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Drug Interactions between Azilect and Novagest with Codeine

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

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Major

codeine rasagiline

Applies to: Novagest with Codeine (codeine / guaifenesin / pseudoephedrine) and Azilect (rasagiline)

GENERALLY AVOID: Coadministration of narcotic analgesics with monoamine oxidase inhibitors (MAOIs) has been associated with rare reports of anxiety, confusion, hypotension, respiratory depression, cyanosis, and coma. The mechanism of interaction is unknown, but may involve potentiation of central nervous system (CNS) and respiratory depressant effects by MAOIs. There have also been reports of serotonin syndrome, which is a rare but serious and potentially fatal condition thought to result from hyperstimulation of brainstem 5-HT1A and 2A receptors. Symptoms of the serotonin syndrome may include mental status changes such as irritability, altered consciousness, confusion, hallucination, and coma; autonomic dysfunction such as tachycardia, hyperthermia, diaphoresis, shivering, blood pressure lability, and mydriasis; neuromuscular abnormalities such as hyperreflexia, myoclonus, tremor, rigidity, and ataxia; and gastrointestinal symptoms such as abdominal cramping, nausea, vomiting, and diarrhea. Some opioids such as fentanyl, meperidine, methadone, tapentadol, and tramadol can inhibit serotonin reuptake. However, serotonin syndrome has also occurred with other opioids. Concomitant use of pentazocine with MAOIs may also cause CNS excitation and hypertension through their respective effects on catecholamines.

MANAGEMENT: Narcotic analgesics should generally not be used with MAOIs or other agents that possess MAOI activity (e.g., furazolidone, linezolid, methylene blue, procarbazine). At least 14 days should elapse between discontinuation of MAOI therapy and initiation of treatment with opioids.

References

  1. Browne B, Linter S "Monoamine oxidase inhibitors and narcotic analgesics: a critical review of the implications for treatment." Br J Psychiatry 151 (1987): 210-2
  2. Evans-Prosser CD "The use of pethidine and morphine in the presence of monoamine oxidase inhibitors." Br J Anaesth 40 (1968): 279-82
  3. "Product Information. MS Contin (morphine)." Purdue Frederick Company PROD (2002):
  4. "Product Information. Roxicodone (oxycodone)." Roxane Laboratories Inc PROD (2001):
  5. "Product Information. Levo-Dromoran (levorphanol)." Roche Laboratories PROD (2001):
  6. Garbutt JC "Potentiation of propoxyphene by phenelzine." Am J Psychiatry 144 (1987): 251-2
  7. Zornberg GL, Hegarty JD "Adverse interaction between propoxyphene and phenelzine." Am J Psychiatry 150 (1993): 1270-1
  8. "Product Information. Tylenol with Codeine (acetaminophen-codeine)." Janssen Pharmaceuticals PROD (2001):
  9. Michaels I, Serrins M, Shier NQ, Barash PG "Anesthesia for cardiac surgery in patients receiving monoamine oxidase inhibitors." Anesth Analg 63 (1984): 1041-4
  10. "Product Information. Nubain (nalbuphine)." Endo Laboratories LLC PROD (2001):
  11. "Product Information. Nardil (phenelzine)." Parke-Davis PROD (2001):
  12. "Product Information. Buprenex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc PROD (2001):
  13. "Product Information. Parnate (tranylcypromine)." SmithKline Beecham PROD (2001):
  14. "Product Information. Marplan (isocarboxazid)." Roche Laboratories PROD (2001):
  15. "Product Information. Emsam (selegiline)." Bristol-Myers Squibb (2006):
  16. "Product Information. Talacen (acetaminophen-pentazocine)." Sanofi-Synthelabo Inc (2006):
View all 16 references

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Moderate

pseudoephedrine rasagiline

Applies to: Novagest with Codeine (codeine / guaifenesin / pseudoephedrine) and Azilect (rasagiline)

MONITOR: Coadministration of nonselective monoamine oxidase (MAO) inhibitors and sympathomimetic amines has been associated with severe hypertensive reactions. The mechanism involves a synergistic sympathomimetic effect due to enhanced norepinephrine storage in adrenergic neurons (MAOI activity) and increased liberation or decreased reuptake of catecholamines (sympathomimetic activity). Concomitant use of sympathomimetic medications was not allowed in clinical studies of rasagiline. Because rasagiline is a selective MAO-B inhibitor, hypertensive reactions would not ordinarily be expected when used with sympathomimetic amines. However, one case of hypertensive crisis has been reported in a patient taking ephedrine with the recommended dosage of a different selective MAO-B inhibitor. In the postmarketing period, elevated blood pressure was reported in a patient using ophthalmic tetrahydrozoline drops while taking the recommended dosage of rasagiline.

MANAGEMENT: Caution is advised if rasagiline is used in combination with sympathomimetic amines. Patients with preexisting hypertension may require more frequent monitoring of their blood pressure.

References

  1. Smookler S, Barmudez AJ "Hypertensive crisis resulting from an MAO inhibitor and an over-the counter appetite suppressant." Ann Emerg Med 11 (1982): 482-4
  2. Krisko I, Lewis E, Johnson JE "Severe hyperpyrexia due to tranylcypromine-amphetamine toxicity." Ann Intern Med 70 (1969): 559-64
  3. Elis J, Laurence DR, Mattie H, Prichard BN "Modification by monoamine oxidase inhibitors of the effect of some sympathomimetics on blood pressure." Br Med J 2 (1967): 75-8
  4. Davies B, Bannister R, Sever P "Pressor amines and monoamine-oxidase inhibitors for treatment of postural hypotension in autonomic failure: limitations and hazards." Lancet 1 (1978): 172-5
  5. Goldberg LI "Monoamine oxidase inhibitors: adverse reactions and possible mechanisms." JAMA 190 (1964): 456-62
  6. Horler AR, Wynne NA "Hypertensive crisis due to pargyline and metaraminol." Br Med J 5459 (1965): 460-1
  7. Sjoqvist F "Psychotropic drugs (2) interaction between monoamine oxidase (MAO) inhibitors and other substances." Proc R Soc Med 58 (1965): 967-78
  8. Harrison WM, McGrath PJ, Stewart JW, Quitkin F "MAOIs and hypertensive crises: the role of OTC drugs." J Clin Psychiatry 50 (1989): 64-5
  9. Cuthbert MF, Greenberg MP, Morley SW "Cough and cold remedies: a potential danger to patients on monoamine oxidase inhibitors." Br Med J 1 (1969): 404-6
  10. Humberstone PM "Hypertension from cold remedies." Br Med J 1 (1969): 846
  11. Wright SP "Hazards with monoamine-oxidase inhibitors: a persistent problem." Lancet 1 (1978): 284-5
  12. Boakes AJ, Laurence DR, Teoh PC, Barar FS, Benedikter LT, Pritchard BN "Interactions between sympathomimetic amines and antidepressant agents in man." Br Med J 1 (1973): 311-5
  13. Dally PJ "Fatal reaction associated with tranylcypromine and methylamphetamine." Lancet 1 (1962): 1235-6
  14. Schildkraut JJ, Klerman GL, Friend DG, Greenblatt M "Biochemical and pressor effects of oral d,l-dihydroxyphenylalanine in patients pretreated with antidepressant drugs." Ann N Y Acad Sci 107 (1963): 1005-15
  15. Smookler S, Bermudez AJ "Hypertensive crisis resulting from an MAO inhibitor and an over-the-counter appetite suppressant." Ann Intern Med 11 (1982): 482-4
  16. Mason AM, Buckle RM ""Cold" cures and monoamine-oxidase inhibitors." Br Med J 1 (1969): 845-6
  17. Boakes AJ, Laurence DR, Teoh PC, Barar FS, Benedikter LT, Prichard BN "Interactions between sympathomimetic amines and antidepressant agents in man." Br Med J 1 (1973): 311-5
  18. Goulet JP, Perusse R, Turcotte JY "Contraindications to vasoconstrictors in dentistry: Part III. Pharmacologic interactions." Oral Surg Oral Med Oral Pathol 74 (1992): 692-7
  19. Ban TA "Drug interactions with psychoactive drugs." Dis Nerv Syst 36 (1975): 164-6
  20. Lefebvre H, Noblet C, Morre N, Wolf LM "Pseudo-phaeochromocytoma after multiple drug interactions involving the selective monoamine oxidase inhibitor selegiline." Clin Endocrinol (Oxf) 42 (1995): 95-8
  21. Darcy PF, Griffin JP "Interactions with drugs used in the treatment of depressive illness." Adverse Drug React Toxicol Rev 14 (1995): 211-31
  22. Markowitz JS, Patrick KS "Pharmacokinetic and pharmacodynamic drug interactions in the treatment of attention-deficit hyperactivity disorder." Clin Pharmacokinet 40 (2001): 753-72
  23. "Product Information. Azilect (rasagiline)." Teva Pharmaceuticals USA (2006):
  24. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  25. "Product Information. Vyvanse (lisdexamfetamine)." Shire US Inc (2007):
View all 25 references

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Drug and food interactions

Moderate

rasagiline food

Applies to: Azilect (rasagiline)

GENERALLY AVOID: Foods that contain large amounts of tyramine may precipitate a hypertensive crisis in patients treated with monoamine oxidase (MAO) inhibitors. The mechanism involves inhibition of MAO-A, the enzyme responsible for metabolizing exogenous amines such as tyramine in the gut and preventing them from being absorbed intact. Once absorbed, tyramine is metabolized to octopamine, a substance that is believed to displace norepinephrine from storage granules. Although rasagiline is a selective inhibitor of MAO-B at the recommended dosages of 0.5 or 1 mg/day, selectivity is not absolute and may diminish with increasing dosage. There were no cases of hypertensive crisis in the clinical development program associated with rasagiline treatment at 1 mg/day, in which most patients did not follow dietary tyramine restriction. However, rare cases of hypertensive crisis have been reported during the postmarketing period in patients who ingested unknown amounts of tyramine-rich foods while taking recommended dosages of rasagiline or selegiline, another MAO-B inhibitor.

Rasagiline peak plasma concentration (Cmax) and systemic exposure (AUC ) are decreased by approximately 60% and 20%, respectively, during coadministration with a high-fat meal. The time to peak concentration (Tmax) is not affected by food.

MANAGEMENT: Dietary restriction is not ordinarily required during rasagiline treatment with respect to most foods and beverages that may contain tyramine such as air-dried and fermented meats or fish, aged cheeses, most soybean products, yeast extracts, red wine, beer, and sauerkraut. However, certain foods like some of the aged cheeses (e.g., Boursault, Liederkrantz, Mycella, Stilton) may contain very high amounts of tyramine and could potentially cause a hypertensive reaction in patients taking rasagiline even at recommended dosages due to increased sensitivity to tyramine. Patients should be advised to avoid ingesting very high levels of tyramine (e.g., greater than 150 mg), and to promptly seek medical attention if they experience potential signs and symptoms of a hypertensive crisis such as severe headache, visual disturbances, confusion, stupor or coma, seizures, chest pain, unexplained nausea or vomiting, and stroke-like symptoms. Rasagiline should not be used at dosages exceeding 1 mg/day (0.5 mg/day for patients with mild hepatic impairment or concomitant use of ciprofloxacin or other CYP450 1A2 inhibitors), as it can increase the risk of hypertensive crisis and other adverse reactions associated with nonselective inhibition of MAO. Rasagiline can be administered with or without food.

References

  1. Goldberg LI "Monoamine oxidase inhibitors: adverse reactions and possible mechanisms." JAMA 190 (1964): 456-62
  2. Nuessle WF, Norman FC, Miller HE "Pickled herring and tranylcypromine reaction." JAMA 192 (1965): 142-3
  3. Sweet RA, Liebowitz MR, Holt CS, Heimberg RG "Potential interactions between monoamine oxidase inhibitors and prescribed dietary supplements." J Clin Psychopharmacol 11 (1991): 331-2
  4. McGrath PJ, Stewart JW, Quitkin FM "A possible L-deprenyl induced hypertensive reaction." J Clin Psychopharmacol 9 (1989): 310-1
  5. Lefebvre H, Noblet C, Morre N, Wolf LM "Pseudo-phaeochromocytoma after multiple drug interactions involving the selective monoamine oxidase inhibitor selegiline." Clin Endocrinol (Oxf) 42 (1995): 95-8
  6. Zetin M, Plon L, DeAntonio M "MAOI reaction with powdered protein dietary supplement." J Clin Psychiatry 48 (1987): 499
  7. Domino EF, Selden EM "Red wine and reactions." J Clin Psychopharmacol 4 (1984): 173-4
  8. Tailor SA, Shulman KI, Walker SE, Moss J, Gardner D "Hypertensive episode associated with phenelzine and tap beer--a reanalysis of the role of pressor amines in beer." J Clin Psychopharmacol 14 (1994): 5-14
  9. Pohl R, Balon R, Berchou R "Reaction to chicken nuggets in a patient taking an MAOI." Am J Psychiatry 145 (1988): 651
  10. Ito D, Amano T, Sato H, Fukuuchi Y "Paroxysmal hypertensive crises induced by selegiline in a patient with Parkinson's disease." J Neurol 248 (2001): 533-4
  11. "Product Information. Azilect (rasagiline)." Teva Pharmaceuticals USA (2006):
View all 11 references

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Moderate

codeine food

Applies to: Novagest with Codeine (codeine / guaifenesin / pseudoephedrine)

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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Moderate

pseudoephedrine food

Applies to: Novagest with Codeine (codeine / guaifenesin / pseudoephedrine)

MONITOR: Coadministration of two or more sympathomimetic agents may increase the risk of adverse effects such as nervousness, irritability, and increased heart rate. Central nervous system (CNS) stimulants, particularly amphetamines, can potentiate the adrenergic response to vasopressors and other sympathomimetic agents. Additive increases in blood pressure and heart rate may occur due to enhanced peripheral sympathetic activity.

MANAGEMENT: Caution is advised if two or more sympathomimetic agents are coadministered. Pulse and blood pressure should be closely monitored.

References

  1. Rosenblatt JE, Lake CR, van Kammen DP, Ziegler MG, Bunney WE Jr "Interactions of amphetamine, pimozide, and lithium on plasma norepineophrine and dopamine-beta-hydroxylase in schizophrenic patients." Psychiatry Res 1 (1979): 45-52
  2. Cavanaugh JH, Griffith JD, Oates JA "Effect of amphetamine on the pressor response to tyramine: formation of p-hydroxynorephedrine from amphetamine in man." Clin Pharmacol Ther 11 (1970): 656
  3. "Product Information. Adderall (amphetamine-dextroamphetamine)." Shire Richwood Pharmaceutical Company Inc PROD (2001):
  4. "Product Information. Tenuate (diethylpropion)." Aventis Pharmaceuticals PROD (2001):
  5. "Product Information. Sanorex (mazindol)." Novartis Pharmaceuticals PROD (2001):
  6. "Product Information. Focalin (dexmethylphenidate)." Mikart Inc (2001):
  7. "Product Information. Strattera (atomoxetine)." Lilly, Eli and Company (2002):
View all 7 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.


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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.