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Naltrexone

Latest prescription information about Naltrexone. Learn how to pronounce the drug’s name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
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Generic Name : Naltrexone
Pronunciation : nal -TREX -own
Therapeutic Classification : Analgesics
ICD Code : Y45.0
Trade Name(s): 
India- Naltima, Nodict.
International- Revia .
Why it is prescribed (Indications) : This medication is an opioid antagonist, prescribed for management of alcoholism and addiction to opioid drugs. Naltrexone is prescribed either alone or with other medications. It blocks the receptors in the brain in order to terminate the action of opioids. 
When it is not to be taken (Contraindications): Contraindicated in patients who are concurrently dependent on opioids, acute liver inflammation or liver failure, acute opioid withdrawal and patients on therapeutic opioid analgesics.

Pregnancy Category :

A B C D X
Category C : Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Dosage & When it is to be taken : Adult: PO- Opioid dependence- Initial: 25 mg, then up to 50 mg/day if no withdrawal signs. Maintenance: 350 mg/week given as 50 mg/day or divided in 3 doses (given on 3 days of the week) for improved compliance.
Adjunct in alcohol dependence- 50 mg/day.
IM- Adjunct in alcohol dependence- 380 mg 4 weekly.
How it should be taken : It comes as a tablet to take by mouth, with or without food.
Warnings and Precautions : 
*Caution should be exercised in patients with history of liver or kidney impairment, bleeding disorder, patient under treatment with disulfiram and thioridazine, pregnancy, breastfeeding, elderly, and in children.
* Monitor liver functions regularly.
* Patient may develop with suicidal thoughts.
* Strictly avoid the usage of heroin or opioid drugs, otherwise it will cause death.
* Patients should be free from opioid at least 10 days before the treatment with this medication.
Side Effects : 
Most Common- Constipation, fatigue, abdominal, joint and muscle pain.
Respiratory - Nasal congestion, itching, runny nose, sneezing, sore throat, excess phlegm, sinus trouble, heavy breathing, hoarseness, cough and shortness of breath.
Heart - Nosebleeds, inflammation of veins, swelling, increased blood pressure, nonspecific ECG changes, palpitations, and fast heart rate.
Gastrointestinal - Nausea, vomiting, diarrhea, ulcer, excessive gas trouble and piles.
Musculoskeletal - Excess pain in the shoulders, legs or knee region, tremors and twitching.
Genitourinary - Increased urination frequency and decreased sexual interest.
Skin - Oily skin, rashes, itching, pimples, athlete’s foot, cold sores and hair loss.
Central Nervous System - Headache, dizziness, nervousness, fearful thought, fatigue, restlessness, drowsiness, confusion, depression, disorientation, hallucinations, nightmares and suicidal thoughts.
Eye and ENT - Blurred vision, burning, light sensitivity, ears “clogged”, aching and ringing in the ear
Miscellaneous - Increased appetite, weight loss, weight gain, yawning, fever, dry mouth, head pounding, swollen glands and cold feet.
Other Precautions : 
* During reversal of this drug, if patient requires opioid painkillers, then the amount of opioid must be increased than the usual dose.
* Monitor for injection-site reactions and bleeding disorders.
Storage Conditions : 
Injection: Store it in refrigerator (2-8°C); do not freeze. Oral: Store it at room temperature (20-25°C).

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Reference  

  • Food and Drug Administration (FDA)
  • National Institutes of Health (NIH)
  • PubMed
  • CIMS
  • Indian Pharma Reference Guide 2012
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