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Actiq (Generic Fentanyl)

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WARNING

Given enough time, fentanyl use has the potential to become addictive. Fentanyl should only be used as prescribed. Never use more fentanyl than your doctor has prescribed, nor should you take it more frequently or for a longer period of time. Discuss your pain management options, treatment duration, and goals with your healthcare professional while using fentanyl. Inform your doctor if you or any family members regularly use significant amounts of alcohol, take street drugs, abuse prescription drugs excessively, experience overdosing, or currently suffer from depression or another mental disorder. If you currently have or have ever had any of these conditions, you are more likely to overuse fentanyl. If you suspect that you may have an opioid addiction, speak with your doctor right away and ask for advice, or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Only medical professionals with experience managing pain in cancer patients should prescribe fentanyl. Only cancer patients who are at least 18 years old (or at least 16 years old if using Actiq brand lozenges) and who are taking regularly scheduled doses of another narcotic (opiate) pain medication and who are tolerant (used to the effects of the medication) to narcotic pain medications should use it to treat breakthrough cancer pain (sudden episodes of pain that occur despite round-the-clock treatment with pain medication). Severe types of pain, particularly acute pain like migraines or other headaches, pain after an injury, or pain following a surgical or dental operation, should not be treated with this medicine. If fentanyl is used by individuals who are not receiving treatment with other narcotic medications or who are not accustomed to narcotic medications, it may result in severe breathing issues or death.

If fentanyl is accidentally consumed by a kid or an adult who has not been prescribed the drug, it could result in significant injury or even death. Fentanyl, even when only partially used, may contain enough drug to seriously injure or kill children or other individuals. Keep fentanyl out of the reach of kids, and if you use the lozenges, ask your doctor how to get a kit from the manufacturer with equipment to stop kids from acquiring the drug. The kit will likely have child safety locks and other materials. As soon as you take a lozenge out of your mouth, dispose of it in accordance with the manufacturer’s instructions. Try to get the fentanyl out of the mouth of any child or adult who is using it without a prescription before calling for emergency medical assistance.

You should combine fentanyl with other painkillers (s). When you start receiving therapy with fentanyl, do not stop using your other painkiller(s). You must stop using fentanyl if you stop taking your other painkiller(s).

Your doctor might advise you to take a second lozenge or tablet if you experience pain even after taking one. Actiq can be taken 15 minutes after the first lozenge is finished, while Abstral and Fentora can be taken 30 minutes after the first tablet was started. If you are treating the same pain episode with a second lozenge or tablet, only do so if your doctor instructs you to. You shouldn’t take a second dose of fentanyl film (Onsolis) to manage the same pain episode if you are already taking one. You must wait at least 2 hours (for Abstral or Onsolis) or 4 hours (for Actiq or Fentora) before treating another episode of breakthrough cancer pain following the administration of 1 or 2 doses of fentanyl as prescribed.

Combining certain drugs with fentanyl may raise your chance of experiencing severe or even fatal respiratory issues, drowsiness, or coma. If you are taking any of the following medications, let your doctor know: aprepitant (Emend); amiodarone (Nexterone, Pacerone); specific antibiotics such troleandomycin (TAO) and erythromycin (Biaxin, in PrevPac); certain antifungals like fluconazole (Diflucan); itraconazole (Onmel, Sporanox); and telithromycin (Erythocin); amiodarone (Nexterone, Pacerone); benzodiazepines including lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion); cimetidine (Tagamet); and diltiazem (Cardizem, Taztia, Tiazac, and others); benzodiazepines like alprazolam (Xanax), chlordiazepoxide (Librium), medication for mental illness and nausea; certain HIV medications, including amprenavir (Agenerase), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); muscle relaxants; nefazodone; sedatives; sleeping pills; tranquillizers; or verapam (Calan, Covera, Verelan).Your doctor will closely monitor you and may need to adjust the dosage of your drugs. Call your doctor right away if you experience any of the following symptoms after taking fentanyl with any of these drugs: unusual dizziness, lightheadedness, excessive drowsiness, sluggish or laboured breathing, or inability to respond. If you are unable to seek treatment on your own, make sure your carer or family members are aware of any symptoms that may be dangerous so they can contact the doctor or emergency services.

There are four main transmucosal formulations of fentanyl, along with several more varieties. One fentanyl product cannot be used in place of another because the drug in each is absorbed by the body differently. Your doctor will recommend the dose that is most suitable for you if you are transitioning from one product to another.

Each fentanyl product has a programme in place to lessen the risk of using the drug. To write a prescription for fentanyl, your doctor must sign up for the programme, and you must pick up your medication from a participating drugstore. As part of the programme, your doctor will discuss with you the advantages and disadvantages of using fentanyl as well as the proper ways to use, store, and discard the drug. After speaking with your doctor, you will be asked to sign a paper indicating that you understand the dangers of fentanyl use and that you will abide by their recommendations for using the drug safely. Your doctor will answer any questions you have about the programme and your fentanyl treatment, as well as provide you with further information about the programme and how to acquire your prescription.

When you start therapy with fentanyl and every time you receive extra medication, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Discuss the dangers of using this drug with your doctor.

Why is this medication prescribed?

Actiq is a lozenge with a handle that contains fentanyl. Abstral is a sublingual tablet that dissolves beneath the tongue. Onsolis is a film. And Fentora is a buccal tablet that dissolves in the mouth between the gum and cheek. Breakthrough pain is treated with fentanyl as needed, but not more than four times a day. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following.

How should this medicine be used?

Actiq is a lozenge with a handle that contains fentanyl. Abstral is a sublingual tablet that dissolves beneath the tongue. Onsolis is a film. And Fentora is a buccal tablet that dissolves in the mouth between the gum and cheek. Breakthrough pain is treated with fentanyl as needed, but not more than four times a day. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following.

Your doctor will likely prescribe you a modest dose of fentanyl to start, and then gradually increase it until you discover the right amount to treat your breakthrough pain. Your doctor may advise you to take another pain reliever if you’re still experiencing discomfort 30 minutes after taking fentanyl films (Onsolis), and they may also raise your dose of the drug to address your next bout of pain. In order for your doctor to determine whether your dose needs to be adjusted, be sure to discuss how well the medicine is working for you as well as any side effects you may be having.

Fentanyl shouldn’t be taken more than four times per day. If you encounter more than four instances of breakthrough pain each day, contact your doctor. To better manage your pain, your doctor may need to change the dosage of your other painkiller(s).

Do not break, chew, or crush the buccal tablet; instead, swallow it whole. Additionally, only suck on this drug as instructed; do not chew or bite the lozenge on a handle.

Avoid stopping your fentanyl use without first consulting your doctor. Your dose could be gradually reduced by your doctor. Unpleasant withdrawal symptoms could occur if you stop using fentanyl abruptly.

Follow these steps to utilise fentanyl lozenges (Actiq):

  1. To ensure that the lozenge includes the dosage of medication that has been recommended for you, look at the blister package and the handle of the lozenge.
  2. Cut the blister package open with scissors to release the lozenge. Before using the drug, wait to open the blister packet.
  3. In your mouth, sandwich the lozenge between your cheek and gum. Do not chew, crush, or bite the lozenge; instead, actively suck on it. Utilizing the handle, move the lozenge around in your mouth from side to side. frequently turn the handle.
  4. While you are chewing the lozenge, avoid eating or drinking anything.
  5. Give the lozenge around 15 minutes to chew.
  6. Before swallowing the entire lozenge, take it out of your mouth if you start to feel lightheaded, drowsy, or sick to your stomach. Put it in the temporary storage bottle for later disposal or get rid of it right away as explained below.
  7. If you consume the entire lozenge, dispose of the handle in a trashcan that is out of children’s reach. If you did not consume the full lozenge, hold the handle under hot running water to completely dissolve the medication, and then dispose of the handle in a trash container that is out of the way of kids and animals.

The steps below should be followed to use fentanyl buccal tablets (Fentora):

  1. By tearing along the perforations, separate one blister unit from the blister card. To open the blister package, peel back the foil. The tablet should not be forced through the foil. Wait until you are ready to use the tablet before opening the blister unit.
  2. Put the tablet between your cheek and gums, above one of your upper back teeth.
  3. Till the tablet is fully dissolved, keep it in place. As the tablet dissolves, you could feel a slight bubbling sensation between your cheek and gum. The tablet might dissolve in 14 to 25 minutes. The tablet should not be chewed, split, bit, or sucked.
  4. After 30 minutes, if any of the tablet is still in your mouth, you should drink some water and then swallow it.
  5. Before the pill dissolves, if you start to feel lightheaded, drowsy, or queasy, rinse your mouth with water and spit the leftover tablet fragments into the sink or toilet. To remove the tablet fragments, flush the toilet or rinse the sink.

Follow these steps to utilise fentanyl sublingual tablets (Abstral):

  1. If your mouth is dry, take a sip of water to wet it. Either spit out or ingest the water. Before handling the pill, make sure your hands are completely dry.
  2. By tearing along the perforations, separate one blister unit from the blister card. To open the blister package, peel back the foil. The tablet should not be forced through the foil. Wait until you are ready to use the tablet before opening the blister unit.
  3. As far back as you can under your tongue, place the tablet. If more than one pill is required for your dosage, distribute them evenly on the tongue-level floor of your mouth.
  4. Till the tablet is fully dissolved, keep it in place. Not to be chewed, sucked, or swallowed.
  5. You shouldn’t consume any food or liquids until the tablet has completely dissolved and you can’t feel it in your mouth any longer.

Take the following actions to use fentanyl films (Onsolis):

  1. To open the foil package, cut along the arrows with scissors. Remove the film by separating the foil package’s layers. Before using the drug, wait to open the foil container. Avoid tearing or cutting the film.
  2. To moisten the area where you will insert the film, wet the inside of your cheek with your tongue or, if necessary, rinse your mouth out with water.
  3. Hold the movie with the pink side facing up on a clean, dry finger. The pink side of the film should be on the inside of your moistened cheek when you place it in your mouth. For five seconds, push the film against your cheek with your finger. The film will then adhere to the inside of your cheek when you withdraw your finger. Do not stack the films if more than one is required to provide your dose. The films may be positioned on either side of your mouth.
  4. Until the film is totally gone, leave it in place. As the film decomposes, a minty flavour will come out. The film may break down in 15 to 30 minutes. Don’t swallow or chew the movie. The film should not be touched or moved while it dissolves.
  5. After five minutes, you may drink liquids, but you shouldn’t eat anything until the film is totally gone.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you want to use this drug for something else.

What special precautions should I follow?

Before using fentanyl,

  • If you have any allergies to fentanyl patches, injections, nasal sprays, tablets, lozenges, or films, any other drugs, or any of the substances in fentanyl tablets, lozenges, or films, let your doctor and pharmacist know right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, and dietary supplements you are currently taking or intend to take. Mention any of the following medications in addition to the ones in the IMPORTANT WARNING section. phenobarbital and other barbiturates, as well as antihistamines; oral steroids such dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol (Stadol); carbamazepine (Carbatrol, Epitol, Tegretol); efavirenz (Sustiva, in Atripla); modafinil (Provigil); pioglitazone (Actos, in Actoplus Met, in Duetact), rifabutin (Mycobutin), oxcarbazepine (Trileptal), pentazocine (Talwin), phenytoin (Dilantin, Phenytek), rifampin, and pentazocine (Rifadin, Rimactane, in Rifamate, in Rifater). Additionally, let your doctor or pharmacist know if you’re taking any of the following drugs or if you’ve recently stopped taking them: monoamine oxidase (MAO) inhibitors such tranylcypromine (Eldepryl, Emsam, Zelapar), phenelzine (Nardil), isocarboxazid (Marplan), and phenelzine (Parnate). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • Inform your doctor if you or any members of your family regularly consume significant amounts of alcohol, use illicit drugs, or take excessive amounts of prescription medication. Additionally, let your doctor know if you now have or previously had any of the following: seizures, delayed heartbeat or other heart issues, low blood pressure, mental health issues including depression, brain tumours, brain injuries, or any other conditions that created excessive pressure inside your skull. Asthma, chronic obstructive pulmonary disease (COPD), a group of lung diseases that includes chronic bronchitis and emphysema, hallucinations (seeing things or hearing voices that are not real), or kidney or liver disease can all affect breathing. Schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) are also common.
  • If you are breastfeeding a child or intend to become pregnant, let your doctor know. Call your doctor if you become pregnant while using fentanyl.
  • You should be aware that this medicine may lower both male and female fertility. Consult your doctor about the dangers of fentanyl use.
  • Inform the surgeon or dentist that you are using fentanyl if you are undergoing surgery, including dental surgery.
    You should be aware that fentanyl may cause you to feel sleepy or lightheaded. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • You should be aware that fentanyl can make you feel weak, lightheaded, and dizzy if you stand up suddenly from a reclining posture. When you initially start using fentanyl, this happens more frequently. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.
  • You should be aware that each Actiq fentanyl lozenge contains roughly 2 grammes of sugar if you have diabetes.
  • Ask your dentist how to best take care of your teeth throughout treatment if you plan to use the lozenges (Actiq). The sugar in the lozenges may contribute to tooth decay and other dental issues.
  • It’s important to be aware that fentanyl can cause constipation. To treat or prevent constipation, discuss with your doctor modifying your diet and taking additional drugs.

What special dietary instructions should I follow?

While using this medication, avoid grapefruit and grapefruit juice.

What should I do if I forget a dose?

As directed, this drug is typically taken as needed.

What side effects can this medication cause?

Side effects from fentanyl could exist. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Drowsiness
  • Abdominal pain
  • Gas
  • Heartburn
  • Loss of weight
  • Having trouble urinating
  • Vision changes
  • Vision changes
  • Depression
  • Unusual viewpoint
  • Strange dreams
  • Having trouble falling or staying asleep
  • Mouth ache
  • Sudden facial, neck, or upper chest redness
  • Back discomfort
  • Uncontrollable trembling of a bodily portion
  • Chest pain
  • When taking the drug, you may experience oral pain, sores, or irritation.
  • Hand, arm, foot, ankle, or lower leg swelling

Some adverse effects can be very harmful. Call your doctor right away if any of these symptoms occur to you:

  • Alterations in heartbeat
  • Hallucinations (seeing or hearing objects or voices that aren’t there), agitation, sweating excessively, confusion, rapid heartbeat, shivering, extremely rigid or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Nausea, vomiting, appetite loss, exhaustion, or lightheadedness
  • Failure to achieve or maintain erection
  • Abnormal menstruation
  • Reduced sexual arousal
  • Seizures
  • Hives
  • Rash
  • Itching

Stop using fentanyl and seek emergency medical attention if you suffer any of the following symptoms:

  • Shallow, sluggish breathing
  • Less need to breathe
  • Breathing or swallowing challenges
  • Extreme somnolence
  • Dizziness
  • Confusion
  • Fainting

Other negative effects of fentanyl are possible. If you experience any strange issues while taking this drug, call 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. To prevent unauthorised or intentional use, store fentanyl in a secure location. To prevent youngsters from accessing the lozenges, use the child-resistant locks and other equipment that the manufacturer has given. To find out if any fentanyl is missing, keep note of how much is still available. Fentanyl should be kept at room temperature away from sources of extreme heat and moisture (not in the bathroom). Avoid freezing fentanyl.

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 close by or that you can quickly reach, flush the fentanyl down the toilet to prevent others from taking it. Unused lozenges can be disposed of by taking them out of the blister container, holding them over the toilet, and using wire cutters to snip off the medicinal end so that it falls into the bowl. If there are still up to five lozenges in the toilet, flush it twice and store the remaining handles somewhere out of the way of kids and dogs. Remove unused tablets or films from their package and flush them down the toilet to dispose of them. Do not flush the remaining fentanyl packing or cartons down the toilet; instead, place them in a garbage can. 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

Remove the fentanyl from the victim’s mouth in the event of an overdose, then dial 911 to contact the nearest emergency services.

You should consult your doctor about keeping naloxone, a life-saving drug, on hand while taking fentanyl (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 and your family, caretakers, or companions are familiar with the signs of an overdose, how to administer naloxone, and what to do until emergency medical 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:

  • Sleepiness or drowsiness
  • Dizziness
  • Confusion
  • Breathing that is shallow or stopped
  • Having trouble breathing
  • Lesser pupils (black circles in the middle of the eyes)
  • Unable to wake up or speak

What other information should I know?

Keep all of your doctor’s appointments.

Even if someone else has the same symptoms you do, do not let them use your prescription. It’s against the law to sell or distribute this medication because doing so could result in serious injury or death to others.

This medication cannot be renewed. In order to prevent running out of medication, make sure you plan regular doctor’s appointments.

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

  • Abstral®
  • Actiq®
  • Fentora®
  • Onsolis®
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