Maxair Autohaler

Generic Name: pirbuterol inhaler (peer BYOO ter ole)

Brand Names: Maxair, Maxair Autohaler

What is pirbuterol inhalation?

Pirbuterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Pirbuterol inhalation is used to treat conditions such as asthma, bronchitis, and emphysema.

Pirbuterol inhalation may also be used for conditions other than those listed in this medication guide.

What is the most important information I should know about pirbuterol inhalation?

It is very important that you use your pirbuterol inhaler properly, so that the medicine gets into your lungs. Your doctor may want you to use a spacer with your inhaler. Talk to your doctor about proper inhaler use.

Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

Who should not use pirbuterol inhalation?

Before using this medication, tell your doctor if you have

• 
  

  heart disease or high blood pressure,

  
  


• 
  

  epilepsy or another seizure disorder,

  
  


• 
  

  diabetes,

  
  


• 
  

  an overactive thyroid (hyperthyroidism), or

  
  


• 
  

  any type of liver or kidney disease.

  
  

You may require a lower dose or special monitoring during therapy with pirbuterol if you have any of the conditions listed above.

Pirbuterol is in the FDA pregnancy category C. This means that it is not known whether pirbuterol inhalation will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is not known whether pirbuterol passes into breast milk. Do not use pirbuterol inhalation without first talking to your doctor if you are breast-feeding a baby. Pirbuterol inhalation is not approved for use by children younger than 12 years of age.

How should I use pirbuterol inhalation?

Take pirbuterol inhalation exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse or doctor to explain them to you.

Shake the inhaler several times and uncap the mouthpiece. Breathe out fully and place your lips around the mouthpiece. Take a deep, slow breath as you push down on the canister. Hold your breath for several seconds, then exhale slowly.

The Autohaler releases the correct amount of drug. The force of your inhalation will trigger the release. You do not have to press down on a canister. Follow the instructions that accompany your inhaler.

If you take more than one dose at a time, wait for at least 1 full minute, then repeat the procedure.

Rinse your mouth after each use of the inhaler.

If you also use a steroid inhaler, use your pirbuterol inhaler first to open up your airways, then use the steroid inhaler as directed.

It is very important that you use your pirbuterol inhaler properly, so that the medicine gets into your lungs. Your doctor may want you to use a spacer with your inhaler. Talk to your doctor about proper inhaler use.

Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

Keep your inhaler clean and dry. Keep the mouthpiece capped to avoid getting dirt inside it. Clean your inhaler once a day by removing the canister and mouthpiece and immersing it in warm water or alcohol. Allow the parts to dry, then reassemble the inhaler.

Carry your inhaler with you at all times in case of emergencies. Get a refill before you run out of medicine and before going on vacation.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a pirbuterol overdose include angina or chest pain, irregular heartbeats or a fluttering heart, seizures, tremor, weakness, headache, nausea, and vomiting.

What should I avoid while using pirbuterol inhalation?

Avoid situations that may trigger an asthma attack such as exercising in cold, dry air; smoking; breathing in dust; and exposure to allergens such as pet fur.

Pirbuterol inhalation side effects

Stop using pirbuterol and seek emergency medical attention if you experience any of the following serious side effects:

• 
  

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

  
  


• 
  

  chest pain or irregular heartbeats.

  
  

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

• 
  

  headache, dizziness, lightheadedness, or insomnia;

  
  


• 
  

  tremor or nervousness;

  
  


• 
  

  sweating;

  
  


• 
  

  nausea, vomiting, or diarrhea; or

  
  


• 
  

  dry mouth.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pirbuterol?

Before using this medication, tell your doctor if you are taking any of the following medicines:

• a beta-blocker (used to treat high blood pressure and other heart conditions) such as atenolol (Tenormin), metoprolol (Lopressor), or propranolol (Inderal). These medicines may greatly decrease the effects of pirbuterol and lead to an asthma attack.


• other commonly used beta-blockers, including acebutolol (Sectral), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), labetalol (Normodyne, Trandate), nadolol (Corgard), and pindolol (Visken).


• a tricyclic antidepressant such as amitriptyline (Elavil), doxepin (Sinequan), or nortriptyline (Pamelor). Very high blood pressure and other effects harmful to the heart may occur if these medicines are taken with pirbuterol.


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


• a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate). Very high blood pressure and other effects harmful to the heart may also occur if these medicines are taken with pirbuterol.


• 
  

  another inhaled bronchodilator such as albuterol (Ventolin, Proventil), bitolterol (Tornalate), isoetharine (Bronkometer, Bronkosol), isoproterenol (Isuprel, Medihaler-Iso), metaproterenol (Alupent, Metaprel), salmeterol (Servent), or terbutaline (Brethaire, Brethine, Bricanyl). Using other inhaled medicines to open up your lungs will increase the risk of damage to your heart when you are taking pirbuterol.

  
  


• 
  

  caffeine, diet pills, or decongestants. These may also increase heart-related side effects.

  
  

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

More Maxair Autohaler resources

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

• Maxair Autohaler Prescribing Information (FDA)


• Maxair Autohaler Advanced Consumer (Micromedex) - Includes Dosage Information


• Maxair Autohaler MedFacts Consumer Leaflet (Wolters Kluwer)


• Maxair Prescribing Information (FDA)

Compare Maxair Autohaler with other medications

• Asthma, acute
• Asthma, Maintenance
• COPD, Acute
• COPD, Maintenance

Where can I get more information?

• Your pharmacist has additional information about pirbuterol written for health professionals that you may read.

See also: Maxair Autohaler side effects (in more detail)

Interferon Beta

Class: Biologic Response Modifiers
VA Class: IM900
Chemical Name: Interferon β1 (human fibroblast protein moiety)
Molecular Formula: C₉₀₈H₁₄₀₆N₂₄₆O₂₅₂S₇C₉₀₈H₁₄₀₆N₂₄₆O₂₅₂S₅
CAS Number: 145258-61-3
Brands: Avonex, Betaseron, Rebif

REMS:

FDA approved a REMS for interferon beta to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Biologic response modifier; biosynthetic (recombinant DNA origin) form of endogenous human interferon beta.^{1 4 8 9 19 20 21 26}

Uses for Interferon Beta

Multiple Sclerosis (MS)

Management of relapsing-remitting MS, relapsing forms of secondary progressive MS†, and of patients at high risk of developing clinically definite MS.^{1 19 20 21}

Not curative, but appears to reduce the frequency of attacks or relapses and produces a beneficial effect on several magnetic resonance imaging (MRI) measures of disease activity.^{6 7 21 26 27 28 30 32 53}

Efficacy in management of primary progressive MS† not demonstrated conclusively;^{13 18} such use not recommended.⁴²

Interferon Beta Dosage and Administration

General

• 
  

  Administer under the supervision of qualified clinicians.^{1 20}

  
  


• 
  

  Prior to initiating therapy, provide patient with the appropriate patient information (medication guide) provided by the manufacturer for interferon beta-1a (Avonex and Rebif) or interferon beta-1b (Betaseron).^{1 19 20}

  
  


• 
  

  If home use is prescribed, carefully instruct patients and/or their caregivers in appropriate use; provide a puncture-resistant container for proper, safe disposal of used syringes and needles.^{1 19 20}

  
  


• 
  

  Patients may feel worse or experience a temporary worsening of MS symptoms immediately following initiation of interferon beta therapy;⁴⁰ these effects often abate with continued therapy and should not be interpreted as an indication of treatment failure.⁴²

  
  


• 
  

  To minimize risk of flu-like syndrome, administer at bedtime⁴⁰ and/or give an NSAIA (e.g., ibuprofen) or acetaminophen to prevent or partially alleviate fever and headache.^{20 40 42}

  
  

Administration

Administer by IM or sub-Q injection.^{1 19 20}

Sub-Q administration associated with higher rates of injection site reactions than IM administration.^{1 19 20 29}

IM Administration, Interferon Beta-1a (Avonex)

Administer once weekly by IM injection.¹⁹

Administer IM into thigh or upper arm using a 23-gauge, 1¼-inch needle.¹⁹ Rotate injection sites; do not use sites that appear irritated prior to injection.¹⁹

Administer Avonex provided in prefilled syringes as supplied; no dilution or reconstitution is necessary.¹⁹ Warm prefilled syringes to room temperature by removing from refrigerator about 30 minutes prior to use; do not use external heat sources (e.g., hot water) to warm syringes.¹⁹

Reconstitution

Reconstitute vial containing 6.6 million units (33 mcg) of interferon beta-1a (Avonex) powder by adding 1.1 mL sterile water for injection to provide a solution containing 6 million units (30 mcg) of interferon beta-1a per mL.^{19 60 62} Use only the diluent supplied by manufacturer.¹⁹

Swirl vial gently to ensure complete dissolution; do not shake.¹⁹

Reconstituted solutions contain no preservatives; solutions preferably should be prepared immediately before use.¹⁹ Vials are for single use only; discard any residual solution.¹⁹

Sub-Q Administration, Interferon Beta-1a (Rebif)

Administer 3 times weekly by sub-Q injection, on the same 3 days (e.g., Monday, Wednesday, and Friday) at least 48 hours apart each week and at the same time (preferably in the late afternoon or evening) each day.²⁰

Administer sub-Q into the abdomen (except waistline),⁶¹ thigh, arm, or buttocks.¹

To minimize risk of serious injection site reactions (e.g., necrosis), rotate injection sites and avoid sites that appear irritated, reddened, bruised, infected, or abnormal in any way.^{1 20 40}

To reduce incidence of injection site pain, warm Rebif prefilled syringes to room temperature by removing from refrigerator 30 minutes prior to use.⁶⁰

Administer Rebif as supplied; no dilution or reconstitution is necessary.²⁰

Rebif solutions contain no preservatives; discard any residual solution remaining in the syringe after single use.²⁰

Sub-Q Administration, Interferon Beta-1b (Betaseron)

Administer by sub-Q injection every other day.¹

Administer sub-Q into the abdomen (except waistline),⁶¹ thigh, arm, or buttocks.¹

To minimize risk of serious injection site reactions (e.g., necrosis), rotate injection sites and avoid sites that appear irritated, reddened, bruised, infected, or abnormal in any way.^{1 20 40}

Reconstitution

Reconstitute vial containing 9.6 million units (0.3 mg) of interferon-beta-1b (Betaseron) powder by attaching prefilled syringe containing 1.2 mL of 0.54% sodium chloride to the vial and slowly injecting entire contents of syringe to provide a solution containing 8 million units (0.25 mg) of interferon beta-1b per mL.¹ Use only the diluent supplied by manufacturer.¹

Swirl vial gently to ensure complete dissolution; do not shake.¹

Reconstituted solutions contain no preservatives; solutions preferably should be prepared immediately before use.¹ Vials are for single use only; discard any residual solution.¹

Dosage

Available as interferon beta-1a or interferon beta-1b; dosage and potency expressed in terms of international units (IU, units) or mg.¹

Each mg of interferon beta-1a is approximately equivalent to 200 million units (for Avonex) and 270 million units (for Rebif);^{19 20} each mg of interferon beta-1b is approximately equivalent to 32 million units (for Betaseron).¹

Adults

Relapsing-remitting MS

Interferon beta-1a (Avonex)

IM

6 million units (30 mcg) once weekly.¹⁹ Safety and efficacy of Avonex given for >3 years not established.¹⁹

Interferon beta-1a (Rebif)

Sub-Q

Gradually titrate dosage over a 4-week period to 6 million units (22 mcg) or 12 million units (44 mcg) 3 times weekly using the schedule in Table 1.²⁰

Table 1. Rebif Dosage Titration Schedule20

Week	Recommended Titration (% of Final Target)	Rebif 22 mcg Target Dose	Rebif 44 mcg Target Dose
Weeks 1–2	20%	1.2 million units (4.4 mcg)	2.4 million units (8.8 mcg)
Weeks 3–4	50%	3 million units (11 mcg)	6 million units (22 mcg)
Weeks 5+	100%	6 million units (22 mcg)	12 million units (44 mcg)

Interferon beta-1b (Betaseron)

Sub-Q

Gradually titrate dosage over a 6-week period to 8 million units (0.25 mg) every other day using the schedule in Table 2.^{1 61}

Table 2. Betaseron Dosage Titration Schedule161

Week	Betaseron Dose
Weeks 1–2	2 million units (0.0625 mg)
Weeks 3–4	4 million units (0.125 mg)
Weeks 5–6	6 million units (0.1875 mg)
Weeks 7+	8 million units (0.25 mg)

Safety and efficacy of interferon beta-1b (Betaseron) given for >3 years not established.^{1 61}

Prescribing Limits

Adults

IM

Safety of interferon beta-1a (Avonex) dosages >12 million units (60 mcg) once weekly not established.¹⁹

Special Populations

Hepatic Impairment

Consider decreasing dosages if serum ALT concentrations >5 times ULN.²⁰

Discontinue therapy if hepatic transaminase (AST, ALT) concentrations >10 times ULN (with or without jaundice or other clinical symptoms of liver dysfunction) or if the serum bilirubin >5 times ULN.^{1 20}

When concentrations return to normal, interferon beta therapy may be restarted at a 50% dose reduction, if clinically appropriate.¹

Geriatric Patients

Titrate dosage, usually initiating therapy at the low end of the dosage range due to possible age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.²⁰

Cautions for Interferon Beta

Contraindications

• 
  

  Known hypersensitivity to natural or recombinant interferon beta or any other component of the formulations.^{1 19 20}

  
  


• 
  

  Administration of preparations containing albumin human in patients with known hypersensitivity to albumin.^{1 19 20} (See Albumin Sensitivity under Cautions.)

  
  

Warnings/Precautions

Warnings

Depression and Suicide

Possible depression, suicidal ideation, and suicide; use with caution in patients with depression or other mood disorders, conditions that are common in individuals with MS.^{1 19 20}

If depression or other severe psychiatric symptoms occur during therapy, monitor closely and consider discontinuing therapy.^{1 19 20}

Hepatotoxicity

Serious hepatic injury including autoimmune hepatitis and possibly severe, fulminant hepatic failure requiring liver transplantation reported.^{19 20 60 62 64 65 66 67 68}

Use with caution in patients with active liver disease, alcohol abuse, increased serum ALT concentrations (>2.5 times ULN), or history of clinically important liver disease.^{19 20 65}

Use with caution in patients receiving concomitant therapy with other drugs associated with hepatic injury; use caution when other drugs are added to an existing interferon beta treatment regimen.^{19 20 65} (See Specific Drugs under Interactions.)

Perform liver function tests prior to initiation of therapy and at regular¹⁹ intervals (e.g., 1, 3, 6 months) and then periodically thereafter in the absence of clinical symptoms.^{1 19 20}

Possible asymptomatic elevation of hepatic transaminases.^{19 20 65}

Injection Site Necrosis

Potentially severe injection site necrosis possible following sub-Q administration, sometimes requiring dermal debridement or skin grafting.^{1 20} Has not been reported to date following IM administration.^{60 62}

If injection site necrosis occurs, reevaluate patient’s understanding and use of aseptic technique and proper procedures for self-administration.^{1 40} Whether to discontinue therapy following a single site of necrosis depends on the extent of necrosis.¹

Sensitivity Reactions

Hypersensitivity Reactions

Possible anaphylaxis or anaphylactoid reactions.^{1 19 20}

If acute, serious hypersensitivity reactions occur, discontinue immediately and initiate appropriate therapy.^{1 19 20}

Albumin Sensitivity

Some formulations (e.g., Avonex powder for injection, Betaseron, Rebif) contain albumin human; contraindicated in sensitive patients.^{1 19 20}

Antibody Formation

Possible development of binding or neutralizing antibodies to interferon beta following long-term therapy.^{21 54 55}

General Precautions

Cardiovascular Effects

Possible cardiomyopathy with or without CHF^{1 19} ; use with caution in patients with cardiac disease or history of any cardiac condition.¹⁹

Closely monitor patients with history of cardiac disease (e.g., angina, arrhythmia, CHF) for worsening of their clinical condition during initiation and continued treatment with interferon beta.¹⁹

Seizures

Possible seizures; use with caution in patients with preexisting seizure disorders.^{19 20}

If patients with no prior history of seizures develop seizures during therapy, establish an etiologic basis and institute appropriate anticonvulsant therapy prior to considering resumption of therapy.^{60 62}

Hematologic Effects

Decreased peripheral blood cell counts in all cell lines, including rare pancytopenia and thrombocytopenia, reported.¹⁹

Use with caution in patients with myelosuppression and in those receiving drugs that may be myelosuppressive.^{60 62} (See Specific Drugs under Interactions.)

Perform CBCs, platelet counts, and appropriate blood chemistry tests prior to initiation of therapy and periodically thereafter.^{1 19 20}

Other Autoimmune Disorders

Possible development of idiopathic thrombocytopenia, hyperthyroidism, hypothyroidism, or autoimmune hepatitis; monitor patients for manifestations and perform appropriate tests when necessary.¹⁹

Infectious Complications

Some formulations (e.g., Avonex powder for injection, Betaseron, Rebif) contain albumin human; theoretical risk for transmission of human viruses and Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD).^{1 19 20}

Specific Populations

Pregnancy

Category C.^{1 19 20}

Pregnancy registry for Rebif at 877-447-3243 or ²⁰ and for Avonex at 800-456-2255.^{19 65}

Lactation

Not known whether interferon beta is distributed into milk; discontinue nursing or the drug.^{1 19 20}

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 19 20}

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.^{1 20} (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution.^{19 20} Adjust dosage in patients with hepatic impairment.^{19 20} (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Flu-like symptoms, local effects at the injection site.^{1 19 20 40}

Interactions for Interferon Beta

No formal drug interaction studies to date.^{1 19 20}

Because of the potential for hepatic injury associated with interferon beta-1a and beta-1b, use caution when another agent is added to an existing interferon beta regimen.^{19 20 65} (See Hepatotoxicity under Cautions.)

Has been used concomitantly with corticosteroids, corticotropin (ACTH), antidepressants, and/or oral contraceptives in clinical studies^{1 19} without unusual adverse effects.¹⁹

Specific Drugs

Drug	Interaction	Comments
Hepatotoxic agents (e.g., alcohol)	Potential for increased risk of hepatotoxicity19 65	Use concomitantly with caution and monitor for hepatotoxicity19 20 65
Myelosuppressive agents	Possible additive myelosuppressive effects1 19 20	Use concomitantly with caution1 19 20 and monitor closely20
Vaccines	Overall effectiveness of vaccination in patients receiving interferon beta has not been determined20 Interferon beta-1a (Rebif) does not appear to interfere with the antibody response to influenza virus vaccine inactivated20	Manufacturer of Rebif states vaccinations may be given to patients receiving interferon beta-1a20

Interferon Beta Pharmacokinetics

Absorption

Bioavailability

Bioavailability of interferon beta-1b (Betaseron) following sub-Q administration is approximately 50%.¹

Elimination

Half-life

Elimination half-life of interferon beta-1a (Avonex) following a single IM dose is 10 hours.¹⁹

Plasma half-life of interferon beta-1a (Rebif) following a single sub-Q dose is approximately 69 hours.²⁰

Stability

Storage

Parenteral

Injection

Interferon beta-1a (Avonex) prefilled syringes: 2–8°C.¹⁹ After removing from refrigerator, warm to room temperature (about 30 minutes) and use within 12 hours.¹⁹ Protect from heat and light; do not freeze.¹⁹

Interferon beta-1a (Rebif) prefilled syringes: 2–8°C (may be stored at up to 25°C for up to 30 days).²⁰ Protect from heat and light; do not freeze.²⁰

Powder for Injection

Interferon beta-1a (Avonex) lyophilized powder: 2–8°C (may be stored at 25°C for up to 30 days).¹⁹ Following reconstitution, store for up to 6 hours at 2–8°C.¹⁹ Protect from heat and light; do not freeze.¹⁹

Interferon beta-1b (Betaseron) lyophilized powder: 25°C (may be exposed to 15–30°C).¹ Following reconstitution, store at 2–8°C and use within 3 hours.¹ Do not freeze.¹

Actions

• 
  

  Has complex antiviral, antineoplastic, and immunomodulating activities.^{1 2 3 4 5 19 26}

  
  


• 
  

  Mechanisms of action in the treatment of MS have not been fully elucidated,^{1 19 20 26} but may involve immunomodulating effects, including anti-inflammatory effects.^{4 8 9 37}

  
  

Advice to Patients

• 
  

  Provide patient a copy of the medication guide and advise patient of the importance of reading this information each time a new or refill prescription is dispensed.^{1 19 20}

  
  


• 
  

  Importance of taking interferon beta exactly as prescribed.^{1 19 20 60} Advise patients not to change interferon beta preparations during a single regimen of therapy without consulting their clinician.^{1 19 20 60 62}

  
  


• 
  

  Risk of developing depression and suicidal ideation.^{1 19 20 60} Importance of notifying clinician immediately if symptoms of depression occur.^{1 19 20 60}

  
  


• 
  

  Potential for temporary worsening of symptoms immediately following initiation of therapy;⁴⁰ advise patients that these symptoms often abate with continued therapy and should not be interpreted as an indication of treatment failure.⁴²

  
  


• 
  

  If patient or caregiver is to administer interferon beta, provide careful instructions on proper administration methods (including aseptic technique) and proper disposal of used needles and syringes.^{1 19 20}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.^{1 19 20}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{1 19 20}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{1 19 20} (See Cautions.)

  
  

Preparations

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

Interferon Beta-1a

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IM use	6.6 million units (33 mcg)	Avonex (with albumin human and with sterile water diluent; preservative-free)	Biogen Idec
	Injection, for IM use	6 million units (30 mcg) per 0.5 mL	Avonex (prefilled syringes with needles)	Biogen Idec
	Injection, for subcutaneous use	2.4 million units (8.8 mcg) per 0.2 mL	Rebif (with albumin human, preservative-free; available as prefilled syringes)	Serono (also promoted by Pfizer)
		6 million units (22 mcg) per 0.5 mL	Rebif (with albumin human, preservative-free; available as prefilled syringes)	Serono (also promoted by Pfizer)
		12 million units (44 mcg) per 0.5 mL	Rebif (with albumin human, preservative-free; available as prefilled syringes)	Serono (also promoted by Pfizer)

Interferon Beta-1b

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for subcutaneous use	9.6 million units (0.3 mg)	Betaseron (with prefilled syringe containing 0.54% sodium chloride diluent, 27-gauge needle, vial adapter, and alcohol swabs)	Berlex

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Avonex 30MCG/VIAL Kit (BIOGEN IDEC): 4/$3,287.12 or 12/$9,704.83

Avonex Prefilled 30MCG/0.5ML Kit (BIOGEN IDEC): 4/$3,028.99 or 12/$9,003.97

Betaseron 0.3MG Solution (BAYER HEALTHCARE PHARMA): 14/$2,989.83 or 28/$5,970.03

Extavia 0.3MG Solution (NOVARTIS): 1/$229.98 or 3/$659.94

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 October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Berlex Laboratories. Betaseron (interferon beta-1b) prescribing information. Richmond, CA; 2003 Oct.

2. Janeway CA, Travers P, Walport M et al eds. Immunology. 5th ed. New York, NY: Garland Publishing; 2001. From the National Library of Medicine website.

3. Pestka S, Langer JA, Zoon KC. Interferons and their actions. Annu Rev Biochem. 1987; 56: 727-77. [PubMed 2441659]

4. Panitch HS. Interferons in multiple sclerosis: a review of the evidence. Drugs. 1992; 44: 946-62. [PubMed 1282865]

5. Hardman JG ed. Goodman and Gilman’s the pharmacological basis of therapeutics. 10th ed. New York, NY: McGraw-Hill; 2001:1332-5.

6. The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology. 1993; 43:655-61. [IDIS 313026] [PubMed 8469318]

7. Paty DW, Li DKB. Interferon beta-1b is effective in relapsing remitting multiple sclerosis. II. MRI analysis of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology. 1993; 43: 627-7.

8. Absher JR. Interferon-1b to reduce exacerbations in multiple sclerosis. ACP J Club. 1993; Sep-Oct:33.

9. Arnason BGW. Interferon beta in multiple sclerosis. Neurology. 1993; 43:641-3. [IDIS 313025] [PubMed 8469315]

10. Reder AT. Interferon-beta treatment does not elevate cortisol in multiple sclerosis. J Interferon Res. 1992; 12:195-8. [PubMed 1640121]

11. Lublin FD, Reingold SC for the National Multiple Sclerosis Society (USA) advisory committee on clinical trials of new agents in multiple sclerosis. Defining the clinical course of multiple sclerosis: results of an international survey. Neurology. 1996; 46:907-11. [PubMed 8780061]

12. Herndon RM. Medical hypothesis: why secondary progressive multiple sclerosis is a relentlessly progressive illness. Arch Neurol. 2002; 59:301-4. [PubMed 11843703]

13. Montalban X, Rio J. Primary progressive multiple sclerosis. Neurol Sci. 2001; 22:S41-8. [PubMed 11794476]

14. Bradley JD, Scott CB, Paris KJ et al. A phase III comparison of radiation therapy with or without recombinant β-interferon for poor-risk patients with locally advanced non-small-cell lung cancer. Int J Radiation Oncol.. 2002; 52:1173-9.

15. Repetto L, Giannessi PG, Campora E et al. Tamoxifen and interferon-beta for the treatment of metastatic breast cancer. Breast Cancer Res Treat. 1996; 39:235-8. Abstract. [PubMed 8872332]

16. Kieburtz K, McDermott M. Needed in MS: evidence not EVIDENCE. Neurology. 2002; 59:1482-3. [IDIS 492413] [PubMed 12451186]

17. Compston A, Coles A. Multiple sclerosis. Lancet. 2002; 359:1221-31. [IDIS 478854] [PubMed 11955556]

18. Leary SM, Miller DH, Stevenson VL et al. Interferon β-1a in primary progressive MS: an exploratory, randomized, controlled trial. Neurology. 2003;60:44-51.

19. Biogen Idec, Inc. Avonex (interferon beta-1a) prescribing information. Cambridge, MA; 2005 Mar.

20. Serono, Inc. Rebif (interferon beta-1b) sterile prescribing information. Randolph, MA; 2005 Sept.

21. Goodin DS, Frohman EM, Garmany GP Jr et al. Disease modifying therapies in multiple sclerosis: report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology and the MS council for clinical practice guidelines. Neurology. 2002; 58: 169-178. From the Neurology website. [IDIS 475332] [PubMed 11805241]

22. Mikaeloff Y, Moreau T, Debouverie M et al. Interferon-β treatment in patients with childhood-onset multiple sclerosis. J Pediatr. 2001; 139:443-6. [IDIS 470673] [PubMed 11562627]

23. Rask C, Unger E, Walton M. BLA STN 103780/0: comparative study of Rebif to Avonex and orphan exclusivity. From the FDA website.

24. Haffner ME. Office of orphan products development (OOPD) analysis of exclusivity issues raised in the Serono BLA for Rebif. From the FDA website.

25. Anon. Serono Rebif approval is first orphan drug challenge based on efficacy. FDC Rep. Mar 11, 2002:19.

26. Goodin DS. Interferon-β therapy in multiple sclerosis: evidence for a clinically relevant dose response. Drugs. 2001; 61:1693-1703. [PubMed 11693459]

27. Rudick RA, Goodkin DE, Jacobs LD et al for the Multiple Sclerosis Collaborative Research Group. Impact of interferon beta-1a on neurologic disability in relapsing multiple sclerosis. Neurology. 1997; 49:358-363. (IDIS 390049) [IDIS 390049] [PubMed 9270562]

28. Simon JH, Jacobs LD, Campion M et al. Magnetic resonance studies of intramuscular interferon β-1a for relapsing multiple sclerosis. Ann Neurol. 1996; 43:79-87. (IDIS 399819)

29. Panitch H, Goodin DS, Francis G et al. Randomized, comparative study of interferon β-1a treatment regimens in MS: the EVIDENCE trial. Neurology. 2002; 59:1496-1506. [IDIS 492414] [PubMed 12451188]

30. PRISMS (Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis) study group. Randomised double-blind placebo-controlled study of interferon β-1a in relapsing/remitting multiple sclerosis. Lancet. 1998; 352:1498-504.

31. PRISMS (Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis) study group. PRISMS-4: Long-term efficacy of interferon β-1a in relapsing MS. Neurology. 2001; 56:1628-36. (IDIS 466251)

32. Li DK Paty DW et al. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon β1a in relapsing-remitting multiple sclerosis. Ann Neurol. 1999; 46:197-206. (IDIS 433793) [IDIS 433793] [PubMed 10443885]

33. The Once Weekly Interferon for MS (OWIMS) study group. Evidence of interferon β-1a dose response in relapsing-remitting MS: the OWIMS study. Neurology. 1999; 53:679-86. [PubMed 10489026]

34. Durelli L, Verdun E, Barbero P et al. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet. 2002; 359:1453-60. [IDIS 481179] [PubMed 11988242]

35. Beghi E, Chio A, Inghilleri M et al for the Italian Amyotrophic Lateral Sclerosis Study Group. A randomized controlled trial of recombinant interferon beta-1a in ALS. Neurology. 2000; 54:469-74. (IDIS 442652) [IDIS 442652] [PubMed 10668716]

36. McDonald WI, Compston A, Edan G et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol. 2001; 50:121-7. [PubMed 11456302]

37. Food and Drug Administration (FDA). Summary basis of approval for interferon beta-1a (Avonex). From the FDA website.

38. Jacobs LD, Beck RW, Simon JH et al., and the CHAMPS Study Group. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. N Engl J Med. 2000; 343:898-904. [IDIS 453132] [PubMed 11006365]

39. Comi G, Filippi M, Barkhof F et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet. 2001; 357:1576-82. [IDIS 465183] [PubMed 11377645]

40. Bayas A, Rieckmann P. Managing the adverse effects of interferon-beta therapy in multiple sclerosis. Drug Saf. 2000; 22:149-59. [PubMed 10672896]

41. Neilley LK, Goodin DS, Goodkin DE et al. Side effect profile of interferon beta-1b in MS: results of an open label trial. Neurology. 1996; 46:552-4. (IDIS 362933). [IDIS 362933] [PubMed 8614531]

42. Lublin FD, Whitaker JN, Eidelman BH et al. Management of patients receiving interferon beta-1b for multiple sclerosis: report of a consensus conference. Neurology. 1996; 46:12-8. (IDIS 362121) [IDIS 362121] [PubMed 8559358]

43. Rice GP, Ebers GC, Lublin FD et al. Ibuprofen treatment versus gradual introduction of interferon β-1b in patients with MS. Neurology. 1999; 52:1893-5. (IDIS 430279). [IDIS 430279] [PubMed 10371541]

44. Brex PA, Ciccarelli O, O’Riodan JI et al. A longitudinal study of abnormalities on MRI and disability from multiple sclerosis. N Engl J Med. 2002; 346:158-64. [PubMed 11796849]

45. Coyle PK, Hartung HP. Use of interferon beta in multiple sclerosis: rationale for early treatment and evidence for dose- and frequency-dependent effects on clinical response. Mult Scler. 2002; 8:2-9. [PubMed 11936484]

46. Stürzebechler S, Maibauer R, Heuner A et al. Pharmacodynamic comparison of single doses of IFN-β1b in healthy individuals. J Interferon Cytokine Res. 1999; 19:1257-64.

47. Deisenhammer F, Mayringer I, Harvey J et al. A comparative study of the relative bioavailability of different interferon beta preparations. Neurology. 2000; 54:2055-60. (IDIS 447724) [IDIS 447724] [PubMed 10851362]

48. European Study Group on interferon beta-1b in secondary progressive MS. Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. Lancet. 1998; 352:1491-7. [PubMed 9820296]

49. Molyneux PD, Barker GJ, Barkhof F et al. Clinical-MRI correlations in a European trial of interferon beta-1b in secondary progressive MS. Neurology. 2001; 57:2191-7. [IDIS 474631] [PubMed 11756596]

50. Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-beta-1a in MS (SPECTRIMS) Study Group. Randomized controlled trial of interferon- beta-1a in secondary progressive MS: clinical results. Neurology. 2001; 56:1496-504. (IDIS 464823) [IDIS 464823] [PubMed 11402106]

51. Li DK, Zhao GJ, Paty DW et al. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: MRI results. Neurology. 2001; 56:1505-13. (IDIS 464824) [IDIS 464824] [PubMed 11402107]

52. Bramanti P, Sessa E, Rifici C et al. Enhanced spasticity in primary progressive MS patients treated with interferon beta-1b. Neurology. 1998; 51:1720-3. (IDIS 420036) [IDIS 420036] [PubMed 9855531]

53. Anon. Beta interferons for multiple sclerosis. Med Lett Drugs Ther. 2002; 44: 88-9.

54. Khan OA, Dhib-Jalbut SS. Neutralizing antibodies to interferon beta-1a and interferon beta-1b in MS patients are cross-reactive. Neurology. 1998; 51:1698-1702. (IDIS 420034) [IDIS 420034] [PubMed 9855525]

55. Ross C, Clemmesen KM, Svenson M et al for the Danish multiple sclerosis study group. Immunogenicity of interferon-beta in multiple sclerosis patients: influence of preparation, dosage, dose frequency, and route of administration. Ann Neurol. 2000; 48:706-12. (IDIS 457072) [IDIS 457072] [PubMed 11079533]

56. The IFNB Multiple Sclerosis Study Group and the University of British Columbia MS/MRI Analysis Group. Neutralizing antibodies during treatment of multiple sclerosis with interferon beta-1b: experience during the first three years. Neurology. 1996; 47:889-94. (IDIS 374809) [IDIS 374809] [PubMed 8857714]

57. Rudick RA, Simonian NA, Alam JA et al. Incidence and significance of neutralizing antibodies to interferon beta-1a in multiple sclerosis. Neurology. 1998; 50:1266-72. (IDIS 405926) [IDIS 405926] [PubMed 9595973]

58. Cook SD, Quinless JR, Jotkowitz A et al. Serum IFN neutralizing antibodies and neopterin levels in a cross-section of MS patients. Neurology. 2001; 57:1080-4. [IDIS 470761] [PubMed 11571337]

59. Deisenhammer F, Reindl M, Harvey J et al. Bioavailability of interferon beta-1b in MS with and without neutralizing antibodies. Neurology. 1999; 52:1239-43. (IDIS 427156) [IDIS 427156] [PubMed 10214750]

60. Reviewer’s comment (personal observation).

61. Berlex Laboratories, Richmond, CA: Personal communication.

62. Biogen, Inc., Cambridge, MA: Personal communication.

63. Joint Commission on Accreditation of Healthcare Organizations. 2004 National patient safety goals—FAQs. From JCAHO website. Accessed 2003 Nov.

64. Food and Drug Administration. Avonex(interferon beta-1a) [March 15, 2005: Biogen Idec]. MedWatch drug labeling changes. Rockville, MD; March 2005. From FDA website. Accessed on Dec 30, 2005.

65. Soo W. Dear healthcare professional letter: Important drug warning regarding hepatic injury associated with Avonex (interferon beta-1a). Cambridge, MA: Biogen Idec; (2005 Mar).

66. Food and Drug Administration. Betaseron (interferon beta-1b) [April 15, 2005: Berlex]. MedWatch reminder regarding hepatic toxicity. Rockville, MD; April 2005. From FDA website. Accessed on Dec 30, 2005.

67. Rabinowicz AL. Dear healthcare professional letter: Important drug warning regarding hepatotoxicity associated with Betaseron (interferon beta-1b). Montville, NJ: Berlex; (2005 Apr 15).

68. Food and Drug Administration. Rebif (interferon beta-1a) [Dec 2004: Serono]. MedWatch drug labeling changes regarding hepatic injury. Rockville, MD; Dec 2005. From FDA website. Accessed on Dec 30, 2005.

Fareston

Generic Name: toremifene (tor EH mih feen)

Brand Names: Fareston

What is Fareston (toremifene)?

Toremifene blocks estrogen from reaching cancer cells. Certain types of breast cancer require estrogen to grow.

Toremifene is used to slow the growth of metastatic breast cancer (cancer that has spread from the original tumor). Unlike chemotherapy, toremifene does not actually destroy cancer cells.

Toremifene may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Fareston (toremifene)?

Do not use toremifene if you are pregnant. It could harm the unborn baby. You should not use toremifene if you are allergic to it, or if you have a history of Long QT syndrome, or an uncontrolled electrolyte imbalance (low levels of potassium or magnesium in your blood).

Before you take toremifene, tell your doctor if you have endometrial hyperplasia (overgrowth of cells lining the uterus), bone cancer, or if you have ever had a blood clot.

Taking toremifene may increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Talk to your doctor about your individual risk. Stop using toremifene and call your doctor at once if you have symptoms of a serious heart rhythm disorder (severe dizziness, fainting, fast or pounding heartbeats) or signs of high levels of calcium in your blood (nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless).

What should I discuss with my healthcare provider before taking Fareston (toremifene)?

You should not use toremifene if you are allergic to it, or if you have:

• 
  

  a history of Long QT syndrome; or

  
  


• 
  

  an uncontrolled electrolyte imbalance (low levels of potassium or magnesium in your blood).

  
  

To make sure you can safely take toremifene, tell your doctor if you have any of these other conditions:

• 
  

  endometrial hyperplasia (overgrowth of cells lining the uterus);

  
  


• 
  

  bone cancer; or

  
  


• 
  

  if you have ever had a blood clot.

  
  

FDA pregnancy category D. Do not use toremifene if you are pregnant. It could harm the unborn baby. Use effective birth control if you are not past menopause, and tell your doctor if you become pregnant during treatment. It is not known whether toremifene passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using toremifene. Taking toremifene may increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Talk to your doctor about your individual risk.

How should I take Fareston (toremifene)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Toremifene is usually taken once a day. Follow your doctor's instructions.

You may take toremifene with or without food. Take the medicine at the same time each day.

To be sure this medicine is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly. Store at room temperature away from moisture, heat, and light.

See also: Fareston dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Fareston (toremifene)?

Grapefruit and grapefruit juice may interact with toremifene and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Fareston (toremifene) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using toremifene and call your doctor at once if you have a serious side effect such as:

• 
  

  severe dizziness, fainting, fast or pounding heartbeats, seizure (convulsions);

  
  


• 
  

  nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless;

  
  


• 
  

  easy bruising, unusual bleeding, purple or red pinpoint spots under your skin;

  
  


• 
  

  vaginal bleeding or discharge;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

  blurred vision, eye pain, or seeing halos around lights;

  
  


• 
  

  jaundice (yellowing of the skin or eyes);

  
  


• 
  

  tremor; or

  
  


• 
  

  loss of movement in any part of your body.

  
  

Less serious side effects may include:

• 
  

  sweating, hot flashes;

  
  


• 
  

  mild nausea, constipation;

  
  


• 
  

  dizziness, spinning sensation;

  
  


• 
  

  depressed mood;

  
  


• 
  

  swelling in your hands or feet;

  
  


• 
  

  itching, skin discoloration; or

  
  


• 
  

  hair loss.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Fareston (toremifene)?

Tell your doctor about all other medicines you use, especially:

• 
  

  arsenic trioxide (Trisenox);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  tacrolimus (Prograf);

  
  


• 
  

  vitamin or mineral supplements that contain calcium or vitamin D;

  
  


• 
  

  warfarin (Coumadin, Jantoven);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), ofloxacin (Floxin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), telithromycin (Ketek), and others;

  
  


• 
  

  an antidepressant such as amitriptylline (Elavil, Vanatrip, Limbitrol), venlafaxine (Effexor), nefazodone, and others;

  
  


• 
  

  antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), voriconazole (Vfend), and others;

  
  


• 
  

  seizure medicine such as carbamazepine (Carbatrol, Tegretol), clonazepam (Klonopin), phenobarbital (Solfoton), or phenytoin (Dilantin);

  
  


• 
  

  a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor HCT, Vasoretic, Zestoretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others;

  
  


• 
  

  heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), verapamil (Calan, Covera, Isoptin, Verelan), and others;

  
  


• 
  

  heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), quinidine (Quin-G), sotalol (Betapace), and others;

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), ritonavir (Norvir, Kaletra), and others;

  
  


• 
  

  medicine to prevent or treat nausea and vomiting such as granisetron (Kytril) or ondansetron (Zofran);

  
  


• 
  

  medicines to treat psychiatric disorders, such as haloperidol (Haldol), thioridazine (Mellaril), and others;

  
  


• 
  

  migraine headache medicine such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig); or

  
  


• 
  

  narcotic medication such as methadone (Methadose, Diskets, Dolophine).

  
  

This list is not complete and there are many other drugs that can interact with toremifene. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Fareston resources

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

• Fareston Prescribing Information (FDA)


• Fareston Monograph (AHFS DI)


• Fareston Advanced Consumer (Micromedex) - Includes Dosage Information


• Fareston MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Fareston with other medications

• Breast Cancer
• Breast Cancer, Metastatic

Where can I get more information?

• Your pharmacist can provide more information about toremifene.

See also: Fareston side effects (in more detail)

Rh-Isoimmunization Medications

Drugs associated with Rh-Isoimmunization

The following drugs and medications are in some way related to, or used in the treatment of Rh-Isoimmunization. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Bayrho-D

Hyperrho-S-D-Full-Dose

Hyperrho-S-D-Mini-Dose

Micrhogam

Micrhogam-Ultra-Filtered-Plus

Rhogam

Rhogam-Ultra-Filtered-Plus

Rhophylac

Winrho-Sdf

Triple X Pediculicide

Generic Name: piperonyl butoxide and pyrethrins topical (pi PER o nil bue TOX ide and pye RETH rins)

Brand Names: A-200 Lice Control, A-200 Lice Treatment, Good Sense Lice Killing Shampoo, Step 1, Lice Treatment Maximum Strength, Pronto Lice Kill System, Pronto Shampoo & Cream Rinse, Pronto Shampoo Kit, Pronto Spray, Pronto with Metal Comb, R & C Lice Treatment Kit, Rid Pediculicide, Tegrin-LT Lice Spray, Tegrin-LT Lice Treatment Kit, Tegrin-LT Shampoo, Triple X Pediculicide

What is Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

Piperonyl butoxide and pyrethrins are insecticide chemicals.

Piperonyl butoxide and pyrethrins topical (for the skin) is used to treat lice.

Piperonyl butoxide and pyrethrins topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

You should not use this medication if you are allergic to piperonyl butoxide and pyrethrins, or if you have an allergy to chrysanthemums or ragweed.

Check all household members for signs of lice. Lice can be spread from person to person by sharing a hairbrush, a comb, hats, or headbands. It can also be spread through head-to-head contact.

Use this medication for the full prescribed length of time. Your symptoms may improve before the lice infestation is completely cleared. Call your doctor if your condition does not improve, or if your symptoms get worse while using this medication.

Stop using piperonyl butoxide and pyrethrins and call your doctor at once if you have severe stinging, burning, itching, swelling, or irritation where the medication is applied.

To prevent reinfection with lice, wash all clothing, hats, bed linens, stuffed toys, hair brushes, and combs in hot water with a strong cleanser to remove any mites or eggs. You may need to use a special lice control spray to treat furniture, mattresses, sports helmets, headphones, and other non-washable items. Ask your doctor of pharmacist about disinfecting your home.

What should I discuss with my healthcare provider before using Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

You should not use this medication if you are allergic to piperonyl butoxide and pyrethrins topical, or if you have an allergy to chrysanthemums or ragweed. It is not known whether piperonyl butoxide and pyrethrins topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Piperonyl butoxide and pyrethrins can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Check for signs of lice on all household members. They may also need to be treated for lice. Lice can be spread from person to person by sharing a hairbrush, a comb, hats, or headbands. It can also be spread through head-to-head contact.

Apply the shampoo form of this medication to dry hair. Wetting the hair first may make the medication less effective. Apply the shampoo to all areas of the scalp, including behind the ears and neck. Treat hair from the roots to the ends and leave the shampoo in the hair for 10 minutes. Add warm water to form a lather and shampoo. Then rinse thoroughly with warm water. Piperonyl butoxide and pyrethrins shampoo is usually used once every 7 to 10 days.

You may need to use a larger amount of the shampoo if you have long hair. Follow the directions on the product label.

Keep your eyes tightly closed while using the shampoo, foam, or spray, and while rinsing it out of your hair. You may use a washcloth or towel to protect your eyes while applying the medication to your head.

Do not apply this medication to your eyebrows or eyelashes. Call your doctor if these areas become infected with lice.

Avoid inhaling the vapors from this medication. Use in a well-ventilated area.

You will need to remove any eggs (nits) from the hair shafts with a special comb. Some piperonyl butoxide and pyrethrins products come provided with a nit comb. If you do not have such a comb, ask your pharmacist where you can get one. Nits may not be removed effectively with a regular fine-tooth comb.

Use this medication for the full prescribed length of time. Your symptoms may improve before the lice infestation is completely cleared. Call your doctor if your condition does not improve, or if your symptoms get worse while using this medication.

To prevent reinfection with lice, wash all clothing, hats, bed linens, stuffed toys, hair brushes, and combs in hot water with a strong cleanser to remove any mites or eggs. You may need to use a special lice control spray to treat furniture, mattresses, sports helmets, headphones, and other non-washable items. Ask your doctor of pharmacist about disinfecting your home.

Store this medication at room temperature away from moisture and heat. Keep the medicine canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or incinerate the can, the contents are under pressure.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

Avoid using other medications or skin products on the areas you treat with piperonyl butoxide and pyrethrins topical, unless you doctor tells you to.

Avoid getting this medication in your eyes, nose, mouth, or vagina. If this does happen, rinse with water. Do not use piperonyl butoxide and pyrethrins topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid close contact with others until the infection has been cured. Also avoid sharing hair combs, hair accessories, hats, clothing, bed linens, pillows, and other items of personal use. Lice infestations are highly contagious.

Triple X Pediculicide (piperonyl butoxide and pyrethrins topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using piperonyl butoxide and pyrethrins and call your doctor at once if you have severe stinging, burning, itching, swelling, or irritation where the medication is applied.

Less serious side effects may include:

• 
  

  mild itching, burning, or stinging;

  
  


• 
  

  mild skin rash; or

  
  


• 
  

  numbness or tingly feeling.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied piperonyl butoxide and pyrethrins. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Triple X Pediculicide resources

• Triple X Pediculicide Use in Pregnancy & Breastfeeding
• Triple X Pediculicide Support Group
• 0 Reviews for Triple X Pediculicide - Add your own review/rating

Compare Triple X Pediculicide with other medications

• Head Lice

Where can I get more information?

• Your pharmacist can provide more information about piperonyl butoxide and pyrethrins.

Amitiza

Generic Name: lubiprostone (Oral route)

loo-bi-PROST-one

Commonly used brand name(s)

In the U.S.

• Amitiza

Available Dosage Forms:

• Capsule, Liquid Filled


• Capsule

Therapeutic Class: Laxative

Uses For Amitiza

Lubiprostone is used to treat chronic constipation in adults. This medicine works by increasing intestinal fluid secretion, which helps ease the passage of stool and helps relieve the symptoms associated with constipation.

Lubiprostone is also used to treat irritable bowel syndrome (IBS) in women who have constipation as the main symptom.

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

Before Using Amitiza

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 lubiprostone in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

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

Breast Feeding

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Bowel blockage, or history of or


• Diarrhea, severe—Should not be used in patients with these conditions.

• Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Amitiza

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Swallow the soft gelatin capsule whole. Do not crush, break, or chew it. It is best to take this medicine with food.

Drink at least 6 to 8 glasses (8 ounces each) of liquid each day. This will help make the stool softer.

Dosing

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

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

• For oral dosage form (soft gelatin capsules):
  
  • For chronic constipation:
    
    • Adults—24 micrograms (mcg) two times a day (once in the morning and once in the evening) with food and water.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For irritable bowel syndrome (IBS):
    
    • Adults—8 micrograms (mcg) two times a day (once in the morning and once in the evening) with food and water.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Amitiza

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. This will also allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Lubiprostone may cause difficulty with breathing, nausea, or severe diarrhea. If your symptoms and condition do not improve within a few days, or if they become worse, check with your doctor.

If you are a woman who can get pregnant, your doctor may want you to have a negative pregnancy test before you will be allowed to take this medicine. Also, use an effective form of birth control to keep from getting pregnant. If you miss a period while you are using this medicine, tell your doctor right away.

Amitiza 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

• Full or bloated feeling or pressure in the stomach


• stomach pain


• swelling of abdominal or stomach area

Less common

• Bladder pain


• bloody or cloudy urine


• blurred vision


• chest discomfort


• chest pain


• chills


• cold flu-like symptoms


• cough that produces mucus


• diarrhea


• difficult, burning, or painful urination


• difficult or labored breathing


• difficulty having a bowel movement (stool)


• dizziness


• fast heartbeat


• fever


• frequent urge to urinate


• general feeling of discomfort or illness


• headache


• hoarseness


• joint pain


• loss of appetite


• lower back or side pain


• muscle aches and pains


• nausea


• nervousness


• pounding in the ears


• runny nose


• shivering


• shortness of breath


• sore throat


• sweating


• swelling of the hands, ankles, feet, or lower legs


• tightness in the chest


• trouble sleeping


• unusual tiredness or weakness


• vomiting


• wheezing

Incidence not known

• Cough


• difficulty with swallowing


• fainting


• hives


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


• skin rash

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

Symptoms of overdose

• Burning, itching, redness, or stinging of the skin


• dry heaves


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


• increased sweating


• lack or loss of strength


• paleness of the skin


• severe, unusual tiredness or weakness


• slow heartbeat


• sudden sweating


• weight loss

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

• Excess air or gas in the stomach or intestines


• passing gas

Less common

• Acid or sour stomach


• back pain


• belching


• body aches or pain


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


• difficulty with moving


• discouragement


• dry mouth


• ear congestion


• fear


• feeling sad or empty


• heartburn


• increased weight


• indigestion


• irritability


• loss of interest or pleasure


• loss of voice


• muscle cramps


• muscle stiffness


• nasal congestion


• pain in the arms or legs


• pain or tenderness around the eyes and cheekbones


• sleeplessness


• sneezing


• stomach soreness, discomfort, or upset


• stuffy nose


• tiredness


• trouble concentrating


• unable to sleep

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: Amitiza side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Amitiza resources

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

• Amitiza Prescribing Information (FDA)


• Amitiza Consumer Overview


• Amitiza Monograph (AHFS DI)


• Amitiza MedFacts Consumer Leaflet (Wolters Kluwer)


• Lubiprostone Professional Patient Advice (Wolters Kluwer)

Compare Amitiza with other medications

• Constipation, Chronic
• Irritable Bowel Syndrome

Ascorbic Acid Tablets 500mg Label Leaflet

Due to technical difficulties in printing the label-leaflet format, please find the relevant text below. Text is representative of the leaflet portion of label-leaflet spec no 50135448.

Ascorbic Acid 500mg tablets

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Index

• 1. What Ascorbic Acid tablets are and what they are used for


• 2. Before you take


• 3. How to take


• 4. Possible side effects


• 5. How to store


• 6. Further information

What Ascorbic Acid tablets are and what they are used for

Ascorbic acid is a man-made vitamin C. Ascorbic Acid tablets are used to treat scurvy (a disease caused by a lack of vitamin C).

Before you take

Do not take Ascorbic Acid tablets and tell your doctor if you:

• have a high level of oxalic acid in your urine (hyperoxaluria)


• are allergic to any of the ingredients in the tablets (see section 6). The tablets contain sodium metabisulphite (E223) which may rarely cause allergic reactions or breathing difficulties.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

• antacids containing aluminium (for indigestion)


• aspirin


• desferrioxamine (for excessive absorption and storage of iron and some blood abnormalities)

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding, tell your doctor or pharmacist before taking any medicine.

Tests

If you need to have any blood or urine tests, tell your doctor you are taking Ascorbic Acid tablets, as they might affect the results.

How to take

Always take Ascorbic Acid tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Chew the tablets before swallowing.

Doses:

Adults (including the elderly): 500mg-1g two or three times a day.

Children over 12 years: 500mg two or three times a day.

Children 6-12 years: 500mg twice a day.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking the tablets

If you have been taking Ascorbic Acid tablets for a long time, you may develop a deficiency if you stop taking them. Talk to your doctor before you stop taking the tablets and follow their advice.

Possible side effects

Like all medicines, Ascorbic Acid tablets can cause side effects although not everybody gets them.

Tell your doctor if you notice any of the following side effects, they get worse or you notice any not listed:

• Allergic reaction: itchy skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.


• Effects on the stomach: feeling or being sick, diarrhoea, stomach cramps.


• Other side effects: flushing or redness of the skin, headache, increased production of urine.

How to store

Keep out of the reach and sight of children.

Store in a cool dry place. Protect from light.

Avoid contact with metal.

Do not use Ascorbic Acid after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Ascorbic Acid tablets contain

• The active substance (the ingredient that makes the tablets work) is ascorbic acid.
  
  
  Each tablet contains 500mg of the active substance.



• The other ingredients are stearic acid, sodium metabisulphate (E223), microcrystalline cellulose (101) (E460).


• The sodium content of each tablet is 0.6mg.

What Ascorbic Acid tablets look like and contents of the pack

Ascorbic Acid tablets are white, circular, flat bevelled-edge, uncoated tablets.

Pack size is 28.

Marketing Authorisation Holder and Manufacturer

Actavis

Barnstaple

EX32 8NS

UK

This leaflet was last revised in October 2007.