Celecoxib 200-HV USP medicine for osteoarthritis, rheumatoid arthritis (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Celecoxib
Ingredient USP

Ingredient

Composition information	Content
Celecoxib	200mg

Uses

Indication

Celecoxib 200-HV drug is indicated in the following cases:

Treatment of symptoms of osteoarthritis (OA) and rheumatoid arthritis (out).

Treatment of Phat Nguyen Phat. At human treatment concentration, Celecoxib does not inhibit cyclooxygenase enzyme-1 (COX-1). COX-2 is created to respond to inflammatory agents. This leads to the synthesis and accumulation of inflammatory prostanoids, especially prostaglandin E2, causing inflammation, edema and pain.

Celecoxib has an effect of anti-inflammatory, analgesic, and cooling substances on animals due to the prevention of the production of inflamed Prostanoids through COX-2 inhibitors. In the colon tumor in animals, Celecoxib reduces the new incidence and multiplication of tumors. In Vivo and EX Vivo studies show that Celecoxib has a very low affinity with Cox-1 enzyme. Therefore, in the treatment dose, Celecoxib does not work on prostanoids synthesized by activating COX -1, therefore, does not affect the normal physiological processes related to COX -1 in tissues, especially with the stomach, intestines and platelets.

Dynamic pharmacokinetics

absorption: When used at Celecoxib, it is easy to be absorbed and reached the peak concentration in plasma after about 2-3 hours. Oral bioavailability capsules is 99% compared to the mixed form.

Distribution: The ratio of cohesion to plasma proteins (this ratio does not depend on concentrations) is about 97% at plasma treatment concentrations and Celecoxib is not prioritized with erythrocytes.

Metabolism: Celecoxib is mainly conversion of intermediaries through Cytochrom P450 2C9. Three metabolic products have no effect inhibiting COX-1 or COX-2 identified in human plasma as the most alcohol, corresponding carboxylic acid and its conjugated form with its glucuronid. The activity of Cytochrom P450 2C9 decreases in genetic polymorphic people and this leads to an enzyme activity.

Elimination: Eliminating Celecoxib is mainly due to the metabolism of the liver with less than 1% of the dosage excreted in the urine. After multi -dose use, the sale time is 8 - 12 hours and the clearance speed is about 500 ml/min.

Before taking Celecoxib 200-HV USP medicine for osteoarthritis, rheumatoid arthritis (3 blisters x 10 tablets)

How to use

drink while eating or after meals.

For patients with difficulty swallowing capsules, it is possible to put the amount of drugs in the pellets into apple smoothies, porridge, yogurt or crushed bananas to drink. At that time, the entire amount of drugs must be added to about a small teaspoon of apple smoothie, porridge, yogurt or crushed bananas at room temperature and must drink immediately with water. The amount of drug mixed with apple juice, porridge or yogurt is stable for about 6 hours when stored in the refrigerator (2 ° C - 8 ° C/35 ° F - 45 ° F). Not stored in the refrigerator, the amount of drug mixed with crushed bananas must be taken immediately.

Dosage

Adults:

Symptomatic treatment in osteoarthritis (OA): Celecoxib's recommendations are 200 mg of single or 100 mg x 2 times/ day.

Treatment of symptoms in rheumatoid arthritis (RA): Celecoxib's recommendations are 100 mg or 200 x 2 times/ day.

Againitis (AS): Celecoxib's recommendations are 200 mg of single or 100 mg twice a day. Some patients may be better if they take a total dose of 400 mg daily. In the following days, the recommended dose is 200 mg x 2 times/ day when needed. In the following days, the recommended dose is 200 mg x 2 times/ day when needed.

People with poor metabolism CYP2C9: Patients who know or suspect poor metabolism through CYP2C9 based on a history of experience with other substrates of CYP2C9 should be cautious when using Celecoxib. Start treatment with the lowest recommended dose.

Elderly: generally do not have to adjust the dose. However, for elderly patients weighing less than 50 kg, it is advisable to start treatment with the lowest recommended dose.

Hepatic failure: No dose adjustment for patients with mild liver failure (group A). Use Celecoxib at half the recommended dose for patients with arthritis or suffer from medium liver failure (group B).

Kidney failure: No dose adjustment for medium and mild renal impairment patients. There are no studies in patients with severe renal impairment.

Use in combination with fluconazole : Celecoxib should be used with half recommended dose because Fluconazole is CYP2C inhibitor.

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 to do when overdose?

Clinical experience of overdose is limited. Use a single dose of up to 1200 mg or multiple doses (2 times/ day) with a total dose of 1200 mg in healthy people does not show any unwanted effects of clinical significance. In case of suspicion of overdose, appropriate medical support measures should be taken. The fertilizer is not an effective measure to eliminate drugs because the drug is strongly connected to the protein.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Celecoxib 200HV USPHARMA 3X10 you can experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological: headache, insomnia.

Digestive: abdominal pain, indigestion , diarrhea, nausea, flatulence.

Eye: conjunctivitis.

Body: chest pain.

Rare, ADR

Mental: Illusion.

Respiratory: Pulmonary embolism, pneumonia.

digestive hemorrhage: gastrointestinal bleeding.

Hepatitis: Hepatitis.

Skin: Reaction sensitive to light.

Kidney: acute renal failure , hypoglyc sodium.

reproductive system: Menstrual disorders.

Very rare

The immune system: Anaphylactic reactions.

Neurology: cerebral hemorrhage, sterile meningitis, loss of taste, loss of smell.

vascular: Vascular inflammation.

liver: Hepatic failure, hepatitis outbreak, liver necrosis, bile stasis, biliary hepatitis, jaundice.

Kidney: interstitial nephritis, nephrotic syndrome , minimum lesions of glomerulonephritis.

Unknown frequency

Reproductive system: Women's fertility disorders.

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

Celecoxib 200-HV contraindicated drug in the following cases:

Patients with a history of hypersensitivity to Celecoxib or any component of the drug.

Patients with a history of hypersensitivity to sulfonamid.

Patients with a history of asthma, urticaria or allergic reactions after taking acetylsalicylic acid (asa [Aspirin]) or other nonsteroidal anti-inflammatory drugs (NSAIDs), including other specific inhibitors Cycloxide-2 (COX-2).

Treatment of pain in coronary artery transplant surgery (CABG).

Caution when using

effect on the heart:

cardiovascular thrombosis: The drug may increase the risk of cardiovascular thrombosis, including myocardial infarction and stroke, which can lead to death. This risk can appear early in the first few weeks of taking the drug and can increase over time. The risk of cardiovascular thrombosis is recorded mainly at high doses. 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. To minimize the risk of adverse incidents, Celecoxib is required at the lowest daily doses to be effective in the shortest possible time. Two major clinical trials, controlled, shows an increase in the rate of myocardial infarction and stroke when using another NSAID selective effect on COX-2 to treat pain in the first 10-14 days after artificial coronary artery transplant surgery (CABG). Celecoxib is not a substitute for acetylsalicylic acid in preventing obstruction, cardiovascular thrombosis due to lack of platelet function. Because Celecoxib does not inhibit plateletic collection, platelet resistance should not be stopped (for example, acetylsalicylic acid) while using Celecoxib.

Hypertension:

Celecoxib may start an increase in hypertension or worsen the inherent hypertension, both of which can increase the risk of cardiovascular events. Caution should be used when using Celecoxib, on hypertension patients. Need to monitor blood pressure closely when starting treatment with Celecoxib as well as during treatment.

Be cautious when using Celecoxib in patients who have been damaged by heart, edema or other conditions may be worse due to fluid and edema, including patients taking diuretics, or at risk of reducing blood volume.

Effects on gastrointestinal tract:

Perforation, ulcers or gastrointestinal bleeding on the upper and lower gastrointestinals occurred with patients using Celecoxib. Patients at risk are mostly elderly, patients with cardiovascular diseases, patients who are taking aspirin, glucocorticoids or other NSAIDs, patients using alcohol, or patients with a history of or suffering from progressive gastrointestinal diseases such as ulcers, bleeding or gastrointestinal inflammation. Most random reports on death -related deaths related to Celecoxib occur in the elderly or patients with weakness.

Effects on the kidneys:

Celecoxib can be toxic to the kidneys. Clinical trials have shown that Celecoxib has the effects on the kidneys similar to other NSAIDs. Patients with the highest risk of kidney toxicity are those who impaired renal function, heart failure, liver failure and the elderly. Careful monitoring for these patients when treated with Celecoxib. Be careful when starting treatment for dehydration patients. First, it is necessary to rehydration for patients and then start treatment with Celecoxib. Progressive renal disease: Need to closely monitor kidney function in patients with renal disease progressive treatment with Celecoxib.

Anaphylactic reaction:

As well as NSAID drugs in general, anaphylactic reactions occur in patients using Celecoxib.

Serious skin reactions, some can lead to death, including flaky dermatitis, Steven-Johnson syndrome and poisoned epidermal necrosis, have been reported but very rare in using Celecoxib. Patients are often at high risk for these events in the early stages of the treatment process, most of these cases occur mainly in the first month of treatment. Celecoxib should be stopped as soon as skin redness appears, mucosal damage or any signs of hypersensitivity.

Effects on the liver: There is no study in patients with severe liver failure (group C). Do not use Celecoxib in patients with severe liver failure. Caution should be used when using Celecoxib in medium-medium liver failure patients (group B) and should start with the dose equal to half the recommended dose (see the dosage and how to use). Very few serious reactions on the liver, including hepatitis outbreak (some cases leading to death), liver necrosis and liver failure (some deaths or liver transplantation) have been reported when using Celecoxib. Patients with symptoms and/ or signs of liver failure or people with abnormal liver function tests need to be closely monitored on signs of serious progression of liver reactions during treatment with Celecoxib.

Use with oral anticoagulants: simultaneous use of NSAIDs with oral anticoagulants increases the risk of bleeding and needs to be cautious when used. Oral anticoagulants include Warfarin/ Coumarin and new oral anticoagulants (such as Apixaban, Dabigatran and Rivaroxaban). There have been reports on serious bleeding in patients who are using Warfarin simultaneously or similar substances, including some deaths. Due to a report on increasing prothrombin (INR) time, prothrombin anti -coagulant/ time anti -coagulants should be monitored in patients who are using Warfarin/ Coumarin anticoagulants after starting treatment with Celecoxib or adjusting the dose of these drugs.

Overview: With anti -inflammatory effects, Celecoxib can fade diagnostic signs, such as fever symptoms in infection diagnosis. Celecoxib simultaneous use with NSAID drugs non -aspirin.

CYP2D6 inhibitor: Celecoxib is a medium level of CYP2D6 inhibitor. For drugs metabolized through CYP2D6, it is necessary to reduce the dose of these drugs when starting to use with Celecoxib or increase the dose of these drugs when stopping using Celecoxib.

Lactose -containing drugs: Patients with rare genetic disorders in galactose tolerance, Lactose Lapp deficiency. Or Glucose-Galactose absorption disorders should not use this drug.

The ability to drive and operate machinery

There is no study of the effect of Celecoxib on the ability to drive and operate machinery, but based on the pharmacological properties and general description of the safety of the drug, can be considered as non -influential drugs.

Pregnancy

There is no research in pregnant women. Some animal studies have shown toxicity on reproduction. There are no equivalent data on humans. Celecoxib, as well as other prostaglandin synthesis inhibitors, can cause powerless uterine muscle and early aortic ductus, so avoid using Celecoxib in the third quarter of pregnancy. Celecoxib should only be used during pregnancy if the potential benefits to the mother outperform the potential risk to the fetus. Prostaglandin synthesis inhibitors can cause disadvantages for pregnant women. Data from epidemiological studies shows increased risk of spontaneous miscarriage after taking prostaglandin synthetic inhibitors in the early stages of pregnancy. In animals, the use of prostaglandin synthetic inhibitors increases the risk of miscarriage before and after the embryo.

The period of breastfeeding

research on rats shows that Celecoxib is excreted in milk with concentrations equivalent to plasma concentrations. In breastfeeding women using Celecoxib, very few Celecoxibs are transferred into milk. Because of the unwanted effects of Celecoxib on breastfeeding children, depending on the desired benefit of the drug for the mother, should consider stopping the medicine or stop breastfeeding.

Drug interaction

Celecoxib mainly metabolizes through Cytocrom P450 (CYP) 2C9 in the liver. Caution should be used when using Celecoxib in patients who have or suspected poor metabolism through CYP2C9 based on a history with other substrates of CYP2C9 because these patients may have Celecoxib concentration in plasma abnormally high due to reduced metabolic clearance. Should start treatment with the dose equal to the lowest recommended dose.

Concomitance Celecoxib with CYP2C9 inhibitors increases the concentration of celecoxib in plasma. Therefore, Celecoxib should be reduced when used simultaneously with CYP2C9 inhibitors.

Concomitance Celecoxib with CYP2C9 induction substances such as Rifampicin, Carbamazepin and Barbiturate reduces the concentration of plasma Celecoxib. Therefore, it is necessary to increase the dose of Celecoxib when used simultaneously with CYP2C9 induction.

Clinical pharmacokinetics research and In vitro studies show that although Celecoxib is not a substrate, CYP2D6 inhibitors. Therefore, there may be in vivo interactions with drugs metabolized by CYP2D6.

Lithium: In healthy objects, plasma lithium concentrations increase by about 17% when used simultaneously lithium and Celecoxib. Need to closely monitor patients being treated with lithium when starting or stopping using simultaneously with Celecoxib.

Aspirin : Celecoxib does not affect the anti -platelet effect of low -dose aspirin. Because there is no platelet effect, Celecoxib is not an alternative to aspirin in the treatment of cardiovascular disease.

Anticboo -pressure drugs include Angiotensin transfer inhibitors (ACEI) and Angiotensin II antagonist (known as Angiotensin, ARB) receptor inhibitors, diuretics and beta receptor blockers: Prostaglandin inhibitors can reduce the anti -hypertension effect of enzyme inhibitors (ACEI) and/ or/ or/ or/ Angiotensin drugs Beta receptor blockers. It should be noted these interactions when using Celecoxib simultaneously and the Angiotensin ACEI ANGOTENSIN ACE inhibitors and /or Angiotensin II antagonists, diuretics and beta receptor blockers.

In elderly patients, people with fluid reduced (including diuretics) or kidney damage, simultaneous use of NSAIDs, including COX-2 inhibitors, with angiotensin (ACEI), Angiotensin II antagonists or diuretics that can lead to kidney function damage including acute renal impairment. These effects can often be recovered. Therefore, it is necessary to be cautious when using Celecoxib with these drugs at the same time. Patients need to be compensated enough and monitor the kidney function when starting a combined use regimen as well as periodic control.

Results of Lisinopril research: In a 28 -day clinical study in stage I and II patients with Lisinopril's control, the use of Celecoxib 200mg x 2 times/day does not cause systolic and diastolic hypertension when compared to the place of placebo use in the process of blood pressure control 24 hours. In the group of patients using simultaneously with Celecoxib 200mg twice a day, 48% of patients do not respond to Lisinopril on the last visitor (meaning diastolic blood pressure greater than 90 mmHg or the center of the center of the school increases more than 10% compared to the original time), for the placebo group this number is 27%. This difference is statistically significant.

cyclosporin : Because NSAIDs work on the kidney prostaglandin, these drugs may increase the risk of cyclosporin.

fluconazole and ketoconazole: simultaneously use Fluconazole at a dose of 200mg, 1 time/ day, double the plasma celecoxib concentration due to fluconazole has the effect of inhibiting enzymes to metabolize Celecoxib CYP P450 2C9. Celecoxib should be started at the dose of the recommended dose in patients who are taking drugs that inhibit CYP2C9 as fluconazole. Ketoconazole, a CYP3A4 inhibitor, has no significant celecoxib metabolism inhibitors.

dextromethorphan and metoprolol: simultaneous use of Celecoxib 200mg twice a day increases 2.6 times and 1.5 times the concentration of dextromethorphan and metoprolol in plasma (substrates of CYP2D6). This is because Celecoxib inhibits metabolism of substrates of CYP2D6. Therefore, it is necessary to reduce the dose of medications as substrate of CYP2D6 when starting to use Celecoxib simultaneously and need to increase the dose of these drugs when stopping using Celecoxib.

Diuretics: Clinical studies show that in some patients, NSAIDs can reduce the effect of increasing sodium exhaust through the urine of Furosemid and Thiazid by inhibiting the synthesis of kidney prostaglandin.

Methotrexate : There are no important clinical and pharmacokinetics between Celecoxib and Methotrexate in clinical research between these two drugs.

Oral contraceptives: In an interactive study, Celecoxib does not have a clinical clear effect with pharmacokinetics of oral contraceptive pills (1 mg norethindron 0.035 mg ethinyl estradiol).

Other drugs: No clinical interactive reports between Celecoxib and antacids (aluminum and magnesium), Omeprazol, Glibenclamid (Glybid), Phenytoin or Tolbutamid.

Storage

Store the drug in a dry, airy place, temperatures below 30 ° C, avoiding light.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.