Lidocaine Hcl - Hydrocortisone Acetate
FDA Drug Information • Also known as: Lidocort, Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream, Radiaura Skin Recovery
- Brand Names
- Lidocort, Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream, Radiaura Skin Recovery
- Route
- TOPICAL
- Dosage Form
- CREAM
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION: Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula: new image description
What Is Lidocaine Hcl - Hydrocortisone Acetate Used For?
INDICATIONS: For the temporary relief of pain and itching associated with minor burns, sunburns or minor skin irritations or hemorrhoids and itching associated with inflammation, and rashes due to eczema.
Dosage and Administration
DOSAGE AND ADMINISTRATION: Apply product to the affected area(s) twice daily or as directed by a licensed healthcare practitioner. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advice of your physician. Wash hands before and after application.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS: During or immediately following application of product, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin.
Warnings and Precautions
WARNINGS: CONCERNS RELATED TO ADVERSE EFFECTS: Methemoglobinemia: Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents. Onset may be immediate or delayed (hours) after anesthetic exposure. Patients with G6PD deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, exposure to oxidizing agents or their metabolites, or infants <6 months of age are more susceptible and should be closely monitored for signs and symptoms of methemoglobinemia (including pale, gray, or blue-colored skin (cyanosis), headache, rapid pulse, shortness of breath, lightheadedness, fatigue). WARNINGS: For external use only. Not for ophthalmic use. Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes and abraded, fissured or irritated skin than through intact skin. Product should not be ingested or applied into the mouth, inside of the nose or in the eyes. Product should not be used in the ears. Any situation where lidocaine penetrates beyond the tympanic membrane into the middle ear is contraindicated because of ototoxicity associated with lidocaine observed in animals when instilled in the middle ear. Product should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation, which reduces protective reflexes and can lead to corneal irritation and possibly abrasion. If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored.
Contraindications
CONTRAINDICATIONS: Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. Product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. Product should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. Product is contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Pregnancy and Breastfeeding
Use in Pregnancy: Teratogenic Effects: Pregnancy Category C. Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
NURSING MOTHERS: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.
How Supplied
HOW SUPPLIED: Lidotral® 3.88% + Hydrocortisone 1% Cream (Lidocaine HCl 3.88% - Hydrocortisone Acetate 1%) is supplied as an off-white cream in a 3 oz. (85 g) tube with CRC Cap - NDC 59088-317-07
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.