Topical Pain Formulas

The Topical Pain Formula is a customized prescription blend that may include ingredients such as; a nonsteroidal anti-inflammatory, muscle relaxer, nerve agent, analgesic, and/or local anesthetic that targets the main symptoms of localized pain. It is an odorless gel typically applied to the painful area(s) two to four times daily.

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What is the Topical Pain Formula?

The Topical Pain Formula combines prescription ingredients in a proprietary base developed specifically to deliver ingredients through the skin. It uses a unique delivery system designed to increase the permeation of those molecules into and through the skin. It is also not tacky or oily, leaving a light and silky feel on the skin. The Topical Pain Formula is specifically made without fragrance, or gluten.

Topical vs. Oral

Topical applications are known to have a lower-side effect profile when compared with systemic administration. Because the drugs are being applied directly to the skin, there is no first-pass metabolism by the liver. As a result, lower doses of the drugs may be used to get the intended response compared to the oral route. Research has shown topical application may reduce the risk of serious gastrointestinal, renal and cardiovascular adverse events compared with oral treatment options. However, you should always discuss the benefit to risk ratio with your healthcare prescriber.

Common Ingredients

Amitriptyline

Amitriptyline is a tricyclic antidepressant that is widely used to treat chronic neuropathic pain (pain due to nerve damage). It has been recommended as a first-line treatment in many guidelines. Neuropathic pain can be treated with antidepressant drugs in doses below those at which the drugs act as antidepressants.

Baclofen

Baclofen is in a class of medications called skeletal muscle relaxants. Baclofen acts on the spinal cord nerves and decreases the number and severity of muscle spasms caused by multiple sclerosis or spinal cord conditions. It also relieves pain and improves muscle movement.

Bupivacaine

Bupivacaine is in a class of medications called local anesthetics. Bupivacaine is a long-acting numbing agent that blocks the nerve impulses that send pain signals to your brain.

Cyclobenzaprine

Cyclobenzaprine is in a class of medications called skeletal muscle relaxants. Cyclobenzaprine acts on the spinal cord nerves and decreases the number and severity of muscle spasms. It also relieves pain and improves muscle movement in patients with fibromyalgia.

Diclofenac

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild-to-moderate pain and helps to relieve symptoms of arthritis (eg, osteoarthritis or rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain.

Gabapentin

Gabapentin belongs to a class of medications called anticonvulsants and has been used to treat nerve pain, such as burning, shooting, or stabbing pain. Gabapentin works by changing the way that nerves send messages to your brain. By altering the way nerves work, gabapentin may reduce your pain.

Ketoprofen

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild-to-moderate pain and helps to relieve symptoms of arthritis (eg, osteoarthritis or rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain.

Lidocaine

Lidocaine is in a class of medications called local anesthetics. Lidocaine is a numbing agent that blocks the nerve impulses that send pain signals to your brain.

Menthol

Menthol is used to treat minor aches and pains of the muscles/joints (such as arthritis, backache, sprains). Menthol is known as a counterirritant. It works by causing the skin to feel cool and then warm. These feelings on the skin distract you from feeling the aches/pains deeper in your muscles and joints.

Frequently asked questions

What is a compounded medication?

One size doesn’t fit all and every patient is unique. Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of a patient by a pharmacist as the result of a practitioner’s prescription drug order. While compounded medications are not FDA-approved, they serve an important patient need—especially when FDA-approved medication is not available for treatment. Our formulations are made to order in small batches to ensure freshness. The specific ingredients in your compounded formula will depend on your specific concerns and goals. It should be understood that your personal healthcare practitioner will make the final decision.

Are compounded medications FSA & HSA eligible?

Yes! All of our compounded formulations, regardless of ingredients, are eligible for Flexible Spending Accounts (FSA) and Health Saving Accounts (HSA).

What is osteoarthritis?

Osteoarthritis (OA) is the most common form of arthritis, affecting over 32.5 million US adults. Some people call it a degenerative joint disease or “wear and tear” arthritis. It occurs most frequently in the hands, hips, and knees. OA can cause pain, stiffness, and swelling. In some cases it also causes reduced function and disability; some people are no longer able to do daily tasks or work. Signs and symptoms may include; pain or aching, stiffness, decreased range of motion and swelling of the joints. Risk factors include increased age and obesity.

What is fibromyalgia?

Fibromyalgia is a condition that causes pain all over the body, sleep problems, fatigue, and often emotional and mental distress. People with fibromyalgia may be more sensitive to pain than people without fibromyalgia. Fibromyalgia affects about 4 million US adults, about 2% of the adult population with women being twice as likely to have fibromyalgia as men. Signs and symptoms may include; pain and stiffness all over the body, fatigue and tiredness, tingling or numbness in hands and feet, pain in the face or jaw.

What is peripheral neuropathy?

Peripheral neuropathy is a result of nerve damage that can be described as a stabbing, burning or tingling pain. It often causes weakness, numbness and pain often found in the hands and feet. Peripheral neuropathy can result from a number of factors including injury or autoimmune diseases; however, the most common cause is diabetes.

Is the Topical Pain Formula a narcotic drug?

No, the Topical Pain Formula does not contain any narcotic medications or controlled substances.

How does the Topical Pain Formula work?

The Topical Pain Formula combines multiple prescription ingredients meant to target the main symptoms associated with localized or generalized pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) are standard therapy for osteoarthritis (OA). Topically applied NSAIDs reduce systemic exposure compared with oral NSAIDs. Baclofen is used to treat pain and certain types of muscle stiffness and tightness. Examples of common painful conditions for which baclofen could be used include peripheral neuropathy, low back pain, and neck pain. Amitriptyline is an antidepressant, and antidepressants are widely recommended for treating neuropathic pain. Lidocaine, with its quick onset, and Bupivacaine, with its long duration of action, is not only as a valuable medication for numerous neuropathic pain conditions but also for the management of chronic pain.

When should I see improvement in my symptoms?

Based on research and patient testimonials, you may see improvement as early as 1 hour after applying, but it often takes a few days of continuous use to see the full benefits. Each patient is unique and time frames may differ.

How should I use the Topical Pain Formula?

  • The Topical Pain Formula is for topical use only. If this medicine gets in your eyes or mouth, rinse with water. Do not apply this medication to your eyelids.

  • Follow all directions on your prescription label and read all medication guides or instruction sheets.

  • Wash your hands with soap and water before and after applying the medicine. Do not allow other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water.

  • Apply a thin layer to cover the affected area(s) two to four times per day

  • Avoid showering/bathing for at least 30 minutes after applying to the treated area(s).

  • Avoid contact with eyes and mucous membranes. Do not apply to open wounds.

  • Do not cover treated skin with a bandage or external heat. Bandaging and heat can increase the amount of drug absorbed through your skin and may cause harmful effects.

  • Avoid wearing clothing over the treated area(s) until the treated area is dry.

  • Protect the treated area(s) from natural and artificial sunlight.

  • Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same area you have just treated. Until the treated area(s) is completely dry, avoid skin-to-skin contact between other people and the treated area(s).

  • Do not use it in combination with other medications in the same class of drugs.

Who should not use the Topical Pain Formula?

Do not start using the Topical Pain Formula if you have a history of hypersensitivity to any of the prescribed ingredients. The prescribed ingredients may include, but are not limited to; NSAIDs (diclofenac, aspirin, ibuprofen, naproxen or others), muscle relaxants (baclofen, cyclobenzaprine, carisoprodol or others), TCAs (amitriptyline, imipramine, mirtazapine or others), or local anesthetics (bupivacaine, lidocaine, prilocaine, benzocaine, tetracaine or others). Please tell your doctor if you are pregnant or thinking about becoming pregnant. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Caution is advised in those patients with renal impairment, liver impairment, cardiovascular disease, or coagulation disorders.

What happens if I miss a dose?

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.

How should I store this medication?

Store at room temperature away from moisture and heat between 68°F to 77°F (20°C to 25°C).

Safety Information

Research has shown, topically applied medications are less likely to cause the same systemic side effects or drug-to-drug interactions as oral medications; however, there is never an absolute zero chance that side effects or drug interactions will not occur. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

What should I avoid while using the Topical Pain Formula?

  • This drug product is contraindicated in individuals with a history of sensitivity to any of its components.

  • Avoid exposure to sunlight or tanning beds. Heat can increase the amount of medication you absorb through your skin.

  • Do not use cosmetics, sunscreen, lotions, insect repellant, or other medicated skin products on the same area you treat with the Topical Pain Formula.

  • Use caution when using other products that may contain similar ingredients in the Topical Pain Formula.


What are the common side effects of the Topical Pain Formula?

Although the risk of serious side effects is low when the Topical Pain Formula is applied to the skin, this medicine can be absorbed through the skin.


Common side effects may include application site reactions of:

  • Skin reactions (dermatitis)

  • Burning, stinging or warmth

  • Itching or tingling

  • Redness, dryness or peeling


Stop using and seek emergency medical attention if you have signs of a heart attack or stroke; chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath or wheezing. Report any symptoms of stomach or intestinal bleeding to your doctor.


Get emergency medical help if you have signs of an allergic reaction: hives, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat. These are not all of the possible side effects of the Topical Pain Formula. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away.


What happens if I overdose?

An overdose is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

References

  • Cline AE, Turrentine JE. Compounded Topical Analgesics for Chronic Pain. Dermatitis. 2016 Sep-Oct;27(5):263-71. doi: 10.1097/DER.0000000000000216. PMID: 27649348.

  • Wadsworth LT, Kent JD, Holt RJ. Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study. Curr Med Res Opin. 2016;32(2):241-50. Doi: 10.1185/03007995.2015.1113400. Epub 2015 Nov 17. PMID: 26506138.

  • Wiffen PJ, Xia J. Systematic review of topical diclofenac for the treatment of acute and chronic musculoskeletal pain. Curr Med Res Opin. 2020 Apr;36(4):637-650. doi: 10.1080/03007995.2020.1716703. Epub 2020 Feb 3. PMID: 31944135.

  • Stanos SP, Galluzzi KE. Topical therapies in the management of chronic pain. Postgrad Med. 2013 Jul;125(4 Suppl 1):25-33. doi: 10.1080/00325481.2013.1110567111. PMID: 24547601.

  • Barton DL, Wos EJ, Qin R, Mattar BI, Green NB, Lanier KS, Bearden JD 3rd, Kugler JW, Hoff KL, Reddy PS, Rowland KM Jr, Riepl M, Christensen B, Loprinzi CL. A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA. Support Care Cancer. 2011 Jun;19(6):833-41. doi: 10.1007/s00520-010-0911-0. Epub 2010 May 25. PMID: 20496177; PMCID: PMC3338170.

  • Moore RA, Derry S, Aldington D, Cole P, Wiffen PJ. Amitriptyline for neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev. 2012 Dec 12;12:CD008242. doi: 10.1002/14651858.CD008242.pub2. Update in: Cochrane Database Syst Rev. 2015;7:CD008242. PMID: 23235657.

  • Maktabi M, Kamali A, Jelodar HT, Shokrpour M. Comparison of Topical and Subcutaneous Bupivacaine Infiltration with Subcutaneous Ketamine on Postoperative Pain in Total Abdominal Hysterectomy. Med Arch. 2019 Feb;73(1):15-18. doi: 10.5455/medarh.2019.73.15-18. PMID: 31097853; PMCID: PMC6445620.

  • Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14. PMID: 24733808.

  • Ala S, Alvandipour M, Saeedi M, Mansourifar M, Monajati M, Shiva A. Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial. J Gastrointest Surg. 2020 Feb;24(2):405-410. doi: 10.1007/s11605-019-04147-7. Epub 2019 Feb 19. PMID: 30783957.

Disclaimer

All prescription medications require a valid and complete online consultation prior to approval and final pricing is determined. All compounded medications in the U.S. are considered off-label use. Licensed healthcare practitioners have the ability to prescribe compounds for off-label treatment, if they believe that it is an appropriate course of treatment.


The drug and medical information provided on this website is not meant to cover all adverse effects, drug interactions, warnings, medical uses, directions and precautions. The information provided is a medical resource and the judgment of your physician and/or healthcare practitioner should not be substituted. Premier Pharmacy has made every effort to ensure the information on the website is accurate and current based on present medical literature.


Premier Pharmacy does not make any guarantees regarding the drug and medical information, and does not assume responsibility regarding the content. The drug safety and drug information contained on the website may be time sensitive and should not be utilized as a medical reference beyond the date hereof. The deficiency of a warning for prescription medications and vitamins provided on this website in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient.


If you have questions or concerns about your medications, please do not hesitate to contact us and/or your medical practitioner, including your pharmacist. Compound prescription products have not been tested or approved by the FDA for their intended use. No claims are made as to the safety, efficacy or use of this compound.