Novarin-SR
Generic Name
Diclofenac Sodium Extended-Release 100 mg Capsule
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
novarin sr 100 mg capsule | ৳ 2.50 | N/A |
Description
Overview of the medicine
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain, inflammation, and fever. The SR (sustained-release) form provides prolonged action.
Uses & Indications
Dosage
Adults
100 mg once daily. The maximum recommended daily dose for Diclofenac SR is generally 100-150 mg depending on formulation and individual response.
Elderly
Initiate treatment with the lowest effective dose and monitor for adverse effects, especially renal function.
Renal_impairment
Use with caution. Dosage reduction may be necessary in patients with severe renal impairment. Regular monitoring of renal function is advised.
How to Take
Take the capsule whole with food or milk to minimize gastrointestinal upset. Do not chew, crush, or break the capsule.
Mechanism of Action
Diclofenac inhibits prostaglandin synthesis by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing inflammation, pain, and fever.
Pharmacokinetics
Onset
Onset of action for SR is typically within 1-2 hours, with peak plasma levels at approximately 4-5 hours.
Excretion
Approximately 60% excreted via urine and 35% via bile/feces as metabolites.
Half life
Plasma elimination half-life is approximately 1-2 hours (parent drug), but active metabolites can persist longer.
Absorption
Well absorbed orally; the extended-release formulation provides prolonged absorption.
Metabolism
Extensively metabolized in the liver, primarily by CYP2C9 and CYP2C19 enzymes, with extensive first-pass metabolism.
Side Effects
Contraindications
- Known hypersensitivity to diclofenac, aspirin, or other NSAIDs
- Active gastrointestinal bleeding or peptic ulceration
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
Drug Interactions
Lithium and Methotrexate
Diclofenac can increase plasma levels of lithium and methotrexate, leading to toxicity.
Diuretics and ACE Inhibitors
Reduced antihypertensive effect; increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
SSRIs (Selective Serotonin Reuptake Inhibitors)
Increased risk of gastrointestinal bleeding.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Management involves symptomatic and supportive treatment. There is no specific antidote for diclofenac overdose. Gastric decontamination (e.g., activated charcoal) may be considered if ingested recently.
Pregnancy & Lactation
Avoid in the third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus. Use with caution in the first and second trimesters and during lactation only if the potential benefit justifies the potential risk to the fetus or infant.
Side Effects
Contraindications
- Known hypersensitivity to diclofenac, aspirin, or other NSAIDs
- Active gastrointestinal bleeding or peptic ulceration
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
Drug Interactions
Lithium and Methotrexate
Diclofenac can increase plasma levels of lithium and methotrexate, leading to toxicity.
Diuretics and ACE Inhibitors
Reduced antihypertensive effect; increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
SSRIs (Selective Serotonin Reuptake Inhibitors)
Increased risk of gastrointestinal bleeding.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Management involves symptomatic and supportive treatment. There is no specific antidote for diclofenac overdose. Gastric decontamination (e.g., activated charcoal) may be considered if ingested recently.
Pregnancy & Lactation
Avoid in the third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus. Use with caution in the first and second trimesters and during lactation only if the potential benefit justifies the potential risk to the fetus or infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, refer to the product packaging for specific details.
Availability
Pharmacies nationwide
Approval Status
Approved by relevant regulatory authorities (e.g., DGDA)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Diclofenac has undergone extensive clinical trials supporting its efficacy and safety for various pain and inflammatory conditions over decades of use.
Lab Monitoring
- Complete Blood Count (CBC)
- Liver Function Tests (LFTs)
- Renal Function Tests (RFTs) - especially with long-term use.
Doctor Notes
- Assess cardiovascular and gastrointestinal risk factors before initiating therapy, especially for long-term use.
- Consider the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
- Monitor blood pressure, renal function, and liver enzymes periodically in patients on prolonged therapy.
- Concomitant use with other NSAIDs or anticoagulants should be avoided or closely monitored.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Always take with food or milk to reduce stomach upset.
- Do not crush or chew the capsule; swallow it whole.
- Report any signs of unusual bleeding, black or tarry stools, or severe abdominal pain immediately to your doctor.
- Do not exceed the recommended dose.
Missed Dose Advice
If a dose is missed, 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
This medicine may cause dizziness, drowsiness, or visual disturbances. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Limit alcohol intake while on this medication.
- Maintain a healthy and balanced diet.
- Avoid smoking, as it can worsen GI adverse effects.
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