Tyzine

30/06/10

Generic Name: tetrahydrozoline hydrochloride
Dosage Form: Nasal Solution

Rx Only

Tyzine Description

Tyzine® Nasal Solution contains tetrahydrozoline hydrochloride, 2-(1,2,3,4-Tetrahydro-1, naphthyl)-2-imidazoline monohydrochloride, as a nasal decongestant. The chemical structure is:

Nasal Solution is available for topical nasal application as 0.1% nasal solution and as 0.05% pediatric nasal drops. The nasal solution is a solution of tetrahydrozoline hydrochloride in water, with sodium chloride, sodium citrate, edetate disodium, and benzalkonium chloride, with hydrochloric acid to adjust to the pH.

Tyzine – Clinical Pharmacology

Tyzine® Nasal Solution (tetrahydrozoline hydrochloride), a sympathomimetic amine, possesses vasoconstrictor and decongestant actions when applied to nasal mucosa, resulting in vasoconstriction of the smaller arterioles of the nasal passages. Information on the absorption, distribution and elimination of the drug is not available.

Indications and Usage for Tyzine

Tyzine® Nasal Solution is indicated for decongestion of nasal and nasopharyngeal mucosa.

Contraindications

Tyzine® Nasal Solution is contraindicated for patients who have shown previous hypersensitivity to its components. The 0.1% solution is contraindicated in children under six years of age. Tyzine® Nasal Solution is not to be used for infants under two years of age. Tyzine® Pediatric Nasal Drops (0.05%) should be used for children between the ages of 2 and 6 years (See “Dosage and Administration“). Tyzine® Nasal Solution should not be used by patients under treatment with Monoamine Oxidase (MAO) Inhibitors.





Warnings

Overdose in children may produce profound sedation. This may be accompanied by profuse sweating, hypotension or even shock (See “Overdosage“).

General

Avoid doses greater or more frequent than those recommended below. Excessive dosage in children may, on rare occasions, cause severe drowsiness. Profuse sweating may accompany this effect. Overdosage may also cause marked hypotension or even shock. Use cautiously in patients with cardiovascular disease (e.g., coronary artery disease, hypertension), and metabolic-endocrine diseases (e.g., hyperthyroidism, diabetes).

Information for Patients

Patients should be advised to follow the prescribed dosage regimen. The spray should be administered with the head held upright. To spray, squeeze bottle quickly and firmly and sniff briskly. Instillation of the nose drops can be most conveniently accomplished with the patient in the lateral head-low position.

Drug Interactions

DRUG EFFECT
Monoamine Oxidase
(MAO) Inhibitors
Hypertension

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Tyzine®. It is also not known whether Tyzine® Nasal Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tyzine® Nasal Solution should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Tyzine® Nasal Solution is administered to a nursing woman.

Adverse Reactions

Local application of Tyzine® Nasal Solution can be associated with burning, stinging, sneezing or dryness of the mucosa. Occasionally, systemic sympathomimetic effects can occur, including headaches, drowsiness, weakness, tremors, light-headedness, insomnia, and palpitations. Rebound congestion can also occur, and is characterized by chronic swelling of the nasal mucosa resulting in chronic redness, swelling and rhinitis. If adverse reactions occur, discontinue use.

Overdosage

The administration or ingestion of overdoses of Tyzine® (tetrahydrozoline hydrochloride) Nasal Solution may result in oversedation in young children. Overdoses have caused hypertension, bradycardia, drowsiness and rebound hypotension in adults; a shock-like syndrome with hypotension and bradycardia may also occur. In either case, the treatment of overdosage is usually that of watchful expectancy and general supportive measures. The patient should be kept warm, fluid balance should be maintained orally, if possible, and parenterally, if necessary.

If the respiratory rate drops to 10 or below, the patient should be given oxygen, and respiration assisted. Blood pressure should be watched carefully to prevent a hypotensive crisis.

There is no known antidote for Tyzine® Nasal Solution. The use of stimulants is contraindicated. To date, we have had no report of fatalities resulting from overdosages of Tyzine® Nasal Solution and while the symptoms resulting from Tyzine® Nasal Solution overdosage may be alarming, they are self-limiting and the patient recovers with no sequelae.

Tyzine Dosage and Administration

Adults and Children 6 Years and Over

Tyzine® 0.1% Nasal Solution

It is recommended that 2 to 4 drops of Tyzine® 0.1% Nasal Solution be instilled in each nostril as needed, never more often than every three hours. Less frequent administration is usually sufficient since relief is maintained for four hours or longer in most cases, and often for as long as eight hours. Bedtime instillation usually assures sleep undisturbed by the need for remedication before morning, or by insomnia from central stimulation.

Tyzine® 0.1% Nasal Spray

It is recommended to squeeze quickly and firmly three or four times Tyzine® 0.1% Nasal Spray in each nostril as needed, never more often than every three hours. Less frequent administration is usually sufficient since relief is maintained for four hours or longer in most cases, and often for as long as eight hours. Bedtime instillation usually assures sleep undisturbed by the need for remedication before morning, or by insomnia from central stimulation.

Children 2 to 6 Years of Age

Tyzine® 0.05 % Pediatric Nasal Drops

Note: Do not use Tyzine® 0.1% Nasal Solution or Tyzine® 0.1% Nasal Spray

It is recommended that 2 to 3 drops of Tyzine® 0.05% Pediatric Nasal Drops be instilled in each nostril as needed, and never more often than every three hours. Relief usually lasts for several hours, so that instillation is usually needed only every four to six hours. Instillation of nose drops can be most conveniently accomplished with the patient in the lateral head-low position.

How is Tyzine Supplied

Tyzine® Nasal Solution (0.1%) is available in:

30 mL bottles – NDC 0482-4760-30
15 mL Nasal Spray Bottles- NDC 0482-4760-15

Tyzine® Pediatric Nasal Drops (0.05%) is available in:

15 mL bottles – NDC 0482-4770-15

Recommended Storage

Store below 86°F (30°C).

Rx Only

Mfd. for

By Denison Pharmaceuticals, Inc.
Pawtucket, Rhode Island 02862

©Copyright 2000 Kenwood Therapeutics

Rev 4/99

IL062-R2

Tyzine PEDIATRIC 
tetrahydrozoline hydrochloride  solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0482-4770
Route of Administration NASAL DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
tetrahydrozoline hydrochloride (tetrahydrozoline) Active 0.5 MILLIGRAM  In 1 MILLILITER
sodium chloride Inactive  
sodium citrate Inactive  
disodium edetate Inactive  
benzalkonium chloride Inactive  
water Inactive  
hydrochloric acid Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0482-4770-15 15 mL (MILLILITER) In 1 BOTTLE, DROPPER None

Tyzine 
tetrahydrozoline hydrochloride  solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0482-4760
Route of Administration NASAL DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
tetrahydrozoline hydrochloride (tetrahydrozoline) Active 1 MILLIGRAM  In 1 MILLILITER
sodium chloride Inactive  
sodium citrate Inactive  
disodium edetate Inactive  
benzalkonium chloride Inactive  
water Inactive  
hydrochloric acid Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0482-4760-30 30 mL (MILLILITER) In 1 BOTTLE, DROPPER None
2 0482-4760-15 15 mL (MILLILITER) In 1 BOTTLE, SPRAY None

Revised: 02/2007BRADLEY PHARMACEUTICALS, INC.

 

Tyzine Nasal

30/06/10

Generic Name: tetrahydrozoline nasal (TE tra hye DROZ oh leen)
Brand Names: Tyzine Nasal

What is Tyzine Nasal (tetrahydrozoline nasal)?

Tetrahydrozoline is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Tetrahydrozoline nasal is used to treat nasal and sinus congestion.

Tetrahydrozoline nasal may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Tyzine Nasal (tetrahydrozoline nasal)?

Do not use tetrahydrozoline nasal if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before using tetrahydrozoline nasal, tell your doctor if you are allergic to any drugs, or if you have heart disease, coronary artery disease, high blood pressure, diabetes, or a thyroid disorder.

The adult dose of this medication (0.1% nasal spray) should not be used in a child younger than 6 years old. The child’s dose (0.05% pediatric drops) should not be used in a child younger than 2 years old.

What should I discuss with my health care provider before taking Tyzine Nasal (tetrahydrozoline nasal)?

Do not use this medication if you are allergic to tetrahydrozoline. Do not use tetrahydrozoline nasal if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before using tetrahydrozoline nasal, tell your doctor if you are allergic to any drugs, or if you have:

  • heart disease or coronary artery disease;

  • high blood pressure;

  • diabetes; or

  • a thyroid disorder.

FDA pregnancy category C. This medication 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 tetrahydrozoline nasal passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child without a doctor’s advice.


How should I take Tyzine Nasal (tetrahydrozoline nasal)?

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

The adult dose of this medication (0.1% nasal spray) should not be used in a child younger than 6 years old. The child’s dose (0.05% pediatric drops) should not be used in a child younger than 2 years old.

Use the nasal spray while standing or sitting, with your head upright. Tilt your head forward slightly, keep the bottle upright, and carefully insert the nasal applicator into your nostril. Squeeze the bottle quickly and sniff deeply at the same time.

If a second spray is required in that nostril, repeat the above steps.

To use the nasal drops, it is best to be lying down.

Store tetrahydrozoline nasal at room temperature away from moisture and heat.

What happens if I miss a dose?

Since tetrahydrozoline is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. 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?

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

Overdose symptoms may include extreme drowsiness, blurred vision, severe sweating, slow heart rate, trouble breathing, and feeling light-headed or fainting.

What should I avoid while taking Tyzine Nasal (tetrahydrozoline nasal)?

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


Tyzine Nasal (tetrahydrozoline nasal) side effects

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

  • severe burning, stinging, redness, or swelling of your nose;

  • fast or pounding heartbeats; or

  • tremors, uncontrolled shaking.

Less serious side effects may include:

  • runny or stuffy nose;

  • sneezing;

  • headache;

  • drowsiness;

  • sleep problems (insomnia); or

  • headache.

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 Tyzine Nasal (tetrahydrozoline nasal)?

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

Where can I get more information?

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:42:54 PM.

 

Tyzine Solution

30/06/10

Generic Name: Tetrahydrozoline (teh-trah-high-DRAHZ-ah-leen)
Brand Name: Tyzine

Tyzine Solution is used for:

Treating nasal congestion due to colds, hay fever, allergies, or sinusitis. It may also be used to treat other conditions as determined by your doctor.

Tyzine Solution is a decongestant. It works by shrinking swollen and congested nasal tissues by constricting blood vessels. This improves drainage of mucus and breathing through the nose.

Do NOT use Tyzine Solution if:

  • you are allergic to any ingredient in Tyzine Solution
  • you are currently taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Tyzine Solution:

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

  • if you are pregnant, plan to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have high blood pressure, heart disease, an overactive thyroid, or diabetes

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

  • Tricyclic antidepressants (eg, amitriptyline) because the effectiveness of Tyzine Solution may be decreased
  • Furazolidone and MAO inhibitors (eg, phenelzine) because side effects such as headache, high blood pressure, and elevated body temperature may occur
  • Bromocriptine or catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone, St. John’s wort) because the actions and side effects of these medicines may be increased

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

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

  • Gently blow your nose before using Tyzine Solution.
  • To use nose drops: Lie down and tilt your head back. Breathe through your mouth. Insert the dropper tip in the nose no more than 13 inch. Try not to touch the dropper tip to the inside of your nose. Place the correct number of drops in your nose. Continue to lie down with your head tilted back for 2 minutes.
  • To use nose spray: Sit down and tilt your head back slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breathe gently through the open nostril and squeeze the spray container. If you are using more than 1 spray, wait for 1 to 2 minutes between sprays. After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.
  • If you miss a dose of Tyzine Solution and you are using it regularly, use it as soon as possible. If it is much more than 1 hour since your missed 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 Tyzine Solution.

Important safety information:

  • Tyzine Solution may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tyzine Solution. Using Tyzine Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Tyzine Solution is for nasal use only. Avoid contact with the eyes and mouth. Illness may occur if Tyzine Solution is taken by mouth.
  • Use Tyzine Solution at bedtime to avoid sleep interruption and sleeplessness.
  • Diabetes patients – Tyzine Solution may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
  • Tyzine Solution is not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Tyzine Solution during pregnancy. It is unknown if Tyzine Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Tyzine Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Tyzine Solution:

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; dry mouth, nose, or throat; increase in nasal discharge; sneezing; stinging.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive sweating; pale skin color; pounding in the chest; severe drowsiness.

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 changes in heartbeat; drowsiness; fainting; pale skin color.

Proper storage of Tyzine Solution:

Store Tyzine Solution below 86 degrees F (30 degrees C) away from heat, moisture, and light. Do not store in the bathroom. Keep Tyzine Solution out of the reach of children and away from pets.

General information:

  • If you have any questions about Tyzine Solution, please talk with your doctor, pharmacist, or other health care provider.
  • Tyzine Solution 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 Tyzine Solution. 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
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Generic Name: treprostinil inhalation (tre PROS ti nil)
Brand Names: Tyvaso, Tyvaso Refill Kit, Tyvaso Starter Kit

What is Tyvaso Starter Kit (treprostinil inhalation)?

Treprostinil works by dilating (widening) blood vessels in your lungs and by keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots. These effects lower blood pressure in the pulmonary artery that leads from your heart to your lungs.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

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


What is the most important information I should know about Tyvaso Starter Kit (treprostinil inhalation)?

Before using this medication, tell your doctor if you have a breathing disorder such as asthma or COPD (chronic obstructive pulmonary disease), an infection in your lungs (including pneumonia), low blood pressure, liver or kidney disease, or a bleeding or blood clotting disorder.

Treprostinil inhalation should be used only with a Tyvaso inhalation system. The inhalation system comes with patient instructions for safe and effective use. Do not use the medication at home if you do not fully understand how to use the inhalation system and properly clean it daily. Ask your doctor or pharmacist if you have any questions.

The effects of treprostinil inhalation will lessen over time between doses. Talk with your doctor if you need to time your dosing around any planned activities.

It is important to use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup inhalation system available so as not to interrupt your treatment if one system stops working.

Call your doctor if your symptoms do not improve or if they get worse.

What should I discuss with my healthcare provider before using Tyvaso Starter Kit (treprostinil inhalation)?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication:

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

  • an infection in your lungs, including pneumonia;

  • low blood pressure;

  • liver disease;
  • kidney disease; or
  • a bleeding or blood clotting disorder.

FDA pregnancy category B. It is not known whether this medication is harmful to an unborn baby. Use an effective form of birth control while you are using treprostinil inhalation. Tell your doctor if you become pregnant during treatment. It is not known whether treprostinil 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 is treprostinil inhalation given?

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

Treprostinil inhalation should be used only with a Tyvaso inhalation system. The inhalation system comes with patient instructions for safe and effective use. Do not use the medication at home if you do not fully understand how to use the inhalation system and properly clean it daily. Ask your doctor or pharmacist if you have any questions.

The inhalation form of treprostinil is usually given 4 times per day at evenly spaced intervals during waking hours. Each time you use the medication, you will inhale up to 9 breaths of the medication. Follow your doctor’s instructions.

Your doctor may occasionally change your dose to make sure you get the best results from this medication. Most people start treatment with 1 to 3 breaths per treatment session, slowly increasing the number to 9 breaths per session.

Do not use more than 9 breaths per treatment session. Wash your hands before preparing your treprostinil doses in the inhalation system.

One ampule of treprostinil inhalation contains enough medicine for all 4 of a day’s doses.

Before your first dose of each day, twist off the top of one ampule and squeeze out the entire contents into the medicine cup of the inhalation system. At the end of the day after the last dose has been given, empty and rinse out the medicine cup, even if there is still unused treprostinil left in it.

To keep the medicine in the cup from spilling, store the inhalation system upright and tightly capped with the plugs when not in use.

The effects of treprostinil inhalation will lessen over time between doses. Talk with your doctor if you need to time your dosing around any planned activities.

Call your doctor if your symptoms do not improve or if they get worse.

It is important to use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup inhalation system available so as not to interrupt your treatment if one system stops working.

Store treprostinil ampules in their foil pouch at room temperature away from moisture, heat, and light. Once you have opened a foil pouch, the ampules in it should be used within 7 days.

Any treprostinil placed into the medicine cup of the inhalation system must be used within 24 hours. Throw away any unused medicine at the end of the day after your last dose.

What happens if I miss a dose?

Call your doctor for instructions.


What happens if I overdose?

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

Overdose symptoms may include flushing (warmth, redness or tingling), headache, nausea, vomiting, diarrhea, feeling light-headed, or fainting.

What should I avoid while using Tyvaso Starter Kit (treprostinil inhalation)?

Avoid getting treprostinil in your eyes or on your skin. If this does happen, rinse with water. Do not swallow treprostinil inhalation. The medication should be inhaled using only the Tyvaso inhalation system. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Tyvaso Starter Kit (treprostinil 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. Call your doctor at once if you have any of these serious side effects:

  • new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin;

  • feeling like you might pass out;

  • fever, chills, cough with yellow or green mucus, stabbing chest pain, wheezing;

  • unusual bleeding such as nosebleeds, bleeding gums, or any bleeding that will not stop;

  • pale skin, weakness, easy bruising;

  • unexpected vaginal bleeding;

  • blood in your urine or stools, black or tarry stools;

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

  • swelling of your ankles or feet.

Less serious side effects may include:

  • cough, sore throat;

  • pain or irritation in your throat after use;

  • dizziness;

  • nausea, diarrhea;

  • headache or jaw pain; or

  • flushing (warmth, redness or tingling).

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 Tyvaso Starter Kit (treprostinil inhalation)?

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

  • gemfibrozil (Lopid);

  • delavirdine (Rescriptor);

  • nicardipine (Cardene);

  • pioglitazone (Actos, ActoPlus Met, Duetact);

  • tolbutamide (Orinase);

  • an antibiotic such as rifampin (Rifater, Rifadin, Rifamate) or rifapentine (Priftin);

  • antifungal medication such as fluconazole (Diflucan), or ketoconazole (Nizoral);

  • blood pressure medication;

  • a blood thinner such as warfarin (Coumadin).

  • a diuretic (water pill);

  • medication to treat congestive heart failure, such as hydralazine (Apresoline, BiDil), nesiritide (Natrecor), nitroglycerin, or nitroprusside (Nitropress);

  • an NSAID (non-steroidal anti-inflammatory drug) such as flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), mefenamic acid (Ponstel), or piroxicam (Feldene);

  • seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin) fosphenytoin (Cerebyx), phenobarbital (Solfoton), primidone (Mysoline), or secobarbital (Seconal);or

  • sulfa drugs such as sulfisoxazole (Bactrim, Cotrim, Gantanol, Gantrisin, Septra), and others.

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

Where can I get more information?

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.01. Revision Date: 08/11/2009 8:45:06 AM.

 

Tyzeka

30/06/10

Generic Name: telbivudine (tel BIV yoo deen)
Brand Names: Tyzeka

What is telbivudine?

Telbivudine is an antiviral medication. It works by preventing viral cells from multiplying in the body and infecting new liver cells.

Telbivudine is used to treat chronic hepatitis B in adults. This medicine will not cure hepatitis.

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


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

Some people have developed a life-threatening condition called lactic acidosis while taking telbivudine. Get emergency medical help if you have any of these symptoms of lactic acidosis: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have hepatitis B you may develop liver symptoms after you stop taking telbivudine, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing hepatitis B to other people. Talk with your doctor about safe methods of preventing hepatitis transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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

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

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

  • kidney disease;
  • other types of hepatitis (C or D);
  • HIV or AIDS;

  • if you have received a liver transplant; or

  • if any hepatitis B medications you received in the past did not work well in treating your condition.

This medication may cause lactic acidosis (the build up of lactic acid in the body, which can be fatal). You may be more likely to develop lactic acidosis if you are overweight, if you are a woman, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. It is not known whether this medication is safe to use while you are pregnant. Telbivudine may not keep you from passing hepatitis B to your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while you are taking telbivudine.

Your name may need to be listed on a pregnancy registry if you become pregnant while you are taking telbivudine. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether the medication had any effect on the baby.

It is not known whether telbivudine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give telbivudine to a child younger than 16 years old without the advice of a doctor.


How should I take telbivudine?

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.

Telbivudine may be taken with or without food. Take the medicine at the same time each day.

It is important to use telbivudine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Do not stop taking this medication without talking to your doctor.

While taking telbivudine, you should remain under the care of a doctor. Your blood will need to be checked on a regular basis.

Your liver symptoms may become severe after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop taking telbivudine. Do not miss any scheduled visits.

If your condition worsens after you stop taking telbivudine, your doctor may recommend that you restart this medication or another treatment for hepatitis B.

Store telbivudine at room temperature away from moisture and heat.

Throw away any unused or expired telbivudine tablets in a closed container or sealed bag. You may also ask your pharmacist where to locate a community pharmaceutical take-back disposal program.

See also: Tyzeka dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a telbivudine overdose are not known.

What should I avoid while taking telbivudine?

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing hepatitis B to other people. Talk with your doctor about safe methods of preventing hepatitis transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Telbivudine 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. This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;

  • numb or cold feeling in your arms and legs;

  • trouble breathing;

  • feeling dizzy, light-headed, tired, or very weak;

  • stomach pain, nausea with vomiting; or

  • fast or uneven heart rate.

Call your doctor at once if you have any of these serious side effects:

  • muscle tenderness, or weakness (may occur several weeks or months after you start taking telbivudine);

  • fever or flu symptoms and dark colored urine;

  • burning, pain or tingly feeling in your arms or legs; or

  • liver symptoms – pain in your upper stomach with low fever, loss of appetite, dark urine, clay-colored stools, and/or jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • cough, sore throat;

  • headache, tired feeling;

  • dizziness;

  • muscle aches;

  • low fever;

  • bloating, mild nausea, vomiting, diarrhea;

  • itching or mild skin rash;

  • joint pain, back pain; or

  • sleep problems (insomnia).

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

What other drugs will affect telbivudine?

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

  • cyclosporine (Gengraf, Neoral, Sandimmune)

  • erythromycin (E.E.S., Ery-Tab, E-Mycin);

  • penicillamine (Cuprimine, Depen);

  • zidovudine (Retrovir);

  • an antifungal antibiotic such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), voriconazole (Vfend);

  • anti-malaria drugs such as chloroquine (Aralen), hydroxychloroquine (Plaquenil, Quineprox);

  • cholesterol-lowering medicines such as atorvastatin (Lipitor), clofibrate (Atromid), fenofibrate (Antara, Lofibra, TriCor), gemfibrozil (Lopid), niacin (Advicor, Niacor, Niaspan, Nicobid), simvastatin (Zocor), and others;

  • an interferon such as Actimmune, Alferon N, Avonex, Betaseron, Infergen, Intron A, Rebetron, Rebif, Roferon-A, or peginterferon alfa-2a (Pegasys); or

  • steroids (prednisone and others).

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

Where can I get more information?

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.02. Revision Date: 11/17/2009 10:03:05 AM.

 

Generic Name: Treprostinil (tre-PROST-i-nil)
Brand Name: Tyvaso

Tyvaso Inhalation Solution is used for:

Treating pulmonary arterial hypertension (PAH) (high blood pressure in the arteries of the lungs) in certain patients to increase walk distance. It may also be used for other conditions as determined by your doctor.

Tyvaso Inhalation Solution is a prostacyclin vasodilator. It works by relaxing blood vessels and increasing the supply of blood to the lungs in patients with high blood pressure in the lungs. This decreases how hard the heart must work to pump blood to the lungs. It also prevents the platelets in your blood from clotting to prevent unwanted blood clots.

Do NOT use Tyvaso Inhalation Solution if:

  • you are allergic to any ingredient in Tyvaso Inhalation Solution

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

Before using Tyvaso Inhalation Solution:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver or kidney problems, bleeding problems, a lung infection (eg, pneumonia) or breathing problems (eg, asthma or chronic obstructive pulmonary disease [COPD]), or low blood pressure

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

  • Anticoagulants (eg, warfarin) because side effects such as bleeding may occur
  • Blood pressure medicines (eg, lisinopril), diuretics (eg, furosemide), or vasodilators (eg, hydralazine) because side effects, such as dizziness, fainting, and very low blood pressure, may occur
  • Cytochrome P450 (CYP-450) inhibitors (eg, gemfibrozil) because it may increase the risk of Tyvaso Inhalation Solution’s side effects
  • CYP-450 inducers (eg, rifampin) because it may decrease Tyvaso Inhalation Solution’s effectiveness

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

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

  • An extra patient leaflet is available with Tyvaso Inhalation Solution. Talk to your pharmacist if you have questions about this information.
  • Tyvaso Inhalation Solution should only be used with the Tyvaso inhalation system. Follow the instructions for use and daily cleaning after the last treatment session of the day. Talk to your pharmacist if you have questions about this information.
  • Tyvaso Inhalation Solution is usually used in 4 treatment sessions each day approximately 4 hours apart during waking hours. Follow the dosing schedule given to you by your doctor carefully.
  • Tyvaso Inhalation Solution is inhaled through your mouth into your lungs.
  • Take your first treatment with Tyvaso Inhalation Solution in the morning and take your last treatment session before bedtime unless your doctor tells you otherwise. Talk with your doctor if you need to time your dosing around any planned activities.
  • One ampule of Tyvaso Inhalation Solution contains enough medicine for all 4 treatment sessions. Tyvaso Inhalation Solution should remain in the inhalation system for no more than 24 hours. Any remaining solution should be discarded at the end of the day.
  • Do not mix Tyvaso Inhalation Solution with other medicines in the inhalation device.
  • Avoid skin or eye contact with Tyvaso Inhalation Solution. If Tyvaso Inhalation Solution comes in contact with skin or eyes, rinse immediately with water.
  • Use Tyvaso Inhalation Solution on a regular schedule to get the most benefit from it.
  • If you miss a dose of Tyvaso Inhalation Solution, 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 Tyvaso Inhalation Solution.

Important safety information:

  • Tyvaso Inhalation Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Tyvaso Inhalation Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Tyvaso Inhalation Solution may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Stopping Tyvaso Inhalation Solution, even briefly, may lead to serious side effects. To avoid interruption in medicine treatment you should have access to a backup inhalation system.
  • Tyvaso Inhalation Solution may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
  • Tyvaso Inhalation Solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Tell your doctor or dentist that you take Tyvaso Inhalation Solution before you receive any medical or dental care, emergency care, or surgery.
  • If your symptoms do not get better or if they get worse, check with your doctor.
  • Lab tests, including lung function, may be performed while you use Tyvaso Inhalation Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Tyvaso Inhalation Solution with caution in the ELDERLY; they may be more sensitive to its effects.
  • Tyvaso Inhalation Solution should be used with extreme caution in CHILDREN younger than 18 years old years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if Tyvaso Inhalation Solution can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tyvaso Inhalation Solution while you are pregnant. It is not known if Tyvaso Inhalation Solution is found in breast milk. If you are or will be breast-feeding while you are using Tyvaso Inhalation Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tyvaso Inhalation Solution:

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:

Cough; diarrhea; dizziness; headache; muscle, jaw, or bone pain; nausea; reddening of the face and neck (flushing); throat irritation or pain.

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); chest pain; coughing up blood; dark, tarry, or bloody stools; fainting; fever, chills, or persistent sore throat; increased cough; new or worsening shortness of breath; pale skin; severe or persistent tiredness, weakness, dizziness, headache, or nausea; swelling of the ankles or feet; unusual bruising or bleeding; vomit that looks like coffee grounds; wheezing.

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.

Proper storage of Tyvaso Inhalation Solution:

Store Tyvaso Inhalation Solution in the unopened foil pouch at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Once the foil pack is opened, use the ampules within 7 days. Store away from heat, moisture, and light. Keep Tyvaso Inhalation Solution out of the reach of children and away from pets.

General information:

  • If you have any questions about Tyvaso Inhalation Solution, please talk with your doctor, pharmacist, or other health care provider.
  • Tyvaso Inhalation Solution 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 Tyvaso Inhalation Solution. 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
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Generic Name: treprostinil inhalation (tre PROS ti nil)
Brand Names: Tyvaso, Tyvaso Refill Kit, Tyvaso Starter Kit

What is Tyvaso Refill Kit (treprostinil inhalation)?

Treprostinil works by dilating (widening) blood vessels in your lungs and by keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots. These effects lower blood pressure in the pulmonary artery that leads from your heart to your lungs.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

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


What is the most important information I should know about Tyvaso Refill Kit (treprostinil inhalation)?

Before using this medication, tell your doctor if you have a breathing disorder such as asthma or COPD (chronic obstructive pulmonary disease), an infection in your lungs (including pneumonia), low blood pressure, liver or kidney disease, or a bleeding or blood clotting disorder.

Treprostinil inhalation should be used only with a Tyvaso inhalation system. The inhalation system comes with patient instructions for safe and effective use. Do not use the medication at home if you do not fully understand how to use the inhalation system and properly clean it daily. Ask your doctor or pharmacist if you have any questions.

The effects of treprostinil inhalation will lessen over time between doses. Talk with your doctor if you need to time your dosing around any planned activities.

It is important to use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup inhalation system available so as not to interrupt your treatment if one system stops working.

Call your doctor if your symptoms do not improve or if they get worse.

What should I discuss with my healthcare provider before using Tyvaso Refill Kit (treprostinil inhalation)?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication:

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

  • an infection in your lungs, including pneumonia;

  • low blood pressure;

  • liver disease;
  • kidney disease; or
  • a bleeding or blood clotting disorder.

FDA pregnancy category B. It is not known whether this medication is harmful to an unborn baby. Use an effective form of birth control while you are using treprostinil inhalation. Tell your doctor if you become pregnant during treatment. It is not known whether treprostinil 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 is treprostinil inhalation given?

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

Treprostinil inhalation should be used only with a Tyvaso inhalation system. The inhalation system comes with patient instructions for safe and effective use. Do not use the medication at home if you do not fully understand how to use the inhalation system and properly clean it daily. Ask your doctor or pharmacist if you have any questions.

The inhalation form of treprostinil is usually given 4 times per day at evenly spaced intervals during waking hours. Each time you use the medication, you will inhale up to 9 breaths of the medication. Follow your doctor’s instructions.

Your doctor may occasionally change your dose to make sure you get the best results from this medication. Most people start treatment with 1 to 3 breaths per treatment session, slowly increasing the number to 9 breaths per session.

Do not use more than 9 breaths per treatment session. Wash your hands before preparing your treprostinil doses in the inhalation system.

One ampule of treprostinil inhalation contains enough medicine for all 4 of a day’s doses.

Before your first dose of each day, twist off the top of one ampule and squeeze out the entire contents into the medicine cup of the inhalation system. At the end of the day after the last dose has been given, empty and rinse out the medicine cup, even if there is still unused treprostinil left in it.

To keep the medicine in the cup from spilling, store the inhalation system upright and tightly capped with the plugs when not in use.

The effects of treprostinil inhalation will lessen over time between doses. Talk with your doctor if you need to time your dosing around any planned activities.

Call your doctor if your symptoms do not improve or if they get worse.

It is important to use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup inhalation system available so as not to interrupt your treatment if one system stops working.

Store treprostinil ampules in their foil pouch at room temperature away from moisture, heat, and light. Once you have opened a foil pouch, the ampules in it should be used within 7 days.

Any treprostinil placed into the medicine cup of the inhalation system must be used within 24 hours. Throw away any unused medicine at the end of the day after your last dose.

What happens if I miss a dose?

Call your doctor for instructions.


What happens if I overdose?

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

Overdose symptoms may include flushing (warmth, redness or tingling), headache, nausea, vomiting, diarrhea, feeling light-headed, or fainting.

What should I avoid while using Tyvaso Refill Kit (treprostinil inhalation)?

Avoid getting treprostinil in your eyes or on your skin. If this does happen, rinse with water. Do not swallow treprostinil inhalation. The medication should be inhaled using only the Tyvaso inhalation system. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Tyvaso Refill Kit (treprostinil 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. Call your doctor at once if you have any of these serious side effects:

  • new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin;

  • feeling like you might pass out;

  • fever, chills, cough with yellow or green mucus, stabbing chest pain, wheezing;

  • unusual bleeding such as nosebleeds, bleeding gums, or any bleeding that will not stop;

  • pale skin, weakness, easy bruising;

  • unexpected vaginal bleeding;

  • blood in your urine or stools, black or tarry stools;

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

  • swelling of your ankles or feet.

Less serious side effects may include:

  • cough, sore throat;

  • pain or irritation in your throat after use;

  • dizziness;

  • nausea, diarrhea;

  • headache or jaw pain; or

  • flushing (warmth, redness or tingling).

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 Tyvaso Refill Kit (treprostinil inhalation)?

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

  • gemfibrozil (Lopid);

  • delavirdine (Rescriptor);

  • nicardipine (Cardene);

  • pioglitazone (Actos, ActoPlus Met, Duetact);

  • tolbutamide (Orinase);

  • an antibiotic such as rifampin (Rifater, Rifadin, Rifamate) or rifapentine (Priftin);

  • antifungal medication such as fluconazole (Diflucan), or ketoconazole (Nizoral);

  • blood pressure medication;

  • a blood thinner such as warfarin (Coumadin).

  • a diuretic (water pill);

  • medication to treat congestive heart failure, such as hydralazine (Apresoline, BiDil), nesiritide (Natrecor), nitroglycerin, or nitroprusside (Nitropress);

  • an NSAID (non-steroidal anti-inflammatory drug) such as flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), mefenamic acid (Ponstel), or piroxicam (Feldene);

  • seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin) fosphenytoin (Cerebyx), phenobarbital (Solfoton), primidone (Mysoline), or secobarbital (Seconal);or

  • sulfa drugs such as sulfisoxazole (Bactrim, Cotrim, Gantanol, Gantrisin, Septra), and others.

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

Where can I get more information?

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.01. Revision Date: 08/11/2009 8:45:06 AM.

 

Tyvaso

30/06/10

Generic Name: treprostinil inhalation (tre PROS ti nil)
Brand Names: Tyvaso, Tyvaso Refill Kit, Tyvaso Starter Kit

What is treprostinil inhalation?

Treprostinil works by dilating (widening) blood vessels in your lungs and by keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots. These effects lower blood pressure in the pulmonary artery that leads from your heart to your lungs.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

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


What is the most important information I should know about treprostinil inhalation?

Before using this medication, tell your doctor if you have a breathing disorder such as asthma or COPD (chronic obstructive pulmonary disease), an infection in your lungs (including pneumonia), low blood pressure, liver or kidney disease, or a bleeding or blood clotting disorder.

Treprostinil inhalation should be used only with a Tyvaso inhalation system. The inhalation system comes with patient instructions for safe and effective use. Do not use the medication at home if you do not fully understand how to use the inhalation system and properly clean it daily. Ask your doctor or pharmacist if you have any questions.

The effects of treprostinil inhalation will lessen over time between doses. Talk with your doctor if you need to time your dosing around any planned activities.

It is important to use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup inhalation system available so as not to interrupt your treatment if one system stops working.

Call your doctor if your symptoms do not improve or if they get worse.

What should I discuss with my healthcare provider before using treprostinil inhalation?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication:

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

  • an infection in your lungs, including pneumonia;

  • low blood pressure;

  • liver disease;
  • kidney disease; or
  • a bleeding or blood clotting disorder.

FDA pregnancy category B. It is not known whether this medication is harmful to an unborn baby. Use an effective form of birth control while you are using treprostinil inhalation. Tell your doctor if you become pregnant during treatment. It is not known whether treprostinil 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 is treprostinil inhalation given?

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

Treprostinil inhalation should be used only with a Tyvaso inhalation system. The inhalation system comes with patient instructions for safe and effective use. Do not use the medication at home if you do not fully understand how to use the inhalation system and properly clean it daily. Ask your doctor or pharmacist if you have any questions.

The inhalation form of treprostinil is usually given 4 times per day at evenly spaced intervals during waking hours. Each time you use the medication, you will inhale up to 9 breaths of the medication. Follow your doctor’s instructions.

Your doctor may occasionally change your dose to make sure you get the best results from this medication. Most people start treatment with 1 to 3 breaths per treatment session, slowly increasing the number to 9 breaths per session.

Do not use more than 9 breaths per treatment session. Wash your hands before preparing your treprostinil doses in the inhalation system.

One ampule of treprostinil inhalation contains enough medicine for all 4 of a day’s doses.

Before your first dose of each day, twist off the top of one ampule and squeeze out the entire contents into the medicine cup of the inhalation system. At the end of the day after the last dose has been given, empty and rinse out the medicine cup, even if there is still unused treprostinil left in it.

To keep the medicine in the cup from spilling, store the inhalation system upright and tightly capped with the plugs when not in use.

The effects of treprostinil inhalation will lessen over time between doses. Talk with your doctor if you need to time your dosing around any planned activities.

Call your doctor if your symptoms do not improve or if they get worse.

It is important to use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup inhalation system available so as not to interrupt your treatment if one system stops working.

Store treprostinil ampules in their foil pouch at room temperature away from moisture, heat, and light. Once you have opened a foil pouch, the ampules in it should be used within 7 days.

Any treprostinil placed into the medicine cup of the inhalation system must be used within 24 hours. Throw away any unused medicine at the end of the day after your last dose.

What happens if I miss a dose?

Call your doctor for instructions.


What happens if I overdose?

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

Overdose symptoms may include flushing (warmth, redness or tingling), headache, nausea, vomiting, diarrhea, feeling light-headed, or fainting.

What should I avoid while using treprostinil inhalation?

Avoid getting treprostinil in your eyes or on your skin. If this does happen, rinse with water. Do not swallow treprostinil inhalation. The medication should be inhaled using only the Tyvaso inhalation system. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Treprostinil 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. Call your doctor at once if you have any of these serious side effects:

  • new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin;

  • feeling like you might pass out;

  • fever, chills, cough with yellow or green mucus, stabbing chest pain, wheezing;

  • unusual bleeding such as nosebleeds, bleeding gums, or any bleeding that will not stop;

  • pale skin, weakness, easy bruising;

  • unexpected vaginal bleeding;

  • blood in your urine or stools, black or tarry stools;

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

  • swelling of your ankles or feet.

Less serious side effects may include:

  • cough, sore throat;

  • pain or irritation in your throat after use;

  • dizziness;

  • nausea, diarrhea;

  • headache or jaw pain; or

  • flushing (warmth, redness or tingling).

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 treprostinil inhalation?

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

  • gemfibrozil (Lopid);

  • delavirdine (Rescriptor);

  • nicardipine (Cardene);

  • pioglitazone (Actos, ActoPlus Met, Duetact);

  • tolbutamide (Orinase);

  • an antibiotic such as rifampin (Rifater, Rifadin, Rifamate) or rifapentine (Priftin);

  • antifungal medication such as fluconazole (Diflucan), or ketoconazole (Nizoral);

  • blood pressure medication;

  • a blood thinner such as warfarin (Coumadin).

  • a diuretic (water pill);

  • medication to treat congestive heart failure, such as hydralazine (Apresoline, BiDil), nesiritide (Natrecor), nitroglycerin, or nitroprusside (Nitropress);

  • an NSAID (non-steroidal anti-inflammatory drug) such as flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), mefenamic acid (Ponstel), or piroxicam (Feldene);

  • seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin) fosphenytoin (Cerebyx), phenobarbital (Solfoton), primidone (Mysoline), or secobarbital (Seconal);or

  • sulfa drugs such as sulfisoxazole (Bactrim, Cotrim, Gantanol, Gantrisin, Septra), and others.

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

Where can I get more information?

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.01. Revision Date: 08/11/2009 8:45:06 AM.

 

Tysabri

30/06/10

Generic Name: natalizumab (nat ta LIZ yoo mab)
Brand Names: Tysabri

What is natalizumab?

Natalizumab is a monoclonal antibody that affects the actions of the body’s immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Natalizumab is used in to treat relapsing forms of multiple sclerosis.

Natalizumab is also used to treat moderate to severe Crohn’s disease in adults. It is usually given after other Crohn’s disease medications have been tried without successful treatment of this condition.

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


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

Natalizumab may cause a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you any change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

Natalizumab is available only to select patients through a restricted-use program called the TOUCH Prescribing Program. To receive this medication, you must be enrolled in this program and meet all requirements. You will be interviewed before receiving each dose of this medicine to make sure you still meet these requirements.

During your natalizumab treatment, it is extremely important that your doctor check you every 3 to 6 months to make sure you are not developing any signs of serious infection. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you develop any symptoms of liver damage, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

You should also call your doctor right away if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination.


What should I discuss with my healthcare provider before receiving natalizumab?

Natalizumab may cause a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines.

Natalizumab is available only to select patients through a restricted-use program called the TOUCH Prescribing Program. To receive this medication, you must be enrolled in this program and meet all requirements. You will be interviewed before receiving each dose of this medicine to make sure you still meet these requirements.

You should not receive natalizumab if you are allergic to it, or if you have ever had a brain infection called progressive multifocal leukoencephalopathy.

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

  • HIV or AIDS;

  • herpes or shingles;

  • leukemia, lymphoma;

  • if you have had a recent organ transplant; or

  • if you are being treated with chemotherapy or radiation.

FDA pregnancy category C. It is not known whether natalizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether natalizumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving natalizumab.

How is natalizumab given?

Natalizumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting every 4 weeks. Natalizumab must be given slowly, and the IV infusion can take up to 1 hour to complete.

Before you receive your first dose of natalizumab, your doctor may want you to have an MRI to make sure you do not have any signs of a brain infection.

After you receive natalizumab, your caregivers may want to watch you for at least 1 hour in case you have any type of reaction to the medication. An allergic reaction can occur up to 2 hours after your infusion.

During your treatment, it is extremely important that your doctor check you every 3 to 6 months to make sure you are not developing any signs of serious infection. Your doctor may also want to check you for several weeks after you stop using natalizumab. Do not miss any scheduled visits to your doctor.

Natalizumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your natalizumab injection.


What happens if I overdose?

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

What should I avoid while receiving natalizumab?

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


Natalizumab side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash, hives, itching; dizziness, fever; nausea, vomiting; feeling flushed; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat; feeling light-headed or fainting. Call your doctor at once if you have a serious side effect such as:

  • change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);

  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • pain or burning when you urinate;

  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

  • flu symptoms, sores or white patches in your mouth or on your lips;

  • vaginal itching or discharge;

  • tooth pain, gum pain or swelling; or

  • flare of herpes infection (cold sores, blisters or lesions of the genital or anal area).

Less serious side effects may include:

  • headache;

  • tired feeling;

  • joint or muscle pain;

  • stomach pain, diarrhea;

  • mild skin rash;

  • depression;

  • painful menstrual cramps; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 natalizumab?

Tell your doctor about all other medicines you use, especially drugs that may affect the immune system such as:

  • drugs that weaken your immune system (such as cancer medicine or steroids);

  • cyclosporine (Neoral, Sandimmune, Gengraf);

  • mercaptopurine (Purinethol);

  • methotrexate (Rheumatrex, Trexall);

  • mycophenolate mofetil (CellCept);

  • azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel);

  • basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);

  • interferon (Roferon, Intron, Rebetron, Alferon, Avonex, Rebif, Betaseron, or Actimmune); or

  • sirolimus (Rapamune), tacrolimus (Prograf).

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 5.01. Revision Date: 05/10/2010 10:37:12 AM.

 

TYE-foid VAX-een, lyve

Commonly used brand name(s):

In the U.S.

  • Vivotif

Available Dosage Forms:

  • Capsule, Delayed Release
  • Capsule

Therapeutic Class: Vaccine

Uses For typhoid vaccine, live

Typhoid fever is a serious disease that can cause death. It is caused by a germ called Salmonella typhi, and is spread most often through infected food or water. Typhoid may also be spread by close person-to-person contact with infected persons (such as occurs with persons living in the same household). Some infected persons do not appear to be sick, but they can still spread the germ to others.

Typhoid fever is very rare in the U.S. and other areas of the world that have good water and sewage (waste) systems. However, it is a problem in parts of the world that do not have such systems. If you are traveling to certain countries or remote areas, typhoid vaccine will help protect you from typhoid fever. The U.S. Centers for Disease Control (CDC) currently recommend caution in the following areas of the world:

  • Africa
  • Asia
  • Latin America

Typhoid vaccine taken by mouth helps prevent typhoid fever, but does not provide 100% protection. Therefore, it is very important to avoid infected persons and food and water that may be infected, even if you have taken the vaccine.

To get the best possible protection against typhoid, you should complete the vaccine dosing schedule (all 4 doses of the vaccine) at least 1 week before travel to areas where you may be exposed to typhoid.

If you will be traveling regularly to parts of the world where typhoid is a problem, you should get a booster (repeat) dose of the vaccine every 5 years.

Typhoid vaccine is available only from a health care professional.


Before Using typhoid vaccine, live

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to typhoid vaccine, live 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

Typhoid vaccine is not recommended for infants and children up to 6 years of age. Although there is no specific information comparing use of typhoid vaccine in children 6 years of age and over with use in other age groups, this vaccine is not expected to cause different side effects or problems in these children than it does in adults.

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. Although there is no specific information comparing use of typhoid vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older people than it does in younger adults.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Receiving this vaccine 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.

  • Aclarubicin
  • Adalimumab
  • Aldesleukin
  • Altretamine
  • Amonafide
  • Amsacrine
  • Asparaginase
  • Azacitidine
  • Azathioprine
  • Bleomycin
  • Broxuridine
  • Busulfan
  • Capecitabine
  • Carboplatin
  • Carmustine
  • Certolizumab Pegol
  • Chlorambucil
  • Cisplatin
  • Cladribine
  • Cyclophosphamide
  • Cytarabine
  • Cytarabine Liposome
  • Dacarbazine
  • Dactinomycin
  • Daunorubicin
  • Daunorubicin Citrate Liposome
  • Decitabine
  • Docetaxel
  • Doxifluridine
  • Doxorubicin Hydrochloride
  • Doxorubicin Hydrochloride Liposome
  • Edatrexate
  • Eflornithine
  • Epirubicin
  • Estramustine
  • Etanercept
  • Etoposide
  • Floxuridine
  • Fludarabine
  • Fluorouracil
  • Fotemustine
  • Gallium Nitrate
  • Gemcitabine
  • Golimumab
  • Hydroxyurea
  • Idarubicin
  • Ifosfamide
  • Irinotecan
  • Lomustine
  • Mechlorethamine
  • Melphalan
  • Mercaptopurine
  • Methotrexate
  • Mitolactol
  • Mitomycin
  • Mitotane
  • Mitoxantrone
  • Mycophenolic Acid
  • Oxaliplatin
  • Paclitaxel
  • Pegaspargase
  • Pentostatin
  • Pipobroman
  • Pirarubicin
  • Plicamycin
  • Procarbazine
  • Raltitrexed
  • Rilonacept
  • Rituximab
  • Sirolimus
  • Streptozocin
  • Tacrolimus
  • Teceleukin
  • Tegafur
  • Temsirolimus
  • Teniposide
  • Thioguanine
  • Thiotepa
  • Topotecan
  • Treosulfan
  • Trimetrexate
  • Trofosfamide
  • Uracil Mustard
  • Vinblastine
  • Vincristine
  • Vincristine Liposome
  • Vindesine
  • Vinorelbine

Receiving this vaccine 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.

  • Abatacept
  • Cytomegalovirus Immune Globulin, Human
  • Leflunomide
  • Proguanil
  • Vaccinia Immune Globulin, Human

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diarrhea or
  • Fever or
  • Other illness (severe) or
  • Stomach or intestinal illness (severe) or
  • Vomiting—The condition may reduce the useful effect of the vaccine
  • Immune deficiency condition, including HIV or AIDS—The condition may increase the chance of side effects of the vaccine




Proper Use of typhoid vaccine, live

It is important that all 4 doses of the vaccine be taken exactly as directed. If all the doses are not taken or if doses are not taken at the correct times, the vaccine may not work properly.

The vaccine capsules are meant to dissolve in the intestines. Therefore, they should be inspected to make sure that they are not broken or cracked when you take them. If any are broken or cracked, you will need to replace them.

Typhoid vaccine must be stored in the refrigerator at a temperature between 2 and 8 °C (35.6 and 46.4 °F) at all times. If the vaccine is left at room temperature, it will lose its effectiveness. Therefore, remember to replace unused vaccine in the refrigerator between doses.

Each dose of the vaccine should be taken approximately 1 hour before a meal. Take with a cold or lukewarm drink that has a temperature that does not exceed body temperature, e.g., 37 °C (98.6 °F).

Swallow the capsule whole. Do not chew it before swallowing. Also swallow the capsule as soon as possible after you place it in your mouth.

Dosing

The dose of typhoid vaccine, live 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 typhoid vaccine, live. 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.

  • Take 1 capsule by mouth every other day for a total of 4 doses.

Missed Dose

Call your doctor or pharmacist for instructions.

If you do not remember the missed dose until the next day, take the missed dose at that time and reschedule your every-other-day doses from then. It is important that this vaccine be taken exactly as directed so it can give you the most protection against typhoid fever.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.


Precautions While Using typhoid vaccine, live

Tell your doctor that you have taken this vaccine:

  • If you are to receive any other live vaccines within 1 month after taking this vaccine.

typhoid vaccine, live 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:

Symptoms of allergic reaction

  • Difficulty in breathing or swallowing
  • hives
  • itching, especially of feet or hands
  • reddening of skin, especially around ears
  • swelling of eyes, face, or inside of nose
  • unusual tiredness or weakness (sudden and severe)

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 or rare

  • Diarrhea
  • fever
  • hives
  • nausea
  • skin rash
  • stomach cramps or pain
  • vomiting

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

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

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

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

 

 

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