کروتامیتان
Crotamiton Cream, Lotion (Eurax)
کروتامیتان

نام ژنریک

Crotamiton

شکل دارویی

اشكال دارويي:


Cream: 10%

موارد مصرف

موارد و مقدار مصرف


الف) جرب‌كش.


بزرگسالان و كودكان: بيمار بدن خود را به طور كامل شسته و پوسته‌هاي شل را از بدن زدوده و بعد با حوله خشك مي‌كند. دارو را به طور كامل بر تمام سطح بدن، از چانه تا انگشتان شست پا (با توجه بخصوص به نقاط چين‌دار پوست و مابين انگشتان) مي‌مالد. اين عمل را مي‌توان 24 ساعت بعد تكرار كرد. 48 ساعت بعد از آخرين بار مصرف دارو، بيمار حمام كرده و تن خود را پاك مي‌كند.


ب) ضد خارش.


بزرگسالان و كودكان: دارو به طور موضعي 3-2 بار در روز به كار مي‌رود.

موارد منع مصرف

عوارض جانبي


موضعي: تحريک، درماتيت تماسي.


توجه: در صورت بروز حساسيت، بايد مصرف دارو قطع شود

موارد قابل توجه

-

تداخل دارویی

ملاحظات اختصاصي


از مصرف کروتاميتون در چشم‌ها، صورت، غشاهاي مخاطي، يا دهانه مجراي ادراري با يد خودداري شود.


ممکن است جداسازي بيماران از سايرين و مراقبت مخصوص از آنها تا درمان کامل ضروري باشد.


در صورت بروز تحريک يا حساسيت مفرط، بايد مصرف دارو قطع شده و با آب و صابون از بدن شسته شود.


هنگام مصرف، پوست بدن بايد خشک باشد.

مکانیزم اثر

ملاحظات اختصاصي


از مصرف کروتاميتون در چشم‌ها، صورت، غشاهاي مخاطي، يا دهانه مجراي ادراري با يد خودداري شود.


ممکن است جداسازي بيماران از سايرين و مراقبت مخصوص از آنها تا درمان کامل ضروري باشد.


در صورت بروز تحريک يا حساسيت مفرط، بايد مصرف دارو قطع شده و با آب و صابون از بدن شسته شود.


هنگام مصرف، پوست بدن بايد خشک باشد.

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد منع مصرف: سابقه حساسيت مفرط به دارو، تحريك اوليه بعد از مصرف دارو.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: نمك صناعي كلروفورمات.


طبقه‌بندي درماني: جرب‌كش و ضد خارش.


طبقه‌بندي مصرف در بارداري: رده C


نکات قابل توصيه به بيمار


کليه لباس‌ها و ملحفه‌هاي استفاده شده توسط بيمار بايد با آب داغ شسته و در دستگاه خشک کن داغ خشک شود.


در صورت شسته شدن اتفاقي دارو ، آن را مجدداً مصرف کنيد، ولي از مصرف بيش از حد آن خودداري کنيد.


ممکن است بعد از درمان خارش ادامه يابد.


در صورت بروز تحريک موضعي و حساسيت، مصرف دارو را قطع کنيد.

Crotamiton Cream, Lotion (Eurax)

Eurax
(crotamiton USP) Lotion/Cream

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIIC, ORAL, OR INTRAVAGINAL USE

DRUG DESCRIPTION

Eurax (crotamiton USP) is a scabicidal and antipruritic agent available as a cream or lotion for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton USP, in a vanishing-cream or emollient-lotion base containing: water, petrolatum, propylene glycol, steareth-2, cetyl alcohol, dimethicone, laureth-23, fragrance, magnesium aluminum silicate, carbomer-934, sodium hydroxide, diazolidinylurea, methylchloroisothiazolinone, methylisothiazolinone and magnesium nitrate. In addition, the cream contains glyceryl stearate. Crotamiton is N-ethyl-N-(o-methylphenyl) -2-butenamide and its structural formula is:

Eurax (crotamiton) Structural Formula Illustration

Crotamiton USP is a colorless to slightly yellowish oil, having a faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203.28.

What are the possible side effects of crotamiton (Eurax)?

Serious side effects are not likely to occur. Stop using crotamiton topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Mild itching, burning, or stinging may occur upon application.

Notify your doctor if your condition worsens or if unusual itching, redness, swelling, burning, or a rash occurs.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You...

Read All Potential Side Effects and See Pictures of Eurax »

What are the precautions when taking crotamiton cream, lotion (Eurax)?

Before using crotamiton, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Eurax »

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

For eradication of scabies (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.

DOSAGE AND ADMINISTRATION

In Scabies: Thoroughly massage into the skin of the whole body from the chin down, paying particular attention to all folds and creases. A second application is advisable 24 hours later. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application.

In Pruritus: Massage gently into affected areas until medication is completely absorbed. Repeat as needed.

LOTION: Shake well before using.

DIRECTIONS FOR PATIENTS WITH SCABIES:

  1. Take a routine bath or shower. Thoroughly massage Eurax (crotamiton cream, lotion) cream or lotion into the skin from the chin to the toes including folds and creases.
  2. Put Eurax (crotamiton cream, lotion) cream or lotion under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the Eurax (crotamiton cream, lotion) cream or lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the same brush in the mouth could lead to poisoning.
  3. A second application is advisable 24 hours later.
  4. This 60 gram tube or bottle is sufficient for two applications.
  5. Clothing and bed linen should be changed the next day. Contaminated clothing and bed linen may be dry-cleaned, or washed in the hot cycle of the washing machine.
  6. A cleansing bath should be taken 48 hours after the last application.

HOW SUPPLIED

Eurax (crotamiton USP)

Cream: 60g tubes (NDC 0072-2103-60; NSN 6505-00-116-0200).

Lotion: 60g (2 oz.) bottles (NDC 0072-2203-60, NSN 6505-01-153- 4423).
454g (16 oz.) bottles (NDC 0072-2203-16).

SHAKE WELL before using.

Store at room temperature.

Keep out of reach of children.

Westwood-Squibb Pharmaceuticals, Inc. A Bristol-Myers Squibb Company, Princeton, NJ 08543, USA. FDA Rev date: 6/26/2003

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Primary irritation reactions, such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients.

Read the Eurax (crotamiton cream, lotion) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

None known.

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.

PRECAUTIONS

General

Eurax (crotamiton cream, lotion) should not be applied in the eyes or mouth because it may cause irritation. It should not be applied to acutely inflamed skin or raw or weeping surfaces until the acute inflammation has subsided.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in animals have not been conducted.

Pregnancy (Category C)

Animal reproduction studies have not been conducted with Eurax (crotamiton cream, lotion) . It is also not known whether Eurax (crotamiton cream, lotion) can cause fetal harm when applied topically to a pregnant woman or can affect reproduction capacity. Eurax (crotamiton cream, lotion) should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies with Eurax (crotamiton USP) Lotion/Cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There is no specific information on the effect of overtreatment with repeated topical applications in humans. A death was reported but cause was not confirmed.

Accidental oral ingestion may be accompanied by burning sensation in the mouth, irritation of the buccal, esophageal and gastric mucosa, nausea, vomiting, abdominal pain.

If accidental ingestion occurs, call your Poison Control Center.

CONTRAINDICATIONS

Eurax (crotamiton cream, lotion) should not be applied topically to patients who develop a sensitivity or are allergic to it or who manifest a primary irritation response to topical medications.

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Eurax (crotamiton cream, lotion) has scabicidal and antipruritic actions. The mechanisms of these actions are not known. The pharmacokinetics of crotamiton and its degree of systemic absorption following topical application have not been determined.

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

See DIRECTIONS FOR PATIENTS WITH SCABIES.

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

See DIRECTIONS FOR PATIENTS WITH SCABIES.

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Eurax Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CROTAMITON - TOPICAL

(crow-TAM-it-un)

COMMON BRAND NAME(S): Eurax

USES: This medication is used to treat scabies. Scabies is a skin infection caused by mites that burrow into the skin. Irritation from the mites leads to severe itching and small bumps/blisters filled with fluid/pus. Crotamiton works by killing the mites that cause scabies. It also helps relieve itching related to scabies and other skin conditions. Crotamiton belongs to two classes of drugs: scabicides and antipruritics.

HOW TO USE: This medication is for use on the skin only. Do not take this medication by mouth. Avoid applying crotamiton on the face, eyes, mouth, vagina, and any skin that is inflamed, raw, or oozing fluid.

If you are using the lotion, shake the bottle thoroughly before use.

To treat scabies, take a bath or shower before using this medication. Remove scaly or crusted skin by rubbing gently. Then dry with a towel. Massage a thin layer of the cream or lotion into all skin from the chin down to the toes, including skin folds/creases, between the fingers and toes, and on the soles of the feet. Trim fingernails short and apply the medication under the nails since the mites often live there. You may use a toothbrush to apply the medication under the fingernails. Immediately after use, wrap the toothbrush in paper and throw it away. Do not use the same toothbrush in the mouth because it may lead to poisoning.

Apply the medication again after 24 hours. Change clothing, towels, and bed sheets the next morning after each application. Wash all clothing, towels, and bedding that have been used in the 3 days before treatment and after each application in hot water and dry in a hot dryer (or dry-clean) to kill all the mites and prevent them from returning. Items that cannot be washed or dry-cleaned should be removed from contact with the body for at least 72 hours.

Take a bath 48 hours after the last application to remove the medication from your skin.

To treat other itching skin conditions besides scabies, massage a thin layer gently into the affected areas until the medication is completely absorbed. Repeat as needed, as directed by your doctor, usually 2 to 3 times a day.

After treating scabies, you may still have itching for several weeks. Ask your doctor about other medications that may help to soothe the itching. Tell your doctor if your condition persists or if it worsens.

Disclaimer

Eurax Consumer (continued)

SIDE EFFECTS: Worsening skin irritation (such as itching, redness) may occur. If any of these effects persist or worsen, stop using this medication and tell your doctor or pharmacist promptly.

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.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

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

Read the Eurax (crotamiton cream, lotion) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using crotamiton, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Eurax Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. If this product is swallowed, symptoms of overdose may include: irritation/burning feeling in the mouth/throat, nausea, vomiting, stomach/abdominal pain.

NOTES: Do not share this medication with others.

If you are being treated for scabies, ask your doctor if people you spent much time with during the previous month (such as household members, sexual partners) should also be checked and treated for scabies.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C). 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 for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Eurax Patient Information Including Side Effects

Brand Names: Eurax

Generic Name: crotamiton topical (Pronunciation: crow TA mi ton)

What is crotamiton topical (Eurax)?

Crotamiton is a scabicide. The exact way that crotamiton works is unknown.

Crotamiton topical is used to treat scabies and to reduce itching associated with certain conditions.

Crotamiton topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of crotamiton (Eurax)?

Serious side effects are not likely to occur. Stop using crotamiton topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Mild itching, burning, or stinging may occur upon application.

Notify your doctor if your condition worsens or if unusual itching, redness, swelling, burning, or a rash occurs.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Eurax (crotamiton cream, lotion) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about crotamiton topical (Eurax)?

Do not take this medication by mouth.

Do not use more of this medication than is recommended.

Avoid application to the mouth, nose, or eyes.

Treat sexual and other close contacts who are also infected.

To prevent reinfection, wash all clothing, hats, bed clothes, bed linens, hair brushes, and combs with a strong cleanser in hot water to remove any mites or eggs.

Side Effects Centers

Eurax Patient Information including How Should I Take

Who should not use crotamiton topical (Eurax)?

Do not use this medication if you have ever had an allergic reaction to it.

Crotamiton topical is in the pregnancy category C. This means that it is not known whether crotamiton topical will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant.

It is also not known whether crotamiton passes into breast milk. Do not use crotamiton topical without first talking to your doctor if you are breast-feeding a baby.

How should I use crotamiton topical (Eurax)?

Use crotamiton topical exactly as directed by your doctor, or follow the directions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Never use more of this medication than is recommended.

To treat scabies:

  • Shake the lotion well before use. Apply a thin layer of the cream or lotion to all body parts from the neck down to the soles of your feet (scabies does not usually infect the head). Apply the medication to dry skin and rub it in well. Leave the medication on for 24 hours, then, without washing, apply a second dose. Thoroughly wash off the medication 48 hours after the last application.

To treat itching:

  • Massage the medication into the affected areas until it is completely absorbed. Repeat as necessary or as directed.

Do not apply this medication to the eyes, nose, or mouth. Flush with water if you get medication in any of these areas.

Do not apply crotamiton topical to open cuts or wounds. Doing so could cause too much medication to be absorbed by your body, which could be very dangerous.

To prevent reinfection, wash all clothing, hats, bed clothes, bed linens, hair brushes, and combs with a strong cleanser in hot water to remove any mites or eggs.

Store crotamiton topical at room temperature away from moisture and heat.

Side Effects Centers

Eurax Patient Information including If I Miss a Dose

What happens if I miss a dose (Eurax)?

Two doses of crotamiton topical, 24 hours apart, are recommended. If the second dose is messed, retreatment may be necessary. Contact your doctor or pharmacist if you miss a dose.

What happens if I overdose (Eurax)?

Seek emergency medical attention.

Symptoms of a crotamiton topical overdose (after ingestion) include a burning feeling in the mouth; irritation or inflammation of the mouth, throat, and stomach lining; nausea; vomiting; and abdominal pain.

What should I avoid while taking crotamiton (Eurax)?

Avoid sexual or intimate contact with others until the infection has been cured. Also avoid sharing hair combs, hair accessories, hats, clothing, bed linens, and other articles of personal use. The infections are highly contagious.

Do not use more of this medication than is directed, and do not apply it to the facial area. Using too much of this medication could be very dangerous.

Do not apply crotamiton topical to open cuts or wounds. Doing so could cause too much medication to be absorbed by your body, which could be very dangerous.

What other drugs will affect crotamiton (Eurax)?

Do not apply other topical preparations to the affected area during treatment with crotamiton topical.

Drugs other than those listed here may also interact with crotamiton topical. Ask your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about crotamiton topical written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.05. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

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