Contrave (bupropion and naltrexone) FDA Approval History

Adipex-P dosing information

Usual Adult Dose of Qsymia for Weight Loss:

-Initial dose: Take one capsule of the lowest dose (phentermine 3.75 mg/topiramate 23 mg extended-release) orally once a day in the morning for the first 14 days.

-Maintenance dose: After 14 days, take one capsule of the recommended dose (phentermine 7.5 mg/topiramate 46 mg extended-release) orally once a day in the morning.

Comments:
-Weight loss should be evaluated after 12 weeks with phentermine 7.5 mg/topiramate 46 mg extended-release. If a patient has not lost at least 3% of baseline body weight, treatment discontinuation or dose escalation should be considered as it is unlikely the patient will achieve and sustain clinically meaningful weight loss at this dose.

Use: Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in 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 comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia.

Qsymia dosage information (in more detail)

Usual Dose for Obesity (Adults and Children Aged 17 and Older):

  • 15 to 37.5 mg orally once a day before breakfast or 1 to 2 hours after breakfast.

Adipex-P should be used only for a short-term period. It should be used as part of a complete weight reduction program that includes dietary changes, exercise, and other behavioral changes.

Adipex-P dosage information (in more detail)

Anorexiants (Appetite Suppressants)

Anorexiants are drugs that act in the brain to help lower a person’s appetite. They have an effect on the parts of the brain which help control how full you feel. Anorexiants are used as a treatment for weight loss, along with a regular plan of diet and exercise.

Stimulants

Side effects of stimulants may include:

  • increased blood pressure and heart rate
  • insomnia
  • nervousness
  • blurred vision
  • restlessness
  • headache.

Some forms may cause stomach side effects like constipation, dry mouth, nausea or vomiting. A healthcare provider should be contacted if side effects like chest pain, pounding or rapid heartbeat, difficulty urinating, or shortness of breath occur.

These drugs are also classified as controlled substances. As these drugs are amphetamine-related, dependence, abuse or withdrawal may occur with long-term use. Keep them in a secure place away from children and pets.

Examples of stimulant weight-loss drugs include:

Serious side effects can occur with weight loss pills (diet pills)

Brand Drug Name Drug Category Common Side Effects
Adipex-P (phentermine) Appetite suppressant; sympathomimetic amine Increased blood pressure and heart rate, insomnia, nervousness, restlessness, dependence, abuse or withdrawal may occur with long-term use. When given as a single agent, phentermine is not implicated in valvular heart disease; avoid use at bedtime.
Alli (orlistat): over-the-counter (OTC) Lipase inhibitor Oily spotting, gas (flatulence), fecal urgency, soft stools, fecal incontinence; take Alli with a daily multivitamin once-a-day at bedtime.
Belviq (lorcaserin) Selective serotonin 2C receptor agonist (suppresses your appetite by affecting a chemical in your brain) Headache, nausea, cough, dizziness, fatigue, dry mouth, constipation; euphoria/dissociation may occur with higher doses; do not exceed 10 mg two times a day.
Bontril PDM, Bontril (phendimetrazine) Appetite suppressant; sympathomimetic amine Increased blood pressure and heart rate, insomnia, nervousness, restlessness, dependence, abuse or withdrawal may occur with long-term use; decreased appetite, avoid use at bedtime.
Contrave (bupropion and naltrexone) Antidepressant (weak inhibitor of norepinephrine and dopamine) and an opioid antagonist Nausea, vomiting, headache, fatigue, constipation, dizziness, difficulty sleeping, dry mouth, diarrhea, increased blood pressure, fast heart rate anxiety, tremor, hot flush, unusual taste.
Desoxyn (methamphetamine) Appetite suppressant; sympathomimetic amine High abuse potential and not frequently prescribed; use only if alternative treatments are ineffective; increased blood pressure and heart rate, insomnia, nervousness, restlessness, dependence, abuse or withdrawal may occur with long-term use; avoid use at bedtime.
Didrex (benzphetamine) Appetite suppressant; sympathomimetic amine Increased blood pressure and heart rate, insomnia, nervousness, restlessness, dependence, abuse or withdrawal may occur with long-term use; decreased appetite, avoid use at bedtime.
diethylpropion (generic only) Appetite suppressant; sympathomimetic amine Constipation, restlessness, dry mouth, increased blood pressure and heart rate, insomnia, nervousness, restlessness, dependence, abuse or withdrawal may occur with long-term use; avoid use at bedtime.
Qsymia (phentermine and topiramate extended-release capsules) Combination appetite suppressant-seizure drug; exact action of topiramate on weight loss is not known Tingling or numbing sensation (paresthesias), dizziness, altered taste, insomnia (difficulty sleeping), constipation, dry mouth. The dose is taken once daily in the morning; avoid an evening dose as it may keep you awake. Do not use if pregnant or planning a pregnancy due to possible birth defects; avoid use at bedtime.
Saxenda (liraglutide) Glucagon-like peptide-1 (GLP-1) receptor agonist; regulates appetite and food intake injection only. Nausea and vomiting, diarrhea, constipation, decreased appetite, dizziness, headache, heartburn, fatigue, dizziness, stomach pain, gas, dry mouth, low blood sugar in type 2 diabetes, elevated heart rate, increased lipase.
Xenical (orlistat) Lipase inhibitor Oily spotting, gas (flatulence), fecal urgency, soft stools, fecal incontinence; take Xenical with a daily multivitamin containing fat-soluble vitamins.

Weight loss drugs can be associated with important or serious side effects, or may have the potential for dependence and abuse. Some important warnings and side effects include:

  • Many of the weight loss drugs known as sympathomimetic amines can stimulate the heart and lead to high blood pressure and a fast heart rate (tachycardia).
  • Amphetamine-derivative, stimulant type weight loss drugs may be associated with constipation, dry mouth, restlessness, withdrawal effects, or insomnia (difficulty falling asleep), drug abuse and addiction.
  • Lipase inhibitors such as Alli or Xenical (orlistat) have been associated with rare liver injury and patients should be alert for signs of liver disease such as itching, yellow skin or eyes (jaundice), stomach pain, loss of appetite, pale or tar-colored stools, brown-colored urine (due to excess bilirubin in the urine).
  • Qsymia (phentermine and topiramate) is an FDA-approved extended-release weight loss medication. Qsymia has restricted access because topiramate, one of the drugs contained in Qsymia, can lead to severe birth defects in pregnant women. This means you may only be able to get Qsymia from certified pharmacies or through the mail by the Qsymia Home Delivery network. Do not use Qsymia if you are pregnant or planning a pregnancy. Women must have a negative pregnancy test before starting Qsymia and each month while taking the medication. 
  • Contrave (bupropion and naltrexone) is not used for depression but contains bupropion from the antidepressant class of drugs. Contrave’s label contains a boxed warning found on all antidepressants: a risk of suicidal thoughts and actions in children, adolescents, and young adults when used for depression. Do not use Contrave with other bupropion-containing products (such as Wellbutrin, Wellbutrin SR, Wellbutrin XL, Aplenzin and Zyban) as it may increase the risk of severe side effects. Do not use if you have a risk for seizures. Serious psychiatric side effects, like mood changes (depression, mania), psychosis, hallucinations, paranoia, delusions, thoughts of suicide, and other serious events have been reported in patients using bupropion for smoking cessation. May cause liver damage; avoid alcohol use with Contrave.
  • Saxenda (liraglutide) contains a boxed warning for thyroid C-cell tumor cancer; however, studies have only identified this risk in animals at this point. If you have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2, you should not use Saxenda due to the possible risk of thyroid tumors.
  • Belviq (lorcaserin) acts on the serotonin system in the brain, and it is important you have a drug interaction review each time you have a new drug prescribed to check for possible interactions with other drugs that may affect serotonin (such as certain antidepressants or migraine drugs, for example). 

Not inclusive of all adverse reactions. For a full listing of all common and serious side effects linked with weight loss drugs, visit each monograph individually.

  • Fenfluramine (Pondimin), used in the combination drug fen-phen (fenfluramine and phentermine) was associated with dangerous heart valve side effects and is no longer available on the U.S. market due to this side effect. Fenfluramine inhibits serotonin reuptake to reduce appetite. In 1997, the FDA withdrew fenfluramine and dexfenfluramine (Redux) from the market, as well.
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