Nystatin/Triamcinolone

Pronunciation: nye-STAT-in/trye-am-SIN-oh-lone
Generic Name: Nystatin/Triamcinolone
Brand Name: Examples include Mycolog II and Mycogen II

Nystatin/Triamcinolone is used for:

Treating or preventing fungal infections of the skin.

Nystatin/Triamcinolone is an antifungal and steroid combination. It works by stopping fungus growth and reducing inflammation.

Do NOT use Nystatin/Triamcinolone if:

• you are allergic to any ingredient in Nystatin/Triamcinolone


• you are taking mifepristone

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

Before using Nystatin/Triamcinolone:

Some medical conditions may interact with Nystatin/Triamcinolone. 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 measles, had a positive skin tuberculin skin test, tuberculosis (TB), chickenpox, shingles, or wasting of the skin (skin atrophy)


• if you have had a vaccination with an inactivated or live vaccine

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

Ask your health care provider if Nystatin/Triamcinolone 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 Nystatin/Triamcinolone:

Use Nystatin/Triamcinolone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• To prevent reinfection, wash your hands thoroughly before and after using Nystatin/Triamcinolone.


• Wash and completely dry the affected area. Gently rub the medicine in until it is evenly distributed. Do not bandage, cover, or wrap the treated skin unless directed to do so by your doctor.


• Nystatin/Triamcinolone works best if used at the same time each day.


• To clear up your infection completely, use Nystatin/Triamcinolone for the full course of treatment. Keep using it even if you feel better in a few days.


• Nystatin/Triamcinolone is for external use only. Do not get it your eyes.


• If you miss a dose of Nystatin/Triamcinolone, 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 Nystatin/Triamcinolone.

Important safety information:

• If Nystatin/Triamcinolone is to be applied to the groin area, apply sparingly and wear loose-fitting clothing. If Nystatin/Triamcinolone is to be applied to skin covered by a diaper, do not use tight-fitting diapers or plastic pants.


• Nystatin/Triamcinolone should not be used if irritation occurs or if symptoms worsen or have not improved within 25 days of use.


• Nystatin/Triamcinolone should not be used 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 Nystatin/Triamcinolone while you are pregnant. It is unknown if Nystatin/Triamcinolone is found in breast milk. If you are or will be breast-feeding while you use Nystatin/Triamcinolone, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Nystatin/Triamcinolone:

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:

Acne; burning; cracking and stinging of the skin; dryness; excessive hair growth; inflamed skin around the mouth; inflammation of hair follicles; irritation; itching; loss of skin color; secondary infection; skin wasting; streaking of 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).

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: Nystatin/Triamcinolone 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. Nystatin/Triamcinolone may be harmful if swallowed.

Proper storage of Nystatin/Triamcinolone:

Store Nystatin/Triamcinolone at controlled room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not freeze. Keep Nystatin/Triamcinolone out of the reach of children and away from pets.

General information:

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


• Nystatin/Triamcinolone 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 Nystatin/Triamcinolone. 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 Nystatin/Triamcinolone resources

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

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Tylophen

Pronunciation: a-seet-a-MIN-oh-fen
Generic Name: Acetaminophen
Brand Name: Examples include Tylenol and Tylophen

Tylophen is used for:

Treating minor aches and pains due to headache, muscle aches, backache, arthritis, the common cold, flu, toothache, menstrual cramps, and immunizations, and for temporarily reducing fever.

Tylophen is an analgesic and antipyretic (lowers fever). It works by lowering a chemical in the brain that stimulates pain nerves and the heat-regulating center in the brain.

Do NOT use Tylophen if:

• you are allergic to any ingredient in Tylophen

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

Before using Tylophen:

Some medical conditions may interact with Tylophen. 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 abuse or you drink more than 3 alcohol-containing drinks every day


• if you have liver or kidney problems, hepatitis, or phenylketonuria (PKU)

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

• Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Tylophen


• Isoniazid because the risk of liver problems may be increased

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

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

• Take Tylophen by mouth with or without food.


• Replace original bottle cap to maintain child resistance.


• If you miss a dose of Tylophen 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 Tylophen.

Important safety information:

• Tylophen has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Tylophen may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylophen. Talk to your doctor before you take Tylophen or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use for more than 2 days or give to children younger than 3 years old unless directed by a doctor.


• Tylophen may cause the results of some in-home test kits for blood cholesterol to be wrong. Check with your doctor or pharmacist if you are taking Tylophen and need to check your blood cholesterol at home.


• For pain and fever in ADULTS: Stop use of Tylophen and ask your doctor if pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, or new symptoms occur or redness or swelling is present.


• For pain and fever in CHILDREN: Stop use and ask a doctor if fever gets worse or lasts more than 3 days, pain gets worse or lasts more than 5 days, or redness or swelling is present or any new symptoms appear.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tylophen while you are pregnant. Tylophen is found in breast milk. If you are or will be breast-feeding while you use Tylophen, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tylophen:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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); dark urine or pale stools; unusual fatigue; 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: Tylophen 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 dark urine; excessive sweating; extreme fatigue; nausea and vomiting; stomach pain.

Proper storage of Tylophen:

Store Tylophen at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylophen out of the reach of children and away from pets.

General information:

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


• Tylophen 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 Tylophen. 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 Tylophen resources

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

• acetaminophen Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Acetaminophen Monograph (AHFS DI)


• Acetazolamide Monograph (AHFS DI)


• Apra Advanced Consumer (Micromedex) - Includes Dosage Information


• Apraclonidine Hydrochloride Monograph (AHFS DI)


• Ofirmev Prescribing Information (FDA)


• Ofirmev Consumer Overview


• Paracetamol Consumer Overview


• Tylenol Consumer Overview

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Salmeterol Xinafoate

Class: Selective beta-2-Adrenergic Agonists
VA Class: RE102
Chemical Name: ±-4-Hydroxy-α1 -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol compd. with 1-hydroxy-2-naphthalenecarboxylic acid (1:1)
Molecular Formula: C₂₅H₃₇NO₄•C₁₁ H₈O₃
CAS Number: 94749-08-3
Brands: Advair, Serevent

Special Alerts:

[Posted 02/18/2010] FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all Long-Acting Beta-Agonists (LABAs). The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.

Healthcare professionals are reminded that to ensure the safe use of these products:

• 
  

  Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.

  
  


• 
  

  LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.

  
  


• 
  

  LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.

  
  


• 
  

  Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.

  
  

FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for salmeterol to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of salmeterol and consists of the following: communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

• 
  

  Possible increase in asthma-related deaths in patients receiving long-acting β₂-adrenergic bronchodilators, including salmeterol, in addition to usual asthma therapy.^{188 221 226 227 241 242 248 249}

  
  


• 
  

  Reserve use of long-acting β₂-adrenergic agonists in patients with asthma for those whose disease is inadequately controlled with other anti-asthma therapy (e.g., low to medium dosage of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies.^{188 221 247 248 249 250 251} (See Increased Risk of Asthma-related Death under Cautions.)

  
  

Introduction

Bronchodilator; a relatively selective, long-acting β₂-adrenergic agonist.^{1 2 3 5 188}

Uses for Salmeterol Xinafoate

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Bronchospasm in Asthma

Long-term prevention of bronchospasm in patients with reversible obstructive airway disease (e.g., asthma) whose symptoms are not adequately managed with other controller therapy (e.g., low to medium dosage of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies.^{222 247 248} Not indicated in patients whose asthma can be successfully managed with occasional use of inhaled, short-acting β₂-adrenergic agonists or in those whose asthma can be successfully managed by inhaled corticosteroids or other controller drugs accompanied by occasional use of an inhaled, short-acting β₂-adrenergic agonist.^{188 221 250 251 a} (See Increased Risk of Asthma-related Death under Cautions.)

Fixed combination of salmeterol and fluticasone propionate recommended in patients who have not responded adequately to low to medium dosages of inhaled corticosteroids without a long-acting β₂-adrenergic agonist or in patients who are already taking an inhaled corticosteroid and a long-acting β₂-adrenergic agonist separately.²⁴⁹ Fixed combination should not be used in patients whose asthma can be successfully managed by inhaled corticosteroids accompanied by occasional use of inhaled, short-acting β₂-adrenergic agonists.^{188 221 250 251 a}

Salmeterol should not be used as initial or sole therapy for asthma and is not a substitute for corticosteroids;^{247 248 249} corticosteroid therapy should not be stopped or reduced in dosage when salmeterol is initiated.^{1 226 247} (See Concomitant Anti-inflammatory Therapy under Cautions.)

Not to be used for immediate relief of bronchospasm or in patients with substantially worsening or acutely deteriorating asthma.^{1 154 188 221 247 248 249 250 251} (See Acute Exacerbations of Asthma or COPD under Cautions.)

Exercise-induced Bronchospasm

Prevention of exercise-induced bronchospasm.^{1 12 21 91 105 172 188 214}

Consider alternative therapy if twice-daily dosing is not effective.^{1 188}

Bronchospasm in COPD

Long-term symptomatic treatment of reversible bronchospasm associated with moderate to severe COPD (e.g., FEV₁ less than 80% of predicted), including chronic bronchitis and emphysema.^{1 182 183 238 239}

Fixed combination of salmeterol and fluticasone propionate for maintenance treatment of airflow obstruction in COPD associated with chronic bronchitis.²²¹

Benefit of therapy with fixed combination of salmeterol and fluticasone propionate for >6 months not established.²²¹ Reevaluate patients receiving long-term therapy (>6 months) periodically to assess continuing benefits and risks.²²¹

Not to be used for immediate relief of acute exacerbations of COPD.^{1 154 188 221} Use a short-acting inhaled β₂-agonist intermittently (as needed) for acute symptoms of COPD.^{238 239} (See Acute Exacerbations of Asthma or COPD under Cautions.)

Salmeterol Xinafoate Dosage and Administration

General

• 
  

  When salmeterol therapy is initiated, regular use of short-acting, inhaled β₂-agonists should be discontinued,^{1 97 113 188} and such agents should be used only for relief of acute symptoms of asthma or COPD that are not controlled by salmeterol.^{1 97 113 188 221}

  
  


• 
  

  Failure to respond to a previously effective dosage may indicate seriously worsening asthma; extra/increased doses are not recommended.^{1 111 112} (See Acute Exacerbations of Asthma or COPD under Cautions.) Consult clinician.^{1 113 188}

  
  


• 
  

  Therapy with salmeterol in fixed combination with fluticasone propionate should be initiated in asthmatic patients ≥12 years of age whose disease severity warrants treatment with 2 maintenance therapies, including those maintained on noncorticosteroid therapy.²²¹

  
  

Administration

Oral Inhalation

Administer by oral inhalation using a special oral inhaler (Diskus device) that delivers powdered salmeterol xinafoate alone (Serevent Diskus) or in fixed combination with fluticasone propionate (Advair Diskus) from foil-wrapped blisters.^{188 221}

Administer twice daily, approximately every 12 hours (morning and evening).^{1 188 221}

Oral Inhalation Powder

Hold the Diskus device in one hand, put the thumb of the other hand on the thumbgrip, and push the thumbgrip until the mouthpiece appears and snaps into position.^{189 a}

To release powdered drug into the exit port, hold the inhaler in a level, horizontal position and depress the lever on the Diskus in a direction away from the patient.^{188 189 a}

To avoid releasing and wasting additional doses of the drug, do not close the Diskus device, play with the lever, or advance the lever more than once.^{189 a} A dose counter will advance each time the lever is depressed.¹⁸⁹

Exhale completely, place the mouthpiece of the inhaler between the lips, and inhale deeply and rapidly through the inhaler with a steady, even breath.^{188 189 190 a} Remove the inhaler from the mouth and hold the breath for 10 seconds before slowly exhaling.^{189 a}

Do not exhale into the Diskus device.^{188 189 190 221 a}

Spacer devices are not recommended with the Serevent or Advair Diskus inhaler.^{188 221 a}

Close the inhalation device and reset for the next dose by sliding the thumbgrip toward the patient as far as it will go.^{189 221 a} Do not wash the inhaler.^{188 189 221} Do not take inhaler apart.^{188 190 221}

Discard the inhaler when every blister of salmeterol alone or in fixed combination with fluticasone propionate has been used.^{188 190 221} Alternatively, discard the inhaler 6 or 4 weeks after removal of salmeterol alone or in fixed combination with fluticasone propionate, respectively, from its foil overwrap pouch.^{188 190 221 a}

Rinse the mouth without swallowing after inhalation of salmeterol in fixed combination with fluticasone propionate.²²¹

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as salmeterol xinafoate; dosage expressed in terms of salmeterol.¹

Each blister in the Serevent or Advair Diskus device contains 50 mcg of salmeterol as salmeterol xinafoate inhalation powder.^{188 221} However, the precise amount of drug delivered to the lungs depends on factors such as the patient’s inspiratory flow.^{188 221}

Pediatric Patients

Asthma

Oral Inhalation

Serevent Diskus: 50 mcg (1 inhalation) twice daily in children ≥4 years of age.^{188 221}

Fixed combination of salmeterol and fluticasone propionate in children 4–11 years of age: Initially, 50 mcg of salmeterol and 100 mcg of fluticasone propionate twice daily in those inadequately controlled with an inhaled corticosteroid.²²¹

Fixed combination of salmeterol and fluticasone propionate in children ≥12 years of age: Initially, 50 mcg of salmeterol and 100 mcg of fluticasone propionate (1 inhalation) twice daily, for children not currently receiving an orally inhaled corticosteroid;²²¹ after 2 weeks, if asthma control is inadequate, increasing the dosage of fluticasone propionate may provide additional asthma control.²²¹ In patients currently receiving inhaled corticosteroid, salmeterol 50 mcg twice daily and a fluticasone propionate dosage based on the dosage of the inhaled corticosteroid currently in use²²¹ . (see Table 1.)

Table 1. Recommended Dosage of Advair Diskus for Adolescents ≥12 Years of Age Taking Inhaled Corticosteroids

Inhaled Corticosteroid	Current Daily Dosage of Inhaled Corticosteroid (mcg)	Recommended Strength of Fluticasone Propionate Contained in Advair Diskus (with 50 mcg of Salmeterol) at Twice-Daily Dosage (mcg)
Beclomethasone Dipropionate HFA Inhalation Aerosol	≤160	100
	320	250
	640	500
Budesonide Inhalation Aerosol	≤400	100
	800–1200	250
	1600	500
Flunisolide Inhalation Aerosol	≤1000	100
	1250–2000	250
Flunisolide HFA Inhalation	≤320	100
	640	250
Fluticasone Propionate HFA Inhalation Aerosol	≤176	100
	440	250
	660–880	500
Fluticasone Propionate Inhalation Powder	≤200	100
	500	250
	1000	500
Mometasone Furoate Inhalation Powder	220	100
	440	250
	880	500
Triamcinolone Acetonide	≤1000	100
	1100–1600	250

Exercise-induced Bronchospasm

Oral Inhalation

50 mcg (1 inhalation) administered via the Serevent Diskus device at least 30 minutes before exercise for children ≥4 years of age.¹⁸⁸

Adults

Asthma

Oral Inhalation

Serevent Diskus: 50 mcg (1 inhalation) twice daily.¹⁸⁸

Fixed combination of salmeterol and fluticasone propionate: Initially, 50 mcg of salmeterol and 100 mcg of fluticasone propionate (1 inhalation) twice daily, in patients not currently receiving an orally inhaled corticosteroid;²²¹ after 2 weeks, if asthma control is inadequate, increasing the dosage of fluticasone propionate may provide additional asthma control.²²¹ In patients currently receiving inhaled corticosteroid, salmeterol 50 mcg twice daily and a fluticasone proprionate dosage based on the dosage of the inhaled corticosteroid currently in use.²²¹ (see Table 2.)

Table 2. Recommended Dosage of Advair Diskus for Adults Taking Inhaled Corticosteroids

Inhaled Corticosteroid	Current Daily Dosage of Inhaled Corticosteroid (mcg)	Recommended Strength of Fluticasone Propionate Contained in Advair Diskus (with 50 mcg of Salmeterol) at Twice-Daily Dosage (mcg)
Beclomethasone Dipropionate HFA Inhalation Aerosol	≤160	100
	320	250
	640	500
Budesonide Inhalation Aerosol	≤400	100
	800–1200	250
	1600	500
Flunisolide Inhalation Aerosol	≤1000	100
	1250–2000	250
Flunisolide HFA Inhalation	≤320	100
	640	250
Fluticasone Propionate HFA Inhalation Aerosol	≤176	100
	440	250
	660–880	500
Fluticasone Propionate Inhalation Powder	≤200	100
	500	250
	1000	500
Mometasone Furoate Inhalation Powder	220	100
	440	250
	880	500
Triamcinolone Acetonide	≤1000	100
	1100–1600	250

If control of asthma is inadequate 2 weeks after initiation of therapy at the initial dosage, a higher strength may provide additional asthma control.²²¹

Exercise-induced Bronchospasm

Oral Inhalation

Serevent Diskus: 50 mcg (1 inhalation) administered at least 30 minutes before exercise.¹⁸⁸

COPD

Oral Inhalation

Serevent Diskus: 50 mcg (1 inhalation) twice daily.¹⁸⁸

Fixed combination of salmeterol and fluticasone propionate: 50 mcg (1 inhalation) of salmeterol with 250 mcg of fluticasone propionate twice daily administered via the Advair Diskus device.²²¹

Use of dosages higher than those recommended (50 mcg of salmeterol and 250 mcg of fluticasone propionate twice daily) produces no additional improvement in lung function.²²¹

Prescribing Limits

Pediatric Patients

Asthma

Oral

Children ≥4 years of age receiving Serevent Diskus: Maximum 50 mcg (1 inhalation) twice daily.¹⁸⁸

Children 4–11 years of age receiving fixed combination of salmeterol and fluticasone propionate: Maximum 50 mcg of salmeterol and 100 mcg of fluticasone propionate twice daily.²²¹

Children or adolescents ≥12 years of age receiving fixed combination of salmeterol and fluticasone propionate: Maximum 50 mcg of salmeterol and 500 mcg of fluticasone propionate (1 inhalation) twice daily.²²¹

Exercise-induced Bronchospasm

Oral Inhalation

Serevent Diskus: 50 mcg (1 inhalation) twice daily (every 12 hours) in children ≥4 years of age.¹⁸⁸

Adults

Asthma

Oral Inhalation

Serevent Diskus: Maximum 50 mcg (1 inhalation) twice daily.¹⁸⁸

Fixed combination of salmeterol and fluticasone propionate: Maximum 50 mcg of salmeterol and 500 mcg of fluticasone propionate (1 inhalation) twice daily.²²¹

Exercise-induced Bronchospasm

Oral Inhalation

Serevent Diskus: 50 mcg (1 inhalation) twice daily (every 12 hours).¹⁸⁸

COPD

Oral Inhalation

Serevent Diskus: 50 mcg (1 inhalation) twice daily.¹⁸⁸

Fixed combination of salmeterol and fluticasone propionate: 50 mcg of salmeterol (1 inhalation) twice daily in fixed combination with fluticasone propionate (250 mcg).²²¹

Special Populations

Hepatic Impairment

Decreased clearance.¹

Monitor patients closely; however, dosage adjustments not required.¹

Renal Impairment

Pharmacokinetics have not been studied; dosage adjustments not required.^{1 154 156 188 221}

Geriatric Patients

Salmeterol in fixed combination with fluticasone propionate: Dosage adjustments not recommended solely because of age in geriatric patients.²²¹

Cautions for Salmeterol Xinafoate

Contraindications

• 
  

  Known hypersensitivity to salmeterol xinafoate or any ingredients in the formulations.^{1 56 57 59 188}

  
  

Warnings/Precautions

Warnings

Increased Risk of Asthma-related Death

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Data from a large study (Salmeterol Multi-center Asthma Research Trial [SMART]) evaluating the safety of salmeterol in patients with asthma suggest that the drug may be associated with an increased risk of asthma-related life-threatening events, including death, in certain patients,^{1 188 221 226 227 248 249} particularly African Americans^{1 188 221 226 227 221 242 248 249} and patients not receiving concomitant inhaled corticosteroid therapy.^{226 227 246} Because of similar mechanisms of action among β₂-adrenergic agonists, it is possible that the increased risk of asthma-related life-threatening events represents a class effect of these drugs.^{1 188 221 228 246} Data from the SMART study are insufficient to determine whether concurrent use of inhaled corticosteroids provides protection from or modifies the risk of asthma-related adverse effects.^{188 221 228} It is not known whether the rate of death is increased in patients with COPD receiving long-acting β₂-adrenergic agonists.¹⁸⁸

Add long-acting bronchodilators such as salmeterol to asthma therapy only when symptoms have not responded adequately to other asthma controller drugs such as low- or medium-dose corticosteroids or in patients whose disease severity warrants treatment with 2 maintenance therapies.^{188 221 247 248 249 250 251} Concomitant use of inhaled corticosteroids recommended by current asthma management guidelines and most experts in patients with asthma who require more than intermittent therapy with inhaled β-agonist bronchodilators.^{25 40 44 110 136 137 156 157 222 226 227}

Acute Exacerbations of Asthma or COPD

Do not initiate therapy in patients with acutely deteriorating or substantially worsening asthma, which may be life-threatening, or in patients with acute symptoms of COPD.^{1 154 188 221 247 248 249 250 251} Do not initiate salmeterol therapy in patients with severe asthma (e.g., unresponsive to usual medications, increasing need for inhaled short-acting β-agonists, marked increase in symptoms, recent emergency room visits, sudden or progressive deterioration in pulmonary function).^{1 154 188 221} Serious acute respiratory events, including fatalities, have been reported.^{1 188 247 248 249 250 251}

Failure to respond to a previously effective dosage may indicate substantially worsening asthma.^{1 154 188 221} Promptly reevaluate asthma therapy if inadequate control of symptoms persists with supplemental short-acting β₂-agonist bronchodilator therapy.^{1 113 134 156 188 214 222 247 248 249 250 251} Do not use extra/increased doses of salmeterol alone or in fixed combination with fluticasone propionate in such situations.^{1 8 113 188 221} Do not use extra doses of salmeterol or other long-acting inhaled β₂-adrenergic agonists (e.g., formoterol) for maintenance therapy of asthma, COPD, or for any other reason.²²¹

If asthma deteriorates in patients receiving salmeterol in fixed combination with fluticasone propionate, prompt reevaluation of asthma therapy is required.^{221 248 249 250 251} Consider increasing the strength of the fixed combination (higher strengths contain higher dosages of fluticasone propionate only), adding additional inhaled corticosteroids, or initiating systemic corticosteroids.^{221 248 249 250 251}

Excessive Doses

Fatalities associated with excessive use of inhaled sympathomimetic drugs.^{1 64 81 110 111 112 115 119 188} For treatment of COPD, do not use higher than recommended dosages of salmeterol in fixed combination with fluticasone propionate, as increased risks of systemic effects exist.²²¹

Patients receiving salmeterol alone or in fixed combination with fluticasone propionate should not use additional salmeterol or other long-acting inhaled β₂-adrenergic agonists for the prevention of exercise-induced bronchospasm or the maintenance treatment of asthma or COPD.^{188 221}

Concomitant Anti-inflammatory Therapy

Salmeterol therapy is not a substitute for inhaled or oral corticosteroids.^{1 188} Possible worsening of asthma if corticosteroid dosage is reduced or discontinued when salmeterol therapy is initiated.^{1 2 5 16 20 40 42 43 45 61 62 63 72 85 97 113 188}

Consider early initiation of concomitant anti-inflammatory therapy (e.g., corticosteroids) since β₂-adrenergic agonists alone may not provide adequate control of asthma in many patients.¹ Continue corticosteroid therapy even if the patient feels better as a result of initiating or increasing salmeterol dosage.^{1 188} Changes in corticosteroid dosage recommended only after clinical evaluation of the patient.¹

Particular care is needed during and after transfer of patients from systemic to inhaled corticosteroid therapy since death resulting from adrenal insufficiency has occurred during such transfer.²²¹ Do not use orally inhaled salmeterol in fixed combination with fluticasone propionate to transfer patients from systemic corticosteroid therapy since such a transfer may unmask conditions previously suppressed by systemic corticosteroid therapy, such as rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.²²¹

Respiratory Effects

Possible symptoms of laryngeal spasm, irritation, or swelling (e.g., stridor, choking).^{1 188} Possible acute bronchospasm;^{1 56 59 111 112 116 153 154 156} may represent a hypersensitivity reaction. (See Sensitivity Reactions under Cautions.)^{17 20 56 57 59 114}

Discontinue therapy immediately if bronchoconstriction occurs and institute alternative therapy.^{1 153 156 188}

Cardiovascular Effects

Possible clinically important changes in SBP and/or DBP, rapid heart rate, ECG changes, palpitations, or chest pain.^{1 154 156 188}

May require discontinuance of the drug.^{1 13 188 210} Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, hypertension, thyrotoxicosis, and in those who are unusually responsive to sympathomimetic amines.^{1 187 188 210}

Sensitivity Reactions

Immediate hypersensitivity reactions (e.g., urticaria, rash/skin eruption, contact dermatitis, anaphylaxis, and angioedema) have been reported.^{1 188} Possible acute bronchospasm; frequently occurs with the first use of a new oral inhalation aerosol canister.^{1 56 59 111 112 116 153 154 156} (See Respiratory Effects under Cautions.)

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Nervous System Effects

Possible CNS stimulation and adverse nervous system effects^{1 2 13 15 19 188} including headache,^{1 16 17 19 23 52} tremor,^{1 16 17 102 107 182} nervousness^{1 154 156} , dizziness/giddiness,^{147 152} or excitement.^{1 106}

Some nervous system effects may require discontinuance of the drug.^{1 106} Use with caution in patients with seizure disorders and in those who are unusually responsive to sympathomimetic amines.^{1 187 188 210}

Metabolic Effects

Possible hypokalemia (usually transient and dose-related);^{2 15 19 25 33 37 42 43} may increase risk of arrhythmias.¹ (See Cardiovascular Effects under Cautions.) Supplemental potassium therapy generally is not required.¹

Possible dose-related hyperglycemia may occur rarely.^{2 15 19 25 33 37}

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether salmeterol is distributed into milk.^{1 188} Discontinue nursing or the drug.^{1 188}

Pediatric Use

Safety and efficacy of salmeterol oral inhalation powder in children 4–11 years of age with asthma have been evaluated for periods up to 1 year.^{188 221} Current data suggest that such children may receive the same dosage as adults for the treatment of asthma or exercise-induced bronchospasm.^{188 221}

Use of salmeterol in fixed combination with fluticasone propionate in children 4–11 years of age is supported by data from one clinical trial and from extrapolation of efficacy data from older patients.²²¹ Safety and efficacy of such a combination in children <4 years of age not established.²²¹

Geriatric Use

Adverse effect profile similar to that in younger adults.^{1 77 82 92 188 221}

Use with caution in geriatric patients who have concomitant cardiovascular disease.^{1 188 221} (See Cardiovascular Effects under Cautions.) Dosage adjustments not needed based solely on age.^{1 154 156 188 221}

Hepatic Impairment

Predominantly metabolized in the liver; possible increased plasma concentrations in patients with hepatic impairment.¹

Close monitoring of such patients recommended.¹

Renal Impairment

Effects on pharmacokinetics of salmeterol not investigated.¹

Common Adverse Effects

Headache, tremor, cough.^{114 154 182}

Interactions for Salmeterol Xinafoate

Specific Drugs

Drug	Interaction	Comments
β2-Adrenergic agonists, short acting	Potential for increased cardiovascular adverse effects, but such effects less likely with a selective β2-adrenergic agonist like salmeterol110 115 116 117 118 120	Safety of concomitant use of > 8 inhalations of supplemental, short-acting β2-agonist therapy with salmeterol inhalation therapy has not been established1
β-Adrenergic blocking agents	Potential for antagonism of pulmonary effects resulting in severe bronchospasm in asthmatic patients1 154 156 188	If concomitant therapy required, consider cautious use of cardioselective β-adrenergic blocking agents1 188
Corticosteroids	Concomitant corticosteroid use may maintain and/or restore sensitivity of β-adrenergic receptors1 78 132 133 151
MAO inhibitors	Potential for increased effect of salmeterol on the vascular system1	Extreme caution recommended with concomitant therapy or in patients receiving salmeterol within 2 weeks of discontinuance of these agents1
Diuretics, nonpotassium-sparing	Potential for additive hypokalemia and/or ECG changes, especially when the recommended β-agonist dose is exceeded1	Cautious use recommended1 188
Tricyclic antidepressants	Potential for increased effect of salmeterol on the vascular system1	Extreme caution recommended with concomitant therapy or in patients receiving salmeterol within 2 weeks of discontinuance of these agents1
Xanthine derivatives	Potential for increased cardiotoxic effects with concomitant administration of sympathomimetic agents and aminophylline but not theophylline1 123 124 154

Salmeterol Xinafoate Pharmacokinetics

Absorption

Bioavailability

Most of an orally inhaled drug actually is swallowed.^{1 2 38 39 188} The bronchodilating action of orally inhaled sympathomimetic agents is believed to result from a local action of the portion of the dose that reaches the bronchial tree.^{1 2 38 39 188} Low or undetectable systemic concentrations of the drug occur after inhalation of the recommended dosage and are not predictive of therapeutic effects.^{1 39 188}

Onset

Time to onset of effective bronchodilation is 30 or 60 minutes with salmeterol in fixed combination with fluticasone propionate²²¹ or the oral inhalation powder, respectively.¹⁸⁸ Maximum benefit may not be achieved for 1 week or longer after initiating treatment with salmeterol in fixed combination with fluticasone propionate.²²¹ Maximum improvement in forced expiratory volume in 1 second (FEV₁) generally occurs within 3 hours after administration of oral inhalation powder.¹⁸⁸

Duration

Clinically important improvements are maintained for up to 12 hours in most patients rece

Triamcinolone Acetonide eent

Class: Corticosteroids
ATC Class: S02CA04
VA Class: NT200
Chemical Name: (11β,16α) - 9 - Fluoro - 11,21 - dihydroxy - 16,17 - [(1 - methylethylidene)bis(oxy)] - pregna - 1,4 - diene - 3,20 - dione
Molecular Formula: C₂₄H₃₁FO₆
CAS Number: 76-25-5
Brands: Nasacort

Introduction

Synthetic corticosteroid.^{1 2 3}

Uses for Triamcinolone Acetonide

Allergic Rhinitis

Symptomatic treatment of seasonal or perennial allergic rhinitis.^{1 2 3 4 5 6 7 8 9 10 11 17}

Triamcinolone Acetonide Dosage and Administration

General

• 
  

  For therapeutic effectiveness, use at regular intervals.^b

  
  

Administration

Intranasal Administration

Administer by nasal inhalation using a metered-dose nasal spray pump.^{2 3 4 5 8 b}

Shake inhaler gently immediately prior to use.^b

Prior to initial use, the metered-dose pump spray must be primed with 5 actuations or until a fine mist appears.^c Prime pump after a period of nonuse (i.e., > 2 weeks) by actuating once.²

Clear nasal passages prior to administration.^c

Tilt the head slightly forward, insert the spray tip into one nostril, and point the tip toward the back of the nose.^c Pump the drug into one nostril while holding the other nostril closed and concurrently inspire through the nose.^c Repeat this procedure for the other nostril.^c

Dosage

After priming, nasal spray pump delivers about 55 mcg of triamcinolone acetonide per metered spray and about 30 or 120 metered doses per 6.5-g or 16.5-g container, respectively.^{2 b}

Once optimal symptomatic relief is achieved, reduce dosage gradually to the lowest effective level.^{1 2 3}

Intranasal triamcinolone acetonide should not be continued beyond 3 weeks in the absence of adequate symptomatic improvement.^{1 2 16 b}

Pediatric Patients

Seasonal Allergic Rhinitis

Intranasal Inhalation

Children 6–11 years of age: Initially 55 mcg (1 spray) in each nostril once daily (110 mcg total).² May be increased to 110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Children ≥12 years of age: 110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Perennial Allergic Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Initially 55 mcg (1 spray) in each nostril once daily (110 mcg total).^{2 b} Maximum, 110 mcg (2 sprays) in each nostril once daily (220 mcg total).^{2 b}

Children ≥12 years of age: Initially 110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Adults

Seasonal Allergic Rhinitis

Intranasal Inhalation

110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Perennial Allergic Rhinitis

Intranasal Inhalation

110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Prescribing Limits

Pediatric Patients

Seasonal or Perennial Allergic Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Maximum 220 mcg (2 sprays in each nostril) daily.^{2 b}

Adults

Seasonal or Perennial Allergic Rhinitis

Intranasal Inhalation

Maximum 220 mcg (2 sprays in each nostril) daily.^b

Perennial Allergic Rhinitis

Intranasal Inhalation

Maximum 220 mcg (2 sprays in each nostril) daily.^b

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.^{1 2 17}

Renal Impairment

No specific dosage recommendations at this time.^{1 2 17}

Geriatric Patients

No specific dosage recommendations at this time.^{1 2 17}

Cautions for Triamcinolone Acetonide

Contraindications

• 
  

  Known hypersensitivity to triamcinolone acetonide or any ingredient in the formulation.^{1 2 17}

  
  

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Possible corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, or severe symptomatic exacerbation of asthma or other clinical conditions if prolonged systemic corticosteroid therapy is replaced with topical corticosteroid therapy; careful monitoring recommended.^{1 2 3 17}

Use particular caution in patients with associated asthma or other conditions that may be exacerbated by too rapid a reduction in systemic corticosteroid dosage.^b

Taper the dosage of the systemic corticosteroid, and carefully monitor patients during dosage reduction.^{1 2 17} In general, the greater the dosage and duration of systemic corticosteroid therapy, the greater the time required for withdrawal of systemic corticosteroids and replacement by intranasal corticosteroids.¹⁶

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs.^{1 2 17} Certain infections (e.g., varicella [chickenpox], measles) can be serious or fatal in such patients, particularly in children.^{1 2 17}

Exposure to varicella and measles should be avoided in previously unexposed patients.^{1 2 17} If exposure to varicella (chickenpox) or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled IM immune globulin (IG) respectively.^{1 2 17} Consider treatment with antiviral agents if varicella (chickenpox) develops.^{1 2}

General Precautions

Systemic Corticosteroid Effects

Possible growth suppression in pediatric patients.^{1 2 17} (See Pediatric Use under Cautions.)

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may increase risk of systemic corticosteroid effects (e.g., hypercortism or adrenal suppression).^b Avoid exceeding the recommended dosages.^{1 2 17}

Nasopharyngeal Effects

Rarely, localized candidial infections of the nose and/or pharynx has been reported.^{1 2 17} Local treatment of such infections and/or discontinuance of intranasal therapy may be required.^{1 2 17}

Nasal septal perforations have been reported rarely.^{1 2 17}

Use with caution until healing occurs in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma.^{1 2 3 17}

Concomitant Infections

Use with extreme caution, if at all, in patients with clinical tuberculosis or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated fungal or bacterial infections; or ocular herpes simplex; or untreated, systemic viral infections.^{1 2 3 16 17}

Specific Populations

Pregnancy

Category C.^b Use during pregnancy may result in hypoadrenalism in infants;^b monitor these infants carefully.^b

Lactation

Not known whether triamcinolone acetonide is distributed in milk.^{1 2 17} Caution if used in nursing women.^{1 2 17}

Pediatric Use

Safety and efficacy not established in children <6 years of age.^{1 2}

Corticosteroids, particularly with high doses for extended periods may cause growth suppression in pediatric patients.^{1 2 17} Titrate dosage to the lowest possible effective level.^b

Geriatric Use

Response similar to that in younger adults.^b

Common Adverse Effects

Pharyngitis, epistaxis, increased cough.^{2 3}

Triamcinolone Acetonide Pharmacokinetics

Absorption

Bioavailability

Systemic absorption is minimal.^{1 2 3} Mean peak plasma concentrations achieved at 1.5 hours following nasal inhalation.^{2 3}

Onset

Symptomatic relief may be evident 10–16 hours following initiation of therapy.^{4 5 8 12 16} Maximum benefit is usually achieved within 1 week.^b

Distribution

Extent

The volume of distribution is 99.5 L.^b

Special Populations

In pediatric patients, similar extent of absorption, peak concentrations, and time to peak concentrations compared to adult patients.^b

Elimination

Metabolism

Metabolized to metabolites that are substantially less active than the parent drug.^b

Half-life

3.1 hours.^b

Stability

Storage

Intranasal Suspension

20–25°C.^b

ActionsActions

• 
  

  Potent glucocorticoid^{1 2 17 b} and weak mineralocorticoid effects.^{3 16}

  
  


• 
  

  May reduce the number of mediator cells (basophils, eosinophils, T-helper cells, mast cells, and neutrophils) in the nasal mucosa.

  
  


• 
  

  Decreases nasal reactivity to allergens and decreases release of inflammatory mediators and proteolytic enzymes.

  
  

Advice to Patients

• 
  

  Provide copy of manufacturer’s patient information.^b

  
  


• 
  

  Importance of understanding proper storage, preparation, and administration techniques.^{1 2 17}

  
  


• 
  

  Importance of shaking container gently prior to each use.^{1 2}

  
  


• 
  

  Importance of avoiding spraying drug directly onto nasal septum.^{1 17}

  
  


• 
  

  Advise patients that containers of triamcinolone acetonide nasal spray should be discarded after 120 actuations.^{1 2}

  
  


• 
  

  Importance of taking as directed and not exceeding prescribed dosage.^{1 2 17}

  
  


• 
  

  Importance of regular use to obtain therapeutic effectiveness.^b

  
  


• 
  

  Importance of contacting a clinician if symptoms worsen or fail to improve after 3 weeks.^{1 2 17 b}

  
  


• 
  

  Necessity of reporting recurrent epistaxis, nasal septum discomfort, irritation, burning, and/or stinging to clinicians.^{1 2 17}

  
  


• 
  

  Importance of avoiding exposure to chickenpox or measles in patients receiving immunosuppressant doses of corticosteroids and, if exposure occurs, consulting a clinician.^{1 2 17 b}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{1 2 17}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.^{1 2 17}

  
  


• 
  

  Importance of advising patients of other important precautionary information.^b (See Cautions.)

  
  

Preparations

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

Triamcinolone Acetonide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Nasal	Suspension	55 mcg/metered spray	Nasacort AQ Nasal Spray (with benzalkonium chloride)	Aventis

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 November 2004. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

1. Aventis. Nasacort (triamcinolone acetonide) nasal inhaler prescribing information. In: Physicians’ desk reference. 55th ed. Montvale, NJ; Medical Economics Company Inc; 2001:717-9.

2. Aventis. Nasacort AQ (triamcinolone acetonide) prescribing information (dated 1997 Oct). In: Physician’s desk reference. 55th ed. Montvale, NJ: Medical Economics Company, Inc; 2001:719-20.

3. Jeal W, Faulds D. Triamcinolone acetonide: a review of its pharmacological properties and therapeutic efficacy in the management of allergic rhinitis. Drugs. 1997; 53:257-80.

4. Settipane G, Korenblat PE, Winder J et al. Triamcinolone acetonide aqueous nasal spray in patients with seasonal ragweed allergic rhinitis: a placebo-controlled, double-blind study. Clin Ther. 1995; 17:252-63.

5. Munk ZM, LaForce C, Furst JA et al. Efficacy and safety of triamcinolone acetonide aqueous nasal spray in patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 1996; 77:277-81.

6. Findlay S, Huber F, Garcia J et al. Efficacy of once-a-day intranasal administration of triamcinolone acetonide in patients with seasonal allergic rhinitis. Ann Allergy. 1992; 68:228-32.

7. Banov CH, Silvers WS, Green AW et al. Placebo-controlled, double-blind study of the efficacy and safety of triamcinolone acetonide aerosol nasal inhaler in pediatric patients with seasonal allergic rhinitis. Clin Ther. 1996; 18:265-72.

8. Kobayashi RH, Beaucher WN, Koepke JW et al. Triamcinolone acetonide aqueous nasal spray for the treatment of patients with perennial allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 1995; 17:503-13.

9. Spector S, Bronsky E, Chervinsky P et al. Multicenter, double-blind, placebo-controlled trial of triamcinolone acetonide nasal aerosol in the treatment of perennial allergic rhinitis. Ann Allergy. 1990; 64:300-5.

10. Storms W, Bronsky E, Findlay S et al. Once daily triamcinolone acetonide nasal spray is effective for the treatment of perennial allergic rhinitis [published erratum appears in Ann Allergy 1991; 66:457]. Ann Allergy. 1991; 66:329-34.

11. Welch MJ, Bronsky EA, Grossman J et al. Clinical evaluation of triamcinolone acetonide nasal aerosol in children with perennial allergic rhinitis.Ann Allergy. 1991; 67:493-8.

12. Day JH, Buckeridge DL, Clark RH et al. A randomized, double-blind, placebo-controlled, controlled antigen delivery study of the onset of action of aerosolized triamcinolone acetonide nasal spray in subjects with ragweed-induced allergic rhinitis. J Allergy Clin Immunol. 1996; 97:1050-7.

13. Howland WC III, Dockhorn R, Gillman S et al. A comparison of effects of triamcinolone acetonide aqueous nasal spray, oral prednisone, and placebo on adrenocortical function in male patients with allergic rhinitis. J Allergy Clin Immunol. 1996; 98:32-8.

14. Feiss G, Morris R, Rom D et al. A comparative study of the effects of intranasal triamcinolone acetonide aerosol (ITAA) and prednisone on adrenocortical function. J Allergy Clin Immunol. 1992; 89:1151-6.

15. Nayak AS, Ellis MH, Gross GN et al. The effects of triamcinolone acetonide aqueous nasal spray on adrenocortical function in children with allergic rhinitis. J Allergy Clin Immunol. 1998; 101(2 Pt 1):157-62.

16. Aventis, Bridgewater, NJ: Personal communication.

17. Muro. Tri-Nasal (triamcinolone acetonide) nasal spray prescribing information. Tewksbury, MA; 2000 Feb.

b. Aventis. Nasacort AQ (triamcinolone acetonide) prescribing information. Bridgewater, NJ; 2004 Mar.

c. Aventis. Nasacort AQ (triamcinolone acetonide) patient information. Bridgewater, NJ; 2004 Mar.

More Triamcinolone Acetonide eent resources

• Triamcinolone Acetonide eent Use in Pregnancy & Breastfeeding
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• 9 Reviews for Triamcinolone Acetonide eent - Add your own review/rating

Compare Triamcinolone Acetonide eent with other medications

• Hay Fever

Keppra XR

Generic Name: levetiracetam (Oral route)

lee-va-tye-RA-se-tam

Commonly used brand name(s)

In the U.S.

• Keppra


• Keppra XR

Available Dosage Forms:

• Tablet, Extended Release


• Tablet


• Solution

Therapeutic Class: Anticonvulsant

Uses For Keppra XR

Levetiracetam is used to help control certain types of seizures in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to use it.

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

Before Using Keppra XR

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 levetiracetam oral solution or tablets in children younger than 1 month of age, and levetiracetam extended-release tablets in teenagers and children younger than 16 years of age. 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 levetiracetam in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving levetiracetam.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 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.

• Ketorolac

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.

• Carbamazepine


• Ginkgo

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:

• Depression, history of or


• Mental illness, history of—Use with caution. May make these conditions worse.

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

Proper Use of levetiracetam

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

Take this medicine only as directed by your doctor, to help your condition as much as possible. 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. Also, do not change your dose without checking first with your doctor.

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

Levetiracetam may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed. You should try to take this medicine at the same time each day.

Swallow the tablet or the extended-release tablet whole. Do not break, crush, or chew it. There is an oral liquid form of this medicine if you or your child cannot swallow the tablets.

Measure the oral liquid with a marked measuring spoon, dropper, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. If you have any questions about this, ask your doctor or pharmacist.

This medicine can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

Take only the form of this medicine that your doctor prescribed. If you refill your prescription and your pills look different, do not take the medicine and tell your doctor or pharmacist right away.

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 partial seizures:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults and teenagers 16 years of age and older—At first, 1000 milligrams (mg) once a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 3000 mg per day.
    
    
    • Teenagers and children younger than 16 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage forms (solution or tablets):
    
    • Adults and teenagers 16 years of age and older—At first, 500 milligrams (mg) two times a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 3000 mg per day.
    
    
    • Teenagers and children 4 to 15 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligram (mg) per kilogram (kg) of body weight two times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 60 mg per kg of body weight per day.
    
    
    • Children and infants 6 months to 3 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 mg per kg of body weight two times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 50 mg per kg of body weight per day.
    
    
    • Infants 1 to 5 months of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 7 mg per kg of body weight two times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 42 mg per kg of body weight per day.
    
    
    • Infants younger than 1 month of age—Use and dose must be determined by your doctor.
    
    
  
  

• For juvenile myoclonic seizures:
  
  • For oral dosage forms (solution or tablets):
    
    • Children 12 years of age and older—At first, 500 milligrams (mg) two times a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 3000 mg per day.
    
    
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  

• For primary generalized tonic-clonic seizures:
  
  • For oral dosage forms (solution or tablets):
    
    • Adults and teenagers 16 years of age and older—At first, 500 milligrams (mg) two times a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 3000 mg per day.
    
    
    • Teenagers and children 6 to 15 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligram (mg) per kilogram (kg) of body weight two times a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 60 mg per kg of body weight per day.
    
    
    • Children younger than 6 years of age—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 Keppra XR

It is very important that your doctor check your or your child's progress at regular visits, especially for the first few months you or your child are taking this medicine. This is necessary to allow dose adjustments and to reduce any unwanted effects.

Make sure your doctor knows if you are pregnant or planning to become pregnant. Your doctor may want you to join the UCB AED Pregnancy Registry or North American Antiepileptic Drug Pregnancy Registry. These registries are used by pregnant patients who are using this medicine.

Levetiracetam may cause changes in mood or behavior, clumsiness or unsteadiness, or unusual tiredness or weakness. Tell your doctor right away if you or your child start to feel depressed, anxious, angry, irritable, restless, or have thoughts about hurting yourself. Report any unusual thoughts or behavior that trouble you, especially if they are new or getting worse quickly.

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.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Do not stop taking levetiracetam without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Keppra XR 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

• Aggressive or angry


• anxiety


• change in personality


• chills


• cough or hoarseness


• crying


• depersonalization


• diarrhea


• dry mouth


• euphoria


• fever


• general feeling of discomfort or illness


• headache


• hyperventilation


• irregular heartbeats


• irritability


• joint pain


• loss of appetite


• lower back or side pain


• mental depression


• muscle aches and pains


• nausea


• nervousness


• painful or difficult urination


• paranoia


• quick to react or overreact emotionally


• rapidly changing moods


• restlessness


• shaking


• shivering


• shortness of breath


• sleepiness or unusual drowsiness


• sore throat


• stuffy or runny nose


• sweating


• trouble with sleeping


• unusual tiredness or weakness


• vomiting

Less common

• Bloody nose


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


• clumsiness or unsteadiness


• discouragement


• dizziness or lightheadedness


• double vision


• earache


• fear or nervousness


• feeling of constant movement of self or surroundings


• feeling sad or empty


• increase in body movements


• loss of bladder control


• loss of memory


• mood or mental changes


• outburst of anger


• pain or tenderness around the eyes and cheekbones


• problems with memory


• redness or swelling in the ear


• seizures


• sensation of spinning


• shakiness and unsteady walk


• shakiness in the legs, arms, hands, or feet


• tightness of the chest or wheezing


• tiredness


• trembling or shaking of the hands or feet


• trouble concentrating


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

Incidence not known

• Attempts at killing oneself


• being forgetful


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• blood in the urine or stools


• bloody, black, or tarry stools


• blurred vision


• changes in vision


• chest pain


• constipation


• dark urine


• difficulty with moving


• fast heartbeat


• general feeling of tiredness or weakness


• high fever


• increase in body movements


• indigestion


• itching


• light-colored stools


• muscle pains or stiffness


• painful or difficult urination


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


• pale skin


• pinpoint red spots on the skin


• red skin lesions, often with a purple center


• red, irritated eyes


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


• stomach pain, continuing


• swollen glands


• swollen joints


• thoughts or attempts at killing oneself


• trouble with balance


• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs


• uncontrolled jerking or twisting movements of the hands, arms, or legs


• uncontrolled movements of the lips, tongue, or cheeks


• unexplained bleeding or bruising


• unusual bleeding or bruising


• upper right abdominal or stomach pain


• weight loss


• 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:

More common

• Loss of strength or energy


• muscle pain or weakness


• pain


• tender, swollen glands in the neck


• trouble with swallowing


• unusual weak feeling


• voice changes

Less common

• Body aches or pain


• burning, dry, or itching eyes


• change in the color of the skin


• congestion


• cough increased


• rash


• sneezing

Incidence not known

• Hair loss or thinning of the hair


• skin rash, encrusted, scaly, and oozing

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: Keppra XR side effects (in more detail)

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More Keppra XR resources

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

• Keppra XR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Keppra Prescribing Information (FDA)


• Keppra Consumer Overview


• Keppra Monograph (AHFS DI)


• Keppra MedFacts Consumer Leaflet (Wolters Kluwer)


• Levetiracetam Prescribing Information (FDA)


• Levetiracetam Professional Patient Advice (Wolters Kluwer)

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