SUBUTEX (buprenorphine) sublingual tablet is an uncoated oval white flat bevelled edged tablet, debossed with an alphanumeric word identifying the product and strength on one side.
2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP).
Each tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate and magnesium stearate.
Subutex can be used under the tongue (sublingual), in the cheek (buccal), by injection (intravenous and subcutaneous), as a skin patch (transdermal), or as an implant.
SUBUTEX is use for the treatment of opioids dependence disorders with the most advisable ways being by induction.
It is use as part of a complete treatment plan to include counseling and psychosocial support.
Important Dosage And Administration Instructions
SUBUTEX is consume sublingually as a single daily dose.
SUBUTEX does not contain naloxone and is good for use only during induction.
Following induction, SUBOXONE sublingual film or SUBOXONE sublingual tablet is good due to the presence of naloxone when clinical use includes illegal administration.
The use of SUBUTEX for illegal administration should be limited to those patients who cannot tolerate SUBOXONE sublingual film or SUBOXONE sublingual tablet;
for example, those patients who have been shown to be hypersensitive to naloxone.
Medication should be prescribe in consideration of the frequency of visits.
Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits.
METHODS OF ADMINISTERING SUBUTEX
SUBUTEX must be consume as a whole.
Do not cut, chew, or swallow SUBUTEX.
it is advisable for patients not to eat or drink anything until the tablet is completely dissolve.
SUBUTEX should be place under the tongue until it completely dissolve.
For doses requiring the use of more than two tablets, patients are advise to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably), place two tablets at a time under the tongue.
Either way, the patients should continue to hold the tablets under the tongue until they dissolve;
swallowing the tablets reduces the bioavailability of the drug.
To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.
The patients should use proper administration techniques
Dosage Forms And Strengths
SUBUTEX sublingual tablet is supplied as an uncoated oval white tablet in two dosage strengths:
- buprenorphine 2 mg, and
- buprenorphine 8 mg
Storage And Handling of SUBUTEX Tablets
SUBUTEX sublingual tablet is an uncoated oval white flat bevelled edged tablet,
deboss with an alphanumeric word identifying the product and strength on one side (“B2” and “B8” on 2 mg and 8 mg tablets respectively),
It is supply in desiccated high density polyethylene (HDPE) bottle:
NDC 12496-1278-2 (buprenorphine 2 mg/sublingual tablet; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP) -30 tablets per bottle.
NDC 12496-1310-2 (buprenorphine 8 mg/sublingual tablet; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP) -30 tablets per bottle.
Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F).
Store SUBUTEX securely and dispose of properly.
Side Effects of SUBUTEX
SUBUTEX is a very powerful opioids and consuming it have several adverse side effects ;
- 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.
WARNINGS AND PRECAUTIONS IN SUBUTEX CONSUMPTION
Addiction, Abuse, And Misuse
SUBUTEX contains buprenorphine, a Schedule III controlled substance that can be abuse in a manner similar to other opioids, legal or illicit.
Prescribe and dispense buprenorphine with appropriate precautions to minimize risk of misuse, abuse, or diversion, and ensure appropriate protection from theft, including in the home.
Clinical monitoring appropriate to the patients level of stability is essential.
Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.
Risk Of Life-Threatening Respiratory And Central Nervous System (CNS) Depression
Buprenorphine has been associated with life-threating respiratory depression and death.
Many, but not all, post-marketing reports regarding coma and death involved misuses by self-injection
or were associated with the concomitant use of benzodiazepines or other CNS depressants, including alcohol.
Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBUTEX.
Use SUBUTEX with caution in patients with compromised respiratory function
(e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression).
Opioid use increases the risk of CSA in a dose-dependent fashion.
In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper.
STORAGE AND DISPOSAL OF SUBUTEX
All patients are advise to read the FDA-approved patient labeling
Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store SUBUTEX securely, out of sight and reach of children,
and in a location not accessible by others, including visitors to the home
Inform patients that leaving SUBUTEX unsecured can pose a deadly risk to others in the home.
Advise patients and guides that when the drugs are not of use, they should dispose it promptly.
Expire, unwanted, or unused SUBUTEX should be dispose of by flushing the unused medication down the toilet,
if a drug take-back option is not readily available.
HOW TO USE SUBUTEX SAFELY
Before initiating treatment with SUBUTEX, explain the points listed below to caregivers and patients.
Instruct patients to read the Medication Guide each time SUBUTEX is dispense because new information may be available.
- Inform patients and caregivers that potentially fatal additive effects may occur if SUBUTEX are use with benzodiazepines or other CNS depressants, including alcohol.
- Counsel patients that such medications should not be use concomitantly unless being supervise by a health care provider.
- Advise patients that SUBUTEX contains an opioid that can be a target for people who abuse prescription medications or street drugs, to keep their tablets in a safe place, and to protect them from theft.
- Instruct patients to keep SUBUTEX in a secure place, out of the sight and reach of children.
- Accidental or deliberate ingestion by a child may cause respiratory depression that can result in death.
- Patients are advise to seek medical attention immediately if a child is expose to SUBUTEX.
- Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs.
- Advise patients seeking to discontinue treatment with buprenorphine for opioid dependence to work closely with their healthcare providers on a tapering schedule and inform them of the potential to relapse to illicit drug use associated with discontinuation of opioid agonist/partial agonist medication-assisted treatment.
- talk to patients that, like other opioids, SUBUTEX may produce orthostatic hypotension in ambulatory individuals
- inform patients or their healthcare providers if any other prescription medications, over-thecounter medications, or herbal preparations are prescribe or currently being use.
HOW WOMEN SHOULD USE SUBUTEX
- women are advise that if they are pregnant and given SUBUTEX, the baby may have signs of withdrawal at birth and that withdrawal is treatable.
- Advise women who are breastfeeding to monitor the infant for drowsiness and difficulty breathing
- Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.
Who should not take SUBUTEX?
Do not take SUBUTEX if you are allergic to buprenorphine.
What should I tell my doctor before taking SUBUTEX?
SUBUTEX may not be right for you. Before taking SUBUTEX, tell your doctor if you:
- are diagnose with liver or kidney problems
- usually have trouble breathing or lung problems
- Got an enlarged prostate gland (men)
- Have a head injury or brain problem
- usually have problems urinating
- Have a curve in your spine that affects your breathing
- Are diagnose with gallbladder problems
- If you have adrenal gland problems
- test positive for Addison disease
- if you have low thyroid (hypothyroidism)
- you and your family have a history of alcoholism
- Have mental problems such as hallucinations (seeing or hearing things that are not there)
- Got any other medical condition
- Are pregnant or plan to become pregnant. If you take SUBUTEX while pregnant, your baby may have signs of opioid withdrawal at birth.
- Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.
- Talk to your doctor if you are pregnant or plan to become pregnant.
- Are breastfeeding or plan to breastfeed. SUBUTEX can pass into your milk and may harm your baby.
- Talk to your doctor about the best way to feed your baby if you take SUBUTEX. Monitor your baby for increased sleepiness and breathing problems.
SUBUTEX VS SUBOXONE
Suboxone and Subutex, both of which are approve by the FDA in 2002,
They are drugs develope for the treatment of opiate addiction.
Prior to 2000 when the Drug Addiction Treatment Act was in action, the primary medication to treat opiate addictions was methadone.
In 2000, however, burprenorphine was approved in the law, and
it could be prescribe by physicians who are qualify and certify by the Center for Substance Abuse Treatment to treat opioid addiction.
The main difference is that Suboxone contains both buprenorphine and naloxone, whereas Subutex contains only buprenorphine.
While methadone is a Schedule II substance, buprenorphine is a Schedule III substance, denoting it as a drug with a lower potential for abuse.
As a result, burprenorphine is often use to be a safer opiate treatment medication than methadone.
According to the Drug Enforcement Agency, almost 16,000 physicians were certified to prescribe buprenorphine-based products, like Suboxone and Subutex, in 2013.
In 2012, 9.3 million prescriptions were available for these medications.