Celosti 200

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Non steroidal anti-inflammatory, analgesics.
Barcode: 8935206016635
Description

CELOSTI 200

Prescription only.

Read the instruction thoroughly before use.

Do not exceed the recommended dose.

Please inform your doctor of all undesirable effects upon drug administration.

Please consult your physician for more information.

Do not use the product after the expiry date.

Keep out of reach of children.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient:

Celecoxib .................................................... 200 mg

Excipients: Lactose monohydrate, sodium laurilsulfate, povidone K30, croscarmellose sodium, magnesium stearate.

PHARMACEUTICAL FORM: Hard capsule for oral use.

Product description: A white to off-white hard capsule with a pattern on the capsule body containing homogeneous drug powder.

THERAPEUTIC INDICATIONS

Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis (RA).

Relief of signs and symptoms of juvenile idiopathic arthritis (JIA) in patients 2 years and older with body weight greater than or equal to 10 kg.

Relief of signs and symptoms of ankylosing spondylitis (AS).

Management of acute pain.

Treatment of primary dysmenorrhea

POSOLOGY AND METHOD OF ADMINISTRATION

Celecoxib capsules, at doses up to 200 mg twice per day, can be taken with or without food.

As the cardiovascular (CV) risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.

Adults

Symptomatic treatment of osteoarthritis (OA): The recommended dose of celecoxib is 200 mg administered as a single dose or as 100 mg twice per day.

Symptomatic treatment of rheumatoid arthritis (RA): The recommended dose of celecoxib is 100 mg or 200 mg twice per day.

Ankylosing spondylitis (AS): The recommended dose of celecoxib is 200 mg administered as a single dose or as 100 mg twice per day. Some patients may benefit from a total daily dose of 400 mg.

Management of acute pain: The recommended dose of celecoxib is 400 mg, initially, 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 recommended dose of celecoxib is 400 mg, initially, 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.

CYP2C9 poor metabolizers: Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose (see sections Interactions and Metabolism).

Elderly

No dosage adjustment is generally necessary. However, for elderly patients weighing less than 50 kg, it is advisable to initiate therapy at the lowest recommended dose.

Children

Juvenile idiopathic arthritis (JIA)

 

 

 

Pediatric Patients (2 years and older)

Dose

≥ 10 kg to ≤ 25 kg

Capsule 50 mg twice daily

> 25 kg

Capsule 100 mg twice daily

Celecoxib has been studied in JIA patients 2 to 17 years of age. Safety and efficacy of celecoxib in children have not been studied beyond 6 months duration or in patients with body weight less than 10 kg (22 lbs), or in patients with active systemic features (see section Clinical studies).

Method of administration

For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce, rice gruel, yogurt or mashed banana. To do so, the entire capsule contents must be carefully emptied onto a level teaspoon of cool or room temperature applesauce, rice gruel, yogurt or mashed banana and should be ingested immediately with water. The sprinkled capsule contents on applesauce, rice gruel or yogurt are stable for up to 6 hours under refrigerated conditions (2-8°C/35-45°F). The sprinkled capsule contents on mashed banana should not be stored under refrigerated conditions and should be ingested immediately.

Hepatic impairment: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Introduce celecoxib at half the recommended dose in arthritis or pain patients with moderate hepatic impairment (Child-Pugh Class B).

Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied (see section Hepatic effects).

Renal impairment: No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is no clinical experience in patients with severe renal impairment (see section Renal effects).

Coadministration with fluconazole: Celecoxib should be introduced at half the recommended dose in patients receiving fluconazole, a CYP2C9 inhibitor. Caution is advised when coadministering celecoxib with other CYP2C9 inhibitors (see section Interactions and other forms of interactions).

CONTRAINDICATIONS

Celecoxib is contraindicated in:

- Patients with known hypersensitivity to celecoxib or any other ingredient of the product.

- Patients with known sulfonamide hypersensitivity.

- Patients who have experienced asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid (ASA [aspirin]) or other nonsteroidal anti-inflammatory drugs (NSAIDs), including other cyclooxygenase-2 (COX-2) specific inhibitors.

- Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see section Special warnings and precautions for use).

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Cardiovascular thrombotic events

Nonsteroidal anti-inflammatory drugs (NSAIDs), non-aspirin, by systemic route, have shown an increased risk of cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. The increase in cardiovascular thrombotic risk has been observed most consistently at higher doses. Physicians should remain alert for the development of such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. To minimize the potential risk for an adverse cardiovascular event in celecoxib-treated patients, use the lowest effective dose for the shortest duration possible.

Cardiovascular effects

Cardiovascular thrombotic events: Celecoxib may cause an increased risk of serious CV thrombotic events, myocardial infarction (MI), and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with dose and duration of use. The relative increase of this risk appears to be similar in those with or without known CV disease or CV risk factors. However, patients with CV disease or CV risk factors may be at greater risk in terms of absolute incidence, due to their increased rate at baseline. To minimize the potential risk for an adverse CV event in patients treated with celecoxib, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and symptoms of serious CV toxicity and the steps to take if they occur (see section Pharmacodynamic properties)

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

Celecoxib is not a substitute for acetylsalicylic acid for prophylaxis of CV thromboembolic diseases because of the lack of effect on platelet function. Because celecoxib does not inhibit platelet aggregation, anti-platelet therapies (e.g., acetylsalicylic acid) should not be 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 CV events. NSAIDs, including celecoxib, should be used with caution in patients with hypertension. 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 known to inhibit prostaglandin synthesis, fluid retention and edema have been observed in some patients taking celecoxib. Therefore, patients with pre-existing congestive heart failure (CHF) or hypertension should be closely monitored. Celecoxib should be used with caution in patients with compromised cardiac function, pre-existing edema, or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolemia.

Gastrointestinal (GI) effects

Upper and lower GI perforations, ulcers or bleeds have occurred in patients treated with celecoxib. Patients most at risk of developing these types of GI complications with NSAIDs are the elderly, patients with CV disease, patients using concomitant glucocorticoids, antiplatelet drugs (such as aspirin), or other NSAIDs, patients using alcohol or patients with a prior history of, or active, GI disease, such as ulceration, GI bleeding or inflammatory conditions. Most spontaneous reports of fatal GI events have been in elderly or debilitated patients.

Renal effects

NSAIDs including celecoxib may cause renal toxicity. Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs. Patients at greatest risk for renal toxicity are those with impaired renal function, heart failure, liver dysfunction, and the elderly. Such patients should be carefully monitored while receiving treatment with celecoxib.

Caution should be used when initiating treatment in patients with dehydration. It is advisable to rehydrate patients first and then start therapy with celecoxib.

Advanced renal disease

Renal function should be closely monitored in patients with advanced renal disease who are administered celecoxib (see section Posology and method of administration).

Anaphylactoid reactions

As with NSAIDs in general, anaphylactoid reactions have occurred in patients exposed to celecoxib (see section Contraindications).

Serious skin reactions

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib. Patients appear to be at highest risk for these events early in the course of therapy, the onset of the event occurring in the majority of cases within the first month of treatment. Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Hepatic effects

Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied. The use of celecoxib in patients with severe hepatic impairment is not recommended. Celecoxib should be used with caution when treating patients with moderate hepatic impairment (Child-Pugh Class B), and initiated at half the recommended dose (see section Posology and method of administration).

Rare cases of severe hepatic reactions, including fulminant hepatitis (some with fatal outcome), liver necrosis, and hepatic failure (some with fatal outcome or requiring liver transplant), have been reported with celecoxib.

A patient with symptoms and/or signs of liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored carefully for evidence of the development of a more severe hepatic reaction while on therapy with celecoxib.

Use with oral anticoagulants

The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding and should be given with caution. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g., apixaban, dabigatran, and rivaroxaban). In patients on concurrent therapy with warfarin or similar agents, serious bleeding events, some of them fatal, have been reported. Because increases in prothrombin time (INR) have been reported, anticoagulation/INR should be monitored in patients taking a warfarin/coumarin-type anticoagulant after initiating treatment with celecoxib or changing the dose (see section Interactions).

Systemic onset JIA

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

General

By reducing inflammation, celecoxib may diminish the utility of diagnostic signs, such as fever, in detecting infections.

The concomitant use of celecoxib and a non-aspirin NSAID should be avoided

CYP2D6 inhibition

Celecoxib has shown to be a moderately potent CYP2D6 inhibitor. For drugs that are metabolized by CYP2D6, a dose reduction during initiation of celecoxib treatment or a dose increase upon termination of celecoxib treatment may be necessary (see section Interactions).

INTERACTIONS

Interactions

General

Celecoxib metabolism is predominantly mediated via cytochrome P450 (CYP) 2C9 in the liver. Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution as they may have abnormally high plasma levels due to reduced metabolic clearance. Consider starting treatment at half the lowest recommended dose (see sections Posology and method of administration and Metabolism).

Concomitant administration of celecoxib with inhibitors of CYP2C9 can lead to increases in plasma concentrations of celecoxib. Therefore, a dose reduction of celecoxib may be necessary when celecoxib is co-administered with CYP2C9 inhibitors.

Concomitant administration of celecoxib with inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates can lead to decreases in plasma concentrations of celecoxib. Therefore, a dose increase of celecoxib may be necessary when celecoxib is co-administered with CYP2C9 inducers.

Clinical pharmacokinetics study and in vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of CYP2D6. Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by CYP2D6.

Drug-specific

Interaction of celecoxib with warfarin or similar agents: (See section Use with oral anticoagulants).

Lithium: In healthy subjects, lithium plasma levels increased approximately 17% in subjects receiving lithium together with celecoxib. Patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.

Aspirin: Celecoxib does not interfere with the anti-platelet effect of low-dose aspirin (See section GI effects). Because of its lack of platelet effects, celecoxib is not a substitute for aspirin in the prophylactic treatment of CV disease.

Anti-hypertensives including Angiotensin-converting enzyme inhibitors (ACEIs), Angiotensin II Antagonists (also known as angiotensin receptor blockers, ARBs), diuretics and beta-blockers: Inhibition of prostaglandins may diminish the effect of anti-hypertensives including ACEIs and/or ARBs, diuretics and beta-blockers. This interaction should be given consideration in patients taking celecoxib concomitantly with ACEIs and/or ARBs, diuretics and beta-blockers.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs including selective COX-2 inhibitors with ACE inhibitors, angiotensin II antagonists or diuretics, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Therefore, the concomitant administration of these drugs should be done with caution. Patients should be adequately hydrate

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