STARCOX Etoricoxib 60mg Film-Coated Tablet 1's
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Features
- Etoricoxib
Description
Indications/Uses
Dosage/Direction for Use
The usual dose for acute pain is 120 mg daily or as prescribed by the physician.
Overdosage
In the event of overdosage, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
Etoricoxib is not dialyzable by hemodialysis; it is not known whether etoricoxib is dialyzable by peritoneal dialysis.
Administration
Contraindications
Active peptic ulceration or active gastrointestinal (GI) bleeding.
Patients who have experienced bronchospasms, acute rhinitis, nasal polyps, angioneurotic edema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score 10 ≥ 10).
Estimated renal clearance creatinine <30 mL/min.
Children and adolescents under 16 years of age.
Inflammatory bowel disease.
Congestive Heart Failure (NYHA II-IV).
Patients with hypertension whole blood pressure has not been adequately controlled.
Established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Warnings
Special Precautions
Etoricoxib should not be taken with any other non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac or pain-relieving doses of aspirin, as this may increase the risk of side effects on the stomach and intestines.
COX-2 inhibitors are not to be given to patients with allergy to NSAIDs and those with asthma.
Exercise caution when prescribing Selective COX-2 inhibitors in patients with ischemic heart disease and those with risk factors for heart disease; hypertension; hyperlipidemia, diabetes, smoking and patients with peripheral arterial disease.
Considering association between cardiovascular risk and exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest duration of treatment.
Intake of COX-2 inhibitors should be stopped with appearance of skin rash and signs of hypersensitivity.
If not yet instituted, warning statement should include potential gastrointestinal (gastric and liver) and renal toxicities.
Use In Pregnancy & Lactation
No clinical data on exposed pregnancies are available for etoricoxib. Studies in animals have shown reproductive toxicity. The potential for human risk in pregnancy is unknown. Etoricoxib, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester. Etoricoxib is contraindicated in pregnancy. If woman becomes pregnant during treatment, etoricoxib must be discontinued.
Reproductive studies conducted in rats have demonstrated evidence of developmental abnormalities at doses up to 15 mg/kg/day (approximately 1.5 times the human dose [90 mg] based on systemic exposure).
At doses approximately 2 times the adult human exposure (90 mg) bases on systemic exposure, a low incidence of cardiovascular malformations and increase in post implantation loss were observed in etoricoxib-treated rabbits. No developmental effects were seen at systemic exposure of approximately equal to or less than daily human dosage (90 mg). However, animal reproduction studies are not always predictive of human response.
There are no adequate and well-controlled studies in pregnant women.
It is not known whether etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats.
Women who use etoricoxib should not breast feed.
Adverse Reactions
Storage
Action
COX-2 inhibitors are a class of drugs which selectively inhibit COX-2, an enzyme involved in the inflammation pathway, while sparing COX-1, thereby reducing gastrointestinal toxicity.
Etoricoxib is a selective COX-2 inhibitor. It selectively inhibits isoform 2 of cyclooxygenase enzyme (COX-2). This reduces the generation of prostaglandins (PGs) from arachidonic acid. Among the different functions exerted by PGs, their role in the inflammation cascade should be highlighted. COX-2 selective inhibitor (aka "COXIB") showed less marked activity on type 1 cyclooxygenase compared to traditional non-steroidal anti-inflammatory drugs (NSAID).
Pharmacokinetics: Absorption: Orally administered etoricoxib is well absorbed. The mean oral bioavailability is approximately 100%. Following 120 mg-once-daily dosing to steady state, the peak plasma concentration (geometric mean Cmax = 3.6 mcg/mL) was observed at approximately 1 hour (Tmax) after administration to fasted adults. The geometric mean AUC0-24 hrs was 37.8 mcg hr/mL. The pharmacokinetics of etoricoxib in 12 healthy subjects were similar (comparable AUC, Cmax within approximately 20%) when administered alone, with a magnesium/aluminum hydroxide antacid, or a calcium carbonate antacid (approximately 50 mEq acid-neutralizing capacity).
Distribution: Etoricoxib is approximately 92% bound to human plasma protein over the range of concentrations of 0.05 to 5 mcg/mL. The volume of distribution at steady state (Vdss) is approximately 120 L in humans.
Metabolism: Etoricoxib is extensively metabolized with <1% of a dose recovered in urine as the parent drug. The major route of metabolism to form the 6-hydroxymethyl derivative. These principal metabolites either demonstrate no measurable activity or are only weakly active as COX-2 inhibitors. None of these metabolites inhibit COX-1.
Elimination: Following administration of a single 25 mg radiolabeled intravenous dose of etoricoxib to healthy subjects, 70% of radioactivity was recovered in urine and 20% in feces, mostly as metabolites. Less than 2% was recovered as unchanged drug.
Elimination of etoricoxib occurs almost exclusively through metabolism followed by renal excretion. Steady state concentrations of etoricoxib are reached within seven days of once-daily administration of 120 mg, with an accumulation half-life of approximately 2, corresponding to an accumulation half-life of approximately 22 hours. The plasma clearance is estimated to be approximately 50 mL/min.