Sample Content Directory Montana: September 2016

Friday, September 30, 2016

Sotradecol

Generic Name: sodium tetradecyl sulfate (Intravenous route)

SOE-dee-um tet-ra-DEK-ul SUL-fate

Commonly used brand name(s)

In the U.S.

Sotradecol

Available Dosage Forms:

Solution

Therapeutic Class: Sclerosing Agent

Uses For Sotradecol

Sodium tetradecyl sulfate is a type of medicine called a sclerosing agent. It is used for the treatment of small varicose veins of the lower extremities.

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

Before Using Sotradecol

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of sodium tetradecyl sulfate in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of sodium tetradecyl sulfate in the elderly with use in other age groups.

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

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 Sotradecol

It is important to have a preinjection evaluation.

It is important to give slow injections with a small amount (not over 2 milliliters) of sodium tetradecyl sulfate solution.

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 injection dosage form:
- For varicose veins:
  - Adults—0.5 to 2 milliliters injected into the vein, depending on the size and degree of varicosity.
  - Children—Use and dose must be determined by your doctor.

Precautions While Using Sotradecol

Embolisms (i.e., blood clots) may occur up to 4 weeks following injection of sodium tetradecyl sulfate.

It is possible that deep vein thrombosis (i.e., blood clot in a deep vein) can develop.

Sotradecol 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:

Frequency not known

Anxiety

burning

chest pain

cough

difficulty breathing

difficulty swallowing

dizziness or light-headedness

fainting

fast heartbeat

hayfever

hives

itching

nausea

noisy breathing

pain, redness, or swelling in arm or leg

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

raised red swellings on the skin, lips, tongue, or in the throat

redness of skin

skin rash

sudden shortness of breath or troubled breathing

tightness in chest

unusual tiredness or weakness

vomiting

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:

Frequency not known

Headache

pain, local

pain or redness at site of injection

pale skin at site of injection

peeling or sloughing of skin

ulceration at site of injection

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: Sotradecol 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.

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More Sotradecol resources

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

Sotradecol Prescribing Information (FDA)

Sotradecol Concise Consumer Information (Cerner Multum)

Sotradecol MedFacts Consumer Leaflet (Wolters Kluwer)

Sodium Tetradecyl Sulfate Professional Patient Advice (Wolters Kluwer)

Compare Sotradecol with other medications

Varicose Veins

Prutetucin

Prutetucin may be available in the countries listed below.

Ingredient matches for Prutetucin

Amikacin

Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Prutetucin in the following countries:

Japan

International Drug Name Search

St. John's Wort

Pronunciation: Not applicable.
Generic Name: St. John's Wort
Brand Name: Generics only. No brands available.

St. John's Wort is used for:

Treating mild to moderate depression, nervousness, insomnia (difficulty sleeping), and infections. It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.

St. John's Wort is an herbal product. It is thought to work by balancing certain chemicals in the brain, which improves mood.

Do NOT use St. John's Wort if:

you are allergic to any ingredient in St. John's Wort

you are pregnant

you are taking an antidepressant, amphetamines, blood thinners (eg, warfarin), bromocriptine, narcotic analgesics, pramipexole, or ropinirole

you are taking or have taken a serotonin reuptake blocker (eg, fluoxetine) within the past 14 days

you have a history of severe depression or feel like harming yourself or others

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

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using St. John's Wort:

Some medical conditions may interact with St. John's Wort. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are planning to become pregnant or 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 history of bipolar disorder (manic-depressive illness) or infertility

Some MEDICINES MAY INTERACT with St. John's Wort. Tell your health care provider if you are taking any other medicines, especially any of the following:

Aldosterone blockers (eg, eplerenone), blood thinners (eg, warfarin), benzodiazepines (eg, alprazolam), cancer chemotherapy medicines, digoxin, HIV medicines (eg, delavirdine, efavirenz, indinavir), HMG-CoA reductase inhibitors (eg, simvastatin), immunosuppressants (eg, cyclosporine, tacrolimus), selective serotonin reuptake inhibitors (SSRIs; eg, fluoxetine), or verapamil because the effectiveness may be decreased by St. John's Wort

This may not be a complete list of all interactions that may occur. Ask your health care provider if St. John's Wort 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 St. John's Wort:

Use St. John's Wort as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take this product with food.

Dosing depends on the use and the source of the product.

Use as directed on the package, unless instructed otherwise by your doctor.

It may take several weeks of St. John's wort use before relief of depression is noticed.

If you miss taking a dose of St. John's Wort for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use St. John's Wort.

Important safety information:

This product may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this product. Using this product alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Do not drink alcohol while taking this product.

St. John's wort interacts with some medicines, which may be dangerous. St. John's wort may affect the way your liver metabolizes other medicines. Check with your doctor before you begin taking any new medicine, either prescription or over-the-counter. This includes medicine that contains pseudoephedrine, phenylpropanolamine, l-tryptophan, herbal phen-fen products, or yohimbine.

Do not exceed the recommended dose for this herbal product.

If you are taking St. John's wort for depression and your symptoms do not improve after 4 to 6 weeks of regular use, contact your doctor. Contact your doctor as soon as possible if your symptoms become worse of if your depression is severe. St. John's wort is Hypericum perforatum and should not be confused with other Hypericum species. Other Hypericum products do not have the same effects. Read the label carefully or ask your doctor or pharmacist.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are taking this product.

This product may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to this product. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of herbal products is not known. Before using any alternative medicine, talk with your doctor or pharmacist.

St. John's wort may decrease the effectiveness of your birth control pill. Use an additional form of contraception (eg, condoms) while using St. John's wort.

St. John's Wort is not recommended for use in CHILDREN.

PREGNANCY and BREAST-FEEDING: Do not take this product if you are pregnant. Do not breast-feed while taking this product.

Possible side effects of St. John's Wort:

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:

Constipation; dizziness; dry mouth; feeling of stomach fullness; increased sensitivity to sunlight; restlessness; tiredness; weight gain.

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); agitation; changes in sexual function; confusion; diarrhea; fever; muscle spasms; nausea; profuse sweating; shivering; tremors or twitching; unusual mental or mood changes.

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: St. John's Wort 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.

Proper storage of St. John's Wort:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep St. John's Wort out of the reach of children and away from pets.

General information:

If you have any questions about St. John's Wort, please talk with your doctor, pharmacist, or other health care provider.

St. John's Wort 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 St. John's Wort. 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 St. John's Wort resources

St. John's Wort Side Effects (in more detail)
St. John's Wort Use in Pregnancy & Breastfeeding
St. John's Wort Drug Interactions
St. John's Wort Support Group
4 Reviews for St. John's Wort - Add your own review/rating

St. John's Wort Natural MedFacts for Professionals (Wolters Kluwer)

St. John's Wort Natural MedFacts for Consumers (Wolters Kluwer)

St. John's wort Concise Consumer Information (Cerner Multum)

Compare St. John's Wort with other medications

Depression
Night Terrors

Snufflebabe Vapour Rub / Lloyds Pharmacy Junior Vapour Rub

1. Name Of The Medicinal Product

Snufflebabe Vapour Rub / Lloyds Pharmacy Junior Vapour Rub

2. Qualitative And Quantitative Composition

Eucalyptus Oil 2.00 %, Menthol 1.5 %, Thyme Oil 0.50%

For excipients, see 6.1

3. Pharmaceutical Form

Inhalation vapour ointment

4. Clinical Particulars

4.1 Therapeutic Indications

To give relief from congestion of the upper respiratory tract.

4.2 Posology And Method Of Administration

Topical.

Snufflebabe may be used without professional supervision from the age of three months. Below this age it is recommended that the mother consults her GP, Pharmacist or Health Visitor.

Rub a small amount on the upper chest and throat. Alternatively Snufflebabe may be placed in a tissue or handkerchief in the clothing. To eliminate the possibility of very young children transferring the product to their eyes, on their fingers, the handkerchief may be tied to their cot just out of reach.

Body heat causes the aromatic oils to vaporise from the product so that they may be breathed in and help give relief of the upper respiratory tract (blocked nose).

4.3 Contraindications

Keep out of reach of children.

4.4 Special Warnings And Precautions For Use

It is dangerous to apply an ointment containing menthol to the nostrils of infants. If symptoms persist consult your GP.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No significant interactions have been reported.

4.6 Pregnancy And Lactation

None stated.

4.7 Effects On Ability To Drive And Use Machines

Not applicable, none reported.

4.8 Undesirable Effects

Could give rise to hypersensitivity reactions including contact dermatitis. If symptoms persist consult you GP.

4.9 Overdose

None stated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Menthol, Eucalyptus Oil and Thyme Oil have all been used for many years for inhalation and in vapour rubs where they have given relief from congestion of the upper respiratory tract.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

White Soft Paraffin

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C and do not freeze.

6.5 Nature And Contents Of Container

Polystyrene jar with screw on polypropylene cap contents: 24 g.

6.6 Special Precautions For Disposal And Other Handling

Snufflebabe may be used without professional supervision from the age of three months. Below this age it is recommended that the mother consults her GP, Pharmacist or Health Visitor.

Administrative Data

7. Marketing Authorisation Holder

DDD Limited

94, Rickmansworth Road

Watford

Hertfordshire

WD18 7JJ

United Kingdom

8. Marketing Authorisation Number(S)

PL 0133/0233

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 30 July 2010

10. Date Of Revision Of The Text

30 July 2010

spironolactone and hydrochlorothiazide

spir-on-oh-LAK-tone, hye-droe-klor-oh-THYE-a-zide

Oral route(Tablet)

Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats. Spironolactone/hydrochlorothiazide should be used only in those conditions specified as indications for use. Unnecessary use of this drug should be avoided. Fixed-dose combination drugs are not indicated for initial therapy of edema or hypertension .

Commonly used brand name(s)

In the U.S.

Aldactazide

Available Dosage Forms:

Tablet

Therapeutic Class: Diuretic, Potassium Sparing/Thiazide Combination

Pharmacologic Class: Aldosterone Receptor Antagonist

Chemical Class: Thiazide

Uses For spironolactone and hydrochlorothiazide

Spironolactone and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). It may also be used to treat water retention (edema) in patients with congestive heart failure, liver cirrhosis, or a kidney disorder called nephrotic syndrome.

Spironolactone helps prevent your body from absorbing too much salt and keeps your potassium levels from getting too low. It can be used to prevent or treat hypokalemia (low potassium levels in the blood).

Spironolactone and hydrochlorothiazide are both diuretic medicines ("water pills"). They reduce the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

spironolactone and hydrochlorothiazide is available only with your doctor's prescription.

Before Using spironolactone and hydrochlorothiazide

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 spironolactone and hydrochlorothiazide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to spironolactone and hydrochlorothiazide 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 spironolactone and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of spironolactone and hydrochlorothiazide combination in geriatric patients.

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

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. When you are taking spironolactone and hydrochlorothiazide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using spironolactone and hydrochlorothiazide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dofetilide

Eplerenone

Triamterene

Using spironolactone and hydrochlorothiazide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetyldigoxin

Alacepril

Arginine

Arsenic Trioxide

Benazepril

Captopril

Cilazapril

Delapril

Deslanoside

Digitalis

Digitoxin

Digoxin

Droperidol

Enalaprilat

Enalapril Maleate

Flecainide

Fosinopril

Imidapril

Ketanserin

Levomethadyl

Lisinopril

Lithium

Metildigoxin

Moexipril

Ouabain

Pentopril

Perindopril

Potassium

Proscillaridin

Quinapril

Ramipril

Sotalol

Spirapril

Tacrolimus

Temocapril

Trandolapril

Zofenopril

Using spironolactone and hydrochlorothiazide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aceclofenac

Acemetacin

Alacepril

Alclofenac

Apazone

Aspirin

Benazepril

Benoxaprofen

Bepridil

Bromfenac

Bufexamac

Captopril

Carbamazepine

Carprofen

Celecoxib

Chlorpropamide

Cholestyramine

Cilazapril

Clometacin

Clonixin

Cyclophosphamide

Delapril

Dexketoprofen

Diclofenac

Diflunisal

Digitoxin

Dipyrone

Droxicam

Enalaprilat

Enalapril Maleate

Etodolac

Etofenamate

Felbinac

Fenbufen

Fenoprofen

Fentiazac

Floctafenine

Flufenamic Acid

Flurbiprofen

Fosinopril

Ginkgo

Glipizide

Gossypol

Ibuprofen

Ibuprofen Lysine

Imidapril

Indomethacin

Indoprofen

Isoxicam

Ketoprofen

Ketorolac

Licorice

Lisinopril

Lornoxicam

Magnesium Salicylate

Meclofenamate

Mefenamic Acid

Meloxicam

Moexipril

Nabumetone

Naproxen

Nepafenac

Niflumic Acid

Nimesulide

Oxaprozin

Oxyphenbutazone

Pentopril

Perindopril

Phenylbutazone

Pirazolac

Piroxicam

Pirprofen

Propyphenazone

Proquazone

Quinapril

Ramipril

Salicylic Acid

Salsalate

Spirapril

Sulindac

Suprofen

Temocapril

Tenidap

Tenoxicam

Tiaprofenic Acid

Tolmetin

Topiramate

Trandolapril

Zofenopril

Zomepirac

Interactions with Food/Tobacco/Alcohol

Proper Use of spironolactone and hydrochlorothiazide

In addition to the use of spironolactone and hydrochlorothiazide, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt) and potassium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that spironolactone and hydrochlorothiazide will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Dosing

The dose of spironolactone and hydrochlorothiazide 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 spironolactone and hydrochlorothiazide. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (tablets):
- For edema:
  - Adults—At first, 100 milligrams (mg) per day, given in either single or divided doses. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.
- For high blood pressure:
  - Adults—At first, 50 to 100 milligrams (mg) per day, given in either single or divided doses. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of spironolactone and hydrochlorothiazide, take 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. Do not double doses.

Storage

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

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 spironolactone and hydrochlorothiazide

It is very important that your doctor check your progress at regular visits to make sure spironolactone and hydrochlorothiazide is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This especially includes potassium supplements or salt substitutes containing potassium; or certain diuretics such as amiloride (Midamor®, Moduretic®), triamterene (Dyazide®, Dyrenium®, Maxzide®), or other products containing spironolactone (Aldactone®).

Stop using spironolactone and hydrochlorothiazide and check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help.

Check with your doctor right away if you become sick while taking spironolactone and hydrochlorothiazide, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium, potassium, or magnesium in the body).

spironolactone and hydrochlorothiazide may increase the amount of potassium in your blood (hyperkalemia). Check with your doctor right away if you are having abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeats; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

spironolactone and hydrochlorothiazide may affect blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

Make sure any doctor or dentist who treats you knows that you are using spironolactone and hydrochlorothiazide. You may need to stop using spironolactone and hydrochlorothiazide several days before having medical tests. The results of some tests may be affected by spironolactone and hydrochlorothiazide.

spironolactone and hydrochlorothiazide may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.

spironolactone and hydrochlorothiazide 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

Abdominal or stomach cramping, burning, or tenderness

back or leg pains

bleeding gums

blistering, peeling, or loosening of the skin

bloating

bloody or black, tarry stools

bloody or cloudy urine

blue lips and fingernails

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

chills

clay-colored stools

clear or bloody discharge from the nipple

cloudy urine

confusion

constipation

cough or hoarseness

coughing that sometimes produces a pink frothy sputum

coughing up blood

dark urine

decrease in urine-concentrating ability

decreased appetite

diarrhea

difficult, fast, or noisy breathing, sometimes with wheezing

difficulty with swallowing

dimpling of the breast skin

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

fast or irregular heartbeat

fever with or without chills

flushed, dry skin

fruit-like breath odor

general body swelling

general feeling of discomfort or illness

greatly decreased frequency of urination or amount of urine

headache

heartburn

hives or welts

increased blood pressure

increased hunger

increased sweating

increased thirst

increased urination

indigestion

inverted nipple

joint pain, stiffness, or swelling

loss of appetite

lower back or side pain

lump in the breast or under the arm

muscle cramps or pain

nausea and vomiting

nosebleeds

numbness, tingling, pain, or weakness in the hands, feet, or lips

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

persistent crusting or scaling of the nipple

pinpoint red or purple spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, irritated eyes

redness or swelling of the breast

redness, soreness, or itching skin

seizures

severe stomach pain

shakiness and unsteady walk

shortness of breath

skin rash

sore on the skin of the breast that does not heal

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sugar in the urine

swelling in the legs and ankles

swelling of the face, hands, fingers, feet, or lower legs

swollen, painful, or tender lymph glands in the neck, armpit, or groin

thickening of bronchial secretions

tightness in the chest

trembling

troubled breathing

unpleasant breath odor

unsteadiness, trembling, or other problems with muscle control or coordination

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight loss

vomiting of blood or material that looks like coffee grounds

weakness and heaviness of the legs

weight gain

wheezing

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Difficulty with sleeping

disorientation

drowsiness to profound coma

hallucination

lethargy

lightheadedness

mood or other mental changes

rash with flat lesions or small raised lesions on the skin

Incidence not known

Absent, missed, or irregular menstrual periods

bleeding after menopause

burning feeling in the chest or stomach

discoloration of the skin

feeling of constant movement of self or surroundings

inability to have or keep an erection

increased sensitivity of the skin to sunlight

muscle spasm

restlessness

sensation of spinning

severe sunburn

stomach upset

stopping of menstrual bleeding

swelling of the breasts or breast soreness in both females and males

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: spironolactone and hydrochlorothiazide side effects (in more detail)

More spironolactone and hydrochlorothiazide resources

Spironolactone and hydrochlorothiazide Side Effects (in more detail)
Spironolactone and hydrochlorothiazide Dosage
Spironolactone and hydrochlorothiazide Use in Pregnancy & Breastfeeding
Drug Images
Spironolactone and hydrochlorothiazide Drug Interactions
Spironolactone and hydrochlorothiazide Support Group
2 Reviews for Spironolactone and hydrochlorothiazide - Add your own review/rating

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Ascites
Edema
Heart Failure
High Blood Pressure
Nephrotic Syndrome

Sulconazole Nitrate Solution

Pronunciation: sul-KON-a-zole
Generic Name: Sulconazole Nitrate
Brand Name: Exelderm

Sulconazole Nitrate Solution is used for:

Treating fungal infections, such as jock itch, ringworm, and tinea versicolor (a fungal infection affecting the skin of the upper arms, chest, back, and sometimes the neck and face).

Sulconazole Nitrate Solution is an antifungal. It works by blocking the growth of fungi.

Do NOT use Sulconazole Nitrate Solution if:

you are allergic to any ingredient in Sulconazole Nitrate Solution

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

Before using Sulconazole Nitrate Solution:

Some medical conditions may interact with Sulconazole Nitrate Solution. 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

Some MEDICINES MAY INTERACT with Sulconazole Nitrate Solution. Because little, if any, of Sulconazole Nitrate Solution is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sulconazole Nitrate Solution 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 Sulconazole Nitrate Solution:

Use Sulconazole Nitrate Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

To clear up your infection completely, continue using Sulconazole Nitrate Solution for the full course of treatment.

Sulconazole Nitrate Solution is for external use only.

Clean the affected area with soap and water and dry thoroughly. Apply enough medicine to cover the affected area. Rub in gently.

Do not cover unless directed otherwise by your doctor.

Wash your hands immediately after using Sulconazole Nitrate Solution, unless your hands are part of the treated area.

If you miss a dose of Sulconazole Nitrate Solution, 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.

Ask your health care provider any questions you may have about how to use Sulconazole Nitrate Solution.

Important safety information:

Sulconazole Nitrate Solution is for external use only.

Do not get Sulconazole Nitrate Solution in your eyes.

Sulconazole Nitrate Solution may be harmful if swallowed. If you may have taken Sulconazole Nitrate Solution by mouth, contact your local poison control center or emergency room immediately.

Overuse of topical products may worsen your condition.

If your condition does not improve within 4 to 6 weeks or if it gets worse, check with your doctor.

Use Sulconazole Nitrate Solution with caution in the ELDERLY because they may be more sensitive to its effects.

Use Sulconazole Nitrate Solution with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Sulconazole Nitrate Solution during pregnancy. It is unknown if Sulconazole Nitrate Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Sulconazole Nitrate Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Sulconazole Nitrate Solution:

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:

Burning; itching; redness; stinging.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

See also: Sulconazole Nitrate 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.

Proper storage of Sulconazole Nitrate Solution:

Store Sulconazole Nitrate Solution at room temperature. Avoid temperatures above 104 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sulconazole Nitrate Solution out of the reach of children and away from pets.

General information:

If you have any questions about Sulconazole Nitrate Solution, please talk with your doctor, pharmacist, or other health care provider.

Sulconazole Nitrate Solution 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 Sulconazole Nitrate Solution. 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 Sulconazole Nitrate resources

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

Compare Sulconazole Nitrate with other medications

Impetigo
Tinea Corporis
Tinea Cruris
Tinea Pedis
Tinea Versicolor

Krystexxa

Generic Name: pegloticase (Intravenous route)

peg-LOE-ti-kase

Intravenous route(Solution)

Anaphylaxis and infusion reactions have been reported to occur during and after administration of pegloticase. Pegloticase should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids and be closely monitored for an appropriate period of time for anaphylaxis after administration of pegloticase. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed .

Commonly used brand name(s)

In the U.S.

Krystexxa

Available Dosage Forms:

Solution

Pharmacologic Class: Enzyme

Uses For Krystexxa

Pegloticase injection is used to treat chronic gout in adult patients who have already been treated with other medicines that did not work well. Gout is a condition that is caused by too much uric acid in the blood (hyperuricemia).

Pegloticase injection works by causing less uric acid to be produced by the body. This medicine will not relieve a gout attack that has already started.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Krystexxa

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pegloticase injection in children. 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 pegloticase injection in the elderly.

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

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of Krystexxa

A nurse or other trained health professional will give you this medicine in a hospital or clinic. This medicine is given through a needle placed in one of your veins.

This medicine must be given slowly, so the needle will remain in place for a few hours (up to 2 hours or longer). You may also receive medicines (e.g., antihistamines, corticosteroids) to help prevent possible allergic reactions to the injection.

This medicine is usually given every two weeks. If you miss a dose or forget to receive your medicine, call your doctor for instructions.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Precautions While Using Krystexxa

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; hives; itching; dizziness; shortness of breath; swelling of your hands, face, mouth, or tongue; trouble with breathing or swallowing; or chest pain after you receive the medicine.

This medicine may cause infusion reactions, such as a rash, itching, or redness of the skin; difficulty with breathing; feeling of warmth or redness of the face, neck, arms and occasionally, upper chest; or chest discomfort or pain, while you are receiving the injection or within 2 hours after you receive it. Stop using this medicine and check with your doctor or nurse right away if you have any of these symptoms.

Patients of African or Mediterranean ancestry are at higher risk of serious side effects and should be carefully evaluated by their doctor before starting this medicine.

Gout flares may occur in the first three months when you start receiving this medicine. Do not stop receiving this medicine even if you have a gout flare. Your doctor may give you medicines (e.g., colchicine, non-steroidal antiinflammatory drug or NSAID) to reduce and prevent worsening of the gout.

Krystexxa 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

Chest pain or discomfort

cough

difficult or labored breathing

difficulty with swallowing

dizziness

facial swelling

fast heartbeat

fever or chills

flushing or redness of the skin

gout flare

headache

hives or welts

itching

nausea or vomiting

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

shortness of breath

skin rash

tightness in the chest

unusual tiredness or weakness

unusually warm skin

wheezing

Rare

Decreased urine output

dilated neck veins

extreme fatigue

irregular breathing

irregular heartbeat

swelling of the face, fingers, feet, or lower legs

troubled breathing

weight gain

More common

Bruise

contusion

difficulty having a bowel movement (stool)

large, flat, blue, or purplish patches in the skin

muscle aches

sore throat

stuffy or runny nose

Less common

Vomiting

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: Krystexxa side effects (in more detail)

More Krystexxa resources

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

Krystexxa Prescribing Information (FDA)

Krystexxa Consumer Overview

Krystexxa Monograph (AHFS DI)

Krystexxa MedFacts Consumer Leaflet (Wolters Kluwer)

Pegloticase Professional Patient Advice (Wolters Kluwer)

Compare Krystexxa with other medications

Gout

Thursday, September 29, 2016

Erasis

Erasis may be available in the countries listed below.

Ingredient matches for Erasis

Erythromycin Acistrate

Erythromycin Acistrate is reported as an ingredient of Erasis in the following countries:

Bahrain

Egypt

Jordan

Kuwait

Lebanon

United Arab Emirates

International Drug Name Search

Cusi Erythromycin

Cusi Erythromycin may be available in the countries listed below.

Ingredient matches for Cusi Erythromycin

Erythromycin

Erythromycin is reported as an ingredient of Cusi Erythromycin in the following countries:

Poland

International Drug Name Search

Soothe & Cool Inzo Antifungal Topical

Generic Name: miconazole (Topical route)

mye-KON-a-zole

Commonly used brand name(s)

In the U.S.

Aloe Vesta 2-N-1 Antifungal

Aloe Vesta Antifungal

Baza Antifungal

Carrington Antifungal

Derma Gran AF

DiabetAid Antifungal Foot Bath

Fungoid

Lotrimin AF

Micatin

Micro-Guard

Mitrazol

Monistat 1

Monistat Derm

Neosporin AF

QC Miconazole Nitrate

Secura Antifungal

Soothe & Cool Inzo Antifungal

Tetterine

Therasoft Antifungal

Triple Care Antifungal

Triple Care EPC

Zeasorb-AF

Available Dosage Forms:

Lotion

Tablet, Effervescent

Cream

Ointment

Powder

Gel/Jelly

Tincture

Spray

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For Soothe & Cool Inzo Antifungal

Miconazole belongs to the group of medicines called antifungals. Topical miconazole is used to treat some types of fungus infections.

Some of these preparations may be available without a prescription.

Before Using Soothe & Cool Inzo Antifungal

Allergies

Pediatric

Although there is no specific information comparing use of topical miconazole in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of topical miconazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of miconazole

This section provides information on the proper use of a number of products that contain miconazole. It may not be specific to Soothe & Cool Inzo Antifungal. Please read with care.

Keep this medicine away from the eyes.

Apply enough miconazole to cover the affected area, and rub in gently.

To use the aerosol powder form of miconazole:

Shake well before using.

From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between the toes, on the feet, and in the socks and shoes.

Do not inhale the powder.

Do not use near heat, near open flame, or while smoking.

To use the aerosol solution form of miconazole:

Shake well before using.

From a distance of 4 to 6 inches, spray the solution on the affected areas. If it is used on the feet, spray it between the toes and on the feet.

Do not inhale the vapors from the spray.

Do not use near heat, near open flame, or while smoking.

To use the powder form of miconazole:

If the powder is used on the feet, sprinkle it between the toes, on the feet, and in the socks and shoes.

When miconazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over this medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.

Dosing

For aerosol powder, aerosol solution, cream , and powder dosage forms:
- For fungus infections:
  - Adults and children—Apply to the affected area(s) of the skin two times a day, morning and evening.

For cream and lotion dosage forms:
- For sun fungus:
  - Adults and children—Apply to the affected area(s) of the skin once a 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.

Precautions While Using Soothe & Cool Inzo Antifungal

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

Soothe & Cool Inzo Antifungal 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 as soon as possible if any of the following side effects occur:

Blistering, burning, redness, skin rash, or other sign of skin irritation not present before use of this medicine

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 Soothe & Cool Inzo Antifungal Topical resources

Soothe & Cool Inzo Antifungal Topical Use in Pregnancy & Breastfeeding
Soothe & Cool Inzo Antifungal Topical Drug Interactions
Soothe & Cool Inzo Antifungal Topical Support Group
8 Reviews for Soothe & Cool Inzo Antifungal Topical - Add your own review/rating

Compare Soothe & Cool Inzo Antifungal Topical with other medications

Cutaneous Candidiasis
Oral Thrush
Tinea Corporis
Tinea Cruris
Tinea Pedis
Tinea Versicolor
Vaginal Yeast Infection

Wednesday, September 28, 2016

Clindox

Clindox may be available in the countries listed below.

Ingredient matches for Clindox

Clindamycin

Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Clindox in the following countries:

Peru

Venezuela

International Drug Name Search

Hydrocortisyl

Hydrocortisyl may be available in the countries listed below.

Ingredient matches for Hydrocortisyl

Hydrocortisone

Hydrocortisone is reported as an ingredient of Hydrocortisyl in the following countries:

Ireland

Malta

Hydrocortisone 21-acetate (a derivative of Hydrocortisone) is reported as an ingredient of Hydrocortisyl in the following countries:

Ethiopia

International Drug Name Search

Erin

Erin may be available in the countries listed below.

Ingredient matches for Erin

Fludiazepam

Fludiazepam is reported as an ingredient of Erin in the following countries:

Taiwan

International Drug Name Search

Sorafenib Tosylate

Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N2-methylpyridine-2-carboxamide
Molecular Formula: C₂₁H₁₆ClF₃N₄O₃
CAS Number: 284461-73-0
Brands: Nexavar

Introduction

Antineoplastic agent; inhibitor of several serine/threonine and receptor tyrosine kinases.¹ ² ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹² ¹³ ¹⁵ ¹⁶ ¹⁷

Uses for Sorafenib Tosylate

Renal Cell Carcinoma

Treatment of advanced renal cell carcinoma (designated an orphan drug by FDA for this use).¹ ³ ⁴ ⁵ ¹⁴ ¹⁵ ¹⁶ ¹⁷

Sorafenib Tosylate Dosage and Administration

General

Monitor BP weekly during the first 6 weeks of therapy; thereafter, monitor and treat, if required, in accordance with established medical practice.¹ (See Cardiovascular Effects under Cautions.)

Administration

Oral Administration

Administer ≥1 hour before or 2 hours after a meal, since administration with a high-fat meal may decrease oral bioavailability.¹

Dosage

Available as sorafenib tosylate; dosage expressed in terms of sorafenib.¹

Adults

Renal Cell Carcinoma

General Dosage

Oral

400 mg twice daily.¹ ² ⁴ ⁵ ¹⁵

Continue therapy for as long as the patient derives clinical benefit from the drug or until unacceptable toxicity occurs.¹

Dosage Modification for Toxicity

Dosage may be reduced or therapy temporarily interrupted if adverse effects, such as cutaneous toxicity, occur.¹

If dosage reduction is necessary, dosage may be decreased to 400 mg once daily.¹ If further dosage reduction is required, dosage may be decreased to 400 mg every other day.¹

Suggested Dosage Modification for Cutaneous Toxicity 1
Cutaneous Toxicity Grade	Occurrence	Suggested Dosage Modification
Grade 1: numbness, dysesthesia, paresthesia, tingling, painless swelling, erythema, and/or discomfort of the hands or feet that does not disrupt the patient’s normal activities	Any occurrence	Continue therapy with sorafenib and consider topical therapy for symptomatic relief
Grade 2: painful erythema and swelling of the hands or feet and/or discomfort affecting the patient’s normal activities	1^st occurrence	Continue therapy with sorafenib and consider topical therapy for symptomatic relief If improvement is not evident within 7 days, see below
	No improvement within 7 days or 2^nd or 3^rd occurrence	Interrupt sorafenib therapy until toxicity resolves to grade 0 or 1 When resuming therapy, decrease sorafenib dosage by one dose level (e.g., to 400 mg once daily or 400 mg every other day)
	4^th occurrence	Discontinue sorafenib therapy
Grade 3: moist desquamation, ulceration, blistering or severe pain of the hands or feet, and/or severe discomfort that causes the patient to be unable to work or perform activities of daily living	1^st or 2^nd occurrence	Interrupt sorafenib therapy until toxicity resolves to grade 0 or 1 When resuming therapy, decrease sorafenib dosage by one dose level (e.g., to 400 mg once daily or 400 mg every other day)
	3^rd occurrence	Discontinue sorafenib therapy

Prescribing Limits

Adults

Renal Cell Carcinoma

Oral

Highest dosage evaluated clinically was 800 mg twice daily.¹

Special Populations

Hepatic Impairment

No dosage adjustment required in patients with mild or moderate (Child-Pugh class A or B) hepatic impairment.¹ Not studied in patients with severe (Child-Pugh class C) hepatic impairment.¹ (See Hepatic Impairment under Cautions.)

Renal Impairment

No specific dosage recommendations for patients with renal impairment.¹ ¹⁴ (See Renal Impairment under Cautions.)

Geriatric Patients

No dosage adjustment is required on the basis of patient age.¹ (See Geriatric Use under Cautions.)

Cautions for Sorafenib Tosylate

Contraindications

Known hypersensitivity to sorafenib or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality.

May cause fetal harm; teratogenicity and embryolethality demonstrated in animals.¹

Pregnancy should be avoided during and for ≥2 weeks following completion of therapy.¹ If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.¹ (See Advice to Patients.)

Major Toxicities

Dermatologic Effects

Palmar-plantar erythrodysesthesia (i.e., hand-foot syndrome) and rash occur frequently.¹ ² ⁴ ⁵ ⁸ ⁹ ¹⁰ ¹¹ ¹² ¹⁵

Reactions (generally grade 1 or 2) typically appear during the first 6 weeks of therapy.¹ ¹⁵

Management includes topical symptomatic therapy, temporary interruption of therapy, and/or dosage modification; consider permanent discontinuance of therapy in severe or persistent cases.¹

Cardiovascular Effects

Mild or moderate treatment-emergent hypertension reported early in the course of treatment;¹ ² ⁴ ⁵ ⁶ ⁸ ⁹ ¹⁰ ¹¹ ¹² ¹⁵ ¹⁷ generally managed with standard antihypertensive therapy.¹ ¹² ¹⁵ (See General under Dosage and Administration.)

If hypertension is severe or persistent despite use of antihypertensive therapy, consider temporary or permanent discontinuance of sorafenib.¹

Treatment-emergent cardiac ischemia or infarction reported; consider temporary or permanent discontinuance of therapy if cardiac ischemia and/or infarction occurs.¹

GI Perforation

GI perforation, sometimes associated with intra-abdominal tumor, reported rarely; discontinue therapy if GI perforation occurs.¹

Hemorrhage

Increased risk of bleeding;¹ ¹⁵ consider permanent discontinuance of therapy if any bleeding episode requiring medical attention occurs.¹

Monitor patients receiving concomitant therapy with warfarin and sorafenib for increased risk of bleeding episodes or INR elevations.¹ Assess for changes in PT or INR regularly and monitor for clinical bleeding episodes.¹

General Precautions

Japanese Populations

Reduction in systemic exposure to sorafenib reported in Japanese patients (see Special Populations under Pharmacokinetics); clinical importance is not known.¹

Wound-healing Complications

Effect on wound healing not established; manufacturer recommends that therapy be temporarily interrupted in patients undergoing major surgery.¹ Decision to resume therapy should be based on clinical assessment of adequacy of wound healing.¹

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹ Discontinue nursing because of potential risk to nursing infants.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹ ¹⁴

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Hepatic Impairment

Systemic exposure and safety data in patients with mild or moderate hepatic impairment (Child-Pugh class A or B) similar to these data in patients without hepatic impairment.¹ ¹⁴ Safety and efficacy not established in patients with severe (Child-Pugh class C) hepatic impairment.¹

Renal Impairment

Systemic exposure data in patients with mild or moderate renal impairment (Cl_cr 30–80 mL/minute) similar to such data in patients without renal impairment.¹ Safety and efficacy not established in patients with severe renal impairment (Cl_cr <30 mL/minute) or in those undergoing peritoneal dialysis or hemodialysis.¹ ¹⁴

Common Adverse Effects

Hypophosphatemia,¹ ¹⁵ diarrhea,¹ ¹⁰ ¹⁵ increased lipase concentrations,¹ ¹⁵ rash/desquamation,¹ ¹⁵ fatigue,¹ ¹⁰ ¹⁵ hand-foot syndrome,¹ ¹⁰ ¹⁵ increased amylase concentrations,¹ alopecia,¹ ¹⁵ nausea,¹ ¹⁵ lymphopenia,¹ ¹⁵ pruritus,¹ ¹⁵ neutropenia,¹ hypertension,¹ ¹⁰ ¹⁵ anorexia,¹ ¹⁵ vomiting,¹ ¹⁵ constipation,¹ ¹⁵ hemorrhage (all sites, including GI and respiratory tract),¹ ¹⁵ dyspnea,¹ ¹⁵ cough,¹ ¹⁵ sensory neuropathy,¹ ¹⁵ dry skin,¹ pain (abdominal, joint, headache, mouth, bone, and tumor),¹ ¹⁵ weight loss,¹ ¹⁵ erythema,¹ asthenia,¹ leukopenia.¹

Interactions for Sorafenib Tosylate

Metabolized by CYP3A4 and uridine diphosphate-glucuronosyltransferase (UGT) 1A9.¹ ⁷

Inhibits CYP isoenzymes 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4 in vitro.¹ Unlikely to induce CYP1A2 or CYP3A4.¹

Inhibits glucuronidation by UGT1A1 and UGT1A9.¹

Drugs Affecting Hepatic Microsomal Enzymes

CYP3A4 inhibitors: Unlikely to alter metabolism of sorafenib based on drug interaction studies with ketoconazole.¹

CYP3A4 inducers: Potential pharmacokinetic interaction (decreased plasma concentrations of sorafenib).¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP isoenzymes 2C19, 2D6, or 3A4: Pharmacokinetic interaction (alteration of substrate metabolism) unlikely.¹

Substrates of CYP2B6 or CYP2C8: Possible pharmacokinetic interaction (increased systemic exposure to the substrate); caution is advised during concomitant use.¹

Drugs Metabolized by Uridine Diphosphate-glucuronosyltransferase

Substrates of UGT1A1 or UGT1A9: Potential pharmacokinetic interaction (increased systemic exposure to the substrate).¹ Caution is advised with concomitant use of sorafenib and substrates of UGT1A1 (e.g., irinotecan).¹

Specific Drugs

Drug	Interaction	Comments
Anticonvulsants (carbamazepine, phenobarbital, phenytoin)	Possible decreased plasma sorafenib concentrations¹
Dexamethasone	Possible decreased plasma sorafenib concentrations¹
Dextromethorphan	Pharmacokinetic interaction unlikely¹
Doxorubicin	Possible increased AUC of doxorubicin¹	Caution is advised¹
Gemcitabine	Sorafenib does not appear to affect gemcitabine pharmacokinetics¹
Irinotecan	Possible increased AUC of irinotecan and its active metabolite, SN-38¹	Caution is advised¹
Ketoconazole	Pharmacokinetic interaction unlikely ¹
Midazolam	Pharmacokinetic interaction unlikely¹
Omeprazole	Pharmacokinetic interaction unlikely¹
Oxaliplatin	Sorafenib does not appear to affect oxaliplatin pharmacokinetics¹
Rifampin	Possible decreased plasma sorafenib concentrations¹
St. John's wort (Hypericum perforatum)	Possible decreased plasma sorafenib concentrations¹
Warfarin	Increased risk of bleeding episodes or INR elevations; sorafenib does not appear to affect warfarin metabolism¹	Monitor regularly for changes in PT or INR and for clinical bleeding episodes¹

Sorafenib Tosylate Pharmacokinetics

Absorption

Bioavailability

Mean relative bioavailability is 38–49% when compared with oral solution.¹ Peak plasma concentrations attained in approximately 3 hours.¹

Food

High-fat meal reduces bioavailability by about 29%.¹

Special Populations

AUC in Japanese patients receiving sorafenib 400 mg twice daily reduced by 45% compared with data from phase 1 studies in Caucasian patients.¹ (See Japanese Populations under Cautions.)

Distribution

Extent

Not known whether sorafenib is distributed into milk.¹

Plasma Protein Binding

99.5%.¹

Elimination

Metabolism

Metabolized mainly in the liver via oxidation by CYP3A4 and glucuronidation by UGT1A9.¹ ⁷

At least 8 metabolites identified.¹ The main circulating metabolite, a pyridine N-oxide derivative, is pharmacologically active and accounts for approximately 9–16% of total plasma concentrations of the drug.¹

Elimination Route

Excreted in feces (77%) and urine (19%).¹

51% of a dose recovered in feces as unchanged drug; unchanged drug not recovered in urine.¹

Half-life

Approximately 25–48 hours.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹ Store in a dry place.¹

ActionsActions

Mechanism of action not fully elucidated; appears to inhibit signal transduction pathways involving multiple intracellular (e.g., c-Raf, b-Raf, mutant b-Raf) and cell surface kinases (e.g., c-Kit, Flt-3, vascular endothelial growth factor receptors 2 and 3, platelet-derived growth factor receptor-β) in vitro.¹ ² ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹² ¹³ ¹⁵ ¹⁶ ¹⁷

Advice to Patients

Importance of reading the manufacturer’s patient information prior to beginning therapy and rereading it each time the prescription is renewed.¹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Necessity of advising women to avoid pregnancy during therapy and for ≥2 weeks following completion of sorafenib therapy, as well as advising women to discontinue nursing while receiving therapy.¹ Necessity of advising women and men to use effective contraceptive methods during sorafenib therapy and for ≥2 weeks following completion of therapy.¹ Advise women of the potential risk to the fetus (e.g., birth defects) and/or the potential risk for loss of the pregnancy.¹

Risk of hand-foot syndrome and rash.¹ Importance of advising patient about appropriate countermeasures.¹

Risk of hypertension, particularly during the first 6 weeks of sorafenib therapy.¹ Importance of monitoring BP regularly during therapy.¹

Risk of bleeding.¹ Importance of patients promptly informing clinicians of any episodes of bleeding.¹

Risk of potential GI perforation.¹

Risk of potential cardiac ischemia and/or infarction.¹ Importance of patients immediately informing clinicians of any episodes of chest pain or other symptoms of cardiac ischemia and/or infarction.¹

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

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

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

Sorafenib Tosylate
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	200 mg (of sorafenib)	Nexavar	Bayer , (comarketed by Onyx)

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.

References

1. Bayer. Nexavar (sorafenib tosylate) tablets prescribing information. West Haven, CT: 2007 Feb.

2. Ahmad T, Eisen T. Kinase inhibition with BAY 43-9006 in renal cell carcinoma. Clin Cancer Res. 2004; 10:6388S-92S. [PubMed 15448036]

3. Food and Drug Administration. Cumulative list of all orphan designated products that have received marketing approval. Available at: . Accessed 2006 Feb 10.

4. Escudier B, Szczylik C, Eisen T et al. Randomized phase III trial of the raf kinase and VEGFR inhibitor sorafenib (BAY 43-9006) in patients with advanced renal cell carcinoma (RCC). Presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). Orlando, FL. 2005 13–17 May. Abstract LBA 4510.

5. Ratain MJ, Eisen T, Stadler WM et al. Final findings from a phase II, placebo-controlled, randomized discontinuation trial (RDT) of sorafenib (BAY 43-9006) in patients with advanced renal cell carcinoma (RCC). Presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). Orlando, FL. 2005 13–17 May. Abstract LBA 4544.

6. Favaro JP, George DJ. Targeted therapy in renal cell carcinoma. Expert Opin Investig Drugs. 2005; 14:1251-8. [PubMed 16185167]

7. Beeram M, Patnaik A, Rowinsky EK. Raf: a strategic target for therapeutic development against cancer. J Clin Oncol. 2005; 23:6771-90. [IDIS 543417] [PubMed 16170185]

8. Cooney MM, Remick SC, Vogelzang NJ. Promising systemic therapy for renal cell carcinoma. Curr Treat Options Oncol. 2005; 6:357-65. [PubMed 16107239]

9. Arora A, Scholar EM. Role of tyrosine kinase inhibitors in cancer therapy. J Pharmacol Exp Ther. 2005; 315:971-9. [PubMed 16002463]

10. Schöffski P, Dumez H, Clement P et al. Emerging role of tyrosine kinase inhibitors in the treatment of advanced renal cell cancer: a review. Ann Oncol . 2006 (Advance access [doi:10.1093/annonc/mdj133]); :.

11. Zakarija A, Soff G. Update on angiogenesis inhibitors. Curr Opin Oncol. 2005; 17:578-83. [PubMed 16224236]

12. Gollob JA. Sorafenib: scientific rationales for single-agent and combination therapy in clear-cell renal cell carcinoma. Clin Genitourin Cancer. 2005; 4:167-74. [PubMed 16425993]

13. Wilhelm SM, Carter C, Tang L et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 2004; 64:7099-109. [PubMed 15466206]

14. Bayer, West Haven, CT: Personal communication.

15. Escudier B, Eisen T, Stadler WM et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007; 356:125-34. [PubMed 17215530]

16. Brugarolas J. Renal-cell carcinoma—molecular pathways and therapies. N Engl J Med. 2007; 356:185-7. [PubMed 17215538]

17. Govindarajan R, Adusumilli J, Baxter DL et al. Reversible posterior leukoencephalopathy syndrome induced by RAF kinase inhibitor BAY 43-9006. J Clin Oncol. 2006; 24:e48. [PubMed 17008686]

More Sorafenib Tosylate resources

Sorafenib Tosylate Side Effects (in more detail)
Sorafenib Tosylate Dosage
Sorafenib Tosylate Use in Pregnancy & Breastfeeding
Sorafenib Tosylate Drug Interactions
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