There are basically 4 reasons/associations for why patients gain weight (fat gain) which are diagnose-able by a physician.
4. Medication induced: (steroids of any type, antihistamines, beta blockers, SSRI/mood medications)
Our
physicians 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 Out of our scope are other causes of weight gain that are related to fluid fluctuations (unrelated to fat gain).
There
are several 4 ways you can try to lose weight (with the assistance
of your physician) but all four of which don't 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. 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 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.
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 2. Reduce the carbohydrates and processed foods you are eating to less
than half of your current intake. Reduce pastas, grains, potatoes, and added
sugar. 3. Convert your entire diet mostly plant-based. (80%+ vegetables). If
this seems daunting or difficult 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. 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, but sometimes patients enjoy this. 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. 6. 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
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.
M | T | W | Th | F | Sa | Su | EAT 10am-6pm & FAST 6pm to 10am | EAT 10am-6pm & FAST 6pm to 10am | EAT 10am-6pm & FAST 6pm to 10am | EAT 10am-6pm & FAST 6pm to 10am | EAT 10am-6pm & FAST 6pm to 10am | EAT 10am-6pm & FAST 6pm to 10am | 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.
M | T | W | Th | F | Sa | Su | EAT 12pm-6pm & FAST 6pm to 12pm | EAT 12pm-6pm & FAST 6pm to 12pm | EAT 12pm-6pm & FAST 6pm to 12pm | EAT 12pm-6pm & FAST 6pm to 12pm | EAT 12pm-6pm & FAST 6pm to 12pm | EAT 12pm-6pm & FAST 6pm to 12pm | EAT 12pm-6pm & FAST 6pm to 12pm |
All the below fasting approaches will require medical supervision and only suggested in some cases, especially if BMI more than 25:
24 hour fasting
| M | Tu | W | Th | F | Sa | Su | Breakfast | FAST | Eat | FAST | Eat | FAST | Eat | FAST | Lunch | FAST | Eat | FAST | Eat | FAST | Eat | FAST | Dinner | Eat | Eat | Eat | Eat | Eat | Eat | Eat |
36 hour fasting
| M | Tu | W | Th | F | Sa | Su | Breakfast | FAST | Eat | FAST | Eat | FAST | Eat | FAST | Lunch | FAST | Eat | FAST | Eat | FAST | Eat | FAST | Dinner | FAST | Eat | FAST | Eat | FAST | Eat | FAST
|
42 hour fasting
| M | Tu | W | Th | F | Sa | Su | Breakfast | FAST | FAST | FAST | FAST | FAST | FAST | FAST | Lunch | FAST | Eat | FAST | Eat | FAST | Eat | Eat | Dinner | FAST | Eat | FAST | Eat | FAST | Eat | Eat
|
Common temporary side effects of intermittent fasting Hunger- very common, but with the above fasts is not harmful. Usually passes within 60 minutes. Drink water to avoid the mimic of thirst. Top natural appetite suppressants- water, green tea, cinnamon, black coffee, Headaches - due to change from high salt to low salt diet. Add in broths for a few weeks to help. Also non-calorie fluids/water Dizziness- due to lack of water Constipation- there will be fewer bowel movement since you are eating less. Use fiber supplements and more water Heartburn- may occur when you start to eat. Take it slow. Always break your fasts gently with a glass of water and light foods, slowly Muscle cramps- can try magnesium over the counter. Increase broth intake.
Should you feel unwell, stop the fasting. Hunger and constipation are common and not necessarily harmful. But persistent nausea, vomiting, belly pains, dizziness, rapid up/down blood sugars are a problem and need to stop fast and talk to your doctor.
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
1. This is a long process and so get informed.
Watch the following
films:
- The Game Changers
- What the Health
- Supersize Me
- Food, Inc
- King Corn
- Fast Food
Nation
- Forks Over Knives
- Planeat
-- Read the following
books:- How Not to Die. by Dr. Michael Greger
- Proteinoholic. by Dr. Garth Davis
- The Original Fast Foods by James and Colleen Simmons
- The China
Study by T. Colin Campbell
- Fit For Life by Harvey and Marilyn Diamond
- 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. Also, eating fake faux meats is not healthy and considered processed food. Chips and crackers are vegan but not healthy.: 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. 2. 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 3.
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. 4. Shop the perimeters of a grocery
store 5. Skip the Eggs 6. Avoid dairy and meat 7. If you really are not
taking any meat, eggs, or dairy, then Dr. Jogi strongly recommends vitamin B12,
1000 units daily.
--------------------.
Weight loss medications Qsymia and Saxenda and Contrave have these known side effects as of 1-2020 A pregnancy test is required on all females before starting Qsymia and Contrave
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 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. f 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. -----------------. | |
|