Astero Gel

Name: Astero Gel

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.

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®.

Adverse Reactions

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:

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.

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.

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.

Use in Specific Populations

8. Use in Specific Populations:

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.

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.

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.

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.

Geriatric use:

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

Astero Gel Description

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)-N-(2,6-dimethylphenyl)-, and has the following structural formula:

Active Ingredients:

Each gram of Astero® contains Lidocaine Hydrochloride USP 4% (40 mg). Lidocaine Hydrochloride USP is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:

Inactive Ingredients:

Polyethylene Glycol(PEG) 400 & Polyethylene Glycol 3350 as base, Oak Extract, Meadowsweet Extract, Zinc Acetate, and Water.

For the Consumer

Applies to lidocaine topical: topical application aerosol liquid, topical application cream, topical application dressing, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment, topical application pad, topical application patch extended release, topical application powder, topical application solution, topical application spray

Along with its needed effects, lidocaine topical (the active ingredient contained in Astero) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lidocaine topical:

Rare
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • cough
  • cracked, dry, or scaly skin
  • fast heartbeat
  • fever
  • hives or welts, itching, or skin rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
Incidence not known
  • Blistering, bruising, burning, discoloration, itching, redness, or swelling at the application site
  • blurred vision
  • chest pain or discomfort
  • cold, clammy, or pale skin
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness or dizziness
  • false or unusual sense of well-being
  • fear or nervousness
  • irregular, fast or slow, or shallow breathing
  • lethargy
  • no blood pressure or pulse
  • pale or blue lips, fingernails, or skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • shakiness in the legs, arms, hands, or feet
  • slow heart rate
  • slow or irregular heartbeat
  • stopping of heart
  • trembling or shaking of the hands or feet
  • twitching
  • unconsciousness
  • unusual tiredness or weakness
  • weakness

Some side effects of lidocaine topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Bad, unusual, or unpleasant (after) taste
  • change in taste
  • cold or numbness
  • confusion about identity, place, and time
  • continuing ringing or buzzing or other unexplained noise in the ears
  • double vision
  • headache
  • hearing loss
  • heat sensation
  • lack or loss of strength
  • metallic taste
  • sleepiness or unusual drowsiness

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