Lindane Safety Reports submitted to FDA
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More Rx Information: A B C D E F G H I J K L M N O P Q R S T U V W X Y ZTotal Lindane reports: 10.
Lindane FDA safety alerts: 2003 .
Reported deaths: 1 Reported hospitalizations: 1.
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FDA Reported Lindane Side Effects: vomiting, nausea, headache, diarrhoea, convulsion, pyrexia, brain stem syndrome, syncope, palpitations, hypoaesthesia, chest pain.
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Lindane Side Effects Report #5265815-9
Consumer or non-health professional from UNITED STATES reported LINDANE problem on Mar 12, 2007. Male patient, weighting 215.0 lb, was treated with LINDANE. After drug was administered, patient experienced the following problems/side effects: diarrhoea, headache, nausea, pharyngolaryngeal pain, vomiting. LINDANE dosage: unknown. Patient recovered.
Lindane Side Effects Report #5265816-0
LINDANE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 12, 2007. Female patient, weighting 100.0 lb, was treated with LINDANE. After drug was administered, patient experienced the following problems/side effects: diarrhoea, headache, nausea, vomiting. LINDANE dosage: unknown. Patient recovered.
Lindane Side Effects Report #5265817-2
Consumer or non-health professional from UNITED STATES reported LINDANE problem on Mar 12, 2007. Male patient, weighting 35.00 lb, was treated with LINDANE. After drug was administered, patient experienced the following problems/side effects: diarrhoea, headache, nausea, pyrexia, vomiting. LINDANE dosage: unknown. Patient recovered.
Lindane Side Effects Report #5265818-4
LINDANE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 12, 2007. Male patient, weighting 55.00 lb, was treated with LINDANE. After drug was administered, patient experienced the following problems/side effects: diarrhoea, headache, nausea, vomiting. LINDANE dosage: unknown. Patient recovered.
Lindane Side Effects Report #5265819-6
Consumer or non-health professional from UNITED STATES reported LINDANE problem on Mar 12, 2007. Female patient, weighting 25.00 lb, was treated with LINDANE. After drug was administered, patient experienced the following problems/side effects: diarrhoea, headache, nausea, pyrexia, vomiting. LINDANE dosage: unknown. Patient recovered.
Lindane Side Effects Report #5282850-5
LINDANE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 29, 2007. Female patient, weighting 136.0 lb, was treated with LINDANE. After drug was administered, patient experienced the following problems/side effects: multiple sclerosis, neuralgia, neurological symptom. LINDANE dosage: unknown. Patient recovered.
Lindane Side Effects Report #5320254-7
Consumer or non-health professional from UNITED STATES reported LINDANE problem on May 03, 2007. Male patient, 17 years of age, weighting 180.0 lb, was diagnosed with lice infestation and was treated with LINDANE. After drug was administered, patient experienced the following problems/side effects: convulsion, electroencephalogram abnormal, excessive eye blinking, eye movement disorder, eye pain. LINDANE dosage: 60 ML ONCE. Patient recovered.
Lindane Side Effects Report #5341878-7
LINDANE problem was reported by a Consumer or non-health professional from UNITED STATES on May 29, 2007. Female patient, weighting 150.0 lb, was diagnosed with arthropod infestation and was treated with LINDANE. After drug was administered, patient experienced the following problems/side effects: feeling abnormal, ill-defined disorder, memory impairment. LINDANE dosage: unknown. Patient recovered.
Lindane Side Effects Report #5066906-8
Consumer or non-health professional from UNITED STATES reported LINDANE problem on July 11, 2006. Female patient, 38 years of age, weighting 120.0 lb, was diagnosed with infestation, skin lesion and was treated with LINDANE. After drug was administered, patient experienced the following problems/side effects: chest pain, headache, hypoaesthesia, nausea, palpitations, syncope, vomiting. LINDANE dosage: unknown. Patient was hospitalized. Patient recovered.
Lindane Side Effects Report #5129511-0
LINDANE problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 29, 2006. Male patient was treated with LINDANE. After drug was administered, patient experienced the following problems/side effects: brain stem syndrome, convulsion. LINDANE dosage: unknown. Patient died on 06/02/2003.
Drug Information: Lindane
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682651.html
(lin' dane)IMPORTANT WARNING:
| Lindane cures lice and scabies, but it may cause serious side effects. Safer medications are available to treat these conditions. You should only use lindane if there is some reason you cannot use the other medications or if you have tried the other medications and they have not worked.In rare cases, lindane has caused seizures and death. Most patients who experienced these severe side effects used too much lindane or used lindane too often or for too long, but a few patients experienced these problems even though they used lindane according to the directions. Babies; children; older people; people who weigh less than 110 lbs; and people who have skin conditions such as psoriasis, rashes, crusty scabby skin, or broken skin are more likely to experience the dangerous effects of lindane. These people should use lindane only if a doctor decides it is really needed.Lindane should not be used to treat premature babies or people who have or have ever had seizures, especially if the seizures are hard to control.Lindane is poisonous if too much is used or if it is used for too long or too often. Your doctor will tell you exactly how to use lindane. Follow these directions carefully. Do not use more lindane or leave the lindane on for a longer time than you are told. Do not use a second treatment of lindane even if you still have symptoms. You may be itchy for several weeks after your lice or scabies are killed. |
Why is this medication prescribed?
Lindane is used to cure infestations of scabies (small bugs that crawl under the skin and cause severe itching) and lice (small bugs that attach themselves to the skin on the head or pubic area ('crabs') and lay eggs called nits in the hair). Lindane is in a class of medications called scabicides and pediculicides. It works by killing the bugs and their eggs.
Lindane does not stop you from getting scabies or lice. You should only use lindane if you already have these conditions, not if you are afraid that you may become infested.
How should this medicine be used?
Lindane comes as a lotion to apply to the skin and a shampoo to apply to the hair and scalp. It should only be used once and then should not be used again for a long time. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use lindane exactly as directed. Do not use more or less of it or use it more often than directed by your doctor.
Before using lindane, ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and read it carefully.
Lindane should only be used on the skin and hair. Never apply lindane to your mouth and never swallow it. Avoid getting lindane into your eyes.
When you apply lindane to yourself or someone else, wear gloves made of nitrile, sheer vinyl, or latex with neoprene. Do not wear gloves made of natural latex because they will not prevent lindane from reaching your skin. Throw away your gloves and wash your hands well when you are finished.
After using lindane, sanitize all the clothing, underwear, pajamas, sheets, pillowcases, and towels you have used recently. These items should be washed in very hot water or dry-cleaned.
Itching may still occur after successful treatment. Do not reapply lindane.
Lindane lotion is used only to treat scabies. Do not use it to treat lice. To use the lotion, follow these steps:
- Your fingernails should be trimmed short and your skin should be clean, dry, and free of other oils, lotions, or creams. If you need to bathe or shower, wait 1 hour before applying lindane to allow your skin to cool.
- Shake the lotion well.
- Put some lotion on a toothbrush. Use the toothbrush to apply the lotion under your fingernails. Wrap the toothbrush in paper and throw it away. Do not use this toothbrush to brush your teeth because it may harm you.
- Apply a thin layer of lotion all over your skin from your neck down to your toes (including the soles of your feet). You might not need all the lotion in the bottle.
- Close the lindane bottle tightly and throw it away in a trashcan that is out of the reach of children. Do not save leftover lotion to use later.
- You may dress in loose fitting clothing, but do not wear tight or plastic clothing or cover your skin with blankets. Do not put plastic lined diapers on a baby who is being treated.
- Leave the lotion on your skin for 8-12 hours, but no longer. If you leave the lotion on longer, it will not kill any more scabies, but it may cause seizures or other serious problems. Do not let anyone else touch your skin during this time. Other people may be harmed if their skin touches the lotion on your skin.
- After 8-12 hours have passed, wash off all of the lotion with warm water. Do not use hot water.
Lindane shampoo is used only for pubic lice (crabs) and head lice. Do not use the shampoo if you have scabies. To use the shampoo, follow these steps:
- Wash your hair with your regular shampoo at least 1 hour before applying lindane and dry it thoroughly. Do not use any creams, oils, or conditioners.
- Shake the shampoo well. Apply just enough shampoo to make your hair, scalp, and the small hairs on the back of your neck wet. If you have pubic lice, apply the shampoo to the hair in your pubic area and the skin underneath. You might not need all of the shampoo in the bottle.
- Close the lindane bottle tightly and throw it away in a trashcan that is out of the reach of children. Do not save leftover shampoo to use later.
- Leave the lindane shampoo on your hair for exactly 4 minutes. Keep track of the time with a watch or clock. If you leave the lotion on for longer than 4 minutes, it will not kill any more lice, but it may cause seizures or other serious problems. Keep your hair uncovered during this time.
- At the end of 4 minutes, use a small amount of warm water to lather the shampoo. Do not use hot water.
- Wash all of the shampoo off of your hair and skin with warm water.
- Dry your hair with a clean towel.
- Comb your hair with a fine tooth comb (nit comb) or use tweezers to remove nits (lice eggs and larvae). You will probably need to ask someone to help you with this, especially if you have head lice.
Other uses for this medicine
This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using lindane,
- tell your doctor and pharmacist if you are allergic to lindane or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antidepressants (mood elevators); antibiotics such as cinoxacin (Cinobac), ciprofloxacin (Cipro), enoxacin (Penetrex), gatifloxacin (Tequin), imipenem/cilastin (Primaxin), levofloxacin (Levaquin), lomefloxacin (Maxequin), moxifloxacin (Avelox), nalidixic acid (NegGram), norfloxacin (Noroxin), ofloxacin (Floxin), penicillin, sparfloxacin (Zagam) and trovofloxacin and alatrofloxacin combination (Trovan); chloroquine sulfate; isoniazid (INH, Laniazid, Nydrazid); medications for mental illness; medications that suppress the immune system such as cyclosporine (Neoral, Sandimmune), mycophenolate mofetil (CellCept), and tacrolimus (Prograf); mepiridine (Demerol); methocarbamol (Robaxin); neostigmine (Prostigmin); pyridostigmine (Mestinon, Regonol); pyrimethamine (Daraprim), radiographic dyes; sedatives; sleeping pills; tacrine (Cognex); and theophylline (TheoDur, Theobid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- in addition to the conditions mentioned in the IMPORTANT WARNING section, tell your doctor if you have or have ever had human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); seizures; a head injury; a tumor in your brain or spine; or liver disease. Also tell your doctor if you drink, used to drink, or have recently stopped drinking large amounts of alcohol and if you have recently stopped using sedatives (sleeping pills).
- tell your doctor if you are pregnant or are breast-feeding. If you are pregnant, wear gloves when applying lindane to another person to prevent its absorption through your skin. If you are breast-feeding, pump and discard your milk for 24 hours after you use lindane. Feed your baby stored breastmilk or formula during this time, and do not allow your baby's skin to touch the lindane on your skin.
- tell your doctor if you have recently used lindane.
- if you have scabies or pubic lice, tell your doctor if you have a sexual partner. This person should also be treated so he or she will not reinfect you. If you have head lice, all people who live in your household or who have been in close contact with you may need to be treated. Do not share your medication with other people because it may harm them.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What side effects can this medication cause?
Lindane may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- skin rash
- itching or burning skin
- dry skin
- numbness or tingling of the skin
- hair loss
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- headache
- dizziness
- drowsiness
- shaking of your body that you cannot control
- seizures
Lindane may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or that remains after treatment. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
If you accidentally get lindane in your mouth, call your local poison control center right away to find out how to get emergency help. If lindane gets into your eyes, wash them with water right away and get medical help if they are still irritated after washing.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else use your medication. Your prescription is not refillable. See your doctor if you feel you need additional treatment.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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