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| Product NDC Code | 71073-207 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Gen7t plus |
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| Type | Brand | ||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 2199672 | ||||||
| Labeler Name | Beijing HKKY Medical Tech. Co., Ltd. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Gen7T Plus
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE There have been no reports of over-dosage with Gen7T Plus Patch ® . Signs of overdosage would include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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 Gen7T Plus 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.
Gen7T Plus Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.DRUG INTERACTIONS Antiarrhythmic Drugs: Gen7T Plus Patch ® should be used with caution in patients receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When Gen7T Plus Patch ® is used concurrently with other products containing local anesthetic agents the amount absorbed from all formulations must be considered.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Lidocaine 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. Menthol has local anesthetic and counterirritant qualities. It also acts as a weak kappa (ĸ) opioid receptor agonist. Menthol chemically triggers the cold-‐sensitive TRPM-8 receptors in the skin, which are responsible for the well-‐documented cooling sensation that occurs when applied to the skin. Menthol’s analgesic properties are not fully understood; however, they are mediated through a selective activation of ĸ-opioid receptors. Menthol also blocks voltage-‐sensitive sodium channels, reducing neural activity that may stimulate muscle tissue. Menthol works by targeting the k-‐opioid receptor on the TRPM8 neuron. The TRPM8 neuron is normally activated at temperatures between (8°-28°C). Menthol causes the neuron to fire at temperatures above normal activation, which triggers the characteristic cooling sensation. Also because of menthol's specific targeting of the k-‐opioid receptor, it is endowed with analgesic properties. Lidocaine is an amide-‐type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses. The penetration of Lidocaine into intact skin after application of patch is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Gen7T Plus Patch ® is contraindicated in patients with a known hypersensitivity to lidocaine, or any of the topical amide-like local anesthetic preparations or to any other component of the product.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Gen7T Plus Patch ® is a prescription topical patch containing 15 articulated patches or 10 articulated patches. Lidocaine is present in a 3.5% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C 14 H 22 N 2 O. The molecular weight of lidocaine is 234.34 g/mol. Lidocaine has an octanol: water partition ration of 43 at pH 7.4, and has the following structure: ** Lidocaine ** Menthol is present in a 7% concentration (w/w). The chemical name is (1R,2S,5R)‐2‐isopropyl-5-methylcyclohexanol. The empirical formula for Menthol is C 10 H 20 O with a molecular weight of 156.27 g/mol. Menthol contains colorless, hexangonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31 O C to 36 O C and has the following structure: ** Menthol ** Gen7T Plus Patch ® uses an adhesive hydrogel technology containing lidocaine 3.5% and menthol 7%, applied to a flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin. Lidocaine Menthol
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Polyvinyl alcohol, non-crystallizing sorbitol solution, polyacrylic acid, glycerin, carboxymethylcellulose sodium, colloidal silicon dioxide, titanium dioxide, propylene glycol, tartaric acid, magnesium hydroxide, sodium polyacrylate, purified water. PRESCRIBER INFORMATION Gen7T Plus Patch ® (Lidocaine 3.5% / Menthol 7%)
Spl product data elements
Usually a list of ingredients in a drug product.Gen7T Plus Lidocaine, Menthol POLYVINYL ALCOHOL, UNSPECIFIED SORBITOL GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM SILICON DIOXIDE TITANIUM DIOXIDE PROPYLENE GLYCOL TARTARIC ACID MAGNESIUM HYDROXIDE WATER SODIUM POLYACRYLATE (8000 MW) POLYACRYLIC ACID (8000 MW) LIDOCAINE LIDOCAINE MENTHOL MENTHOL
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.CARC INOGENESIS , MUTAGENESIS , IMPAIRMENT OF FERTILITY : A minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. The blood concentration of this metabolite is negligible following application of topical lidocaine. The effect of Gen7T Plus Patch ® on fertility has not been studied.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL PATCH Lidocaine 3.5% + Menthol 7% 15 PATCHES PRINCIPAL DISPLAY PANEL NDC 70645-628-35 GEN 7T PLUS PATCH Lidocaine 3.5% + Menthol 7% 15 PATCHES
PRINCIPAL DISPLAY PANEL GEN 7T PLUS PATCH Dispense by Prescription Lidocaine 3.5% + Menthol 7% 10 PATCHES NDC 70645-628-10 GEN 7T PLUS PATCH Dispense by Prescription Lidocaine 3.5% + Menthol 7% 10 PATCHES
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Gen7T Plus Patch --------- What is Gen7T Plus Patch ® ? This is a topical hydrogel patch consisting of the local anesthetic, lidocaine, and the topical analgesic, menthol. What is Gen7T Plus Patch ® used for? This patch is applied topically for use on normal intact skin for the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains. Read the information sheet provided before you start using this medication 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. The use of this medication shall be used under the supervision of a physician only as it may be used in conjunction with other therapies. This information may not include all of the information needed to use Gen7T Plus Patch ® safely and effectively. For Topical Use Only What are the possible side effects with Gen7T Plus Patch ® Common: itching, redness or flaking of the skin following application (note: the majority of patients experience no significant adverse events following patch 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 or using this patch in conjunction with other lidocaine containing products. Tell your healthcare provider about all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Avoid excessive alcohol usage, since it may increase the potential for Central Nervous System (CNS) effects such as dizziness, confusion, lightheadedness and orthostatic hypotension. This is not a complete list of the possible side effects. For more information, talk with your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . KEEP OUT OF REACH OF CHILDREN
DIRECTIONS FOR USE Adults and children 12 years and over : Apply 1 patch to the affected area of intact skin. Gen7T Plus Patch ® should be removed after 12 hours of continuous use and remain off for at least 12 hours. 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. Remove the transparent release liner (clear plastic backing) before application of patches to the skin. Apply immediately after removal from the protective envelope. 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 (12 hours on / 12 hours off). Remove patch if irritation occurs. Children under 12 years of age: Consult a doctor
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.NURSING MOTHERS The effect of Gen7T Plus Patch ® on the nursing infant has not been evaluated. Caution should be exercised when Gen7T Plus Patch ® is administered to a nursing mother.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.PEDIATRIC / GERIATRIC USE Safety and effectiveness in pediatric and geriatric patients have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)PREGNANCY: The safety of Gen7T Plus Patch ® has not been established during pregnancy. There are no well-controlled studies in pregnant women. Gen7T Plus Patch ® should not be used during pregnancy unless absolutely needed and discussed with a physician.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Because of the possibility of sedation, patients should be cautioned regarding the operation of heavy machinery or automobiles, and any activities made hazardous by decreased alertness. Hepatic Disease: Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of Lidocaine, because of their inability to metabolize Lidocaine normally. Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to Lidocaine. However, this product should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of Lidocaine from increased absorption. Gen7T Plus Patch ® is only recommended for use on intact skin. Eye Exposure: The contact of this product with the eyes, although not studied, should be avoided based on the findings of severe eye irritations with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. External Heat Sources: Placement of external heat sources, such as heating pads or electric blankets, over patches is not recommended as this has not been evaluated and may increase plasma Lidocaine levels. DRUG INTERACTIONS Antiarrhythmic Drugs: Gen7T Plus Patch ® should be used with caution in patients receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When Gen7T Plus Patch ® is used concurrently with other products containing local anesthetic agents the amount absorbed from all formulations must be considered. CARC INOGENESIS , MUTAGENESIS , IMPAIRMENT OF FERTILITY : A minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. The blood concentration of this metabolite is negligible following application of topical lidocaine. The effect of Gen7T Plus Patch ® on fertility has not been studied. PREGNANCY: The safety of Gen7T Plus Patch ® has not been established during pregnancy. There are no well-controlled studies in pregnant women. Gen7T Plus Patch ® should not be used during pregnancy unless absolutely needed and discussed with a physician. NURSING MOTHERS The effect of Gen7T Plus Patch ® on the nursing infant has not been evaluated. Caution should be exercised when Gen7T Plus Patch ® is administered to a nursing mother. PEDIATRIC / GERIATRIC USE Safety and effectiveness in pediatric and geriatric patients have not been established. 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 Gen7T Plus 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS FOR EXTERNAL USE ONLY 1. Do not use : More than 1 patch on your body at a time or on irritated or swollen skin On wounds, damaged or infected skin On eyes, mouth, genitals, or other mucous membranes With a heating pad 2. Consult physician for children under 12 years of age 3. Stop and consult your prescriber If condition or pain worsens If you are allergic to any of the ingredients in this product If using concurrently with any other external pain-relieving products If you are pregnant, planning to become pregnant, or breastfeeding If symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days Call your healthcare provider right away if you get 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 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. General information about the safe and effective use Gen7T Plus Patch ® Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use this product for another indication unless instructed and prescribed by a physician. Do not give this drug to anyone else, even if they have the same condition. This product is intended for use as prescribed by a physician. How should I store Gen7T Plus Patch ® 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. Safely discard product after expiration date posted on the product label. Discard patches away from small children or animals. DO NOT use the product after the expiration date printed on the box. What are the active ingredients in Gen7T Plus Patch ® ? The patch consists of 3.5% lidocaine and 7% menthol.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API