Celecoxib 200 - HV USP treatment of osteoarthritis, rheumatoid arthritis (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Celecoxib
Ingredient Gout, dysmenorrhea, colon polyps, rectal polyps, arthritis, rheumatoid arthritis, osteoarthritis, inflammation, toothache

Ingredient

Composition information	Content
Celecoxib	200mg

Uses

Indications

Celecoxib 200 - HV is indicated in the following cases:

Treatment of symptoms of osteoarthritis (OA) and rheumatoid arthritis (out). Celecoxib is a new generation NSAID (NSAID) analgesic (NSAID).

In the body there exist two types of cyclooxygenase enzymes (COX): COX-1 and COX-2. Cox-1 catalyst creates beneficial substances that protect the stomach and kidney mucosa. COX-2 is found in inflammatory tissues.

Celecoxib inhibits prostaglandin synthesis due to selective inhibition on cyclooxygenase 2 (COX -2) enzyme (COX -2), which minimizes the harm to the stomach - intestines, kidneys and does not interfere with blood clotting.

pharmacokinetic

absorption

Celecoxib's peak concentration is about 2-3 hours after 1 dose. Food does not affect the absorption of the drug.

distribution

Celecoxib is connected to strong proteins (about 97%), Celecoxib is not given priority associated with red blood cells.

transformation

Celecoxib is mainly conversion of intermediaries through Cytochrome P450 2C9. Three metabolic products do not have the effect of inhibiting COX-1 or COX-2 identified in human plasma is the most alcohol, corresponding carboxylic acid and its form of glucuronic

Elimination

Celecoxib is excreted mainly by metabolism in the liver, with less than 1% of the dose is excreted in the urine.

Before taking Celecoxib 200 - HV USP treatment of osteoarthritis, rheumatoid arthritis (10 blisters x 10 tablets)

How to use

Celecoxib 200 - HV hard capsules for oral. Drinking while eating or after meals, can be used with food or not.

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 medicine 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 drugs has been stably mixed for about 6 hours when stored in the refrigerator (2 - 8 ° C). Not stored in the refrigerator, the amount of drug mixed with crushed bananas must be taken immediately.

Dosage

Due to the cardiovascular risks of Celecoxib may increase the dose over time of drug use, the lowest dose should be used in the shortest possible time.

Adults:

Dosage in case of symptomatic treatment in osteoarthritis (OA):

Celecoxib's recommendations are 200mg of single doses or 100mg x 2 times/day.

Celecoxib's recommendations are 100mg or 200mg x 2 times/day.

Celecoxib's recommendations are 200mg of single or 100mg x 2 times/day.

The starting dose as recommended by Celecoxib is 400 mg, taking an additional 200mg dose of the first day if necessary.

The starting dose as recommended by Celecoxib is 400mg, taking another 200mg dose of the first day if necessary.

Patients who know or suspect poor metabolism through CYP2C9 based on a history/experience with other substrates of CYP2C9 should be cautious when using Celecoxib.

generally not adjust the dose.

There is no need to adjust the dose for patients with mild liver failure (group A). For patients with medium and mild renal failure. There are no studies in patients with severe renal failure.

Used in combination with fluconazol:

should use Celecoxib with 1/2 recommended dose in patients being treated with fluconazole, a CYP2C9 inhibitor. Caution should be used when using Celecoxib with CYP2C9 inhibitors.

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 using overdose? Use single dose up to 1200mg 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 an overdose suspected, 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.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

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

Unwanted effects when using Celecoxib 200 - HV that you can meet.

Common:

Neurology: headache, insomnia.

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

Uncommon:

Eye: conjunctivitis.

Spirit: chest pain.

rare:

Mental: illusion.

Respiratory: pulmonary embolism, pneumonia.

Gastrointestinal: gastrointestinal bleeding.

Hepatitis: Hepatitis.

Skin: Light sensitive reaction.

Kidney: Acute renal failure, hypoglyc sodium.

reproductive system: Menstrual disorders.

Very rare:

The immune system: Anaphylaxis reactions.

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

Vascular: vasculitis.

Hepatitis: Hepatitis, hepatitis outbreak, liver necrosis, biliary stasis, bile hepatitis, jaundice.

Skin: Stevens-Johnson syndrome, diverse roses, poisoned epidermal necrosis, drugs due to drugs accompanied by eosin leukemia and systemic symptoms (dress or hypersensitivity syndrome), acute overseas acne acne (AGEP), peeling dermatitis.

Kidney: interstitial nephritis, nephrotic syndrome, glomerulonephritis minimal damage.

Unknown frequency:

Reproductive system: Reproductive disorders in women. Pregnant women are expected to be excluded from these tests, so the reference of clinical data on frequency for these unwanted effects is inappropriate.

Risk of cardiovascular thrombosis.

Other side effects are fainting, kidney failure, heart failure, severe progression of high blood pressure, tinnitus, stomach ulcers, glare, anxiety, weight gain, water retention, symptoms of influenza, dizziness and weakness.

allergic reactions may occur with Celecoxib.

Instructions on how to handle ADR: notify your doctor unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Celecoxib 200 - HV Contraindications in the following cases:

Patients with a history of hypersensitivity to Celecoxib or any component of the drug. Cycloxygenase-2 (COX-2).

Caution when using

This long -term use can increase cardiovascular risk including heart attack, blood clotting, chest pain, cardiac arrest, stroke and gastrointestinal complications such as ulcers, bleeding, perforation.

Increased risk of cardiovascular thrombosis, including myocardial infarction and stroke, 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 in high doses. Doctors need to periodically evaluate the appearance of cardiovascular events, even if the patient has no previous cardiovascular symptoms.

Patients should be warned of symptoms of serious cardiovascular events and need to see a doctor as soon as they show these symptoms. To minimize the risk of adverse incidents, it is necessary to use Celecoxib at the lowest daily dosage effectively in the shortest possible time.

Hypertension: Like all other NSAIDs, Celecoxib may start the hypertension or worsen the inherent hypertension, both of which can increase the risk of cardiovascular events. Be careful when using NSAIDs, including Celecoxib, on hypertension patients.

fluid and edema: Like drugs that inhibit prostaglandin synthesis, edema and fluids have been observed on some patients using Celecoxib. Therefore, it is necessary to closely monitor patients with congestion or hypertension in advance.

Effects on the gastrointestinal tract: Perforation, ulcers or gastrointestinal bleeding up and below have occurred with patients using Celecoxib. Patients who are at risk of these gastrointestinal tract complications when taking NSAID drugs are mostly elderly people, patients with cardiovascular diseases, patients taking aspirin, glucocorticoids or other NSAIDs, patients using alcohol, or patients with a history or suffering from progressive gastrointestinal diseases such as ulcers, bleeding or gastrointestinal inflammation.

Effects on the kidneys: NSAIDs including Celecoxib may be toxic to the kidneys. Patients with the highest risk of kidney toxicity are those who fail kidney function, heart failure, liver failure and the elderly, need to carefully monitor these patients when treated with Celecoxib.

Be careful when starting to treat patients dehydration. First need to rehydrate the patient and then start treatment with Celecoxib.

Anaphylactic reactions, serious skin reactions may also (very rare). Celecoxib should be stopped as soon as skin redness appears, mucosal damage or any signs of hypersensitivity.

Use with oral anticoagulants: simultaneous use of NSAIDs with oral anticoagulants increases the risk of bleeding and needs to be cautious when used.

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

The ability to drive and operate machinery

The drug does not affect the ability to drive and operate machinery.

Pregnancy

There are no studies here enough to use Celecoxib in pregnant women. Celecoxib should only be used for pregnant women when the benefit is higher than the risk that may occur for fetuses. Do not use Celecoxib in the last 3 months of pregnancy.

Breastfeeding period

In nursing women using Celecoxib, very few Celecoxibs are transferred into milk. Because of the unwanted effects of Celecoxib on breastfeeding, it is necessary to consider benefits/harms or stop breastfeeding or stop using Celecoxib.

Drug interaction

metabolism of Celecoxib via cytochrome p450 2c9 in the liver.

Celecoxib simultaneous use with drugs that inhibit this enzyme can affect the pharmacokinetics of Celecoxib, so be careful when used simultaneously with this drug. Celecoxib may 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.

Celecoxib also inhibits Cytochrom P450 2D6. Therefore, the interaction between Celecoxib and drugs is metabolized by Cytochrom P450 2D6.

Celecoxib may reduce the anti -hypertension effect of enzyme inhibitors or angiotensin II receptor blockers, diuretics and beta receptor blockers. Prostaglandin inhibitors can reduce the effects of these drugs.

Celecoxib may reduce the effect of increasing the excretion of sodium sodium of Furosemid and Thiazid in some patients.

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

Celecoxib may increase the rate of gastrointestinal ulcers or other complications if used simultaneously with aspirin.

Simultaneous use of Celecoxib and Fluconazole/ Ketoconazole can lead to significantly increasing plasma concentrations of Celecoxib.

Lithi: Celecoxib may reduce lithium renal clearance, which leads to an increase in lithium levels in plasma, which should be adjusted accordingly at the beginning and stop using Celecoxib.

Celecoxib may increase Warfarin's anticoagulant effect.

Simultaneous use of Celecoxib with aspirin or other NSAIDs (ibuprofen, Naproxen ...) can increase the risk of gastric ulcer.

Storage

Store in a dry place, temperatures below 300C and avoid light.

To be out of reach of children.

Other drugs

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