CONOGES 200

ADMINISTRATION AND DOSAGE
Dosage

The dose is up to 200 mg twice daily, may be taken with or without food.

The cardiovascular risks of celecoxib may increase with dose and duration of exposure, and the shortest duration possible and the lowest effective dose should be used.

Adult

Symptomatic treatment in osteoarthritis (OA):

The recommended dose of celecoxib is 200 mg as a single dose or 100 mg twice daily.

Symptomatic treatment in rheumatoid arthritis (RA): 

The recommended dose of celecoxib is 100 mg or 200 mg twice daily.

Ankylosing spondylitis (AS): 

The recommended dose of celecoxib is 200 mg as a single dose or 100 mg twice daily. Some patients may be able to achieve a better therapeutic effect with a total daily dose of 400 mg.

Management of acute pain: 

The recommended dose of celecoxib is 400 mg, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.

Treatment of primary dysmenorrhea: 

The initial recommended dose of celecoxib is 400 mg, followed by an additional 200 mg dose on the first day if needed. On subsequent days, the recommended dose is 200 mg twice daily as needed.

Special patient groups

CYP2C9 Poor Metabolisers: 

Patients who are known or suspected to be CYP2C9 poor metabolisers based on history/experience with other CYP2C9 substrates should be administered celecoxib with caution. Initiate treatment with half of the lowest recommended dose (see section Interactions and Pharmacokinetics - Metabolism).

Elderly: 

In general, no dose adjustment is required. However, in elderly patients weighing less than 50 kg, treatment should be initiated with the lowest recommended dose.

Pediatric patients 

Juvenile Idiopathic Arthritis (JIA)

(*) The dosage is not suitable with the content and dosage form of CONOGES 200, the doctor should guide the patient to choose another preparation with the dosage form and concentration suitable to the indicated dose.

Celecoxib has been studied in juvenile idiopathic arthritis patients aged 2 to 17 years. The safety and effectiveness of celecoxib in children have not been studied for more than 6 months or in patients weighing less than 10 kg (22 lbs) or in patients with systemic manifestations (see section clinical trials).

Hepatic impairment: 

No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh class A).In patients with moderate hepatic impairment (Child-Pugh class B), reduce the dose by 50% for patients with arthritis or pain.

There are no studies in patients with severe hepatic impairment (Child-Pugh class C).

Renal impairment: 

No dose adjustment is required in patients with moderate to mild renal impairment. There are no clinical studies in patients with severe renal impairment (see section Warmings and precautions - Effects on the kidneys).

Concomitant administration of fluconazole: 

Celecoxib should be used at half the recommended dose in patients receiving fluconazole, a CYP2C9 inhibitor. Caution should be exercised when combining celecoxib with CYP2C9 inhibitors.

Administration

For patients who have difficulty swallowing capsules, the contents of a capsule can be added to applesauce, porridge, yogurt or mashed bananas to drink. At that time, the entire capsule contents are emptied onto a small spoon of room temperature applesauce, porridge, yogurt or mashed banana and ingested immediately with water. The sprinkled capsule contents on applesauce, porridge or yogurt are stable to 6 hours when stored in the refrigerator (2°C-8°C). Do not store in the refrigerator the contents of a capsule on mashed bananas, but must be taken immediately. 

CONTRAINDICATIONS

Celecoxib is contraindicated for:

Patients with a history of hypersensitivity to celecoxib or any excipients of the drug.

Patients with a history of hypersensitivity to sulfonamides.

Patients who have experienced asthma, urticaria or allergic-type reactions after taking of acetylsalicylic acid (ASA [aspirin]) or other NSAIDs, including other selective COX-2 inhibitors.

Treatment of pain during coronary artery bypass graft (CABG) surgery (see Warnings and Precautions).

WARNINGS AND PRECAUTIONS 

Cardiovascular effects

Cardiovascular thrombosis:

Non-steroidal anti-inflammatory drugs (NSAIDs), other than aspirin, may increase the risk of cardiovascular thrombotic events, including myocardial infarction and stroke, which can lead to fenal. This risk may appear early in the first few weeks of taking the drug and may increase with duration of use. The risk of cardiovascular thrombosis was observed mainly at high doses.

Physicians should periodically evaluate the occurrence of cardiovascular events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and see a doctor immediately when these symptoms appear.

Undesirable effects may be minimised by using the lowest effective dose of celecoxib for the shortest duration necessary.

Two large, controlled clinical trials of another COX-2-selective NSAID for the treatment of pain in the first 10-14 days following coronary artery bypass graft (CABG) surgery found an increased incidence of myocardial infarction and stroke (see Contraindications).

Celecoxib is not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thromboembolic diseases because of their lack of platelet effects. Because celecoxib does not inhibit platelet aggregation, antiplatelet therapy (eg, acetylsalicylic acid) should be not discontinued when taking celecoxib.

Hypertension: As with all NSAIDs celecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased the risk of cardiovascular events. NSAIDs, including celecoxib, should be used with caution in hypertensive patients. Blood pressure should be monitored closely during the initiation of therapy with celecoxib and throughout the course of therapy.

Fluid retention and edema: As with other drugs that inhibit prostaglandin synthesis, edema, and fluid retention have been observed in some patients taking celecoxib. Therefore, patients with congestive heart failure or pre-existing hypertension should be monitored closely. Celecoxib should be used with caution in patients with cardiac dysfunction, edema, or worsening conditions because of fluid retention and edema including those taking diuretics, or otherwise at risk of hypovolaemia.

Gastrointestinal effects:

Upper and lower gastrointestinal perforation, ulceration, or bleeding have occurred in patients taking celecoxib. Patients most at risk of these gastrointestinal complications with NSAIDs almost the elderly, patients with cardiovascular disease, patients taking aspirin, glucocorticoids, or other NSAID, patients consuming alcoholic beverages, or patients with a history of or ongoing gastrointestinal diseases such as ulcers, bleeding conditions or inflammation of the gastrointestinal tract. Most randomized reports of celecoxib-related gastrointestinal deaths have been in physically frail or elderly patients.

Renal effects

NSAIDs including celecoxib can be nephrotoxic. Clinical trials with celecoxib have shown effects similar to those of other NSAIDs compared. Patients with the highest risk of nephrotoxicity are those with impaired renal fuction, heart failure, impaired liver function, and the elderly. These patients should be carefully monitored during treatment with celecoxib.

Caution should be exercised when initiating treatment in dehydrated patients. The patient should be rehydrated first and then initiate celecoxib therapy.

Advanced Renal Disease: 

Close monitoring of renal function is required in patients with advanced renal disease receiving celecoxib. (see Posology and method of administration).

Anaphylactic reaction:

As with NSAIDs in general, anaphylactic reactions have occurred in patients receiving celecoxib (see Contraindications).

Serious skin reactions:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Steven-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely with the use of celecoxib. Patients are often at high risk for these events in the early stages of treatment, which occur mainly during the first month of treatment. Celecoxib should be discontinued immediately upon the appearance of skin redness, mucosal lesions, or any other signs of hypersensitivity.

Hepatic Effects

There are no studies on patients with severe hepatic impairment (Child-Pugh class C). Do not use celecoxib in patients with severe hepatic impairment. Celecoxib should be used with caution in patients with moderate hepatic impairment (Child-Pugh class B) and should be initiated at half the recommended dose (see Posology and method of administration).

Rare serious liver side effects, including fulminant hepatitis (some fatal), hepatic necrosis, and liver failure (some fatal or requiring liver transplantation) have been reported with celecoxib.

Patients with symptoms and/or signs of liver failure or those with abnormal liver function tests should be monitored closely for signs of developing more serious liver reactions during treatment with celecoxib.

Concomitant use with oral anticoagulants:

Concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding and should be used with caution. Oral anticoagulants include warfarin/coumarin forms and newer oral anticoagulants (eg, apixaban, dabigatran, and rivaroxaban). Cases of serious bleeding have been reported in patients concomitantly with warfarin or its analogs, some of which have been fatal. As an increase in prothrombin time (international normalized ratio, INR) has been reported, the anticoagulant effect/INR should be monitored in patients receiving warfarin/coumarin-type anticoagulants or adjusted after initiation of celecoxib therapy (see section Interactions).

Systemic-onset juvenile idiopathic arthritis

NSAIDs, including celecoxib, should be used with caution in patients with systemic-onset juvenile idiopathic arthritis, due to the risk of disseminated intravascular coagulation. Patients with systemic-onset juvenile idiopathic arthritis receiving celecoxib should be monitored for the development of abnormal coagulation tests.

General

With its anti-inflammatory effect, celecoxib can obscure diagnostic markers, such as fever, in diagnosing infections.

Concomitant use of celecoxib with  non-aspirin NSAIDs should be avoided.

Inhibitors of CYP 2D6:

Celecoxib has shown moderate inhibition of CYP2D6. A dose reduction may be necessary for drugs that are metabolised by CYP2D6 when initiating treatment with celecoxib or increase the dose upon discontinuation of celecoxib therapy (see Interactions).

Excipients

Lactose: The hard capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

SHELF LIFE: 36 months from the manufacturing date. Do not use after the expiry use.