What happens if I overdose Subutex 0.4mg?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include abnormal snoring; bluish skin or nails; cold and clammy skin; coma; difficult, shallow, or slow breathing; fainting; limp muscles; pinpoint or enlarged pupils; severe drowsiness, dizziness, or light-headedness; shortness of breath; slow or irregular heartbeat.
Proper storage of Subutex 0.4mg patch:
Store Subutex 0.4mg patch at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Subutex 0.4mg patch out of the reach of children and away from pets.
Overdose of Subutex 0.4mg in details
Clinical Presentation
Acute overdosage with Subutex 0.4mg transdermal system is manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations.
Treatment of Overdose
In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.
Naloxone may not be effective in reversing any respiratory depression produced by Subutex 0.4mg. High doses of naloxone, 10-35 mg/70 kg, may be of limited value in the management of Subutex 0.4mg overdose. The onset of naloxone effect may be delayed by 30 minutes or more. Doxapram hydrochloride (a respiratory stimulant) has also been used.
Remove Subutex 0.4mg transdermal system immediately. Because the duration of reversal would be expected to be less than the duration of action of Subutex 0.4mg from Subutex 0.4mg transdermal system, carefully monitor the patient until spontaneous respiration is reliably re-established. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects as Subutex 0.4mg continues to be absorbed from the skin. After removal of Subutex 0.4mg transdermal system, the mean Subutex 0.4mg concentrations decrease approximately 50% in 12 hours (range 10-24 hours) with an apparent terminal half-life of approximately 26 hours. Due to this long apparent terminal half-life, patients may require monitoring and treatment for at least 24 hours.
In an individual physically dependent on opioids, administration of an opioid receptor antagonist may precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
What should I avoid while taking Subutex 0.4mg?
This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Subutex 0.4mg will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid using any opioid pain medicine without approval from the doctor who is treating you with Subutex 0.4mg. Opioid pain medicine will not work as well while you are receiving Subutex 0.4mg. Talk with your doctor about other options for pain relief while you are using Subutex 0.4mg.
Subutex 0.4mg warnings
Impaired Respiration: As with other potent opioids, clinically significant respiratory depression may occur within the recommended dose range in patients receiving therapeutic doses of Subutex 0.4mg. Subutex 0.4mg (Subutex 0.4mg) should be used with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression). Particular caution is advised if Subutex 0.4mg (Subutex 0.4mg) is administered to patients taking or recently receiving drugs with CNS/respiratory depressant effects. In patients with the physical and/or pharmacological risk factors above, the dose should be reduced by approximately one-half.
NALOXONE MAY NOT BE EFFECTIVE IN REVERSING THE RESPIRATORY DEPRESSION PRODUCED BY Subutex 0.4mg (Subutex 0.4mg). THEREFORE, AS WITH OTHER POTENT OPIOIDS, THE PRIMARY MANAGEMENT OF OVERDOSE SHOULD BE THE REESTABLISHMENT OF ADEQUATE VENTILATION WITH MECHANICAL ASSISTANCE OF RESPIRATION, IF REQUIRED.
Interaction with Other Central Nervous System Depressants: Patients receiving Subutex 0.4mg (Subutex 0.4mg) in the presence of other narcotic analgesics, general anesthetics, antihistamines, benzodiazepines, phenothiazines, other tranquilizers, sedative/hypnotics or other CNS depressants (including alcohol) may exhibit increased CNS depression. When such combined therapy is contemplated, it is particularly important that the dose of one or both agents be reduced.
Head Injury and Increased Intracranial Pressure: Subutex 0.4mg (Subutex 0.4mg), like other potent analgesics, may itself elevate cerebrospinal fluid pressure and should be used with caution in head injury, intracranial lesions and other circumstances where cerebrospinal pressure may be increased. Subutex 0.4mg (Subutex 0.4mg) can produce miosis and changes in the level of consciousness which may interfere with patient evaluation.
Use in Ambulatory Patients: Subutex 0.4mg (Subutex 0.4mg) may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery. Therefore, Subutex 0.4mg (Subutex 0.4mg) should be administered with caution to ambulatory patients who should be warned to avoid such hazards.
Use in Narcotic-Dependent Patients: Because of the narcotic antagonist activity of Subutex 0.4mg (Subutex 0.4mg), use in the physically dependent individual may result in withdrawal effects.
What should I discuss with my healthcare provider before taking Subutex 0.4mg?
Do not use this medication if you are allergic to Subutex 0.4mg or naloxone (Narcan), or if you have used another narcotic drug within the past 4 hours.
To make sure you can safely take Subutex 0.4mg, tell your doctor if you have any of these other conditions:
- asthma, COPD, sleep apnea, or other breathing disorders;
- liver disease (especially hepatitis B or C);
- kidney disease;
- a thyroid disorder;
- stomach problems;
- enlarged prostate, urination problems;
- gallbladder disease;
- curvature of the spine;
- Addison's disease (an adrenal gland disorder);
- a history of mental illness, personality disorder, or psychotic episode;
- a history of drug or alcohol addiction; or
- a history of seizures, head injury, or brain tumor.
Subutex 0.4mg may be habit forming and should be used only by the person it was prescribed for. Never share Subutex 0.4mg with another person, especially someone with a history of drug abuse or addiction. Subutex 0.4mg can cause withdrawal effects in a person who is addicted to narcotics. Keep the medication in a place where others cannot get to it.
FDA pregnancy category C. It is not known whether Subutex 0.4mg will harm an unborn baby. Subutex 0.4mg may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using Subutex 0.4mg.
Subutex 0.4mg can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Subutex 0.4mg.
Do not give this medication to a child.
Subutex 0.4mg precautions
Subutex 0.4mg should be used with caution in patients with severely impaired respiratory function and in patients concurrently receiving monoamine oxidase inhibitors (MAOIs) or who have received MAOIs within the previous two weeks.
Subutex 0.4mg should be used with particular caution in patients with head injury, intracranial lesions or increased intracranial pressure, shock, a reduced level of consciousness of uncertain origin, or in patients with severe hepatic impairment.
Subutex 0.4mg may lower the seizure threshold in patients with a history of seizure disorder.
Severe febrile illness may increase the rate of Subutex 0.4mg absorption from Subutex 0.4mg.
Significant respiratory depression has been associated with Subutex 0.4mg, particularly by the intravenous route. A number of deaths have occurred when addicts have intravenously abused Subutex 0.4mg, usually with benzodiazepines concomitantly. Additional overdose deaths due to ethanol and benzodiazepines in combination with Subutex 0.4mg have been reported. Caution should be exercised when prescribing Subutex 0.4mg to patients known to have, or suspected of having, problems with drug or alcohol abuse or serious mental illness.
Subutex 0.4mg is not recommended for analgesia in the immediate post-operative period or in other situations characterized by rapidly varying analgesic requirement.
Subutex 0.4mg is a μ-opioid partial agonist.
Subutex 0.4mg produces morphine-like effects, including euphoria and physical dependence, but the magnitude of these effects is less than for comparable doses of full μ-opioid agonists. Administration of Subutex 0.4mg to persons who are physically dependent on full μ-opioid agonists may precipitate an abstinence syndrome depending on the level of physical dependence, and the timing and dose of Subutex 0.4mg.
Effects on Ability to Drive and Use Machines: Subutex 0.4mg may impair the ability to drive and operate machinery.
What happens if I miss a dose of Subutex 0.4mg?
Since Subutex 0.4mg is used on an as needed basis, you are not likely to miss a dose. Never use Subutex 0.4mg in larger amounts, or more often than recommended by your doctor.
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).
- DrugBank. "buprenorphine". http://www.drugbank.ca/drugs/DB00921 (accessed September 17, 2018).
- MeSH. "Analgesics, Opioid". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
