Conoges 100

POSOLOGY AND METHOD OF ADMINISTRATION

Posology 

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.

CYP2C9 Poor Metabolisers: Patients who are known or suspected to be CYP2C9 poor metabolites 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).

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.

Method of administration

Celecoxib capsules, 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.

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 for 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.

+ 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 on 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 on patients with severe renal impairment.

+ 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.

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 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).

- Risk of gastrointestinal bleeding, peptic ulcer.

- Ischemic heart disease, peripheral vascular disease, cerebrovascular disease, congestive heart failure II-IV according to the New York Heart Association NYHA.

- Severe kidney failure, severe liver failure.

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 death. This risk may appear early in the first few weeks of taking the drug and may increase with the 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 minimized 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.

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 incidence 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 include the elderly, patients with cardiovascular disease, patients taking aspirin, glucocorticoids, or other NSAIDs, 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 function, 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).

General

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

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

Inhibitors of CYP 2D6:

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

STORAGE: In a dry place, below 30oC, protect from light.

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

Al/PVC blister. Box of 03 blisters x 10 hard capsules.

Al/PVC blister. Box of 05 blisters x 10 hard capsules.

Al/PVC blister. Box of 10 blisters x 10 hard capsules.