- 1 Important to know about Celebrex (Celecoxib) Capsule ?
- 2 what is celebrex (Celecoxib) Capsule used for and indication
- 3 Celebrex (Celecoxib) Capsule Dosage
- 4 How it works Celebrex (Celecoxib) Capsule
- 5 Celebrex (Celecoxib) Capsule Side Effects
- 6 Celebrex (Celecoxib) Capsule Interactions
- 7 Celebrex (Celecoxib) Capsule Warnings and Precautions
- 8 Drive and use machines
- 9 Celebrex and Pregnancy / Breastfeeding / Fertility
- 10 What should I do if I miss a dose?
- 11 What happens if I overdose from Celebrex (Celecoxib) Capsule ?
- 12 What is Forms and Composition Celebrex (Celecoxib) Capsule?
Important to know about Celebrex (Celecoxib) Capsule ?
- Celecoxib stagnates pain, inhibits inflammation and lowers fever.
- For joint pain , rheumatoid arthritis and Bechterew’s disease. Sometimes also used in other types of pain, such as osteoarthritis (worn joints) or menstrual pain.
- The pain is reduced 1 to 2 hours after ingestion . The operation lasts for 12 to 24 hours. Inflammation reduces redness and swelling within one to two weeks.
- Note: chances of gastrointestinal ulcers and bleeding. Are you over 70 years old, have you had a stomach or intestinal ulcer before, or do you use anti-coagulation medication? Then you need a stomach protector . Ask your doctor or pharmacist about this
- Watch out with alcohol. Alcohol increases the risk of stomach problems.
- Many interactions with other medicines. Ask your pharmacist if you can safely use celecoxib with your other medicines, including medicines that you have bought without a prescription.
what is celebrex (Celecoxib) Capsule used for and indication
- Celebrex (Celecoxib) Capsule 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 (COX-2) inhibitor should be based on the assessment of all risks specific to each patient (see sections Contraindications and Warnings and Precautions). employment ).
Celebrex (Celecoxib) Capsule Dosage
- Due to the potential increase in cardiovascular risks of celecoxib depending on the dose and duration of treatment, this drug should be prescribed at the lowest effective daily dose for the shortest period possible.
- The need for symptomatic treatment and its therapeutic efficacy for the patient should be re-evaluated periodically, especially in patients with osteoarthritis (see sections Contraindications , Warnings and Precautions for Use , Adverse Reactions and Pharmacodynamic Properties ).
- The recommended daily dose is 200 mg divided into one or two doses.
- In some patients whose symptoms are insufficiently relieved, increasing the dose to 200 mg twice daily may increase efficacy.
- In the absence of improvement in therapeutic benefit after 2 weeks, other therapeutic options should be considered.
- The recommended initial daily dose is 200 mg divided into 2 doses.
- If necessary, the dose may be increased later to 200 mg twice daily. In the absence of improvement in therapeutic benefit after 2 weeks, other therapeutic options should be considered.
- The recommended daily dose is 200 mg divided into one or two doses.
- For a small number of patients whose symptoms are not sufficiently relieved, increasing the dose to 400 mg divided into one or two doses may increase efficacy.
- In the absence of improvement in therapeutic benefit after 2 weeks, other therapeutic options should be considered.
- The maximum recommended daily dose for all indications is 400 mg.
Elderly (> 65 years old)
As with any patient, treatment will be started at 200 mg daily.
If necessary, the dose may be increased later to 200 mg twice daily. Special attention should be paid to elderly subjects with body weight below 50 kg (see Warnings and Precautions and Pharmacokinetic Properties sections ).
Celecoxib is not indicated in children.
CYP2C9 slow metabolizers
Since the risk of dose-related adverse events is higher, celecoxib should be given with caution to patients known or suspected to be poor metabolisers of CYP2C9, based on genotyping or previous history / experience with other substrates. of CYP2C9. A reduction in the dose to half the lowest recommended dose should be considered (see section 5.2 Pharmacokinetic properties ).
Patients with hepatic impairment
In patients with moderate hepatic impairment with serum albumin of 25-35 g / l, treatment should be initiated at half the recommended dose. The experience in this type of patients is limited to that of cirrhotic patients (see sections Contraindications , Warnings and Precautions and Pharmacokinetic Properties ).
Patients with renal insufficiency
Since the experience with celecoxib in patients with mild to moderate renal impairment is limited, these patients should be treated with caution (see sections Contraindications , Warnings and Precautions and Pharmacokinetic Properties ).
Celebrex (Celecoxib) Capsule can be taken during or outside meals. Patients who have difficulty swallowing capsules may add the content of the celecoxib capsule to applesauce, rice pudding, yoghurt or banana puree. For this, the entire contents of the capsule should be carefully emptied in a teaspoon of applesauce, rice pudding, yoghurt or banana puree, cold or at room temperature, and be ingested immediately with 240 ml of water. Once sprinkled on applesauce, rice pudding or yoghurt, the capsule content remains stable for 6 hours in the refrigerator (between 2 and 8 ° C). If the contents of the capsule are sprinkled on banana puree, it should not be refrigerated and should be ingested immediately.
How it works Celebrex (Celecoxib) Capsule
Pharmacotherapeutic group: non-steroidal anti-inflammatory, antirheumatic, NSAID, Coxibs. ATC Code: M01AH01.
Mechanisms of action
Celecoxib is a selective oral cyclooxygenase-2 (COX-2) inhibitor at clinical doses (200 mg to 400 mg daily). No statistically significant inhibition of COX-1 evaluated by ex-vivo inhibition of thromboxane B2 (TxB2) formation was observed at these doses in healthy volunteers.
Cyclooxygenase is responsible for the synthesis of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. Cyclooxygenase-2 (COX-2) is the isoform of the enzyme induced by pro-inflammatory stimuli and is believed to be the main culprit in the synthesis of prostanoid mediators of pain, inflammation and fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and some CNS functions (fever induction, pain perception, and cognitive function). It could also play a role in the healing of ulcers. COX-2 has been shown in tissues around gastric ulcers in humans but its involvement in the healing of ulcers
The difference in anti-platelet activity between some COX-1 inhibitory NSAIDs and the selective COX-2 inhibitors may be of clinical significance in patients at risk for thromboembolic reactions. Selective COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin, without altering platelet thromboxane.
Celecoxib is a pyrazole derivative substituted with two aryl groups, a chemical analogue of other non-arylamine sulfonamides (eg thiazides, furosemide) but it differs from arylamine sulfamides (eg, sulfamethoxazole and other sulfonamide antibiotics).
A dose-dependent effect on TxB2 formation was observed after high doses of celecoxib. However, in healthy subjects and in low-dose, multiple dose studies with 600 mg twice daily (equivalent to three times the highest recommended dose), celecoxib had no effect on platelet aggregation, neither on bleeding time compared to placebo.
Efficacy and clinical safety
Several clinical trials confirming the efficacy and safety of celecoxib in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis have been performed. Celecoxib was evaluated for 12 weeks in the treatment of inflammation and pain of osteoarthritis of the knee and hip in approximately 4200 patients in placebo-controlled trials and reference products. It was also evaluated for 24 weeks in the treatment of inflammation and pain of rheumatoid arthritis in approximately 2100 patients in placebo-controlled trials and reference products. Celecoxib at a daily dose of 200 mg to 400 mg relieved pain within 24 hours of administration. Celecoxib was evaluated for 12 weeks in the symptomatic treatment of ankylosing spondylitis in 896 patients in placebo-controlled trials and reference products. In these trials celecoxib, at doses of 100 mg twice daily, 200 mg once daily, 200 mg twice daily and 400 mg once daily, demonstrated significant improvement in pain, index overall activity of disease and function in ankylosing spondylitis.
Five randomized, double-blind controlled trials, including endoscopy of the upper gastrointestinal tract, were conducted at doses of 50-400 mg, twice daily, of celecoxib in approximately 4500 patients without initial ulceration. In 12-week endoscopic studies versus naproxen (1000 mg daily) and ibuprofen (2400 mg daily), celecoxib (100-800 mg daily) was associated with a significantly lower risk of peptic ulcers.
Data obtained in comparison with diclofenac (150 mg daily) were inconsistent. In two of the 12-week studies, the percentage of patients with endoscopically detected gastroduodenal ulcer was not significantly different on placebo, with celecoxib 200 mg twice daily and celecoxib 400 mg twice daily.
In a prospective long-term safety study (duration 6 to 15 months, CLASS study), 5800 osteoarthritis patients and 2200 patients with rheumatoid arthritis received celecoxib 400 mg twice daily (ie four times and two recommended dose for osteoarthritis and rheumatoid arthritis), ibuprofen 800 mg three times daily or diclofenac 75 mg twice daily (each at therapeutic doses). Twenty-two percent of patients included low doses of acetylsalicylic acid (≤ 325 mg daily), primarily for cardiovascular prevention. With respect to the primary endpoint identified as complicated ulcers (defined as haemorrhage, gastrointestinal perforation or occlusion), celecoxib was not significantly different from ibuprofen or diclofenac individually. There was also no statistically significant difference in the combined NSAID group for complicated ulcers (relative risk 0.77, 95% CI 0.41 – 1.46, lifetime values). of the study). In the mixed complication and symptomatic ulcer criteria, the incidence was significantly lower in the celecoxib group compared to the NSAID group (relative risk 0.66, 95% CI 0.45-0.97), but not between celecoxib and diclofenac. Patients taking concomitant celecoxib and low doses of acetylsalicylic acid showed 4-fold higher complicated ulcers compared to those under celecoxib alone. The incidence of clinically significant reductions in hemoglobin (> 2 g / dl), confirmed by repeated dosing, was significantly lower in patients receiving celecoxib compared to the NSAID group (relative risk 0.29, 95% CI 0.17 – 0.48). The significantly lower incidence of this event under celecoxib was maintained with or without taking acetylsalicylic acid.
0001). Rates of gastrointestinal complications with clinical manifestations such as perforation, obstruction or hemorrhage were very low and not different between treatment groups (4-5 per group).
Cardiovascular Tolerance – Long-term studies in patients with sporadic adenomatous polyps.
Two studies evaluating celecoxib in subjects with sporadic adenomatous polyps were conducted: APC (Adenoma Prevention with Celecoxib) and PreSAP (Prevention of Spontaneous Adenomatous Polyps).
In the APC trial, a dose-dependent increase in the composite endpoint of cardiovascular death, myocardial infarction (MI), and cerebrovascular accident (CVA) was observed with celecoxib compared with placebo over 3 years of treatment. The PreSAP trial did not show a statistically significant increase in risk for the same composite endpoint.
Dans l’essai APC, le risque relatif regroupant décès d’origine cardiovasculaire, IDM et AVC (critère composite) était de 3,4 (IC à 95% 1,4-8,5) avec 400mg de célécoxib deux fois par jour et de 2,8 (IC à 95% 1,1-7,2) avec 200mg de célécoxib deux fois par jour, comparativement au placebo. Les valeurs cumulées pour ce critère composite sur une période de 3 ans étaient de 3,0 % (20/671 sujets) et 2,5% (17/685 sujets), respectivement comparé à 0,9% (6/679 sujets) pour le placebo. Les augmentations observées comparativement au placebo pour les deux groupes de dose célécoxib étaient principalement dues à une incidence accrue d’infarctus du myocarde.
In the PreSAP trial, the relative risk for this same composite endpoint was 1.2 (95% CI 0.6-2.4) with celecoxib 400mg twice daily compared to placebo. The cumulative values for this composite criterion over a 3-year period were 2.3% (21/933 subjects) and 1.9% (12/628 subjects) respectively for celecoxib and placebo. The incidence of myocardial infarction was 1.0% (9/933 subjects) with daily administration of 400 mg celecoxib and 0.6% (4/628 subjects) with placebo.
Data from a third long-term ADAPT study did not show a significant increase in cardiovascular risk with celecoxib 200 mg twice daily compared to placebo. The relative risk for a similar composite endpoint (cardiovascular death, MI, stroke) was 1.14 (95% CI 0.61-2.12) with 200 mg celecoxib twice daily compared to placebo. The incidence of myocardial infarction was 1.1% (8/717 patients) with 200 mg celecoxib twice daily and 1.2% (13/1070 patients) with placebo.
Celebrex (Celecoxib) Capsule Side Effects
In addition to the desired effect, this can cause drug side effects.
The most common side effects are the following.
Sometimes (from 10 to 30 people in 100)
- Increase in blood pressure . Do you have high blood pressure or do you use blood pressure reducers? Then this medication can increase blood pressure . Consult with your doctor. Perhaps the doctor can prescribe another anti-inflammatory analgesicsuch as diclofenac or ibuprofen. If you do need to use celecoxib your doctor will check your blood pressure extra.
Rarely (from 1 to 10 in 100 people)
- Stomach complaints : stomach irritation, abdominal pain, nausea, vomiting, feeling full, lack of appetite, farmers and heartburn. You have less chance if you take this medicine with some food and a glass of water or milk. Do not use alcohol or other foods that irritate the stomach, such as sharp herbs. Do you suffer from esophageal inflammation due to rising stomach acid? The complaints can worsen. Contact your doctor if you notice. People over seventy years are more likely to experience side effects with this medication. Doctors therefore usually also prescribe a stomach protector . Even if you only use this medicine for a few days.
- Intestinal complaints : diarrhea, constipation and flatulence.
- A stomach or intestinal ulcer or other severe damage to the stomach, intestines or esophagus. You notice that with nagging pain in the upper abdomen, severe stomach pain or pain behind the sternum. These damages can cause bleeding in the stomach and intestines. This can be seen in bloody diarrhea or black, tarry stools . Then discontinue use and contact a doctor. With a stomach haemorrhage it can happen that you vomit blood. Contact a doctor immediately. Have you ever had a stomach or intestinal ulcer?or have any other severe gastrointestinal disease, such as a stomach or intestinal bleed? You are more likely to have side effects on the stomach and intestines. Discuss with your doctor whether this medication is suitable for you. Your doctor may prescribe a stomach-protecting medication in addition to this medication. Even if you will only use this medicine for a few days.
- Do you have an esophageal stenosis, a narrowing of the esophagus? You are more likely to have damage to the esophagus. Consult with your doctor about this. Maybe you can switch to a different medication.
- Headache, dizziness and dizziness. This is usually about if you have become accustomed to this medication.
- Skin rash with itching. This skin rash is very rarely caused by allergies . The rash can very rarely worsen or develop under the influence of strong sunlight or UV light from tanning beds. If you suffer from psoriasis : you may suffer more from this. Contact your doctor if your symptoms worsen.
- Hypersensitivity to this medication. You will notice this by skin rash, hives and itching. Consult your doctor. Very rarely, a severe rash can develop with fever or blisters. Then contact a doctor immediately.
Severe hypersensitivity can be seen from chest tightness or a swollen face. Then go immediately to a doctor. You may not use this medicine afterwards. Therefore, tell the pharmacist that you are hypersensitive to celecoxib. The pharmacy team can then ensure that you do not get this medicine or any other anti-inflammatory painkilleragain.
- Thick ankles or wrists by retaining fluid in the arms and legs ( edema ).
- Tightness due to fluid accumulation in the lungs . Especially people with heart failure can suffer from this. Talk to your doctor if your symptoms, such as tightnessand fluid retention, increase.
Very rare (affects less than 1 in 100 people)
- Inflammation in the oral cavity and on the tongue.
- Tinnitus or worse hearing. Contact your doctor for these symptoms.
- Blurred vision or double vision. This is usually about if you have become accustomed to this medication.
- Palpitations , chest pain and an accelerated heartbeat . Have you had angina (heart cramp), or have ever had a stroke or heart attack. Then you may only use this medication for a short time. Namely no longer than two weeks in a row. Consult with your doctor about this. Your doctor may be able to prescribe a different medication.
- Hair loss .
- Psychological complaints such as insomnia, fatigue, drowsiness, nightmares, anxiety, agitation, confusion, memory disorders, nervousness, anxiety, depression and hallucinations .
- Impairment of the kidneys . You will notice this by swollen ankles and feet. Contact your doctor or pharmacist if this occurs.
- Blood disorders, inflammation of the pancreas or liver inflammation . Consultyour doctor for one or more of the following symptoms: sudden severe upper abdominal pain, jaundice, unexplained bruising, extreme fatigue, sore throat with fever and blisters in the mouth. Talk to your doctor if you suffer from your pancreas. The complaints can worsen.
Very rare, when used for several weeks
- Cardiovascular disease , such as more likely to have a heart attack or stroke . The risk of cardiovascular disease is greater in people who are more likely to have cardiovascular disease. People with high blood pressure , high cholesterol, diabetes, angina pectoris, window bones, narrowing or closing of the leg artery, people who smoke and people who have ever had a heart attack or thrombosis : consult your doctor before using this medicine . Your doctor may be able to prescribe another anti-inflammatory analgesic .
Consult your doctor if you suffer too much from one of the above mentioned side effects or if you experience other side effects that you are worried about.
Celebrex (Celecoxib) Capsule Interactions
Anti-coagulant activity should be monitored in patients taking warfarin or similar products, particularly in the first few days following initiation or change of celecoxib dosage as these patients have an increased risk of bleeding complications. For this reason, the use of oral anticoagulants should be accompanied by close monitoring of patients’ INR prothrombin levels, mainly in the first few days after initiation of celecoxib treatment or when the dosage of the drug is changed. celecoxib (see Warnings and Precautions section)). Haemorrhage, including some fatal outcome, associated with prothrombin and INR prolongation have been observed in patients, particularly in elderly patients, concomitantly receiving celecoxib and warfarin.
NSAIDs can reduce the effects of antihypertensive drugs, including ACE inhibitors, angiotensin II receptor antagonists, diuretics and beta blockers. As with NSAIDs, the risk of acute renal failure, which is usually reversible, may be increased in some patients with impaired renal function (eg, dehydrated patients, patients taking diuretics or elderly patients) with the combination of ACE inhibitors, angiotensin II receptor antagonists, and / or diuretics with NSAIDs, including celecoxib (see Warnings and Precautions section).). Therefore, this combination should be administered with caution, especially in the elderly. Patients should be properly hydrated and renal function should be monitored after initiation of concomitant therapy and then periodically.
In a 28-day clinical trial in lisinopril-treated patients with stage I and II hypertension, 200 mg celecoxib twice daily did not result in a clinically increased significant mean systolic or diastolic blood pressure compared to placebo. The evaluation was performed by ambulatory monitoring of blood pressure for 24 hours. Of the patients treated with 200 mg celecoxib twice daily, 48% of them were considered non-responders to lisinopril at the final clinical visit versus 27% of placebo-treated patients (were defined as non-responders, subjects whose diastolic blood pressure measured with a blood pressure monitor> 90 mmHg or whose
Ciclosporin and tacrolimus
Joint administration of NSAIDs with ciclosporin or tacrolimus may increase the nephrotoxicity of ciclosporin or tacrolimus, respectively. Renal function should be monitored if celecoxib is combined with any of these drugs.
Celecoxib can be used in combination with a low dose of acetylsalicylic acid but can not be substituted for acetylsalicylic acid for cardiovascular prevention. In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications was found when concomitant administration of low doses of acetylsalicylic acid compared with use of celecoxib alone (see section 5.1 Pharmacodynamic properties ).
Effects of celecoxib on other drugs
Inhibition of CYP2D6
Celecoxib is an inhibitor of cytochrome CYP2D6. Plasma drug concentrations substrates of this enzyme may be increased when combined with celecoxib. Drugs metabolized by CYP2D6 include, for example, antidepressants (tricyclics and selective serotonin reuptake inhibitors), neuroleptics, antiarrhythmics, etc. The dosage of the CYP2D6 substrates, the dose of which is adapted for each patient, may be reduced if necessary at the beginning of treatment with celecoxib or increased at the end of treatment with celecoxib.
Concomitant administration of 200 mg celecoxib twice daily resulted in 2.6 and 1.5 fold increase in plasma concentrations of dextromethorphan and metoprolol (CYP2D6 substrates), respectively. These increases are due to inhibition of metabolism of CYP2D6 substrates by celecoxib.
Inhibition of CYP2C19
In vitro studies have shown that celecoxib has the potential to inhibit cytochrome CYP2C19 catalyzed metabolism. The clinical significance of this in vitro observation is not known. Drugs metabolized by CYP2C19 are, for example, diazepam, citalopram and imipramine.
In patients with rheumatoid arthritis, celecoxib has no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (at doses used in rheumatology). However, adequate monitoring of the toxicity of methotrexate should be considered when combining these two drugs.
In healthy subjects, concomitant administration of 200 mg, twice daily, of celecoxib and 450 mg, twice daily, of lithium resulted in an average increase of 16% in C max and 18% in AUC lithium. Therefore, patients treated with lithium should be closely monitored during the introduction or discontinuation of celecoxib.
In an interaction study, celecoxib did not have clinically significant effects on the pharmacokinetic parameters of oral contraceptives (1 mg norethisterone / 35 μg ethinyl estradiol).
Glibenclamide / tolbutamide
Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate) or glibenclamide clinically significantly.
Effect of other drugs on celecoxib
CYP2C9 slow metabolizers
In CYP2C9 slow metabolizing subjects with increased systemic exposure to celecoxib, concomitant treatment with CYP2C9 inhibitors such as fluconazole may further increase celecoxib exposure. It is to avoid such associations in poor metabolisers known CYP2C9 (see Dosage and Administration and Pharmacokinetics )
Inhibitors and inducers of CYP2C9
Since 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 with 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean C max increase of 60% and 130% of celecoxib. Concomitant use with CYP2C9 inducers such as rifampicin, carbamazepine, or barbiturates may result in reduced plasma concentrations of celecoxib.
Ketoconazole and antacids
There was no change in the pharmacokinetic parameters of celecoxib with ketoconazole or antacids.
Interaction studies have only been performed in adults.
Celebrex (Celecoxib) Capsule Warnings and Precautions
Gastrointestinal (GI) effects
Upper and lower gastrointestinal complications [perforations, ulcers or haemorrhages (PUH)], some of which were fatal, have been observed in celecoxib-treated patients.
Caution should be exercised in patients most at risk of developing a gastrointestinal complication with NSAIDs:
- Elderly subjects,
- Patients also treated with other NSAIDs,
- Or with acetylsalicylic acid,
- With glucocorticoids,
- Patients who consume alcohol,
- Or patients with a history of gastrointestinal illness such as ulcer and hemorrhage.
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 at low dosages).
A significant difference in gastrointestinal tolerance between the combination of selective COX-2 inhibitors and acetylsalicylic acid compared with NSAID and acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 4.8). Pharmacodynamic properties ).
Concomitant use of NSAIDs
Concomitant use of celecoxib with NSAIDs other than aspirin should be avoided.
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 doses of 200 mg twice daily and 400 mg twice daily (see section 5.1 Pharmacodynamic properties ).
Due to the potential increase in cardiovascular risks of celecoxib depending on the dose and duration of treatment, this drug should be prescribed at the lowest effective daily dose for the shortest possible time.
The need for symptomatic treatment and its therapeutic efficacy for the patient should be re-evaluated periodically, particularly in patients with osteoarthritis (see sections Posology and method of administration , 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 5.1 ).
Because of their lack of antiplatelet effects, selective COX-2 inhibitors can not replace acetylsalicylic acid in the prevention of cardiovascular thromboembolic diseases. Therefore, antiplatelet therapy should not be discontinued (see section 5.1 ).
Fluid retention and edema
As with other drugs known to 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 arterial hypertension and in patients with pre-existing edema irrespective of the origin of the disorder. Prostaglandin inhibition may result in deterioration of renal function and fluid retention. Precautions will also be necessary in patients treated with diuretics or at risk of hypovolemia.
Like all NSAIDs, celecoxib can cause hypertension or worsen pre-existing hypertension, increasing the incidence of cardiovascular events. Close monitoring of blood pressure at the start of treatment with celecoxib and during treatment should therefore be performed.
Renal and hepatic effects
The existence of impaired renal or hepatic function, particularly cardiac dysfunction, is more likely in the elderly. Therefore, appropriate medical supervision must be ensured.
NSAIDs, including celecoxib, may be responsible for renal toxicity. Clinical trials with celecoxib showed renal effects similar to those seen with comparator NSAIDs. The patients most at risk of developing renal toxicity are patients with renal insufficiency, heart failure, liver disorders, those taking diuretics, angiotensin-converting enzyme inhibitors, angiotensin II, as well as elderly patients (see section Interactions with other medicinal products and other forms of interaction ). These patients should be closely monitored during treatment with celecoxib.
Some cases of severe liver reactions have been reported with celecoxib, including fulminant hepatitis (some with fatal outcome), liver necrosis, and liver failure (some with fatal outcome or requiring liver transplantation). In cases where time to onset was reported, most severe hepatic reactions occurred within one month of starting treatment (see section 4.8 ).
During treatment, appropriate measures will be taken and discontinuation of celecoxib therapy should be considered if there is any functional impairment of the above mentioned organs.
Inhibition of CYP2D6
Celecoxib inhibits CYP2D6. Although it is not a potent inhibitor of this enzyme, a dose reduction may be necessary for drugs that are dose-adjusted for each patient and are metabolized by CYP2D6 (see section 4.5). and other forms of interaction ).
CYP2C9 slow metabolizers
Patients known to be poor metabolisers of CYP2C9 should be treated with caution (see section 5.2 ).
Skin reactions and systemic hypersensitivity reactions
Serious skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (Lyell’s syndrome), have been very rarely reported in association with the use of celecoxib (see section 5.2). Side effects ). The risk of these effects appears to be highest at the beginning of treatment, the appearance of these effects being in the majority of cases during the first month of treatment. Severe hypersensitivity reactions (including anaphylaxis, angioedema, and drug-induced rash with eosinophilia and systemic symptoms (DRESS))). Patients with a history of allergy to sulfonamides or any other drug may have an increased risk of serious skin reactions or hypersensitivity (see section 4.3 ). Celecoxib should be stopped at the first signs of skin rash, mucosal lesions or any other sign of hypersensitivity.
Celecoxib may mask fever and other signs of inflammation.
Use with oral anticoagulants
In patients treated concurrently with warfarin, serious bleeding, including some fatal outcome, have been reported. Increased prothrombin time (INR) has been reported with concomitant treatments. It should therefore be closely monitored in patients receiving warfarin / coumarin-type oral anticoagulants, particularly when initiating celecoxib therapy or when changing the dosage of celecoxib (see section 4.5). and other forms of interaction). Concomitant use of anticoagulants and NSAIDs may increase the risk of bleeding. Caution should be exercised when co-administering celecoxib with warfarin or other oral anticoagulants, including new anticoagulants (eg, apixaban, dabigatran and rivaroxaban).
Celebrex (Celecoxib) Capsule 100 mg capsules contain lactose (149.7 mg). Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Drive and use machines
Patients who experience dizziness, lightheadedness or drowsiness while taking Celebrex (Celecoxib) Capsule should refrain from driving or operating machinery.
Celebrex and Pregnancy / Breastfeeding / Fertility
Studies in animals (rats and rabbits) have shown reproductive toxicity including malformations (see sections Contraindications and Preclinical Safety Data ). Inhibition of prostaglandin synthesis may have a deleterious effect on pregnancy. Data from epidemiological studies point to an increased risk of spontaneous miscarriage after the use of prostaglandin synthesis inhibitors in early pregnancy.
In humans, the risk during pregnancy is unknown but can not be ruled out. Like other drugs that inhibit prostaglandin synthesis, celecoxib can cause uterine inertia and premature closure of the ductus arteriosus in the last trimester of pregnancy. Celecoxib is contraindicated in pregnancy and in women who may become pregnant (see sections Contraindications and Warnings and Precautions for Use ). If pregnancy is discovered during treatment, celecoxib should be discontinued.
Celecoxib is excreted in female milk at concentrations similar to those found in plasma.
The administration of celecoxib to a small number of breastfeeding women has shown a very small passage of celecoxib in breast milk. Patients treated with celecoxib should not breastfeed.
Because of their mechanism of action, the use of NSAIDs, including celecoxib, can delay or prevent the rupture of ovarian follicles, which has been associated with reversible infertility in some women.
What should I do if I miss a dose?
With chronic pain it is important to consistently take this medication. If you have forgotten a dose :
If you take this medicine once a day :
does it take more than 8 hours before you take the next dose normally?
Take the forgotten dose as yet. Does it take less than 8 hours? Skip the forgotten dose .
If you take this medicine twice a day :
does it take more than 4 hours before you take the next dose normally?
Take the forgotten dose as yet. Does it take less than 4 hours? Skip the forgotten dose .
What happens if I overdose from Celebrex (Celecoxib) Capsule ?
There is no clinical experience of overdose.
Single doses up to 1200 mg and repeated doses up to 1200 mg twice daily have been administered for 9 days to healthy subjects without causing clinically significant adverse effects.
In case of possible overdose, appropriate medical management is necessary, eg evacuation of gastric contents, clinical monitoring and, if necessary, symptomatic treatment.
Dialysis is unlikely to be an effective means of eliminating the drug because of its strong protein binding.
What is Forms and Composition Celebrex (Celecoxib) Capsule?
Capsule 100 mg (with two blue bands indicating respectively 7767 and 100, white and opaque): Box of 30, under platelets.
Hospital model: Box of 100, under pads. 200 mg capsule (with two gold bands indicating 7767 and 200 respectively, white and opaque): Box of 30, under platelets. Hospital model: Box of 100, under pads.
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