Celecoxib 100 mg

Rx

Indications

• Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis (RA).
• Relief the signs and symptoms of juvenile idiopathic arthritis (JIA) in patients ≥ 2 years of age weighing ≥ 10 kg.
• Relief the signs and symptoms of ankylosing spondylitis.
• Management of acute pain.
• Treatment of primary dysmenorrhoea.

Dosage
Adults

• Symptomatic treatment of osteoarthritis (OA): The recommended dose of celecoxib is 200 mg administered as a single dose or as 100 mg twice per day.
• Symptomatic treatment of rheumatoid arthritis (RA): The recommended dose of celecoxib is 100 mg or 200 mg twice per day.
• Ankylosing spondylitis (AS): The recommended dose of celecoxib is 200 mg administered as a single dose or 100 mg twice per day. Some patients may benefit from a total daily dose of 400 mg.
• Management of acute pain: The recommended dose of celecoxib is 400 mg, initially, followed by an additional 200 mg dose, if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily, as needed.
• Treatment of primary dysmenorrhoea: The recommended dose of celecoxib is 400 mg, initially, followed by an additional 200 mg dose, if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily, as needed.

Elderly

• Elderly patients with a lower than average body weight (< 50 kg), it is advisable to initiate therapy at the lowest recommended dose.

Pediatric population

Juvenile idiopathic arthritis (JIA)

• Children ≥ 2 years of age weighing ≥ 10 kg to ≤ 25 kg, the recommended dose is 50 mg twice daily.
• Children ≥ 2 years of age weighing > 25 kg, the recommended dose is 100 mg twice daily.
• The use of celecoxib in patients 2 to 17 years of age with juvenile idiopathic arthritis (JIA) was studied.

Hepatic impairment

• No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Introduce celecoxib at half the recommended dose in arthritis or pain patients with moderate hepatic impairment (Child-Pugh Class B).

Renal impairment

• No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is no clinical experience in patients with severe renal impairment.

CYP2C9 poor metabolisers

• Patients who are known, or suspected to be CYP2C9 poor metabolisers based on genotyping or previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution as the risk of dose-dependent adverse effects is increased. Consider reducing the dose to half the lowest recommended dose.

Co-administration with fluconazole

• Celecoxib should be introduced at half the recommended dose in patients receiving fluconazole, a CYP2C9 inhibitor. Caution is advised when co-administering celecoxib with other CYP2C9 inhibitors.

Usage

Celecoxib is administered orally with or without food.
For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce, rice gruel, yogurt or mashed banana. To do so, the entire capsule contents must be carefully emptied onto a level teaspoon of room temperature applesauce, rice gruel, yogurt or mashed banana and should be ingested immediately with water. The sprinkled capsule contents on applesauce, rice gruel or yogurt are stable for up to 6 hours under refrigerated conditions (2 – 8^oC/35 – 45^oF). The sprinkled capsule contents on mashed banana should not be stored under refrigerated conditions and should be ingested immediately.

• Known hypersensitivity to celecoxib, to any of the ingredients.
• Who have demonstrated allergic-type reactions to sulfonamides.
• Who have experienced of asthma, urticaria, or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors.
• In the setting of coronary artery bypass graft (CABG) surgery.
• Active peptic ulceration or gastrointestinal (GI) bleeding.
• In pregnancy and in women of childbearing potential unless using an effective method of contraception.
• Breast-feeding.
• Severe hepatic dysfunction (serum albumin < 25 g/l or Child-Pugh score ≥ 10).
• Patients with estimated creatinine clearance < 30 ml/min.
• Inflammatory bowel disease.
• Congestive heart failure (NYHA II – IV).
• Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

Uncommon

• Conjunctivitis, chest pain.

Rare

• Hallucination, pulmonary embolism, pneumonitis, gastrointestinal haemorrhage, hepatitis, photosensitivity reaction, renal failure acute, hyponatremia, menstrual disorder.

Cardiovascular effects

• Risk of cardiovascular thrombotic events: Systemic non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, either of which can be fatal.
• Hypertension: Celecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension.
• Fluid retention and oedema: Fluid retention and oedema have been observed in patients taking celecoxib.

Gastrointestinal (GI) effect

• Most spontaneous reports of fatal GI events have been in elderly or debilitated patients.

Renal effects

• Patients at greatest risk for renal toxicity are those with impaired renal function, heart failure, liver dysfunction and the elderly. Such patients should be carefully monitored while receiving treatment with celecoxib.
• Caution should be used when initiating treatment in patients with dehydration. It is advisable to rehydrate patients first and then start therapy with celecoxib.

Advanced renal disease

• Renal function should be closely monitored in patients with advanced renal disease who are administered celecoxib.

Anaphylactoid reactions

• Anaphylactoid reactions have occurred in patients exposed to celecoxib.

Serious skin reactions

• Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Hepatic effects

• Celecoxib should be used with caution when treating patients with moderate hepatic impairment (Child-Pugh Class B), and initiated at half the recommended dose.
  Rare cases of severe hepatic reactions, including fulminant hepatitis (some with fatal outcome), liver necrosis, and hepatic failure (some with fatal outcome or requiring liver transplant), have been reported with celecoxib.
• A patient with symptoms and/or signs of liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored carefully for evidence of the development of a more severe hepatic reaction while on therapy with celecoxib.

Use with oral anticoagulants

• In patients on concurrent therapy with warfarin or similar agents, serious bleeding events, some of them fatal, have been reported.

Systemic onset JIA

• NSAIDs including celecoxib should be used with caution in patients with systemic onset JIA, due to the risk of disseminated intravascular coagulation.

General

• By reducing inflammation, celecoxib may diminish the utility of diagnostic signs, such as fever, in detecting infections.
• The concomitant use of celecoxib and a non-aspirin NSAID should be avoided.

CYP2D6 inhibition

• Celecoxib has shown to be a moderately potent CYP2D6 inhibitor. For drugs that are metabolized by CYP2D6, a dose reduction during initiation of celecoxib treatment or a dose increase upon termination of celecoxib treatment may be necessary.

Excipients

• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Fertility

• Consider withdrawal of NSAIDs, including celecoxib, in women who have difficulties conceiving or who are undergoing investigation of infertility.

Pregnancy

• Celecoxib, as with other drugs inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus and should be avoided during the third trimester of pregnancy.
• Celecoxib should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Effects on ability to drive and use machines

• Patients who experience dizziness, vertigo or somnolence while taking celecoxib should refrain from driving or operating machinery.