Nadox
Generic Name
Naltrexone
Manufacturer
Renata Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nadox 100 mg tablet | ৳ 2.50 | ৳ 25.00 |
Description
Overview of the medicine
Nadox 100 mg Tablet contains Naltrexone, an opioid antagonist used in the management of alcohol dependence and opioid dependence.
Uses & Indications
Dosage
Adults
For alcohol dependence: 50 mg orally once daily. Alternatively, a schedule of 100 mg every other day, or 150 mg every third day, or 100 mg on Mondays, Wednesdays, and Fridays may be used. For opioid dependence: 25 mg orally initially, then if no withdrawal symptoms occur, 50 mg once daily.
Elderly
No specific dose adjustment required for elderly patients, but use with caution due to potential age-related decrease in renal or hepatic function.
Renal_impairment
Use with caution in patients with renal impairment. Dose reduction may be necessary in severe renal dysfunction. Not recommended for patients with end-stage renal disease.
How to Take
Take orally, with or without food. It can be taken at any time of day, but consistency is recommended.
Mechanism of Action
Naltrexone is a pure opioid antagonist that works by competitively binding to opioid receptors (mu, delta, and kappa) in the central nervous system, thereby blocking the euphoric and sedative effects of opioids. In alcohol dependence, its mechanism is not fully understood, but it is believed to modulate endogenous opioid systems, reducing craving.
Pharmacokinetics
Onset
Peak plasma levels within 1 hour. Onset of action for blocking opioid effects is rapid (within minutes).
Excretion
Predominantly excreted via the kidneys (approximately 60% of an oral dose as metabolites and unchanged drug in urine). Minor fecal excretion.
Half life
Naltrexone: approximately 4 hours. Active metabolite (6-β-naltrexol): approximately 13 hours.
Absorption
Rapidly and almost completely absorbed from the gastrointestinal tract (approximately 96%). Undergoes extensive first-pass metabolism.
Metabolism
Extensively metabolized in the liver, primarily to its major active metabolite, 6-β-naltrexol, by dihydrodiol dehydrogenase.
Side Effects
Contraindications
- Patients receiving opioid analgesics.
- Patients in acute opioid withdrawal.
- Failure of the naloxone challenge test or a positive urine screen for opioids.
- History of hypersensitivity to naltrexone or any component of the formulation.
- Acute hepatitis or liver failure.
Drug Interactions
Thioridazine
Concurrent use may result in lethargy and somnolence.
Other hepatotoxic drugs
Caution when co-administering with other drugs known to be hepatotoxic due to increased risk of liver damage.
Opioid-containing medicines
Naltrexone will block the effects of opioid-containing medicines (e.g., cough suppressants, antidiarrheals, analgesics), rendering them ineffective or precipitating withdrawal symptoms.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited experience with naltrexone overdose. In overdose, patients should be treated symptomatically and supportive measures instituted.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Naltrexone and its active metabolite are excreted in human milk; therefore, caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Patients receiving opioid analgesics.
- Patients in acute opioid withdrawal.
- Failure of the naloxone challenge test or a positive urine screen for opioids.
- History of hypersensitivity to naltrexone or any component of the formulation.
- Acute hepatitis or liver failure.
Drug Interactions
Thioridazine
Concurrent use may result in lethargy and somnolence.
Other hepatotoxic drugs
Caution when co-administering with other drugs known to be hepatotoxic due to increased risk of liver damage.
Opioid-containing medicines
Naltrexone will block the effects of opioid-containing medicines (e.g., cough suppressants, antidiarrheals, analgesics), rendering them ineffective or precipitating withdrawal symptoms.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited experience with naltrexone overdose. In overdose, patients should be treated symptomatically and supportive measures instituted.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Naltrexone and its active metabolite are excreted in human milk; therefore, caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Refer to the packaging for the exact expiry date.
Availability
Pharmacies, Hospitals
Approval Status
FDA approved (for Naltrexone)
Patent Status
Generic
WHO Essential Medicine
YesClinical Trials
Naltrexone has undergone extensive clinical trials supporting its efficacy and safety for alcohol and opioid dependence. Ongoing research explores its use in other conditions like behavioral addictions.
Lab Monitoring
- Liver function tests (LFTs) at baseline and periodically during treatment (e.g., monthly for the first 6 months, then every 3-6 months) to monitor for hepatotoxicity.
- Renal function tests if renal impairment is suspected.
Doctor Notes
- Ensure patient is opioid-free (verified by urine screen and naloxone challenge) before initiating naltrexone for opioid dependence to avoid precipitated withdrawal.
- Emphasize the importance of patient education regarding the risks of attempting to overcome naltrexone blockade with high doses of opioids.
- Regular monitoring of liver function tests is crucial, especially during the initial phase of treatment and with any dose adjustments.
- Naltrexone is most effective when used as part of a comprehensive management program that includes psychosocial support and counseling.
Patient Guidelines
- Do not take any opioid-containing medications (including street drugs) while on naltrexone, as it will block their effects and may precipitate withdrawal.
- Always carry identification stating you are taking naltrexone.
- Inform all healthcare providers, including dentists, that you are taking naltrexone.
- Report any symptoms of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain) 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
Nadox 100 mg Tablet 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
- Adhere strictly to your prescribed dosage and treatment plan.
- Avoid alcohol completely, especially when treating alcohol dependence.
- Seek support from counseling or therapy as part of a comprehensive treatment program for addiction.
- Maintain a healthy diet and stay hydrated.
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