Probenecid

Pronunciation: proe-BEN-a-sid
Generic Name: Probenecid
Brand Name: Generic only. No brands available.

Probenecid is used for:

Treating high levels of uric acid in the blood caused by gout or gouty arthritis. It may be used to increase blood levels of certain antibiotics (eg, penicillin). It may also be used for other conditions as determined by your doctor.

Probenecid is a uricosuric agent. It works by increasing the excretion of uric acid from the body.

Do NOT use Probenecid if:

• you are allergic to any ingredient in Probenecid


• you have blood problems or kidney stones caused by uric acid


• the patient is a child younger than 2 years of age


• you are taking salicylates (eg, aspirin)

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

Before using Probenecid:

Some medical conditions may interact with Probenecid. 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 liver or kidney problems, kidney stones, high levels of uric acid in the urine, stomach or intestinal problems (eg, ulcer, spastic colon), diabetes, or glucose-6 phosphate dehydrogenase deficiency


• if you are undergoing radiation therapy

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

• Acidifying agents (eg, ammonium chloride), pyrazinamide, or salicylates (eg, aspirin) because effectiveness of Probenecid may be decreased


• Acetaminophen, beta lactam antibiotics (eg, imipenem), cephalosporins (eg, cephalexin), certain anesthesias (eg, ketamine, thiopental), ganciclovir, indomethacin, lorazepam, methotrexate, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, ketoprofen), penicillins (eg, amoxicillin), rifampin, sulfonamides (eg, sulfamethoxazole), sulfonylureas (eg, glipizide), theophyllines (eg, dyphylline), or zidovudine because their actions and side effects may be increased by Probenecid

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

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

• Probenecid may be taken with or without food.


• You should not start taking Probenecid if you are currently having a gout attack. Wait until the gout attack stops to begin taking Probenecid unless directed otherwise by your doctor. If you are already taking Probenecid, you may continue to take it during a gout attack unless your doctor tells you otherwise.


• Drinking extra fluids while you are taking Probenecid is recommended. Check with your doctor for instructions.


• Follow the dietary plan given to you by your doctor or other health care professional.


• If you miss a dose of Probenecid, take 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. Do not take 2 doses at once.

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

Important safety information:

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


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


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


• Probenecid may interfere with some lab tests (eg, blood or hemoglobin urine tests, theophylline levels). Make sure your doctor and lab personnel know you are using Probenecid.


• LAB TESTS, including tests for sugar in the urine, may be required to monitor your progress. Be sure to keep all doctor and lab appointments.


• Use of Probenecid is not recommended in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.


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

Possible side effects of Probenecid:

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:

Dizziness; flushing; hair loss; headache; loss of appetite; nausea; sore gums; vomiting.

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); blood in the urine; chills; dark urine; decreased or increased urination; fever; lower back, lower stomach, genital, or inner thigh pain; persistent sore throat; severe or persistent nausea, vomiting, or stomach pain; unusual bleeding or bruising; unusual tiredness or weakness; worsening gout; yellowing of the eyes or 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: Probenecid 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 (http://www.aapcc.org ), or emergency room immediately. Symptoms may include severe or persistent nausea, stomach pain, or vomiting.

Proper storage of Probenecid:

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

General information:

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


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


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


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

This information is summary only. It does not contain all information about Probenecid. 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 Probenecid resources

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

• Probenecid Prescribing Information (FDA)


• Probenecid Monograph (AHFS DI)


• Probenecid Professional Patient Advice (Wolters Kluwer)


• probenecid Concise Consumer Information (Cerner Multum)


• probenecid Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Probenecid with other medications

• Adjunct to Antibiotic Therapy
• Gout

Azilsartan

Pronunciation: AY-zil-SAR-tan
Generic Name: Azilsartan medoxomil
Brand Name: Edarbi

Azilsartan medoxomil may cause injury or death to the fetus if taken while you are pregnant. If you think you may be pregnant, contact your doctor right away.

Azilsartan medoxomil is used for:

Treating high blood pressure alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Azilsartan medoxomil is an angiotensin II receptor blocker (ARB). It works by relaxing blood vessels. This helps to lower blood pressure.

Do NOT use Azilsartan medoxomil if:

• you are allergic to any ingredient in Azilsartan medoxomil


• you are in your second or third trimester of pregnancy

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

Before using Azilsartan medoxomil:

Some medical conditions may interact with Azilsartan medoxomil. Tell your health care provider 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 are able to become pregnant


• if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness), including angioedema caused by treatment with an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril)


• if you have a history of heart problems (eg, heart failure), blood vessel problems, blood flow problems, liver problems, or kidney problems (eg, renal artery stenosis)


• if you have a history of a stroke or a recent heart attack


• if you are dehydrated or have low blood volume


• if you have electrolyte problems (eg, high blood potassium levels, low blood sodium levels), vomiting or diarrhea, or are on a low-salt (sodium) diet


• if you have diabetes, especially if you are also taking aliskiren


• if you are scheduled to have major surgery


• if you take other medicines for high blood pressure or heart problems

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

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood pressure may be increased


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) because the risk of kidney problems and high blood potassium levels may be increased


• Aliskiren, potassium-sparing diuretics (eg, spironolactone, triamterene), or potassium supplements because the risk of high blood potassium levels may be increased


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, indomethacin, celecoxib) because they may decrease Azilsartan medoxomil's effectiveness


• Lithium because the risk of its side effects may be increased by Azilsartan medoxomil

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

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

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


• Take Azilsartan medoxomil by mouth with or without food.


• Taking Azilsartan medoxomil at the same time each day will help you remember to take it.


• Take Azilsartan medoxomil on a regular schedule to get the most benefit from it.


• Continue to take Azilsartan medoxomil even if you feel well. Do not miss any doses.


• If you miss a dose of Azilsartan medoxomil, take 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. Do not take 2 doses at once.

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

Important safety information:

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


• Azilsartan medoxomil may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Dehydration, excessive sweating, vomiting, or diarrhea may increase the risk of low blood pressure. Contact your health care provider at once if any of these occur.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


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


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.


• Lab tests, including blood pressure, blood electrolyte levels, and heart or kidney function, may be performed while you use Azilsartan medoxomil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Azilsartan medoxomil with caution in the ELDERLY; they may be more sensitive to its effects.


• Azilsartan medoxomil should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Azilsartan medoxomil may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Azilsartan medoxomil is found in breast milk. Do not breast-feed while taking Azilsartan medoxomil.

Possible side effects of Azilsartan medoxomil:

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

Diarrhea; dizziness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain; fast, slow, or irregular heartbeat; muscle pain or cramps; symptoms of low blood pressure (eg, fainting, severe dizziness, lightheadedness).

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: Azilsartan 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 Azilsartan medoxomil:

Store Azilsartan medoxomil at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store Azilsartan medoxomil in its original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Azilsartan medoxomil out of the reach of children and away from pets.

General information:

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


• Azilsartan medoxomil 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 Azilsartan medoxomil. 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 Azilsartan resources

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

• azilsartan Advanced Consumer (Micromedex) - Includes Dosage Information


• Edarbi Prescribing Information (FDA)


• Edarbi Consumer Overview

Compare Azilsartan with other medications

• High Blood Pressure

gallium nitrate

Generic Name: gallium nitrate (GAL ee um NYE trate)

Brand Names: Ganite

What is gallium nitrate?

Gallium nitrate is a form of nitrate salt.

Gallium nitrate is used to lower blood levels of calcium when they have become dangerously high in cancer patients.

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

What is the most important information I should know about gallium nitrate?

Before receiving gallium nitrate, tell your doctor if you are allergic to any drugs, if you have heart disease, or if you take diuretics (water pills). If you have any of these conditions, you may need dosage adjustments or special tests during treatment.

Many other drugs can damage the kidneys and should not be used together with gallium nitrate. Tell your doctor if you are receiving chemotherapy, taking an NSAID (non-steroidal anti-inflammatory drug) pain medicine, or using medicines used to treat a bowel disorder, medications to prevent organ transplant rejection, antiviral medications, or any injected antibiotics.

Gallium nitrate must be given as an IV infusion around the clock for up to 5 days, or until blood calcium levels are lowered to a safe level.

During your treatment with gallium nitrate, you may also need to be put on IV fluids to keep you from getting dehydrated.

To be sure this medication is helping your condition, your blood and urine will need to be tested often. This will help your doctor determine how long to treat you with gallium nitrate.

What should I discuss with my health care provider before receiving gallium nitrate?

You should not use this medication if you are allergic to gallium nitrate, or if you have severe kidney disease.

Before receiving gallium nitrate, tell your doctor if you are allergic to any drugs, if you have heart disease, or if you take diuretics (water pills). If you have any of these conditions, you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant before you receive gallium nitrate. It is not known whether gallium nitrate passes into breast milk or if it could harm a nursing baby. Do not receive this medication before telling your doctor if you are breast-feeding a baby.

How is gallium nitrate given?

Gallium nitrate is given as an injection through a needle placed into a vein. You will receive this injection in a hospital or emergency setting.

Gallium nitrate must be given as an IV infusion around the clock for up to 5 days, or until blood calcium levels are lowered to a safe level.

During your treatment with gallium nitrate, you may also need to be put on IV fluids to keep you from getting dehydrated.

To be sure this medication is helping your condition, your blood and urine will need to be tested often. This will help your doctor determine how long to treat you with gallium nitrate.

What happens if I miss a dose?

Since gallium nitrate is given by a healthcare provider, it is not likely that you will miss a dose.

What happens if I overdose?

Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include nausea and vomiting, or urinating less than usual.

What should I avoid while receiving gallium nitrate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you receive gallium nitrate.

Gallium nitrate 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. Tell your caregivers right away if you have any of these serious side effects:

• 
  

  increased thirst, swelling in your lower legs;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  pale skin, easy bruising or bleeding;

  
  


• 
  

  blurred vision, headache or pain behind your eyes;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  noisy breathing, feeling short of breath;

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, diarrhea, constipation;

  
  


• 
  

  tired feeling;

  
  


• 
  

  feeling hot or cold;

  
  


• 
  

  numbness or tingling; or

  
  


• 
  

  fast heart rate.

  
  

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 gallium nitrate?

Before receiving gallium nitrate, tell your doctor if you are using any of the following drugs:

• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  a steroid such as prednisone;

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexal);

  
  


• 
  

  pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

  
  


• 
  

  medicines used to treat a ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

  
  


• 
  

  medicines used to prevent organ transplant rejection, such as tacrolimus (Prograf);

  
  


• 
  

  IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  
  


• 
  

  antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

  
  


• 
  

  cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

  
  

Many of these other drugs can damage the kidneys If you are using any of these drugs, you may not be able to receive gallium nitrate, or you may need dosage adjustments or special tests during treatment.

This list is not complete and there may be other drugs that can interact with gallium nitrate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors.

More gallium nitrate resources

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

• gallium nitrate Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Gallium Nitrate Professional Patient Advice (Wolters Kluwer)


• Gallium Nitrate Monograph (AHFS DI)


• Ganite Prescribing Information (FDA)


• Ganite MedFacts Consumer Leaflet (Wolters Kluwer)

Compare gallium nitrate with other medications

• Hypercalcemia
• Hypercalcemia of Malignancy

Where can I get more information?

• Your doctor or pharmacist can provide more information about gallium nitrate.

Americaine

Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B

What is Americaine (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

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

What is the most important information I should know about Americaine (benzocaine topical)?

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

What should I discuss with my health care provider before using Americaine (benzocaine topical)?

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  asthma, bronchitis, emphysema, or other breathing disorder;

  
  


• 
  

  heart disease;

  
  


• 
  

  a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category C. It is not known whether benzocaine topical 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 benzocaine topical 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. Do not use this medicine on a child younger than 2 years old without medical advice.

How should I use Americaine (benzocaine topical)?

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

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.

To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Americaine (benzocaine topical)?

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.

Americaine (benzocaine topical) side effects

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• 
  

  headache, tired feeling, confusion;

  
  


• 
  

  fast heart rate;

  
  


• 
  

  feeling light-headed or short of breath; and

  
  


• 
  

  pale, blue, or gray appearance of your skin, lips, or fingernails.

  
  

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 benzocaine topical and call your doctor at once if you have any of these other serious side effects:

• 
  

  headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);

  
  


• 
  

  severe burning, stinging, or sensitivity where the medicine is applied;

  
  


• 
  

  swelling, warmth, or redness; or

  
  


• 
  

  oozing, blistering, or any signs of infection.

  
  

Less serious side effects may include:

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  mild stinging, burning, or itching where the medicine is applied;

  
  


• 
  

  skin tenderness or redness; or

  
  


• 
  

  dry white flakes where the medicine was applied.

  
  

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 Americaine (benzocaine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. 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 Americaine resources

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

• Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Anacaine Advanced Consumer (Micromedex) - Includes Dosage Information


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• Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Americaine with other medications

• Anal Itching
• Hemorrhoids

Where can I get more information?

• Your pharmacist can provide more information about benzocaine topical.

See also: Americaine side effects (in more detail)

Hydrocodone and Homatropine

Dosage Form: syrup
Hydrocodone Bitartrate and Homatropine Methylbromide Syrup

Hydrocodone and Homatropine Description

This product contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting narcotic antitussive. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage.

Each teaspoonful (5 mL) for oral administration contains:

Hydrocodone Bitartrate, USP 5 mg

WARNING: May be habit forming.

Homatropine Methylbromide, USP 1.5 mg

Hydrocodone Bitartrate and Homatropine Methylbromide Syrup also contains: Caramel color, cherry flavor, citric acid, FD&C Red #40, methylparaben, propylparaben, purified water, sorbitol solution and sucrose syrup. Citric acid and/or sodium citrate may be added to adjust pH.

The hydrocodone component is a 4,5α- epoxy-3-methoxy-17-methylmorphinan- 6-one tartrate (1:1) hydrate (2:5), a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine, has a molecular weight of (494.50) and may be represented by the following structural formula:

Homatropine methylbromide is 8- Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenylacetyl) oxy]-8,8-dimethyl-,bromide, endo-; a white crystal or fine white crystalline powder, with a molecular weight of (370.29).

Hydrocodone and Homatropine - Clinical Pharmacology

Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, physical and physiological dependence.

Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α-and 6-β-hydroxymetabolites.

Indications and Usage for Hydrocodone and Homatropine

Hydrocodone bitartrate and homatropine methylbromide syrup is indicated for the symptomatic relief of cough.

Contraindications

Hydrocodone bitartrate and homatropine methylbromide syrup should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.

Warnings

May be habit forming. Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of hydrocodone bitartrate and homatropine methylbromide and it should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic drugs (see DRUG ABUSE AND DEPENDENCE).

Respiratory Depression

Hydrocodone bitartrate and homatropine methylbromide produces dose-related respiratory depression by directly acting on brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated.

Head Injury and Increased Intracranial Pressure

The respiratory depression properties of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of hydrocodone bitartrate and homatropine methylbromide or other narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Pediatric Use

In young pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Benefit to risk ratio should be carefully considered especially in the pediatric population with respiratory embarrassment (e.g., croup).

Precautions

General

Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is provided.

Special Risk Patients

Hydrocodone bitartrate and homatropine methylbromide should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal functions, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture, asthma, and narrow-angle glaucoma.

Information for patients

Hydrocodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using hydrocodone bitartrate and homatropine methylbromide should be cautioned accordingly.

Drug Interactions

Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and homatropine methylbromide may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

Carcinogenesis, mutagenesis, impairment of fertility

Studies of hydrocodone bitartrate and homatropine methylbromide in animals to evaluate the carcinogenic and mutagenic potential and the effect on fertility have not been conducted.

Pregnancy

Teratogenic Effects

Pregnancy Category C: Animal reproduction studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide. It is also not known whether hydrocodone bitartrate and homatropine methylbromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydrocodone bitartrate and homatropine methylbromide should be given to a pregnant woman only if clearly needed.

Nonteratogenic effects

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.

Labor and delivery

As with all narcotics, administration of hydrocodone bitartrate and homatropine methylbromide to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

Nursing Mothers

It is not known whether this drug is 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 hydrocodone bitartrate and homatropine methylbromide, 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

Safety and effectiveness of hydrocodone bitartrate and homatropine methylbromide in pediatric patients under six have not been established.

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch.

Central Nervous System

Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.

Gastrointestinal System

Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of hydrocodone bitartrate and homatropine methylbromide may produce constipation.

Genitourinary System

Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.

Respiratory System

Hydrocodone bitartrate and homatropine methylbromide may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE).

Dermatological

Skin rash, pruritus.

Drug Abuse and Dependence

Hydrocodone bitartrate and homatropine methylbromide syrup is a Schedule III narcotic. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, hydrocodone bitartrate and homatropine methylbromide should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and homatropine methylbromide is used for a short time for the treatment of cough. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy.

Overdosage

Signs and Symptoms

Serious overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. The ingestion of very large amounts of hydrocodone bitartrate and homatropine methylbromide may, in addition, result in acute homatropine intoxication.

Treatment

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to narcotics including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

Hydrocodone and Homatropine Dosage and Administration

Adults

One (1) teaspoonful (5 mL) of the syrup every 4 to 6 hours as needed; do not exceed six (6) teaspoonfuls in 24 hours.

Children 6 to 12 Years of Age

One-half (1/2) teaspoonful (2.5 mL) of the syrup every 4 to 6 hours as needed; do not exceed three (3) teaspoonfuls in 24 hours.

How is Hydrocodone and Homatropine Supplied

Hydrocodone Bitartrate and Homatropine Methylbromide Syrup is available as a clear red colored, cherry flavored syrup in:

Bottles of 16 fl. oz. (one pint)

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

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

Oral prescription where permitted by state law.

Manufactured By:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 043:00 3/09

MG #21271

PRINCIPAL DISPLAY PANEL

NDC 50383-043-16

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP

5 mg/1.5 mg per 5 mL

Each 5 mL (teaspoonful) contains:

Hydrocodone Bitartrate, USP....................................5 mg

Homatropine Methylbromide, USP..........................1.5 mg

Usual Dosage: Read accompanying product information.

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

KEEPT TIGHTLY CLOSED.

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Oral prescription where permitted by state law.

Rx only

16 fl oz (473 mL)

HI-TECH PHARMACAL CO., INC.

Amityville, NY 11701

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE  hydrocodone bitartrate and homatropine methylbromide  syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50383-043 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg  in 5 mL HOMATROPINE METHYLBROMIDE (HOMATROPINE) HOMATROPINE METHYLBROMIDE 1.5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID   CARAMEL   CHERRY   FD&C RED NO. 40   METHYLPARABEN   PROPYLPARABEN   SODIUM CITRATE   SORBITOL   SUCROSE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50383-043-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040613	02/08/2008

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Revised: 11/2011Hi-Tech Pharmacal Co., Inc.

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Definition of Acidosis: Acidosis is a condition characterized by excessive acid in the body fluids.

Learn more about Acidosis

Medical Encyclopedia:

• Acidosis
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