Weight Loss Ideas

Summary of below ideas. Discuss any changes with your doctor before starting:

1. Foods to avoid: 1) Anything with a nutrition label 2) Fruits 3) Restaurant foods- alternatives are to fast or only eat the vegetables and ask for no added sugar

2. Eat these foods: Vegetables (80% of the plate and daily 30+ grams insoluble fiber), meats (avoid chicken), and fish that you prepare

3. Follow time restricted, intermittent feeding patterns with a base of 16:8 and twice a week 24:4 (see below)

4. Exercise: during your fasting period is best. (see details below)

5. Daily monitoring: proper use of CGM for monitoring and Ketone blood testing for goal above 1.0 at end of fasting periods. (see below)

6. Get a baseline DEXA body composition scan and check yearly the changes in % visceral fat, VAT, ALMI, FFMI

7. Read these books and details below.

Steps to Becoming a Vegan if This Interests You or how to increase veges in your diet.

Following a vegan dietary regimen is NOT necessary, but many patients ask how to begin such a diet. Below are suggestions and reading material.

This is a long process and so get informed

Watch the following films:

1. The Game Changers

2. What the Health

3. Supersize Me

4. Food, Inc

5. King Corn

6. Fast Food Nation

7. Forks Over Knives

8. Planeat

Read the following books:

1. How Not to Die. by Dr. Michael Greger

2. Metabolical: by Dr. Lustig

3. The Original Fast Foods by James and Colleen Simmons

4. The China Study by T. Colin Campbell

5. Fit For Life by Harvey and Marilyn Diamond

6. Eat More, Weigh Less: Dr. Dean Ornish's Life Choice Program for Losing Weight Safely While Eating Abundantly by Dr. Dean Ornish

Consider visiting the following websites for RECIPES.

FYI Vegan DOES NOT MEAN EATING SALADS EVERY DAY and does not include processed vegan items (fake meat, sodas, chips, etc).:

http://www.veganpeace.com/animal_cruelty/animal_cruelty.htm

http://www.tcolincampbell.org

http://www.vegfamily.com/vegan-pregnancy/index.htm

http://www.vegansociety.com

https://cleanfooddirtygirl.com/ also has support group

Ditch dieting and start permanent changes

You don't have to be vegan. But you should pick one type of diet and stick with it

Baby Steps

Dr. Jogi recommends a gradual approach to improving you diet. It takes years to build a habit, so don't change it overnight. Make these very gradual changes:

a. Take into account all of the junk food in your home. This includes anything with sugar, refined flour, and has been processed. Make a list of it and post it on the fridge. This should also include fake faux meats, chips, crackers, tortillas, and pasta.

b. On a weekly basis, target one junk food that you have decided you are not going to buy anymore and replace it with a healthier food that you like. For example, if you cook with white flour start buying whole wheat flour. If you buy potato chips and cheese dip every week, start buying corn chips and salsa instead. If you eat raisinets every day, start buying plain raisins or grapes instead.

Shop the perimeters of a grocery store

Reduce the Eggs

Avoid dairy and chicken meat

If you really are not taking any meat, eggs, or dairy, then Dr. Jogi strongly recommends vitamin B12, 1000 units daily.

Pharmaceuticals for weight loss ... buyer beware

The  pharmaceutical answer for weight loss is life long treatment with medication. Note that there are FDA approved drugs for weight loss such as Saxenda and Wegovy which have the same active ingredient as their lower dose diabetes counterparts Victoza and Ozempic. The diabetes versions are not meant for weight loss. Trulicity, Byetta, Bydureon are also in the GLP-1 agonist class of medications.

There is a similar class of medication called  Glucose-dependent insulinotropic polypeptide (GIP) receptor + glucagon-like peptide-1 (GLP-1) receptor agonist such as Mounjaro (tirzepatide) with similar side effects as Victoza and Ozempic.. This class is meant for diabetes mellitus and not meant be used for weight loss. 

Dr. Jogi wants patients to strongly consider these reasons NOT  to use a GLP1 or GLP1/GIP agonist medication (Byetta, Bydureon, Victoza, Trulicity, Ozempic, Rybelsus, Mounjaro) for an OFF LABEL weight loss indication. The indications to use Wegovy or Saxenda specifically are obesity (BMI more than 30). Dr. Jogi wants patients to consider the theoretical concepts below. 

1. The use of GLP1 agonist DOES NOT CURE OBESITY: 

These medications have  prescribed since 2005 and Dr. Jogi was involved with early research studies (animal studies and human studies on liver fat)about these medications. Initially the results seemed too good to be true (TGBT) and one should know what happens with things that are TGBT.  If this class of medication really were a true fix then the effects on weight would be permanent. In his experience the GLP1 agonist appetite effects leading to weight loss effects are temporary (18-24 months on average) and then the effect wanes and patients gain weight again. 

2. The use of GLP1 and GLP1/GIP agonists frequently seem to cause REDUCED MUSCLE STRENGTH. 

Once the GLP1 appetite effect weans or the patient stops the medication after more than 3 months of use, the weight rapidly rises. There may be a reduction in effective muscle strength and quality. More research is needed. So during the use of these medications regular strength training is advised.

3. The actual weight loss effect of GLP1 and GLP1/GIP agonists is probably only due to PAID-FOR, UNPREDICTABLE IATROGENIC GASTROPARESIS: 

Many patients have already experienced how a GLP1 agonist will reduce appetite because it is similar to a viral gastroenteritis. A viral gastroenteritis (stomach flu) is a viral cause of a severe slowing of stomach emptying time (gastroparesis) which leads to a sensation of fullness and therefore reduced appetite. This is probably the mechanism by which GLP1 agonists cause patients to lose weight.  Studies show that the most common side effect of the GLP1 agonist class of medications is a  "gastrointestinal adverse reaction" which is probably due to the know effect of GLP1 on the body, but what does that mean?  Nausea, Vomiting, Constipation, Diarrhea: these are consequences of a stomach slow down. No one really knows how the true pathogenesis of gastroparesis but there are many theories which include direct and indirect effects on the autonomic nervous system (the automated nervous system which allows the gut to move without conscious thought). Controlled GLP-1 induced gastroparesis sounds good in theory but generally the effects are unpredictable and sometimes severe. Dr. Jogi is a strong proponent of the ingestion of high amounts of insoluble fiber as a way to treat obesity and diabetes and note that insoluble fiber also can induce temporary controlled gastroparesis, for a much lower cost than GLP-1 agonist medications. If the weight loss from these drugs is due to reduced food intake, why pay pharmaceutical companies for the privilege of not eating? Why not read the above ideas about fasting and diet and take them to heart? 

4. The use of GLP1 and GLP1/GIP agonist medication can cause SYMPTOMATIC OF ASYMPTOMATIC PANCREATITIS: 

One of the most feared side effects of a GLP-1 or GLP1/GIP agonist is pancreatitis. The pancreas is an organ which normally creates digestive juices when a person is eating which travel in a secure mechanism into the small intestines as part of the normal digestive process. Pancreatitis is a condition in which the pancreas becomes inflamed and leaks out the digestive juices when someone is eating so that the person starts to digest themselves along with the food. "Clinical Acute Pancreatitis" means that a patient says they have a sensation of pain in their abdomen which sometimes travels to their back when they are eating. The only screening for pancreatitis is "are you having abdominal pain" and the only treatment for pancreatitis is NOT TO EAT for several days or weeks to stop the production of the digestive juices that are eating the patient's insides. If left unchecked then this can lead to "Clinical Chronic Pancreatitis" which means even if the cause was stopped (GLP1 agonist) the damage is permanent and so every time a person eats they are in pain. The most common known cause of pancreatic cancer is chronic pancreatitis. OK, so what? You have abdominal pains, you stop the medication and hope there is not too much damage....but what if the pancreatitis is silent? There is very little data on the number of patients on  long term GLP-1 agonists who will develop "Subclinical (silent) Chronic Pancreatitis" which then may cause unknown issues far into the future. There are no clear guidelines for screening for patients for pancreatic cancer risk in those with clinical pancreatitis, let along silent chronic pancreatitis. 

5. GLP-1 and GLP1/GIP agonist medications have unknown IMMUNE EFFECTS: 

As of December of 2022, there are now known connections of GLP1 agonists on the modulation of  innate immune system, but all is essentially unknown. It would be nice to know more about these good and bad effects and weight them against any possible benefit from GLP1 agonist medications. 

6. The positive molecular benefits of GLP1 and GLP1/GIP agonists are SIMILAR BENEFITS OF INTERMITTENT FASTING: 

There is a lot of investment in researching the "mechanisms" by which metabolic disease is ameliorated with the use of GLP1 agonist medications. See figure 1 in this paper about the molecular benefits with the GLP1 agonists. Numerous papers (here and here) show the same or better effects of intermittent fasting and papers showing the same benefit of insoluble fiber. 

Saxenda (Liraglutide) Side Effects

The recommended dosage of Saxenda is 3 mg daily. The dose escalation schedule should be used to reduce the likelihood of gastrointestinal symptoms. If patients do not tolerate an increased dose during dose escalation, consider delaying dose escalation for approximately one additional week. Saxenda should be discontinued, however, if a patient cannot tolerate the 3 mg dose, as efficacy has not been established at lower doses (0.6, 1.2, 1.8, and 2.4 mg) Saxenda should be taken once daily at any time of day, without regard to the timing of meals. Saxenda can be injected subcutaneously in the abdomen, thigh, or upper arm. The injection site and timing can be changed without dose adjustment. Saxenda must not be administered intravenously or intramuscularly

Week 1 0.6 mg

Week 2 1.2 mg

Week 3 1.8 mg

Week 4 2.4 mg

Week 5 and onward 3 mg

--

WARNING:

RISK OF THYROID C-CELL TUMORS

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda* causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Saxenda* is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the risk of MTC with use of Saxenda* and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Saxenda*.

Indications and Usage

Saxenda* (liraglutide [rDNA origin] injection) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients 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).

Limitations of Use

Saxenda* is not indicated for the treatment of type 2 diabetes.

Saxenda* and Victoza* both contain the same active ingredient, liraglutide, and therefore should not be used together. Saxenda* should not be used in combination with any other GLP-1 receptor agonist.

Saxenda* has not been studied in patients taking insulin. Saxenda* and insulin should not be used together.

The effects of Saxenda* on cardiovascular morbidity and mortality have not been established.

The safety and efficacy of Saxenda* in combination with other products for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Saxenda* has not been studied in patients with a history of pancreatitis.

Contraindications

Saxenda* is contraindicated in the following conditions:

Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Patients with a prior serious hypersensitivity reaction to liraglutide or to any of the product components

Pregnancy

Warnings and Precautions

Risk of Thyroid C-cell Tumors: If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

Acute Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide. After initiation of Saxenda* observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Saxenda* should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Saxenda* should not be restarted.

Acute Gallbladder Disease: Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in patients treated with Saxenda* than with placebo even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

Risk of Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy: When Saxenda* is used with an insulin secretagogue (e.g., a sulfonylurea) serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia. Monitor blood glucose parameters prior to starting Saxenda* and during Saxenda* treatment in patients with type 2 diabetes mellitus.

Heart Rate Increase: Mean increases in resting heart rate of 2 to 3 beats per minute (bpm) were observed with routine clinical monitoring in patients treated with Saxenda* compared to placebo in clinical trials. Heart rate should be monitored at regular intervals consistent with usual clinical practice. Patients should inform healthcare providers of palpitations or feelings of a racing heartbeat while at rest during Saxenda* treatment. For patients who experience a sustained increase in resting heart rate while taking Saxenda*, Saxenda* should be discontinued.

Renal Impairment: In patients treated with GLP-1 receptor agonists, including Saxenda*, there have been reports of acute renal failure and worsening of chronic renal failure, usually in association with nausea, vomiting, diarrhea, or dehydration, which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Saxenda* in patients with renal impairment.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported during postmarketing use of liraglutide. If symptoms of hypersensitivity reactions occur, patients must stop taking Saxenda* and promptly seek medical advice.

Suicidal Behavior and Ideation: In the Saxenda* clinical trials, 6 (0.2%) of 3,384 patients treated with Saxenda* and none of the 1,941 with placebo reported suicidal ideation; one of the patients treated with Saxenda* attempted suicide. Patients treated with Saxenda* should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Saxenda* in patients who experience suicidal thoughts or behaviors. Avoid Saxenda* in patients with a history of suicidal attempts or active suicidal ideation.

Adverse Events

The most common adverse reactions, reported in =5% are: nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase.

Drug Interactions

Oral Medications: Saxenda* causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. Monitor for potential consequences of delayed absorption of oral medications concomitantly administered with Saxenda*.

Use in Specific Populations

Nursing mothers should either discontinue Saxenda* or discontinue nursing.

Safety and effectiveness of Saxenda* have not been established in pediatric patients and is not recommended for use in pediatric patients.

Saxenda* slows gastric emptying. Saxenda* has not been studied in patients with preexisting gastroparesis.

Wegovy (Semeglutide) side effects

The recommended dosage of Wegovy is 2.4 mg WEEKLY. The dose

escalation schedule should be used to reduce the likelihood of gastrointestinal symptoms. If patients do not tolerate an increased dose during dose escalation, consider delaying dose escalation for approximately one additional week. Wegovy should be discontinued, however, if a patient cannot tolerate the 2.4 mg dose, as efficacy has not been established at lower doses. If you cannot tolerate and escalation dose, delay another 4 weeks. If not tolerating the 2.4 mg maintenance dosing, then can temporarily decrease to 1.7 mg weekly dosing for a maximum of 4 weeks, then after 4 weeks increase to 2.4 mg. DISCONTINUE IF YOU CANNOT TOLERATE THE 2.4 MG DOSING. Wegovy should be taken once daily at any time of day, without regard to the timing of meals. Wegovy can be injected subcutaneously in the abdomen, thigh, or upper arm. The injection site and timing can be changed without dose adjustment. Wegovy must not be administered intravenously or intramuscularly

(Dose escalation)

Weeks 1-4 0.25 mg

Week 5-8 0.5 mg

Week 9-12 1 mg

Week 13-16 1.7 mg

(Maintenance dosing)

Week 17 and onward 2.4 mg

--

WARNING:

RISK OF THYROID C-CELL TUMORS

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Wegovy* causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Wegovy* is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the risk of MTC with use of Wegovy* and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Wegovy*.

Indications and Usage

Wegovy* (liraglutide [rDNA origin] injection) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients 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).

Limitations of Use

Wegovy* is not indicated for the treatment of type 2 diabetes.

Suicidal Behaviors- have been reported. Discontinue if you have any changes in mood or behavior.

DO NOT USE IN PREGNANCY, STOP 4 months prior to conception

Acute Pancreatitis In WEGOVY clinical trials, acute pancreatitis was confirmed by adjudication in 4 WEGOVY- treated patients (0.2 cases per 100 patient years) versus 1 in placebo-treated patients (less than 0.1 cases per 100 patient years). One additional case of acute pancreatitis was confirmed in a patient treated with WEGOVY in another clinical trial.

Acute kidney injury occurred in clinical trials in 7 patients (0.4 cases per 100 patient years) receiving WEGOVY versus 4 patients (0.2 cases per 100 patient years of exposure) receiving placebo. Some of these adverse reactions occurred in association with gastrointestinal adverse reactions or dehydration. In addition, 2 patients treated with WEGOVY had acute kidney injury with dehydration in other clinical trials. The risk of renal adverse reactions with WEGOVY was increased in patients with a history of renal impairment (trials included 65 patients with a history of moderate or severe renal impairment at baseline), and occurred more frequently during dose titration

Increase in Heart Rate Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed with routine clinical monitoring in WEGOVY-treated patients compared to placebo in clinical trials. In trials in which patients were randomized prior to dose-escalation, more patients treated with WEGOVY*, compared with placebo, had maximum changes from baseline at any visit of 10 to 19 bpm (41% versus 34%, respectively) and 20 bpm or more (26% versus 16%, respectively).

Wegovy* and OZEMPIC * both contain the same active ingredient, liraglutide, and therefore should not be used together. Wegovy* should not be used in combination with any other GLP-1 receptor agonist.

Wegovy* has not been studied in patients taking insulin. Wegovy* and insulin should not be used together.

The effects of Wegovy* on cardiovascular morbidity and mortality have not been established.

The safety and efficacy of Wegovy* in combination with other products for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Wegovy* has not been studied in patients with a history of pancreatitis.

Contraindications

Wegovy* is contraindicated in the following conditions:

Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Patients with a prior serious hypersensitivity reaction to liraglutide or to any of the product components

Pregnancy

Warnings and Precautions

Risk of Thyroid C-cell Tumors: If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

Acute Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide. After initiation of Wegovy* observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Wegovy* should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Wegovy* should not be restarted.

Acute Gallbladder Disease: Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in patients treated with Wegovy* than with placebo even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

Risk of Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy: When Wegovy* is used with an insulin secretagogue (e.g., a sulfonylurea) serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia. Monitor blood glucose parameters prior to starting Wegovy* and during Wegovy* treatment in patients with type 2 diabetes mellitus.

Heart Rate Increase: Mean increases in resting heart rate of 2 to 3 beats per minute (bpm) were observed with routine clinical monitoring in patients treated with Wegovy* compared to placebo in clinical trials. Heart rate should be monitored at regular intervals consistent with usual clinical practice. Patients should inform healthcare providers of palpitations or feelings of a racing heartbeat while at rest during Wegovy* treatment. For patients who experience a sustained increase in resting heart rate while taking Wegovy*, Wegovy* should be discontinued.

Renal Impairment: In patients treated with GLP-1 receptor agonists, including Wegovy*, there have been reports of acute renal failure and worsening of chronic renal failure, usually in association with nausea, vomiting, diarrhea, or dehydration, which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Wegovy* in patients with renal impairment.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported during postmarketing use of liraglutide. If symptoms of hypersensitivity reactions occur, patients must stop taking Wegovy* and promptly seek medical advice.

Suicidal Behavior and Ideation: In the Wegovy* clinical trials, 6 (0.2%) of 3,384 patients treated with Wegovy* and none of the 1,941 with placebo reported suicidal ideation; one of the patients treated with Wegovy* attempted suicide. Patients treated with Wegovy* should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Wegovy* in patients who experience suicidal thoughts or behaviors. Avoid Wegovy* in patients with a history of suicidal attempts or active suicidal ideation.

Adverse Events

The most common adverse reactions, reported in =5% are: nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase.

Drug Interactions

Oral Medications: Wegovy* causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. Monitor for potential consequences of delayed absorption of oral medications concomitantly administered with Wegovy*.

Use in Specific Populations

Nursing mothers should either discontinue Wegovy* or discontinue nursing.

Safety and effectiveness of Wegovy* have not been established in pediatric patients and is not recommended for use in pediatric patients.

Wegovy* slows gastric emptying. Wegovy* has not been studied in patients with preexisting gastroparesis.

Qsymia FAQ & Side Effects (Dr. Jogi does not prescribe this as of 1-2022, nor does he prescribe phentermine)

Brand Names: US Qsymia

What is this drug used for?

--> It is used to help you lose weight.

What do I need to tell my doctor BEFORE I take this drug?

For all patients taking this drug:

--> If you have an allergy to phentermine, topiramate or any other part of this drug.

--> If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

--> If you have any of these health problems: Glaucoma or overactive thyroid disease.

--> If you have or have ever had low mood (depression) or thoughts of killing yourself.

--> If you have any of these health problems: Kidney disease or liver disease.

--> If you are taking any of these drugs: Acetazolamide, dichlorphenamide, methazolamide, or zonisamide.

--> If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.

--> If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.

--> If you are breast-feeding or plan to breast-feed.

Children:

--> If the patient is a child. Do not give this drug to a child.

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

--> Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.

--> Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.

--> Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of seizures. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.

--> Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.

--> Have blood work checked as you have been told by the doctor. Talk with the doctor.

--> Avoid drinking alcohol while taking this drug.

--> Talk with your doctor before you use other drugs and natural products that slow your actions.

--> If you have high blood sugar (diabetes) and take drugs to lower blood sugar, talk with your doctor. Weight loss may raise the chance of low blood sugar if you take drugs to lower blood sugar. Call your doctor right away if you have signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.

--> If you are being treated for high blood pressure, talk with your doctor. Weight loss may raise the chance of low blood pressure in people who are treated for high blood pressure. Call your doctor right away if you have signs of low blood pressure like very bad dizziness or passing out.

--> This drug may cause an acid blood problem (metabolic acidosis). The chance may be higher in children and in people with kidney problems, breathing problems, or loose stools (diarrhea). The chance may also be higher if you take certain other drugs, if you have surgery, or if you are on a ketogenic diet. Over time, metabolic acidosis can cause kidney stones, bone problems, or growth problems in children. Talk with your doctor.

--> Follow the diet and workout plan that your doctor told you about.

--> Sweating less and high body temperatures have happened with this drug. Sometimes, this has led to the need for treatment in a hospital. Be careful in hot weather and while being active. Call your doctor right away if you have a fever or you do not sweat during activities or in warm temperatures.

--> If you take birth control, your monthly period (menstrual bleeding) may change while taking this drug. Talk with your doctor if this happens.

--> This drug may cause harm to the unborn baby if you take it while you are pregnant.

--> If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting this drug. Talk with your doctor.

--> A pregnancy test will be done every month during care.

--> Use birth control that you can trust to prevent pregnancy while taking this drug.

--> If you are pregnant or you get pregnant while taking this drug, call your doctor right away.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

--> Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

--> Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.

--> Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.

--> Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.

--> Feeling confused.

--> Chest pain or pressure or a fast heartbeat.

--> Not able to focus.

--> Memory problems or loss.

--> Trouble speaking.

--> Not able to sleep.

--> Back pain, belly pain, or blood in the urine. May be signs of a kidney stone.

--> Patients who take this drug may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.

--> This drug may cause very bad eye problems. If left untreated, this can lead to lasting eyesight loss. Call your doctor right away if you have new eye signs like blurred eyesight or other changes in eyesight, eye pain, or eye redness.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

--> Headache.

--> Constipation.

--> Dry mouth.

--> Numbness and tingling.

--> Dizziness.

--> Change in taste.

--> Upset stomach.

--> Diarrhea.

--> Feeling tired or weak.

--> Nose or throat irritation.

--> Back pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

--> Take this drug early in the day to prevent sleep problems.

--> Take with or without food.

--> Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

--> Skip the missed dose and go back to your normal time.

--> Do not take 2 doses at the same time or extra doses.

Contrave Side Effects and Dosing ( Dr. Jogi stopped prescribing this in 2019)

Dosing

One tablet (naltrexone 8 mg/bupropion 90 mg) once daily in the morning for 1 week; at week 2, increase to 1 tablet twice daily administered in the morning and evening and continue for 1 week; at week 3, increase to 2 tablets in the morning and 1 tablet in the evening and continue for 1 week; at week 4, increase to 2 tablets twice daily administered in the morning and evening and continue for the remainder of the treatment course.

If the patient has not lost at least 5% of baseline body weight after 12 weeks at the maintenance dosage, discontinue therapy; clinically meaningful weight loss is unlikely with continued treatment.

MUST have pregnancy testing before starting. It is contraindicted during a pregnancy

Contrave is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. Contrave contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Aplenzin). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on Contrave, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Contrave is not approved for use in pediatric patients.

1. Accidental opioid overdose: Patients treated with naltrexone may respond to lower opioid doses than previously used. This could result in potentially life-threatening opioid intoxication. Warn patients that any attempt to overcome opioid blockade during naltrexone therapy is dangerous and could potentially lead to fatal opioid overdose; the opioid competitive receptor blockade produced by naltrexone is potentially surmountable in the presence of large amounts of opioids. If chronic opiate therapy is required, naltrexone/bupropion should be stopped; if intermittent opiate therapy is required, temporarily discontinue naltrexone/bupropion and lower doses of opioids may be needed.

2. Acute opioid withdrawal: May precipitate symptoms of acute withdrawal in opioid-dependent patients. An opioid-free interval of a at least 7 to 10 days is recommended for patients previously dependent on short-acting opioids (including tramadol); consider an opioid-free interval of up to 2 weeks in patients transitioning from buprenorphine or methadone.

3. Cardiovascular effects: May elevate heart rate, blood pressure and cause hypertension; use is contraindicated in patients with uncontrolled hypertension. Events have been observed in patients with or without evidence of preexisting hypertension. Risks may be greater during the initial 3 months of therapy. Assess heart rate and blood pressure before initiating treatment and monitor periodically.

4. Hepatotoxicity: Cases of hepatitis, significant liver dysfunction, and transient, asymptomatic hepatic transaminase elevations have been observed with naltrexone use. Discontinue therapy if signs/symptoms of acute hepatitis develop. Clinicians should note that elevated transaminases may be a result of preexisting alcoholic liver disease, hepatitis B and/or C infection, or concomitant use of other hepatotoxic drugs; abrupt opioid withdrawal may also lead to acute liver injury.

5. Hypersensitivity reactions: Anaphylactoid/anaphylactic reactions have occurred, including pruritus, urticaria, angioedema, and dyspnea. Serious reactions have been (rarely) reported with bupropion, including erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock. Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity resembling serum sickness have been reported with bupropion.

6. Neuropsychiatric effect: Although naltrexone/bupropion is not approved for smoking cessation, serious neuropsychiatric events have occurred in patients taking bupropion for smoking cessation, including changes in mood (eg, depression, mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, panic, suicidal ideation, suicide attempt, and completed suicide. The majority of these reactions occurred during bupropion treatment; however some occurred during treatment discontinuation. A causal relationship is uncertain as depressed mood may be a symptom of nicotine withdrawal. Some cases also occurred in patients taking bupropion who continued to smoke. Neuropsychiatric effects occurred in patients with and without preexisting psychiatric disease; some patients experienced a worsening of their psychiatric illnesses. Observe all patients taking bupropion for neuropsychiatric reactions. Instruct patients to stop taking naltrexone/bupropion and contact a health care provider if neuropsychiatric reactions occur. Depression, suicide, attempted suicide, and suicidal ideation have also been reported with naltrexone use for the treatment of opioid dependence; however, no causal relationship has been demonstrated.

7. Ocular effects: Bupropion may cause mild pupillary dilation, which in susceptible individuals can lead to an episode of narrow-angle glaucoma. Consider evaluating patients who have not had an iridectomy for narrow-angle glaucoma risk factors.

8. Seizures: Bupropion may cause a dose-related risk of seizures. Use is contraindicated in patients with a seizure disorder or a history of seizures, current or past diagnosis of bulimia or anorexia nervosa, or those undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Use caution with concurrent use of antipsychotics, antidepressants, theophylline, systemic corticosteroids, or hypoglycemic agents, or with excessive use of ethanol, benzodiazepines, sedative/hypnotics, or opioids. Use with caution in seizure-potentiating metabolic disorders (hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia), in patients with an addiction to cocaine or stimulants, in patients withdrawing from sedatives, and in patients with a history of head trauma, severe stroke, arteriovenous malformation, or central nervous system tumor or infection. To minimize the risk of seizures, increase the dose gradually, administer the dose twice daily with no more than 2 tablets taken at a time, avoid administration with high-fat meals, skip missed doses, and limit the daily dose of bupropion to =360 mg. Use of multiple bupropion formulations is contraindicated. Permanently discontinue if seizure occurs during therapy.