COXID Celecoxib 400mg Capsule 30's
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Features
- Celecoxib
Description
Indications/Uses
Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) in patients 2 years and older.
Management of acute pain, including postoperative dental or orthopedic pain, and treatment of primary dysmenorrheal.
Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib.
Dosage/Direction for Use
As with other NSAIDs, the lowest effective dose of celecoxib should be used for the shortest possible time. (See Table 1 and Table 2.)
Administration
Special Precautions
Renal Insufficiency: There is no clinical experience in patients with severe renal impairment thus the use of celecoxib is not advised.
Poor Metabolizers of CYP2C9 Substrates: Celecoxib should be administered with caution in patients who are poor CYP2C9 metabolizers based on genotype or previous history with other CYP2C9 substrates such as warfarin or phenytoin. Consider starting treatment at half of the lowest recommended dose in poor metabolizers and consider using alternative management in JRA patients who are poor metabolizers.
Adverse Reactions
Cardiovascular: peripheral edema, angina pectoris, chest pain, coronary artery disorder, myocardial infarction, palpitation, tachycardia, aggravated hypertension, syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, thrombophlebitis, deep-vein thrombosis, vasculitis.
Gastrointestinal: dyspepsia, diarrhea, constipation, abdominal pain, nausea, vomiting, flatulence, anorexia, diverticulitis, dry mouth, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, increased appetite, melena, stomatitis, taste perversion, tenesmus, tooth disorder, dry socket, intestinal obstruction, intestinal perforation, GI bleeding, colitis with bleeding, esophageal perforation, pancreatitis, cholelithiasis, ileus, intestinal anastomotic ulceration.
Nervous System: headache, migraine, dizziness, insomnia, somnolence, anxiety, asthenia, depression, hypertonia, hypoesthesia, nervousness, neuralgia, neuropathy, paresthesia, vertigo, aseptic meningitis, ataxia, ageusia, anosmia, fatal intracranial hemorrhage, suicide.
Respiratory: upper respiratory tract infection, sinusitis, pharyngitis, rhinitis, bronchitis, bronchospasm (including aggravated bronchospasm), coughing, dyspnea, laryngitis, pneumonia, nasopharyngitis.
Dermatologic and Sensitivity Reactions: rash, alopecia, dermatitis, dry skin, erythematous rash, maculopapular rash, nail disorder, photosensitivity reaction, pruritus, skin disorder, increased sweating, urticaria.
Allergic Reactions: aggravated allergy, bronchospasm, generalized or facial edema, angioedema, anaphylactoid reactions, erythema multiforme, exfoliative dermatitis, Sweet's syndrome, Stevens-Johnson Syndrome, toxic epidermal necrolysis.
Hematologic: anemia, ecchymosis, epistaxis, thrombocythemia, agranulocytosis, aplastic anemia, pancytopenia, leukopenia, thrombocytopenia.
Renal and Genitourinary: albuminuria, cystitis, dysuria, hematuria, frequent micturition, renal calculus, urinary incontinence, urinary tract infection, dysmenorrhea, genital moniliasis, menstrual disorder, vaginal hemorrhage, vaginitis, prostatic disorder, acute renal failure, interstitial nephritis, renal papillary necrosis, renal injury.
Hepatic: Borderline elevations in serum ALT (SGPT) or AST (SGOT), jaundice, hepatitis, fatal fulminant hepatitis, liver necrosis, liver failure.
Musculoskeletal: back pain, arthralgia, arthrosis, bone disorder, leg cramps, myalgia, neck stiffness, synovitis, tendinitis, accidental fracture.
Special Senses: blurred vision, cataract, conjunctivitis, ocular pain, glaucoma, deafness, ear abnormality, earache, otitis media, tinnitus.
Metabolic: increases in: blood urea nitrogen (BUN), creatinine phosphokinase (CPK), nonprotein nitrogen (NPN), creatinine, alkaline phosphatase; diabetes mellitus, hyperglycemia, hypoglycemia, hypercholesterolemia, hypokalemia, hyponatremia, weight gain.
General: hot flushes, influenza-like symptoms, accidental injury, cysts, fatigue, fever, flu-like symptoms, soft tissue infection, bacterial infections, fungal infections (including moniliasis), viral infections (including herpes simplex or herpes zoster), pain and peripheral pain, sepsis, sudden death.
Action
At therapeutic doses, celecoxib does not inhibit COX-1 isoenzyme, thus, it does not interfere with the normal COX-1 related physiological processes in tissues, such as the stomach, intestine and platelets.
Pharmacokinetics: Bioavailability: Celecoxib is well absorbed from the GI tract. Peak plasma levels occur approximately 2 to 3 hours after the drug is given orally under fasting conditions. After oral administration of a single 200 mg dose of celecoxib in healthy fasting adults, peak plasma concentrations (Cmax) of the drug averaged 705 ng/mL. When celecoxib was taken with a high fat meal (24 g fat), bioavailability (AUC) was increased by 10 to 20% and time to reach peak plasma levels (tmax) was delayed by 1 to 2 hours compared with administration with a medium-fat meal (8 g fat) or under fasting conditions. The AUC and plasma concentration 12 hours after a celecoxib dose were slightly higher when the drug was given in the evening versus in the morning. Under fasting conditions, at doses above 200 mg, there is less than a proportional increase in Cmax and AUC, which is thought to be due to the low solubility of the drug in aqueous media. After oral administration of celecoxib at recommended doses of 200 to 400 mg/day, steady-state plasma concentrations are reached within five days. Celecoxib doses up to 200 mg twice a day can be administered without regard to timing of meals. Higher doses (400 mg twice a day) should be given with food to improve absorption. Celecoxib's protein binding is 97%. The apparent volume of distribution at steady state is about 400 L (about 7.14 L/kg), suggestive of extensive tissue distribution. Celecoxib is not bound to erythrocytes. It is not known whether celecoxib crosses human placenta.
Celecoxib is extensively metabolized in the liver; metabolism is primarily mediated via cytochrome P450 2C9. Three metabolites have been identified in human plasma: a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate.
Celecoxib's metabolites do not have pharmacologic activity as COX-1 and 2 inhibitors. (See Interactions).
Celecoxib is excreted in urine and feces principally as metabolites; less than 3% of the dose is excreted unchanged. Under fasted condition, the effective half-life is approximately 11 hours. The apparent plasma clearance (CL/F) is about 500 mL/min.
MedsGo Class
Celecoxib is prescribed to treat osteoarthritis (arthritis caused by the breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by the swelling of the lining of the joints), ankylosing spondylitis (arthritis of the spine which can lead to fusion of the vertebral column), acute pain and other painful conditions such as dysmenorrhea (menstrual pain), lumbago (low back pain).
Dosage/Direction for Use
Use celecoxib exactly as instructed by your doctor for it to be effective.
Take celecoxib with or without food; with food if it causes stomach upset.
Swallow the capsule whole with a full glass of water. If you have difficulty swallowing the capsule, you may open the capsule and sprinkle the contents on a teaspoon of applesauce, swallow all of the mixture and follow with water.
If you forget to use this medicine on schedule, use it immediately as you remember. However, if it is already time for the next dose, just proceed with your next regular dose schedule.
Unless advised by your doctor, do not double or adjust dosage, or use longer than prescribed.
Contraindications and Special Precautions
Inform your doctor or pharmacist:
- if you are pregnant, trying for a baby or breast-feeding;
- if you have any of the following conditions: allergy, kidney problem, liver problem, gastrointestinal problem (ulcers, bleeding, heartburn), asthma, heart problem (angina, heart failure), high blood pressure, high cholesterol, history of heart attack or stroke, blood problem (bleeding, clotting, anemia), diabetes, nasal polyps;
- if you are using any other prescription or over-the-counter (OTC) medicines and dietary or herbal supplements.
If you become pregnant while using this medicine, stop taking it and inform your doctor immediately.
Keep a regular check-up schedule. Your doctor may prescribe tests to check and monitor your progress while under treatment with this medicine.
If you need to undergo surgery or dental procedure, inform your doctor or dentist that you are using this medicine before going through it.
Side effects may possibly occur as with most medicines. You may not experience any side effect; however, if you experience any of these side effects with celecoxib, inform your doctor immediately, especially if they become severe or persistent: nausea, vomiting, stomach upset or pain, gas, bloating, diarrhea, loss of appetite, loss of taste, difficult or painful swallowing, headache, dizziness, confusion, tiredness, hallucinations, lack of energy, back pain, blurred vision, ringing in the ears, sleepiness, sore throat, unexplained weight gain, swelling of hands or feet, pain or swelling in the groin or calf, unusual bleeding or bruising, rash, itching, pale skin, cough, hair loss, fast or irregular heartbeat, dark urine, painful or difficult urination, yellowing of the skin or eyes, flu-like symptoms, sensitivity to light, chest pain and allergic reactions such as hives, difficulty breathing and swelling of the face, lips, tongue or throat.
If you experience dizziness or vision problems, do not drive, operate machinery or perform any activity which will need you to be alert or to see clearly.
The side effects mentioned here are not complete and others may occur. If you observe other side effects or reactions, call your doctor for advice.
Do not share your medicine with others even if you have the same disease symptoms.
Storage
Store in a cool, dry place, protected from light and moisture. Keep the medicine out of childrens reach. Discard it properly when it is expired or no longer needed.