Monday, April 30, 2012

Herpes Simplex, Suppression Medications


Drugs associated with Herpes Simplex, Suppression

The following drugs and medications are in some way related to, or used in the treatment of Herpes Simplex, Suppression. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.





Drug List:

Thymoglobulin rabbit


Generic Name: anti-thymocyte globulin (rabbit) (AN tee THYE moe syt GLOB ue lin)

Brand Names: Thymoglobulin


What is anti-thymocyte globulin (rabbit)?

Anti-thymocyte globulin is a sterilized solution made of the cells of rabbits that have been injected with white blood cells from humans.


Anti-thymocyte globulin lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.


Anti-thymocyte globulin is used together with other medicines to prevent your body from rejecting a kidney transplant.


Anti-thymocyte globulin may also be used for purposes not listed in this medication guide.


What is the most important information I should know about anti-thymocyte globulin (rabbit)?


You should not use this medication if you are allergic to rabbit proteins, or if you have ever had an allergic reaction to anti-thymocyte globulin.

To make sure you can safely take anti-thymocyte globulin, tell your doctor if you have an active or chronic infection, or a serious infection called sepsis.


Serious and sometimes fatal infections may occur during treatment with anti-thymocyte globulin. Call your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, weakness, tired feeling, or feeling like you might pass out. Do not receive a "live" vaccine while using anti-thymocyte globulin. The vaccine may not work as well during this time, and may not fully protect you from disease.

What should I discuss with my healthcare provider before receiving anti-thymocyte globulin (rabbit)?


You should not use this medication if you are allergic to rabbit proteins, or if you have ever had an allergic reaction to anti-thymocyte globulin.

To make sure you can safely take anti-thymocyte globulin, tell your doctor if you have any of these other conditions:



  • an active or chronic infection; or




  • a serious infection called sepsis.




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

Using anti-thymocyte globulin may increase your risk of developing certain types of cancer, such as lymphoma (cancer of the lymph nodes). Talk with your doctor about your specific risk.


How is anti-thymocyte globulin (rabbit) given?


Anti-thymocyte globulin is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Anti-thymocyte globulin must be given slowly, and the IV infusion can take 4 to 6 hours to complete.


You may be given other medications to help prevent serious side effects or allergic reaction.


Anti-thymocyte globulin can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

What happens if I miss a dose?


Call your doctor for instructions if you miss an appointment for your anti-thymocyte globulin injection.


What happens if I overdose?


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

Overdose symptoms may include some of the serious side effects listed in this medication guide.


What should I avoid while receiving anti-thymocyte globulin (rabbit)?


Do not receive a "live" vaccine while using anti-thymocyte globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Anti-thymocyte globulin (rabbit) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Serious and sometimes fatal infections may occur during treatment with anti-thymocyte globulin. Stop using this medicine and call your doctor right away if you have signs of infection such as:

  • fever, chills, body aches, flu symptoms;




  • mouth and throat ulcers;




  • rapid heart rate, rapid and shallow breathing;




  • weakness, tired feeling; or




  • feeling like you might pass out.




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

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;




  • white patches inside your mouth or on your lips;




  • swollen glands, rash or itching, joint pain;




  • pain or burning when you urinate;




  • dry cough, wheezing, feeling short of breath;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling; or




  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).



Less serious side effects may include:



  • headache, dizziness;




  • nausea, vomiting, diarrhea, stomach pain;




  • swelling in your hands or feet; or




  • pain, swelling, or redness where the injection was given.



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 anti-thymocyte globulin (rabbit)?


Tell your doctor about all other medicines you use, especially other drugs that weaken the immune system.


There may be other drugs that can interact with anti-thymocyte globulin (rabbit). 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 Thymoglobulin resources


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


Compare Thymoglobulin with other medications


  • Renal Transplant


Where can I get more information?


  • Your pharmacist can provide more information about anti-thymocyte globulin (rabbit).

See also: Thymoglobulin side effects (in more detail)


Saturday, April 28, 2012

Seb-Prev Gel



sodium sulfacetamide

Dosage Form: gel
SEB-PREV™ GEL (SODIUM SULFACETAMIDE 10%)

Seb-Prev Gel


(Sodium Sulfacetamide 10%)


Rx Only


FOR DERMATOLOGIC USE ONLY


NOT FOR OPHTHALMIC USE



Seb-Prev Gel Description


Each gram of Seb-Prev™ Gel contains 100 mg of Sulfacetamide Sodium USP in a vehicle consisting of edetate disodium, glycerin, methylparaben, propylene glycol, purified water, sodium thiosulfate, and xanthan gum.


Sulfacetamide sodium is C8H9N2NaO3S•H2O with a molecular weight of 254.24. Chemically, it is Acetamide N-[(4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula:



Sulfacetamide sodium is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform, and in ether.



Seb-Prev Gel - Clinical Pharmacology


Sulfacetamide sodium exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There are no clinical data available on the degree and rate of systemic absorption of Seb-Prev™ Gel when applied to the skin or scalp. However, significant absorption of sulfacetamide sodium through the skin has been reported.


The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sulfacetamide sodium are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.



Indications and Usage for Seb-Prev Gel


Seb-Prev™ Gel is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.



Contraindications


Seb-Prev™ Gel is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.



Warnings


Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sulfacetamide sodium topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.



Precautions



General


Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If Seb-Prev™ Gel produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed.



Information For Patients


Patients should discontinue Seb-Prev™ Gel if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Seb-Prev™ Gel also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop. For external use only. Avoid contact with eyes and mucous membranes. Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or poison control center immediately (see OVERDOSAGE).



Drug Interactions


Seb-Prev™ Gel is incompatible with silver preparations.



Carcinogenesis, Mutagenesis, and Impairment of Fertility


Long-term animal studies for carcinogenic potential have not been performed on Seb-Prev™ Gel to date. Studies on reproduction and fertility also have not been performed. One author detected chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sulfacetamide sodium. The significance of this finding to the topical use of sulfacetamide sodium in the human is unknown.



Pregnancy


Teratogenic effects

Pregnancy Category C


Animal reproduction studies have not been conducted with Seb-Prev™ Gel. It also is not known whether Seb-Prev™ Gel can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Seb-Prev™ Gel should be given to a pregnant woman only if clearly needed.



Nursing Mothers


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



Pediatric Use


Safety and effectiveness in children under the age of 12 years have not been established.



Adverse Reactions


Reports of irritation and hypersensitivity to sulfacetamide sodium are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sulfacetamide sodium, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome has been reported (see WARNINGS).



Overdosage


The oral LD50 of sulfacetamide in mice is 16.5 g/kg. The LD50 for topical administration of sulfacetamide has not been determined. Oral overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. In the event of overdosage, call a physician or poison control center; emergency treatment should be started immediately.


Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of eight to twelve fluid ounces of water. If emesis does not occur within 15 minutes, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should


be performed. Isotonic and one-half isotonic saline are the lavage solutions of choice. Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and, therefore, may be valuable for their action in rapid dilution of bowel content. After emergency treatment, the patient should continue to be medically monitored.


Observe kidney function for up to 1 week and have the patient ingest copious amounts of fluid during this period. Mannitol infusions may be helpful at the first sign of oliguria. Alkalinization of the urine by ingestion of bicarbonate is very helpful in preventing crystallization of sulfa drug in the kidney.



Seb-Prev Gel Dosage and Administration


Seborrheic dermatitis including seborrhea sicca: Apply to affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Repeat application as described for eight to ten days.


As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of Seb-Prev™ Gel should be reinitiated as at the beginning of treatment.


Secondary cutaneous bacterial infections: Apply to affected areas twice daily for eight to ten days.



How is Seb-Prev Gel Supplied


Seb-Prev™ Gel is available as follows:


30 g tube (NDC 45802-960-94)


60 g tube (NDC 45802-960-96)



Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Do not freeze.


Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration is readily removed by ordinary laundering without bleaches.



MANUFACTURED BY


STIEFEL LABORATORIES, INC.


CORAL GABLES, FL 33134


DISTRIBUTED BY


PERRIGO®


ALLEGAN, MI 49010


Rev. 10/07


81084


: 5P600 RC J1



Principal Display Panel - 30 g Carton


Seb-Prev™ Gel


(Sodium Sulfacetamide 10%)


For Dermatologic Use Only. Not for Ophthalmic Use.


Rx Only


Seb-Prev(tm) Gel - 30 g Carton




Principal Display Panel - 30 g Tube


Seb-Prev™ Gel


(Sodium Sulfacetamide 10%)


For Dermatologic Use Only. Not for Ophthalmic Use.


Rx Only


Seb-Prev(tm) Gel - 30 g Tube




Principal Display Panel - 60 g Carton


Seb-Prev™ Gel


(Sodium Sulfacetamide 10%)


For Dermatologic Use Only. Not for Ophthalmic Use.


Rx Only


Seb-Prev(tm) Gel - 60 g Carton




Principal Display Panel - 60 g Tube


Seb-Prev™ Gel


(Sodium Sulfacetamide 10%)


For Dermatologic Use Only. Not for Ophthalmic Use.


Rx Only


Seb-Prev(tm) Gel - 60 g Tube










PERRIGO SEB PREV 
sodium sulfacetamide  gel










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)45802-960
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFACETAMIDE SODIUM (SULFACETAMIDE)SULFACETAMIDE SODIUM100 mg  in 1 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorYELLOW (clear to pale yellow)Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
145802-960-941 TUBE In 1 CARTONcontains a TUBE
130 g In 1 TUBEThis package is contained within the CARTON (45802-960-94)
245802-960-961 TUBE In 1 CARTONcontains a TUBE
260 g In 1 TUBEThis package is contained within the CARTON (45802-960-96)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/19/2008


Labeler - Perrigo New York Inc (078846912)
Revised: 11/2009Perrigo New York Inc

More Seb-Prev Gel resources


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


Compare Seb-Prev Gel with other medications


  • Seborrheic Dermatitis
  • Secondary Cutaneous Bacterial Infections

Friday, April 27, 2012

cabergoline


Generic Name: cabergoline (ca BER goe leen)

Brand Names: Dostinex


What is cabergoline?

Cabergoline is in a group of drugs called dopamine receptor antagonists. It works by reducing the amount of prolactin (a hormone) that is released from the pituitary gland.


Cabergoline is used to treat a hormone imbalance in which there is too much prolactin in the blood (also called hyperprolactinemia).


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


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


Do not use this medication if you are allergic to cabergoline, or if you have uncontrolled high blood pressure, pregnancy-related high blood pressure, or if you are allergic to any type of ergot medicine such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine).

Before taking cabergoline, tell your doctor if you are allergic to any drugs, or if you have liver disease, heart disease, or a breathing disorder.


Cabergoline is usually taken twice each week for at least 6 months. Do not take this medication every day unless your doctor tells you to.


To be sure this medication is helping your condition, your blood will need to be tested on a regular basis to measure your prolactin levels. Your doctor may want to continue checking your prolactin levels for several months after you stop taking cabergoline. Do not miss any scheduled visits.


Tell your doctor if you are also taking metoclopramide (Reglan), blood pressure medications, diuretics, or any medication to treat a psychiatric disorder.


What should I discuss with my health care provider before taking cabergoline?


Do not use this medication if you are allergic to cabergoline, or if you have:

  • uncontrolled high blood pressure (hypertension);




  • hypertension caused by pregnancy, including eclampsia and preeclampsia; or




  • if you are allergic to any type of ergot medicine such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine).



Before taking cabergoline, tell your doctor if you are allergic to any drugs, or if you have:



  • liver disease;




  • heart disease; or




  • a breathing disorder.



If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.


FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether cabergoline 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 cabergoline?


Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.


Your doctor may occasionally change your dose to make sure you get the best results from this medication.


Cabergoline is usually taken twice each week for at least 6 months. Do not take this medication every day unless your doctor tells you to.


To be sure this medication is helping your condition, your blood will need to be tested on a regular basis to measure your prolactin levels. Your doctor may want to continue checking your prolactin levels for several months after you stop taking cabergoline. Do not miss any scheduled appointments.


Store cabergoline at room temperature away from moisture and heat.

See also: Cabergoline dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include stuffy nose, confusion, hallucinations, feeling light-headed, or fainting.


What should I avoid while taking cabergoline?


Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using cabergoline.


Cabergoline side effects


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

  • cough or trouble breathing; or




  • feeling light-headed, fainting.



Less serious side effects may include:



  • nausea, vomiting, stomach pain, constipation;




  • headache;




  • dizziness, drowsiness, nervousness;




  • numbness or tingly feeling; or




  • hot flashes.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


Cabergoline Dosing Information


Usual Adult Dose for Hyperprolactinemia:

Initial dose: 0.25 mg orally twice a week. Dosage may be increased by 0.25 mg twice a week.

Maximum dose: 1 mg orally twice a week (according to patient serum prolactin level).


What other drugs will affect cabergoline?


Before using cabergoline, tell your doctor if you are using any of the following drugs:



  • metoclopramide (Reglan);




  • an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);




  • a beta-blocker such as acebutolol (Sectral), atenolol (Tenormin), betaxolol (Kerlone), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), penbutolol (Levatol), pindolol (Visken), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren);




  • a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), nimodipine (Nimotop), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin, Verelan);




  • a diuretic (water pill) such as amiloride (Midamor, Moduretic), bumetanide (Bumex), chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), indapamide (Lozol), metolazone (Mykrox, Zarxolyn), spironolactone (Aldactazide, Aldactone), triamterene (Dyrenium, Maxzide, Dyazide), torsemide (Demadex), and others; or




  • other blood pressure medications such as irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan).



This list is not complete and there may be other drugs that can interact with cabergoline. 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 cabergoline resources


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


  • cabergoline Advanced Consumer (Micromedex) - Includes Dosage Information

  • Cabergoline Prescribing Information (FDA)

  • Cabergoline Monograph (AHFS DI)

  • Cabergoline MedFacts Consumer Leaflet (Wolters Kluwer)

  • Dostinex Prescribing Information (FDA)



Compare cabergoline with other medications


  • Hyperprolactinemia


Where can I get more information?


  • Your pharmacist can provide more information about cabergoline.

See also: cabergoline side effects (in more detail)


Wednesday, April 25, 2012

follitropin beta Subcutaneous


fol-i-TROE-pin BAY-ta


Commonly used brand name(s)

In the U.S.


  • Follistim

  • Follistim AQ

  • Gonal-f RFF

Available Dosage Forms:


  • Solution

  • Powder for Solution

  • Kit

Therapeutic Class: Human Follicle Stimulating Hormone Combination


Pharmacologic Class: Human Follicle Stimulating Hormone


Uses For follitropin beta


Follitropin beta injection is used to treat infertility in both men and women. follitropin beta is a man-made hormone called follicle-stimulating hormone (FSH). FSH is produced in the body by the pituitary gland. FSH helps to develop eggs in the ovaries of women and sperm in the testes of men. Follitropin beta replaces natural FSH in the body.


Follitropin beta will help develop eggs in women who have not been able to become pregnant because of problems with ovulation. Some women will use follitropin beta while enrolled in a fertility program called Assisted Reproductive Technology (ART). ART uses procedures such as in vitro fertilization (IVF) or embryo transfer (ET). Follitropin beta is used together with human chorionic gonadotropin (hCG) in these procedures.


Follistim® AQ Cartridge is also used in women with healthy ovaries who are undergoing reproductive procedures such as IVF or intracytoplasmic sperm injection (ICSI) cycle. follitropin beta is used together with human chorionic gonadotropin (hCG) in these procedures.


Follitropin beta is used together with human chorionic gonadotropin (hCG) to increase sperm production in men.


follitropin beta is available only with your doctor's prescription.


Before Using follitropin beta


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 follitropin beta, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to follitropin beta 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 follitropin beta injection in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies on the relationship of age to the effects of follitropin beta injection have not been performed in the geriatric population.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Adrenal gland problems, uncontrolled or

  • Allergy to certain antibiotics (e.g., neomycin, streptomycin), or history of or

  • Cysts in the ovaries or enlarged ovaries or

  • High levels of FSH in the blood or

  • Pituitary gland problems, uncontrolled or

  • Thyroid gland problems, uncontrolled or

  • Tumor in the brain (hypothalamus area or pituitary gland) or

  • Tumor in the breast or

  • Tumor in the ovary or uterus or

  • Tumor in the testis or

  • Vaginal bleeding of unknown cause, heavy or irregular—Should not be used in patients with these conditions.

  • Blood clots (thrombosis), or history of or

  • Blood vessel problems or

  • Lung or breathing problems or

  • Ovarian torsion (twisting of the ovary), history of or

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

Proper Use of follitropin beta


A nurse or other trained health professional will give you follitropin beta. follitropin beta is given as a shot under the skin (for men and women) or into a muscle (for women only).


Follitropin beta is used with another hormone called human chorionic gonadotropin (hCG). At the proper time, your doctor or nurse will give you follitropin beta.


follitropin beta comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.


follitropin beta is available in two forms: a cartridge and a vial. Ask your doctor which dosage form is right for you.


You might be taught how to give your medicine at home. If you are using follitropin beta at home:


  • Wash your hands with soap and water and use a clean work area to prepare your injection.

  • Make sure you understand and carefully follow your doctor's instructions on how to give yourself an injection, including the proper use of a needle and syringe, or a cartridge and pen.

  • Do not mix follitropin beta with other medicines in the same cartridge, vial, or syringe.

  • Check the solution in the cartridge or vial. It should be clear and colorless. If it is cloudy, discolored, or contains large flecks (particles), do not use it.

  • Do not inject more or less of the medicine than your doctor ordered.

  • You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will prevent skin problems.

  • Use a new needle and syringe each time you inject your medicine.

  • It is very important that you keep track of each dose you inject. Your doctor or nurse will help you with this.

If you are using the Follistim® AQ cartridge:


  • follitropin beta should only be used with the Follistim® pen.

  • Do not use follitropin beta if you are blind or have vision problems, unless another person with good vision who is trained in the proper use of the cartridge injects your medicine.

  • Do not re-use the BD Micro-Fine™ pen needle.

Dosing


The dose of follitropin beta 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 follitropin beta. 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 injection dosage form:
    • For the treatment of infertility in men:
      • Adults—450 international units (IU) per week injected under the skin, divided and given as either 225 IU two times per week or 150 IU three times per week.

      • Children—Use is not recommended.


    • For the treatment of infertility in women:
      • Adults—
        • Follistim® AQ injection: At first, 75 international units (IU) once a day injected under the skin or into a muscle. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 IU per day.

        • Follistim® AQ cartridge: At first, 50 IU once a day injected under the skin for at least the first 7 days. Your doctor may increase your dose as needed. However, the dose is usually not more than 250 IU per day.


      • Children—Use is not recommended.


    • For use with assisted reproductive technology procedures:
      • Follistim® AQ injection: Adults—150 to 225 international units (IU) once a day injected under the skin or into a muscle. Your doctor may increase your dose as needed. However, the dose is usually not more than 600 IU per day.

      • Children—Use is not recommended.


    • For women with healthy ovaries undergoing reproductive procedures (such as IVF or ICSI):
      • Follistim® AQ cartridge: Adults—At first, 200 international units (IU) once a day injected under the skin for at least the first 7 days of treatment. Your doctor may increase your dose as needed. However, the dose is usually not more than 500 IU per day.

      • Children—Use is not recommended.



Missed Dose


Call your doctor or pharmacist for instructions.


Storage


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


You may store Follistim® AQ cartridge or injection in a refrigerator or at room temperature. If you store the medicine at room temperature, it will only be good for a maximum of 3 months unless the expiration date is less than 3 months. If the Follistim® AQ cartridge has been pierced by a needle, you may store it up to 28 days. Keep the cartridge away from light.


Throw away used needles and syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.


Ask your pharmacist, doctor, or nurse about the best way to dispose of any leftover medicine, glass containers (vials), cartridges, and other supplies. You should not use any leftover medicine in the glass container (vial) or cartridge.


Precautions While Using follitropin beta


It is very important that your doctor check your progress at regular visits while you are using follitropin beta, to make sure that the medicine is working properly and to check for unwanted effects. Blood and urine tests will be needed to make sure that the medicine is working properly.


Call your doctor right away if you think you have become pregnant while you are using follitropin beta. You may have a higher risk of an ectopic pregnancy if you get pregnant while undergoing IVF or ICSI procedures. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.


follitropin beta may increase your risk of having a blood clot, heart attack, or stroke. This is more likely in people who already have heart disease. Contact your doctor right away if you have chest pain, tightness in the chest, a fast or irregular heartbeat, unusual flushing or warmth of the skin, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems or blood clots.


For women who are using follitropin beta:


  • If your doctor has asked you to record your basal body temperature (BBT) each day, make sure that you understand how to do this. Carefully follow your doctor's instructions.

  • follitropin beta may increase your risk of having a problem with the ovaries called ovarian hyperstimulation syndrome (OHSS). OHSS is a serious problem that can be life-threatening. Stop using follitropin beta and call your doctor right away if you have severe pain in the lower stomach area, nausea, vomiting, weight gain, diarrhea, decreased urine output, or trouble with breathing.

  • follitropin beta may cause more than one egg to be released from your ovary at the same time. This means you may become pregnant with more than one baby. Talk with your doctor about this possibility before you start using follitropin beta.

follitropin beta 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
  • Abdominal or stomach pain that is severe

  • bloating

  • diarrhea

  • severe nausea or vomiting

  • stomach or pelvic discomfort, aching, or heaviness

  • weight gain that is rapid

Less common
  • Heavy non-menstrual vaginal bleeding

  • redness, pain, or swelling at the injection site

  • unusual tiredness or weakness

Incidence not known
  • Difficulty with breathing

  • pain in the chest, groin, or legs, especially the calves

  • severe, sudden headache

  • slurred speech

  • sudden loss of coordination

  • sudden, severe weakness or numbness in the arm or leg

  • sudden, unexplained shortness of breath

  • vision changes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Blemishes on the skin

  • headache

  • pimples

Less common
  • Body aches or pain

  • chills

  • difficulty having a bowel movement (stool)

  • dizziness

  • dry skin

  • fast or racing heart

  • fever

  • hair loss

  • hives

  • quick or shallow breathing

  • rash

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

Incidence not known
  • Breast tenderness

  • normal menstrual bleeding occurring earlier, possibly lasting longer than expected

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: follitropin beta Subcutaneous 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 follitropin beta Subcutaneous resources


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


Compare follitropin beta Subcutaneous with other medications


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Sunday, April 22, 2012

DIOVAN Capsules






Diovan 40, 80 and 160 mg Capsules


Valsartan



Read all of this leaflet carefully before you start taking this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:


  • 1. What Diovan is and what it is used for

  • 2. Before you take Diovan

  • 3. How to take Diovan

  • 4. Possible side effects

  • 5. How to store Diovan

  • 6. Further information




What Diovan Is And What It Is Used For


Diovan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase. Diovan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.


Diovan 40, 80 and 160 mg Capsules can be used



  • to treat people after a recent heart attack (myocardial infarction). “Recent” here means
    between 12 hours and 10 days.


  • to treat symptomatic heart failure. Diovan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used, or it may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure) cannot be used.

    Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid build-up. It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body.

In addition


Diovan 80 and 160 mg Capsules can be used



  • to treat high blood pressure. High blood pressure increases the workload on the heart and arteries. If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.



Before You Take Diovan



Do not take Diovan:


  • if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Diovan. These are listed in Section 6.

  • if you have severe liver disease.

  • if you are more than 3 months pregnant (it is also better to avoid Diovan in early pregnancy - see pregnancy section).


If any of these apply to you, speak to your doctor.




You must be especially careful and talk to your doctor before taking Diovan if any of the following apply to you.


  • If you have liver disease.

  • If you have severe kidney disease or if you are undergoing dialysis.

  • If you are suffering from a narrowing of the kidney artery.

  • If you have recently undergone kidney transplantation (received a new kidney).

  • If you are being treated after a heart attack or for heart failure. Your doctor may check your kidney function.

  • If you have severe heart disease other than heart failure or heart attack.

  • If you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. It may be necessary to check the amount of potassium in your blood at regular intervals.

  • If you suffer from aldosteronism. This is a disease in which your adrenal glands make too much of the hormone aldosterone. If this applies to you, the use of Diovan is not recommended.

  • If you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water pills (diuretics).

  • The use of Diovan in children and adolescents below the age of 18 years is not recommended.

  • You must tell your doctor if you think you are (or might become) pregnant. Diovan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).



Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.


The effect of the treatment can be influenced if Diovan is taken together with certain other medicines. It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:



  • other medicines that lower blood pressure, especially water pills (diuretics).


  • medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.


  • certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).


  • lithium, a medicine used to treat some types of psychiatric illness.


In addition:


  • if you are being treated after a heart attack, a combination with ACE inhibitors (a medication to treat heart attack) is not recommended.

  • if you are being treated for heart failure, a triple combination with ACE inhibitors and beta
    blockers
    (medications to treat heart failure) is not recommended.



Taking Diovan with food and drink


You can take Diovan with or without food.




Pregnancy and breast-feeding


Ask your doctor or pharmacist for advice before taking any medicine.



  • You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Diovan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan. Diovan is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.


  • Tell your doctor if you are breast-feeding or about to start breast-feeding. Diovan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.



Driving and using machines


Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Diovan affects you. Like many other medicines used to treat high blood pressure, Diovan may in rare cases cause dizziness and affect the ability to concentrate.





How To Take Diovan


Always take Diovan exactly as your doctor has told you in order to get the best results and reduce the risk of side effects. You should check with your doctor or pharmacist if you are not sure. People with high blood pressure often do not notice any signs of this problem. Many may feel quite normal. This makes it all the more important for you to keep your appointments with the doctor even if you are feeling well.



After a recent heart attack: After a heart attack the treatment is generally started as early as after 12 hours, usually at a low dose of 20 mg twice daily. You obtain the 20 mg dose by dividing the 40 mg tablet. Your doctor will increase this dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate. Diovan can be given together with other treatment for heart attack, and your doctor will decide which treatment is suitable for you.



Heart failure: Treatment starts generally with 40 mg twice daily. Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate.


Diovan can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.



High blood pressure: The usual dose is 80 mg daily. In some cases your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). He may also combine Diovan with an additional medicine (e.g. a diuretic).


You can take Diovan with or without food. Swallow Diovan with a glass of water.


Take Diovan at about the same time each day.



If you take more Diovan than you should


If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.


If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.




If you forget to take Diovan


Do not take a double dose to make up for a forgotten dose.


If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed.




If you stop taking Diovan


Stopping your treatment with Diovan may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.



If you have further questions on the use of this product, ask your doctor or pharmacist.




DIOVAN Capsules Side Effects


Like all medicines, Diovan can cause side effects, although not everybody gets them.


These side effects may occur with certain frequencies, which are defined as follows:


  • very common: affects more than 1 user in 10

  • common: affects 1 to 10 users in 100

  • uncommon: affects 1 to 10 users in 1,000

  • rare: affects 1 to 10 users in 10,000

  • very rare: affects less than 1 user in 10,000

  • not known: frequency cannot be estimated from the available data.


Some symptoms need immediate medical attention:


You may experience symptoms of angioedema, such as


  • swollen face, tongue or throat

  • difficulty in swallowing

  • hives and difficulties in breathing


If you get any of these, see a doctor immediately.




Other side effects include:



Common:


  • dizziness, postural dizziness

  • low blood pressure with symptoms such as dizziness

  • decreased kidney function (signs of renal impairment)


Uncommon:


  • allergic reaction with symptoms such as rash, itching, dizziness, swelling of face or lips or tongue or throat, difficulty breathing or swallowing (signs of angioedema)

  • sudden loss of consciousness

  • spinning sensation

  • severely decreased kidney function (signs of acute renal failure)

  • muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)

  • breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure)

  • headache

  • cough

  • abdominal pain

  • nausea

  • diarrhoea

  • tiredness

  • weakness


Not known:


  • rash, itching, together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)

  • purple-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)

  • unusual bleeding or bruising (signs of thrombocytopenia)

  • muscle pain (myalgia)

  • fever, sore throat or mouth ulcers due to infections (symptoms of low level of white blood cells also called neutropenia)

  • decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can, in severe cases, lead to anaemia)

  • increase of level of potassium in the blood (which can, in severe cases, trigger muscle spasms, abnormal heart rhythm)

  • elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can, in severe cases, trigger yellow skin and eyes)

  • increase of level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function)

The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in patients treated with high blood pressure than in patients treated for heart failure or after a recent heart attack.




If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How To Store Diovan


  • Keep your capsules in their original pack at a temperature below 30ÂşC. Protect from moisture and heat.

  • Keep out of the reach and sight of children.

  • Do not use Diovan after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

  • Do not use Diovan if you notice that the pack is damaged or shows signs of tampering.

  • If your doctor tells you to stop taking Diovan Capsules, please take any unused capsules back to your pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.



Further Information



What Diovan contains


Diovan Capsules are available in three different strengths containing either 40, 80 or 160 mg of the active ingredient valsartan. The gelatin capsules also contain the following inactive ingredients: microcrystalline cellulose, polyvidone, crospovidone, sodium lauryl sulfate and magnesium stearate. Colouring materials used in the capsule shell and ink are titanium dioxide (E171) and iron oxides (E172). The ink also contains shellac and propylene glycol.




What Diovan looks like and contents of the pack


Diovan 40 mg Capsules are pale grey, marked CG HBH in black ink on the cap. Pack sizes of 7 or 28 capsules are registered.


Diovan 80 mg Capsules have a pale grey cap and flesh pink body and are marked CG FZF in black ink on the cap. Pack sizes of 28 or 98 capsules are registered.


Diovan 160 mg Capsules have a dark grey cap and flesh pink body and are marked CG GOG in white ink on the cap. Pack sizes of 28 or 98 capsules are registered.


Some pack sizes may not be marketed.




Marketing Authorisation Holder and Manufacturer


The product licence holder is:



Novartis Pharmaceuticals UK Limited

Trading as: Ciba Laboratories

Frimley Business Park

Frimley

Camberley

Surrey
GU16 7SR

United Kingdom


Diovan Capsules are released onto the market by:



Novartis Pharmaceuticals UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

United Kingdom



If you would like any more information, or would like this leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.




This leaflet was last approved in September 2009


Copyright Novartis Pharmaceuticals UK Limited


Ciba logo





Friday, April 20, 2012

Trimox


Generic Name: amoxicillin (Oral route)

a-mox-i-SIL-in

Commonly used brand name(s)

In the U.S.


  • Amoxicot

  • Amoxil

  • DisperMox

  • Moxatag

  • Moxilin

  • Trimox

In Canada


  • Amoxil Pediatric

  • Apo-Amoxi

  • Apo-Amoxi Sugar-Free

  • Gen-Amoxicillin

  • Med Amoxicillin

  • Novamoxin

  • Novamoxin Reduced Sugar

  • Nu-Amoxi

  • Riva-Amoxicillin

  • Scheinpharm Amoxicillin

  • Zimamox

Available Dosage Forms:


  • Tablet

  • Tablet, Chewable

  • Tablet for Suspension

  • Powder for Suspension

  • Tablet, Extended Release

  • Capsule

Therapeutic Class: Antibiotic


Pharmacologic Class: Penicillin, Aminopenicillin


Uses For Trimox


Amoxicillin is used to treat bacterial infections in many different parts of the body. It is also used with other medicines (e.g., clarithromycin, lansoprazole) to treat H. pylori infection and duodenal ulcers.


Amoxicillin belongs to the group of medicines known as penicillin antibiotics. It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.


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


Before Using Trimox


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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin in children. However, newborns and infants 3 months of age and younger have incompletely developed kidney functions, which may need a lower dose of this medicine.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amoxicillin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving amoxicillin.


Pregnancy








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

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 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.


  • Methotrexate

  • Venlafaxine

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.


  • Acenocoumarol

  • Desogestrel

  • Dienogest

  • Drospirenone

  • Estradiol Cypionate

  • Estradiol Valerate

  • Ethinyl Estradiol

  • Ethynodiol Diacetate

  • Etonogestrel

  • Khat

  • Levonorgestrel

  • Medroxyprogesterone Acetate

  • Mestranol

  • Norelgestromin

  • Norethindrone

  • Norgestimate

  • Norgestrel

  • Probenecid

  • 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:


  • Allergy to penicillins or cephalosporin antibiotics (e.g., cefaclor, cefadroxil, cephalexin, Ceftin®, or Keflex®) or

  • Mononucleosis (viral infection)—Should not be used in patients with these conditions.

  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

  • Phenylketonuria (PKU)—The chewable tablet contains phenylalanine, which can make this condition worse.

Proper Use of amoxicillin

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


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.


You may take this medicine with or without food.


For patients using the oral liquid:


  • Shake the bottle well before each use. Measure the dose with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

  • You may mix the oral liquid with a baby formula, milk, fruit juice, water, ginger ale, or another cold drink. Be sure the child drinks all of the mixture immediately.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.


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, powder for suspension, and tablets):
    • For bacterial infections:
      • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every 8 hours, or 500 to 875 mg every 12 hours.

      • Children and infants older than 3 months of age weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 40 milligrams (mg) per kilogram (kg) of body weight per day, divided and given every 8 hours, or 25 to 45 mg per kg of body weight per day, divided and given every 12 hours.

      • Infants 3 months of age and younger—Dose is based on body weight and must be determined by your doctor. The usual dose is 30 mg per kg of body weight per day, divided and given every 12 hours.


    • For treatment of gonorrhea:
      • Adults, teenagers, and children weighing 40 kilograms (kg) or more—3-grams (g) taken as a single dose.

      • Children 2 years of age and older weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 milligrams (mg) per kilogram (kg) of body weight per day, combined with 25 mg per kg of probenecid, taken as a single dose.

      • Children younger than 2 years of age—Use is not recommended.


    • For treatment of H. pylori infection:
      • Adults—
        • Dual therapy: 1000 milligrams (mg) of amoxicillin and 30 mg of lansoprazole, each given three times a day (every 8 hours) for 14 days.

        • Triple therapy: 1000 mg of amoxicillin, 500 mg of clarithromycin, and 30 mg of lansoprazole, all given two times a day (every 12 hours) for 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


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.


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


You may store the oral liquid in the refrigerator. Throw away any unused medicine after 14 days. Do not freeze.


Precautions While Using Trimox


If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.


This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a skin rash; itching; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, mouth, or throat after you or your child receive this medicine.


Amoxicillin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.


Before you have any medical tests, tell the doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.


In some young patients, tooth discoloration may occur while using this medicine. The teeth may appear to have brown, yellow, or gray stains. To help prevent this, brush and floss your teeth regularly or have a dentist clean your teeth.


Birth control pills may not work while you are using this medicine. To keep from getting pregnant, use another form of birth control along with your birth control pills. Other forms include a condom, a diaphragm, or a contraceptive foam or jelly.


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.


Trimox 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:


Incidence not known
  • Abdominal or stomach cramps or tenderness

  • back, leg, or stomach pains

  • black, tarry stools

  • bleeding gums

  • blistering, peeling, or loosening of the skin

  • bloating

  • blood in the urine

  • bloody nose

  • chest pain

  • chills

  • clay-colored stools

  • cough

  • dark urine

  • diarrhea

  • diarrhea, watery and severe, which may also be bloody

  • difficulty with breathing

  • difficulty with swallowing

  • dizziness

  • fast heartbeat

  • feeling of discomfort

  • fever

  • general body swelling

  • headache

  • heavier menstrual periods

  • hives or welts

  • increased thirst

  • inflammation of the joints

  • itching

  • joint or muscle pain

  • loss of appetite

  • muscle aches

  • nausea or vomiting

  • nosebleeds

  • pain

  • pain in the lower back

  • pain or burning while urinating

  • painful or difficult urination

  • pale skin

  • pinpoint red spots on the skin

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

  • rash

  • red, irritated eyes

  • redness, soreness, or itching skin

  • shortness of breath

  • sore throat

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

  • sores, welting, or blisters

  • sudden decrease in the amount of urine

  • swollen, lymph glands

  • tenderness

  • tightness in the chest

  • unpleasant breath odor

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • unusual weight loss

  • vomiting of blood

  • watery or bloody diarrhea

  • wheezing

  • yellow eyes or skin

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
  • Bad, unusual, or unpleasant (after) taste

  • change in taste

Incidence not known
  • Agitation

  • black, hairy tongue

  • changes in behavior

  • confusion

  • convulsions

  • discoloration of the tooth (brown, yellow, or gray staining)

  • dizziness

  • sleeplessness

  • trouble with sleeping

  • unable to sleep

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

  • white patches with diaper rash

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.

Hydrotussin HD


Generic Name: guaifenesin, hydrocodone, and pseudoephedrine (gwye FEN e sin, HYE droe KOE done, SOO doe ee FED rin)

Brand Names: Drituss HD, Dynex HD, Entex HC, Hydro-Tuss XP, Hydrotussin HD, Nalex Expectorant, Poly-Tussin XP, Pseudatex HC, Su-Tuss HD Elixir, Tussgen Expectorant, Vanacon


What is Hydrotussin HD (guaifenesin, hydrocodone, and pseudoephedrine)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.


Hydrocodone is a narcotic. It is a pain reliever and a cough suppressant.


Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of guaifenesin, hydrocodone, and pseudoephedrine is used to treat cough and nasal congestion, and to reduce chest congestion caused by the common cold, infections, or allergies.


Guaifenesin, hydrocodone, and pseudoephedrine may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Hydrotussin HD (guaifenesin, hydrocodone, and pseudoephedrine)?


Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Hydrocodone may be habit-forming and should be used only by the person this medicine was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cold, allergy, or cough medicine without first asking your doctor or pharmacist. Guaifenesin and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug.

What should I discuss with my healthcare provider before taking Hydrotussin HD (guaifenesin, hydrocodone, and pseudoephedrine)?


Do not use this medication if you are allergic to guaifenesin, hydrocodone, or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with 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.

Before taking guaifenesin, hydrocodone, and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:



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




  • heart disease or high blood pressure;




  • diabetes;




  • a thyroid disorder;



  • liver or kidney disease;


  • a seizure disorder;




  • Addison's disease or other adrenal gland disorders;




  • enlarged prostate, urination problems;




  • mental illness; or




  • a history of drug or alcohol addiction.



If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.


FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication 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.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.


How should I take Hydrotussin HD (guaifenesin, hydrocodone, and pseudoephedrine)?


Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.


Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine 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 for one.


Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take guaifenesin, hydrocodone, and pseudoephedrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.


Store this medicine at room temperature, away from heat, light, and moisture.


Keep track of how much of this medicine has been used from each new bottle. Hydrocodone 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 cough or cold medicine is usually taken only 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 your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.

What should I avoid while taking Hydrotussin HD (guaifenesin, hydrocodone, and pseudoephedrine)?


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. Avoid drinking alcohol while you are taking this medicine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Do not use any other over-the-counter cold, allergy, or cough medicine without first asking your doctor or pharmacist. Guaifenesin and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains guaifenesin or pseudoephedrine.

Hydrotussin HD (guaifenesin, hydrocodone, and pseudoephedrine) side effects


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

  • fast, pounding, or uneven heartbeat;




  • severe dizziness, anxiety, restless feeling, or nervousness;




  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or




  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).



Less serious side effects may include:



  • dizziness or headache;




  • feeling excited or restless;




  • sleep problems (insomnia);




  • nausea, vomiting, or stomach upset;




  • mild loss of appetite;




  • warmth, tingling, or redness under your skin; or




  • skin rash or itching.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Hydrotussin HD (guaifenesin, hydrocodone, and pseudoephedrine)?


Before taking guaifenesin, hydrocodone, and pseudoephedrine, tell your doctor if you are using any of the following drugs:



  • methyldopa (Aldomet);




  • medicines to treat high blood pressure;




  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or




  • an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.



This is not a complete list and there may be other drugs that can affect guaifenesin, hydrocodone, and pseudoephedrine. 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 Hydrotussin HD resources


  • Hydrotussin HD Drug Interactions
  • Hydrotussin HD Support Group
  • 0 Reviews for Hydrotussin HD - Add your own review/rating


Compare Hydrotussin HD with other medications


  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about guaifenesin, hydrocodone, and pseudoephedrine.