Archive for the ‘miscellaneous respiratory agents’ Category

Pulmozyme

Pulmozyme

Generic Name: dornase alfa (inhalation) (DOOR nase AL fa)

What is Pulmozyme?

Pulmozyme is a synthetic protein that breaks down excess DNA in the pulmonary secretions of people with cystic fibrosis.

Pulmozyme is used to improve lung function in people with cystic fibrosis by thinning pulmonary secretions and reducing the risk of respiratory tract infections.

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

Important information about Pulmozyme

Do not dilute or mix the Pulmozyme solution with any other drugs in the nebulizer. Mixing of Pulmozyme with other drugs could lead to changes in the actions of the medications.

Ampules of Pulmozyme do not contain a preservative. Once opened, the entire contents of the ampule must be used or discarded.

Pulmozyme must be stored in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius) and protected from strong light. Keep unused ampules in the protective foil pouch. Pulmozyme should be kept refrigerated during transport. Combined lengths of exposure of the medication to room temperature should not exceed 24 hours.

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

Do not use Pulmozyme if you have had an allergic reaction to it or to other Chinese Hamster Ovary cell products.

Before using Pulmozyme, tell your doctor if you have any other medical conditions or if you take other prescription or over-the-counter medicines. You may require a dosage adjustment or special monitoring during your treatment.

Pulmozyme is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Pulmozyme passes into breast milk. Do not use Pulmozyme without first talking to your doctor if you are breast-feeding a baby.

How should I use Pulmozyme?

Use Pulmozyme exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Pulmozyme is administered by inhalation using a recommended nebulizer. Your doctor or other healthcare provider will give you detailed instructions on the use and maintenance of the nebulizer.

Do not dilute or mix the Pulmozyme solution with any other drugs in the nebulizer. Mixing of Pulmozyme with other drugs could lead to changes in the actions of the medications.

If you are also taking other respiratory medications, use them in the order directed by your doctor (e.g., a bronchodilator, followed by chest physiotherapy, then Pulmozyme, etc.) Do not dilute or mix Pulmozyme with other agents in the nebulizer at the same time.

Ampules of Pulmozyme do not contain a preservative. It is intended for one-time use only. Once opened, the entire contents of the ampule must be used or discarded.

Do not use any Pulmozyme solution that is cloudy or discolored. Throw away any unused Pulmozyme on the expiration date stamped on the ampule.

Pulmozyme should be used on a regular basis to get the most benefit.

Pulmozyme must be stored in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius) and protected from strong light. Keep unused ampules in the protective foil pouch. Pulmozyme should be kept refrigerated during transport. Combined lengths of exposure of the medication to room temperature should not exceed 24 hours.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and use only the next regularly scheduled dose as directed. Do not use a double dose.

What happens if I overdose?

An overdose of Pulmozyme is unlikely to threaten life. If an overdose is suspected, contact your doctor, a hospital emergency room, or a poison control center.

Symptoms of a Pulmozyme overdose are not known.

What should I avoid while using Pulmozyme?

Do not dilute or mix the Pulmozyme solution with any other drugs in the nebulizer. Mixing of Pulmozyme with other drugs could lead to changes in the actions of the medications.

What are the possible side effects of Pulmozyme?

If you experience any of the following serious side effects while taking Pulmozyme, seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

increased difficulty breathing;

chest pain; or

fever.

Less serious side effects may be more likely to occur with the use of Pulmozyme. Talk to your doctor if you experience any of the following side effects:

voice alteration;

sore throat;

rash;

laryngitis;

eye redness, irritation, or inflammation; or

nasal stuffiness or discharge.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Pulmozyme?

There are no known interactions between Pulmozyme and other medicines. Talk to your doctor or pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with Pulmozyme.

Pulmozyme

Pulmozyme

Generic Name: dornase alfa (inhalation) (DOOR nase AL fa)

What is Pulmozyme?

Pulmozyme is a synthetic protein that breaks down excess DNA in the pulmonary secretions of people with cystic fibrosis.

Pulmozyme is used to improve lung function in people with cystic fibrosis by thinning pulmonary secretions and reducing the risk of respiratory tract infections.

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

Important information about Pulmozyme

Do not dilute or mix the Pulmozyme solution with any other drugs in the nebulizer. Mixing of Pulmozyme with other drugs could lead to changes in the actions of the medications.

Ampules of Pulmozyme do not contain a preservative. Once opened, the entire contents of the ampule must be used or discarded.

Pulmozyme must be stored in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius) and protected from strong light. Keep unused ampules in the protective foil pouch. Pulmozyme should be kept refrigerated during transport. Combined lengths of exposure of the medication to room temperature should not exceed 24 hours.

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

Do not use Pulmozyme if you have had an allergic reaction to it or to other Chinese Hamster Ovary cell products.

Before using Pulmozyme, tell your doctor if you have any other medical conditions or if you take other prescription or over-the-counter medicines. You may require a dosage adjustment or special monitoring during your treatment.

Pulmozyme is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Pulmozyme passes into breast milk. Do not use Pulmozyme without first talking to your doctor if you are breast-feeding a baby.

How should I use Pulmozyme?

Use Pulmozyme exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Pulmozyme is administered by inhalation using a recommended nebulizer. Your doctor or other healthcare provider will give you detailed instructions on the use and maintenance of the nebulizer.

Do not dilute or mix the Pulmozyme solution with any other drugs in the nebulizer. Mixing of Pulmozyme with other drugs could lead to changes in the actions of the medications.

If you are also taking other respiratory medications, use them in the order directed by your doctor (e.g., a bronchodilator, followed by chest physiotherapy, then Pulmozyme, etc.) Do not dilute or mix Pulmozyme with other agents in the nebulizer at the same time.

Ampules of Pulmozyme do not contain a preservative. It is intended for one-time use only. Once opened, the entire contents of the ampule must be used or discarded.

Do not use any Pulmozyme solution that is cloudy or discolored. Throw away any unused Pulmozyme on the expiration date stamped on the ampule.

Pulmozyme should be used on a regular basis to get the most benefit.

Pulmozyme must be stored in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius) and protected from strong light. Keep unused ampules in the protective foil pouch. Pulmozyme should be kept refrigerated during transport. Combined lengths of exposure of the medication to room temperature should not exceed 24 hours.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and use only the next regularly scheduled dose as directed. Do not use a double dose.

What happens if I overdose?

An overdose of Pulmozyme is unlikely to threaten life. If an overdose is suspected, contact your doctor, a hospital emergency room, or a poison control center.

Symptoms of a Pulmozyme overdose are not known.

What should I avoid while using Pulmozyme?

Do not dilute or mix the Pulmozyme solution with any other drugs in the nebulizer. Mixing of Pulmozyme with other drugs could lead to changes in the actions of the medications.

What are the possible side effects of Pulmozyme?

If you experience any of the following serious side effects while taking Pulmozyme, seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

increased difficulty breathing;

chest pain; or

fever.

Less serious side effects may be more likely to occur with the use of Pulmozyme. Talk to your doctor if you experience any of the following side effects:

voice alteration;

sore throat;

rash;

laryngitis;

eye redness, irritation, or inflammation; or

nasal stuffiness or discharge.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Pulmozyme?

There are no known interactions between Pulmozyme and other medicines. Talk to your doctor or pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with Pulmozyme.

Prolastin

Prolastin

Generic Name: alpha 1-proteinase inhibitor (AL fa 1-PRO tee nase in HIB i tor)

What is Prolastin (alpha 1-proteinase inhibitor)?

Alpha 1-proteinase inhibitor is a protein, also called alpha 1-antitrypsin. This protein occurs naturally in the body and is important for preventing the breakdown of tissues in the lungs.

In people who lack the alpha 1-antitrypsin protein, breakdown of lung tissues can lead to emphysema (damage to the air sacs in the lungs).

Alpha 1-proteinase inhibitor is used to treat alpha 1-antitrypsin deficiency in people who have symptoms of emphysema.

Alpha 1-antitrypsin deficiency is a genetic (inherited) disorder and alpha 1-proteinase inhibitor will not cure this condition.

Alpha 1-proteinase inhibitor may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Prolastin (alpha 1-proteinase inhibitor)?

You should not use this medication if you have ever had an allergic reaction to alpha 1-proteinase inhibitor, or if you have an IgA deficiency or antibody against IgA.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

You will most likely receive your first few doses of this medication in a hospital or clinic setting where your vital signs can be watched closely in case the medication causes serious side effects.

Alpha 1-proteinase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my health care provider before using Prolastin (alpha 1-proteinase inhibitor)?

You should not use this medication if you have ever had an allergic reaction to alpha 1-proteinase inhibitor, or if you have an IgA deficiency or antibody against IgA.

Before you receive alpha 1-proteinase inhibitor, tell your doctor about all of your medication conditions.

FDA pregnancy category C. Alpha 1-proteinase inhibitor may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alpha 1-proteinase inhibitor 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.

Alpha 1-proteinase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use Prolastin (alpha 1-proteinase inhibitor)?

Alpha 1-proteinase inhibitor is usually given once per week. Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Alpha 1-proteinase inhibitor is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

You will most likely receive your first few doses of this medication in a hospital or clinic setting where your vital signs can be watched closely in case the medication causes serious side effects.

You will need to mix alpha 1-proteinase inhibitor with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. After mixing alpha 1-proteinase inhibitor with a diluent, you must use the medicine within 3 hours. It is best not to mix your alpha 1-proteinase inhibitor dose until you are ready to give the injection. The mixture should look clear or slightly yellow-green and may have a few small particles in it.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. You may gently swirl the medication while mixing.

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

Store the Aralast brand of this medication in the refrigerator. Do not freeze. Store Prolastin or Zemaira at cool room temperature (no warmer than 77 degrees F), away from moisture and heat. Aralast may also be stored at room temperature but you must use it within 30 days after removing it from the refrigerator.

Do not use this medication after the expiration date on the medicine label has passed.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of alpha 1-proteinase inhibitor.

What happens if I overdose?

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

An overdose of alpha 1-proteinase inhibitor is not expected to produce life-threatening symptoms.

What should I avoid while taking Prolastin (alpha 1-proteinase inhibitor)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using alpha 1-proteinase inhibitor.

Prolastin (alpha 1-proteinase inhibitor) side effects

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

chest pain, severe headache, buzzing in your ears, uneven heartbeats;

fast heart rate;

problems with vision; or

fever, chills, runny nose, skin rash, and joint pain.

Less serious side effects may include:

drowsiness, dizziness, weakness;

cough, sore throat, stuffy nose;

pain or bleeding where the medication was injected;

warmth, redness, or tingly feeling under your skin;

nausea, diarrhea, stomach pain;

headache; or

mild itching.

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

What other drugs will affect Prolastin (alpha 1-proteinase inhibitor)?

There may be other drugs that can interact with alpha 1-proteinase inhibitor. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Prolastin

Prolastin

Generic Name: alpha 1-proteinase inhibitor (AL fa 1-PRO tee nase in HIB i tor)

What is Prolastin (alpha 1-proteinase inhibitor)?

Alpha 1-proteinase inhibitor is a protein, also called alpha 1-antitrypsin. This protein occurs naturally in the body and is important for preventing the breakdown of tissues in the lungs.

In people who lack the alpha 1-antitrypsin protein, breakdown of lung tissues can lead to emphysema (damage to the air sacs in the lungs).

Alpha 1-proteinase inhibitor is used to treat alpha 1-antitrypsin deficiency in people who have symptoms of emphysema.

Alpha 1-antitrypsin deficiency is a genetic (inherited) disorder and alpha 1-proteinase inhibitor will not cure this condition.

Alpha 1-proteinase inhibitor may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Prolastin (alpha 1-proteinase inhibitor)?

You should not use this medication if you have ever had an allergic reaction to alpha 1-proteinase inhibitor, or if you have an IgA deficiency or antibody against IgA.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

You will most likely receive your first few doses of this medication in a hospital or clinic setting where your vital signs can be watched closely in case the medication causes serious side effects.

Alpha 1-proteinase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my health care provider before using Prolastin (alpha 1-proteinase inhibitor)?

You should not use this medication if you have ever had an allergic reaction to alpha 1-proteinase inhibitor, or if you have an IgA deficiency or antibody against IgA.

Before you receive alpha 1-proteinase inhibitor, tell your doctor about all of your medication conditions.

FDA pregnancy category C. Alpha 1-proteinase inhibitor may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alpha 1-proteinase inhibitor 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.

Alpha 1-proteinase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use Prolastin (alpha 1-proteinase inhibitor)?

Alpha 1-proteinase inhibitor is usually given once per week. Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Alpha 1-proteinase inhibitor is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

You will most likely receive your first few doses of this medication in a hospital or clinic setting where your vital signs can be watched closely in case the medication causes serious side effects.

You will need to mix alpha 1-proteinase inhibitor with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. After mixing alpha 1-proteinase inhibitor with a diluent, you must use the medicine within 3 hours. It is best not to mix your alpha 1-proteinase inhibitor dose until you are ready to give the injection. The mixture should look clear or slightly yellow-green and may have a few small particles in it.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. You may gently swirl the medication while mixing.

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

Store the Aralast brand of this medication in the refrigerator. Do not freeze. Store Prolastin or Zemaira at cool room temperature (no warmer than 77 degrees F), away from moisture and heat. Aralast may also be stored at room temperature but you must use it within 30 days after removing it from the refrigerator.

Do not use this medication after the expiration date on the medicine label has passed.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of alpha 1-proteinase inhibitor.

What happens if I overdose?

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

An overdose of alpha 1-proteinase inhibitor is not expected to produce life-threatening symptoms.

What should I avoid while taking Prolastin (alpha 1-proteinase inhibitor)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using alpha 1-proteinase inhibitor.

Prolastin (alpha 1-proteinase inhibitor) side effects

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

chest pain, severe headache, buzzing in your ears, uneven heartbeats;

fast heart rate;

problems with vision; or

fever, chills, runny nose, skin rash, and joint pain.

Less serious side effects may include:

drowsiness, dizziness, weakness;

cough, sore throat, stuffy nose;

pain or bleeding where the medication was injected;

warmth, redness, or tingly feeling under your skin;

nausea, diarrhea, stomach pain;

headache; or

mild itching.

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

What other drugs will affect Prolastin (alpha 1-proteinase inhibitor)?

There may be other drugs that can interact with alpha 1-proteinase inhibitor. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

INOmax

INOmax

Generic Name: nitric oxide (inhalation gas) (NYE trik OX ide)

What is nitric oxide?

Nitric oxide is a gas that is inhaled. It works by relaxing smooth muscle to widen (dilate) blood vessels, especially in the lungs.

Nitric oxide is used together with a breathing machine (ventilator) to treat respiratory failure in premature babies.

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

What is the most important information I should know about nitric oxide?

Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting.

Nitric oxide is inhaled into the baby’s lungs through the mouth or nose. Your baby may also be using a breathing tube connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen).

Your baby will remain under constant supervision during treatment with nitric oxide.

What should I discuss with my health care provider before my child receives nitric oxide?

To best participate in the care of your baby while he or she is in the NICU, carefully follow all instructions provided by your baby’s caregivers.

How is nitric oxide given?

Nitric oxide is inhaled into the baby’s lungs through the mouth or nose. Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting.

Your baby may also be using a breathing tube connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen).

Nitric oxide is usually given for up to 14 days. You baby may need to be weaned off this medication slowly, using less and less before treatment is stopped completely.

Your baby’s breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during treatment with nitric oxide.

What happens if a dose is missed?

Since nitric oxide is given as needed by a healthcare professional, it is not likely that your baby will miss a dose.

What happens if an overdose is given?

Since nitric oxide is given in a controlled medical setting by a healthcare professional, an overdose is not likely to occur. However, an overdose of nitric oxide is not expected to produce life-threatening symptoms.

What should be avoided after receiving nitric oxide?

Follow your doctor’s instructions about any restrictions in feeding, medications, or activity after your baby has been treated with nitric oxide.

Nitric oxide side effects

Nitric oxide causes few side effects, but your baby may have noisy breathing, blood in the urine, or possibly a collapsed lung. There is also a possibility that the baby will have breathing difficulties after the nitric oxide treatment is stopped.

These problems may require further treatment by health care professionals. Your baby will remain under constant supervision during treatment with nitric oxide.

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

What other drugs will affect nitric oxide?

Your baby’s caregivers will manage and monitor all medications given to your baby during treatment in the NICU. A drug interaction between nitric oxide and other medications is not expected to occur.

Do not give any medications to your baby that have not been prescribed by the baby’s doctor. This includes vitamins, minerals, or herbal products.

INOmax

INOmax

Generic Name: nitric oxide (inhalation gas) (NYE trik OX ide)

What is nitric oxide?

Nitric oxide is a gas that is inhaled. It works by relaxing smooth muscle to widen (dilate) blood vessels, especially in the lungs.

Nitric oxide is used together with a breathing machine (ventilator) to treat respiratory failure in premature babies.

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

What is the most important information I should know about nitric oxide?

Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting.

Nitric oxide is inhaled into the baby’s lungs through the mouth or nose. Your baby may also be using a breathing tube connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen).

Your baby will remain under constant supervision during treatment with nitric oxide.

What should I discuss with my health care provider before my child receives nitric oxide?

To best participate in the care of your baby while he or she is in the NICU, carefully follow all instructions provided by your baby’s caregivers.

How is nitric oxide given?

Nitric oxide is inhaled into the baby’s lungs through the mouth or nose. Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting.

Your baby may also be using a breathing tube connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen).

Nitric oxide is usually given for up to 14 days. You baby may need to be weaned off this medication slowly, using less and less before treatment is stopped completely.

Your baby’s breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during treatment with nitric oxide.

What happens if a dose is missed?

Since nitric oxide is given as needed by a healthcare professional, it is not likely that your baby will miss a dose.

What happens if an overdose is given?

Since nitric oxide is given in a controlled medical setting by a healthcare professional, an overdose is not likely to occur. However, an overdose of nitric oxide is not expected to produce life-threatening symptoms.

What should be avoided after receiving nitric oxide?

Follow your doctor’s instructions about any restrictions in feeding, medications, or activity after your baby has been treated with nitric oxide.

Nitric oxide side effects

Nitric oxide causes few side effects, but your baby may have noisy breathing, blood in the urine, or possibly a collapsed lung. There is also a possibility that the baby will have breathing difficulties after the nitric oxide treatment is stopped.

These problems may require further treatment by health care professionals. Your baby will remain under constant supervision during treatment with nitric oxide.

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

What other drugs will affect nitric oxide?

Your baby’s caregivers will manage and monitor all medications given to your baby during treatment in the NICU. A drug interaction between nitric oxide and other medications is not expected to occur.

Do not give any medications to your baby that have not been prescribed by the baby’s doctor. This includes vitamins, minerals, or herbal products.

Hyper-Sal

Hyper-Sal

Generic Name: sodium chloride (inhalation) (SOE dee um KLOR ide)

What is Hyper-Sal (sodium chloride (inhalation))?

Sodium chloride is the chemical name for salt. Sodium chloride can reduce some types of bacteria in certain body secretions, such as saliva.

Sodium chloride inhalation is used to produce sputum (mucus, or phlegm) from the mouth in order to collect it for medical testing. This medication may also be used to dilute other medications inhaled through a nebulizer.

Sodium chloride inhalation may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Hyper-Sal (sodium chloride (inhalation))?

Before using sodium chloride inhalation, tell your doctor if you have asthma, congestive heart failure, heart disease, high blood pressure, epilepsy, kidney or liver disease, migraine headaches, any type of edema (swelling), if you have recently had surgery, or if you are on a low-salt diet.

Tell your doctor about all other medications you use, especially potassium supplements, diuretics, steroids, blood pressure medications, or medications that contain sodium (such as Alka-Seltzer or Zegrid).

Tell your caregivers at once if you have a serious side effect such as chest pain, trouble breathing, swelling in your hands or feet, feeling like you might pass out, tired feeling, muscle twitching, confusion, uneven heart rate, extreme thirst, increased or decreased urination, leg discomfort, muscle weakness or limp feeling.

What should I discuss with my health care provider before using Hyper-Sal (sodium chloride (inhalation))?

You should not use this medication if you have ever had an allergic reaction to sodium chloride inhalation.

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

asthma;

congestive heart failure;

heart disease or high blood pressure;

epilepsy;

kidney or liver disease;

migraine headaches;

any type of edema (swelling);

if you have recently had surgery; or

if you are on a low-salt diet.

How is sodium chloride inhalation given?

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

Sodium chloride inhalation is given using a nebulizer. You will inhale the medication through a face mask, mouth piece, or other device connected to the nebulizer.

Your doctor, nurse, or other healthcare provider can show you how to properly use the nebulizer.

Sodium chloride is a liquid that is placed into the medication chamber of the nebulizer. A mouthpiece or face mask is then attached to the drug chamber, along with an air compressor.

To prepare for inhaling sodium chloride through a nebulizer, you may be given another inhaled medication to prevent bronchospasm (muscle contractions within the airways of the lungs). Your doctor may also ask you to blow your nose, rinse your mouth with water, or wipe the inside of your mouth with a tissue. Follow your doctor’s instructions carefully for best results.

In most cases, you will use this medication while you are sitting upright in a comfortable position. Breathe slowly and evenly while you are using the mask, mouthpiece, or other breathing device. You may also be given a nose clip to wear that will close your nasal passages so that you inhale only through your mouth.

If you are using this medication as part of a sputum test, you will need to spit about every 5 minutes or as directed by your healthcare provider. Cough deeply from your chest to produce an optimal specimen for testing.

Continue breathing through the nebulizer for as long as directed by your doctor. Once you have completed the inhalation for the prescribed amount of time, throw away any liquid that is left in the medicine chamber. Do not save it for later use.

If you store sodium chloride at home, keep it at room temperature away from moisture and heat.

What happens if I miss a dose?

Since sodium chloride inhalation is sometimes 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. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Tell your caregivers at once if you think you have used too much of this medicine.

Overdose symptoms may include increased thirst, drowsiness, restless feeling, confusion, muscle pain or weakness, nausea, vomiting, increased urination, fast heart rate, fainting, and seizure (convulsions).

What should I avoid after receiving Hyper-Sal (sodium chloride (inhalation))?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity after using sodium chloride inhalation.

Hyper-Sal (sodium chloride (inhalation)) side effects

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

chest pain, trouble breathing;

feeling like you might pass out;

swelling in your hands or feet;

tired feeling, muscle twitching;

confusion, uneven heart rate, extreme thirst, increased or decreased urination, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include a salty taste or slight burning or irritation in your mouth.

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

What other drugs will affect Hyper-Sal (sodium chloride (inhalation))?

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

potassium supplements;

a diuretic (water pill);

a steroid such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others;

blood pressure medications; or

medications that contain sodium, such as Alka-Seltzer or Zegrid (omeprazole and sodium bicarbonate).

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

Hyper-Sal

Hyper-Sal

Generic Name: sodium chloride (inhalation) (SOE dee um KLOR ide)

What is Hyper-Sal (sodium chloride (inhalation))?

Sodium chloride is the chemical name for salt. Sodium chloride can reduce some types of bacteria in certain body secretions, such as saliva.

Sodium chloride inhalation is used to produce sputum (mucus, or phlegm) from the mouth in order to collect it for medical testing. This medication may also be used to dilute other medications inhaled through a nebulizer.

Sodium chloride inhalation may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Hyper-Sal (sodium chloride (inhalation))?

Before using sodium chloride inhalation, tell your doctor if you have asthma, congestive heart failure, heart disease, high blood pressure, epilepsy, kidney or liver disease, migraine headaches, any type of edema (swelling), if you have recently had surgery, or if you are on a low-salt diet.

Tell your doctor about all other medications you use, especially potassium supplements, diuretics, steroids, blood pressure medications, or medications that contain sodium (such as Alka-Seltzer or Zegrid).

Tell your caregivers at once if you have a serious side effect such as chest pain, trouble breathing, swelling in your hands or feet, feeling like you might pass out, tired feeling, muscle twitching, confusion, uneven heart rate, extreme thirst, increased or decreased urination, leg discomfort, muscle weakness or limp feeling.

What should I discuss with my health care provider before using Hyper-Sal (sodium chloride (inhalation))?

You should not use this medication if you have ever had an allergic reaction to sodium chloride inhalation.

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

asthma;

congestive heart failure;

heart disease or high blood pressure;

epilepsy;

kidney or liver disease;

migraine headaches;

any type of edema (swelling);

if you have recently had surgery; or

if you are on a low-salt diet.

How is sodium chloride inhalation given?

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

Sodium chloride inhalation is given using a nebulizer. You will inhale the medication through a face mask, mouth piece, or other device connected to the nebulizer.

Your doctor, nurse, or other healthcare provider can show you how to properly use the nebulizer.

Sodium chloride is a liquid that is placed into the medication chamber of the nebulizer. A mouthpiece or face mask is then attached to the drug chamber, along with an air compressor.

To prepare for inhaling sodium chloride through a nebulizer, you may be given another inhaled medication to prevent bronchospasm (muscle contractions within the airways of the lungs). Your doctor may also ask you to blow your nose, rinse your mouth with water, or wipe the inside of your mouth with a tissue. Follow your doctor’s instructions carefully for best results.

In most cases, you will use this medication while you are sitting upright in a comfortable position. Breathe slowly and evenly while you are using the mask, mouthpiece, or other breathing device. You may also be given a nose clip to wear that will close your nasal passages so that you inhale only through your mouth.

If you are using this medication as part of a sputum test, you will need to spit about every 5 minutes or as directed by your healthcare provider. Cough deeply from your chest to produce an optimal specimen for testing.

Continue breathing through the nebulizer for as long as directed by your doctor. Once you have completed the inhalation for the prescribed amount of time, throw away any liquid that is left in the medicine chamber. Do not save it for later use.

If you store sodium chloride at home, keep it at room temperature away from moisture and heat.

What happens if I miss a dose?

Since sodium chloride inhalation is sometimes 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. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Tell your caregivers at once if you think you have used too much of this medicine.

Overdose symptoms may include increased thirst, drowsiness, restless feeling, confusion, muscle pain or weakness, nausea, vomiting, increased urination, fast heart rate, fainting, and seizure (convulsions).

What should I avoid after receiving Hyper-Sal (sodium chloride (inhalation))?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity after using sodium chloride inhalation.

Hyper-Sal (sodium chloride (inhalation)) side effects

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

chest pain, trouble breathing;

feeling like you might pass out;

swelling in your hands or feet;

tired feeling, muscle twitching;

confusion, uneven heart rate, extreme thirst, increased or decreased urination, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include a salty taste or slight burning or irritation in your mouth.

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

What other drugs will affect Hyper-Sal (sodium chloride (inhalation))?

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

potassium supplements;

a diuretic (water pill);

a steroid such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others;

blood pressure medications; or

medications that contain sodium, such as Alka-Seltzer or Zegrid (omeprazole and sodium bicarbonate).

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

Broncho Saline

Broncho Saline

Generic Name: sodium chloride (inhalation) (SOE dee um KLOR ide)

What is Broncho Saline (sodium chloride (inhalation))?

Sodium chloride is the chemical name for salt. Sodium chloride can reduce some types of bacteria in certain body secretions, such as saliva.

Sodium chloride inhalation is used to produce sputum (mucus, or phlegm) from the mouth in order to collect it for medical testing. This medication may also be used to dilute other medications inhaled through a nebulizer.

Sodium chloride inhalation may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Broncho Saline (sodium chloride (inhalation))?

Before using sodium chloride inhalation, tell your doctor if you have asthma, congestive heart failure, heart disease, high blood pressure, epilepsy, kidney or liver disease, migraine headaches, any type of edema (swelling), if you have recently had surgery, or if you are on a low-salt diet.

Tell your doctor about all other medications you use, especially potassium supplements, diuretics, steroids, blood pressure medications, or medications that contain sodium (such as Alka-Seltzer or Zegrid).

Tell your caregivers at once if you have a serious side effect such as chest pain, trouble breathing, swelling in your hands or feet, feeling like you might pass out, tired feeling, muscle twitching, confusion, uneven heart rate, extreme thirst, increased or decreased urination, leg discomfort, muscle weakness or limp feeling.

What should I discuss with my health care provider before using Broncho Saline (sodium chloride (inhalation))?

You should not use this medication if you have ever had an allergic reaction to sodium chloride inhalation.

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

asthma;

congestive heart failure;

heart disease or high blood pressure;

epilepsy;

kidney or liver disease;

migraine headaches;

any type of edema (swelling);

if you have recently had surgery; or

if you are on a low-salt diet.

How is sodium chloride inhalation given?

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

Sodium chloride inhalation is given using a nebulizer. You will inhale the medication through a face mask, mouth piece, or other device connected to the nebulizer.

Your doctor, nurse, or other healthcare provider can show you how to properly use the nebulizer.

Sodium chloride is a liquid that is placed into the medication chamber of the nebulizer. A mouthpiece or face mask is then attached to the drug chamber, along with an air compressor.

To prepare for inhaling sodium chloride through a nebulizer, you may be given another inhaled medication to prevent bronchospasm (muscle contractions within the airways of the lungs). Your doctor may also ask you to blow your nose, rinse your mouth with water, or wipe the inside of your mouth with a tissue. Follow your doctor’s instructions carefully for best results.

In most cases, you will use this medication while you are sitting upright in a comfortable position. Breathe slowly and evenly while you are using the mask, mouthpiece, or other breathing device. You may also be given a nose clip to wear that will close your nasal passages so that you inhale only through your mouth.

If you are using this medication as part of a sputum test, you will need to spit about every 5 minutes or as directed by your healthcare provider. Cough deeply from your chest to produce an optimal specimen for testing.

Continue breathing through the nebulizer for as long as directed by your doctor. Once you have completed the inhalation for the prescribed amount of time, throw away any liquid that is left in the medicine chamber. Do not save it for later use.

If you store sodium chloride at home, keep it at room temperature away from moisture and heat.

What happens if I miss a dose?

Since sodium chloride inhalation is sometimes 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. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Tell your caregivers at once if you think you have used too much of this medicine.

Overdose symptoms may include increased thirst, drowsiness, restless feeling, confusion, muscle pain or weakness, nausea, vomiting, increased urination, fast heart rate, fainting, and seizure (convulsions).

What should I avoid after receiving Broncho Saline (sodium chloride (inhalation))?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity after using sodium chloride inhalation.

Broncho Saline (sodium chloride (inhalation)) side effects

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

chest pain, trouble breathing;

feeling like you might pass out;

swelling in your hands or feet;

tired feeling, muscle twitching;

confusion, uneven heart rate, extreme thirst, increased or decreased urination, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include a salty taste or slight burning or irritation in your mouth.

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

What other drugs will affect Broncho Saline (sodium chloride (inhalation))?

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

potassium supplements;

a diuretic (water pill);

a steroid such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others;

blood pressure medications; or

medications that contain sodium, such as Alka-Seltzer or Zegrid (omeprazole and sodium bicarbonate).

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

Broncho Saline

Broncho Saline

Generic Name: sodium chloride (inhalation) (SOE dee um KLOR ide)

What is Broncho Saline (sodium chloride (inhalation))?

Sodium chloride is the chemical name for salt. Sodium chloride can reduce some types of bacteria in certain body secretions, such as saliva.

Sodium chloride inhalation is used to produce sputum (mucus, or phlegm) from the mouth in order to collect it for medical testing. This medication may also be used to dilute other medications inhaled through a nebulizer.

Sodium chloride inhalation may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Broncho Saline (sodium chloride (inhalation))?

Before using sodium chloride inhalation, tell your doctor if you have asthma, congestive heart failure, heart disease, high blood pressure, epilepsy, kidney or liver disease, migraine headaches, any type of edema (swelling), if you have recently had surgery, or if you are on a low-salt diet.

Tell your doctor about all other medications you use, especially potassium supplements, diuretics, steroids, blood pressure medications, or medications that contain sodium (such as Alka-Seltzer or Zegrid).

Tell your caregivers at once if you have a serious side effect such as chest pain, trouble breathing, swelling in your hands or feet, feeling like you might pass out, tired feeling, muscle twitching, confusion, uneven heart rate, extreme thirst, increased or decreased urination, leg discomfort, muscle weakness or limp feeling.

What should I discuss with my health care provider before using Broncho Saline (sodium chloride (inhalation))?

You should not use this medication if you have ever had an allergic reaction to sodium chloride inhalation.

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

asthma;

congestive heart failure;

heart disease or high blood pressure;

epilepsy;

kidney or liver disease;

migraine headaches;

any type of edema (swelling);

if you have recently had surgery; or

if you are on a low-salt diet.

How is sodium chloride inhalation given?

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

Sodium chloride inhalation is given using a nebulizer. You will inhale the medication through a face mask, mouth piece, or other device connected to the nebulizer.

Your doctor, nurse, or other healthcare provider can show you how to properly use the nebulizer.

Sodium chloride is a liquid that is placed into the medication chamber of the nebulizer. A mouthpiece or face mask is then attached to the drug chamber, along with an air compressor.

To prepare for inhaling sodium chloride through a nebulizer, you may be given another inhaled medication to prevent bronchospasm (muscle contractions within the airways of the lungs). Your doctor may also ask you to blow your nose, rinse your mouth with water, or wipe the inside of your mouth with a tissue. Follow your doctor’s instructions carefully for best results.

In most cases, you will use this medication while you are sitting upright in a comfortable position. Breathe slowly and evenly while you are using the mask, mouthpiece, or other breathing device. You may also be given a nose clip to wear that will close your nasal passages so that you inhale only through your mouth.

If you are using this medication as part of a sputum test, you will need to spit about every 5 minutes or as directed by your healthcare provider. Cough deeply from your chest to produce an optimal specimen for testing.

Continue breathing through the nebulizer for as long as directed by your doctor. Once you have completed the inhalation for the prescribed amount of time, throw away any liquid that is left in the medicine chamber. Do not save it for later use.

If you store sodium chloride at home, keep it at room temperature away from moisture and heat.

What happens if I miss a dose?

Since sodium chloride inhalation is sometimes 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. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Tell your caregivers at once if you think you have used too much of this medicine.

Overdose symptoms may include increased thirst, drowsiness, restless feeling, confusion, muscle pain or weakness, nausea, vomiting, increased urination, fast heart rate, fainting, and seizure (convulsions).

What should I avoid after receiving Broncho Saline (sodium chloride (inhalation))?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity after using sodium chloride inhalation.

Broncho Saline (sodium chloride (inhalation)) side effects

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

chest pain, trouble breathing;

feeling like you might pass out;

swelling in your hands or feet;

tired feeling, muscle twitching;

confusion, uneven heart rate, extreme thirst, increased or decreased urination, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include a salty taste or slight burning or irritation in your mouth.

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

What other drugs will affect Broncho Saline (sodium chloride (inhalation))?

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

potassium supplements;

a diuretic (water pill);

a steroid such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others;

blood pressure medications; or

medications that contain sodium, such as Alka-Seltzer or Zegrid (omeprazole and sodium bicarbonate).

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

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