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ASTERO

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Overview

What is ASTERO?

A soothing hydrogel wound dressing that promotes a moist wound environment that is ideal for the healing process

ASTERO contains Lidocaine HCl USP 4%, which is chemically designated as acetamide, 2-(diethylamino)--(2,6-dimethylphenyl)-, and has the following structural formula:



What does ASTERO look like?



What are the available doses of ASTERO?

Astero® is a topical medicated hydrogel wound dressing. Each gram of Astero® contains 4% Lidocaine Hydrochloride USP (40mg).

What should I talk to my health care provider before I take ASTERO?

8. Use in Specific Populations:

How should I use ASTERO?

Astero® is indicated for associated pain, painful wounds and wound healing in either open and closed injuries or conditions. Conditions of pain include topical pain, postsurgical pain and pain associated w/various types of closed or open wounds. Conditions of closed wounds include soft tissue and bony injuries caused by contusions, hematomas, crush injuries and sprains/strains due to torsion, traction, compression and/or blunt trauma.

Each pump of the Astero® bottle (30mL Airless Metered Dose bottle) (NDC:35781-2500-3) will deliver 0.25 mL of Astero® (10 mg Lidocaine Hydrochloride USP), enough to cover a 2-inch by 2-inch area of skin. A single application should not exceed 4 pumps of the M-DOSE bottle, equal to 1 gram of Astero®, (40 mg of Lidocaine Hydrochloride USP).No more than 12 pumps of the M-DOSE bottle, approximately 3 grams of Astero® (120 mg Lidocaine Hydrochloride USP,) should be administered in any one day. Although the incidence of adverse effects with Astero® is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.2.1 Dosage for children: The recommended dose of Astero® varies as a function of age and weight. For children less than ten years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark’s rule). For example, a child of five years weighing 50 lbs., the dose of lidocaine should not exceed 75-100 mg (approximately 1.9 to 2.5 grams of Astero®) when calculated according to Clark’s rule. In general, the maximum amount of lidocaine administered should not exceed 4.5 mg/kg (2.0 mg/lb) of body weight of the child. Do not use on children under 2 unless directed by a physician.2.2 Administration: Apply as directed. Do not exceed 12 pumps in a twenty-four-hour (24-hour) period. One pump covers an area of 2 x2 inches.


What interacts with ASTERO?

Sorry No Records found


What are the warnings of ASTERO?

Sorry No Records found


What are the precautions of ASTERO?

Sorry No Records found


What are the side effects of ASTERO?

Sorry No records found


What should I look out for while using ASTERO?

Lidocaine Hydrochloride USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Astero®.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS OF LIDOCAINE AND SERIOUS ADVERSE EFFECTS, PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.


What might happen if I take too much ASTERO?

Sorry No Records found


How should I store and handle ASTERO?

Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Product: 53149-2500NDC: 53149-2500-1 30 g in a BOTTLEProduct: 53149-2500NDC: 53149-2500-1 30 g in a BOTTLE


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Astero, when applied to wounds, provides for analgesia by the release of lidocaine from the gel into the epidermal and dermal layers of the skin and by the accumulation of lidocaine in the vicinity of dermal pain receptors and nerve endings. Astero® is a hydrated polymer (Hydrogel) wound dressing containing 4% w/w Lidocaine HCl USP. By providing moisture to the wound, Astero® creates a moist healing environment, which promotes granulation, epithelialization, and autolytic debridement. The high water content of hydrogel dressings cools the wound, producing pain relief that can last up to 6 hours. Dressing-change discomfort is also reduced because Astero® doesn’t adhere to the wound surface.Astero® releases Lidocaine Hydrochloride USP from the Neutral (pH 7-7.2) hydrogel to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action.

Non-Clinical Toxicology
Lidocaine Hydrochloride USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Astero®.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS OF LIDOCAINE AND SERIOUS ADVERSE EFFECTS, PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.

Adverse experiences following the administration of Lidocaine Hydrochloride USP are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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