Clob

Clob may be available in the countries listed below.

Ingredient matches for Clob

Clobazam

Clobazam is reported as an ingredient of Clob in the following countries:

• Bangladesh

International Drug Name Search

Mintezol

In some countries, this medicine may only be approved for veterinary use.

In the US, Mintezol (thiabendazole systemic) is a member of the drug class anthelmintics and is used to treat Angiostrongylosis, Ascariasis, Capillariasis, Cutaneous Larva Migrans, Dracunculiasis, Hookworm Infection - Necator or Ancylostoma, Strongyloidiasis, Trichinosis, Trichostrongylosis, Visceral Larva Migrans - Toxicariasis and Whipworm Infection.

US matches:

• Mintezol


• Mintezol Suspension

Ingredient matches for Mintezol

Tiabendazole

Tiabendazole is reported as an ingredient of Mintezol in the following countries:

• Egypt


• Ethiopia


• Greece


• Ireland


• United Kingdom


• United States

International Drug Name Search

Fosfestrolo

Fosfestrolo may be available in the countries listed below.

Ingredient matches for Fosfestrolo

Fosfestrol

Fosfestrolo (DCIT) is also known as Fosfestrol (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Proxalyoc

Proxalyoc may be available in the countries listed below.

Ingredient matches for Proxalyoc

Piroxicam

Piroxicam is reported as an ingredient of Proxalyoc in the following countries:

• France


• Tunisia

International Drug Name Search

Ropenem

Ropenem may be available in the countries listed below.

Ingredient matches for Ropenem

Meropenem

Meropenem trihydrate (a derivative of Meropenem) is reported as an ingredient of Ropenem in the following countries:

• Bangladesh

International Drug Name Search

Aptivus

Aptivus is a brand name of tipranavir, approved by the FDA in the following formulation(s):

APTIVUS (tipranavir - capsule; oral)

• 
  Manufacturer: BOEHRINGER INGELHEIM
  
  Approval date: June 22, 2005
  
  Strength(s): 250MG ^[RLD]

APTIVUS (tipranavir - solution; oral)

• 
  Manufacturer: BOEHRINGER INGELHEIM
  
  Approval date: June 23, 2008
  
  Strength(s): 100MG/ML ^[RLD]

Has a generic version of Aptivus been approved?

No. There is currently no therapeutically equivalent version of Aptivus available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Aptivus. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Pyranone compounds useful to treat retroviral infections
  Patent 5,852,195
  Issued: December 22, 1998
  Inventor(s): Romines; Karen Rene & Bundy; Gordon L. & Schwartz; Theresa M. & Tommasi; Ruben A. & Strohbach; Joseph W. & Turner; Steven Ronald & Thaisrivongs; Suvit & Aristoff; Paul Adrian & Johnson; Paul D. & Skulnick; Harvey Irving & Skaletzky; Louis L. & Anderson; David John & Morris; Joel
  Assignee(s): Pharmacia & Upjohn Company
  The present invention relates to compounds of formulae (I) and (II) which are pyran-2-ones, 5,6-dihydro-pyran-2-ones, 4-hydroxy-benzopyran-2-ones, 4-hydroxy-cycloalkyl›b!pyran-2-ones, and derivatives thereof, useful for inhibiting a retrovirus in a mammalian cell infected with said retrovirus, wherein R.sub.10 and R.sub.20 taken together are formulae (III) and (IV). ##STR1##
  
  Patent expiration dates:
  
  
  • June 22, 2019
    
    ✓ 
    Drug substance
  
  
  
  • December 22, 2019
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Method for improving the pharmacokinetics of tipranavir
  Patent 6,147,095
  Issued: November 14, 2000
  Inventor(s): Ferry; James J. & Baldwin; John R. & Borin; Marie T.
  Assignee(s): Pharmacia & Upjohn Company
  The present invention relates to a novel method for improving the pharmacokinetics of tipranavir, comprising administering to a human in need of such treatment a combination of a therapeutically effective amount of tipranavir or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of ritonavir or a pharmaceutically acceptable salt thereof.
  
  Patent expiration dates:
  
  
  • October 29, 2019
    
    ✓ 
    Patent use: TREATMENT OF HIV-1 INFECTION BY THE CO-ADMINISTRATION OF TIPRANAVIR AND RITONAVIR.
  
  
  
  • April 29, 2020
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Compounds useful to treat retroviral infections
  Patent 6,169,181
  Issued: January 2, 2001
  Inventor(s): Romines; Karen Rene & Bundy; Gordon L. & Schwartz; Theresa M. & Tommasi; Ruben A. & Strohbach; Joseph W. & Turner; Steven Ronald & Thaisrivongs; Suvit & Aristoff; Paul Adrian & Johnson; Paul D. & Skulnick; Harvey Irving & Skaletzky; Louis L. & Anderson; David John & Morris; Joel
  Assignee(s): Pharmacia & Upjohn Company
  The present invention relates to compounds of formula I and II which are pyran-2-ones, 5,6-dihydro-pyran-2-ones, 4-hydroxy-benzopyran-2-ones, 4-hydroxy-cycloalkyl[b]pyran-2-ones, and derivatives thereof, useful for inhibiting a retrovirus in a mammalian cell infected with said retrovirus. ##STR1## wherein R.sub.10 and R.sub.20 taken together are: ##STR2##
  
  Patent expiration dates:
  
  
  • May 6, 2014
    
    ✓ 
    Drug substance
  
  
  
  • November 6, 2014
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Pharmaceutical composition for acidic lipophilic compounds in a form of a self-emulsifying formulation
  Patent 6,231,887
  Issued: May 15, 2001
  Inventor(s): Gao; Ping & Morozowich; Walter
  Assignee(s): Pharmacia & Upjohn Company
  The present invention provides a novel pharmaceutical composition based on the use of a particular amount of basic amine which comprises a pyranone compound as a pharmaceutically active agent, a basic amine in an amount of from about 0.1% to about 10% by weight of the total composition, one or more pharmaceutically acceptable solvents, and one or more pharmaceutically acceptable surfactants. In addition, the composition may further comprises one or more pharmaceutically acceptable oils. The composition is in a form of self-emulsifying formulation which provides high concentration and high oral bioavailability for lipophilic pyranone compounds.
  
  Patent expiration dates:
  
  
  • July 27, 2018
    
    ✓ 
    Drug product
  
  
  
  • January 27, 2019
    
    ✓ 
    Pediatric exclusivity
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • December 22, 2010 - PEDIATRIC EXCLUSIVITY
  
  
  • June 23, 2011 - USE OF APTIVUS, CO-ADMINISTERED W/RITONAVIR, FOR COMBINATION ANTIRETROVIRAL TREATMENT OF HIV-1 INFECTED PED (AGE 2-18 YRS) PATIENTS WHO ARE TREATMENT-EXPERIENCED AND INFECTED W/HIV-1 STRAINS RESISTANT TO MORE THAN ONE PROTEASE INHIBITOR
  
  
  • December 23, 2011 - PEDIATRIC EXCLUSIVITY
  
  

See also...

• Aptivus Consumer Information (Drugs.com)
• Aptivus Consumer Information (Wolters Kluwer)
• Aptivus Solution Consumer Information (Wolters Kluwer)
• Aptivus Consumer Information (Cerner Multum)
• Aptivus Advanced Consumer Information (Micromedex)
• Aptivus AHFS DI Monographs (ASHP)
• Tipranavir Consumer Information (Wolters Kluwer)
• Tipranavir Solution Consumer Information (Wolters Kluwer)
• Tipranavir Consumer Information (Cerner Multum)
• Tipranavir Advanced Consumer Information (Micromedex)
• Tipranavir AHFS DI Monographs (ASHP)

Misol

Misol may be available in the countries listed below.

Ingredient matches for Misol

Sertraline

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Misol in the following countries:

• Turkey

International Drug Name Search

Budesonide

Class: Adrenals
VA Class: NT200
Chemical Name: [11β,16α(R)]-16,17-Butylidene-bis(oxy)-11,21-dihydroxy-pregna-1,4-diene-3,20-dione and 16α,17-[(S)-butylidinebis(oxy)]-11β,21-dihydroxypregna-1,4-diene-3,20-dione
Molecular Formula: C₂₅H₃₄O₆
CAS Number: 51333-22-3
Brands: Entocort EC, Pulmicort, Symbicort

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

Introduction

Synthetic, nonhalogenated corticosteroid; potent glucocorticoid and weak mineralocorticoid activity.^{1 2 3 6 31 j}

Uses for Budesonide

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.

Crohn’s Disease

Used orally for the management of an active episode of mild-to-moderate Crohn’s disease involving the ileum and/or ascending colon^{1 4 5 6 7 8 9 10 11 12 13 15 16 17 18 31} and for maintenance of clinical remission for up to 3 months in this condition.^{1 40}

Has been used for the management of mild to moderately active Crohn’s disease† in a limited number of children 9.5–18 years of age.¹⁰

Asthma

Long-term prevention of bronchospasm in patients with asthma.^{3 28 j}

In corticosteroid-dependent patients, may permit a substantial reduction in daily maintenance dosage of systemic corticosteroid and gradual discontinuance of corticosteroid maintenance dosages.^{2 3 28 j}

Used in fixed combination with formoterol in asthmatic patients whose disease is inadequately controlled with other anti-asthma therapy (e.g., low-to-medium dosages of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies.^g

Fixed combination with formoterol should not be used in patients whose asthma can be successfully managed with inhaled corticosteroids and occasional use of inhaled short-acting β₂-adrenergic agonists.^g

Not indicated for management of acute bronchospasm.^{2 3 g j}

Not indicated for treatment or prevention of exercise-induced bronchospasm.^g

Budesonide Dosage and Administration

General

Asthma

• 
  

  Individualize dosage carefully according to disease severity.^j

  
  


• 
  

  Base initial and maximum dosages of oral inhalation on previous asthma therapy.^{2 3}

  
  


• 
  

  After a satisfactory response is obtained, decrease dosage gradually to the lowest dosage that maintains an adequate clinical response.^{2 3 j} Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth.^{g j} (See Pediatric Use under Cautions.)

  
  

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

• 
  

  When switching from systemic corticosteroids to orally inhaled budesonide, asthma should be reasonably stable before initiating withdrawal from systemic corticosteroids.^j

  
  


• 
  

  Initially, administer the oral inhalation therapy concurrently with the maintenance dosage of the systemic corticosteroid.^{2 a j} After about 1 week, gradually withdraw systemic corticosteroid, followed by further reductions after an interval of 1 or 2 weeks.^{2 3 j}

  
  


• 
  

  Usual decrements of ≤2.5 mg or ≤25% of prednisone dosage (or its equivalent) every 1–2 weeks used in patients receiving budesonide powder for inhalation or inhalation suspension, respectively.^{2 3 j} Once oral corticosteroids are discontinued and symptoms of asthma have been controlled, titrate the dosage to the lowest effective level.^{2 3 g}

  
  


• 
  

  Death has occurred in some individuals due to adrenal insufficiency in whom systemic corticosteroids were withdrawn too rapidly.^j If evidence of adrenal insufficiency occurs, increase systemic corticosteroid dosage temporarily and then continue withdrawal from systemic corticosteroids more slowly.^j (See Withdrawal of Systemic Corticosteroid Therapy under Cautions.)

  
  

Administration

Administer orally as delayed-release capsules.^{1 6 7 9 11 12 15 31}

Administer by oral inhalation via nebulization (Pulmicort Respules),^{2 d} an oral aerosol inhaler (Symbicort), or an oral powder inhaler (Pulmicort Flexhaler, Pulmicort Turbuhaler).^{3 28 g j}

Oral Administration

Administer orally once daily as delayed-release capsules containing enteric-coated granules.^{1 6 28 31}

Swallow the capsules intact; do not chew or break.^{1 6} However, limited data indicate that the release characteristics of capsules were not affected when unencapsulated granules were added to applesauce for 30 minutes.²⁸

Avoid concomitant use of the capsules and grapefruit juice.^{1 6} (See Specific Drugs or Food under Interactions.)

Manufacturer makes no specific recommendations regarding administration with meals;¹ a high-fat meal may decrease the rate of absorption.^{1 6} (See Absorption under Pharmacokinetics.)

Oral Inhalation

Following each dose, rinse the mouth with water to remove residual drug and to minimize the development of fungal overgrowth and/or infection.^{2 3 24 25 28 g h}

Inhalation Powder

Prime the oral inhaler prior to initial use.^{3 25 j k}

Do not shake Pulmicort Flexhaler.^j

Actuate inhaler and inhale deeply and forcefully.^{3 25 j k}

Pulmicort Turbuhaler and Pulmicort Flexhaler cannot be refilled; discard when empty.^{3 25 j k}

Inhalation Suspension

Do not administer the oral inhalation suspension parenterally or use with ultrasonic nebulizers.^{2 24 28}

Using in vitro testing at a flow rate of 5.5 L per minute for an average of 5 minutes, the Pari-LC-Jet Plus nebulizer delivered at the mouthpiece approximately 17% of the original dose.^f

Administer using a jet nebulizer (with face mask or mouthpiece) connected to a compressor that has an adequate air flow.^{2 28} To optimize delivery and to avoid exposure of the eyes to nebulized drug, adjust the face mask properly.^{2 24}

When a face mask is used for nebulization, wash the face after each use to avoid dermatologic corticosteroid effects (e.g., rash, contact dermatitis).^{2 28}

Safety and efficacy of budesonide inhalation suspension administered by a nebulizer other than the Pari-LC-Jet Plus Nebulizer or a compressor other than the Pari Master compressor not established.^{2 28}

Inhalation Aerosol

Administer budesonide in fixed combination with formoterol using an aerosol inhaler device.^g Administer twice daily (morning and evening).^{g h}

Test spray 2 times before first use, if not used for >7 days, or if dropped.^{g h}

Shake well for 5 seconds immediately prior to use.^{g h}

Clean inhaler every 7 days by wiping mouthpiece with a dry cloth.^{g h}

Use the actuator supplied with the product to administer budesonide in fixed combination with formoterol.^{g h}

Symbicort cannot be refilled; discard when empty.^h

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.

Dosage of budesonide inhalation powder is expressed in mcg delivered from the mouthpiece.^{a j} The amount of drug powder delivered to the lungs depends on factors such as the patient’s inspiratory flow.^{3 28 j}

Each actuation of the Pulmicort Turbuhaler inhaler contains 200 mcg of budesonide inhalation powder and delivers approximately 160 mcg of budesonide per activation from the mouthpiece.³

Each actuation of the Pulmicort Flexhaler inhaler contains 90 or 180 mcg of budesonide inhalation powder and delivers approximately 80 or 160 mcg of budesonide, respectively, per activation from the mouthpiece.^j

When switching between Pulmicort Turbuhaler and Pulmicort Flexhaler, dose may vary and is not predictable by dose of other inhaler.^j Follow dosage recommendations; titrate based on clinical response.^j

Delivery of oral inhalation suspension (Pulmicort Respules) to the lungs depends on the type of jet nebulizers used, performance of the compressor, and on factors such as the patient’s inspiratory flow.^{2 28}

Dosage of budesonide in fixed combination with formoterol fumarate dihydrate (Symbicort) inhalation aerosol is expressed in mcg delivered from the mouthpiece.^g Each actuation of the Symbicort inhalation aerosol delivers 91 or 181 mcg of budesonide and 5.1 mcg of formoterol fumarate dihydrate from the valve, and 80 or 160 mcg of budesonide and 4.5 mcg of formoterol fumarate dihydrate from the actuator per metered spray.^g The amount of drug delivered to the lungs depends on factors such as the patient’s inspiratory flow.^g The aerosol inhaler delivers 60 metered sprays per 6- or 6.9-g canister, and 120 metered sprays per 10.2-g canister.^g

Pediatric Patients

Asthma

Maintenance Monotherapy

Oral Inhalation Powder (Pulmicort Turbuhaler)

Children ≥6 years of age previously receiving bronchodilators alone: Initially, 160 mcg (labeled 200 mcg) twice daily.^{3 28 a} If required, may increase dosage to a maximum of 320 mcg (labeled 400 mcg) twice daily.^{3 28 a}

Children ≥6 years of age previously receiving inhaled corticosteroids: Initially, 160 mcg (labeled 200 mcg) twice daily.^{3 28 a} If required, may increase dosage to a maximum of 320 mcg (labeled 400 mcg) twice daily.^{3 28 a}

In children with mild-to-moderate asthma whose asthma is adequately controlled with inhaled corticosteroids, consider 160 or 320 mcg (labeled 200 or 400 mcg, respectively) once daily.^{3 a}

Oral Inhalation Powder (Pulmicort Flexhaler)

Children and adolescents 6–17 years of age: Initially, 160 mcg (labeled 180 mcg) twice daily.^j If required, may increase dosage to a maximum of 320 mcg (labeled 360 mcg) twice daily.^j In some patients, an initial dosage of 320 mcg (labeled 360 mcg) twice daily may be appropriate.^j

Oral Inhalation Suspension

Children 1–8 years of age inadequately controlled with nonsteroidal (e.g., bronchodilator, mast-cell stabilizer) therapy: Initially, 0.25 mg once daily.^{2 28} If the response is inadequate, increase the total daily dosage and/or administer in divided doses.²

Children 1–8 years of age previously receiving bronchodilators alone: 0.5 mg daily, given in 1 or 2 divided doses.^{2 28}

Children 1–8 years of age previously receiving inhaled corticosteroids: Initially, 0.5 mg daily, given in 1 or 2 divided doses.² If response is inadequate, dosage may be increased to a maximum of 1 mg daily and/or administered in divided doses.²

Children 1–8 years of age previously receiving oral corticosteroids: 1 mg daily, given in 1 or 2 divided doses.²

Budesonide/Formoterol Fixed-combination Therapy

Oral Inhalation Aerosol

Adolescents ≥12 years of age not currently receiving an orally inhaled corticosteroid: Initially, 160 or 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily, depending on asthma severity.^g

Adolescents ≥12 years of age inadequately controlled with low-to-medium dosages of an inhaled corticosteroid: Initially, 160 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

Adolescents ≥12 years of age inadequately controlled with medium-to-high dosages of an inhaled corticosteroid: Initially, 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

If control of asthma is inadequate after 1–2 weeks of therapy at the lower dosage, a higher strength (higher strengths contain higher dosages of budesonide only) may provide additional asthma control.^g

Adults

Crohn’s Disease

Management of Mild to Moderately Active Crohn’s Disease

Oral

Initially, 9 mg daily in the morning for 8 weeks.^{1 6}

In patients who have not experienced remission during the initial 8-week course,^{28 29} a second 8-week course (16 weeks of continuous therapy) may be used.^{1 6 28 29}

Maintenance of Remission

Oral

6 mg once daily for up to 3 months.^{1 40} If symptom control is maintained at 3 months, attempt to taper dosage to complete cessation.¹ The manufacturer states that continued therapy beyond 3 months has not been shown to provide substantial clinical benefit.¹

Asthma

Maintenance Monotherapy

Oral Inhalation Powder (Pulmicort Turbuhaler)

Previously receiving bronchodilators alone: Initially, 160–320 mcg (labeled 200–400 mcg) twice daily.^{3 a} If required, dosage may be increased to a maximum of 320 mcg (labeled 400 mcg) twice daily.^{3 a}

Previously receiving inhaled corticosteroids: Initially, 160–320 mcg (labeled 200–400 mcg) twice daily.^{3 a} If required, may increase dosage to a maximum 640 mcg (labeled 800 mcg) twice daily.^{3 a}

In patients with mild-to-moderate asthma whose asthma is adequately controlled with inhaled corticosteroids, consider 160 or 320 mcg (labeled 200 or 400 mcg, respectively) once daily.^{3 a}

Pulmicort Turbuhaler in adults previously receiving oral corticosteroids: Initially, 320–640 mcg (labeled 400–800 mcg) twice daily.^{3 a} If required, may increase dosage to a maximum of 640 mcg (labeled 800 mcg) twice daily.^{3 a}

Oral Inhalation Powder (Pulmicort Flexhaler)

Usual initial dosage is 320 mcg (labeled 360 mcg) twice daily.^j In some patients and in well-controlled patients, an initial dosage of 160 mcg (labeled 180 mcg) twice daily may be adequate.^j If required, may increase dosage to a maximum of 640 mcg (labeled 720 mcg) twice daily.^j

Budesonide/Formoterol Fixed-combination Therapy

Oral Inhalation Aerosol

Patients not currently receiving an orally inhaled corticosteroid: Initially, 160 or 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily, depending on asthma severity.^g

Patients inadequately controlled with low-to-medium dosages of an inhaled corticosteroid: Initially, 160 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

Patients inadequately controlled with medium-to-high dosages of an inhaled corticosteroid: Initially, 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

If control of asthma is inadequate after 1–2 weeks of therapy at the lower dosage, a higher strength (higher strengths contain higher dosages of budesonide only) may provide additional asthma control.^g

Prescribing Limits

Pediatric Patients

Asthma

Maintenance Monotherapy

Oral Inhalation Powder

Pulmicort Turbuhaler in children ≥6 years of age: Maximum 320 mcg (labeled 400 mcg) twice daily.^{3 a}

Pulmicort Flexhaler in children and adolescents 6–17 years of age: Maximum 320 mcg (labeled 360 mcg) twice daily.^j

Oral Inhalation Suspension

Children 1–8 years of age, previously receiving bronchodilators alone: Maximum 0.5 mg daily.^{2 28}

Children 1–8 years of age, previously receiving inhaled corticosteroids: Maximum 1 mg daily.²

Children 1–8 years of age, previously receiving oral corticosteroids: Maximum 1 mg daily.²

Budesonide/Formoterol Fixed-combination Therapy

Oral Inhalation Aerosol

Adolescents ≥12 years of age: Maximum 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

Adults

Asthma

Maintenance Monotherapy

Oral Inhalation Powder

Pulmicort Turbuhaler in patients previously receiving bronchodilators alone: Maximum 320 mcg (labeled 400 mcg) twice daily.^{3 a}

Pulmicort Turbuhaler in patients previously receiving inhaled corticosteroids: Maximum 640 mcg (labeled 800 mcg) twice daily.^{3 a}

Pulmicort Turbuhaler in patients previously receiving oral corticosteroids: Maximum 640 mcg (labeled 800 mcg) twice daily.^{3 a}

Pulmicort Flexhaler in patients ≥18 years of age: Maximum 640 mcg (labeled 720 mcg) twice daily.^j

Budesonide/Formoterol Fixed-combination Therapy

Oral Inhalation Aerosol

Maximum 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

Special Populations

Hepatic Impairment

Crohn’s Disease

Consider dosage reduction in moderate to severe hepatic impairment.^{1 6} (See Special Populations under Absorption in Pharmacokinetics.)

Asthma

No specific dosage recommendations at this time.^g

Renal Impairment

Asthma

No specific dosage recommendations at this time.^g

Geriatric Patients

Oral monotherapy: Careful dosage selection recommended due to possible age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Oral inhalation powder (Pulmicort Flexhaler): Careful dosage selection recommended due to possible age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.^j

Fixed combination of budesonide and formoterol fumarate dihydrate: No dosage adjustment required.^g (See Geriatric Use under Cautions.)

Cautions for Budesonide

Contraindications

• 
  

  Known hypersensitivity to budesonide or any ingredient in the formulation.^{1 2 3 g j}

  
  


• 
  

  Orally inhaled budesonide for primary treatment of acute asthmatic attacks or status asthmaticus when intensive measures (e.g., an orally inhaled β₂-adrenergic agonist, an orally inhaled anticholinergic agent, subcutaneous epinephrine, IV aminophylline, and/or an oral/IV glucocorticoid) are required.^{2 3 19 27 g j}

  
  

Warnings/Precautions

Warnings

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.

Withdrawal of Systemic Corticosteroid Therapy

Possible life-threatening adrenal insufficiency in patients being switched from systemic corticosteroids to orally inhaled budesonide.^{2 3 28 j}

Withdraw systemic corticosteroid therapy gradually.^{1 2 3 6 j} 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 orally inhaled corticosteroids.¹⁴

Monitor carefully for objective signs of adrenal insufficiency (e.g., fatigue, lassitude, weakness, nausea, vomiting, hypotension) and asthma instability (e.g., airway function) during withdrawal of systemic therapy.^{1 j} Carefully monitor lung function (forced expiratory volume in 1 second [FEV₁], morning peak expiratory flow [PEF]), adjunctive β₂-adrenergic agonist use, and asthma symptoms.^j Patients who have been maintained on ≥20 mg of prednisone (or its equivalent) daily may be most susceptible to such adverse events, particularly during latter part of the transfer.^{2 3 j} (See Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids under Dosage and Administration.)

Corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression) may occur.^{1 2 3 g j}

Adrenal insufficiency may occur during exposure to trauma, surgery, infection (particularly gastroenteritis), or other conditions associated with acute electrolyte loss.^{1 2 3 j}

Possible unmasking of allergic conditions previously controlled by systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions).^{1 2 3 6 j}

Do not use the fixed combination of budesonide and formoterol fumarate dihydrate for transferring therapy from systemic to inhaled corticosteroids.^g

Immunosuppressed Patients

Increased susceptibility to infections in patients taking immunosuppressant drugs compared with healthy individuals.^{1 2 3 g j} Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients, particularly in children.^{1 2 3 g}

Take particular care to avoid exposure in susceptible patients.^{1 2 3 e g j} If exposure to varicella or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled immune globulin (IG), respectively.^{1 2 3 28 e g j} Consider treatment with an antiviral agent if varicella develops.^{1 2 3 e g j}

Paradoxical Bronchospasm

Possible life-threatening, acute, paradoxical bronchospasm and/or wheezing.^{2 3 g j} If bronchospasm occurs, treat immediately with a short-acting bronchodilator, discontinue treatment with budesonide, and institute alternative therapy.^{2 3 28 g j}

General Precautions

Ocular Effects

Glaucoma, increased IOP, and cataracts reported rarely in patients receiving orally inhaled corticosteroids.^{2 3 g h j}

Use delayed-release capsules with caution in patients with glaucoma, cataracts, or a family history of glaucoma.^{1 6}

Consider regular eye examinations.^{h j}

Systemic Corticosteroid Effects

Administration of higher than recommended dosages of orally inhaled budesonide or prolonged oral administration of budesonide capsules may result in manifestations of hypercorticism and suppression of HPA function.^{1 2 3 g j} To minimize potential for such changes, do not exceed recommended dosages of orally inhaled budesonide-containing therapy.^{a g j}

Monitor patients receiving orally inhaled budesonide-containing therapy for any evidence of systemic corticosteroid effects.^{a g} If systemic corticosteroid effects occur, reduce the dosage of budesonide-containing therapy slowly, consistent with accepted procedures for reducing corticosteroid dosage and management of asthma symptoms.^{a g j}

Take particular care in monitoring patients postoperatively or during periods of stress for evidence of inadequate adrenal response.^{a g j} Supplemental therapy with a systemic corticosteroid required during stress or severe asthma attacks.^{1 a g}

Musculoskeletal Effects

Long-term use may affect normal bone metabolism, resulting in a loss of bone mineral density (BMD).^g

Use of orally inhaled corticosteroids can pose additional risks in patients with major risk factors for decreased BMD, such as tobacco use, advanced age, sedentary lifestyle, poor nutrition, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, additional corticosteroids).^{g h}

Use delayed-release capsules with caution in patients with osteoporosis.^{1 6}

Possible growth suppression in pediatric patients.^{2 3 g j} (See Pediatric Use under Cautions.)

Concomitant Disease States

Use delayed-release capsules with caution in patients with hypertension, diabetes mellitus, peptic ulcer, a family history of diabetes, or any other condition in which glucocorticoids may be associated with adverse effects.^{1 6}

Infection

Localized candidal infections of the mouth and/or pharynx reported with oral inhalation therapy.^{2 3 g j}

If infection occurs, initiate appropriate local or systemic antifungal treatment while still continuing with inhaled budesonide therapy.^{2 3 g j} May require discontinuance of budesonide therapy (under close medical supervision) in some patients.^{2 3 g j}

Lower respiratory tract infections, including pneumonia, reported with orally inhaled corticosteroid therapy.^g Use oral inhalation therapy with extreme caution, if at all, in patients with clinical tuberculosis or latent M. tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.^{2 3 g j}

Use delayed-release capsules with caution in patients with tuberculosis.^{1 6}

Other Effects

Unknown long-term local and systemic effects of the drug in humans, particularly local effects on developmental or immunologic processes in the mouth, pharynx, trachea, and lung.^{2 g j}

Use of Fixed Combinations

When used in fixed combination with formoterol fumarate dihydrate, consider the cautions, precautions, and contraindications associated with formoterol.^g

Specific Populations

Pregnancy

Category B (orally inhaled powder and inhalation suspension); category C (oral capsules, inhalation aerosol).^{1 2 3 28 g j}

Hypoadrenalism may occur in infants of women receiving corticosteroid therapy during pregnancy; monitor these infants carefully.^{1 2 3 g j}

Lactation

Distributed into milk.^{g j}

Use of oral capsules, oral inhalation aerosol, or oral inhalation powder (Pulmicort Turbuhaler) not recommended; discontinue nursing or the drug.^{1 3 g} Caution advised if inhalation suspension is used.^f

Use oral inhalation powder (Pulmicort Flexhaler) only if clinically appropriate; titrate to lowest effective dosage and use inhaler immediately after nursing to minimize infant exposure.^j

Pediatric Use

Safety and efficacy of oral budesonide delayed-release capsules not established in pediatric patients <18 years of age with Crohn’s disease.^{1 28}

Safety and efficacy of budesonide inhalation powder not established in children <6 years of age.^{3 j}

Efficacy of budesonide inhalation suspension not established in children <1 year of age,² while safety of the suspension not evaluated in children <6 months of age.²

Efficacy of inhalation aerosol containing budesonide in fixed combination with formoterol fumarate dihydrate not established in children <12 years of age.^g Safety of combination therapy in children 6 to <12 years of age similar to that in adolescents and adults.^g

With long-term use, slows growth rate in children and adolescents.^{2 3 g j} Monitor routinely (e.g., via stadiometry) growth and development of pediatric patients receiving orally inhaled corticosteroid therapy.^{2 3 g j} Weigh benefits of orally inhaled corticosteroid therapy versus possibility of growth suppression and the risks associated with alternative therapies.^{a g} Use the lowest possible dosage that effectively controls asthma.^{35 a g}

Geriatric Use

Insufficient experience with oral drug in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.^{1 6} (See Geriatric Patients under Dosage and Administration.)

Safety and efficacy of inhalation powder, inhalation suspension, or inhalation aerosol in patients ≥65 years of age similar to that in younger adults.^{2 3 6 28 g}

Hepatic Impairment

Monitor patients with Crohn’s disease and moderate to severe hepatic impairment for increased signs and symptoms of hypercorticism.^{1 6} (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

With oral capsules, headache,^{1 6 7 40} dizziness,¹ nausea,^{1 6 7 11 40} vomiting,^{1 6 7 11 40} dyspepsia,^{1 6 11 40} diarrhea,^{1 40} sinusitis,^{1 40} symptoms of hypercorticism,¹ respiratory infection,^{1 6 40} viral infection,^{1 40} pain (including back pain),^{1 40} arthralgia,^{1 40} fatigue.^{1 6 40} Adverse effect profile in long-term treatment similar to short-term treatment.¹

With oral inhalation, respiratory infection,^{2 3} pharyngitis,³ rhinitis,^{2 3} sinusitis, ³ cough,^{2 3} otitis (media or externa),² flu-like syndrome,² headache,³ pain (e.g., back pain).³

Interactions for Budesonide

Metabolized by the CYP3A4 isoenzyme.^{1 2 3 6 31 g j}

Drugs or Foods Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma budesonide concentrations).^{1 2 3 6 31 g j}

Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased plasma budesonide concentrations).¹

Drugs Affecting GI pH

Potential pharmacokinetic interaction (may affect release properties and systemic absorption of enteric coated budesonide capsules).^{1 6}

Specific Drugs or Food

Drug	Interaction	Comments
Antibiotics, macrolide (e.g., clarithromycin, erythromycin)	Increased systemic exposure of budesonide1 2 3 6 31 j	Monitor carefully if used concomitantly with oral budesonide capsules;2 3 31 consider reduction of budesonide dosage1 6 8
Antifungals, azole (e.g., itraconazole, ketoconazole)	Increased systemic exposure of budesonide1 2 3 6 31 g j	Monitor carefully if used concomitantly with oral budesonide capsules;3 31 consider reduction of budesonide dosage1

Depakote Delayed-Release Tablets

Pronunciation: dye-VAL-proe-ex
Generic Name: Divalproex
Brand Name: Depakote

Life-threatening liver failure has occurred in patients taking Depakote Delayed-Release Tablets. Children younger than 2 years old are at increased risk of developing life-threatening liver damage, especially those on more than 1 medicine to treat seizures, and those with metabolic disorders, severe seizure disorders accompanied by retardation, or organic brain disease. Contact your doctor immediately if you or your child experiences a general feeling of discomfort, sluggishness, weakness, severe drowsiness, swelling of the face, loss of appetite, vomiting, or loss of seizure control. Liver function tests may be performed before and during therapy with Depakote Delayed-Release Tablets. Be sure to keep all doctor and lab appointments.

Depakote Delayed-Release Tablets can cause severe birth defects if it is used during pregnancy. Contact your doctor if you become pregnant or think you may be pregnant while taking Depakote Delayed-Release Tablets. Depakote Delayed-Release Tablets comes with an additional patient leaflet, "Important Information for Women Who Could Become Pregnant." Read it carefully.

Cases of life-threatening inflammation of the pancreas have occurred with the use of Depakote Delayed-Release Tablets. Report any stomach pain, nausea, vomiting, or loss of appetite to your doctor at once.

Depakote Delayed-Release Tablets are used for:

Controlling certain types of seizures in the treatment of epilepsy. It is also used to treat the manic phase of bipolar disorders (manic-depressive illness), and to prevent migraine headaches.

Depakote Delayed-Release Tablets are an anticonvulsant. It works by reducing or preventing the number of seizures by controlling the abnormal activity of nerve impulses in the brain and central nervous system. Exactly how it works to treat bipolar disorder and migraine headache is not known.

Do NOT use Depakote Delayed-Release Tablets if:

• you are allergic to any ingredient in Depakote Delayed-Release Tablets


• you have liver problems or a urea cycle disorder

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

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Before using Depakote Delayed-Release Tablets:

Some medical conditions may interact with Depakote Delayed-Release 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, are breast-feeding, or are of childbearing age


• 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, liver problems, metabolic disease, blood disease, HIV infection, cytomegalovirus (CMV) infection, high blood levels of ammonia or glutamine, low body temperature, low levels of albumin, brain problems (eg, organic brain disease), mental retardation, inflammation of the pancreas, kidney problems, or low levels of white blood cells, or if you are scheduled for surgery


• if you have a history of ornithine transcarbamylase deficiency or unexplained coma


• if you have a family history of urea cycle disorders or unexplained infant deaths


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


• if you take any other medicine for seizures

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

• Benzodiazepines (eg, diazepam), carbamazepine, erythromycin, felbamate, fluoxetine, guanfacine, isoniazid, ketoconazole, risperidone, or salicylates (eg, aspirin) because the risk of serious side effects of Depakote Delayed-Release Tablets, including changes in vision or other vision problems, clumsiness or unsteadiness, drowsiness, nausea, or vomiting, may be increased


• Clonazepam because the risk of seizures may be increased


• Topiramate because the risk of high ammonium levels, brain problems, or an unusual drop in body temperature may be increased


• Acyclovir, cancer medicines, carbapenem antibiotics (eg, ertapenem, imipenem, meropenem), cholestyramine, hydantoins (eg, phenytoin), mefloquine, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), oral contraceptives (eg, birth control pills), or rifampin because they may decrease Depakote Delayed-Release Tablets's effectiveness


• Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital), ethosuximide, lamotrigine, methylphenidate, primidone, tolbutamide, tricyclic antidepressants (eg, amitriptyline), or zidovudine because the risk of their side effects may be increased by Depakote Delayed-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Depakote Delayed-Release 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 Depakote Delayed-Release Tablets:

Use Depakote Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Depakote Delayed-Release Tablets. Talk to your pharmacist if you have questions about this information.


• Take Depakote Delayed-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Swallow Depakote Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.


• Do not stop taking Depakote Delayed-Release Tablets suddenly, especially if you are taking Depakote Delayed-Release Tablets to prevent seizures. Suddenly stopping Depakote Delayed-Release Tablets may cause severe seizures to occur. If you need to stop Depakote Delayed-Release Tablets, your doctor will gradually lower your dose.


• Taking Depakote Delayed-Release Tablets at the same time each day will help you remember to take it.


• Continue to take Depakote Delayed-Release Tablets even if you feel well. Do not miss any doses. Depakote Delayed-Release Tablets works best when there is a constant level of it in your body.


• If you miss a dose of Depakote Delayed-Release Tablets, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Depakote Delayed-Release Tablets.

Important safety information:

• Depakote Delayed-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Depakote Delayed-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


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


• Inflammation of the pancreas is a potentially life-threatening illness associated with Depakote Delayed-Release Tablets. Symptoms include stomach pain, vomiting, or loss of appetite. Contact your doctor at once if any of these symptoms occur.


• Patients who take Depakote Delayed-Release 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. Patients who have bipolar (manic-depressive) illness may also have an increased risk for suicidal thoughts or actions. Watch patients who take Depakote Delayed-Release Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, irritable behavior; 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.


• Depakote Delayed-Release Tablets may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Tell your doctor or dentist that you take Depakote Delayed-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Diabetes patients - Depakote Delayed-Release Tablets may cause the results of some tests for urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.


• Depakote Delayed-Release Tablets may increase the ammonia levels in your blood. Contact your doctor right away if you experience unexplained sluggishness and vomiting or mental changes.


• Depakote Delayed-Release Tablets may cause an unusual drop in body temperature (hypothermia). Symptoms may include confusion, lack of energy, loss of coordination, shivering, slow heartbeat, slow or shallow breathing, slurred speech, or unusual drowsiness. Contact your doctor right away if you have any of these symptoms.


• Depakote Delayed-Release Tablets may interfere with certain lab tests, including thyroid function. Be sure your doctor and lab personnel know you are taking Depakote Delayed-Release Tablets


• Lab tests, including complete blood cell counts, blood ammonia levels, and liver function, may be performed while you use Depakote Delayed-Release 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 Depakote Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness.


• Depakote Delayed-Release Tablets should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed. CHILDREN younger than 2 years old may be at increased risk of serious liver problems.


• PREGNANCY and BREAST-FEEDING: Depakote Delayed-Release Tablets has been shown to cause harm to the fetus. Use an effective form of birth control while you take Depakote Delayed-Release Tablets. If you think you may be pregnant or if you wish to become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Depakote Delayed-Release Tablets while you are pregnant. Depakote Delayed-Release Tablets are found in breast milk. Do not breast-feed while you are taking Depakote Delayed-Release Tablets.

Possible side effects of Depakote Delayed-Release 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:

Change in appetite; constipation; diarrhea; dizziness; drowsiness; hair loss; headache; indigestion; nausea; stomach cramps or pain; trouble sleeping; vomiting; weakness; weight changes.

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); abnormal thinking; change in menstrual period; changes in behavior; chest pain; confusion; dark, tarry, or bloody stools; dark urine; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fast or irregular heartbeat; hallucinations; hearing loss; involuntary movements of the arms and legs; involuntary movements or chewing movements of the face, jaw, mouth, or tongue; joint pain; lack of energy; loss of appetite; loss of coordination; loss of seizure control; memory loss; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness); nosebleed; pounding in the chest; red, swollen, blistered, or peeling skin; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; suicidal thoughts or actions; swelling of the arms or legs; symptoms of infection (eg, fever, chills, sore throat); tremor; unusual bleeding or bruising; unusual weakness; vision changes or blurred vision; 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: Depakote 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 deep sleep; drowsiness; irregular heartbeat; loss of consciousness.

Proper storage of Depakote Delayed-Release Tablets:

Store Depakote Delayed-Release Tablets 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 Depakote Delayed-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Depakote Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Depakote Delayed-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If using Depakote Delayed-Release Tablets for an extended period of time, obtain refills before your supply runs out.


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

This information is a summary only. It does not contain all information about Depakote Delayed-Release 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 Depakote resources

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

Compare Depakote with other medications

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