Naltrexone (Oral)

Generic name: Naltrexone

Usage of Naltrexone (Oral)

Naltrexone is used to help narcotic Dependents who have stopped taking narcotics to stay drug-free. It is also used to help alcoholics stay alcohol-free. The medicine is not a cure for addiction. It is used as part of an overall program that may include counseling, attending support group meetings, and other treatment recommended by your doctor.

Naltrexone is not a narcotic. It works by blocking the effects of narcotics, especially the "high'' feeling that makes you want to use them. It also may block the "high'' feeling that may make you want to use alcohol. It will not produce any narcotic-like effects or cause mental or physical dependence. It will not prevent you from becoming impaired while drinking alcohol.

Naltrexone will cause withdrawal symptoms in people who are physically dependent on narcotics. Naltrexone treatment is started after you are no longer dependent on narcotics. The length of time this takes may depend on which narcotic you took, the amount you took, and how long you took it. Before you start taking this medicine, be sure to tell your doctor if you think you are still having withdrawal symptoms.

This medicine is available only with your doctor's prescription.

Naltrexone (Oral) side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Skin rash

Rare

Abdominal or stomach pain (severe)

blurred vision, aching, burning, or swollen eyes

chest pain

confusion

discomfort while urinating or frequent urination

fever

hallucinations or seeing, hearing, or feeling things that are not there

itching

mental depression or other mood or mental changes

ringing or buzzing in the ears

shortness of breath

swelling of the face, feet, or lower legs

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach cramping or pain (mild or moderate)

anxiety, nervousness, restlessness or trouble sleeping

headache

joint or muscle pain

nausea or vomiting

unusual tiredness

Less common

Chills

constipation

cough, hoarseness, runny or stuffy nose, sinus problems, sneezing, or sore throat

diarrhea

dizziness

fast or pounding heartbeat

increased thirst

irritability

loss of appetite

sexual problems in males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Naltrexone (Oral)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic Reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of naltrexone in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of naltrexone in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Alfentanil

Alphaprodine

Anileridine

Benzhydrocodone

Buprenorphine

Butorphanol

Codeine

Diacetylmorphine

Difenoxin

Dihydrocodeine

Diphenoxylate

Ethylmorphine

Fentanyl

Hydrocodone

Hydromorphone

Ketobemidone

Levorphanol

Meperidine

Methadone

Morphine

Morphine Sulfate Liposome

Nalbuphine

Nicomorphine

Opium

Opium Alkaloids

Oxycodone

Oxymorphone

Papaveretum

Paregoric

Piritramide

Propoxyphene

Remifentanil

Sufentanil

Tapentadol

Tilidine

Tramadol

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Bremelanotide

Naldemedine

Naloxegol

Venlafaxine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Lofexidine

Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

How to use Naltrexone (Oral)

Take naltrexone regularly as ordered by your doctor. It may be helpful to have someone else, such as a family member, doctor, or nurse, give you each dose as scheduled.

You will need to stop using opioids (narcotics) for at least 7 to 10 days before you can start taking naltrexone. Your doctor may need to do the naloxone challenge test or a urine test for opioids to make sure you are opioid-free.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral doSage form (tablets):

For alcoholism:

Adults—50 milligrams (mg) once a day.

Children—Use and dose must be determined by your doctor.

For narcotic addiction:

Adults—At first, 25 milligrams (mg) (one-half tablet) for the first dose, then another 25 mg 1 hour later. After that, the dose is 350 mg per week. Your doctor will direct you to divide up this weekly dose and take naltrexone according to one of the following schedules:

50 mg (one tablet) every day; or

50 mg a day during the week and 100 mg (two tablets) on Saturday; or

100 mg every other day; or

150 mg every 3 days.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Warnings

It is very important that your doctor check your progress at regular visits. Your doctor may want to do certain blood tests to see if the medicine is causing unwanted effects.

This medicine blocks the "high" feeling you get from narcotic (opioid) drugs, including heroin. Since naltrexone may make you more sensitive to lower doses of opioids than you have previously used, you should not use heroin or any other narcotic drugs to overcome what the medicine is doing. You could overdose and develop serious problems.

This medicine may cause serious problems with your liver. Call your doctor right away if you start having dark urine, pain in the upper stomach, or yellowing of the eyes or skin while you are using this medicine.

This medicine may increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed. Also tell your doctor right away if you have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you feel tired all the time, sleep a lot more or a lot less than usual, feel hopeless or helpless, or if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared.

Remember that use of naltrexone is only part of your treatment. Be sure that you follow all of your doctor's orders, including seeing your therapist and/or attending support group meetings on a regular basis.

Do not try to overcome the effects of naltrexone by taking narcotics. To do so may cause coma or death. You may be more sensitive to the effects of narcotics than you were before beginning naltrexone therapy.

Naltrexone also blocks the useful effects of narcotics. Always use a non-narcotic medicine to treat pain, diarrhea, or a cough. If you have any questions about the proper medicine to use, check with your doctor.

Naltrexone will not prevent you from becoming impaired when you drink alcohol. Do not take naltrexone in order to drive or perform other activities while under the influence of alcohol.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert while you are taking naltrexone.

Never share this medicine with anyone else, especially someone who is using narcotics. Naltrexone causes withdrawal symptoms in people who are using narcotics.

Tell all medical doctors, dentists, and pharmacists you go to that you are taking naltrexone.

It is recommended that you carry identification stating that you are taking naltrexone. Identification cards may be available from your doctor.

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