Ibuprofen Pseudoephedrine

Ibuprofen Pseudoephedrine Brand Names

Advil Children’s Cold | Advil Cold and Sinus | Advil Flu and Body Ache | Dimetapp Children’s Cold and Fever | Dristan Sinus

What is Ibuprofen Pseudoephedrine

Ibuprofen and pseudoephedrine are used together in oral preparations for the temporary relief of symptoms associated with sinusitis, the common cold or flu including nasal congestion, headache, mild pain, and fever.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic effects.

Pseudoephedrine is a sympathomimetic amine used for its nasal and sinus decongestant properties. All NSAIDs, including ibuprofen, carry an increased risk of serious gastrointestinal (GI) adverse effects and may carry an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke.

A retrospective review by CDER of short-term efficacy trials of non-prescription strength naproxen indicated that an increase in CV events was not apparent during the studies.

However, it is important to note that CV risk was not the focus of the studies, and further information is needed to determine if a cause and effect relationship exists between non-prescription strength NSAID use and adverse cardiovascular outcomes.

The FDA-approved labeling of OTC ibuprofen; pseudoephedrine products advises patients to not exceed recommended dose or duration, as the risk for adverse effects may increase with increased use.

Further, if such a product is needed for longer than 10 days, the patient should consult their health care provider.

Pseudoephedrine can be diverted for use as a substrate for the illegal synthesis of amphetamine and methamphetamine. As a result, the Combat Methamphetamine Epidemic Act of 2005 was implemented.

This Act governs the sale and purchase of all OTC products containing pseudoephedrine, ephedrine, or phenylpropanolamine in the U.S..

Retailers must keep products in locked cabinets or behind counters prior to purchase, enter individual product purchases and amounts into a log and maintain it for at least 2 years following each sale, require photo identification and verify customer-required entries into the log, and ensure daily and monthly allowable limits on purchases are not exceeded (review Patriot Act Title VII for more information on legal requirements).

Ibuprofen pseudoephedrine is available as an over-the-counter (OTC) product, either in a tablet formulation or as an oral suspension for children.

Indications

  1. common cold
  2. fever
  3. headache
  4. mild pain
  5. nasal congestion

Side Effects

  1. abdominal pain
  2. agranulocytosis
  3. angina
  4. angioedema
  5. anorexia
  6. anxiety
  7. aplastic anemia
  8. arrhythmia exacerbation
  9. aseptic meningitis
  10. azotemia
  11. blurred vision
  12. bullous rash
  13. colitis
  14. confusion
  15. constipation
  16. contact dermatitis
  17. diarrhea
  18. dizziness
  19. drowsiness
  20. dyspepsia
  21. dysuria
  22. elevated hepatic enzymes
  23. erythema
  24. esophagitis
  25. flatulence
  26. gastritis
  27. GI bleeding
  28. GI obstruction
  29. GI perforation
  30. hallucinations
  31. headache
  32. hearing loss
  33. heart failure
  34. hematuria
  35. hemolytic anemia
  36. hepatitis
  37. hyperkalemia
  38. hypertension
  39. hyperuricemia
  40. insomnia
  41. interstitial nephritis
  42. jaundice
  43. maculopapular rash
  44. myocardial infarction
  45. nausea
  46. nephrotic syndrome
  47. neutropenia
  48. ocular hypertension
  49. palpitations
  50. pancreatitis
  51. pancytopenia
  52. peptic ulcer
  53. peripheral edema
  54. photophobia
  55. photosensitivity
  56. platelet dysfunction
  57. premature ventricular contractions (PVCs)
  58. proteinuria
  59. pseudotumor cerebri
  60. psychosis
  61. pyrosis (heartburn)
  62. rash
  63. renal papillary necrosis
  64. restlessness
  65. seizures
  66. sinus tachycardia
  67. stroke
  68. supraventricular tachycardia (SVT)
  69. thrombocytopenia
  70. tinnitus
  71. toxic epidermal necrolysis
  72. urticaria
  73. vasculitis
  74. visual impairment
  75. vomiting

Monitoring Parameters

  • laboratory monitoring not necessary

Contraindications

  • acute bronchospasm
  • acute myocardial infarction
  • alcoholism
  • angina
  • anticoagulant therapy
  • asthma
  • bone marrow suppression
  • breast-feeding
  • cardiac arrhythmias
  • cardiac disease
  • cardiomyopathy
  • chemotherapy
  • children
  • closed-angle glaucoma
  • coagulopathy
  • coronary artery bypass graft surgery (CABG)
  • coronary artery disease
  • corticosteroid therapy
  • dental disease
  • dental work
  • diabetes mellitus
  • geriatric
  • GI bleeding
  • GI disease
  • heart failure
  • hematological disease
  • hemophilia
  • hepatic disease
  • hypertension
  • hyperthyroidism
  • immunosuppression
  • infants
  • intramuscular injections
  • jaundice
  • MAOI therapy
  • myocardial infarction
  • nasal polyps
  • neutropenia
  • NSAID hypersensitivity
  • peptic ulcer disease
  • pregnancy
  • prostatic hypertrophy
  • renal disease
  • renal failure
  • renal impairment
  • salicylate hypersensitivity
  • stroke
  • substance abuse
  • systemic lupus erythematosus (SLE)
  • tachycardia
  • thrombocytopenia
  • tobacco smoking
  • ulcerative colitis
  • urinary retention
  • urticaria
  • varicella

Interactions

  • Abciximab
  • Acarbose
  • Acebutolol
  • Acetaminophen; Aspirin, ASA; Caffeine
  • Acetaminophen; Butalbital; Caffeine
  • Acetaminophen; Butalbital; Caffeine; Codeine
  • Acetaminophen; Caffeine
  • Acetaminophen; Caffeine; Dihydrocodeine
  • Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
  • Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
  • Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
  • Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
  • Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine
  • Acetaminophen; Dextromethorphan; Phenylephrine
  • Acetaminophen; Guaifenesin; Phenylephrine
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  • Docetaxel
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  • food
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  • Trandolapril; Verapamil
  • Tranylcypromine
  • Trazodone
  • Treprostinil
  • Tretinoin, ATRA
  • Triamcinolone
  • Triamterene
  • Tricyclic antidepressants
  • Umeclidinium; Vilanterol
  • Urea
  • Urokinase
  • Valacyclovir
  • Valganciclovir
  • Valsartan
  • Vancomycin
  • Vasodilators
  • Vasopressors
  • Vemurafenib
  • Venlafaxine
  • Verapamil
  • Verteporfin
  • Vilazodone
  • Vincristine
  • Vincristine Liposomal
  • Vorapaxar
  • Voriconazole
  • Vorinostat
  • Vortioxetine
  • Warfarin
  • Yohimbine
  • Zafirlukast
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