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List of products by manufacturer BioDelivery Sciences International, Inc.

Adult Dosing .

Dosage forms:  BUC STRIP: 2.1 mg/0.3 mg, 4.2 mg/0.7 mg, 6.3 mg/1 mg

BUNAVAIL® is a registered trademark of BioDelivery Sciences International, Inc. The BUNAVAIL and BioDelivery Sciences logos are trademarks owned by BioDelivery Sciences International, Inc. 



Renal dosing


[no adjustment]

Hepatic dosing


[induction tx]
mod-severe impairment: avoid use
[maintenance tx]
moderate impairment: caution advised; severe impairment: avoid use


Peds Dosing .


Peds dosing is currently unavailable or not applicable for this drug.




Contraindications / Cautions .


  • hypersens. to drug/class/compon.

  • avoid abrupt withdrawal

  • hepatic impairment, severe

  • hepatic impairment, moderate (induction tx)

  • caution if hepatic impairment, moderate (maintenance tx)

  • caution in elderly or debilitated pts

  • caution if pulmonary impairment

  • caution if CNS depression

  • caution if concurrent CNS depressant use

  • caution if alcohol use

  • caution if delirium tremens

  • caution if toxic psychosis

  • caution if ICP incr.

  • caution if head injury

  • caution if hypothyroidism or myxedema

  • caution if electrolyte abnormalities

  • caution if congenital long QT syndrome

  • caution if QT prolongation

  • caution if QT prolongation family hx

  • caution if torsades de pointes hx

  • caution if ventricular arrhythmias

  • caution if bradycardia

  • caution if recent MI

  • caution if CHF

  • caution if acute abdomen

  • caution if biliary surgery or dz

  • caution if adrenal insufficiency

  • caution if prostatic hypertrophy

  • caution if urethral stricture

  • caution if kyphoscoliosis

  • caution in pts trying to conceive (long-term use)



Drug Interactions .



Overview


buprenorphine


partial opioid agonist


Interaction Characteristics:

  • CYP3A4 substrate

  • anticholinergic-like effects

  • CNS depression

  • delays gastric emptying

  • hypotensive effects

  • lowers seizure threshold

  • partial opioid agonist

  • prolongs QT interval (conditional)

  • serotonergic effects, weak


naloxone (abuse deterrent)


opioid antagonist


Interaction Characteristics:

  • None
Other Info

  • no pharmacologic activity when administered as directed



Contraindicated



    • naltrexone



    • pimozide



    • thioridazine




Adverse Reactions .


Serious Reactions


  • respiratory depression

  • respiratory arrest

  • hypersensitivity rxn

  • anaphylaxis

  • hypotension, orthostatic

  • hepatotoxicity

  • dependency, abuse

  • adrenal insufficiency

  • opioid-induced androgen deficiency (long-term use)

Common Reactions


  • headache

  • insomnia

  • pain

  • withdrawal sx

  • asthenia

  • nausea

  • constipation

  • diaphoresis

  • diarrhea

  • rhinitis

  • depression

  • anxiety

  • dizziness/vertigo

  • vasodilation

  • rigors

  • vomiting

  • oral mucosa erythema (buccal/SL strip forms)



Safety/Monitoring .


Monitoring Parameters 
LFTs at baseline, then periodically




Pregnancy/Lactation


Pregnancy


Clinical Summary


consider alternative during pregnancy, buprenorphine monotherapy preferred over buprenorphine/naloxone; risk of fetal harm low based on limited human data w/ buprenorphine; risk of neonatal opioid withdrawal syndrome based on human data w/ buprenorphine and drug's mechanism of action


Individuals of Reproductive Potential


caution advised in pts trying to conceive if long-term use; long-term opioid use may result in androgen deficiency based on limited human data and drug's mechanism of action


Lactation


Clinical Summary


may use while breastfeeding; no known risk of infant harm based on limited human data and drug properties; possible decr. milk production based on conflicting human data


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