what is suboxone strips used for and indication?
Substitution treatment for drug dependence on opioids in the context of medical, social and psychological care. Naloxone is a component intended to prevent misuse of the product by intravenous route.
Treatment is reserved for adults and adolescents over the age of 15 who have agreed to be treated for their addiction.
Treatment should be under the supervision of a doctor specializing in the management of opioid dependence / addiction.
Precautions to be taken before induction
- A liver test and testing for viral hepatitis is recommended before starting treatment. Patients with viral hepatitis, under concomitant medical treatment (see section Interactions with other medicinal products and other forms of interactions ) and / or suffering from hepatic dysfunction are at risk of increased liver damage. It is recommended that hepatic function be monitored regularly (see section 4.4).). Before initiating treatment, the physician should consider the type of opioid dependence (long-acting or short-acting opioids), the time interval since the last opioid use, and the level of dependence on the opioids. opioids. In order to avoid precipitating the onset of a withdrawal syndrome, the induction of treatment with buprenorphine / naloxone or with buprenorphine alone should be carried out as soon as the objective and obvious signs of withdrawal appear.
- For patients who are dependent on heroin or short-acting opioids, the first dose of buprenorphine / naloxone should be taken when the first signs of withdrawal appear, but should be at least 6 hours after the last taking opioids.
- For patients receiving methadone, the methadone dose should be reduced to a maximum dose of 30 mg / day before initiating treatment with buprenorphine / naloxone. The long half-life of methadone should be taken into account when initiating treatment with buprenorphine / naloxone. The first dose of buprenorphine / naloxone should only be taken when the first signs of withdrawal appear, but should be taken at least 24 hours after the patient’s last dose of methadone. Buprenorphine may precipitate the onset of withdrawal symptoms in methadone dependent patients.
Initiation of treatment (induction)
- The recommended starting dose for adults and adolescents over 15 years of age is one to two tablets of Suboxone 2 mg / 0.5 mg. An additional dose of one to two tablets of Suboxone 2 mg / 0.5 mg may be given on the first day depending on the individual needs of the patient. During the initiation phase of treatment, it is recommended to monitor its administration daily to ensure that the dose is placed correctly under the tongue and to observe the patient’s response to treatment, which will allow effective adjustment of the dose. dose administered according to the clinical effect obtained in the patient.
Dosage adjustment and maintenance dose
- Following the induction of treatment on day 1, the patient should be stabilized at a maintenance dose over the next few days by gradually adjusting the administered dose according to the clinical effect achieved in the patient. The dosage adjustment in steps of 2 to 8 mg is based on the reassessment of the patient’s clinical and psychological condition and should not exceed the maximum dosage of 24 mg per day.
- After achieving satisfactory stabilization, the frequency of administration of the treatment can be reduced to once every other day by doubling the patient’s daily dose. For example, a stabilized patient receiving a daily dose of 8 mg may receive 16 mg every other day, without treatment on the intervening days. In some patients, after satisfactory stabilization is achieved, the frequency of treatment administration may be reduced to
- 3 administrations per week (for example Monday, Wednesday and Friday). The Monday and Wednesday dose should be twice the patient’s daily dose, and the Friday dose should be three times the patient’s daily dose, without treatment on the intervening days. In no case should the dose exceed 24 mg per day. This dosage may not be suitable for patients requiring a daily dose> 8 mg / day.
Discontinuation of treatment
After satisfactory stabilization has been achieved, if accepted by the patient, the dosage may be gradually reduced until a lower maintenance dose is reached; in favorable cases, the treatment can be stopped. The availability of tablets of 2 mg / 0.5 mg and 8 mg / 2 mg allows a gradual reduction in the dosage. In patients requiring lower doses of buprenorphine, buprenorphine 0.4 mg tablets can be used. Patients should be monitored after stopping treatment because of the risk of relapse.
The safety and efficacy of buprenorphine / naloxone in patients over 65 years of age have not been established. No recommendation on dosage can be given.
- A liver test and testing for viral hepatitis is recommended before initiating treatment. Patients with viral hepatitis, under concomitant medical treatment (see section Interactions with other medicinal products and other forms of interactions ) and / or suffering from hepatic dysfunction are at risk of increased liver damage. It is recommended that hepatic function be monitored regularly .
- The consequences of hepatic impairment on the pharmacokinetics of buprenorphine and naloxone are not known. Due to the extensive metabolism of the two active substances, higher plasma levels can be expected in patients with moderate to severe hepatic impairment. It is not known whether the two active substances are affected as much as the other. As the pharmacokinetics of buprenorphine / naloxone may be altered in patients with hepatic impairment, it is recommended to initiate treatment at a lower dose and dose adjustment with caution in patients with mild hepatic impairment. to moderatePharmacokinetic properties). The administration of buprenorphine / naloxone is contraindicated in patients with severe hepatic dysfunction .
- Dosage modification of buprenorphine / naloxone is not necessary in patients with renal impairment. Caution is advised in patients with severe renal impairment (CL cr <30 ml / min).
The safety and efficacy of buprenorphine / naloxone in children less than 15 years of age have not been established. No data is available.
- Hypersensitivity to the active substances or to any of the excipients
- Severe respiratory failure
- Severe hepatic impairment
- Acute alcohol poisoning or delirium tremens .
how to take suboxone strips ?
- Physicians should inform patients that the sublingual route is the only effective and well-tolerated route for the administration of this medicinal product (see section 4.4 ). The tablet should be kept under the tongue until it is completely dissolved. Patients should not swallow or consume food or drink until the tablet has completely dissolved.
- The dose consists of Suboxone 2 mg / 0.5 mg tablets and Suboxone 8 mg / 2 mg tablets, which can be taken simultaneously or in two parts; the second part should be taken as soon as the tablet (s) of the first part have dissolved.
how does suboxone work?
Pharmacotherapeutic group: other central nervous system drugs, drugs used to treat addictive disorders, ATC code: N07BC51.
- Buprenorphine is a partial agonist / antagonist that binds to brain and opioid receptors (kappa). Its activity in opioid substitution therapy is attributed to its slowly reversible binding to opioid receptors which, over a prolonged period, may minimize the need for drugs in drug addicted patients.
- Ceiling effects of opioid agonists have been observed in clinical pharmacology studies in people with opioid dependence.
- Naloxone is an opioid receptor antagonist. When naloxone is administered orally or sublingually, at usual dosages, to patients with opioid withdrawal syndrome, it exhibits little or no pharmacological effects due to its almost complete metabolism during the first phase. passage. However, when administered intravenously to persons dependent on opioids, the presence of naloxone in Suboxone® causes marked opioid antagonist effects as well as an opioid withdrawal syndrome, thus deterring any misuse of the product by the intravenous route.
- The efficacy and safety data for the buprenorphine / naloxone combination come mainly from results obtained in a clinical study conducted over one year, including the comparison of the randomized, double-blind administration of buprenorphine tablets. / naloxone, buprenorphine and placebo over a period of 4 weeks, followed by a buprenorphine / naloxone tolerance study for 48 weeks. In this study, 326 heroin addicts were randomized to receive either 16 mg per day of buprenorphine / naloxone, 16 mg per day of buprenorphine, or a placebo. Subjects randomized to one of the active treatments began with 8 mg of buprenorphine on Day 1, then 16 mg (two 8 mg tablets) of buprenorphine on Day 2. On Day 3, subjects randomized to receive the buprenorphine / naloxone combination switched to the combined tablet. The subjects were followed daily at the clinic (Monday to Friday) to assess dosage and efficacy. Doses were issued to patients to take at home on weekends. The main objective of the study was to individually compare the effectiveness of buprenorphine and the buprenorphine / naloxone combination versus placebo. The percentage of urine samples, taken three times per week, which tested negative for opioids not included in the study was statistically higher in the buprenorphine / naloxone group than in the placebo group (p <0,
- In a double-blind, double-placebo, parallel-group study comparing an ethanolic buprenorphine solution with an active full agonist control, 162 subjects were randomized to receive an ethanolic solution of sublingual buprenorphine at a dose of 8 mg / day (a dose roughly comparable to a 12 mg / day dose of buprenorphine / naloxone), or two relatively low doses of the active control, one of which is low enough to serve as an alternative to placebo , during an induction phase of 3 to 10 days, a maintenance phase of 16 weeks and a detoxification phase of 7 weeks. The maintenance dose of buprenorphine was reached on Day 3; the doses of active control were adjusted more gradually. Based on continued treatment and on the percentage of urine samples taken three times a week that were negative for opioids not included in the study, buprenorphine was found to be more effective than the low dose of the control group in making it possible to keeping heroin users on treatment and reducing their opioid use during treatment. The effectiveness of taking 8 mg per day of buprenorphine was similar to that of the moderate dose of active control; however, equivalence has not been demonstrated. was found to be more effective than the low dose of the control group in keeping heroin addicts on treatment and reducing their opioid use during treatment. The effectiveness of taking 8 mg per day of buprenorphine was similar to that of the moderate dose of active control; however, equivalence has not been demonstrated. was found to be more effective than the low dose of the control group in keeping heroin addicts on treatment and reducing their opioid use during treatment. The effectiveness of taking 8 mg per day of buprenorphine was similar to that of the moderate dose of active control; however, equivalence has not been demonstrated.
suboxone Side Effects
Summary of the safety profile
- The most frequently reported treatment-related adverse reactions in the pivotal clinical studies were constipation and symptoms commonly associated with withdrawal syndrome (i.e. insomnia, headache, nausea and hyperhidrosis). Among the reported cases of seizures, vomiting, diarrhea and elevated liver function test results, some were considered serious.
Table summarizing adverse reactions
- Table 1 summarizes the adverse reactions reported in the pivotal clinical studies in which 342 of 472 patients (72.5%) reported adverse reactions.
The frequency of possible side effects, listed below, is defined using the following convention:
very common (≥1 / 10), common (≥1 / 100, <1/10), uncommon (≥1 / 1,000, <1/100), rare (≥1 / 10,000, <1/1000 ), very rare (<1 / 10,000), frequency not known (events which have not been reported in registered clinical trials cannot be estimated from the available spontaneous post-marketing reports).
Table 1: Treatment-Related Adverse Reactions Reported in Clinical Studies Using Buprenorphine / Naloxone
(≥1 / 10)
(≥1 / 100, 1/10 <)
(≥1 / 1000, 1/100 <)
|Frequency not known|
|Infections and infestations|
|Influenza Infection Pharyngitis Rhinitis||Urinary tract infection Vaginal infection|
|Blood and lymphatic system disorders|
|Immune system disorders|
|Metabolism and nutrition disorders|
|Decreased appetite||Hyperglycemia Hyperlipidemia Hypoglycemia|
|Insomnia||Anxiety Depression Decreased libido Nervousness Thinking abnormal||Abnormal dreams
|Nervous system disorders|
|Amnesia Convulsion Hyperkinesia Language disorder Tremor|
|Amblyopia Lacrimal disorder||Conjunctivitis Miosis|
|Angina pectoris Bradycardia Myocardial infarction Palpitations Tachycardia|
|Respiratory, thoracic and mediastinal disorders|
|Cough||Asthma Dyspnea Yawning|
|Constipation Nausea||Abdominal pain
|Oral ulceration Tongue discoloration|
|Abnormal liver function|
|Skin and subcutaneous tissue disorders|
|Hyperhidrosis||Pruritus Rash Urticaria||Acne Alopecia
Exfoliative dermatitis Skin dryness Skin mass
|Musculoskeletal and connective tissue disorders|
|Back pain Arthralgia
Muscle spasms Myalgia
|Kidney and urinary tract disorders|
|Urine abnormality||Albuminuria Dysuria Hematuria Nephrolithiasis|
|Pregnancy, puerperium and perinatal conditions|
|Reproductive system and breast disorders|
|Dyserection||Amenorrhea Ejaculation disorder Menorrhagia Metrorrhagia|
|General disorders and administration site conditions|
|Drug withdrawal syndrome||Asthenia
|Weight reduced||Blood creatinine increased|
|Injury, poisoning and procedural complications|
Table 2: Adverse reactions reported with buprenorphine used alone in the treatment of opioid dependence.
(≥1 / 10)
(≥1 / 100, 1/10 <)
(≥1 / 1000, 1/100 <)
(≥1 / 10,000, <1 / 1,000)
|Frequency not known|
|Immune system disorders|
|Insomnia||Hallucination||Intentional misuse of the drug|
|Nervous system disorders|
|Respiratory, thoracic and mediastinal disorders|
|Respiratory depression Bronchospasm|
|Skin and subcutaneous tissue disorders|
|Pregnancy, puerperium and perinatal conditions|
|General disorders and administration site conditions|
drug withdrawal syndrome
drug, neonatal Local reaction
Description of other side effects that were selected
Adverse reactions listed in Tables 1 and 2, with frequency not known, have been reported in the following circumstances:
- In the event of intentional misuse of an intravenous drug, local reactions, sometimes septic, and potentially serious acute hepatitis have been reported (see section Warnings and precautions for use ).
- In patients with a palpable drug, the first administration of buprenorphine can cause a drug withdrawal syndrome similar to that associated with naloxone (see sections Dosage and Administration and Warnings and Precautions ).
- Cases of spontaneous abortion have been reported with both buprenorphine and the buprenorphine / naloxone combination. It is not possible to establish a causal link or a frequency of occurrence because these cases usually involve the use of other drugs or the presence of other risk factors for spontaneous abortion (see section Pregnancy and breast-feeding ). .
- Neonatal drug withdrawal syndrome has been reported in neonates of women who received buprenorphine during pregnancy. The syndrome may be milder and longer than that induced by complete short-acting µ opioid receptor agonists.
The nature of the syndrome may vary depending on the mother’s history of drug use (see section Pregnancy and breast-feeding ).
Suboxone® must not be taken in combination with:
- alcoholic drinks or medicines containing alcohol, due to the alcohol enhancement of the sedative effect of buprenorphine (see section Effects on ability to drive and use machines).
Suboxone® should be used with caution when co-administered with:
- benzodiazepines: this combination can cause death from central respiratory depression. Dosages should therefore be limited and this combination avoided if there is a risk of misuse. Patients should be advised that it is extremely dangerous to self-administer benzodiazepines which have not been prescribed while taking this product, and should also be cautioned that they should strictly follow their doctor’s directions when taking this product. ‘they take benzodiazepines simultaneously with this product (see section 4.4).
- other central nervous system depressants, other opioid derivatives (e.g. methadone, analgesics and cough suppressants), certain antidepressants, sedating H1 antihistamines, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: these associations increase central nervous system depression. Impaired vigilance can make driving and using machines dangerous.
- Furthermore, adequate analgesia may be difficult to obtain when administering a full opioid agonist in patients receiving the buprenorphine / naloxone combination. Therefore, the risk of overdose with a full agonist exists, especially when trying to overcome the effects of the partial agonist buprenorphine or when the plasma concentrations of buprenorphine decrease.
- naltrexone and nalmefene are opioid antagonists which may block the pharmacological effects of buprenorphine. For opioid dependent patients receiving buprenorphine / naloxone treatment, co-administration of naltrexone and nalmefene is contraindicated, as naltrexone and nalmefene may precipitate the sudden onset of prolonged and intense opioid withdrawal symptoms (see Contraindications section).
- CYP3A4 inhibitors: an interaction study between buprenorphine and ketoconazole (a potent inhibitor of CYP3A4) showed an increase in Cmax and AUC (area under the curve) of buprenorphine (respectively by approximately 50% and 70%) and, to a lesser extent, norbuprenorphine. Patients treated with Suboxone ® should be closely monitored, and dosage reduction may be necessary when combined with a strong CYP3A4 inhibitor (eg protease inhibitors, such as ritonavir, nelfinavir or indinavir, or azole antifungals, such as ketoconazole or itraconazole, macrolide type antibiotic).
- CYP3A4 inhibitors: the concomitant use of CYP3A4 inducers and buprenorphine may reduce the plasma concentrations of buprenorphine and potentially make the treatment of opioid dependence with buprenorphine suboptimal. Close monitoring is recommended in patients treated with buprenorphine / naloxone if inducers (eg, phenobarbital, carbamazepine, phenytoin, rifampicin) are coadministered. The dosage of buprenorphine or CYP3A4 inducers can be adjusted accordingly.
According to the data available on morphine, the concomitant use of monoamine oxidase inhibitors (MAOIs) may cause an increase in the effects of opioids.
Warnings and Precautions
- Reserved for adults
- Deliberate misuse
- Drug abuse
- Insufficient breathing
Misuse, abuse and misuse
- Like other opioids, legal or illicit, buprenorphine can be misused or abused. The risks of misuse and abuse include overdose, spread of viral infections or localized and systemic infections transmitted through the blood, respiratory depression and liver damage. The misuse of buprenorphine by someone other than the patient for whom the product is intended also risks creating a new category of individuals primarily dependent on this substance. This type of use can also occur when the drug is dispensed directly by the patient for illicit use or when the drug is stolen, not being stored in a safe place.
- Suboptimal treatment with buprenorphine / naloxone may indicate patient misuse of the drug, which may lead to overdose or discontinuation of treatment. A patient who is underdosed on buprenorphine / naloxone may continue to manage their withdrawal symptoms with opioids, alcohol, or other nooleptics (eg, benzodiazepines).
- To reduce the risk of misuse, abuse, and diversion, physicians should take appropriate steps when prescribing and administering buprenorphine, such as avoiding prescribing for multiple refills immediately. beginning of treatment ; on the other hand, they must carry out follow-up visits to the patient while setting up a clinical control adapted to the patient’s needs.
- The combination of buprenorphine and naloxone in Suboxone® aims to prevent any misuse or abuse of buprenorphine. Compared to buprenorphine alone, Suboxone® is less likely to be misused intravenously or intranasally, as the presence of naloxone in this product precipitates the onset of withdrawal syndrome in heroin dependent individuals. methadone or any other opioid agonist.
- Deaths from respiratory depression have been observed, particularly when buprenorphine has been used in combination with benzodiazepines (see section 4.5) or when buprenorphine has not been used properly. to the prescribing information. Deaths have also been reported after the concomitant use of buprenorphine and other central nervous system depressants, such as alcohol or other opioids. Giving buprenorphine to non-opioid dependent individuals who are not tolerant of the effects of opioids can lead to life-threatening respiratory depression.
- This product should be used with caution in patients with asthma or respiratory failure (such as chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory capacity, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis (deformity of the spine which can lead to dyspnea).
- Buprenorphine / naloxone can cause severe respiratory depression which can be fatal in children and non-dependent people who ingest it accidentally or on purpose. Patients should be instructed to keep the blister packs safe, never take the tablets out of the blister pack in advance, keep blisters out of the reach of children and other family members, and not take this medicine in front of the blister. children. An emergency service should be contacted immediately in the event of accidental ingestion or suspected ingestion.
- The combination buprenorphine / naloxone may cause drowsiness, especially when taken / administered concomitantly with alcohol or central nervous system depressants (such as tranquilizers, sedatives or hypnotics) (see section Interactions with other drugs and other forms of interactions).
- Buprenorphine is a partial agonist acting on the µ (mu) opiate receptor; prolonged use of this product results in opioid-type dependence. Animal studies, as well as clinical data, have shown that buprenorphine can be addictive, although this is less than that caused by a full agonist, such as morphine.
- Abrupt discontinuation of treatment is not recommended, as it can lead to a withdrawal syndrome, the first signs of which may appear later.
Hepatitis and liver damage
- Acute hepatic injury has been reported in opioid dependent addicts, both in clinical trial reports and post-marketing adverse reaction reports. The observed abnormalities range from an asymptomatic transient elevation of hepatic transaminases to cases of hepatic failure, hepatic necrosis, hepato-renal syndrome, hepatic encephalopathy and death. In many cases, the presence of pre-existing mitochondrial dysfunction (genetic disease, liver enzyme abnormalities, infection with hepatitis B virus or hepatitis C, alcohol abuse, anorexia, concomitant use of other drugs potentially hepatotoxic) and the persistence of Drug injections can be responsible for or contribute to liver damage. These underlying factors should be taken into account before prescribing buprenorphine / naloxone and during treatment. If hepatic damage is suspected, a thorough biological and etiological assessment should be performed. Depending on the results obtained, treatment may be cautiously interrupted in order to prevent the onset of withdrawal symptoms and to avoid a return to illicit drug use. If treatment is continued, hepatic function should be closely monitored. liver damage, a thorough biological and etiological assessment should be performed. Depending on the results obtained, treatment may be cautiously interrupted in order to prevent the onset of withdrawal symptoms and to avoid a return to illicit drug use. If treatment is continued, hepatic function should be closely monitored. liver damage, a thorough biological and etiological assessment should be performed. Depending on the results obtained, treatment may be cautiously interrupted in order to prevent the onset of withdrawal symptoms and to avoid a return to illicit drug use. If treatment is continued, hepatic function should be closely monitored.
Precipitation of opioid withdrawal syndrome
- When initiating treatment with buprenorphine / naloxone, the physician should take into account the partial agonist profile of buprenorphine and be aware that treatment may precipitate the onset of withdrawal syndrome in opioid dependent patients, particularly if treatment is given less than 6 hours after the last use of heroin or another short-acting opioid, or if it is given less than 24 hours after the last dose of methadone. Patients should be closely monitored when switching from buprenorphine or methadone to buprenorphine / naloxone, as withdrawal symptoms have been reported. In order to avoid precipitating the onset of a withdrawal syndrome, the
- Withdrawal symptoms can also be associated with underdosing.
- The effect of hepatic impairment on the pharmacokinetics of buprenorphine and naloxone was evaluated in a post-marketing study. Due to the extensive metabolism of buprenorphine and naloxone, higher plasma levels of buprenorphine and naloxone are found in patients with moderate to severe hepatic impairment after single dose administration. Patients should be monitored to avoid signs and symptoms of precipitating opioid withdrawal syndrome, toxicity or overdose caused by high levels of naloxone and / or buprenorphine. Suboxone sublingual tablet should be used with caution in patients with moderate hepatic impairment (see sections 4.3 and Pharmacokinetic properties). In patients with severe hepatic impairment the use of buprenorphine / naloxone is contraindicated.
- Renal elimination may be prolonged because 30% of the administered dose is eliminated via the kidneys. The metabolites of buprenorphine accumulate in patients with renal impairment. Caution is recommended in patients with severe renal impairment (creatinine clearance <30 ml / min) (see sections 4.2 and Pharmacokinetics).
Use in adolescents (aged 15 to less than 18 years)
- Due to the lack of data in adolescents (aged 15 to less than 18 years), patients in this age group should be more closely monitored during treatment.
- Drugs that inhibit the CYP3A4 enzyme may contribute to increased levels of buprenorphine. It may be necessary to reduce the dose of buprenorphine / naloxone. In patients already treated with CYP3A4 inhibitors, the dosage of buprenorphine / naloxone should be adjusted with caution, as a lower dose may be sufficient in these patients (see section 4.5). ).
General Warnings Regarding Opioid Administration
- The administration of opioids may induce orthostatic hypotension in patients treated on an outpatient basis.
- Opioids can increase the pressure of the cerebrospinal fluid, which can cause seizures. For this reason, opioids should be used with caution in patients with brain damage, intracranial damage and other conditions that may cause increased cerebrospinal pressure or in patients with a history of seizures.
- Opioids should be used with caution in patients with hypotension, prostatic hypertrophy, or urethral stricture.
- Opioid-induced miosis, alterations in level of consciousness or perception of pain as a symptom of disease, may interfere with patient assessment or complicate the diagnosis or clinical treatment of concomitant disease.
- Opioids should be used with caution in patients with myxedema, hypothyroidism, or adrenocortical insufficiency (eg, Addison’s disease).
- Opioids may be responsible for an increase in intra-choledochal pressure and therefore should be used with caution in patients with bile duct dysfunction.
- Opioids should be administered with caution in elderly or debilitated patients.
- Based on the available data on morphine, the concomitant use of monoamine oxidase inhibitors (MAOIs) may increase the effects of opioids (see section Interactions with other medicinal products and other forms of interactions).
Suboxone® contains lactose. This medicine should not be prescribed in patients with a rare hereditary disease such as galactose intolerance.
PREGNANCY & BREAST-FEEDING & FERTILITY
- There are no adequate data from the use of Suboxone® in pregnant women. Studies in animals have shown reproductive toxicity (see section Preclinical safety data). The potential risk in humans is not known.
- In late pregnancy, buprenorphine can cause respiratory depression in the newborn baby, even if the duration of administration is short. Long-term administration of buprenorphine during the last three months of pregnancy may cause the onset of withdrawal syndrome in the newborn (eg, hypertonia, newborn tremor, neonatal agitation, myoclonus or convulsions). The syndrome is usually delayed for several hours to several days after birth.
- Due to the long half-life of buprenorphine, neonatal monitoring for several days should be considered at the end of pregnancy, to avoid the risk of respiratory depression or withdrawal syndrome in the newborn.
- Furthermore, the use of the buprenorphine / naloxone combination during pregnancy should be evaluated by the doctor. Buprenorphine / naloxone should only be used during pregnancy if the potential benefit outweighs the potential risk to the fetus.
Feeding with milk
- It is not known whether naloxone is excreted in human milk. Buprenorphine and its metabolites are excreted in human milk. In rats, buprenorphine has been shown to inhibit lactation. Breast-feeding should therefore be discontinued during treatment with Suboxone®.
- Animal studies have shown decreased fertility in females at high doses (systemic exposure> 2.4 times human exposure at the maximum recommended dose of 24 mg buprenorphine, based on the SC). See section Preclinical safety data.
What happens if I overdose from suboxone ?
- The main symptom requiring medical intervention in case of overdose is respiratory depression following central nervous system depression, as it can lead to respiratory arrest and death. Other signs of overdose include drowsiness, amblyopia, miosis, hypotension, nausea, vomiting and / or speech disturbances
- Comprehensive management, including close monitoring of the patient’s respiratory and cardiac status, should be instituted. Symptomatic treatment of respiratory depression and standard intensive care measures should be implemented. The release of the upper airways as well as assisted or controlled ventilation must be ensured. The patient should be transferred to a unit with all the necessary resuscitation facilities.
- If the patient vomits, precautions should be taken to prevent the patient inhaling his vomit.
- The use of an opioid antagonist (namely naloxone) is recommended, despite the modest effect it may have in suppressing the respiratory symptoms induced by the intake of buprenorphine compared to its effects on full opioid agonists.
- When using naloxone, the long duration of action of buprenorphine should be taken into account in order to determine the duration of treatment and the medical supervision necessary to suppress the effects of overdose. Naloxone can be eliminated faster than buprenorphine; therefore symptoms of buprenorphine overdose, previously controlled by naloxone, may recur. An infusion may therefore be necessary. If this is not possible, a repeated dose of naloxone may be required. Initial doses of naloxone can reach a maximum of 2 mg and be repeated every 2 to 3 minutes until an adequatesatisfactory response, without exceeding a starting dose of 10 mg. Continuous intravenous infusion rates should be titrated according to patient response.
What is Forms and Composition ?
Appearance and shape
- White, 11 mm biconvex hexagonal tablet debossed with “N8” on one side.
- 7 tablets in Paper / Aluminum / Nylon / Aluminum / PVC blister packs.
- SUBOXONE 2 mg / 0.5 mg, sublingual tablet, box of 7
- SUBOXONE 2 mg / 0.5 mg, sublingual tablet, box of 28
- SUBOXONE 8 mg / 2 mg, sublingual tablet, box of 28.
Active ingredient Sublingual tablet
Buprenorphine 8 mg *Naloxone 2 mg *
* per unit dose
Excipients with known effects ? : Lactose monohydrate
Other excipients: Mannitol, Corn starch, Povidone K30, Citric acid anhydrous, Sodium citrate, Magnesium
stearate, Potassium acesulfame, Natural flavors: Lemon, Lime
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