Myrox-SR
Generic Name
Aceclofenac (Sustained Release)
Manufacturer
ACI Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| myrox sr 75 mg capsule | ৳ 5.04 | ৳ 50.40 |
Description
Overview of the medicine
Myrox-SR 75 mg capsule contains Aceclofenac, a non-steroidal anti-inflammatory drug (NSAID) used for the relief of pain and inflammation. The sustained-release formulation ensures prolonged action, making it suitable for chronic conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
Uses & Indications
Dosage
Adults
The usual recommended dose is 75 mg once or twice daily, or 150 mg once daily, as directed by a physician. Maximum recommended daily dose is 150 mg.
Elderly
No dosage adjustment is usually required, but caution is advised due to increased risk of adverse effects. Consider the lowest effective dose.
Renal_impairment
No specific dose reduction for mild renal impairment, but caution is advised. Avoid in severe renal impairment (creatinine clearance < 30 mL/min).
How to Take
Myrox-SR 75 mg capsules should be swallowed whole with water, preferably with or after food, to minimize gastrointestinal discomfort. Do not chew, crush, or break the capsule.
Mechanism of Action
Aceclofenac exerts its anti-inflammatory and analgesic effects by inhibiting cyclooxygenase (COX) enzymes, particularly COX-2, which are responsible for the synthesis of prostaglandins. Prostaglandins are key mediators of inflammation, pain, and fever.
Pharmacokinetics
Onset
Symptomatic relief usually begins within 1-2 hours for immediate release; sustained release formulations have a more gradual onset and prolonged effect.
Excretion
Approximately two-thirds of the dose is excreted in the urine, and one-third in the faeces, mainly as hydroxylated metabolites.
Half life
The plasma elimination half-life is approximately 4-4.3 hours. However, the sustained-release formulation allows for once-daily dosing due to extended release.
Absorption
Rapidly and almost completely absorbed from the gastrointestinal tract after oral administration. Sustained-release formulation provides prolonged absorption. Peak plasma concentrations are typically reached within 1.25 to 3 hours for immediate release, with a more gradual profile for SR.
Metabolism
Extensively metabolized in the liver, primarily by cytochrome P450 enzymes (CYP2C9), to form 4'-hydroxyaceclofenac as the main metabolite, along with other inactive or less active metabolites.
Side Effects
Contraindications
- Hypersensitivity to aceclofenac, aspirin, or other NSAIDs
- History of active gastrointestinal ulceration, bleeding, or perforation
- Severe heart failure, renal impairment, or hepatic impairment
- Third trimester of pregnancy
- Patients in whom aspirin or other NSAIDs precipitate attacks of asthma, urticaria, or acute rhinitis
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Lithium
Decreased renal excretion of lithium, leading to increased plasma lithium levels and potential toxicity.
Methotrexate
Reduced tubular secretion of methotrexate, resulting in increased plasma concentrations and toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Diuretics and ACE inhibitors
Reduced natriuretic and antihypertensive effects, increased risk of renal impairment, especially in dehydrated patients.
Warfarin and other anticoagulants
Increased risk of bleeding due to synergistic antiplatelet effect and GI irritation.
Storage
Store in a cool, dry place below 30°C, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of aceclofenac overdose may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, and occasionally convulsions. Management involves symptomatic and supportive measures. Gastric lavage and activated charcoal may be considered within one hour of ingestion.
Pregnancy & Lactation
Myrox-SR is contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use in the first and second trimesters should only be considered if the potential benefit justifies the potential risk to the fetus. It is generally not recommended during breastfeeding as aceclofenac may be excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to aceclofenac, aspirin, or other NSAIDs
- History of active gastrointestinal ulceration, bleeding, or perforation
- Severe heart failure, renal impairment, or hepatic impairment
- Third trimester of pregnancy
- Patients in whom aspirin or other NSAIDs precipitate attacks of asthma, urticaria, or acute rhinitis
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Lithium
Decreased renal excretion of lithium, leading to increased plasma lithium levels and potential toxicity.
Methotrexate
Reduced tubular secretion of methotrexate, resulting in increased plasma concentrations and toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Diuretics and ACE inhibitors
Reduced natriuretic and antihypertensive effects, increased risk of renal impairment, especially in dehydrated patients.
Warfarin and other anticoagulants
Increased risk of bleeding due to synergistic antiplatelet effect and GI irritation.
Storage
Store in a cool, dry place below 30°C, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of aceclofenac overdose may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, and occasionally convulsions. Management involves symptomatic and supportive measures. Gastric lavage and activated charcoal may be considered within one hour of ingestion.
Pregnancy & Lactation
Myrox-SR is contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use in the first and second trimesters should only be considered if the potential benefit justifies the potential risk to the fetus. It is generally not recommended during breastfeeding as aceclofenac may be excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Generally 24 to 36 months from the manufacturing date, depending on the specific product and manufacturer.
Availability
Pharmacies, hospitals
Approval Status
Approved by national regulatory bodies (e.g., DGDA in Bangladesh)
Patent Status
Generic available
Clinical Trials
Aceclofenac has been extensively studied in numerous clinical trials demonstrating its efficacy and safety in various painful and inflammatory conditions, including osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. These trials support its use in sustained-release formulations for prolonged effect.
Lab Monitoring
- Liver function tests (ALT, AST, ALP) periodically, especially with long-term use.
- Kidney function tests (serum creatinine, BUN) and electrolyte levels.
- Complete blood count (CBC) to monitor for anemia or other hematologic effects.
- Blood pressure monitoring, especially in hypertensive patients.
Doctor Notes
- Educate patients on the potential cardiovascular and gastrointestinal risks associated with NSAID therapy, especially for long-term use.
- Consider co-prescription of a proton pump inhibitor (PPI) in patients at high risk of GI complications.
- Regularly monitor renal function, liver enzymes, and blood pressure, particularly in elderly or high-risk patients.
- Caution advised in patients with pre-existing cardiovascular conditions, hypertension, or fluid retention.
Patient Guidelines
- Take Myrox-SR 75 mg capsule exactly as prescribed by your doctor; do not alter the dose or stop without consultation.
- Swallow the capsule whole; do not chew, crush, or break it.
- Take with food or after meals to minimize stomach upset.
- Report any signs of gastrointestinal bleeding (e.g., black, tarry stools, vomiting blood) or severe skin reactions immediately.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. 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
Myrox-SR may cause dizziness or drowsiness in some individuals. Patients should exercise caution when driving or operating machinery until they are certain how the medication affects them.
Lifestyle Advice
- Maintain a healthy and balanced diet.
- Limit or avoid alcohol consumption to reduce the risk of stomach irritation and bleeding.
- Avoid smoking, as it can worsen cardiovascular risks associated with NSAID use.
- Engage in appropriate physical activity as tolerated to manage joint pain and stiffness.
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