ASTERO

ASTERO- lidocaine gel
Gensco Laboratories, LLC

Rx only

DO NOT USE IN THE EYES.

1 Indicatgions

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.

2 Dosage and Administration

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.

3 Dosage Form and Strength

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

4 Contraindications

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®.

5 Warnings and Precautions

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.

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Astero® should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of Lidocaine Hydrochloride USP. In case of accidental ingestion get medical help or contact Poison Control Center right away.

6 Adverse Reactions to ASTERO

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:

6.1 Central nervous system

CNS manifestations of Lidocaine toxicity are excitatory and/or depressant and may be characterized by lightheadedness, 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. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of Lidocaine Hydrochloride USP is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

6.2 Cardiovascular system

Cardiovascular manifestations of Lidocaine toxicity are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.

6.3 Allergic

Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation. Allergic reactions as a result of sensitivity to Lidocaine Hydrochloride USP are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

7 Drug Interactions:

7.1 Serious interactions:

Antiarrhythmic Drugs: Astero® should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Bupivacaine liposome: Lidocaine Hydrochloride USP increases toxicity of Bupivacaine by increasing the free (unencapsulated) bupivacaine. Dofetilide: Lidocaine Hydrochloride USP increases effects of dofetilide through pharmacodynamic synergism. Lomitapide: Lidocaine Hydrochloride USP increases levels of lomitapide by affecting hepatic/intestinal enzymes CYP3A4 metabolism.

7.2 General interactions:

Drugs metabolized via CYP3A4 enzyme: (ex. Antipsychotics, SSRIs, TCAs, many chemotherapeutics, calcium channel blockers, benzodiazepines) Lidocaine Hydrochloride USP may increase serum levels of many drugs metabolized by hepatic / intestinal CYP3A4 enzymes. Drugs that affect hepatic CYP1A2 enzyme: (ex. Quinolone antibiotics, cimetidine, barbiturates, benzodiazepines, erythromycin) May increase serum Lidocaine Hydrochloride USP levels by decreasing Lidocaine Hydrochloride USP metabolism by CYP1A2 enzyme.

8 Use in Specific Populations:

8. Use in Specific Populations:

8.1 Use in Pregnancy:

Teratogenic Effects of Lidocaine Hydrochloride USP. Pregnancy Category B. Reproduction studies have been performed 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 Hydrochloride USP. 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 Hydrochloride USP to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

8.2 Labor and Delivery:

Lidocaine Hydrochloride USP is not contraindicated in labor and delivery. Should Astero® be used concomitantly with other products containing Lidocaine Hydrochloride USP, the total dose contributed by all formulations must be kept in mind.

8.3 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 Lidocaine Hydrochloride USP is administered to a nursing woman.

8.4 Pediatric use:

Dosage in children should be reduced, commensurate with age, body weight and physical condition. Caution must be taken to avoid over dosage when applying Astero® to large areas of injured or abraded skin, since the systemic absorption of Lidocaine Hydrochloride USP may be increased under such conditions. Do not use on children under 2 unless directed by a physician.

8.5 Geriatric use:

No overall clinical differences in safety or effectiveness have been observed between the healthy elderly and other adult patients.

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