Kwell Topical

Name: Kwell Topical

Side Effects

See also Warning section.

This medication may cause stinging, burning, or redness of the skin. Inform your doctor promptly if these symptoms persist or worsen. It may mean that some of the medication was absorbed through the skin.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if these rare but very seriousvomiting, dizziness, drowsiness, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Kwell Shampoo side effects by likelihood and severity.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include nausea, vomiting, restlessness, unsteadiness, seizures, irregular heartbeat.

Notes

Do not share this medication with others.

Lice are easily passed from one person to another. All family members and people you have close contact with (especially if you have crab/pubic hair lice) should be examined.

After treatment, soak all possibly infested combs, brushes, and other hair care items in water that has been heated to 130 degrees F (54 degrees C) for 5 to 10 minutes. Also, any recently worn clothing, hats, sheets/blankets, plush/fabric toys, and towels should be washed in very hot water or dry-cleaned.

This drug is not effective for scabies. Another form of lindane is used for treating scabies.

This medication is used to treat a current infestation only. It cannot be used to prevent future infestations.

Missed Dose

Not applicable.

Storage

Store at room temperature away from light and moisture. Keep the bottle tightly closed. Do not store in the bathroom. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised August 2016. Copyright(c) 2016 First Databank, Inc.

Usual Adult Dose for Lice

Apply 30 mL of shampoo directly to dry hair without adding water and give special attention to the fine hairs along the neck; after 4 minutes, add small quantities of water to hair until a good lather forms then immediately rinse all the lather away.

Maximum Dose: Up to 60 mL may be needed for long and dense hair.

Comments:
-Avoid unnecessary contact of lather with other body surfaces.
-Use only once; do not re-treat.

Use: Treatment of head lice (infestations of Pediculosis humanis capitis), crab lice (Pthirus pubis), and their ova in patients who cannot tolerate or who have failed treatment with other approved therapies.

Usual Pediatric Dose for Lice

-Premature Infants: Contraindicated.
-Infants and Children: Use with caution.

Renal Dose Adjustments

Data not available.

Precautions

US BOXED WARNINGS:
-APPROPRIATE USE: This drug is contraindicated in premature infants and individuals with known uncontrolled seizure disorders. Only use this drug in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of scabies (lotion) or lice (shampoo). Instruct patients on the proper use of this drug (e.g., amount to apply, how long to leave it on, avoiding retreatment). Inform patients that itching occurs after the successful killing of scabies/lice and is not necessarily an indication for retreatment with this drug.
-NEUROLOGIC TOXICITY: Seizures and deaths have been reported following use of this drug with repeat or prolonged application, and also following a single application in rare cases. Use this drug with caution in infants, children, the elderly, and individuals with other skin conditions (e.g., atopic dermatitis, psoriasis) and in those who weigh less than 110 pounds (50 kg) as they may be at risk of serious neurotoxicity.

Consult WARNINGS section for additional precautions.

Other Comments

Administration Advice:
-Consult the manufacturer product information for step-by-step instructions on applying the lotion to the skin and the shampoo to the hair/scalp.
-Advise caregivers to wear gloves less permeable to this drug (e.g., nitrile, latex with neoprene, sheer vinyl), and thoroughly clean hands after application; natural latex gloves are more permeable and should not be used.

General:
-This drug does not prevent infestation or re-infestation; it should not be used to ward off a possible infestation.

Patient Advice:
-Avoid contact with the eyes when applying this drug; if contact occurs, immediately flush eyes with water and consult a healthcare provider if irritation or sensitization occurs.
-Unless specifically directed by your healthcare provider, do not use this drug if you have open wounds, cuts, or sores.
-You may still itch after using this drug; do not use more of this drug to treat the itching. Consult your healthcare provider for other treatments that can be used to soothe the itching.

Lindane Levels and Effects while Breastfeeding

Summary of Use during Lactation

Topical application of lindane can increase lindane milk levels for at least several days. Because it is potentially toxic in infants, is a persistent environmental contaminant, and possibly has estrogenic effects that could decrease lactation as well as affect the nursing infant, another agent is preferred.[1][2][3][4]

Drug Levels

Lindane (gamma-benzenehexachloride; hexachlorocyclohexane, gamma isomer) is a fat-soluble insecticide that is a persistent environmental contaminant. Residues from its use as a pesticide are found in food and subsequently in breastmilk, particularly the milkfat. Recent data from the United States are lacking, but levels appear to be trending downward in industrialized countries.[5] Hexachlorocyclohexane appears to have some estrogenic activity.[6]

Maternal Levels. A German woman with a 2-month-old breastfed infant was treated with lindane 0.3% lotion (the product available in the United States contains 1%) for scabies. The lotion was left on for 24 hours, then washed off. The extent of application was not stated, but is usually applied to all skin from the neck down. A baseline lindane concentration in breastmilk was not obtained, but the average value of lindane in mothers' milk in Germany from pesticides in the food chain at the time of the study was 30 mcg/kg of milk fat. Milk from day 4 to 10 contained lindane in the range of 500 to 900 mcg/kg of milk fat. After another repeat application of lindane, lindane was found in aa concentration of 2000 mcg/kg on day 11. Additional measurements on days 18 and 26 were 600 mcg/kg and 400 mcg/kg, respectively.[7]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

In a telephone follow-up study, 9 mothers used lindane topically for head lice during breastfeeding. One reported irritability in her breastfed infant.[8]

Effects on Lactation and Breastmilk

Hexachlorocyclohexane appears to have some estrogenic activity which could suppress lactation.[6]

Alternate Drugs to Consider

Permethrin, Pyrethrins

References

1. Porto I. Antiparasitic drugs and lactation: focus on anthelmintics, scabicides, and pediculicides. J Hum Lact. 2003;19:421-5. PMID: 14620457

2. Morin AK, Stoukides CA. Scabicides and pediculocides and breastfeeding. J Hum Lact. 1994;10:267-8. PMID: 7619283

3. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II Lactation. J Am Acad Dermatol. 2014;70:417.e1-417.e10. PMID: 24528912

4. Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64:1-137. PMID: 26042815

5. LaKind JS, Amina Wilkins A, Berlin CM Jr. Environmental chemicals in human milk: a review of levels, infant exposures and health, and guidance for future research. Toxicol Appl Pharmacol. 2004;198:184-208. PMID: 15236953

6. Massart F, Harrell JC, Federico G, Saggese G. Human breast milk and xenoestrogen exposure: a possible impact on human health. J Perinatol. 2005;25:282-8. PMID: 15605068

7. Senger VE, Menzel I, Holzmann H. [Therapy-induced lindane concentration in breast milk]. Derm Beruf Umwelt. 1989;37:167-70. PMID: 2478352

8. Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID: 8498418

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