Warnings
IMPORTANT SAFETY INFORMATION
Naltrexone + Topiramate + Vitamin B12 can cause serious side effects, including:
Tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.
Your compounded medication contains Vitamin B12. Please use caution when taking additional over-the-counter vitamins or supplements and ensure that your total daily intake does not exceed recommended limits.
Talk to your healthcare provider about naloxone, a medicine that is available to patients for the emergency treatment of an opioid overdose. Call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered.
Sudden opioid withdrawal. To avoid sudden opioid withdrawal, you must stop taking any type of opioid, including street drugs; prescription pain medicines; cough, cold, or diarrhea medicines that contain opioids; or opioid-dependence treatments, including buprenorphine or methadone, for at least 7 to 14 days before starting Naltrexone + Topiramate + Vitamin B12. Sudden opioid withdrawal can be severe and may require hospitalization.
Liver damage or hepatitis. Naltrexone + Topiramate + Vitamin B12 can cause liver damage or hepatitis. Tell your healthcare provider if you have any of these symptoms during treatment with Naltrexone + Topiramate + Vitamin B12:
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.
You must stop taking opioids before you start taking Naltrexone + Topiramate + Vitamin B12. It is not known if Naltrexone + Topiramate + Vitamin B12 is safe and effective in children.
Naltrexone + Topiramate + Vitamin B12 may cause eye problems. Serious eye problems include:
These eye problems can lead to permanent loss of vision if not treated.
Should you notice any new eye symptoms, including any new problems with your vision, immediately discontinue use of Topiramate and seek urgent in-person evaluation. Please also message your provider team as soon as you are able.
Naltrexone + Topiramate + Vitamin B12 may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. If a high fever, a fever that does not go away, or decreased sweating develops, message your healthcare provider right away.
Naltrexone + Topiramate + Vitamin B12 can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will:
Feel tired
Not feel hungry (loss of appetite)
Feel changes in heartbeat
Have trouble thinking clearly
While not a standard of care for healthcare providers who specialize in weight loss, a blood test to measure the level of acid in your blood before treatment with Naltrexone + Topiramate + Vitamin B12, can be considered. Should you wish to have this testing completed please inform a member of our care team. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.
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
Naltrexone + Topiramate + Vitamin B12 may lower bone mineral density. Naltrexone + Topiramate + Vitamin B12 may decrease the density of bones when used over a long period.
Naltrexone + Topiramate + Vitamin B12 may have negative effects on growth in children. Naltrexone + Topiramate + Vitamin B12 may slow height increases and weight gain in children and adolescents when used over a long period
Do not stop Naltrexone + Topiramate + Vitamin B12 without first talking to a healthcare provider.
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.
Naltrexone + Topiramate + Vitamin B12 can harm your unborn baby.
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?
Do not take Naltrexone + Topiramate + Vitamin B12 if you:
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
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:
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.
Ask your healthcare provider if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.
Medication disposal
If you no longer need your medication, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.
If no drug take back sites, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can visit FDA- Disposal of Unused Medicines for more information or follow these simple steps to dispose of most medicines in your trash at home:
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.
This is only a summary of the most important information about Naltrexone + Topiramate + Vitamin B12.
Need more information?
Ask your healthcare provider or pharmacist.
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