Celebrex (celecoxib)

Celecoxib is a prescription nonsteroidal anti-inflammatory drug used for the relief of pain, fever, swelling and tenderness caused by arthritis. Celecoxib is also used for familial Familial Adenomatous Polyposis (FAP).

Celecoxib is available under the following different brand names: Celebrex.

Adults and Pediatric Dosages

Capsule

• 50 mg
• 100 mg
• 200 mg
• 400 mg

Dosage Considerations – Should be Given as Follows:

Acute Pain and Primary Dysmenorrhea

• 400 mg orally initially, then 200 mg as needed on the first day; 200 mg every 12 hours as needed on subsequent days

Ankylosing Spondylitis

• 200 mg orally once daily or divided every 12 hours; if no effect after 6 weeks, may increase to 400 mg/day; if no adequate response observed after 6 weeks of taking 400 mg/day consider discontinuing therapy

Osteoarthritis

• 200 mg orally once daily or divided every 12 hours

Rheumatoid Arthritis

• 100-200 mg orally every 12 hours

Juvenile Rheumatoid Arthritis

• Children under 2 years: safety and efficacy not established
• Children 2 years and 10-25 kg: 50 mg orally every 12 hours
• Children 2 years and over 25 kg: 100 mg orally every 12 hours
• Consider alternative management in patients who are poor CYP2C9 metabolizers

Familial Adenomatous Polyposis (off-label)

• 400 mg orally every 12 hours, taken with food
• Usual medical care should be continued during celecoxib therapy

Dosage Modifications

Adult:

• Liver (hepatic) impairment:
• Moderate (child-pugh class B): decrease dose by 50%
• Severe (child-pugh class C): Not recommended
• Kidney (renal) impairment:
  • Relative contraindication to use

Pediatric:

• Poor CYP2C9 Metabolizers
• May consider reducing the initial dose by 50%; consider alternative therapy in patients that are poor CYP2C9 metabolizers

Side effects of celecoxib include:

• headache
• high blood pressure (hypertension)
• fever
• indigestion
• upper respiratory tract infection
• joint pain
• cough
• vomiting
• diarrhea
• gastroesophageal reflux
• runny or stuffy nose
• abdominal pain
• nausea
• back pain
• insomnia
• sore throat
• gas (flatulence)
• bloating
• rash
• dizziness
• swelling of the arms and legs
• anemia
• skin reaction with lesion
• redness and peeling of the skin (exfoliative dermatitis)
• hepatitis
• yellowing of skin and eyes (jaundice)
• blistering and peeling of the skin (Steven-Johnson syndrome)
• acute skin condition caused by medication (toxic epidermal necrolysis [TEN])
• increased serum asparate aminotransferase concentration (AST), indicating possible liver damage

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Celecoxib has no known severe interactions with other drugs.
• Serious interactions of celecoxib include:
  • apixaban
  • benazepril
  • captopril
  • enalapril
  • fosinopril
  • ketorolac
  • ketorolac internasal
  • lisinopril
  • methotrexate
  • moexipril
  • pemetrexed
  • perindopril
  • quinapril
  • ramipril
  • thioridazine
  • trandolapril
• Celecoxib has moderate interactions with at least 255 different drugs.
• Celecoxib has minor interactions with at least 136 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

Cardiovascular risk

• Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase risk of serious cardiovascular thrombotic events, heart attack (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

This medication contains celeoxib. Do not take Celebrex if you are allergic to celecoxib or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Aspirin allergy, chronic hepatitis, perioperative pain resulting from coronary artery bypass graft surgery

Effects of Drug Abuse

• Ingestion of large quantities of celecoxib may cause stomach and intestinal irritation, kidney damage and/or toxicity

Short-Term Effects

• Celecoxib has convulsant/epileptogenic properties and may cause seizures. Celecoxib may also cause allergic contact dermatitis, although not generally considered to be a human sensitizer
• See "What Are Side Effects Associated with Using Celecoxib?"

Long-Term Effects

• Long-term administration of nonsteroidal anti-inflammatory drugs (NSAIDs) may result in renal papillary necrosis and other kidney (renal) injury; patients at greatest risk include elderly individuals; those with impaired kidney (renal) function, too much fluid in the blood (hypovolemia), heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
• Anemia may occur; monitor hemoglobin or hematocrit in long-term treatment patients
• See "What Are Side Effects Associated with Using Celecoxib?"

Cautions

• Congestive heart failure, high blood pressure
• Increased risk of adverse cardiovascular events and skin reactions
• Caution in asthma (bronchial), bleeding disorder, sudden difficulty breathing, duodenal/gastric/peptic ulcer, kidney (renal) impairment
• Risk of gastrointestinal bleeding, ulceration, and perforation
• Long-term administration of NSAIDs may result in renal papillary necrosis and other kidney (renal) injury; patients at greatest risk include elderly individuals; those with impaired kidney (renal) function, too much fluid in the blood (hypovolemia), heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
• Anemia may occur; monitor hemoglobin or hematocrit in long-term treatment patients
• Heart Failure (HF) risk
  • NSAIDs have the potential to trigger heart failure by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
  • NSAIDs should be avoided or withdrawn whenever possible

Pregnancy and Lactation

• Use celecoxib during pregnancy with caution if benefits outweigh risks
• Animal studies show risk and human studies are not available, or neither animal nor human studies were done
• At 30 weeks gestation or greater, use of celecoxib may cause premature closure of ductus arteriosus
• Therefore, use celecoxib during pregnancy only in LIFE-THREATENING emergencies when no safer drug is available
• There is positive evidence of human fetal risk
• Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls
• Celecoxib enters breast milk; use caution if breastfeeding