Dalatic Plus
Generic Name
Diclofenac Potassium + Paracetamol
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
dalatic plus 12 0025 topical gel | ৳ 150.45 | N/A |
Description
Overview of the medicine
Dalatic Plus is a combination medicine containing Diclofenac Potassium, a non-steroidal anti-inflammatory drug (NSAID), and Paracetamol, an analgesic and antipyretic. It is used for the relief of various types of pain, inflammation, and fever.
Uses & Indications
Dosage
Adults
One tablet (Diclofenac Potassium 50 mg + Paracetamol 500 mg) two to three times daily, preferably after food, or as directed by a physician.
Elderly
Generally, the lowest effective dose should be used, and caution is advised due to increased risk of side effects, especially gastrointestinal and renal.
Renal_impairment
Use with caution and consider dose reduction in patients with mild to moderate renal impairment. Contraindicated in severe renal impairment.
How to Take
Dalatic Plus tablets should be taken orally, preferably with or after food, to minimize gastrointestinal upset. Swallow the tablet whole with a glass of water.
Mechanism of Action
Diclofenac Potassium primarily inhibits prostaglandin synthesis by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, leading to anti-inflammatory, analgesic, and antipyretic effects. Paracetamol produces analgesia by elevating the pain threshold and antipyresis through action on the hypothalamic heat-regulating center, mainly by inhibiting prostaglandin synthesis in the CNS.
Pharmacokinetics
Onset
Onset of pain relief usually within 30 minutes to 1 hour.
Excretion
Both components and their metabolites are predominantly excreted via the urine. Diclofenac also undergoes biliary excretion.
Half life
Diclofenac: Approximately 1-2 hours. Paracetamol: Approximately 1.5-3 hours.
Absorption
Both Diclofenac Potassium and Paracetamol are rapidly and almost completely absorbed after oral administration. Peak plasma concentrations are usually reached within 1-2 hours for both components.
Metabolism
Both are extensively metabolized in the liver. Diclofenac primarily undergoes hydroxylation and glucuronidation. Paracetamol is mainly metabolized by glucuronidation and sulfation, with a small amount metabolized by the cytochrome P450 enzyme system.
Side Effects
Contraindications
- Hypersensitivity to Diclofenac, Paracetamol, or any component of the formulation.
- Active gastrointestinal bleeding or peptic ulcer.
- Severe hepatic or renal impairment.
- Severe heart failure.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Third trimester of pregnancy.
Drug Interactions
Lithium
Increased plasma lithium levels.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Other NSAIDs or aspirin
Increased risk of adverse effects.
Diuretics and ACE inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Warfarin and other anticoagulants
Increased risk of bleeding.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Diclofenac overdose may include lethargy, drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding. Paracetamol overdose can cause severe hepatic necrosis, which may be fatal. Management includes supportive care, gastric lavage, activated charcoal, and administration of N-acetylcysteine (for Paracetamol overdose) if within the therapeutic window.
Pregnancy & Lactation
Dalatic Plus is contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use in earlier pregnancy and during lactation should only be if clearly needed and with caution, under strict medical supervision. Diclofenac and Paracetamol pass into breast milk in small amounts.
Side Effects
Contraindications
- Hypersensitivity to Diclofenac, Paracetamol, or any component of the formulation.
- Active gastrointestinal bleeding or peptic ulcer.
- Severe hepatic or renal impairment.
- Severe heart failure.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Third trimester of pregnancy.
Drug Interactions
Lithium
Increased plasma lithium levels.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Other NSAIDs or aspirin
Increased risk of adverse effects.
Diuretics and ACE inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Warfarin and other anticoagulants
Increased risk of bleeding.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Diclofenac overdose may include lethargy, drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding. Paracetamol overdose can cause severe hepatic necrosis, which may be fatal. Management includes supportive care, gastric lavage, activated charcoal, and administration of N-acetylcysteine (for Paracetamol overdose) if within the therapeutic window.
Pregnancy & Lactation
Dalatic Plus is contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use in earlier pregnancy and during lactation should only be if clearly needed and with caution, under strict medical supervision. Diclofenac and Paracetamol pass into breast milk in small amounts.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Available in pharmacies nationwide in Bangladesh
Approval Status
Approved by DGDA, Bangladesh
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical data exist for the individual active ingredients, Diclofenac and Paracetamol, as well as for their fixed-dose combinations, demonstrating their efficacy and safety in various pain and inflammatory conditions.
Lab Monitoring
- Regular monitoring of renal function, liver function tests, and complete blood count is recommended during long-term therapy, especially in elderly patients.
Doctor Notes
- Prescribe the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals. Exercise caution in patients with a history of GI issues, cardiovascular disease, or renal/hepatic impairment. Monitor patients for signs of GI bleeding or cardiovascular adverse events.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not exceed the recommended dose or duration of treatment.
- Take with or after food to minimize stomach upset.
- Avoid alcohol while on this medication.
- Report any unusual symptoms or side effects to your doctor 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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Dalatic Plus may cause dizziness or drowsiness in some individuals. Patients should be advised to exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain adequate hydration. Avoid activities requiring mental alertness if you experience dizziness or drowsiness. Follow a balanced diet.
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