Το όνομα αυτού του συνδυασμού είναι Contrave
What is Contrave?
Contrave contains a combination of bupropion and naltrexone. Bupropion is an antidepressant medicine that can also decrease appetite. Naltrexone is usually given to block the effects of narcotics or alcohol in people with addiction problems. Naltrexone may also curb hunger and food cravings.
Contrave will not treat any weight-related medical condition, such as high blood pressure, diabetes, or high cholesterol.
Contrave is not approved to treat depression or other psychiatric conditions, or to help you quit smoking.
You should not use Contrave if you have uncontrolled high blood pressure, seizures, an eating disorder, opioid addiction, if you take narcotic medicine or other forms of bupropion, or if you have suddenly stopped using alcohol, seizure medication, or a sedative.
Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with bupropion and naltrexone, and some drugs should not be used together.
Do not use Contrave if you are pregnant.
Some young people have thoughts about suicide when first taking bupropion. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
Do not take Contrave if you also take narcotic medicine or other forms of bupropion (such as Wellbutrin or Zyban), or if you are going through withdrawal from alcohol or drug addiction.
Before taking this medicine
Do not use Contrave if you are pregnant. Weight loss during pregnancy can harm an unborn baby, even if you are overweight. Tell your doctor right away if you become pregnant during treatment.
You should not use Contrave if you are allergic to bupropion or naltrexone, or if you have:
- untreated or uncontrolled high blood pressure;
- an eating disorder (anorexia or bulimia);
- a history of seizures;
- opioid addiction or withdrawal (or if you take methadone or buprenorphine);
- if you take other forms of bupropion (Wellbutrin, Aplenzin, Budeprion, Forfivo, Zyban, and others); or
- if you have suddenly stopped using alcohol, seizure medication, or a sedative such as Xanax, Valium, Fiorinal, Klonopin, and others).
Do not use an MAO inhibitor within 14 days before or 14 days after you take Contrave. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
To make sure Contrave is safe for you, tell your doctor if you have ever had:
- depression, bipolar disorder, or mental illness;
- suicidal thoughts or actions;
- a head injury;
- a tumor or infection in your brain or spinal cord;
- diabetes or low blood sugar;
- low sodium levels;
- liver or kidney disease;
- heart disease, high blood pressure, heart attack, or stroke; or
- drug addiction, or if you normally drink a lot of alcohol.
Some young people have thoughts about suicide when first taking bupropion. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Bupropion and naltrexone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
Contrave is not approved for use by anyone younger than 18 years old.
How should I take Contrave?
Take Contrave exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Do not crush, chew, or break the tablet. Swallow it whole. Do not take more than 2 tablets at once.
Do not take Contrave with a high-fat meal, or you may be more likely to have a seizure.
If you need to use narcotic medicine for any reason (such as pain, surgery, or treatment for drug addiction) you may need to stop taking Contrave for a short time. Follow your doctor’s dosing instructions very carefully.
Store Contrave at room temperature away from moisture and heat.
If you have not lost at least 5% of your starting weight after 16 weeks of treatment, Contrave may not be right for you.
Contrave dosing information
Usual Adult Dose of Contrave for Weight Loss:
-Week 1: One tablet (8 mg naltrexone/90 mg bupropion) orally once in the morning; then
-Week 2: One tablet orally twice a day (once in the morning and once in the evening); then
-Week 3: Two tablets orally in the morning and one tablet orally in the evening
Maintenance dose: Week 4 and onward: Two tablets orally twice a day (morning and evening)
Maximum dose: Two tablets orally twice a day
–Discontinue therapy if a patient has not lost at least 5% of baseline body weight after 12 weeks at the maintenance dose.
-The effect of this drug on cardiovascular morbidity and mortality has not been established.
-The safety and effectiveness of this drug in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
An adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
-30 kg/m2 or greater (obese) or
-27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
See also: Dosage Information (in more detail)
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Do not take more than 4 tablets in 1 day.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially if you also take a narcotic (opioid medicine).
What should I avoid while taking Contrave?
Follow your doctor’s instructions about any restrictions on food, beverages, or activity. Do not take other weight-loss products or diet pills unless your doctor has told you to.
Do not use narcotic medication, methadone, heroin, or other street drugs while you are taking Contrave. Doing so could result in dangerous effects, including coma and death.
Drinking alcohol with Contrave may increase your risk of seizures. If you drink alcohol regularly, talk with your doctor before changing the amount you drink. Bupropion can also cause seizures in a regular drinker who suddenly stops drinking.
Contrave side effects
Get emergency medical help if you have signs of an allergic reaction to Contrave: fever, swollen glands, mouth sores, muscle or joint pain; hives, rash or itching; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.
A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, severe drowsiness, or if you are hard to wake up.
Stop taking this medicine and call your doctor right away if you have:
- a seizure (convulsions);
- blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- changes in mood or behavior – anxiety, depression, panic attacks, trouble sleeping, agitation, thoughts about suicide or hurting yourself;
- a manic episode – racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative;
- liver problems – upper stomach pain, tiredness, dark urine, jaundice (yellowing of the skin or eyes);
- increased blood pressure – severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
- severe skin reaction – fever, mouth or throat pain, burning eyes, skin pain, red or purple rash that spreads and causes blisters and peeling.
Older adults may be more likely to have certain side effects.
Common Contrave side effects may include:
- nausea, vomiting, diarrhea, constipation;
- headache, dizziness;
- dry mouth; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Contrave?
When you start or stop taking Contrave, your doctor may need to adjust the doses of other medicines you take on a regular basis.
Tell your doctor about all your current medicines and any you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Common side effects of Contrave include: constipation, dizziness, headache, insomnia, nausea, and vomiting. Other side effects include: anxiety, diarrhea, increased blood pressure, tremor, depression, hypertension, and xerostomia. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to bupropion / naltrexone: oral tablet extended release
In addition to its needed effects, some unwanted effects may be caused by bupropion / naltrexone. In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking bupropion / naltrexone:
- Blurred vision
- fear or nervousness
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- pounding in the ears
- slow or fast heartbeat
- trouble concentrating
- trouble sleeping
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- fast, irregular, pounding, or racing heartbeat or pulse
- frequent urge to urinate
- lower back or side pain
- shakiness in the legs, arms, hands, or feet
- trembling or shaking of the hands or feet
Less common or rare:
- Chest pain or discomfort
- pain or discomfort in the arms, jaw, back, or neck
- Changes in behavior
- thoughts of killing oneself
Incidence not known:
- Abdominal or stomach pain or tenderness
- aggressive or angry
- blistering, peeling, or loosening of the skin
- clay colored stools
- dark urine
- decreased appetite
- delusions of persecution, mistrust, suspiciousness, or combativeness
- difficulty with moving
- difficulty with swallowing
- dry mouth
- false beliefs that cannot be changed by facts
- feeling that others are watching you or controlling your behavior
- feeling, seeing, or hearing things that are not there
- hives, itching, or rash
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- muscle stiffness
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- severe mood or mental changes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- swelling of the feet or lower legs
- tightness in the chest
- unusual behavior unusual tiredness or weakness yellow eyes or skin
If any of the following symptoms of overdose occur while taking bupropion / naltrexone, get emergency help immediately:
Symptoms of overdose:
- Blue lips, fingernails, or skin
- change in consciousness
- decreased awareness or responsiveness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- loss of consciousness
- muscle cramps or spasms
- severe sleepiness
Minor Side Effects
Some of the side effects that can occur with bupropion / naltrexone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
- difficulty having a bowel movement (stool)
- Abdominal or stomach pain
- change or loss of taste
- continuing ringing or buzzing or other unexplained noise in the ears
- feeling of warmth
- hearing loss
- increased sweating
- redness of the face, neck, arms, and occasionally, upper chest
- sudden sweating
Less common or rare:
- Dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- hair loss
- sensation of spinning
- severe nausea or vomiting
- thinning of the hair
For Healthcare Professionals
Applies to bupropion / naltrexone: oral tablet extended release
Very common (10% or more): Sleep disorders (up to 13.8%)
Common (1% to 10%): Depression, anxiety, irritability
Uncommon (0.1% to 1%): Insomnia, abnormal dreams, nervousness, dissociation (feeling spacey), tension, agitation, mood swings
Rare (less than 0.1%): Suicidal ideation[Ref]
Very common (10% or more): Headache (up to 17.6%), dizziness (up to 10.4%)
Common (1% to 10%): Tremor, dysgeusia, attention disorders
Uncommon (0.1% to 1%): Vertigo, motion sickness, disturbance in attention, lethargy, intention tremor, balance disorder, memory impairment, amnesia, mental impairment, presyncope/syncope, hernia, seizure[Ref]
Common (1% to 10%): Hot flush, hypertension, increased blood pressure, palpitations
Uncommon (0.1% to 1%): Tachycardia, myocardial infarction
Frequency not reported: Increased heart rate[Ref]
Uncommon (0.1% to 1%): Cholecystitis, increased hepatic enzymes[Ref]
Common (1% to 10%): Hyperhidrosis, rash
Uncommon (0.1% to 1%): Alopecia[Ref]
Very common (10% or more): Nausea (up to 32.5%), constipation (up to 19.2%), vomiting (up to 10.7%)
Common (1% to 10%): Dry mouth, diarrhea, upper abdominal pain, viral gastroenteritis, abdominal pain
Uncommon (0.1% to 1%): Lower abdominal pain, eructation, lip swelling, hematochezia[Ref]
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Vaginal hemorrhage, irregular menstruation, erectile dysfunction, vulvovaginal dryness[Ref]
Uncommon (0.1% to 1%): Decreased hematocrit[Ref]
Common (1% to 10%): Influenza[Ref]
Uncommon (0.1% to 1%): Dehydration[Ref]
Common (1% to 10%): Muscle strain
Uncommon (0.1% to 1%): Intervertebral disc protrusion, jaw pain[Ref]
Common (1% to 10%): Fatigue, tinnitus
Uncommon (0.1% to 1%): Feeling jittery, feeling abnormal, asthenia, thirst, feeling hot, staphylococcal infection[Ref]
Uncommon (0.1% to 1%): Kidney infection, increased blood creatinine, increased serum creatinine, micturition urgency[Ref]
Uncommon (0.1% to 1%): Pneumonia[Ref]
- “Product Information. Contrave (buPROPion-naltrexone).” Takeda Pharmaceuticals America, Lincolnshire, IL.
Not all side effects for Contrave may be reported.
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