Skip to Content

Saleto-D (acetaminophen / caffeine / phenylpropanolamine / salicylamide) Disease Interactions

There are 25 disease interactions with Saleto-D (acetaminophen / caffeine / phenylpropanolamine / salicylamide):

Major

Acetaminophen (applies to Saleto-D) alcoholism

Major Potential Hazard, High plausibility.

Chronic alcohol abusers may be at increased risk of hepatotoxicity during treatment with acetaminophen (APAP). Severe liver injury, including cases of acute liver failure resulting in liver transplant and death, has been reported in patients using acetaminophen. Therapy with acetaminophen should be administered cautiously, if at all, in patients who consume three or more alcoholic drinks a day. In general, patients should avoid drinking alcohol while taking acetaminophen-containing medications. Patients should be warned not to exceed the maximum recommended total daily dosage of acetaminophen (4 g/day in adults and children 12 years of age or older), and to read all prescription and over-the-counter medication labels to ensure they are not taking multiple acetaminophen-containing products, or check with a healthcare professional if they are unsure. They should also be advised to seek medical attention if they experience signs and symptoms of liver injury such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, and jaundice.

References

  1. Whitcomb DC, Block GD "Association of acetaminopphen hepatotoxicity with fasting and ethanol use." JAMA 272 (1994): 1845-50
  2. Bonkovsky HL "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301
  3. Kaysen GA, Pond SM, Roper MH, Menke DJ, Marrama MA "Combined hepatic and renal injury in alcoholics during therapeutic use of acetaminophen." Arch Intern Med 145 (1985): 2019-23
  4. O'Dell JR, Zetterman RK, Burnett DA "Centrilobular hepatic fibrosis following acetaminophen-induced hepatic necrosis in an alcoholic." JAMA 255 (1986): 2636-7
  5. Kartsonis A, Reddy KR, Schiff ER "Alcohol, acetaminophen, and hepatic necrosis." Ann Intern Med 105 (1986): 138-9
  6. "Product Information. Tylenol (acetaminophen)." McNeil Pharmaceutical, Raritan, NJ.
  7. McClain CJ, Kromhout JP, Peterson FJ, Holtzman JL "Potentiation of acetaminophen hepatotoxicity by alcohol." JAMA 244 (1980): 251-3
  8. Zimmerman HJ, Maddrey WC "Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure." Hepatology 22 (1995): 767-73
  9. Nelson EB, Temple AR "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301
  10. Seeff LB, Cuccherini BA, Zimmerman HJ, Adler E, Benjamin SB "Acetaminophen hepatotoxicity in alcoholics." Ann Intern Med 104 (1986): 399-404
  11. Prescott LF, Critchley JA "Drug interactions affecting analgesic toxicity." Am J Med 75 (1983): 113-6
View all 11 references
Major

Acetaminophen (applies to Saleto-D) liver disease

Major Potential Hazard, High plausibility.

Acetaminophen is primarily metabolized in the liver to inactive forms. However, small quantities are converted by minor pathways to metabolites that can cause hepatotoxicity or methemoglobinemia. Patients with hepatic impairment may be at increased risk of toxicity due to increased minor metabolic pathway activity. Likewise, chronic or overuse of acetaminophen can saturate the primary hepatic enzymes and lead to increased metabolism by minor pathways. Severe liver injury, including cases of acute liver failure resulting in liver transplant and death, has been reported in patients using acetaminophen. Therapy with acetaminophen should be administered cautiously in patients with hepatic insufficiency. Clinical monitoring of hepatic function is recommended. Instruct patients to avoid drinking alcohol while taking acetaminophen-containing medications. Patients should be warned not to exceed the maximum recommended total daily dosage of acetaminophen (4 g/day in adults and children 12 years of age or older), and to read all prescription and over-the-counter medication labels to ensure they are not taking multiple acetaminophen-containing products, or check with a healthcare professional if they are unsure.

References

  1. Gillette JR "An integrated approach to the study of chemically reactive metabolites of acetaminophen." Arch Intern Med 141 (1981): 375-9
  2. Clements JA, Critchley JA, Prescott LF "The role of sulphate conjugation in the metabolism and disposition of oral and intravenous paracetamol in man." Br J Clin Pharmacol 18 (1984): 481-5
  3. Forrest JA, Adriaenssens P, Finlayson ND, Prescott LF "Paracetamol metabolism in chronic liver disease." Eur J Clin Pharmacol 15 (1979): 427-31
  4. Arnman R, Olsson R "Elimination of paracetamol in chronic liver disease." Acta Hepatogastroenterol (Stuttg) 25 (1978): 283-6
  5. Venkataramanan R, Kalp K, Rabinovitch M, et al "Conjugative drug metabolism in liver transplant patients." Transplant Proc 21 (1989): 2455
  6. "Product Information. Tylenol (acetaminophen)." McNeil Pharmaceutical, Raritan, NJ.
View all 6 references
Major

CNS stimulants (applies to Saleto-D) cardiac disease

Major Potential Hazard, Moderate plausibility. Applicable conditions: Hypertension, Hyperthyroidism, Heart Disease, Pheochromocytoma, Peripheral Arterial Disease

The use of CNS stimulants is contraindicated in patients with significant cardiovascular impairment such as uncompensated heart failure, severe coronary disease, severe hypertension (including that associated with hyperthyroidism or pheochromocytoma), cardiac structural abnormalities, serious arrhythmias, etc. Sudden death has been reported in adults and children taking CNS stimulant treatment. Additionally, stroke, myocardial infarction, chest pain, syncope, arrhythmias and other symptoms have been reported in adults under treatment. A careful assessment of the cardiovascular status should be done in patients being considered for treatment. This includes family history, physical exam and further cardiac evaluation (EKG and echocardiogram). Patients who develop symptoms should have a detailed cardiac evaluation and if needed, treatment should be suspended.

References

  1. "Product Information. Dopram (doxapram)." West-Ward Pharmaceutical Corporation, Eatontown, NJ.
Major

CNS stimulants (applies to Saleto-D) hypertension

Major Potential Hazard, Moderate plausibility.

CNS stimulant medications have shown to increase blood pressure, and their use might be contraindicated in patients with severe hypertension. Caution should be used when administering to patients with preexisting high blood pressure and other cardiovascular conditions. All patients under treatment should be regularly monitored for changes in blood pressure and heart rate.

References

  1. "Product Information. Dopram (doxapram)." West-Ward Pharmaceutical Corporation, Eatontown, NJ.
Major

CNS stimulants (applies to Saleto-D) liver disease

Major Potential Hazard, Moderate plausibility.

In general, CNS stimulants are extensively metabolized by the liver. Their plasma clearance may be decreased and their half-life prolonged in patients with impaired hepatic function. Therapy with CNS stimulants should be administered cautiously in patients with moderate to severe liver disease, and the dosage should be adjusted accordingly. Additionally, postmarketing reports have shown that atomoxetine can cause severe liver injury. Laboratory testing should be done at the first sign or symptom of liver dysfunction (jaundice, dark urine, upper quadrant tenderness) and treatment should be discontinued in patients with evidence of liver injury.

References

  1. "Product Information. Provigil (modafinil)." Cephalon, Inc, West Chester, PA.
Major

Methylxanthines (applies to Saleto-D) PUD

Major Potential Hazard, High plausibility. Applicable conditions: Peptic Ulcer

Methylxanthines are known to stimulate peptic acid secretion. Therapy with products containing methylxanthines should be administered with extreme caution in patients with active peptic ulcer disease. Some manufacturers consider their use to be contraindicated under such circumstance.

References

  1. "Product Information. Theo-Dur (theophylline)." Schering Laboratories, Kenilworth, NJ.
  2. Stoller JL "Oesophageal ulceration and theophylline." Lancet 2 (1985): 328-9
  3. "Product Information. Lufyllin (dyphylline)" Wallace Laboratories, Cranbury, NJ.
  4. Alterman P, Spiegel D, Feldman J, Yaretzky A "Histamine h2-receptor antagonists and chronic theophylline toxicity." Am Fam Physician 54 (1996): 1473
View all 4 references
Major

Salicylates (applies to Saleto-D) GI toxicity

Major Potential Hazard, High plausibility. Applicable conditions: Duodenitis/Gastritis, Gastrointestinal Hemorrhage, Gastrointestinal Perforation, History - Peptic Ulcer, Peptic Ulcer, Alcoholism, Colitis/Enteritis (Noninfectious), Colonic Ulceration

Salicylates, particularly aspirin, can cause dose-related gastrointestinal bleeding and mucosal damage, which may occur independently of each other. Occult, often asymptomatic GI blood loss is quite common with usual dosages of aspirin and stems from the drug's local effect on the GI mucosa. During chronic therapy, this type of bleeding may occasionally produce iron deficiency anemia. In contrast, major upper GI bleeding rarely occurs except in patients with active peptic ulcers or recent GI bleeding. However, these patients generally do not experience greater occult blood loss than healthy patients following small doses of aspirin. Mucosal damage associated with the use of salicylates may lead to development of peptic ulcers with or without bleeding, reactivation of latent ulcers, and ulcer perforation. Therapy with salicylates and related agents such as salicylamide should be considered and administered cautiously in patients with a history of GI disease or alcoholism, particularly if they are elderly and/or debilitated, since such patients may be more susceptible to the GI toxicity of these drugs and seem to tolerate ulceration and bleeding less well than other individuals. Extreme caution and thorough assessment of risks and benefits are warranted in patients with active or recent GI bleeding or lesions. Whenever possible, especially if prolonged use is anticipated, treatment with non-ulcerogenic agents should be attempted first. If salicylates are used, close monitoring for toxicity is recommended. Some adverse GI effects may be minimized by administration with high dosages of antacids, use of enteric-coated or extended-release formulations, and/or concurrent use of a histamine H2-receptor antagonist or a cytoprotective agent such as misoprostol. Patients with active peptic ulceration or GI bleeding treated with salicylates should generally be administered a concomitant anti-ulcer regimen.

References

  1. Lanas A, Serrano P, Bajador E, Esteva F, Benito R, Sainz R "Evidence of aspirin use in both upper and lower gastrointestinal perforation." Gastroenterology 112 (1997): 683-9
  2. Savon JJ, Allen ML, Dimarino AJ, Hermann GA, Krum RP "Gastrointestinal blood loss with low dose (325 mg) plain and enteric-coated aspirin administration." Am J Gastroenterol 90 (1995): 581-5
  3. "Product Information. Salflex (salsalate)." Carnrick Laboratories Inc, Cedar Knolls, NJ.
  4. Roderick PJ, Wilkes HC, Meade TW "The gastrointestinal toxicity of aspirin: an overview of randomised controlled trials." Br J Clin Pharmacol 35 (1993): 219-26
  5. American Medical Association, Division of Drugs and Toxicology "Drug evaluations annual 1994." Chicago, IL: American Medical Association; (1994):
  6. Stalnikowiczdarvasi R "Gastrointestinal bleeding during low-dose aspirin administration for prevention of arterial occlusive events: a critical analysis." J Clin Gastroenterol 21 (1995): 13-6
  7. Bergmann JF, Chassany O, Geneve J, Abiteboul M, Caulin C, Segrestaa JM "Endoscopic evaluation of the effect of ketoprofen, ibuprofen and aspirin on the gastroduodenal mucosa." Eur J Clin Pharmacol 42 (1992): 685-8
  8. "Product Information. Ecotrin (aspirin)." SmithKline Beecham, Philadelphia, PA.
  9. Levy M, Miller DR, Kaufman DW, Siskind V, Schwingl P, Rosenberg L, Strom B, Shapiro S "Major upper gastrointestinal tract bleeding. Relation to the use of aspirin and other nonnarcotic analgesics." Arch Intern Med 148 (1988): 281-5
  10. Sabesin SM, Boyce HW Jr, King CE, Mann JA, Ruoff G, Wall E "Comparative evaluation of gastrointestinal intolerance produced by plain and tri-buffered aspirin tablets." Am J Gastroenterol 83 (1988): 1220-5
  11. Wilcox CM, Shalek KA, Cotsonis G "Striking prevalence of over-the-counter nonsteroidal anti- inflammatory drug use in patients with upper gastrointestinal hemorrhage." Arch Intern Med 154 (1994): 42-6
  12. Silagy CA, McNeil JJ, Donnan GA, Tonkin AM, Worsam B, Campion K "Adverse effects of low-dose aspirin in a healthy elderly population." Clin Pharmacol Ther 54 (1993): 84-9
  13. Greenberg PD, Cello JP, Rockey DC "Asymptomatic chronic gastrointestinal blood loss in patients taking aspirin or warfarin for cardiovascular disease." Am J Med 100 (1996): 598-604
  14. Marks RD "Aspirin use and fecal occult blood testing." Am J Med 100 (1996): 596-7
  15. Mehta S, Dasarathy S, Tandon RK, Mathur M, Malaviya AN "A prospective randomized study of the injurious effects of aspirin and naproxen on the gastroduodenal mucosa in patients with rheumatoid arthritis." Am J Gastroenterol 87 (1992): 996-1000
  16. Naschitz JE, Yeshurun D, Odeh M, Bassan H, Rosner I, Stermer E, Levy N "Overt gastrointestinal bleeding in the course of chronic low-dose aspirin administration for secondary prevention of arterial occlusive disease." Am J Gastroenterol 85 (1990): 408-11
  17. Weil J, Colinjones D, Langman M, Lawson D, Logan R, Murphy M, Rawlins M, Vessey M, Wainwright P "Prophylactic aspirin and risk of peptic ulcer bleeding." BMJ 310 (1995): 827-30
  18. Graham DY, Smith JL "Aspirin and the stomach." Ann Intern Med 104 (1986): 390-8
  19. Prichard PJ, Kitchingman GK, Walt RP, Daneshmend TK, Hawkey CJ "Human gastric mucosal bleeding induced by low dose aspirin, but not warfarin." BMJ 298 (1989): 493-6
View all 19 references
Major

Salicylates (applies to Saleto-D) Reye's syndrome

Major Potential Hazard, Moderate plausibility. Applicable conditions: Varicella-Zoster, Influenza

The use of salicylates, primarily aspirin, in children with varicella infections or influenza-like illnesses has been associated with an increased risk of Reye's syndrome. Although a causal relationship has not been established, the majority of evidence to date seems to support the association. Most authorities, including the American Academy of Pediatrics Committee on Infectious Diseases, recommend avoiding the use of salicylates in children and teenagers with known or suspected varicella or influenza and during presumed outbreaks of influenza. If antipyretic or analgesic therapy is indicated under these circumstances, acetaminophen may be an appropriate alternative. The same precautions should also be observed with related agents such as salicylamide or diflunisal because of their structural and pharmacological similarities to salicylate.

References

  1. Belay ED, Bresee JS, Holman RC, Khan AS, Shahriari A, Schonberger LB "Reye's syndrome in the United States from 1981 through 1997." N Engl J Med 340 (1999): 1377-82
  2. "Product Information. Salflex (salsalate)." Carnrick Laboratories Inc, Cedar Knolls, NJ.
  3. "Product Information. Rexolate (sodium thiosalicylate)" Hyrex Pharmaceuticals, Memphis, TN.
  4. American Academy of Pediatrics. Committee on Infectious Diseases; Peter G, ed. "Red BooK: Report of the Committee on Infectious Diseases. 24th" Grove Village, IL: American Academy of Pediatrics (1997):
  5. "Product Information. Ecotrin (aspirin)." SmithKline Beecham, Philadelphia, PA.
  6. Epidemiology Office, Divisiion of Viral and Rickettsial Diseasses, Center for Infectious Diseases, Centers for Disease Control. "Leads from the MMWR. Reye syndrome surveillance--United States, 1987 and 1988." JAMA 261 (1989): 3520,
  7. "Product Information. Pepto-Bismol (bismuth subsalicylate)." Procter and Gamble Pharmaceuticals, Cincinnati, OH.
  8. Hasking GJ, Duggan JM "Encephalopathy from bismuth subsalicylate." Med J Aust 2 (1982): 167
  9. Behrman R, Kliegman R, Arvin A, Nelson W, eds. "Nelson Textbook of Pediatrics. 15th ed." Philadelphia, PA: W.B. Saunders Company (1996):
View all 9 references
Major

Sympathomimetics (applies to Saleto-D) cardiovascular disease

Major Potential Hazard, High plausibility. Applicable conditions: Hyperthyroidism, Cerebrovascular Insufficiency

Sympathomimetic agents may cause adverse cardiovascular effects, particularly when used in high dosages and/or in susceptible patients. In cardiac tissues, these agents may produce positive chronotropic and inotropic effects via stimulation of beta- 1 adrenergic receptors. Cardiac output, oxygen consumption, and the work of the heart may be increased. In the peripheral vasculature, vasoconstriction may occur via stimulation of alpha-1 adrenergic receptors. Palpitations, tachycardia, arrhythmia, hypertension, reflex bradycardia, coronary occlusion, cerebral vasculitis, myocardial infarction, cardiac arrest, and death have been reported. Some of these agents, particularly ephedra alkaloids (ephedrine, ma huang, phenylpropanolamine), may also predispose patients to hemorrhagic and ischemic stroke. Therapy with sympathomimetic agents should generally be avoided or administered cautiously in patients with sensitivity to sympathomimetic amines, hyperthyroidism, or underlying cardiovascular or cerebrovascular disorders. These agents should not be used in patients with severe coronary artery disease or severe/uncontrolled hypertension.

References

  1. Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):
  2. Frewin DB "Phenylpropanolamine. How safe is it?" Med J Aust 2 (1983): 54-5
  3. Horowitz JD, Lang WJ, Howes LG, Fennessy MR, Christophidis N, Rand MJ, Louis WJ "Hypertensive responses induced by phenylpropanolamine in anorectic and decongestant preparations." Lancet 1 (1980): 60-1
  4. Gordon RD, Ballantine DM, Bachmann AW "Effects of repeated doses of pseudoephedrine on blood pressure and plasma catecholamines in normal subjects and in patients with phaeochromocytoma." Clin Exp Pharmacol Physiol 19 (1992): 287-90
  5. Shapiro SR "Hypertension due to anorectic agent." N Engl J Med 280 (1969): 1363
  6. Leo PJ, Hollander JE, Shih RD, Marcus SM "Phenylpropanolamine and associated myocardial injury." Ann Emerg Med 28 (1996): 359-62
  7. Frewin DB, Leonello PP, Frewin ME "Hypertension after ingestion of Trimolets." Med J Aust 2 (1978): 497-8
  8. American Medical Association, Division of Drugs and Toxicology "Drug evaluations annual 1994." Chicago, IL: American Medical Association; (1994):
  9. Kroenke K, Omori DM, Simmons JO, Wood DR, Meier NJ "The safety of phenylpropanolamine in patients with stable hypertension." Ann Intern Med 111 (1989): 1043-4
  10. Mansoor GA "Herbs and alternative therapies in the hypertension clinic." Am J Hypertens 14(9 Pt 1) (2001): 971-5
  11. Loizou LA, Hamilton JG, Tsementzis SA "Intracranial haemorrhage in association with pseudoephedrine overdose." J Neurol Neurosurg Psychiatry 45 (1982): 471-2
  12. Kase CS, Foster TE, Reed JE, Spatz EL, Girgis GN "Intracerebral hemorrhage and phenylpropanolamine use." Neurology 37 (1987): 399-404
  13. Elliott CF, Whyte JC "Phenylpropanolamine and hypertension." Med J Aust 1 (1981): 715
  14. Noble R "A controlled clinical trial of the cardiovascular and psychological effects of phenylpropanolamine and caffeine." Drug Intell Clin Pharm 22 (1988): 296-9
  15. Fallis RJ, Fisher M "Cerebral vasculitis and hemorrhage associated with phenylpropanolamine." Neurology 35 (1985): 405-7
  16. Kikta DG, Devereaux MW, Chandar K "Intracranial hemorrhages due to phenylpropanolamine." Stroke 16 (1985): 510-2
  17. Dickerson J, Perrier D, Mayersohn M, Bressler R "Dose tolerance and pharmacokinetic studies of L (+) pseudoephedrine capsules in man." Eur J Clin Pharmacol 14 (1978): 253-9
  18. O'Connell MB, Gross CR "The effect of multiple doses of phenylpropanolamine on the blood pressure of patients whose hypertension was controlled with beta blockers." Pharmacotherapy 11 (1991): 376-81
  19. Lee KY, Beilin LJ, Vandongen R "Severe hypertension after ingestion of an appetite suppressant (phenylpropanolamine) with indomethacin." Lancet 1 (1979): 1110-1
  20. Gill ND, Shield A, Blazevich AJ, Zhou S, Weatherby RP "Muscular and cardiorespiratory effects of pseudoephedrine in human athletes." Br J Clin Pharmacol 50 (2000): 205-13
  21. Bernstein E, Diskant BM "Phenylpropanolamine: a potentially hazardous drug." Ann Emerg Med 11 (1982): 311-5
  22. Lee KY, Beilin LJ, Vandongen R "Severe hypertension after administration of phenylpropanolamine" Med J Aust 1 (1979): 525-6
  23. Teh AY "Phenylpropanolamine and hypertension" Med J Aust 2 (1979): 425-6
  24. Rosen RA "Angina associated with pseudoephedrine ." Ann Emerg Med 10 (1981): 230-1
  25. Lake CR, Gallant S, Masson E, Miller P "Adverse drug effects attributed to phenylpropanolamine: a review of 142 case reports." Am J Med 89 (1990): 195-208
  26. Humberstone PM "Hypertension from cold remedies." Br Med J 1 (1969): 846
  27. Maher LM, Peterson PL, Dela-Cruz C "Postpartum intracranial hemorrhage and phenylpropanolamine use" Neurology 37 (1987): 1686
  28. Haller CA, Benowitz NL "Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids." N Engl J Med 343 (2000): 1833-8
  29. Dowse R, Scherzinger SS, Kanfer I "Serum concentrations of phenylpropanolamine and associated effects on blood pressure in normotensive subjects: a pilot-study." Int J Clin Pharmacol Ther Toxicol 28 (1990): 205-10
  30. McDowell JR, LeBlanc HJ "Phenylpropanolamine and cerebral hemorrhage." West J Med 142 (1985): 688-91
  31. Howrie DL, Wolfson JH "Phenylpropanolamine-induced hypertensive seizures." J Pediatr 102 (1983): 143-5
  32. Bruno A, Nolte KB, Chapin J "Stroke associated with ephedrine use." Neurology 43 (1993): 1313-6
  33. Gibson GJ, Warrell DA "Hypertensive crises and phenylpropanolamine." Lancet 2 (1972): 492-3
  34. Finton CK, Barton M, Chernow B "Possible adverse effects of phenylpropanolamine (diet pills) on sympathetic nervous system function--caveat emptor!" Mil Med 147 (1982): 1072
  35. Williams DM "Phenylpropanolamine hydrochloride" Am Pharm NS30 (1990): 47-50
  36. Clark JE, Simon WA "Cardiac arrhythmias after phenylpropanolamine ingestion." Drug Intell Clin Pharm 17 (1983): 737-8
  37. "Product Information. Sudafed (pseudoephedrine)." Glaxo Wellcome, Research Triangle Park, NC.
  38. Lake CR, Zaloga G, Bray J, Rosenberg D, Chernow B "Transient hypertension after two phenylpropanolamine diet aids and the effects of caffeine: a placebo-controlled follow-up study." Am J Med 86 (1989): 427-32
  39. Wiener I, Tilkian AG, Palazzolo M "Coronary artery spasm and myocardial infarction in a patient with normal coronary arteries: temporal relationship to pseudoephedrine ingestion." Cathet Cardiovasc Diagn 20 (1990): 51-3
  40. McEwen J "Phenylpropanolamine-associated hypertension after the use of "over- the-counter" appetite-suppressant products." Med J Aust 2 (1983): 71-3
  41. O'Connell MB, Gross CR "The effect of single-dose phenylpropanolamine on blood pressure in patients with hypertension controlled by beta blockers." Pharmacotherapy 10 (1990): 85-91
  42. Stoessl AJ, Young GB, Feasby TE "Intracerebral haemorrhage and angiographic beading following ingestion of catecholaminergics." Stroke 16 (1985): 734-6
  43. Edwards M, Russo L, Harwood-Nuss A "Cerebral infarction with a single oral dose of phenylpropanolamine." Am J Emerg Med 5 (1987): 163-4
  44. Kizer KW "Intracranial hemorrhage associated with overdose of decongestant containing phenylpropanolamine" Am J Emerg Med 2 (1984): 180-1
  45. Chin C, Choy M "Cardiomyopathy induced by phenylpropanolamine." J Pediatr 123 (1993): 825-7
  46. Wooten MR, Khangure MS, Murphy MJ "Intracerebral hemorrhage and vasculitis related to ephedrine abuse." Ann Neurol 13 (1983): 337-40
  47. Lake CR, Zaloga G, Clymer R, Quirk RM, Chernow B "A double dose of phenylpropanolamine causes transient hypertension." Am J Med 85 (1988): 339-43
  48. Johnson DA, Etter HS, Reeves DM "Stroke and phenylpropanolamine use" Lancet 2 (1983): 970
  49. Pentel PR, Aaron C, Paya C "Therapeutic doses of phenylpropanolamine increase supine systolic blood pressure." Int J Obes 9 (1985): 115-9
  50. Samenuk D, Link MS, Homoud MK, et al. "Adverse cardiovascular events temporally associated with ma huang, an herbal source of ephedrine." Mayo Clin Proc 77 (2002): 12-6
  51. Horowitz JD, McNeil JJ, Sweet B, Mendelsohn FA, Louis WJ "Hypertension and postural hypotension induced by phenylpropanolamine (Trimolets)." Med J Aust 1 (1979): 175-6
  52. Maher LM, Peterson PL, Dela-Cruz C "Postpartum intracranial hemorrhage and phenylpropanolamine use." Neurology 37 (1987): 1886,1890
  53. Caperton E "Raynaud's phenomenon. Role of diet pills and cold remedies." Postgrad Med 73 (1983): 291-2
  54. To LB, Sangster JF, Rampling D, Cammens I "Ephedrine-induced cardiomyopathy." Med J Aust 2 (1980): 35-6
  55. Mariani PJ "Pseudoephedrine-induced hypertensive emergency: treatment with labetalol." Am J Emerg Med 4 (1986): 141-2
  56. Pentel PR, Mikell FL, Zavoral JH "Myocardial injury after phenylpropanolamine ingestion." Br Heart J 47 (1982): 51-4
View all 56 references
Moderate

Acetaminophen (applies to Saleto-D) PKU

Moderate Potential Hazard, High plausibility. Applicable conditions: Phenylketonuria

Several oral acetaminophen and acetaminophen-combination products, particularly flavored chewable tablets, contain the artificial sweetener, aspartame (NutraSweet). Aspartame is converted to phenylalanine in the gastrointestinal tract following ingestion. Chewable and effervescent formulations of acetaminophen products may also contain phenylalanine. The aspartame/phenylalanine content should be considered when these products are used in patients who must restrict their intake of phenylalanine (i.e. phenylketonurics).

References

  1. "Product Information. Tylenol (acetaminophen)." McNeil Pharmaceutical, Raritan, NJ.
Moderate

Caffeine (applies to Saleto-D) cardiotoxicity

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Tachyarrhythmia, Myocardial Infarction, Post MI Syndrome, Hypertension, Hyperthyroidism, Angina Pectoris

Like other methylxanthines, caffeine at high dosages may be associated with positive inotropic and chronotropic effects on the heart. Caffeine may also produce an increase in systemic vascular resistance, resulting in elevation of blood pressure. Therapy with products containing caffeine should be administered cautiously in patients with severe cardiac disease, hypertension, hyperthyroidism, or acute myocardial injury. Some clinicians recommend avoiding caffeine in patients with symptomatic cardiac arrhythmias and/or palpitations and during the first several days to weeks after an acute myocardial infarction.

References

  1. "Multum Information Services, Inc. Expert Review Panel"
Moderate

CNS stimulants (applies to Saleto-D) bipolar disorders

Moderate Potential Hazard, Moderate plausibility.

Central nervous system (CNS) stimulants may induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, and depression). Close monitoring is recommended when using these agents in patients with bipolar disorders.

Moderate

CNS stimulants (applies to Saleto-D) psychiatric disorders

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Psychosis, Depression

The use of CNS stimulants can cause psychotic or maniac symptoms, suicidal ideation, aggression and can exacerbate symptoms of behavior disturbance and thought disorder. Psychiatric symptoms have been reported in patients with and without history of psychiatric disorders, and all patients should be monitored closely, specially during treatment initiation and at times of dose changes. Extreme caution should be exercised when CNS stimulants are given to patients with a history of psychosis, depression, mania, or bipolar disorder. All patients receiving treatment should be screened for bipolar disease prior to initiation. If any psychiatric symptoms emerge or are exacerbated, treatment suspension should be considered. CNS stimulants are contraindicated in patients with marked agitation or anxiety.

References

  1. "Product Information. Provigil (modafinil)." Cephalon, Inc, West Chester, PA.
Moderate

CNS stimulants (applies to Saleto-D) psychotic disorders

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Psychosis

Central nervous system (CNS) stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. Close monitoring is recommended when using these agents in patients with psychotic disorders.

Moderate

CNS stimulants (applies to Saleto-D) renal dysfunction

Moderate Potential Hazard, Moderate plausibility.

Overall CNS stimulants should be administered with caution in patients with significantly impaired renal function as the reduction in the rate of elimination may alter the therapeutic response. The dosage should be adjusted accordingly.

References

  1. "Product Information. Provigil (modafinil)." Cephalon, Inc, West Chester, PA.
Moderate

CNS stimulants (applies to Saleto-D) seizure disorders

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Seizures

Due to general central nervous system stimulation, therapy with CNS stimulant drugs may cause seizures. These drugs may lower the convulsive threshold in patients with prior history of seizures or EEG abnormalities, and very rarely in patients with no previous history of seizures. Therapy with CNS stimulants should be used with caution in patients with or predisposed to seizures. If seizures appear, therapy should be discontinued.

References

  1. American Medical Association, Division of Drugs and Toxicology "Drug evaluations annual 1994." Chicago, IL: American Medical Association; (1994):
Moderate

Methylxanthines (applies to Saleto-D) GERD

Moderate Potential Hazard, High plausibility. Applicable conditions: Gastroesophageal Reflux Disease

Methylxanthines increase gastric acidity and may also relax lower esophageal sphincter, which can lead to gastric reflux into the esophagus. Therapy with products containing methylxanthines should be administered cautiously in patients with significant gastroesophageal reflux.

References

  1. American Medical Association, Division of Drugs and Toxicology "Drug evaluations annual 1994." Chicago, IL: American Medical Association; (1994):
  2. Stoller JL "Oesophageal ulceration and theophylline." Lancet 2 (1985): 328-9
  3. "Product Information. Lufyllin (dyphylline)" Wallace Laboratories, Cranbury, NJ.
  4. Alterman P, Spiegel D, Feldman J, Yaretzky A "Histamine h2-receptor antagonists and chronic theophylline toxicity." Am Fam Physician 54 (1996): 1473
View all 4 references
Moderate

PPA (applies to Saleto-D) psychosis

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: History - Psychiatric Disorder

Phenylpropanolamine may precipitate or exacerbate psychotic symptoms, particularly at high dosages. Therapy with phenylpropanolamine should be administered cautiously in patients with a history of psychiatric disorders.

References

  1. Cornelius JR, Soloff PH, Reynolds CF, 3d "Paranoia, homicidal behavior, and seizures associated with phenylpropanolamine." Am J Psychiatry 141 (1984): 120-1
  2. Grieger TA, Clayton AH, Goyer PF "Affective disorder following use of phenylpropanolamine" Am J Psychiatry 147 (1990): 367-8
  3. Wharton BK "Nasal decongestants and paranoid psychosis." Br J Psychiatry 117 (1970): 439-40
  4. Finton CK, Barton M, Chernow B "Possible adverse effects of phenylpropanolamine (diet pills) on sympathetic nervous system function--caveat emptor!" Mil Med 147 (1982): 1072
  5. Stroe AE, Hall J, Amin F "Psychotic episode related to phenylpropanolamine and amantadine in a healthy female." Gen Hosp Psychiatry 17 (1995): 457-8
  6. Lake CR "Manic psychosis after coffee and phenylpropanolamine." Biol Psychiatry 30 (1991): 401-4
  7. Schaffer CB, Pauli MW "Psychotic reaction caused by proprietary oral diet agents." Am J Psychiatry 137 (1980): 1256-7
  8. Strauss A "Homicidal psychosis during the combined use of cocaine and an over- the-counter cold preparation." J Clin Psychiatry 50 (1989): 147
  9. Dietz AJ, Jr "Amphetamine-like reactions to phenylpropanolamine." JAMA 245 (1981): 601-2
  10. Lake CR, Tenglin R, Chernow B, Holloway HC "Psychomotor stimulant-induced mania in a genetically predisposed patient: a review of the literature and report of a case." J Clin Psychopharmacol 3 (1983): 97-100
  11. Mueller SM "Neurologic complications of phenylpropanolamine use." Neurology 33 (1983): 650-2
  12. Lambert MT "Paranoid psychoses after abuse of proprietary cold remedies." Br J Psychiatry 151: (1987): 548-50
  13. Norvenius G, Widerlov E, Lonnerholm G "Phenylpropanolamine and mental disturbances" Lancet 2 (1979): 1367-8
  14. Dewsnap P, Libby G "A case of affective psychosis after routine use of proprietary cold remedy containing phenylpropanolamine" Hum Exp Toxicol 11 (1992): 295-6
  15. Lake CR, Gallant S, Masson E, Miller P "Adverse drug effects attributed to phenylpropanolamine: a review of 142 case reports." Am J Med 89 (1990): 195-208
  16. Achor MB, Extein I "Diet aids, mania, and affective illness" Am J Psychiatry 138 (1981): 392
  17. Marshall RD, Douglas CJ "Phenylpropanolamine-induced psychosis: potential predisposing factors." Gen Hosp Psychiatry 16 (1994): 358-60
View all 17 references
Moderate

Salicylates (applies to Saleto-D) anemia

Moderate Potential Hazard, Moderate plausibility.

Occult, often asymptomatic GI blood loss occurs quite frequently with the use of normal dosages of aspirin and stems from the drug's local effect on the GI mucosa. During chronic therapy, this type of bleeding may occasionally produce iron deficiency anemia. Other salicylates reportedly cause little or no GI blood loss at usual dosages, but may do so at high dosages. Prolonged therapy with salicylates, particularly aspirin, should be administered cautiously in patients with or predisposed to anemia. Periodic monitoring of hematocrit is recommended. The same precautions should also be observed with the use of related agents such as salicylamide because of their structural and pharmacological similarities to salicylate.

References

  1. Naschitz JE, Yeshurun D, Odeh M, Bassan H, Rosner I, Stermer E, Levy N "Overt gastrointestinal bleeding in the course of chronic low-dose aspirin administration for secondary prevention of arterial occlusive disease." Am J Gastroenterol 85 (1990): 408-11
  2. Savon JJ, Allen ML, Dimarino AJ, Hermann GA, Krum RP "Gastrointestinal blood loss with low dose (325 mg) plain and enteric-coated aspirin administration." Am J Gastroenterol 90 (1995): 581-5
  3. Stalnikowiczdarvasi R "Gastrointestinal bleeding during low-dose aspirin administration for prevention of arterial occlusive events: a critical analysis." J Clin Gastroenterol 21 (1995): 13-6
  4. Marks RD "Aspirin use and fecal occult blood testing." Am J Med 100 (1996): 596-7
  5. "Product Information. Ecotrin (aspirin)." SmithKline Beecham, Philadelphia, PA.
  6. Prichard PJ, Kitchingman GK, Walt RP, Daneshmend TK, Hawkey CJ "Human gastric mucosal bleeding induced by low dose aspirin, but not warfarin." BMJ 298 (1989): 493-6
  7. Greenberg PD, Cello JP, Rockey DC "Asymptomatic chronic gastrointestinal blood loss in patients taking aspirin or warfarin for cardiovascular disease." Am J Med 100 (1996): 598-604
  8. "Product Information. Salflex (salsalate)." Carnrick Laboratories Inc, Cedar Knolls, NJ.
View all 8 references
Moderate

Salicylates (applies to Saleto-D) coagulation

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Bleeding, Coagulation Defect, Thrombocytopathy, Thrombocytopenia, Vitamin K Deficiency

All salicylates can interfere with the action of vitamin K and induce a dose-dependent alteration in hepatic synthesis of coagulation factors VII, IX and X. At usual recommended dosages, a slight increase in prothrombin time (PT) may occur. Therapy with salicylates, especially if given in high dosages, should be administered cautiously in patients with significant active bleeding or a hemorrhagic diathesis, including hemostatic and/or coagulation defects associated with hemophilia, vitamin K deficiency, hypoprothombinemia, thrombocytopenia, thrombocytopathy, or severe hepatic impairment. The same precaution should also be observed with the use of related agents such as salicylamide because of their structural and pharmacological similarities to salicylate.

References

  1. Fausa O "Salicylate-induced hypoprothrombinemia: a report of four cases." Acta Med Scand 188 (1970): 403-8
  2. "Product Information. Pepto-Bismol (bismuth subsalicylate)." Procter and Gamble Pharmaceuticals, Cincinnati, OH.
  3. American Medical Association, Division of Drugs and Toxicology "Drug evaluations annual 1994." Chicago, IL: American Medical Association; (1994):
  4. "Product Information. Salflex (salsalate)." Carnrick Laboratories Inc, Cedar Knolls, NJ.
  5. Barrow MV, Quick DT, Cunningham RW "Salicylate hypoprothrombinemia in rheumatoid arthritis with liver disease. Report of two cases." Arch Intern Med 120 (1967): 620-4
View all 5 references
Moderate

Salicylates (applies to Saleto-D) G-6-PD deficiency

Moderate Potential Hazard, Low plausibility.

Salicylates, particularly aspirin, may cause or aggravate hemolysis in patients with pyruvate kinase or glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. However, this effect has not been clearly established. Until more data are available, therapy with salicylates should be administered cautiously in patients with G-6-PD deficiency. The same precaution should also be observed with the use of related agents such as salicylamide because of their structural and pharmacological similarities to salicylate.

References

  1. "Product Information. Salflex (salsalate)." Carnrick Laboratories Inc, Cedar Knolls, NJ.
  2. "Product Information. Rexolate (sodium thiosalicylate)" Hyrex Pharmaceuticals, Memphis, TN.
  3. "Product Information. Ecotrin (aspirin)." SmithKline Beecham, Philadelphia, PA.
Moderate

Salicylates (applies to Saleto-D) hepatotoxicity

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Liver Disease

The use of salicylates has occasionally been associated with acute, reversible hepatotoxicity, primarily manifested as elevations of serum transaminases, alkaline phosphatase and/or, rarely, bilirubin. Hepatic injury consistent with chronic active hepatitis has also been reported in a few patients, which resulted rarely in encephalopathy or death. Salicylate-induced hepatotoxicity appears to be dependent on serum salicylate concentration (> 25 mg/dL) and has occurred most frequently in patients with juvenile arthritis, active systemic lupus erythematosus, rheumatic fever, or preexisting hepatic impairment. Therapy with salicylates, particularly when given in high dosages, should be administered cautiously in these patients, and periodic monitoring of liver function is recommended. The same precautions should also be observed with the use of related agents such as salicylamide because of their structural and pharmacological similarities to salicylate. A dosage reduction may be necessary if liver function abnormalities develop and serum salicylate concentration exceeds 25 mg/dL, although serum transaminase elevations may sometimes be transient and return to pretreatment values despite continued therapy without dosage adjustment.

References

  1. "Product Information. Rexolate (sodium thiosalicylate)" Hyrex Pharmaceuticals, Memphis, TN.
  2. Wolfe JD, Metzger AL, Goldstein RC "Aspirin hepatitis." Ann Intern Med 80 (1974): 74-6
  3. "Product Information. Salflex (salsalate)." Carnrick Laboratories Inc, Cedar Knolls, NJ.
  4. Patel DK, Hesse A, Ogunbona A, Notarianni LJ, Bennett PN "Metabolism of aspirin after therapeutic and toxic doses." Hum Exp Toxicol 9 (1990): 131-6
  5. Jorup-Ronstrom C, Beermann B, Wahlin-Boll E, Melander A, Britton S "Reduction of paracetamol and aspirin metabolism during viral hepatitis." Clin Pharmacokinet 11 (1986): 250-6
  6. Seaman WE, Ishak KG, Plotz PH "Aspirin-induced hepatotoxicity in patients with systemic lupus erythematosus." Ann Intern Med 80 (1974): 1-8
  7. Sbarbaro JA, Bennett RM "Aspirin hepatotoxicity and disseminated intravascular coagulation." Ann Intern Med 86 (1977): 183-5
  8. American Medical Association, Division of Drugs and Toxicology "Drug evaluations annual 1994." Chicago, IL: American Medical Association; (1994):
View all 8 references
Moderate

Sympathomimetics (applies to Saleto-D) BPH

Moderate Potential Hazard, High plausibility. Applicable conditions: Benign Prostatic Hyperplasia, Prostate Tumor

Sympathomimetic agents may cause or worsen urinary difficulty in patients with prostate enlargement due to smooth muscle contraction in the bladder neck via stimulation of alpha-1 adrenergic receptors. Therapy with sympathomimetic agents should be administered cautiously in patients with hypertrophy or neoplasm of the prostate.

References

  1. "Product Information. Sudafed (pseudoephedrine)." Glaxo Wellcome, Research Triangle Park, NC.
  2. Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):
  3. Williams DM "Phenylpropanolamine hydrochloride" Am Pharm NS30 (1990): 47-50
Moderate

Sympathomimetics (applies to Saleto-D) diabetes

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Diabetes Mellitus

Sympathomimetic agents may cause increases in blood glucose concentrations. These effects are usually transient and slight but may be significant with dosages higher than those normally recommended. Therapy with sympathomimetic agents should be administered cautiously in patients with diabetes mellitus. Closer monitoring of blood glucose concentrations may be appropriate.

References

  1. "Product Information. Sudafed (pseudoephedrine)." Glaxo Wellcome, Research Triangle Park, NC.
  2. American Medical Association, Division of Drugs and Toxicology "Drug evaluations annual 1994." Chicago, IL: American Medical Association; (1994):
  3. Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):
  4. Williams DM "Phenylpropanolamine hydrochloride" Am Pharm NS30 (1990): 47-50
View all 4 references
Moderate

Sympathomimetics (applies to Saleto-D) glaucoma

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Glaucoma/Intraocular Hypertension

Sympathomimetic agents can induce transient mydriasis via stimulation of alpha-1 adrenergic receptors. In patients with anatomically narrow angles or narrow-angle glaucoma, pupillary dilation can provoke an acute attack. In patients with other forms of glaucoma, mydriasis may occasionally increase intraocular pressure. Therapy with sympathomimetic agents should be administered cautiously in patients with or predisposed to glaucoma, particularly narrow-angle glaucoma.

References

  1. Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):
  2. Fraunfelder FT, Fraunfelder FW; Randall JA "Drug-Induced Ocular Side Effects 5th" Boston, MA: Butterworth-Heinemann (2001):
  3. "Product Information. Sudafed (pseudoephedrine)." Glaxo Wellcome, Research Triangle Park, NC.

Saleto-D (acetaminophen / caffeine / phenylpropanolamine / salicylamide) drug interactions

There are 417 drug interactions with Saleto-D (acetaminophen / caffeine / phenylpropanolamine / salicylamide)

Saleto-D (acetaminophen / caffeine / phenylpropanolamine / salicylamide) alcohol/food interactions

There are 5 alcohol/food interactions with Saleto-D (acetaminophen / caffeine / phenylpropanolamine / salicylamide)

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.