Rubalon
Generic Name
Rubalon-01 suspension
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rubalon 01 suspension | ৳ 100.00 | N/A |
Description
Overview of the medicine
Rubalon-01 suspension is a potent non-steroidal anti-inflammatory drug (NSAID) used for the relief of mild to moderate pain, fever, and various inflammatory conditions.
Uses & Indications
Dosage
Adults
100-200 mg (5-10 ml) orally every 4-6 hours as needed. Do not exceed 800 mg (40 ml) in 24 hours.
Elderly
Lower initial doses may be required due to potential age-related renal impairment. Monitor renal function closely.
Renal_impairment
Use with caution. Dose reduction may be necessary in mild to moderate impairment. Avoid in severe renal impairment.
How to Take
Shake the bottle well before each use. Administer orally with food or milk to minimize gastrointestinal upset. Use a calibrated measuring device to ensure accurate dosing.
Mechanism of Action
Rubalon-01 inhibits cyclooxygenase (COX-1 and COX-2) enzymes, which are responsible for the synthesis of prostaglandins, key mediators of pain, inflammation, and fever.
Pharmacokinetics
Onset
Analgesic effects typically begin within 30 minutes to 1 hour.
Excretion
The drug and its metabolites are mainly excreted by the kidneys, primarily as inactive conjugates.
Half life
The plasma elimination half-life is approximately 2 to 4 hours.
Absorption
Rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations are typically achieved within 1 to 2 hours after oral administration.
Metabolism
Primarily metabolized in the liver via hydroxylation and conjugation to inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to Rubalon-01, aspirin, or other NSAIDs
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Active peptic ulcer, gastrointestinal bleeding, or a history of recurrent ulceration/hemorrhage
- Severe renal or hepatic impairment
- Severe heart failure
- Third trimester of pregnancy (due to risk of premature closure of ductus arteriosus)
Drug Interactions
Lithium
May increase plasma lithium levels, leading to lithium toxicity.
Methotrexate
May increase methotrexate toxicity by reducing its renal clearance.
Diuretics and ACE inhibitors
May reduce the antihypertensive effect and increase the risk of renal impairment, especially in dehydrated patients.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding due to additive effects on platelet function and potential gastrointestinal irritation.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, abdominal pain, drowsiness, lethargy, tinnitus, and headache. More severe cases may involve gastrointestinal bleeding, acute renal failure, hypotension, respiratory depression, and coma. Treatment is primarily supportive and symptomatic. Gastric lavage or activated charcoal may be considered if ingestion is recent.
Pregnancy & Lactation
Avoid Rubalon-01 during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use with caution during the first and second trimesters only if the potential benefit outweighs the potential risk to the fetus. Small amounts may pass into breast milk; use with caution during lactation and consult a healthcare professional.
Side Effects
Contraindications
- Known hypersensitivity to Rubalon-01, aspirin, or other NSAIDs
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Active peptic ulcer, gastrointestinal bleeding, or a history of recurrent ulceration/hemorrhage
- Severe renal or hepatic impairment
- Severe heart failure
- Third trimester of pregnancy (due to risk of premature closure of ductus arteriosus)
Drug Interactions
Lithium
May increase plasma lithium levels, leading to lithium toxicity.
Methotrexate
May increase methotrexate toxicity by reducing its renal clearance.
Diuretics and ACE inhibitors
May reduce the antihypertensive effect and increase the risk of renal impairment, especially in dehydrated patients.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding due to additive effects on platelet function and potential gastrointestinal irritation.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, abdominal pain, drowsiness, lethargy, tinnitus, and headache. More severe cases may involve gastrointestinal bleeding, acute renal failure, hypotension, respiratory depression, and coma. Treatment is primarily supportive and symptomatic. Gastric lavage or activated charcoal may be considered if ingestion is recent.
Pregnancy & Lactation
Avoid Rubalon-01 during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use with caution during the first and second trimesters only if the potential benefit outweighs the potential risk to the fetus. Small amounts may pass into breast milk; use with caution during lactation and consult a healthcare professional.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture when stored under recommended conditions.
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Patent Pending
Clinical Trials
Clinical trials for Rubalon-01 suspension involved various phases to assess its efficacy, safety, and optimal dosage for indicated conditions. Results demonstrated significant pain relief and anti-inflammatory effects with a generally well-tolerated safety profile.
Lab Monitoring
- Complete Blood Count (CBC): Monitor for anemia and other hematological abnormalities, especially during long-term therapy.
- Renal function tests (Creatinine, BUN): Essential for patients at risk of renal impairment or on prolonged therapy.
- Liver function tests (ALT, AST): Recommended periodically in patients on long-term treatment to detect potential liver dysfunction.
Doctor Notes
- Counsel patients on the importance of taking with food to reduce GI side effects.
- Emphasize the black box warnings regarding cardiovascular and gastrointestinal risks.
- Monitor renal function, especially in elderly patients or those with pre-existing renal conditions, during prolonged therapy.
- Advise patients to report any unusual symptoms, especially gastrointestinal bleeding or cardiovascular events.
Patient Guidelines
- Always take Rubalon-01 suspension with food or milk to minimize stomach upset.
- Do not exceed the recommended dose or duration of treatment without consulting your doctor.
- Report any unusual bleeding, black/tarry stools, severe stomach pain, or persistent indigestion to your doctor immediately.
- Avoid concurrent use with alcohol or other NSAIDs to reduce the risk of side effects.
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
Rubalon-01 suspension may cause dizziness, drowsiness, or visual disturbances in some individuals. Patients should be advised to exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Maintain a healthy and balanced diet to support overall well-being.
- Stay well-hydrated, especially if experiencing fever or diarrhea.
- Limit or avoid smoking, as it can worsen gastrointestinal irritation and increase cardiovascular risk.
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Global Brand Names
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