Monday, September 17, 2012

Allegra ODT


Generic Name: fexofenadine (FEX oh FEN a deen)

Brand Names: Allegra, Allegra ODT


What is Allegra ODT (fexofenadine)?

Fexofenadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Fexofenadine is used to treat the symptoms of seasonal allergies (hay fever) in adults and children.


Fexofenadine is also used to treat skin itching and hives caused by a condition called chronic idiopathic urticaria in adults and children.


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


What is the most important information I should know about Allegra ODT (fexofenadine)?


Ask a doctor or pharmacist before taking this medicine if you are allergic to any drugs, or if you have kidney disease.


Fruit juices and certain antacids can make it harder for your body to absorb fexofenadine. Take the disintegrating tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

There may be other drugs that can affect fexofenadine. 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.


Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor if your symptoms do not improve, or if they get worse after you start taking fexofenadine. Never take more of the medication than your doctor has prescribed.


What should I discuss with my healthcare provider before taking Allegra ODT (fexofenadine)?


Ask a doctor or pharmacist if it is safe for you to take this medicine if you are allergic to any drugs, or if you have kidney disease.


FDA pregnancy category C. It is not known whether fexofenadine 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 fexofenadine 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. Fexofenadine tablets and capsules may be used to treat seasonal allergy symptoms in children who are at least 6 years old. Fexofenadine oral suspension (liquid) may be used in children ages 2 through 11. When treating chronic idiopathic urticaria, the liquid may be used in children as young as 2 months old. Do not give this medicine to a child without medical advice.

How should I take Allegra ODT (fexofenadine)?


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


Take the regular tablet with a full glass of water. Do not use any other type of liquid. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To take fexofenadine orally disintegrating tablets (Allegra ODT):



  • 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. If desired, you may drink liquid to help swallow the dissolved tablet.




Take the disintegrating tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

Tell your doctor if your symptoms do not improve, or if they get worse after you start taking fexofenadine. Never take more of the medication than your doctor has prescribed.


Store at room temperature away from moisture and heat. Keep the medicine bottle tightly closed.

What happens if I miss a dose?


Since cold or allergy medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


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

Overdose symptoms may include dry mouth, dizziness, or drowsiness.


What should I avoid while taking Allegra ODT (fexofenadine)?


Avoid using antacids within 15 minutes before or after taking a medication that contains fexofenadine. Antacids can make it harder for your body to absorb this medication.


Do not take fexofenadine with fruit juice (such as apple, orange, or grapefruit).


Avoid taking any other cold or allergy medicines unless your doctor has told you to.

Allegra ODT (fexofenadine) 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 fexofenadine and call your doctor if you have fever, chills, body aches, cough, or other flu symptoms.

Less serious side effects may include:



  • nausea, diarrhea, upset stomach;




  • menstrual cramps;




  • drowsiness, tired feeling;




  • headache; or




  • muscle or back pain.



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 Allegra ODT (fexofenadine)?


Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by fexofenadine.

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



  • ketoconazole (Nizoral); or




  • erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole).



This list is not complete and other drugs may interact with fexofenadine. 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 Allegra ODT resources


  • Allegra ODT Side Effects (in more detail)
  • Allegra ODT Use in Pregnancy & Breastfeeding
  • Allegra ODT Drug Interactions
  • Allegra ODT Support Group
  • 1 Review for Allegra ODT - Add your own review/rating


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

  • Allegra ODT Advanced Consumer (Micromedex) - Includes Dosage Information

  • Fexofenadine Prescribing Information (FDA)

  • Allegra Prescribing Information (FDA)

  • Allegra Monograph (AHFS DI)

  • Allegra Consumer Overview

  • Allegra MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Allegra ODT with other medications


  • Hay Fever
  • Urticaria


Where can I get more information?


  • Your pharmacist can provide more information about fexofenadine.

See also: Allegra ODT side effects (in more detail)


Saturday, September 15, 2012

Axid AR



nizatidine

Dosage Form: tablet, film coated
Axid AR (nizatidine)

DRUG FACTS



ACTIVE INGREDIENT (IN EACH TABLET)


Nizatidine 75 mg



PURPOSE


Acid reducer



USES


  • relieves heartburn associated with acid indigestion and sour stomach

  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages


Warnings



Allergy alert:


Do not use if you are allergic to nizatidine or other acid reducers



Do not use


  • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

  • with other acid reducers


Ask a doctor before use if you have


  • had heartburn over 3 months. This may be a sign of a more serious condition.

  • heartburn with lightheadedness, sweating or dizziness

  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

  • frequent chest pain

  • frequent wheezing, particularly with heartburn

  • unexplained weight loss

  • nausea or vomiting

  • stomach pain


Stop use and ask a doctor if


  • your heartburn continues or worsens

  • you need to take this product for more than 14 days


If pregnant or breast feeding,


ask a health professional before use.



Keep out of reach of children.


In case of overdose, get medical help or contact a Poison Control Center right away



DIRECTIONS


  • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a full glass of water

    • to prevent symptoms, swallow 1 tablet with a full glass of water right before eating or up to 60 minutes before consuming food and beverages that cause you heartburn

    • do not use more than 2 tablets in 24 hours


  • children under 12 years: ask a doctor


OTHER INFORMATION


  • store at 20-25°C (68-77°F)

  • protect from light

  • replace cap tightly after opening bottle

  • keep the carton and package insert. They contain important information


INACTIVE INGREDIENTS


colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pharmaceutical ink, polyethylene glycol, pregelatinized starch, propylene glycol, synthetic iron oxides, titanium dioxide



QUESTIONS OR COMMENTS?


Call 1-800-555-2943 Monday through Friday 9 AM to 5 PM EST



PRODUCT INFORMATION SHEET


PLEASE SAVE THIS SHEET FOR FUTURE USE


Bottle sealed with printed foil under cap. Do Not Use if foil imprinted “SEALED FOR YOUR PROTECTION” is open or torn.


  • Axid AR is a non-prescription medicine that contains nizatidine, an ingredient that doctors have prescribed for years.

  • Axid AR works by reducing the production of stomach acid that can cause heartburn.

  • In clinical studies, Axid AR was significantly better than placebo in relieving and preventing heartburn symptoms.


Heartburn: a problem that can interfere with your lifestyle


The stomach normally produces acid, especially following eating and drinking. Sometimes acid backing up into the esophagus can cause a burning pain and discomfort. This pain and discomfort is commonly known as heartburn.


When taken as directed, Axid AR relieves and/or prevents heartburn.



Tips for managing heartburn


  • Avoid lying down flat or bending over soon after eating.

  • Avoid eating late at night, or just before bedtime.

  • Avoid certain foods or beverages more likely to cause heartburn, such as rich, spicy, fried foods; chocolate, caffeine, alcohol; even some fruits and vegetables.

  • Eat slowly and do not eat big meals.

  • If you are overweight, lose weight.

  • If you smoke, stop or cut down.

  • Elevate the head of your bed.

  • Avoid wearing tight fitting clothing around your stomach.


Studies






Wyeth Consumer Healthcare, Madison, NJ 07940



PRODUCT PACKAGING


The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.


Axid-AR


Nizatidine Tablets 75 mg


Acid Reducer


Relieves and Prevents Heartburn Associated with Acid Indigestion and Sour Stomach


50 Tablets (50 Doses)


Wyeth Consumer Healthcare, Madison, NJ 07940


U.S. Patent No. 4,375,547


Eli Lilly and Company owns the registered trademark Axid AR.


50’s Value Pack


Bottle sealed with printed foil under cap. Do Not Use if foil imprinted “SEALED FOR YOUR PROTECTION” is open or torn.










Axid AR 
nizatidine  tablet, film coated










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-2400
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
nizatidine (nizatidine)nizatidine75 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Coloryellow (slightly glossy light yellow flaxen color)Scoreno score
ShapeOVAL (slightly convex on sides)Size15mm
FlavorImprint CodeAxid;AR
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-2400-451 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
150 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (0573-2400-45)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02055505/09/1996


Labeler - Wyeth Consumer Healthcare (828831730)
Revised: 06/2009Wyeth Consumer Healthcare




More Axid AR resources


  • Axid AR Side Effects (in more detail)
  • Axid AR Use in Pregnancy & Breastfeeding
  • Axid AR Drug Interactions
  • Axid AR Support Group
  • 1 Review for Axid AR - Add your own review/rating


  • Axid AR MedFacts Consumer Leaflet (Wolters Kluwer)

  • Nizatidine Professional Patient Advice (Wolters Kluwer)

  • Axid Monograph (AHFS DI)

  • Axid Consumer Overview



Compare Axid AR with other medications


  • Duodenal Ulcer
  • Duodenal Ulcer Prophylaxis
  • Erosive Esophagitis
  • GERD
  • Indigestion
  • Stomach Ulcer

Aminohippurate Sodium




Aminohippurate Sodium “PAH”

INJECTION

Aminohippurate Sodium Description


Aminohippurate Sodium1 is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated “PAH”. It is water soluble, lipid-insoluble, and has a pKa of 3.83. The empirical formula of the anhydrous salt is C9H9N2NaO3 and its structural formula is:



It is provided as a sterile, non-preserved 20 percent aqueous solution for injection, with a pH of 6.7 to 7.6. Each 10 mL contains: Aminohippurate Sodium 2 g. Inactive ingredients: Sodium hydroxide to adjust pH, water for injection, q.s.



1


Formerly referred to as Sodium para-Aminohippurate.




Aminohippurate Sodium - Clinical Pharmacology


PAH is filtered by the glomeruli and is actively secreted by the proximal tubules. At low plasma concentrations (1.0 to 2.0 mg/100 mL), an average of 90 percent of PAH is cleared by the kidneys from the renal blood stream in a single circulation. It is ideally suited for measurement of ERPF since it has a high clearance, is essentially nontoxic at the plasma concentrations reached with recommended doses, and its analytical determination is relatively simple and accurate.


PAH is also used to measure the functional capacity of the renal tubular secretory mechanism or transport maximum (TmPAH). This is accomplished by elevating the plasma concentration to levels (40-60 mg/100 mL) sufficient to saturate the maximal capacity of the tubular cells to secrete PAH.


Inulin clearance is generally measured during TmPAH determinations since glomerular filtration rate (GFR) must be known before calculations of secretory Tm measurements can be done (see DOSAGE AND ADMINISTRATION, Calculations).



Indications and Usage for Aminohippurate Sodium


Estimation of effective renal plasma flow.


Measurement of the functional capacity of the renal tubular secretory mechanism.



Contraindications


Hypersensitivity to this product or to its components.



Precautions



General


Intravenous solutions must be given with caution to patients with low cardiac reserve, since a rapid increase in plasma volume can precipitate congestive heart failure.


For measurement of ERPF, small doses of PAH are used. However, in research procedures to measure TmPAH, high plasma levels are required to saturate the capacity of the tubular cells. During these procedures, the intravenous administration of PAH solutions should be carried out slowly and with caution. The patient should be continuously observed for any adverse reactions.


Use caution when injecting this product into latex-sensitive individuals, since the vial stopper contains dry natural latex rubber that may cause allergic reactions.



Drug Interactions


Renal clearance measurements of PAH cannot be made with any significant accuracy in patients receiving sulfonamides, procaine, or thiazolesulfone. These compounds interfere with chemical color development essential to the analytical procedures.


Probenecid depresses tubular secretion of certain weak acids such as PAH. Therefore, patients receiving probenecid will have erroneously low ERPF and TmPAH values.



Carcinogenesis, Mutagenesis, Impairment of Fertility


Long-term studies in animals have not been done to evaluate any effects upon fertility or carcinogenic potential of PAH.



Pregnancy



Pregnancy Category C


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



Nursing Mothers


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



Pediatric Use


Safety and effectiveness in pediatric patients have not been established.



Geriatric Use


Clinical studies of PAH did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.



Adverse Reactions


Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, vasomotor disturbances, flushing, tingling, nausea, vomiting, and cramps may occur.


Patients may have a sensation of warmth or the desire to defecate or urinate during or shortly following initiation of infusion.



OVERDOSE


The intravenous LD50 in female mice is 7.22 g/kg.



Aminohippurate Sodium Dosage and Administration


For intravenous use only


Clearance measurements using single injection techniques are generally inaccurate, particularly in the measurement of ERPF. For this reason, intravenous infusions at fixed rates are used to sustain the plasma PAH concentration at the desired level.


To measure ERPF, the concentration of PAH in the plasma should be maintained at 2 mg per 100 mL, which can be achieved with a priming dose of 6 to 10 mg/kg and an infusion dose of 10 to 24 mg/min.


As a research procedure for the measurement of TmPAH, the plasma level of PAH must be sufficient to saturate the capacity of the tubular secretory cells. Concentrations from 40 to 60 mg per 100 mL are usually necessary.


Technical details of these tests may be found in Smith {1}; Wesson {2}; Bauer {3}; Pitts{4}; and Schnurr {5}.


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit. NOTE: The normal color range for this product is a colorless to yellow/brown solution. The efficacy is not affected by color changes within this range.



Calculations


Effective Renal Plasma Flow (ERPF)

The clearance of PAH, which is extracted almost completely from the plasma during its passage through the renal circulation, constitutes a measure of ERPF. Hence:


ERPF = UPAHV/PPAH


Where UPAH = concentration of PAH (mg/mL) in the urine


V = rate of urine excretion (mL/min), and


PPAH = plasma concentration of PAH (mg/mL).


Example:


UPAH = 8.0 mg/mL


V = 1.5 mL/min


PPAH = 0.02 mg/mL


ERPF = 8.0 x 1.5/0.02 = 600 mL/min


Based on PAH clearance studies, the normal values for ERPF are:


men 675 ± 150 mL/min


women 595 ± 125 mL/min


Maximum Tubular Secretory

(TmPAH ) Mechanism 

The quantity of PAH secreted by the tubules (TmPAH) is given by the difference between the total rate of excretion (UPAHV) and the quantity filtered by the glomeruli (GFR x PPAH). Hence:


TmPAH = UPAHV – (GFR x PPAH x 0.83)


The factor, 0.83, corrects for that portion of PAH which is bound to plasma protein and hence is unfilterable.


Example:


UPAH = 9.55 mg/mL


V = 16.68 mL/min


GFR = 120 mL/min


PPAH = 0.60 mg/mL


Then TmPAH = 9.55 x 16.68 – (120 x 0.60 x 0.83) = 100 mg/min.


Average normal values of TmPAH are 80-90 mg/min.


The value of the expression UPAHV, used in calculations of ERPF and TmPAH, may be found by determining the amount of PAH in a measured volume of urine excreted within a specific period of time.


These calculations are based on a body surface area of 1.73 m2. Corrections for variations in surface area are made by multiplying the values obtained for ERPF and TmPAH by 1.73/A, where A is the subject surface area.



How is Aminohippurate Sodium Supplied


No. 95 — Aminohippurate Sodium, 20 percent sterile solution for intravenous injection, is supplied as follows:


NDC 0006-3395-11 in 10 mL vials.



Storage


Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].



REFERENCES


  1. Smith, H.W.: Lectures on the kidney, University Extension Division, University of Kansas, Lawrence, Kansas, 1943.

  2. Wesson, L.G., Jr.: "Physiology of the Human Kidney," New York, Grune & Stratton, 1969, pp. 632-655.

  3. Bauer, J.D.; Ackermann, P.G.; Toro, G.: "Brays Clinical Laboratory Methods," ed. 7, St. Louis, Mosby, 1968.

  4. Pitts, R.F.: "Physiology of the Kidney and Body Fluids," ed. 2, Chicago, Year Book Medical Publishers, 1968.

  5. Schnurr, E.; Lahme, W.; Kuppers, H.: Measurement of renal clearance of inulin and PAH in the steady state without urine collection; Clinical Nephrology, 13(1): (26-29), 1980.

Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA


Issued January 2011


Printed in USA


9051026


Copyright © 1983 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

All rights reserved



This is a representative sample of the packaging. Please see How Supplied section for a complete list of available packaging.


PRINCIPAL DISPLAY PANEL - Carton - 10 mL Single Dose Vial


NDC 0006-3395-11


SINGLE DOSE VIAL

10 mL INJECTION


Aminohippurate Sodium


2 g in 10 mL

(20% solution)


FOR INTRAVENOUS USE ONLY TO DETERMINE KIDNEY FUNCTION


Rx only


Merck Sharp & Dohme Corp.,

a subsidiary of

MERCK & CO., INC.

Whitehouse Station, NJ 08889, USA










Aminohippurate Sodium  PAH
Aminohippurate Sodium  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0006-3395
Route of AdministrationINTRAVENOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aminohippurate Sodium (AMINOHIPPURIC ACID)Aminohippurate Sodium2 g  in 10 mL








Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE 
WATER 


















Product Characteristics
ColorYELLOW, BROWN (colorless to yellow/brown)Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10006-3395-111 VIAL In 1 CARTONcontains a VIAL, SINGLE-DOSE
110 mL In 1 VIAL, SINGLE-DOSEThis package is contained within the CARTON (0006-3395-11)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00561912/30/1944


Labeler - Merck Sharp & Dohme Corp. (001317064)









Establishment
NameAddressID/FEIOperations
Merck Sharp & Dohme Corp.002387926MANUFACTURE
Revised: 01/2011Merck Sharp & Dohme Corp.

More Aminohippurate Sodium resources


  • Aminohippurate Sodium Support Group
  • 0 Reviews for Aminohippurate Sodium - Add your own review/rating


Compare Aminohippurate Sodium with other medications


  • Diagnosis and Investigation

Tuesday, September 11, 2012

GTC Biotherapeutics, Inc.


Address


GTC Biotherapeutics, Inc.,
175 Crossing Boulevard PO Box 9322

Framingham, MA 01702

Contact Details

Phone: (508) 620-9700
Website: http://www.gtc-bio.com
Careers: http://www.gtc-bio.com/about/career.html

Corticotropin Gel


Pronunciation: core-tih-koe-TROE-pin
Generic Name: Corticotropin
Brand Name: HP Acthar


Corticotropin Gel is used for:

Diagnosing adrenal gland function. It may be used to treat certain conditions caused by allergies; breathing, blood, or endocrine problems; arthritis; skin or eye problems; bowel inflammation; multiple sclerosis; or certain cancers. It may also be used for other conditions as determined by your doctor.


Corticotropin Gel is a hormone. It works by stimulating the body to produce more adrenocortical hormones (eg, corticosteroids, glucocorticoids).


Do NOT use Corticotropin Gel if:


  • you are allergic to any ingredient in Corticotropin Gel or to pork products

  • you have primary adrenocortical overactivity or underactivity

  • you have recently had surgery or trauma

  • you have certain skin problems (scleroderma), osteoporosis (weakened bones), a fungal infection, a herpes infection of the eye, congestive heart failure, high blood pressure, or a history of stomach ulcers

  • you have recently had or are scheduled to have a smallpox vaccination

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



Before using Corticotropin Gel:


Some medical conditions may interact with Corticotropin Gel. 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 diabetes, glaucoma, diarrhea, an underactive thyroid, liver problems, kidney problems, diverticulitis (intestinal problem), myasthenia gravis, high blood sodium levels, low blood potassium levels, or a history of heart problems

  • if you have measles, tuberculosis (TB), a positive TB skin test, chickenpox, or shingles, or you have recently had or are planning to have a vaccination (especially for smallpox)

Some MEDICINES MAY INTERACT with Corticotropin Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Clarithromycin or itraconazole because the side effects of Corticotropin Gel may be increased

  • Ritodrine because the risk of severe breathing problems (pulmonary edema) may be increased

  • Aspirin, diuretics (eg, furosemide), or smallpox vaccine because side effects may be increased by Corticotropin Gel

  • Carbamazepine or live vaccines because effectiveness may be decreased by Corticotropin Gel

This may not be a complete list of all interactions that may occur. Ask your health care provider if Corticotropin Gel 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 Corticotropin Gel:


Use Corticotropin Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Corticotropin Gel is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Corticotropin Gel at home, carefully follow the injection procedures taught to you by your health care provider.

  • Check with your doctor before using any medicines that contain aspirin, ibuprofen, or naproxen.

  • Warm Corticotropin Gel to room temperature before using.

  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

  • If you miss a dose of Corticotropin Gel, and you are using 1 dose every other day, use the missed dose the following morning. Then skip 1 day and go back to your regular dosing schedule of using a dose every other day. If you miss a dose of Corticotropin Gel, and you are using 1 or more doses each day, use it as soon as possible and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Corticotropin Gel.



Important safety information:


  • Corticotropin Gel may lower your body's ability to fight infection or illnesses, especially if you use it for an extended period of time. Prevent infection by avoiding contact with people with colds or other infections. If you are exposed to chickenpox, measles, or TB while taking Corticotropin Gel or during the 12 months after stopping Corticotropin Gel, call your doctor. Notify your doctor of any signs of infection, including fever, sore throat, pain during urination, muscle aches, rash, or chills for up to 12 months after stopping Corticotropin Gel.

  • Do not stop using Corticotropin Gel without first checking with your doctor. Serious side effects may occur if you suddenly stop using Corticotropin Gel.

  • Long-term use of Corticotropin Gel may cause eye problems, such as cataracts, glaucoma, and optic nerve damage. Do not use Corticotropin Gel for longer than prescribed. Contact your doctor immediately if you experience any changes in your vision.

  • Check with your doctor before having any vaccinations, especially for smallpox, while you are using Corticotropin Gel.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Corticotropin Gel.

  • Diabetes patients - Corticotropin Gel may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

  • LAB TESTS, including blood electrolytes, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Corticotropin Gel with extreme caution in CHILDREN because they may be more sensitive to its effects.

  • Corticotropin Gel may affect growth rate in CHILDREN and adolescents in some instances. Your child's growth may need to be checked regularly while using Corticotropin Gel.

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

If you suddenly stop taking Corticotropin Gel, you may experience WITHDRAWAL symptoms, including worsening of symptoms of the problem being treated.



Possible side effects of Corticotropin Gel:


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:



Acne; changes in appetite; constipation; diarrhea; difficulty sleeping; headache; heartburn; nausea; restlessness; sweating; vomiting.



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); changes in mood; changes in vision; fever or chills; muscle pain or weakness; pain, redness, or swelling at the injection site; seizures; slow wound healing; sore throat.



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: Corticotropin 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.


Proper storage of Corticotropin Gel:

Store Corticotropin Gel in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Corticotropin Gel out of the reach of children and away from pets.


General information:


  • If you have any questions about Corticotropin Gel, please talk with your doctor, pharmacist, or other health care provider.

  • Corticotropin Gel 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 Corticotropin Gel. 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 Corticotropin resources


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


Compare Corticotropin with other medications


  • Allergies
  • Eye Conditions
  • Inflammatory Bowel Disease
  • Multiple Sclerosis
  • Psoriasis
  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Ulcerative Colitis

Friday, September 7, 2012

Alti-Ipratropium



Generic Name: ipratropium (Inhalation route)


ip-ra-TROE-pee-um BROE-mide


Commonly used brand name(s)

In the U.S.


  • Atrovent

In Canada


  • Alti-Ipratropium

  • Alti-Ipratropium With Preservative

  • Apo-Ipravent

  • Ipratropium Bromide Nebuamp

  • Ipratrovent Sterules

  • Ratio-Ipratropium

  • Ratio-Ipratropium Udv

Available Dosage Forms:


  • Solution

  • Aerosol Powder

Therapeutic Class: Bronchodilator


Pharmacologic Class: Ipratropium


Uses For Alti-Ipratropium


Ipratropium is used to help control the symptoms of lung diseases, such as asthma, chronic bronchitis, and emphysema. It is also used to treat air flow blockage and prevent the worsening of chronic obstructive pulmonary disease (COPD).


Ipratropium belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs.


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


Before Using Alti-Ipratropium


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of ipratropium in the pediatric population. Safety and efficacy have not been established.


Geriatric


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


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Betel Nut

Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Allergy to atropine, scopolamine, or hyoscyamine—Should not be used in patients with this condition.

  • Difficult urination or

  • Enlarged prostate or

  • Narrow-angle glaucoma or

  • Urinary bladder blockage—Use with caution. May make these conditions worse.

Proper Use of ipratropium

This section provides information on the proper use of a number of products that contain ipratropium. It may not be specific to Alti-Ipratropium. Please read with care.


This medicine usually comes with patient instructions. Read them carefully before using the medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you how to use it.


Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may cause your lung condition to become worse.


Keep the spray or solution away from the eyes. This medicine may cause eye pain or discomfort, irritation, blurred vision, or start seeing halos or odd colors when you look at things. Closing your eyes while you are inhaling ipratropium may keep the medicine from getting into your eyes. If it does come into contact with your eyes, check with your doctor right away.


If you are taking this medicine every day to help control your symptoms, it must be taken at regularly spaced times as ordered by your doctor.


For patients using ipratropium inhalation aerosol:


  • If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you how to use it. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

  • There are two formulas of the inhaled aerosol. One contains chlorofluorocarbons and the other contains HFA as the propellant. The taste and inhalation of these may seem different, but the safety and effectiveness of both formulas are similar.

  • The ipratropium aerosol canister provides about 200 inhalations, depending on the size of the canister your doctor ordered. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike some other aerosol canisters, cannot be floated in water to test its fullness.

  • When you use the inhaler for the first time, or if you have not used it for a while, the inhaler may not give the right amount of medicine with the first puff. Therefore, before using the inhaler, test or prime it.

  • To test or prime the inhaler:
    • Insert the canister firmly into the clean mouthpiece according to the manufacturer's instructions. Check to make sure it is placed properly into the mouthpiece.

    • Take the cap off the mouthpiece and shake the inhaler three or four times.

    • Hold the inhaler away from you at arm's length and press the top of the canister, spraying the medicine two times into the air. The inhaler will now be ready to give the right amount of medicine when you use it.

    • If the inhaler is not used for more than 3 days, prime the inhaler two times to prepare it for use.


  • To use the inhaler:
    • Using your thumb and one or two fingers, hold the inhaler upright, with the mouthpiece end down and pointing toward you.

    • Take the cap off the mouthpiece. Check the mouthpiece to make sure it is clear. Then, gently shake the inhaler three or four times.

    • Breathe out slowly to the end of a normal breath.

    • Use the inhalation method recommended by your doctor:
      • Open-mouth method—Place the mouthpiece about 1 or 2 inches (2 finger-widths) in front of your widely opened mouth. Make sure the inhaler is aimed into your mouth so the spray does not hit the roof of your mouth or your tongue.

      • Closed-mouth method—Place the mouthpiece in your mouth between your teeth and over your tongue with your lips closed tightly around it. Make sure your tongue or teeth are not blocking the opening.


    • Start to breathe in slowly and deeply through your mouth. At the same time, press the top of the canister once to get one puff of medicine. Continue to breathe in slowly for 5 to 10 seconds. Count the seconds while breathing in. It is important to press the canister and breathe in slowly at the same time so the medicine gets into your lungs. This step may be difficult at first. If you are using the closed-mouth method and you see a fine mist coming from your mouth or nose, the inhaler is not being used correctly.

    • Hold your breath as long as you can up to 10 seconds. This gives the medicine time to settle into your airways and lungs.

    • Take the mouthpiece away from your mouth and breathe out slowly.

    • If your doctor has told you to inhale more than one puff of medicine at each dose, gently shake the inhaler again, and take the second puff following exactly the same steps you used for the first puff. Press the canister one time for each puff of medicine.

    • When you are finished, wipe off the mouthpiece and replace the cap.


  • Your doctor may want you to use a spacer device or holding chamber with the inhaler. A spacer helps get the medicine into the lungs and reduces the amount of medicine that stays in your mouth and throat.
    • To use a spacer device with the inhaler:
      • Attach the spacer to the inhaler according to the manufacturer's directions. There are different types of spacers available, but the method of breathing remains the same with most spacers.

      • Gently shake the inhaler and spacer three or four times.

      • Hold the mouthpiece of the spacer away from your mouth and breathe out slowly to the end of a normal breath.

      • Place the mouthpiece into your mouth between your teeth and over your tongue with your lips closed around it.

      • Press the top of the canister once to release one puff of medicine into the spacer. Within 1 or 2 seconds, start to breathe in slowly and deeply through your mouth for 5 to 10 seconds. Count the seconds while inhaling. Do not breathe in through your nose.

      • Hold your breath as long as you can up to 10 seconds.

      • Take the mouthpiece away from your mouth and breathe out slowly.

      • If your doctor has told you to take more than one puff of medicine at each dose, gently shake the inhaler and spacer again and take the next puff, following exactly the same steps you used for the first puff. Do not put more than one puff of medicine into the spacer at a time.

      • When you are finished, remove the spacer device from the inhaler and replace the cap.



  • The mouthpiece has a dose indicator window that shows how much medicine is left. When the dose indicator window displays "40" or changes from green to red color background, this means that you need to refill your prescription or ask your doctor if you need another prescription of this medicine.

  • Clean the inhaler, mouthpiece, and spacer at least once a week.
    • To clean the inhaler:
      • Remove the canister from the inhaler and set aside.

      • Wash the mouthpiece, cap, and the spacer with warm, soapy water. Then, rinse well with warm, running water.

      • Shake off the excess water and let the inhaler parts air dry completely before putting the inhaler back together.



For patients using the inhalation solution:


  • Use this medicine only in a power-operated nebulizer with an adequate flow rate and equipped with a face mask or mouthpiece. Your doctor will tell you which nebulizer to use. Make sure you understand exactly how to use it. If you have any questions about this, check with your doctor.

  • To prepare the medicine for use in the nebulizer:
    • If you are using the single-dose vial of ipratropium:
      • Break away one vial by pulling it firmly from the strip.

      • Twist off the top to open the vial. Use the contents of the vial as soon as possible after opening it.

      • Squeeze the contents of the vial into the cup of the nebulizer. If your doctor has told you to use less than a full vial of solution, use a syringe to withdraw the correct amount of solution from the vial and add it to the nebulizer cup. Be sure to throw away the syringe after one use.


    • If you are using the multiple-dose bottle of ipratropium:
      • Use a syringe to withdraw the correct amount of solution from the bottle and add it to the nebulizer cup. Do not use the same syringe more than once.



  • If you have been told to dilute the ipratropium inhalation solution in the nebulizer cup with the sodium chloride solution provided, use a new syringe to add the sodium chloride solution to the cup as directed by your doctor.

  • If your doctor told you to use another inhalation solution with the ipratropium inhalation solution, add that solution also to the nebulizer cup.

  • To use the nebulizer:
    • Gently shake the nebulizer cup to mix the solutions well.

    • Connect the nebulizer tube to the air or oxygen pump and begin the treatment. Adjust the mask, if you are using one, to prevent mist from getting into your eyes.

    • Use the method of breathing your doctor told you to use to take the treatment. One way is to breathe slowly and deeply through the mask or mouthpiece. Another way is to breathe in and out normally with the mouthpiece in your mouth, taking a deep breath every 1 or 2 minutes. Continue to breathe in the medicine as instructed until no more mist is formed in the nebulizer cup or until you hear a sputtering (spitting or popping) sound.

    • When you have finished, replace the caps on the solutions. Store the bottles of solution in the refrigerator until the next treatment.

    • Clean the nebulizer according to the manufacturer's directions.


Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.


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 asthma:
    • For inhalation aerosol dosage form (used with an inhaler):
      • Adults and children 12 years of age and older—1 to 4 puffs four times a day, at regularly spaced times, as needed.

      • Children up to 12 years of age—1 or 2 puffs three or four times a day, at regularly spaced times, as needed.


    • For inhalation solution dosage form (used with a nebulizer):
      • Adults and children 12 years of age and older—500 mcg used in a nebulizer three or four times a day, every 6 to 8 hours, as needed.

      • Children 5 to 12 years of age—125 to 250 mcg used in a nebulizer three or four times a day, every 4 to 6 hours as needed.

      • Children up to 5 years of age—Use and dose must be determined by your doctor.



  • For symptoms of chronic obstructive pulmonary disease (COPD):
    • For inhalation aerosol dosage form (used with an inhaler):
      • Adult—At first, 2 puffs four times a day and as needed. Do not use more than 12 puffs in any 24-hour period.

      • Children—Use and dose must be determined by your doctor.


    • For inhalation solution dosage form (used with a nebulizer):
      • Adults and children 12 years of age and older—250 to 500 mcg used in a nebulizer three or four times a day, every 6 to 8 hours.

      • Children up to 12 years of age—Use and dose must be determined by your doctor.



Missed Dose


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


Storage


Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using Alti-Ipratropium


It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to help reduce any unwanted effects.


Check with your doctor at once if your symptoms do not improve within 30 minutes after using a dose of this medicine or if your condition gets worse.


For patients using ipratropium inhalation solution:


  • If you are also using cromolyn inhalation solution, do not mix that solution with the ipratropium inhalation solution containing the preservative benzalkonium chloride for use in a nebulizer. To do so will cause the solution to become cloudy. However, if your condition requires you to use cromolyn inhalation solution with ipratropium inhalation solution, it may be mixed with ipratropium inhalation solution that is preservative-free.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash; itching; hives; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, mouth, or throat while you are using this medicine.


This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.


This medicine may cause dizziness, blurred vision, or trouble in seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to see well.


Take all of your COPD medicines as your doctor ordered. If you use any type of corticosteroid medicine to control your breathing, keep using it as ordered by your doctor. This includes corticosteroid medicines that are taken by mouth or inhaled (such as prednisone, Azmacort®, or Flovent®). If any of your COPD medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.


Alti-Ipratropium 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
  • Bladder pain

  • bloody or cloudy urine

  • cough producing mucus

  • difficult, burning, or painful urination

  • difficulty with breathing

  • frequent urge to urinate

  • lower back or side pain

  • shortness of breath

  • tightness in the chest

  • wheezing

Less common
  • Body aches or pain

  • chills

  • cough

  • ear congestion

  • fever

  • headache

  • loss of voice

  • runny nose

  • sneezing

  • sore throat

  • unusual tiredness or weakness

Rare
  • Constipation (continuing) or lower abdominal pain or bloating

  • fainting

  • fast, pounding, or irregular heartbeat or pulse

  • severe eye pain

  • skin rash or hives

  • swelling of the face, lips, or eyelids

Incidence not known
  • Blindness

  • blurred vision

  • confusion

  • decrease in the frequency of urination

  • decrease in the urine volume

  • decreased vision

  • difficulty in passing urine (dribbling)

  • difficulty with swallowing

  • dizziness

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • hives or welts

  • itching

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • nausea or vomiting

  • noisy breathing

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

  • redness of the skin

  • redness of the white part of the eyes or inside of the eyelids

  • sweating

  • tearing

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
  • Back pain

  • dryness of the mouth

  • unpleasant taste

Less common or rare
  • Acid or sour stomach

  • belching

  • burning eyes

  • diarrhea

  • general feeling of discomfort or illness

  • heartburn

  • indigestion

  • joint pain

  • loss of appetite

  • muscle aches and pains

  • nervousness

  • pain or tenderness around the eyes and cheekbones

  • shivering

  • stomach discomfort, upset, or pain

  • trembling

  • trouble sleeping

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


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


More Alti-Ipratropium resources


  • Alti-Ipratropium Use in Pregnancy & Breastfeeding
  • Alti-Ipratropium Drug Interactions
  • Alti-Ipratropium Support Group
  • 5 Reviews for Alti-Ipratropium - Add your own review/rating


Compare Alti-Ipratropium with other medications


  • Asthma
  • COPD, Maintenance

Thursday, September 6, 2012

Alendronate



Pronunciation: a-LEN-droe-nate
Generic Name: Alendronate
Brand Name: Fosamax


Alendronate is used for:

Treating Paget disease. It may also be used for other conditions as determined by your doctor.


Alendronate is a bisphosphonate. It works by slowing bone loss.


Do NOT use Alendronate if:


  • you are allergic to any ingredient in Alendronate

  • you have certain esophagus problems (eg, narrowing, blockage)

  • you are unable to stand or sit upright for at least 30 minutes

  • you have low blood calcium levels or severe kidney problems

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



Before using Alendronate:


Some medical conditions may interact with Alendronate. 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 a history of stomach or bowel problems (eg, inflammation, ulcer), esophagus problems (eg, heartburn, reflux disease, severe irritation), or kidney problems, or if you have difficult or painful swallowing

  • if you have low blood vitamin D levels, cancer, anemia, blood clotting problems, an infection, calcium metabolism problems, or nutrient absorption problems (eg, malabsorption syndrome), or you are unable to take calcium or vitamin D supplements

  • if you have poor dental hygiene, other dental problems, or you will be having a dental procedure (eg, tooth extraction)

  • if you smoke or drink alcohol

  • if you have had or will be having chemotherapy or radiation treatment

  • if you have a mental disorder or other condition that may decrease your ability to follow the dosing instructions for Alendronate

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


  • Aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of side effects, such as esophagus or stomach irritation, may be increased

  • Corticosteroids (eg, prednisone) because the risk of jawbone problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alendronate 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 Alendronate:


Use Alendronate as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Alendronate comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Alendronate refilled.

  • Swallow Alendronate whole. Do not break, crush, chew, or suck on the tablet before swallowing.

  • Take Alendronate by mouth on an empty stomach in the morning at least 30 minutes before your first food, drink, or other medicine of the day. Do NOT take Alendronate at bedtime or before you get out of bed in the morning.

  • Take Alendronate with a full glass of plain water (8 oz/240 mL). Do not take Alendronate with mineral water, coffee, tea, or juice. Do not lie down for 30 minutes after taking Alendronate and until you eat your first food of the day.

  • Be sure you understand how to take Alendronate. Contact your doctor or pharmacist if you have any questions.

  • Continue to use Alendronate even if you feel well. Do not miss any doses.

  • If you miss a dose of Alendronate, do not take it later in the day. Skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses within the same day.

Ask your health care provider any questions you may have about how to use Alendronate.



Important safety information:


  • Alendronate may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Alendronate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Talk with your doctor before you drink alcohol, smoke, or use other tobacco products while taking Alendronate.

  • Follow the diet and exercise program given to you by your health care provider. Talk to your doctor about whether you should take a calcium and vitamin D supplement while you use Alendronate.

  • Talk to your doctor about the use of weight-bearing exercises to help prevent weak bones.

  • Certain fractures of the thigh bone (femur) have been reported in patients using bisphosphonates. It is unknown if bisphosphonates contributed to the fractures. Contact your doctor right away if you experience hip, thigh, or groin pain. Discuss any questions or concerns with your doctor.

  • Alendronate may cause jawbone problems in some patients. Your risk may be greater if you have cancer, poor dental hygiene, ill-fitting dentures, or certain other conditions (eg, anemia, blood clotting problems, dental problems, infection). Your risk may also be greater if you have certain dental procedures or you use certain medicines or therapies (eg, chemotherapy, corticosteroids, radiation). Talk to your doctor about having a dental exam before you start to use Alendronate. Ask your doctor any questions you may have about dental treatment while you use Alendronate.

  • Proper dental care is important while you are taking Alendronate. Brush and floss your teeth and visit the dentist regularly.

  • Alendronate may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Alendronate. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Certain dental procedures should be avoided if possible while you are using Alendronate. Tell your doctor or dentist that you take Alendronate before you receive any medical or dental care, emergency care, or surgery.

  • Lab tests, including bone density and blood calcium levels, may be performed while you use Alendronate. These tests may be used to monitor your condition or check for side effects. Your doctor may also want to evaluate you periodically while you take Alendronate to assess the need to continue treatment. Be sure to keep all doctor and lab appointments.

  • Alendronate should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Alendronate while you are pregnant. It is not known if Alendronate is found in breast milk. If you are or will be breast-feeding while you use Alendronate, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Alendronate:


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; dizziness; feeling bloated or full; flu-like symptoms at the start of treatment; gas; headache; mild back, muscle, or joint pain; mild stomach pain or upset; nausea; taste changes; vomiting.



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, throat, or tongue); black, tarry, or bloody stools; chest pain; coughing or vomiting blood; difficult or painful swallowing; mouth sores; new, worsening, or persistent heartburn; red, swollen, blistered, or peeling skin; severe bone, muscle, or joint pain (especially in the hip, groin, or thigh); severe or persistent sore throat or stomach pain; swelling of the hands, legs, or joints; swelling or pain in the jaw; symptoms of low blood calcium (eg, spasms, twitches, or cramps in your muscles; numbness or tingling in your fingers, toes, or around your mouth).



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: Alendronate 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. Drink a full glass (8 oz/240 mL) of milk. Do not lie down for at least 30 minutes or as directed by your doctor. Do not try to vomit. Symptoms may include painful swallowing; severe heartburn; stomach pain or upset.


Proper storage of Alendronate:

Store Alendronate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alendronate out of the reach of children and away from pets.


General information:


  • If you have any questions about Alendronate, please talk with your doctor, pharmacist, or other health care provider.

  • Alendronate 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 Alendronate. 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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