Prescription only.
Read the instructions thoroughly before use.
Do not exceed the recommended dose.
Please inform your doctor of all undesirable effects upon drug administration.
Please consult your physician for more information.
Do not use the product after the expiry date.
Keep out of reach of children.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Celecoxib .................................................... 200 mg
Excipients: q.s ………………………………………. 1 capsule
Hard capsule.
Product description: A white to off-white hard capsule with a pattern on the capsule body filled with homogeneous powder.
Box of 2 blisters x 10 capsules.
Absorption
The pharmacokinetics of celecoxib has been evaluated in approximately 1500 individuals. When given under fasting conditions celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours. Oral bioavailability from capsules is about 99% relative to administration in suspension (optimally available oral dosage form). Under fasting conditions, both peak plasma levels (Cmax) and area under the curve (AUC) are roughly dose proportional up to 200 mg twice daily; at higher doses there are less than proportional increases in Cmax and AUC.
Distribution
Plasma protein binding, which is concentration independent, is about 97% at therapeutic plasma concentrations and celecoxib is not preferentially bound to erythrocytes in the blood.
Metabolism
Celecoxib metabolism is primarily mediated via cytochrome P450 2C9. Three metabolites, inactive as COX-1 or COX-2 inhibitors, have been identified in human plasma: a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate.
Cytochrome P450 2C9 activity is reduced in individuals with genetic polymorphisms that lead to reduced
enzyme activity, such as those homozygous for the CYP2C9*3 polymorphism.
In a pharmacokinetic study of celecoxib 200 mg administered once daily in healthy volunteers, genotyped as either CYP2C9*1/*1, CYP2C9*1/*3, or CYP2C9*3/*3, the median Cmax and AUC0-24 of celecoxib on day 7 were approximately 4-fold and 7-fold, respectively, in subjects genotyped as CYP2C9*3/*3 compared to other genotypes. In three separate single dose studies, involving a total of 5 subjects genotyped as CYP2C9*3/*3, single-dose AUC0-24 increased by approximately 3-fold compared to normal metabolizers. It is estimated that the frequency of the homozygous *3/*3 genotype is 0.3 – 1.0% among different ethnic groups.
Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose (see sections Posology and Method of administration and Interactions).
Excretion
Elimination of celecoxib is mostly by hepatic metabolism with less than 1% of the dose excreted unchanged in urine. After multiple dosing, elimination half-life is 8 to12 hours and the rate of clearance is about 500 mL/min. With multiple dosing steady-state plasma concentrations are reached before Day 5. The intersubject variability on the main pharmacokinetic parameters (AUC, Cmax, elimination half-life) is about 30%. The mean steady-state volume of distribution is about 500 L/70 kg in young healthy adults indicating wide distribution of celecoxib into the tissues. Preclinical studies indicate that the drug crosses the blood/brain barrier.
Food effects
Dosing with food (high fat meal) delays absorption of celecoxib resulting in a Tmax of about 4 hours and increases bioavailability by about 20% (see section Posology and method of administration).
In healthy adult volunteers, the overall systemic exposure (AUC) of celecoxib was equivalent when celecoxib was administered as intact capsule or capsule contents sprinkled on applesauce. There were no significant alterations in Cmax, Tmax or T1/2 after administration of capsule contents on applesauce.
Special populations
Elderly
In the population > 65 years there is a one and a half to two-fold increase in mean Cmax and AUC for celecoxib. This is a predominantly weight-related rather than age-related change, celecoxib levels being higher in lower weight individuals and consequently higher in the elderly population who are generally of lower mean weight than the younger population. Therefore, elderly females tend to have higher drug plasma concentrations than elderly males. No dosage adjustment is generally necessary. However, for elderly patients with a lower than average body weight (< 50 kg), initiate therapy at the lowest recommended dose.
Children
The steady-state pharmacokinetics of celecoxib administered as an investigational oral suspension was
evaluated in 152 JIA patients 2 years to 17 years of age weighing ³10 kg with oligoarticular, oligoarticular extended, or polyarticular rheumatoid factor positive or negative course JIA, and in patients with systemic-onset JIA (with currently inactive systemic features). Population pharmacokinetic analysis indicated that the oral clearance (unadjusted for body weight) of celecoxib increases less than proportionally to increasing weight, with 10 kg and 25 kg patients predicted to have 40% and 24% lower clearance, respectively, compared with a 70 kg adult RA patient.
Twice-daily administration of 50 mg capsules to JIA patients weighing ³10 to £25 kg, and twice-daily
administration of 100 mg capsules to JIA patients weighing >25 kg should achieve plasma concentrations
similar to those observed in the clinical trial that demonstrated the non-inferiority of celecoxib to naproxen 7.5 mg/kg twice daily (see section Posology and method of administration). Celecoxib has not been studied in JIA patients under the age of 2 years, in patients with body weight less than 10 kg (22 lbs), or beyond 24 weeks.
Race
A meta-analysis of pharmacokinetic studies has suggested an approximately 40% higher AUC of celecoxib in the Black population compared to Caucasians. The cause and clinical significance of this finding is unknown.
Hepatic impairment: Plasma concentrations of celecoxib in patients with mild hepatic impairment (Child-Pugh Class A) are not significantly different from those of age and sex matched controls. In patients with moderate hepatic impairment (Child-Pugh Class B) celecoxib plasma concentrations are about twice those of matched controls (see section Posology and Method of administration).
Renal impairment: In elderly volunteers with age-related reductions in glomerular filtration rate (GFR) (mean GFR > 65mL/min/1.73m2) and in patients with chronic stable renal insufficiency (GFR 35-60mL/min/1.73m2) celecoxib pharmacokinetics was comparable to those seen in patients with normal renal function. No significant relationship was found between serum creatinine (or creatinine clearance) and celecoxib clearance. Severe renal insufficiency would not be expected to alter clearance of celecoxib since the main route of elimination is via hepatic metabolism to inactive metabolites.
Renal effects: The relative roles of COX-1 and COX-2 in renal physiology are not completely understood. Celecoxib reduces the urinary excretion of PGE2 and 6-keto-PGF1 α (a prostacyclin metabolite) but leaves serum thromboxane B2 (TXB2) and urinary excretion of 11-dehydro-TXB2, a thromboxane metabolite (both COX-1 products) unaffected. Specific studies have shown celecoxib produces no decreases in GFR in the elderly or those with chronic renal insufficiency. These studies have also shown transient reductions in fractional excretion of sodium. In studies in patients with arthritis a comparable incidence of peripheral edema has been observed to that seen with non-specific COX-inhibitors (which also possess COX-2 inhibitory activity). This was most evident in patients receiving concomitant diuretic therapy. However increased incidences of hypertension and cardiac failure have not been observed and the peripheral edema has been mild and self-limiting.
The effect of celecoxib on ability to drive or use machinery has not been studied, but based on its pharmacodynamic properties and overall safety profile it is unlikely to have an effect.
Fertility
Based on the mechanism of action, the use of NSAIDs, including celecoxib, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including celecoxib, should be considered.
Pregnancy
There are no studies in pregnant women. Studies in animals have shown reproductive toxicity (see Section Preclinical safety data). The relevance of these data for humans is unknown.
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.
Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss.
Lactation
Studies in rats show that celecoxib is excreted in milk at concentrations similar to those in plasma. Administration of celecoxib to lactating women has shown very low transfer of celecoxib into breast milk. Because of the potential for adverse reactions in nursing infants from celecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the expected benefit of the drug to the mother.
Interactions
General
Celecoxib metabolism is predominantly mediated via cytochrome P450 (CYP) 2C9 in the liver. Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution as they may have abnormally high plasma levels due to reduced metabolic clearance. Consider starting treatment at half the lowest recommended dose (see sections Posology and Method of administration and Metabolism).
Concomitant administration of celecoxib with inhibitors of CYP2C9 can lead to increases in plasma concentrations of celecoxib. Therefore, a dose reduction of celecoxib may be necessary when celecoxib is co-administered with CYP2C9 inhibitors.
Concomitant administration of celecoxib with inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates can lead to decreases in plasma concentrations of celecoxib. Therefore, a dose increase of celecoxib may be necessary when celecoxib is co-administered with CYP2C9 inducers.
Clinical pharmacokinetics study and in vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of CYP2D6. Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by CYP2D6.
Drug-specific
Interaction of celecoxib with warfarin or similar agents: (See section Use with oral anticoagulants).
Lithium: In healthy subjects, lithium plasma levels increased approximately 17% in subjects receiving lithium together with celecoxib. Patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
Aspirin: Celecoxib does not interfere with the anti-platelet effect of low-dose aspirin (See section GI effects). Because of its lack of platelet effects, celecoxib is not a substitute for aspirin in the prophylactic treatment of CV disease.
Anti-hypertensives including Angiotensin-converting enzyme inhibitors (ACEIs), Angiotensin II Antagonists (also known as angiotensin receptor blockers, ARBs), diuretics and beta-blockers: Inhibition of prostaglandins may diminish the effect of anti-hypertensives including ACEIs and/or ARBs, diuretics and beta-blockers. This interaction should be given consideration in patients taking celecoxib concomitantly with ACEIs and/or ARBs, diuretics and beta-blockers.
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs including selective COX-2 inhibitors with ACE inhibitors, angiotensin II antagonists or diuretics, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Therefore, the concomitant administration of these drugs should be done with caution. Patients should be adequately hydrated and the clinical need to monitor the renal function should be assessed at the beginning of the concomitant treatment and periodically thereafter.
Results from lisinopril study: In a 28-day clinical study in patients with lisinopril-controlled Stage I and II hypertension, administration of celecoxib 200 mg BID resulted in no clinically significant increases, when compared to placebo treatment, in mean daily systolic or diastolic blood pressure as determined using 24-hour ambulatory blood pressure monitoring. Among patients co-administered with celecoxib 200 mg BID, 48% were considered unresponsive to lisinopril at the final clinic visit (defined as either cuff diastolic blood pressure >90 mmHg or cuff diastolic blood pressure increased >10% compared to baseline), compared to 27% of patients co-administered with placebo; this difference was statistically significant.
Cyclosporine: Because of their effect on renal prostaglandins, NSAIDs may increase the risk of nephrotoxicity with cyclosporine.
Fluconazole and ketoconazole: Concomitant administration of fluconazole at 200 mg once daily resulted in a two-fold increase in celecoxib plasma concentration. This increase is due to the inhibition of celecoxib metabolism via CYP2C9 by fluconazole. Celecoxib should be introduced at half the recommended dose in patients receiving the CYP2C9 inhibitor fluconazole (see section Posology and Method of administration). Ketoconazole, a CYP3A4 inhibitor, showed no clinically relevant inhibition in the metabolism of celecoxib.
Dextromethorphan and metoprolol: Concomitant administration of celecoxib 200 mg twice daily resulted in a 2.6-fold and a 1.5-fold increases in plasma concentrations of dextromethorphan and metoprolol (CYP2D6 substrates), respectively. These increases are due to celecoxib inhibition to the CYP2D6 substrate metabolism via CYP2D6. Therefore, the dose of drugs as CYP2D6 substrate may need to be reduced when treatment with celecoxib is initiated or increased when treatment with celecoxib is terminated (see section Use with oral anticoagulants).
Diuretics: Clinical studies have shown that NSAIDs, in some patients, can reduce the natriuretic effect of furosemide and thiazides by inhibition of renal prostaglandin synthesis.
Methotrexate: No pharmacokinetic and clinically important interactions have been observed in a clinical study between celecoxib and methotrexate.
Oral contraceptives: In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of a prototype combination oral contraceptive (1 mg norethindrone/ 0.035 mg ethinyl estradiol).
Other drugs: No clinically important interactions have been observed with celecoxib and antacids (aluminum and magnesium), omeprazole, glibenclamide (glyburide), phenytoin, or tolbutamide.
Incompatibilities: None known.
Clinical experience of overdose is limited. Single doses up to 1200 mg and multiple doses up to 1200 mg twice daily have been administered to healthy subjects without clinically significant adverse effects.
In the event of suspected overdose, appropriate supportive medical care should be provided. Dialysis is unlikely to be an efficient method of drug removal because of high protein binding of the drug.
Store in dry places, not exceeding 30°C, protect from light. The sprinkled capsule contents on applesauce, rice gruel or yogurt are stable for up to 6 hours under refrigerated conditions (2-8°C/35-45°F). The sprinkled capsule contents on mashed banana should not be stored under refrigerated conditions.
- Individuals with fatigue, asthenia.
- Weak elderly people, individuals who recover from an illness.
- Individuals with poor resistance.
Cardiovascular thrombotic events
Nonsteroidal anti-inflammatory drugs (NSAIDs), non-aspirin, by systemic route, have shown an increased risk of cardiovascular thrombotic events, including myocardial infarction , and stroke , which can be fatal. This risk may occur early in treatment and may increase with duration of use. The increase in cardiovascular thrombotic risk has been observed most consistently at higher doses. Physicians should remain alert for the development of such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. To minimize the potential risk for an adverse cardiovascular event in celecoxib-treated patients, use the lowest effective dose for the shortest duration possible.
Cardiovascular effects
Cardiovascular thrombotic events: Celecoxib may cause an increased risk of serious CV thrombotic events, myocardial infarction (MI), and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with dose and duration of use. The relative increase of this risk appears to be similar in those with or without known CV disease or CV risk factors. However, patients with CV disease or CV risk factors may be at greater risk in terms of absolute incidence, due to their increased rate at baseline. To minimize the potential risk for an adverse CV event in patients treated with celecoxib, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and symptoms of serious CV toxicity and the steps to take if they occur (see section Pharmacodynamic properties).
Two large, controlled, clinical trials of a different COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see section Contraindications).
Celecoxib is not a substitute for acetylsalicylic acid for prophylaxis of CV thromboembolic diseases because of the lack of effect on platelet function. Because celecoxib does not inhibit platelet aggregation, anti-platelet therapies (e.g., acetylsalicylic acid) should not be discontinued.
Hypertension: As with all NSAIDs, celecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. NSAIDs, including celecoxib, should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of therapy with celecoxib and throughout the course of therapy.
Fluid retention and edema: As with other drugs known to inhibit prostaglandin synthesis, fluid retention and edema have been observed in some patients taking celecoxib. Therefore, patients with pre-existing congestive heart failure (CHF) or hypertension should be closely monitored. Celecoxib should be used with caution in patients with compromised cardiac function, pre-existing edema, or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolemia.
Gastrointestinal (GI) effects
Upper and lower GI perforations, ulcers or bleeds have occurred in patients treated with celecoxib. Patients most at risk of developing these types of GI complications with NSAIDs are the elderly, patients with CV disease, patients using concomitant glucocorticoids, antiplatelet drugs (such as aspirin), or other NSAIDs, patients using alcohol or patients with a prior history of, or active, GI disease, such as ulceration, GI bleeding or inflammatory conditions. Most spontaneous reports of fatal GI events have been in elderly or debilitated patients.
Renal effects
NSAIDs including celecoxib may cause renal toxicity. Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs. 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 (see section Posology and Method of administration).
Anaphylactoid reactions
As with NSAIDs in general, anaphylactoid reactions have occurred in patients exposed to celecoxib (see section Contraindications).
Serious skin reactions
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib. Patients appear to be at highest risk for these events early in the course of therapy, the onset of the event occurring in the majority of cases within the first month of treatment. Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Hepatic effects
Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied. The use of celecoxib in patients with severe hepatic impairment is not recommended. Celecoxib should be used with caution when treating patients with moderate hepatic impairment (Child-Pugh Class B), and initiated at half the recommended dose (see section Posology and Method of administration).
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
The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding and should be given with caution. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g., apixaban, dabigatran, and rivaroxaban). In patients on concurrent therapy with warfarin or similar agents, serious bleeding events, some of them fatal, have been reported. Because increases in prothrombin time (INR) have been reported, anticoagulation/INR should be monitored in patients taking a warfarin/coumarin-type anticoagulant after initiating treatment with celecoxib or changing the dose (see section Interactions).
Systemic onset JIA
NSAIDs including celecoxib should be used only with caution in patients with systemic-onset JIA, due to the risk of disseminated intravascular coagulation. Patients receiving celecoxib who have systemic-onset JIA should be monitored for the development of abnormal coagulation tests.
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 (see section Interactions).
Excipients
Lactose monohydrate: Patients with problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially “sodium-free”.
PRECLINICAL SAFETY DATA
Nonclinical safety data revealed no special hazard for humans based on conventional studies of repeated dose toxicity, mutagenicity or carcinogenicity.
Celecoxib at oral doses ³ 150 mg/kg/day (approximately 2-fold human exposure at 200 mg twice daily as measured by AUC0-24), caused an increased incidence of ventricular septal defects, a rare event, and fetal alterations, such as ribs fused, sternebrae fused and sternebrae misshapen when rabbits were treated throughout organogenesis. A dose-dependent increase in diaphragmatic hernias was observed when rats were given celecoxib at oral doses ³ 30 mg/kg/day (approximately 6-fold human exposure based on the AUC0-24 at 200 mg twice daily) throughout organogenesis. These effects are expected following inhibition of prostaglandin synthesis. In rats, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses, and reduced embryo/fetal survival.
Animal toxicology
An increase in the incidence of background findings of spermatocele with or without secondary changes such as epididymal hypospermia as well as minimal to slight dilation of the seminiferous tubules was seen in the juvenile rat. These reproductive findings while apparently treatment-related did not increase in incidence or severity with dose and may indicate an exacerbation of a spontaneous condition. Similar reproductive findings were not observed in studies of juvenile or adult dogs or in adult rats treated with celecoxib. The clinical significance of this observation is unknown.
Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis (RA).
Relief of signs and symptoms of juvenile idiopathic arthritis (JIA) in patients 2 years and older with body weight greater than or equal to 10 kg.
Relief of signs and symptoms of ankylosing spondylitis (AS).
Management of acute pain.
Treatment of primary dysmenorrhea.
Celecoxib is contraindicated in:
- Patients with known hypersensitivity to celecoxib or any other ingredient of the product.
- Patients with known sulfonamide hypersensitivity.
- Patients who have experienced asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid (ASA [aspirin]) or other nonsteroidal anti-inflammatory drugs (NSAIDs), including other cyclooxygenase-2 (COX-2) specific inhibitors.
- Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see section Special warnings and precautions for use).
Celecoxib capsules, at doses up to 200 mg twice per day, can be taken with or without food.
As the cardiovascular (CV) risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
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 as 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 dysmenorrhea: 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.
CYP2C9 poor metabolizers: Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose (see sections Interactions and Metabolism).
Elderly
No dosage adjustment is generally necessary. However, for elderly patients weighing less than 50 kg, it is advisable to initiate therapy at the lowest recommended dose.
Children
Juvenile idiopathic arthritis (JIA)
|
Pediatric Patients (2 years and older) |
Dose |
|
≥ 10 kg to ≤ 25 kg |
Capsule 50 mg twice daily |
|
> 25 kg |
Capsule 100 mg twice daily |
Celecoxib has been studied in JIA patients 2 to 17 years of age. Safety and efficacy of celecoxib in children have not been studied beyond 6 months duration or in patients with body weight less than 10 kg (22 lbs), or in patients with active systemic features (see section Clinical studies).
Method of administration
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 cool or 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°C/35-45°F). The sprinkled capsule contents on mashed banana should not be stored under refrigerated conditions and should be ingested immediately.
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).
Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied (see section Hepatic effects).
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 (see section Renal effects) .
Coadministration 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 (see section Drug interactions, incompatibilities).
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