LidoSport Pain Relief Patch by CENTURA PHARMACEUTICALS INC
LidoSport Pain Relief Patch by
Drug Labeling and Warnings
LidoSport Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by CENTURA PHARMACEUTICALS INC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
LIDOSPORT PAIN RELIEF PATCH- lidocaine, menthol patch
CENTURA PHARMACEUTICALS INC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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WARNINGS
For external use only Avoid contact with eyes or mucus membranes Do not apply
to open wounds or damaged skin If symptoms persist for more than seven days,
discontinue use and consult physician Keep out of reach of children. If swallowed,
contact Poison Control Center Do not bandage tightly If pregnant or breast feeding,
contact physician prior to use Do not use in large quantities, particularly over raw
surfaces or blistered areas Do not use if excessive irritation of the skin develops
Do not use if condition worsens Do not use if symptoms clear and occur again
within a few days Do not use if you are allergic to any ingredient in patch.
DIRECTIONS
Adults and Children 12 years of age and older: Apply one patch only once for up to
12-hours, within a 24 hour period Children under 12 years of age should consult a
physician before use.
INSTRUCTIONS FOR USE
Clean and dry affected area Open pouch to remove patch
Remove protective film and apply directly to affected area Dispose used patches by
folding sticky ends together Wash hands with soap after applying patch.
INACTIVE INGREDIENTS
Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-ethylhexyl Acrylate, Glycerin,
Isopropyl Myristate, Methyl Acrylate, Nonoxynol-30, Sodium Polyacrylate, Polyacrylic
Acid, Polysorbate 80, Sorbitan Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Dioxide,
Purified Water.
PATIENT MEDICATION INFORMATION
LidoSport Patch is manufactured in accordance with FDA regulations by an FDA registered manufacturer.
Scientific studies have shown that both ingredients used in this product significantly reduce pain and inflammation.i A combination of ingredients with analgesics and anesthetic properties are used in a unique way to maximize its pain relieving effects and to aid in addition to other therapies. This offers long lasting relief for a variety of pain conditions.
Mechanism of Action:
Lidocaine is a common local anesthetic that relieves itching, burning, and pain. Topically, it blocks both initiation and conduction of nerve impulses by decreasing ionic flux through the neuronal membrane. Since it penetrates the skin, it creates an anesthetic effect by not just preventing pain signals from propagating to the brain, but by stopping them before they begin.
Menthol has some local anesthetic and counterirritant qualities and also acts as a weak kappa opioid receptor agonist making it an analgesic as well. Its ability to chemically trigger the cold-sensitive TRPM8 receptors in the skin is responsible for its cooling sensation when applied to the skin. Lastly, it enhances the efficacy of other topical applications by increasing penetration via vasodilation.
Benefits:
The use of this topical medication, LidoSport Patch, over other oral options for pain relief can benefit patients in many different ways. Conventional therapies using opioids (hydrocodone, hydromorphone, morphine, oxycodone) can cause systemic adverse effects such as constipation, drowsiness, dizziness, lightheadedness, nausea, vomiting, sedation, and/or confusion. NSAIDs (ibuprofen, naproxen) can increase cardiovascular risk, decrease platelet aggregation, and cause gastrointestinal bleeding or ulcers. Other classes of medications such as antidepressants (nortriptyline, duloxetine) or anticonvulsants (gabapentin) also come with its costs and side effects. LidoSport Patch acts only locally since it penetrates the skin and not into the bloodstream. In addition, patients can have one or multiple disease states including renal or hepatic dysfunction which can prevent them from taking ibuprofen (Advil) or acetaminophen (Tylenol) respectively. More importantly, this patch gives physicians an option to provide effective pain relief treatment while avoiding the addictive properties of conventional oral medications. It can also be supplemented with other topical pain lotions. In addition, it avoids messy application and reduces risk of getting ingredients in eyes or other mucous membranes.
Product Information and Data:
Pharmacists that have been in the field of pain management for many years used research from all parts of the world to carefully formulate this patch in order to maximize its pain relieving properties.iii Skin penetrating mixtures have also been added to enhance rapid absorption of the active ingredients through the skin to allow deeper penetration into the muscles, joints, and nerves. Lidocaine patches for therapy of neuropathic and non-neuropathic pain was concluded “to be an effective and safe option for add-on therapy” (Nervenarzt, 2010) in a clinical case series using 87 patients.iv Another study in 2010 concluded that a single 8 hour application of a combination patch of menthol provided significant pain relief associated with mild to moderate strains when compared to a placebo patch.v The use of these pharmaceutical components provides effective pain relief and makes the patch address pain. These ingredients comply with The Chronic Pain Medical Treatment Guidelines and the ACOEM guidelines for pain management.vi Page 111 of the Chronic Pain Medical Treatment Guidelines concludes that topical analgesics are “primarily recommended for neuropathic pain when trials of antidepressants and anticonvulsants have failed (Namaka, 2004).” In addition to this, “these agents are applied locally to painful areas with advantages that include lack of systemic side effects, absence of drug interactions, and no need to titrate (Colombo, 2006).” This product is “recognized as safe and effective” because it meets all conditions of the CFR.vii LidoSport Patch complies with The Chronic Pain Medical Treatment Guidelines and the ACOEM guidelines for a variety of pain conditions.
Other off-label uses:
LidoSport Patches (lidocaine) are used by many professionals for several situations (these are off-label uses), such as treating other types of pain disorders and by esthetic professionals for various beauty treatments. Examples include:
Low back pain,osteoarthritis and various neuropathic and non-neuropthic pain.
Dermal procedures that induce pain such as venipuncture (blood sampling)
Intravenous cannulation (administration of fluids, medications, hemodialysis and blood products)
Laser treatment
Body hair removal
Body art (tattoo and piercings)
Cosmetic procedures (microdermabrasion, microneedle procedures)
Other conditions/procedures where topical anesthetics are medically necessary
Adverse Reactions:
Even though adverse reactions are rare, a very small percentage of patients experience an unpleasant burning sensation, redness, warmth, or stinging. Please be aware of any unpleasant side effects as described. If any of these effects persists or worsens, contact your physician or pharmacist immediately. This medication is not absorbed systemically but if any serious side effects (i.e. rash, itching/swelling, severe dizziness) are experienced, discontinue use immediately and contact your pharmacist or physician. This is not a complete list of all side effects that may occur. You may report side effects to the FDA at 800-FDA-1088 or at http://www.fda.gov/medwatch
Keep Out of Reach of Children
Consult physician for children under 12 years.
Overdosage:
In Case of Ingestion or Overdose, get medical help or contact a Poison Control Center (800-222-1222) right away.
References:
i. Dunteman E. Targeted peripheral analgesics in Chronic Pain Syndromes. Practical Pain Management 2005; July/August: 14-25
ii. Jones M. Chronic neuropathic pain: Pharmacologic interventions in the new millennium. A theory of efficacy. International J Pharmaceutical Compounding. 2004(1):6-15.
iii. Baron R, Mahn F. Types of topical treatment for peripheral neuropathic pain: Mechanism of action and indications. Schmerz 2010;24(4):317-25.
iv. Kern KU, Kohl M, Kiefer RT. Lidocaine patch for therapy of neuropathic and non-neuropathic pain. A clinical case series of 87 patients. Nervenarzt 2010 Dec;81(12): 1490-7
v. Higashi Y, Kiuchi T, Furuta K. Efficacy and safety profile of a topical methyl salicylate and menthol patch in adult patients with mild to moderate muscle strain: a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. Clinical Therapeutics. 2010 Jan;32(1): 34-43.
vi. ACOEM. Occupational Medicine Practice Guidelines, 2nd Edition. American College of Occupational and Environmental Medicine, 25 Northwest Point Blvd., Suite 700, Elk Grove Village, Illinois, 60007-1030 (www.acoem.org.). 2004:116.
vii. CFR – Code of Federal Regulations. Food and Drug Administration. Chapter 1: Part 346. Revised April 1, 2010.
Chronic Pain Medical Treatment Guidelines, Medical Treatment Utilization Schedule (MTUS). Effective July 18, 2009.
| LIDOSPORT PAIN RELIEF PATCH
lidocaine, menthol patch |
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| Labeler - CENTURA PHARMACEUTICALS INC (084921637) |