Generic Name: capsaicin topical (kap SAY sin TOP i kal)
Brand Names: Axsain, Capsicum Oleoresin, Capsin, Capzasin Back and Body, Capzasin-HP, Capzasin-P, Castiva Warming, Icy Hot PM, Icy Hot with Capsaicin, Menthac Arthritis Cream with Capsaicin, Salonpas Gel-Patch, Salonpas Pain Patch with Capsaicin, Sloan’s Liniment, Trixaicin, Trixaicin HP, Zostrix, Zostrix Sports, Zostrix-HP

What is Zostrix-HP (capsaicin topical)?

Capsaicin is the active ingredient in chili peppers that makes them hot. Capsaicin is used in medicated creams and lotions to relieve muscle or joint pain.

Capsaicin used on the body causes a sensation of heat that activates certain nerve cells. With regular use of capsaicin, this heating effect reduces the amount of substance P, a chemical that acts as a pain messenger in the body.

Capsaicin topical is used for temporary relief of muscle or joint pain caused by strains, sprains, arthritis, bruising, or backaches. Capsaicin topical is also used to treat nerve pain (neuralgia) in people who have had herpes zoster, or “shingles.”

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

What is the most important information I should know about Zostrix-HP (capsaicin topical)?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies or serious medical conditions. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

Capsaicin can cause a burning sensation, which is usually mild and should lessen over time with continued use. If the burning sensation causes significant discomfort, wash the treated skin area with soap and cool water. Stop using the medication and call your doctor if you have severe burning or redness where the medicine was applied.

Avoid getting capsaicin topical in your mouth or eyes or near your nose.

Do not apply to open wounds or irritated skin, and avoid getting the medicine on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. Accidental swallowing of capsaicin can cause problems with swallowing or breathing.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days.

What should I discuss with my healthcare provider before using Zostrix-HP (capsaicin topical)?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies (especially to plants), or if you have a serious medical condition.

It is not known whether this medication is harmful to an unborn baby. Do not use capsaicin topical without telling your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether capsaicin topical passes into breast milk. Do not use capsaicin topical without telling your doctor if you are breast-feeding a baby. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

How should I use Zostrix-HP (capsaicin topical)?

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

Capsaicin can cause a burning sensation wherever it is applied. This sensation is usually mild and should gradually lessen over time with continued regular use of the medicine.

Do not apply capsaicin topical to open wounds, or to skin that is sunburned, windburned, dry, chapped, or otherwise irritated. Do not get this medication in your mouth or eyes, or near your nose where you might inhale it. If it does get into any of these areas, rinse thoroughly with water.

Also avoid getting this medication on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

To keep the medication from getting on your fingers when you apply it, you may use a rubber glove, finger cot, cotton ball, or clean tissue to apply the medicine.

Make sure your skin is clean and dry before you apply capsaicin topical.

When using capsaicin topical cream or lotion, apply a thin layer to the affected area and rub in gently until completely absorbed.

To use capsaicin topical liquid or stick, uncap the applicator and press it firmly on your skin to apply the medication. Massage gently onto the affected are until completely absorbed.

Capsaicin topical may be used up to 4 times daily or as directed on the medicine label.

To apply a capsaicin topical patch, remove the liner and apply the patch to your skin over the area of pain. Press the edges firmly into place. Remove the patch and apply a new patch 1 or 2 times daily if needed.

Wash your hands with soap and water immediately after applying capsaicin topical or handling the topical patch. If you have applied the medicine to your hands or fingers to treat pain in those areas, wait at least 30 minutes before washing your hands. Do not cover treated skin with a bandage or heating pad, which can increase the burning sensation. You may cover the skin with clothing.

Avoid taking a bath or shower within 1 hour before or after you apply capsaicin topical to your skin. Also avoid swimming or vigorous exercise. Warm water or perspiration can increase the burning sensation caused by capsaicin.

If the burning sensation caused by capsaicin is painful or causes significant discomfort, wash the treated skin area with soap and cool water.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed. Pain relief should occur gradually as the substance P in your body is decreased in the nerve cells.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days. Store capsaicin topical at room temperature away from moisture and heat, in a place where children and pets cannot get to it.

Capsaicin topical liquid is flammable. Do not use or store near fire or open flame.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply capsaicin more than 4 times in one day, or use extra medicine to make up a missed dose .

A missed dose of capsaicin topical will not cause harm but may make the medication less effective reducing substance P and relieving your pain.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it.

Accidental swallowing of capsaicin can cause severe burning in or around the mouth, watery eyes, runny nose, and trouble swallowing or breathing.

Applying too much capsaicin topical to the skin can cause severe burning or redness.

What should I avoid while using Zostrix-HP (capsaicin topical)?

Avoid inhaling the odor or dried residue of capsaicin topical. Inhaling capsaicin can cause coughing, sneezing, or watery eyes, and can irritate your throat or lungs.

Avoid touching your eyes, mouth, nose, genitals, or rectum until the medication has been washed off your hands. Also avoid handling food while the medication is still on your hands.

Avoid exposing treated skin to sunlight, sunlamps, tanning beds, or a hot tub. Capsaicin can cause a burning sensation that may be made worse by heat.

Do not use other medicated skin products, including muscle pain creams or lotions, on areas where you have applied capsaicin, unless your doctor has told you to.

Zostrix-HP (capsaicin topical) side effects

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

• severe burning or irritation where the medicine was applied;

• skin redness where the medicine was applied; or

• trouble breathing or swallowing (after accidental inhalation of capsaicin odor or dried residue).

Less serious side effects may include a mild burning sensation that can last for several hours or days, especially after your first use of capsaicin topical.

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 Zostrix-HP (capsaicin topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied capsaicin topical. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about capsaicin topical.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.02. Revision Date: 4/12/2009 4:39:41 PM.

Generic Name: capsaicin topical (kap SAY sin TOP i kal)
Brand Names: Axsain, Capsicum Oleoresin, Capsin, Capzasin Back and Body, Capzasin-HP, Capzasin-P, Castiva Warming, Icy Hot PM, Icy Hot with Capsaicin, Menthac Arthritis Cream with Capsaicin, Salonpas Gel-Patch, Salonpas Pain Patch with Capsaicin, Sloan’s Liniment, Trixaicin, Trixaicin HP, Zostrix, Zostrix Sports, Zostrix-HP

What is Zostrix (capsaicin topical)?

Capsaicin is the active ingredient in chili peppers that makes them hot. Capsaicin is used in medicated creams and lotions to relieve muscle or joint pain.

Capsaicin used on the body causes a sensation of heat that activates certain nerve cells. With regular use of capsaicin, this heating effect reduces the amount of substance P, a chemical that acts as a pain messenger in the body.

Capsaicin topical is used for temporary relief of muscle or joint pain caused by strains, sprains, arthritis, bruising, or backaches. Capsaicin topical is also used to treat nerve pain (neuralgia) in people who have had herpes zoster, or “shingles.”

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

What is the most important information I should know about Zostrix (capsaicin topical)?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies or serious medical conditions. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

Capsaicin can cause a burning sensation, which is usually mild and should lessen over time with continued use. If the burning sensation causes significant discomfort, wash the treated skin area with soap and cool water. Stop using the medication and call your doctor if you have severe burning or redness where the medicine was applied.

Avoid getting capsaicin topical in your mouth or eyes or near your nose.

Do not apply to open wounds or irritated skin, and avoid getting the medicine on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. Accidental swallowing of capsaicin can cause problems with swallowing or breathing.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days.

What should I discuss with my healthcare provider before using Zostrix (capsaicin topical)?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies (especially to plants), or if you have a serious medical condition.

It is not known whether this medication is harmful to an unborn baby. Do not use capsaicin topical without telling your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether capsaicin topical passes into breast milk. Do not use capsaicin topical without telling your doctor if you are breast-feeding a baby. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

How should I use Zostrix (capsaicin topical)?

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

Capsaicin can cause a burning sensation wherever it is applied. This sensation is usually mild and should gradually lessen over time with continued regular use of the medicine.

Do not apply capsaicin topical to open wounds, or to skin that is sunburned, windburned, dry, chapped, or otherwise irritated. Do not get this medication in your mouth or eyes, or near your nose where you might inhale it. If it does get into any of these areas, rinse thoroughly with water.

Also avoid getting this medication on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

To keep the medication from getting on your fingers when you apply it, you may use a rubber glove, finger cot, cotton ball, or clean tissue to apply the medicine.

Make sure your skin is clean and dry before you apply capsaicin topical.

When using capsaicin topical cream or lotion, apply a thin layer to the affected area and rub in gently until completely absorbed.

To use capsaicin topical liquid or stick, uncap the applicator and press it firmly on your skin to apply the medication. Massage gently onto the affected are until completely absorbed.

Capsaicin topical may be used up to 4 times daily or as directed on the medicine label.

To apply a capsaicin topical patch, remove the liner and apply the patch to your skin over the area of pain. Press the edges firmly into place. Remove the patch and apply a new patch 1 or 2 times daily if needed.

Wash your hands with soap and water immediately after applying capsaicin topical or handling the topical patch. If you have applied the medicine to your hands or fingers to treat pain in those areas, wait at least 30 minutes before washing your hands. Do not cover treated skin with a bandage or heating pad, which can increase the burning sensation. You may cover the skin with clothing.

Avoid taking a bath or shower within 1 hour before or after you apply capsaicin topical to your skin. Also avoid swimming or vigorous exercise. Warm water or perspiration can increase the burning sensation caused by capsaicin.

If the burning sensation caused by capsaicin is painful or causes significant discomfort, wash the treated skin area with soap and cool water.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed. Pain relief should occur gradually as the substance P in your body is decreased in the nerve cells.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days. Store capsaicin topical at room temperature away from moisture and heat, in a place where children and pets cannot get to it.

Capsaicin topical liquid is flammable. Do not use or store near fire or open flame.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply capsaicin more than 4 times in one day, or use extra medicine to make up a missed dose .

A missed dose of capsaicin topical will not cause harm but may make the medication less effective reducing substance P and relieving your pain.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it.

Accidental swallowing of capsaicin can cause severe burning in or around the mouth, watery eyes, runny nose, and trouble swallowing or breathing.

Applying too much capsaicin topical to the skin can cause severe burning or redness.

What should I avoid while using Zostrix (capsaicin topical)?

Avoid inhaling the odor or dried residue of capsaicin topical. Inhaling capsaicin can cause coughing, sneezing, or watery eyes, and can irritate your throat or lungs.

Avoid touching your eyes, mouth, nose, genitals, or rectum until the medication has been washed off your hands. Also avoid handling food while the medication is still on your hands.

Avoid exposing treated skin to sunlight, sunlamps, tanning beds, or a hot tub. Capsaicin can cause a burning sensation that may be made worse by heat.

Do not use other medicated skin products, including muscle pain creams or lotions, on areas where you have applied capsaicin, unless your doctor has told you to.

Zostrix (capsaicin topical) side effects

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

• severe burning or irritation where the medicine was applied;

• skin redness where the medicine was applied; or

• trouble breathing or swallowing (after accidental inhalation of capsaicin odor or dried residue).

Less serious side effects may include a mild burning sensation that can last for several hours or days, especially after your first use of capsaicin topical.

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 Zostrix (capsaicin topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied capsaicin topical. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about capsaicin topical.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.02. Revision Date: 4/12/2009 4:39:41 PM.

Generic Name: zoster vaccine live (ZOS ter vak SEEN LYV)
Brand Names: Zostavax

What is zoster vaccine live?

Herpes zoster is caused by the same virus that causes chickenpox in children. When this virus becomes active again in an adult, it can cause herpes zoster, or shingles. Zoster vaccine is a live vaccine that helps prevent shingles.

This vaccine works by exposing you to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Zoster vaccine is used to prevent herpes zoster virus (shingles) in people age 60 and older.

Zoster vaccine will not treat shingles or nerve pain caused by shingles (post-herpetic neuralgia).

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

What is the most important information I should know about zoster vaccine live?

You can still receive a vaccine if you have a minor cold. If you have tuberculosis, or any other severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with herpes zoster (shingles) is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Do not receive this vaccine if you have leukemia or lymphoma (or other cancer affecting bone marrow), a history of allergic reaction to neomycin (Mycifradin, Neo-Fradin, Neo-Tab). You should not receive this vaccine if you are pregnant, or if you have active untreated tuberculosis, any type of cancer that affects bone marrow, or a weak immune system caused by disease (such as HIV or AIDS) or by receiving medications such as steroids or chemotherapy.

What should I discuss with my health care provider before receiving zoster vaccine live?

You should not receive this vaccine if you have:

• active untreated tuberculosis;

• leukemia, lymphoma, or other cancer affecting bone marrow;

• a history of allergic reaction to gelatin or neomycin (Mycifradin, Neo-Fradin, Neo-Tab);

• a weak immune system caused by disease (such as HIV or AIDS), or by receiving medications such as steroids or chemotherapy; or

• if you are pregnant.

Before receiving zoster vaccine, tell your doctor if you have:

• a history of allergic reaction to any vaccine;

• if you have received a “live” vaccine within the past 4 weeks; or

• if you have never had chickenpox.

You can still receive a vaccine if you have a minor cold. If you have tuberculosis, or any other severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

FDA pregnancy category C. It is not known whether zoster vaccine is harmful to an unborn baby. However, this vaccine is not for use in women of child-bearing age and should not be given to a pregnant woman It is not known whether zoster vaccine 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. Zoster vaccine should not be given to a child.

How is zoster vaccine given?

Zoster vaccine is given as an injection under the skin. You will receive this vaccine in a doctor’s office or other clinic setting.

Zoster vaccine is usually given as a one-time injection. Unless your doctor tells you otherwise, you will not need a booster vaccine.

You may receive other vaccines at the same time you receive zoster vaccine.

What happens if I miss a dose?

Since zoster vaccine is given as a one-time injection, you are not likely to be on a dosing schedule.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving zoster vaccine live?

If you need to receive a “live” vaccine, wait at least 4 weeks after your zoster vaccine to receive the live vaccine. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), typhoid, BCG (Bacillus Calmette and Guérin), and nasal flu vaccine. You should not receive a pneumonia vaccine (Pneumovax 23) at the same time you receive your zoster vaccine.

After receiving zoster vaccine, if you develop a skin rash that looks like shingles, avoid coming into contact with other people who have never had chickenpox (especially newborns, pregnant women, or someone with a weak immune system). Also avoid contact with these individuals if you develop a rash or other reaction where the vaccine was injected into your skin.

Zoster vaccine live side effects

You should not receive a second zoster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with shingles is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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

• fever, swollen glands, sore throat, flu symptoms;

• breathing problems; or

• severe or painful skin rash.

Less serious side effects include:

• pain, warmth, redness, bruising, itching, or swelling where the shot was given;

• diarrhea;

• joint or muscle pain;

• headache; 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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Zoster vaccine live Dosing Information

Usual Adult Dose for Herpes Zoster — Prophylaxis:

60 years of age and older:
Inject the total volume of reconstituted vaccine subcutaneously once; preferably in the upper arm.

What other drugs will affect zoster vaccine live?

There may be other drugs that can affect zoster vaccine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.06. Revision Date: 01/05/2010 1:05:12 PM.

Generic Name: zoster vaccine live (ZOS ter vak SEEN LYV)
Brand Names: Zostavax

What is zoster vaccine live?

Herpes zoster is caused by the same virus that causes chickenpox in children. When this virus becomes active again in an adult, it can cause herpes zoster, or shingles. Zoster vaccine is a live vaccine that helps prevent shingles.

This vaccine works by exposing you to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Zoster vaccine is used to prevent herpes zoster virus (shingles) in people age 60 and older.

Zoster vaccine will not treat shingles or nerve pain caused by shingles (post-herpetic neuralgia).

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

What is the most important information I should know about zoster vaccine live?

You can still receive a vaccine if you have a minor cold. If you have tuberculosis, or any other severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with herpes zoster (shingles) is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Do not receive this vaccine if you have leukemia or lymphoma (or other cancer affecting bone marrow), a history of allergic reaction to neomycin (Mycifradin, Neo-Fradin, Neo-Tab). You should not receive this vaccine if you are pregnant, or if you have active untreated tuberculosis, any type of cancer that affects bone marrow, or a weak immune system caused by disease (such as HIV or AIDS) or by receiving medications such as steroids or chemotherapy.

What should I discuss with my health care provider before receiving zoster vaccine live?

You should not receive this vaccine if you have:

• active untreated tuberculosis;

• leukemia, lymphoma, or other cancer affecting bone marrow;

• a history of allergic reaction to gelatin or neomycin (Mycifradin, Neo-Fradin, Neo-Tab);

• a weak immune system caused by disease (such as HIV or AIDS), or by receiving medications such as steroids or chemotherapy; or

• if you are pregnant.

Before receiving zoster vaccine, tell your doctor if you have:

• a history of allergic reaction to any vaccine;

• if you have received a “live” vaccine within the past 4 weeks; or

• if you have never had chickenpox.

You can still receive a vaccine if you have a minor cold. If you have tuberculosis, or any other severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

FDA pregnancy category C. It is not known whether zoster vaccine is harmful to an unborn baby. However, this vaccine is not for use in women of child-bearing age and should not be given to a pregnant woman It is not known whether zoster vaccine 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. Zoster vaccine should not be given to a child.

How is zoster vaccine given?

Zoster vaccine is given as an injection under the skin. You will receive this vaccine in a doctor’s office or other clinic setting.

Zoster vaccine is usually given as a one-time injection. Unless your doctor tells you otherwise, you will not need a booster vaccine.

You may receive other vaccines at the same time you receive zoster vaccine.

What happens if I miss a dose?

Since zoster vaccine is given as a one-time injection, you are not likely to be on a dosing schedule.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving zoster vaccine live?

If you need to receive a “live” vaccine, wait at least 4 weeks after your zoster vaccine to receive the live vaccine. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), typhoid, BCG (Bacillus Calmette and Guérin), and nasal flu vaccine. You should not receive a pneumonia vaccine (Pneumovax 23) at the same time you receive your zoster vaccine.

After receiving zoster vaccine, if you develop a skin rash that looks like shingles, avoid coming into contact with other people who have never had chickenpox (especially newborns, pregnant women, or someone with a weak immune system). Also avoid contact with these individuals if you develop a rash or other reaction where the vaccine was injected into your skin.

Zoster vaccine live side effects

You should not receive a second zoster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with shingles is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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

• fever, swollen glands, sore throat, flu symptoms;

• breathing problems; or

• severe or painful skin rash.

Less serious side effects include:

• pain, warmth, redness, bruising, itching, or swelling where the shot was given;

• diarrhea;

• joint or muscle pain;

• headache; 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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What other drugs will affect zoster vaccine live?

There may be other drugs that can affect zoster vaccine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.06. Revision Date: 01/05/2010 1:05:12 PM.

Generic Name: everolimus (E ver OH li mus)
Brand Names: Afinitor, Zortress

What is everolimus?

Everolimus is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Everolimus also lowers your body’s immune system. The immune system helps your body fight infections. The immune system can also fight or “reject” a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

The Afinitor brand of everolimus is used to treat advanced kidney cancer. Afinitor is usually given after sorafenib (Nexavar) or sunitinib (Sutent) have been tried without successful treatment of symptoms.

The Zortress brand of everolimus is used to prevent organ rejection after a kidney transplant. Zortress is used together with cyclosporine (Gengraf, Neoral, Sandimmune) and other medications.

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

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

You should not use this medication if you are allergic to everolimus, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel), or if you have problems digesting lactose or galactose (sugar). Do not use the Zortress brand of everolimus if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using Zortress and for at least 8 weeks after your treatment ends.

Before taking everolimus, tell your doctor if you have a breathing disorder such as asthma or COPD, liver disease, diabetes, high cholesterol, or a history of skin cancer.

Do not receive a “live” vaccine while using everolimus. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine. There are many other drugs that can interact with everolimus. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

To be sure this medicine is not causing harmful effects, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

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

You should not use this medication if you are allergic to everolimus, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel), or if you have problems digesting lactose or galactose (sugar).

If you have any of these other conditions, you may need an everolimus dose adjustment or special tests:

• a breathing disorder, such as asthma or COPD (chronic obstructive pulmonary disease);

• liver disease;

• diabetes;

• high cholesterol or triglycerides.

• a personal or family history of skin cancer (melanoma).

Taking everolimus may increase your risk of developing other types of cancer. Ask your doctor about your individual risk.

FDA pregnancy category C. It is not known whether Afinitor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. FDA pregnancy category D. Do not use Zortress if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using Zortress and for at least 8 weeks after your treatment ends.

This medication can affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether everolimus passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking everolimus.

How should I take everolimus?

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.

Everolimus should be taken at the same time each day. You may take everolimus with or without food, but take it the same way each time. If you also take cyclosporine, take both medications at the same time.

Take this medication with a full glass (8 ounces) of water. Swallow the tablet whole. Do not crush or chew. The medicine from a crushed pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a crushed tablet.

Everolimus can lower 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 will need to be tested often. Your liver and kidney function will also need to be tested. Visit your doctor regularly.

Store at room temperature in the original container, away from moisture, heat, and light. Keep each tablet in its blister pack until you are ready to take it.

See also: Zortress dosage in more detail

What happens if I miss a dose?

If you are less than 6 hours late in taking your medicine, 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.

What should I avoid while taking everolimus?

Do not receive a “live” vaccine while using everolimus. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine. Everolimus may increase your risk of developing skin cancer. Avoid exposure to sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Grapefruit and grapefruit juice may interact with everolimus and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Everolimus side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain, difficult 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, cough with yellow or green mucus;

• stabbing chest pain, wheezing, feeling short of breath;

• pain in your stomach, groin, lower back or side,

• swelling, rapid weight gain, urinating less than usual or not at all;

• blood in your urine, dark colored urine, pain or burning when you urinate;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

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

• redness, warmth, swelling, oozing, or slow healing of a wound or surgical incision;

• white patches or sores inside your mouth or on your lips; or

• other signs of infection such as sore throat, flu symptoms, loss of appetite, nausea and vomiting, or unusual weakness.

Less serious side effects may include:

• tired feeling;

• headache, pain in your arms and legs;

• diarrhea;

• dry skin; or

• sleep problems (insomnia);

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 everolimus?

Many drugs can interact with everolimus. Below is just a partial list. Tell your doctor if you are using:

• aprepitant (Emend);

• dexamethasone (Decadron, Hexadrol);

• isoniazid (for treating tuberculosis);

• rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);

• St. John’s wort;

• an antidepressant such as nefazodone;

• other drugs that weaken your immune system;

• an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

• an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);

• a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), or phenobarbital (Solfoton);

• heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;

• HIV medication such as delavirdine (Rescriptor), efavirenz efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Kaletra, Norvir), or saquinavir (Invirase); or

• seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and there are many other drugs that can interact with everolimus. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about everolimus.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.01. Revision Date: 05/13/2010 11:24:54 AM.

Generic Name: aspirin (oral) (AS pir in)
Brand Names: Arthritis Pain, Aspergum Cherry, Aspergum Orginal, Aspir 81, Aspir-Low, Aspirin Lite Coat, Aspirin Litecoat, Aspirin Low Dose, Aspirin Low Strength, Bayer Aspirin, Bayer Aspirin Regimen, Bayer Aspirin Sugar Free, Bayer Aspirin with Calcium, Bayer Childrens Aspirin, Bayer Low Strength, Bayer Plus, Buffered Aspirin, Bufferin, Bufferin Arthritis Strength, Bufferin Extra Strength, Easprin, Ecotrin, Ecotrin Adult Low Strength, Ecotrin Maximum Strength, Fasprin, Genacote, Halfprin, Litecoat Aspirin, Norwich Aspirin, St. Joseph Aspirin, St. Joseph Aspirin Adult Chewable, St. Joseph Aspirin Adult EC, Stanback Analgesic, Tri-Buffered Aspirin, YSP Aspirin, Zorprin

What is aspirin?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Aspirin is used to treat mild to moderate pain, and also to reduce fever or inflammation. Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

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

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

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

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye’s syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding.

Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

What should I discuss with my healthcare provider before taking aspirin?

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye’s syndrome in children. Do not use this medication if you are allergic to aspirin, or if you have:

• a recent history of stomach or intestinal bleeding;

• a bleeding disorder such as hemophilia; or

• an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take aspirin:

• asthma or seasonal allergies;

• stomach ulcers;

• liver disease;
• kidney disease;

• a bleeding or blood clotting disorder;

• heart disease, high blood pressure, or congestive heart failure;

• gout; or

• nasal polyps.

If you are taking aspirin to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). This medication may be harmful to an unborn baby’s heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin. Aspirin 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 aspirin?

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

Take this medication with a full glass of water. Taking aspirin with food or milk can lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach, but you may take it with food or milk if desired. Do not crush, chew, break, or open an enteric-coated or extended-release pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. The extended-release tablet is specially made to release medicine slowly in the body. Breaking this pill would cause too much of the drug to be released at one time.

The chewable tablet form of aspirin must be chewed before swallowing.

Keep the orally disintegrating tablet in its package until you are ready to take the medicine. Open the package and peel the back cover from the tablet. Using dry hands, place the tablet into your mouth. It will begin to dissolve right away, without water. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

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

Do not take this medication if you smell a strong vinegar odor in the aspirin bottle. The medicine may no longer be effective. Store aspirin at room temperature away from moisture and heat.

What happens if I miss a dose?

Since aspirin is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include ringing in your ears, headache, nausea, vomiting, dizziness, confusion, hallucinations, rapid breathing, fever, seizure (convulsions), or coma.

What should I avoid while taking aspirin?

Do not use any other over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid taking an NSAID (non-steroidal anti-inflammatory drug) while you are taking aspirin. NSAIDs include ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding. Avoid taking ibuprofen (Advil, Motrin) if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Aspirin side effects

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

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• severe nausea, vomiting, or stomach pain;

• fever lasting longer than 3 days;

• swelling, or pain lasting longer than 10 days; or

• hearing problems, ringing in your ears.

Less serious side effects may include:

• upset stomach, heartburn;

• drowsiness; or

• headache.

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 aspirin?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.

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

• a blood thinner such as warfarin (Coumadin); or

• another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan’s, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

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

Where can I get more information?

• Your pharmacist can provide more information about aspirin.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 12.01. Revision Date: 08/24/2009 12:53:47 PM.

Generic Name: somatropin (soe ma TROE pin)
Brand Names: Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive

What is somatropin?

Somatropin is a form of human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.

Somatropin is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, short stature at birth with no catch-up growth, and other causes. Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome.

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

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

Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.

Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor’s advice.

If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Call your doctor at once if you have sudden and severe pain or tenderness in your upper stomach, with nausea, vomiting, sweating, fever, fast heartbeat, and yellowing of the skin or eyes. You should also call your doctor promptly if you have vision changes and sudden, severe pain behind your eyes.

What should I discuss with my healthcare provider before using somatropin?

Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin.

You should not use this medication if you are allergic to somatropin, or if you have:

• diabetic retinopathy (a serious eye condition caused by diabetes);

• cancer; or

• Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.

You should also not use somatropin if you have a serious medical condition after having:

• open heart surgery or stomach surgery;

• trauma or other medical emergency; or

• breathing problems (such as lung failure).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using somatropin, tell your doctor if you have:

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

• diabetes;

• scoliosis;

• high blood pressure (hypertension);

• a pancreas disorder;

• a history of cancer;

• carpal tunnel syndrome;

• underactive thyroid; or

• a brain tumor or lesion.

FDA pregnancy category B. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive. FDA pregnancy category C. It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin,Nutropihn, and Tev-tropin. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby.

How should I use somatropin?

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

Your dose and brand of somatropin, and how often you give it will depend on what you are being treated for. Follow the directions on your prescription label.

Somatropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Do not inject this medicine into skin or muscle that is red, sore, infected, or injured.

Do not shake the medication bottle or you may ruin the medicine. When mixing somatropin with a diluent (liquid), use a gentle swirling motion. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition and not causing harm, your blood and growth progress will need to be tested on a regular basis. Your eyes may also need to be checked. Visit your doctor regularly.

If you are being treated for short bowel syndrome, follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel syndrome.

If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only the pen injection system provided with the somatropin brand you use.

How you store this medicine will depend on what brand you are using and what diluent you are mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Read and carefully follow the instructions provided with your medicine about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication.

Throw away any somatropin left over after the expiration date on the label has passed.

What happens if I miss a dose?

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.

Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?

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

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

What should I avoid while using somatropin?

If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.

Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

Somatropin side effects

If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.

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

• sudden and severe pain or tenderness in your upper stomach;

• nausea, vomiting, sweating, fever, fast heartbeat, yellowing of the skin or eyes;

• increased thirst and urination;

• sudden and severe pain behind your eyes, vision changes;

• swelling in your head, face, hands, or feet; or

• numbness or tingling in your wrist, hand, or fingers.

Less serious side effects may include:

• headache;

• redness, soreness, swelling, skin rash, itching, pain, or bruising where the medicine was injected;

• breast swelling;

• joint pain, swelling, or stiffness; or

• mild nausea, stomach pain, gas.

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 somatropin?

Before using somatropin, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Somatropin may affect blood sugar levels and you may need to adjust your dose of the diabetes medication. Do not change the dose of your diabetes medication without your doctor’s advice.

Tell your doctor if you use any type of steroid medicine such as cortisone, dexamethasone, methylprednisolone, prednisone, and others. Steroids can make somatropin less effective and your doses may need to be adjusted. Do not stop using a steroid suddenly. Follow your doctor’s instructions.

Tell your doctor about all other medications you use, especially cyclosporine (Gengraf, Neoral, Sandimmune), seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women.

This list is not complete and other drugs may interact with somatropin. 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.

Where can I get more information?

• Your pharmacist can provide more information about somatropin.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 9.01. Revision Date: 04/14/2010 1:58:00 PM.

Generic Name: hydrocortisone and pramoxine topical (HYE droe KOR ti sone and pra MOX een)
Brand Names: Analpram E, Analpram-HC, Epifoam, HC Pramoxine, Hydropram, Novacort, Pramosone, Proctofoam HC, Rectocort HC, ZyPram

What is Zone-A (hydrocortisone and pramoxine topical)?

Pramoxine is an anesthetic. It works by interfering with pain signals sent from the nerves to the brain.

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

The combination of hydrocortisone and pramoxine topical is used to treat pain, itching, or inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, psoriasis, insect bites, and minor burns or scrapes. This medication is also used on the rectal area to treat itching and inflammation caused by hemorrhoids, anal fissures, or other rectal irritation.

Hydrocortisone and pramoxine topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Zone-A (hydrocortisone and pramoxine topical)?

You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.

Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or “numbing medicines.”

Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor’s advice. Children are more sensitive to the effects of topical hydrocortisone. Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

Do not use hydrocortisone and pramoxine topical for any condition that has not been checked by a doctor.

What should I discuss with my health care provider before using Zone-A (hydrocortisone and pramoxine topical)?

You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.

Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or “numbing medicines.” Also tell your doctor if you have:

• liver disease;

• diabetes;

• problems with your eyes;

• a stomach or intestinal disorder;

• a rectal sore or infection; or

• if you use any drugs that weaken the immune system, including steroids.

Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using hydrocortisone and pramoxine topical, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone and pramoxine 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 medication on a child without a doctor’s advice. Children are more sensitive to the effects of topical hydrocortisone.

How should I use Zone-A (hydrocortisone and pramoxine topical)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Hydrocortisone and pramoxine topical is usually applied 3 or more times daily, depending on which form of this medication you use. Follow the label directions or your doctor’s instructions about how much of this medication to use and how often. Do not use hydrocortisone and pramoxine topical for any condition that has not been checked by a doctor.

Wash your hands before and after applying this medication, unless you are using hydrocortisone and pramoxine topical to treat a hand condition.

When using this medication on the skin, apply just enough of the medication to cover the area to be treated. Rub in gently.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions.

Before apply the rectal form of this medication (cream, lotion, or foam), clean the rectal area with mild soap and pat dry.

Use only a small amount of medicine when applying hydrocortisone and pramoxine around the outside of the rectum. You may first place the medicine onto a clean tissue and then wipe it gently onto your rectum.

When using this medication inside the rectum, insert only the applicator tip of the medicine tube or foam can into the anus, no deeper than 1 inch.

Shake the hydrocortisone and pramoxine rectal foam before each use. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days, or if your condition clears up and then comes back. Do not stop using hydrocortisone and pramoxine topical suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using the medication. Store this medication at room temperature away from moisture and heat. Keep the rectal foam canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. 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 hydrocortisone and pramoxine topical is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Zone-A (hydrocortisone and pramoxine topical)?

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin. If it does get into any of these areas, wash with water. Do not use hydrocortisone and pramoxine topical on deep skin wounds, blistered skin, severe burns, irritated skin, or large skin areas. Also avoid using this medication in open wounds.

Avoid applying other skin medications on the same treatment area with hydrocortisone and pramoxine topical, unless your doctor has told you to.

Using a steroid can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicines.

Hydrocortisone pramoxine topical side effects

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

• blurred vision, or seeing halos around lights;

• uneven heartbeats;

• sleep problems (insomnia);

• ongoing headache;

• weight gain, puffiness in your face;

• increased thirst or urination, weight loss, unusual weakness;

• fever, sore throat, tired feeling;

• severe pain, burning, or irritation of treated skin;

• rectal bleeding;

• any new redness or swelling where the medicine was applied; or

• itching, oozing, or other signs of infection.

Less serious side effects may include:

• mild skin redness, burning, itching, dryness, or peeling;

• acne;

• changes in the color of treated skin;

• thinning of your skin;

• blistering skin; or

• stretch marks.

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 Zone-A (hydrocortisone and pramoxine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone and pramoxine. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone and pramoxine topical.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.04. Revision Date: 03/04/2010 12:01:57 PM.

Generic Name: hydrocortisone and pramoxine topical (HYE droe KOR ti sone and pra MOX een)
Brand Names: Analpram E, Analpram-HC, Epifoam, HC Pramoxine, Hydropram, Novacort, Pramosone, Proctofoam HC, Rectocort HC, ZyPram

What is Zone-A Forte (hydrocortisone and pramoxine topical)?

Pramoxine is an anesthetic. It works by interfering with pain signals sent from the nerves to the brain.

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

The combination of hydrocortisone and pramoxine topical is used to treat pain, itching, or inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, psoriasis, insect bites, and minor burns or scrapes. This medication is also used on the rectal area to treat itching and inflammation caused by hemorrhoids, anal fissures, or other rectal irritation.

Hydrocortisone and pramoxine topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Zone-A Forte (hydrocortisone and pramoxine topical)?

You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.

Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or “numbing medicines.”

Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor’s advice. Children are more sensitive to the effects of topical hydrocortisone. Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

Do not use hydrocortisone and pramoxine topical for any condition that has not been checked by a doctor.

What should I discuss with my health care provider before using Zone-A Forte (hydrocortisone and pramoxine topical)?

You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.

Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or “numbing medicines.” Also tell your doctor if you have:

• liver disease;

• diabetes;

• problems with your eyes;

• a stomach or intestinal disorder;

• a rectal sore or infection; or

• if you use any drugs that weaken the immune system, including steroids.

Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using hydrocortisone and pramoxine topical, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone and pramoxine 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 medication on a child without a doctor’s advice. Children are more sensitive to the effects of topical hydrocortisone.

How should I use Zone-A Forte (hydrocortisone and pramoxine topical)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Hydrocortisone and pramoxine topical is usually applied 3 or more times daily, depending on which form of this medication you use. Follow the label directions or your doctor’s instructions about how much of this medication to use and how often. Do not use hydrocortisone and pramoxine topical for any condition that has not been checked by a doctor.

Wash your hands before and after applying this medication, unless you are using hydrocortisone and pramoxine topical to treat a hand condition.

When using this medication on the skin, apply just enough of the medication to cover the area to be treated. Rub in gently.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions.

Before apply the rectal form of this medication (cream, lotion, or foam), clean the rectal area with mild soap and pat dry.

Use only a small amount of medicine when applying hydrocortisone and pramoxine around the outside of the rectum. You may first place the medicine onto a clean tissue and then wipe it gently onto your rectum.

When using this medication inside the rectum, insert only the applicator tip of the medicine tube or foam can into the anus, no deeper than 1 inch.

Shake the hydrocortisone and pramoxine rectal foam before each use. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days, or if your condition clears up and then comes back. Do not stop using hydrocortisone and pramoxine topical suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using the medication. Store this medication at room temperature away from moisture and heat. Keep the rectal foam canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. 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 hydrocortisone and pramoxine topical is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Zone-A Forte (hydrocortisone and pramoxine topical)?

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin. If it does get into any of these areas, wash with water. Do not use hydrocortisone and pramoxine topical on deep skin wounds, blistered skin, severe burns, irritated skin, or large skin areas. Also avoid using this medication in open wounds.

Avoid applying other skin medications on the same treatment area with hydrocortisone and pramoxine topical, unless your doctor has told you to.

Using a steroid can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicines.

Hydrocortisone pramoxine topical side effects

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

• blurred vision, or seeing halos around lights;

• uneven heartbeats;

• sleep problems (insomnia);

• ongoing headache;

• weight gain, puffiness in your face;

• increased thirst or urination, weight loss, unusual weakness;

• fever, sore throat, tired feeling;

• severe pain, burning, or irritation of treated skin;

• rectal bleeding;

• any new redness or swelling where the medicine was applied; or

• itching, oozing, or other signs of infection.

Less serious side effects may include:

• mild skin redness, burning, itching, dryness, or peeling;

• acne;

• changes in the color of treated skin;

• thinning of your skin;

• blistering skin; or

• stretch marks.

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 Zone-A Forte (hydrocortisone and pramoxine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone and pramoxine. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone and pramoxine topical.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.04. Revision Date: 03/04/2010 12:01:57 PM.

Generic Name: benzonatate (ben ZOE na tate)
Brand Names: Tessalon, Tessalon Perles, Zonatuss

What is Zonatuss (benzonatate)?

Benzonatate is a non-narcotic cough medicine. It works by numbing the throat and lungs, making the cough reflex less active.

Benzonatate is used to relieve coughing.

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

What is the most important information I should know about Zonatuss (benzonatate)?

You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams). Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects.

Serious side effects of benzonatate include choking feeling, chest pain or numbness, feeling like you might pass out, confusion, or hallucinations. Some of these side effects may result from chewing or sucking on a benzonatate capsule.

Do not give this medication to a child younger than 10 years old without the advice of a doctor.

What should I discuss with my healthcare provider before taking Zonatuss (benzonatate)?

You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams). FDA pregnancy category C. It is not known whether benzonatate 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 benzonatate 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 give this medication to a child younger than 10 years old without the advice of a doctor.

How should I take Zonatuss (benzonatate)?

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.

Take each dose with a full glass of water. Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects. Store at room temperature away from moisture, heat, and light.

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. An overdose of benzonatate can be fatal.

Overdose symptoms may include numbness in the mouth or throat, feeling restless or very sleepy, tremors or shaking, or seizure (convulsions).

What should I avoid while taking Zonatuss (benzonatate)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using benzonatate

Zonatuss (benzonatate) side effects

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

• a choking feeling;

• chest pain or numbness;

• feeling like you might pass out;

• confusion; or

• hallucinations.

Some of these side effects may result from chewing or sucking on a benzonatate capsule.

Less serious side effects may include:

• headache;

• dizziness;

• drowsiness;

• nausea, upset stomach, constipation; or

• mild itching or 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 Zonatuss (benzonatate)?

There may be other drugs that can interact with benzonatate. 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.

Where can I get more information?

• Your pharmacist can provide more information about benzonatate.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 6.01. Revision Date: 04/27/2010 3:37:30 PM.