Medical Description
Analgesic, Nonopioid; Nonsteroidal Anti-inflammatory Drug (NSAID), Selective COX-2 inhibitor used for the treatment of dysmenorrhea, Juvenile idiopathic arthritis, migraine, osteoarthritis and for the treatment of acute pain.
Indication & Usage
-Anti-inflammatory (eg, for arthritis associated with inflammatory rheumatic disease): Oral: Initial: 200 mg once daily or 100 mg twice daily; may increase to a maximum of 200 mg twice daily for several weeks during a disease flare until the flare resolves.
-Dysmenorrhea: Oral: Initial: 400 mg, followed by an additional 200 mg approximately 12 hours later, if needed, on day 1; maintenance dose: 200 mg twice daily as needed; maximum daily maintenance dose: 400 mg/day. Begin at menses onset or 1 to 2 days prior to onset of menses for severe symptoms; usual duration: 1 to 5 days
-Gout: Initial: 400 mg, followed by 200 mg approximately 12 hours later on day 1, then continue 200 mg twice daily thereafter; maximum daily maintenance dose: 400 mg/day. Begin within 24 to 48 hours of flare onset; discontinue 2 to 3 days after resolution of clinical signs; usual duration: 5 to 7 days.
-Osteoarthritis: Oral: 200 mg once daily or 100 mg twice daily.
-Acute pain (monotherapy or as an adjunctive agent): Oral: Initial: 400 mg, followed by 200 mg approximately 12 hours later, if needed, on day 1; thereafter, 200 mg twice daily as needed or scheduled.
-Pediatric dose: Juvenile idiopathic arthritis (JIA): Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals.
Children ≥2 years and Adolescents:
≥10 kg to ≤25 kg: Oral: 50 mg twice daily
>25 kg: Oral: 100 mg twice daily
Active Ingredients
Celecoxib
Dosage & Administration
May be administered without regard to meals.
Side Effects
Acute myocardial infarction, angina pectoris, chest pain, coronary artery disease edema, exacerbation of hypertension, facial edema, palpitations, peripheral edema, tachycardia ,alopecia, cellulitis, contact dermatitis, diaphoresis, ecchymoses, erythematous rash, maculopapular rash, pruritus, , skin photosensitivity, urticaria, xeroderma, albuminuria, hot flash hypercholesterolemia, hyperglycemia, hypokalemia, abdominal pain, anorexia constipation, diarrhea, diverticulitis of the gastrointestinal tract, dyspepsia dysphagia, esophagitis, flatulence, gastritis, gastroenteritis, gastroesophageal reflux disease, hemorrhoids, hiatal hernia, increased appetite, melena, stomatitis, tenesmus, vomiting and xerostomia ,cystitis, dysuria, hematuria, urinary frequency, anemia, thrombocythemia, Increased liver enzymes, increased serum alkaline phosphatase.
Safety Advice
-In case of renal impairment: Creatinine clearance ≤30 mL/minute: Avoid use due to increased risk of acute kidney injury
-In case of hepatic impairment: Moderate impairment: Reduce dose by 50%. Severe impairment: Use is not recommended.
-contraindicated in patients with hypersensitivity to sulfonamide-containing drugs
-Avoid use in patients with active gastrointestinal bleeding. Use with caution for the patients having a history of GI ulcers, concurrent therapy known to increase the risk of gastrointestinal bleeding (eg, aspirin, anticoagulants and/or corticosteroids, selective serotonin reuptake inhibitors), smoking, use of alcohol, or in elderly or debilitated patients. Use the lowest effective dose for the shortest duration of time, to reduce risk of gastrointestinal adverse events; alternate therapies should be considered for patients at high risk. When used concomitantly with aspirin, a substantial increase in the risk of gastrointestinal complications (eg, ulcer) occurs; concomitant gastroprotective therapy (eg, proton pump inhibitors) is recommended
-Coronary artery bypass graft surgery: Risk of myocardial infarction and stroke may be increased with use following CABG surgery.
-Incase of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.
Storage
Store at room temperature.
Drug Interactions
-Alcohol (Ethyl): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of GI bleeding may be increased with this combination
-Angiotensin II Receptor Blockers: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, this combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Angiotensin II Receptor Blockers.
-Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Angiotensin-Converting Enzyme Inhibitors
-Anticoagulants: Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may enhance the anticoagulant effect of Anticoagulants.
-Aspirin: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective).
-Beta-Blockers: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Beta-Blockers.
-Bile Acid Sequestrants: May decrease the absorption of Nonsteroidal Anti-Inflammatory Agents.
-Corticosteroids (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective)
-Digoxin: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Digoxin.
-Enoxaparin: Nonsteroidal Anti-Inflammatory Agents may enhance the anticoagulant effect of Enoxaparin.
-Eplerenone: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Eplerenone.
-Estrogen Derivatives: Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may enhance the thrombogenic effect of Estrogen Derivatives. Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may increase the serum concentration of Estrogen Derivatives.
Pregnancy & Lactation
-The use of nonsteroidal anti-inflammatory drugs (NSAIDs) close to conception may be associated with an increased risk of miscarriage due to cyclooxygenase-2 inhibition interfering with implantation. Maternal use of NSAIDs should be avoided beginning at 20 weeks' gestation. If NSAID use is necessary between 20 and 30 weeks of gestation, limit use to the lowest effective dose and shortest duration possible. Based on available information, NSAIDs can be continued during the first 2 trimesters of pregnancy in patients with rheumatic and musculoskeletal diseases; use in the third trimester is not recommended.
-Celecoxib is present in breast milk. The relative infant dose (RID) of celecoxib is 1.7%. In general, breastfeeding is considered acceptable when the RID of a medication is <10%. the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Maternal use of NSAIDs should be avoided if the breastfeeding infant has platelet dysfunction, thrombocytopenia.