Gammexane

Gammexane Shampoo is indicated for the treatment of head lice (infestations of Pediculosis humanis capitis), crab lice (infestations of Pthirus pubis), and their ova only in patients who

1. cannot tolerate other approved therapies, or
2. have failed treatment with other approved therapies.

Gammexane Shampoo should be used in the context of an overall lice management program that includes:

• Visual inspection to ensure that the patient is currently infested with live lice (empty egg casings or "nits" can remain on hair shaft long after true infestation).
• Manual removal of nits using a comb designed for this purpose and/or individual removal with tweezers followed by close examination of the hair and scalp.
• Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Gammexane Shampoo only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies.
• All recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.

Caregivers applying this product to patients should wear gloves less permeable to Gammexane such as nitrile, latex with neoprene or sheer vinyl, and thoroughly clean hands after application. Natural latex gloves should be avoided because they are more permeable to Gammexane.

Gammexane Shampoo does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.

Gammexane, formerly known as gamma benzene hexachloride, is an insecticide and is used to treat scabies and lice infestations.

Gammexane cream and lotion are usually used to treat only scabies infestation. Gammexane shampoo is used to treat only lice infestations.

Gammexane is available only with your doctor's prescription.

Apply a thin layer of Gammexane 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 8 to 12 hours. Do not retreat.

Patients should be provided specific information on use of product. Patients should be instructed on proper use of Gammexane Lotion, especially the amount to apply, how long to leave on and the need to avoid retreatment. Patients should be informed that itching occurs after the successful killing of scabies (lice) and continued itching is not necessarily an indication for retreatment with Gammexane Lotion.

A Gammexane Lotion Medication Guide must be given to the patient each time Gammexane Lotion is dispensed, as required by law. The Gammexane Lotion Medication Guide is an important part of the risk management program for the patient.

How supplied

Gammexane Lotion, USP 1% is supplied in patient-size 2 fl oz (60 mL) bottles. SHAKE WELL BEFORE USING

Store at controlled room temperature, 15 ° - 30 °C (59 ° - 86 °F).

Manufactured By: Morton Grove Pharmaceuticals, Inc. Morton Grove, IL 60053. REV. 06-05. Distributed By: Alliant Pharmaceuticals, Inc. Alpharetta, GA 30004. FDA Rev date: 10/9/2001

See also:
What is the most important information I should know about Gammexane?

Do not apply this medication to the face, eyes, nose, or mouth. Flush with water if you get medication in any of these areas. Seek medical attention if Gammexane topical is ingested or if irritation is persistent.

Do not use more of this medication than is recommended. Using more than the prescribed amount of Gammexane topical may cause seizures or other dangerous side effects.

Treat sexual and other close contacts who are also infected. Do not use Gammexane topical to treat contacts who are not infected in an attempt to prevent infection from occurring.

To prevent reinfection, wash all clothing, hats, bed clothes, bed linens, hair brushes, and combs in hot water with a strong cleanser.

Talk to your doctor before using a second dose of Gammexane topical. Using Gammexane topical too soon after the first dose may cause seizures and/or death.

Use Gammexane lotion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gammexane lotion comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Gammexane lotion refilled.
• Gammexane lotion is for external use only.
• Shake well before using.
• Do not use other creams, lotions, ointments, or oils immediately before or after applying Gammexane. Oil-based products may increase the absorption of Gammexane through your skin and into your bloodstream, increasing the risk of serious side effects.
• Wait at least 1 hour after bathing or showering before using Gammexane lotion. Wet or warm skin can make Gammexane lotion go through the skin faster, increasing the risk of serious side effects.
• Apply a thin layer of Gammexane lotion over all of the skin from the neck down to the bottoms of your feet.
• Apply Gammexane lotion only once. Do not use it again without checking with your doctor.
• Thoroughly wash the medicine off in a shower or bath with warm (not hot) water after 8 to 12 hours. Never leave Gammexane lotion on the treated area for more than 12 hours. Leaving it on for a longer than 8 to 12 hours will not kill more scabies, but may cause serious health problems, such as a seizure (and in some cases death). Do not re-treat.
• Put Gammexane lotion under the fingernails after trimming the fingernails short, because scabies are likely to remain there. A toothbrush can be used to apply Gammexane lotion under the fingernails. The toothbrush should be wrapped in paper and thrown away immediately after using. Do not use the same toothbrush in your mouth because this could lead to poisoning.
• If applying Gammexane to another person, wear disposable gloves (made of nitrite, latex with neoprene, or sheer vinyl). Do not use natural latex gloves because more Gammexane can penetrate them. Hands should be thoroughly washed after applying Gammexane lotion.
• Do not cover the treated areas with bandages or other dressings that do not breathe, such as diapers with plastic lining, plastic clothes, tight clothes, or blankets.
• Discard the Gammexane container (and gloves if you used them) in the trash out of the reach of children and away from pets.
• If you miss a dose of Gammexane lotion, use it as soon as you remember. Continue to use it as directed by your doctor.

Ask your health care provider any questions you may have about how to use Gammexane lotion.

This medication is used to treat scabies only after safer medications (such as permethrin or crotamiton) have failed or caused side effects. It works by killing the tiny insects (mites) and their eggs, which cause scabies. An infection with scabies is also called an infestation. This drug should not be used to prevent scabies infestation or re-infestation.

How to use Gammexane topical

Read the Medication Guide provided by your pharmacist before you start using Gammexane. If you have any questions, consult your doctor or pharmacist.

This drug can be poisonous if used incorrectly. Do not take this drug by mouth, and avoid contact with your eyes, nose, or mouth. If Gammexane gets in these areas, rinse with water right away and seek immediate medical attention if a burning feeling remains. Do not use if there is skin irritation (e.g., open wounds, rash, cuts, or sores) on the area to be treated unless directed to do so by your doctor.

Trim your nails short and clean your skin well with warm (not hot) water before using, but wait at least 1 hour after bathing/showering before use. Wet or warm skin can increase the absorption of Gammexane into your bloodstream. An average-sized adult requires only 1 ounce (30 milliliters), but larger persons should use no more than 2 ounces (60 milliliters).

Make sure your skin is clean and does not have other lotions, creams, ointments, or oils on it. These products can increase the absorption of Gammexane through your skin and into your bloodstream, which increases the risk of serious side effects. If you are currently using any of these products, they must be washed off before you apply Gammexane.

Shake the bottle well before use. Apply a very thin layer of lotion once over your entire body from the neck down to the bottoms of your feet or as directed by your doctor. Use a toothbrush to apply Gammexane under your nails (scabies mites prefer this area). Do not use this toothbrush in your mouth afterward. Wrap the toothbrush and throw it in the trash with the closed bottle of any unused Gammexane out of the reach of children and pets.

After application, do not cover your skin with fabric that does not breathe (e.g., disposable/plastic diaper, tight clothes, blankets). Avoid skin-to-skin contact with anyone while Gammexane is on your body.

Leave the medication on the skin for 8-12 hours. Leaving it on overnight is usually enough. Do not leave it on the skin more than 12 hours. Leaving it on longer will not kill any more scabies mites/eggs, but your risk of serious (possibly fatal) seizures will be increased. Remove Gammexane lotion by washing very well in a shower or bath, using warm (not hot) water.

If an infant or young child is prescribed Gammexane, watch the child carefully after applying the lotion to make sure the child does not put their hands/feet into their mouth while the medication is on their skin.

If you are applying Gammexane on another person, wear disposable gloves (made of nitrile, latex with neoprene, or sheer vinyl) to decrease the risk of contacting this drug and possible side effects. Do not use natural latex gloves because more Gammexane can penetrate that type of glove. Wash your hand well afterwards.

Symptoms of scabies include an intense itching which is generally worse at bedtime. You may also see small, fine, wavy lines on the skin with a tiny insect at the end (a burrow). Burrows are usually found on finger/toe webs, wrists, elbows, armpits, belt line, lower buttocks, female nipples, or male genitals. Even if Gammexane kills all the scabies, the dead mites can still make you itch for a long time after treatment. Ask your doctor about other medications that may be used to soothe the itching. Inform your doctor if your condition persists or worsens 2-3 weeks after treatment.

See also:
What other drugs will affect Gammexane?

Oils may enhance absorption of Gammexane, therefore, patients and caregivers applying the shampoo to others should avoid using oil treatments, or oil-based hair dressings or conditioners immediately before and after applying Gammexane Shampoo.

In addition, there are many drugs that may lower the seizure threshold, and Gammexane Shampoo should be prescribed with caution in patients taking these medications. Drugs that may lower the seizure threshold include, but are not limited to the following:

• Antipsychotics
• Antidepressants
• Theophylline
• Cyclosporine, mycophenolate mofetil, tacrolimus capsules
• Penicillins, imipenem, quinolone antibiotics
• Chloroquine sulfate, pyrimethamine
• Isoniazid
• Meperidine
• Radiographic contrast agents
• Centrally active anticholinesterases
• Methocarbamol

See also:
What are the possible side effects of Gammexane?

Applies to Gammexane topical: topical cream, topical lotion, topical shampoo

In addition to its needed effects, some unwanted effects may be caused by Gammexane topical. In the event that any of these side effects do occur, they may require medical attention.

Severity: Moderate

If any of the following side effects occur while taking Gammexane topical, check with your doctor or nurse as soon as possible:

Rare

• Convulsions (seizures)
• dizziness, clumsiness, or unsteadiness
• fast heartbeat
• muscle cramps
• nervousness, restlessness, or irritability
• vomiting
• skin irritation not present before use of Gammexane
• skin rash

Side Effects: Post Treatment

After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

Serious side effects have resulted in patients using Gammexane. Sometime it has occurred even when used according to the labeled directions. Serious side effects have been reported following Gammexane use with repeat or prolonged use, but also in rare cases following a single application. You should discuss these possible effects with your doctor.

An organochlorine insecticide that has been used as a pediculicide and a scabicide. Gammexane has been banned in California, United Kingdom, Australia, and many western countries due to concerns about neurotoxicity and adverse effects on the environment. In Canada, Gammexane is not recommmended as a first-line therapy due to reports of resistance, neurotoxicity, and bone marrow suppression, but has been approved by the FDA as a second-line therapy for topical treatment of pediculosis capitis (head lice), pediculosis pubis (pubic lice), or scabies in patients greater than two years of age who cannot tolerate or have failed first-line treatment. Gammexane is still allowed for pharmaceutical use until 2015.