Newbain
Generic Name
Tramadol Hydrochloride
Manufacturer
Medix Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| newbain 20 mg injection | ৳ 100.68 | N/A |
Description
Overview of the medicine
Newbain 20 mg Injection contains Tramadol Hydrochloride, a centrally acting opioid analgesic used for the management of moderate to moderately severe pain.
Uses & Indications
Dosage
Adults
Usually 50-100 mg every 4-6 hours, not exceeding 400 mg/day. For 20 mg injection, dose adjustment is necessary based on patient's condition and prescriber's discretion.
Elderly
No specific dose adjustment needed unless renal or hepatic impairment is present. Max 300 mg/day for patients over 75 years.
Renal_impairment
Dose interval should be extended to 12 hours for creatinine clearance less than 30 mL/min.
How to Take
For intravenous (IV) or intramuscular (IM) injection. IV administration should be done slowly over 2-3 minutes. Not for subcutaneous use.
Mechanism of Action
Tramadol acts as a synthetic opioid analgesic that binds to μ-opioid receptors. It also inhibits the reuptake of norepinephrine and serotonin, which contributes to its analgesic effect.
Pharmacokinetics
Onset
Within 30-60 minutes after injection.
Excretion
Mainly renal (approximately 90%), with a small amount excreted in feces.
Half life
Approximately 5-7 hours (parent drug), 7-9 hours (active metabolite O-desmethyltramadol).
Absorption
Rapidly absorbed after intramuscular administration, achieving peak plasma concentration within 1-2 hours. Bioavailability is high.
Metabolism
Primarily hepatic via CYP2D6 and CYP3A4 into active (O-desmethyltramadol) and inactive metabolites.
Side Effects
Contraindications
- Acute intoxication with alcohol, hypnotics, analgesics, opioids, or other psychotropic drugs
- Epilepsy not controlled by treatment
- Severe respiratory depression
- Known hypersensitivity to tramadol or any excipients
Drug Interactions
Warfarin
Increased INR and bleeding risk.
Carbamazepine
Significantly reduces tramadol plasma concentrations.
MAO Inhibitors
Increased risk of serotonin syndrome or CNS excitation.
Serotonergic Drugs (e.g., SSRIs, SNRIs)
Increased risk of serotonin syndrome.
CNS Depressants (e.g., alcohol, benzodiazepines)
Increased risk of sedation, respiratory depression.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms include respiratory depression, seizures, miosis, cardiovascular collapse, and coma. Treatment involves supportive measures, maintaining a patent airway, and administration of naloxone (an opioid antagonist) to reverse respiratory depression.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy, especially in the third trimester due to risk of neonatal opioid withdrawal syndrome. Excreted in breast milk, so not recommended during breastfeeding.
Side Effects
Contraindications
- Acute intoxication with alcohol, hypnotics, analgesics, opioids, or other psychotropic drugs
- Epilepsy not controlled by treatment
- Severe respiratory depression
- Known hypersensitivity to tramadol or any excipients
Drug Interactions
Warfarin
Increased INR and bleeding risk.
Carbamazepine
Significantly reduces tramadol plasma concentrations.
MAO Inhibitors
Increased risk of serotonin syndrome or CNS excitation.
Serotonergic Drugs (e.g., SSRIs, SNRIs)
Increased risk of serotonin syndrome.
CNS Depressants (e.g., alcohol, benzodiazepines)
Increased risk of sedation, respiratory depression.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms include respiratory depression, seizures, miosis, cardiovascular collapse, and coma. Treatment involves supportive measures, maintaining a patent airway, and administration of naloxone (an opioid antagonist) to reverse respiratory depression.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy, especially in the third trimester due to risk of neonatal opioid withdrawal syndrome. Excreted in breast milk, so not recommended during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Tramadol has undergone extensive clinical trials demonstrating its efficacy and safety for pain management.
Lab Monitoring
- Monitor liver function tests (LFTs) periodically with long-term use.
- Monitor renal function tests (RFTs) for patients with kidney impairment.
Doctor Notes
- Assess patient for risk factors of abuse, addiction, and misuse before prescribing.
- Use the lowest effective dose for the shortest duration possible.
- Counsel patients on safe storage and disposal.
Patient Guidelines
- Do not exceed the prescribed dose.
- Avoid alcohol while taking this medicine.
- Report any unusual side effects or signs of addiction to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
May cause drowsiness or dizziness; therefore, caution is advised when driving or operating machinery.
Lifestyle Advice
- Avoid driving or operating heavy machinery due to potential dizziness and somnolence. Maintain regular bowel habits to mitigate constipation.
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Global Brand Names
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