Celosti 100

Print
Non steroidal anti-inflammatory, analgesics.
Barcode: 8935206009439
Description

CELOSTI 100

COMPOSITION: Celecoxib..................................................... 100 mg

                               Excipients.q.s........................................... 1 capsule

(Lactose, PVP K30, sodium starch glycolate, talc, magnesium stearate).

DOSAGE FORM: Hard capsule.

PRESENTATION: Box of 2 blisters x 10 capsules.

PHARMACODYNAMICS: Celosti contains celecoxib, a non-steroidal anti-inflammatory drug (NSAID), is a selective inhibitor of the cyclooxygenase-2 (COX-2). It exhibits anti-inflammatory, analgesic, and antipyretic activity. Celecoxib inhibits appears to inhibit prostaglandin synthesis, principally through inhibition of the COX-2, that catalyze the formation of prostaglandins. Since celecoxib does not inhibit the COX-1, it rarely causes a risk of adverse effects to gastric mucosa and platelet.

PHARMACOKINETICS: Celecoxib is rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations of celecoxib occur approximately 3 hours after a single oral dose of 200 mg under fasting conditions. The plasma concentrations of celecoxib under stable conditions obtain within 5 days without accumulation. At therapeutic plasma concentrations, celecoxib is about 97% bound to plasma proteins. The plasma half-life of celecoxib is approximately 11 hours. The half-life may be prolonged in patients with renal or hepatic impairment. Approximately 27% and 57% of the dose was excreted in urine and feces, respectively; less than 3% of the dose is excreted unchanged.

INDICATIONS:

Celosti is indicated in adults for symptomatic treatment of osteoarthritis, rheumatoid arthritis; for supportive treatment to reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis; for management of acute pains including post-operation pains, tooth extraction; for treatment of primary dysmenorrhoea. 

CONTRAINDICATIONS: Celosti is contraindicated in patients with known hypersensitivity to celecoxib, sulfonamides; in patients with severe liver and heart failure, serious renal impairment (creatinine clearance of less than 30 ml per min); enteritis (Crohn’s disease, ulcerative colitis); history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

WARNINGS AND PRECAUTIONS:

Patients with a prior history of gastro-duodenal ulcer or gastrointestinal bleeding; history of asthma, allergy to aspirin or other NSAIDs due to risk of anaphylactic shock. Patients with older age and asthenia because of risk of gastrointestinal bleeding and impaired renal function by age. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction. Patients with oedema, fluid retention (heart and kidney failure); and those with extra-cellular dehydration (due to taking potent diuretics).

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 NSAID-treated patients, use the lowest effective dose for the shortest duration possible.

PREGNANCY AND LACTATION: Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The drug should not be used the third trimester of pregnancy, since inhibitors of prostaglandin synthesis may have adverse effects on the fetal cardiovascular system.

Celecoxib may cause serious adverse effects to breast-fed infants. Discontinuation of breast-feeding should be considered during taking celecoxib.

EEFECTS ON ABILITY TO DRIVE AND USE MACHINES:

The drug should be used with caution in drivers and machinery users.

INTERACTIONS: Anti-hypertensive effect may occur when celecoxib is administered concomitantly with an angiotensin-converting enzyme inhibitor. Celecoxib may interfere with the natriuretic response to furosemide and thiazides. Concomitant use of celecoxib with aspirin can increase the incidence of gastrointestinal ulceration. Concomitant administration of celecoxib with fluconazole resulted in  substantially increased plasma concentrations of celecoxib. Celecoxib may decrease renal clearance of lithium, which may lead to increased plasma lithium concentrations. Bleeding complications associated with increases in prothrombin time were reported some (mainly geriatric) patients receiving celecoxib concomitantly with warfarin.

ADVERSE EFFECTS: Frequently: Gastrointestinal effects: abdominal pain, diarrhoea, dyspepsia, flatulence, nausea. Respiratory effects: pharyngitis, rhinitis, sinusitis, upper respiratory infections. Nervous system effects: insomnia, dizziness, headache. Dermatologic reactions: rash. Others: back pain, peripheral oedema.

Rarely: Cardiovascular effects: syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, thrombophlebitis, vasculitis. Gastrointestinal effects: ileus, intestinal perforation, gastrointestinal haemorrhage, bleeding colitis, esophageal perforation, pancreatitis. Hepatic and biliary effects: cholelithiasis, jaundice, hepatitis and liver failure. Hematologic effects: thrombocytopenia, agranulocytosis, aplastic anemia, pancytopenia, leucopenia. Metabolic effects: hypoglycemia. Nervous system effects: ataxia, suicide.  Renal effects: acute renal failure, interstitial nephritis. Dermatologic reactions: erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome. Others: sepsis, anaphylactoid reaction, angioedema.

Cardiovascular thrombotic events (see Warnings and Precautions).

Inform your physician about any adverse effects occur during treatment.

TREATMENT OF ADRs: If manifestations of renal toxicity occur during the treatment, the drug should be discontinued. Renal function usually returns to the level as pre-treated after discontinuation of the drug. An increase in liver test may have been reported (approximately 3 times the upper limit of normal). This increase can progress or do not change, or is only temporary in a period of time when continuing the therapy. If severe symptoms of hepatitis (jaundice, manifestations of liver failure) occur, the drug should be discontinued.

Generally, celecoxib is well tolerated with normal dosage and short-term therapy.

OVERDOSAGE:

Manifestations: Overdosage of NSAIDs can cause lethargy, drowsiness, nausea, vomiting, and epigasric pain; these manifestations generally are reversible with supportive care. Gastrointestinal bleeding also has been reported. Rarely, hypertension, acute renal failure, respiratory depression and coma may occur. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following an overdose.

Treatment: Treatment of NSAIDs overdosage involves symptomatic and supportive care; there are no specific antidote for NSAID overdosage. During the first 4 hours after overdosage, emesis and/or administration of activated charcoal and/or an osmotic cathartic may be useful in symptomatic patients or in those who reportedly ingested a large overdosage.

DOSAGE & ADMINISTRATION:

Osteoarthritis: 1 capsule twice daily or 2 capsules once daily.

Rheumatoid arthritis in adults: 100 - 200 mg twice daily.

Colorectal polyps: 4 capsules twice daily.

For the relief of acute pain and dysmenorrhea, the usually initial adult dosage of celecoxib is 4 capsules given as a single dose, followed by an additional dose of 2 capsules dose, if necessary, on the first day. For continued relief, 2 capsules may be administered twice daily as needed.

Dosage adjustment in geriatric individuals older than 65 years of age is not required. However, for geriatric patients weighing less than 50 kg, celecoxib therapy should be initiated at the lowest recommended dosage.

Celecoxib should not be used in patients with severe renal and hepatic impairment. In patients with moderate hepatic impairment, celecoxib dosage should be reduced approximately by 50%.

Or as directed by the physician.

Read the directions carefully before use.                                 

This drug is for prescriptions only.

Consult the physician for more information.                            

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

Reviews

There are yet no reviews for this product.