Provided by You Health for patients

What is Naltrexone + Topiramate + Vitamin B12?

In this medication overview

1. Usage

   How to get the most out of your treatment

2. Side Effects

   What to look out for when using your treatment

3. Warnings

   Important safety information

Usage

1. To get started, follow your provider's dosing instructions
   You will begin treatment by slowly titrating up the dose of Naltrexone + Topiramate + Vitamin B12 over a 4 or 5 week period, depending on the instructions given by your provider. Both schedules are shown in the tables below. Once you reach a dose of 1 tablet in the morning and 1 tablet in the evening you will remain at this dose unless instructed otherwise.
2. Missed a dose?
   Take a missed dose as soon as you think about it. If it is less than 6 hours until the next dose, skip the missed dose and go back to the normal time. Do not take 2 doses at the same time or extra doses. If you miss 2 doses, contact your healthcare provider.
3. Do not abruptly stop taking Naltrexone + Topiramate + Vitamin B12 or change your dose without talking with your healthcare provider first. Studies have shown that slowly decreasing your dose over time can reduce possible side-effects caused by stopping the medication abruptly.
   
   If you are taking Naltrexone + Topiramate + Vitamin B12 one-half tablet daily (27.5 mg/day), you may stop taking your medication immediately without tapering.
   
   If you are currently taking Naltrexone + Topiramate + Vitamin B12 one-half tablet twice daily (55 mg/day), you may stop taking your medication immediately without tapering.
   
   If you are currently taking Naltrexone + Topiramate + Vitamin B12 one-half tablet in the morning and 1 tablet in the evening (82.5 mg/day), please take 1 tablet daily for one week and then you may stop the medication.
   
   If you are currently taking Naltrexone + Topiramate + Vitamin B12 one tablet in the morning and one tablet in the evening (110 mg/day), please take 1 tablet daily for one week and then you may stop the medication.
   
   If you have any medical questions, feel free to message your Care Team anytime.
4. Undergoing a planned medical/surgical procedure, or have an injury that requires the use of opioid/narcotic pain medications?
   
   If at any time during treatment with Naltrexone + Topiramate + Vitamin B12, you are planning to undergo an elective surgical procedure that may require opioid/narcotic pain medication use, such as but not limited to (morphine (MS Contin®), hydrocodone (Vicodin®), oxycodone (Oxycontin®), hydromorphone (Percocet®), codeine, tramadol) please discontinue use of Naltrexone + Topiramate + Vitamin B12 a minimum of 3 full days (72 hours) prior to the procedure. If anything unplanned, such as an accident or injury, requires the use of a pain medication you should use a non-opioid type, such as ibuprofen or another NSAID type medication if tolerated. It is important to inform all healthcare providers who are involved in your care for any procedures or injury that may require pain medication that you take Naltrexone + Topiramate + Vitamin B12, and when you last took a dose.

How should I take Naltrexone + Topiramate + Vitamin B12?

• take exactly as prescribed.
• your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• take tablets whole. Do not chew the tablets.
• can be taken before, during, or after a meal. Drink plenty of fluids during the day. This may help prevent kidney stones while taking Naltrexone + Topiramate + Vitamin B12.
• If you take too much Naltrexone + Topiramate + Vitamin B12, message your healthcare provider right away or go to the nearest emergency room.
• If you miss a single dose, take it as soon as you can. However, if you are within 6 hours of taking your next scheduled dose, wait until then to take your usual dose and skip the missed dose. Do not double your dose. If you have missed more than one dose, you should message your healthcare provider for advice.
• Do not stop taking Naltrexone + Topiramate + Vitamin B12 without talking to your healthcare provider. Stopping suddenly may cause serious problems. Your healthcare provider will tell you how to stop taking Naltrexone + Topiramate + Vitamin B12 slowly.

What should I avoid while taking Naltrexone + Topiramate + Vitamin B12?

• You should not drink alcohol while taking Naltrexone + Topiramate + Vitamin B12 as alcohol Naltrexone + Topiramate + Vitamin B12 can affect each other, causing side effects such as sleepiness and dizziness.
• Do not drive a car or operate machinery until you know how Naltrexone + Topiramate + Vitamin B12 affects you. This medication can slow your thinking and motor skills, and may affect vision.

Side effects

Common side effects of Naltrexone + Topiramate + Vitamin B12 may include:

• nausea
• sleepiness/drowsiness
• headache
• dizziness
• vomiting
• decreased appetite
• painful joints
• muscle cramps
• cold symptoms
• trouble sleeping
• toothache
• tingling of the arms and legs (paresthesia)
• a change in the way foods taste, especially with carbonated beverages
• diarrhea
• weight loss
• nervousness
• upper respiratory tract infection
• speech problems
• slow reactions
• difficulty with memory
• abdominal pain
• feeling faint or passing out
• low energy
• anxiety
• fever
• abnormal vision
• decreased feeling or sensitivity, especially in the skin

Naltrexone + Topiramate + Vitamin B12 may cause serious side effects including:

• Depressed mood. Sometimes this leads to suicide, or suicidal thoughts, and suicidal behavior. Tell your family members and people closest to you that you are taking Naltrexone + Topiramate + Vitamin B12.
• Pneumonia. Some people receiving Naltrexone + Topiramate + Vitamin B12 treatment have had a type of pneumonia that is caused by an allergic reaction. If this happens to you, you may need to be treated in the hospital.
• Serious allergic reactions. Serious allergic reactions can happen during or soon after an injection of Naltrexone + Topiramate + Vitamin B12. Tell your healthcare provider or get medical help right away if you have any of these symptoms:
  • skin rash
  • swelling of your face, eyes, mouth, or tongue
  • trouble breathing or wheezing
  • chest pain
  • feeling dizzy or faint
• High blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. This has happened when the active ingredient Topiramate is taken with a medicine called valproic acid (Depakene® or Depakote®).
• Effects on thinking and alertness. Naltrexone + Topiramate + Vitamin B12 may affect how you think and cause confusion, problems with concentration, attention, memory, or speech. Naltrexone + Topiramate + Vitamin B12 may cause depression or mood problems, tiredness, and sleepiness.
• Dizziness or loss of muscle coordination.
• Serious skin reactions. Naltrexone + Topiramate + Vitamin B12 may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). Naltrexone + Topiramate + Vitamin B12 may also cause a rash with blisters and peeling skin over much of the body that may cause death (toxic epidermal necrolysis). Message your healthcare provider right away if you develop a skin rash or blisters.
• Kidney stones. Drink plenty of fluids when taking Naltrexone + Topiramate + Vitamin B12 to decrease your chances of getting kidney stones.
• Low body temperature. Taking Naltrexone + Topiramate + Vitamin B12 when you are also taking valproic acid can cause a drop in body temperature to less than 95°F, feel tired, confusion, or coma.

Warnings

IMPORTANT SAFETY INFORMATION

Naltrexone + Topiramate + Vitamin B12 can cause serious side effects, including:

• Risk of opioid overdose. You can accidentally overdose in two ways.
  • Naltrexone + Topiramate + Vitamin B12 blocks the effects of opioids, such as heroin or opioid pain medicines, examples include, but are not limited to; morphine (MS Contin®), hydrocodone (Vicodin®), oxycodone (Oxycontin®), hydromorphone (Percocet®), codeine, or tramadol. Do not try to overcome this blocking effect by taking large amounts of opioids—this can lead to serious injury, coma, or death.
  • After you receive a dose of Naltrexone + Topiramate + Vitamin B12, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with Naltrexone + Topiramate + Vitamin B12 can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:
    • after you have gone through detoxification
    • when your next Naltrexone + Topiramate + Vitamin B12 dose is due
    • if you miss a dose of Naltrexone + Topiramate + Vitamin B12
    • after you stop Naltrexone + Topiramate + Vitamin B12 treatment

• stomach area pain lasting more than a few days
• dark urine
• yellowing of the whites of your eyes
• tiredness
• Your healthcare provider may need to stop treating you with Naltrexone + Topiramate + Vitamin B12 if you get signs or symptoms of a serious liver problem.

• Any sudden decrease in vision with or without eye pain and redness.
• A blockage of fluid in the eye causing increased pressure in the eye (closed angle closure glaucoma).

• Feel tired
• Not feel hungry (loss of appetite)
• Feel changes in heartbeat
• Have trouble thinking clearly

Naltrexone + Topiramate + Vitamin B12 may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Contact a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• Thoughts about suicide or dying
• Attempts to commit suicide
• New or worse depression
• New or worse anxiety
• Panic attacks
• An extreme increase in activity and talking (mania)
• Feeling agitated or restless
• Trouble sleeping (insomnia)
• New or worse irritability
• Acting aggressive, being angry or violent
• Acting on dangerous impulses
• Other unusual changes in behavior or mood

• Stopping Naltrexone + Topiramate + Vitamin B12 suddenly can cause serious problems.
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
• If you have epilepsy and you stop taking Naltrexone + Topiramate + Vitamin B12 suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking Naltrexone + Topiramate + Vitamin B12 slowly.
• If you miss a single dose of Naltrexone + Topiramate + Vitamin B12, take it as soon as you can. However, if you are within 6 hours of taking your next scheduled dose, wait until then to take your usual dose of Naltrexone + Topiramate + Vitamin B12 and skip the missed dose. Do not double your dose. If you have missed more than one dose, you should message your healthcare provider for advice.

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Message your healthcare provider between visits as needed, especially if you are worried about symptoms.

• If you take Naltrexone + Topiramate + Vitamin B12 during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant.
• Cleft lip and cleft palate may happen even in children born to women who are not taking any medicines and do not have other risk factors.
• There may be other medicines to treat your condition that have a lower chance of birth defects.
• All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of Naltrexone + Topiramate + Vitamin B12. If the decision is made to use Naltrexone + Topiramate + Vitamin B12, you should use effective birth control (contraception). You should talk to your doctor about the best kind of birth control to use while you are taking Naltrexone + Topiramate + Vitamin B12.
• Tell your healthcare provider right away if you become pregnant while taking Naltrexone + Topiramate + Vitamin B12. You and your healthcare provider should decide if you will continue to take Topiramate + Vitamin B12 while you are pregnant.
• If you take Naltrexone + Topiramate + Vitamin B12 during pregnancy, your baby may be smaller than expected at birth. The long-term effects of this are not known. Talk to your healthcare provider if you have questions about this risk during pregnancy.
• Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if Naltrexone + Topiramate + Vitamin B12 has caused metabolic acidosis during your pregnancy.
• Pregnancy Registry: If you become pregnant while taking Naltrexone + Topiramate + Vitamin B12, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of Naltrexone + Topiramate + Vitamin B12 and other antiepileptic drugs during pregnancy.

Who should not take Naltrexone + Topiramate + Vitamin B12?

• are using or have a physical dependence on opioid-containing medicines or opioid street drugs, such as heroin.
• are having opioid withdrawal symptoms. Opioid withdrawal symptoms may happen when you have been taking opioid containing medicines or opioid street drugs regularly and then stop. Symptoms of opioid withdrawal may include: anxiety, sleeplessness, yawning, fever, sweating, teary eyes, runny nose, goosebumps, shakiness, hot or cold flushes, muscle aches, muscle twitches, restlessness, nausea and vomiting, diarrhea, or stomach cramps.
• are allergic to Naltrexone + Topiramate + Vitamin B12, or any of the inactive ingredients in Naltrexone + Topiramate + Vitamin B12. Inactive ingredients include: magnesium stearate, maltodextrin, dextrose, sucralose, FD&C Yellow #5/Tartrazine, green color, silicon dioxide, microcrystalline cellulose, silica.

What should I tell my healthcare provider before taking Naltrexone + Topiramate + Vitamin B12?

• Before you take Naltrexone + Topiramate + Vitamin B12, tell your healthcare provider if you:
• use or abuse street (illegal) drugs
• have hemophilia or other bleeding problems
• are pregnant or plan to become pregnant.
• are breastfeeding. Naltrexone + Topiramate + Vitamin B12 passes into breast milk. Talk to your healthcare provider about whether you will breastfeed or take Naltrexone + Topiramate + Vitamin B12. You should not do both.
• Have or have had depression, mood problems, or suicidal thoughts or behavior
• Have kidney problems, have kidney stones, or are getting kidney dialysis
• Have a history of metabolic acidosis (too much acid in the blood)
• Have liver problems
• Have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density)
• Have lung or breathing problems
• Have eye problems, especially glaucoma
• Have diarrhea
• are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet
• are having surgery
• have any other medical conditions

• any opioid-containing medicines for pain, cough or colds, or diarrhea.
• valproic acid (such as Depakene® or Depakote®).
• any medicines that impair or decrease your thinking, concentration, or muscle coordination.
• birth control that contains hormones (such as pills, implants, patches or injections). Topiramate may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you are using birth control and Topiramate.

Medication disposal

• Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;
• Place the mixture in a container such as a sealed plastic bag;
• Throw away the container in your trash at home; and
• Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.