LINDANE Lotion (2011)

Βιβλιογραφική αναφορά

Συγγραφείς

VersaPharm Incorporated

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BOXED WARNING SECTION

WARNINGS Lindane Lotion should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of scabies. (See INDICATIONS AND USAGE.) Neurologic ...

1. Description

Lindane Lotion USP, 1%, is an ectoparasiticide and ovicide. In addition to the active ingredient, lindane, it contains 2-amino-2-methyl-1-propanol, butylparaben, carrageenan, cetyl alcohol, glyceryl monostearate, ...

2. Clinical Pharmacology

Lindane Lotion USP, 1%, is an ectoparasiticide and ovicide effective against Sarcoptes scabiei (scabies). Lindane exerts its parasiticidal action by being directly absorbed into the parasites ...

3. Indications and Usage

Lindane Lotion is indicated for the treatment of scabies (infestations of Sarcoptes scabei) only in patients who: cannot tolerate other approved therapies, or have failed treatment with other ...

4. Contraindications

Lindane Lotion is contraindicated for premature infants because their skin may be more permeable than that of full term infants and their liver enzymes may not be sufficiently developed to metabolize Lindane. ...

5. Warnings

Seizures and deaths have been reported following Lindane Lotions use with repeat or prolonged application, but also in rare cases following a single application reportedly used according to directions. ...

6.1. General

Care should be taken to avoid contact with the eyes. If such contact occurs, eyes should be immediately flushed with water. If irritation or sensitization occurs, the patient should be advised to consult ...

6.2. Information for Patients

This product can be poisonous if misused. Other important information is found in the Medication Guide, which by law, must be dispensed with Lindane Lotion. If someone other than the patient ...

6.4. Drug Interactions

Oils may enhance absorption of Lindane, therefore, patients or caregivers applying Lindane Lotion should be warned about simultaneous use of creams, ointments, or oils. In addition, there are many drugs ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Although no studies have been conducted with Lindane Lotion, numerous long-term feeding studies have been conducted in mice and rats to evaluate the carcinogenic potential of the technical grade of hexachlorocyclohexane ...

6.7. Pregnancy

Pregnancy Category C All pregnancies have a risk of birth defect, loss, or other adverse event regardless of drug exposure. Predictions of fetal risk from drug exposure rely heavily on animal data. However, ...

6.9. Nursing Mothers

Lindane is lipophilic and is present in human breast milk, but exact quantities are not known. There may be a risk of toxicity if lindane is ingested from breast milk, or from skin absorption from mother ...

6.10. Pediatric Use

Animal data demonstrated increased risk of adverse events in the young across species. Pediatric patients have a higher surface to volume ratio and may be at risk of greater systemic exposure when Lindane ...

6.11. Geriatric Use

There have been no studies of Lindane Lotion in the elderly. There are four postmarketing reports of deaths in elderly patients who were treated for scabies with Lindane Lotion. Two patients died within ...

7. Adverse Reactions

Lindane Lotion has been reported to cause central nervous system stimulation ranging from dizziness to seizures. Although seizures were almost always associated with ingestion or misuse of the product ...

9. Overdosage

Contact the closest Poison Control Center in the event of suspected overdosage with Lindane Lotion. If accidental ingestion occurs, prompt gastric lavage should be instituted. However, since oils enhance ...

10. Dosage and Administration

Apply a thin layer of Lindane Lotion over all skin from the neck down. One ounce is sufficient for an average adult. Do not prescribe more than 2 ounces for larger adults. Apply only once. Wash off in ...

11. How Supplied

Lindane Lotion USP, 1% is supplied in 2 fl oz (60 mL) NDC 61748-401-02 bottles. SHAKE WELL BEFORE USING Manufactured by: AL&S, LLC, De Kalb, MS 39328 Marketed by: VersaPharm Incorporated, Marietta, GA ...

12. Storage and Handling

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

14. References

Feldmann, R.J. and Maibach, H.I., Toxicol. Applied. Pharmacol., 28:126, 1974. Dale, W.E., Curly, A. and Cueto, C. Life Sci 5:47, 1966. Ginsburg, C.M., et al., J. Pediatr. 91:6, ...