What is Buprenorphine HCl?
Buprenorphine HCl is an opioid medication, sometimes called a narcotic.
This medication guide provides information about the Buprenorphine HCl brand of Buprenorphine HCl injection. Buprenorphine HCl is another brand of Buprenorphine HCl injection that is used to treat moderate to severe pain.
Buprenorphine HCl is used to treat opioid addiction. Buprenorphine HCl is not for use as a pain medication.
Buprenorphine HCl is given to people who have started addiction treatment with an oral form of Buprenorphine HCl placed under the tongue or inside the cheek (such as Suboxone or Buprenorphine HCl).
Buprenorphine HCl is available only in a certified healthcare setting under a special program. You will not be able to give yourself this medicine.
Buprenorphine HCl may also be used for purposes not listed in this medication guide.
Buprenorphine HCl indications
Buprenorphine HCl is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal Buprenorphine HCl-containing product (i.e., doses of no more than 8 mg per day of Buprenorphine HCl or Suboxone sublingual tablet equivalent or generic equivalent).
Buprenorphine HCl should be used as part of a complete treatment program to include counseling and psychosocial support.
Buprenorphine HCl is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged clinical stability, while being maintained on Buprenorphine HCl 8 mg per day or less of a Buprenorphine HCl or Suboxone sublingual tablet equivalent or generic equivalent.
How should I use Buprenorphine HCl?
Follow all directions on your prescription label. Buprenorphine HCl can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use Buprenorphine HCl in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Buprenorphine HCl may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.
Buprenorphine HCl is injected into a muscle or into a vein through an IV. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine.
Buprenorphine HCl is usually given at evenly spaced intervals, up to 6 hours apart. Tell your doctor if Buprenorphine HCl does not relieve your pain within 1 hour after an injection.
Prepare your dose in a syringe or IV only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
This medicine can cause irritation if it gets on your skin. If this occurs, remove any clothing the medicine has spilled onto, and rinse your skin with water.
If you need surgery, tell the surgeon ahead of time that you are using Buprenorphine HCl. You may need to stop using the medicine for a short time.
Do not stop using Buprenorphine HCl suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Buprenorphine HCl.
Wear a medical alert tag or carry an ID card stating that you use Buprenorphine HCl. Any medical care provider who treats you should know that you are using Buprenorphine HCl. Make sure your family members know you are using Buprenorphine HCl in case they need to speak for you during an emergency.
Store at room temperature away from moisture, heat, and light. Keep track of the amount of medicine used from each new ampule. Buprenorphine HCl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Uses of Buprenorphine HCl in details
Use: Labeled Indications
Opioid use disorder:
Extended-release injection: Maintenance treatment of moderate to severe opioid use disorder in patients who have initiated treatment with 8 to 24 mg of a transmucosal Buprenorphine HCl-containing product, followed by dose adjustment for a minimum of 7 days.
Subdermal implant: Maintenance treatment of opioid use disorder in patients who have achieved and sustained prolonged clinical stability on low to moderate doses (≤8 mg/day) of a transmucosal Buprenorphine HCl-containing product for 3 months or longer with no need for supplemental dosing or adjustments
Sublingual tablet: Medically supervised withdrawal and maintenance treatment of opioid use disorder.
Limitations of use: Buprenorphine HCl should be used as part of a complete treatment program to include counseling and psychosocial support.
Pain management:
Buccal film, transdermal patch: Management of pain severe enough to require around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
Immediate-release injection: Management of pain severe enough to require an opioid analgesic and for which treatments are inadequate
Limitations of use: Reserve Buprenorphine HCl for use in patients for whom alternative treatment options (eg, nonopioid analgesics, opioid combination products, immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Buprenorphine HCl buccal film and transdermal patch are not indicated as an as needed analgesic.
Off Label Uses
Opioid withdrawal in heroin-dependent hospitalized patients (immediate-release injection)
Data from a limited number of patients studied who received Buprenorphine HCl parenterally for opioid withdrawal during hospitalization for an acute medical problem suggests that Buprenorphine HCl is safe when used in this setting; Additional data may be necessary to further define the role of Buprenorphine HCl in the management of postoperative pain as a perineural adjunct.
Buprenorphine HCl description
Buprenorphine HCl (Buprenorphine HCl) transdermal patch is available in three strengths: Buprenorphine HCl (Buprenorphine HCl) 5 mg contains 5 mg Buprenorphine HCl in a drug-containing matrix that releases a nominal 5 micrograms of Buprenorphine HCl per hour over 7 days.
Buprenorphine HCl (Buprenorphine HCl) 10 mg contains 10 mg Buprenorphine HCl in a drug-containing matrix that releases a nominal 10 micrograms of Buprenorphine HCl per hour over 7 days.
Buprenorphine HCl (Buprenorphine HCl) 20 mg contains 20 mg Buprenorphine HCl in a drug-containing matrix that releases a nominal 20 micrograms of Buprenorphine HCl per hour over 7 days.
Buprenorphine HCl (Buprenorphine HCl) is a rectangular or square, transdermal patch consisting of a protective liner and functional layers including a Buprenorphine HCl-containing adhesive matrix.
Excipients/Inactive Ingredients: Levulinic acid, oleyl oleate, povidone (PVP), polyacrylate (dry solids), polyethylene terephthalate (PET).
Buprenorphine HCl dosage
Buprenorphine HCl Dosage
Generic name: Buprenorphine HCl HYDROCHLORIDE 75ug
Dosage form: buccal film
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
2.1 Important Dosage and Administration Instructions
Buprenorphine HCl should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Buprenorphine HCl buccal film is for oral buccal use only and is to be applied to the buccal mucosa every 12 hours.
Instruct patients not to use Buprenorphine HCl if the pouch seal is broken or the buccal film is cut, damaged, or changed in any way and to avoid applying Buprenorphine HCl to areas of the mouth with any open sores or lesions.
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with Buprenorphine HCl and adjust the dosage accordingly.
Initial Dosing
Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
Use of Buprenorphine HCl as the Initial Opioid Analgesic (Opioid Naïve Patients)
Initiate treatment in opioid naïve patients with a 75 mcg film once daily or, if tolerated, every 12 hours for at least 4 days, then increase dose to 150 mcg every 12 hours. Individual titration to a dose that provides adequate analgesia and minimizes adverse reactions should proceed in increments of 150 mcg every 12 hours, no more frequently than every 4 days. Doses up to 450 mcg every 12 hours were studied in opioid naïve patients in the clinical trials.
Conversion from Other Opioids to Buprenorphine HCl
There is a potential for Buprenorphine HCl to precipitate withdrawal in patients who are already on opioids. To reduce the risk of opioid withdrawal, taper patients to no more than 30 mg oral morphine sulfate equivalents (MSE) daily before beginning Buprenorphine HCl. Following analgesic taper, base the starting dose on the patient’s daily opioid dose prior to taper, as described in Table 1. Patients may require additional short-acting analgesics during the taper period and during titration.
Buprenorphine HCl may not provide adequate analgesia for patients requiring greater than 160 mg oral MSE per day. Consider the use of an alternate analgesic.
| Prior Daily Dose of Opioid Analgesic Before Taper to 30 mg Oral MSE | Initial Buprenorphine HCl Dose |
| Less than 30 mg oral MSE | Buprenorphine HCl 75 mcg once daily or every 12 hours |
| 30 mg to 89 mg oral MSE | Buprenorphine HCl 150 mcg every 12 hours |
| 90 mg to 160 mg oral MSE | Buprenorphine HCl 300 mcg every 12 hours |
| Greater than 160 mg oral MSE | Consider alternate analgesic |
Buprenorphine HCl doses of 600 mcg, 750 mcg, and 900 mcg are only for use following titration from lower doses of Buprenorphine HCl. Individual titration should proceed in increments of 150 mcg every 12 hours, no more frequently than every 4 days.
Conversion from Methadone to Buprenorphine HCl
Close monitoring is of particular importance when converting from methadone to other opioid agonists, including Buprenorphine HCl. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.
Titration and Maintenance of Therapy
Individually titrate Buprenorphine HCl to a dose that provides adequate analgesia and minimizes adverse reactions Continually reevaluate patients receiving Buprenorphine HCl to assess the maintenance of pain control and the relative incidence of adverse reactions and monitor for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During long-term therapy, periodically reassess the continued need for opioid analgesics.
The minimum titration interval of Buprenorphine HCl is 4 days, based on the pharmacokinetic profile and time to reach steady-state plasma levels.
Individual titration should proceed in increments of no more than 150 mcg every 12 hours.
The maximum Buprenorphine HCl dose is 900 mcg every 12 hours. Do not exceed a dose of Buprenorphine HCl 900 mcg every 12 hours due to the potential for QTc interval prolongation.. If pain is not adequately managed on Buprenorphine HCl 900 mcg, consider an alternate analgesic.
Patients who experience breakthrough pain may require dosage adjustment of Buprenorphine HCl or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the Buprenorphine HCl dose.
If unacceptable opioid-related adverse reactions are observed, adjust the dose to obtain an appropriate balance between the management of pain and opioid-related adverse reactions.
2.4 Discontinuation of Buprenorphine HCl
When a patient no longer requires therapy with Buprenorphine HCl, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue Buprenorphine HCl.
2.5 Dosage Modifications in Patients with Severe Hepatic Impairment
In patients with severe hepatic impairment (i.e., Child-Pugh C), reduce the starting dose and reduce the titration dose by half that of patients with normal liver function, from 150 mcg to 75 mcg..
2.6 Dosage Modifications in Patients with
Oral Mucositis
In patients with known or suspected mucositis, reduce the starting dosage and titration incremental dosage by half compared to patients without mucositis..
2.7 Administration of Buprenorphine HCl
Buprenorphine HCl should not be used if the package seal is broken or the film is cut, damaged, or changed in any way.
First, the patient must use the tongue to wet the inside of the cheek or rinse the mouth with water to wet the area for placement of Buprenorphine HCl. Buprenorphine HCl is then applied immediately after removal from the individually sealed package.. The yellow side of the Buprenorphine HCl film is placed against the inside of the cheek. The entire Buprenorphine HCl film is held in place with clean, dry fingers for 5 seconds and then left Buprenorphine HCl in place on the inside of the cheek until fully dissolved.
Buprenorphine HCl adheres to the moist buccal mucosa and will completely dissolve after application, usually within 30 minutes. The film should not be manipulated with the tongue or finger(s) and eating food and drinking liquids should be avoided until the film has dissolved.
A Buprenorphine HCl film, if chewed or swallowed, may result in lower peak concentrations and lower bioavailability than when used as directed.
Demonstrate proper administration technique to the patient.
2.8 Disposal Instructions
Dispose of unused Buprenorphine HCl as soon as it is no longer needed.
To dispose of unused Buprenorphine HCl film:
- Remove all Buprenorphine HCl films from their foil packages.
- Drop the Buprenorphine HCl films into toilet and flush.
- Discard foil packaging in trash.
Do not flush Buprenorphine HCl down the toilet in the foil packages or cartons [s ee Patient Counseling Information ( 17)].
More about Buprenorphine HCl (Buprenorphine HCl)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Espanol
- 28 Reviews - Add your own review/rating
Consumer resources
- Buprenorphine HCl
- Buprenorphine HCl oral/buccal
- Buprenorphine HCl (Advanced Reading)
- Other brands: Butrans, Buprenorphine HCl, Buprenorphine HCl, Buprenorphine HCl
Professional resources
- Buprenorphine HCl (FDA)
- Buprenorphine HCl, Buprenorphine HCl Hydrochloride (AHFS Monograph)
Related treatment guides
- Pain
- Chronic Pain
Buprenorphine HCl interactions
See also:
What other drugs will affect Buprenorphine HCl?
Drug interactions common to other potent opioid analgesics also may occur with Buprenorphine HCl (Buprenorphine HCl). Particular care should be taken when Buprenorphine HCl (Buprenorphine HCl) is used in combination with central nervous system depressant drugs. Although specific information is not presently available, caution should be exercised when Buprenorphine HCl (Buprenorphine HCl) is used in combination with MAO inhibitors. There have been reports of respiratory and cardiovascular collapse in patients who received therapeutic doses of diazepam and Buprenorphine HCl (Buprenorphine HCl). A suspected interaction between Buprenorphine HCl (Buprenorphine HCl) and phenprocoumon resulting in purpura has been reported.
CYP3A4 Inhibitors: Since the metabolism of Buprenorphine HCl is mediated by the CYP3A4 isozyme, coadministration of drugs that inhibit CYP3A4 activity may cause decreased clearance of Buprenorphine HCl. Thus patients coadministered with inhibitors of CYP3A4 such as macrolide antibiotics (e.g., erythromycin), azole antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritanovir) while receiving Buprenorphine HCl (Buprenorphine HCl) should be carefully monitored and dosage adjustment made if warranted.
CYP3A4 Inducers: Cytochrome P450 inducers, such as rifampin, carbamazepine, and phenytoin, induce metabolism and as such may cause increased clearance of Buprenorphine HCl. Caution is advised when administering Buprenorphine HCl (Buprenorphine HCl) to patients receiving these medications and if necessary dose adjustments should be considered
Buprenorphine HCl side effects
See also:
What are the possible side effects of Buprenorphine HCl?
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Addiction, Abuse, and Misuse
- Respiratory and CNS Depression
- Neonatal Opioid Withdrawal Syndrome
- Adrenal Insufficiency
- Opioid Withdrawal
- Hepatitis, Hepatic Events
- Hypersensitivity Reactions
- Orthostatic Hypotension
- Elevation of Cerebrospinal Fluid Pressure
- Elevation of Intracholedochal Pressure
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Buprenorphine HCl was evaluated in 848 opioid-dependent subjects. In these studies, there was a total of 557 subjects who received at least 6 monthly SC injections of Buprenorphine HCl and 138 subjects who received 12 monthly SC injections. Adverse events led to premature discontinuation in 4% of the group receiving Buprenorphine HCl compared with 2% in the placebo group (13-0001, NCT02357901).
In the Phase 3 open-label study (13-0003, NCT02510014), adverse events leading to drug dose reductions were reported in 7.3% of subjects receiving Buprenorphine HCl.
| Study 13-0001 (NCT02357901) Up to 6 Injections | Study 13-0003 (NCT02510014) | Total Subjects Exposed To Buprenorphine HCl | |||||
|---|---|---|---|---|---|---|---|
| *Not included in total subjects exposed to Buprenorphine HCl | |||||||
| † FLEX = 300 mg initial dose with an option to receive either 100 mg or 300 mg for subsequent dosing per clinician's discretion | |||||||
| ‡ = Not included in total unique subjects exposed to Buprenorphine HCl, already accounted for in Study 13-0001 section of table | |||||||
| Roll-Over Up to 6 Injections | De-Novo Up to 12 Injections | ||||||
| Buprenorphine HCl 300/100 mg | Buprenorphine HCl 300/300 mg | Placebo | From Buprenorphine HCl 300/100 mg To Buprenorphine HCl 300/Flex† | From Buprenorphine HCl 300/300 mg To Buprenorphine HCl 300/Flex† | From Placebo To Buprenorphine HCl 300/Flex† | Buprenorphine HCl 300/Flex | |
| N = 203 | N = 201 | N = 100* | N = 112‡ | N = 113‡ | N= 32 | N = 412 | N = 848 |
Table 2 shows the non-injection site-related adverse reactions (ADRs) for the groups receiving Buprenorphine HCl 300/300 mg (6 doses of 300 mg SC injections) 300/100 mg (300 mg SC injections for the first two doses followed by 4 doses of 100 mg SC injections) and placebo (volume-matched ATRIGEL® delivery system subcutaneous injections) reported following administration in the 6 month, double-blind, placebo-controlled study. The systemic safety profile for Buprenorphine HCl, given by a healthcare provider in clinical trials, was consistent with the known safety profile of transmucosal Buprenorphine HCl. Common adverse reactions associated with Buprenorphine HCl included constipation, nausea, vomiting, abnormal liver enzymes, headache, sedation and somnolence. Dose dependent hepatic effects observed in the Phase 3, double-blind study (13-0001, NCT02357901) included the incidence of ALT more than 3 times the upper limit of normal (> 3 × ULN) in 12.4%, 5.4%, and 4.0% of the Buprenorphine HCl 300/300-mg, Buprenorphine HCl 300/100-mg, and placebo groups, respectively. The incidence of AST > 3 × ULN was 11.4%, 7.9%, and 1.0%, respectively. Adverse drug reactions [by MedDRA Preferred Terms (PT)] reported in at least 2% of subjects receiving Buprenorphine HCl are grouped by System Organ Class (SOC).
| System Organ Class Preferred Term | PLACEBO | Buprenorphine HCl 300/100 mg | Buprenorphine HCl 300/300 mg |
|---|---|---|---|
| Count (%) | Count (%) | Count (%) | |
| *There were no cases of serious liver injury attributed to study drug. | |||
| Total | N = 100 | N = 203 | N = 201 |
| Gastrointestinal disorders | 12 (12%) | 51 (25.1%) | 45 (22.4%) |
| Constipation | 0 | 19 (9.4) | 16 (8) |
| Nausea | 5 (5) | 18 (8.9) | 16 (8) |
| Vomiting | 4 (4) | 19 (9.4) | 11 (5.5) |
| General disorders and administration site conditions | 17 (17%) | 40 (19.7%) | 49 (24.4%) |
| Fatigue | 3 (3) | 8 (3.9) | 12 (6) |
| Investigations* | 2 (2%) | 21 (10.3%) | 19 (9.5%) |
| Alanine aminotransferase increased (ALT) | 0 | 2 (1) | 10 (5) |
| Aspartate aminotransferase increased (AST) | 0 | 7 (3.4) | 9 (4.5) |
| Blood creatine phosphokinase increased (CPK) | 1 (1) | 11 (5.4) | 5 (2.5) |
| Gamma-glutamyl transferase increased (GGT) | 1 (1) | 6 (3) | 8 (4) |
| Nervous system disorders | 7 (7%) | 35 (17.2%) | 25 (12.4%) |
| Headache | 6 (6) | 19 (9.4) | 17 (8.5) |
| Sedation | 0 | 7 (3.4) | 3 (1.5) |
| Dizziness | 2 (2) | 5 (2.5) | 3 (1.5) |
| Somnolence | 0 | 10 (4.9) | 4 (2) |
Table 3 shows the injection site-related adverse events reported by ≥2 subjects in the Phase 3 studies. Most injection site adverse drug reactions (ADRs) were of mild to moderate severity, with one report of severe injection site pruritus. None of the injection site reactions were serious. One reaction, an injection site ulcer, led to study treatment discontinuation.
| *Patients received SUBOXONE film for a run-in period before they switched to Buprenorphine HCl injection. | ||||||||
| Preferred term, n (%) | 13-0001 (Ph3DB) | 13-0003 (Ph3OL) | All Phase 3* | |||||
| Roll–over | De-novo | |||||||
| Buprenorphine HCl 300/300 (N = 201) | Buprenorphine HCl 300/100 (N = 203) | Placebo (N = 100) | Buprenorphine HCl 300 → Buprenorphine HCl 300/Flex (N = 113) | Buprenorphine HCl 100 → Buprenorphine HCl 300/Flex (N = 112) | Placebo → Buprenorphine HCl 300/Flex (N = 32) | Buprenorphine HCl 300/Flex (N = 412) | Total Buprenorphine HCl (N = 848) | |
| Subjects with any injection site reactions | 38 (18.9%) | 28 (13.8%) | 9 (9.0%) | 6 (5.3%) | 13 (11.6%) | 2 (6.3%) | 61 (14.8%) | 140 (16.5%) |
| Injection site pain | 12 (6.0%) | 10 (4.9%) | 3 (3.0%) | 4 (3.5%) | 2 (1.8%) | 2 (6.3%) | 33 (8.0%) | 61 (7.2%) |
| Injection site pruritus | 19 (9.5%) | 13 (6.4%) | 4 (4.0%) | 2 (1.8%) | 6 (5.4%) | 1 (3.1%) | 17 (4.1%) | 56 (6.6%) |
| Injection site erythema | 6 (3.0%) | 9 (4.4%) | 0 | 1 (0.9%) | 4 (3.6%) | 0 | 21 (5.1%) | 40 (4.7%) |
| Injection site induration | 2 (1.0%) | 2 (1.0%) | 0 | 0 | 1 (0.9%) | 0 | 7 (1.7%) | 12 (1.4%) |
| Injection site bruising | 2 (1.0%) | 2 (1.0%) | 0 | 0 | 0 | 0 | 2 (0.5%) | 6 (0.7%) |
| Injection site swelling | 1 (0.5%) | 2 (1.0%) | 0 | 1 (0.9%) | 1 (0.9%) | 0 | 1 (0.2%) | 6 (0.7%) |
| Injection site discomfort | 1 (0.5%) | 1 (0.5%) | 0 | 0 | 0 | 0 | 3 (0.7%) | 5 (0.6%) |
| Injection site reaction | 1 (0.5%) | 0 | 0 | 0 | 3 (2.7%) | 0 | 1 (0.2%) | 5 (0.6%) |
| Injection site cellulitis | 0 | 1 (0.5%) | 0 | 0 | 0 | 0 | 2 (0.5%) | 3 (0.4%) |
| Injection site infection | 1 (0.5%) | 0 | 1 (1.0%) | 0 | 0 | 0 | 2 (0.5%) | 3 (0.4%) |
Longer-term experience
In an interim analysis of the ongoing open-label long-term safety study (13-0003), safety was evaluated for up to 12 injections over the course of a year. Adverse events were reported for 432 of 669 subjects during the treatment period. The overall adverse event profile was similar to the double-blind trial described above.
Postmarketing Experience
The most frequently reported systemic postmarketing adverse event observed with Buprenorphine HCl sublingual tablets was drug misuse or abuse. The most frequently reported systemic postmarketing adverse event with Buprenorphine HCl/naloxone sublingual tablets and film was peripheral edema.
The following adverse reactions have been identified during post-approval use of Buprenorphine HCl. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Buprenorphine HCl.
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.
Buprenorphine HCl contraindications
See also:
What is the most important information I should know about Buprenorphine HCl?
Hypersensitivity (eg, anaphylaxis) to Buprenorphine HCl or any component of the formulation
Buccal film, immediate-release injection, transdermal patch: Additional contraindications: Significant respiratory depression; acute or severe asthma in an unmonitored setting or in the absence of resuscitative equipment; GI obstruction, including paralytic ileus (known or suspected)
Documentation of allergenic cross-reactivity for opioids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Canadian labeling: Additional contraindications (not in US labeling): Acute respiratory depression; hypercapnia; cor pulmonale; acute alcoholism or current physiological alcohol dependence; delirium tremens; convulsive disorders; severe CNS depression; increased cerebrospinal or intracranial pressure; head injury; severe hepatic insufficiency
Buccal film, transdermal patch: Additional contraindications: Hypersensitivity to other opioids; suspected surgical abdomen (eg, acute appendicitis or pancreatitis); mild, intermittent or short duration pain that can otherwise be managed; management of acute pain, including use in outpatient or day surgeries; management of perioperative pain relief, or in other situations characterized by rapidly varying analgesic requirements; obstructive airway (other than asthma); status asthmaticus; concurrent use or use within 14 days of MAOIs; myasthenia gravis; patients with opioid use disorder and for opioid withdrawal treatment; pregnancy or during labor and delivery; breastfeeding; known or suspected oral mucositis (buccal film only)
Subdermal implant: Additional contraindications: Severe respiratory insufficiency, opioid-naive patients, known or suspected GI obstruction or any condition affecting bowel transit, congenital long QT prolongation or QTc prolongation at baseline, uncorrected hypokalemia, hypomagnesemia, hypocalcemia
Active ingredient matches for Buprenorphine HCl:
Buprenorphine HCl
| Unit description / dosage (Manufacturer) | Price, USD |
| Buprenorphine HCl tablet 8 mg/1 (Lake Erie Medical DBA Quality Care Products LLC (US)) | |
| Buprenorphine HCl tablet 2 mg/1 (Cardinal Health (US)) |
References
- DailyMed. "BUPRENORPHINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "buprenorphine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "buprenorphine". http://www.drugbank.ca/drugs/DB00921 (accessed September 17, 2018).
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