Deroximel-DR
Generic Name
Dexketoprofen (Delayed-Release)
Manufacturer
PharmaOne Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Deroximel-DR is a non-steroidal anti-inflammatory drug (NSAID) containing dexketoprofen in a delayed-release formulation. It is used for the symptomatic treatment of acute musculoskeletal pain, dysmenorrhea, and dental pain.
Uses & Indications
Dosage
Adults
Typically 25 mg once daily, or as directed by physician. Maximum daily dose is 25 mg.
Elderly
Lower doses may be required, monitor renal function. Generally, the lowest effective dose for the shortest duration.
Renal_impairment
In mild renal impairment, initial dose should be reduced. Contraindicated in moderate to severe renal impairment.
How to Take
Take orally, preferably with food to minimize gastrointestinal upset. Do not crush, chew, or break the delayed-release tablet.
Mechanism of Action
Dexketoprofen inhibits the activity of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, which are involved in the synthesis of prostaglandins. Prostaglandins are mediators of pain, inflammation, and fever.
Pharmacokinetics
Onset
Analgesic effect typically begins within 30-60 minutes, with delayed-release potentially extending onset but prolonging duration.
Excretion
Mainly excreted in the urine as glucuronide conjugates.
Half life
Plasma elimination half-life is approximately 1.5-2.5 hours for the active enantiomer.
Absorption
Rapid absorption after oral administration; delayed-release formulation extends the time to peak plasma concentration.
Metabolism
Primarily metabolized by glucuronidation to inactive conjugates.
Side Effects
Contraindications
- Hypersensitivity to dexketoprofen or other NSAIDs
- Active peptic ulcer or gastrointestinal bleeding
- History of gastrointestinal bleeding or perforation related to previous NSAID therapy
- Crohn's disease or ulcerative colitis
- Severe heart failure
- Moderate to severe renal impairment
- Severe hepatic impairment
- Third trimester of pregnancy
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Lithium
Increased plasma lithium levels, potentially leading to toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Methotrexate (high dose)
Increased plasma methotrexate levels, potentially leading to toxicity.
Warfarin and other anticoagulants
Increased risk of bleeding.
ACE inhibitors, Angiotensin II receptor antagonists, Diuretics
Reduced antihypertensive effect and increased risk of renal impairment.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, abdominal pain, headache, and dizziness. In severe cases, gastrointestinal bleeding, acute renal failure, and CNS depression may occur. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered if ingested recently.
Pregnancy & Lactation
Use of NSAIDs, including Deroximel-DR, should be avoided during the third trimester of pregnancy due to potential fetal harm and complications during delivery. During the first and second trimesters, use only if clearly necessary and with the lowest effective dose for the shortest duration. Small amounts of dexketoprofen may pass into breast milk; therefore, it is generally not recommended during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to dexketoprofen or other NSAIDs
- Active peptic ulcer or gastrointestinal bleeding
- History of gastrointestinal bleeding or perforation related to previous NSAID therapy
- Crohn's disease or ulcerative colitis
- Severe heart failure
- Moderate to severe renal impairment
- Severe hepatic impairment
- Third trimester of pregnancy
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Lithium
Increased plasma lithium levels, potentially leading to toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Methotrexate (high dose)
Increased plasma methotrexate levels, potentially leading to toxicity.
Warfarin and other anticoagulants
Increased risk of bleeding.
ACE inhibitors, Angiotensin II receptor antagonists, Diuretics
Reduced antihypertensive effect and increased risk of renal impairment.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, abdominal pain, headache, and dizziness. In severe cases, gastrointestinal bleeding, acute renal failure, and CNS depression may occur. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered if ingested recently.
Pregnancy & Lactation
Use of NSAIDs, including Deroximel-DR, should be avoided during the third trimester of pregnancy due to potential fetal harm and complications during delivery. During the first and second trimesters, use only if clearly necessary and with the lowest effective dose for the shortest duration. Small amounts of dexketoprofen may pass into breast milk; therefore, it is generally not recommended during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities
Patent Status
Generic available
Clinical Trials
Clinical trials have demonstrated the efficacy and safety of dexketoprofen in various acute pain conditions. Delayed-release formulations aim to improve tolerability and extend the duration of action compared to immediate-release formulations.
Lab Monitoring
- Monitor renal function (creatinine, BUN) periodically, especially in elderly or patients with renal impairment.
- Monitor liver function tests (ALT, AST) periodically with long-term use.
- Monitor complete blood count (CBC) with long-term therapy.
Doctor Notes
- Prescribe the lowest effective dose for the shortest possible duration.
- Monitor for signs of GI bleeding or cardiovascular adverse events.
- Caution in patients with a history of GI disease, hypertension, or heart failure.
- Consider renal function monitoring, especially in elderly patients.
Patient Guidelines
- Take Deroximel-DR exactly as prescribed by your doctor.
- Do not crush, chew, or break the tablet; swallow it whole.
- Take with food to reduce stomach upset.
- Report any signs of gastrointestinal bleeding (e.g., black, tarry stools) or allergic reactions immediately.
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
May cause dizziness or drowsiness. Patients should be cautioned about operating machinery or driving until they know how the medication affects them.
Lifestyle Advice
- Avoid alcohol consumption while taking this medicine.
- Stay well-hydrated.
- Discuss any other medicines or supplements you are taking with your doctor.
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