hydrochlorothiazide and captopril

Generic Name: hydrochlorothiazide and captopril (hye droe klor oh THY a zide and KAP toe pril)

Brand Names: Capozide 25/15, Capozide 25/25, Capozide 50/15, Capozide 50/25

What is hydrochlorothiazide and captopril?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Captopril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme. Captopril lowers blood pressure and also relieves symptoms of fluid retention.

The combination of hydrochlorothiazide and captopril is used to treat hypertension (high blood pressure).

Hydrochlorothiazide and captopril may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrochlorothiazide and captopril?

You should not use this medication if you are allergic to hydrochlorothiazide or captopril, or if you have a history of asthma or allergies, or you are unable to urinate.

You should not use this medication if you are allergic to any other ACE inhibitor, such as benazepril (Lotensin), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik).

Before taking hydrochlorothiazide and captopril, tell your doctor if you have kidney disease (or are on dialysis), liver disease, glaucoma, congestive heart failure, gout, lupus, diabetes, or an allergy to sulfa drugs or penicillin.

Do not use hydrochlorothiazide and captopril if you are pregnant. It could harm the unborn baby.

Do not use potassium supplements or salt substitutes while you are taking hydrochlorothiazide and captopril, unless your doctor has told you to.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking hydrochlorothiazide and captopril. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

What should I discuss with my healthcare provider before taking hydrochlorothiazide and captopril?

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

• 
  

  a history of asthma or allergies; or

  
  


• 
  

  if you are unable to urinate.

  
  

You should not use this medication if you are allergic to any other ACE inhibitor, such as benazepril (Lotensin), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik).

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

• kidney disease (or if you are on dialysis);


• liver disease;


• 
  

  glaucoma;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  gout;

  
  


• 
  

  lupus;

  
  


• 
  

  diabetes; or

  
  


• 
  

  an allergy to sulfa drugs or penicillin

  
  

FDA pregnancy category D. Do not use hydrochlorothiazide and captopril if you are pregnant. It could harm the unborn baby. Stop using this medication and tell your doctor right away if you become pregnant. Use effective birth control while taking hydrochlorothiazide and captopril. Hydrochlorothiazide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take hydrochlorothiazide and captopril?

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

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

Take each dose with a full glass of water.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking hydrochlorothiazide and captopril. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. Your blood and urine may also be tested if you have been vomiting or are dehydrated. Visit your doctor regularly.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using a thiazide diuretic.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

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

See also: Hydrochlorothiazide and captopril dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include nausea, weakness, dizziness, dry mouth, thirst, muscle pain or weakness, or feeling like you might pass out.

What should I avoid while taking hydrochlorothiazide and captopril?

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and captopril.

Do not use potassium supplements or salt substitutes while you are taking hydrochlorothiazide and captopril, unless your doctor has told you to.

Hydrochlorothiazide and captopril side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  eye pain, vision problems;

  
  


• 
  

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

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

  
  


• 
  

  dry mouth, thirst, nausea, vomiting;

  
  


• 
  

  feeling weak, drowsy, restless, or light-headed;

  
  


• 
  

  a red, blistering, peeling skin rash;

  
  


• 
  

  jaundice (yellowing of the skin or eyes);

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  swelling, weight gain, feeling short of breath; or

  
  


• 
  

  fever, chills, body aches, flu symptoms.

  
  

Less serious side effects may include:

• 
  

  cough;

  
  


• 
  

  dizziness, headache, tired feeling;

  
  


• 
  

  blurred vision;

  
  


• 
  

  diarrhea, constipation, upset stomach; or

  
  


• 
  

  mild skin rash, increased sweating.

  
  

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

Hydrochlorothiazide and captopril Dosing Information

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 1 tablet of (captopril-hydrochlorothiazide 25 mg/15 mg) orally once a day, one hour before meals. Determine dosage by individual titration.
Maintenance dose: May use additional captopril or hydrochlorothiazide as individual components or change to an increased strength of the combination tablet. May give the combination tablet in divided doses up to 3 times a day. In general, daily doses of captopril should not exceed 150 mg and of hydrochlorothiazide should not exceed 50 mg.

Usual Adult Dose for Hypertension:

Initial dose: 1 tablet of (captopril-hydrochlorothiazide 25 mg/15 mg) orally once a day, one hour before meals. Determine dosage by individual titration.
Maintenance dose: May use additional captopril or hydrochlorothiazide as individual components or change to an increased strength of the combination tablet. May give the combination tablet in divided doses up to 3 times a day. In general, daily doses of captopril should not exceed 150 mg and of hydrochlorothiazide should not exceed 50 mg.

What other drugs will affect hydrochlorothiazide and captopril?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to the side effects of hydrochlorothiazide and captopril. Tell your doctor if you regularly use any of these medicines, or any other blood pressure medications.

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

• 
  

  gold injections to treat arthritis;

  
  


• 
  

  other diuretics (water pills) or blood pressure medications;

  
  


• 
  

  lithium (Lithobid, Eskalith);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  digoxin (Lanoxin);

  
  


• 
  

  nitroglycerin (Nitrolingual, Nitrostat, Nitro-Dur, and others);

  
  


• 
  

  cholestyramine (Prevalite, Questran) or colestipol (Colestid);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or

  
  


• 
  

  insulin or diabetes medicine taken by mouth.

  
  

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

More hydrochlorothiazide and captopril resources

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

Compare hydrochlorothiazide and captopril with other medications

• Heart Failure
• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about hydrochlorothiazide and captopril.

See also: hydrochlorothiazide and captopril side effects (in more detail)

Flumazenil

Pronunciation: FLOO-may-ze-nil
Generic Name: Flumazenil
Brand Name: Romazicon

Flumazenil may cause seizures, especially in patients who have been on benzodiazepines (eg, diazepam) for a long time or if a patient has taken too much of a benzodiazepine (overdose).

Flumazenil is used for:

Reversing drowsiness, sedation, and other effects caused by benzodiazepines.

Flumazenil is a benzodiazepine antagonist. It works by blocking receptors in the brain and central nervous system that benzodiazepines need to reach to be active, which helps reduce drowsiness and sedation.

Do NOT use Flumazenil if:

• you are allergic to any ingredient in Flumazenil or to benzodiazepines (eg, alprazolam)


• you have been given a benzodiazepine for control of a potentially life-threatening condition (eg, increased pressure in the head, seizures)


• you are experiencing side effects due to an overdose of a medicine used to treat depression

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

Video: Treatment for Depression

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

Before using Flumazenil:

Some medical conditions may interact with Flumazenil. 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 (especially benzodiazepines), herbal preparation, or dietary supplement


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


• if you have a history of seizures, panic disorder, liver problems, alcohol or other substance abuse, or you have had a recent head injury

Some MEDICINES MAY INTERACT with Flumazenil. However, no specific interactions with Flumazenil are known at this time.

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

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

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


• If Flumazenil contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• If Flumazenil accidentally spills on your skin, wash it off immediately with soap and water.


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


• If you miss a dose of Flumazenil, contact your doctor immediately.

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

Important safety information:

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


• Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) for at least 24 hours after receiving Flumazenil. Flumazenil will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Although Flumazenil is given to reverse drowsiness, you may experience a return of drowsiness for up to 24 hours after Flumazenil is given. If you notice a return of drowsiness or experience shortness of breath, contact your doctor as soon as possible.


• Flumazenil is not recommended for use in CHILDREN younger than 1 year of age. Safety and effectiveness in this age group have not been confirmed.


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

Possible side effects of Flumazenil:

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

Abnormal or blurred vision; abnormal skin sensations; changes in vision; clumsiness; dizziness; dry mouth; feeling of a whirling motion; flushing; general body discomfort; headache; hot flashes; increased sweating; nausea; nervousness; pain at the injection site; restlessness; sleeplessness; sweating; tiredness; tremors; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; change in behavior, mood, or emotions (eg, anxiety, depression); pounding in the chest; rapid deep breathing; seizures.

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

See also: Flumazenil side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; anxiety; emotional or mood changes; increased sensitivity to pain or touch; seizures.

Proper storage of Flumazenil:

Flumazenil is usually handled and stored by a health care provider. If you are using Flumazenil at home, store Flumazenil as directed by your pharmacist or health care provider. Keep Flumazenil out of the reach of children and away from pets.

General information:

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


• Flumazenil is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Flumazenil resources

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

• Flumazenil Monograph (AHFS DI)


• Flumazenil Professional Patient Advice (Wolters Kluwer)


• flumazenil Concise Consumer Information (Cerner Multum)


• Romazicon Prescribing Information (FDA)

Compare Flumazenil with other medications

• Benzodiazepine Overdose
• Reversal of Sedation

Etopophos

Generic Name: etoposide phosphate (e TOE poe side FOS fate)

Brand Names: Etopophos

What is Etopophos (etoposide phosphate)?

Etoposide phosphate is a cancer medicine that interferes with the growth of cancer cells and slows their growth and spread in the body.

Etoposide phosphate is used to treat cancer of the lung or testicles.

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

What is the most important information I should know about Etopophos (etoposide phosphate)?

Do not receive etoposide phosphate if you are pregnant. It could harm the unborn baby.

Before receiving etoposide phosphate, tell your doctor if you have kidney disease or a weak immune system.

Etoposide phosphate can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury. Tell your doctor at once if you develop signs of infection.

Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

Using etoposide phosphate may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.

What should I discuss with my health care provider before using Etopophos (etoposide phosphate)?

You should not use this medication if you are allergic to etoposide.

To make sure you can safely receive etoposide phosphate, tell your doctor if you have any of these other conditions:

• kidney disease; or


• 
  

  a weak immune system (from disease or from taking certain medicines).

  
  

FDA pregnancy category D. Do not use etoposide phosphate if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether etoposide phosphate passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are being treated with etoposide phosphate.

Using etoposide phosphate may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.

How is etoposide phosphate given?

Etoposide phosphate is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. The medicine is sometimes given slowly through an IV infusion, and can take up to 3-1/2 hours to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when etoposide phosphate is injected.

Etoposide phosphate is usually given for 4 or 5 days in a row every 3 to 4 weeks. Follow your doctor's instructions.

Etoposide phosphate can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Your blood may need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

Etoposide phosphate is used together with other cancer medications. Read the medication guide or patient instructions provided with each of your medications.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your etoposide phosphate injection.

What happens if I overdose?

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

What should I avoid while receiving Etopophos (etoposide phosphate)?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Etopophos (etoposide phosphate) 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 a serious side effect such as:

• 
  

  fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  
  


• 
  

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

  
  


• 
  

  pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  
  


• 
  

  pain, burning, irritation, or skin changes where the injection was given;

  
  


• 
  

  feeling like you might pass out; or

  
  


• 
  

  severe nausea and vomiting.

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, stomach pain, loss of appetite;

  
  


• 
  

  constipation, diarrhea;

  
  


• 
  

  dizziness, feeling tired or weak;

  
  


• 
  

  temporary hair loss; or

  
  


• 
  

  mild skin rash.

  
  

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 Etopophos (etoposide phosphate)?

Before you receive etoposide phosphate, tell your doctor if you are using cyclosporine (Neoral, Sandimmune, Gengraf).

There may be other drugs that can interact with etoposide phosphate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Etopophos resources

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

• Etopophos Prescribing Information (FDA)


• Etopophos Advanced Consumer (Micromedex) - Includes Dosage Information


• Etopophos MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Etopophos with other medications

• Cancer
• Hodgkin's Lymphoma
• Ovarian Cancer
• Small Cell Lung Cancer
• Testicular Cancer

Where can I get more information?

• Your doctor or pharmacist can provide more information about etoposide phosphate.

See also: Etopophos side effects (in more detail)

Victrelis

Generic Name: boceprevir (Oral route)

boe-SE-pre-vir

Commonly used brand name(s)

In the U.S.

• Victrelis

Available Dosage Forms:

• Capsule

Pharmacologic Class: Protease Inhibitor

Uses For Victrelis

Boceprevir is used in combination with injectable peginterferon alfa (Pegasys®, Pegintron®) and ribavirin (Copegus®, Rebetol®) to treat chronic hepatitis C infection. These medicines are used in patients with compensated liver disease (including cirrhosis), who have not been treated before or who have received other medicines but did not work well. Boceprevir is a direct-acting antiviral agent that treats hepatitis C infection.

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

Before Using Victrelis

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

Allergies

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

Pediatric

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

Geriatric

Although appropriate studies on the relationship of age to the effects of boceprevir have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver problems, which may require caution in patients receiving boceprevir.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin


• Carbamazepine


• Cisapride


• Colchicine


• Dihydroergotamine


• Drospirenone


• Ergonovine


• Ergotamine


• Lovastatin


• Methylergonovine


• Midazolam


• Phenobarbital


• Phenytoin


• Pimozide


• Rifampin


• Sildenafil


• Simvastatin


• St John's Wort


• Tadalafil


• Triazolam

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.

• Alprazolam


• Amiodarone


• Bepridil


• Budesonide


• Dexamethasone


• Digoxin


• Efavirenz


• Ethinyl Estradiol


• Flecainide


• Fluticasone


• Itraconazole


• Posaconazole


• Propafenone


• Quinidine


• Rifabutin


• Ruxolitinib


• Salmeterol


• Sirolimus


• Sunitinib


• Vardenafil


• Voriconazole

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.

• Ketoconazole

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:

• Blood or bone marrow problems (e.g., anemia, neutropenia)—Use with caution. May make these conditions worse.

Proper Use of Victrelis

To help clear up your infection completely, boceprevir must be taken together with peginterferon alfa and ribavirin for the full time of treatment, even if you begin to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, boceprevir must be used on a regular schedule.

Take this medicine with a meal or light snack.

Do not change or suddenly stop using this medicine without checking first with your doctor.

This medicine should come with a Medication Guide. Read and follow the information carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

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 form (capsules):
  
  • For hepatitis C virus infection, in combination with peginterferon alfa and ribavirin:
    
    • Adults—800 milligrams (mg) (four 200-mg capsules) three times a day with food. Each dose should be taken 7 to 9 hours apart.
    
    
    • 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.

If you miss a dose or forget to use it, and it is less than 2 hours before your next regular dose, wait until then to take the medicine and skip the missed dose. If you miss a dose and it is more than 2 hours before your next regular dose, go ahead and take the missed dose and take the next regular dose as scheduled. If you have any questions about this, ask your pharmacist or doctor.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Victrelis

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine together with peginterferon alfa and ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines, tell your doctor right away.

To make sure you are not pregnant, your doctor may ask you to have a pregnancy test before you start using this medicine. You must have a negative pregnancy test before you will be allowed to use this medicine with ribavirin. Two forms of birth control must be used during treatment and for 6 months after treatment ends. You should test for pregnancy every month while you are using this medicine, and for 6 months after your treatment ends.

Birth control pills may not work while you are using this medicine. To keep from getting pregnant, use two other forms of birth control. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Do not use this medicine together with the following medicines: alfuzosin (Uroxatral®), cisapride (Propulsid®), drospirenone (Yasmin®, Yaz®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), St. John's wort, tadalafil (Adcirca®), triazolam (Halcion®), certain medicines to lower cholesterol (such as lovastatin, simvastatin, Mevacor®, or Zocor®), medicines to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®), or ergot medicines (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine, DHE 45®, Ergomar®, Ergotrate®, or Methergine®). Using boceprevir with any of these medicines can cause very serious medical problems.

Check with your doctor right away if you have back, leg, or stomach pains; bleeding gums; chills; dark urine; difficulty with breathing; fever; general body swelling; headache; loss of appetite; nausea or vomiting; nosebleeds; pale skin; sore throat; unusual tiredness or weakness; or yellowing of the eyes or skin. These could be symptoms of a blood disorder called anemia.

Birth control pills may not work while you are using this medicine. To keep from getting pregnant, use two other forms of birth control. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Using this medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets in the blood, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

This medicine will not keep you from giving hepatitis C to other people. Follow your doctor's instructions about how to prevent the spread of this infection.

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.

Victrelis Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

• Black, tarry stools


• chills


• cough


• difficult or labored breathing


• fever


• lower back or side pain


• painful or difficult urination


• pale skin


• shortness of breath


• sore throat


• tightness in the chest


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unusual bleeding or bruising


• unusual tiredness or weakness


• wheezing

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

• Change in taste


• decreased appetite


• diarrhea


• difficulty with moving


• dizziness


• dry mouth


• dry skin


• hair loss or thinning of the hair


• irritability


• lack or loss of strength


• loss of taste


• muscle pain or stiffness


• nausea


• pain in the joints


• rash


• sleeplessness


• trouble sleeping


• unable to sleep


• vomiting

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.

Azelex Cream

Pronunciation: aze-eh-LAY-ik ASS-id
Generic Name: Azelaic Acid
Brand Name: Azelex

Azelex Cream is used for:

Treating mild to moderate acne.

Azelex Cream is a topical antibacterial. Exactly how it works is unknown, but it may block production of proteins necessary for the bacteria to survive.

Do NOT use Azelex Cream if:

• you are allergic to any ingredient in Azelex Cream

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

Before using Azelex Cream:

Some medical conditions may interact with Azelex Cream. 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 asthma or cold sores

Some MEDICINES MAY INTERACT with Azelex Cream. Because little, if any, of Azelex Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Azelex Cream 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 Azelex Cream:

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

• Before using Azelex Cream, wash the affected area with warm water and soap, rinse, and pat dry. Cover the affected area with a thin film of medicine and gently rub in until medicine is evenly distributed. Allow the medicine to dry.


• Wash your hands immediately before and after using Azelex Cream.


• Do not cover the affected area with gauze or a bandage unless your doctor tells you to do so.


• Continue to use Azelex Cream for the full course of treatment even if your condition improves. Do not miss any doses.


• If you miss a dose of Azelex Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

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

Important safety information:

• It may take several weeks for Azelex Cream to work. If your symptoms do not get better within 4 weeks or if they get worse, check with your doctor.


• Azelex Cream is for external use only. Avoid getting Azelex Cream in your vagina, eyes, nose, or mouth. If Azelex Cream does get into your eyes, wash your eyes immediately with plenty of water. If eye irritation continues, contact your doctor.


• If you use topical products too often, your condition may become worse.


• Azelex Cream may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Azelex Cream should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Azelex Cream:

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

Dryness; temporary burning, itching, redness, stinging, or tingling at the application site.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in skin color; peeling, irritation, or inflammation of skin.

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

See also: Azelex side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Azelex Cream:

Store Azelex Cream at room temperature, between 59 and 86 degrees F (15 to 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Keep Azelex Cream out of the reach of children and away from pets.

General information:

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


• Azelex Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Azelex resources

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

Compare Azelex with other medications

• Acne
• Rosacea

Testosterone Enanthate Ampoules (Cambridge Laboratories)

What you should know about Testosterone Enantate Ampoules

Please read this leaflet carefully. This leaflet contains information about Testosterone Enantate Ampoules, which will be given to you by injection. Although you will not be taking this medicine yourself, this leaflet contains important information to help you understand how Testosterone Enantate is used. Keep it until the course of treatment has been finished, as you may want to read it again.

Always follow your doctor's advice, and if there is anything you do not understand, please ask your doctor or nurse to explain it.

What do Testosterone Enantate Ampoules contain?

Each ampoule contains 250 mg of Testosterone Enantate (the active ingredient) together with the inactive ingredients benzyl benzoate and castor oil for injection.

Testosterone Enantate is supplied in packs of 3 ampoules, each ampoule containing 1 ml.

Testosterone Enantate is an androgen, a male type of hormone.

The holder of the product licence for this medicine is

Cambridge Laboratories Limited

Deltic House

Kingfisher Way

Silverlink Business Park

Wallsend

Tyne & Wear

NE28 9NX

The ampoules are made by

Schering AG

Berlin

Germany

What is Testosterone Enantate used for?

In men Testosterone Enantate is used when natural levels of this hormone are low, which can cause loss of interest in sex, low fertility and other problems. In women Testosterone Enantate is used to treat certain diseases of the breast.

When should Testosterone Enantate not be used?

Since androgens (male hormones) can stimulate the growth of cancer of the prostate gland, men must not be given Testosterone Enantate if they have prostatic cancer. For this reason, men should have regular examinations of the prostate gland during treatment with Testosterone Enantate. Men with breast cancer should not be given Testosterone Enantate.

Testosterone Enantate Ampoules should not be used to treat women who are pregnant or breast-feeding.

You should not be given Testosterone Enantate Ampoules if you have a liver tumour or a history of such tumours, if you have a kidney disease called nephrosis or if you have too much calcium in your blood.

What else should you know before having an injection of Testosterone Enantate?

Male hormones such as Testosterone Enantate are not suitable for increasing muscular development in healthy people or for increasing physical ability.

Special care is needed when Testosterone Enantate is used in the elderly and in patients with the following conditions:

• Kidney problems


• Heart disease


• Liver disease


• High blood pressure


• Migraine


• Diabetes


• Cancer that has spread to the bones

If you suffer from any of these and think that the doctor who has prescribed Testosterone Enantate for you is not aware of this, you should tell him or her straight away.

Regular blood tests may be needed if you are also being treated with some medicines that slow down the clotting of the blood. Testosterone Enantate may be less effective in epileptic patients who are taking Phenobarbital, so if this applies to you please make sure that the doctor treating you knows about it.

How Testosterone Enantate is used

Testosterone Enantate is given by injection into a muscle, usually every 2 to 3 weeks. The injections are continued for as long as your doctor considers necessary, but men receiving long-term treatment may later be given injections at 3 to 6 week intervals.

If you would like any other information about the use of Testosterone Enantate, please ask your doctor or nurse.

Side-effects

When hormones such as Testosterone Enantate are used in high doses or over a long period of time, they may result in the retention of too much water, and even swelling of the ankles in some cases. If you have a tendency to this problem, make sure your doctor checks you very carefully while you are receiving treatment with Testosterone Enantate Ampoules.

Women who receive Testosterone Enantate may develop acne, increased growth of hair on the face and body, thinning of scalp hair and deepening of the voice (particular care is necessary in women whose occupations involve singing or speaking).

If men receive long-term and high-dose treatment with Testosterone Enantate, the number of sperms they produce is reduced. Men may experience frequent or persistent erections whilst under Testosterone Enantate treatment. If this happens, make sure to tell your doctor so that he may reduce the dose or stop the treatment in order to avoid injury to the penis.

Occasionally coughing, shortness of breath and changes in the circulation of the blood may develop while Testosterone Enantate is being injected or immediately after the injection.

The doctor may arrange for women receiving Testosterone Enantate to have regular blood tests. If these show an increased level of calcium, he will stop the treatment.

In very rare cases liver tumours have been observed after the use of hormones such as Testosterone Enantate. In a few isolated cases this has been followed by internal bleeding which can be life-threatening. Tell your doctor if you have any new "stomach" discomfort or pain that does not soon clear up.

Other side effects that have sometimes occurred with Testosterone Enantate are headache, depression, feeling sick, jaundice, breast enlargement in men, an increase in the number of red blood cells, anxiety, feeling weak, abnormal sensations, increased bone growth and premature sexual development in boys.

If you are worried about side-effects or if you think that Testosterone Enantate has caused any other side-effect, please tell your doctor, nurse or pharmacist about it.

Storing Testosterone Enanthate

Testosterone Enantate Ampoules should not be used after the expiry date given on the label. They should be stored away from light.

All medicines should be kept out of the reach of children.

Date of preparation of this leaflet: August 2001

Androxy

fluoxymesterone

Dosage Form: Tablets

CIII

REV. 5-04

15021-09

Androxy™ (Fluoxymesterone Tablets, USP)

Rx only

Androxy Description

Androxy™ (Fluoxymesterone Tablets, USP) contains fluoxymesterone, a synthetic androgen. The androgens are steroids that develop and maintain primary and secondary male sex characteristics. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone is a synthetic derivative of testosterone.

In their active form, all drugs in the class have a 17-beta-hydroxy group. 17-alpha-alkylation and halogenation at position 9 (fluoxymesterone) increase the pharmacologic activity per unit weight compared to testosterone when given orally. Fluoxymesterone is a white or practically white odorless, crystalline powder, melting at about 240°C with some decomposition. It is practically insoluble in water, sparingly soluble in alcohol and slightly soluble in chloroform. Chemically fluoxymesterone is designated 9-fluoro-11β, 17β-dihydroxy-17-methylandrost-4-en-3-one. Structurally it may be represented as follows:

Androxy™ (Fluoxymesteron Tablets, USP) for oral administration contains 10 mg of fluoxymesterone USP.

Inactive Ingredients: croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and sodium lauryl sulfate.

Androxy - Clinical Pharmacology

Endogenous androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement; vocal cord thickening; alterations in body musculature; and fat distribution.

Androgens also cause retention of nitrogen, sodium, potassium, and phosphorus, and decreased urinary excretion of calcium. Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein.

Androgens are responsible for the growth spurt of adolescence and for the eventual termination of linear growth which is brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates but may cause a disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of growth process. Androgens have been reported to stimulate the production of red blood cells by enhancing the production of erythropoietic stimulating factor.

During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).

There is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding.

Pharmacokinetics

Testosterone given orally is metabolized by the gut, and 44 percent is cleared by the liver in the first pass. Oral doses as high as 400 mg per day are needed to achieve clinically effective blood levels for full replacement therapy. The 17-alpha-alkylated derivatives (fluoxymesterone and methyltestosterone) are less extensively metabolized by the liver and have longer half lives. They are more suitable for oral administration than testosterone.

Testosterone in plasma is 98 percent bound to a specific testosterone-estradiol binding globulin, and about two percent is free. Generally, the amount of this sex-hormone binding globulin in the plasma will determine the distribution of testosterone between free and bound forms, and the free testosterone concentration will determine its half-life.

About 90 percent of a dose of testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about six percent of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways. There are considerable variations of the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes. The half-life of fluoxymesterone is reported to be 10 hours.

In responsive tissues the activity of testosterone appears to depend on reduction to dihydrotestosterone, which binds to cytosol receptor proteins. The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action.

Indications and Usage for Androxy

Males

Androxy™ Tablets are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.

Primary hypogonadism (congenital or acquired)—Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.

Hypogonadotropic hypogonadism (congenital or acquired)—Idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.)

If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.

Delayed puberty—Androxy™ (Fluoxymesterone Tablets, USP) may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers (see WARNINGS).

Females

Metastatic mammary cancer—Androxy™ (Fluoxymesterone Tablets, USP) may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. This treatment has been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field.

Contraindications

Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate and in women who are or may become pregnant. When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is related to the amount of drug given and the age of the fetus and is most likely to occur in the female fetus when the drugs are given in the first trimester. If the patient becomes pregnant while taking androgens, she should be apprised of the potential hazard to the fetus.

Warnings

This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.

In patients with breast cancer and in immobilized patients, androgen therapy may cause hypercalcemia by stimulating osteolysis. In patients with cancer, hypercalcemia may indicate progression of bony metastasis. If hypercalcemia occurs, the drug should be discontinued and appropriate measures instituted.

Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma (see PRECAUTIONS, Carcinogenesis). Peliosis hepatis can be a life-threatening or fatal complication.

Cholestatic hepatitis and jaundice occur with 17-alpha-alkylated androgens at a relatively low dose. If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, the androgen should be discontinued and the etiology should be determined. Drug-induced jaundice is reversible when the medication is discontinued.

Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.

Due to sodium and water retention, edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. If the administration of fluoxymesterone is restarted, a lower dosage should be used.

Gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism.

Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every six months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height.

Precautions

General

Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly, and menstrual irregularities). Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. Such virilization is usual following androgen use at high doses and is not prevented by concomitant use of estrogens. A decision may be made by the patient and the physician that some virilization will be tolerated during treatment for breast carcinoma.

Because androgens may alter serum cholesterol concentration, caution should be used when administering these drugs to patients with a history of myocardial infarction or coronary artery disease. Serial determinations of serum cholesterol should be made and therapy adjusted accordingly. A causal relationship between myocardial infarction and hypercholesterolemia has not been established.

Information for Patients

Male adolescent patients receiving androgens for delayed puberty should have bone development checked every six months.

The physician should instruct patients to report any of the following side effects of androgens:

Adult or adolescent males—too frequent or persistent erections of the penis.

Women—hoarseness, acne, changes in menstrual periods, or more facial hair.

All patients—Any nausea, vomiting, changes in skin color, or ankle swelling.

Laboratory Tests

Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of androgen therapy (see WARNINGS).

Because of the hepatotoxicity associated with the use of 17-alpha-alkylated androgens, liver function tests should be obtained periodically.

Periodic (every six months) X-ray examinations of bone age should be made during treatment of prepubertal males to determine the rate of bone maturation and the effects of androgen therapy on the epiphyseal centers.

Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of androgens.

Drug Interactions

When administered concurrently, the following drugs may interact with androgens:

Anticoagulants, oral—C-17 substituted derivatives of testosterone, such as methandrostenolone, have been reported to decrease the anticoagulant requirement. Patients receiving oral anticoagulant therapy require close monitoring especially when androgens are started or stopped.

Antidiabetic drugs and insulin—In diabetic patients, the metabolic effects of androgens may decrease blood glucose and insulin requirements.

ACTH and corticosteroids—Enhanced tendency toward edema. Use caution when giving these drugs together, especially in patients with hepatic or cardiac disease.

Oxyphenbutazone—May result in elevated serum levels of oxyphenbutazone.

Drug/Laboratory Test Interactions

Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Carcinogenesis

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically-induced carcinomas of the liver in rats.

There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.

Pregnancy—Teratogenic Effects

Category X (see CONTRAINDICATIONS)

Nursing Mothers

It is not known whether androgens are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from androgens, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Androgen therapy should be used very cautiously in children and only by specialists who are aware of the adverse effects on bone maturation. Skeletal maturation must be monitored every six months by an X-ray of the hand and wrist (see INDICATIONS AND USAGE, and WARNINGS).

Adverse Reactions

Endocrine and Urogenital, Female—The most common side effects of androgen therapy are amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued. When administered to a pregnant woman, androgens cause virilization of external genitalia of the female fetus.

Male—Gynecomastia, and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages (see CLINICAL PHARMACOLOGY).

Skin and Appendages—Hirsutism, male pattern baldness, and acne.

Fluid and Electrolyte Disturbances—Retention of sodium, chloride, water, potassium, calcium (see WARNINGS), and inorganic phosphates.

Gastrointestinal—Nausea, cholestatic jaundice, alterations in liver function tests; rarely, hepatocellular neoplasms, peliosis hepatis, hepatic coma, and death. (See WARNINGS.)

Hematologic—Suppression of clotting factors II, V, VII, and X; bleeding in patients on concomitant anticoagulant therapy; and polycythemia.

Nervous System—Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Metabolic—Increased serum cholesterol.

Miscellaneous—Hypersensitivity; rarely, anaphylactoid reactions.

Drug Abuse and Dependence

Androxy™ Tablets are classified as a Schedule III controlled substance under the Anabolic Steroids Control Act of 1990.

Overdosage

There have been no reports of acute overdosage with androgens.

Androxy Dosage and Administration

Androxy™ (Fluoxymesterone Tablets, USP), for oral administration, may be given as a single daily dose or in divided doses. Dosage and duration of therapy will depend on age, sex, diagnosis, patient's response to treatment, and appearance of adverse effects. The following recommendations will serve as a guide to therapy with Androxy™ Tablets.

In males with delayed puberty: Various dosage regimens have been used; some call for lower dosages initially with gradual increases as puberty progresses, with or without a decrease to maintenance levels. Other regimens call for higher dosage to induce pubertal changes and lower dosage for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. Dosage is within the range of 2.5 to 20 mg daily, although generally in the lower range of 2.5 to 10 mg daily, and for a limited duration, for example 4 to 6 months. X-rays should be taken at appropriate intervals to determine the amount of bone maturation and skeletal development (see INDICATIONS AND USAGE, and WARNINGS).

Male hypoganadism: As replacement therapy, i.e., for eunuchism, a daily dose of 5 to 20 mg is suggested. It is usually preferable to start therapy at a higher level within the range (e.g., 10 mg), with subsequent adjustment as required.

Palliation of inoperable mammary cancer in women: A daily dose of 10 to 40 mg, given in divided doses, is recommended. To determine if there will be an objective response, treatment should be continued for three months or more. Patients must be followed closely because androgen therapy occasionally appears to accelerate the disease. Thus, many experts prefer to use a shorter acting androgen preparation, such as Androxy™ Tablets, rather than those with prolonged activity, particularly during the early stages of androgen therapy.

In palliation of advanced mammary carcinoma: Hormone therapy is adjunctive to and not a replacement for conventional therapy. Duration of therapy will depend on the response of the condition and the appearance of adverse reactions.

How is Androxy Supplied

Androxy™ (Fluoxymesterone Tablets, USP) 10 mg are round, green, scored compressed tablets debossed with 832 and 86 and are available in bottles of 100.

Dispense in a tight, light-resistant container as defined in the USP.

Store at controlled room temperature 15 - 30°C (59 - 86°F).

Keep out of reach of children.

REV. 05-04

15021-09

Manufactured by:

UPSHER-SMITH LABORATORIES, INC.

Minneapolis, MN 55447

Androxy  fluoxymesterone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0832-0086 Route of Administration ORAL DEA Schedule CIII

INGREDIENTS Name (Active Moiety) Type Strength fluoxymesterone (fluoxymesterone) Active 10 MILLIGRAM  In 1 TABLET croscarmellose sodium Inactive   D&C Yellow #10 Aluminum Lake Inactive   FD&C Blue #1 Aluminum Lake Inactive   FD&C Yellow #6 Aluminum Lake Inactive   anhydrous lactose Inactive   magnesium stearate Inactive   microcrystalline cellulose Inactive   pregelatinized corn starch Inactive   sodium lauryl sulfate Inactive

Product Characteristics Color GREEN (GREEN) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 832;86 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0832-0086-00 100 TABLET In 1 BOTTLE None

Revised: 12/2006UPSHER-SMITH LABORATORIES, INC.

More Androxy resources

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

• Androxy Concise Consumer Information (Cerner Multum)


• Androxy MedFacts Consumer Leaflet (Wolters Kluwer)


• Fluoxymesterone Professional Patient Advice (Wolters Kluwer)


• Fluoxymesterone Monograph (AHFS DI)

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