Friday, 23 September 2016

Zeel




Zeel 2.0 ml Injection

Zeel Description




Injection Solution Ingredient Information: Each 2.0 ml ampule contains: Arnica Montana, radix 4X 200 mcl, Rhus toxicodendron 2X 10 mcl, Dulcamara 3X 10 mcl, Symphytum officinale 6X 10 mcl, Sulphur 6X 3.6 mcl, Sanguinaria Canadensis 4X 3 mcl, Cartilago suis 6X 2 mcl, Embryo suis 6X 2 mcl, Funiculus umbillicalis suis 6X 2 mcl, Placenta suis 6X 2 mcl, α-Lipoicum acidum 8X 2 mcl, Coenzyme A 8X 2 mcl, Nadidum 8X 2 mcl, Natrum oxalaceticum 8X 2 mcl. Inactive ingredient: Sterile isotonic sodium chloride solution.



Indications and Usage for Zeel


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Zeel® Injection Solution is indicated for the temporary relief of mild to moderate arthritic pain, osteoarthritis and joint stiffness.



Zeel Dosage and Administration


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The dosage schedule listed below can be used as a general guide for the administration of Zeel® Injection Solution. Zeel® Injection Solution shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient's response to therapy.

Adults and children 7 years and older: 1 ampule daily for acute disorders, or 1 ampule 1 to 3 times per week. Children ages 2 to 6 receive: ½ the adult dosage.


Discard unused solution.


Zeel® Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. The required dose of Zeel® Injection Solution is first withdrawn from the ampule into the syringe, and the syringe is then shaken briefly. Zeel® Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like Zeel® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Zeel® Injection Solution is a clear, colorless solution.


Discolored solutions should be discarded.

Warnings and Precautions


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Zeel® Injection Solution should not be administered for pain for more than 10 days for adults or five days for children. If new symptoms occur, or if redness, pain or swelling at the puncture site persists, the patient should be carefully re-evaluated because these could be signs of a more serious condition. Zeel® Injection Solution should not be administered to children for the pain of arthritis unless directed by a physician.

Pregnancy Category C. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.




To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203 or info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch






Overdosage


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Due to the low concentration of active ingredients in homeopathic preparations such as Zeel® Injection Solution, adverse reactions following overdosage are extremely unlikely. However care must be taken not to exceed the recommended dosage.

Zeel - Clinical Pharmacology


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The exact mechanism of action of Zeel® Injection Solution is not fully understood. In-vitro data indicates that the ingredients in Zeel® Injection Solution may reduce pain, stiffness and inflammation in arthritic joints via immunomodulation. Hence, it has been shown that Zeel® Injection Solution inhibits activity of the leukocyte elastase. This enzyme is released during inflammatory reactions and attacks the articular cartilage which is rich in proteoglycans. A study of human whole blood cultures demonstrated that certain plant extracts contained in Zeel® Injection Solution (e.g. Rhus toxicodendron, Arnica montana) stimulates lymphocytes to release the transforming growth factor β. The protective effect of Zeel® Injection Solution upon cartilage has also been demonstrated by in-vitro and in-vivo studies. The clinical effectiveness and tolerance of Zeel® Injection Solution has also been demonstrated in a drug monitoring study.

PRINCIPAL DISPLAY PANEL


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Zeel_injectable box.jpg









Zeel 
arnica montana and toxicodendron pubescens leaf and solanum dulcamara stem and symphytum tuberosum root and sulfur and sanguinaria canadensis root and sus scrofa cartilage and sus scrofa embryo and sus scrofa umbilical cord and sus scrofa placenta and alpha lipoic acid and coenzyme a and nadide and sodium diethyl oxalacetate   injection










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)52919-116
Route of AdministrationINTRADERMAL, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUSDEA Schedule    















































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (ARNICA MONTANA)ARNICA MONTANA4 [hp_X]  in 2.0 mL
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF)TOXICODENDRON PUBESCENS LEAF2 [hp_X]  in 2.0 mL
SOLANUM DULCAMARA STEM (SOLANUM DULCAMARA STEM)SOLANUM DULCAMARA STEM3 [hp_X]  in 2.0 mL
SYMPHYTUM TUBEROSUM ROOT (SYMPHYTUM TUBEROSUM ROOT)SYMPHYTUM TUBEROSUM ROOT6 [hp_X]  in 2.0 mL
SULFUR (SULFUR)SULFUR6 [hp_X]  in 2.0 mL
SANGUINARIA CANADENSIS ROOT (SANGUINARIA CANADENSIS ROOT)SANGUINARIA CANADENSIS ROOT4 [hp_X]  in 2.0 mL
SUS SCROFA CARTILAGE (SUS SCROFA CARTILAGE)SUS SCROFA CARTILAGE6 [hp_X]  in 2.0 mL
SUS SCROFA EMBRYO (SUS SCROFA EMBRYO)SUS SCROFA EMBRYO6 [hp_X]  in 2.0 mL
SUS SCROFA UMBILICAL CORD (SUS SCROFA UMBILICAL CORD)SUS SCROFA UMBILICAL CORD6 [hp_X]  in 2.0 mL
SUS SCROFA PLACENTA (SUS SCROFA PLACENTA)SUS SCROFA PLACENTA6 [hp_X]  in 2.0 mL
ALPHA LIPOIC ACID (ALPHA LIPOIC ACID)ALPHA LIPOIC ACID8 [hp_X]  in 2.0 mL
COENZYME A (COENZYME A)COENZYME A8 [hp_X]  in 2.0 mL
NADIDE (NADIDE)NADIDE8 [hp_X]  in 2.0 mL
SODIUM DIETHYL OXALACETATE (SODIUM CATION)SODIUM DIETHYL OXALACETATE8 [hp_X]  in 2.0 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
152919-116-102.0 mL In 1 AMPULENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/24/2011


Labeler - Hameln Pharma GmbH (315869123)
Revised: 01/2011Hameln Pharma GmbH



Tetracycline-Vet




In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Tetracycline-Vet



Tetracycline

Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of Tetracycline-Vet in the following countries:


  • United States

International Drug Name Search

Thursday, 22 September 2016

Zinc-220


Generic Name: zinc sulfate (ZINK SUL fate)

Brand Names: Orazinc 110, Orazinc 220, Verazinc, Zinc-220, Zincate


What is Zinc-220 (zinc sulfate)?

Zinc is a naturally occurring mineral. Zinc is important for growth and for the development and health of body tissues.


Zinc sulfate is used to treat and to prevent zinc deficiency.


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


What is the most important information I should know about Zinc-220 (zinc sulfate)?


Before using zinc sulfate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc sulfate if you have certain medical conditions.


Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc sulfate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa.

Zinc sulfate can make certain antibiotics less effective. Tell your doctor about all other medications you are using before you start taking zinc sulfate.


What should I discuss with my healthcare provider before taking Zinc-220 (zinc sulfate)?


Before using zinc sulfate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc sulfate if you have certain medical conditions.


It is not known whether zinc sulfate will harm an unborn baby. Do not take zinc sulfate without telling your doctor if you are pregnant or could become pregnant during treatment. It is not known whether zinc sulfate 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 Zinc-220 (zinc sulfate)?


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 zinc sulfate with a full glass of water. Take zinc sulfate with food if it upsets your stomach.

Your healthcare provider may occasionally change your dose to make sure you get the best results from zinc sulfate. The recommended dietary allowance of zinc sulfate increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


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


What happens if I overdose?


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

Overdose symptoms may include nausea, severe vomiting, dehydration, and restlessness.


What should I avoid while taking Zinc-220 (zinc sulfate)?


Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc sulfate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa.

Zinc-220 (zinc sulfate) 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.

Less serious side effects may include:



  • nausea; or




  • upset stomach.



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 Zinc-220 (zinc sulfate)?


The following drugs can interact with or be made less effective by zinc sulfate. Tell your doctor if you are using any of these:



  • a blood thinner such as warfarin (Coumadin);




  • methyltestosterone (Android, Methitest, Oreton);




  • penicillamine (Cuprimine, Depen);




  • risedronate (Actonel);




  • a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or




  • an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), and others.



This list is not complete and other drugs may interact with zinc sulfate. Tell your healthcare provider 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 Zinc-220 resources


  • Zinc-220 Use in Pregnancy & Breastfeeding
  • Zinc-220 Drug Interactions
  • Zinc-220 Support Group
  • 0 Reviews for Zinc-220 - Add your own review/rating


  • Zinc-220 Advanced Consumer (Micromedex) - Includes Dosage Information

  • Zinc Sulfate Professional Patient Advice (Wolters Kluwer)

  • Zinc Sulfate MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Zinc-220 with other medications


  • Vitamin/Mineral Supplementation and Deficiency


Where can I get more information?


  • Your pharmacist can provide more information about zinc sulfate.


Zenapax


Generic Name: daclizumab (dah KLIH zyoo mab)

Brand Names: Zenapax


What is Zenapax (daclizumab)?

Daclizumab is an immunosuppressant. Immunosuppressants decrease the actions of the body's immune system.


Daclizumab is used to prevent the body from rejecting a transplanted kidney. Daclizumab is usually used as part of a treatment regimen including other medications.


Daclizumab may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Zenapax (daclizumab)?


Because it may cause serious side effects, daclizumab should only be prescribed by a doctor experienced in immunosuppressive therapy and the management of organ transplant patients. Discuss the risks and benefits of using this medication with your doctor.


There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.


What should I discuss with my healthcare provider before using Zenapax (daclizumab)?


Because it may cause serious side effects, daclizumab should only be prescribed by a doctor experienced in immunosuppressive therapy and the management of organ transplant patients. Discuss the risks and benefits of using this medication with your doctor.


Before using daclizumab, tell your doctor if you



  • have used daclizumab in the past;




  • have had a previous allergic reaction to daclizumab;




  • have any active or chronic viral, bacterial, or fungal infection; or




  • have a suppressed immune system or take medications that may suppress the immune system (e.g., medicines to prevent rejection of a transplanted organ, some cancer medicines, others).



You may not be able to use daclizumab, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.


Daclizumab is in the FDA pregnancy category C. This means that it is not known whether daclizumab will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. For women who could become pregnant, contraception is recommended before starting, during, and for four months following treatment with daclizumab to ensure protection from pregnancy. It is not known whether daclizumab passes into breast milk. Do not use daclizumab without first talking to your doctor if you are breast-feeding a baby.

How should I use Zenapax (daclizumab)?


Daclizumab is administered as an intravenous (into the vein) injection. In most cases, your healthcare provider will administer daclizumab in a hospital or clinic setting. If you are using daclizumab at home, your healthcare provider will give you detailed instructions regarding preparation, administration, and storage of the medication.


The first dose of daclizumab is usually administered within 24 hours of the kidney transplant. Four additional doses are then given at 14 day intervals following transplantation.


When mixing the solution for injection, the bag should be gently inverted to ensure mixing. Do not shake the mixture.


After mixing the solution for injection, it should be used within 4 hours. If the mixture cannot be used within 4 hours, it should be refrigerated between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius) for up to 24 hours. If it is not used within 24 hours, it must be discarded.


Do not use any solution that is discolored or that has particles in it.

Your doctor may want you to have blood tests or other medical evaluations during treatment with daclizumab to monitor progress and side effects.


Your healthcare provider will store daclizumab as directed by the manufacturer. If you are using daclizumab at home, your healthcare provider will give you detailed storage instructions.


What happens if I miss a dose?


Contact your doctor if you miss a dose of daclizumab.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

Symptoms of a daclizumab overdose are not known.


What should I avoid while using Zenapax (daclizumab)?


Daclizumab can lower the activity of the immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop any signs of illness or infection.


Talk to your doctor before receiving any vaccines during treatment with daclizumab. Some vaccines may not be effective, or may be harmful, if received during treatment with daclizumab. In addition, avoiding close contact with people who have recently been vaccinated with a "live" vaccine (e.g. oral polio vaccine, nasal influenza vaccine) may be recommended. There is a chance that the virus can be passed on to you.


Tell your doctor and dentist that you are using this medication before having surgery and before starting any other medicines.


Zenapax (daclizumab) side effects


There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.


If you experience a serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to daclizumab, seek emergency medical attention.

Other, less serious side effects may also occur. Continue to use daclizumab and notify your doctor if you experience



  • upset stomach, nausea, or vomiting;




  • diarrhea or constipation;




  • tremor or dizziness;




  • headache; or




  • swelling of the hands, feet or legs.



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


What other drugs will affect Zenapax (daclizumab)?


Talk to your doctor before receiving any vaccines during treatment with daclizumab. Some vaccines may not be effective, or may be harmful, if received during treatment with daclizumab. In addition, avoiding close contact with people who have recently been vaccinated with a "live" vaccine (e.g. oral polio vaccine, nasal influenza vaccine) may be recommended. There is a chance that the virus can be passed on to you.


Drugs other than those listed here may also interact with daclizumab. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.



More Zenapax resources


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


  • Zenapax Prescribing Information (FDA)

  • Zenapax MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zenapax Monograph (AHFS DI)

  • Zenapax Advanced Consumer (Micromedex) - Includes Dosage Information

  • Daclizumab Professional Patient Advice (Wolters Kluwer)



Compare Zenapax with other medications


  • Organ Transplant, Rejection Prophylaxis


Where can I get more information?


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

See also: Zenapax side effects (in more detail)


Wednesday, 21 September 2016

Zyrtec Syrup





Dosage Form: children's syrup
Children's

ZYRTEC®

Drug Facts



Active ingredient (in each 5 mL teaspoonful)


Cetirizine HCl 5 mg



Purpose


Antihistamine



Uses


temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


  • runny nose

  • sneezing

  • itchy, watery eyes

  • itching of the nose or throat


Warnings



Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.



Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.



Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.



When using this product


  • drowsiness may occur

  • avoid alcoholic drinks

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when driving a motor vehicle or operating machinery


Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.



If pregnant or breast-feeding:


  • if breast-feeding: not recommended

  • if pregnant: 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. (1-800-222-1222)



Directions


  • use only with enclosed dosing cup











adults and children 6 years and over1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information


  • store between 20° to 25°C (68° to 77°F)

  • do not use if carton is opened; or if bottle wrap or foil inner seal printed with "Safety Seal®" is broken or missing

  • see bottom panel for lot number and expiration date


Inactive ingredients


anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose



Questions?


call 1-800-343-7805



PRINCIPAL DISPLAY PANEL


NDC 50580-730-04


Children's

ZYRTEC®

ALLERGY


Cetirizine HCl

1 mg/mL oral solution

antihistamine


Indoor & Outdoor Allergies


24

hour

Relief of

•Sneezing

•Runny Nose

•Itchy, Watery Eyes

•Itchy Throat or Nose


2 yrs.

& older


Grape

Syrup


Dye-Free • Sugar-Free


4 FL OZ (118 mL)

Dosing Cup Included










CHILDRENS ZYRTEC 
cetirizine hydrochloride  syrup










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)50580-730
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine)Cetirizine Hydrochloride5 mg  in 5 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains      






























Packaging
#NDCPackage DescriptionMultilevel Packaging
150580-730-041 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
1118 mL In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-730-04)
250580-730-092 BOTTLE In 1 PACKAGE, COMBINATIONcontains a BOTTLE, PLASTIC
2118 mL In 1 BOTTLE, PLASTICThis package is contained within the PACKAGE, COMBINATION (50580-730-09)
350580-730-1512 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
315 mL In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-730-15)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02215506/01/2009


Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
Revised: 10/2009McNeil Consumer Healthcare Div McNeil-PPC, Inc




More Zyrtec Syrup resources


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


Compare Zyrtec Syrup with other medications


  • Hay Fever
  • Urticaria

Zegerid


Generic Name: omeprazole and sodium bicarbonate (Oral route)


oh-MEP-ra-zole, SOE-dee-um bye-KAR-bo-nate


Commonly used brand name(s)

In the U.S.


  • Zegerid

Available Dosage Forms:


  • Packet

  • Capsule

Therapeutic Class: Gastric Acid Secretion Inhibitor


Pharmacologic Class: Proton Pump Inhibitor


Uses For Zegerid


Omeprazole and sodium bicarbonate combination is used to treat certain conditions where there is too much acid in the stomach. It is used to treat gastric and duodenal ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. Sometimes this medicine is used in combination with antibiotics (e.g., amoxicillin, clarithromycin) to treat ulcers associated with infection caused by the H. pylori bacteria (germ).


Omeprazole and sodium bicarbonate combination is used to prevent upper gastrointestinal tract bleeding in seriously ill patients.


Omeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.


Sodium bicarbonate, also known as baking soda, is an antacid. It works by neutralizing the excess acid in the stomach.


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


Before Using Zegerid


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 omeprazole and sodium bicarbonate combination in children. 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 omeprazole and sodium bicarbonate combination in the elderly.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Atazanavir

  • Bendamustine

  • Citalopram

  • Clopidogrel

  • Clorazepate

  • Dasatinib

  • Delavirdine

  • Erlotinib

  • Indinavir

  • Methotrexate

  • Mycophenolate Mofetil

  • Nelfinavir

  • Nilotinib

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.


  • Armodafinil

  • Carbamazepine

  • Cilostazol

  • Cranberry

  • Dasatinib

  • Digoxin

  • Disulfiram

  • Fluconazole

  • Ginkgo Biloba

  • Iron

  • Itraconazole

  • Raltegravir

  • Saquinavir

  • St John's Wort

  • Tipranavir

  • Triazolam

  • Voriconazole

  • Warfarin

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:


  • Bartter's syndrome (rare kidney problem) or

  • Hypokalemia (low potassium in the blood) or

  • Hypomagnesemia (low magnesium in the blood), history of or

  • Osteoporosis (bone problem) or

  • Respiratory alkalosis (low levels of carbon dioxide in the blood) or

  • Seizures, history of—Use with caution. May make these conditions worse.

  • Liver disease—You may need a dose adjustment. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Zegerid


Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not stop taking this medicine if your doctor told you to take it for a specific amount of time, even if you feel better.


This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.


This medicine contains sodium (salt). Talk to your doctor before using this medicine if you are on a low-sodium (low-salt) diet or if you have or are at risk for congestive heart failure.


Tell your doctor if you are taking calcium supplements on a regular basis.


Both 20 and 40 milligrams oral suspension packets ro capsules contain the same amount of sodium bicarbonate. Do not substitute two 20 milligrams (mg) oral suspension packets or capsules with one 40 mg oral suspension packets or capsules. Talk to your doctor if you have any questions.


Take this medicine on an empty stomach at least 1 hour before a meal. For patients receiving continuous feeding through a tube, feeding should be temporarily stopped about 3 hours before and 1 hour after administration of Zegerid® powder for oral suspension.


Swallow the capsules whole with water. Do not take it with other liquids. Do not break, crush, or chew it. Do not open the capsule and sprinkle the contents into food.


To use the powder for oral suspension:


  • Empty packet of powder into a small cup containing 1 to 2 tablespoons of water.

  • Do not use other liquids or foods.

  • Stir well and drink immediately.

  • Refill cup with water and drink.

If you are using the powder for oral suspension with a nasogastric or orogastric tube:


  • Mix the packet of powder with approximately 20 mL of water.

  • Stir well and draw up into appropriately sized syringe.

  • Give the medicine through the nasogastric or orogastric tube into the stomach right away.

  • Refill the syringe with an equal amount of water.

  • Shake and flush any remaining contents from the nasogastric or orogastric tube into the stomach.

Dosing


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


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


  • For oral dosage forms (capsules or powder for suspension):
    • To treat duodenal ulcers, erosive esophagitis, and GERD:
      • Adults—20 milligrams (mg) once a day at least 1 hour before a meal. Your doctor may adjust your dose if needed.

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


    • To treat gastric ulcers:
      • Adults—40 milligrams (mg) once a day at least 1 hour before a meal. Your doctor may adjust your dose if needed.

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



  • For oral dosage form (powder for suspension):
    • To prevent upper gastrointestinal tract bleeding in seriously ill patients:
      • Adults—The first day: 40 milligrams (mg) for the first dose; then after 6 to 8 hours, a second 40 mg dose. After the first day: 40 mg once a day for up to 14 days.

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



Missed Dose


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


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using Zegerid


It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects. If your condition does not improve, or if it becomes worse, check with your doctor.


Tell your doctor if you have Asian relatives, such as Filipino, Chinese, Japanese, Korean, or Taiwanese. You may need a lower dose of this medicine to treat erosive esophagitis.


This medicine is sometimes given together with other medicines to treat ulcers. Be sure you understand about the risks and proper use of any other medicine your doctor gives you together with omeprazole and sodium bicarbonate combination.


Atrophic gastritis (inflammation in the stomach) may occur, especially if you take this medicine for a long time. Talk with your doctor if you have concerns about this.


This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you receive high doses of this medicine or use it for one year or more.


This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Stop using this medicine and check with your doctor right away if you have convulsions (seizures); fast, racing, or uneven heartbeat; muscle spasms (tetany); tremors; or unusual tiredness or weakness.


Do not stop taking this medicine without first checking with your doctor, or unless told to do so by 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 and herbal or vitamin supplements.


Zegerid 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
  • Black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • blurred vision

  • chest pain

  • confusion

  • convulsions

  • cough

  • decreased urine

  • dizziness

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

  • drowsiness

  • dry mouth

  • fainting

  • fast or irregular heartbeat

  • fever or chills

  • headache

  • increased thirst

  • irregular heartbeat

  • lightheadedness

  • loss of appetite

  • mood or mental changes

  • muscle pain or cramps

  • muscle spasms (tetany) or twitching

  • nausea or vomiting

  • nervousness

  • numbness or tingling in the hands, feet, or lips

  • pale skin

  • pinpoint red spots on the skin

  • pounding in the ears

  • rapid, shallow breathing

  • seizures

  • shortness of breath

  • slow heartbeat

  • sneezing

  • sore throat

  • sweating

  • tightness in the chest

  • trembling

  • troubled breathing

  • troubled breathing with exertion

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • wheezing

Less common
  • Abdominal cramps or pain

  • bladder pain

  • bloody or cloudy urine

  • blue lips, fingernails, or skin

  • bone pain

  • chest discomfort

  • coma

  • decreased urine output

  • difficult or troubled breathing

  • difficult, burning, or painful urination

  • fast, pounding, or irregular heartbeat or pulse

  • frequent urge to urinate

  • headache

  • high blood pressure

  • irregular, fast or slow, or shallow breathing

  • irritability

  • lower back or side pain

  • muscle cramps in the hands, arms, feet, legs, or face

  • restlessness

  • swelling

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

  • weakness or heaviness of the legs

Rare
  • Severe pain in the chest

  • sudden onset of severe breathing difficulty

Incidence not known
  • Arm, back, or jaw pain

  • blistering, peeling, or loosening of the skin

  • bloating or swelling of the face, arms, hands, lower legs, or feet

  • chest tightness or heaviness

  • constipation

  • cough or hoarseness

  • dark-colored urine

  • diarrhea

  • difficulty with swallowing

  • fever with or without chills

  • general body swelling

  • general feeling of tiredness or weakness

  • greatly decreased frequency of urination or amount of urine

  • high fever

  • hives

  • indigestion

  • joint or muscle pain

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

  • light-colored stools

  • noisy breathing

  • nosebleeds

  • pain with swallowing

  • pains in the stomach, side, or abdomen, possibly radiating to the back

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

  • rapid weight gain

  • red skin lesions, often with a purple center

  • red, irritated eyes

  • skin rash

  • sores, ulcers, or white spots on the lips or in the mouth

  • stomach pain, continuing

  • sweating

  • swollen glands

  • unexplained bleeding or bruising

  • unusual weight gain or loss

  • weight gain

  • yellow eyes or skin

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


Symptoms of overdose
  • Feeling of warmth

  • increased sweating

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

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:


Less common
  • Agitation

  • anxiety

  • cold sweats

  • cool, pale skin

  • depression

  • excess air or gas in the stomach or intestines

  • flushed, dry skin

  • fruit-like breath odor

  • full feeling

  • increased hunger

  • increased thirst

  • increased urination

  • lack or loss of strength

  • nightmares

  • passing gas

  • shakiness

  • slurred speech

  • white patches in the mouth or throat or on the tongue

  • white patches with diaper rash

Incidence not known
  • Abnormal dreams

  • attack, assault, or force

  • bad, unusual, or unpleasant (after) taste

  • blindness

  • blue-yellow color blindness

  • change in taste

  • continuing ringing or buzzing or other unexplained noise in the ears

  • decreased vision

  • double vision

  • dry eyes or skin

  • eye pain

  • feeling of constant movement of self or surroundings

  • general feeling of discomfort or illness

  • hair loss or thinning of the hair

  • hearing loss

  • hives or welts

  • increased sensitivity of the skin to sunlight

  • itching, redness, tearing, or other sign of eye irritation not present before use of this medicine or becoming worse during use

  • lack of feeling or emotion

  • pain in the testes

  • pinpoint red or purple spots on the skin

  • redness or other discoloration of the skin

  • seeing, hearing, or feeling things that are not there

  • sensation of spinning

  • severe sunburn

  • sleepiness or unusual drowsiness

  • sleeplessness

  • sugar in the urine

  • swelling of the breasts or breast soreness in both females and males

  • swelling or inflammation of the mouth

  • trouble sleeping

  • unable to sleep

  • uncaring

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Zegerid side effects (in more detail)



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


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


More Zegerid resources


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


  • Zegerid Prescribing Information (FDA)

  • Zegerid Consumer Overview

  • Zegerid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zegerid OTC Consumer Overview

  • Zegerid OTC MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Zegerid with other medications


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Tuesday, 20 September 2016

Orlistat


Pronunciation: OR-li-stat
Generic Name: Orlistat
Brand Name: Alli


Orlistat is used for:

Managing obesity in overweight adults. It may also be used to reduce the risk of weight regain after previous weight loss. It is used along with a reduced-calorie, low-fat diet.


Orlistat is a gastrointestinal lipase inhibitor. It works by blocking the digestion of fats from the diet.


Do NOT use Orlistat if:


  • you are allergic to any ingredient in Orlistat

  • you are not overweight

  • you have gallbladder problems, bile flow problems (eg, cholestasis), or problems absorbing food (malabsorption)

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



Before using Orlistat:


Some medical conditions may interact with Orlistat. 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 an eating disorder (eg, anorexia, bulimia)

  • if you have a history of gallbladder, liver, pancreas, or thyroid problems; diabetes; or kidney stones

  • if you take medicine for diabetes or thyroid problems, or if you take any other medicines for weight loss

  • if you have received an organ transplant or if you take cyclosporine

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


  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Orlistat

  • Amiodarone, cyclosporine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Orlistat

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


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


  • An extra patient leaflet is available with Orlistat. Talk to your pharmacist if you have questions about this information.

  • Read the chart on the medicine package. You may consider starting Orlistat if your weight is the same or more than the weight shown for your height. Talk to your doctor or pharmacist if you have any questions.

  • Take Orlistat by mouth with each meal. Do not take more than 3 capsules daily.

  • If a meal is missed or contains no fat, do not take a dose of Orlistat.

  • Orlistat may decrease your absorption of vitamins. Take a multivitamin once a day at bedtime.

  • If you also take a thyroid hormone (eg, levothyroxine), do not take it within 4 hours before or after taking Orlistat. Check with your doctor if you have questions.

  • If you also take cyclosporine, do not take it within 2 hours before or after taking Orlistat. Check with your doctor before you take Orlistat with cyclosporine.

  • If you miss a dose of Orlistat, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

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



Important safety information:


  • Do NOT take more than the recommended dose without checking with your doctor. Taking more than the recommended dose may not help you lose more weight. It may increase your risk of side effects.

  • Proper diet and exercise are important in order to lose weight and keep it off. Follow the diet and exercise program given to you by your health care provider.

  • Orlistat may cause changes in your bowel or stool (eg, gas with oily spotting, loose stools, more frequent stools). Eating a low-fat diet may help lessen these side effects.

  • Tell your doctor or dentist that you take Orlistat before you receive any medical or dental care, emergency care, or surgery.

  • Diabetes patients - Orlistat may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Rarely, some patients taking Orlistat have developed severe liver problems. Contact your doctor right away if you experience yellowing of the skin or eyes, dark urine, pale stools, unusual weakness, loss of appetite, or severe or persistent nausea.

  • Orlistat should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Do not take Orlistat if you are pregnant. If you become pregnant, contact your doctor. It is not known if Orlistat is found in breast milk. Do not breast-feed while taking Orlistat.


Possible side effects of Orlistat:


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:



Diarrhea; frequent or loose stools; gas with discharge; oily spotting; trouble controlling bowel movements.



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); bloody urine; new or unusual back pain; severe or persistent stomach pain (with or without nausea and vomiting); symptoms of liver damage (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, severe or persistent nausea).



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: Orlistat 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 Orlistat:

Store Orlistat between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Orlistat out of the reach of children and away from pets.


General information:


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

  • Orlistat 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 summary only. It does not contain all information about Orlistat. 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 Orlistat resources


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


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