Suboxone Special Precautions

Patients should be closely monitored during the switching period from buprenorphine or methadone to Suboxone since withdrawal symptoms have been reported.
Diversion: Diversion refers to the introduction of buprenorphine into the illicit market either by patients or by individuals who obtain the medicinal product through theft from patients or pharmacies. This diversion may lead to new addicts using buprenorphine as the primary drug of abuse, with the risks of overdose, spread of blood-borne viral infections, respiratory depression and hepatic injury. Because the naloxone in the combination tablet precipitated withdrawal in individuals dependent on heroin, methadone or other full agonists, Suboxone is expected to be less likely to be diverted for IV use.
Precipitated Withdrawal: When initiating treatment with buprenorphine, the physician must be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal in opioid-dependent patients particularly if administered <6 hrs after the last use of heroin or other short-acting opioid, or if administered <24 hrs after the last dose of methadone (see Dosage & Administration). Conversely, withdrawal symptoms may also be associated with suboptimal dosing.
The risk of serious undesirable effects eg, overdose or treatment dropout is greater if a patient is underdosed with Suboxone and continues to self-medicate withdrawal symptoms with opioids, alcohol or other sedative-hypnotics in particular benzodiazepines.
Dependence: Buprenorphine is a partial agonist at the mu-opiate receptor and chronic administration produces dependence of the opioid type.
Discontinuation of treatment may result in a withdrawal syndrome that may be delayed.
Suboxone may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants (eg, tranquilizers, sedatives or hypnotics) (see Interactions).
Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence but at a lower level than morphine.
Respiratory Depression: A number of cases of death due to respiratory depression have been reported, particularly when buprenorphine was used in combination with benzodiazepines (see Interactions), or when buprenorphine was not used according to prescribing information.
Deaths have been reported in association with concomitant administration of buprenorphine and other depressants eg, alcohol or other opioids.
Hepatitis, Hepatic Events: Cases of acute hepatic injury have been reported in opioid-dependent addicts both in clinical trials and in post-marketing adverse event reports. The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure, hepatic necrosis, hepatorenal syndrome and hepatic encephalopathy. In many cases, the presence of preexisting liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, concomitant use of other potentially hepatotoxic medicines and ongoing injecting drug use may have a causative or contributory role. These underlying factors must be taken into consideration before prescribing Suboxone and during treatment. When a hepatic event is suspected, further biological and etiological evaluation is required. Depending upon the findings, the medicinal product may be discontinued cautiously so as to prevent withdrawal symptoms and to prevent a return to illicit drug use. If the treatment is continued, hepatic function should be monitored closely.
As buprenorphine is an opioid, pain as a symptom of a disease may be attenuated.
Athletes must be aware that Suboxone may cause a positive reaction to 'anti-doping' tests.
As with other opioids, caution is requested in patients using buprenorphine and having head injury, increased intracranial pressure, hypotension, prostatic hypertrophy or urethral stenosis.
Suboxone should be used with care in patients with: Asthma or respiratory insufficiency (cases of respiratory depression have been reported with buprenorphine); renal insufficiency (30% of the administered dose is eliminated by the renal route; thus, renal elimination may be prolonged); hepatic insufficiency (hepatic metabolism of buprenorphine may be altered) (see Contraindications ).
Medicines that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine. A reduction of the Suboxone dose may be needed. Patients already treated with CYP3A4 inhibitors should have their dose of Suboxone titrated carefully since a reduced dose may be sufficient in these patients (see Interactions).
The concomitant use of monoamine oxidase inhibitors (MAOI) might produce exaggeration of the effects of opioids, based on experience with morphine.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take Suboxone.
Effects on the Ability to Drive or Operate Machinery: In general, Suboxone has minor to moderate influence on the ability to move safely in traffic, use machines, or perform other hazardous activities. Suboxone may cause drowsiness, dizziness, or impaired thinking, particularly when taken together with alcohol or central nervous system depressants. Therefore,caution is advised when performing the above mentioned activities (see Interactions and Precautions).
Use in pregnancy & lactation: There is very limited experience with buprenorphine/naloxone in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Towards the end of pregnancy, high doses of buprenorphine may induce respiratory depression in the neonate even after a short period of administration. Long-term administration of buprenorphine during the last 3 months of pregnancy may cause a withdrawal syndrome in the neonate.
Suboxone should not be used during pregnancy. If it is the prescriber's opinion that therapy in pregnancy is required, the use of buprenorphine may be considered according to the local buprenorphine labeling.
In case pregnancy occurs while on Suboxone treatment, the mother and the unborn child should be closely monitored and switched to buprenorphine if further treatment is required. It is unknown whether naloxone is excreted in human breast milk. Buprenorphine and its metabolites are excreted in human breast milk. In rats, buprenorphine has been found to inhibit lactation. Therefore, breastfeeding should be discontinued during treatment with Suboxone.