Bugesic Tablet

Bugesic Tablet is used for: Pain, Opioid dependence

Adult: Sublingual Moderate to severe pain 200-400 mcg 6-8 hrly. Premedication Sublingual Adult: 400 micrograms

Moderate to severe pain Sublingual Child (body-weight 16–25 kg): 100 micrograms every 6–8 hours Child (body-weight 25–37.5 kg): 100–200 micrograms every 6–8 hours Child (body-weight 37.5–50 kg): 200–300 micrograms every 6–8 hours Child (body-weight 50 kg and above): 200–400 micrograms every 6–8 hours

RENAL IMPAIRMENT Avoid use or reduce dose; opioid effects increased and prolonged; increased cerebral sensitivity.

Acute alcoholism; convulsive disorders; head injuries; increased intracranial pressure; comatose patients; resp depression and obstructive airway disease; patients on established opioid agonists.

Addiction, abuse, and misuse Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death Assess each patient’s risk prior to prescribing and reassess all patients regularly for development of these behaviors and conditions Life-threatening respiratory depression Serious, life-threatening, or fatal respiratory depression may occur Monitor for respiratory depression, especially during initiation or following a dose increase To reduce risk of respiratory depression, proper dosing and titration of this drug are essential Accidental exposure Accidental exposure of even 1 dose, especially by children, can result in a fatal overdose Neonatal opioid withdrawal syndrome Use for an extended period of time during pregnancy can result in withdrawal in the neonate; neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly; advise pregnant women using opioids for an extended period of time of the risk of neonatal opioid withdrawal syndrome and ensure that management by neonatology experts will be available at delivery Syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, and failure to gain weight Onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn Risks from concomitant use with benzodiazepines or other CNS depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; reserve concomitant use in patients for whom alternative treatment options are inadequate; limit dosages and durations to minimum required; and monitor for signs and symptoms of respiratory depression and sedation Monitoring Parameters Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events.

Pregnancy Data in pregnancy are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure; observational studies reported on congenital malformations among exposed pregnancies, but were also not designed appropriately to assess risk of congenital malformations specifically due to drug exposure Dosage adjustments of buprenorphine may be required during pregnancy, even if patient was maintained on stable dose prior to pregnancy; withdrawal signs and symptoms should be monitored closely and the dose adjusted as necessary Fetal/neonatal adverse reactions Neonatal opioid withdrawal syndrome may occur in newborn infants of mothers who are receiving treatment Lactation Data on two studies in 13 lactating women receiving therapy where the drug and it metabolite were present in low levels in human milk did not show adverse reactions in breastfed infants; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition Advise breastfeeding women taking buprenorphine products to monitor infant for increased drowsiness and breathing difficulties

Benzodiazepines: Use caution in prescribing Buprenorphine for patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant self administration/misuse. CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over- or under-dosing. Antiretrovirals: Patients who are on chronic buprenorphine treatment should have their dose monitored if NNRTIs are added to their treatment regimen. Monitor patients taking buprenorphine and atazanavir with and without ritonavir, and reduce dose of buprenorphine if warranted. Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Buprenorphine if serotonin syndrome is suspected. Potentially Fatal: Diazepam may produce resp and cardiac collapse. Contraindicated (5) alvimopan dronedarone lefamulin olanzapine/samidorphan thioridazine

Side effects of Buprenorphine : >10% (SL) Headache (29.1-30%) Pain (18.4-24%) Withdrawal syndrome (18.4-22%) Insomnia (21.4%) Infection (20%) Asthenia (14%) Back pain (7.8-14%) Nausea (10-13.6%) Sweating (12-12.6%) Abdominal pain (11.7%) Infection (11.7%) Constipation (7.8-11%) 1-10% (SL) Rhinitis (9.7%) Chills (6-7.8%) Vomiting (5-7.8%) Flu syndrome (6%) Nervousness (6%) Runny eyes (5%) Diarrhea (4.9-5%) Asthenia (4.9%) Vasodilation (3.9%) Fever (3%) Dyspepsia (3%) Accidental injury (2-3%) Abscess (2%) <1% Confusion, blurred vision, euphoria, weakness/fatigue, dry mouth, nervousness, depression, slurred speech, paresthesia Hypertension, tachycardia, bradycardia Constipation Dyspnea, cyanosis Pruritus Diplopia, visual abnormalities Injection site reaction, urinary retention, dreaming, flushing/warmth, chills/cold, tinnitus, conjunctivitis, Wenckebach block, and psychosis Other effects observed infrequently include malaise, hallucinations, depersonalization, coma, dyspepsia, flatulence, apnea, rash, amblyopia, tremor, and pallor

Buprenorphine exerts its analgesic effect by binding to the mu-opioid receptors in the CNS. It has a longer duration of analgesic action than morphine. Its partial agonist activity gives it a low level of physical dependence. Buprenorphine and morphine show similar dose-related resp depressant effect.

Bugesic 200 mcg Tablet manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Buprenorphine. Bugesic is availble in Bangladesh. Farmaco BD drug index information on Bugesic Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.