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Nitroglycerin Patch

30/06/10

Generic Name: Nitroglycerin (NYE-troe-GLIS-er-in)
Brand Name: Examples include Minitran and Nitro-Dur

Nitroglycerin Patch is used for:

Preventing chronic chest pain caused by heart disease. It also may be used for other conditions as determined by your doctor.

Nitroglycerin Patch is a nitrate. It works by relaxing (widening) blood vessels. Chest pain occurs when the heart needs more oxygen than it can get. Relaxing blood vessels allows blood to flow more easily. This reduces the heart’s workload and the amount of oxygen needed by the heart.

Do NOT use Nitroglycerin Patch if:

you are allergic to any ingredient in Nitroglycerin Patch
you are allergic to the adhesive that makes the patch stick to your skin
you have increased pressure in or severe injury to the head
you have severe anemia
you are taking a phosphodiesterase type 5 inhibitor (eg, sildenafil)

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

Before using Nitroglycerin Patch:

Some medical conditions may interact with Nitroglycerin Patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you drink alcoholic beverages
if you have a history of other heart problems (eg, heart failure, enlarged heart, heart attack), overactive thyroid, stroke or other bleeding in the brain, or recent head injury
if you have anemia, low blood pressure, dehydration, or low blood volume

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

Beta-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem), diuretics (eg, furosemide, hydrochlorothiazide), medicines for high blood pressure, phenothiazines (eg, thioridazine), or phosphodiesterase type 5 inhibitors (eg, sildenafil) because the risk of low blood pressure and dizziness on standing may be increased
Salicylates (eg, aspirin) because they may increase the risk of Nitroglycerin Patch’s side effects
Alteplase because the effectiveness of Nitroglycerin Patch may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitroglycerin Patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nitroglycerin Patch:

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

An extra patient leaflet is available with Nitroglycerin Patch. Talk to your pharmacist if you have questions about this information.
Nitroglycerin Patch is for external use only.
Apply the patch at the same time every day.
Wash your hands thoroughly before and after applying the patch.
Apply the patch to a non-hairy area of the chest, inner side of the upper arm, back, or shoulder.
Clean and completely dry the skin before applying the patch. If necessary, hair should be removed by clipping or lightly shaving.
Remove the patch from the package. Apply with a firm pressure to the skin. To avoid skin irritation, change the treatment site daily. Do not apply to irritated or damaged skin.
If the patch becomes loose, remove it and apply a new patch at a different site.
After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.
This patch should only be worn for up to 12 to 14 hours a day, or as directed by your doctor, so that you will have a 10 to 12 hour “nitrate-free” period each day. Do not use more of Nitroglycerin Patch than prescribed. It is important to have a “nitrate-free” period of time each day for Nitroglycerin Patch to continue to work well and to decrease the risk of physical dependence.
If you miss a dose of Nitroglycerin Patch, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

Nitroglycerin Patch may cause dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Nitroglycerin Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with your doctor before you drink alcohol while you are taking Nitroglycerin Patch. Drinking alcohol may increase the risk of low blood pressure with Nitroglycerin Patch.
Nitroglycerin Patch may cause dizziness, lightheadedness, or fainting. Sit down while taking Nitroglycerin Patch to avoid falling caused by lightheadedness or dizziness.
Contact your doctor right away if you develop slow heartbeat or new or worsening chest pain after you take Nitroglycerin Patch.
Tell your doctor or dentist that you take Nitroglycerin Patch before you receive any medical or dental care, emergency care, or surgery.
Nitroglycerin Patch may give you daily headaches. This should become less noticeable with time.
Other dosage forms of Nitroglycerin Patch (eg, sublingual, or under the tongue, tablets) may not work as well while you are taking Nitroglycerin Patch.
Nitroglycerin Patch takes about 1 to 2 hours to start working and should not be used for a sudden chest pain attack.
Lab tests, including heart function, blood pressure, and blood electrolyte levels, may be performed while you use Nitroglycerin Patch. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Nitroglycerin Patch with caution in the ELDERLY; they may be more sensitive to its effects.
Nitroglycerin Patch is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nitroglycerin Patch while you are pregnant. It is not known if Nitroglycerin Patch is found in breast milk. If you are or will be breast-feeding while you are using Nitroglycerin Patch, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time without a break, Nitroglycerin Patch may not work as well. This is known as TOLERANCE. Increasing the dose is not effective in managing tolerance to Nitroglycerin Patch. Tolerance to other nitrates or nitrites may also occur. Be sure to have a “nitrate-free” period of time each day to help prevent this tolerance. Talk with your doctor if Nitroglycerin Patch stops working well. Do not take more than prescribed.

Some people who use Nitroglycerin Patch for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. If you use Nitroglycerin Patch without a break and then suddenly stop using it, you may get WITHDRAWAL symptoms. These may include chest pain, heart attack, or possibly sudden death. Be sure to have a “nitrate-free” period of time each day; this may help prevent dependence and withdrawal problems.

Possible side effects of Nitroglycerin Patch:

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

Dizziness, lightheadedness, or fainting when sitting up or standing; flushing of face and neck; headache; irritation at site of patch; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dry mouth; fainting; flushing; heavy sweating; irregular heartbeat; new or worsening chest pain; pale skin; pounding in the chest; rapid heartbeat; severe dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; slow heartbeat; swelling of the hands, ankles, or feet; unusual weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include cold or blue skin; confusion; diarrhea; excessive sweating; fainting; fast, slow, or irregular heartbeat; persistent throbbing headache; seizures; trouble breathing; vision problems.

Proper storage of Nitroglycerin Patch:

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

General information:

If you have any questions about Nitroglycerin Patch, please talk with your doctor, pharmacist, or other health care provider.
Nitroglycerin Patch is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,N

Comments (0)

Nitroglycerin Spray

30/06/10

Generic Name: Nitroglycerin (NYE-troe-GLIS-er-in)
Brand Name: Nitrolingual Pumpspray

Nitroglycerin Spray is used for:

Preventing or relieving a sudden attack of angina (chest pain) caused by heart disease. It may also be used for other conditions as determined by your doctor.

Nitroglycerin Spray is a nitrate. It works by dilating (widening) blood vessels. Chest pain occurs when the heart needs more oxygen than it can get. Dilating blood vessels allows blood to flow more easily. This reduces the heart’s workload and the amount of oxygen needed by the heart.

Do NOT use Nitroglycerin Spray if:

you are allergic to any ingredient in Nitroglycerin Spray
you are also taking a phosphodiesterase type 5 inhibitor (eg, sildenafil)

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

Before using Nitroglycerin Spray:

Some medical conditions may interact with Nitroglycerin Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you drink alcoholic beverages
if you have a history of other heart problems (eg, heart failure, enlarged heart, heart attack), overactive thyroid, stroke or other bleeding in the brain, increased pressure in the head, or recent head injury
if you have anemia, low blood pressure, dehydration, or low blood volume

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

Beta-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem), diuretics (eg, furosemide, hydrochlorothiazide), medicines for high blood pressure, phenothiazines (eg, thioridazine), or phosphodiesterase type 5 inhibitors (eg, sildenafil) because the risk of low blood pressure and dizziness on standing may be increased
Salicylates (eg, aspirin) because they may increase the risk of Nitroglycerin Spray’s side effects
Long-acting nitrates (eg, nitroglycerin patch) because they may decrease Nitroglycerin Spray’s effectiveness
Alteplase because its effectiveness may be decreased by Nitroglycerin Spray

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitroglycerin Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nitroglycerin Spray:

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

An extra patient leaflet is available with Nitroglycerin Spray. Talk to your pharmacist if you have questions about this information.
Do NOT shake Nitroglycerin Spray.
Do NOT inhale the spray. Nitroglycerin Spray is to be used on or under the tongue.
Before using the medicine for the first time, prime the pump by spraying once into the air away from yourself and others. If you do not use Nitroglycerin Spray within 6 weeks, reprime by spraying once into the air.
To use Nitroglycerin Spray, remove the plastic cover. Hold the container upright with your forefinger on top of the grooved button. Open your mouth and bring the container as close to your mouth as possible. Press the button firmly to release the spray onto or under your tongue. Do NOT inhale the spray. Release the button and close your mouth.
Replace the plastic cover after you are finished using Nitroglycerin Spray.
Do not swallow right away you use a dose. Do not spit or rinse your mouth for 5 to 10 minutes after you use Nitroglycerin Spray.
To treat an angina attack, use 1 to 2 sprays on or under the tongue as directed by your doctor. Sit quietly after using a dose. A spray may be repeated every 3 to 5 minutes as directed by your doctor. Do not use more than 3 sprays in 15 minutes unless your doctor tells you otherwise. If chest pain continues after a total of 3 sprays, seek medical attention at once, unless your doctor gives you different instructions.
If you use Nitroglycerin Spray to prevent angina caused by physical activity, use it 5 to 10 minutes before activity unless your doctor tells you otherwise.
If you miss a dose of Nitroglycerin Spray and you are still having chest pain, contact your doctor right away. Ask your health care provider any questions you may have about the proper use of Nitroglycerin Spray.

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

Important safety information:

Nitroglycerin Spray may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Nitroglycerin Spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with your doctor before you drink alcohol while you are using Nitroglycerin Spray. Drinking alcohol may increase the risk of low blood pressure with Nitroglycerin Spray.
Nitroglycerin Spray may cause dizziness, lightheadedness, or fainting. Sit down while taking Nitroglycerin Spray to avoid falling caused by lightheadedness or dizziness.
Nitroglycerin Spray can cause tingling or burning when you put it under your tongue. However, lack of tingling or burning does not mean the medicine is not working.
Contact your doctor right away if you develop slow heartbeat or new or worsening chest pain after you take Nitroglycerin Spray.
The risk of tolerance to Nitroglycerin Spray may be greater if you take Nitroglycerin Spray in high doses or more often than prescribed. Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.
Nitroglycerin Spray is flammable. Do not store near an open flame. Do not force open or burn the container.
Keep medicine in the original glass bottle with cap tightly closed. Throw away the cotton inside once the bottle is opened.
Tell your doctor or dentist that you take Nitroglycerin Spray before you receive any medical or dental care, emergency care, or surgery.
Nitroglycerin Spray may interfere with certain lab tests, including certain cholesterol tests. Be sure your doctor and lab personnel know you are using Nitroglycerin Spray.
Lab tests, including heart function, blood pressure, and blood electrolyte levels, may be performed while you use Nitroglycerin Spray. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Nitroglycerin Spray should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nitroglycerin Spray while you are pregnant. It is not known if Nitroglycerin Spray is found in breast milk. If you are or will be breast-feeding while you are using Nitroglycerin Spray, check with your doctor. Discuss any possible risks to your baby.

When used at higher doses or more often than prescribed, Nitroglycerin Spray may not work as well. This is known as TOLERANCE. Tolerance to other nitrates and nitrites may also occur. Increasing the dose is not effective in managing tolerance to Nitroglycerin Spray. Talk with your doctor if Nitroglycerin Spray stops working well. Do not take more than prescribed.

Possible side effects of Nitroglycerin Spray:

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

Burning or tingling sensation; dizziness; headache; lightheadedness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dry mouth; fainting; flushing; heavy sweating; irregular heartbeat; nausea; new or worsening chest pain; pale skin; pounding in the chest; severe dizziness or headache; shortness of breath; slow heartbeat; swelling of the hands, ankles, or feet; unusual weakness; vomiting.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include changes in heart rate; changes in vision; confusion; dizziness; flushing; nausea; persistent, throbbing headache; sweating; vomiting; weakness.

Proper storage of Nitroglycerin Spray:

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

General information:

If you have any questions about Nitroglycerin Spray, please talk with your doctor, pharmacist, or other health care provider.
Nitroglycerin Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,N

Comments (0)

Nitroglycerin Ointment

30/06/10

Generic Name: Nitroglycerin (NYE-troe-GLIS-er-in)
Brand Name: Nitro-Bid

Nitroglycerin Ointment is used for:

Preventing chronic chest pain caused by heart disease. It also may be used for other conditions as determined by your doctor.

Nitroglycerin Ointment is a nitrate. It works by relaxing (widening) blood vessels. Chest pain occurs when the heart needs more oxygen than it can get. Relaxing blood vessels allows blood to flow more easily. This reduces the heart’s workload and the amount of oxygen needed by the heart.

Do NOT use Nitroglycerin Ointment if:

you are allergic to any ingredient in Nitroglycerin Ointment
you have increased pressure in or severe injury to the head
you have severe anemia
you are taking a phosphodiesterase type 5 inhibitor (eg, sildenafil)

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

Before using Nitroglycerin Ointment:

Some medical conditions may interact with Nitroglycerin Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you drink alcoholic beverages
if you have a history of other heart problems (eg, heart failure, enlarged heart, heart attack), overactive thyroid, stroke or other bleeding in the brain, or recent head injury
if you have anemia, low blood pressure, dehydration, or low blood volume

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

Beta-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem), diuretics (eg, furosemide, hydrochlorothiazide), medicines for high blood pressure, phenothiazines (eg, thioridazine), or phosphodiesterase type 5 inhibitors (eg, sildenafil) because the risk of low blood pressure and dizziness on standing may be increased
Salicylates (eg, aspirin) because they may increase the risk of Nitroglycerin Ointment’s side effects
Alteplase because the effectiveness of Nitroglycerin Ointment may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitroglycerin Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nitroglycerin Ointment:

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

Nitroglycerin Ointment comes with an additional patient leaflet. Read it carefully and reread it each time you get Nitroglycerin Ointment refilled.
Nitroglycerin Ointment is for external use only.
Wash hands before and after applying.
Apply using the applicator. Place the applicator on a flat surface with the printed side down. Squeeze the prescribed amount of ointment from the tube onto the applicator. Place the applicator on the skin with the ointment side down on the desired area of skin. Using the applicator, spread the ointment in a thin, uniform layer. Cover the area with plastic wrap held in place with adhesive tape.
Remove the plastic wrap from the old dose when you apply a new dose.
Nitroglycerin Ointment lasts for about 6 hours. Do not use more of Nitroglycerin Ointment than prescribed. It is important to have a “nitrate-free” period of time for 10 to 12 hours each day for Nitroglycerin Ointment to continue to work well and to decrease the risk of physical dependence.
If you miss a dose of Nitroglycerin Ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

Nitroglycerin Ointment may cause dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Nitroglycerin Ointment with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with your doctor before you drink alcohol while you are using Nitroglycerin Ointment. Drinking alcohol may increase the risk of low blood pressure with Nitroglycerin Ointment.
Nitroglycerin Ointment may cause dizziness, lightheadedness, or fainting. Sit down while taking Nitroglycerin Ointment to avoid falling caused by lightheadedness or dizziness.
Contact your doctor right away if you develop slow heartbeat or new or worsening chest pain after you take Nitroglycerin Ointment.
Tell your doctor or dentist that you take Nitroglycerin Ointment before you receive any medical or dental care, emergency care, or surgery.
Nitroglycerin Ointment may give you daily headaches. This should become less noticeable with time.
Other dosage forms of Nitroglycerin Ointment (eg, sublingual, or under the tongue, tablets) may not work as well while you are taking Nitroglycerin Ointment.
Nitroglycerin Ointment takes about 1 to 2 hours to start working and should not be used for a sudden chest pain attack.
Nitroglycerin Ointment may stain clothing.
Lab tests, including heart function, blood pressure, and blood electrolyte levels, may be performed while you use Nitroglycerin Ointment. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Nitroglycerin Ointment with caution in the ELDERLY; they may be more sensitive to its effects.
Nitroglycerin Ointment is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nitroglycerin Ointment while you are pregnant. It is not known if Nitroglycerin Ointment is found in breast milk. If you are or will be breast-feeding while you are using Nitroglycerin Ointment, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time without a break, Nitroglycerin Ointment may not work as well. This is known as TOLERANCE. Increasing the dose is not effective in managing tolerance to Nitroglycerin Ointment. Tolerance to other nitrates or nitrites may also occur. Be sure to have a “nitrate-free” period of time each day to help prevent this tolerance. Talk with your doctor if Nitroglycerin Ointment stops working well. Do not take more than prescribed.

Some people who use Nitroglycerin Ointment for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. If you use Nitroglycerin Ointment without a break and then suddenly stop using it, you may get WITHDRAWAL symptoms. These may include chest pain, heart attack, or possibly sudden death. Be sure to have a “nitrate-free” period of time each day; this may help prevent dependence and withdrawal problems.

Possible side effects of Nitroglycerin Ointment:

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

Dizziness, lightheadedness, or fainting when sitting up or standing; flushing of face and neck; headache; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dry mouth; fainting; flushing; heavy sweating; irregular heartbeat; new or worsening chest pain; pale skin; pounding in the chest; rapid heartbeat; severe dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; slow heartbeat; swelling of the hands, ankles, or feet; unusual weakness.

If OVERDOSE is suspected:

Proper storage of Nitroglycerin Ointment:

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

General information:

If you have any questions about Nitroglycerin Ointment, please talk with your doctor, pharmacist, or other health care provider.
Nitroglycerin Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,N

Comments (0)

Nitroglycerin Controlled-Release Capsules

30/06/10

Generic Name: Nitroglycerin (NYE-troe-GLIS-er-in)
Brand Name: Nitro-Time

Nitroglycerin Controlled-Release Capsules are used for:

Preventing chronic chest pain caused by heart disease. It also may be used for other conditions as determined by your doctor.

Nitroglycerin Controlled-Release Capsules are a nitrate. It works by relaxing (widening) blood vessels. Chest pain occurs when the heart needs more oxygen than it can get. Relaxing blood vessels allows blood to flow more easily. This reduces the heart’s workload and the amount of oxygen needed by the heart.

Do NOT use Nitroglycerin Controlled-Release Capsules if:

you are allergic to any ingredient in Nitroglycerin Controlled-Release Capsules
you have increased pressure in or severe injury to the head
you have severe anemia
you are taking a phosphodiesterase type 5 inhibitor (eg, sildenafil)

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

Before using Nitroglycerin Controlled-Release Capsules:

Some medical conditions may interact with Nitroglycerin Controlled-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you drink alcoholic beverages
if you have a history of other heart problems (eg, heart failure, enlarged heart, heart attack), overactive thyroid, stroke or other bleeding in the brain, or recent head injury
if you have anemia, low blood pressure, dehydration, or low blood volume

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

Beta-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem), diuretics (eg, furosemide, hydrochlorothiazide), medicines for high blood pressure, phenothiazines (eg, thioridazine), or phosphodiesterase type 5 inhibitors (eg, sildenafil) because the risk of low blood pressure and dizziness on standing may be increased
Salicylates (eg, aspirin) because they may increase the risk of Nitroglycerin Controlled-Release Capsules’s side effects
Alteplase because the effectiveness of Nitroglycerin Controlled-Release Capsules may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitroglycerin Controlled-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nitroglycerin Controlled-Release Capsules:

Use Nitroglycerin Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Nitroglycerin Controlled-Release Capsules by mouth with or without food.
Swallow Nitroglycerin Controlled-Release Capsules whole. Do not break, crush, or chew before swallowing.
Nitroglycerin Controlled-Release Capsules lasts for about 12 hours. Do not take more of Nitroglycerin Controlled-Release Capsules than prescribed. It is important to have a “nitrate-free” period of time for 10 to 12 hours each day for Nitroglycerin Controlled-Release Capsules to continue to work well and to decrease the risk of physical dependence.
If you miss a dose of Nitroglycerin Controlled-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Nitroglycerin Controlled-Release Capsules.

Important safety information:

Nitroglycerin Controlled-Release Capsules may cause dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Nitroglycerin Controlled-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with your doctor before you drink alcohol while you are taking Nitroglycerin Controlled-Release Capsules. Drinking alcohol may increase the risk of low blood pressure with Nitroglycerin Controlled-Release Capsules.
Nitroglycerin Controlled-Release Capsules may cause dizziness, lightheadedness, or fainting. Sit down while taking Nitroglycerin Controlled-Release Capsules to avoid falling caused by lightheadedness or dizziness.
Contact your doctor right away if you develop slow heartbeat or new or worsening chest pain after you take Nitroglycerin Controlled-Release Capsules.
Tell your doctor or dentist that you take Nitroglycerin Controlled-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
Nitroglycerin Controlled-Release Capsules may give you daily headaches. This should become less noticeable with time.
Other dosage forms of Nitroglycerin Controlled-Release Capsules (eg, sublingual, or under the tongue, tablets) may not work as well while you are taking Nitroglycerin Controlled-Release Capsules.
Nitroglycerin Controlled-Release Capsules takes about 1 to 2 hours to start working and should not be used for a sudden chest pain attack.
Lab tests, including heart function, blood pressure, and blood electrolyte levels, may be performed while you use Nitroglycerin Controlled-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Nitroglycerin Controlled-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
Nitroglycerin Controlled-Release Capsules are not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nitroglycerin Controlled-Release Capsules while you are pregnant. It is not known if Nitroglycerin Controlled-Release Capsules are found in breast milk. If you are or will be breast-feeding while you are using Nitroglycerin Controlled-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time without a break, Nitroglycerin Controlled-Release Capsules may not work as well. This is known as TOLERANCE. Increasing the dose is not effective in managing tolerance to Nitroglycerin Controlled-Release Capsules. Tolerance to other nitrates or nitrites may also occur. Be sure to have a “nitrate-free” period of time each day to help prevent this tolerance. Talk with your doctor if Nitroglycerin Controlled-Release Capsules stops working well. Do not take more than prescribed.

Some people who use Nitroglycerin Controlled-Release Capsules for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. If you use Nitroglycerin Controlled-Release Capsules without a break and then suddenly stop using it, you may get WITHDRAWAL symptoms. These may include chest pain, heart attack, or possibly sudden death. Be sure to have a “nitrate-free” period of time each day; this may help prevent dependence and withdrawal problems.

Possible side effects of Nitroglycerin Controlled-Release Capsules:

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

Dizziness, lightheadedness, or fainting when sitting up or standing; flushing of face and neck; headache; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dry mouth; fainting; flushing; heavy sweating; irregular heartbeat; new or worsening chest pain; pale skin; pounding in the chest; rapid heartbeat; severe dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; slow heartbeat; swelling of the hands, ankles, or feet; unusual weakness.

If OVERDOSE is suspected:

Proper storage of Nitroglycerin Controlled-Release Capsules:

Store Nitroglycerin Controlled-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nitroglycerin Controlled-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Nitroglycerin Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Nitroglycerin Controlled-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,N

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nitroglycerin (Oral route, Sublingual route)

30/06/10

nye-troe-GLIS-er-in

Commonly used brand name(s):

In the U.S.

Nitrocot
Nitrolingual
NitroMist
Nitroquick
Nitrostat
Nitrotab
Nitro-Time

In Canada

Gen-Nitro
Nitrolingual Pumpspray

Available Dosage Forms:

Spray
Tablet, Extended Release
Tablet
Capsule, Extended Release

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Uses For nitroglycerin

Nitroglycerin is used to prevent angina (chest pain) caused by coronary artery disease. nitroglycerin is also used to relieve an angina attack that is already occurring.

Nitroglycerin belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, or just before exercise or a stressful event, this helps prevent angina attacks from occurring.

nitroglycerin is available only with your doctor’s prescription.

Before Using nitroglycerin

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

Allergies

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

Pediatric

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

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

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

Sildenafil
Tadalafil
Vardenafil

Using nitroglycerin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alteplase, Recombinant

Using nitroglycerin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetylcysteine
Aspirin
Dihydroergotamine
Pancuronium

Interactions with Food/Tobacco/Alcohol

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

Proper Use of nitroglycerin

Take nitroglycerin exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Nitroglycerin is available as two types of products that are used for different reasons. The extended-release capsules are used every day on a specific schedule to prevent angina attacks. The oral spray and sublingual tablets work quickly to stop an angina attack that has already started or they can be used to prevent angina if you plan to exercise or expect a stressful event.

When you begin to feel an attack of angina starting (chest pains; tightness or squeezing in the chest), sit down. Then place a sublingual tablet in your mouth or under your tongue. If you use the oral spray, you should spray it on or under the tongue. You may become dizzy, lightheaded, or faint soon after using a tablet or spray, so it is safer to sit rather than stand while the medicine is working. If you become dizzy or faint while sitting, take several deep breaths and bend forward with your head between your knees. Remain calm and you should feel better in a few minutes.

Nitroglycerin sublingual tablets should not be chewed, crushed, or swallowed. They work much faster when absorbed through the lining of the mouth. Place the tablet under the tongue or between the cheek and gum, and let it dissolve. Do not eat, drink, smoke, or use chewing tobacco while a tablet is dissolving.

Nitroglycerin oral spray and sublingual tablets usually give relief in 1 to 5 minutes. However, if the pain is not relieved, you may use a second spray or tablet. If the pain continues for another 5 minutes, a third spray or tablet may be used. If you still have chest pain after a total of 3 sprays or 3 tablets in a 15-minute period, contact your doctor or go to a hospital emergency room right away.

Swallow the extended-release capsule whole. Do not split, crush, or chew it.

You should take the extended-release capsule first thing in the morning and follow the same schedule each day. nitroglycerin works best if you have a “drug-free” period of time every day when you do not take it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.

nitroglycerin comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

To use the oral spray:

Remove the plastic cap.
Do not shake the container.
If this is a new bottle or container, prime the pump before use by releasing a test spray. This must be done 5 or 10 times into the air away from your face and other people.
If this is an old bottle and you have not used it for more than 6 weeks, you must prime it again with 1 or 2 test sprays.
Hold the container upright with your forefinger on top of the grooved button. Open your mouth and bring the container as close to it as possible.
Press the button firmly with the forefinger to release the spray onto or under the tongue. Do not inhale or breathe in the spray.
Release the button and close your mouth, but do not swallow right away. Do not spit out the spray or rinse your mouth for at least 5 to 10 minutes.
If you need a second spray, use exactly the same steps you used for the first spray.
Replace the cover after using the medicine.
Do not use the spray near heat, an open flame, or while smoking.

Dosing

The dose of nitroglycerin will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of nitroglycerin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For angina prevention or treatment:
- For oral dosage form (extended-release capsules):
  - Adults—2.5 to 6.5 milligrams (mg) three to four times a day. Your doctor may increase your dose as needed.
  - Children—Use and dose must be determined by your doctor.
- For sublingual dosage form (spray):
  - Adults—One or two sprays on or under the tongue at the first sign of an angina attack. A spray may be repeated every 5 minutes as needed, for up to 15 minutes. Do not use the medicine more than 3 times in 15 minutes. To prevent angina from exercise or stress, use 1 or 2 sprays 5 to 10 minutes before the activity.
  - Children—Use and dose must be determined by your doctor.
- For sublingual dosage form (tablets):
  - Adults—One tablet placed under the tongue or between the cheek and gum at the first sign of an angina attack. One tablet may be used every 5 minutes as needed, for up to 15 minutes. Do not use the medicine more than 3 times in 15 minutes. To prevent angina from exercise or stress, use 1 tablet 5 to 10 minutes before the activity.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of nitroglycerin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Store the extended-release capsules in a closed container at room temperature, away from heat, moisture, and direct light.

Sublingual tablets should be kept in the original glass bottle. Screw the cap on tightly after each use and store the bottle at room temperature, away from heat, moisture, and direct light.

Store the oral spray at room temperature, away from heat and direct light. Do not freeze. Do not keep nitroglycerin inside a car where it could be exposed to extreme heat or cold. Do not forcefully open the container or throw it into a fire, even if it is empty.

Precautions While Using nitroglycerin

If you will be taking nitroglycerin for a long time, it is very important that your doctor check your progress at regular visits to make sure nitroglycerin is working properly. Blood tests may be needed to check for unwanted effects.

Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using nitroglycerin. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.

nitroglycerin may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking nitroglycerin, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

Do not stop using nitroglycerin without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Blurred vision or dryness of the mouth may occur while using nitroglycerin. Check with your doctor if this concerns you.

Serious skin reactions can occur with nitroglycerin. Check with your doctor right away if you have cracks in the skin; feeling of warmth; loss of heat from the body; rash; red, swollen skin; redness of the face, neck, arms and occasionally, upper chest; or scaly skin while you are using nitroglycerin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

nitroglycerin Side Effects

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

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

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
difficult or labored breathing
feeling faint, dizzy, or lightheadedness
feeling of warmth or heat
flushing or redness of the skin, especially on the face and neck
headache
rapid weight gain
shortness of breath
sweating
tightness in the chest
tingling of the hands or feet
unusual weight gain or loss
wheezing

Rare

Bluish-colored lips, fingernails, or palms
dark urine
fever
pale skin
rapid heart rate
sore throat
unusual bleeding or bruising
unusual tiredness or weakness

Incidence not known

Arm, back, or jaw pain
blurred vision
chest pain or discomfort
chest tightness or heaviness
confusion
cough
cracks in the skin
difficulty with swallowing
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
fainting
fast, irregular, pounding, or racing heartbeat or pulse
feeling of constant movement of self or surroundings
feeling of warmth
hives
increased sweating
itching
loss of heat from the body
nausea or vomiting
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rash
red, swollen skin
redness of the face, neck, arms, and occasionally, upper chest
scaly skin
sensation of spinning
skin rash
weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred or loss of vision
bulging soft spot on the head of an infant
change in consciousness
change in the ability to see colors, especially blue or yellow
cold, clammy skin
disturbed color perception
double vision
flushed skin
halos around lights
headache, severe and throbbing
increased sweating
loss of appetite
loss of consciousness
night blindness
overbright appearance of lights
paralysis
slow or irregular heartbeat
tunnel vision

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

Less common

Abdominal or stomach pain
body aches or pain
congestion
hoarseness
lack or loss of strength
runny nose
sneezing
stuffy nose
tender, swollen glands in the neck
voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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nitroglycerin (Intravenous route)

30/06/10

nye-troe-GLIS-er-in

Commonly used brand name(s):

In the U.S.

Nitro-Bid

Available Dosage Forms:

Solution
Kit
Injectable

Therapeutic Class: Coronary Vasodilator

Chemical Class: Nitrate

Uses For nitroglycerin

Nitroglycerin injection is used to treat hypertension (high blood pressure) during surgery or to control congestive heart failure in patients who have had a heart attack. It may also be used to produce hypotension (low blood pressure) during surgery. Nitroglycerin injection is sometimes used to treat angina (chest pain) in patients who have been treated with other medicines that did not work well.

Nitroglycerin injection belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load.

nitroglycerin is available only with your doctor’s prescription.

Before Using nitroglycerin

Allergies

Pediatric

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

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

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

Sildenafil
Tadalafil
Vardenafil

Alteplase, Recombinant
Heparin

Acetylcysteine
Aspirin
Dihydroergotamine
Pancuronium

Interactions with Food/Tobacco/Alcohol

Proper Use of nitroglycerin

A nurse or other trained health professional will give you nitroglycerin in a hospital. nitroglycerin is given through a needle placed in one of your veins.

Precautions While Using nitroglycerin

It is very important that your doctor check your progress closely while you are receiving nitroglycerin to make sure it is working properly.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

nitroglycerin may cause headaches. These headaches are a sign that the medicine is working. If you have severe pain, talk with your doctor.

nitroglycerin Side Effects

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

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

Rare

Bluish-colored lips, fingernails, or palms
dark urine
difficulty with breathing
dizziness or lightheadedness
fever
headache
pale skin
rapid heart rate
shortness of breath
sore throat
unusual bleeding or bruising
unusual tiredness or weakness

Incidence not known

Arm, back, or jaw pain
blurred vision
chest pain or discomfort
chest tightness or heaviness
confusion
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
fainting
fast or irregular heartbeat
sweating

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred or loss of vision
bulging soft spot on the head of an infant
change in consciousness
change in the ability to see colors, especially blue or yellow
cold, clammy skin
convulsions
disturbed color perception
double vision
feeling of constant movement of self or surroundings
flushed skin
halos around lights
headache, severe and throbbing
increased sweating
loss of appetite
loss of consciousness
nausea or vomiting
night blindness
overbright appearance of lights
paralysis
sensation of spinning
slow or irregular heartbeat
tunnel vision
wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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nitroglycerin (Transdermal route)

30/06/10

nye-troe-GLIS-er-in

Commonly used brand name(s):

In the U.S.

Minitran
Nitrek
Nitro-Dur

In Canada

Nitrodur 0.2
Nitro-Dur 0.2
Nitro-Dur 0.3
Nitrodur 0.4
Nitro-Dur 0.4
Nitrodur 0.6
Nitro-Dur 0.6
Nitro-Dur 0.8
Transderm-Nitro
Trinipatch 0.2
Trinipatch 0.4
Trinipatch 0.6

Available Dosage Forms:

Ointment
Patch, Extended Release

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Uses For nitroglycerin

Nitroglycerin transdermal is used to prevent angina (chest pain) caused by coronary artery disease. It does not work fast enough to relieve the pain of an angina attack that has already started.

Nitroglycerin transdermal belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, this helps prevent angina attacks from occurring.

nitroglycerin is available only with your doctor’s prescription.

Before Using nitroglycerin

Allergies

Pediatric

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

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

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

Sildenafil
Tadalafil
Vardenafil

Alteplase, Recombinant

Acetylcysteine
Aspirin
Dihydroergotamine
Pancuronium

Interactions with Food/Tobacco/Alcohol

Proper Use of nitroglycerin

Use nitroglycerin exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. It will only work if applied correctly.

This form of nitrate is used to reduce the number of angina attacks over a long time. It will not relieve an attack that has already started because it works too slowly. The ointment and patch forms release medicine gradually to provide an effect for 7 to 10 hours. Check with your doctor if you also need a fast-acting medicine to relieve the pain of an angina attack.

You should use nitroglycerin first thing in the morning and follow the same schedule each day. nitroglycerin works best if you have a “drug-free” period of time every day when you do not use it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.

nitroglycerin comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

For patients using the ointment:

Before applying a new dose of ointment, remove any ointment remaining on the skin from a previous dose. This will allow the fresh ointment to release the nitroglycerin properly.
nitroglycerin comes with papers to help measure the dose. Use them to measure the length of ointment squeezed from the tube and to apply the ointment to the skin. Do not rub or massage the ointment into the skin. Spread it in a thin, even layer, and cover an area of skin that is the same size each time it is applied.
Apply the ointment to skin with little or no hair that is free of scars, cuts, or irritation.
Apply each dose of ointment to a different area of skin to prevent irritation.
If your doctor has ordered an airtight covering or dressing (such as plastic kitchen wrap) be placed over nitroglycerin, make sure you know how to apply it. Airtight dressings will increase the amount of medicine absorbed through the skin and may cause more side effects. Use them only as directed and check with your doctor if you have any questions about this.

For patients using the patch system:

Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.
Do not try to trim or cut the adhesive patch to adjust the dosage. Check with your doctor if you think the medicine is not working as it should.
Apply the patch to a clean, dry skin area with little or no hair that is free of scars, cuts, or irritation.
Always remove a previous patch before applying a new one.
Apply a new patch if the first one becomes loose or falls off.
Apply each patch to a different area to prevent skin irritation.

Dosing

For angina prevention:
- For transdermal dosage form (ointment):
  - Adults—At first, 7.5 milligrams (mg), one-half inch of ointment, two times a day. Apply the first dose in the morning right after you wake up, and the second dose 6 hours later. Your doctor may increase your dose as needed.
  - Children—Use and dose must be determined by your doctor.
- For transdermal dosage form (skin patch):
  - Adults—Apply one patch once a day in the morning. Leave the patch in place for a total of 12 to 14 hours.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of nitroglycerin, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

After removing a used patch, fold it in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

Precautions While Using nitroglycerin

If you will be taking nitroglycerin for a long time, it is very important that your doctor check your progress at regular visits to make sure that nitroglycerin is working properly. Blood tests may be needed to check for unwanted effects.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

Do not stop using nitroglycerin without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Tell the doctor in charge that you are using nitroglycerin before having a magnetic resonance imaging (MRI) scan. Skin burns may occur at the site where the patch is worn during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.

nitroglycerin Side Effects

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

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

More common

Lightheadedness

Less common

Arm, back, or jaw pain
blurred vision
chest pain or discomfort
chest tightness or heaviness
confusion
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
fainting
fast or irregular heartbeat
nausea
shortness of breath
sweating
unusual tiredness or weakness

Rare

Bluish-colored lips, fingernails, or palms
dark urine
difficulty with breathing
fever
headache
pale skin
rapid heart rate
sore throat
unusual bleeding or bruising

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin
cough
difficulty with swallowing
hives
itching, scaling, severe redness, soreness, or swelling of the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
skin rash
wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred or loss of vision
bulging soft spot on the head of an infant
change in consciousness
change in the ability to see colors, especially blue or yellow
cold, clammy skin
disturbed color perception
double vision
feeling of constant movement of self or surroundings
halos around lights
headache, severe and throbbing
loss of consciousness
night blindness
overbright appearance of lights
paralysis
sensation of spinning
tunnel vision

Rare

Burning, itching, redness, skin rash, swelling, or soreness at the application site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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nitroglycerin

30/06/10

Generic Name: nitroglycerin (oral/sublingual) (NYE troe GLI ser in (OR al/sub LIN gwal))
Brand Names: Nitrolingual, Nitrolingual Duo Pack, Nitrostat

What is nitroglycerin?

Nitroglycerin is in a group of drugs called nitrates. Nitroglycerin dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump.

Nitroglycerin is used to treat or prevent attacks of chest pain (angina).

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

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

Do not use nitroglycerin if you are taking sildenafil (Viagra). Serious, life-threatening side effects can occur if you take nitroglycerin while you are using sildenafil.

Nitroglycerin can cause severe headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use nitroglycerin. Do not stop taking the medication. Ask your doctor before using any headache pain medication.

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

Do not use nitroglycerin if you are taking sildenafil (Viagra). Serious, life-threatening side effects can occur if you take nitroglycerin while you are using sildenafil.

Do not use this medication without the advice of a doctor if you have early signs of a heart attack (chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling). Seek emergency medical attention if you have symptoms of a heart attack.

You should not use this medication if you are allergic to nitroglycerin, isosorbide mononitrate (Imdur), or isosorbide dinitrate (BiDil, Isordil), or if you have:

severe anemia (a lack of red blood cells); or
a brain injury, hemorrhage, or tumor.

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

congestive heart failure;
a history of heart attack, stroke, or head injury;
low blood pressure;
glaucoma;
migraine headaches; or
liver disease.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before you take nitroglycerin, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether nitroglycerin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take nitroglycerin?

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

If possible, try to rest or stay seated when you use this medication. Nitroglycerin can cause dizziness or fainting.

If you use nitroglycerin sublingual spray to treat an angina attack: At the first sign of an attack, apply the spray directly on or under your tongue. Close your mouth after each spray. Do not inhale the spray. Do not shake the spray before or during use. You may use additional sprays every 5 minutes, but not more than 3 sprays in 15 minutes.

You may use nitroglycerin spray within 5 to 10 minutes before an activity you think might cause chest pain. Follow your doctor’s instructions.

The nitroglycerin sublingual tablet should be placed under your tongue and allowed to dissolve slowly. Do not chew or swallow it.

You may feel a slight burning or stinging in your mouth when you use this medication. However, this sensation is not a sign of how well the medication is working. Do not use more medication just because you do not feel a burning or stinging. Do not crush, chew, break, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Seek emergency medical attention if your chest pain gets worse or lasts more than 5 minutes, especially if you have trouble breathing or feel weak, dizzy, or nauseated, or lightheaded.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using nitroglycerin.

It is important to keep this medicine on hand at all times in case of an angina attack. Get your prescription refilled before you run out of medicine completely.

If you take nitroglycerin on a regular schedule to prevent angina, do not stop taking it suddenly or you could have a severe attack of angina. Store nitroglycerin tablets in the glass container at room temperature, away from moisture and heat. Keep the spray away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot.

What happens if I miss a dose?

Since nitroglycerin is often used only as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 2 hours away. 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 nitroglycerin can be fatal.

Overdose symptoms may include a severe throbbing headache, confusion, fever, fast or pounding heartbeats, dizziness, vision problems, nausea, vomiting, bloody diarrhea, trouble breathing, cold or clammy skin, feeling light-headed, fainting, and seizures.

What should I avoid while taking nitroglycerin?

Nitroglycerin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of nitroglycerin, such as dizziness, drowsiness, feeling light-headed, or fainting.

Nitroglycerin side effects

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

fast, slow, pounding, or uneven heart rate;
blurred vision or dry mouth;
nausea, vomiting, sweating, pale skin, feeling like you might pass out; or
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

mild burning or tingling with the tablet in your mouth;
warmth, redness, or tingly feeling under your skin; or
feeling weak or dizzy.

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.

Nitroglycerin Dosing Information

Usual Adult Dose for Angina Pectoris:

For relief of acute anginal attack:

Lingual spray: 1 to 2 sprays (0.4 to 0.8 mg) onto or under the tongue every 3 to 5 minutes as needed, up to 3 sprays in 15 minutes. If pain persists after the maximum number of doses, prompt medical attention is recommended.

Sublingual tablet: 0.3 to 0.6 mg dissolved under the tongue or in the buccal pouch every 5 minutes as needed, up to 3 doses in 15 minutes. If pain persists after the maximum number of doses, prompt medical attention is recommended.

IV continuous infusion (via non-PVC tubing): 5 mcg/min initially, increased by 5 mcg/min every 3 to 5 minutes as needed up to 20 mcg/min, then gradually by 10 and then 20 mcg/min if needed, up to a usual maximum of 200 and generally no more than 400 mcg/min. Starting dosages of 25 mcg/min or higher have been used with PVC administration sets.

Usual Adult Dose for Angina Pectoris Prophylaxis:

Lingual spray: 1 to 2 sprays (0.4 to 0.8 mg) onto or under the tongue 5 to 10 minutes prior to engaging in activities which might precipitate an acute attack

Sublingual tablet: 0.3 to 0.6 mg dissolved under the tongue or in the buccal pouch 5 to 10 minutes prior to engaging in activities which might precipitate an acute attack

Topical ointment: 1/2 inch initially, applied to a non-hairy area of the trunk every 6 to 8 hours during waking hours (2 times a day); titrate as needed and tolerated. If angina occurs while the ointment is in place, the dose should be increased; if angina occurs several hours after application, the dosing frequency should be increased. Usual range is 1/2 to 2 inches (7.5 to 30 mg) every 8 hours, typically applied to 36 square inches of truncal skin.

Transdermal patch: 0.1 to 0.4 mg/hr patch applied to a dry and hairless area of the upper arm or body for 12 to 14 hours per day; titrate as needed and tolerated up to 0.8 mg/hr. Application sites should be rotated to avoid skin irritation.

Transmucosal (buccal) tablet: 1 mg dissolved between the lip and gum above the upper incisors or between the cheek and gum every 3 to 5 hours during waking hours (approximately 3 times a day); titrate as needed and tolerated. If angina occurs while a tablet is in place, the dose should be increased to the next strength; if angina occurs after dissolution of tablet, the dosing frequency should be increased. Usual maintenance dosage is 2 mg three times a day. If an acute attack occurs while a tablet is in place, another tablet may be administered on the opposite side from the one already in place. Sublingual nitroglycerin is recommended if prompt relief is not attained.

Oral: 2.5 every 8 to 12 hours; titrate as needed and tolerated up to 9 mg every 8 to 12 hours

Because tolerance to nitroglycerin may develop if plasma levels are maintained continuously, a nitrate-free interval of 10 to 12 hours per day may be appropriate during chronic prophylaxis of angina pectoris. However, clinical studies suggest that such intermittent use may be associated with hemodynamic rebound during drug withdrawal and decreased exercise tolerance during the latter part of the nitrate-free interval. Although the clinical relevance of this observation is unknown, a potentially increased risk of anginal attack during the nitrate-free interval should be considered. Therefore, dosing regimens should be carefully individualized to each patient. Other antianginal drugs such as beta-blockers and calcium channel blockers may be prescribed to reduce the risk of aggravating myocardial ischemia during the drug-free intervals.

Usual Adult Dose for Congestive Heart Failure:

Topical ointment: 1/2 inch initially, applied to a non-hairy area of the trunk every 6 to 8 hours during waking hours (2 times a day); titrate as needed and tolerated. Usual range is 1/2 to 2 inches (7.5 to 30 mg) every 8 hours, typically applied to 36 square inches of truncal skin.

Oral: 2.5 every 8 to 12 hours; titrate as needed and tolerated up to 9 mg every 8 to 12 hours

Usual Adult Dose for Myocardial Infarction:

For the initial 24 to 48 hours after an acute myocardial infarction:

IV continuous infusion (via non-PVC tubing): 5 mcg/min initially, increased by 5 mcg/min every 3 to 5 minutes as needed up to 20 mcg/min, then gradually by 10 and then 20 mcg/min if needed up to a usual maximum of 200 and generally no more than 400 mcg/min. Starting dosages of 25 mcg/min or higher have been used with PVC administration sets.

Usual Adult Dose for Hypertension:

IV continuous infusion (via non-PVC tubing): 5 mcg/min initially, increased by 5 mcg/min every 3 to 5 minutes as needed up to 20 mcg/min, then gradually by 10 and then 20 mcg/min if needed up to a usual maximum of 100 mcg/min. Starting dosages of 25 mcg/min or higher have been used with PVC administration sets.

What other drugs will affect nitroglycerin?

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

alteplase (Activase);
aspirin or heparin;
bladder or urinary medications such as oxybutynin (Ditropan) or tolterodine (Detrol);
blood pressure medication;
bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
dihydroergotamine (D.H.E. 45, Migranal) or ergotamine (Ergomar, Cafergot, and others);
an erectile dysfunction medication such as tadalafil (Cialis) or vardenafil (Levitra);
an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), imipramine (Tofranil), and others;
a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), and others;
a calcium channel blocker such as diltiazem (Tiazac, Cardizem), nifedipine (Procardia), nimodipine (Nimotop), verapamil (Calan, Covera, Verelan), and others;
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, and others), or propantheline (Pro-Banthine);
any medication that causes dry mouth; or
medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), thioridazine (Mellaril), and others.

This list is not complete and there are many other drugs that can interact with nitroglycerin. 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 nitroglycerin.

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.

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Nitrofurantoin Capsules

30/06/10

Generic Name: nitrofurantoin monohydrate and nitrofurantoin
Dosage Form: capsule

Nitrofurantoin Capsules Description

Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin monohydrate/macrocrystals is a hard gelatincapsule containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals, USP and 75 mg of nitrofurantoin monohydrate, USP.

The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl] methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following:

The molecular formula is C8H6N4O5 and the molecular weight is 238.16.

The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl] methylene]amino]-2,4-imidazolidinedione monohydrate. The chemical structure is the following:

The molecular formula is C8H6N4O5 •H2O and the molecular weight is 256.17.

Inactive Ingredients: Each capsule contains carbomer 934P, compressible sugar, D&C yellow #10, FD&C yellow #6, gelatin, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, lecithin, magnesium stearate, povidone, pregelatinized starch,propylene glycol, shellac, simethicone and titanium dioxide.

This product comforms to USP dissolution test 3.

Nitrofurantoin Capsules – Clinical Pharmacology

Each nitrofurantoin monohydrate/macrocrystals capsule contains two forms of nitrofurantoin. Twenty-five percent is macrocrystalline nitrofurantoin, which has slower dissolution and absorption than nitrofurantoin monohydrate. The remaining 75% is nitrofurantoin monohydrate contained in a powder blend which, upon exposure to gastric and intestinal fluids, forms a gel matrix that releases nitrofurantoin over time. Based on urinary pharmacokinetic data, the extent and rate of urinary excretion of nitrofurantoin from the 100 mg nitrofurantoin monohydrate/macrocrystalscapsule are similar to those of the 50 mg or 100 mg nitrofurantoin macrocrystals capsule. Approximately 20 to 25% of a single dose of nitrofurantoin is recovered from the urine unchanged over 24 hours.

Plasma nitrofurantoin concentrations after a single oral dose of the 100 mg nitrofurantoin monohydrate/macrocrystals capsule are low, with peak levels usually less than 1 mcg/mL. Nitrofurantoin is highly soluble in urine, to which it may impart a brown color. When nitrofurantoin monohydrate/macrocrystals is administered with food, the bioavailability of nitrofurantoin is increased by approximately 40%.

Microbiology: Nitrofurantoin is bactericidal in urine at therapeutic doses. The mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials. Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates which inactivate or alter bacterial ribosomal proteins and other macromolecules. As a result of such inactivations, the vital biochemical processes of protein synthesis, aerobic energy metabolism, DNA synthesis, RNA synthesis, and cell wall synthesis are inhibited. The broad-based nature of this mode of action may explain the lack of acquired bacterial resistance to nitrofurantoin, as the necessary multiple and simultaneous mutations of the target macromolecules would likely be lethal to the bacteria. Development of resistance to nitrofurantoin has not been a significant problem since its introduction in 1953. Cross-resistance with antibiotics and sulfonamides has not been observed, and transferable resistance is, at most, a very rare phenomenon.

Nitrofurantoin, in the form of nitrofurantoin monohydrate/macrocrystals, has been shown to be active against most strains of the following bacteria both in vitro and in clinical infections: (See INDICATIONS AND USAGE).

Gram-Positive Aerobes

Staphylococcus saprophyticus

Gram-Negative Aerobes

Escherichia coli

Nitrofurantoin also demonstrates in vitro activity against the following microorganisms, although the clinical significance of these data with respect to treatment with nitrofu-rantoin monohydrate/macrocrystals is unknown:

Gram-Positive Aerobes

Coagulase-negative staphylococci

(including Staphylococcus epidermidis)

Enterococcus faecalis

Staphylococcus aureus

Streptococcus agalactiae

Group D streptococci

Viridans group streptococci

Gram-Negative Aerobes

Citrobacter amalonaticus

Citrobacter diversus

Citrobacter freundii

Klebsiella oxytoca

Klebsiella ozaenae

Nitrofurantoin is not active against most strains of Proteus species or Serratia species. It has no activity against Pseudomonas species.

Antagonism has been demonstrated in vitro between nitrofurantoin and quinolone antimicrobials. The clinical significance of this finding is unknown.

Susceptibility Tests:

Dilution techniques:

Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MIC’s). These MIC’s provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC’s should be determined using a standardized procedure. Standardized procedures are based on a dilution method1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of nitrofurantoin powder. The MIC values should be interpreted according to the following criteria:

MIC (mcg/mL)	Interpretation
≤ 32	Susceptible (S)
64	Intermediate (I)
≥ 128	Resistant (R)

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the urine reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the urine reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard nitrofurantoin powder should provide the following MIC values:

Microorganism	MIC (mcg/mL)
E. coli ATCC 25922	4 to 16
S. aureus ATCC 29213	8 to 32
E. faecalis ATCC 29212	4 to 16

Diffusion techniques:

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 300 mcg nitrofurantoin to test the susceptibility of microorganisms to nitrofurantoin.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 300 mcg nitrofurantoin disk should be interpreted according to the following criteria:

Zone Diameter (mm)	Interpretation
≥ 17	Susceptible (S)
15 to 16	Intermediate (I)
≤ 14	Resistant (R)

Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for nitrofurantoin.

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 300 mcg nitrofurantoin disk should provide the following zone diameters in these laboratory test quality control strains:

Microorganism	Zone Diameter (mm)
E. coli ATCC 25922	20 to 25
S. aureus ATCC 25923	18 to 22

Indications and Usage for Nitrofurantoin Capsules

Nitrofurantoin monohydrate/macrocrystals capsules, USP is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.

Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules, USP and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules, USP, are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals capsules, USP, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, USP, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.

Contraindications

Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug.

Beause of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent. For the same reason, the drug is contraindicated in neonates under one month of age.

Nitrofurantoin monohydrate/macrocrystals is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin.

Nitrofurantoin monohydrate/macrocrystals is also contraindicated in those patients with known hypersensitivity to nitrofurantoin.

Warnings

Pulmonary reactions:

ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS SHOULD BE DISCONTINUED AND APPROPRIATE MEASURES TAKEN. REPORTS HAVE CITED PULMONARY REACTIONS AS A CONTRIBUTING CAUSE OF DEATH.

CHRONIC PULMONARY REACTIONS (DIFFUSE INTERSTITIAL PNEUMONITIS OR PULMONARY FIBROSIS, OR BOTH) CAN DEVELOP INSIDIOUSLY. THESE REACTIONS OCCUR RARELY AND GENERALLY IN PATIENTS RECEIVING THERAPY FOR SIX MONTHS OR LONGER. CLOSE MONITORING OF THE PULMONARY CONDITION OF PATIENTS RECEIVING LONG-TERM THERAPY IS WARRANTED AND REQUIRES THAT THE BENEFITS OF THERAPY BE WEIGHED AGAINST POTENTIAL RISKS. (SEE RESPIRATORY REACTIONS).

Hepatotoxicity:

Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in biochemical tests that would indicate liver injury. If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures should be taken.

Neuropathy:

Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been reported. Conditions such as renal impairment (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating disease may enhance the occurrence of peripheral neuropathy. Patients receiving long-term therapy should be monitored periodically for changes in renal function.

Optic neuritis has been reported rarely in postmarketing experience with nitrofurantoin formulations.

Hemolytic anemia

Cases of hemolytic anemia of the primaquine-sensitivity type have been induced by nitrofurantoin. Hemolysis appears to be linked to a glucose-6-phosphate dehydrogenase deficiency in the red blood cells of the affected patients. This deficiency is found in 10 percent of Blacks and a small percentage of ethnic groups of Mediterranean and Near-Eastern origin. Hemolysis is an indication for discontinuing nitrofurantoin monohydrate/macrocrystals; hemolysis ceases when the drug is withdrawn.

Clostridium difficile-associated diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including nitrofurantoin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Precautions

Information for Patients:

Patients should be advised to take nitrofurantoin monohydrate/ macrocrystals with food (ideally breakfast and dinner) to further enhance tolerance and improve drug absorption. Patients should be instructed to complete the full course of therapy; however, they should be advised to contact their physician if any unusual symptoms occur during therapy.

Patients should be advised not to use antacid preparations containing magnesium trisilicate while taking nitrofurantoin monohydrate/ macrocrystals.

Patients should be counseled that antibacterial drugs including nitrofurantoin monohydrate/ macrocrystals capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When nitrofurantoin monohydrate/macrocrystals capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by nitrofurantoin monohydrate/macrocrystals capsules or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

General:

Prescribing nitrofurantoin monohydrate/macrocrystals capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Drug Interactions:

Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate.

Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.

Drug/Laboratory Test Interactions:

As a result of the presence of nitrofurantoin, a false-positive reaction for glucose in the urine may occur. This has been observed with Benedict’s and Fehling’s solutions but not with the glucose enzymatic test.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Nitrofurantoin was not carcinogenic when fed to female Holtzman rats for 44.5 weeks or to female Sprague-Dawley rats for 75 weeks. Two chronic rodent bioassays utilizing male and female Sprague-Dawley rats and two chronic bioassays in Swiss mice and in BDF1 mice revealed no evidence of carcinogenicity.

Nitrofurantoin presented evidence of carcinogenic activity in female B6C3F1 mice as shown by increased incidences of tubular adenomas, benign mixed tumors, and granulosa cell tumors of the ovary. In male F344/N rats, there were increased incidences of uncommon kidney tubular cell neoplasms, osteosarcomas of the bone, and neoplasms of the subcutaneous tissue. In one study involving subcutaneous administration of 75 mg/kg nitrofurantoin to pregnant female mice, lung papillary adenomas of unknown significance were observed in the F1 generation.

Nitrofurantoin has been shown to induce point mutations in certain strains of Salmonella typhimurium and forward mutations in L5178Y mouse lymphoma cells. Nitrofurantoin induced increased numbers of sister chromatid exchanges and chromosomal aberrations in Chinese hamster ovary cells but not in human cells in culture. Results of the sex-linked recessive lethal assay in Drosophila were negative after administration of nitrofurantoin by feeding or by injection. Nitrofurantoin did not induce heritable mutation in the rodent models examined.

The significance of the carcinogenicity and mutagenicity findings relative to the therapeutic use of nitrofurantoin in humans is unknown.

The administration of high doses of nitrofurantoin to rats causes temporary spermatogenic arrest; this is reversible on discontinuing the drug. Doses of 10 mg/kg/day or greater in healthy human males may, in certain unpredictable instances, produce a slight to moderate spermatogenic arrest with a decrease in sperm count.

Pregnancy

Teratogenic effects: Pregnancy Category B. Several reproduction studies have been performed in rabbits and rats at doses up to six times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to nitrofurantoin. In a single published study conducted in mice at 68 times the human dose (based on mg/kg administered to the dam), growth retardation and a low incidence of minor and common malformations were observed. However, at 25 times the human dose, fetal malformations were not observed; the relevance of these findings to humans is uncertain. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Non-teratogenic effects: Nitrofurantoin has been shown in one published transplacental carcinogenicity study to induce lung papillary adenomas in the F1 generation mice at doses 19 times the human dose on a mg/kg basis. The relationship of this finding to potential human carcinogenesis is presently unknown. Because of the uncertainty regarding the human implications of these animal data, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery:

See CONTRAINDICATIONS.

Nursing Mothers:

Nitrofurantoin has been detected in human breast milk in trace amounts. Because of the potential for serious adverse reactions from nitrofurantoin in nursing infants under one month of age, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (See CONTRAINDICATIONS).

Pediatric Use:

Nitrofurantoin monohydrate/macrocrystals is contraindicated in infants below the age of one month (See CONTRAINDICATIONS). Safety and effectiveness in pediatric patients below the age of twelve years have not been established.

Geriatric Use:

Clinical studies of nitrofurantoin monohydrate/macrocrystals capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Spontaneous reports suggest a higher proportion of pulmonary reactions, including fatalities, in elderly patients; these differences appear to be related to the higher proportion of elderly patients receiving long-term nitrofurantoin therapy. As in younger patients, chronic pulmonary reactions generally are observed in patients receiving therapy for six months or longer (See WARNINGS). Spontaneous reports also suggest an increased proportion of severe hepatic reactions, including fatalities, in elderly patients (See WARNINGS).

In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing nitrofurantoin monohydrate/macrocrystals. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications (See CONTRAINDICATIONS). Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.

Adverse Reactions

In clinical trials of nitrofurantoin monohydrate/macrocrystals, the most frequent clinical adverse events that were reported as possibly or probably drug-related were nausea (8%), headache (6%), and flatulence (1.5%). Additional clinical adverse events reported as possibly or probably drug-related occurred in less than 1% of patients studied and are listed below within each body system in order of decreasing frequency:

Gastrointestinal: Diarrhea, dyspepsia, abdominal pain, constipation, emesis

Neurologic: Dizziness, drowsiness, amblyopia

Respiratory: Acute pulmonary hypersensitivity reaction (See WARNINGS)

Allergic: Pruritus, urticaria

Dermatologic: Alopecia

Miscellaneous: Fever, chills, malaise

The following additional clinical adverse events have been reported with the use of nitrofurantoin:

Gastrointestinal: Sialadenitis, pancreatitis. There have been sporadic reports of pseudomembranous colitis with the use of nitrofurantoin. The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment. (See WARNINGS.)

Neurologic: Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been reported. Conditions such as renal impairment (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating diseases may increase the possibility of peripheral neuropathy (See WARNINGS).

Asthenia, vertigo, and nystagmus also have been reported with the use of nitrofurantoin.

Benign intracranial hypertension (pseudotumor cerebri), confusion, depression, optic neuritis, and psychotic reactions have been reported rarely. Bulging fontanels, as a sign of benign intracranial hypertension in infants, have been reported rarely.

Respiratory

CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR WITH THE USE OF NITROFURANTOIN.

CHRONIC PULMONARY REACTIONS GENERALLY OCCUR IN PATIENTS WHO HAVE RECEIVED CONTINUOUS TREATMENT FOR SIX MONTHS OR LONGER. MALAISE, DYSPNEA ON EXERTION, COUGH, AND ALTERED PULMONARY FUNCTION ARE COMMON MANIFESTATIONS WHICH CAN OCCUR INSIDIOUSLY. RADIOLOGIC AND HISTOLOGIC FINDINGS OF DIFFUSE INTERSTITIAL PNEUMONITIS OR FIBROSIS, OR BOTH, ARE ALSO COMMON MANIFESTATIONS OF THE CHRONIC PULMONARY REACTION. FEVER IS RARELY PROMINENT.

THE SEVERITY OF CHRONIC PULMONARY REACTIONS AND THEIR DEGREE OF RESOLUTION APPEAR TO BE RELATED TO THE DURATION OF THERAPY AFTER THE FIRST CLINICAL SIGNS APPEAR. PULMONARY FUNCTION MAY BE IMPAIRED PERMANENTLY, EVEN AFTER CESSATION OF THERAPY. THE RISK IS GREATER WHEN CHRONIC PULMONARY REACTIONS ARE NOT RECOGNIZED EARLY.

In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form. Upon cessation of therapy, recovery may require several months. If the symptoms are not recognized as being drug-related and nitrofurantoin therapy is not stopped, the symptoms may become more severe.

Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnea, pulmonary infiltration with consolidation or pleural effusion on x-ray, and eosinophilia. Acute reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Resolution often is dramatic (See WARNINGS).

Changes in EKG (e.g., non-specific ST/T wave changes, bundle branch block) have been reported in association with pulmonary reactions.

Cyanosis has been reported rarely.

Hepatic: Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely (See WARNINGS).

Allergic: Lupus-like syndrome associated with pulmonary reaction to nitrofurantoin has been reported. Also, angioedema; maculopapular, erythematous, or eczematous eruptions; anaphylaxis; arthralgia; myalgia; drug fever; and chills have been reported. Hypersensitivity reactions represent the most frequent spontaneously-reported adverse events in worldwide postmarketing experience with nitrofurantoin formulations.

Dermatologic: Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson syndrome) have been reported rarely.

Hematologic: Cyanosis secondary to methemoglobinemia has been reported rarely.

Miscellaneous: As with other antimicrobial agents, superinfections caused by resistant organisms, e.g., Pseudomonas species or Candida species, can occur.

In clinical trials of nitrofurantoin monohydrate/macrocrystals, the most frequent laboratory adverse events (1 to 5%), without regard to drug relationship, were as follows: eosinophilia, increased AST (SGOT), increased ALT (SGPT), decreased hemoglobin, increased serum phosphorus. The following laboratory adverse events also have been reported with the use of nitrofurantoin: glucose-6-phosphate dehydrogenase deficiency anemia (See WARNINGS), agranulocytosis, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia, megaloblastic anemia. In most cases, these hematologic abnormalities resolved following cessation of therapy. Aplastic anemia has been reported rarely.

Overdosage

Occasional incidents of acute overdosage of nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. Nitrofurantoin is dialyzable.

Nitrofurantoin Capsules Dosage and Administration

Nitrofurantoin monohydrate/macrocrystals capsules, USP should be taken with food.

Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for seven days.

How is Nitrofurantoin Capsules Supplied

Nitrofurantoin monohydrate/macrocrystals capsules, USP is available as 100 mg opaque black cap and yellow body, size”0” hard gelatin capsules printed with ‘RX 518’ in white ink on cap and in black ink on body containing off-white to light yellow powder and a yellow tablet debossed with ‘RX595’ on one side and plain on the other side.

NDC 63304-518-20 Bottles of 20

NDC 63304-518-05 Bottles of 500

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

Dispense in a tight, light resistant container.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

REFERENCES

National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – 5th Edition. Approved Standard NCCLS Document M7-A5.NCCLS: Wayne, PA; 2003
National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-8th Edition. Approved Standard NCCLS Document M2-A7.NCCLS: Wayne, PA; 2003.

Clinical Studies

Controlled clinical trials comparing nitrofurantoin monohydrate/macrocrystals100 mg p.o. q12h and nitrofurantoin macrocrystals 50 mg p.o. q6h in the treatment of acute uncomplicated urinary tract infections demonstrated approximately 75% microbiologic eradication of susceptible pathogens in each treatment group.

Manufactured for:

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257 USA

by: Ranbaxy Laboratories Ltd.

New Delhi – 110 019, India

April 2009

NITROFURANTOIN
nitrofurantoin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	63304-518
Route of Administration	ORAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
nitrofurantoin monohydrate (nitrofurantoin)	Active	75 MILLIGRAM In 1 CAPSULE
nitrofurantoin (nitrofurantoin)	Active	25 MILLIGRAM In 1 CAPSULE
carbomer 934P	Inactive
compressible sugar	Inactive
D&C yellow #10	Inactive
FD&C yellow #6	Inactive
gelatin	Inactive
iron oxides yellow, black, red	Inactive
lactose monohydrate	Inactive
magnesium stearate	Inactive
povidone	Inactive
pregelatinized starch	Inactive
titanium dioxide	Inactive
lecithin	Inactive
propylene glycol	Inactive
shellac	Inactive
simethicone	Inactive

Product Characteristics
Color	black (Opaque) , yellow (YELLOW)	Score	no score
Shape	CAPSULE (Capsule)	Size	22mm
Flavor		Imprint Code	RX;518
Contains
Coating	false	Symbol	false

Packaging
#	NDC	Package Description	Multilevel Packaging
1	63304-518-20	20 CAPSULE In 1 BOTTLE	None
2	63304-518-05	500 CAPSULE In 1 BOTTLE	None

Revised: 04/2009Ranbaxy Pharmaceuticals Inc.

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nitrofurazone (Topical route)

30/06/10

nye-troe-FURE-a-zone

Commonly used brand name(s):

In the U.S.

Furacin

Available Dosage Forms:

Ointment
Solution
Cream

Therapeutic Class: Antibacterial

Uses For nitrofurazone

Nitrofurazone is used to treat burns that have become infected. It is also used to treat skin infections due to skin grafts. It works by killing bacteria or preventing their growth.

Nitrofurazone may be applied directly to the skin or placed on a gauze pad that will cover the skin.

nitrofurazone is available only with your doctor’s prescription.

Before Using nitrofurazone

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

Allergies

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

Pediatric

Studies on nitrofurazone have been done only in adult patients, and there is no specific information comparing use of nitrofurazone in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of nitrofurazone in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Proper Use of nitrofurazone

Apply sufficient medication to affected area or place medication on gauze and cover the affected area.

Dosing

The dose of nitrofurazone will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of nitrofurazone. If your dose is different, do not change it unless your doctor tells you to do so.

For cream dosage form:
- Burns or skin infections:
  - Adults—Apply directly to the lesion, or place on gauze that will cover the lesion, once daily or every few days, depending on the usual dressing technique of the affected area.
  - Children—Use and dose must be determined by your doctor.
For soluble dressing dosage form:
- Burns or skin infections:
  - Adults—Apply directly to the lesion or place on gauze that will cover the lesion, depending on the usual dressing technique of the affected area.
  - Children—Use and dose must be determined by your doctor.
For topical solution dosage form:
- Burns:
  - Adults—Apply directly to the burn.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of nitrofurazone, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Keep away from alkaline materials, such as soap and ammonia.

Precautions While Using nitrofurazone

If your burn or skin infection does not improve, or if it becomes worse, check with your health care professional.

nitrofurazone Side Effects

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

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Itching
rash
swelling

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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nitroglycerin Side Effects

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