Patient Drug Information
Commercial and Compounded Oral Tablets
For weight loss and treatment of obesity
BPG-WEIGHTLOSS-PIB-02
About your medication: Written information about this prescription has been provided for you. Please read this information before you take this medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions.
Your treatment plan is personalized for you and may include a combination of commercially available medications and custom compounded medications. PLEASE CAREFULLY REVIEW YOUR MEDICATION LABELS TO DETERMINE WHICH OF THE FOLLOWING INGREDIENTS IN THIS GUIDE ARE CONTAINED IN YOUR MEDICATIONS.
If your treatment plan contains Bupropion hydrochloride a medication guide will also be included.
This is a compounded prescription product and has not been approved by the FDA. The FDA does not verify the safety, effectiveness, or quality of compounded drugs.
Warning for Metformin Hydrochloride: Rarely, metformin may cause too much lactic acid in the blood (lactic acidosis). The risk is higher in people who have kidney problems, liver problems, heart failure, use alcohol, or take other drugs like topiramate. The risk is also higher in people who are 65 or older and in people who are having surgery, an exam or test with contrast dye, or other procedures. If lactic acidosis happens, it can lead to other health problems and can be deadly. Kidney tests may be done while taking this drug at higher doses. Warning for Bupropion Hydrochloride: Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Contact your medical provider, the national Suicide and Crisis Lifeline by dialing 988, or call 911 if you experience any of the following symptoms: attempts to commit suicide; acting on dangerous impulses; acting aggressive or violent; thoughts about dying or suicide; new or worse depression; new or worse anxiety or panic attack; feeling agitated, restless, angry, or irritable; trouble sleeping;an increase in activity or talking more than what is normal for you; or other unusual changes in behavior or mood. |
Important Information:
This should only be taken by the patient whose name appears on the prescription label.
Active Ingredients
- Metformin Hydrochloride Extended-Release (ER) is an anti-diabetes agent and biguanide, FDA-approved to treat type 2 diabetes and used off-label to help with weight loss.
- Metformin’s most common side effects are stomach upset, such as cramping, gas, diarrhea, nausea, or vomiting. These typically subside over time. You may also experience headache or feeling tired. Side effects are best lessened by taking this medication with food.
- Bupropion Hydrochloride Extended-Release (XL) is a Dopamine/Norepinephrine-Reuptake Inhibitor and antidepressant FDA-approved to treat major depressive disorder and seasonal affective disorder and used off-label to help with weight loss.
- Bupropion’s most common side effects are dizziness or headache, nausea, decreased appetite, shakiness, excitability or nervousness, dry mouth, and trouble sleeping. The side effects usually go away in 48-72 hours.
- Naltrexone hydrochloride is an opioid antagonist, FDA-approved to treat alcohol use disorder and opioid dependence and used off-label to help with weight loss.
- Naltrexone’s most common side effects are headache, joint stiffness, nervousness, constipation, diarrhea, nausea and vomiting, or dizziness. Contact your provider right away if you notice signs of liver problems, such as dark urine, light colored stools, and/or yellowing of the skin or eyes.
- Topiramate is an anti-seizure agent FDA-approved to treat seizure disorders and migraine prevention and used off-label to help with weight loss.
- Topiramate’s most common side effects are constipation, diarrhea, nausea, or vomiting, change in taste, nervousness, headache, flushing, or paresthesias (a tingly, burning or numb feeling in the skin). Topiramate can potentially cause closed-angle glaucoma as a rare but serious side effect. If you experience vision changes, seek immediate medical attention. You may experience language problems, such as difficulty recalling words. This is not permanent and resolves within a few days after you stop taking the drug.
- Vitamin B12 (Cyanocobalamin) is a B vitamin used to supplement the diet. It is FDA-approved to treat pernicious anemia and off-label to reduce the chance of B12 deficiency associated with metformin or reduced dietary intake.
- Cyanocobalamin’s most common side effects are headache, diarrhea, dizziness, or joint pain.
Precautions and contraindications
- Do not take this medication if you are allergic to any of the components. Do not take if you are pregnant or breastfeeding.
- Metformin HCL ER: Do not take if you have severe kidney disease. You may see something that looks like a tablet in your stool. This is normal and is an inactive component of the drug. Seek emergency medical care if you experience signs of too much acid in the blood (acidosis) like confusion; fast breathing; rapid heartbeat; a heartbeat that does not feel normal; severe stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
- Bupropion XL: Do not take if you have a seizure disorder or a condition that increases seizure risk such as severe head injury, stroke, anorexia or bulimia, brain tumor or infection. Do not abruptly stop alcohol or benzodiazepines while taking bupropion.Do not take with medications called MAOIs, or monoamine oxidase inhibitors.
- Naltrexone HCL: Do not take naltrexone if you are currently using medications or substances that contain opioids, such as narcotic pain medications. If you are currently using, or have used opioids in the last 7-10 days, then you may experience signs and symptoms of withdrawal. These include but are not limited to: sweating, shaking, fever, chills, diarrhea, upset stomach, throwing up, stomach cramps, goosebumps, body aches, anxiety, feeling irritable, yawning, or fast heartbeat. Sudden opioid withdrawal can be severe and you may need to seek medical attention right away. Contact your doctor or pharmacist if you have been prescribed opioids after starting Naltrexone.
- Topiramate: Use with caution in combination with medications that may make you drowsy, as it may enhance the effect. Do not suddenly stop taking this medication as it may increase your risk of seizure. Do not take this medication if you are pregnant or breastfeeding. Topiramate can cause serious harm to an unborn baby. It's important to be aware of the risks of taking topiramate during pregnancy and to take steps to prevent pregnancy while taking this medication. Seek emergency medical care if you experience signs of too much acid in the blood (acidosis) like confusion; fast breathing; rapid heartbeat; a heartbeat that does not feel normal; severe stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak
- Vitamin B12 (cyanocobalamin): Use with caution in combination with chloramphenicol, as it may decrease the effect of B12.
Directions for use
- For commercial Metformin ER: Take metformin one to two times daily with meals as directed by your provider.
- For compounded medications containing Naltrexone Hydrochloride, Topiramate, or Vitamin B12 (Cyanocobalamin): Take one-half to one tablet once or twice daily, as directed by your prescriber.
- For commercial Bupropion XL: Take bupropion once daily in the morning, as it may cause trouble sleeping if taken later.
- It is recommended that you slowly increase the dose of these medications in order to decrease the side effects. The suggested dose titration schedules are provided by your prescriber in your treatment plan. If side effects persist, talk to your pharmacist or medical provider, as they may recommend changes to the below escalation schedule.
- Storage
Store your medication at room temperature between 68 and 77 degrees F/(20°C to 25°C) in the packaging provided by the pharmacy until you need it. Keep out of reach of children. - Under certain circumstances a prescription drug’s effectiveness may be affected by exposure to extremes of heat, cold, or humidity.
Missed Dose
If you miss a dose of the medication, take it as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for the missed dose. Check your prescription label for the correct dose prescribed by your medical provider.
Disposal of Medications
This medication may contain a hazardous drug. Do not flush unused medication down the toilet or pour in the sink or drain. Dispose according to local regulations.
Questions
This written information may not cover all possible information. If you have any questions, talk to your pharmacist or medical provider.
A local or a toll-free telephone service is available, staffed by a registered pharmacist, to answer questions about your medication. You can find the number for the pharmacy on the label of your prescription product.
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