Weight Loss Ideas

Processed foods are the leading source of metabolic syndrome /weight gain. But, there are basically 4 reasons/associations for why patients gain weight (fat gain) which are diagnose-able by a physician.


  1. Diabetes mellitus

  2. Cortisol producing tumors

  3. Severe thyroid disease: hypothyroidism or hyperthyroidism

  4. Medication induced: (steroids of any type, antihistamines, beta blockers, SSRI/mood medications)

Dr. Jogi can help you evaluate for these 4 concepts. Beyond these causes, there are numerous genetic causes for weight gain for which there are usually not tests available, nor are there any specific treatments for those gene disorders. We cannot test for genetic causes in our clinic and nor can we treat for those.

Even if you have all 4 above issues you can still maintain a normal weight with or without medications. Out of our scope are other causes of weight gain that are related to fluid fluctuations (unrelated to fat gain).

Concepts for good health:

  1. Eat Real food (vegetables, grass fed meats, fruits, free range eggs. If it has a nutrition label don't consume it)

  2. Not too much (intermittent fasting)

  3. Feed the gut (insoluble fiber)

  4. Protect your liver

Reference book: Metabolical by Dr. Lustig


There are 4 ways you can try to lose weight (with the assistance of your physician) but all four of which DO NOT work well


  1. Calorie restriction. Works very poorly and is not long lasting. Chronic consistent restriction in an already overweight individual can later slow your metabolism and reduce your basal metabolic rate. In general don't drink your calories (just drink water if you are thirsty) and eat lots of plants. Eating healthy is recommended and a good source of information is the book and movie "In Defense of Food: An Eater's Manifesto" by Michael Pollan. An updated and more in depth book is "Metabolical" by Dr. Lustig.

  2. Exercise - there are two types. muscle building and aerobic. It takes A LOT of exercise to lose weight and many studies show that exercise is generally NOT effective for weight loss so there is controversy. There are many other benefits to physical activity however including cardiac and cancer benefits

  3. Weight loss medications - generally these are NOT a long term solution to weight loss, COST quite a bit/usually not covered by insurance (Qsymia, Wegovy, and Saxenda) and have MANY side effects. Best case scenario in the published studies for these medication is 5-15 pound weight loss after 1 year of use. The medications are meant to be used for years. ** See list of side effects at the bottom of this page

  4. Gastric surgery - in some cases this may be indicated a patient has obesity co-morbidities and your physician can help your decide if this is worthwhile.


Recommendations

Dr. Jogi has some specific recommendations for weight loss for his patients. Consult your doctor for what is right for you

There are 5 steps that Dr. Jogi can suggest. Try "baby-steps" by doing one step at a time. Please set your expectations first: if you were to follow all the steps, a good amount of weight loss would be 1-2 pounds every 1-3 months, with intermittent intervals of no weight gain or loss for several months. Anything more suggests you are doing something to lose weight that is not sustainable. Exercise is fine to do for mental, cardiac, and bone health. But you should have no expectation that exercise alone will lead to sustained weight loss, usually studies have show it can lead to weight gain. Not recommended for pregnancy


1. Time restricted feeding - The "16:8" is a good place to start but is not the final goal. If you are overweight , after several years the final goal is several long-fasts per week. Use your watch by compressing the time that you eat any food into a continuous 8 hour period. For example :12pm to 8pm or 10am to 6pm. Stay consistent. Then the subsequent 16 hours you may only drink non-calorie liquids (Best is water). This is generally safe for 95% of patients to start. Dr. Jogi may provide additional details for individuals during clinic visits. Some but not all patients may need to work up to a 36 hour fast, 2-3 times per week.

If the thought of not eating for a 12-16 hour period seems impossible for you, then for more details you can google search "Dr. Fung diet" and his books are very useful. A good beginners' introduction to intermittent fasting is called "Life in the Fasting Lane" which Dr. Jogi recommends highly. For more technical details there are two other books that go into more details: "Obesity Code" and "Diabetes Code". Or you can simply watch his free youtube videos. Expectation is at least 2-3 pounds every 2-3 months. If you are significantly over-weight, try a change to a 24 hour period twice per week. After 2 months, if weight still not coming down, then increase to 36 hours 1-2 times per week but need MD supervision for this. For very details help on implementing and maintaining any new habit Dr. Jogi recommends the book "Atomic Habits" by James Clear

Start with 16 hours, then later alternate 16 and 18 hours. Add in a 24 hour period once or twice a month if desired weight loss not reached.



2. STOP PROCESSED FOODS. Reduce the carbohydrates and processed foods you are eating to less than half of your current intake. Using the google to search "grams of carbohydrates in ...." Reduce pastas, grains, potatoes, and added sugar. Patients with BMI with BMI more than 24, not pregnant, no seizure disorders, with no eating disorders, and not on hypoglycemia inducing medications can consider this nomogram for grams of carbohydrates per 24 hour period: height more than 6 feet: take less than 100grams, 5'5" to 6' take less than 70 grams, Height less than 5'5" take less than 60 grams.

PROVE IT TO YOURSELF IN REAL TIME with CGM- SEE DETAILS HERE


3. Convert your entire diet mostly plant-based. (80%+ vegetables). If this seems daunting try the "Broccoli 2" approach and please review the reading list below. A good way to start is to consider getting meals from www.VeginOut.com which is a vegan ready-made food service delivery. We do not recommend "fake meat" products which are just as unhealthy as any processed foods. Eat "real" food. Feed the gut (fiber) and stop damaging your liver (toxins) - Reference book Metabolical by Dr. Lustig.


4. Prepare it yourself. Don't eat food from outside of your home: more than twice a month is too much.


5. Calorie tracking can be frustrating and does NOT work well since it does not take into consideration food science (ground to packaging) but only nutrition content which is missing the processing of foods which have slow poisons, but sometimes patients enjoy this process of counting. Download myfitnesspal app to track your calorie intake for a week, note the average calories per day. Then plan to eat 150 less calories less per day from that day forward. Alternatively you can try Weight Watchers online system and follow their point system. Physically going to Weight Watcher meetings is very useful. If you are overweight, place "sedentary" as lifestyle and you do not get credit/extra calories for exercise until you are at your goal weight.


Expectation is a loss of 4-7 pounds per year. If you feel you need to lose weight much fasting than 4-7 pounds a year, then you should consider a meal-replacement program such as the Methodist Medical Weight loss program 832.667.5673 in which you meet weekly and interact with dietitians, nutritionists, psychologists, and internist. They frequently have free information session. Remember that it is best to stick with these types of meal-replacement programs for at least 3-5 years to maintain the lowered weight.


Diagrams

These below are merely for illustration/education and Dr. Jogi would have to provide more specific for individuals based on their medical history and medications after a meeting with him. This is not meant for pregnant persons, breastfeeding, persons with eating disorders, persons with advanced kidney disease, or anyone with BMI less than 24. Caution and Medical supervision is needed in most cases, especially if on insulin, oral hypoglycemia medications and anti hypertension medications. The doses may need to rapidly be reduced or stopped in order to avoid hypoglycemias and dangerously low blood pressures.

Only certain fluids can be consumed during fasting periods: water, tea and coffee (hot or iced), and homemade broth.

REMEMBER: your body can only be in one of these two places in terms of fat storage

1) Fed State- insulin (fat storage hormone) levels are HIGH and you will store glycogen and fat

2) Fasting State - insulin levels are LOW, and you are more likely to use up your glycogen and then burn fat



All the below fasting approaches beyond 18 hours will require medical supervision and only suggested in some cases, especially if BMI more than 25:

Usually would alternate 18 and 16 hour fasting every other day. Add in a 24 hour period twice a month if desired weight loss achieved. Can go longer but really need to determine carbohydrate intake if needing more.


Basic 16: 8 diet

This is how everyone should be eating in general. Start with this regimen. If you are unable, work up to this schedule with 14:10 or 12:8.

Monday: EAT 10am-6pm & FAST 6pm to 10am

Tuesday: EAT 10am-6pm & FAST 6pm to 10am

Wednesday: EAT 10am-6pm & FAST 6pm to 10am

Thursday: EAT 10am-6pm & FAST 6pm to 10am

Friday: EAT 10am-6pm & FAST 6pm to 10am

Saturday: EAT 10am-6pm & FAST 6pm to 10am

Sunday: EAT 10am-6pm & FAST 6pm to 10am

Basic 18: 6 diet

After 8 weeks of 16:8 change to this schedule if more weight loss desired.

Monday: EAT 12pm-6pm & FAST 6pm to 12pm

Tuesday: EAT 12pm-6pm & FAST 6pm to 12pm

Wednesday: EAT 12pm-6pm & FAST 6pm to 12pm

Thursday: EAT 12pm-6pm & FAST 6pm to 12pm

Friday: EAT 12pm-6pm & FAST 6pm to 12pm

Saturday: EAT 12pm-6pm & FAST 6pm to 12pm

Sunday: EAT 12pm-6pm & FAST 6pm to 12pm

24 hour fasting

Monday: Breakfast FAST; Lunch FAST; Dinner EAT

Tuesday Breakfast EAT; Lunch EAT; Dinner EAT

Wednesday Breakfast FAST; Lunch FAST; Dinner EAT

Thursday Breakfast EAT; Lunch EAT; Dinner EAT

Friday Breakfast FAST; Lunch FAST; Dinner EAT

Saturday Breakfast EAT; Lunch EAT; Dinner EAT

Sunday Breakfast FAST; Lunch FAST; Dinner EAT

36 hour fasting

Monday Breakfast FAST; Lunch FAST; Dinner FAST

Tuesday Breakfast EAT; Lunch EAT; Dinner EAT

Wednesday Breakfast FAST; Lunch FAST; Dinner FAST

Thursday Breakfast EAT; Lunch EAT; Dinner EAT

Friday Breakfast FAST; Lunch FAST; Dinner FAST

Saturday Breakfast EAT; Lunch EAT; Dinner EAT

Sunday Breakfast FAST; Lunch FAST; Dinner FAST

42 hour fasting

Monday Breakfast FAST; Lunch FAST; Dinner FAST

Tuesday Breakfast FAST; Lunch EAT; Dinner EAT

Wednesday Breakfast FAST; Lunch FAST; Dinner FAST

Thursday Breakfast FAST; Lunch EAT; Dinner EAT

Friday Breakfast FAST; Lunch FAST; Dinner FAST

Steps to Becoming a Vegan if This Interests You

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. Proteinoholic. by Dr. Garth Davis

  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


Get excellent home food delivery of vegan food to reduce your chopping time. Prep time is 2-3 minutes on your stove for ready-made food. www.VeginOut.com and consider writting "Referred by Medhavi Jogi" in the comments box when you order the first time.


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 meat

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




Here is the pharmaceutical answer for weight loss, life ling treatment with some of these medications


Saxenda 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.


Qsymia FAQ & Side Effects

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

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.