Monday, October 8, 2012

Tramacet


Generic Name: tramadol and acetaminophen (Oral route)


TRAM-a-dol hye-droe-KLOR-ide, a-seet-a-MIN-oh-fen


Oral route(Tablet)

Ultracet(R) contains tramadol hydrochloride and acetaminophen; acetaminophen has been associated with acute liver failure, with some cases resulting in liver transplant and death and most cases of liver injury associated with doses exceeding 4000 mg/day and often involve more than one acetaminophen-containing product



Commonly used brand name(s)

In the U.S.


  • Ultracet

In Canada


  • Tramacet

Available Dosage Forms:


  • Tablet

Therapeutic Class: Analgesic Combination


Chemical Class: Tramadol


Uses For Tramacet


Tramadol and acetaminophen combination is used to relieve pain. When used together, the combination provides better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.


Tramadol belongs to the group of medicines called opioid analgesics (narcotics). It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine. Since this medicine is only used for the short-term relief of pain, physical dependence will probably not occur.


Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.


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


Before Using Tramacet


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 have not been performed on the relationship of age to the effects of tramadol and acetaminophen combination 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 tramadol and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems which may require caution and an adjustment in the dose for patients receiving tramadol and acetaminophen combination.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal 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. When you are taking this medicine, 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 this medicine 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.


  • Rasagiline

  • Selegiline

Using this medicine 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.


  • Acetophenazine

  • Amitriptyline

  • Amoxapine

  • Bromperidol

  • Carbamazepine

  • Chlorpromazine

  • Chlorprothixene

  • Citalopram

  • Clobazam

  • Clomipramine

  • Clorgyline

  • Clovoxamine

  • Clozapine

  • Cyclobenzaprine

  • Desipramine

  • Desvenlafaxine

  • Dothiepin

  • Doxepin

  • Duloxetine

  • Escitalopram

  • Ethopropazine

  • Femoxetine

  • Fluoxetine

  • Flupenthixol

  • Fluphenazine

  • Fluvoxamine

  • Haloperidol

  • Imipramine

  • Isocarboxazid

  • Ketamine

  • Linezolid

  • Lofepramine

  • Loxapine

  • Melperone

  • Mesoridazine

  • Methotrimeprazine

  • Milnacipran

  • Mirtazapine

  • Moclobemide

  • Molindone

  • Nortriptyline

  • Olanzapine

  • Paroxetine

  • Penfluridol

  • Perphenazine

  • Phenelzine

  • Pimozide

  • Pipotiazine

  • Prochlorperazine

  • Promazine

  • Promethazine

  • Propiomazine

  • Protriptyline

  • Remoxipride

  • Risperidone

  • Sertraline

  • Sulpiride

  • Tapentadol

  • Thiethylperazine

  • Thioridazine

  • Thiothixene

  • Tranylcypromine

  • Trifluoperazine

  • Triflupromazine

  • Trimeprazine

  • Trimipramine

  • Venlafaxine

  • Vilazodone

  • Zuclopenthixol

Using this medicine 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.


  • Acenocoumarol

  • Carbamazepine

  • Digoxin

  • Isoniazid

  • Phenytoin

  • Quinidine

  • Warfarin

  • Zidovudine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Cabbage

Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Alcohol abuse, history of or

  • Central nervous system (CNS) depression (not awake and alert) or

  • Central nervous system (CNS) infection (e.g., meningitis) or

  • Depression, history of or

  • Drug abuse, history of or

  • Head injury or

  • Increased pressure in the head or

  • Mental illness, history of or

  • Metabolic disorders or

  • Respiratory depression (hypoventilation or slow breathing) or

  • Seizures or epilepsy, history of or

  • Stomach problems, severe—Use with caution. The chance of side effects may be increased.

  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

  • Liver disease—Should not be used in patients with this condition.

Proper Use of tramadol and acetaminophen

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


Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.


This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).


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 oral dosage form (tablets):
    • For pain:
      • Adults—2 tablets every 4 to 6 hours as needed for up to 5 days.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, 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 Tramacet


It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.


Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.


This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines; medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; opioids; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.


This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.


Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet.


Make sure your doctor knows about all the other medicines you are using. This medicine may increase your risk for seizures (convulsions) and may cause a serious condition called serotonin syndrome.


This medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.


This medicine 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 with breathing; trouble with swallowing; swelling of your hands, face, or mouth; or chest pain while you are using this medicine.


This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.


Make sure your doctor knows if you are pregnant, may be pregnant, or planning to become pregnant.


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


Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness, that may occur.


Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine.


Analgesics may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.


If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include dark urine, difficult or troubled breathing; irregular, fast or slow, or shallow breathing; nausea or vomiting; pain in the upper stomach; pale or blue lips, fingernails, or skin; pinpoint pupils of the eyes, shortness of breath, or yellow eyes or skin.


Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble with sleeping.


Tramacet 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:


Rare
  • Burning, itching, and redness of the skin

  • chest pain

  • cough

  • difficulty with swallowing

  • dizziness

  • fast heartbeat

  • hives

  • itching

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

  • seizures (convulsions)

  • shortness of breath

  • skin rash

  • tightness in the chest

  • unusual tiredness or weakness

  • vomiting

  • wheezing

Incidence not known
  • Blistering, peeling, or loosening of the skin

  • chills

  • diarrhea

  • difficulty with breathing

  • joint or muscle pain

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • noisy breathing

  • red skin lesions, often with a purple center

  • red, irritated eyes

  • sore throat

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

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


Symptoms of overdose
  • Abdominal or stomach pain

  • black, tarry stools

  • chest pain or discomfort

  • dark urine

  • difficulty with sleeping

  • disorientation

  • drowsiness to profound coma

  • fever

  • headache

  • irregular, fast or slow, or shallow breathing

  • lethargy

  • light-colored stools

  • lightheadedness

  • loss of appetite

  • mood or other mental changes

  • nausea

  • pale or blue lips, fingernails, or skin

  • seeing, hearing, or feeling things that are not there

  • unpleasant breath odor

  • vomiting of blood

  • yellow eyes or skin

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:


Less common
  • Acid or sour stomach

  • anxiety

  • belching

  • bloated or full feeling

  • constipation

  • dry mouth

  • excess air or gas in the stomach or intestines

  • false or unusual sense of well-being

  • feeling of warmth

  • heartburn

  • increase in bowel movements

  • increased sweating

  • indigestion

  • loose stools

  • loss of strength or energy

  • muscle pain or weakness

  • nervousness

  • numbness or tingling of the hands, legs, and feet

  • painful or difficult urination

  • redness of the face, neck, arms, and occasionally the upper chest

  • sleepiness or unusual drowsiness

  • sleeplessness

  • soft stools

  • stomach discomfort

  • trouble with sleeping

  • unable to sleep

  • weight loss

Rare
  • Abnormal thinking

  • blurred vision

  • change in vision

  • clumsiness, unsteadiness, trembling, or problems with muscle control or coordination

  • cold sweats

  • continuing ringing, buzzing, or unexplained noise in the ears

  • crying

  • decrease in the frequency or amount of urination

  • decreased awareness or responsiveness

  • decreased interest in sexual intercourse

  • depression

  • difficulty in passing urine (dribbling)

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

  • dysphoria

  • euphoria

  • fainting

  • fast, pounding, or irregular heartbeat or pulse

  • feeling of constant movement of self or surroundings

  • feeling unusually cold

  • headache, severe or continuing

  • high or low blood pressure

  • increased muscle tone

  • involuntary muscle contractions

  • loss of memory

  • loss of sense of reality

  • loss of sexual ability, desire, drive, or performance

  • migraine headache

  • morbid dreaming

  • paranoia

  • pounding in the ears

  • problems with memory

  • quick to react or overreact emotionally

  • rapidly changing moods

  • sensation of spinning

  • severe stomach pain

  • shakiness and unsteady walk

  • shivering

  • swelling of the tongue

  • vomiting of blood or material that looks like coffee grounds

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.



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 Tramacet resources


  • Tramacet Use in Pregnancy & Breastfeeding
  • Drug Images
  • Tramacet Drug Interactions
  • Tramacet Support Group
  • 25 Reviews for Tramacet - Add your own review/rating


Compare Tramacet with other medications


  • Pain
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Friday, October 5, 2012

Selenium Foam


Pronunciation: se-LEE-nee-um
Generic Name: Selenium
Brand Name: Tersi Foam


Selenium Foam is used for:

Treating scalp and skin conditions such as seborrhea or tinea versicolor (a fungal infection). It may also be used for other conditions as determined by your doctor.


Selenium Foam is a antiseborrheic and antifungal combination. It decreases skin cell growth associated with flaking and itching. It also kills sensitive fungi.


Do NOT use Selenium Foam if:


  • you are allergic to any ingredient in Selenium Foam

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



Before using Selenium Foam:


Some medical conditions may interact with Selenium 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 broken, irritated, inflamed, or oozing skin at the application site

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


Ask your health care provider if Selenium 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 Selenium Foam:


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


  • Remove jewelry before using Selenium Foam.

  • Shake well before each use.

  • Turn the container upside down to dispense medicine. Apply enough medicine to cover the affected area as directed by your doctor. Rub the medicine in until it is completely absorbed. Wash your hands immediately after using Selenium Foam.

  • If you miss a dose of Selenium 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 Selenium Foam.



Important safety information:


  • Selenium Foam is for external use only. Do not get Selenium Foam in your eyes, nose, mouth, or in the genital area. If you get it in any of these areas, rinse right away with cool water.

  • If your symptoms do not get better or if they get worse, check with your doctor.

  • Do not use more often or for longer than prescribed without checking with your doctor. If you use topical products too often, some conditions may become worse.

  • Do not use Selenium Foam for another skin condition at a later time.

  • Do not use Selenium Foam on broken, blistered, or inflamed skin.

  • Selenium Foam may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

  • Selenium Foam should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Selenium Foam while you are pregnant. It is not known if Selenium Foam is found in breast milk after topical use. If you are or will be breast-feeding while you use Selenium Foam, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Selenium 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:



Temporary mild stinging, burning, itching, or irritation of the skin.



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); severe redness, stinging, burning, or irritation.



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: Selenium 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. Selenium Foam may be harmful if swallowed.


Proper storage of Selenium Foam:

Store Selenium Foam at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Selenium Foam out of the reach of children and away from pets.


General information:


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

  • Selenium 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 Selenium 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Selenium resources


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


Compare Selenium with other medications


  • Seborrheic Dermatitis
  • Tinea Versicolor


Thursday, October 4, 2012

Solaquin


Generic Name: hydroquinone topical (HYE droe KWIN one)

Brand Names: Aclaro, Aclaro PD, Alera, Alphaquin HP, Alustra, Claripel, Eldopaque, Eldopaque Forte, Eldoquin, Eldoquin Forte, EpiQuin Micro, Esoterica, Esoterica with Sunscreen, Glyquin, Glyquin-XM, Hydroquinone and Sunscreen, Lustra, Lustra-AF, Lustra-Ultra, Melpaque HP, Melquin HP, Melquin-3, Nuquin HP, Solaquin, Solaquin Forte


What is Solaquin (hydroquinone topical)?

Hydroquinone decreases the formation of melanin in the skin. Melanin is the pigment in skin that gives it a brown color.


Hydroquinone topical is used to lighten areas of darkened skin such as freckles, age spots, chloasma, and melasma.


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


What is the most important information I should know about Solaquin (hydroquinone topical)?


Before using hydroquinone topical, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.


Do not use hydroquinone topical on skin that is sunburned, windburned, dry, chapped, or irritated, or on an open wound. It could make these conditions worse. Wait until these conditions have healed before applying hydroquinone topical. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.


Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Hydroquinone topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What should I discuss with my healthcare provider before using Solaquin (hydroquinone topical)?


Do not use hydroquinone topical on skin that is sunburned, windburned, dry, chapped, or irritated, or on an open wound. It could make these conditions worse. Wait until these conditions have healed before applying hydroquinone topical.

Before using hydroquinone topical, tell your doctor if you are allergic to any drugs, or if you have:



  • liver disease; or




  • kidney disease.



If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.


This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydroquinone topical 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.

How should I use Solaquin (hydroquinone topical)?


Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.


Hydroquinone topical is for external use only. Wash your hands before and after applying this medication, unless you are treating a skin area on your hand.

Apply the medication to clean, dry skin. Apply just enough medication to cover the affected area. Avoid applying to the unaffected surrounding skin. Rub in the medication gently and completely.


Avoid getting this medication on your lips or inside your nose or mouth. Hydroquinone may cause numbness of these areas. If the medication does get on any of these areas, rinse with water.


It is important to use hydroquinone topical regularly to get the most benefit.


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

What happens if I miss a dose?


Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of topically applied hydroquinone is not likely to cause life-threatening symptoms.


What should I avoid while using Solaquin (hydroquinone topical)?


Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use hydroquinone topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Your skin may be more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing cream or lotion as needed.


Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.


Using hydroquinone topical together with benzoyl peroxide, hydrogen peroxide, or other peroxide products may cause a temporary staining of your skin. This staining can usually be removed with soap and water. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Hydroquinone topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Solaquin (hydroquinone topical) 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 hydroquinone topical and call your doctor if you have severe burning, stinging, or other irritation of your skin after apply the medication.

Less serious side effects may include mild burning, stinging, itching, redness, or irritation of treated skin.


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 Solaquin (hydroquinone topical)?


It is not likely that other drugs you take orally or inject will have an effect on topically applied hydroquinone. But many drugs can interact with each other. 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 Solaquin resources


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


  • Alustra MedFacts Consumer Leaflet (Wolters Kluwer)

  • Epiquin Micro Prescribing Information (FDA)

  • Esoterica Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Solaquin Forte Cream MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Solaquin with other medications


  • Dermatological Disorders


Where can I get more information?


  • Your pharmacist can provide more information about hydroquinone topical.

See also: Solaquin side effects (in more detail)



Wednesday, October 3, 2012

Temozolomide


Class: Antineoplastic Agents
VA Class: AN100
Chemical Name: 3,4-Dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide
Molecular Formula: C6H6N6O2
CAS Number: 85622-93-1
Brands: Temodar

Introduction

Alkylating antineoplastic agent; prodrug.1 2 3


Uses for Temozolomide


Brain Tumors


Adjunct to radiation therapy for treatment of newly diagnosed glioblastoma multiforme; also used as maintenance therapy.1


Treatment of refractory anaplastic astrocytoma in adults whose disease has progressed after therapy with a nitrosourea and procarbazine.1


Temozolomide Dosage and Administration


General



  • Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.




  • Monitor CBC periodically and adjust dosage and dosing schedule as appropriate.1 Adjust dosage based on nadir platelet and ANC during the previous cycle and on ANC and platelet counts on day 1 of the next cycle.1 (See Dosage and also see Dosage Modification under Dosage and Administration.)



Pneumocystis jiroveci (formerly P. carinii) Pneumonia (PCP)



  • Prophylaxis for PCP (e.g., inhaled pentamidine, oral co-trimoxazole) required for all patients receiving concomitant temozolomide and radiation therapy for the 42-day regimen for treatment of glioblastoma multiforme.1 8 In patients with lymphocytopenia, continue PCP prophylaxis until recovery from lymphocytopenia occurs.1




  • Closely monitor all patients, particularly those receiving concomitant corticosteroids, for the development of PCP.1 (See Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia under Cautions.)



Administration


Administer orally or by IV infusion.1


Oral Administration


Administer orally once daily with a full glass of water and in a consistent manner relative to food intake.1 Swallow capsule intact.1


Administration on an empty stomach may reduce incidence of nausea and vomiting; may give antiemetics prior to and/or following temozolomide administration.1


Bedtime administration may be advisable.1


Do not open capsules.1 If accidentally opened or damaged, avoid inhalation or contact with skin or mucous membranes.1


Dispensing and Administration Precautions

Based on the dose prescribed, determine the number of each strength capsules needed (e.g., for a dose of 275 mg daily for 5 days, dispense five 250 mg-capsules, five 20-mg capsules, and five 5-mg capsules).12 Dispense each strength of capsules in a separate container.12 Label each container with the strength per capsule and with the appropriate number of capsules to be taken each day.12 Instruct the patient to take the appropriate number of capsules from each container to equal the total daily dose.12


IV Infusion


Administer by IV infusion.1


Handle cautiously (e.g., use gloves); avoid exposure during handling of powder and preparation of IV solution.1


Vials are for single use only.1


Use an infusion pump to administer the drug.1 Flush the IV line before and after each temozolomide infusion.1


Reconstitution

Must be reconstituted prior to administration.1


Allow vials to reach room temperature prior to reconstitution.1 Reconstitute powder for injection by adding 41 mL of sterile water for injection to a vial containing 100 mg of temozolomide, resulting in a solution containing 2.5 mg/mL of temozolomide; gently swirl (do not shake).1


Do not further dilute the reconstituted solution prior to administration.1 Using aseptic technique, transfer up to 40 mL from each vial of reconstituted solution needed to reach the calculated dosage to an empty 250-mL polyvinylchloride (PVC) infusion bag; compatibility studies with non-PVC bags have not been conducted.1 Do not infuse other drugs through the same IV line.1


Store reconstituted solution at room temperature for up to 14 hours (including infusion time).1


Rate of Administration

Administer by IV infusion over 90 minutes using an infusion pump.1 Infusion over a shorter or longer duration may result in suboptimal dosing or an increase in infusion-related adverse reactions.1


Dosage


Calculate dosage according to body surface area.1


Recommended IV dosage is the same as the oral dose.1 Bioequivalence of oral and IV doses of temozolomide established only when temozolomide for injection is administered by IV infusion over 90 minutes.1


Adults


Brain Tumors

Glioblastoma Multiforme

Oral or IV

Initial Phase: 75 mg/m2 daily for 42 days (up to 49 days) concomitantly with focal radiotherapy (60 Gy administered in 30 fractions).1 Monitor CBC weekly; interrupt or discontinue temozolomide if severe hematologic or nonhematologic toxicities occur.1 (See Table 1)


Four weeks after completing initial phase (temozolomide and radiation therapy), initiate maintenance therapy (six 28-day cycles of temozolomide).1 8


Maintenance Phase: 150 mg/m2 once daily for 5 consecutive days followed by a 23-day rest period for a 28-day cycle (six cycles).1 Periodically monitor CBC; do not resume dosing until criteria for continuance of therapy are met.1 (See Table 2.) For cycle 2, may increase dosage to 200 mg/m2 once daily for 5 days only if nonhematologic toxicity (excluding alopecia, nausea, and vomiting) from cycle 1 is ≤ grade 2, ANC ≥1500/mm3, and platelet count ≥100,000/mm3.1 For cycles 3–6, continue dosage of 200 mg/m2 once daily for 5 consecutive days of each 28-day cycle, unless toxicity occurs.1 If dosage was not increased for cycle 2, do not increase dosage for subsequent cycles.1


Refractory Anaplastic Astrocytoma

Oral or IV

Initially, 150 mg/m2 once daily for 5 consecutive days of a 28-day treatment cycle.1 Monitor CBC periodically; adjust subsequent dosages and dosing schedule as appropriate.1 (See Table 3.) For next cycle, increase dosage to 200 mg/m2 once daily for 5 days only if nadir and day-of-dosing (day 29, day 1 of next cycle) ANC and platelet count ≥1500/mm3 and ≥100,000/mm3, respectively.1


Continue therapy until disease progression occurs.1 In the pivotal clinical study, treatment could be continued for a maximum of 2 years; however, optimum duration of therapy is not known.1


Dosage Modification for Toxicity

Glioblastoma Multiforme

Oral or IV

During initial phase (concomitant temozolomide and radiotherapy), monitor CBC at baseline, then weekly, and adjust dosing schedule as appropriate.1 (See Table 1.)











Table 1. Dosage Adjustments during Initial Phase1

Hematologic and Nonhematologic Measurements



Comments



If ANC ≥1500/mm3, platelet count ≥100,000/mm3, and nonhematologic toxicity ≤ grade 1 (excluding alopecia, nausea, and vomiting)



Continue recommended initial dosage (75 mg/m2 daily concomitantly with radiation therapy) for 42 days (up to 49 days)1



If ANC 500–1499/mm3, platelet count 10,000–99,999/mm3, or grade 2 nonhematologic toxicity (excluding alopecia, nausea, and vomiting)



Postpone therapy until ANC ≥1500/mm3, platelet count ≥100,000/mm3, and nonhematologic toxicity ≤ grade 1; then resume therapy at previous dosage1



If ANC <500/mm3, platelet count <10,000/mm3, or grade 3 or 4 nonhematologic toxicity (excluding alopecia, nausea, and vomiting)



Discontinue temozolomide1


During maintenance therapy, obtain CBC at baseline, then on day 22 (i.e., 21 days after first dose) of cycle or within 48 hours of that day, and weekly until ANC is >1500/mm3 and platelet count is >100,000/mm3.1 Withhold next cycle until these counts are exceeded.1 Adjust dosage and schedule for next cycle based on nadir hematologic measurements (i.e., ANC and platelet counts) and most severe nonhematologic toxicity during previous cycle.1 (See Table 2.)













Table 2. Dosage Adjustments during Maintenance Therapy1

Hematologic and Nonhematologic Measurements



Comments



If ANC >1500/mm3, platelet count >100,000/mm3, and nonhematologic toxicity ≤ grade 2 (excluding alopecia, nausea, and vomiting)



Administer 200 mg/m2 daily for 5 consecutive days of cycle 2.1 For subsequent cycles, administer 200 mg/m2 daily for 5 consecutive days, unless toxicity occurs1



If ANC 1000–1500/mm3or platelet count 50,000–100,000/mm3 during previous cycle



Postpone therapy until ANC >1500/mm3and platelet count >100,000/mm3; then, resume therapy at previous dosage1



If ANC <1000/mm3, platelet count <50,000/mm3, or nonhematologic toxicity grade 3 during previous cycle (excluding alopecia, nausea, and vomiting)



Postpone therapy until ANC >1500/mm3and platelet count >100,000/mm3; then, reduce dosage for next cycle by 50 mg/m2 daily, but not to <100 mg/m2 daily (lowest recommended dosage)1



If nonhematologic toxicity grade 4 occurs (excluding alopecia, nausea, and vomiting); the same nonhematologic toxicity grade 3 recurs after dosage reduction; or dosage reduction to <100 mg/m2 daily is required



Discontinue temozolomide1


Refractory Anaplastic Astrocytoma

Oral or IV

Obtain CBC at baseline and then on day 22 (i.e., 21 days after first dose) of cycle or within 48 hours of that day, and weekly until ANC is >1500/mm3 and platelet count is >100,000/mm3.1 Withhold next cycle until these counts are exceeded; adjust subsequent dosages based on nadir hematologic measurements (i.e., ANC and platelet counts) during previous cycle and on day 29 (i.e., day 1 of next cycle).1 (See Table 3.)











Table 3. Dosage Adjustments for Hematologic Toxicity

Hematologic Measurements



Comments



If both ANC and platelet count >1500/mm3 and >100,000/mm3, respectively, at nadir and day-of-dosing



Administer 200 mg/m2 daily for 5 consecutive days of next 28-day cycle1



If ANC 1000–1500/mm3or platelet count 50,000–100,000/mm3



Postpone therapy until ANC >1500/mm3 and platelet count >100,000/mm3; then administer 150 mg/m2 daily for 5 consecutive days1



If ANC <1000/mm3or platelet count <50,000/mm3 during previous cycle



Postpone therapy until ANC >1500/mm3 and platelet count >100,000/mm3; then reduce dosage for next cycle by 50 mg/m2 daily, but not to <100 mg/m2 daily (lowest recommended dosage)1


Special Populations


Geriatric Patients


Increased risk of developing myelosuppression, but no specific dosage recommendations other than usual adjustment for hematologic toxicity.1 (See Hematologic Effects under Cautions.)


Select dosage with caution in geriatric patients because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1


Female Patients


Increased risk of myelosuppression but no specific dosage recommendations other than usual adjustment for hematologic toxicity.1 (See Hematologic Effects under Cautions.)


Cautions for Temozolomide


Contraindications



  • Known hypersensitivity (e.g., urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson syndrome) to temozolomide or any ingredient in the formulation.1




  • Known hypersensitivity to dacarbazine (DTIC), since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC).1



Warnings/Precautions


Warnings


Hematologic Effects

Prolonged pancytopenia reported; may result in potentially fatal aplastic anemia.1 Assessment of patients for such effects may be complicated by concomitant administration of drugs associated with aplastic anemia (i.e., carbamazepine, phenytoin, co-trimoxazole).1 (See Specific Drugs under Interactions.)


Myelosuppression (dose-limiting thrombocytopenia and neutropenia).1 Higher incidence of grade 4 thrombocytopenia and/or neutropenia in women and geriatric patients.1


In patients with refractory anaplastic astrocytoma, myelosuppression generally occurs late in treatment cycle (e.g., 26–28 days), usually develops during first few cycles of therapy, resolves within 14 days, and is not cumulative.1


Hospitalization, blood transfusion, or drug discontinuance may be required.1


Monitor CBC periodically and adjust dosage and schedule as appropriate.1 (See Dosage and Administration.)


Secondary Malignancies

Myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, reported.1


Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia

Risk of Pneumocystis jiroveci pneumonia (PCP), particularly with longer dosage regimen.1


Closely monitor all patients (particularly those receiving corticosteroids) for development of PCP (regardless of regimen).1


PCP prophylaxis required for all patients receiving temozolomide in conjunction with radiation therapy for glioblastoma multiforme; continue prophylaxis in patients who develop lymphocytopenia until lymphocytopenia resolves (≤ grade 1).1 12


Hepatic Effects

Fatal reactivation of hepatitis B reported.9 Consider hepatitis screening and prophylactic antiviral therapy when clinically appropriate.9


Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.1 Teratogenicity and embryolethality demonstrated in animals.1


Avoid pregnancy during therapy.1


If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard.1


Sensitivity Reactions


Serious hypersensitivity reactions, including anaphylaxis, erythema multiforme, toxic epidermal necrolysis, and Stevens-Johnson syndrome reported.1


Specific Populations


Pregnancy

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


Lactation

Not known whether temozolomide is distributed into milk.1 Discontinue nursing because of potential risk to nursing infants.1


Pediatric Use

Safety and efficacy not demonstrated in children.1 Adverse effects reported in children 3–18 years of age were similar to those in adults in a clinical study.1


Geriatric Use

Experience in patients ≥65 years of age insufficient to determine whether geriatric patients respond differently than younger adults.1 Caution advised.1 (See Geriatric Patients under Dosage and Administration.)


In patients with refractory anaplastic astrocytoma, higher incidence of grade 4 thrombocytopenia and/or neutropenia reported in those ≥70 years of age compared with younger adults.1


In patients with glioblastoma multiforme, adverse effect profile in those ≥65 years of age similar to that in younger adults.1


Hepatic Impairment

Use with caution in patients with severe hepatic impairment.1


Renal Impairment

Use with caution in patients with severe renal impairment.1


Common Adverse Effects


In patients with glioblastoma multiforme: Alopecia, nausea, vomiting, anorexia, headache, constipation.1


In patients with refractory anaplastic astrocytoma: Nausea, vomiting, headache, fatigue.1


With IV therapy, pain, irritation, pruritus, warmth, swelling, erythema at the injection site, petechiae, hematoma.1


Interactions for Temozolomide


Temozolomide and MTIC only minimally metabolized by CYP isoenzymes.1


Specific Drugs

































Drug



Interaction



Comments



Carbamazepine



Unlikely to affect temozolomide clearance1


Possible additive hematologic toxicity (i.e., aplastic anemia)1



Concomitant administration may complicate assessment of hematologic toxicity 1 (see Hematologic Effects under Cautions)



Co-trimoxazole



Possible additive hematologic toxicity (i.e., aplastic anemia)1



Concomitant administration may complicate assessment of hematologic toxicity 1 (see Hematologic Effects under Cautions)



Dexamethasone



Unlikely to affect temozolomide clearance1



Histamine H2-receptor antagonists



Unlikely to affect temozolomide clearance1


Ranitidine did not affect maximum plasma concentrations or AUC of temozolomide or MTIC1



Ondansetron



Unlikely to affect temozolomide clearance1



Phenobarbital



Unlikely to affect temozolomide clearance1



Phenytoin



Unlikely to affect temozolomide clearance1


Possible additive hematologic toxicity (i.e., aplastic anemia)1



Concomitant administration may complicate assessment of hematologic toxicity 1 (see Hematologic Effects under Cautions)



Prochlorperazine



Unlikely to affect temozolomide clearance1



Valproic acid



5% decrease in temozolomide clearance 1



Clinical importance unknown1


Temozolomide Pharmacokinetics


Absorption


Bioavailability


Rapidly and completely absorbed after oral administration, with nearly 100% bioavailability.1 3 10 Peak plasma concentrations usually are attained within 1 hour.1 10


Bioequivalence of temozolomide (with respect to both peak plasma concentration and AUC) administered orally or as an IV infusion over 90 minutes at a dosage of 150 mg/m2 has been demonstrated.1


Food


Food decreases rate and extent of absorption after oral administration.1 Modified high fat breakfast decreased mean peak plasma temozolomide concentrations (32%) and AUC (9%).1


Distribution


Extent


Efficiently crosses the blood brain barrier.10


Not known whether temozolomide is distributed into milk.1


Plasma Protein Binding


Approximately 15%.1


Elimination


Metabolism


Temozolomide is a prodrug;1 2 3 undergoes rapid, nonenzymatic hydrolysis at physiologic pH to MTIC.1 2 3 4 MTIC is further hydrolyzed to 5-amino-imidazole-4-carboxamide (AIC) and to methylhydrazine.1


CYP isoenzymes play only a minor role in metabolism of temozolomide and MTIC.1


Elimination Route


About 38% of administered dose is recovered over 7 days, principally in urine with <1% in feces.1


Half-life


Approximately 1.8 hours.1 3 10 Apparent half-lives for metabolites MTIC and AIC are 2.1 and 2.6 hours, respectively.3


Special Populations


In patients with mild to moderate hepatic impairment, pharmacokinetic profile resembles that in patients with normal hepatic function.1


Clearance is not affected by renal function in patients with Clcr 36–130 mL/minute per m2.1 Not studied in patients with severe renal impairment (Clcr<36 mL/minute per m2) or patients receiving dialysis.1


Stability


Storage


Oral


Capsules

25°C (may be exposed to 15–30°C).1


Parenteral


Powder for Injection

2–8°C.1 Store reconstituted solution at 25°C and use within 14 hours (including infusion time).1


ActionsActions



  • Temozolomide is a prodrug and has little, if any, pharmacologic activity until hydrolyzed in vivo to MTIC.1




  • MTIC is further hydrolyzed to active metabolites that may alkylate DNA at the O6 and N7 positions of guanine.1 2 3 4 10



Advice to Patients



  • Importance of adhering to dosage and laboratory appointment schedules.1




  • Importance of PCP prophylaxis for patients with glioblastoma multiforme.1 (See Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia (PCP), under Cautions.) Importance of patients informing clinicians of signs and symptoms of PCP infection (e.g., shortness of breath, fever, chills, dry cough).7




  • Importance of women informing clinicians immediately if they are or plan to become pregnant or plan to breast-feed.1 Advise women and men to avoid pregnancy during therapy.1 Advise pregnant women of risk to the fetus.1




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




  • Importance of taking temozolomide in a consistent manner relative to food.1




  • Importance of swallowing capsules whole without chewing.1




  • Importance of avoiding exposure to capsule contents and of correct, safe storage and disposal away from children and pets.1




  • Risk of nausea and vomiting.1 Premedication with antiemetics and bedtime administration recommended.1




  • Advise of risk of low platelet counts and possible risk of bleeding.7 Importance of patients informing clinicians of any unusual bruising or bleeding.7




  • Importance of providing patient a copy of manufacturer’s patient information, including written, patient-specific instructions on how to take temozolomide.7




  • 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.











































Temozolomide

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



5 mg



Temodar



Schering



20 mg



Temodar



Schering



100 mg



Temodar



Schering



140 mg



Temodar



Schering



180 mg



Temodar



Schering



250 mg



Temodar



Schering



Parenteral



For injection, for IV infusion



100 mg



Temodar for Injection



Schering


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Temodar 100MG Capsules (SCHERING): 5/$929.6 or 15/$2777.89


Temodar 180MG Capsules (SCHERING): 14/$4786.94 or 28/$9459.2


Temodar 20MG Capsules (SCHERING): 5/$201.33 or 15/$569.39


Temodar 250MG Capsules (SCHERING): 5/$2300.06 or 15/$6859.96


Temodar 5MG Capsules (SCHERING): 5/$54.19 or 15/$136.54



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 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Schering Corp. Temodar (temozolomide) capsules, Temodar (temozolomide) for injection prescribing information. Kenilworth, NJ: 2009 Apr.



2. Anon. Temozolomide. Drugs Future. 1994; 19:746-9.



3. Baker SD, Wirth M, Statkevich P et al. Absorption, metabolism, and excretion of14C-temozolomide following oral administration to patients with advanced cancer. Clin Cancer Res. 1999; 5:309-17. [IDIS 424069] [PubMed 10037179]



4. Yung WKA, Prados MD, Yaya-Tur R et al. Multicenter phase II trial of temozolomide in patients with anaplastic astrocytoma or anaplastic oligoastrocytoma at first relapse. J Clin Oncol. 1999; 17:2762-71. [IDIS 435278] [PubMed 10561351]



5. Schering Corp, Kenilworth, NJ. Personal communication.



7. Schering Corp. Temodar (temozolomide) capsules, Temodar (temozolomide) for injection patient package insert. Kenilworth, NJ: 2009 Feb.



8. Stupp R, Mason WP van den Bent MJ et al. Radiotherapy plus concomitant and adjuvant temozolomide. N Engl J Med. 2007; 356:1591-2. [PubMed 17429098]



9. Grewal J, Dellinger CA, Yung WK. Fatal reactivation of hepatitis B with temozolomide. N Engl J Med. 2007;356:1591-2.



10. Baker SD, Wirth M, Statkevich P et al. Absorption, metabolism, and excretion of14C-temozolomide following oral administration to patients with advanced cancer. Clin Cancer Res. 1999; 5:309-17. [IDIS 424069] [PubMed 10037179]



11. Agarwala SS, Kirkwood JM. Temozolomide, a novel alkylating agent with activity in the central nervous system, may improve the treatment of advanced metastatic melanoma. Oncologist. 2000; 5:144-51. [PubMed 10794805]



12. Schering Corporation. Temodar (temozolomide) capsules pharmacist information sheet. Kenilworth, NJ: 2009 Feb



More Temozolomide resources


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


  • Temozolomide MedFacts Consumer Leaflet (Wolters Kluwer)

  • Temozolomide Professional Patient Advice (Wolters Kluwer)

  • temozolomide Advanced Consumer (Micromedex) - Includes Dosage Information

  • Temodar Prescribing Information (FDA)

  • Temodar Consumer Overview



Compare Temozolomide with other medications


  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Glioblastoma Multiforme
  • Melanoma
  • Melanoma, Metastatic


Tobradex



Generic Name: tobramycin and dexamethasone (Ophthalmic route)


toe-bra-MYE-sin, dex-a-METH-a-sone


Commonly used brand name(s)

In the U.S.


  • Tobradex

  • Tobradex ST

In Canada


  • Tobradex Ointment

  • Tobradex Suspension

Available Dosage Forms:


  • Ointment

  • Suspension

Therapeutic Class: Aminoglycoside/Corticosteroid Combination


Pharmacologic Class: Adrenal Glucocorticoid


Chemical Class: Aminoglycoside


Uses For Tobradex


Tobramycin and dexamethasone is a combination of an antibiotic and a corticosteroid. It is used in the eye to prevent permanent damage, which may occur with certain eye problems.


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


Before Using Tobradex


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 ophthalmic tobramycin and dexamethasone 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 use of ophthalmic tobramycin and dexamethasone in the elderly with use in other age groups.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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. When you are taking this medicine, 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 this medicine 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.


  • Praziquantel

  • Rilpivirine

  • Rotavirus Vaccine, Live

Using this medicine 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.


  • Alcuronium

  • Aldesleukin

  • Atracurium

  • Boceprevir

  • Bupropion

  • Cidofovir

  • Cisatracurium

  • Colistimethate Sodium

  • Darunavir

  • Dasatinib

  • Decamethonium

  • Doxacurium

  • Efavirenz

  • Ethacrynic Acid

  • Etravirine

  • Fazadinium

  • Fosamprenavir

  • Furosemide

  • Gallamine

  • Hexafluorenium

  • Imatinib

  • Ixabepilone

  • Lapatinib

  • Lysine

  • Metocurine

  • Mivacurium

  • Nevirapine

  • Nilotinib

  • Pancuronium

  • Pipecuronium

  • Quetiapine

  • Rapacuronium

  • Rivaroxaban

  • Rocuronium

  • Romidepsin

  • Succinylcholine

  • Sunitinib

  • Tacrolimus

  • Telaprevir

  • Temsirolimus

  • Thalidomide

  • Ticagrelor

  • Tubocurarine

  • Vancomycin

  • Vandetanib

  • Vecuronium

Using this medicine 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.


  • Alatrofloxacin

  • Alcuronium

  • Aminoglutethimide

  • Aprepitant

  • Aspirin

  • Atracurium

  • Balofloxacin

  • Caspofungin

  • Cinoxacin

  • Ciprofloxacin

  • Cisplatin

  • Clinafloxacin

  • Cyclosporine

  • Enoxacin

  • Fleroxacin

  • Fluindione

  • Flumequine

  • Fosaprepitant

  • Fosphenytoin

  • Gallamine

  • Gemifloxacin

  • Grepafloxacin

  • Hexafluorenium

  • Itraconazole

  • Levofloxacin

  • Licorice

  • Lomefloxacin

  • Metocurine

  • Moxifloxacin

  • Norfloxacin

  • Ofloxacin

  • Pancuronium

  • Pefloxacin

  • Phenobarbital

  • Phenytoin

  • Primidone

  • Prulifloxacin

  • Rifampin

  • Rifapentine

  • Ritonavir

  • Rosoxacin

  • Rufloxacin

  • Saiboku-To

  • Sparfloxacin

  • Temafloxacin

  • Tosufloxacin

  • Trovafloxacin Mesylate

  • Vecuronium

  • Warfarin

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.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Glaucoma—The dexamethasone in the eyedrops may cause glaucoma or make it worse if the eyedrops are used for a long time

  • Herpes infection of the eye or

  • Any other eye infection, including bacterial and fungal—The dexamethasone in the eyedrops may make existing infections worse or cause new infections

Proper Use of tobramycin and dexamethasone

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


For patients using the ophthalmic suspension (eye drops) form of this medicine:


  • Always shake the container very well just before applying the eye drops.

  • To use:
    • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.

    • If you think you did not get the drop of medicine into your eye properly, use another drop.

    • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Always keep the container tightly closed.


For patients using the ophthalmic ointment form of this medicine:


  • To use:
    • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1/2-inch strip of ointment is usually enough. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the irritation.

    • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye ointment, wipe the tip of the ointment tube with a clean tissue. Do not wash the tip with water. Always keep the tube tightly closed.


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 ophthalmic ointment dosage form:
    • For eye disorders:
      • Adults—Use about a 1/2-inch strip of ointment in the eye up to three or four times a day.

      • Children—Use and dose must be determined by your doctor.



  • For ophthalmic suspension (eye drops) dosage form:
    • For eye disorders:
      • Adults—Use 1 or 2 drops in the eye every four to six hours. Your doctor may have you use the drops more frequently during the first day or two and will probably have you space the doses farther apart as the eye gets better.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, 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.


Precautions While Using Tobradex


If you will be using this medicine for more than a few weeks, an ophthalmologist (eye doctor) should examine your eyes at regular visits to make sure it does not cause unwanted effects.


Tobradex 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:


Less common
  • Itching and swelling of eyelid

  • redness of eye

Rare
  • Delayed wound healing

  • eye pain

  • gradual blurring or loss of vision

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: Tobradex side effects (in more detail)



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More Tobradex resources


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


  • Tobradex Consumer Overview

  • TobraDex Prescribing Information (FDA)

  • TobraDex Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • TobraDex ST Prescribing Information (FDA)

  • TobraDex ST Drops MedFacts Consumer Leaflet (Wolters Kluwer)



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