Subutex Tablets / Sublingual
Buprenorphine
8mg
SCHERING-PLOUGH LTD.
| Pack size | 7's Blister |
|---|---|
| Dispensing mode | CD |
| Source | UK |
| Agent | CITY MEDICAL STORE |
| Retail Price | 152.50 AED |
Available as:
Indications
Subutex Tablets / Sublingual is used for:
Pain, Anaesthesia, Opioid dependence
Adult Dose
Adult: Sublingual Moderate to severe pain 200-400 mcg 6-8 hrly.
IV Perioperative analgesia 300-450 mcg via slow inj.
IV/IM Moderate to severe pain 300-600 mcg 6-8 hrly.
IM Anesth premed 300 mcg.
Elderly:
Moderate-to-Severe Pain
0.15 mg IV/IM q6hr; for IV, administered slowly over 2 minutes
Child Dose
Moderate-to-Severe Pain
<2 years: Safety and efficacy not established
2-12 years: 2-6 mcg/kg slow IV/IM q4-6hr PRN
>12 years: As in adults
Renal Dose
Administration
V Preparation
Solution: Dilute to final concentration of 15 mcg/mL in D5W, D5/NS, NS, or LR
Administer via controlled infusion device
IV/IM Administration
Administer by deep IM injection, by slow IV injection over >2 minutes, or by continuous IV infusion
Also may be given by epidural injection at concentration of 6-30 mcg/mL
Contra Indications
Acute alcoholism; convulsive disorders; head injuries; increased intracranial pressure; comatose patients; resp depression and obstructive airway disease; patients on established opioid agonists.
Precautions
Hepatic or renal disease; pregnancy, lactation; hypothyroidism; adrenocortical insufficiency; asthma; prostatic hyperplasia; shock; hypotension; inflammatory or obstructive bowel disorders; myasthaenia gravis; infants/neonates. Reduce dose in elderly and debilitated patients. May precipitate withdrawal symptoms in narcotic addicts.
Lactation: Drug enters breast milk; use not recommended
Pregnancy-Lactation
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
Interactions
Plasma-buprenorphine concentrations may be affected when co-administered with drugs that induce or inhibit cytochrome P450 isoenzyme CYP3A4. Enhanced depressant effects with other CNS depressants e.g. alcohol, anaesthetics, anxiolytics, hypnotics, TCAs and antipsychotics.
Potentially Fatal: Diazepam may produce resp and cardiac collapse.
Adverse Effects
Side effects of Buprenorphine :
>10%
Sedation (2/3 of patients)
1-10%
Dizziness, Headache, Hypotension, Hypoventilation, Miosis, Nausea, Sweating, Vertigo, Vomiting
<1%
Abdominal cramps, Amblyopia, Apnea, Blurred vision, Bradycardia, Coma, Confusion, Conjunctivitis, Constipation, Cyanosis, Depersonalization, Diplopia, Dreaming, Dry mouth, Dyspepsia, Dyspnea, Electrocardiographic (ECG) abnormalities, Euphoria, Fatigue, Flatulence, Hallucinations, Hypertension, Injection-site reactions, Malaise, Mental depression, Mydriasis, Nervousness, Paresthesia, Pruritus, Psychosis, Respiratory depression, Slurred speech, Tachycardia, Urticaria
Mechanism of Action
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.
Note
Subutex 8mg Tablets / Sublingual manufactured by SCHERING-PLOUGH LTD.. Its generic name is Buprenorphine. Subutex is availble in United Arab Emirates.
Farmaco UAE drug index information on Subutex Tablets / Sublingual is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.