Use
Therapeutic indications
CELEBREX is indicated in adults for the relief of symptoms in the treatment of osteoarthritis, rheumatoid arthritis (RA) and ankylosing spondylitis (AS).
The decision to prescribe a selective cyclooxygenase-2 inhibitor (COX-2) should be based on the evaluation of all the specific risks of each patient (see sections Contraindications and Warnings and precautions for work)
Dosage and method of administration
Dose
Due to the possible increase in cardiovascular risks of celecoxib depending on the dose and duration of treatment, this drug should be prescribed at the minimum effective daily dose for the shortest possible period. The need for symptomatic treatment and its therapeutic efficacy for the patient should be reassessed periodically, particularly in patients with osteoarthritis (see sections Contraindications, Warnings and precautions for use, Adverse effects and Pharmacodynamic properties).
Osteoarthritis
The usual recommended daily dose is 200 mg divided into one or two doses. In some patients whose symptoms are not sufficiently alleviated, increasing the dose to 200 mg twice daily may increase effectiveness. If the therapeutic benefit does not improve after 2 weeks, other therapeutic options should be considered.
Rheumatoid polyarthritis
The recommended starting daily dose is 200 mg divided into 2 doses.
If necessary, the dose can be further increased to 200 mg twice a day. If the therapeutic benefit does not improve after 2 weeks, other therapeutic options should be considered.
Ankylosing spondylitis
The recommended daily dose is 200 mg divided into one or two doses. For a small number of patients whose symptoms are not adequately alleviated, increasing the dose to 400 mg in one or two divided doses may increase effectiveness. If the therapeutic benefit does not improve after 2 weeks, other therapeutic options should be considered.
The maximum recommended daily dose for all indications is 400 mg.
Special populations
Older subject (over 65 years old)
As with any patient, treatment will start with 200 mg per day.
If necessary, the dose can be further increased to 200 mg twice a day. Particular attention should be paid to elderly subjects with a body weight of less than 50 kg (see sections 4.4 and 4.4).
Pediatric populations
Celecoxib is not indicated in children.
CYP2C9 slow metabolizers
As the risk of dose-dependent adverse reactions is higher, celecoxib should be administered with caution to patients known or suspected to be slow metabolizers of CYP2C9, depending on genotype or previous history / experience with other substrates. CYP2C9. A dose reduction to half of the lowest recommended dose should be considered (see Pharmacokinetic properties section).
Patients with liver failure.
In patients with known moderate hepatic impairment with serum albumin between 25 and 35 g / l, treatment should be started at half the recommended dose. Experience in this type of patient is limited to that of cirrhotic patients (see sections Contraindications, Warnings and precautions for use and Pharmacokinetic properties).
Patients with kidney failure.
Since experience with celecoxib in patients with mild to moderate renal impairment is limited, these patients should be treated with caution (see Contraindications, Warnings and Precautions for Use and Pharmacokinetic Properties).
Administration form
Oral use
CELEBREX can be taken with or without food. Patients who have difficulty swallowing the capsules can add the contents of the celecoxib capsule to applesauce, rice pudding, yogurt, or banana puree. For this, the entire contents of the capsule should be carefully emptied into a teaspoon of applesauce, rice pudding, yogurt or banana puree, cold or at room temperature, and immediately ingested with 240 ml of water. Once sprinkled on applesauce, rice pudding or yogurt, the contents of the capsule remain stable for 6 hours in the refrigerator (between 2 and 8 ° C). If the contents of the capsule are drizzled over mashed bananas, they should not be refrigerated and should be swallowed immediately.
Prescription and delivery conditions
List I.
Duration and special precautions for conservation
Shelf life: 3 years.
Special precautions for storage: Store at a temperature not exceeding + 30 ° C.
Preclinical safety data
Conventional embryo-fetal toxicity studies have shown the appearance of dose-dependent diaphragmatic hernias in the rat fetus and cardiovascular malformations in the rabbit fetus, during systemic exposures to the free substance approximately 5 times (in rat) and 3 times ( in rabbits) higher than those obtained with the maximum recommended daily dose in humans (400 mg). Diaphragmatic hernias were also found in a peri and postnatal toxicity study in rats that included exposure to the product during the period of organogenesis.
In this latest study, at the lowest systemic exposure for which this abnormality occurred in a single animal, the relative margin of safety was estimated to be 3 times the maximum recommended daily dose in humans.
In animals, exposure to celecoxib during the early stages of embryonic development has led to pre- and post-implantation losses. These effects are expected after inhibition of prostaglandin synthesis.
Celecoxib is excreted in the milk of rats. In a peri and postnatal study in rats, toxicity was observed in the offspring.
Based on the results of conventional studies, genotoxicity or carcinogenesis, no particular risk has been observed in humans, except those mentioned in other sections of the SPC. In a two-year toxicity study, an increase in non-adrenal thrombosis was observed at high doses in the male rat.
Incompatibilities
Aimlessly.
Employment precautions
Contraindications
- History of hypersensitivity to the active substance or to any of the excipients included in the Composition section.
- Known hypersensitivity to sulfonamides.
- Active peptic ulcer or gastrointestinal (GI) bleeding.
- History of asthma, acute rhinitis, nasal polyps, angioedema, urticaria, or other allergic-type reactions triggered by taking aspirin or other NSAIDs, including COX-2 inhibitors.
- Pregnancy and women of childbearing age, in the absence of effective contraception (see section Pregnancy and lactation). In the two animal species studied celecoxib caused malformations (see sections Pregnancy and lactation and Preclinical safety data). In humans, the risk during pregnancy is not known but cannot be excluded.
- Lactation (see sections Pregnancy and lactation and Preclinical safety data).
- Severe liver failure (serum albumin minus 25 g / l or Child-Pugh score ³ 10).
- Patients with an estimated creatinine clearance less than 30 ml / min.
- Inflammatory bowel disease.
- Congestive heart failure (NYHA II-IV).
- Proven ischemic heart disease, peripheral artery disease, and / or a history of stroke (including transient ischemic attack).
Pregnancy and lactation
Pregnancy
Animal studies (rats and rabbits) have shown toxicity to reproductive functions, including malformations (see Contraindications and Preclinical Safety Data sections). Inhibition of prostaglandin synthesis could have a deleterious effect on pregnancy. Data from epidemiological studies point to an increased risk of miscarriage after the use of prostaglandin synthesis inhibitors in early pregnancy.
In humans, the risk during pregnancy is unknown but cannot be excluded. Like other drugs that inhibit prostaglandin synthesis, celecoxib can cause uterine inertia and premature closure of the arterial duct during the last trimester of pregnancy. Celecoxib is contraindicated during pregnancy and in women who may become pregnant (see Contraindications and Warnings and precautions for use). If a pregnancy is discovered during treatment, the use of celecoxib should be discontinued.
Breastfeeding
Celecoxib is excreted in rat milk at concentrations similar to those found in plasma. Administration of celecoxib to a limited number of breastfeeding women has shown very little celecoxib in breast milk. Patients treated with celecoxib should not breastfeed.
Fertility
Due to its mechanism of action, the use of NSAIDs, including celecoxib, can delay or prevent the breakdown of ovarian follicles, which has been associated with reversible sterility in some women.
Warnings and precautions for use
Gastrointestinal (GI) effects
Upper and lower gastrointestinal complications (perforations, ulcers, or bleeding (PUH)), some of which have been fatal, have been observed in patients treated with celecoxib.
Caution should be exercised in patients at increased risk of developing a gastrointestinal complication with NSAIDs:
- the elders
- patients also treated with other NSAIDs,
- or with acetylsalicylic acid,
- with glucocorticoids,
- patients who consume alcohol,
- or patients with a history of gastrointestinal disease such as ulcer and bleeding.
There is an increased risk of gastrointestinal side effects (gastrointestinal ulceration or other gastrointestinal complications) when celecoxib is used in combination with acetylsalicylic acid (even in low doses).
No significant difference in gastrointestinal tolerance has been demonstrated between the combination of COX-2 inhibitors and acetylsalicylic acid compared to the combination of NSAIDs and acetylsalicylic acid in long-term clinical trials (see Pharmacodynamic Properties section).
Concomitant use of NSAIDs
Concomitant use of celecoxib and an NSAID other than aspirin should be avoided.
Cardiovascular effects
Compared to placebo, an increase in the number of serious cardiovascular (CV) events, mainly myocardial infarction (MI), was observed in a long-term study in patients with sporadic adenomatous polyps treated with celecoxib at a dose of 200 mg two times a day and 400 mg twice a day (see section Pharmacodynamic properties).
Due to the possible increase in cardiovascular risks of celecoxib depending on the dose and duration of treatment, this drug should be prescribed at the minimum effective daily dose for the shortest possible period.
The need for symptomatic treatment and its therapeutic efficacy for the patient should be reassessed periodically, particularly in patients with osteoarthritis (see sections 4.2 and 5.1, Contraindications, adverse effects and pharmacodynamic properties).
Patients with significant risk factors for cardiovascular events (eg, hypertension, hyperlipidemia, diabetes, smoking) should be treated with celecoxib only after a thorough evaluation (see section Pharmacodynamic properties).
Due to their absence of antiplatelet effects, selective COX-2 inhibitors cannot replace acetylsalicylic acid in the prevention of thromboembolic cardiovascular disease. Consequently, antiplatelet aggregation treatments should not be discontinued (see section Pharmacodynamic properties).
Fluid retention and edema.
As with other drugs that inhibit prostaglandin synthesis, fluid retention and edema have been observed in patients treated with celecoxib. Therefore, celecoxib should be administered with caution in patients with a history of heart failure, left ventricular dysfunction, or high blood pressure and in patients with pre-existing edema of any origin because inhibition of prostaglandins can lead to impaired renal function and retention of liquids. Precautions will also be necessary in patients treated with diuretics or at risk of hypovolemia.
Hypertension
Like all NSAIDs, celecoxib can cause hypertension or worsen pre-existing hypertension, increasing the incidence of cardiovascular events. Therefore, close monitoring of blood pressure should be carried out at the start of treatment with celecoxib and then during treatment.
Kidney and liver effects
The existence of kidney or liver failure, and particularly cardiac dysfunction, is more likely in the elderly. Therefore, adequate medical surveillance should be ensured.
NSAIDs, including celecoxib, may be responsible for kidney toxicity. Clinical trials with celecoxib have shown similar renal effects to those observed with comparator NSAIDs. Patients at increased risk of developing kidney toxicity are patients with kidney failure, heart failure, liver problems, those taking diuretics, ACE inhibitors, receptor antagonists. angiotensin II, as well as the elderly (see section Interactions with other medications and other forms of interaction). These patients should be closely monitored while receiving celecoxib therapy.
Some cases of serious liver reactions have been reported with celecoxib, including fulminant hepatitis (some fatal), liver necrosis, and liver failure (some fatal or requiring liver transplantation). In cases where the onset delay was reported, the most severe liver reactions occurred within one month of starting treatment (see section 4.8).
During treatment, appropriate measures will be taken and discontinuation of celecoxib treatment should be considered if there is any functional impairment of the aforementioned organs.
CYP2D6 inhibition
Celecoxib inhibits CYP2D6. Even if it is not a strong inhibitor of this enzyme, a reduction in the dose of the medicines whose dose is adapted to each patient and which are metabolized by CYP2D6 may be necessary (see section Interactions with other medicines and other forms of interactions).
CYP2C9 slow metabolizers
Patients known to be slow CYP2C9 metabolizers should be treated with caution (see Pharmacokinetic properties section).
Skin reactions and systemic hypersensitivity reactions.
Serious skin reactions, some of which are fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome) have been reported rarely in association with the use of celecoxib (see section Undesirable Effects). The risk that these effects appear to be higher at the beginning of treatment, the appearance of these effects occurs in most cases during the first month of treatment. Serious hypersensitivity reactions (such as anaphylaxis, angioedema, and rash with eosinophilia and systemic symptoms (DRESS) or hypersensitivity syndrome) have been reported in patients receiving celecoxib (see section 4.8). Patients with a history of allergy to sulfonamides or any other medicinal product may have an increased risk of severe skin reactions or hypersensitivity (see section 4.3). Celecoxib should be discontinued at the first sign of a rash, mucosal damage, or any other sign of hypersensitivity.
General effects
Celecoxib may mask fever and other signs of inflammation.
Use with oral anticoagulants.
Severe bleeding, some of which has been fatal, has been reported in warfarin-treated patients. An increase in prothrombin time (INR) has been reported with concomitant treatments. Therefore, it should be closely monitored in patients receiving warfarin / oral couico-anticoagulants, especially when initiating treatment with celecoxib or when changing the dose of celecoxib (see section Interactions with other medicinal products and other forms of interactions). Concomitant use of anticoagulants and NSAIDs may increase the risk of bleeding. Caution should be exercised when celecoxib is co-administered with warfarin or other oral anticoagulants, including new anticoagulants (eg, apixaban, dabigatran, and rivaroxaban).
Excipients
CELEBREX 100 mg capsules contain lactose (149.7 mg). Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency, or malabsorption of glucose or galactose (rare inherited diseases).
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions
Anticoagulants
Anticoagulant activity should be monitored in patients taking warfarin or similar products, especially in the first few days after starting or changing the dose of celecoxib as these patients are at increased risk of bleeding complications. For this reason, the use of oral anticoagulants should be accompanied by close monitoring of the INR prothrombin level of the patients, mainly during the first days after starting celecoxib treatment or during a change in celecoxib dose (see section 4.4 ). Bleeding, some of which is fatal, associated with increased prothrombin and INR levels has been observed in patients, especially the elderly, receiving concomitant celecoxib and warfarin.
Antihypertensive
NSAIDs can reduce the effects of antihypertensive drugs, including ACE inhibitors, angiotensin II receptor blockers, diuretics, and beta blockers. As with NSAIDs, the risk of generally reversible acute kidney failure may increase in certain patients with kidney failure (for example: dehydrated patients, patients taking diuretics or elderly patients) by combining ACE inhibitors, antagonists of angiotensin II receptors and / or diuretics with NSAIDs, including celecoxib (see section 4.4). Therefore, this combination should be administered with caution, especially in the elderly. Patients must be adequately hydrated and renal function must be monitored after initiating concomitant therapy, and periodically thereafter.
In a 28-day clinical study in patients with lisinopril-controlled stage I and II hypertension, administration of celecoxib 200 mg twice daily did not lead to significantly lower clinical increases in mean systolic or diastolic blood pressure compared to placebo. The evaluation was carried out by ambulatory blood pressure monitoring for 24 hours. Among patients treated with celecoxib 200 mg twice daily, 48% of them were considered non-responders to lisinopril at the final clinical visit compared to 27% of patients treated with placebo (defined as non-responders, subjects whose diastolic blood pressure was measured on the blood pressure monitor plus 90 mmHg or whose increase in diastolic blood pressure was more than 10% compared to inclusion), this difference was statistically significant.
Cyclosporine and tacrolimus
Co-administration of NSAIDs with cyclosporine or tacrolimus may increase the nephrotoxicity of cyclosporine or tacrolimus, respectively. Kidney function should be monitored if celecoxib is used in combination with any of these medications.
Acetylsalicylic acid
Celecoxib can be used in combination with a low dose of acetylsalicylic acid, but it cannot be used as a substitute for acetylsalicylic acid as part of cardiovascular prevention. In the studies presented, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications has been demonstrated when co-administered with low doses of acetylsalicylic acid, compared to using celecoxib alone (see section Pharmacodynamic properties).
Pharmacokinetic interactions
Celecoxib effects on other medicines.
CYP2D6 inhibition
Celecoxib is a CYP2D6 cytochrome inhibitor. The plasma concentrations of the pharmacological substrates of this enzyme can be increased when combined with celecoxib. The drugs metabolized by CYP2D6 are, for example, antidepressants (tricyclics and selective serotonin reuptake inhibitors), neuroleptics, antiarrhythmics, etc. The dose of CYP2D6 substrates, the dose of which is appropriate for each patient, can be reduced if necessary at the start of treatment with celecoxib or increased when treatment with celecoxib is discontinued.
Co-administration of 200 mg celecoxib twice daily resulted in an increase in plasma concentrations of dextromethorphan and metoprolol by 2.6 and 1.5 times (CYP2D6 substrates), respectively. These increases are due to inhibition of the metabolism of CYP2D6 substrates by celecoxib.
CYP2C19 inhibition
In vitro studies have shown that celecoxib has the potential to inhibit CYP2C19 cytochrome catalyzed metabolism. The clinical significance of this in vitro observation is unknown. Medicinal products metabolized by CYP2C19 are, for example, diazepam, citalopram and imipramine.
Methotrexate
In rheumatoid arthritis patients, celecoxib does not have a statistically significant effect on the pharmacokinetic parameters (plasma or renal clearance) of methotrexate (at the doses used in rheumatology). However, proper monitoring of methotrexate toxicity should be considered when combining these two drugs.
Lithium
In healthy subjects, co-administration of 200 mg twice daily with celecoxib and 450 mg twice daily with lithium resulted in an average increase of 16% in Cmax and 18% in lithium AUC. Therefore, patients treated with lithium they must be closely monitored when starting or stopping celecoxib.
Oral contraceptives
In an interaction study, celecoxib had no clinically significant effect on the pharmacokinetics of oral contraceptives (1 mg norethisterone / 35 µg ethinyl estradiol).
Glibenclamide / tolbutamide
Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate) or glibenclamide significantly.
Effect of other medicinal products on celecoxib
CYP2C9 slow metabolizers
In patients with slow CYP2C9 metabolizers with increased systemic exposure to celecoxib, concomitant therapy with CYP2C9 inhibitors, such as fluconazole, may further increase celecoxib exposure. Such combinations should be avoided in known slow CYP2C9 metabolizers (see section 4.2, Pharmacology and Pharmacokinetics).
CYP2C9 inhibitors and inducers
Because celecoxib is primarily metabolized by cytochrome CYP2C9, it should be used at half the recommended dose in patients treated with fluconazole. Concomitant use of a single 200 mg dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in an average increase in Cmax of 60% and an AUC of 130% celecoxib. Concomitant use with CYP2C9 inducers such as rifampin, carbamazepine, or barbiturates may cause a reduction in plasma concentrations of celecoxib.
Ketoconazole and antacids
No changes in the pharmacokinetics of celecoxib have been observed with ketoconazole or antacids.
Pediatric population
Interaction studies have only been performed in adults.
Caution
Undesirable effects
Adverse reactions listed by organ class and ranked by frequency in Table 1 correspond to data presented from the following sources:
- Adverse reactions reported incidence rates above 0.01% and above those reported for placebo in 12 placebo-controlled clinical trials with reference therapy, conducted for up to 12 weeks in patients with rheumatoid arthritis treated with daily doses of celecoxib from 100 mg to 800 mg. In additional studies using comparators such as non-selective NSAIDs, approximately 7,400 patients with osteoarthritis were treated with celecoxib in daily doses up to 800 mg, of which approximately 2,300 patients were treated for 1 year or more. The observed side effects with celecoxib in these Additional studies were consistent with those observed in patients with osteoarthritis and rheumatoid arthritis, as shown in Table 1.
- Adverse reactions were reported at higher rates than placebo for subjects treated with celecoxib 400 mg daily during long-term trials, up to 3 years in prevention of polyps (Celecoxib adenoma prevention (APC) and prevention trials). of sporadic colorectal adenomatous polyps (PreSAP); see section Pharmacodynamic properties, cardiovascular tolerance: long-term studies in patients with sporadic adenomatous polyps.
- Spontaneous reports of post-marketing adverse reactions during a period in which it is estimated that more than 70 million patients have been treated with celecoxib (various doses, durations and indications). Although these were identified as effects of post-marketing reporting, trial data were consulted to estimate frequency. Frequencies are based on a cumulative meta-analysis pooling trials pooling exposure of 38,102 patients.
Table 1. Adverse Reactions Observed in Clinical Trials with Celecoxib and During Post-Market Surveillance (MedDRA Terms) 1,2
Frequency of side effects.
Organ classification system
Very common
(≥1 / 10)
Frequent
(≥1 / 100 to at least 1/10)
Rare
(≥1 / 1,000 to at least 1/100)
Rare
(≥1 / 10,000 to at least 1/1000)
Very rare
(minus 1 / 10,000)
Frequency not known
Infections and infestations.
Sinusitis, upper respiratory tract infection, pharyngitis, urinary tract infection
Blood and lymphatic system disorders.
Anemia
Leukopenia, thrombocytopenia
Pancytopenia4
Immune system disorders.
Hypersensitivity
Anaphylactic shock4, anaphylactic reaction4
Metabolism and nutrition disorders.
Hyperkalemia
Psychiatric disorders
Insomnia
Anxiety, depression, fatigue.
Confused state, hallucinations4
Nervous system disorders
Dizziness, hypertonia, headache4
Cerebral infarction1, paresthesia, drowsiness
Ataxia, dysgeusia
Intracranial hemorrhage (including fatal intracranial hemorrhage) 4, aseptic meningitis4, epilepsy (including worsening epilepsy) 4, ageusia4, anosmia4
Eye conditions
Blurred vision, conjunctivitis4
Eye hemorrhage4
Retinal artery occlusion4, retinal vein occlusion4
Ear and labyrinth disorders.
Tinnitus, hearing loss1
Heart conditions
Myocardial infarction1
Heart failure, palpitations, tachycardia.
Arrhythmia4
Vascular disorders
Hypertension1 (including worsening hypertension)
Pulmonary embolism4, redness4
Vasculitis4
Respiratory, thoracic and mediastinal disorders.
Rhinitis, cough, dyspnea1
Bronchospasm4
Pneumonite4
Gastrointestinal disorders.
Nausea4, abdominal pain, diarrhea, dyspepsia, flatulence, vomiting1, dysphagia1
Constipation, gastritis, stomatitis, gastrointestinal inflammation (including worsening of gastrointestinal inflammation), belching
Gastrointestinal bleeding4, duodenal ulcer, gastric ulcer, esophageal ulcer, intestinal ulcer and colon ulcer, intestinal perforation, esophagitis, melena, pancreatitis, colitis4
Hepatobiliary disorders.
Abnormal liver function, increased liver enzyme (including increased ALT and ASAT)
Hepatitis 4
Hepatic failure4 (sometimes fatal or requiring liver transplantation), fulminant hepatitis4 (sometimes fatal), liver necrosis4, cholestasis4, cholestatic hepatitis4, jaundice4
Skin and subcutaneous tissue disorders.
Rash, itching (includes generalized itching)
Urticaria, bruises4
Angioedema4, alopecia, photosensitivity.
Exfoliative dermatitis4, erythema multiforme4, Stevens-Johnson syndrome4, toxic epidermal necrolysis4, pharmacological reaction with eosinophilia and systemic symptoms (DRESS) 4, generalized exanthematous pustulosis (PEAG) 4, bullous dermatitis4
Musculoskeletal and connective tissue disorders.
Artralgia4
Muscle contractures (cramps in the lower extremities)
Myosite4
Kidney and urinary tract disorders.
Increased serum creatinine, increased blood urea.
Acute renal failure4, hyponatremia4
Tubulointerstitial nephritis4, nephrotic syndrome4, minimal lesion glomerulonephritis4
Reproductive system and breast disorders.
Menstrual disorders4
Female infertility (decreased fertility in women) 3
General disorders and administration site conditions.
Flu-like syndrome, peripheral edema / fluid retention.
Facial edema, chest pain4
Injuries, poisonings and procedural complications.
Injury (accidental injury)
1_ Adverse reactions that have occurred during studies conducted in the prevention of polyps, involving subjects treated with 400 mg of celecoxib per day during two clinical trials of a maximum duration of 3 years (APC and PreSAP trials). The unwanted effects listed above for polyps prevention trials are only those already identified during pharmacovigilance reports or occurring more frequently than in trials involving osteoarthritis.
²_ In addition, the following previously unknown unwanted effects have occurred in studies conducted on the prevention of polyps, involving subjects treated with 400 mg celecoxib per day during two clinical trials of a maximum duration of 3 years. (APC and PreSAP tests):
Common: angina, irritable bowel syndrome, nephrolithiasis, increased blood creatinine, benign prostatic hyperplasia, weight gain.
Uncommon: helicobacter infection, herpes zoster, erysipelas, bronchopneumonia, labyrinthitis, gingival infection, lipoma, vitreous flotation, conjunctival hemorrhage, deep vein thrombosis, dysphonia, hemorrhoidal hemorrhage, frequent feces, mouth ulcers, allergic dermatitis, dermatitis, nocturnal, hemorrhage vaginal, breast tenderness, lower limb fracture, increased sodium in the blood.
3 Women who want to have a child are excluded from all studies. Therefore, consulting the study database to determine the frequency of this event was not valid.
4 Frequencies based on a cumulative meta-analysis pooling trials pooling exposure of 38,102 patients.
Assessment of the final results of the APC and PreSAP trials (pooled data from the two trials; for the results of the individual trials, see section Pharmacodynamic properties), for patients treated with 400 mg celecoxib per day for up to 3 years, showed an increase in the number of myocardial infarctions in 7.6 events per 1000 patients (uncommon) compared to placebo; there was no increase in the number of strokes (undifferentiated types) compared to placebo.
Overdose
There is no clinical experience of overdose. Single doses of up to 1,200 mg and repeated doses of up to 1,200 mg have been administered twice daily for 9 days to healthy subjects without causing clinically significant adverse effects. In the event of an overdose, appropriate medical treatment is necessary, for example, evacuation of the gastric contents, clinical monitoring and, if necessary, symptomatic treatment. Dialysis is unlikely to be an effective means of removing the drug because of its strong protein binding.
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