Ezy Capsule

Ezy Capsule is used for: Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis, Dysmenorrhea, Acute pain, Familial adenomatous polyposis

Oral Osteoarthritis Adult: 200 mg/day as a single dose or in 2 divided doses. May increase to 200 mg bid, if necessary. Rheumatoid arthritis Adult: 100-200 mg bid. Dysmenorrhoea; Pain relief Adult: Initially, 400 mg followed by 200 mg if necessary on the 1st day. Maintenance: 200 mg bid. Ankylosing spondylitis Adult: Initially, 200 mg/day as a single dose or in 2 divided doses. May increase to 400 mg/day after 6 wk.

Juvenile Rheumatoid Arthritis <2 years: Safety and efficacy not established >2 years and 10-25 kg: 50 mg PO hourly >2 years and >25 kg: 100 mg PO 12 hourly

Renal impairment Relative contraindication to use

May be taken with or without food. Dose for OA/RA may be given w/ or w/o meals, but doses for FAP must be given w/ meals.

Known hypersensitivity (eg, anaphylactic reactions, serious skin reactions) to celecoxib or its components History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; severe, sometimes fata, anaphylactic reactions reported In the setting of coronary artery bypass graft Demonstrated allergic-type reactions to sulfonamides

Cardiovascular risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal Risk may increase with duration of use Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk NSAIDs are contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery Gastrointestinal risk NSAIDs increase risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal GI adverse events may occur at any time during use and without warning symptoms Elderly patients are at greater risk for serious GI events Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Heart Failure and Edema: Avoid use of Celecoxib in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of Celecoxib in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs Exacerbation of Asthma Related to Aspirin Sensitivity: Celecoxib is contraindicated in patients with aspirin-sensitive asthma. Serious Skin Reactions: Discontinue Celecoxib at first appearance of skin rash or other signs of hypersensitivity Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks of gestation Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia MONITORING PARAMETERS Monitor blood pressure before and during treatment. Monitor patients with preexisting asthma (without aspirin sensitivity)

Pregnancy There are no adequate and well-controlled studies on pregnant women; data from observational studies regarding potential embryofetal risks of NSAIDs during the 1st or 2nd trimesters are inconclusive Fetal toxicity Use of NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment; because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases risk of premature closure of fetal ductus arteriosus Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to lowest effective dose and shortest duration possible; if treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue drug and follow up according to clinical practice Animal studies Administration during pregnancy resulted in adverse effects on development, including increases in embryonic death and fetal malformations, at doses or maternal plasma drug exposures greater than those used clinically Prostaglandins have shown an important role in endometrial vascular permeability, blastocyst implantation, and decidualization; in animal studies, administration of prostaglandin synthesis inhibitors resulted in increased pre- and postimplantation loss Labor or delivery There are no studies on the effects of celecoxib during labor or delivery In animal studies, NSAIDs inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth Infertility Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin mediated follicular rupture required for ovulation Consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility Lactation Limited data from 12 breastfeeding women showed low levels of celecoxib in breast milk Calculated average daily infant dose was 10-40 mcg/kg/day, <1% of the weight-based therapeutic dose for a 2-year old child There is no information available regarding effects of drug on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking Celecoxib with drugs that interfere with hemostasis. Concomitant use of Celecoxib and analgesic doses of aspirin is not generally recommended ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or BetaBlockers: Concomitant use with Celecoxib may diminish the antihypertensive effect of these drugs. Monitor blood pressure ACE Inhibitors and ARBs: Concomitant use with Celecoxib in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects Digoxin: Concomitant use with Celecoxib can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels Contraindicated (0) Serious (23) aminolevulinic acid oral aminolevulinic acid topical apixaban benazepril captopril enalapril etrasimod fosinopril ivosidenib ketorolac ketorolac intranasal lisinopril methotrexate methyl aminolevulinate moexipril pemetrexed perindopril quinapril ramipril thioridazine tovorafenib trandolapril tucatinib

Side effects of Celecoxib : >10% Headache (10-16%),Hypertension (13%) 1-10% Fever (9%),Dyspepsia (8.8%),Upper respiratory tract infection (8.1%),Arthralgia (7%),Cough (7%),Vomiting (6%),Diarrhea (5.6%),Gastroesophageal reflux (5%),Sinusitis (5%),Abdominal pain (4.1%),Nausea (3.5%),Back pain (2.8%),Insomnia (2.3%),Pharyngitis (2.3%),Flatulence (2.2%),Rash (2.2%),Dizziness (2%),Peripheral edema (2%) <1% Anemia,Erythema multiforme,Exfoliative dermatitis,Hepatitis,Jaundice,Stevens-Johnson syndrome,Toxic epidermal necrolysis Frequency Not Defined Increased serum asparate aminotransferase concentration Potentially Fatal: Serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor primarily responsible to reduce mediators of pain and inflammation. Its action is due to inhibition of prostaglandin synthesis via inhibition of COX-2.

Ezy 200mg Capsule manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Celecoxib. Ezy is availble in Bangladesh. Farmaco BD drug index information on Ezy Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.