Thursday, 10 May 2012

Jabastatina




Jabastatina may be available in the countries listed below.


Ingredient matches for Jabastatina



Simvastatin

Simvastatin is reported as an ingredient of Jabastatina in the following countries:


  • Portugal

International Drug Name Search

Monday, 7 May 2012

Sensodyne Mint





1. Name Of The Medicinal Product



Macleans Sensitive/Sensodyne Mint


2. Qualitative And Quantitative Composition



Macleans Sensitive/Sensodyne Mint contains the active ingredients Strontium acetate hemihydrate 8.0% w/w and Sodium Fluoride 0.23% w/w (1040 ppm fluoride).



For excipients, see 6.1.



3. Pharmaceutical Form



Toothpaste



4. Clinical Particulars



4.1 Therapeutic Indications



Macleans Sensitive/Sensodyne Mint is recommended for the relief of tooth sensitivity and the prevention of dental caries.



4.2 Posology And Method Of Administration



For external administration to the teeth.



To be used in the normal manner of toothpastes, morning and night.



Not to be used by children under 7 years unless recommended by a dentist.



4.3 Contraindications



Hypersensitivity to the active ingredients or to any of the other constituents.



4.4 Special Warnings And Precautions For Use



Sensitive teeth may indicate an underlying problem which needs prompt care by a dentist. Dental advice should be sought as soon as possible after the problem develops.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



At the active ingredient levels in the toothpaste, no interactions are expected.



4.6 Pregnancy And Lactation



No adverse effects known.



4.7 Effects On Ability To Drive And Use Machines



None.



4.8 Undesirable Effects



When used in the normal manner of toothpastes the product is not expected to cause side-effects, except rarely allergic reactions of a non-serious nature.



4.9 Overdose



No symptoms of strontium acetate hemihydrate overdose are known.



Theoretically, acute overdosage is possible in children but symptoms of fluoride toxicity would only arise after ingestion of large quantities of the product. Symptoms may include salivation, nausea, vomiting and diarrhoea.



Treatment would be by provision of a calcium containing drink e.g. milk or lime water.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Strontium acetate hemihydrate desensitises dentine. Sodium fluoride is a well known anti-caries agent.



5.2 Pharmacokinetic Properties



Not applicable as the product activity is by local action in the oral cavity only.



5.3 Preclinical Safety Data



There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Glycerol



Sorbitol liquid (non-crystallising)



Xanthan Gum



Silica, Dental Type



Precipitated Silica



Sodium N-Methy-N-Cocoyl Taurate



Titanium Dioxide (E171)



Flavour



Saccharin Sodium



Sodium Methy-p-Hydroxybenzoate (E219)



Sodium Propyl-p-Hyrdroxybenzoate (E217)



Purified Water



Composition of Flavour



Peppermint Oil



Menthol



Anethole



L-Carvone



L-Menthyl Acetate



Limonene



Eucalyptol



L-Menthone



6.2 Incompatibilities



None known.



6.3 Shelf Life



24 months.



6.4 Special Precautions For Storage



None.



6.5 Nature And Contents Of Container



1. Aluminium laminate tube with either a plain plastic screw-threaded cap or a plastic screw-threaded cap with a flip-top lid containing 17, 25, 45, 50, 55, 75 or 125 ml. Tubes may be contained in an outer box-board carton.



2. Plastic barrier laminate flexible tube with either a plain plastic screw-threaded cap or a plastic screw-threaded cap with a flip-top lid containing 17, 25, 45, 50, 55, 75 or 125 ml. Tubes may be contained in an outer box-board carton.



3. Polypropylene pump pack with a polyethylene piston and a polypropylene cap. The pack is covered with a tamper-evident, shrink-wrap seal. The pump contains 100ml of toothpaste.



6.6 Special Precautions For Disposal And Other Handling



None.



Administrative Data


7. Marketing Authorisation Holder



Beecham Group plc



980 Great West Road



Brentford



Middlesex TW8 9GS



U.K.



Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.



8. Marketing Authorisation Number(S)



PL 00079/0225



9. Date Of First Authorisation/Renewal Of The Authorisation



7 March 1986 / 19 April 1993 / 26 November 1998



10. Date Of Revision Of The Text



June 2007




Mannitol Irrigation




5% Mannitol Irrigation

Package Insert


PIC™ (Plastic Irrigation Containers)


Nonelectrolyte Irrigating Fluid for Transurethral

Surgical Procedures.


For Urologic Irrigation Only.


Not for Injection.



Mannitol Irrigation Description


Each 100 mL contains:

Mannitol USP 5 g

Water for Injection USP qs


pH: 5.5 (4.5–7.0)

Calculated Osmolarity: 275 mOsmol/liter


The formula of the active ingredient is:








IngredientMolecular FormulaMolecular Weight
 Mannitol USP  182.17

5% Mannitol Irrigation is a prediluted, sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. The solution is approximately isotonic.


Mannitol USP is chemically designated D-mannitol (C6H14O6). Mannitol is a hexitol naturally occurring in fruits and vegetables and is produced commercially by the reduction of glucose.


The solution contains no antimicrobial or bacteriostatic agents or added buffers.


The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.


The PIC™ Container is PVC-free and DEHP-free.



Mannitol Irrigation - Clinical Pharmacology


In humans, mannitol is confined to the extracellular space and is only slightly metabolized. It is rapidly excreted in the urine. When mannitol is absorbed intravascularly, it produces osmotic diuresis and will be excreted by the kidneys.


Mannitol is nonelectrolytic and is, therefore, nonconductive, making it suitable for urologic irrigation during electrosurgical procedures.


5% Mannitol is a nonhemolytic irrigating solution.



Indications and Usage for Mannitol Irrigation


5% Mannitol is indicated for use as a urologic irrigation fluid for transurethral prostatic resection and other transurethral surgical procedures.



Contraindications


5% Mannitol is not for injection. It is contraindicated in patients with anuria.



Warnings


FOR UROLOGIC IRRIGATION ONLY. NOT FOR INJECTION.


Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction.


Since irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes, any irrigation solution must be regarded as a systemic drug.


Absorption of large amounts of fluids containing mannitol and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics.


Do not warm above 150°F (66°C)


After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.


Discard unused portion of irrigating solution since it contains no preservative.



Precautions



General


Use aseptic technique when preparing and administering sterile irrigation solutions.


Use only if solution is clear and container and seal are intact.


Cardiovascular status, especially in patients with cardiac disease, should be carefully determined before and during transurethral resection of the prostate when using 5% Mannitol as an irrigant. The fluid absorbed into the systemic circulation via severed prostatic veins may produce significant extracellular fluid expansion and lead to fulminating congestive heart failure.


Shift of sodium-free intracellular fluid into the extracellular compartment following systemic absorption of 5% Mannitol may lower serum sodium concentration and aggravate pre-existing hyponatremia.


Excessive loss of water and electrolytes may lead to serious imbalances. Continuous administration of 5% Mannitol may cause loss of water in excess of electrolytes and produce hypernatremia.


Sustained diuresis from transurethral irrigation with 5% Mannitol may obscure and intensify inadequate hydration or hypovolemia.


When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.



Carcinogenesis, Mutagenesis, Impairment of Fertility


Studies with 5% Mannitol Irrigation have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.



Pregnancy


Teratogenic Effects

Pregnancy Category C


Animal reproduction studies have not been conducted with 5% Mannitol Irrigation. It is also not known whether 5% Mannitol Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Mannitol Irrigation should be given to a pregnant woman only if clearly needed.



Nursing Mothers


Caution should be exercised when 5% Mannitol Irrigation is administered to a nursing woman.



Pediatric Use


Safety and effectiveness in pediatric patients have not been established.



Geriatric Use


Clinical studies of 5% Mannitol Irrigation did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.


This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. See WARNINGS.



Adverse Reactions


Occasional adverse reactions to intravenous mannitol infusions have been reported. These include fluid and electrolyte disturbances, such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of the mouth, thirst and dehydration, cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pain, and thrombophlebitis, and other general reactions such as blurred vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo, backache, and urticaria.


If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.



Overdosage


In the event of dehydration or fluid or solute overload, discontinue the irrigant, evaluate the patient and institute appropriate corrective treatment. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.



Mannitol Irrigation Dosage and Administration


As required for urologic irrigation.


5% Mannitol Irrigation should be administered only by the appropriate transurethraI urologic instrumentation.


Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.


Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.



How is Mannitol Irrigation Supplied


5% Mannitol Irrigation is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Containers). The 2000 mL containers are packaged 8 per case and the 4000 mL containers are packaged 4 per case.














NDCCat. No.Size
 5% Mannitol Irrigation

(Canada DIN 01963953)
  
 0264-2303-50 R6515-01 2000 mL
 0264-2303-70 R6517 4000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.


Do not warm above 150°F (66°C).



Rx only


Revised: March 2009


PIC is a trademark of B. Braun Medical Inc.



Directions for Use of PIC™ (Plastic Irrigation Containers)


Not for injection.


Aseptic technique is required.


1. Caution – Before use, perform the following checks:

             (a) Read the label. Ensure solution is the one ordered and is within the expiration date.


             (b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate 

                  matter; check the container for leakage or damage. Any container which is suspect

                  should not be used.


Use only if solution is clear and container and seal are intact.


Single dose container.


2. Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring 

    counterclockwise with the other hand until slight resistance is felt. Then, twisting the 

    container in the opposite direction, turn the breakaway ring sharply until the entire outer

    cap is loose and can be lifted off.


3. Connect the administration set through the sterile port according to set instructions or 

    remove screw cap and pour.


4. Do not warm above 150°F to assure minimal bottle distortion. Keep bottles upright.



B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA


In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4


Y36-002-697



PRINCIPAL DISPLAY PANEL - 2000 mL Label


5% Mannitol Irrigation


For Urologic Irrigation


REF R6515-01

NDC 0264-2303-50

DIN 01963953


2000 mL


Lot

Exp.


Each 100 mL contains:

Mannitol USP 5 g

Water for Injection USP qs


pH: 5.5 (4.5-7.0)

Calc. Osmolarity: 275 mOsmol/liter


Not for Injection: Use only if

solution is clear and container

and seal are intact.


Sterile, nonpyrogenic.

Single dose container.


Warning: Do not warm above

150°F (66°C).


Recommended Storage:

Room temperature (25°C).

Avoid excessive heat.

Protect from freezing.

See Package Insert.


Rx only


PVC-free and DEHP-free


B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA


In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4


Y37-002-334










MANNITOL 
mannitol  irrigant










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0264-2303
Route of AdministrationIRRIGATIONDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MANNITOL (MANNITOL)MANNITOL5 g  in 100 mL






Inactive Ingredients
Ingredient NameStrength
WATER 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
10264-2303-508 CONTAINER In 1 CASEcontains a CONTAINER
12000 mL In 1 CONTAINERThis package is contained within the CASE (0264-2303-50)
20264-2303-704 CONTAINER In 1 CASEcontains a CONTAINER
24000 mL In 1 CONTAINERThis package is contained within the CASE (0264-2303-70)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA01677202/10/1978


Labeler - B. Braun Medical Inc. (002397347)
Revised: 07/2011B. Braun Medical Inc.

More Mannitol Irrigation resources


  • Mannitol Irrigation Support Group
  • 0 Reviews · Be the first to review/rate this drug

Sunday, 6 May 2012

Narvox


Generic Name: acetaminophen and oxycodone (a SEET a MIN oh fen and OX i KOE done)

Brand Names: Endocet, Magnacet, Percocet 10/325, Percocet 10/650, Percocet 2.5/325, Percocet 5/325, Percocet 7.5/325, Percocet 7.5/500, Perloxx, Primalev, Roxicet, Tylox, Xolox


What is Narvox (acetaminophen and oxycodone)?

Oxycodone is in a group of drugs called narcotic pain relievers. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone.


The combination of acetaminophen and oxycodone is used to relieve moderate to severe pain.


Acetaminophen and oxycodone may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Narvox (acetaminophen and oxycodone)?


Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.


Oxycodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before taking Narvox (acetaminophen and oxycodone)?


Do not use this medication if you are allergic to acetaminophen (Tylenol) or oxycodone. Oxycodone may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and oxycodone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take acetaminophen and oxycodone, tell your doctor if you are allergic to any drugs, or if you have:



  • asthma, COPD, sleep apnea, or other breathing disorders;



  • liver or kidney disease;


  • a history of head injury or brain tumor;




  • epilepsy or other seizure disorder;




  • low blood pressure;




  • a stomach, intestinal, or pancreas disorder;




  • underactive thyroid;




  • Addison's disease or other adrenal gland disorder;




  • enlarged prostate, urination problems;




  • curvature of the spine;




  • mental illness; or




  • a history of drug or alcohol addiction.



Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.


FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Before you take acetaminophen and oxycodone, tell your doctor if you are pregnant or plan to become pregnant during treatment. Acetaminophen and oxycodone may pass into breast milk and 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 Narvox (acetaminophen and oxycodone)?


Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.


An overdose of acetaminophen can cause serious harm to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. One acetaminophen and oxycodone tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Measure the liquid form of this medication with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and oxycodone. Do not use a stool softener (laxative) without first asking your doctor. You may have withdrawal symptoms when you stop using acetaminophen and oxycodone after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

This medication can cause you to have unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and oxycodone.


If you need to have any type of surgery, tell the surgeon ahead of time that you are using acetaminophen and oxycodone. You may need to stop using the medicine for a short time.


Store acetaminophen and oxycodone at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Oxycodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.


What happens if I miss a dose?


Since acetaminophen and oxycodone 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. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of acetaminophen and oxycodone can be fatal.

Overdose symptoms may include extreme drowsiness, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, coma, blue lips, shallow breathing, or no breathing.


What should I avoid while taking Narvox (acetaminophen and oxycodone)?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. Avoid drinking alcohol while taking acetaminophen and oxycodone. Alcohol may increase your risk of liver damage while taking acetaminophen.

Narvox (acetaminophen and oxycodone) 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. Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;




  • feeling light-headed, fainting;




  • confusion, unusual thoughts or behavior;




  • seizure (convulsions); or




  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects include:



  • feeling dizzy or drowsy;




  • mild nausea, vomiting, upset stomach, constipation;




  • blurred vision; or




  • dry mouth.



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 Narvox (acetaminophen and oxycodone)?


Cold or allergy medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by oxycodone. Tell your doctor if you regularly use any of these medicines, or any other narcotic pain medicine.

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



  • glycopyrrolate (Robinul);




  • mepenzolate (Cantil);




  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);




  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);




  • a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or




  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).



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



More Narvox resources


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


  • Narvox Advanced Consumer (Micromedex) - Includes Dosage Information

  • Endocet Prescribing Information (FDA)

  • Endocet MedFacts Consumer Leaflet (Wolters Kluwer)

  • Endocet Consumer Overview

  • Magnacet Prescribing Information (FDA)

  • Primlev Prescribing Information (FDA)

  • Roxicet Prescribing Information (FDA)

  • Roxicet Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Roxicet Consumer Overview

  • Tylox Prescribing Information (FDA)

  • Tylox Consumer Overview



Compare Narvox with other medications


  • Pain


Where can I get more information?


  • Your pharmacist can provide more information about acetaminophen and oxycodone.

See also: Narvox side effects (in more detail)


Friday, 4 May 2012

Infibutabletas




Infibutabletas may be available in the countries listed below.


Ingredient matches for Infibutabletas



Ibuprofen

Ibuprofen is reported as an ingredient of Infibutabletas in the following countries:


  • Colombia

International Drug Name Search

Thursday, 3 May 2012

Gamma E Plus


Generic Name: vitamin e (Oral route)


VYE-ta-min E


Commonly used brand name(s)

In the U.S.


  • Alpha-E

  • Aqua Gem-E

  • Aquasol E

  • D-Alpha Gems

  • E-400

  • E-600

  • E-Gems

  • Formula E 400

  • Gamma E-Gems

  • Gamma E Plus

  • Key-E

  • Natural Vitamin Blend E-400IU

  • Nutr-E-Sol

Available Dosage Forms:


  • Liquid

  • Solution

  • Tablet

  • Capsule, Liquid Filled

  • Tablet, Chewable

  • Powder for Solution

  • Capsule

Therapeutic Class: Nutritive Agent


Pharmacologic Class: Vitamin E (class)


Uses For Gamma E Plus


Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.


Some conditions may increase your need for vitamin E. These include:


  • Intestine disease

  • Liver disease

  • Pancreas disease

  • Surgical removal of stomach

Increased need for vitamin E should be determined by your health care professional.


Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.


Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being used to prevent certain types of cancer, there is not enough information to show that this is effective.


Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.


Vitamin E is available without a prescription.


Importance of Diet


For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.


Vitamin E is found in various foods including vegetable oils (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storage may destroy some of the vitamin E in foods.


Vitamin supplements alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, small amounts of fat are needed so that vitamin E can be absorbed into the body.


The daily amount of vitamin E needed is defined in several different ways.


  • For U.S.—

  • Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).

  • Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

  • For Canada—

  • Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Vitamin E is available in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E have been expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equivalent to 1 mg of dl-alpha tocopherol acetate or 0.6 mg d-alpha tocopherol. Most products available in stores continue to be labeled in Units.


Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E are generally defined as follows:











































































     
     
     
     
     
PersonsU.S.Canada
mg

alpha-TE
Unitsmg

alpha-TE
Units 
Infants and children

Birth to 3 years of

age
3–65–103–45–6.7
4 to 6 years of age711.758.3
7 to 10 years of age711.76–810–13
Adolescent and adult

males
1016.76–1010–16.7
Adolescent and adult

females
8135–78.3–11.7
Pregnant females1016.78–913–15
Breast-feeding

females
11–1218–209–1015–16.7

Before Using Gamma E Plus


If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, 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


Problems in children have not been reported with intake of normal daily recommended amounts. You should check with your health care professional if you are giving your baby an unfortified formula. In that case, the baby must get the vitamins needed some other way. Some studies have shown that premature infants may have low levels of vitamin E. Your health care professional may recommend a vitamin E supplement.


Geriatric


Problems in older adults have not been reported with intake of normal daily recommended amounts.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersAAdequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

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 receiving this dietary supplement, 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 dietary supplement 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.


  • Dicumarol

Using this dietary supplement 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.


  • 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 dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:


  • Bleeding problems—Vitamin E, when taken in doses greater than 800 Units a day for long periods of time, may make this condition worse

Proper Use of vitamin e

This section provides information on the proper use of a number of products that contain vitamin e. It may not be specific to Gamma E Plus. Please read with care.


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 solution dosage form:
    • To prevent the following deficiencies in infants:
      • Infants receiving a formula high in polyunsaturated fatty acids—15 to 25 Units per day or 7 Units per 32 ounces of formula.

      • Infants with certain colon problems—15 to 25 Units per kilogram (kg) (6.8 to 11 Units per pound) of body weight per day. The water-soluble form of vitamin E must be used.

      • Infants of normal birthweight—5 Units per 32 ounces of formula.



  • For oral dosage forms (capsules, tablets, oral solution):
    • To prevent deficiency for individuals (other than infants), the amount taken by mouth is based on normal daily recommended intakes:
      • For the U.S.

      • Adult and teenage males—10 milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) or 16.7 Units per day.

      • Adult and teenage females—8 mg alpha-TE or 13 Units per day.

      • Pregnant females—10 mg alpha-TE or 16.7 Units per day.

      • Breast-feeding females—11 to 12 mg alpha-TE or 18 to 20 Units per day.

      • Children 4 to 10 years of age—7 mg alpha-TE or 11.7 Units per day.

      • Children birth to 3 years of age—3 to 6 mg alpha-TE or 5 to 10 Units per day.

      • For Canada

      • Adult and teenage males—6 to 10 mg alpha-TE or 10 to 16.7 Units per day.

      • Adult and teenage females—5 to 7 mg alpha-TE or 8.3 to 11.7 Units per day.

      • Pregnant females—8 to 9 mg alpha-TE or 13 to 15 Units per day.

      • Breast-feeding females—9 to 10 mg alpha-TE or 15 to 16.7 Units per day.

      • Children 7 to 10 years of age—6 to 8 mg alpha-TE or 10 to 13 Units per day.

      • Children 4 to 6 years of age—5 mg alpha-TE or 8.3 Units per day.

      • Children birth to 3 years of age—3 to 4 mg alpha-TE or 5 to 6.7 Units per day.


    • To treat deficiency:
      • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.



For individuals taking the oral liquid form of this dietary supplement:


  • This preparation should be taken by mouth even though it comes in a dropper bottle.

  • This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

Missed Dose


If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the dietary supplement 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.


Gamma E Plus 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 as soon as possible if any of the following side effects occur:


With doses greater than 400 Units a day and long-term use
  • Blurred vision

  • diarrhea

  • dizziness

  • headache

  • nausea or stomach cramps

  • unusual tiredness or weakness

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 Gamma E Plus resources


  • Gamma E Plus Use in Pregnancy & Breastfeeding
  • Gamma E Plus Drug Interactions
  • Gamma E Plus Support Group
  • 2 Reviews for Gamma E Plus - Add your own review/rating


Compare Gamma E Plus with other medications


  • Alzheimer's Disease
  • Anemia, Sickle Cell
  • Cystic Fibrosis
  • Dietary Supplementation
  • Nocturnal Leg Cramps
  • Retinopathy Prophylaxis
  • Tardive Dyskinesia
  • Vitamin E Deficiency

Wednesday, 2 May 2012

Tronolane Suppositories


Pronunciation: fen-il-EF-rin
Generic Name: Phenylephrine
Brand Name: Examples include Anu-Med and Tronolane


Tronolane Suppositories are used for:

Treating swelling, itching, burning, and discomfort associated with hemorrhoids. It may also be used for other conditions as determined by your doctor.


Tronolane Suppositories are a vasoconstrictor. It works by temporarily shrinking swollen hemorrhoidal tissues and relieving symptoms.


Do NOT use Tronolane Suppositories if:


  • you are allergic to any ingredient in Tronolane Suppositories

  • you take droxidopa

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

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



Before using Tronolane Suppositories:


Some medical conditions may interact with Tronolane Suppositories. 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 depression, glaucoma, heart problems, high blood pressure, trouble urinating due to an enlarged prostate gland, an overactive thyroid, or diabetes

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


  • Droxidopa, furazolidone , or an MAO inhibitor (eg, phenelzine) because the risk of severe high blood pressure and fast or irregular heartbeat may be increased

  • Tricyclic antidepressants because side effects may be increased by Tronolane Suppositories

  • Medicines for high blood pressure (eg, atenolol, captopril, verapamil) because effectiveness may be decreased by Tronolane Suppositories

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


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


  • When practical, cleanse the affected area with a hemorrhoidal pad or mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with a tissue or soft cloth before applying Tronolane Suppositories.

  • If the suppository is too soft to use, put it in the refrigerator for about 15 minutes or run cold water over it. Then remove the wrapper and moisten the suppository with cool water. Lie down on your side. Insert the pointed end of the suppository into the rectum, then use your finger to push it in completely. Wash your hands thoroughly after using Tronolane Suppositories.

  • If your condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor immediately.

  • If you miss a dose of Tronolane Suppositories and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

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



Important safety information:


  • Use Tronolane Suppositories with caution in the ELDERLY because they may be more sensitive to its effects.

  • Use Tronolane Suppositories with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tronolane Suppositories, discuss with your doctor the benefits and risks of using Tronolane Suppositories during pregnancy. It is unknown if Tronolane Suppositories are excreted in breast milk. If you are or will be breast-feeding while you are using Tronolane Suppositories, check with your doctor or pharmacist to discuss the risks to your baby.


Possible side effects of Tronolane Suppositories:


All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:



Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dizziness; headache; irregular heartbeat; nervousness; rectal bleeding; tremor; trouble sleeping.



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



If OVERDOSE is suspected:


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


Proper storage of Tronolane Suppositories:

Store Tronolane Suppositories at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Tronolane Suppositories out of the reach of children and away from pets.


General information:


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

  • Tronolane Suppositories are 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 Tronolane Suppositories. 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.