Skip to main content

Compounded Topical Pain Creams Review of Select Ingredients for Safety, Effectiveness, and Use (2020) / Chapter Skim
Currently Skimming:

Appendix G: Potential Adverse Effects from Oral Administration of 20 Active Pharmaceutical Ingredients Commonly Used in Compounded Topical Pain Creams
Pages 305-312

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 305...
... Given the limited data, little is known regarding the relative risk for adverse effects caused by systemic absorption. To consider the potential safety concerns for the systemic absorption of APIs in this report, below is a summarized list of the known adverse events derived from the U.S.
Read the entire page →
From page 306...
... 306 COMPOUNDED TOPICAL PAIN CREAMS TABLE G-1 Adverse Events Associated with Systemic Absorption of Active Pharmaceutical Ingredients Used in Compounded Topical Pain Creams FDA- Off-Label/ Approved Pain Non-FDA Drug Product Formulation(s) Drug Class Indications Uses for Pain Amitriptyline Oral Tricyclic None Fibromyalgia, antidepressants postherpertic neuralgia Baclofen Oral, Skeletal muscle Muscle spasms Trigeminal intrathecal relaxant neuralgia, peripheral neuropathy Bupivacaine Injection Local anesthetic None Pain Cannabidiol Oral Cannabinoid None None Carbamezapine Oral Anticonvulsants Trigeminal None neuralgia Clonidine Transdermal Alpha-2 None None adrenergic agonist Clonidine HCl Epidural, oral Alpha-2 None Muscle adrenergic agonist spasms Cyclobenzaprine Oral Skeletal muscle Skeletal muscle Fibromyalgia relaxant spasm Dexamethasone Oral, Adrenal None None ophthalmic, corticosteroid injection Doxepin Oral, topical Tricyclic None Chronic pain antidepressants Gabapentin Oral, topical Anticonvulsants Postherpetic Fibromyalgia, neuralgia diabetic peripheral neuropathy
Read the entire page →
From page 307...
... The most toxic epidermal necrolysis, severe reactions observed have been in atrioventricular block, syncope, the hemopoietic system, skin, liver, and liver failure cardiovascular system (Novartis, 2009) Dry mouth, drowsiness, fatigue, headache, Atrioventricular block lethargy, and sedation (Boehringer Ingelheim Pharmaceuticals, 2011)
Read the entire page →
From page 308...
... Food and Drug Administration; HCl = hydrochloride; IM = intramuscular; IV = intravenous; NMDA = N-methyl-D-aspartate; NSAID = nonsteroidal anti-inflammatory drug; REMS = Risk Evaluation and Mitigation Strategy.
Read the entire page →
From page 309...
... gastrointestinal bleeding and ulceration Dizziness, headaches, confusion, and Cerebrovascular accident, gastrointestinal adverse effects (Forest seizures, kidney failure Pharmaceuticals, 2013) Gastrointestinal, the CNS, dermatologic, Black box warning for increased cardiovascular and special senses disturbances risk of cardiovascular events, (visual and hearing)
Read the entire page →
From page 310...
... Doxepin Concurrent use of NSAIDS and TRICYCLIC ANTIDEPRESSANTS may result in an increased risk of bleeding. Concurrent use of TRAMADOL and SEROTONERGIC AGENTS WITH ANTICHOLINGERIC PROPERTIES may result in increased risk of paralytic ileus and increased risk of serotonin syndrome.
Read the entire page →
From page 311...
... Tramadol Concurrent use of TRAMADOL and CNS DEPRESSANTS may result in an increased risk of respiratory and CNS depression. NOTE: CNS = central nervous system; NSAIDS = nonsteroidal anti-inflammatory drugs.
Read the entire page →
From page 312...
... extended release tablets label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018631s041lbl.pdf (accessed December 17, 2019)
Read the entire page →

Key Terms

  • adverse reactions
  • tricyclic antidepressants
  • dry mouth
  • box warning
  • boehringer ingelheim

  • serotonin syndrome
  • release tablets
  • ingelheim pharmaceuticals
  • black box
  • cns depression

  • gastrointestinal bleeding
  • atrioventricular block
  • paralytic ileus
  • accessed december
  • extended release

  • systemic absorption
  • tablets label
  • cns depressants
  • kidney damage
  • peripheral edema

  • adverse events
  • gastrointestinal adverse
  • cardiovascular events
  • myocardial infarction
  • scilex pharmaceuticals

  • respiratory tract
  • bupivacaine hydrochloride
  • gastrointesinal ulcer
  • syncope allergic
  • mcneil consumer


    • This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
    More information on Chapter Skim is available.