LIDOCAINE HCL HYDROCORTISONE ACETATE
-
lidocaine hydrochloride and
hydrocortisone acetate cream
River's Edge Pharmaceuticals, LLC
----------
Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with AloeMECHANISM OF ACTION: Product releases lidocaine to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. Hydrocortisone acetate provides relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
This product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.
This 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. River’s Edge Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe 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. River’s Edge Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. River’s Edge Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe 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.
If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. If extensive areas are treated, the possibility of systemic absorption exists. Systemic absorption of topical steroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glycosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of potent topical steroids applied to a large surface area, or under an occlusive dressing, should be evaluated periodically for evidence of HPA axis suppression. If noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of the HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionately larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. If irritation develops, topical steroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.
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 systematically 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 topical 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.
During or immediately following application of River’s Edge Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
River’s Edge Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe, NDC 68032-318-15, contains one (1) multi-use 100 g tube, NDC 68032-318-95, and 15 single-use applicators.
KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
Store at controlled room temperature 20°-25°C (68°-77°F).
Protect from freezing.
Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
318-11 Iss. 09/09
68032-318-15
Rx Only
Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe
Anti-Inflammatory, Anesthetic, Hemorrhoidal 100 grams
Contents: 100 g Tube and 15 Single-Use Applicators
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DIRECTIONS FOR RECTAL ADMINISTRATION:
1. Remove the tube from the unit box and unscrew the cap.
2. The first time the tube is opened, remove safety seal from the tube.
3. Remove an applicator from the unit box and firmly screw the threaded tip onto the open tube. Do not over tighten.
4. Squeeze the tube to push gel into the applicator until the plunger stops.
5. While maintaining neutral pressure on the tube, separate the applicator from the tube, replace the cap, and roll the tube up from the bottom.
6. Gently inset the tip of the filled applicator approximately ½ inch into the anal area and apply steady even pressure on the plunger applying 5ml of River’s Edge Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe to the anus and the peri-anal area. Do not insert the applicator any additional length into the anus or into the rectum.
7. Remove both parts of the applicator and discard. After the final use, also discard the tube.
If directed by a physician, a small amount of gel may be applied to the anal area using a fingertip.
WARNING: Product and applicators could harm small children if chewed or swallowed. Individual tubes are NOT child resistant.
DESCRIPTION: Each gram of River’s Edge Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel contains Lidocaine HCl 2.8% and Hydrocortisone Acetate 0.55%
Inactive Ingredients include: Purified Water, Polyethyleneglycol 200, Propylene Glycol NF, Hydroxyethylcellulose, Methylparaben NF, Citric Acid Anhydrous USP, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propylparaben NF.
ADDITIONAL PRODUCT INFORMATION ENCLOSED.
CAUTION: For external use only. Not for ophthalmic use. If irritation or sensitivity occurs or infection appears, discontinue use and consult your physician.
DOSAGE AND ADMINISTRATION: Use three times daily or as directed by a physician.
KEEP OUT OF REACH OF CHILDREN.
TAMPER-EVIDENT: DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING.
Store at controlled room temperature 20°-25°C (68°-77°F). Protect from freezing.
LIDOCAINE HCL HYDROCORTISONE ACETATE
lidocaine hcl hydrocortisone acetate cream |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
unapproved drug other | 09/01/2008 |
Labeler - River's Edge Pharmaceuticals, LLC (133879135) |