been established, so it is advisable not to use it. Elderly individuals may have impaired liver and kidney function, thus require closer monitoring during use, adjusting the dosage according to a doctor's direction and closely observing the condition. In cases of overdose, symptoms like nausea, vomiting, drowsiness, lethargy, gastrointestinal bleeding, hypertension, acute renal failure may occur; in such cases, immediate emergency treatment is required. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects

Gastrointestinal bleeding, serious cardiovascular thrombotic reactions, myocardial infarction, stroke, upper abdominal pain, dyspepsia, nasopharyngitis, pneumonia, tinea manuum, bronchitis, soft tissue inflammation, abscess, shingles, influenza, syphilis, urinary tract infection, onychomycosis, colonic adenoma, anemia, skin papilloma, eosinophilia, hypersensitivity reactions, chemical allergies, diabetes, hypercholesterolemia, hyperkalemia, depressed mood, major depressive disorder, headache, insomnia, paresthesia, conscious depressive state, dizziness, drowsiness, apathy, Alzheimer's type dementia, tremors, eye swelling, eyelid swelling, blepharitis, eyelid spasms, dry eyes, keratitis, macular hole, ear discomfort, positional vertigo, palpitations, angina, radial nerve block, myocardial ischemia, hypertension, arrhythmia, high blood pressure, facial flushing, abnormal blood pressure, cough, dyspnea, asthma, rhinitis, oral pharyngeal pain, productive cough, rhinitis, allergic rhinitis, upper abdominal pain, diarrhea, nausea, abdominal pain, vomiting, gastrointestinal motility disorders, irritable bowel syndrome, stool discoloration, food poisoning, gastric ulcer, gingivitis, dental disorders, dry mouth, enteritis, upper abdominal discomfort, gastritis, abdominal discomfort, lower abdominal pain, aphthous stomatitis, constipation, gastroesophageal reflux disease, colon polyps, esophagitis, hyperbilirubinemia, facial swelling, urticaria, erythema, neurodermatitis, itching, generalized itching, xerotic eczema, arthralgia, back pain, flatfoot, joint swelling, neck pain, limb pain, plantar fasciitis, musculoskeletal pain, intervertebral disc herniation, muscle cramps, frequent urination, chronic kidney failure, microalbuminuria, urinary stones, breast pain, chest discomfort, facial edema, edema, peripheral edema, fatigue, generalized edema, influenza-like illness, weight gain, asthenia, thirst, contusions, abrasions, lacerations, traffic accidents, spinal compression fractures, chills, fever, insect bites, concussion, ligament rupture, ligament sprain, wounds, wrist fractures, 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 congestion, gastrointestinal disorders, abdominal bloating, decreased appetite, daydreaming, dysuria, lethargy, drowsiness, nausea, vomiting, upper abdominal pain, high blood pressure, acute kidney failure, respiratory depression, coma, exfoliative dermatitis, mucous membrane 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 may be sensitive to air or moisture; therefore, it must be stored in a tightly sealed container. The optimal storage temperature is room temperature, between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Hard capsules in white and light yellow powder.

Package unit

For domestic use - 30 capsules/bottle, for domestic use - 100 capsules/bottle, for export - 10 capsules/bottle, for export - 30 capsules/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.

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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.