Novetor
Generic Name
Etoricoxib
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
novetor 400 mg tablet | ৳ 9.00 | ৳ 90.00 |
Description
Overview of the medicine
Novetor 400 mg Tablet contains Etoricoxib, a selective COX-2 inhibitor used to relieve pain and inflammation. While Etoricoxib is commonly used for various painful conditions, the 400 mg strength is unusually high and not a standard therapeutic dose for human use in most regions.
Uses & Indications
Dosage
Adults
The 400 mg strength of Etoricoxib is not a standard therapeutic dose for human use. Standard recommended dosages vary by condition: for Osteoarthritis: 60 mg once daily; for Rheumatoid Arthritis/Ankylosing Spondylitis: 90 mg once daily; for Acute Gouty Arthritis/Acute Pain: 120 mg once daily for up to 8 days.
Elderly
No specific dosage adjustment is generally required, but caution should be exercised and the lowest effective dose used due to increased susceptibility to adverse effects.
Renal_impairment
For mild renal impairment (CrCl 30-80 mL/min), no dosage adjustment. For moderate impairment (CrCl <30 mL/min), use with caution, reduced dosage may be considered. Not recommended in severe renal disease.
How to Take
Novetor 400 mg tablet should be taken orally, with or without food. To minimize potential gastrointestinal upset, it may be taken with food. Swallow the tablet whole with a glass of water.
Mechanism of Action
Etoricoxib selectively inhibits Cyclooxygenase-2 (COX-2), an enzyme responsible for the synthesis of prostaglandins, which are mediators of pain, inflammation, and fever. By inhibiting COX-2, Etoricoxib reduces prostaglandin production, thereby alleviating symptoms.
Pharmacokinetics
Onset
Analgesic effect typically begins within 24 minutes to 1 hour.
Excretion
Approximately 70% is excreted in the urine and 20% in the feces as metabolites, with less than 1% as unchanged drug.
Half life
Approximately 22 hours, allowing for once-daily dosing.
Absorption
Rapidly and well absorbed after oral administration, with an average oral bioavailability of approximately 100%. Peak plasma concentration is reached in about 1 hour.
Metabolism
Extensively metabolized in the liver, primarily by cytochrome P450 (CYP) enzymes, mainly CYP3A4, to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Etoricoxib or any component of the tablet
- Active peptic ulceration or gastrointestinal bleeding
- Severe hepatic dysfunction (Child-Pugh score ≥10)
- Severe renal dysfunction (creatinine clearance <30 mL/min)
- Congestive heart failure (NYHA Class II-IV)
- Uncontrolled hypertension
- Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
Drug Interactions
Lithium
May increase plasma lithium levels, leading to toxicity. Monitor lithium levels.
Warfarin
May increase INR and bleeding risk. Monitor INR closely.
Diuretics
May reduce the natriuretic effect of loop and thiazide diuretics.
Methotrexate
May increase methotrexate plasma concentrations, enhancing toxicity. Use with caution.
Ciclosporin / Tacrolimus
May increase the nephrotoxicity of these drugs.
ACE Inhibitors / Angiotensin II Receptor Blockers (ARBs)
May reduce the antihypertensive effect and increase the risk of renal impairment.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In case of overdose (e.g., significantly exceeding the standard 120 mg daily maximum, particularly with a 400 mg tablet), symptoms may include gastrointestinal disturbances, renal toxicity, and cardiovascular events. Management is symptomatic and supportive; there is no specific antidote. Gastric decontamination (e.g., activated charcoal) may be considered if ingestion is recent.
Pregnancy & Lactation
Not recommended during pregnancy, especially in the third trimester due to potential adverse effects on the fetus (e.g., premature closure of ductus arteriosus). Etoricoxib is excreted in human milk, so it should not be used during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to Etoricoxib or any component of the tablet
- Active peptic ulceration or gastrointestinal bleeding
- Severe hepatic dysfunction (Child-Pugh score ≥10)
- Severe renal dysfunction (creatinine clearance <30 mL/min)
- Congestive heart failure (NYHA Class II-IV)
- Uncontrolled hypertension
- Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
Drug Interactions
Lithium
May increase plasma lithium levels, leading to toxicity. Monitor lithium levels.
Warfarin
May increase INR and bleeding risk. Monitor INR closely.
Diuretics
May reduce the natriuretic effect of loop and thiazide diuretics.
Methotrexate
May increase methotrexate plasma concentrations, enhancing toxicity. Use with caution.
Ciclosporin / Tacrolimus
May increase the nephrotoxicity of these drugs.
ACE Inhibitors / Angiotensin II Receptor Blockers (ARBs)
May reduce the antihypertensive effect and increase the risk of renal impairment.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In case of overdose (e.g., significantly exceeding the standard 120 mg daily maximum, particularly with a 400 mg tablet), symptoms may include gastrointestinal disturbances, renal toxicity, and cardiovascular events. Management is symptomatic and supportive; there is no specific antidote. Gastric decontamination (e.g., activated charcoal) may be considered if ingestion is recent.
Pregnancy & Lactation
Not recommended during pregnancy, especially in the third trimester due to potential adverse effects on the fetus (e.g., premature closure of ductus arteriosus). Etoricoxib is excreted in human milk, so it should not be used during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Generally 2 to 3 years from the date of manufacture, specific to lot.
Availability
Pharmacies nationwide
Approval Status
Approved for human use
Patent Status
Generics available
Clinical Trials
Etoricoxib has undergone extensive clinical trials demonstrating its efficacy and safety for approved indications. Post-marketing surveillance continues to monitor for rare or long-term adverse effects.
Lab Monitoring
- Blood pressure monitoring (especially at initiation and during long-term use)
- Renal function tests (e.g., serum creatinine, BUN, eGFR)
- Liver function tests (e.g., ALT, AST)
- Complete blood count (CBC) for signs of GI bleeding with long-term use
Doctor Notes
- Etoricoxib 400 mg is an atypical strength for human therapeutic use; confirm the indication and patient's medical history for such a dose.
- Monitor cardiovascular risk factors and gastrointestinal safety profile, especially in elderly patients or those with a history of GI events.
- Prescribe the lowest effective dose for the shortest possible duration.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor. Do not exceed the prescribed dose or duration of treatment.
- Inform your doctor if you have a history of heart disease, high blood pressure, stomach ulcers, kidney or liver problems.
- Report any unusual bleeding, persistent stomach pain, dark stools, or signs of allergic reaction immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Etoricoxib may cause dizziness in some patients. If you experience dizziness or lightheadedness, avoid driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Avoid excessive alcohol consumption, as it may increase the risk of gastrointestinal side effects.
- Maintain a healthy lifestyle, including regular exercise and a balanced diet, to support overall health.
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