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Bunavail (Generic Buprenorphine Sublingual and Buccal (opioid dependence))

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Why is this medication prescribed?

Opioid dependency is treated with buprenorphine and the combination of buprenorphine and naloxone (addiction to opioid drugs, including heroin and narcotic painkillers). Naloxone and buprenorphine both belong to the drug classes known as opioid antagonists and opioid partial agonist-antagonists, respectively. When someone ceases taking opioid medicines, buprenorphine alone or in combination with naloxone prevents withdrawal symptoms by having effects that are similar to those of the opioids.

How should this medicine be used?

Supralingual tablets of buprenorphine are available. The buprenorphine and naloxone combination is available as a buccal film (Bunavail) to place between the gum and cheek, a sublingual tablet (Zubsolv), and a sublingual film (Suboxone) to ingest under the tongue. The recommended dosage for these products will be determined by your doctor, and they are typically taken once day. Take or apply buprenorphine, or buprenorphine plus naloxone, at roughly the same time each day to assist you remember to do so. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Just as instructed, consume or apply buprenorphine or buprenorphine plus naloxone. Never take or apply it in amounts or frequencies other than those recommended by your doctor.

Buprenorphine, which you will take at the doctor’s office, may be chosen by your doctor to begin your treatment. Before transferring you on buprenorphine and naloxone, your doctor will start you on a low dose of buprenorphine and gradually increase it over the course of one or two days. Your doctor may decide to begin your buprenorphine and naloxone treatment immediately soon, depending on the kind of opioid you were using. Depending on how you react, your doctor may change the doses of buprenorphine and naloxone that you are taking.

In order for the sublingual pills to dissolve completely, you must place them beneath your tongue. Place up to two tablets under your tongue at a time if you are taking more than two, or place them all under your tongue at once. The tablets shouldn’t be chewed or taken whole. Until the tablet has completely dissolved, avoid eating, drinking, or speaking.

If you’re applying buccal film, moisten the inside of your cheek with your tongue or rinse your mouth with water first. Using a dry finger, apply the film to the inside of the cheek. The film will then adhere to the inside of your cheek when you withdraw your finger. If you need to use two films, apply the second one simultaneously to the inside of the other cheek. Applying more than two films to the inside of the mouth at once is not recommended, nor should you layer films. The film(s) should be left in the mouth until they disappear. While the film is dissolving, do not cut, rip, eat, swallow, touch, or move it. Eat nothing and refrain from drinking anything until the film is entirely gone.

Before applying the sublingual film, rinse your mouth out with water if you’re using one. To the right or left of the centre, insert the film under your tongue with a dry finger and hold it there for five seconds. If you are using two films, place the second one under the tongue on the other side. Do not stack or place the movies close together. Use no more than two movies at once. While the film is dissolving, do not cut, rip, eat, swallow, touch, or move it. Eat nothing and refrain from drinking anything until the film is entirely gone.

Your doctor might need to change your dose if you need to switch from one buprenorphine or buprenorphine and naloxone product to another. Verify that you have received the buprenorphine product that was prescribed for you each time you receive a dose of medication. If you are unsure if you were given the correct medication, speak with your pharmacist.

Without consulting your doctor, do not discontinue taking buprenorphine or buprenorphine plus naloxone. Withdrawal symptoms may develop if you stop using buprenorphine or buprenorphine plus naloxone too rapidly. When and how to quit taking buprenorphine or buprenorphine plus naloxone will be determined by your doctor. You may have withdrawal symptoms such as hot or cold flushes, restlessness, teary eyes, runny nose, sweating, chills, muscle soreness, vomiting, or diarrhoea if you abruptly stop using buprenorphine or buprenorphine plus naloxone.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking buprenorphine or buprenorphine and naloxone,

  • If you have any allergies to any of the substances in buprenorphine or buprenorphine and naloxone sublingual tablets or film, tell your doctor and pharmacist right once. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any vitamins, nutritional supplements, herbal items, and prescription and over-the-counter drugs you are using. Any of the following should be mentioned: Antipsychotics such aripiprazole (Abilify), asenapine (Saphris), and cariprazine; antihistamines (found in cold and allergy treatments); and anti-inflammatory drugs (Vraylar), thioridazine, thiothixene, trifluoperazine, and ziprasidone (Geodon); chlorpromazine, clozapine (Versacloz), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), loxapine, lurasidone (Latuda), paliperidone (Invega), perphenazine; diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, quazepam (Doral), temazepam (Restoril), and triazolam (Halcion) are examples of benzodiazepines. Other examples include chlordiazepoxide (Librium), clobazam (Onfi), clonazepam (Klonopin); diuretics (also known as “water pills”); erythromycin (E.E.S., Eryc, Erythrocin, among others); specific HIV meds as atazanavir (Reyataz, in Evotaz), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune); ketoconazole, hypnotics, ipratropium (Atrovent), medications for irritable bowel syndrome, motion sickness, Parkinson’s disease, ulcers, or urinary issues, as well as drugs for migraines like almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan, rifampin (Rifadin, Rimactane, in Rifater, in Rifamate); mirtazapine (Remeron); muscle relaxants such cyclobenzaprine (Amrix), dantrolene (Dantrium), and metaxalone (Skelaxin); opiate (narcotic) drugs for pain relief and cough; sedatives; 5HT3 serotonin blockers such as alosetron (Lotronex), granisetron (Sancuso, Sustol), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); drugs for seizures such as carbamazepine (Epitol, Tegretol, Teril, and other brands); phenobarbital; and phenytoin (Dilantin, Phenytek);  selective serotonin-reuptake inhibitors such paroxetine (Brisdelle, Prozac, Pexeva), fluoxetine (Prozac, Sarafem, in Symbyax), citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox), and fluoxetine (escitalopram, escitalopram, in Lexapro), as well as sertraline (Zoloft); sleeping medications, tramadol (Conzip), trazodone, and serotonin and norepinephrine reuptake inhibitors such duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor); amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine are examples of tricyclic antidepressants (sometimes known as “mood elevators”) (Surmontil). Tell your physician or pharmacist if you are taking any of the following monoamine oxidase (MAO) inhibitors or have stopped taking them within the previous two weeks: methylene blue, isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Buprenorphine or buprenorphine and naloxone may interact with a wide variety of other drugs, therefore it is important to let your doctor know about all the drugs you are taking, even ones that do not appear on this list. Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
  • Inform your doctor about the herbal supplements you are taking, especially if you take St. John’s wort or tryptophan.
  • Inform your doctor if you consume large amounts of alcohol or have ever done so, as well as if you suffer from or have ever had adrenal issues such as Addison’s disease (a condition in which the adrenal glands produce less hormone than normal), benign prostatic hypertrophy (BPH), difficulty urinating, a head injury, hallucinations (seeing or hearing things that are not there), or difficulty urinating; a breathing obstruction caused by a spine curvature; Various illnesses that impact the lungs and airways include chronic obstructive pulmonary disease (COPD), thyroid, renal, liver, and lung ailments.
  • If you are pregnant or plan to become pregnant, let your doctor know. Call your doctor if you become pregnant while taking buprenorphine or buprenorphine plus naloxone. Regular use of buprenorphine or buprenorphine plus naloxone tablets or films during pregnancy increases the risk that your unborn child will develop potentially fatal withdrawal symptoms. If your infant exhibits any of the following signs, you should contact your doctor right away: irritability, seizures, excessive shaking of a body part, vomiting, diarrhoea, or inability to gain weight.
  • If you are breastfeeding, let your doctor know. If your infant seems more lethargic than usual or has breathing issues while you’re taking this medicine, call your doctor straight away.
  • Inform the surgeon or dentist that you are using buprenorphine or buprenorphine plus naloxone if you are having surgery, including dental surgery.
  • You should be aware that both men and women who use this medicine may have decreased fertility. The dangers of using buprenorphine or buprenorphine plus naloxone should be discussed with your doctor.
  • You should be aware that naloxone or naloxone plus buprenorphine may cause you to feel sleepy. Before you know how this prescription affects you, do not operate machinery or drive a car.
  • While taking this medication, you shouldn’t consume alcohol or take any prescription or over-the-counter drugs that do.
  • You should be aware that when you get up too rapidly from a laying position, buprenorphine or buprenorphine plus naloxone may produce dizziness, lightheadedness, and fainting. When you initially start using buprenorphine or buprenorphine plus naloxone, this is more typical. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

As soon as you realise you missed a dose, take it or apply it. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take or apply a second dose.

What side effects can this medication cause?

There could be negative consequences from buprenorphine or buprenorphine plus naloxone. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Abdominal pain
  • Constipation
  • Difficulty Sleeping or remaining asleep
  • Numbness or redness in the mouth
  • Tongue ache
  • Fuzzy vision
  • Back ache

Some adverse effects can be very harmful. Call your doctor right away if you have any of the following symptoms or any of those detailed in the IMPORTANT WARNINGS or SPECIAL PRECAUTIONS sections:

  • Hives
  • Rash
  • Itching
  • Breathing or swallowing challenges
  • Edoema of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, and eyes
  • Agitation, hallucinations (hearing voices or seeing things that are not there), disorientation, fever, sweating, shivering, extremely stiff or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Nausea, vomiting, weight loss, anorexia, or lightheadedness
  • Failure to achieve or maintain erection
  • Irregular periods of time
  • Less sexual arousal
  • Decreased breathing
  • Uneasy stomach
  • Extreme fatigue
  • Confusion
  • Fuzzy vision
  • Muddled speech
  • Uncommon bruising or bleeding
  • Not enough energy
  • Stomach ache in the top right corner
  • Eyes or skin that have a yellow tint
  • Urine with a dark colour
  • Stools with colour

Other negative effects of buprenorphine or buprenorphine plus naloxone are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly packed in the original container away from the reach of children. People who abuse prescription pharmaceuticals or illegal substances may target buprenorphine or buprenorphine plus naloxone. So that nobody else can use it intentionally or accidently, store it in a secure location. Buprenorphine or buprenorphine plus naloxone should be kept in a cool, dry place away from sources of extreme heat and moisture (not in the bathroom). Neither buprenorphine nor buprenorphine and naloxone should be frozen.

Any medication that has expired or is no longer needed must be disposed of right away via a medicine take-back programme. If there isn’t a take-back programme available to you locally or that you can quickly reach, you can get rid of unwanted tablets or movies by taking them out of their packaging and flushing them down the toilet. If you have any questions or need assistance getting rid of unwanted medication, contact your pharmacist or the manufacturer.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

You should discuss with your doctor having a rescue drug called naloxone on hand while taking buprenorphine or buprenorphine plus naloxone (e.g., home, office). Naloxone is used to undo an overdose’s potentially fatal consequences. To treat harmful symptoms brought on by excessive levels of opiates in the blood, it functions by inhibiting the effects of opiates. If you live with young children or someone who has abused prescription or illicit drugs, your doctor could also advise you to get naloxone. Make sure you, your family, your caretakers, and anyone else who spends time with you are aware of the signs of an overdose, how to administer naloxone, and what to do until emergency assistance arrives. You and your family members will be shown how to use the medication by your doctor or pharmacist. For the directions, speak to your pharmacist or go to the manufacturer’s website. If you start to experience overdose symptoms, a friend or family member should administer the first dose of naloxone, contact 911 right away, and stay by your side while keeping a careful eye on you until emergency medical assistance comes. After receiving naloxone, your symptoms can come back a short while later. The person should administer you another dose of naloxone if your symptoms come back. If symptoms reappear before receiving medical attention, more doses may be given every 2 to 3 minutes.

Overdose signs could include the following:

  • Precise pupils
  • Excessive tiredness or sleepiness
  • Dizziness
  • Fuzzy vision
  • Weak or sluggish breathing
  • Having trouble breathing
  • Not able to speak or awaken

What other information should I know?

Keep all of your appointments with your physician and the lab. To determine how well your body responds to buprenorphine and naloxone, your doctor will request a number of lab tests.

Inform your doctor and the lab staff that you are taking buprenorphine or buprenorphine plus naloxone prior to any laboratory test (particularly ones involving methylene blue).

You or a family member should inform the attending physician or emergency department staff that you are taking buprenorphine or buprenorphine plus naloxone in the event of an emergency.

Buprenorphine or buprenorphine plus naloxone sublingual film or tablets should not be injected. There could be severe effects, such as withdrawal symptoms.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Subutex®
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