Difficulty Swallowing / Dysphagia Support
CreamTopicalNon sterile Rx only

Ketoprofen/Lidocaine/Baclofen/Cyclobenzaprine Topical

Transdermal Cream Base (Lipoderm®)

A compounded cream with ketoprofen, lidocaine, baclofen, and cyclobenzaprine in Lipoderm base, prepared in Chino, CA to a prescriber's order.

Reviewed by Linda Pungpravat, Compounding Pharmacist, RPh Mixwell Compounding Pharmacy, Chino, CA

  • USP <795> compliant
  • USP <800> hazardous drug lab
  • PCCA member

Clinical Advantages

  • Multiple actives in one base
  • Custom strength available
  • Applied topically
  • Non sterile preparation

How It Works

What is Ketoprofen/Lidocaine/Baclofen/Cyclobenzaprine Topical?

It is a compounded cream that combines four medicines in Lipoderm, a cream base made by PCCA. Ketoprofen is a nonsteroidal anti inflammatory drug (NSAID). Lidocaine is a local anesthetic. Baclofen and cyclobenzaprine are muscle relaxants. Mixwell prepares it in Chino, California by prescription, at the strengths the prescriber sets.

What Lipoderm is designed to do

PCCA describes Lipoderm as a permeation enhancing cream base, designed for topical formulations that act locally or are absorbed through the skin. PCCA lists these features:

  • A smooth, thick cream
  • Physical stability: it does not separate with refrigeration
  • Use with more than one active ingredient, up to four at one time
  • It is the base named in the USP compounded preparation monograph for Ondansetron Compounded Topical Gel, 20 mg/mL

These are the manufacturer's descriptions, not findings by the FDA.

When prescribers choose it

  • Prescribers who want several medicines in one topical cream
  • Prescribers whose patients cannot take these medicines by mouth
  • Pain management, sports medicine, and physical medicine practices

Clinical Details

What does the evidence show?
  • FDA approved ketoprofen is an oral capsule labeled for the management of pain and for primary dysmenorrhea [1].
  • FDA approved cyclobenzaprine is an oral tablet labeled as an adjunct to rest and physical therapy for muscle spasm with acute, painful musculoskeletal conditions, for up to two or three weeks [2].
  • FDA approved baclofen is an oral tablet labeled for spasticity from multiple sclerosis. It is not indicated for muscle spasm from rheumatic disorders [3].
  • FDA approved topical lidocaine includes a 5% patch labeled for pain from postherpetic neuralgia [4].
  • No FDA approved product contains all four ingredients, and none is approved as a cream with these ingredients. The FDA has not reviewed this preparation.

Findings come from the cited studies and do not promise any individual outcome.

Why is it compounded, and how is it typically used?

Why it is compounded

No commercial product combines these four ingredients in one topical. A prescriber who wants them together, or who wants a strength no approved product offers, orders the cream compounded.

Dosage forms and strengths

  • Strength of each ingredient set by the prescriber
  • Lipoderm cream base
  • Quantities matched to the prescribed course

Dosing and duration are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this cream in Chino, California under USP 795 standards for non sterile preparations [6]. Our pharmacist confirms the strengths and application directions with the prescriber before compounding. Batch records document every preparation, and finished creams ship across California.

Safety information

Oral ketoprofen carries a boxed warning for serious cardiovascular thrombotic events, including heart attack and stroke, and for serious gastrointestinal bleeding, ulceration, and perforation. Elderly patients are at greater risk. It is contraindicated around coronary artery bypass graft surgery [1].

Cyclobenzaprine labeling warns of serotonin syndrome with other serotonergic drugs and contraindicates use with MAO inhibitors [2]. Baclofen labeling reports hallucinations and seizures on abrupt withdrawal of oral baclofen [3]. Lidocaine patch labeling states that applying it to larger areas or for longer than directed can raise absorption and cause serious adverse effects, and that the amount absorbed from all lidocaine and other local anesthetic products must be counted [4].

These warnings come from labeling for oral or other approved forms. No FDA labeling states how much of each ingredient is absorbed from a compounded cream, so prescribers count the cream toward a patient's total exposure to each drug. Patient selection, dosing, and duration are the prescriber's responsibility.

References

1. Ketoprofen capsules, USP. Prescribing information. DailyMed. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=ketoprofen%20capsules

2. Cyclobenzaprine hydrochloride tablets, USP. Prescribing information. DailyMed. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=cyclobenzaprine%20tablets

3. Baclofen tablets, USP. Prescribing information. DailyMed. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=baclofen%20tablets

4. LIDODERM (lidocaine patch 5%). Prescribing information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020612s011lbl.pdf

5. Lipoderm. Product information. PCCA. https://www.pccarx.com/BuyProducts/CompoundingBaseTechnology/PermeationEnhancingBases

6. United States Pharmacopeia. General Chapter 795, Pharmaceutical Compounding: Nonsterile Preparations. USP NF. Official November 1, 2023.

What to include on the prescription

  • APIs and strengths
  • Base or vehicle
  • Quantity
  • Directions for use
  • Refills
  • Allergies or dye free needs
Call (909) 378-7301 Fax (909) 378-7071
Commonly prescribed for Difficulty Swallowing / Dysphagia Support

Compounded in Chino, CA. Delivered across California.

  • Chino
  • Chino Hills
  • Ontario
  • Pomona
  • Diamond Bar
  • Rancho Cucamonga
  • Eastvale
Mixwell Compounding Pharmacy 13788 Roswell Ave, Ste 158, Chino, CA 91710
(909) 378-7301

Compounded medications are not reviewed or approved by the FDA. Dispensed only with a valid prescription. Mixwell is a non sterile pharmacy and does not prepare sterile products or injectables. Compounded preparations are not presented as superior to commercially available products, and nothing here promises a specific result. Mixwell does not accept insurance. Call for pricing.

Call pharmacist Send Rx

Want to learn more about Ketoprofen/Lidocaine/Baclofen/Cyclobenzaprine Topical

Are you a healthcare provider or patient in Chino, Chino Hills, Ontario, Eastvale, Rancho Cucamonga, or Upland? Mixwell Pharmacy provides specialized pharmaceutical support throughout San Bernardino, Los Angeles, and Orange Counties. Contact our Chino laboratory to learn how we facilitate customized Ketoprofen/Lidocaine/Baclofen/Cyclobenzaprine Topicalfor practitioners across Southern California.

(909) 378-7301

Serving Los Angeles County, Orange County, San Bernardino County, Riverside County, Ventura County, and the Inland Empire