Rotalac
Generic Name
Hypothetical NSAID (similar to Ketorolac)
Manufacturer
PharmaCorp Innovations
Country
USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rotalac 60 mg injection | ৳ 95.00 | N/A |
Description
Overview of the medicine
Rotalac 60 mg Injection is a potent non-steroidal anti-inflammatory drug (NSAID) used for the short-term management of moderate to severe acute pain, including post-operative pain. It works by reducing pain, fever, and inflammation.
Uses & Indications
Dosage
Adults
Initial dose 60 mg IM or 30 mg IV as a single dose, or 30 mg every 6 hours. Maximum daily dose should not exceed 120 mg. Treatment duration generally limited to 5 days.
Elderly
Reduced dosage, typically 30 mg IM or IV every 6 hours, not exceeding 60 mg/day. Close monitoring for adverse effects.
Renal_impairment
Significant dose reduction required; 15 mg IM or IV every 6 hours, not exceeding 60 mg/day. Contraindicated in severe renal failure.
How to Take
Rotalac Injection can be administered intramuscularly (IM) into a large muscle mass or intravenously (IV) as a bolus or infusion. IV administration should be slow, over at least 15 seconds.
Mechanism of Action
Rotalac inhibits cyclooxygenase (COX-1 and COX-2) enzymes, leading to a decreased synthesis of prostaglandins, which are key mediators of pain, inflammation, and fever.
Pharmacokinetics
Onset
Analgesic effect typically begins within 30 minutes of administration.
Excretion
The majority of the drug and its metabolites are excreted renally (via urine), with a small portion excreted in feces.
Half life
Approximately 4-6 hours, allowing for multiple daily dosing.
Absorption
Rapidly and completely absorbed following intramuscular (IM) or intravenous (IV) administration. Peak plasma concentrations are achieved within 30-50 minutes after IM injection.
Metabolism
Primarily metabolized in the liver, mainly via glucuronidation and hydroxylation, to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Rotalac, aspirin, or other NSAIDs.
- Active peptic ulcer disease, gastrointestinal bleeding, or perforation.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Moderate to severe hepatic impairment.
- Coagulation disorders or patients at high risk of bleeding.
- As a prophylactic analgesic before major surgery or during CABG (Coronary Artery Bypass Graft) surgery.
- During pregnancy, especially in the third trimester, and lactation.
Drug Interactions
Lithium
May increase plasma lithium levels, leading to toxicity.
Methotrexate
May increase plasma methotrexate levels and enhance its toxicity.
Cyclosporine, Tacrolimus
Increased risk of nephrotoxicity.
Diuretics (e.g., Furosemide, Thiazides)
May reduce the natriuretic and diuretic effects of diuretics.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding due to additive antiplatelet effects and potential displacement from plasma protein binding.
ACE Inhibitors / Angiotensin Receptor Blockers (ARBs)
May diminish the antihypertensive effect and increase the risk of renal impairment, especially in elderly or volume-depleted patients.
Antiplatelet agents (e.g., Aspirin, Clopidogrel) and SSRIs/SNRIs
Increased risk of gastrointestinal bleeding.
Storage
Store at room temperature (below 25°C). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include abdominal pain, nausea, vomiting, lethargy, drowsiness, and headache. More severe symptoms like gastrointestinal bleeding, renal failure, acute respiratory depression, and coma may occur. Management is symptomatic and supportive. Gastric emptying (if recently ingested oral form) and administration of activated charcoal may be considered. Monitor vital signs, renal and liver function.
Pregnancy & Lactation
Not recommended during pregnancy, especially in the third trimester, due to the potential for premature closure of the fetal ductus arteriosus and other adverse effects on the fetus. Excreted in breast milk; therefore, use is not recommended during lactation.
Side Effects
Contraindications
- Hypersensitivity to Rotalac, aspirin, or other NSAIDs.
- Active peptic ulcer disease, gastrointestinal bleeding, or perforation.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Moderate to severe hepatic impairment.
- Coagulation disorders or patients at high risk of bleeding.
- As a prophylactic analgesic before major surgery or during CABG (Coronary Artery Bypass Graft) surgery.
- During pregnancy, especially in the third trimester, and lactation.
Drug Interactions
Lithium
May increase plasma lithium levels, leading to toxicity.
Methotrexate
May increase plasma methotrexate levels and enhance its toxicity.
Cyclosporine, Tacrolimus
Increased risk of nephrotoxicity.
Diuretics (e.g., Furosemide, Thiazides)
May reduce the natriuretic and diuretic effects of diuretics.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding due to additive antiplatelet effects and potential displacement from plasma protein binding.
ACE Inhibitors / Angiotensin Receptor Blockers (ARBs)
May diminish the antihypertensive effect and increase the risk of renal impairment, especially in elderly or volume-depleted patients.
Antiplatelet agents (e.g., Aspirin, Clopidogrel) and SSRIs/SNRIs
Increased risk of gastrointestinal bleeding.
Storage
Store at room temperature (below 25°C). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include abdominal pain, nausea, vomiting, lethargy, drowsiness, and headache. More severe symptoms like gastrointestinal bleeding, renal failure, acute respiratory depression, and coma may occur. Management is symptomatic and supportive. Gastric emptying (if recently ingested oral form) and administration of activated charcoal may be considered. Monitor vital signs, renal and liver function.
Pregnancy & Lactation
Not recommended during pregnancy, especially in the third trimester, due to the potential for premature closure of the fetal ductus arteriosus and other adverse effects on the fetus. Excreted in breast milk; therefore, use is not recommended during lactation.
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, Hospitals, Clinics
Approval Status
Approved
Patent Status
Under patent
Clinical Trials
Rotalac has undergone extensive Phase I, II, and III clinical trials demonstrating its efficacy and safety profile for acute pain management. Post-marketing surveillance and ongoing studies continue to monitor long-term outcomes and explore new indications.
Lab Monitoring
- Renal function tests (Serum creatinine, BUN) – especially in elderly or patients with pre-existing renal impairment.
- Liver function tests (ALT, AST) – periodically, particularly with prolonged use.
- Complete Blood Count (CBC) – if used for an extended period, to monitor for anemia or other hematologic abnormalities.
- Blood pressure monitoring.
Doctor Notes
- Prior to initiation, assess cardiovascular risk factors, renal function, and GI risk in all patients.
- Use with extreme caution in patients with a history of hypertension, heart failure, or fluid retention.
- Monitor for signs of GI bleeding or ulceration throughout the course of treatment.
- Advise patients on the importance of adhering to the prescribed dose and duration to minimize risks.
Patient Guidelines
- Inform your doctor about all medical conditions and medications you are currently taking.
- Report any unusual bleeding, persistent abdominal pain, dark stools, or changes in urine output immediately.
- Do not exceed the recommended dose or duration of treatment, as this increases the risk of serious side effects.
- Avoid concurrent use of other NSAIDs or aspirin without consulting your doctor.
Missed Dose Advice
If a dose is missed, administer it as soon as you remember, unless it is almost time for your next scheduled dose. Do not double the dose to catch up.
Driving Precautions
Rotalac may cause dizziness, drowsiness, or visual disturbances in some patients. Patients should be cautious when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Avoid alcohol consumption while taking Rotalac, as it may increase the risk of gastrointestinal adverse effects.
- Maintain adequate hydration, especially if you have renal concerns.
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