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Suboxone, a combination medication containing buprenorphine and naloxone, is one of the main medications used for medication-assisted therapy (MAT) for opiate addiction.

Description

Suboxone (buprenorphine and naloxone)

What is Suboxone?

Suboxone (buprenorphine/naloxone) is a brand-name prescription drug. It’s used to treat dependence on opioid drugs.

Suboxone comes as an oral film that’s placed under your tongue (sublingual) or between your gums and cheek (buccal). The film dissolves in your mouth.

Suboxone contains two drugs in each film: buprenorphine and naloxone. It’s available in four strengths:

  • 2 mg buprenorphine / 0.5 mg naloxone
  • 4 mg buprenorphine / 1 mg naloxone
  • 8 mg buprenorphine / 2 mg naloxone
  • 12 mg buprenorphine / 3 mg naloxone

Studies show that Suboxone is effective for reducing opioid misuse. It’s also effective for keeping people with opioid dependence in treatment over a period of 24 weeks. (How well a drug such as Suboxone performs is partly assessed based on how long people stay in treatment.)

Is Suboxone a controlled substance?

Yes, Suboxone is a controlled substance. It’s classified as a schedule three (III) prescription drug. This means that it has an accepted medical use, but it may cause physical or psychological dependence and may be abused.

The government has created special rules for how schedule III drugs can be prescribed by a doctor and dispensed by a pharmacist. Your doctor or pharmacist can tell you more.

Doctors can only prescribe this drug for opioid dependence after receiving special training and certification through the U.S. federal government.

Suboxone generic

Suboxone is a brand-name drug that contains two ingredients: buprenorphine and naloxone.

Suboxone is also available in a generic version. The generic version comes in two forms: an oral film and an oral tablet. Both the film and the tablet are sublingual forms, which means you place them under your tongue to dissolve. The film can also be placed between your gums and cheek to dissolve (buccal).

Suboxone side effects

Suboxone can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Suboxone. This list does not include all possible side effects.

For more information on the possible side effects of Suboxone, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Suboxone include:

  • headache
  • opioid withdrawal symptoms, such as body aches, abdominal cramps, and rapid heart rate
  • anxiety
  • insomnia (trouble sleeping)
  • sweating
  • depression
  • constipation
  • nausea
  • weakness or fatigue
  • back pain
  • burning tongue
  • redness in the mouth

Some of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Serious side effects from Suboxone aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects can include the following:

  • severe allergic reaction
  • abuse and dependence
  • breathing problems
  • coma
  • hormone problems (adrenal insufficiency)
  • liver damage
  • severe withdrawal symptoms

See below for information about each serious side effect.

5 myths about using Suboxone to treat opiate addiction

What is Suboxone and how does it work?

Suboxone, a combination medication containing buprenorphine and naloxone, is one of the main medications used for medication-assisted therapy (MAT) for opiate addiction. Use of MATs has been shown to lower the risk of fatal overdoses by approximately 50%. Suboxone works by tightly binding to the same receptors in the brain as other opiates, such as heroin, morphine, and oxycodone. By doing so, it blunts intoxication with these other drugs, it prevents cravings, and it allows many people to transition back from a life of addiction to a life of relative normalcy and safety.

A key goal of many advocates is to make access to Suboxone much more widely available, so that people who are addicted to opiates can readily access it. Good places to start are in the emergency department and in the primary care doctor’s office. More doctors need to become “waivered” to prescribe this medication, which requires some training and a special license. The vast majority of physicians, addiction experts, and advocates agree: Suboxone saves lives.

Common myths about using Suboxone to treat addiction

Unfortunately, within the addiction community and among the public at large, certain myths about Suboxone persist, and these myths add a further barrier to treatment for people suffering from opiate addiction.

Myth #1: You aren’t really in recovery if you’re on Suboxone.

Reality: While it depends on how you define “recovery,” the abstinence-based models that have dominated the past century of addiction care are generally giving way to a more modern conception of recovery that encompasses the use of medications such as Suboxone that regulate your brain chemistry. As addiction is increasingly viewed as a medical condition, Suboxone is viewed as a medication for a chronic condition, such as a person with diabetes needing to take insulin. To say that you aren’t really in recovery if you are on Suboxone is stigmatizing to people who take Suboxone, and it’s not the medical reality of effective addiction treatment.

Myth #2: People frequently abuse Suboxone.

Reality: Suboxone, like any opiate, can be abused. However, because it is only a “partial” agonist of the main opiate receptor (the “mu” receptor), it causes less euphoria than the other opiates such as heroin and oxycodone. In many cases, people may use Suboxone (or “abuse” it, if that is defined as using it illegally) to help themselves manage their withdrawal, or even to get themselves off of heroin.

Myth #3: It’s as easy to overdose on Suboxone as it is to overdose with other opiates.

Reality: It is extremely difficult to overdose on Suboxone alone. It is more difficult to overdose on Suboxone compared to other opiates, because Suboxone is only a partial opiate receptor agonist, so there is a built-in “ceiling” effect. This means there is a limit to how much the opioid receptors are able to be activated by Suboxone, so there isn’t as great a risk of slowed breathing compared with potent opiates such as heroin, oxycodone, or morphine. When people do overdose on Suboxone, it is almost always because they are mixing it with sedatives such as benzodiazepines, medicines that also slow breathing.

Myth #4: Suboxone isn’t treatment for addiction if you aren’t getting therapy along with it.

Reality: In a perfect world, addiction treatment would include MAT and therapy, support groups, housing assistance, and employment support. But that doesn’t mean that one component, in the absence of all of the others, doesn’t constitute valid treatment for addiction. About 10% of people with addiction are getting treatment, so while combination treatment is an admirable goal, it is unrealistic to expect that everyone with an addiction will receive all the aspects of treatment that they need, especially without access to regular healthcare, insurance, or both.

Myth #5: Suboxone should only be taken for a short period of time.

Reality: Expert practitioners have different theories on how long Suboxone treatment should last for, but there is no evidence to support the claim that Suboxone should be taken for a short period of time as opposed to being maintained on it for the long term, just as a person would manage their diabetes with insulin for the long term.

One of the main obstacles to getting lifesaving treatment for addiction is the stigma people face. Fortunately, our society’s perception is slowly starting to transform away from an outdated view of addiction as a moral failing, toward a more realistic, humane view of addiction as a complex disease that needs to be addressed with compassion, as well as modern medical care. Eliminating myths and misinformation about addiction, and supplanting them with up-to-date, evidence-based treatments, is a critical step in the evolution of addiction treatment.

Important Information

This medicine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Taking Suboxone during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use Suboxone if you are allergic to buprenorphine or naloxone (Narcan).

Tell your doctor if you have ever had:

Some medicines can interact with buprenorphine and naloxone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson’s diseasemigraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use Suboxone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant.

Buprenorphine and naloxone can pass into breast milk and may cause drowsiness or breathing problems in the nursing baby. Tell your doctor if you are breast-feeding.

What other drugs will affect Suboxone?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • other narcotic medications – opioid pain medicine or prescription cough medicine;
  • a sedative like Valium – diazepamalprazolamlorazepamAtivanKlonopinRestorilTranxeneVersedXanax, and others; or
  • drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine.

This list is not complete. Other drugs may affect Suboxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Suboxone only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Popular FAQ

More FAQ

 Summary

Common side effects of Suboxone include: constipation, diarrhea, headache, and nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to buprenorphine / naloxone: film, tablet

Side effects requiring immediate medical attention

Along with its needed effects, buprenorphine/naloxone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking buprenorphine / naloxone:

More common

  • Chills
  • cough
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • fever
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • hoarseness
  • lower back or side pain
  • painful or difficult urination
  • sweating

Incidence not known

  • Agitation
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • darkening of the skin
  • diarrhea
  • difficulty swallowing
  • dizziness
  • fainting
  • fast heartbeat
  • hives, itching, skin rash
  • loss of appetite
  • mental depression
  • nausea
  • overactive reflexes
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • restlessness shivering talking or acting with excitement you cannot control tightness in the chest
  • tingling of the hands or feet
  • trembling or shaking twitching
  • unusual weight gain or loss
  • vomiting

Get emergency help immediately if any of the following symptoms of overdose occur while taking buprenorphine / naloxone:

Symptoms of overdose

  • Blurred vision
  • confusion
  • difficult or troubled breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • irregular, fast, slow, or shallow breathing
  • pale or blue lips, fingernails, or skin
  • pinpoint pupils
  • relaxed and calm feeling
  • sleepiness
  • unusual tiredness or weakness

Side effects not requiring immediate medical attention

Some side effects of buprenorphine / naloxone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Difficulty having a bowel movement
  • lack or loss of strength
  • stomach pain
  • trouble sleeping

Less common

Incidence not known

  • Burning or sore mouth
  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings inside the mouth
  • decline or loss of libido or sexual desire
  • irritability
  • mood swings
  • poor concentration
  • redness, swelling, or soreness of the tongue
  • reduced muscle strength
  • swelling, inflammation, or redness of the mouth

 

For Healthcare Professionals

Applies to buprenorphine / naloxone: buccal film, sublingual film, sublingual tablet

General

The most commonly observed adverse events included headache, nausea, vomiting, hyperhidrosisconstipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema. Additionally, oral hypoesthesia was reported with the sublingual film.[Ref]

Other

Very common (10% or more): Pain (22.4%)

Common (1% to 10%): Asthenia, chills, pyrexia, malaise, injury, ear pain

Uncommon (0.1% to 1%): Hypothermia, heat stroke

Postmarketing reportsVertigo[Ref]

Nervous system

Very common (10% or more): Headache (36.4%)

Common (1% to 10%): Migraine, dizziness, hypertonia, paraesthesia, somnolence

Uncommon (0.1% to 1%): Amnesia, convulsion, hyperkinesia, speech disorder, tremor

 

Buprenorphine:

Postmarketing reportsNeonatal withdrawal syndrome including symptoms of hypertonia, neonatal tremor, neonatal agitation, and myoclonus; reports of neonatal convulsions, apnea, respiratory depression, and bradycardia[Ref]

Respiratory

Buprenorphine-naloxone:

Common (1% to 10%): Pharyngitis, rhinitis, cough, sinusitis, upper respiratory infection, asthma, bronchitis, dyspneapneumonia, increased sputum

Uncommon (0.1% to 1%): Yawning

Frequency not reported: Rhinorrhea

 

Buprenorphine:

Frequency not reported: Significant respiratory depression, coma, death[Ref]

There have been postmarketing reports coma and death associated with concomitant use of buprenorphine and benzodiazepines; many of these reports have involved misuse by self-injection.[Ref]

Gastrointestinal

Very common (10% or more): Constipation (12.1%), nausea (15%), abdominal pain (11.2%)

Common (1% to 10%): Vomiting, diarrhea, dyspepsiaflatulence, oral hypoesthesia

Uncommon (0.1% to 1%): Mouth ulceration, tongue discoloration, tooth abscess, glossodynia, mucosal erythema (oral), toothache

Frequency not reported: Stomach discomfort,

Postmarketing reportsStomatitis, glossitis, tongue disorder, pancreatitis[Ref]

Endocrine

Common (1% to 10%): Erectile dysfunction, decreased libido

Uncommon (0.1% to 1%): Amenorrhea, ejaculation disorder, menorrhagia, metrorrhagia

Postmarketing reports: Disorders of pregnancy

 

Opioids:

Postmarketing reportsAdrenal insufficiency, androgen deficiency[Ref]

Hypersensitivity

Buprenorphine:

Frequency not reported: Hypersensitivity reactions including bronchospasm, angioneurotic edema, and anaphylactic shock; more commonly reported as rash hives, and pruritus

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