Sample PLR Content Directory Idaho

Sunday, 19 August 2012

incobotulinumtoxina Intramuscular

in-koe-bot-ue-LYE-num-tox-in-ay

Intramuscular route(Powder for Solution)

The effects of incobotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. Cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses .

Commonly used brand name(s)

In the U.S.

Xeomin

Available Dosage Forms:

Powder for Solution

Pharmacologic Class: Botulinum Toxin Type A

Uses For incobotulinumtoxina

IncobotulinumtoxinA is used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). incobotulinumtoxina is also used to treat certain eye condition called blepharospasm (a condition where the eyelid will not stay open because of a muscle spasm) in patients who have already been treated with onabotulinumtoxinA (Botox®). IncobotulinumtoxinA is also used cosmetically to improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines).

IncobotulinumtoxinA is a botulinum toxin A product. It works on the nervous system to relax the muscles.

incobotulinumtoxina is available only with your doctor's prescription and will be administered by your doctor.

Before Using incobotulinumtoxina

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For incobotulinumtoxina, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to incobotulinumtoxina or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of incobotulinumtoxinA in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of incobotulinumtoxinA in the elderly. However, elderly patients are more likely to have side effects such as difficulty with swallowing, lack or loss of strength, or dizziness, which may require caution in patients receiving incobotulinumtoxinA.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of incobotulinumtoxina

Your doctor will give you incobotulinumtoxina in a hospital or clinic setting. incobotulinumtoxina is given as a shot into one of your muscles.

incobotulinumtoxina should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Your doctor will only use incobotulinumtoxinA (Xeomin®) to treat your condition. Other botulinum toxin products may not work the same way.

Precautions While Using incobotulinumtoxina

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Serious muscle reactions have been reported within hours to weeks after receiving incobotulinumtoxina. If you start to have muscle weakness, loss of bladder control, or trouble with swallowing, talking, or breathing, call your doctor right away. In some situations, these problems could be life-threatening and may require treatment in a hospital or clinic.

incobotulinumtoxina may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using incobotulinumtoxina.

incobotulinumtoxina may make your muscles weak and cause vision problems. Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well.

incobotulinumtoxina may reduce blinking of the eye which can lead to an increased risk of eye problems (such as corneal exposure and ulcers). Tell your doctor right away if you have a reduced blinking of the eye.

After you have received incobotulinumtoxina and your vision or muscle spasms are better, you may find that you are a lot more active than you were before. You should slowly increase your activities to allow time for your body to get stronger. Also, before you start an exercise program, check with your doctor.

One part of incobotulinumtoxina is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

incobotulinumtoxina Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common—for cervical dystonia

Difficulty with swallowing

muscle or bone pain

muscle weakness

pain in the neck

More common—for blepharospasm

Dry eyes

Rare—for glabellar lines

Itching, pain, redness, or swelling at the injection site

pain in the face

swelling of the eyelids

Incidence not known

Changes in patterns and rhythms of speech

fast heartbeat

fever

hives

hoarseness

irritation

itching

joint pain, stiffness, or swelling

muscle spasm

pain at the injection site

rash

redness of the skin

shortness of breath

slurred speech

swelling of the eyes or eyelids

swelling of the face, lips, hands, or feet

tightness in the chest

trouble with speaking

troubled breathing or swallowing

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common—for cervical dystonia

Chills

cough

lower back or side pain

painful or difficult urination

More common—for blepharospasm

Blurred vision

diarrhea

drooping upper eyelids

dry mouth

headache

Less common—for blepharospasm

Difficult or labored breathing

muscle aches

sneezing

sore throat

stuffy or runny nose

unusual tiredness or weakness

Rare—for glabellar lines

Drooping of the eyelids

increased blinking

twitching of the eyelids

Incidence not known

Difficulty with moving

joint pain

muscle aching or cramping

muscle pains or stiffness

nausea

painful blisters on the trunk of the body

swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: incobotulinumtoxina Intramuscular side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More incobotulinumtoxina Intramuscular resources

Incobotulinumtoxina Intramuscular Side Effects (in more detail)
Incobotulinumtoxina Intramuscular Use in Pregnancy & Breastfeeding
Incobotulinumtoxina Intramuscular Drug Interactions
Incobotulinumtoxina Intramuscular Support Group
0 Reviews for Incobotulinumtoxina Intramuscular - Add your own review/rating

Compare incobotulinumtoxina Intramuscular with other medications

Blepharospasm
Cervical Dystonia
Facial Wrinkles

Monday, 13 August 2012

incobotulinumtoxinA

Generic Name: incobotulinumtoxinA (IN koe BOT ue LYE num TOX in A)

Brand Names: Xeomin

What is incobotulinumtoxinA?

IncobotulinumtoxinA, also called botulinum toxin type A, is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

IncobotulinumtoxinA is used to treat cervical dystonia (severe spasms in the neck muscles).

IncobotulinumtoxinA is also used to treat certain eye muscle conditions caused by nerve disorders. This includes uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes do not point in the same direction.

IncobotulinumtoxinA may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about incobotulinumtoxinA?

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection. Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

You should not receive this medication if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.

Before receiving a botulinum toxin injection, tell your doctor if you have ALS (Lou Gehrig's disease), myasthenia gravis, Lambert-Eaton syndrome, a breathing disorder, trouble swallowing, facial muscle weakness, a change in the appearance of your face, seizures, bleeding problems, heart disease, if you have had or will have surgery, or if you have ever received other botulinum toxin injections such as Botox, Dysport, or Myobloc.

What should I discuss with my healthcare provider before taking incobotulinumtoxinA?

You should not receive this medication if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected. Tell your doctor if you have ever had a side effect after receiving a botulinum toxin in the past

To make sure you can safely receive incobotulinumtoxinA, tell your doctor if you have any of these other conditions:

amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");

myasthenia gravis;

Lambert-Eaton syndrome;

a breathing disorder such as asthma or emphysema;

problems with swallowing;

facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);

a change in the normal appearance of your face;

a seizure disorder;

bleeding problems;

heart disease;

if you have had or will have surgery (especially on your face); or

if you have ever received other botulinum toxin injections such as Botox, Dysport, or Myobloc (especially in the last 4 months).

IncobotulinumtoxinA is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether botulinum toxin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether botulinum toxin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is incobotulinumtoxinA given?

This medication is injected into a muscle. A doctor, nurse, or other healthcare provider will give you this injection. IncobotulinumtoxinA injections should be spaced at least 3 months apart.

Botulinum toxin injections should be given only by a trained medical professional.

Your injection may be given into more than one area at a time, depending on the condition being treated.

While receiving botulinum toxin injections for an eye muscle conditions, you may need to use eye drops, ointment, a special contact lens or other device to protect the surface of your eye. Follow your doctor's instructions.

It may take up to 7 days after injection before neck muscle spasm symptoms begin to improve.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin. Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

What happens if I miss a dose?

Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may not appear right away, but can include severe muscle weakness, trouble swallowing, weak or shallow breathing, or loss of movement in any part of your body.

What should I avoid while taking incobotulinumtoxinA?

This medication may impair your vision or depth perception. Be careful if you drive or do anything that requires you to be able to see clearly.

Avoid going back to your normal physical activities too quickly after receiving an injection.

IncobotulinumtoxinA side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an injection:

trouble breathing, talking, or swallowing;

hoarse voice, drooping eyelids;

blurred vision, double vision;

unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

loss of bladder control;

wheezing, tightness in your chest;

eye pain or irritation;

severe skin rash or itching; or

feeling like you might pass out.

Less serious side effects may include:

neck pain;

dry eyes;

headache, tired feeling;

diarrhea;

eyelid swelling or bruising, blinking less than usual; or

pain, redness, or swelling where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

IncobotulinumtoxinA Dosing Information

Usual Adult Dose for Cervical Dystonia:

Initial total dose: 120 Units

In a placebo-controlled trial utilizing initial incobotulinumtoxinA doses of 120 Units and 240 Units, no meaningful difference in effectiveness was demonstrated between the doses.

In previously treated patients, their past dose, response to treatment, duration of effect, and adverse event history should be taken into consideration when determining the incobotulinumtoxinA dose.

In the treatment of cervical dystonia, incobotulinumtoxinA is usually injected into the sternocleidomastoid, levator scapulae, splenius capitis, scalenus, and/or the trapezius muscle(s). This list is not exhaustive, as any of the muscles responsible for controlling head position may require treatment. The dose and number of injection sites in each treated muscle should be individualized based on the number and location of the muscle(s) to be treated, the degree of spasticity/dystonia, muscle mass, body weight, and response to any previous botulinum toxin injections.

The frequency of incobotulinumtoxinA repeat treatments should be determined by clinical response, but should generally be no more frequent than every 12 weeks.

Usual Adult Dose for Blepharospasm:

The recommended initial total dose of incobotulinumtoxinA should be the same dose as the patient's previous treatment of onabotulinumtoxinA (Botox), although responses to incobotulinumtoxinA and onabotulinumtoxinA (Botox) may differ in individual patients.

In a placebo-controlled trial in which patients were dosed with the same number of Units as they had received previously with onabotulinumtoxinA (Botox), the mean dose per eye was about 33 Units (range 10 to 50 Units), and the mean number of injections per eye was 6. The maximum dose per eye in the controlled trials was 50 Units, with a range of 10 to 50 Units. In the controlled trial, few patients received a total dose of greater than 75 Units.

If the previous dose of Botox is not known, the initial dose of incobotulinumtoxinA should be between 1.25 to 2.5 Units/injection site.

The total initial dose of incobotulinumtoxinA in both eyes should not exceed 70 Units (35 Units/eye).

The number and location of injection sites should be based on the severity of blepharospasm, and previous dose and response to onabotulinumtoxinA (Botox) injections. Subsequent dosing should be tailored to the individual patient, based on response, up to a maximum dose of 35 Units per eye.
IncobotulinumtoxinA dosing has not been established in patients with blepharospasm who have not been previously treated with onabotulinumtoxinA (Botox).

The frequency of incobotulinumtoxinA repeat treatments should be determined by clinical response but should generally be no more frequent than every 12 weeks.

Usual Adult Dose for Glabellar Lines:

The total recommended incobotulinumtoxinA dose is 20 units per treatment session divided into five equal intramuscular injections of 4 units each. The five injection sites are: 2 injections in each corrugator muscle and 1 injection in the procerus muscle.

Retreatment with incobotulinumtoxinA should be administered no more frequently than every 3 months.

What other drugs will affect incobotulinumtoxinA?

Other medications such as cold or allergy medicine, muscle relaxers, sleeping pills, bronchodilators, bladder or urinary medicines, and irritable bowel medicines can increase some of the side effects of incobotulinumtoxinA. Tell your doctor if you regularly use any of these medications.

Tell your doctor about all other medications you have recently used, especially:

a blood thinner such as warfarin (Coumadin, Jantoven); or

an injected antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), paromomycin (Humatin, Paromycin), streptomycin, tobramycin (Nebcin, Tobi).

This list is not complete and there may be other drugs that can interact with incobotulinumtoxinA. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More incobotulinumtoxinA resources

IncobotulinumtoxinA Side Effects (in more detail)
IncobotulinumtoxinA Use in Pregnancy & Breastfeeding
IncobotulinumtoxinA Drug Interactions
IncobotulinumtoxinA Support Group
0 Reviews for IncobotulinumtoxinA - Add your own review/rating

IncobotulinumtoxinA Professional Patient Advice (Wolters Kluwer)

IncobotulinumtoxinA MedFacts Consumer Leaflet (Wolters Kluwer)

Xeomin Prescribing Information (FDA)

Xeomin Consumer Overview

incobotulinumtoxina Intramuscular Advanced Consumer (Micromedex) - Includes Dosage Information

Compare incobotulinumtoxinA with other medications

Blepharospasm
Cervical Dystonia
Facial Wrinkles

Where can I get more information?

Your doctor or pharmacist can provide more information about incobotulinumtoxinA.

See also: incobotulinumtoxinA side effects (in more detail)

Saturday, 11 August 2012

Podofilox

Class: Skin and Mucous Membrane Agents, Miscellaneous
ATC Class: D06BB04
VA Class: DE500
Chemical Name: [5R - (5α,5aβ,8aα,9α)] - 5,8,8a,9 - Tetrahydro - 9 - hydroxy - 5 - (3,4,5 - trimethoxyphenyl) - furo[3′,4′:6,7[naphtho[2,3 - d]]] - 1,3 - dioxol - 6(5aH) - one
Molecular Formula: C₂₂H₂₂O₈
CAS Number: 518-28-5
Brands: Condylox

Introduction

Antimitotic agent.¹ ² ⁶ ³¹ ⁴⁴

Uses for Podofilox

Human Papillomavirus (HPV) Infections

Treatment of external genital and perianal exophytic warts (condylomata acuminata) caused by HPV.¹ ² ⁵ ⁷ ⁹ ¹⁰ ¹² ¹³ ¹⁴ ¹⁶ ²¹ ²² ²³ ²⁴ ²⁵ ²⁶ ²⁷ ²⁸ ⁴⁴ ⁴⁵ ⁴⁶

CDC and others recommend that external HPV warts be treated with a self-administered topical therapy (podofilox, imiquimod), a topical therapy administered by a health-care provider (podophyllum resin, trichloroacetic acid [TCA], bichloroacetic acid [BCA]), or a surgical technique (cryotherapy, electrosurgery, surgical excision).⁵ ⁶ ¹⁵ ²⁰ ²² Alternative therapies include intralesional interferon alfa or laser surgery.²²

A preferred treatment regimen for external genital HPV warts in HIV-infected adults and adolescents;⁴⁵ response rate may be lower than in those without HIV infection.³⁴ An alternative treatment regimen for external HPV warts in HIV-infected children†; topical therapies often are ineffective in such children and a surgical technique (cryotherapy, electrosurgery) usually is preferred.⁴⁶

Primary goal is destruction or clearance of visible, symptomatic warts.⁴ ⁵ ⁶ ²² No regimen has been shown to eradicate HPV or affect natural history of HPV infection;³ ⁴ ⁶ ¹⁶ ¹⁹ ²² effect on transmission of HPV unknown.²²

Should not be used to treat subclinical genital HPV infection (without exophytic warts).²² Should not be used to treat squamous cell carcinoma.¹ ² ⁴⁴

Safety and efficacy for treatment of urethral, intravaginal, cervical, rectal, anal, or oral HPV warts have not been established.¹ ² ²² ³² ⁴⁰ Some clinicians suggest use of podofilox for treatment of distal meatal HPV warts†, but data are limited.²²

Molluscum Contagiosum

Has been effective in a limited number of children†, adolescents, and adults for treatment of molluscum contagiosum†.³³ ³⁵ ³⁶

Podofilox Dosage and Administration

Administration

Topical Administration

Apply topically to skin as a 0.5% gel¹ or 0.5% solution.² ⁴⁴

Topical gel and solution are intended for external use only.¹ ² ⁴⁴ Topical gel may be applied to genital and anogenital areas;¹ topical solution should be applied only to the genital area.² ⁴⁴

Suitable for self-administration.¹ ² ⁴⁴ The initial dose preferably should be applied by a clinician to ensure that patient understands correct administration techniques and to identify specific warts that should be treated.¹ ² ¹⁶ ²² ⁴⁴

Apply the gel to external genital and perianal warts using the applicator tip or fingers.¹ ²² Apply the solution to external genital warts using a disposable applicator supplied with the solution;² ²² ⁴⁴ use a new applicator each time the solution is applied.² ⁴⁴

Avoid applying podofilox to surrounding normal tissue; allow the gel or solution to dry before opposing skin surfaces are returned to their normal position.¹ ² ⁴⁴

Do not use occlusive dressings or wrappings.³² ⁴⁰

Avoid contact with the eyes.¹ ² ⁴⁴ If contact occurs, patient should wash affected eye(s) with large amounts of water and consult a clinician.¹ ² ⁴⁴

Wash hands before and after applying the gel or solution.¹ ²

Do not wash podofilox off the treatment area, unless a severe adverse reaction (e.g., bleeding, swelling, excessive pain, burning, or itching) occurs.⁴² ⁴³ ⁴⁷

Dosage

Pediatric Patients

HPV Infections

External Genital HPV Warts

Topical

HIV-infected children†: Apply 0.5% gel or solution to affected area twice daily (morning and evening) for 3 consecutive days followed by 4 consecutive days without treatment.⁴⁶ This weekly cycle may be repeated until there are no visible warts or for a maximum of 4 cycles (4 weeks).⁴⁶ If response is incomplete after 4 treatment cycles, discontinue the drug and consider alternative therapy.⁴⁶

Adults

HPV Infections

External Genital and Perianal HPV Warts

Topical

Genital HPV warts: Apply 0.5% gel or solution to affected area twice daily (morning and evening) for 3 consecutive days followed by 4 consecutive days without treatment.¹ ² ²² ⁴⁴ This weekly cycle may be repeated until there are no visible warts or for a maximum of 4 cycles (4 weeks).¹ ² ²² ⁴⁴ If response is incomplete after 4 treatment cycles, discontinue the drug and consider alternative therapy.¹ ² ⁴⁴

Perianal HPV warts: Apply 0.5% gel to affected area twice daily (morning and evening) for 3 consecutive days followed by 4 consecutive days without treatment.¹ ²² This weekly cycle may be repeated until there are no visible warts or for a maximum of 4 cycles (4 weeks).¹ ²² If response is incomplete after 4 treatment cycles, discontinue the drug and consider alternative therapy.¹

Follow-up examinations not generally required for patients self-administering podofilox, but may be useful several weeks after initiation of therapy to determine response to treatment, to monitor and treat complications of therapy, and provide additional patient education and counseling.²² A follow-up examination 3 months after completion of treatment may be beneficial since identification of external genital warts may be difficult.²²

Prescribing Limits

Adults

HPV Infections

External Genital and Perianal HPV Warts

Topical

Do not exceed recommended dose, frequency of application, and duration of treatment.¹ ² ⁴⁴

There is no evidence that more frequent application will increase efficacy; more frequent application may increase risk of local adverse reactions and increase systemic absorption of the drug.¹ ² ⁹ ³⁰

Maximum of 4 weeks (4 cycles) of therapy.¹ ² ²² ⁴⁴ Has been used for up to 6–8 consecutive cycles without unusual adverse effects,²³ ²⁷ ³² but safety and efficacy of >4 cycles have not been established.¹ ² ²² ⁴⁴

Total wart area being treated should not exceed 10 cm².¹ ² ²² ⁴⁴

Apply no more than 0.5 g of the gel or 0.5 mL of the solution daily.¹ ² ²² ⁴⁴

Special Populations

No special population dosage recommendations.

Cautions for Podofilox

Contraindications

Known hypersensitivity or intolerance to podofilox or any ingredient in the formulation.¹ ² ⁴⁴

Warnings/Precautions

Warnings

Differential Diagnosis

Correct diagnosis is essential.¹ ² ⁴⁴ Differentiating HPV warts from squamous cell carcinoma and bowenoid papulosis is particularly important.¹ ² ⁴⁴

Because HPV genital warts have a characteristic appearance, biopsy generally is necessary only if the diagnosis is uncertain, warts do not respond to standard therapies, the disease worsens during therapy, the patient is immunocompromised (e.g., HIV infection), and/or warts are pigmented, indurated, fixed, and ulcerated.²² ⁴⁵

General Precautions

Precautions Related to Treatment of External Genital and Perianal HPV Warts

Safety and efficacy for treatment of urethral, intravaginal, cervical, rectal, anal, or oral HPV warts not established.¹ ² ²² ³² ⁴⁰

Follow-up visits are not required for patients self-administering podofilox, but may be useful several weeks after initiation of therapy to determine response to treatment, to monitor and treat complications of therapy, and to provide additional patient education and counseling.²²

Follow-up examinations not mandatory if visible genital and perianal warts have cleared after treatment, but may be beneficial 3 months after treatment is completed since identification of external genital warts may be difficult.²²

Examination of sexual partners is not necessary for the management of genital HPV warts because data do not indicate that reinfection plays a role in recurrences and, in the absence of curative therapy, treatment to reduce transmission is not realistic.²² However, sexual partners of patients with genital HPV warts may benefit from examination to assess the presence of HPV warts or other sexually transmitted diseases and also may benefit from counseling about the implications of having a partner who has HPV warts.²²

HIV-infected individuals† may not respond as well and may have more frequent recurrences of genital HPV warts after treatment compared with immunocompetent individuals.²² ³⁴ ⁴⁵ ⁴⁶

Women with genital HPV warts should be advised to undergo regular Papanicolaou (Pap) tests as recommended for women without genital HPV warts.²²

Specific Populations

Pregnancy

Category C.¹ ² ⁴⁴

Lactation

Not known whether topically applied podofilox is distributed into human milk.¹ ² ⁴⁴ Discontinue nursing or the drug.¹ ² ⁴⁴

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹ ² ⁴⁰ ⁴⁴

In a study in pediatric patients 2–15 years of age† with molluscum contagiosum†, adverse effects reported following topical application of podofilox 0.5% solution to lesions once daily for 7–30 days included local burning, discomfort, pruritus, and erythema (which did not require discontinuance) and perilesional erythema, marked inflammatory reaction, and diarrhea with fever (which resulted in discontinuance in 3 children).³³

Common Adverse Effects

Adverse local reactions (generally mild to moderate burning, pain, inflammation, erosion, pruritus, bleeding, stinging, erythema),¹ ² ⁷ ⁹ ¹⁰ ¹² ¹³ ²¹ ²³ ⁴⁴ headache.¹

Podofilox Pharmacokinetics

Absorption

Bioavailability

Small amounts may be absorbed systemically following topical application.¹ ² ³³ ³⁹ ⁴⁴

Topical application of 0.05 mL of podofilox 0.5% solution to external genitalia resulted in undetectable serum concentrations of the drug;¹ ² ³⁹ ⁴⁴ topical application of 0.1–1.5 mL of the solution resulted in peak serum concentrations of 1–17 ng/mL at 1–2 hours after application.¹ ² ⁸ ³⁹ ⁴⁴

Does not appear to accumulate in serum following repeated topical application.¹ ² ⁸ ³³ ³⁹ ⁴⁴

Elimination

Half-life

Following systemic absorption, half-life is 1–4.5 hours.¹ ² ⁸ ³⁹ ⁴⁴

Stability

Storage

Topical

Gel

15–30°C.¹ ² ⁸ Keep away from open flames;¹ do not expose to excessive heat; avoid freezing.¹ ² ⁸

Solution

15–30°C.¹ ² ⁸ ⁴⁴ Do not expose to excessive heat; avoid freezing.¹ ² ⁸ ⁴⁴

ActionsActions

Topical application to external genital and perianal HPV warts generally results in necrosis of visible wart tissue.¹ ² ¹⁰ ⁴⁴ The effect on HPV warts may be related to interference with microtubular function of the keratinocytes contained in the warts and local vascular structures and also may be related to local immunomodulating effects.¹⁰ ³² ⁴⁰

Arrests mitosis in metaphase in a manner similar to that of colchicine.¹⁰ ³¹ Podofilox reversibly binds to tubulin, thereby preventing polymerization of tubulin into microtubules.⁹ ³¹ As a result of inhibition of microtubule formation, podofilox has a variety of biologic effects and, depending on the cell system, can stimulate or arrest cell proliferation and affect cell differentiation.³¹

Reportedly inhibits the mitogen response of human lymphocytes, inhibits growth factor-stimulated macrophage proliferation, and induces production of interleukin-1 (IL-1) and interleukin-2 (IL-2).¹⁰ ³¹

May have anti-inflammatory activity related to a decrease in tumor necrosis factor receptors.³¹

Advice to Patients

Importance of providing patient a copy of the manufacturer’s patient information.² ⁴⁴

Advise patients that podofilox is not a cure for HPV infection; new HPV warts may develop during or after therapy with the drug.¹ ² ²² Importance of patient watching for recurrences, particularly during the first 3 months.²²

Importance of not exceeding the recommended dosage or duration of therapy.⁴² ⁴³ ⁴⁴ Do not use more than twice daily, do not use >3 days in a row, and discontinue use and informing clinician if no improvement occurs after 4 weeks of treatment..⁴² ⁴³ ⁴⁴

Importance of reporting adverse reactions to the clinician.¹ ² If a severe adverse reaction (e.g., bleeding, swelling, excessive pain, burning, or itching) occurs, wash podofilox from the treatment area, discontinue the drug, and contact clinician.³² ⁴⁰ ⁴² ⁴³ ⁴⁴ ⁴⁷

Importance of carefully instructing the patient regarding proper techniques for application, including washing hands after each use.¹ ² ²² ⁴⁴ (See Topical Administration under Dosage and Administration.)

Importance of not engaging in sexual intercourse on days when podofilox is applied.⁴² ⁴³ ⁴⁷

Importance of not using the drug for any disorder other than that for which it was prescribed.¹ ⁴⁴ ⁴⁷

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹ ² ⁴⁴

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ ² ⁴⁴

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Podofilox
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Gel	0.5%	Condylox	Oclassen
	Solution	0.5%*	Condylox (with alcohol 95% lactic acid and sodium lactate)	Oclassen
			Podofilox Solution	Paddock

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Oclassen Dermatologics. Condylox gel 0.5% (podofilox gel) prescribing information. Corona, CA; 2006 Mar.

2. Oclassen Dermatologics. Condylox (podofilox) topical solution 0.5% prescribing information. Corona, CA; 2005 Oct.

3. Apgar BS. Changes in strategies for human papillomavirus genital disease. Am Fam Physician. 1997; 55:1545-7. [IDIS 384817] [PubMed 9105185]

4. Phelps WC, Alexander KA. Antiviral therapy for human papillomaviruses: rationale and prospects. Ann Intern Med. 1995; 123:368-382. [PubMed 7625626]

5. Drake LA, Ceilley RI, Cornelison RL et al. Guidelines of care for warts: human papillomavirus. J Am Acad Dermatol. 1995; 32:98-103. [IDIS 341409] [PubMed 7822522]

6. Beutner KR, Ferenczy A. Therapeutic approaches to genital warts. Am J Med. 1997; 102:28-37. [IDIS 389026] [PubMed 9217660]

7. Baker DA, Douglas JM, Buntin DM et al. Topical podofilox for the treatment of condylomata acuminata in women. Obstet Gynecol. 1990; 76:656-9. [IDIS 273143] [PubMed 2216198]

8. Oclassen Pharmaceuticals. Product information form for Condylox (podofilox) topical solution.

9. Beutner KR, von Krogh G. Current status of podophyllotoxin for the treatment of genital warts. Semin Dermatol. 1990; 9:148-51. [PubMed 2202410]

10. Beutner KR, Conant MA, Friedman-Kien AE et al. Patient-applied podofilox for treatment of genital warts. Lancet. 1989; 1:831-4. [IDIS 253600] [PubMed 2564912]

11. Beutner KR. Bridging the gap. Arch Dermatol. 1990; 126:1432-34. [PubMed 2173496]

12. Greenberg MD, Rutledge LH, Reid R et al. A double-blind, randomized trial of 0.5% podofilox and placebo for the treatment of genital warts in women. Obstet Gynecol. 1991; 77:735-9. [IDIS 281405] [PubMed 2014088]

13. Bonnez W, Elswick RK, Bailey-Farchione A et al. Efficacy and safety of 0.5% podofilox solution in the treatment and suppression of anogenital warts. Am J Med. 1994; 96:420-5. [IDIS 330975] [PubMed 8192173]

14. White DJ, Billingham C, Chapman S et al. Podophyllin 0.5% or 2.0% v podophyllotoxin 0.5% for the self treatment of penile warts: a double blind randomised study. Genitourin Med. 1997; 73:184-7. [PubMed 9306898]

15. Tyring SK, Cauda R, Baron S et al. Condyloma acuminatum: epidemiological, clinical and therapeutic aspects. Eur J Epidemiol. 1987; 3:209-15. [PubMed 3308509]

16. Stone KM. Human papillomavirus infection and genital warts: update on epidemiology and treatment. Clin Infect Dis. 1995; 20(Suppl 1):S91-7. [IDIS 345864] [PubMed 7540876]

17. Syrjanen KJ. Epidemiology of human papillomavirus (HPV) infections and their associations with genital squamous cell cancer. APMIS. 1989; 97:957-70. [PubMed 2556164]

18. Raab-Traub N. The human DNA tumor viruses: human papilloma virus and Epstein-Barr virus. Cancer Treatment Res. 1989; 47:285-302.

19. Verdon ME. Issues in the management of human papillomavirus genital disease. Am Fam Physician. 1997; 55:1813-6. [PubMed 9105207]

20. Baker GE, Tyring SK. Therapeutic approaches to papillomavirus infections. Dermatol Clin. 1997; 15:331-40. [PubMed 9098642]

21. Kirby P, Dunne A, King DH et al. Double-blind randomized clinical trial of self-administered podofilox solution versus vehicle in the treatment of genital warts. Am J Med. 1990; 88:465-9. [IDIS 266338] [PubMed 2186623]

22. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2006. MMWR Recomm Rep. 2006; 55(RR-11):1-94.

23. Tyring S, Edwards L, Cherry LK et al. Safety and efficacy of 0.5% podofilox gel in the treatment of anogenital warts. Arch Dermatol. 1998; 134:33-8. [IDIS 399334] [PubMed 9449907]

24. Lassus A. Comparison of podophyllotoxin and podophyllin in treatment of genital warts. Lancet. 1987; 2:512-3. [IDIS 233338] [PubMed 2887805]

25. Strand A, Brinkeborn RM, Siboulet A. Topical treatment of genital warts in men, an open study of podophyllotoxin cream compared with solution. Genitourin Med. 1995; 71:387-90. [PubMed 8566979]

26. Petersen CS, Agner T, Ottevanger V et al. A single-blind study of podophyllotoxin cream 0.5% and podophyllotoxin solution 0.5% in male patients with genital warts. Genitourin Med. 1995; 71:391-2. [PubMed 8566980]

27. Edwards A, Atma-Ram A, Thin RN. Podophyllotoxin 0.5% v podophyllin 20% to treat penile warts. Genitourin Med. 1988; 64:263-5. [PubMed 3169757]

28. von Krogh G, Szpak E, Andersson M et al. Self-treatment using 0.25%–0.5% podophyllotoxin-ethanol solutions against penile condylomata acuminata: a placebo-controlled comparative study. Genitourin Med. 1994; 70:105-9. [PubMed 8206467]

29. Paddock Laboratories. Podocon-25 (25% podophyllin in benzoin tincture) prescribing information. Minneapolis. MN; 2005 Aug.

30. von Krogh G. Topical self-treatment of penile warts with 0.5% podophyllotoxin in ethanol for four or five days. Sex Transm Dis. 1987:14:135-40.

31. Sackett DL. Podophyllotoxin, steganacin and combretastatin: natural products that bind at the colchicine site of tubulin. Pharmacol Ther. 1993; 59:163-228. [PubMed 8278462]

32. Reviewers’ comments (personal observations).

33. Teillac-Hamel D, Roux A, Loeb G et al. Pharmacokinetic and safety profile of topical podophyllotoxin (0.5% solution) on molluscum contagiosum in children. Eur J Dermatol. 1996; 6:437-40.

34. Kilewo CDS, Urassa WK, Pallangyo K et al. Response to podophyllotoxin treatment of genital warts in relation to HIV-1 infection among patients in Dar es Salaam, Tanzania. Int J STD AIDS. 1995; 6:114-6. [PubMed 7779923]

35. Syed TA, Lundin S, Ahmad M. Topical 0.3% and 0.5% podophyllotoxin cream for self-treatment of molluscum contagiosum in males. Dermatology. 1994; 189:65-8. [PubMed 8003791]

36. Deleixhe-Mauhin F, Piérard-Franchimont C, Piérard GE. Podophyllotoxin in the treatment of molluscum contagiosum. J Dermatol Treatment. 1991; 2:99-101.

37. Neff JM. Parapoxviruses, molluscum contagiosum, and tanapox viruses. In: Mandell GL, Bennett JE, and Dolin R, eds. Principles and practices of infections diseases. 6th ed. New York: Churchill Livingston; 2000:1556-7.

38. Lewis EJ, Lam M, Crutchfield CE. An update on molluscum contagiosum. Cutis. 1997; 60:29-34. [PubMed 9252731]

39. von Krogh G. Podophyllotoxin in serum: absorption subsequent to three day repeated applications of a 0.5% ethanolic preparation on condylomata acuminata. Sex Transm Dis. 1982; 9:26-33. [PubMed 10328020]

40. Watson Laboratories, Corona, CA: Personal communication.

41. Syed TA, Lundin S, Ahmad SA. Topical 0.3% and 0.5% podophyllotoxoin cream for self-treatment of condylomata acuminata in women. Dermatology. 1994; 189:142-5. [PubMed 8075441]

42. Oclassen Dermatologics. Condylox gel 0.5% (podofilox gel) patient information. Corona, CA; 2005 Oct.

43. Oclassen Dermatologics. Condylox (podofilox) topical solution 0.5% patient information. Corona, CA; 2005 Oct.

44. Paddock. Podofilox topical solution 0.5% prescribing information. Minneapolis, MN. 2005 Jul.

45. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-15):1-112.

46. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-exposed and infected children: recommendations from CDC, the National Institutes of Health, and the Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-14):1-92.

47. Paddock. Podofilox topical solution 0.5% patient information. Minneapolis, MN. 2005 Aug.

More Podofilox resources

Podofilox Side Effects (in more detail)
Podofilox Dosage
Podofilox Use in Pregnancy & Breastfeeding
Podofilox Support Group
7 Reviews for Podofilox - Add your own review/rating

Compare Podofilox with other medications

Condylomata Acuminata

Zytopic

Generic Name: triamcinolone (Topical application route)

trye-am-SIN-oh-lone a-SEET-oh-nide

Commonly used brand name(s)

In the U.S.

Aristocort A

Cinolar

Kenalog

Pediaderm TA

Triacet

Triamcot

Triderm

Zytopic

In Canada

Aristocort C Concentrate

Aristocort D Dilute

Aristocort R Ointment Regular

Aristocort R Regular

Kenalog Cream

Kenalog Ointment

Kenalog Spray

Triaderm Mild Cream

Triaderm Mild Ointment

Triaderm Regular Cream

Triaderm Regular Ointment

Trianide Mild-Cream

Available Dosage Forms:

Cream

Lotion

Spray

Ointment

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Triamcinolone

Uses For Zytopic

Triamcinolone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

Before Using Zytopic

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of triamcinolone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of triamcinolone topical in geriatric patients.

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of triamcinolone

This section provides information on the proper use of a number of products that contain triamcinolone. It may not be specific to Zytopic. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

If you or your child are using the spray form on or near the face, protect your nose to avoid breathing it in and make sure that your eyes are covered.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use the spray on the groin or underarms unless directed to do so by your doctor.

To use:

Wash your hands with soap and water before and after using this medicine.

Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.

Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.

If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

The spray form is flammable until it dries on the skin. Do not use it near heat, an open flame, or while smoking. Do not puncture, break, or burn the aerosol can.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For redness, itching, and swelling of the skin:
- For topical dosage forms (cream, lotion, and ointment):
  - Adults—Apply to the affected area of the skin two to four times per day.
  - Children—Apply to the affected area of the skin two to four times per day.
- For topical dosage form (aerosol spray):
  - Adults—Spray to the affected area of the skin three to four times per day.
  - Children—Spray to the affected area of the skin three to four times per day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Zytopic

It is very important that your doctor check the progress of you or your child at regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve within a few weeks, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use this medication with other corticosteroid (eg, hydrocortisone) containing products without checking with your doctor first. .

Do not use cosmetics or other skin care products on the treated areas.

Zytopic Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin

irritation

itching, scaling, severe redness, soreness, or swelling of the skin

redness and scaling around the mouth

thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

Incidence not known

Acne or pimples

burning and itching of the skin with pinhead-sized red blisters

burning, itching, and pain in hairy areas, or pus at the root of the hair

increased hair growth on the forehead, back, arms, and legs

lightening of normal skin color

lightening of treated areas of dark skin

reddish purple lines on the arms, face, legs, trunk, or groin

softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

More Zytopic resources

Zytopic Use in Pregnancy & Breastfeeding
Zytopic Drug Interactions
Zytopic Support Group
22 Reviews for Zytopic - Add your own review/rating

Compare Zytopic with other medications

Aphthous Ulcer
Atopic Dermatitis
Dermatitis
Lichen Planus
Psoriasis

Thursday, 9 August 2012

Itch-X Foam

Pronunciation: HYE-droe-KOR-ti-sone
Generic Name: Hydrocortisone
Brand Name: Itch-X

Itch-X Foam is used for:

Reducing itching, redness, and swelling associated with many skin conditions.

Itch-X Foam is a topical corticosteroid. It works by depressing the formation, release, and activity of different cells and chemicals that cause swelling, redness, and itching.

Do NOT use Itch-X Foam if:

you are allergic to any ingredient in Itch-X Foam

Contact your doctor or health care provider right away if any of these apply to you.

Before using Itch-X Foam:

Some medical conditions may interact with Itch-X Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a skin infection, thinning of the skin, tuberculosis (TB), chickenpox, shingles, a positive TB skin test, or have recently had a vaccination

Some MEDICINES MAY INTERACT with Itch-X Foam. Because little, if any, of Itch-X Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Itch-X Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Itch-X Foam:

Use Itch-X Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Shake well before each use.

Apply a small amount of medicine to the affected area. Gently rub it in until it is evenly distributed. Wash your hands after applying Itch-X Foam, unless your hands are part of the treated area.

Do not bandage or wrap the affected area unless directed otherwise by your doctor.

If you miss a dose of Itch-X Foam, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Itch-X Foam.

Important safety information:

Itch-X Foam is for external use only. Do not get Itch-X Foam in your eyes. If you get Itch-X Foam in your eyes, immediately flush them with cool tap water.

Do not use Itch-X Foam for diaper rash or for external vaginal itching if vaginal discharge is present .

Check with your doctor before having vaccinations while you are using Itch-X Foam.

Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better within 7 days, if they get worse, or if they clear up and then come back, check with your doctor.

Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Itch-X Foam, especially if the child is using a large amount of it or using it for a long period of time.

Itch-X Foam should not be used in CHILDREN younger than 2 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Itch-X Foam while you are pregnant. It is not known if Itch-X Foam is found in breast milk. If you are or will be breast-feeding while you use Itch-X Foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Itch-X Foam:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild, temporary stinging; skin irritation or dryness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); infection; itching, burning, pain, redness, or swelling of the skin not present before using Itch-X Foam; skin thinning and discoloration.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Itch-X side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Itch-X Foam may be harmful if swallowed.

Proper storage of Itch-X Foam:

Store Itch-X Foam at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Itch-X Foam out of the reach of children and away from pets.

General information:

If you have any questions about Itch-X Foam, please talk with your doctor, pharmacist, or other health care provider.

Itch-X Foam is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Itch-X Foam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Itch-X resources

Itch-X Side Effects (in more detail)
Itch-X Use in Pregnancy & Breastfeeding
Itch-X Drug Interactions
Itch-X Support Group
0 Reviews for Itch-X - Add your own review/rating

Compare Itch-X with other medications

Anal Itching
Aphthous Stomatitis, Recurrent
Atopic Dermatitis
Dermatitis
Eczema
Gingivitis
Proctitis
Pruritus
Psoriasis
Seborrheic Dermatitis
Skin Rash
Ulcerative Colitis, Active

Wednesday, 8 August 2012

PEG-Intron Redipen

Generic Name: peginterferon alfa-2b (peg in ter FEAR on AL fa 2 b)

Brand Names: PegIntron, PegIntron Redipen

What is PEG-Intron Redipen (peginterferon alfa-2b)?

Peginterferon alfa-2b is made from human proteins that help the body fight viral infections.

Peginterferon alfa-2b is used to treat chronic hepatitis C in adults. Peginterferon alfa-2b is often used in combination with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab) to treat hepatitis C in adults and children who are at least 3 years old.

Peginterferon alfa-2b may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about PEG-Intron Redipen (peginterferon alfa-2b)?

You should not use this medication if you are allergic to peginterferon alfa-2b, or if you have autoimmune hepatitis, severe liver or kidney disease, or a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia. Peginterferon alfa-2b is often used together with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab), which is known to cause birth defects or death in an unborn baby. Do not use peginterferon alfa-2b and ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant.

Before using peginterferon alfa-2b, tell your doctor about all of your medical conditions, especially kidney disease, liver problems other than hepatitis, heart disease or high blood pressure, a thyroid disorder, eye problems, HIV or AIDS, ulcerative colitis, a blood cell disorder, an autoimmune disorder such as lupus or psoriasis, or a history of heart attack, stroke, organ transplant, depression, mental illness, drug or alcohol addiction, or suicidal thoughts or behaviors.

There are many other medicines that can interact with peginterferon alfa-2b. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before using PEG-Intron Redipen (peginterferon alfa-2b)?

You should not use this medication if you are allergic to peginterferon alfa-2b, or if you have:

autoimmune hepatitis;

liver failure;

severe kidney disease;

a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia;

if you are pregnant; or

if you are a man and your female sexual partner is pregnant.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use peginterferon alfa-2b:

lung disease;

kidney disease (or if you are on dialysis);

hepatitis B, or liver problems other than hepatitis;

a thyroid disorder;

uncontrolled diabetes;

new or worsening problems with your eyes;

cancer;

HIV or AIDS;

pancreatitis or ulcerative colitis;

heart disease, high blood pressure, high cholesterol or triglycerides, or a history of heart attack, or stroke;

dental problems or gum disease;

an allergy causing severe reaction;

history of organ transplant;

anemia (low red blood cells) caused by taking ribavirin (Rebetol);

any blood cell disorder causing bleeding episodes, infections, or fever-related illness;

an autoimmune disorder such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or psoriasis; or

a history of drug or alcohol addiction, depression, anxiety, or suicidal thoughts or behaviors.

Peginterferon alfa-2b may be harmful to an unborn baby. Do not use peginterferon alfa-2b without telling your doctor if you are pregnant. Peginterferon alfa-2b is often used together with another medication called ribavirin (Copegus). Ribavirin is known to cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before taking these two medications together and every month during your treatment.

If you are a woman, do not use peginterferon alfa-2b and ribavirin if you are pregnant.

If you are a man, do not use peginterferon alfa-2b and ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

Use at least 2 effective forms of birth control while either sexual partner is using peginterferon alfa-2b with ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using peginterferon alfa-2b together with ribavirin.

It is not known whether peginterferon alfa-2b passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Peginterferon alfa-2b can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I use PEG-Intron Redipen (peginterferon alfa-2b)?

Peginterferon alfa-2b is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Peginterferon alfa-2b is usually given once per week. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

If you are being treated with combination therapy, you will also take ribavirin (Rebetol) capsules or liquid by mouth every day. Ribavirin should be taken with food.

Do not shake the medication vial (bottle) or Redipen while mixing. Vigorous shaking can ruin the medicine. Do not draw your peginterferon alfa-2b dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested on a regular basis. You may also need regular eye exams. Do not miss any scheduled appointments.

Store this medication in the refrigerator, protected from light. Do not allow the medicine to freeze. Mixed medicine may be stored in the refrigerator but you must use it within 24 hours after mixing.

The PegIntron Redipen and single-use vials are for one use only. Do not reuse a vial or injection pen.

What happens if I miss a dose?

Use the medicine as soon as you remember the missed dose, then go back to your regular schedule on the day your next dose is due. If you are more than 2 days late in using your injection, call your doctor for instructions. Do not use extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a peginterferon alfa-2b overdose are not known.

What should I avoid while using PEG-Intron Redipen (peginterferon alfa-2b)?

Treatment with this medication does not prevent spread of the hepatitis virus to other people. Follow your doctor's instructions about how to prevent passing the disease to another person.

PEG-Intron Redipen (peginterferon alfa-2b) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using peginterferon alfa-2b and call your doctor at once if you have any of these serious side effects:

confusion, severe depression or anxiety, aggression, thoughts of hurting yourself or others;

vision problems;

fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, unusual weakness;

high fever with severe stomach pain and bloody diarrhea.

severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

cough, feeling short of breath, chest pain, uneven heartbeats;

sudden numbness or weakness, headache, confusion, problems with vision, speech, or balance; or

new or worsening liver symptoms (upper stomach pain, dark urine, jaundice).

Less serious side effects may include:

dizziness, tired feeling;

headache, joint or muscle pain;

nausea, dry mouth, loss of appetite, weight loss;

sleep problems (insomnia);

feeling mildly anxious, depressed, or irritable; or

pain, redness, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect PEG-Intron Redipen (peginterferon alfa-2b)?

Many drugs can interact with peginterferon alfa-2b. Below is just a partial list. Tell your doctor if you are using:

a blood thinner such as warfarin (Coumadin);

fosphenytoin (Cerebyx) or phenytoin (Dilantin);

methadone (Diskets, Dolophine, Methadose);

ADHD medication such as Adderall, Ritalin, and others;

rifampin (Rifadin, Rifater, Rifamate);

voriconazole (Vfend);

an antidepressant or anti-psychotic medication;

cancer medication such as doxorubicin (Adriamycin), lomustine (Ceenu), paclitaxel (Taxol), or tamoxifen (Soltamox);

cough medicine (prescription or over-the-counter);

diabetes medications you take by mouth;

heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), captopril (Capoten), carvedilol (Coreg), flecainide (Tambocor), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), propranolol (Inderal), and others;

HIV or AIDS medication;

medicines used to prevent organ transplant rejection; or

a sulfa drug (Bactrim, Cotrim, Gantanol, Septra, SMX-TMP, and others).

This list is not complete and there are many other medicines that can interact with peginterferon alfa-2b. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More PEG-Intron Redipen resources

PEG-Intron Redipen Side Effects (in more detail)
PEG-Intron Redipen Use in Pregnancy & Breastfeeding
PEG-Intron Redipen Drug Interactions
PEG-Intron Redipen Support Group
0 Reviews for PEG-Intron Redipen - Add your own review/rating

Compare PEG-Intron Redipen with other medications

Chronic Myelogenous Leukemia
Hepatitis B
Hepatitis C
Melanoma
Melanoma, Metastatic
Renal Cell Carcinoma
Thrombocythemia

Where can I get more information?

Your pharmacist can provide more information about peginterferon alfa-2b.

See also: PEG-Intron Redipen side effects (in more detail)

Sunday, 19 August 2012

incobotulinumtoxina Intramuscular

Commonly used brand name(s)

Uses For incobotulinumtoxina

Before Using incobotulinumtoxina

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of incobotulinumtoxina

Precautions While Using incobotulinumtoxina

incobotulinumtoxina Side Effects

More incobotulinumtoxina Intramuscular resources

Compare incobotulinumtoxina Intramuscular with other medications

Monday, 13 August 2012

incobotulinumtoxinA

What is incobotulinumtoxinA?

What is the most important information I should know about incobotulinumtoxinA?

What should I discuss with my healthcare provider before taking incobotulinumtoxinA?

How is incobotulinumtoxinA given?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking incobotulinumtoxinA?

IncobotulinumtoxinA side effects

IncobotulinumtoxinA Dosing Information

What other drugs will affect incobotulinumtoxinA?

More incobotulinumtoxinA resources

Compare incobotulinumtoxinA with other medications

Where can I get more information?

Saturday, 11 August 2012

Podofilox

Introduction

Uses for Podofilox

Human Papillomavirus (HPV) Infections

Molluscum Contagiosum

Podofilox Dosage and Administration

Administration

Topical Administration

Dosage

Pediatric Patients

HPV Infections

External Genital HPV Warts

Adults

HPV Infections

External Genital and Perianal HPV Warts

Prescribing Limits

Adults

HPV Infections

External Genital and Perianal HPV Warts

Special Populations

Cautions for Podofilox

Contraindications

Warnings/Precautions

Warnings

Differential Diagnosis

General Precautions

Precautions Related to Treatment of External Genital and Perianal HPV Warts

Specific Populations

Pregnancy

Lactation

Pediatric Use

Common Adverse Effects

Podofilox Pharmacokinetics

Absorption

Bioavailability

Elimination

Half-life

Stability

Storage

Topical

Gel

Solution

ActionsActions

Advice to Patients

Preparations

Disclaimer