Thursday, September 29, 2016

Clobetasol Foam


Pronunciation: kloe-BAY-ta-sol
Generic Name: Clobetasol
Brand Name: Olux/Olux-E Complete Pack


Clobetasol Foam is used for:

The short-term treatment of burning and itching caused by moderate to severe skin diseases. The regular foam may also be used to treat psoriasis and burning and itching caused by moderate to severe skin diseases of the scalp.


Clobetasol Foam is a topical corticosteroid. This kit contains the same medicine in 2 different types of foam. It works by reducing skin inflammation (redness, swelling, itching, and irritation).


Do NOT use Clobetasol Foam if:


  • you are allergic to any ingredient in Clobetasol Foam or to other corticosteroid medicines (eg, prednisone)

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



Before using Clobetasol Foam:


Some medical conditions may interact with Clobetasol 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 chickenpox, shingles, measles, or tuberculosis (TB), or have had a positive TB skin test or a recent vaccination

  • if you have had a skin infection, thinning of the skin (atrophy), or a certain type of severe acne (rosacea)

  • if you are taking an oral corticosteroid (eg, prednisone)

Some MEDICINES MAY INTERACT with Clobetasol Foam. However, no specific interactions with Clobetasol Foam are known at this time.


Ask your health care provider if Clobetasol 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 Clobetasol Foam:


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


  • Wash your hands before using Clobetasol Foam. If your fingers are warm, rinse them in cold water and dry before you apply Clobetasol Foam.

  • Use the smallest amount of medicine necessary to cover the affected area.

  • If you are using the emollient foam, shake well before each use.

  • Turn the can upside down and squirt a small amount of foam (up to the size of a golf ball) into the cap of the can, onto a clean saucer, or onto another cool, clean surface. You may also squirt it directly onto the affected area. Do not squirt the medicine directly into the hand because it will start to melt immediately upon touching warm skin.

  • If you are applying the regular foam to the scalp, move the hair away from the affected area and gently rub the medicine into the affected area until the foam disappears. Repeat until the entire affected area of the scalp is treated.

  • If you are applying Clobetasol Foam to other areas, gently rub the medicine into the skin until it disappears.

  • Throw away any unused medicine that has been squirted out of the can.

  • Wash your hands immediately after using Clobetasol Foam, unless your hands are a part of the treated area.

  • Do not use Clobetasol Foam on your face, groin, or underarms unless your doctor tells you otherwise.

  • Do not use Clobetasol Foam over large areas of the body without first checking with your doctor.

  • Do not bandage or wrap the affected area unless directed to do so by your doctor.

  • If the can seems warm or the foam seems runny, rinse the can with cool water.

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

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



Important safety information:


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

  • Do NOT use more than the recommended dose or use for longer than 2 weeks without checking with your doctor.

  • If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.

  • Talk with your doctor before you use any other medicines or cleansers on your skin.

  • Do not use Clobetasol Foam for other skin conditions at a later time.

  • Clobetasol Foam has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid (eg, hydrocortisone) in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Tell your doctor or dentist that you use Clobetasol Foam before you receive any medical or dental care, emergency care, or surgery.

  • Check with your doctor before you receive any vaccination while you are using Clobetasol Foam.

  • Serious side effects may occur if too much of Clobetasol Foam is absorbed through the skin. This may be more likely to occur if you use Clobetasol Foam over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply Clobetasol Foam. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.

  • Clobetasol Foam is flammable. Do not store near fire or an open flame. Avoid fire, open flame, or smoking during and immediately after use.

  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Clobetasol Foam.

  • Caution is advised when using Clobetasol Foam in CHILDREN older than 12 years old; they may be more sensitive to its effects.

  • Clobetasol Foam should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

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


Possible side effects of Clobetasol 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:



Dryness, burning, or mild skin irritation.



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); acne-like rash; burning, cracking, irritation, peeling, or swelling not present before you began using Clobetasol Foam; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of the fingers; symptoms of high blood sugar (eg, confusion; flushing; increased hunger, thirst, or urination; rapid breathing; unusual drowsiness); thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.



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: Clobetasol 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. Clobetasol Foam may be harmful if swallowed.


Proper storage of Clobetasol Foam:

Store Clobetasol Foam at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat and direct sunlight. Do not expose to heat or store at temperatures above 120 degrees F (49 degrees C). Do not puncture, break, or burn the canister, even if it appears to be empty. Keep Clobetasol Foam out of the reach of children and away from pets.


General information:


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

  • Clobetasol 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 Clobetasol 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 Clobetasol resources


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


Compare Clobetasol with other medications


  • Anal Itching
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  • Cutaneous T-cell Lymphoma
  • Dermatitis
  • Lichen Planus
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  • Necrobiosis Lipoidica Diabeticorum
  • Psoriasis
  • Seborrheic Dermatitis

Control


Generic Name: phenylpropanolamine (fen ill proe pa NOLE a meen)

Brand Names: Acutrim 16 Hour, Acutrim II, Maximum Strength, Acutrim Late Day, Control, Dexatrim, Empro, Mega-Trim, Phenyldrine, Propagest, Propan, Rhindecon, Westrim, Westrim LA


What is Control (phenylpropanolamine)?

Phenylpropanolamine is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. Constriction of blood vessels in your sinuses, nose, and chest allows drainage of those areas, which decreases congestion.


Phenylpropanolamine is used to treat the congestion associated with allergies, hay fever, sinus irritation, and the common cold. Phenylpropanolamine also causes a decrease in appetite and is used in some over-the-counter diet aids.


Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


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


What is the most important information I should know about Control (phenylpropanolamine)?


Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Do not take phenylpropanolamine for longer than 7 days if your condition does not improve or if your symptoms are accompanied by a high fever.


Do not take more of this medication than is recommended on the package or by your doctor. Use caution when driving, operating machinery, or performing other hazardous activities. Phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Who should not take Control (phenylpropanolamine)?


Do not take phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.


Before taking this medication, tell your doctor if you have



  • high blood pressure;




  • any type of heart disease, hardening of the arteries, or irregular heartbeat;




  • thyroid problems;




  • diabetes;




  • glaucoma or increased pressure in your eye;




  • an enlarged prostate or difficulty urinating; or




  • liver or kidney disease.



You may not be able to take phenylpropanolamine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.


It is not known whether phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of phenylpropanolamine. Do not take this drug if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from phenylpropanolamine. You may require a lower dose of this medication. Using a short-acting formulation of phenylpropanolamine (not a long-acting or a controlled-release formulation) may be safer if you are over 60 years of age.

How should I take Control (phenylpropanolamine)?


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


Take each dose with a full glass of water. Never take this medication in larger doses or more often than is recommended. Too much phenylpropanolamine could be very harmful.

If your symptoms are accompanied by a high fever, or if they do not improve in 7 days, see your doctor.


Store phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a phenylpropanolamine overdose include extreme tiredness, sweating, dizziness, a slow heart beat, and a coma.


What should I avoid while taking Control (phenylpropanolamine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Never take this medication in larger doses or more often than is recommended. Too much phenylpropanolamine could be very harmful.

Control (phenylpropanolamine) side effects


If you experience any of the following serious side effects from this medication, stop taking phenylpropanolamine and seek emergency medical attention:



  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);




  • seizures;




  • unusual behavior or hallucinations; or




  • an irregular or fast heartbeat.



Other, less serious side effects may be more likely to occur. Continue to take phenylpropanolamine and talk to your doctor if you experience



  • dizziness, lightheadedness, or drowsiness;




  • headache;




  • insomnia;




  • anxiety;




  • tremor (shaking) or restlessness;




  • nausea or vomiting; or




  • sweating.



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


What other drugs will affect Control (phenylpropanolamine)?


Do not take phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.


Phenylpropanolamine may also interact with the following medicines:



  • furazolidone (Furoxone);




  • guanethidine (Ismelin);




  • indomethacin (Indocin);




  • methyldopa (Aldomet);




  • bromocriptine (Parlodel);




  • caffeine in cola, tea, coffee, chocolate, and other products;




  • theophylline (Theo-Dur, Theochron, Theolair, others);



  • tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor);

  • other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil);

  • phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and prochlorperazine (Compazine); and

  • other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).

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



More Control resources


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


  • Propantheline Bromide Monograph (AHFS DI)



Compare Control with other medications


  • Nasal Congestion
  • Weight Loss


Where can I get more information?


  • Your pharmacist has more information about phenylpropanolamine written for health professionals that you may read.

What does my medication look like?


Phenylpropanolamine is available over the counter under the brand name Propagest, and with a prescription under the brand name Rhindecon. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



  • Propagest 25 mg--oval, white, scored tablets




  • Rhindecon 75 mg--timed-release capsules



See also: Control side effects (in more detail)


Clonazepam Orally Disintegrating Tablets


Pronunciation: kloe-NAZ-e-pam
Generic Name: Clonazepam
Brand Name: Klonopin Wafer


Clonazepam Orally Disintegrating Tablets are used for:

Controlling certain types of seizures in the treatment of epilepsy. It is also used for the treatment of panic disorders.


Clonazepam Orally Disintegrating Tablets are a benzodiazepine. It works by increasing the activity of a naturally occurring chemical in the brain.


Do NOT use Clonazepam Orally Disintegrating Tablets if:


  • you are allergic to any ingredient in Clonazepam Orally Disintegrating Tablets or to another benzodiazepine (eg, diazepam)

  • you have a severe mental disorder, acute angle-closure glaucoma, or severe liver disease

  • you are taking sodium oxybate (GHB)

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



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






Before using Clonazepam Orally Disintegrating Tablets:


Some medical conditions may interact with Clonazepam Orally Disintegrating Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


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

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

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

  • if you have a history of alcohol or substance abuse or dependence, or if you consume more than 3 alcohol-containing drinks per day

  • if you have a history of mental or mood problems (eg, depression, suicidal thoughts or attempts)

  • if you have myasthenia gravis (a condition in which the muscles become progressively weakened)

  • if you have angle-closure glaucoma, kidney or liver problems, or the blood disorder porphyria

  • if you have chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, or other breathing problems

Some MEDICINES MAY INTERACT with Clonazepam Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Methadone or sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe may occur

  • Paroxetine or tricyclic antidepressants (eg, amitriptyline) because side effects, including confusion, excessive sweating, fever, restlessness, seizures, and twitching, which can rarely be life-threatening, may occur

  • Antifungals (eg, fluconazole), cimetidine, disulfiram, hormonal contraceptives (eg, birth control pills), nefazodone, omeprazole, or valproic acid because they may increase the risk of Clonazepam Orally Disintegrating Tablets's side effects

  • Rifampin or St. John's wort because they may decrease Clonazepam Orally Disintegrating Tablets's effectiveness

  • Valproic acid because the effectiveness of both drugs may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Clonazepam Orally Disintegrating Tablets 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 Clonazepam Orally Disintegrating Tablets:


Use Clonazepam Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Clonazepam Orally Disintegrating Tablets by mouth with or without food.

  • Do not remove the blister from the outer pouch until you are ready to take Clonazepam Orally Disintegrating Tablets. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Take Clonazepam Orally Disintegrating Tablets with water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use

  • If you are taking Clonazepam Orally Disintegrating Tablets for the prevention of seizures, taking Clonazepam Orally Disintegrating Tablets at the same times each day will help you remember to take it.

  • Continue to take Clonazepam Orally Disintegrating Tablets even if you feel well. Do not miss any doses. Clonazepam Orally Disintegrating Tablets works best when there is a constant level of Clonazepam Orally Disintegrating Tablets in your body.

  • If you miss a dose of Clonazepam Orally Disintegrating Tablets and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Clonazepam Orally Disintegrating Tablets.



Important safety information:


  • Clonazepam Orally Disintegrating Tablets may cause drowsiness, dizziness, lightheadedness, blurred vision, or difficulty with coordination. These effects may be worse if you take it with alcohol or certain medicines. Use Clonazepam Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Clonazepam Orally Disintegrating Tablets may cause you to lose consciousness if you have a history of seizures. Use Clonazepam Orally Disintegrating Tablets with caution. Do not perform tasks that could be unsafe for you or others if you should lose consciousness (eg, driving, swimming, running heavy machinery).

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Clonazepam Orally Disintegrating Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Patients who take Clonazepam Orally Disintegrating Tablets may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Clonazepam Orally Disintegrating Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as anxious, restless, or irritable behavior; depressed mood; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.

  • Notify your doctor if seizure control worsens.

  • Carry an ID card at all times that says you take Clonazepam Orally Disintegrating Tablets if it is used for seizures.

  • Lab tests, including liver function, complete blood cell counts, and electrocardiograms, may be performed while you use Clonazepam Orally Disintegrating Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Clonazepam Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion and drowsiness.

  • Clonazepam Orally Disintegrating Tablets should not be used in CHILDREN younger than 18 years old with panic disorder; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Clonazepam Orally Disintegrating Tablets may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clonazepam Orally Disintegrating Tablets while you are pregnant. Clonazepam Orally Disintegrating Tablets are found in breast milk. Do not breast-feed while taking Clonazepam Orally Disintegrating Tablets.

When used for long periods of time or at high doses, Clonazepam Orally Disintegrating Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Clonazepam Orally Disintegrating Tablets stops working well. Do not take more than prescribed.


When used for longer than a few weeks or at high doses, some people develop a need to continue taking Clonazepam Orally Disintegrating Tablets. This is known as DEPENDENCE or addiction. If you stop taking Clonazepam Orally Disintegrating Tablets suddenly, you may have WITHDRAWAL symptoms. These may include abnormal thoughts or behavioral disorder, anxiety, depression, hallucinations, personality changes, or loss of contact with reality; convulsions (seizures); insomnia; stomach and muscle cramps; tremor. Do not suddenly stop taking Clonazepam Orally Disintegrating Tablets. If you need to stop Clonazepam Orally Disintegrating Tablets, your doctor will lower your dose over time.



Possible side effects of Clonazepam Orally Disintegrating Tablets:


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; cough; dizziness; drowsiness; dry mouth; headache; increased saliva production; lightheadedness; loss of coordination; nausea; runny nose; tiredness.



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); behavior changes; blurred vision or other vision changes; change in appetite; change in the amount of urine produced or painful urination; changes in sexual function; confusion; dark urine; excessive hair growth or loss; fever, chills, or sore throat; hallucinations; irregular heartbeat; memory loss or problems; muscle aches or weakness; new or worsening mental or mood changes (eg, agitation, aggression, anxiety, behavior changes, depression, hostility, irritability, nervousness); new or worsening seizures; painful menstrual periods; pale stools; severe drowsiness; severe or persistent tiredness or weakness; shortness of breath; slow or shallow breathing; slurred speech or other speech problems; suicidal thoughts or actions; tremor; unusual bruising or bleeding; yellowing of the skin or eyes.



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: Clonazepam 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. Symptoms may include clumsiness; confusion; difficult or slow breathing; dizziness; drowsiness leading to unresponsiveness or coma; lightheadedness, especially upon standing; loss of consciousness.


Proper storage of Clonazepam Orally Disintegrating Tablets:

Store Clonazepam Orally Disintegrating Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in original foil packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Clonazepam Orally Disintegrating Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Clonazepam Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Clonazepam Orally Disintegrating Tablets are 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 Clonazepam Orally Disintegrating Tablets. 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 Clonazepam resources


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


Compare Clonazepam with other medications


  • Anxiety
  • Benzodiazepine Withdrawal
  • Bipolar Disorder
  • Burning Mouth Syndrome
  • Hyperekplexia
  • Insomnia
  • Migraine Prevention
  • Night Terrors
  • Panic Disorder
  • Periodic Limb Movement Disorder
  • Restless Legs Syndrome
  • Seizure Prevention

Carboplatin


Class: Antineoplastic Agents
VA Class: AN900
CAS Number: 41575-94-4
Brands: Paraplatin



  • Use only under the supervision of a qualified clinician experienced in the use of cytotoxic therapy.1 Use only when adequate treatment facilities for appropriate management of therapy and complications are available.1




  • Dose-related bone marrow suppression may result in infection and/or bleeding.1 Anemia may be cumulative and may require transfusion support.1




  • Vomiting is a common adverse effect.1 201




  • Anaphylactic-like reactions may occur within minutes of administration.1 Administer epinephrine, corticosteroids, and/or antihistamines to relieve symptoms.1




Introduction

Antineoplastic agent; platinum-containing compound.1 2 3 4 5 6 92 93


Uses for Carboplatin


Carboplatin and cisplatin appear to have similar efficacy in the treatment of platinum-responsive ovarian tumors,1 5 9 10 11 12 60 137 184 185 lung cancers,18 29 121 137 and certain head and neck cancers;17 137 carboplatin is less effective than cisplatin in certain testicular cancers.24 78 137 193


Because carboplatin and cisplatin have different toxicity profiles,1 2 3 4 5 8 9 10 11 12 68 carboplatin may be effective in patients with platinum-responsive tumors who are unable to tolerate cisplatin because of renal impairment, refractory nausea, hearing impairment, or neuropathy;4 40 137 cisplatin may be preferred in patients with decreased bone marrow reserve or high risk of sepsis or those requiring anticoagulation therapy.10 137


Ovarian Cancer


Treatment of ovarian cancer (alone and as combination therapy).1 9 29


Combination therapy with platinum-containing agent (carboplatin or cisplatin) and paclitaxel is the preferred regimen for initial treatment of advanced epithelial ovarian cancer; therapy with platinum-containing agent and paclitaxel is superior to therapy with platinum-containing agent and cyclophosphamide.9 29 60 137 139 147 Carboplatin is as effective as but less toxic than cisplatin when used in combination with paclitaxel184 185 or cyclophosphamide.10 11


Carboplatin in combination with docetaxel has been used for the first-line treatment of ovarian cancer and has demonstrated similar efficacy and a different tolerability profile (i.e., more hematologic toxicity but less neurotoxicity) compared with carboplatin in combination with paclitaxel.196


Has been used as a single agent in the first-line treatment of advanced ovarian cancer.9 29 Role remains to be established, but some clinicians consider single-agent carboplatin a reasonable option.29 137 187


Used alone as second-line therapy for palliative treatment of recurrent ovarian cancer in patients with platinum-sensitive disease;1 2 9 nonplatinum-based regimens generally preferred for retreatment of patients with platinum-refractory disease.2 9 60 72


Being studied for use in combination regimens for second-line treatment of advanced ovarian epithelial cancer.9 188 189


Has been used alone or in combination therapy for adjuvant treatment of early-stage ovarian cancer.9 179 180 Survival benefit may be limited to patients whose disease is associated with poorer prognosis.137 179


Lung Cancer


Treatment of small cell lung cancer as a component of combination regimens.3 4 18 19 20 29 75 76


An active agent in non-small cell lung cancer.29 121 132 133 137 152 177 178 197 198


Cervical Cancer


Role in the treatment of cervical cancer remains to be established.157 166 Current evidence supports use of cisplatin in chemotherapy regimens given concurrently with radiation therapy in patients with locally advanced cervical cancer; similar benefit from carboplatin-containing chemotherapy cannot be assumed.157 166


An active agent in the treatment of metastatic or recurrent cervical cancer.29 163 164 165 May be considered an alternative to cisplatin, particularly in patients with nephrotoxicity or neurotoxicity caused by advanced cervical tumor who are not candidates for cisplatin therapy.163 164 165


Head and Neck Cancer


May be useful in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck.3 4 5 15 16 17 29 41 128 135 200


Wilms’ Tumor


Has shown activity in the management of Wilms’ tumor.29 65


Brain Tumors


Has been used for palliative treatment of various primary brain tumors.3 29


Has shown activity in the treatment of progressive or recurrent low-grade gliomas in children;29 56 57 responses observed in adults with recurrent glioma, including those who had received previous chemotherapy with nitrosoureas.29 170 171


Has shown activity in the treatment of recurrent medulloblastoma.56 130


Combination therapy with platinum-containing agent (cisplatin or carboplatin) and etoposide is used for treatment of intracranial germ cell tumors.29 169 176


Neuroblastoma


Used (as combination therapy) fortreatment of neuroblastoma.26 29


Testicular Cancer


Cisplatin-based regimen (i.e., cisplatin/etoposide or cisplatin/etoposide/bleomycin) is more effective than carboplatin-based regimen (i.e., carboplatin/etoposide or carboplatin/etoposide/bleomycin) for initial treatment of good-prognosis metastatic nonseminomatous germ cell tumor; generally reserve use of carboplatin regimen for patients who do not tolerate or who refuse cisplatin.24 78 137 193


Limited data suggest that high-dose carboplatin and etoposide may be effective in some patients with relapsed or refractory germ cell tumors.23 30 59


Bladder Cancer


Has been substituted as a less toxic alternative to cisplatin in the treatment of advanced bladder cancer in some patients receiving combination chemotherapy.143 146


Combination therapy with paclitaxel followed by carboplatin is being studied in patients with advanced bladder cancer, including those with abnormal renal function.97 131 168 190


Retinoblastoma


Has been used in combination with etoposide in a limited number of children with recurrent or progressive retinoblastoma.102 106


Breast Cancer


Has been used in a limited number of patients with metastatic breast cancer.199


Endometrial Cancer


Being studied in the treatment of advanced or recurrent endometrial cancer.195


Carboplatin Dosage and Administration


General



  • Consult specialized references for procedures for proper handling and disposal of antineoplastics.1




  • Carboplatin is considered a moderate antiemetic risk antineoplastic (i.e., 30–90% incidence of emesis without antiemetics).201 Antiemetic therapy (e.g., a 5-HT3 receptor antagonist and dexamethasone) is recommended to prevent nausea and vomiting.201 (See Emetogenic Effects under Cautions.)




  • Pretreatment and posttreatment hydration and/or diuresis are not necessary.1 10 11 24 27 37 (See Renal Effects under Cautions.)



Administration


IV Administration


For solution and drug compatibility information, see Compatibility under Stability.


Administer by IV infusion;1 also has been administered intraperitoneally.2 3 4 32 43 47


Needles, syringes, catheters, and IV administration sets that contain aluminum parts which may come in contact with carboplatin should not be used for preparation or administration.1


Reconstitution

Reconstitute vial containing 50, 150, or 450 mg of carboplatin powder for injection with 5, 15, or 45 mL, respectively, of sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection to provide a solution containing 10 mg/mL.b


Resulting solutions can be further diluted to concentrations as low as 0.5 mg/mL with 5% dextrose injection or 0.9% sodium chloride injection.b


Reconstituted solutions contain no preservatives; solutions preferably should be prepared immediately before use.b


Dilution

May be diluted with 0.9% sodium chloride injection or 5% dextrose injection to a concentration as low as 0.5 mg/mL.1


Rate of Administration

Administer by IV infusion over a period of ≥15 minutes;1 2 4 10 13 25 27 42 also has been administered by continuous IV infusion over 24 hours.1 2 3


Dosage


Base dosage on the clinical, renal, and hematologic response and tolerance of the patient in order to obtain optimum therapeutic response with minimum adverse effects.1 10 11


Initial dosage can be based on body surface area, but dosage may be more accurately calculated using formula dosing methods based on the patient’s renal function.1 81 82 83 84 85 93 107 108 137 (See Methods for Individualization of Dosage under Dosage and Administration.)


When used as a component of a multiple-drug regimen, consult published protocols for the dosage of each chemotherapeutic agent and the method and sequence of administration.


Adults


Ovarian Cancer

Initial Therapy for Advanced (Stage III and IV) Ovarian Carcinoma

IV

Initially, 300 mg/m2 given in combination with cyclophosphamide.1 10 11 Adjust subsequent dosage according to the patient’s hematologic tolerance of the previous dose (see Dosage Adjustment in the Treatment of Ovarian Cancer); do not administer doses until hematologic function is within acceptable limits.1


Alternatively, calculate dosage using formula dosing methods (see Methods for Individualization of Dosage).1 81 82 83 84 85 93 107 108 137


A course of carboplatin consists of single doses administered once every 4 weeks (or longer if delayed for hematologic toxicity) for a total of 6 cycles.1 10 11 69 70 71


Secondary Treatment of Advanced Ovarian Cancer

IV

Initially, 360 mg/m2 as monotherapy.1 Administer drug once every 4 weeks (or longer if delayed for hematologic toxicity).1 Adjust subsequent dosage according to the patient’s hematologic tolerance of the previous dose (see Dosage Adjustment in the Treatment of Ovarian Cancer); do not administer doses until hematologic function is within acceptable limits.1 137


Dosage Adjustment in the Treatment of Ovarian Cancer










Dosage Adjustment Based on Hematologic Response to Previous Dose

Hematologic Toxicity



Recommended Dosage Adjustment



No hematologic toxicity (platelet count >100,000/mm3 and neutrophil count >2000/mm3)



Increase dosage by 25%1 10 11



Mild or moderate hematologic toxicity (platelet count 50,000–100,000/mm3 or neutrophil count 500–2000/mm3)



No adjustment in dosage1 10 11



Moderate to severe hematologic toxicity (platelet count <50,000/mm3 or neutrophil count <500/mm3)



Decrease dosage by 25%1 10 11 137


Other Malignant Neoplasms

IV

Consult published protocols for dosages and methods and sequences of administration. In general, escalation of dosages above 400 mg/m2 results in substantial hematologic toxicity, but high-dose carboplatin (900–2000 mg/m2) has been used with colony-stimulating factors,40 67 121 autologous bone marrow rescue, and/or peripheral stem cell rescue.28 30 37 40 59 111 137


Methods for Individualization of Dosage

Alternative methods for calculating initial carboplatin dosage have been suggested based on the patient’s pretreatment renal function or pretreatment renal function and desired platelet nadir.1 38 81 82 83 84 85 93 107 108


Calvert Formula

Calculation is based on the patient’s GFR (in mL/minute) and the target AUC (in mg/mL per minute).1 81 82 83 93 137 Dosage is calculated in mg, not mg/m2.1





Calvert Formula for Carboplatin Dosing:



total dose (mg) = target AUC (in mg/mL per min) × [GFR (in mL/min) + 25]


A target AUC of 5 (range: 4–6) mg/mL per minute appears to provide the most appropriate dosage range for use of carboplatin alone in patients previously treated with chemotherapeutic agents.1 82 83 93












Actual Toxicity in Previously Treated Patients1828393

AUC (mg/mL x min)



Percentage of Patients with Grade 3 or 4 Thrombocytopenia



Percentage of Patients with Grade 3 or 4 Leukopenia



4–5



16%



13%



6–7



33%



34%


For patients who previously did not receive chemotherapy, a target AUC of 7 (range: 6–8) mg/mL per minute has been recommended when carboplatin is used alone.82 83 93 Higher target AUCs (e.g., 7.5 mg/mL) also have been used (e.g., when carboplatin was used as a component of high-intensity dosing with paclitaxel and a hematopoietic agent for non-small cell lung carcinoma).121 Subsequent carboplatin dosage has been adjusted according to hematologic tolerance to the previous dose (e.g., reducing the dose by 25% for moderate to severe hematologic toxicity).121


Formula is not sufficiently accurate to determine dosage for children or for adults with severe renal impairment (i.e., GFR <20 mL/minute); therefore, do not use this formula in such patients.83 Consult specialized references for an alternative pediatric formula.83 93 119 120


Chatelut (French) Formula

Method does not require determination of GFR.84 85 93 Dosage is calculated in mg, not mg/m2.84 93





Chatelut (French) Formula for Carboplatin Dosing:



total dose (mg) = target AUC (in mg/mL per min) × carboplatin clearance (in mL/min)


When carboplatin clearance is calculated as follows:





Carboplatin Clearance:



Carboplatin clearance (mL/min) = (0.134 × wt) + ([218 × wt × (1 - {0.00457 × age})] × [1 - {0.314 × gender}] / serum creatinine (mcmol/L)) (where weight is in kg, age is in years, and gender is 0 for males and 1 for females)


Do not use this formula for calculating dosage in pediatric patients or those undergoing hemodialysis.84


Special Populations


Renal Impairment


Reduce dosage in patients with Clcr <60 mL/minute.3 5 38









Dosage Recommendations for Patients with Impaired Renal Function

Baseline Clcr



Initial Dose



41–59 mL/min



250 mg/m2



16–40 mL/min



200 mg/m2


Incidence of severe leukopenia, neutropenia, or thrombocytopenia at these adjusted initial dosages is about 25%.1 Adjust subsequent dosage according to the patient’s hematologic tolerance to the previous dose.1 Experience in patients with Clcr <15 mL/minute is too limited to make dosage recommendations.1


Geriatric Patients


Use of dosing formulas incorporating estimates of GFR to determine dosage recommended in geriatric patients.1


Cautions for Carboplatin


Contraindications



  • History of sensitivity reactions to carboplatin or other platinum-containing compounds (e.g., cisplatin).1




  • Severe bone marrow depression or significant bleeding.1



Warnings/Precautions


Warnings


Highly toxic drug with a low therapeutic index; therapeutic response is not likely to occur without some evidence of toxicity.1 10 11


Hematologic Effects

The major and dose-limiting adverse effects are dose-related hematologic toxicity (thrombocytopenia, leukopenia, neutropenia, and/or anemia).1 2 3 4 5 10 11 27 28 53 56 66 67 79 80 93 121


Myelosuppression appears to be most common and more severe in patients who received prior antineoplastic therapy (especially cisplatin-containing regimens), those concurrently receiving or having recently received other myelosuppressive drugs or radiation therapy, and those with renal impairment.1 3 38 53 66 67 82 83 84 85 93 101 121 137 Patients with poor performance status also appear to be at increased risk for severe leukopenia and thrombocytopenia.1 (See Interactions.)


At usual dosages, thrombocytopenia is more common and pronounced than leukopenia.53 82 93 Thrombocytopenia may be cumulative and occasionally require transfusions.121 Potential for infection.1 10 11


Anemia may be severe or symptomatic (e.g., accompanied by asthenia).1 10 11 Incidence appears to be cumulative.1 93 121 Transfusions may be required, particularly in patients receiving prolonged (>6 cycles) therapy.1 121 137


Monitor hematologic status carefully; perform peripheral blood counts at frequent intervals.1 121


Do not administer to patients with severe bone marrow depression or substantial bleeding.1 In patients who experience myelosuppression, withhold subsequent cycles until neutrophil counts are >2000/mm3 and platelet counts are >100,000/mm3.1


Treatment of severe hematologic toxicity may consist of supportive care, anti-infective agents for complicating infections, blood product transfusions, autologous bone marrow rescue, peripheral stem cell transplantation, and hematopoietic agents (colony-stimulating factors).1 30 40 93 121 137


Emetogenic Effects

Carboplatin is classified as an antineoplastic agent of moderate emetic risk (i.e., 30–90% incidence of emesis without antiemetics).201 Acute vomiting episodes are most common in patients who received prior emetogenic antineoplastic regimens (especially cisplatin-containing regimens) and in those receiving other emetogenic agents concurrently.1 201


Possible reduction in the incidence of nausea and vomiting when given as a 24-hour continuous IV infusion or IV in divided doses over 5 consecutive days rather than as a single IV infusion; however, efficacy of these schedules not established.1


Pretreatment with antiemetics may reduce incidence and severity of emesis; rarely, nausea and vomiting may be refractory to antiemetic therapy.1 3 93 103 136 201 For prevention of acute emesis, ASCO recommends a 2-drug antiemetic regimen consisting of a type 3 serotonin (5-HT3) receptor antagonist and dexamethasone given before carboplatin.201


For the prevention of delayed emesis following administration of carboplatin, ASCO recommends single-agent therapy with dexamethasone or a 5-HT3 receptor antagonist.201


Optimal use of antiemetics for prevention of acute and delayed emesis during early courses of therapy is the most important means for preventing anticipatory vomiting; behavioral modification, hypnosis, and drug therapy (e.g., benzodiazepine with or without conventional antiemetics) also may be useful.136 201


Peripheral Neuropathies

Possible peripheral neuropathies, generally sensory (e.g., paresthesia).1 10 11 93 Increased incidence in patients >65 years of age,1 those receiving prolonged therapy, and/or those who have received prior cisplatin therapy.1 93 121


Preexisting cisplatin-induced peripheral neurotoxicity generally does not worsen during carboplatin therapy.1


Otic Effects

Possible ototoxicity in patients receiving usual dosages of carboplatin in conjunction with cyclophosphamide.1


Concomitant use of ototoxic drugs (e.g., aminoglycosides, furosemide, ifosfamide) may increase risk.93 111 (See Interactions.)


Ocular Effects

Loss of vision (sometimes complete for light and colors) reported in patients receiving higher than usually recommended dosages; improvement and/or total recovery of vision has occurred within weeks following drug discontinuance.1 31


Hepatic Effects

Possible substantial abnormalities in liver function test results in patients receiving high doses (>4 times usual recommended dose) and autologous bone marrow transplantation.1


Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; avoid pregnancy during therapy.1 If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.1


Embryotoxic and teratogenic in rats.1


Sensitivity Reactions


Hypersensitivity Reactions

Prior exposure to other platinum-containing agents increases the risk for carboplatin-induced allergic reactions, including anaphylaxis.1


Exposure (e.g., industrial) to platinum-containing compounds can cause asthma and immediate and delayed hypersensitivity reactions;33 36 93 consider the possibility that patients with a history of such exposure may be cross-sensitive to carboplatin.36


Observe closely for possible hypersensitivity reactions.1 61 Appropriate equipment for maintenance of an adequate airway and other supportive measures and agents for the treatment of such reactions (e.g., antihistamines, epinephrine, oxygen, corticosteroids) should be readily available when carboplatin is administered.1 61


General Precautions


Mutagenicity and Carcinogenicity

Mutagenic in vitro and in vivo.1


Carcinogenic potential not fully studied; however, drugs with similar mechanisms of action and evidence of mutagenic effects have been reported to be carcinogenic.1 Secondary malignancies reported in patients receiving carboplatin in combination with other agents.1


Renal Effects

Nephrotoxicity is less common and severe than that associated with cisplatin; concomitant IV hydration and diuresis generally not necessary.1 10 11 24 27 37 92 93 However, consider the possibility that nephrotoxicity may be potentiated by other nephrotoxic drugs.1 (See Interactions.)


Specific Populations


Pregnancy

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


Lactation

Not known whether carboplatin or its platinum-containing products are distributed into milk.1 Discontinue nursing during therapy.1


Pediatric Use

Safety and efficacy not established.1


Limited experience in the treatment of germ cell tumors in adolescents ≥16 years of age,24 various brain tumors or neuroblastoma in children 6 months to 19 years of age,26 27 28 56 62 and Wilms’ tumor in children 2–15 years of age.66 79 80


Adverse effects reported to date in children are similar to those reported in adults and include hematologic toxicity (principally thrombocytopenia),27 28 56 66 79 80 adverse GI effects (e.g., nausea, vomiting),27 28 56 66 hypersensitivity reactions (e.g., urticaria, facial swelling, abdominal pain, coryza, cough),62 and hearing loss (particularly at higher than recommended doses in combination with other ototoxic agents).1


Geriatric Use

In clinical trials evaluating carboplatin as combination therapy for ovarian cancer, age was not found to be a factor for survival in patients ≥65 years of age relative to younger adults.1


Possible increased incidence of severe thrombocytopenia and carboplatin-induced peripheral neuropathy in adults ≥65 years of age compared with younger patients.1


Consider increased incidence of decreased renal function in geriatric population (see Geriatric Patients under Dosage and Administration).137


Renal Impairment

Increased risk of severe bone marrow depression in patients with renal impairment; monitor renal function carefully.1 40 82 83 84 85 93 Clcr appears to most accurately reflect kidney function in patients receiving carboplatin.1 40 82 83 84 85 93


Reduce dosage in patients with renal impairment.3 5 38 (See Renal Impairment under Dosage and Administration.)


Common Adverse Effects


Thrombocytopenia,1 neutropenia,1 leukopenia,1 anemia,1 nausea,1 201 vomiting,1 201 electrolyte abnormalities (hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia),1 alkaline phosphatase elevations.1


Interactions for Carboplatin


Ototoxic Drugs


Hearing loss reported in children receiving carboplatin at higher than recommended doses in combination with other ototoxic drugs.1


Nephrotoxic Drugs


Possible potentiation of renal effects.1


Emetogenic Drugs


Concomitant use with emetogenic drugs or use in individuals who previously received emetogenic therapy is associated with an increased incidence of emesis.1 201


Specific Drugs and Therapies


















Drug or Therapy



Interaction



Comments



Aminoglycosides



Increased risk of nephrotoxicity and/or ototoxicity1



Use with caution1



Antineoplastic agents



Prior antineoplastic therapy may increase risk of bone marrow suppression1



Myelosuppressive agents



Possible potentiation of hematologic toxicity1 3 66 67 101



Monitor carefully; manage dosage and time of administration to minimize additive toxic effects1 93 137



Radiation therapy



Possible potentiation of hematologic toxicity1 3 66 67 101



Monitor carefully; manage dosage and time of administration to minimize additive toxic effects1 93 137


Carboplatin Pharmacokinetics


Complex pharmacokinetics involve the parent compound as well as total platinum (protein-bound and nonprotein-bound platinum) and ultrafilterable platinum (carboplatin and nonprotein-bound carboplatin metabolites).1 2 3 4 43 44


Absorption


Bioavailability


Following IV infusion, peak plasma concentrations of carboplatin, total platinum, and ultrafilterable platinum occur immediately.3 42 44 46


Following intraperitoneal administration, peak plasma concentrations of total platinum, free platinum, and carboplatin are attained within 2–4 hours following instillation.3 4 43 47


Distribution


Extent


Widely distributed into body tissues and fluids, with highest concentrations in the kidney, liver, skin, and tumor tissue;3 43 44 lower concentrations found in fat and brain.3 43 Also distributed into erythrocytes.43 44


Not known whether carboplatin or its platinum-containing products cross the placenta or are distributed into milk.1


Plasma Protein Binding


Carboplatin is not bound to plasma proteins, but degrades to platinum-containing products which rapidly bind to protein.45 49


<24% of platinum is bound to plasma proteins during the first 4 hours after IV administration of carboplatin; within 24 hours, 87% is protein bound.46


Elimination


Metabolism


Metabolic fate has not been completely elucidated.1 3 4 5 6 7 43 No evidence to date that the drug undergoes enzymatic biotransformation; the bidentate dicarboxylate ligands of carboplatin are believed to be displaced by water, forming positively charged platinum complexes that react with nucleophilic sites on DNA.1 3 4 5 6 7 43


Elimination Route


Carboplatin and its platinum-containing product(s) are excreted principally in urine (predominantly via glomerular filtration).1 3 4 43 44


Carboplatin (as ultrafilterable carboplatin) is removed extensively by hemodialysis.54 86


Half-life


Plasma elimination half-lives (t½β) for carboplatin and ultrafilterable platinum: 2–3 hours.1 43 44


Terminal elimination half-life (t½γ) for total platinum: 4–6 days.43 44


Special Populations


In patients with impaired renal function, renal clearance and total body clearance of platinum are reduced.3 4 38 54 In patients undergoing hemodialysis, t½β values for total and ultrafilterable platinum are increased compared with values in individuals with normal renal function.43 54


Stability


Storage


Parenteral


Injection Concentrate

25°C (may be exposed to 15–30°C).1 Protect from light.1


Discard unused solution 14 days after initial entry into vial.1


Discard diluted solutions 8 hours after preparation.1


Powder for Injection

20–25°C; protect from light.b


Reconstituted solutions are stable for 8 hours at room temperature (25°C).b Reconstituted solutions contain no preservatives; discard after 8 hours.b


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Parenteral


Solution Compatibilitya







Compatible



Dextrose 5% in sodium chloride 0.2, 0.45, or 0.9%



Dextrose 5% in water



Sodium chloride 0.9%



Incompatible



Sodium bica

Cormax


Generic Name: clobetasol (Topical application route)


kloe-BAY-ta-sol PROE-pee-oh-nate


Commonly used brand name(s)

In the U.S.


  • Clobevate

  • Clobex

  • Cormax

  • Embeline

  • Embeline E

  • Embeline Scalp Application

  • Olux

  • Olux/Olux-E Complete Pack

  • Olux-E

  • Temovate

  • Temovate E

In Canada


  • Clobetasol Propionate

  • Dermovate

  • Dermovate Scalp Application

  • Med Clobetasol Scalp Application

  • Ratio-Clobetasol

Available Dosage Forms:


  • Cream

  • Ointment

  • Gel/Jelly

  • Spray

  • Solution

  • Foam

  • Emollient Cream

  • Lotion

  • Shampoo

Therapeutic Class: Corticosteroid, Very Strong


Pharmacologic Class: Clobetasol


Uses For Cormax


Clobetasol topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. The solution and foam are used for scalp problems, the lotion and spray are used for moderate to severe plaque psoriasis, and the shampoo is used for moderate to severe scalp psoriasis. This medicine is a corticosteroid (cortisone-like medicine or steroid).


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


Before Using Cormax


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


Allergies


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


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clobetasol topical gel, foam, cream, ointment, or scalp solution in children 12 years of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. Safety and efficacy have not been established in children younger than 12 years of age and the use of clobetasol topical gel, foam, cream, ointment, or scalp solution is not recommended. The safety and efficacy of clobetasol topical spray, lotion, or shampoo have not been established in children and use is not recommended.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clobetasol topical in the elderly.


Interactions with Medicines


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


Interactions with Food/Tobacco/Alcohol


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


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:


  • Cushing's syndrome (adrenal gland disorder) or

  • Diabetes or

  • Hyperglycemia (high blood sugar) or

  • Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

  • Infection of the skin at or near the place of application or

  • Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

  • Perioral dermatitis (skin problem) or

  • Rosacea (skin problem)—Should not be used in patients with these conditions.

Proper Use of clobetasol

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


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


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


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


Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor.


To use the cream, foam, gel, lotion, ointment, or spray:


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

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

  • With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.

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

To use the foam, scalp solution, or shampoo:


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

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

  • Do not cover the scalp (e.g., shower cap, bathing cap) while it is being treated.

  • Do not use the shampoo for more than 4 weeks, the foam and scalp solution for more than 2 weeks unless your doctor has told you to.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.


Dosing


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


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


  • For redness, itching, and swelling of the skin:
    • For topical dosage forms (cream, gel, or ointment):
      • Adults—Apply to the affected area of the skin two times per day.

      • Children 12 to 17 years of age—Apply to the affected area of the skin two times per day.

      • Children younger than 12 years of age—Use is not recommended.


    • For topical dosage form (lotion):
      • Adults—Apply to the affected area of the skin two times per day.

      • Children—Use is not recommended.



  • For plaque psoriasis:
    • For topical dosage form (foam):
      • Adults—Apply to the affected area of the skin two times per day, once in the morning and once at night.

      • Children 12 to 17 years of age—Apply to the affected area of the skin two times per day, once in the morning and once at night.

      • Children younger than 12 years of age—Use is not recommended.


    • For topical dosage form (spray):
      • Adults—Spray to the affected area of the skin two times per day.

      • Children—Use is not recommended.



  • For scalp problems:
    • For topical dosage form (foam or scalp solution):
      • Adults—Apply to the affected area of the scalp two times per day, once in the morning and once at night.

      • Children 12 to 17 years of age—Apply to the affected area of the scalp two times per day, once in the morning and once at night.

      • Children younger than 12 years of age—Use is not recommended.


    • For topical dosage form (shampoo):
      • Adults—Apply to the affected area of the scalp once a day.

      • Children—Use is not recommended.



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


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.


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


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


Precautions While Using Cormax


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


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


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


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


Make sure your doctor knows that you are using clobetasol gel. You may need to stop using this medicine several days before having surgery.


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


Cormax 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:


More common
  • Burning or stinging at the application site

Less common
  • Burning sensation of the skin

  • dry skin

  • flushing or redness of the skin

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

  • skin irritation

  • skin rash, encrusted, scaly and oozing

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

Incidence not known
  • Burning, itching, and pain in hairy areas, or pus at the root of the hair

  • hair loss

  • redness and scaling around the mouth

  • thinning of the hair

  • thinning, weakness, or wasting away of the 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:


More common
  • Cough

  • sore throat

Less common
  • Burning, itching, and pain in hairy areas, or pus at the root of the hair

  • changes in skin coloring

  • body aches or pain

  • congestion

  • cough

  • dryness or soreness of the throat

  • fever

  • headache

  • hoarseness

  • raised, dark red, wart-like spots on the skin, especially when used on the face

  • skin discomfort

  • stuffy or runny nose

  • tender, swollen glands in the neck

  • trouble with swallowing

  • unusual tiredness or weakness

  • voice changes

Incidence not known
  • Acne or pimples

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

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

  • lightening of normal skin color

  • lightening of treated areas of dark skin

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

  • softening of the skin

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


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

See also: Cormax side effects (in more detail)



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