Thursday, October 6, 2016

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, Fryer0.0075%  68    3/4
Chickens and0.0100%  90.71
Growing Turkeys0.01125%102    1 1/8
Broiler, Fryer Chickens, Growing Turkeys, Rabbits, Chukar Partridges0.0125%  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 TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGNDC Product Code (Source)46573-313
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lasalocid Sodium (Lasalocid)Lasalocid90.7 g  in 0.45 kg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBROWN (light brown)Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
146573-313-0022.68 kg In 1 BAGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA09629801/01/2009


Labeler - Alpharma Inc. Animal Health (070954094)
Revised: 08/2009Alpharma Inc. Animal Health



anesthetic, local Parenteral


Class Name: anesthetic, local (Parenteral route)


Uses For This Medicine

Parenteral-local anesthetics are given by injection to cause loss of feeling before and during surgery, dental procedures (including dental surgery), or labor and delivery. These medicines do not cause loss of consciousness.


These medicines are given only by or under the immediate supervision of a medical doctor or dentist, or by a specially trained nurse, in the doctor's office or in a hospital.


Before Using This Medicine


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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


Children may be especially sensitive to the effects of parenteral-local anesthetics. This may increase the chance of side effects.


Geriatric


Elderly people are especially sensitive to the effects of parenteral-local anesthetics. This may increase the chance of side effects.


Pregnancy


Local anesthetics have not been reported to cause birth defects in humans.


Use of a local anesthetic during labor and delivery may rarely cause unwanted effects. These medicines may increase the length of labor by making it more difficult for the mother to bear down (push). They may also cause unwanted effects in the fetus or newborn baby, especially if certain medical problems are present at the time of delivery. Before receiving a local anesthetic for labor and delivery, you should discuss with your doctor the good that this medicine will do as well as the risks of receiving it.


Breast Feeding


It is not known whether local anesthetics pass into breast milk. However, these medicines have not been reported to cause problems in nursing babies.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Asthma—Increased chance of allergic-like reactions with use of some local anesthetics

  • Brain infection or tumor or

  • Blood clotting disorders—Increased chance of bleeding with injection of local anesthetics

  • Type 2 diabetes mellitus—Use of local anesthetics can cause stress on your heart if you have diabetes mellitus.

  • Heart disease—Use of local anesthetics can worsen some kinds of heart disease.

  • History of migraine headaches—Use of local anesthetics can worsen headaches.

  • Hypertension (high blood pressure) or

  • Hypotension (low blood pressure)—Use of local anesthetics can cause hypotension or hypertension.

  • Hyperthyroidism—Use of some local anesthetics can cause stress on your heart if you have hyperthyroidism.

  • Kidney disease or

  • Liver disease—Increased chance of side effects

  • Methemoglobinemia—Prilocaine may make this condition worse.

  • Peripheral vascular disease—Use of some local anesthetics can make this condition worse or can cause your blood pressure to increase.

  • Skin infection or inflammation—Your physician may not want to inject the local anesthetic into infected or inflamed skin because the local anesthetic may not work as well.

Proper Use of This Medicine


Dosing


The dose medicines in this class 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 these medicines. 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.


The dose of a local anesthetic will be different for different patients. Your health care professional will decide on the right amount for you, depending on:


  • Your age;

  • Your general physical condition;

  • The reason the local anesthetic is being given; and

  • Other medicines you are taking or will receive before or after the local anesthetic is given.

Precautions While Using This Medicine


For patients going home before the numbness or loss of feeling caused by a local anesthetic wears off:


  • During the time that the injected area feels numb, serious injury can occur without your knowing about it. Be especially careful to avoid injury until the anesthetic wears off or feeling returns to the area.

  • If you have received a local anesthetic injection in your mouth, do not chew gum or food while your mouth feels numb. You may injure yourself by biting your tongue or the inside of your cheeks

Side Effects of This Medicine


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.


While you are in the hospital or your medical doctor's or dentist's office, your medical doctor, dentist, or nurse will carefully follow the effects of any medicine you have received. However, some effects may not be noticed until later.


Check with your doctor immediately if any of the following side effects occur:


Less common or rare
  • Bluish lips and fingernails

  • breathing problems

  • chest pain

  • convulsions (seizures)

  • dizziness

  • drowsiness

  • fatigue

  • fever

  • headache

  • irregular heartbeat

  • itching

  • nausea and/or vomiting

  • pale skin, troubled breathing, exertional, unusual bleeding or bruising, unusual tiredness or weakness

  • raised red swellings on the skin, lips, tongue, or in the throat

  • rapid heart rate

  • restlessness

  • unusual tiredness or weakness

Check with your doctor as soon as possible if any of the following side effects occur:


Less common or rare
  • Back pain

  • constipation

  • difficulty in opening the mouth

  • inability to hold bowel movement and/or urine

  • loss of sexual function

  • paralysis of legs

  • persistent numbness

  • prolonged numbness or tingling of lips and mouth

  • shivering

  • skin rash

  • tingling or “pins and needles sensation

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.



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


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

Aplenzin


Generic Name: bupropion (byoo PRO pee on)

Brand Names: Aplenzin, Budeprion SR, Budeprion XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban, Zyban Advantage Pack


What is bupropion?

Bupropion is an antidepressant medication.


Bupropion is used to treat major depressive disorder and seasonal affective disorder. The Zyban brand of bupropion is used to help people stop smoking by reducing cravings and other withdrawal effects.


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


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


Do not take bupropion if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. You should not take bupropion if you have seizures, an eating disorder, if you are using a second form of bupropion, or if you have suddenly stopped using alcohol or sedatives.

Bupropion may cause seizures, especially in people with certain medical conditions or when using certain drugs. Tell your doctor about all of your medical conditions and the drugs you use.



Video: Treatment for Depression







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





You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.


Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before taking bupropion?


Do not take bupropion if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. You should not take bupropion if you have:

  • epilepsy or a seizure disorder;




  • an eating disorder such as anorexia or bulimia;




  • if you are using a second form of bupropion; or




  • if you have suddenly stopped using alcohol or sedatives (such as Valium).



Bupropion may cause seizures, especially in people with certain medical conditions. Tell your doctor about all of your medical conditions.


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



  • a history of head injury, seizures, or brain or spinal cord tumor;




  • heart disease, high blood pressure, history of heart attack;




  • kidney or liver disease (especially cirrhosis); or




  • bipolar disorder (manic depression).



You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.


Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.


FDA pregnancy category C. It is not known whether bupropion will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Bupropion passes into breast milk and could be harmful to a nursing baby. You should not breast-feed while you are taking bupropion.

How should I take bupropion?


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


Bupropion can be taken with or without food.


Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time, which could increase side effects including seizures.

If you take Zyban to help you stop smoking, you may continue to smoke for about 1 week after you start the medicine. Set a date to quit smoking during the second week of treatment. Talk to your doctor if you are having trouble quitting after you have used Zyban for at least 7 weeks.


Your doctor may prescribe nicotine patches or gum to help support your smoking cessation treatment. Be sure you read all directions and safety information for the nicotine product. Using nicotine with Zyban may raise your blood pressure and your doctor may want to check your blood pressure regularly. Do not smoke at any time if you are using a nicotine product along with Zyban. Too much nicotine can cause serious side effects.


Do not stop taking bupropion without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly. This medication can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking bupropion. Store at room temperature away from moisture and heat.

What happens if I miss a dose?


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


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of bupropion can be fatal. Overdose symptoms may include muscle stiffness, hallucinations, fast or uneven heartbeat, shallow breathing, or fainting.

What should I avoid while taking bupropion?


Drinking alcohol may increase your risk of seizures. If you drink alcohol regularly, talk with your doctor before changing the amount you drink. Bupropion can cause seizures in people who drink a lot of alcohol and then suddenly quit drinking. when they start using the medication.

Avoid using bupropion to treat more than one condition at a time. If you take Wellbutrin for depression, do not also take Zyban to quit smoking. Too much of this medicine can increase your risk of a seizure.


Bupropion may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Bupropion 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.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.


Call your doctor at once if you have a serious side effect such as:

  • seizure (convulsions);




  • severe blistering, peeling, and red skin rash;




  • fever, swollen glands, rash or itching, joint pain, or general ill feeling;




  • confusion, trouble concentrating; or




  • hallucinations, unusual thoughts or behavior.



Less serious side effects may include:



  • headache or migraine, dizziness, tremors (shaking);




  • sleep problems (insomnia), loss of interest in sex;




  • nausea, vomiting, constipation, dry mouth;




  • appetite changes, weight loss or gain; or




  • mild itching or skin rash, increased sweating.



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


What other drugs will affect bupropion?


Many drugs can interact with bupropion. Below is just a partial list. Tell your doctor if you are using:



  • medication used to prevent blood clots, such as clopidogrel (Plavix) or ticlopidine (Ticlid), tirofiban (Aggrastat);




  • cancer medicine such as cyclophosphamide (Cytoxan, Neosar), doxorubicin (Adriamycin, Doxil), irinotecan (Camptosar), or thiotepa (Thioplex);




  • heart or blood pressure medication such as atenolol (Tenormin), flecainide (Tambocor), metoprolol (Lopressor, Toprol), propafenone (Rythmol), propranolol (Inderal), and others; or




  • HIV or AIDS medications such as efavirenz (Atripla, Sustiva) or ritonavir (Norvir, Kaletra).




This list is not complete and there are many other drugs that can interact with bupropion. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. You may have a higher risk of seizures if you use certain medications together with bupropion. Tell your doctor about all other medications you use, especially:

  • any other antidepressant, or a medicine to treat a psychiatric disorder;




  • antihistamines that make you sleepy;




  • asthma medications or bronchodilators;




  • birth control pills or hormone replacement estrogens;




  • bladder or urinary medications such as oxybutynin (Ditropan, Urotrol);




  • antibiotics such as cefdinir (Omnicef), cephalexin (Keflex), ciprofloxacin (Cipro), amoxicillin (Amoxil, Augmentin), penicillin, and others;




  • diet pills, a stimulant, or ADHD medication such as Adderall or Ritalin;




  • insulin or diabetes medications you take by mouth;




  • medication for nausea, vomiting, or motion sickness;




  • medications to treat or prevent malaria;




  • medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor (prolactinoma);




  • medicines used to prevent organ transplant rejection;




  • narcotic pain medication;




  • a sedative such as diazepam (Valium), and others;




  • a steroid such as prednisone, and others;




  • street drugs such as "speed" or cocaine;




  • theophylline (Theo-Dur, Slo-Bid, Bronkodyl Theolair, Respbid); or




  • ulcer or irritable bowel medications.




More Aplenzin resources


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


  • Aplenzin Consumer Overview

  • Aplenzin Prescribing Information (FDA)

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

  • Aplenzin Advanced Consumer (Micromedex) - Includes Dosage Information

  • Budeprion XL Prescribing Information (FDA)

  • Bupropion Prescribing Information (FDA)

  • Bupropion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Bupropion Professional Patient Advice (Wolters Kluwer)

  • Bupropion Hydrochloride Monograph (AHFS DI)

  • Wellbutrin Consumer Overview

  • Wellbutrin Prescribing Information (FDA)

  • Wellbutrin SR Prescribing Information (FDA)

  • Wellbutrin SR Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Wellbutrin XL Prescribing Information (FDA)

  • Wellbutrin XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zyban Prescribing Information (FDA)

  • Zyban Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zyban Consumer Overview



Compare Aplenzin with other medications


  • Depression


Where can I get more information?


  • Your pharmacist can provide more information about bupropion.

See also: Aplenzin side effects (in more detail)


Aluminum/Magnesium/Simethicone Suspension


Pronunciation: a-LOO-min-uhm/mag-NEE-zee-uhm/si-METH-i-kone
Generic Name: Aluminum/Magnesium/Simethicone
Brand Name: Examples include Di-Gel Liquid and Mylanta


Aluminum/Magnesium/Simethicone Suspension is used for:

Treating acid indigestion, heartburn, gas, and sour stomach. It may also be used for other conditions as determined by your doctor.


Aluminum/Magnesium/Simethicone Suspension is an antacid and antiflatulent. It works by neutralizing acid in the stomach. It also causes the gas produced by some foods to remain dissolved, allowing it to be passed through the system more comfortably.


Do NOT use Aluminum/Magnesium/Simethicone Suspension if:


  • you are allergic to any ingredient in Aluminum/Magnesium/Simethicone Suspension

  • you are also taking citrate salts (found in some calcium supplements, antacids, and laxatives)

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



Before using Aluminum/Magnesium/Simethicone Suspension:


Some medical conditions may interact with Aluminum/Magnesium/Simethicone Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have Alzheimer disease, kidney problems, appendicitis, diarrhea, a stomach blockage, or an ileostomy

  • if you have recently had stomach bleeding

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


  • Cation exchange resins (eg, sodium polystyrene sulfonate) and citrate salts (found in some calcium supplements, antacids, and laxatives) because they may increase the actions and the risk of Aluminum/Magnesium/Simethicone Suspension's side effects

  • Anticoagulants (eg, warfarin), quinidine, or sulfonylureas (eg, glyburide) because their actions and the risk of their side effects may be increased

  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), bisphosphonates (eg, risedronate), cephalosporins (eg, cephalexin), corticosteroids (eg, hydrocortisone), cyclosporine, delavirdine, digoxin, imidazoles (eg, ketoconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Aluminum/Magnesium/Simethicone Suspension, especially when taken at the same time as Aluminum/Magnesium/Simethicone Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aluminum/Magnesium/Simethicone Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Aluminum/Magnesium/Simethicone Suspension:


Use Aluminum/Magnesium/Simethicone Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Aluminum/Magnesium/Simethicone Suspension by mouth with or without food.

  • Shake well before each use.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • Do not use Aluminum/Magnesium/Simethicone Suspension within 2 hours before or after taking a beta-blocker (eg, propranolol), bisphosphonate (eg, risedronate), cephalosporin (eg, cephalexin), corticosteroid (eg, hydrocortisone), delavirdine, digoxin, imidazole (eg, ketoconazole), penicillamine, or sulfonylurea (eg, glyburide) because their effectiveness may be decreased by Aluminum/Magnesium/Simethicone Suspension.

  • If you miss a dose of Aluminum/Magnesium/Simethicone Suspension and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aluminum/Magnesium/Simethicone Suspension.



Important safety information:


  • Do NOT take more than the recommended dose or take the maximum dose for longer than 2 weeks without checking with your doctor.

  • If your symptoms do not get better within 2 weeks or if they get worse, or if you experience black, tarry stools or vomit that looks like coffee grounds, check with your doctor.

  • Aluminum/Magnesium/Simethicone Suspension has aluminum and magnesium in it. Before you begin taking any new prescription or over-the-counter medicine, read the ingredients to see has aluminum or magnesium in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aluminum/Magnesium/Simethicone Suspension while you are pregnant. If you are or will be breast-feeding while you use Aluminum/Magnesium/Simethicone Suspension, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Aluminum/Magnesium/Simethicone Suspension:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; diarrhea.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; muscle weakness; nausea; slow reflexes; vomiting.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Aluminum/Magnesium/Simethicone Suspension:

Store Aluminum/Magnesium/Simethicone Suspension between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aluminum/Magnesium/Simethicone Suspension out of the reach of children and away from pets.


General information:


  • If you have any questions about Aluminum/Magnesium/Simethicone Suspension, please talk with your doctor, pharmacist, or other health care provider.

  • Aluminum/Magnesium/Simethicone Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

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

This information is a summary only. It does not contain all information about Aluminum/Magnesium/Simethicone Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Aluminum/Magnesium/Simethicone resources


  • Aluminum/Magnesium/Simethicone Use in Pregnancy & Breastfeeding
  • Aluminum/Magnesium/Simethicone Drug Interactions
  • Aluminum/Magnesium/Simethicone Support Group
  • 1 Review for Aluminum/Magnesium/Simethicone - Add your own review/rating


Compare Aluminum/Magnesium/Simethicone with other medications


  • Gas
  • GERD
  • Indigestion

Aminocaproic Acid


Class: Hemostatics
VA Class: BL300
CAS Number: 60-32-2
Brands: Amicar

Introduction

A synthetic monoamino carboxylic acid that is an inhibitor of fibrinolysis.b


Uses for Aminocaproic Acid


Bleeding Due to Elevated Fibrinolytic Activity


Treatment of excessive bleeding resulting from systemic hyperfibrinolysis and urinary fibrinolysis.b In life-threatening situations, fresh whole blood, fibrinogen infusions, and other emergency measures also may be required.b


Used in systemic hyperfibrinolysis associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; in carcinoma of the lung, prostate, cervix, or stomach; in abruptio placentae; and in hematologic disorders such as amegakaryocytic thrombocytopenia accompanying aplastic anemia (reduces the need for platelet transfusions).108 b


Used in urinary fibrinolysis associated with complications of severe trauma, anoxia, and shock,a and as manifested by surgical hematuria especially following prostatectomy and nephrectomy,b or in nonsurgical hematuria accompanying polycystic or neoplastic disease of the GU tract.b


Used in conjunction with heparin therapy in patients with acute promyelocytic leukemia; initiate therapy when plasma α2-antiplasmin (α2-plasmin inhibitor) levels have decreased to <40% of normal levels.107


Ocular Hemorrhage


Has been used effectively for the prevention of secondary ocular hemorrhage in patients with nonperforating traumatic hyphema.100 101 102 103 104 105 106 Designated an orphan drug by FDA for topical treatment of traumatic hyphema.119


Hereditary Hemorrhagic Telangiectasia


Has been used orally for the management of hereditary hemorrhagic telangiectasia.112


Aminocaproic Acid Dosage and Administration


Administration


Administer orally or by IV infusion.b


Oral Administration


Administer orally if the patient is able to take oral medication.b


IV Administration


For solution and drug compatibility information, see Compatibility under Stability.


Administer by IV infusion.b


Avoid rapid IV administration; hypotension, bradycardia, and/or arrhythmia may result.b


Dilution

For the initial infusion (loading dose), add 4–5 g of aminocaproic acid (16–20 mL of the injection) to 250 mL of diluent.b


For maintenance infusions, add 1 g of aminocaproic acid (4 mL of the injection) to 50 mL of diluent to provide a final concentration of approximately 20 mg/mL.b


Rate of Administration

Initial infusion (loading dose): Infuse 4–5 g over 1 hour in adults.b


Maintenance infusion: Infuse 1 g per hour in adults.b


Dosage


Pediatric Patients


Bleeding Due to Elevated Fibrinolytic Activity

Oral

100 mg/kg or 3 g/m2 during the first hour, then 33.3 mg/kg per hour or 1 g/m2 per hour (maximum 18 g/m2 in 24 hours) has been used.a Manufacturer states that safety and efficacy not established in pediatric patients.b


IV

Initial infusion (loading dose): 100 mg/kg or 3 g/m2 over 1 hour has been used.a Manufacturer states that safety and efficacy not established in pediatric patients.b


Maintenance infusion

Maintenance infusion: 33.3 mg/kg per hour or 1 g/m2 per hour (maximum 18 g/m2 in 24 hours) has been used.a Manufacturer states that safety and efficacy not established in pediatric patients.b


Adults


Bleeding Due to Elevated Fibrinolytic Activity

Oral

5 g during the first hour, then 1–1.25 g per hour for about 8 hours or until bleeding has been controlled.a b


IV

Initial infusion (loading dose): 4–5 g over 1 hour.b


Maintenance infusion: 1 g per hour for about 8 hours or until bleeding has been controlled.b


Ocular Hemorrhage

Oral

100 mg/kg (up to 5 g) every 4 hours, up to a maximum daily dosage of 30 g, for 5 days has been used;100 101 102 103 lower daily dosages also may be effective.102


Hereditary Hemorrhagic Telangiectasia

Oral

1 or 1.5 g twice daily for 1–2 months, followed by 1–2 g daily.112


Prescribing Limits


Pediatric Patients


Bleeding Due to Elevated Fibrinolytic Activity

Oral or IV

Maximum 18 g/m2 in 24 hours.a


Adults


Ocular Hemorrhage

Oral

Maximum 30 g daily.100 101 102 103


Cautions for Aminocaproic Acid


Contraindications



  • Active intravascular clotting process.b




  • When it is not clear whether hemorrhage is secondary to primary fibrinolysis or disseminated intravascular coagulation (DIC), the distinction must be made before aminocaproic acid is administered.b Do not use without concomitant heparin therapy in patients with evidence of DIC.b



Warnings/Precautions


Warnings


Urinary Tract Bleeding

Intrarenal obstruction via glomerular capillary thrombosis or clots in the renal pelvis and ureters reported in patients with upper urinary tract bleeding.b The drug should not be used in patients with hematuria of upper urinary tract origin unless the potential benefits outweigh risks.b


Musculoskeletal Effects

Skeletal muscle weakness with necrosis of muscle fiber reported with prolonged administration.b Presentation may range from mild myalgias with weakness and fatigue to severe proximal myopathy with rhabdomyolysis, myoglobinuria, and renal failure; CK levels are elevated.b Manifestations resolve with drug discontinuance but may recur if therapy is reinstated.b


Monitor CK concentrations with long-term therapy.b Discontinue drug if an increase in CK occurs.b


If skeletal myopathy occurs, consider possibility of cardiac muscle damage.b


Benzyl Alcohol in Neonates

Aminocaproic acid injection contains as a preservative benzyl alcohol, which has been associated with toxicity (fatalities) in neonates.b (See Pediatric Precautions.)


General Precautions


Should be used only in acute, life-threatening situationsa involving hemorrhage resulting from hyperfibrinolysis that has been confirmed by laboratory studies.b


Clot Formation

If aminocaproic acid is present, clots formed in vivo may not undergo spontaneous lysis as do normal clots because aminocaproic acid in the clot may inhibit spontaneous fibrinolysis.b No clear-cut evidence for in vivo drug-induced thrombosis; however, the hazard of this theoretical complication remains a possibility.b


CNS Effects

Neurological deficits (hydrocephalus, cerebral ischemia, cerebral vasospasm) associated with use of antifibrinolytic agents in the management of subarachnoid hemorrhage.b Causal relationship to the drugs not established.b


Specific Populations


Pregnancy

Category C.b


Lactation

Not known if aminocaproic acid is distributed into milk; caution if used in nursing women.b


Pediatric Use

Safety and efficacy not established.b 111


Large amounts of benzyl alcohol (i.e., 100–400 mg/kg daily) have been associated with toxicity (fatal “gasping syndrome”) in neonates (see Warnings); each mL of aminocaproic acid injection in multiple-dose vials contains 9 mg of benzyl alcohol.b


Common Adverse Effects


Nausea,b vomiting,b cramping,a abdominal pain,b diarrhea,b dizziness,b malaise,b fever,a conjunctival suffusion,a dyspnea,b nasal congestion,b headache,b edema,b pruritus,b rash.b


Interactions for Aminocaproic Acid


Specific Drugs









Drug



Interaction



Anti-inhibitor coagulant complex



Increased risk of thrombosisb



Factor IX complex



Increased risk of thrombosisb


Aminocaproic Acid Pharmacokinetics


Absorption


Bioavailability


Rapidly and completely absorbed from the GI tract; peak plasma concentrations are attained within about 1 hour following a 5-g dose.b 111


Special Populations


Plasma concentrations may be higher in patients with severe renal impairment.b


Distribution


Extent


Distributed through extravascular as well as intravascular compartments; penetrates human red blood cells and other body cells.b


Not known if aminocaproic acid is distributed into milk.b


Plasma Protein Binding


Not bound.a


Elimination


Metabolism


The major portion of aminocaproic acid is not metabolized.b 111


Elimination Route


Eliminated principally in urine as unchanged drug (65%) and the adipic acid metabolite (11%).b 111


Half-life


2 hours.b


Special Populations


Removed by hemodialysis; may be removed by peritoneal dialysis.b 111 121


Stability


Storage


Oral


Tablets

15–30°C; tight containers.b


Syrup

15–30°C; tight containers.b Do not freeze.b


Parenteral


Injection

15–30°C.b Do not freeze.b


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Parenteral


Solution CompatibilityHID





Compatible



Dextrose 5% in water



Sodium chloride 0.9%


Y-Site CompatibilityHID




Compatible



Fenoldopam mesylate


ActionsActions



  • Aminocaproic acid inhibits the activation of plasminogen; also inhibits the action of fibrinolysin (plasmin).b



Advice to Patients



  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products.b




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




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



Preparations


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











































Aminocaproic Acid

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Solution



1.25 g/5 mL



Amicar Syrup (with parabens)



Xanodyne



Aminocaproic Acid Syrup



VersaPharm



Tablets



500 mg



Amicar (with povidone; scored)



Xanodyne



Aminocaproic Acid Tablets



VersaPharm



1 g



Amicar (with povidone; scored)



Xanodyne



Parenteral



For injection concentrate, for IV infusion



250 mg/mL (5 g)



Amicar Intravenous (with benzyl alcohol 0.9%)



Xanodyne



Aminocaproic Acid Injection (with benzyl alcohol 0.9%)



American Regent, Hospira


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.


Amicar 500MG Tablets (XANODYNE PHARMACEUTICALS INC): 30/$103.39 or 90/$285.98


Aminocaproic Acid 500MG Tablets (VERSAPHARM): 100/$186.47 or 300/$539.22



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 August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


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




References


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



100. Crouch ER Jr, Frenkel M. Aminocaproic acid in the treatment of traumatic hyphema. Am J Ophthalmol. 1976; 81:355-60. [IDIS 70329] [PubMed 769560]



101. McGetrick JJ, Jampol LM, Goldberg MF et al. Aminocaproic acid decreases secondary hemorrhage after traumatic hyphema. Arch Ophthalmol. 1983; 101:1031-3. [IDIS 172818] [PubMed 6870623]



102. Palmer DJ, Goldberg MF, Frenkel M et al. A comparison of two dose regimens of epsilon aminocaproic acid in the prevention and management of secondary traumatic hyphemas. Ophthalmology. 1986; 93:102-8. [PubMed 3951807]



103. Kutner B, Fourman S, Brein K et al. Aminocaproic acid reduces the risk of secondary hemorrhage in patients with traumatic hyphema. Arch Ophthalmol. 1987; 105:206-8. [IDIS 225461] [PubMed 3813951]



104. Goldfarb MS, Bulas KE, Rosenberg S et al. Aminocaproic acid treatment of recurrent postoperative hyphemas. Ann Ophthalmol. 1984; 16:690,692-3,696-7. [PubMed 6476703]



105. Goldberg MF. Antifibrinolytic agents in the management of traumatic hyphema. Arch Ophthalmol. 1983; 101:1029-30. [PubMed 6347147]



106. Love DC. Treatment of traumatic hyphema. JAMA. 1985; 253:345-6. [IDIS 194852] [PubMed 3965787]



107. Schwartz BS, Williams EC, Conlan MG et al. Epsilon-aminocaproic acid in the treatment of patients with acute promyelocytic leukemia and acquired alpha-2-plasmin inhibitor deficiency. Ann Intern Med. 1986; 105:873-7. [IDIS 223520] [PubMed 3465267]



108. Gardner FH, Helmer RE III. Aminocaproic acid: use in control of hemorrhage in patients with amegakaryocytic thrombocytopenia. JAMA. 1980; 243:35-7. [IDIS 107007] [PubMed 6965311]



109. Kang Y, Lewis JH, Navalgund A et al. Epsilon-aminocaproic acid for the treatment of fibrinolysis during liver transplantation. Anesthesiology. 1987 66:766-73. (IDIS 230629)



110. Immunex Corporation. Amicar (aminocaproic acid) syrup, tablets, and injection prescribing information. Seattle, WA; 1998 Apr 13.



111. Abbott Laboratories. Aminocaproic acid injection prescribing information. Chicago, IL; 1992 May.



112. Saba HI, Morelli GA, Logrono LA. Brief report: treatment of bleeding in hereditary hemorrhagic telangiectasia with aminocaproic acid. N Engl J Med. 1994; 330:1789-90. [IDIS 331546] [PubMed 8190155]



113. Phillips MD. Stopping bleeding in hereditary telangiectasia. N Engl J Med. 1994; 330:1822-3. [IDIS 331549] [PubMed 8190162]



114. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356-8. [IDIS 175725] [PubMed 6889041]



115. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12(2):10-1. [PubMed 7188569]



116. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384-8. [IDIS 160823] [PubMed 7133084]



117. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288-92. [PubMed 6440575]



118. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344-6. [IDIS 181207] [PubMed 6695984]



119. Food and Drug Administration. Orphan designations pursuant to section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414) to June 28, 1996. Rockville, MD; 1996 Jul.



120. Food and Drug Administration. Amicar (aminocaproic acid) syrup [September 14, 1999: Immunex]. MedWatch drug labeling changes. Rockville, MD; September 1999. From FDA website ().



121. Food and Drug Administration. Amicar (aminocaproic acid) tablets, injection, syrup [April 16, 1997: Immunex]. MedWatch drug labeling changes. Rockville, MD; April 1997. From FDA website ().



122. Mangano DT, for the Multicenter Study of Perioperative Ischemia Research Group. Aspirin and mortality from coronary bypass surgery. N Engl J Med. 2002; 347:1309-17. [IDIS 488783] [PubMed 12397188]



HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:98.



a. AHFS drug information 2006. McEvoy GK, ed. Aminocaproic Acid. Bethesda, MD: American Society of Health-System Pharmacists; 2006:1544-46.



b. Xanodyne Pharmaceuticals. Amicar (aminocaproic acid) injection, syrup, and tablets prescribing information. Florence, KY; 2004 Sep.



c. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356 8. [IDIS 175725] [PubMed 6889041]



d. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12(2):10 11.



e. Centers for Disease Control. Neonatal deaths associated with use of benzyl alcohol. MMWR. 1982; 31:290 1. [IDIS 150868] [PubMed 6810084]



f. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384 8. [IDIS 160823] [PubMed 7133084]



g. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288 92. [PubMed 6440575]



h. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344 6. [IDIS 181207] [PubMed 6695984]



More Aminocaproic Acid resources


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


  • Aminocaproic Acid Professional Patient Advice (Wolters Kluwer)

  • Aminocaproic Acid MedFacts Consumer Leaflet (Wolters Kluwer)

  • aminocaproic acid Concise Consumer Information (Cerner Multum)

  • aminocaproic acid Advanced Consumer (Micromedex) - Includes Dosage Information

  • Amicar Prescribing Information (FDA)



Compare Aminocaproic Acid with other medications


  • Fibrinolytic Bleeding

alendronate



Generic Name: alendronate (a LEN dro nate)

Brand Names: Fosamax


What is alendronate?

Alendronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Alendronate slows bone loss while increasing bone mass, which may prevent bone fractures.


Alendronate is used in men and women to treat or prevent osteoporosis that is caused by menopause or by taking steroids. Alendronate is also used to increase bone mass in men who have osteoporosis, and to treat Paget's disease of bone in men and women.


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


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


Do not take an alendronate tablet if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

Take the alendronate tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.


Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water, coffee, tea, or juice) when taking an alendronate tablet.

For at least the first 30 minutes after taking an alendronate tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.


Some people using medicines similar to alendronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.


If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate. You may need to stop using the medicine for a short time.

Talk with your doctor about the risks and benefits of using this medication.


What should I discuss with my healthcare provider before taking alendronate?


Do not take an alendronate tablet if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication. You should not take alendronate if you are allergic to it, or if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

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



  • trouble swallowing;




  • a vitamin D deficiency;




  • a dental problem;




  • kidney disease; or




  • an ulcer or other problem in your stomach or esophagus.



Some people using medicines similar to alendronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.


You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.


Talk with your doctor about the risks and benefits of using this medication.


FDA pregnancy category C. It is not known whether alendronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take alendronate?


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


Alendronate tablets are taken either once each day or once each week.


Take the alendronate tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take an alendronate tablet only once a week, take it on the same day each week and always first thing in the morning.


Take each alendronate tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an alendronate tablet. Do not crush, chew, or suck the alendronate tablet. Swallow the pill whole.

After taking an alendronate tablet, carefully follow these instructions:


  • Do not lie down or recline for at least 30 minutes after taking alendronate.

  • Do not eat or drink anything other than plain water.

  • Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking alendronate. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. Visit your doctor regularly.


If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate. You may need to stop using the medicine for a short time.

Alendronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.


Store at room temperature away from moisture and heat.

See also: Alendronate dosage (in more detail)

What happens if I miss a dose?


If you take alendronate tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.


If you take alendronate tablets once a week: If you forget to take alendronate on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.


What should I avoid while taking alendronate?


Avoid taking any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking an alendronate tablet. Some medicines can make it harder for your body to absorb alendronate. Do not lie down for at least 30 minutes after you take an alendronate tablet.

Alendronate side effects


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

  • chest pain;




  • difficulty or pain when swallowing;




  • pain or burning under the ribs or in the back;




  • severe heartburn, burning pain in your upper stomach, or coughing up blood;




  • new or worsening heartburn;




  • fever, body aches, flu symptoms;




  • severe joint, bone, or muscle pain;




  • new or unusual pain in your thigh or hip;




  • jaw pain, numbness, or swelling.



Less serious side effects may include:



  • mild heartburn, bloating;




  • mild nausea, vomiting, or stomach pain;




  • diarrhea, gas, or constipation;




  • mild joint pain or swelling;




  • swelling in your hands or feet; or




  • dizziness, eye pain, headache.



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.


Alendronate Dosing Information


Usual Adult Dose for Osteoporosis:

10 mg orally once a day.

-or-

70 mg orally once a week.

For glucocorticoid induced osteoporosis the initial dosage recommended is 5 mg orally once a day, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is 10 mg orally once a day. Patients treated with glucocorticoids should receive adequate supplements of calcium and vitamin D.

Usual Adult Dose for Paget's Disease:

40 mg orally once a day.

Therapy for Paget's disease should continue for 6 months and may need to be repeated for another 6 months if relapse occurs.

Usual Adult Dose for Prevention of Osteoporosis:

For the prevention of postmenopausal osteoporosis:

5 mg orally once a day.

-or-

35 mg orally once a week.


What other drugs will affect alendronate?


Tell your doctor about all other medicines you use, especially aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as:



  • celecoxib (Celebrex);




  • diclofenac (Voltaren);




  • diflunisal (Dolobid);




  • ibuprofen (Motrin, Advil);




  • indomethacin (Indocin);




  • ketoprofen (Orudis)




  • ketorolac (Toradol);




  • naproxen (Aleve, Naprosyn); or




  • piroxicam (Feldene), and others.



This list is not complete and other drugs may interact with alendronate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More alendronate resources


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


  • alendronate Advanced Consumer (Micromedex) - Includes Dosage Information

  • Alendronate Prescribing Information (FDA)

  • Alendronate MedFacts Consumer Leaflet (Wolters Kluwer)

  • Alendronate Sodium Monograph (AHFS DI)

  • Fosamax Prescribing Information (FDA)

  • Fosamax Consumer Overview



Compare alendronate with other medications


  • Aseptic Necrosis
  • Osteoporosis
  • Paget's Disease
  • Prevention of Osteoporosis


Where can I get more information?


  • Your pharmacist can provide more information about alendronate.

See also: alendronate side effects (in more detail)


Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules


Pronunciation: a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/gwye-FEN-e-sin/sue-doe-eh-FED-rin
Generic Name: Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine
Brand Name: Examples include Robitussin Cold/Cough/Flu and Sudafed Cold/Cough


Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules is used for:

Relieving pain, congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.


Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules is an analgesic, decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The analgesic and cough suppressant works in the brain to decrease pain and to help decrease the cough reflex to reduce a dry cough.


Do NOT use Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules if:


  • you are allergic to any ingredient in Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules

  • you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)

  • you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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



Before using Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules:


Some medical conditions may interact with Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, plan to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, or liver problems, or if you consume more than 3 alcohol-containing drinks per day

  • if you have a chronic cough, lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules may be increased

  • Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat or heart attack may be increased

  • Bromocriptine because the risk of side effects may be increased by Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules:


Use Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules may be taken with or without food.

  • Drink plenty of water while taking Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules.

  • If you miss a dose of Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules.



Important safety information:


  • Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules. Using Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

  • Do not take appetite suppressants while you are taking Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules without checking with your doctor.

  • Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.

  • Do NOT exceed the recommended dose or take Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules for longer than prescribed without checking with your doctor.

  • If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.

  • Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules or other pain relievers/fever reducers. Alcohol use combined with Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules may increase your risk for liver damage.

  • Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules.

  • Use Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules with caution in the ELDERLY because they may be more sensitive to its effects.

  • Caution is advised when using Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules in CHILDREN because they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules, discuss with your doctor the benefits and risks of using Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules during pregnancy. It is unknown if Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules is excreted in breast milk. Do not breast-feed while taking Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules.


Possible side effects of Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.


Proper storage of Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules:

Store Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules out of the reach of children and away from pets.


General information:


  • If you have any questions about Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules, please talk with your doctor, pharmacist, or other health care provider.

  • Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

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

This information is a summary only. It does not contain all information about Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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