Name: Buprenorphine Transdermal
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Dosing & Uses
Dosing Form & Strengths
transdermal patch: Schedule III
Chronic Severe Pain
Indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
Each patch is worn for 7 days (except during titration)
Opioid-naïve: Initiate with 5 mcg/hr patch; may supplement with prompt-acting opioid and nonopioid analgesic for break-through pain
Do not increase patch until patient has been exposed continually to previous dose for 72 hr
Based on requirement for supplemental short-acting analgesics, upward titration may be instituted with at a minimum interval of 72 hr
Do not exceed dose of one 20 mcg/hr transdermal system (risk of QT prolongation with higher doses)
Conversion from other opioids
- Oral morphine equivalent <30 mg/day: Initiate with 5 mcg/hr patch
- Oral morphine equivalent 30-80 mg/day: Initiate with 10 mcg/hr patch
- May supplement with prompt-acting opioid and nonopioid analgesic for break-through pain
- Use caution when prescribing to opioid-experienced patients requiring high doses of opioids (ie, >80 mg/day oral morphine equivalent); buprenorphine transdermal 20 mcg/hr may not provide adequate analgesia for patients previously on high-dose opioids
- Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression
- Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day PO morphine, 25 mcg/hr transdermal fentanyl, 30 mg/day PO oxycodone, 8 mg/day PO hydromorphone, 25 mg/day PO oxymorphone, or an equianalgesic dose of another opioid
Limitations of use
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve for patients whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain
- Not indicated as a PRN analgesic
Although specific dose adjustments on the basis of advanced age are not required for pharmacokinetic reasons, use caution in the elderly population to ensure safe use
Clinical trials observed that some adverse effects (ie, respiratory depression, constipation, urinary retention) occur more frequently in elderly patients
Only intended for 7-day application, consider use of an alternate analgesic that permits flexible dosing
Mild-to-moderate: Initiate with 5 mcg/hr dose; titrate to provide adequate analgesia and tolerable adverse effects
Severe: Not yet studied with severe hepatic impairment
Apply to hairless or nearly hairless skin site; if none available, clip hair at application site (do not shave)
Do not apply to irritated skin
Clean application site with water only; do not use soaps, alcohol, oils, lotions, or abrasive devices
Allow skin to dry completely before application
If problems with adhesion occur, may tape edges with first aid tape
If transdermal patch falls off during the 7 days, discard patch and apply new patch to different skin site
Rotate application site: after each patch removal, wait a minimum of 3 weeks before reapplying to same application site
When discontinuing patch, taper dose as part of comprehensive treatment plan; consider use of immediate-release opioid analgesics
Safety and efficacy not established
Pregnancy & Lactation
Pregnancy Category: C
Opioids cross the placenta and may produce respiratory depression and psychophysiologic effects in neonates; not recommended for use in women immediately prior to and during labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate
Neonates whose mothers have been taking opioids chronically may also exhibit withdrawal signs, either at birth and/or in the nursery, because they have developed physical dependence; neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening and should be treated according to protocols developed by neonatology experts
Lactation: Detected in low concentrations in human milk; breastfeeding not advised
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Uses For buprenorphine
Buprenorphine skin patch is used to treat moderate to severe chronic pain when around-the-clock pain relief is needed for a long period of time. It belongs to the group of medicines called narcotic analgesics (pain medicines). Buprenorphine acts on the central nervous system (CNS) to relieve pain.
The buprenorphine skin patch should not be used if you need pain medicine for just a short time, such as after surgery. Do not use buprenorphine for mild pain or pain that you only have once in a while or "as needed."
When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve the pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. Severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time.
buprenorphine is available only with your doctor's prescription.
Before Using buprenorphine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For buprenorphine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to buprenorphine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine skin patch in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine skin patch in the elderly. However, elderly patients are more likely to have constipation and difficult or painful urination, and have age-related heart, kidney, liver, or lung problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine skin patch to avoid serious side effects.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using buprenorphine.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking buprenorphine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using buprenorphine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using buprenorphine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloral Hydrate
- Methylene Blue
- Nitrous Oxide
- Opium Alkaloids
- Sodium Oxybate
- St John's Wort
- Tolonium Chloride
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using buprenorphine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use buprenorphine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of buprenorphine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, or history of or
- Angina or
- Atrial fibrillation (abnormal heart rhythm) or
- Bradycardia (slow heartbeat) or
- Brain tumor, history of or
- Central nervous system (CNS) depression, history of or
- Chronic obstructive pulmonary disease (COPD) or
- Congenital long QT syndrome (abnormal heart rhythm) or
- Congestive heart failure or
- Cor pulmonale (serious heart problem) or
- Depression, history of or
- Drug dependence, including narcotic or illicit drug abuse or dependence, or history of or
- Gallbladder disease or gallstones or
- Head injury, history of or
- Heart disease or
- Heart rhythm problem, or family history of or
- Hypokalemia (low potassium in the blood) or
- Hypothyroidism (an underactive thyroid) or
- Liver disease (including hepatitis B or C) or
- Lung or breathing problems (eg, low oxygen levels) or
- Mental health problems, or history of or
- Problems with passing urine or
- Sleep apnea or
- Stomach or bowel problems (eg, blockage) or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Hypotension (low blood pressure) or
- Pancreatitis (inflammation or swelling of the pancreas), acute or
- Seizures, history of—Use with caution. May make these conditions worse.
This medication is used to help relieve severe ongoing pain (such as due to arthritis, chronic back pain). Buprenorphine belongs to a class of drugs known as opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.
The higher strengths of this drug (7.5, 10, 15, or 20 micrograms per hour patches) should be used only if you have been regularly taking moderate amounts of opioid pain medication. These strengths may cause overdose (even death) if used by a person who has not been regularly taking opioids.
Do not use this medication to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
How to use Buprenorphine Patch, Transdermal Weekly
See also Warning section.
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Learn how to properly use, store, and discard the patches. If you have any questions, ask your doctor or pharmacist.
Use this medication on a regular schedule as directed by your doctor, not as needed for sudden (breakthrough) pain. If you are already using an opioid medication, ask your doctor or pharmacist if you should stop or change how you use your other opioid medication. It may take 24 hours or longer before you have pain relief from buprenorphine patches. Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using buprenorphine safely with other drugs.
Apply this medication to the skin as directed by your doctor. Do not apply on burns, cuts, irritated skin, or skin that has been exposed to radiation (x-ray treatment). Select a dry, non-hairy area on a flat part of your body, such as the upper chest, sides of the chest, upper back, or upper outer arms. In people unable to think clearly (such as due to dementia), apply the patch on the upper back to lessen the chance it might be removed or placed in the mouth. If there is hair on the skin, use scissors to clip the hair as close as possible to the skin. Do not shave hair since this might cause skin irritation. If needed, use water to clean the area. Do not use soap, oils, lotions, or alcohol on the application site. Dry the skin well before applying the patch.
The patch is usually changed every 7 days. To avoid irritation, apply to a different area each time and do not apply to the same site within 3 weeks. Be sure to remove the old patch before applying a new patch. The used patch should be folded in half with the sticky sides together and properly discarded. If your manufacturer has supplied a patch disposal unit, follow directions for its use.
Do not use the patch if it appears to be broken, cut, or damaged. Remove from the sealed pouch, peel off the protective liner, and apply right away to the skin. Press firmly in place with the palm of the hand for about 15 to 30 seconds, making sure the contact is complete (especially around the edges). If your prescribed dose is for more than one patch, apply them right next to each other but make sure the edges of the patches do not touch or overlap. After applying the patch, wash your hands with water only.
You may bathe, shower, or swim while wearing the patch. If you have problems with the patch not sticking at the application site, you may tape the edges in place with certain kinds of clear tape. Ask your doctor or pharmacist about which type of tape should be used. If this problem persists, ask your doctor for advice. If the patch falls off before 7 days, a new patch may be applied to a different skin site. Be sure to let your doctor know if this happens.
If you accidentally touch the sticky layer to your skin or handle a cut or damaged patch, wash the area well with clear water. If the patch comes off and accidentally sticks to the skin of another person, immediately remove the patch, wash the area with water, and get medical help for them right away. Do not use soap, alcohol, or other products to wash the area.
The dosage is based on your medical condition and response to treatment. Do not apply more patches than directed, change them more frequently, or use them for a longer time than prescribed. Your risk for side effects will increase.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. Withdrawal can also occur if you are switching from another opioid medication to buprenorphine. Symptoms of withdrawal include restlessness, watering eyes, runny nose, nausea, sweating, or muscle aches. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions right away.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Use this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if your pain is not relieved or if it worsens.