What is Supprexone?

Supprexone is a compounded medication containing low-dose Naltrexone (4.5mg), Bupropion (75mg), Liothyronine T3 (.01mg), and Chromium (.4mg)

To be administered orally once daily in the morning.

Appetite Control

Supprexone is a combination medicine used with diet & exercise to help manage weight in obese or overweight adults with weight-related medical problems.

Bupropion is an antidepressant medicine that can also decrease appetite. Naltrexone is usually given to block the effects of opioids or alcohol in people with addiction problems. Naltrexone may also curb hunger and food cravings.

Note:

• Bupropion and naltrexone will not treat any weight-related medical condition, such as high blood pressure, diabetes, or high cholesterol.
• This medication is not approved to treat depression or other psychiatric conditions, or to help you quit smoking.
• Bupropion and naltrexone may also be used for purposes not listed in this medication guide.

Additional Benefits of Low-Dose Naltrexone

Low-dose naltrexone (LDN) has garnered attention for its potential therapeutic benefits across a range of conditions. Here are some potential benefits associated with LDN:

• Pain Management: LDN is believed to modulate pain perception and can be effective in managing various types of pain, including neuropathic pain, fibromyalgia, and chronic inflammatory conditions.
• Autoimmune Disorders: Some research suggests that LDN may help modulate the immune system’s response, potentially reducing inflammation associated with autoimmune diseases like multiple sclerosis, Crohn’s disease, rheumatoid arthritis, and lupus.
• Improved Mood: There’s anecdotal evidence suggesting LDN may have mood-enhancing effects, potentially helping with conditions like depression and anxiety.
• Better Sleep: LDN has been reported to improve sleep quality in some individuals, possibly due to its effects on pain and mood regulation.
• Potential Cancer Treatment: There’s ongoing research exploring LDN’s role in cancer treatment, particularly in conjunction with conventional therapies. It’s thought to have anti-inflammatory and immune-modulating effects that could aid in cancer treatment.
• Reduced Inflammation: LDN may help reduce inflammation throughout the body, which could be beneficial for various conditions characterized by chronic inflammation.
• Improved Quality of Life: Many individuals report an overall improvement in their quality of life while taking LDN, attributing it to reduced pain, improved mood, better sleep, and increased energy levels.
• Fewer Side Effects: At low doses, naltrexone tends to have fewer side effects compared to higher doses used for treating opioid addiction. Common side effects reported with LDN are typically mild and transient.
• Potential Neuroprotective Effects: Some research suggests LDN may have neuroprotective properties, making it a potential candidate for treating neurodegenerative diseases like Alzheimer’s and Parkinson’s disease.

It’s important to note that while LDN shows promise for various conditions, more research is needed to fully understand its mechanisms of action and effectiveness across different medical conditions. Additionally, individual responses to LDN can vary, and it may not be suitable for everyone. As with any medication or treatment, it’s essential to consult with a healthcare professional before starting LDN therapy.

Warnings

You should not use this medicine if you have uncontrolled high blood pressure, seizures, an eating disorder, opioid addiction, if you are pregnant, if you take opioid medicine or other forms of bupropion, or if you have suddenly stopped using alcohol, seizure medication, or a sedative.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with bupropion and naltrexone, and some drugs should not be used together.

Some young people have thoughts about suicide when first taking bupropion. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before taking this medicine

Do not use bupropion and naltrexone if you are pregnant. Weight loss during pregnancy can harm an unborn baby, even if you are overweight. Tell your doctor right away if you become pregnant.

You should not use this medicine if you are allergic to bupropion or naltrexone, or if you have:

• untreated or uncontrolled high blood pressure;
• an eating disorder (anorexia or bulimia);
• a history of seizures;
• opioid addiction or withdrawal (or if you take methadone or buprenorphine);
• if you take other forms of bupropion (Wellbutrin, Aplenzin, Budeprion, Forfivo, Zyban, and others); or
• if you have suddenly stopped using alcohol, seizure medication, or a sedative such as Xanax, Valium, Fiorinal, Klonopin, and others).

Do not use opioid medication for a minimum of 7 to 10 days before starting bupropion and naltrexone.

Do not use an MAO inhibitor within 14 days before or 14 days after you take bupropion and naltrexone. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Tell your doctor if you have ever had:

• depression, bipolar disorder, or mental illness;
• suicidal thoughts or actions;
• a head injury;
• a tumor or infection in your brain or spinal cord;
• diabetes or low blood sugar;
• low sodium levels;
• liver or kidney disease;
• heart disease, high blood pressure, heart attack, or stroke; or
• drug addiction, or if you normally drink a lot of alcohol.

Some young people have thoughts about suicide when first taking bupropion. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

You should not breastfeed while using this medicine.

This medicine is not approved for use by anyone younger than 18 years old.

How should I take bupropion and naltrexone?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Swallow the tablet whole and do not crush, chew, or break it.

Do not take more than 2 tablets at once.

Do not take this medicine with a high-fat meal, or you may be more likely to have a seizure.

If you need to use opioid medicine for any reason (such as pain, surgery, or treatment for drug addiction) you may need to stop taking bupropion and naltrexone for a short time. Follow your doctor’s dosing instructions very carefully.

This medicine may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use bupropion and naltrexone.

Store at room temperature away from moisture and heat.

If you have not lost at least 5% of your starting weight after 16 weeks of treatment, this medicine may not be right for you.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Do not take more than 4 tablets in 1 day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of bupropion and naltrexone can be fatal, especially if you also take an opioid medicine.

What should I avoid while taking bupropion and naltrexone?

Drinking alcohol with bupropion may increase your risk of seizures. If you drink alcohol regularly, talk with your doctor before changing the amount you drink. Bupropion can also cause seizures in a regular drinker who suddenly stops drinking.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity. Do not take other weight-loss products or diet pills unless your doctor has told you to.

Do not use opioid medication, methadone, heroin, or other street drugs while you are taking bupropion and naltrexone. Doing so could result in dangerous effects, including coma and death.

Bupropion and naltrexone side effects

Get emergency medical help if you have signs of an allergic reaction: fever, swollen glands, mouth sores, muscle or joint pain; hives, rash or itching; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, severe drowsiness, or if you are hard to wake up.

Stop taking bupropion and naltrexone and call your doctor right away if you have:

• severe headache, blurred vision, pounding in your neck or ears, fast heartbeats;
• a seizure (convulsions);
• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• changes in mood or behavior–anxiety, depression, panic attacks, trouble sleeping, agitation, thoughts about suicide or hurting yourself;
• a manic episode–racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative;
• liver problems–upper stomach pain, tiredness, dark urine, jaundice (yellowing of the skin or eyes); or
• severe skin reaction–fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling.

Older adults may be more likely to have certain side effects.

Common side effects may include:

• nausea, vomiting, diarrhea, constipation;
• headache, dizziness;
• dry mouth; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Bupropion and naltrexone dosing information

Usual Adult Dose for Weight Loss:

Each extended-release tablet contains naltrexone 8 mg/bupropion 90 mg:

Initial dose:
-Week 1: One tablet orally once a day in the morning
-Week 2: One tablet orally 2 times a day (morning and evening)
-Week 3: Two tablets orally in the morning and 1 tablet orally in the evening
-Week 4: Two tablets orally 2 times a day (morning and evening)
Maintenance dose: 2 tablets orally 2 times a day (morning and evening)
Maximum dose: 4 tablets/day (naltrexone 32 mg/bupropion 360 mg)

Comments:
-Therapy should be discontinued if a patient has not lost at least 5% of baseline body weight after 12 weeks at maintenance dose as it is unlikely that clinically meaningful weight loss will occur with continued treatment.
-The effect of this drug on cardiovascular morbidity and mortality has not been established.
-The safety and effectiveness of this drug in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Uses: As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).