Lidocaine Hcl And Diclofenac Sodium
FDA Drug Information • Also known as: Diclona Gel
- Brand Names
- Diclona Gel
- Drug Class
- Amide Local Anesthetic [EPC], Antiarrhythmic [EPC]
- Route
- TOPICAL
- Dosage Form
- GEL
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
Description Diclona Gel (Lidocaine 4.5%, Diclofenac 1%) is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Triethanolamine, Water.
What Is Lidocaine Hcl And Diclofenac Sodium Used For?
Indications and Usage Diclona Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.
Dosage and Administration
Dosage and Administration Apply Diclona Gel to intact skin to cover the most painful area. Clean and dry the affected area. Apply product directly to your skin, up to 4 times daily. Clothing may be worn over the area of application. If irritation or a burning sensation occurs during application, wash the product off your skin and do not reapply until the irritation subsides. When Diclona Gel is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Side Effects (Adverse Reactions)
Adverse Reactions Application Site Reactions During or immediately after treatment with Diclona Gel, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Other Adverse Events Due to the nature and limitation of spontaneous reports in post marketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor. Systemic (Dose-Related) Reactions Systemic adverse reactions following appropriate use of Diclona Gel are unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics). Systemic adverse effects of lidocaine is similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.
Contraindications
Contraindications Diclona Gel is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. Diclona Gel is contraindicated in patients with a known hypersensitivity to diclofenac sodium. Diclona Gel is contraindicated in patients in the setting of coronary artery bypass graft (CABG) surgery.
Overdosage
Overdosage Lidocaine overdose from cutaneous absorption is rare but could occur. Excessive dosing by applying Diclona Gel to larger areas could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS, Systemic Reactions). Longer duration of application of more than the recommended number of doses, smaller patients, or impaired elimination may all contribute to increased blood concentration of lidocaine. Due to the low systemic absorption of topically-applied diclofenac sodium, overdosage of diclofenac sodium is unlikely.
How Supplied
How Supplied Diclona Gel is available as the following: 1 tube, 3.5oz NDC: 80425-0250-01 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. For more information, contact Terrain Pharmaceuticals. [email protected] Manufactured for: Terrain Pharmaceuticals Reno, NV 89501 Printed in the U.S.A Distributed by: Advanced Rx Pharmacy of Tennessee, LLC
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.