selegiline

Generic Name: selegiline (oral) (se LE ji leen)

Brand Names: Eldepryl, Zelapar

What is selegiline?

Selegiline prevents the breakdown of a chemical in your brain called dopamine (DO pa meen). Low levels of this chemical are associated with Parkinson's disease.

Selegiline is used together with other medicines to treat symptoms of Parkinson's disease.

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

What is the most important information I should know about selegiline?

There are many other medicines that can cause serious medical problems if you take them together with selegiline. Tell your doctor about all other prescription and over-the-counter medications you use, including vitamins, minerals, and herbal products.

While taking selegiline, do not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while using selegiline?" section of this leaflet. Eating tyramine while you are using selegiline can raise your blood pressure to dangerous levels and cause life-threatening symptoms.

You should become very familiar with the list of foods to avoid while you are using selegiline.

Video: Treatment for Depression

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

Do not stop taking selegiline suddenly or you may have harmful side effects. Keep taking the medicine as prescribed. Talk with your doctor before stopping the medication.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking selegiline.

What should I discuss with my healthcare provider before using selegiline?

Do not use this medication if you are allergic to selegiline, or if you have used any of the following drugs within the past 14 days:

• 
  

  cough or cold medicine that contains dextromethorphan;

  
  


• 
  

  meperidine (Demerol), propoxyphene (Darvon, Darvocet), or tramadol (Ultram, Ultracet);

  
  


• 
  

  methadone (Dolophine, Methadose); or

  
  


• 
  

  other MAO inhibitors such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or transdermal selegiline (Emsam).

  
  

After you stop taking selegiline, you must wait at least 14 days before taking any of the medications listed above.

Before using this medicine, tell your doctor if you have kidney disease, liver disease, heart disease, high or low blood pressure, or a seizure disorder. If you have any of these conditions, you may need a dose adjustment or special tests to safely take selegiline.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking selegiline. It is not known whether the medicine actually causes this effect. Talk with your doctor if you believe you have any intense or unusual urges while taking selegiline.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before you take selegiline, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether selegiline passes into breast milk or if it could harm a nursing baby. Do not take selegiline without telling your doctor if you are breast-feeding a baby.

The selegiline disintegrating tablets may contain phenylalanine. Talk to your doctor before using this form of selegiline if you have phenylketonuria (PKU).

How should I take selegiline?

Take selegiline exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. Larger doses will not have any greater effect, but serious side effects could result. Follow the directions on your prescription label.

While you are using selegiline and for 14 days after you stop, you must not eat foods listed in the "What should I avoid while using selegiline?" section of this leaflet. Eating these foods while you are using selegiline can raise your blood pressure to dangerous levels.

Foods that you MAY eat include:

• 
  

  fresh meat, poultry, or fish (including lunch meat, hot dogs, breakfast sausage, and cooked sliced ham);

  
  


• 
  

  any vegetables except broad bean pods (fava beans);

  
  


• 
  

  processed cheese, mozzarella, ricotta, cottage cheese;

  
  


• 
  

  pizza made with cheeses low in tyramine;

  
  


• 
  

  soy milk, yogurt; or

  
  


• 
  

  Brewer's or baker's yeast.

  
  

Selegiline capsules are usually taken twice a day, at breakfast and lunch. Follow your doctor's instructions. The disintegrating tablet form of selegiline (Zelapar) should be taken once a day before breakfast and without any liquid.

To take selegiline orally disintegrating tablets (Zelapar):

• 
  

  Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

  
  


• 
  

  Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.

  
  


• 
  

  Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves.

  
  


• 
  

  Do not drink or eat anything for at least 5 minutes after taking a Zelapar orally disintegrating tablet.

  
  

Parkinson's disease is often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. When you start taking selegiline, your doses of the other medications may need to change. Do not change your doses or medication schedule without advice from your doctor.

Do not stop taking selegiline suddenly or you may have harmful side effects. For best results, keep taking the medicine as prescribed. Store this medicine at room temperature away from moisture and heat.

See also: Selegiline dosage (in more detail)

What happens if I miss a dose?

Take the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include severe headache, hallucinations, vision problems, sweating, cool or clammy skin, fast or uneven heart rate, feeling light-headed, fainting, or seizure (convulsions).

What should I avoid while using selegiline?

You must NOT eat foods that are high in tyramine, including:

• 
  

  air dried meats, aged or fermented meats, sausage or salami (including cacciatore and mortadella), pickled herring, and any spoiled or improperly stored beef, poultry, fish, or liver;

  
  


• 
  

  beer from a tap, beer that has not been pasteurized;

  
  


• 
  

  aged cheeses, including blue, boursault, brick, brie, camembert, cheddar, emmenthaler, gruyere, parmesan, romano, roquefort, stilton, and swiss;

  
  


• 
  

  over-the-counter supplements or cough and cold medicines that contain tyramine;

  
  


• 
  

  sauerkraut, soy beans, soy sauce, tofu, miso soup, bean curd, fava beans; or

  
  


• 
  

  yeast extracts (such as Marmite).

  
  

Eating tyramine while you are taking selegiline can raise your blood pressure to dangerous levels which could cause life-threatening side effects.

You should become very familiar with the list of foods to avoid while you are taking selegiline.

Avoid drinking alcohol while taking selegiline. Selegiline can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Selegiline 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 taking selegiline and call your doctor at once if you have any of these serious side effects:

• 
  

  sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body);

  
  


• 
  

  feeling light-headed, fainting;

  
  


• 
  

  hallucinations;

  
  


• 
  

  feeling restless, agitated, or irritable;

  
  


• 
  

  twitching muscle movements; or

  
  


• 
  

  painful or difficult urination.

  
  

Less serious side effects may include:

• 
  

  dizziness, weakness;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  runny or stuffy nose;

  
  


• 
  

  back pain;

  
  


• 
  

  constipation; or

  
  


• 
  

  mouth sores or ulcers, pain with swallowing (while using Zelapar).

  
  

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.

Selegiline Dosing Information

Usual Adult Dose for Parkinson's Disease:

Adjunct to levodopa/carbidopa:

Oral tablet: 5 mg twice a day at breakfast and lunch.

Oral disintegrating tablet: 1.25 mg once a day, before breakfast, for at least 6 weeks. After 6 weeks, the dose may be increased to 2.5 mg once a day if needed.

Usual Adult Dose for Depression:

Major Depressive Disorder:

Initial: Apply one transdermal patch (6 mg/24 hours) to intact skin once every 24 hours.
Maintenance: 6 mg/24 hours up to a maximum of 12 mg/24 hours.

What other drugs will affect selegiline?

Before taking selegiline, tell your doctor if you are using any of the following drugs:

• 
  

  carbamazepine (Tegretol);

  
  


• 
  

  diet pills or cold medicines that contain ephedrine, pseudoephedrine, or phenylephrine;

  
  


• 
  

  nafcillin (Unipen);

  
  


• 
  

  phenobarbital (Luminal, Solfoton);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil), amoxapine (Ascendin), bupropion (Wellbutrin, Zyban), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), protriptyline (Vivactil), sertraline (Zoloft), venlafaxine (Effexor), or trimipramine (Surmontil).

  
  

This list is not complete and there are many other medicines that can cause serious medical problems if you take them together with selegiline. Do not take selegiline before telling your doctor about all other prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

More selegiline resources

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

• selegiline Advanced Consumer (Micromedex) - Includes Dosage Information


• Selegiline Prescribing Information (FDA)


• Selegiline MedFacts Consumer Leaflet (Wolters Kluwer)


• Eldepryl Monograph (AHFS DI)


• Eldepryl Consumer Overview


• Emsam Prescribing Information (FDA)


• Emsam Consumer Overview


• Emsam Advanced Consumer (Micromedex) - Includes Dosage Information


• Emsam System MedFacts Consumer Leaflet (Wolters Kluwer)


• Zelapar Prescribing Information (FDA)


• Zelapar Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Zelapar Consumer Overview

Compare selegiline with other medications

• ADHD
• Depression
• Parkinson's Disease

Where can I get more information?

• Your pharmacist can provide more information about selegiline.

See also: selegiline side effects (in more detail)

Fexofenadine Hydrochloride

Class: Second Generation Antihistamines
ATC Class: R06AX26
VA Class: AH106
Chemical Name: 4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl] butyl]-α,α-dimethylbenzeneacetic acid hydrochloride
Molecular Formula: C₃₂H₃₉NO₄•HCl
CAS Number: 138452-21-8
Brands: Allegra, Allegra-D

Introduction

Second generation antihistamine; active carboxylic acid metabolite of terfenadine (no longer commercially available in the US).^{1 2 3 18 79 80}

Uses for Fexofenadine Hydrochloride

Allergic Rhinitis

Symptomatic relief (alone or in fixed combination with pseudoephedrine hydrochloride) of seasonal allergic rhinitis (e.g., hay fever).^{1 77 88}

Use fixed-combination preparation only when both antihistamine and nasal decongestant activity are desired.^{77 88}

Chronic Idiopathic Urticaria

Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.^{1 70 79}

Substantially reduces pruritus and the number of wheals.¹

Fexofenadine Hydrochloride Dosage and Administration

Administration

Oral Administration

Administer conventional tablets or capsules orally without regard to meals.⁸

Fixed-combination fexofenadine hydrochloride/pseudoephedrine hydrochloride preparations: Administer orally on an empty stomach with water.^{77 88} Swallow tablets whole; do not break, crush, or chew.^{77 88}

Dosage

Available as fexofenadine hydrochloride; dosage expressed in terms of the salt.^{1 77 88}

Fixed-combination preparations available as Allegra-D 12 Hour and Allegra-D 24 Hour.^{77 88} Allegra-D 12 Hour and Allegra-D 24 Hour tablets contain 60 or 180 mg of fexofenadine hydrochloride, respectively, in an immediate-release layer and 120 or 240 mg of pseudoephedrine hydrochloride, respectively, in an extended-release matrix layer that slowly releases the drug.^{70 77 88}

Pediatric Patients

Allergic Rhinitis

Oral

Children 6–11 years of age: 30 mg twice daily (as conventional tablets).¹

Children ≥12 years of age: 60 mg twice daily or 180 mg once daily (as conventional capsules or tablets).^{1 2 39}

Children ≥12 years of age: 60 mg twice daily (as Allegra-D 12 Hour)⁷⁷ or 180 mg once daily (as Allegra-D 24 Hour).⁸⁸

Chronic Idiopathic Urticaria

Oral

Children 6–11 years of age: 30 mg twice daily (as conventional tablets).¹

Children ≥12 years of age: 60 mg twice daily (as conventional capsules or tablets).¹

Adults

Allergic Rhinitis

Oral

60 mg twice daily or 180 mg once daily (as conventional capsules or tablets).^{1 2 39}

60 mg twice daily (as Allegra-D 12 Hour)⁷⁷ or 180 mg once daily (as Allegra-D 24 Hour).⁸⁸

Chronic Idiopathic Urticaria

Oral

60 mg twice daily (as conventional capsules or tablets).¹

Special Populations

Hepatic Impairment

Dosage adjustment not necessary.^{1 2 79}

Renal Impairment

Children 6–11 years of age with decreased renal function: 30 mg once daily (as conventional tablets).¹

Adults and children ≥12 years of age with decreased renal function: 60 mg once daily (as conventional capsules or tablets or in fixed combination with 120 mg of pseudoephedrine hydrochloride [Allegra-D 12 Hour]).^{1 2 77} Avoid use of fixed-combination preparation containing 180 mg of fexofenadine hydrochloride and 240 mg of pseudoephedrine hydrochloride (Allegra-D 24 Hour) in patients with renal impairment because of possible risk of pseudoephedrine accumulation.⁸⁸

Geriatric Patients

Select dosage carefully.^{1 77} (See Geriatric Use under Cautions.)

Cautions for Fexofenadine Hydrochloride

Contraindications

• 
  

  Known hypersensitivity to fexofenadine or any ingredient in the formulation.^{1 77 88}

  
  

Warnings/Precautions

Sensitivity Reactions

Rash, urticaria, pruritus, and hypersensitivity reactions (e.g., angioedema, chest tightness, dyspnea, flushing, anaphylaxis) reported rarely.^{1 77 88}

General Precautions

Fixed-combination Preparations

When used in fixed combination with pseudoephedrine, consider the cautions, precautions, and contraindications associated with pseudoephedrine.^{77 88}

Specific Populations

Pregnancy

Category C.^{1 77 88}

Lactation

Not known if fexofenadine is distributed into milk; however, pseudoephedrine (a component of the fixed-combination preparations) distributes into milk.^{77 88} Use with caution in nursing women.^{1 77 88} Discontinue nursing or fixed-combination preparation.^{77 88}

Pediatric Use

Conventional tablets or capsules: Safety and efficacy not established in children <6 years of age.^{1 2}

Extended-release fexofenadine hydrochloride/pseudoephedrine hydrochloride preparations: Safety and efficacy not established in children <12 years of age; use not recommended in this age group.^{77 88} Doses of fexofenadine hydrochloride and pseudoephedrine hydrochloride in these preparations exceed those recommended for children <12 years of age.^{77 88}

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.^{89 90} Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.⁸⁹ Therefore, FDA recommended not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.

Geriatric Use

Insufficient experience in patients ≥65 years of age in clinical trials, but other clinical experience has not identified overall differences in response relative to younger patients.^{1 77 88}

Risk of severe adverse reactions may be increased in patients with impaired renal function since fexofenadine is substantially excreted by the kidney.¹ Select dosage carefully due to greater frequency of decreased renal function;^{1 77} renal function monitoring may be useful.^{1 77 88}

Renal Impairment

Dosage reduction necessary.^{1 77} (See Renal Impairment under Dosage and Administration.)

Avoid use of fixed-combination preparation containing 180 mg of fexofenadine hydrochloride and 240 mg of pseudoephedrine hydrochloride (Allegra-D 24 Hour) in patients with renal impairment; possible risk of pseudoephedrine accumulation.⁸⁸

Common Adverse Effects

Children 6–11 years of age receiving conventional tablets: Headache, upper respiratory tract infection, coughing, accidental injury, fever, pain, otitis media.¹

Adults and children ≥12 years of age receiving conventional capsules or tablets: Viral infection (e.g., cold, flu), nausea, dysmenorrhea, sinusitis, dizziness, drowsiness, dyspepsia, fatigue, headache, upper respiratory tract infection, back pain.¹

Fixed-combination fexofenadine hydrochloride (60 mg)/pseudoephedrine hydrochloride (120 mg): Headache, insomnia, nausea, dry mouth, dyspepsia, throat irritation, dizziness, agitation, back pain, palpitation, nervousness, anxiety, upper respiratory tract infection, abdominal pain.⁷⁷

Interactions for Fexofenadine Hydrochloride

Minimally metabolized by CYP microsomal enzymes.¹

When using fixed-combination preparations containing pseudoephedrine hydrochloride, consider the drug interactions associated with pseudoephedrine.^{77 88}

Specific Drugs and Foods

Drug or Food	Interaction	Comments
Antacids	Decreased fexofenadine concentrations when administered within 15 minutes of an aluminum- and magnesium-containing antacid (Maalox)1	Avoid administering closely in time with antacids containing aluminum and magnesium1 77 88
Erythromycin	Increased absorption and decreased biliary excretion of fexofenadine, resulting in increased fexofenadine concentrations;1 77 88 however, no clinically important adverse effects or changes in the QT interval corrected for rate (QTc) reported1 2 77 79 83 88
Fruit (apple, grapefruit, orange) juices	Possibly reduced bioavailability and systemic exposure of fexofenadine77 88	Administer with water77 88
Ketoconazole	Increased absorption and decreased secretion of fexofenadine, resulting in increased fexofenadine concentrations;1 77 88 however, no clinically important adverse effects or changes in the QTc reported1 2 77 79 83 88

Fexofenadine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from the GI tract following oral administration,^{1 2 38 77 81} with peak plasma concentrations achieved in about 2.6 hours after administration as conventional capsules ^{1 2} or in about 1.8–2 hours after administration as extended-release tablets in fixed combination with pseudoephedrine hydrochloride.^{77 88}

Conventional capsules and tablets are bioequivalent when administered at equal doses.¹

Onset

Antihistaminic effect occurs within 1–3 hours.¹

Duration

Antihistaminic effect persists for about 12 hours following oral administration of 20- or 40-mg doses.^{1 41 77 79 81 88}

Food

No substantial alterations in fexofenadine pharmacokinetics observed in adults when contents of the 60-mg capsules were mixed with applesauce prior to administration.¹

Administration with fruit juices (e.g., apple, grapefruit, orange) may reduce fexofenadine bioavailability compared with administration with water.^{77 88}

Decreased rate and/or extent of absorption of fexofenadine observed when the fixed-combination preparations were administered concomitantly with a high-fat meal.^{77 88} (See Administration under Dosage and Administration.)

Special Populations

In patients with mild to severe renal impairment (Cl_cr of 11–80 mL/minute) and in those on hemodialysis (Cl_cr ≤ 10 mL/minute), peak plasma fexofenadine concentrations were increased by 87–111 and 82%, respectively, compared with those in healthy adults.^{1 77 88}

In geriatric patients ≥65 years of age, peak plasma fexofenadine concentrations were 99% greater than in younger adults.^{1 2 36 77 79 88}

Distribution

Extent

Distribution into human body tissues and fluid not fully elucidated;² distributes into the small and large intestines, stomach, pancreas, liver, and kidney in animals.² Distributed more extensively into plasma than blood or saliva.² Does not appear to cross the blood-brain barrier.^{1 2 77 79 81 88}

Not known whether fexofenadine crosses the placenta or distributes into milk.²

Plasma Protein Binding

60–70% (mainly albumin and α₁-acid glycoprotein).^{1 2 77 88}

Elimination

Metabolism

About 0.5–1.5% of a dose is metabolized in the liver by CYP enzymes, while about 3.5% is metabolized by a second metabolic pathway.⁷⁰

Elimination Route

Excreted in feces (80%) and urine (11–12%).^{1 2 77 79 81 88}

Half-life

14.4–14.6 hours.^{1 2 77 88}

Special Populations

In patients with mild to severe renal impairment (Cl_cr of 11–80 mL/minute) and in those on hemodialysis (Cl_cr ≤10 mL/minute), half-life was 59–72 and 31% longer, respectively, compared with that in healthy adults.^{1 77 88}

Stability

Storage

Oral

Capsules and Tablets

20–25°C.¹ Protect foil-backed blister packs containing capsules and all tablet packaging from excessive moisture.¹

Fixed-Combination Tablets

Tight containers at 20–25°C.^{77 88}

ActionsActions

• 
  

  Specific, selective, histamine H₁-receptor antagonist.^{1 2 3 18 19 20 22 80}

  
  


• 
  

  Lacks cardiotoxic potential of terfenadine^{15 16 17 36 66 67 80} since it does not block the potassium channel involved in repolarization of cardiac cells (i.e., blockade of the delayed rectifier potassium current I_K).^{1 8 16 36 66 67 80}

  
  


• 
  

  No appreciable anticholinergic,^{1 2 77 80 88} antidopaminergic,² or α- or β-adrenergic blocking^{1 77 88} effects at usual antihistaminic doses in pharmacologic studies.

  
  


• 
  

  In clinical studies, incidence of CNS effects (e.g., sedation, EEG disturbances, impaired psychomotor performance) associated with fexofenadine is similar to that with placebo and less than that with first generation antihistamines (e.g., chlorpheniramine, clemastine, diphenhydramine, triprolidine).^{1 70}

  
  

Advice to Patients

• 
  

  Importance of taking only as prescribed; do not exceed prescribed dosage.^{77 88}

  
  


• 
  

  Importance of consulting a clinician if nervousness, dizziness, or sleeplessness occurs with fixed-combination preparations containing pseudoephedrine hydrochloride.^{77 88}

  
  


• 
  

  Importance of swallowing fixed-combination tablets whole; do not break, crush, or chew.^{77 88} Inform patients that inert ingredients of Allegra-D 12 Hour tablets occasionally may be eliminated in feces in a form resembling the original tablet.⁷⁷

  
  


• 
  

  Advise patients to avoid concomitant use of fixed-combination preparations with other OTC antihistamines and/or decongestants.^{77 88}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.^{1 77 88}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{1 77 88} (See Cautions.)

  
  

Preparations

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

Fexofenadine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	60 mg	Allegra	Sanofi-Aventis
	Tablets, film-coated	30 mg	Allegra	Sanofi-Aventis
		60 mg	Allegra	Sanofi-Aventis
		180 mg	Allegra	Sanofi-Aventis

Fexofenadine Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, extended-release layer (pseudoephedrine hydrochloride only), film-coated	60 mg with Pseudoephedrine Hydrochloride 120 mg	Allegra-D 12 Hour	Sanofi-Aventis
		180 mg with Pseudoephedrine Hydrochloride 240 mg	Allegra-D 24 Hour	Sanofi-Aventis

Comparative Pricing

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

Allegra 180MG Tablets (SANOFI-AVENTIS U.S.): 30/$79.98 or 90/$225.95

Allegra 30MG/5ML Suspension (SANOFI-AVENTIS U.S.): 300/$69.99 or 900/$199.98

Allegra 60MG Tablets (SANOFI-AVENTIS U.S.): 60/$98.99 or 180/$287.98

Allegra-D 12 Hour 60-120MG 12-hr Tablets (SANOFI-AVENTIS U.S.): 30/$81.57 or 60/$150.18

Allegra-D 24 Hour 180-240MG 24-hr Tablets (SANOFI-AVENTIS U.S.): 30/$147.98 or 90/$414.97

Fexofenadine-Pseudoephedrine 60-120MG 12-hr Tablets (TEVA PHARMACEUTICALS USA): 30/$62.99 or 90/$175.96

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 February 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Aventis. Allegra (fexofenadine hydrochloride) capsules and tablets prescribing information. Kansas City, MO; 2003 May.

2. Hoechst Marion Roussel, Inc. Product information form for American hospital formulary service: Allegra (fexofenadine HCl). Kansas City, MO; 1996.

3. Sorkin EM, Heel RC. Terfenadine: a review of its pharmacodynamic properties and therapeutic efficacy. Drugs. 1985; 29:34-56. [IDIS 197286] [PubMed 2857636]

4. Borge PA. Problems in allergic rhinitis. Arzneimittelforschung. 1982; 32:1199-201. [PubMed 6891258]

5. Buckley CE, Klemawesch SJ, Lucas SK. Treatment of allergic rhinitis with a new selective H₁ antihistamine: terfenadine. N Engl J Med. 1985; 6:63-70.

6. Food and Drug Administration. Over-the-counter drugs: establishment of a monograph for OTC cold, cough, allergy, bronchodilator and antihistaminic products. [21 CFR 341]. Fed Regist. 1976; 41:38312-424.

7. Babe KS Jr, Serafin WE. Histamine, bradykinin and their antagonists. In: Hardman JG, Limbird LE, Molinoff PB et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 9th ed. New York: McGraw-Hill; 1996:581-600.

8. Hoechst Marion Roussel, Kansas City, MO: Personal communication.

9. Marion Merrell Dow, Kansas City, MO: Personal communication on terfenadine.

10. Honig PK, Woosley RL, Zamani K et al. Changes in the pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine with concomitant administration of erythromycin. Clin Pharmacol Ther. 1992; 52:231-8. [IDIS 302453] [PubMed 1526078]

11. Woosley RL, Chen Y, Freiman JP et al. Mechanism of the cardiotoxic actions of terfenadine. JAMA. 1993; 269:1532-6. [IDIS 311127] [PubMed 8445816]

12. Peck CC, Temple R, Collins JM. Understanding consequences of concurrent therapies. JAMA. 1993; 269:1550-2. [IDIS 311129] [PubMed 8445821]

13. Pohjola-Sintonen S, Viitasalo M, Toivonen L et al. Torsades de pointes after terfenadine-itraconazole interaction. BMJ. 1993; 306:186.

14. Antihistamines, nonsedating/azole antifungal agents. In: Tatro DS, Olin BR, Hebel SK, eds. Drug interaction facts. St. Louis: JB Lippincott Co; 1997(October):109b.

15. Antihistamines, nonsedating/macrolide antibiotics. In: Tatro DS, Olin BR, Hebel SK eds. Drug interaction facts. St. Louis: JB Lippincott Co; 1997 (Oct):110d.

16. Food and Drug Administration. Hoechst Marion Roussel, Inc, and Baker Norton Pharmaceuticals, Inc; terfenadine; proposal to withdraw approval of two new drug applications and one abbreviated new drug application; opportunity for a hearing. [Docket No.96N-0512] Fed Regist. 1997; 62:1889-92.

17. Cruzan S. FDA proposes to withdraw Seldane approval. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 1997 Jan 13.

18. Merrell Dow Pharmaceuticals Inc. Seldane (terfenadine) monograph. Cincinnati, OH; 1985.

19. Merrell Dow Pharmaceuticals Inc. Product information form for American hospital formulary service on Seldane. Cincinnati, OH; 1985 Apr 1.

20. Cheng HC, Woodward JK. A kinetic study of the antihistaminic effect of terfenadine. Arzneimittelforschung. 1982; 32:1160-6. [PubMed 6129862]

21. Koch H. Terfenadine: specific peripheral H₁-histamine receptor antagonist. Pharm Int. 1983; 4:252-3.

22. Cheng HC, Woodward JK. Antihistaminic effect of terfenadine: a new piperidine-type antihistamine. Drug Dev Res. 1982; 2:181-96.

23. Wiech NL, Martin JS. Absence of an effect of terfenadine on guinea pig brain histamine H₁-receptors in vivo determined by receptor binding techniques. Arzneimittelforschung. 1982; 32:1167-70. [PubMed 6817763]

24. Rose C, Quach TT, Llorens C et al. Relationship between occupation of cerebral H₁-receptors and sedative properties of antihistamines: assessment in the case of terfenadine. Arzneimittelforschung. 1982; 32:1171-3. [PubMed 6129863]

25. Nicholson AN. Antihistamines and sedation. Lancet. 1983; 2:211-2. [IDIS 173746] [PubMed 6135040]

26. Norman PS. New developments in treating allergic rhinitis. Drug Ther. 1984; 14:117,126,127,130-2.

27. Hoechst Marion Roussel. Seldane (terfenadine) tablets prescribing information. Kansas City, MO; 1997 Sep.

28. Anon. Treatment of seasonal and perennial rhinitis. BMJ. 1981; 283:808-10. [PubMed 6117350]

29. Douglas WW. Histamine and 5-hydroxytryptamine (serotonin)and their antagonists. In: Gilman AG, Goodman LS, Rall TW et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 7th ed. New York: Macmillan Publishing Company; 1985:605-38.

30. Cirillo VJ, Tempero KF. The pharmacology and therapeutic use of H₁ and H₂ antihistamines. In: Miller RR, Greenblatt DJ, eds. Drug therapy reviews. Vol 2. New York: Elsevier/North Holland Inc; 1979:24-47.

31. Church JA. Allergic rhinitis: diagnosis and management. Clin Pediatr (Philadelphia). 1980; 19:655-9.

32. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; tentative final monograph for OTC antihistamine drug products. [21 CFR Part 341] Fed Regist. 1985; 50:2200-18. (IDIS 195256)

33. AMA Division of Drugs. AMA drug evaluations. 5th ed. Chicago: American Medical Association; 1983:1465-79.

34. Bernstein D, Schoenwetter W, Nathan R et al. Fexofenadine: a new nonsedating antihistamine is effective in the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol. 1996; 97:435.

35. Holgate S. Comparative trial of two non-sedative H₁antihistamines, terfenadine and astemizole, for hay fever. Thorax. 1985; 40:399.

36. Anon. Fexofenadine hydrochloride: terfenadine carboxylate hydrochloride MDL- 16455A Allegra. Drugs Future. 1996; 21:1017-21.

37. Nightingale SL. From the Food and Drug Administration: FDA proposes to withdraw terfenadine approval. JAMA. 1997; 277:370. [PubMed 9010159]

38. Simons FER, Bergman JN, Watson WTA et al. Allergens, IgE, mediators, inflammatory mechanisms: the clinical pharmacology of fexofenadine in children. J Allergy Clin Immunol. 1996; 98:1062-4. [IDIS 378437] [PubMed 8977506]

39. Anon. Fexofenadine. Med Lett Drugs Ther. 1996; 38:95-6. [PubMed 8906132]

40. Day JH, Briscoe MP, Welsh A et al. Onset of action, efficacy and safety of a single dose of 60 mg and 120 mg fexofenadine HCl for ragweed (RW) allergy using controlled antigen exposure in an enviromental exposure unit (EEU). J Allergy Clin Immunol. 1996; 97:434.

41. Tinkelman D, Falliers C, Bronsky E et al. Efficacy and safety of fexofenadine HCl in fall seasonal allergic rhinitis. J Allergy Clin Immunol. 1996; 97:435.

43. Crutcher JE, Kantner TR. The effectiveness of antihistamines in the common cold. J Clin Pharmacol. 1981; 21:9-15. [IDIS 128348] [PubMed 7012191]

44. West S, Brandon B, Stolley P et al. A review of antihistamines and the common cold. Pediatrics. 1975; 56:100-7. [IDIS 56748] [PubMed 240145]

45. Howard JC Jr, Kantner TR, Lilienfield LS et al. Effectiveness of antihistamines in the symptomatic management of the common cold. JAMA. 1979; 242:2414-7. [IDIS 108056] [PubMed 490852]

46. Food and Drug Administration. Over-the-counter drugs: establishment of a monograph for OTC cold, cough, allergy, bronchodilator and antiasthmatic products. [DES No. 11935] Fed Regist. 1983; 48:56854-6.

47. Bryant BG, Cormier JF. Cold and allergy products. In: American Pharmaceutical Association. Handbook of nonprescription drugs. 8th ed. Washington, DC: American Pharmaceutical Association; 1986:127-74.

48. Gaffey MJ, Gwaltney JM Jr, Sastre A et al. Intranasally and orally administered antihistamine treatment of experimental rhinovirus colds. Am Rev Respir Dis. 1987; 136:556-60. [IDIS 245031] [PubMed 3307567]

49. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for OTC antihistamine drug products. Final rule. 21 CFR Parts 201, 310, 341, and 369. Fed Regist. 1992; 57:58356-8.

50. Simons FER, Simons KJ. The pharmacology and use of H₁-receptor-antagonist drugs. N Engl J Med. 1994; 330:1663-70. [IDIS 330632] [PubMed 7909915]

51. Burroughs Wellcome Co. Semprex-D (acrivastine and pseudoephedrine HCl) capsules. Research Triangle Park, NC; 1994 Apr.

52. Douglass JA, Dhami D, Gurr CE et al. Influence of interleukin-8 challenge in the nasal mucosa in atopic and nonatopic subjects. Am J Respir Crit Care Med. 1994; 150:1108-13. [IDIS 338161] [PubMed 7921444]

53. Turner RB, Sperber SJ, Sorrentino JV et al. Effectiveness of clemastine fumarate for treatment of rhinorrhea and sneezing associated with the common cold. Clin Infect Dis. 1997; 25:824-30. [IDIS 395789] [PubMed 9356796]

54. Doyle WJ, McBride TP, Skoner DP et al. A double-blind, placebo-controlled clinical trial of the effect of chlorpheniramine on the response of the nasal airway, middle ear and eustachian tube to provocative rhinovirus challenge. Pediatr Infect Dis J. 1988; 7:229-38. [PubMed 3282216]

55. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; tentative final monograph for combination drug products. [21 FR Part 341] Fed Regist. 1988; 53:30522-64.

56. Turner RB. Elaboration of intereleukin 8 from fibroblast cells and human nasal epithelium in response to rhinovirus challenge. Proceedings of ICAAC Orlando 1994. Abstract No. B43.

57. Berkowitz RB, Tinkelman DG. Evaluation of terfenadine for treatment of the common cold. Ann Allergy. 1991; 67:593-7. [IDIS 294960] [PubMed 1750722]

58. Gaffey MJ, Kaiser DL, Hayden FG. Ineffectiveness of oral terfenadine in natural colds: evidence against histamine as a mediator of common cold symptoms. Pediatr Infect Dis J. 1988; 7:223-8. [PubMed 2895909]

59. Proud D, Naclerio RM, Gwaltney JM et al. Kinins are generated in nasal secretions during natural rhinovirus colds. J Infect Dis. 1990; 161:120-3. [PubMed 2295843]

60. Proud D, Gwaltney JM Jr., Hendley JO et al. Increased levels of interleukin-1 are detected in nasal secretions of volunteers during experimental rhinovirus colds. J Infect Dis. 1994; 169:1007-13. [IDIS 329294] [PubMed 8169385]

61. Woodward JK, Munro NL. Terfenadine, the first non-sedating antihistamine. Arzneimittelforschung. 1982; 32:1154-6. [PubMed 6129860]

62. Fink M, Irwin P. CNS effects of the antihistamines diphenhydramine and terfenadine (RMI 9918). Pharmakopsychiatr Neuro Psychopharmakol. 1979; 12:35-44.

63. Lundberg PK. Assessment of drugs’ side effects: visual analogue scale versus checklist format. Percept Mot Skills. 1980; 50:1067-73. [PubMed 6774312]

64. Roehrs TA, Tietz EI, Zorick FJ et al. Daytime sleepiness and antihistamines. Sleep. 1984; 7:137-41. [IDIS 199927] [PubMed 6146180]

65. Garteiz DA, Hook RH, Walker BJ et al. Pharmacokinetics and biotransformation studies of terfenadine in man. Arzneimittelforschung. 1982; 32:1185-90. [PubMed 6817765]

66. Hey JA, del Prado M, Sherwood J et al. Comparative analysis of cardiotoxicity proclivities of second generation antihistamines in an experimental model predictive of adverse clinical ECG effects. Arneim-Forsch. 1996; 46:153-8.

67. Rampe D, Wible B, Brown AM et al. Effects of terfenadine and its metabolites on a delayed rectifier K⁺ channel cloned from human heart. Mol Pharmacol. 1993; 44:1240-5. [PubMed 8264561]

68. Smith MBH, Feldman W. Over-the-counter cold medications: a critical review of clinical trials between 1950 and 1991. JAMA. 1993; 269: 2258-63. [IDIS 313601] [PubMed 8097268]

69. D Agostino RB, Weintraub M. Meta-analysis: a method for synthesizing research. Clin Pharmacol Ther. 1995; 58:605-16. [PubMed 8529325]

70. Hoechst Marion Roussel, Kansas City, MO: Personal communication.

71. Nsouli SM. Treatment of allergic rhinitis fexofenadine (FF) versus loratadine (LR). Presented at the meeting of the American College of Allergy, Asthma and Immunology. San Diego, CA: 1997 November 7-12. Abstract.

72. Hüther KJ, Renftle G, Barraud N et al. Inhibitory activity of terfenadine on histamine-induced skin wheals in man. Eur J Clin Pharmacol. 1977; 12:195-99. [PubMed 22436]

73. Merrell Dow, Cincinnati, OH: Personal communication.

74. Bateman DN, Woodhouse KW, Rawlins MD. Adverse reactions to N-acetylcysteine. Hum Toxicol. 1984; 3:393-8. [IDIS 199928] [PubMed 6436169]

75. Fleischer Kupec I. FDA approves Allegra D, manufacturer to withdraw Seldane from marketplace. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 1997 Dec 29.

76. Anon. Allergy drug to be pulled off U.S. shelves. Wall St J. 1997, Dec 30.

77. Aventis. Allegra-D 12 Hour (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg) extended-release tablets prescribing information. Kansas City, MO; 2004 Dec.

78. Pinto YM, van Gelder IC, Heeringa M et al. QT lengthening and life-threatening arrhythmias associated with fexofenadine. Lancet. 1999; 353:980. [IDIS 421822] [PubMed 10459910]

79. Markham A, Wagstaff AJ. Comment on fexofenadine. Drugs. 1998; 55:269-74. [PubMed 9506246]

80. Galant SP. Comments on fexofenadine. Drugs. 1998; 55:275.

81. Simons FER. Comments on fexofenadine. Drugs. 1998; 55:275-6.

82. Sussman GL, Mason J, Compton D et al. The efficacy and safety of fexofenadine HCl and pseudoephedrine, alone and in combination, in seasonal allergic rhinitis. J Allergy Clin Immunol. 1999; 104:100-6. [IDIS 432261] [PubMed 10400846]

83. Pratt CM, Mason J, Russell T et al. Cardiovascular safety of fexofenadine HCl. Am J Cardiol. 1999; 83:1451-1454. [IDIS 428538] [PubMed 10335761]

84. Giraud T. QT lengthening and arrhythmias associated with fexofenadine. Lancet. 1999; 353:2072. [IDIS 428826] [PubMed 10376646]

85. Pinto YM, van Gelder IC, Heeringa M at al. QT lengthening and arrhythmias associated with fexofenadine. Lancet. 1999; 353:2072-3. [IDIS 428826] [PubMed 10376646]

86. Rao N, Weilert DR, Grace MGA et al. Pharmacokinetics of terfenadine-acid metabolite, MDL 16,455, in healthy geriatric subjects. Pharm Res. 1995 12 (Suppl 9):S-386. Abstract No. PPDM 8240.

87. Russell T, Arumugham T, Eller M et al. A comparison of MDL 16,455A pharmacokinetics by gender. Pharm Res. 1995 12 (Suppl 9): S-389. Abstract No. PPDM 8252.

88. Aventis. Allegra-D 24 Hour (fexofenadine hydrochloride 180 mg and pseudoephedrine hydrochloride 240 mg) extended-release tablets prescribing information. Kansas City, MO; 2005 Jan.

89. Srinivasan A, Budnitz D, Shehab N et al. Infant deaths associated with cough and cold medications—two states, 2005. MMWR Morb Mortal Wkly Rep. 2007; 56:1-4. [PubMed 17218934]

90. Food and Drug Administration. Cough and cold medications in children less than two years of age. Rockville, MD; 2007 Jan 12. From FDA website ().

More Fexofenadine Hydrochloride resources

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

• Fexofenadine Prescribing Information (FDA)


• Allegra Prescribing Information (FDA)


• Allegra Advanced Consumer (Micromedex) - Includes Dosage Information


• Allegra Consumer Overview


• Allegra MedFacts Consumer Leaflet (Wolters Kluwer)


• Allegra ODT Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Fexofenadine Hydrochloride with other medications

• Hay Fever
• Urticaria

Avatec

Dosage Form: FOR ANIMAL USE ONLY
Avatec®

Lasalocid Sodium

Type A Medicated Article

(medicated premix)

Coccidiocidal

Active drug ingredient

Each pound contains 90.7 g (20%) of lasalocid sodium activity in a carrier suitable for incorporation in feed.

For use in the manufacture of medicated feeds only

For the prevention of coccidiosis in

Target Species:	Caused by:
Broiler or Fryer Chickens:	Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima
Growing Turkeys:	E. meleagrimitis, E. gallopavonis, E. adenoeides
Rabbits:	Eimeria stiedae
Chukar Partridges:	Eimeria legionensis

Directions for use

Broiler, Fryer Chickens and Growing Turkeys

Use Avatec® continuously in the feed to provide from 68 g per ton (0.0075%) to 113 g per ton (0.0125%) lasalocid sodium concentration. The dosage range allows adjustment of drug level to severity of exposure. The higher levels are indicated for severe exposure. Consult a poultry disease diagnostician for advice regarding the optimal level of drug.

Rabbits

Use Avatec® continuously in the feed for rabbits up to 6 1/2 weeks of age to provide 113 g per ton (0.0125%) lasalocid sodium concentration.

Chukar Partridges

Use Avatec® continuously in the feed for young birds up to 8 weeks of age to provide 113 g per ton (0.0125%) lasalocid sodium concentration.

Mixing directions

Thoroughly mix the following amounts of Avatec® to make one ton of feed to provide from 68 g per ton (0.0075%) to 113 g per ton (0.0125%) lasalocid sodium concentration. When adding less than one pound of premix per ton of feed, it is recommended that the premix first be mixed with a small amount of feed (10-25 lbs.) prior to incorporation into the final feed.

Dosage for use in target species	Concentration % in Feed	Lasalocid grams/ton	lbs Avatec® per ton feed
Broiler, Fryer	0.0075%	68	3/4
Chickens and	0.0100%	90.7	1
Growing Turkeys	0.01125%	102	1 1/8
Broiler, Fryer Chickens, Growing Turkeys, Rabbits, Chukar Partridges	0.0125%	113	1 1/4

Warning

When mixing and handling lasalocid premix, use protective clothing, impervious gloves and a dust mask. Avoid contact with eyes. Operators should wash thoroughly with soap and water after handling.

Note: In addition to label statements of identity, ingredients and directions for use, labeling of feeds containing Avatec® must contain the following statements:

FOR BROILER OR FRYER CHICKENS ONLY and/or

FOR GROWING TURKEYS ONLY and/or

FOR CHUKAR PARTRIDGES (UP TO EIGHT WEEKS OF AGE) ONLY and/or

FOR RABBITS (UP TO SIX AND ONE HALF WEEKS OF AGE) ONLY

Additionally, all feed labeling must state:

FEED CONTINUOUSLY AS THE SOLE RATION

NADA 96-298, Approved by FDA

Marketed by

Alpharma Inc.

Bridgewater, New Jersey 08807

Net wt 50 LB (22.68 kg)

Made in USA

Trademarks registered

by Alpharma Inc.

710309 0904

PRINCIPAL DISPLAY PANEL - 50 LB Label

Avatec®

ALPHARMA

Lasalocid Sodium

Type A Medicated Article

(medicated premix)

Coccidiocidal

See back panel for use directions.

Net wt 50 LB (22.68 kg)

ALPHARMA®

Avatec®

Avatec  lasalocid sodium  granule

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 46573-313 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lasalocid Sodium (Lasalocid) Lasalocid 90.7 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN (light brown) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 46573-313-00 22.68 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA096298	01/01/2009

Labeler - Alpharma Inc. Animal Health (070954094)

Revised: 08/2009Alpharma Inc. Animal Health

Hair Regrowth Treatment Extra Strength For Men

Generic Name: minoxidil

Dosage Form: solution
Kroger Co. Hair Regrowth Treatment For Men Drug Facts

Active ingredient

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men

Uses

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Do not use if

• you are a woman


• your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.


• you have no family history of hair loss


• your hair loss is sudden and/or patchy


• you do not know the reason for your hair loss


• you are under 18 years of age. Do not use on babies and children.


• your scalp is red, inflamed, infected, irritated, or painful


• you use other medicines on the scalp

Ask a doctor before use if you have

heart disease

When using this product

• do not apply on other parts of the body


• avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.


• some people have experienced changes in hair color and/or texture


• it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.


• the amount of hair regrowth is different for each person. This product will not work for all men.

Stop use and ask a doctor if

• chest pain, rapid heartbeat, faintness, or dizziness occurs


• sudden, unexplained weight gain occurs


• your hands or feet swell


• scalp irritation or redness occurs


• unwanted facial hair growth occurs


• you do not see hair regrowth in 4 months

May be harmful if used when pregnant or breast-feeding.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area


• using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Other information

• see hair loss pictures on side of this carton


• before use, read all information on carton and enclosed leaflet


• keep the carton. It contains important information.


• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men


• in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%


• store at 20° to 25°C (68° to 77°F). Keep tightly closed.

Inactive ingredients

alcohol, propylene glycol, purified water

Questions or comments?

1-800-632-6900

Principal Display Panel

Compare to active ingredient of Men’s Rogaine® Extra Strength see side panel

Extra Strength for Men

Minoxidil Topical Solution USP, 5%

Hair Regrowth Treatment

Clinically Proven to Help Regrow Hair

Revitalizes Hair Follicles

Unscented

# Month Supply

Easy to use dropper

Not for Use by Women

Hair Regrowth Treatment for Men Carton

HAIR REGROWTH TREATMENT  EXTRA STRENGTH FOR MEN minoxidil  solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30142-798 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (MINOXIDIL) MINOXIDIL 3 g  in 60 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW (Light Amber) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 30142-798-16 1 BOTTLE In 1 CARTON contains a BOTTLE 1 60 mL In 1 BOTTLE This package is contained within the CARTON (30142-798-16) 2 30142-798-30 3 BOTTLE In 1 CARTON contains a BOTTLE 2 60 mL In 1 BOTTLE This package is contained within the CARTON (30142-798-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075598	12/05/2009

Labeler - Kroger Company (006999528)

Revised: 06/2009Kroger Company

More Hair Regrowth Treatment Extra Strength For Men resources

• Hair Regrowth Treatment Extra Strength For Men Use in Pregnancy & Breastfeeding
• Hair Regrowth Treatment Extra Strength For Men Drug Interactions
• Hair Regrowth Treatment Extra Strength For Men Support Group
• 7 Reviews for Hair Regrowth Treatment Extra Strength For Men - Add your own review/rating

Compare Hair Regrowth Treatment Extra Strength For Men with other medications

• Alopecia

hepatitis A and hepatitis B vaccine

Generic Name: hepatitis A and hepatitis B vaccine (HEP a TYE tis)

Brand names: Twinrix, Twinrix Preservative-Free

What is hepatitis A and hepatitis B vaccine?

Hepatitis A and B are serious diseases caused by virus.

Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.

Hepatitis B is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when a baby is born to a mother who is infected.

Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The hepatitis A and hepatitis B vaccine is used to help prevent these diseases. The vaccine works by exposing you to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaccination with hepatitis A and hepatitis B is recommended for all adults who are at risk of getting hepatitis A or B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has either hepatitis A or B infection.

Like any vaccine, the hepatitis A and hepatitis B vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

You should not receive this vaccine if you are allergic to yeast or neomycin (Mycafradin, Neo-Fradin, Neo-Tab), or if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A or hepatitis B.

Before receiving this vaccine, tell the doctor if you have multiple sclerosis, a bleeding or blood clotting disorder, seizures, a weak immune system, if you are taking a blood thinner, or if you are allergic to rubber.

Vaccination with hepatitis A and hepatitis B is recommended for all adults who are at risk of getting hepatitis A or B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has either hepatitis A or B infection.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Hepatitis A and hepatitis B vaccine will not protect you against infection with hepatitis C or E, or other viruses that affect the liver. It will also not protect you from hepatitis if you are already infected with the virus, even if you do not yet show symptoms.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis A or B is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

Hepatitis A and hepatitis B vaccine will not protect you against infection with hepatitis C or E, or other viruses that affect the liver. It will also not protect you from hepatitis A or B if you are already infected with the virus, even if you do not yet show symptoms.

You should not receive this vaccine if you are allergic to yeast or neomycin (Mycafradin, Neo-Fradin, Neo-Tab), or if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A or hepatitis B.

Before receiving this vaccine, tell the doctor if you have:

• 
  

  multiple sclerosis;

  
  


• 
  

  a bleeding or blood clotting disorder such as hemophilia or easy bruising;

  
  


• 
  

  a history of seizures;

  
  


• 
  

  an allergy to latex rubber;

  
  


• 
  

  a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or

  
  


• 
  

  if you are taking a blood thinner such as warfarin (Coumadin).

  
  

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

FDA pregnancy category C. It is not known whether hepatitis A and hepatitis B vaccine is harmful to an unborn baby. Before receiving this vaccine, tell your doctor if you are pregnant. It is not known whether hepatitis A and hepatitis B vaccine passes into breast milk or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

How is this vaccine given?

This vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.

The hepatitis A and hepatitis B vaccine is given in a series of shots. The booster shots are sometimes given 1 month and 6 months after the first shot.

If you have a high risk of hepatitis infection, you may be given 3 shots within 30 days of each other, and a fourth shot 12 months after the first.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

What happens if I miss a dose?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

This vaccine side effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis A or B is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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.

Call your doctor at once if you have any of these serious side effects:

• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  
  


• 
  

  fast or pounding heartbeats; or

  
  


• 
  

  easy bruising or bleeding.

  
  

Less serious side effects include:

• 
  

  redness, pain, tenderness, swelling, or a hard lump where the shot was given;

  
  


• 
  

  headache, tired feeling;

  
  


• 
  

  mild fever;

  
  


• 
  

  runny or stuffy nose, sore throat, other cold symptoms; or

  
  


• 
  

  nausea, vomiting, loss of appetite, diarrhea.

  
  

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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Hepatitis A and hepatitis B vaccine Dosing Information

Usual Adult Dose for Hepatitis B Prophylaxis:

Primary immunization: 1 mL IM in the deltoid area at 0, 1 and 6 months.
Alternatively, a 4 dose schedule given on days 0, 7, and 21 to 30 followed by a booster at month 12 may be used.

Usual Adult Dose for Hepatitis A Prophylaxis:

Primary immunization: 1 mL IM in the deltoid area at 0, 1 and 6 months.
Alternatively, a 4 dose schedule given on days 0, 7, and 21 to 30 followed by a booster at month 12 may be used.

What other drugs will affect hepatitis A and hepatitis B vaccine?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have received drugs or treatments in the past 2 weeks that can weaken the immune system, including:

• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

  
  


• 
  

  medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

This list is not complete and there may be other drugs that can interact with hepatitis A and hepatitis B vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More hepatitis A and hepatitis B vaccine resources

• Hepatitis A and hepatitis B vaccine Use in Pregnancy & Breastfeeding
• Hepatitis A and hepatitis B vaccine Drug Interactions
• Hepatitis A and hepatitis B vaccine Support Group
• 0 Reviews for Hepatitis A and hepatitis B vaccine - Add your own review/rating

Compare hepatitis A and hepatitis B vaccine with other medications

• Hepatitis A Prophylaxis
• Hepatitis B Prevention

Where can I get more information?

• Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

Perrigo Benzoyl Peroxide Gel

Dosage Form: aqueous base gel
BENZOYL PEROXIDE GEL, 2.5%

Benzoyl Peroxide Gel, 2.5% Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 5% Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 10% Aqueous Base Acne Gel

Rx only

For Topical Use Only

Perrigo Benzoyl Peroxide Gel Description

Benzoyl Peroxide Gel, 2.5%, 5%, and 10% Aqueous Base Acne Gels are topical preparations containing benzoyl peroxide as the active ingredient.

Benzoyl Peroxide Gel, 2.5% Aqueous Base Acne Gel contains: 2.5% benzoyl peroxide, in an aqueous gel base formulated with carbomer homopolymer type C, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, hydrated silica, methylparaben, poloxamer 182, purified water, and sodium hydroxide.

Benzoyl Peroxide Gel, 5% Aqueous Base Acne Gel contains: 5% benzoyl peroxide, in an aqueous gel base formulated with carbomer homopolymer type C, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, hydrated silica, methylparaben, poloxamer 182, purified water, and sodium hydroxide.

Benzoyl Peroxide Gel, 10% Aqueous Base Acne Gel contains: 10% benzoyl peroxide, in an aqueous gel base formulated with carbomer 940, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, hydrated silica, methylparaben, poloxamer 182, purified water, and sodium hydroxide.

The structural formula of benzoyl peroxide is:

Perrigo Benzoyl Peroxide Gel - Clinical Pharmacology

The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne.

Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

Indications and Usage for Perrigo Benzoyl Peroxide Gel

Benzoyl Peroxide Gel 2.5%, 5%, and 10% are indicated for use in the topical treatment of mild to moderate acne vulgaris. Benzoyl Peroxide Gel 2.5%, 5%, and 10% may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations.

Contraindications

Benzoyl Peroxide Gel 2.5%, 5%, and 10% should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.

Precautions

General -

For external use only. Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known.

Pregnancy:

Teratogenic Effects:

Pregnancy Category C -

Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be given to a pregnant woman only if clearly needed.

Nursing Mothers -

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Pediatric Use -

Safety and effectiveness in children below the age of 12 have not been established.

Adverse Reactions

Contact sensitization reactions are associated with the use of topical benzoyl peroxide products and may be expected to occur in 10 to 25 of 1000 patients. The most frequent adverse reactions associated with benzoyl peroxide use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use.

Perrigo Benzoyl Peroxide Gel Dosage and Administration

It is recommended that therapy be initiated with Benzoyl Peroxide Gel, 2.5%, applying the medication to the affected areas once a day during the first week, and twice a day thereafter as tolerated. Frequency of use should be adjusted to obtain the desired clinical response. Therapy with Benzoyl Peroxide Gel, 5% or Benzoyl Peroxide Gel, 10% may be initiated in patients who demonstrate accommodation to Benzoyl Peroxide Gel, 2.5%.

Gentle cleansing of the affected areas prior to application of Benzoyl Peroxide Gel, 2.5%, 5%, or 10% may be beneficial.

Clinically visible improvements will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response.

How is Perrigo Benzoyl Peroxide Gel Supplied

Benzoyl Peroxide Gel 2.5%, 5%, and 10% are available as follows:

Benzoyl Peroxide Gel, 2.5%Aqueous Base Acne Gel

60 g tube (NDC 45802-905-96)

Benzoyl Peroxide Gel, 5%Aqueous Base Acne Gel

60 g tube (NDC 45802-910-96)

90 g tube (NDC 45802-910-01)

Benzoyl Peroxide Gel, 10%Aqueous Base Acne Gel

60 g tube (NDC 45802-915-96)

90 g tube (NDC 45802-915-01)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Manufactured by Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev. 12/10

305253

: 0H400 RC J2

Principal Display Panel - Carton

Rx Only

Benzoyl Peroxide Gel, 2.5%

For Topical Use Only

Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 2.5% Carton

Principal Display Panel - Tube

Rx Only

Benzoyl Peroxide Gel, 2.5%

For Topical Use Only

Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 2.5% Tube

BENZOYL PEROXIDE  AQUEOUS BASE benzoyl peroxide  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45802-905 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 2.5 g  in 100 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45802-905-96 1 TUBE In 1 CARTON contains a TUBE 1 60 g In 1 TUBE This package is contained within the CARTON (45802-905-96)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/24/2008

Labeler - Perrigo New York Inc (078846912)

Revised: 10/2011Perrigo New York Inc

More Perrigo Benzoyl Peroxide Gel resources

• Perrigo Benzoyl Peroxide Gel Side Effects (in more detail)
• Perrigo Benzoyl Peroxide Gel Use in Pregnancy & Breastfeeding
• Perrigo Benzoyl Peroxide Gel Drug Interactions
• Perrigo Benzoyl Peroxide Gel Support Group
• 15 Reviews for Perrigo Benzoyl Peroxide - Add your own review/rating

Compare Perrigo Benzoyl Peroxide Gel with other medications

• Acne
• Perioral Dermatitis