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Bugesic

Tablet - 200mcg
Generic: Buprenorphine
1 Tablet

Description

Medicine Overview of Bugesic 200mcg Tablet

Introduction

Bugesic is used to treat moderate to severe pain and drug dependence/addiction to opioids. It helps to prevent withdrawal symptoms that may be caused due to withdrawal of other opioids.

Bugesic is only prescribed to individuals who are at least 16 years of age or above. It may be habit forming and should be taken only as directed by your doctor. The medicine may be a part of your treatment which could include receiving social and psychological support.

It can be taken with or without food. You should continue taking this medicine regularly until the doctor tells you it is alright to stop. Try not to miss doses as this will make the medicine less effective.

Some common side effects of this medicine include weakness, drug withdrawal syndrome, anxiety, nervousness, dizziness, headache, sleepiness, diarrhea, nausea, vomiting, and abdominal pain. If any of these side effects do not resolve with time or get worse, you should let your doctor know. Your doctor may be able to suggest ways of preventing or reducing the symptoms.

To make it sure it is safe for you, before taking this medicine, let your doctor know if you have any medical conditions or disorders. You should also tell your doctor all the other medicines you are using or taking. Pregnant and breastfeeding women should consult their doctors before using this medicine.

Uses of Bugesic
  • Opioid (Morphine) dependence
Side effects of Bugesic
Common
  • Weakness
  • Drug withdrawal syndrome
How to use Bugesic
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Bugesic may be taken with or without food, but it is better to take it at a fixed time.
How Bugesic works
Bugesic is a opioid partial agonist. It prevents withdrawal symptoms in patients who stop taking opioid drugs by producing similar effects to these drugs.
Quick Tips
  • Take it at the same time every day to help you remember to take it.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down.
  • Use caution while driving or doing anything that requires concentration as Bugesic can cause dizziness and sleepiness.
  • Avoid drinking alcohol or taking other medicines that can cause drowsiness.
  • Discontinue the medicine and inform your doctor if you experience difficulty breathing.
  • Do not stop taking Bugesic without talking to your doctor first as it may cause a worsening of symptoms.
  • Your doctor may get regular blood tests to check for liver function while taking this medicine.
Brief Description
Indication
Pain, Anaesthesia, Opioid dependence
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

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

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

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

Side Effect

>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

Pregnancy Category Note

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

Interaction

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.

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