Usage
Diclofenac + Tramadol is prescribed for the symptomatic treatment of moderate to severe acute pain, such as postoperative pain, trauma pain, low back pain, and musculoskeletal pain. It is also used to manage acute flares of osteoarthritis and rheumatoid arthritis. This fixed-dose combination (FDC) is classified as an analgesic, combining a nonsteroidal anti-inflammatory drug (NSAID) with an opioid analgesic. It provides multimodal analgesia by targeting different pain pathways. Diclofenac reduces inflammation by inhibiting cyclooxygenase (COX) enzymes, which are involved in prostaglandin synthesis. Tramadol acts on mu-opioid receptors in the brain and spinal cord, modulating pain perception.
Alternate Names
This FDC is often referred to as Tramadol/Diclofenac. Brand names in India include DURAPAIN®, RESYNC®, DIBOL®, and DIBOLS®. International brand names may vary.
How It Works
Pharmacodynamics:
Diclofenac, an NSAID, inhibits COX-1 and COX-2 enzymes, thereby reducing prostaglandin production. This leads to a decrease in inflammation, pain, and fever. Tramadol, an opioid analgesic, binds to mu-opioid receptors in the central nervous system, inhibiting pain signal transmission. It also inhibits the reuptake of norepinephrine and serotonin, further contributing to analgesia.
Pharmacokinetics:
- Absorption: Both drugs are well-absorbed orally. Diclofenac’s sustained-release formulation provides prolonged action.
- Metabolism: Diclofenac is primarily metabolized in the liver by CYP2C9. Tramadol is metabolized in the liver primarily by CYP2D6 to its active metabolite, O-desmethyltramadol (M1).
- Elimination: Diclofenac is eliminated through renal and hepatic routes. Tramadol and its metabolites are primarily excreted in the urine.
Dosage
Standard Dosage
Adults:
The recommended dose is one tablet of Diclofenac 75 mg/Tramadol 50 mg twice daily, after meals, for a maximum of 5 days.
Children:
The safety and efficacy of this FDC have not been established in children under 12 years of age. For adolescents 12 years and older, dosage should be determined by a physician.
Special Cases:
- Elderly Patients: Patients over 75 years may require dosage adjustment or increased dosing intervals due to potential for reduced drug clearance.
- Patients with Renal Impairment: Dosage adjustments are necessary for patients with severe renal impairment.
- Patients with Hepatic Dysfunction: Dose modification should be considered in patients with hepatic impairment.
- Patients with Comorbid Conditions: Caution is advised in patients with cardiovascular disease, gastrointestinal disorders, or a history of seizures.
Clinical Use Cases
Dosage recommendations for specific clinical use cases like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be determined on a case-by-case basis by a qualified physician, considering the patient’s individual needs and condition. Data specific to this FDC in these settings is limited.
Side Effects
Common Side Effects:
Nausea, vomiting, dizziness, drowsiness, constipation, indigestion, dry mouth, stomach pain, loss of appetite.
Rare but Serious Side Effects:
Allergic reactions, seizures, respiratory depression, gastrointestinal bleeding, serotonin syndrome.
Long-Term Effects:
Potential for dependence with prolonged tramadol use.
Contraindications
Hypersensitivity to diclofenac or tramadol, active gastrointestinal bleeding, peptic ulcer disease, severe hepatic or renal impairment, acute intoxication with alcohol or opioids, uncontrolled epilepsy, pregnancy (especially near term), breastfeeding.
Drug Interactions
Other NSAIDs, anticoagulants (e.g., warfarin), antidepressants (e.g., SSRIs, SNRIs), MAO inhibitors, opioids, alcohol, CYP2D6 inhibitors and inducers.
Pregnancy and Breastfeeding
This combination is contraindicated during pregnancy, particularly in the third trimester, due to the risk of premature closure of the ductus arteriosus and potential neonatal withdrawal symptoms. Tramadol and its metabolites are excreted in breast milk. Use during breastfeeding is not recommended due to potential risks to the infant, including drowsiness and respiratory depression.
Drug Profile Summary
- Mechanism of Action: Diclofenac inhibits COX enzymes, reducing inflammation. Tramadol acts on mu-opioid receptors and inhibits reuptake of norepinephrine and serotonin.
- Side Effects: Nausea, vomiting, dizziness, drowsiness, constipation, serious effects include seizures and respiratory depression.
- Contraindications: Hypersensitivity, GI bleeding, peptic ulcer, hepatic/renal impairment, pregnancy, breastfeeding.
- Drug Interactions: NSAIDs, anticoagulants, antidepressants, opioids, alcohol.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: One tablet (Diclofenac 75mg/Tramadol 50mg) twice daily after meals for up to 5 days.
- Monitoring Parameters: Pain level, respiratory rate, liver and kidney function, signs of GI bleeding or serotonin syndrome.
Popular Combinations
Not applicable for a fixed-dose combination product.
Precautions
Pre-existing gastrointestinal, cardiovascular, or seizure disorders, hepatic/renal impairment. Avoid alcohol. Use caution when driving or operating machinery.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Diclofenac + Tramadol?
A: One tablet of Diclofenac 75 mg/Tramadol 50 mg twice daily after meals, for a maximum of 5 days.
Q2: Can this FDC be used in children?
A: No, safety and efficacy have not been established in children under 12. Adolescent use should be carefully determined by a physician.
Q3: What are the serious side effects to watch out for?
A: Seizures, respiratory depression, allergic reactions, serotonin syndrome, and gastrointestinal bleeding.
Q4: Can a patient take this medication with other pain relievers?
A: Avoid concomitant use with other NSAIDs or opioids. Consult a physician regarding other pain medications.
A: Yes, this FDC is contraindicated during pregnancy, especially near term, and during breastfeeding.
Q6: Can patients with kidney or liver problems take Diclofenac + Tramadol?
A: Patients with severe renal or hepatic impairment should not take this medication. Dose adjustments may be needed in milder cases.
Q7: What precautions should be taken by patients with a history of seizures?
A: This medication can lower the seizure threshold. Use with extreme caution and under close medical supervision.
Q8: What should a patient do if they miss a dose?
A: Take the missed dose as soon as remembered, unless it is close to the next scheduled dose. Do not double the dose.
Q9: Can this FDC be used long-term for chronic pain?
A: No, it is indicated for short-term management of acute pain (maximum 5 days). Long-term use is not advised due to the potential for dependence and other adverse effects.
