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Description

belbuca 600mcg online

belbuca 600mcg online is a buccal film providing transmucosal delivery of buprenorphine hydrochloride, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the buccal film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves.

The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17- (cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl- , hydrochloride, [5α, 7α, (S)]. The structural formula is:

 

BELBUCA™ (bupreno rphine) - Structural Formula Illustration

The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4·HCl. Buprenorphine hydrochloride occurs as a white or off white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function

NDICATIONS

BELBUCA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations Of Use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioid formulations , reserve BELBUCA for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • BELBUCA is not indicated as an as-needed (prn) analgesic.

DOSAGE AND ADMINISTRATIONImportant Dosage And Administration Instructions

BELBUCA should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
  • Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse .
  • Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with BELBUCA and adjust the dosage accordingly .

BELBUCA buccal film is for oral buccal use only and is to be applied to the buccal mucosa every 12 hours.

Instruct patients not to use BELBUCA if the pouch seal is broken or the buccal film is cut, damaged, or changed in any way and to avoid applying BELBUCA to areas of the mouth with any open sores or lesions.

Initial Dosing

Use Of BELBUCA As The Initial Opioid Analgesic (Opioid-Naïve Patients) Or In Patients Who Are Not Opioid Tolerant (Opioid-Non-Tolerant Patients)

Initiate treatment in opioid-naïve and opioid-non-tolerant patients with a 75 mcg film once daily or, if tolerated, every 12 hours (see Table 1) for at least 4 days, then increase dose to 150 mcg every 12 hours. Individual titration to a dose that provides adequate analgesia and minimizes adverse reactions should proceed in increments of 150 mcg every 12 hours, no more frequently than every 4 days. Doses up to 450 mcg every 12 hours were studied in opioid-naïve patients in the clinical trials [see Clinical Studies].

Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

Conversion From Other Opioids To BELBUCA

Discontinue all other around-the-clock opioid drugs when BELBUCA therapy is initiated.

There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids. To reduce the risk of opioid withdrawal, taper patients to no more than 30 mg oral morphine sulfate equivalents (MSE) daily before beginning BELBUCA. Following analgesic taper, base the starting dose on the patient’s daily opioid dose prior to taper, as described in Table 1. Patients may require additional short-acting analgesics during the taper period and during titration.

BELBUCA may not provide adequate analgesia for patients requiring greater than 160 mg oral MSE per day. Consider the use of an alternate analgesic.

There is inter-patient variability in the relative potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of BELBUCA. It is safer to underestimate a patient’s 24-hour oral buprenorphine dosage and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour buprenorphine dosage and manage an adverse reaction due to overdose.

SIDE EFFECTS

The following serious adverse reactions described elsewhere in the labeling include:

  • Addiction, Abuse, and Misuse
  • Life-Threatening Respiratory Depression
  • Neonatal Opioid Withdrawal Syndrome
  • Interactions with Benzodiazepines and Other CNS Depressants
  • Adrenal Insufficiency
  • QTc Prolongation
  • Severe Hypotension
  • Hepatotoxicity
  • Anaphylactic/Allergic Reactions
  • Gastrointestinal Adverse Reactions
  • Seizures

 

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