Generic Name: menthol and lidocaine
Dosage Form: patch
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Use only as directed by a healthcare professional.
Solmara Patch Description
Solmara contains Lidocaine, and Menthol in a localized topical delivery system.
The Lidocaine in Solmara is a topical anesthetic and stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Lidocaine HCL is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C14 H22 N20. The molecular weight of lidocaine HCL is 234.34 g/mol. Lidocaine has the following structure:
The Menthol in Solmara has local anesthetic and counterirritant qualities and it also acts as a weak kappa (k) opioid receptor agonist. Menthol is slightly soluble in water. The empirical formula for menthol is C H O, with a molecular weight of 156.27. The chemical compound menthol [(1R, 2S, 5R)-2-isopropyl- 5-methylcyclohexanol] is an activating ligand for transient receptor potential action channel subfamily M member 8 (TRPM8). It has the following structure:
Solmara is a single-use patch stored in a plastic pouch. The size of each Solmara Patch is 3 in by 5 in.
Each adhesive patch contains the following active ingredients:
Solmara contains the following inactive ingredients:
methacrylic acid, ethylhexylacrylate, bentonite, sodium stearate.
Indications and Usage for Solmara Patch
Solmara is indicated for the temporary relief of minor to moderate acute or chronic aches and muscle pains associated with arthritis, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. Solmara is a topical analgesic / counterirritant.
Solmara is contraindicated for those patients with a history of hypersensitivity to lidocaine and menthol or to any of the components used in this preparation.
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.
Because of the possibility of sedation, patients should be cautioned regarding the operation of heavy machinery or automobiles, and activities made hazardous by decreased alertness.
No Drug interactions have been assessed with Solmara.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
Nonclinical 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.
The safety of Solmara has not been established during pregnancy. There are no well-controlled studies in pregnant women.
PEDIATRIC / GERIATRIC USE
Safety and effectiveness in pediatric and geriatric patients have not been established.
The effect of Solmara on the nursing infant has not been evaluated.
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 Solmara 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.
There have been no reports of over-dosage with Solmara. Signs of over dosage would include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an over dosage, discontinue use of the product immediately, treat the patient symptomatically, and dial emergency services.
Store at room temperature at 68°F to 77°F (20°C to 25° C). This is "controlled room temperature". Keep away from heat or sunlight. Protect from excessive moisture. The product can be considered safe and effective to use when maintained under these recommended conditions within the posted expiration date.
KEEP OUT OF REACH OF CHILDREN.
Solmara Patch Dosage and Administration
Solmara contains 4.00% Lidocaine and 5.00% Menthol.
DIRECTIONS FOR USE
This patch is recommended for use in patient's 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 reach them.
2. Remove the white release liner (paper 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 patch only once during each 24-hr period.
4. Remove patch if irritation occurs.
General information about the safe and effective use of Solmara:
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.
How is Solmara Patch Supplied
Solmara is supplied in the following format:
Carton of 15 patches, packaged into individual child-resistant envelopes
DO NOT use the product after the expiration date printed on box.
Manufactured for and Distributed by:
Spring Hill Therapeutics LLC
Tampa, FL 33614
Made in USA
PRINCIPAL DISPLAY PANEL - 15 Patch Carton
Lidocaine 4%,Menthol 5%
menthol, unspecified form and lidocaine patch
|Labeler - Spring Hill Therapeutics LLC (079813250)|