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Drug Interactions between Bunavail and M-Clear WC

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

codeine buprenorphine

Applies to: M-Clear WC (codeine / guaifenesin) and Bunavail (buprenorphine / naloxone)

GENERALLY AVOID: Concomitant use of opioids with other central nervous system (CNS) depressants including mixed agonist-antagonist or partial agonist opioids may result in profound sedation, respiratory depression, coma, and death. The risk of hypotension may also be increased. On the other hand, mixed agonist-antagonist or partial agonist opioids can reduce the pharmacologic effects of other opioid agonists. Reduced efficacy or withdrawal symptoms may occur in patients maintained on their opioid regimen following the addition of a mixed agonist-antagonist or partial agonist opioid.

MANAGEMENT: The use of opioids in conjunction with other CNS depressants including mixed agonist-antagonist or partial agonist opioids should generally be avoided unless alternative treatment options are inadequate. If coadministration is necessary (e.g., when initiating a switch from one opioid to the other), the dosage and duration of each drug should be limited to the minimum required to achieve desired clinical effect, and patients should be closely monitored for signs and symptoms of CNS and respiratory depression. Additional caution is advisable when a mixed agonist-antagonist or partial agonist opioid is added to an existing opioid regimen, as there may be an increased risk of withdrawal symptoms (e.g., restlessness, insomnia, sweating, lacrimation, or rhinorrhea) following initiation of the mixed agonist-antagonist or partial agonist opioid. A dosage adjustment for one or both drugs may be required.

References

  1. Moldenhauer CC, Roach GW, Finlayson DC, et al. "Nalbuphine antagonism of ventilatory depression following high-dose fentanyl anesthesia." Anesthesiology 62 (1985): 647-50
  2. Gilman AG, eds., Nies AS, Rall TW, Taylor P "Goodman and Gilman's the Pharmacological Basis of Therapeutics." New York, NY: Pergamon Press Inc. (1990):
  3. Strain EC, Preston KL, Liebson IA, Bigelow GE "Precipitated withdrawal by pentazocine in methadone-maintained volunteers." J Pharmacol Exp Ther 267 (1993): 624-34
  4. "Product Information. Nubain (nalbuphine)." Endo Laboratories LLC PROD (2001):
  5. "Product Information. Buprenex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc PROD (2001):
  6. "Product Information. Talwin NX (pentazocine)." Sanofi Winthrop Pharmaceuticals PROD (2001):
  7. "Product Information. Stadol (butorphanol)." Allscrips Pharmaceutical Company PROD (2001):
  8. "Product Information. Dalgan (dezocine)." Astra-Zeneca Pharmaceuticals PROD (2001):
  9. "Product Information. Suboxone (buprenorphine-naloxone)." Reckitt and Colman Pharmaceuticals Inc (2002):
  10. "Product Information. Subutex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc (2002):
  11. "Product Information. Butrans (buprenorphine)." Purdue Pharma LP (2010):
View all 11 references

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Moderate

codeine naloxone

Applies to: M-Clear WC (codeine / guaifenesin) and Bunavail (buprenorphine / naloxone)

MONITOR: This warning does not apply to the naloxone component in non-injectable formulations of naloxone-containing combination medicines. Naloxone injection is an antagonist that will reverse the actions of opiates. This reversal can occur when the opiate drug is being used clinically and when it is being abused. Physically dependent patients may experience withdrawal symptoms. Abrupt postoperative opioid reversal has resulted in hypotension, ventricular tachycardia and fibrillation, pulmonary edema, cardiac arrest, encephalopathy, and death.

MANAGEMENT: Patients receiving naloxone injection should be monitored for changes in vital signs, nausea, vomiting, diarrhea, aches, fever, runny nose, sneezing, nervousness, irritability, shivering, abdominal cramps.

References

  1. Gilman AG, eds., Nies AS, Rall TW, Taylor P "Goodman and Gilman's the Pharmacological Basis of Therapeutics." New York, NY: Pergamon Press Inc. (1990):
  2. "Product Information. Narcan (naloxone)." DuPont Pharmaceuticals PROD (2001):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
View all 4 references

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Drug and food interactions

Major

buprenorphine food

Applies to: Bunavail (buprenorphine / naloxone)

GENERALLY AVOID: Concomitant use of buprenorphine with benzodiazepines or other central nervous system (CNS) depressants (e.g., nonbenzodiazepine sedatives/hypnotics, anxiolytics, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol) may increase the risk of buprenorphine overdose, severe respiratory depression, coma, and death. Reported cases have primarily occurred in the setting of buprenorphine maintenance treatment for opiate addiction, and many, but not all, involved abuse or misuse of buprenorphine including intravenous self-injection. The mechanism of interaction probably involves some degree of additive pharmacologic effects. Preclinical studies also suggest that benzodiazepines can alter the usual ceiling effect on buprenorphine-induced respiratory depression and render the respiratory effects of buprenorphine appear similar to those of full opioid agonists. Coadministration of buprenorphine with some CNS depressants such as alcohol, benzodiazepines, and phenothiazines may also increase the risk of hypotension.

MANAGEMENT: The use of opioids in conjunction with benzodiazepines or other CNS depressants should generally be avoided unless alternative treatment options are inadequate. If coadministration is necessary, the dosage and duration of each drug should be limited to the minimum required to achieve desired clinical effect. Patients should be monitored closely for signs and symptoms of respiratory depression and sedation, and advised to avoid driving or operating hazardous machinery until they know how these medications affect them. Extreme caution is advised when prescribing buprenorphine to patients who are addicted to opioids and also abusing benzodiazepines or alcohol. Due to potential risk of overdose and death, dependence on sedative-hypnotics such as benzodiazepines or alcohol is considered a relative contraindication for office-based buprenorphine treatment of opioid addiction. For patients who have been receiving extended therapy with both an opioid and a benzodiazepine and require discontinuation of either medication, a gradual tapering of dose is advised, since abrupt withdrawal may lead to withdrawal symptoms. Severe cases of benzodiazepine withdrawal, primarily in patients who have received excessive doses over a prolonged period, may result in numbness and tingling of extremities, hypersensitivity to light and noise, hallucinations, and epileptic seizures.

References

  1. "Product Information. Suboxone (buprenorphine-naloxone)." Reckitt and Colman Pharmaceuticals Inc (2002):
  2. Kilicarslan T, Sellers EM "Lack of interaction of buprenorphine with flunitrazepam metabolism." Am J Psychiatry 157 (2000): 1164-6
  3. Reynaud M, Petit G, Potard D, Courty P "Six deaths linked to concomitant use of buprenorphine and benzodiazepines." Addiction 93 (1998): 1385-92
  4. Tracqui A, Kintz P, Ludes B "Buprenorphine-related deaths among drug addicts in France: a report on 20 fatalities." J Anal Toxicol 22 (1998): 430-4
  5. Reynaud M, Tracqui A, Petit G, Potard D, Courty P "Six deaths linked to misuse of buprenorphine-benzodiazepine combinations." Am J Psychiatry 155 (1998): 448-9
  6. Kintz P "A new series of 13 buprenorphine-related deaths." Clin Biochem 35 (2002): 513-6
  7. Martin HA "The possible consequences of combining lorazepam and buprenorphine/naloxone: a case review." J Emerg Nurs 37 (2011): 200-2
  8. Hakkinen M, Launiainen T, Vuori E, Ojanpera I "Benzodiazepines and alcohol are associated with cases of fatal buprenorphine poisoning." Eur J Clin Pharmacol 68 (2012): 301-9
  9. Substance Abuse and Mental Health Services Administration (US) "Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series, No. 40 http://www.ncbi.nlm.nih.gov/books/NBK64245/" (2013):
  10. Schuman-Olivier Z, Hoeppner BB, Weiss RD, Borodovsky J, Shaffer HJ, Albanese MJ "Benzodiazepine use during buprenorphine treatment for opioid dependence: clinical and safety outcomes." Drug Alcohol Depend 132 (2013): 580-6
  11. Ferrant O, Papin F, Clin B, et al. "Fatal poisoning due to snorting buprenorphine and alcohol consumption." Forensic Sci Int 204 (2011): e8-11
  12. Pirnay S, Borron SW, Giudicelli CP, Tourneau J, Baud FJ, Ricordel I "A critical review of the causes of death among post-morten toxicological investigations: analysis of 34 buprenorphine-associated and 35 methadone-associated deaths." Addiction 99 (2004): 978-88
  13. Kintz P "Deaths involving buprenorphine: a compendium of French cases." Forensic Sci Int 121 (2001): 65-9
  14. Sekar M, Mimpriss TJ "Buprenorphine, benzodiazepines and prolonged respiratory depression." Anaesthesia 42 (1987): 567-8
  15. Gueye PN, Borron SW, Risede P, et al. "Buprenorphine and midazolalm act in combination to depress respiration in rats." Toxicol Sci 65 (2002): 107-14
  16. US Food and Drug Administration "FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM518672.pdf" (2016):
View all 16 references

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Moderate

codeine food

Applies to: M-Clear WC (codeine / guaifenesin)

GENERALLY AVOID: Ethanol may potentiate the central nervous system (CNS) depressant effects of opioid analgesics. Concomitant use may result in additive CNS depression and impairment of judgment, thinking, and psychomotor skills. In more severe cases, hypotension, respiratory depression, profound sedation, coma, or even death may occur.

MANAGEMENT: Concomitant use of opioid analgesics with ethanol should be avoided.

References

  1. Linnoila M, Hakkinen S "Effects of diazepam and codeine, alone and in combination with alcohol, on simulated driving." Clin Pharmacol Ther 15 (1974): 368-73
  2. Sturner WQ, Garriott JC "Deaths involving propoxyphene: a study of 41 cases over a two-year period." JAMA 223 (1973): 1125-30
  3. Girre C, Hirschhorn M, Bertaux L, et al. "Enhancement of propoxyphene bioavailability by ethanol: relation to psychomotor and cognitive function in healthy volunteers." Eur J Clin Pharmacol 41 (1991): 147-52
  4. Levine B, Saady J, Fierro M, Valentour J "A hydromorphone and ethanol fatality." J Forensic Sci 29 (1984): 655-9
  5. Sellers EM, Hamilton CA, Kaplan HL, Degani NC, Foltz RL "Pharmacokinetic interaction of propoxyphene with ethanol." Br J Clin Pharmacol 19 (1985): 398-401
  6. Carson DJ "Fatal dextropropoxyphene poisoning in Northern Ireland. Review of 30 cases." Lancet 1 (1977): 894-7
  7. Rosser WW "The interaction of propoxyphene with other drugs." Can Med Assoc J 122 (1980): 149-50
  8. Edwards C, Gard PR, Handley SL, Hunter M, Whittington RM "Distalgesic and ethanol-impaired function." Lancet 2 (1982): 384
  9. Kiplinger GF, Sokol G, Rodda BE "Effect of combined alcohol and propoxyphene on human performance." Arch Int Pharmacodyn Ther 212 (1974): 175-80
View all 9 references

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

See also

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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