COFIDEC 200mg Sandoz analgesic and soft tissue swelling in osteoarthritis (2 blisters x 10 tablets)
Dosage form Box of 2 blisters x 10 tablets
Specifications Celecoxib
Ingredient Dysmenorrhea, arthritis, rheumatoid arthritis, osteoarthritis, acute pain
Ingredient
| Composition information | Content |
| Celecoxib | 200mg |
Uses
indications
Cofidec 200 mg drugs are indicated in the following cases:
Pharmacology
Celecoxib is an oral drug, belonging to the nonsteroidal anti -inflammatory drug group (NSAIDs), selective inhibition of COX - 2.
The mechanism of impact of nsaids drugs related to the inhibition of cyclooxygenase enzyme - 1 (COX - 1) and/or COX - 2
Inhibition of COX - 1 will lead to mucosal damage, ulcers and ulcerative complications throughout the digestive tract. COX - 2 is manifested in inflamed tissues, where it is created by intermediate inflammatory substances. This enzyme inhibitor reduces the synthesis of metabolites including prostaglandin E2 (PGE2), Prostacyclin (PGI2), Thromboxan (TXA2), Prostaglandin D2 (PGD2) and Prostaglandin F2 (PGF2). The inhibitory results of these intermediate substances lead to analgesic and inflammation.
Unlike most NSAIDs, inhibiting both types of cyclooxygenase (COX - 1 and COX - 2), Celecoxib is a selective competitive inhibitor of the cyclooxygenase enzyme - 2 (COX - 2). Therefore, Celecoxib is less likely to cause an ulcer more than other NSAIDs because it only reduces prostagladin production that causes pain and swelling but does not reduce prostaglandin that protects the stomach.
A few clinical studies have been conducted to confirm the effectiveness and safety in osteoarthritis, rheumatoid arthritis and joint spondylitis.
Pharmacokinetics
absorption
Celecoxib is well absorbed, reaching the peak plasma concentration after about 2-3 hours. Use with food (fat -rich meals) slows down about 1 hour absorption. The variation between patients about Celecoxib absorption is about 10 times.
Distribution
The cohesion with plasma proteins is about 97% at plasma treatment concentrations and this active ingredient does not prioritize red blood cells. Plasma concentrations in a stable state are achieved within 5 days of treatment.
Metabolism
The main metabolites found in the circulation are not active in COX - 1 or COX - 2 can be detected. Celecoxib metabolizes mainly through cytochrome P450 2C9. Three metabolites, not active as COX - 1 or COX - 2 inhibitors, found in human plasma such as, original alcohol, corresponding carboxylic acid and its glucuronide. The activity of Cytochrome P450 2C9 is to decrease in people with polymorphism that leads to the reduction of enzyme activity, such as its contract for the polymorphic CYP2C9*3.
.Elimination
Celecoxib is excreted mainly in the form of metabolism. Under 1% of the dose is excreted in urine in the form of constant. Selling time is from 8 to 12 hours.
Before taking COFIDEC 200mg Sandoz analgesic and soft tissue swelling in osteoarthritis (2 blisters x 10 tablets)
How to use
swallow the tablet with a cup of water. Should take the drug at the same time of the day. Can be used with or not accompanied by food.
Dosage
to treat osteoarthritis (osteoarthritis)
The usual dose is 200 mg per day, which can increase to a maximum of 400 mg if necessary.
Common dose:
A capsule 100 mg x twice daily.
To treat rheumatoid arthritis
The usual dose is 200 mg per day, which can increase to a maximum of 400 mg if necessary. Common dose: A capsule 100 mg x twice daily.
To treat some arthritis around the spine (joint spondylitis)
The usual dose is 200 mg per day, which can increase to a maximum of 400 mg if necessary.
Common dose:
A capsule 100 mg x twice daily.
Elderly people
If you are over 65 years old, especially when your weight is under 50 kg, you may need to monitor you more often during treatment.
liver or kidney disease
Make sure you know your condition if you have liver or kidney disease because you may need lower doses. You should not take the dose higher than 400 mg daily.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do
do when overdose? Bring this medicine for the doctor to know the medicine you used. What to do when you forget a dose? However, if you forget to take one or more doses, use this medication as soon as you remember and then continue taking the medication as usual. Do not use double dose to compensate for the neglected dose.
Side Effects
When using 200 mg confidec, you may experience unwanted effects (ADR).
Common, ADR> 1/100
The whole body: ankle edema, legs and hands due to fluid fluid, influenza symptoms, unintentional injuries, worsen previous allergies.
Neurology: Difficulty sleep, dizziness, headache.
Respiratory: cough, shortness of breath, sinusitis, upper respiratory tract infection, runny nose, sneezing.
Cardiovascular: myocardial infarction.
Digestive: Nausea, vomiting, difficulty swallowing, stomach pain, diarrhea, indigestion.
Skin and subcutaneous tissue: rash, itching.
Bone muscle and connective tissue: joint pain, stiffness.
Kidney and urinary tract: Middle times, urinary tract infections.
Uncommon, 1/1000 Body: stroke. Neurology: anxiety, depression. Eyes: blurred vision, conjunctivitis. Respiratory: Bronchospasm. Cardiovascular: Heart failure, tachycardia or chest drum. Gastrointestinal: gastritis, constipation. Skin and subcutaneous tissue: The upper itching (urticaria), changing skin color (bruises). Bone muscle and connective tissue: Bone pain, stiffness. Blood and lymphatic system: Red blood cells. Liver: Change liver function, increase blood enzyme activity in blood such as AST, ALT. Instructions on how to handle ADR When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
COFIDEC 200 mg is contraindicated in the following cases:
Progressive stomach ulcers or gastrointestinal bleeding.
Determined ischemic heart disease, peripheral artery disease and/or cerebrovascular disease.
Be cautious when using
Precautions when used on objects:
Similar to other NSAIDs (such as ibuprofen or diclofenac), this drug can lead to hypertension and therefore, you can ask you to check blood pressure regularly. Some cases of serious reactions on the liver, including severe hepatitis, liver damage, liver failure (some cases of death or liver transplant) have been recorded with Celecoxib.
Non -steroid anti -inflammatory drugs (NSAIDs), non -aspirin, use systemic sugar, may increase the risk of cardiovascular thrombosis, including myocardial infarction and stroke, which can lead to death. Doctors need to periodically assess the appearance of cardiovascular events, even if the patient has no previous cardiovascular symptoms. Patients need to be warned of symptoms of serious cardiovascular events and need to see a doctor as soon as they appear. In order to minimize the risk of adverse incidents, the lowest daily daily daily dose is required in the shortest possible time.
COFIDEC is only used for adults. Do not use this drug for children.
The ability to drive and operate machinery
You may feel dizzy or dizzy after using COFIDEC. If these symptoms appear, do not drive or operate machinery until these symptoms retreat.
Pregnant women
You must not use Cofidec if you are pregnant or may be pregnant (that is, women who are likely to be pregnant but do not use appropriate contraception) during medication.
breastfeeding women
Do not take this medication if you are breastfeeding.
Drug interaction
Pharmacological interaction
Anticoneal drugs
Antaginal effect should be monitored especially in the early days after starting or changing the dosage of Celecoxib in patients using warfarin or other anticoagulants because these patients are at higher risk of hemorrhage complications. Therefore, patients taking oral anticoagulant should be closely monitored Prothrombin Inr, especially in the first days at the beginning of Celecoxib or the dose of Celecoxib. Bleeding combined with increased prothrombin time has been recorded, mainly in the elderly, in patients using Celecoxib simultaneously with Warfarin, some died.
Antid for hypertension
NSAIDS can reduce the effect of anti -hypertension drugs including ACE inhibitors, Angiotension II receptor antagonists, diuretics and beta blockers.
For NSAIDs, the risk of acute renal failure can be increased in some patients with kidney function damage (such as patients with dehydration, diuretics or elderly) when taking ACE inhibitors or Angiotensin II receptor antagonists in combination with NSAIDs, including Celecoxib.
Therefore, be careful when used in combination, especially in the elderly. Patients need adequate water rehydration and consider monitoring of kidney function after starting combined therapy, and periodically later.
ciclosporin and tacrolimus
Simultaneous use of NSAIDs and Ciclosporin or Tacrolimus may increase the toxicity on the body of Ciclosporin and Tacrolimus. Kidney function should be monitored when sharing Celecoxib with any drug.
Acetylsalicylic acid
Celecoxib may be used with acetylsalicylic acid but cannot replace acetylsalicylic acid in cardiovascular disease. In a submitted study, such as other NSAIS, increased the risk of gastrointestinal ulcers or digestive complications other than using Celecoxib alone compared to simultaneous use with low -dose acetylsalicylic acid.
Mobile interaction
CYP2D6 inhibitors
Celecoxib is a CYP2D6 inhibitor.
The plasma concentration of active ingredients is the enzyme's substrate increases when Celecoxib is used simultaneously.
Examples of active ingredients metabolized by CYP2D6 are antidepressants (three -round depression and SSRIs), sedative drugs, anti -arrhythmias, etc.The dose of CYP2D6 substrates on each patient should be reduced when starting with Celecoxib or increased when used for treatment with Celecoxib.
Simultaneous use of Celecoxib 200 mg twice a day increases 2.6 times and 1.5 times the plasma concentration of dextromethorphan and the corresponding Metoprolol (CYP2D6). This increase is due to Celecoxib inhibiting CYP2D6 The metabolism of CYP2D6 substrates.
CYP2C19 inhibitors
In In vitro studies shows the ability of Celecoxib in inhibiting catalyst metabolism by CYP2C19. The clinical significance of these in vitro findings is not known. Examples of active ingredients metabolized through CYP2C19 are diazepam, citalopram and imipramine.
lithium
In healthy volunteers, simultaneously using Celecoxib 200 mg twice a day with 450 mg lithium twice a day, increasing an average of 16% cmax and 18% AUC of lithium. Therefore, patients treated with lithium should be closely monitored when starting or stopping Celecoxib.
Poor metabolites CYP2C9
In patients with poor metabolites CYP2C9 and increased system exposure to Celecoxib, simultaneous treatment with CYP2C9 inhibitors such as fluconazole may cause increased Celecoxib exposure. Should avoid such combination with poor metabolites.
CYP2C9 inhibitors and Touchs
Because Celecoxib is metabolized mainly by CYP2C9, therefore, half the recommended dose in patients using Fluconazole. Simultaneously use 200 mg of Celecoxib and 200 mg once a day, fluconazole, a strong CYP2C9 inhibitor, causing an average increase of 60% cmax and 130% AUC. Simultaneous use of CYP2C9 induction such as rifampicin, carbamazepine and barbiturates can reduce plasma concentrations of Celecoxib.Storage
Store at temperatures below 30 ° C.
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