Seromycin

Generic Name: cycloserine (Oral route)

sye-kloe-SER-een

Commonly used brand name(s)

In the U.S.

• Seromycin

Available Dosage Forms:

• Capsule

Therapeutic Class: Antitubercular

Uses For Seromycin

Cycloserine belongs to the family of medicines called antibiotics. It is used to treat tuberculosis (TB). When cycloserine is used for TB, it is given with other medicines for TB. Cycloserine may also be used for other conditions as determined by your doctor.

To help clear up your tuberculosis (TB) completely, you must keep taking this medicine for the full time of treatment, even if you begin to feel better. This is very important. It is also important that you do not miss any doses.

Cycloserine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, cycloserine is used in certain patients with the following medical condition:

• Atypical mycobacterial infections, such as Mycobacterium avium complex (MAC)

Before Using Seromycin

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

Although there is no specific information comparing use of cycloserine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of cycloserine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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:

• Alcohol abuse (or history of) or


• Convulsive disorders such as seizures or epilepsy—Cycloserine may increase the risk of seizures in patients who drink alcohol or have a history of seizures

• Kidney disease—Cycloserine is removed from the body through the kidneys, and patients with kidney disease may need an adjustment in dose or the medicine may need to be discontinued

• Mental disorders such as mental depression, psychosis, or severe anxiety—Cycloserine may cause anxiety, mental depression, or psychosis

Proper Use of Seromycin

Cycloserine may be taken after meals if it upsets your stomach.

To help clear up your infection completely, it is very important that you keep taking this medicine for the full time of treatment , even if you begin to feel better after a few weeks. If you are taking this medicine for TB, you may have to take it every day for as long as 1 to 2 years or more. If you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 2 doses a day, the doses should be spaced about 12 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

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 the oral dosage form (capsules):
  
  • For treatment of tuberculosis:
    
    • Adults and teenagers—250 milligrams (mg) two times a day to start. Your doctor may slowly increase your dose up to 250 mg three or four times a day. This medicine must be taken along with other medicines to treat tuberculosis.
    
    
    • Children—Use and dose must be determined by your doctor. Doses of 10 to 20 mg per kilogram (4.5 to 9.1 mg per pound) of body weight per day have been used. This medicine must be taken along with other medicines to treat tuberculosis.
    
    
  
  

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.

Precautions While Using Seromycin

It is very important that your doctor check your progress at regular visits.

If your symptoms do not improve within 2 to 3 weeks, or if they become worse, check with your doctor.

If cycloserine causes you to feel very depressed or to have thoughts of suicide, check with your doctor immediately. Your doctor will probably want to change your medicine.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Some of cycloserine's side effects (for example, convulsions [seizures]) may be more likely to occur if you drink alcoholic beverages regularly while you are taking this medicine. Therefore, you should not drink alcoholic beverages while you are taking this medicine.

Seromycin 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

• Anxiety


• confusion


• dizziness


• drowsiness


• increased irritability


• increased restlessness


• mental depression


• muscle twitching or trembling


• nervousness


• nightmares


• other mood or mental changes


• speech problems


• thoughts of suicide

Less common

• Convulsions (seizures)


• numbness, tingling, burning pain, or weakness in the hands or feet


• skin rash

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

• Headache

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: Seromycin 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.

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More Seromycin resources

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

• Seromycin Prescribing Information (FDA)


• Seromycin Concise Consumer Information (Cerner Multum)


• Seromycin Monograph (AHFS DI)


• Seromycin MedFacts Consumer Leaflet (Wolters Kluwer)


• Cycloserine


• Cycloserine Professional Patient Advice (Wolters Kluwer)

Compare Seromycin with other medications

• Tuberculosis, Active
• Tuberculosis, Extrapulmonary

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]

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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.

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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]

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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.

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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.

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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

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