Prescriber Information

K2C Patch®

(Menthol 5% / Capsaicin 0.025% topical patch)

DESCRIPTION:

K2C Patch® is a prescription topical patch containing 15 articulated patches (5 per resealable pouch x 3 pouches).

Menthol is present in a 5% concentration (w/w). The empirical formula for menthol is C10H20O with a molecular weight of 156.27 g/mol. The chemical name is (1R,2S,5R)-2-isopropyl-5-methylcyclohexanol.

The structural formula is:

** Menthol **

Capsaicin is present in a 0.025% concentration (w/w). The molecular weight of capsaicin is 305.41 g/mol. It has an empirical formula of C18H27NO3 and is chemically designated as 8-methyl-N-vanillyl-6-nonenamide.

The structural formula is:

** Capsaicin**

CLINICAL PHARMACOLOGY:

Menthol has local anesthetic and counterirritant qualities, and it also acts as a weak kappa (κ) opioid receptor agonist. Menthol acts to chemically trigger the cold-sensitive TRPM-8 receptors in the skin - responsible for the well-known cooling sensation it stimulates when applied directly to the skin. Menthol's analgesic properties are not fully understood, however they are mediated through a selective activation of κ-opioid receptors. Menthol also blocks voltage-sensitive sodium channels, reducing neural activity that may stimulate muscle tissue.

Capsaicin is an active component of chili peppers known clinically as a rubefacient. It acts as a counter-irritant by producing heat when in contact with human tissue. It exerts its analgesic effects by mimicking a burning sensation which overwhelms the nerves by calcium influx, thereby rendering the nerves unable to signal a pain response for an extended period of time. With repeated use, the neurons become depleted of neurotransmitters (i.e. substance P) leading to a reduction in the sensation of pain and the blockage of neurogenic inflammation. This process is reversed when the capsaicin is discontinued.

DRUG INTERACTIONS:

Drug-drug interactions have not been clinically assessed with K2C Patch®

INDICATIONS AND USE:

K2C Patch® is a formulation used to aid patients in the pharmaceutical management of topical mild to moderate acute or chronic aches or pain. Muscle or joint pain can stem from many disease states - musculoligamentous strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies, such as diabetic neuropathy, post herpetic neuralgia, and other complex regional pains.

This patch has also been used as adjunct therapy to certain types of headaches, but it is advised to use with caution when applying in order to avoid eye contact. If instructed otherwise by your practitioner, it may be used for other conditions as well.

PRECAUTIONS:

Because of the possibility of sedation, patients should be cautioned regarding the operation of serious machinery or automobiles, and activities made hazardous by decreased alertness.

CONTRAINDICATIONS:

Known hypersensitivity to menthol, capsaicin, or any of the topical amide-like anesthetic preparations.

CARCINOGENESIS, MUTAGENESIS, FERTILITY IMPAIRMENT:

Non-clinical toxicity studies to determine the potential of this topical preparation to cause carcinogenicity or mutagenicity have not been performed. The effect of the product on fertility has not been evaluated in animals.

USE IN PEDIATRIC & GERIATRIC POPULATION:

Safety and effectiveness in pediatric and geriatric patients have not been established.

PREGNANCY CONSIDERATIONS:

The safety of K2C Patch® has not been established during pregnancy. There are no well-controlled studies in pregnant women.

WARNINGS:

Excessive dosage, or short interval between doses, can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs.

LACTATION CONSIDERATIONS:

The effect of K2C Patch® on the nursing infant has not been evaluated.

ADVERSE REACTIONS:

• The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time.
  
• Serious adverse experiences following the administration of K2C Patch® are similar in nature to those observed in other amide anesthetic-containing agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.

PRODUCT STORAGE:

Store at room temperature at 68°F to 77°F (20°C to 25° C). Protect from excessive moisture. Keep away from heat or sunlight. The product can be considered safe and effective to use when maintained under these recommended conditions within the posted expiration date.

OVERDOSAGE:

There have been no reports of over-dosage with K2C Patch®. Signs of over-dosage would be consistent to those of other analgesic-based preparations - vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an over-dosage, discontinue the product immediately, treat the patient symptomatically, institute supportive measures, and call 9-1-1 if necessary.

HOW IS K2C Patch® SUPPLIED:

• 15 Articulated Patches [ (5 per Re-sealable Pouch) x 3]

Manufactured for: 
Kaylana Pharm, Inc
23678 Calabasas Road
Calabasas, CA 91302
Phone: 877.865.9338
Fax: 844.388.0797

K2C Patch

Patient Information
(insert updated Jan 2015)

Read this information sheet intended for patients prior to beginning medication therapy and each time you get a refill. If you have any questions, please consult your doctor or pharmacist. Inform your doctor if your condition does not improve or if it worsens.

This information may not include all of the information needed to use K2C Patch® safely and effectively.

** For Topical Use Only **

What constitutes K2C Patch®?
This is a topical patch consisting of the topical analgesic, capsaicin, and the analgesic, menthol.

Why was K2C Patch® prescribed by my doctor?
When unwrapped and accurately placed against the skin, the patch is applied to the skin and greatly assists sufferers in the management of mild to moderate topical acute aches or pains.

We are not concerned simply with the masking of serious pain triggers. The experiencing of acute or chronic topical pain is a reflection and the body’s method of telling you that something (potentially serious, potentially causing long term damage) needs attention. If the cause of recurrent pain is identified, the pain needs to be assessed by the appropriate healthcare professional, and a diagnosis made. This root cause diagnosis will dictate the course of treatment.

Capsaicin and menthol have been used separately for centuries to reap the pain relieving and numbing effects, however we have created a combination of the two that is absorbed through the dermal layer of the skin and instantly has a positive effect on the topical pain. The combination of these two ingredients is a highly effective combination that work together to lessen the discomfort, while the root cause is being managed and treated by your healthcare team.

What side effects should I expect with K2C Patch®

• Common (≥10%): redness, itching, flaking of the skin following application NOTE: serious side effects are, in general, related to accidental toxicity of medication by applying considerably more than directed by your doctor or pharmacist or by ingesting the contents of the patch.
  
• Please disclose to your doctor of pharmacist any current Rx or OTC medications you are taking. Excessive alcohol usage, since it may increase the potential for dizziness, confusion, lightheadedness and orthostatic hypotension.

Call your healthcare provider right away if you experience any of the following warning signs or any other unusual symptoms that concern you:

• Shortness of breath
  
• Swelling or numbness of the tongue or throat
  
• Severe headache or vomiting
  
• Dizziness or faintness
  
• Changes in vision or speech

Tell your healthcare provider if you:

• are hypersensitive (allergic) to any of the active ingredients used in the preparation of this product: menthol, capsaicin or chili peppers, local analgesics, or any of the inactive ingredients listed below in this insert.
  
• develop an undiagnosed rash following administration - the reaction will often be immediate, however occasionally may occur weeks or even months following treatment initiation
  
• are breastfeeding. It is unknown if the patch absorbs to an extent where the breast milk may be affected (Preg Category IV). .

This list is not comprehensive to the possible side effects or interactions involving any of the active or inactive ingredients. For more information, you may consider speaking with your doctor or pharmacist. You may report any side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DIRECTIONS FOR USE
This patch is recommended for use in patients ages 12 years and older.

1. Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors. Safely discard the remaining unused pieces of cut patches where children and pets cannot get to them.
   
2. Remove the transparent release liner (clear plastic backing) before application of patches to the skin. Apply immediately after removal from the protective envelope.
   
3. Apply 1 patch to the affected area so that the patch covers most of the painful area. Apply 1 K2C patch three times a day and do not leave it on for more than 8 hours at a time.
   
4. Remove patch if irritation occurs.

Warnings:

• Keep out of reach of children
  
• Wash hands with soap and water after handling the patches
  
• Do not use immediately after a bath or shower and discontinue use at least 1 hour before a bath or shower.

K2C Patch®storage:
Store product at room temperature at 68°F to 77°F (20°C to 25°C). Keep away from heat or sunlight. Protect from excessive moisture. Discard product after expiration date posted on the product label.

DO NOT use the product after the expiration date printed on the box.

Additional information regarding the safe and effective use of the K2C Patch®
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use this product for another indication. Your doctor has prescribed this drug for you and you alone. Do not give this drug to anyone else, even if they have the same condition.

**KEEP OUT OF REACH OF CHILDREN**

This leaflet provides the most important information about K2C Patch®. If you would like more information, talk with your healthcare provider or pharmacist. There is additional information in the following sections intended for healthcare professionals.

Ingredients in K2C  Patch®?

ACTIVE INGREDIENTS:
Menthol 5%
Capsaicin 0.0255

INACTIVE INGREDIENTS:
Water, Aloe barbadesis Leaf (Aloe Vera Gel) Juice, Glycerol, EDTA Disodium salt, Sodium Polyacrylate, Diazolidinyl Urea, Polysorbate 80, Propylparaben, Iodopropynyl Butylcarbamate, Methylparaben, Citrus Medica Limonum (Lemon) Peel Oil

PRINCIPAL DISPLAY PANEL

Rx Only
NDC: 69120-3000-1
K2C
Patch
Pain Relieving Patch
Qty: 15 Patches:
(5 per Resealable Pouch x 3)