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
• Acetazolamide
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• Aluminum Hydroxide; Magnesium Trisilicate
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• Aspirin, ASA; Caffeine; Dihydrocodeine
• Aspirin, ASA; Caffeine; Orphenadrine
• Aspirin, ASA; Carisoprodol
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• Aspirin, ASA; Citric Acid; Sodium Bicarbonate
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• Chlorpheniramine; Phenylephrine
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• Diazoxide
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• Dyphylline
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• Edoxaban
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• Efavirenz; Emtricitabine; Tenofovir
• Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
• Elexacaftor; tezacaftor; ivacaftor
• Eltrombopag
• Elvitegravir
• Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
• Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
• Empagliflozin
• Empagliflozin; Linagliptin
• Empagliflozin; Linagliptin; Metformin
• Empagliflozin; Metformin
• Emtricitabine
• Emtricitabine; Rilpivirine; Tenofovir alafenamide
• Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
• Emtricitabine; Tenofovir alafenamide
• Emtricitabine; Tenofovir disoproxil fumarate
• Enalapril, Enalaprilat
• Enalapril; Felodipine
• Enalapril; Hydrochlorothiazide, HCTZ
• Enoxaparin
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• Flurbiprofen
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• Fondaparinux
• food
• Formoterol
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• Foscarnet
• Fosinopril
• Fosinopril; Hydrochlorothiazide, HCTZ
• Furosemide
• Gadoterate meglumine
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• Gallium Ga 68 Dotatate
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• Garlic, Allium sativum
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• Glimepiride
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• Glimepiride; Rosiglitazone
• Glipizide
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• Glyburide
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• Gold
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• Halogenated Anesthetics
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• Hydralazine
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• Hydrochlorothiazide, HCTZ; Irbesartan
• Hydrochlorothiazide, HCTZ; Lisinopril
• Hydrochlorothiazide, HCTZ; Losartan
• Hydrochlorothiazide, HCTZ; Methyldopa
• Hydrochlorothiazide, HCTZ; Metoprolol
• Hydrochlorothiazide, HCTZ; Moexipril
• Hydrochlorothiazide, HCTZ; Olmesartan
• Hydrochlorothiazide, HCTZ; Propranolol
• Hydrochlorothiazide, HCTZ; Quinapril
• Hydrochlorothiazide, HCTZ; Spironolactone
• Hydrochlorothiazide, HCTZ; Telmisartan
• Hydrochlorothiazide, HCTZ; Triamterene
• Hydrochlorothiazide, HCTZ; Valsartan
• Hydrocodone; Phenylephrine
• Hydrocortisone
• Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate
• Ibritumomab Tiuxetan
• Ibuprofen lysine
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