Acthar

Generic Name: corticotropin (Injection route)

kor-ti-koe-TROE-pin ree-POZ-i-tor-ee

Commonly used brand name(s)

In the U.S.

• H.P. Acthar

In Canada

• Acthar

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Diagnostic Agent, Adrenocortical Function

Pharmacologic Class: Corticotropin

Uses For Acthar

Repository corticotropin injection is used to treat infantile spasms (seizures) in babies and children younger than 2 years of age. It is also used to treat multiple sclerosis in adults.

This medicine is also used to treat joint disorders (e.g., psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis); autoimmune diseases (e.g., systemic lupus erythematosus or SLE, polymyositis); and certain conditions of the skin (e.g., erythema multiforme, Stevens-Johnson syndrome), eyes (e.g., keratitis, optic neuritis), and lungs (e.g., sarcoidosis). It is also used to treat certain allergies (e.g., serum sickness) and swelling (edema) of the body.

This medicine is available only with your doctor's prescription.

Before Using Acthar

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of repository corticotropin injection to treat infantile spasms in babies and children younger than 2 years of age.

Geriatric

No information is available on the relationship of age to the effects of repository corticotropin injection in geriatric patients.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Rotavirus Vaccine, Live

Using this medicine 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.

• Bupropion

Using this medicine 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.

• Alatrofloxacin


• Balofloxacin


• Cinoxacin


• Ciprofloxacin


• Clinafloxacin


• Enoxacin


• Fleroxacin


• Flumequine


• Gemifloxacin


• Grepafloxacin


• Itraconazole


• Levofloxacin


• Licorice


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rosoxacin


• Rufloxacin


• Saiboku-To


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal problems or


• Allergy to pork proteins, history of or


• Congenital (inborn) infections or


• Congestive heart failure or


• Fungus infections, systemic or


• Herpes simplex of the eye or


• Hypertension (high blood pressure), uncontrolled or


• Osteoporosis (thinning of the bones) or


• Peptic ulcer, or history of or


• Scleroderma (autoimmune disease) or


• Surgery, recent—Should not be used in patients with these conditions.

• Cataracts or


• Cirrhosis (liver problem) or


• Cushing's syndrome (adrenal gland disorder) or


• Depression, history of or


• Diabetes or


• Edema (fluid retention or swelling) or


• Emotional problems or


• Eye infections (fungus, virus) or


• Glaucoma or


• Hypertension (high blood pressure), controlled or


• Hypokalemia (low potassium in the blood) or


• Hypothyroidism (underactive thyroid) or


• Kidney disease, severe or


• Mental illness (e.g., psychosis) or


• Myasthenia gravis (severe muscle weakness) or


• Stomach problems (ulcer, bleeding, or perforation) or


• Tuberculosis, latent—Use with caution. May make these conditions worse.

• Infection (bacteria, virus, parasite, or protozoa)—May decrease your body's ability to fight infection.

• Lennox-Gastaut syndrome—May cause this condition to occur while using this medicine to treat infantile spasms.

Proper Use of corticotropin

This section provides information on the proper use of a number of products that contain corticotropin. It may not be specific to Acthar. Please read with care.

A nurse or other trained health professional will give you or your child this medicine. This medicine is given as a shot under your skin or into one of your muscles.

Repository corticotropin injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your or your child's doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

If your child is receiving repository corticotropin injection to treat infantile spasms, this medicine usually comes with a Medication Guide. It is very important that you read and follow the instructions carefully. Be sure to ask your child's doctor about anything you do not understand.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

To use:

• Take the vial from the refrigerator and let it warm to room temperature before using it. Do not over-pressurize the vial before withdrawing the medicine.


• Wash your hands before and after using this medicine.


• Wipe the injection site with a new sterile alcohol wipe and let it dry before giving an injection.


• Clean the top of the rubber stopper vial with a new sterile alcohol wipe.


• Use a new needle or syringe to get the prescribed amount of medicine to be injected.


• Give the medicine the way your doctor has instructed you.


• Return the vial to the refrigerator after using it.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For injection dosage form (gel):
  
  • For infantile spasms:
    
    • Children 2 years of age and older—Use and dose must be determined by your doctor.
    
    
    • Infants and children younger than 2 years of age—Dose is based on body size and must be determined by your child's doctor. The dose is 150 units per square meter (U/m2) of body size divided into two equal doses injected into a muscle per day for 2 weeks. Your child's doctor will adjust the dose as needed.
    
    
  
  
  • For multiple sclerosis:
    
    • Adults—The dose is usually 80 to 120 units injected under your skin or into a muscle per day for 2 to 3 weeks. Your doctor will adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For other indications (joint disorders, autoimmune diseases, allergies, swelling, and certain conditions of the skin, eyes, and lungs):
    
    • Adults—The dose is usually 40 to 80 units injected under your skin or into a muscle every 24 to 72 hours. Your doctor will adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

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.

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

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using Acthar

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Do not receive live vaccines while you or your child are using this medicine.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems (e.g., Cushing's syndrome). The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; fractures; increased thirst or urination; irritability; round or "moon" face, neck, or trunk; stomach pain; thin skin or easy bruising; weight gain or loss; or unusual tiredness or weakness.

This medicine may cause fluid retention (edema) in some patients. Carefully follow your doctor's instructions about any special diet (especially on salt intake).

This medicine may mask or hide symptoms of other diseases while you are using it. Check with your doctor if you or your child have symptoms of infection; black, tarry stools; changes in body weight; difficulty with breathing; fast heart rate; increased thirst; stomach pain; unusual tiredness; or vomiting.

Check with your doctor right away if you start having severe abdominal or stomach burning, cramps, or pains; bloody or black, tarry stools; constipation or diarrhea; heartburn; indigestion; nausea; or vomiting of material that looks like coffee grounds. These could be symptoms of a serious stomach or bowel problem.

This medicine may cause changes in mood and behavior. Check with your doctor if you or your child have trouble sleeping, feeling depressed or irritable, mood swings, or other changes in behavior.

Check with your doctor right away if you or your child have any changes to your eyes, such as redness, itching, swelling, or vision changes while you are using this medicine. Your doctor may want you to have your eyes checked by an eye doctor.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause slow growth and may lead to osteoporosis at any age. If you have any questions about this ask your doctor.

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

Acthar Side Effects

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

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

More common

• Backache


• blurred vision


• body aches or pain


• chest pain


• cough


• difficulty with breathing


• dizziness


• ear congestion


• earache


• facial hair growth in females


• fever or chills


• fractures


• full or round face, neck, or trunk


• headache


• increased thirst or urination


• irritability


• loss of sexual desire or ability


• loss of voice


• menstrual irregularities


• muscle wasting


• nasal congestion


• nervousness


• pounding in the ears


• redness or swelling in the ear


• runny nose


• shortness of breath


• slow or fast heartbeat


• sneezing


• sore throat


• tightness in the chest


• troubled breathing


• unusual tiredness or weakness


• wheezing


• white patches in the mouth or throat or on the tongue


• white patches with diaper rash

Less common

• Convulsions (seizures)

Incidence not known

• Accumulation of pus


• bruising


• bulging soft spot on the head of an infant


• change in the ability to see colors, especially blue or yellow


• cold, clammy skin


• confusion


• decreased range of motion


• decreased urine output


• dilated neck veins


• extreme fatigue


• eyeballs bulge out of eye sockets


• fast, weak pulse


• full or bloated feeling


• heartburn


• insomnia


• irregular breathing


• irregular heartbeat


• joint pain


• large, flat, blue, or purplish patches in the skin


• lightheadedness


• limp


• loss of appetite


• nausea and vomiting


• pressure in the stomach


• severe headache


• small red or purple spots on the skin


• sweating


• swelling of abdominal or stomach area


• swelling of the face, fingers, feet, or lower legs


• swollen, red, or tender area of infection


• trouble healing


• weight gain


• wheezing

Incidence not known-For adults only

• Bloating


• chills


• confusion


• constipation


• coughing up blood


• darkened urine


• fast heartbeat


• fever


• headache


• headache, sudden and severe


• increased sweating


• indigestion


• loss of appetite


• pain in the muscles


• pains in the stomach, side, or abdomen, possibly radiating to the back


• redness of the face


• skin rash


• unusual weight loss


• weakness


• yellow eyes or skin

Incidence not known-For infants only

• Decreased carbohydrate tolerance


• hypokalemic alkalosis


• reversible brain shrinkage

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:

More common

• Blemishes on the skin


• diarrhea


• pimples

Less common

• Increased or decreased appetite

Incidence not known

• Increased hair growth, especially on the face


• menstrual changes


• muscle weakness

Incidence not known-For adults only

• Feeling of constant movement of self or surroundings


• sensation of spinning


• thinning of the skin

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.

More Acthar resources

• Acthar Use in Pregnancy & Breastfeeding
• Acthar Drug Interactions
• Acthar Support Group
• 1 Review for Acthar - Add your own review/rating

• Corticotropin Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Corticotropin Monograph (AHFS DI)


• Acthar Gel, H.P. Concise Consumer Information (Cerner Multum)

Compare Acthar with other medications

• Allergies
• Eye Conditions
• Inflammatory Bowel Disease
• Multiple Sclerosis
• Psoriasis
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus
• Ulcerative Colitis

Triaminic Cold/Allergy Elixir

Pronunciation: klor-fen-IR-a-meen/fen-il-EF-rin
Generic Name: Chlorpheniramine/Phenylephrine
Brand Name: Examples include Novahistine and Triaminic Cold/Allergy

Triaminic Cold/Allergy Elixir is used for:

Relieving symptoms of sinus congestion, sinus pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Triaminic Cold/Allergy Elixir is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.

Do NOT use Triaminic Cold/Allergy Elixir if:

• you are allergic to any ingredient in Triaminic Cold/Allergy Elixir


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you take sodium oxybate (GHB) or you have taken furazolidone or 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 Triaminic Cold/Allergy Elixir:

Some medical conditions may interact with Triaminic Cold/Allergy Elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat


• if you have a history of asthma; lung problems (eg, emphysema); adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, intestines, or bladder; ulcers; trouble urinating; an enlarged prostate; seizures; or an overactive thyroid

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

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase Triaminic Cold/Allergy Elixir's risk of side effects


• Bromocriptine or hydantoins (eg, phenytoin) because their risk of side effects may be increased by Triaminic Cold/Allergy Elixir


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Triaminic Cold/Allergy Elixir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triaminic Cold/Allergy Elixir 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 Triaminic Cold/Allergy Elixir:

Use Triaminic Cold/Allergy Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Triaminic Cold/Allergy Elixir may be taken with or without food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Triaminic Cold/Allergy Elixir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Triaminic Cold/Allergy Elixir.

Important safety information:

• Triaminic Cold/Allergy Elixir may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Triaminic Cold/Allergy Elixir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take diet or appetite control medicines while you are taking Triaminic Cold/Allergy Elixir without checking with you doctor.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Triaminic Cold/Allergy Elixir may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Triaminic Cold/Allergy Elixir. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Triaminic Cold/Allergy Elixir may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Triaminic Cold/Allergy Elixir for a few days before the tests.


• Tell your doctor or dentist that you take Triaminic Cold/Allergy Elixir before you receive any medical or dental care, emergency care, or surgery.


• Use Triaminic Cold/Allergy Elixir with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Triaminic Cold/Allergy Elixir in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Triaminic Cold/Allergy Elixir while you are pregnant. It is not known if Triaminic Cold/Allergy Elixir is found in breast milk. If you are or will be breast-feeding while you use Triaminic Cold/Allergy Elixir, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Triaminic Cold/Allergy Elixir:

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:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Triaminic Cold/Allergy side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Triaminic Cold/Allergy Elixir:

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

General information:

• If you have any questions about Triaminic Cold/Allergy Elixir, please talk with your doctor, pharmacist, or other health care provider.


• Triaminic Cold/Allergy Elixir is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Triaminic Cold/Allergy resources

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

Compare Triaminic Cold/Allergy with other medications

• Cold Symptoms
• Hay Fever

Chlornade

Generic Name: chlorpheniramine and phenylpropanolamine (klor feh NEER a meen and feh nill proe pa NO la meen)

Brand Names: A.R.M. Allergy Relief, Allerest 12 Hour, Chlornade, Condrin, Contac 12 Hour, Decongex-3, Demazin, Dura-Vent/A, Equi-Nade, Genamin, Gencold, Histade, Or-Phen-Ade, Ordrine, Ornade Spansules, Resaid, Rescon Liquid, Rhinolar-EX, Teldrin, Triac, Triaminic, Vanex Forte-R

What is Chlornade (chlorpheniramine and phenylpropanolamine)?

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal passages to open up.

Chlorpheniramine and phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Chlorpheniramine and phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Chlornade (chlorpheniramine and phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine and phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take Chlornade (chlorpheniramine and phenylpropanolamine)?

Do not take chlorpheniramine and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

You may not be able to take chlorpheniramine and phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Chlorpheniramine and phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from chlorpheniramine and phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Chlornade (chlorpheniramine and phenylpropanolamine)?

Take chlorpheniramine and phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure of the formulation of your medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of the medication.

To ensure that you get a correct dose, measure the liquid forms of chlorpheniramine and phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take chlorpheniramine and phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store chlorpheniramine and phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a chlorpheniramine and phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.

What should I avoid while taking Chlornade (chlorpheniramine and phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine and phenylpropanolamine.

Chlorpheniramine and phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine and phenylpropanolamine is taken with any of these medications.

Chlornade (chlorpheniramine and phenylpropanolamine) side effects

Serious side effects are unlikely to occur. Stop taking chlorpheniramine and phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine and phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

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

What other drugs will affect Chlornade (chlorpheniramine and phenylpropanolamine)?

Do not take chlorpheniramine and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking chlorpheniramine and phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Chlorpheniramine and phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine and phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with chlorpheniramine and phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Chlornade resources

• Chlornade Drug Interactions
• Chlornade Support Group
• 0 Reviews for Chlornade - Add your own review/rating

• Triaminic Consumer Overview

Compare Chlornade with other medications

• Cold Symptoms
• Cough and Nasal Congestion
• Hay Fever
• Sinusitis
• Upper Respiratory Tract Infection

Where can I get more information?

• Your pharmacist has additional information about chlorpheniramine and phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Many formulations of chlorpheniramine and phenylpropanolamine are available both over-the-counter and with a prescription. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Inomax

Dosage Form: gas, for inhalation
FULL PRESCRIBING INFORMATION

Indications and Usage for Inomax

Treatment of Hypoxic Respiratory Failure

Inomax® is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.

Utilize additional therapies to maximize oxygen delivery. In patients with collapsed alveoli, additional therapies might include surfactant and high-frequency oscillatory ventilation.

The safety and effectiveness of inhaled nitric oxide have been established in a population receiving other therapies for hypoxic respiratory failure, including vasodilators, intravenous fluids, bicarbonate therapy, and mechanical ventilation. Different dose regimens for nitric oxide were used in the clinical studies [see Clinical Studies (14)].

Monitor for PaO2, methemoglobin, and inspired NO2 during Inomax administration.

Inomax Dosage and Administration

Dosage

Term and near-term neonates with hypoxic respiratory failure

The recommended dose of Inomax is 20 ppm. Treatment should be maintained up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from Inomax therapy.

An initial dose of 20 ppm was used in the NINOS and CINRGI trials. In CINRGI, patients whose oxygenation improved with 20 ppm were dose-reduced to 5 ppm as tolerated at the end of 4 hours of treatment. In the NINOS trial, patients whose oxygenation failed to improve on 20 ppm could be increased to 80 ppm, but those patients did not then improve on the higher dose. As the risk of methemoglobinemia and elevated NO2 levels increases significantly when Inomax is administered at doses >20 ppm, doses above this level ordinarily should not be used.

Administration

The nitric oxide delivery systems used in the clinical trials provided operator-determined concentrations of nitric oxide in the breathing gas, and the concentration was constant throughout the respiratory cycle. Inomax must be delivered through a system with these characteristics and which does not cause generation of excessive inhaled nitrogen dioxide. The INOvent® system and other systems meeting these criteria were used in the clinical trials. In the ventilated neonate, precise monitoring of inspired nitric oxide and NO2 should be instituted, using a properly calibrated analysis device with alarms. The system should be calibrated using a precisely defined calibration mixture of nitric oxide and nitrogen dioxide, such as INOcal®. Sample gas for analysis should be drawn before the Y-piece, proximal to the patient. Oxygen levels should also be measured.

In the event of a system failure or a wall-outlet power failure, a backup battery power supply and reserve nitric oxide delivery system should be available.

Do not discontinue Inomax abruptly, as it may result in an increase in pulmonary artery pressure (PAP) and/or worsening of blood oxygenation (PaO2). Deterioration in oxygenation and elevation in PAP may also occur in children with no apparent response to Inomax. Discontinue/wean cautiously.

Dosage Forms and Strengths

Nitric oxide is a gas available in 100 ppm and 800 ppm concentrations.

Contraindications

Inomax is contraindicated in the treatment of neonates known to be dependent on right-to-left shunting of blood.

Warnings and Precautions

Rebound

Abrupt discontinuation of Inomax may lead to worsening oxygenation and increasing pulmonary artery pressure.

Methemoglobinemia

Methemoglobinemia increases with the dose of nitric oxide. In clinical trials, maximum methemoglobin levels usually were reached approximately 8 hours after initiation of inhalation, although methemoglobin levels have peaked as late as 40 hours following initiation of Inomax therapy. In one study, 13 of 37 (35%) of neonates treated with Inomax 80 ppm had methemoglobin levels exceeding 7%. Following discontinuation or reduction of nitric oxide, the methemoglobin levels returned to baseline over a period of hours.

Elevated NO2 Levels

In one study, NO2 levels were <0.5 ppm when neonates were treated with placebo, 5 ppm, and 20 ppm nitric oxide over the first 48 hours. The 80 ppm group had a mean peak NO2 level of 2.6 ppm.

Heart Failure

Patients who had pre-existing left ventricular dysfunction treated with inhaled nitric oxide, even for short durations, experienced serious adverse events (e.g., pulmonary edema).

Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Clinical Trials Experience

Controlled studies have included 325 patients on Inomax doses of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials was 11% on placebo and 9% on Inomax, a result adequate to exclude Inomax mortality being more than 40% worse than placebo.

In both the NINOS and CINRGI studies, the duration of hospitalization was similar in Inomax and placebo-treated groups.

From all controlled studies, at least 6 months of follow-up is available for 278 patients who received Inomax and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae.

In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.

The table below shows adverse reactions that occurred in at least 5% of patients receiving Inomax in the CINRGI study with event rates >5% and greater than placebo event rates. None of the differences in these adverse reactions were statistically significant when inhaled nitric oxide patients were compared to patients receiving placebo.

Table 1: Adverse Reactions in the CINRGI Study

Adverse Event	Placebo (n=89)	Inhaled NO (n=97)
Hypotension	9 (10%)	13 (13%)
Withdrawal	9 (10%)	12 (12%)
Atelectasis	8 (9%)	9 (9%)
Hematuria	5 (6%)	8 (8%)
Hyperglycemia	6 (7%)	8 (8%)
Sepsis	2 (2%)	7 (7%)
Infection	3 (3%)	6 (6%)
Stridor	3 (3%)	5 (5%)
Cellulitis	0 (0%)	5 (5%)

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of Inomax. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. The listing is alphabetical: dose errors associated with the delivery system; headaches associated with environmental exposure of Inomax in hospital staff; hypotension associated with acute withdrawal of the drug; hypoxemia associated with acute withdrawal of the drug; pulmonary edema in patients with CREST syndrome.

Drug Interactions

No formal drug-interaction studies have been performed, and a clinically significant interaction with other medications used in the treatment of hypoxic respiratory failure cannot be excluded based on the available data. Inomax has been administered with tolazoline, dopamine, dobutamine, steroids, surfactant, and high-frequency ventilation. Although there are no study data to evaluate the possibility, nitric oxide donor compounds, including sodium nitroprusside and nitroglycerin, may have an additive effect with Inomax on the risk of developing methemoglobinemia. An association between prilocaine and an increased risk of methemoglobinemia, particularly in infants, has specifically been described in a literature case report. This risk is present whether the drugs are administered as oral, parenteral, or topical formulations.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Inomax. It is not known if Inomax can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Inomax is not intended for adults.

Labor and Delivery

The effect of Inomax on labor and delivery in humans is unknown.

Nursing Mothers

Nitric oxide is not indicated for use in the adult population, including nursing mothers. It is not known whether nitric oxide is excreted in human milk.

Pediatric Use

The safety and efficacy of nitric oxide for inhalation has been demonstrated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension [see Clinical Studies (14.1)]. Additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy [see Clinical Studies (14.3)]. No information about its effectiveness in other age populations is available.

Geriatric Use

Nitric oxide is not indicated for use in the adult population.

Overdosage

Overdosage with Inomax will be manifest by elevations in methemoglobin and pulmonary toxicities associated with inspired NO2. Elevated NO2 may cause acute lung injury. Elevations in methemoglobinemia reduce the oxygen delivery capacity of the circulation. In clinical studies, NO2 levels >3 ppm or methemoglobin levels >7% were treated by reducing the dose of, or discontinuing, Inomax.

Methemoglobinemia that does not resolve after reduction or discontinuation of therapy can be treated with intravenous vitamin C, intravenous methylene blue, or blood transfusion, based upon the clinical situation.

Inomax Description

Inomax (nitric oxide gas) is a drug administered by inhalation. Nitric oxide, the active substance in Inomax, is a pulmonary vasodilator. Inomax is a gaseous blend of nitric oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm; 0.01% and 99.99%, respectively for 100 ppm). Inomax is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]).

The structural formula of nitric oxide (NO) is shown below:

Inomax - Clinical Pharmacology

Mechanism of Action

Nitric oxide is a compound produced by many cells of the body. It relaxes vascular smooth muscle by binding to the heme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation. When inhaled, nitric oxide selectively dilates the pulmonary vasculature, and because of efficient scavenging by hemoglobin, has minimal effect on the systemic vasculature.

Inomax appears to increase the partial pressure of arterial oxygen (PaO2) by dilating pulmonary vessels in better ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward regions with normal ratios.

Pharmacodynamics

Effects on Pulmonary Vascular Tone in PPHN

Persistent pulmonary hypertension of the newborn (PPHN) occurs as a primary developmental defect or as a condition secondary to other diseases such as meconium aspiration syndrome (MAS), pneumonia, sepsis, hyaline membrane disease, congenital diaphragmatic hernia (CDH), and pulmonary hypoplasia. In these states, pulmonary vascular resistance (PVR) is high, which results in hypoxemia secondary to right-to-left shunting of blood through the patent ductus arteriosus and foramen ovale. In neonates with PPHN, Inomax improves oxygenation (as indicated by significant increases in PaO2).

Pharmacokinetics

The pharmacokinetics of nitric oxide has been studied in adults.

Pharmacokinetics: Uptake and Distribution

Nitric oxide is absorbed systemically after inhalation. Most of it traverses the pulmonary capillary bed where it combines with hemoglobin that is 60% to 100% oxygen-saturated. At this level of oxygen saturation, nitric oxide combines predominantly with oxyhemoglobin to produce methemoglobin and nitrate. At low oxygen saturation, nitric oxide can combine with deoxyhemoglobin to transiently form nitrosylhemoglobin, which is converted to nitrogen oxides and methemoglobin upon exposure to oxygen. Within the pulmonary system, nitric oxide can combine with oxygen and water to produce nitrogen dioxide and nitrite, respectively, which interact with oxyhemoglobin to produce methemoglobin and nitrate. Thus, the end products of nitric oxide that enter the systemic circulation are predominantly methemoglobin and nitrate.

Pharmacokinetics: Metabolism

Methemoglobin disposition has been investigated as a function of time and nitric oxide exposure concentration in neonates with respiratory failure. The methemoglobin (MetHb) concentration-time profiles during the first 12 hours of exposure to 0, 5, 20, and 80 ppm Inomax are shown in Figure 1.

Figure 1: Methemoglobin Concentration-Time Profiles Neonates Inhaling 0, 5, 20 or 80 ppm Inomax

Methemoglobin concentrations increased during the first 8 hours of nitric oxide exposure. The mean methemoglobin level remained below 1% in the placebo group and in the 5 ppm and 20 ppm Inomax groups, but reached approximately 5% in the 80 ppm Inomax group. Methemoglobin levels >7% were attained only in patients receiving 80 ppm, where they comprised 35% of the group. The average time to reach peak methemoglobin was 10 ± 9 (SD) hours (median, 8 hours) in these 13 patients, but one patient did not exceed 7% until 40 hours.

Pharmacokinetics: Elimination

Nitrate has been identified as the predominant nitric oxide metabolite excreted in the urine, accounting for >70% of the nitric oxide dose inhaled. Nitrate is cleared from the plasma by the kidney at rates approaching the rate of glomerular filtration.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 hr/day for up to two years. Higher exposures have not been investigated.

Nitric oxide has demonstrated genotoxicity in Salmonella (Ames Test), human lymphocytes, and after in vivo exposure in rats. There are no animal or human studies to evaluate nitric oxide for effects on fertility.

Clinical Studies

Treatment of Hypoxic Respiratory Failure (HRF)

The efficacy of Inomax has been investigated in term and near-term newborns with hypoxic respiratory failure resulting from a variety of etiologies. Inhalation of Inomax reduces the oxygenation index (OI= mean airway pressure in cm H2O × fraction of inspired oxygen concentration [FiO2]× 100 divided by systemic arterial concentration in mm Hg [PaO2]) and increases PaO2 [see Clinical Pharmacology (12.1)].

NINOS Study

The Neonatal Inhaled Nitric Oxide Study (NINOS) group conducted a double-blind, randomized, placebo-controlled, multicenter trial in 235 neonates with hypoxic respiratory failure. The objective of the study was to determine whether inhaled nitric oxide would reduce the occurrence of death and/or initiation of extracorporeal membrane oxygenation (ECMO) in a prospectively defined cohort of term or near-term neonates with hypoxic respiratory failure unresponsive to conventional therapy. Hypoxic respiratory failure was caused by meconium aspiration syndrome (MAS; 49%), pneumonia/sepsis (21%), idiopathic primary pulmonary hypertension of the newborn (PPHN; 17%), or respiratory distress syndrome (RDS; 11%). Infants ≤14 days of age (mean, 1.7 days) with a mean PaO2 of 46 mm Hg and a mean oxygenation index (OI) of 43 cm H2O / mm Hg were initially randomized to receive 100% O2 with (n=114) or without (n=121) 20 ppm nitric oxide for up to 14 days. Response to study drug was defined as a change from baseline in PaO2 30 minutes after starting treatment (full response = >20 mm Hg, partial = 10–20 mm Hg, no response = <10 mm Hg). Neonates with a less than full response were evaluated for a response to 80 ppm nitric oxide or control gas. The primary results from the NINOS study are presented in Table 2.

Table 2: Summary of Clinical Results from NINOS Study

	Control (n=121)	NO (n=114)	P value
* Extracorporeal membrane oxygenation † Death or need for ECMO was the study's primary end point
Death or ECMO*,†	77 (64%)	52 (46%)	0.006
Death	20 (17%)	16 (14%)	0.60
ECMO	66 (55%)	44 (39%)	0.014

Although the incidence of death by 120 days of age was similar in both groups (NO, 14%; control, 17%), significantly fewer infants in the nitric oxide group required ECMO compared with controls (39% vs. 55%, p = 0.014). The combined incidence of death and/or initiation of ECMO showed a significant advantage for the nitric oxide treated group (46% vs. 64%, p = 0.006). The nitric oxide group also had significantly greater increases in PaO2 and greater decreases in the OI and the alveolar-arterial oxygen gradient than the control group (p<0.001 for all parameters). Significantly more patients had at least a partial response to the initial administration of study drug in the nitric oxide group (66%) than the control group (26%, p<0.001). Of the 125 infants who did not respond to 20 ppm nitric oxide or control, similar percentages of NO-treated (18%) and control (20%) patients had at least a partial response to 80 ppm nitric oxide for inhalation or control drug, suggesting a lack of additional benefit for the higher dose of nitric oxide. No infant had study drug discontinued for toxicity. Inhaled nitric oxide had no detectable effect on mortality. The adverse events collected in the NINOS trial occurred at similar incidence rates in both treatment groups [see Adverse Reactions (6.1)]. Follow-up exams were performed at 18–24 months for the infants enrolled in this trial. In the infants with available follow-up, the two treatment groups were similar with respect to their mental, motor, audiologic, or neurologic evaluations.

CINRGI Study

This study was a double-blind, randomized, placebo-controlled, multicenter trial of 186 term and near-term neonates with pulmonary hypertension and hypoxic respiratory failure. The primary objective of the study was to determine whether Inomax would reduce the receipt of ECMO in these patients. Hypoxic respiratory failure was caused by MAS (35%), idiopathic PPHN (30%), pneumonia/sepsis (24%), or RDS (8%). Patients with a mean PaO2 of 54 mm Hg and a mean OI of 44 cm H2O / mm Hg were randomly assigned to receive either 20 ppm Inomax (n=97) or nitrogen gas (placebo; n=89) in addition to their ventilatory support. Patients who exhibited a PaO2 >60 mm Hg and a pH < 7.55 were weaned to 5 ppm Inomax or placebo. The primary results from the CINRGI study are presented in Table 3.

Table 3: Summary of Clinical Results from CINRGI Study

	Placebo	Inomax	P value
* Extracorporeal membrane oxygenation † ECMO was the primary end point of this study
ECMO*,†	51/89 (57%)	30/97 (31%)	<0.001
Death	5/89 (6%)	3/97 (3%)	0.48

Significantly fewer neonates in the Inomax group required ECMO compared to the control group (31% vs. 57%, p<0.001). While the number of deaths were similar in both groups (Inomax, 3%; placebo, 6%), the combined incidence of death and/or receipt of ECMO was decreased in the Inomax group (33% vs. 58%, p<0.001).

In addition, the Inomax group had significantly improved oxygenation as measured by PaO2, OI, and alveolar-arterial gradient (p<0.001 for all parameters). Of the 97 patients treated with Inomax, 2 (2%) were withdrawn from study drug due to methemoglobin levels >4%. The frequency and number of adverse events reported were similar in the two study groups [see Adverse Reactions (6.1)].

Ineffective in Adult Respiratory Distress Syndrome (ARDS)

ARDS Study

In a randomized, double-blind, parallel, multicenter study, 385 patients with adult respiratory distress syndrome (ARDS) associated with pneumonia (46%), surgery (33%), multiple trauma (26%), aspiration (23%), pulmonary contusion (18%), and other causes, with PaO2/FiO2 <250 mm Hg despite optimal oxygenation and ventilation, received placebo (n=193) or Inomax (n=192), 5 ppm, for 4 hours to 28 days or until weaned because of improvements in oxygenation. Despite acute improvements in oxygenation, there was no effect of Inomax on the primary endpoint of days alive and off ventilator support. These results were consistent with outcome data from a smaller dose ranging study of nitric oxide (1.25 to 80 ppm). Inomax is not indicated for use in ARDS.

Ineffective in Prevention of Bronchopulmonary Dysplasia (BPD)

The safety and efficacy of Inomax for the prevention of chronic lung disease [bronchopulmonary dysplasia, (BPD)] in neonates ≤ 34 weeks gestational age requiring respiratory support has been studied in three large, multi-center, double-blind, placebo-controlled clinical trials in a total of 2,149 preterm infants.1,2,3 Of these, 1,068 received placebo, and 1,081 received inhaled nitric oxide at doses ranging from 5-20 ppm, for treatment periods of 7-24 days duration. The primary endpoint for these studies was alive and without BPD at 36 weeks postmenstrual age (PMA). The need for supplemental oxygen at 36 weeks PMA served as a surrogate endpoint for the presence of BPD. Overall, efficacy for the prevention of bronchopulmonary dysplasia in preterm infants was not established. There were no meaningful differences between treatment groups with regard to deaths, methemoglobin levels, or adverse events commonly observed in premature infants, including intraventricular hemorrhage, patent ductus arteriosus, pulmonary hemorrhage, and retinopathy of prematurity. The use of Inomax for prevention of BPD in preterm neonates ≤ 34 weeks gestational age is not indicated.

REFERENCES

1

Kinsella JP, Cutter GR, Walsh WF, Gerstmann DR, Bose CL, Hart C, et al. Early inhaled nitric oxide therapy in premature newborns with respiratory failure. N Engl J Med 2006 Jul 27;355(4):354-64.

2

Ballard RA, Truog WE, Cnaan A, Martin RJ, Ballard PL, Merrill JD, et al. Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. N Engl J Med 2006 Jul 27;355(4):343-53.

3

Mercier JC, Hummler H, Durrmeyer X, Sanchez-Luna M, Carnielli V, Field D, et al. Inhaled nitric oxide for prevention of bronchopulmonary dysplasia in premature babies (EUNO): a randomised controlled trial. Lancet 2010 Jul 31;376(9738):346-54.

How Supplied/Storage and Handling

Inomax (nitric oxide) is available in the following sizes:

Size D	Portable aluminum cylinders containing 353 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 344 liters) (NDC 64693-002-01)
Size D	Portable aluminum cylinders containing 353 liters at STP of nitric oxide gas in 100 ppm concentration in nitrogen (delivered volume 344 liters) (NDC 64693-001-01)
Size 88	Aluminum cylinders containing 1963 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 1918 liters) (NDC 64693-002-02)
Size 88	Aluminum cylinders containing 1963 liters at STP of nitric oxide gas in 100 ppm concentration in nitrogen (delivered volume 1918 liters) (NDC 64693-001-02)

Store at 25°C (77°F) with excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Occupational Exposure

The exposure limit set by the Occupational Safety and Health Administration (OSHA) for nitric oxide is 25 ppm, and for NO2 the limit is 5 ppm.

INO Therapeutics

Perryville III Corporate Park

53 Frontage Road, Third Floor

P.O. Box 9001

Hampton, NJ 08827-9001

USA

© 2011 INO Therapeutics

PRINCIPAL DISPLAY PANEL - 800 PPM Size 88 Cylinder

Inomax®

nitric oxide FOR INHALATION

800 PPM

CAUTION: Federal Law Prohibits Dispensing without Prescription.

CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment

rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve

after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE MSDS.

WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the

supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and is familiar

with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards,

contraindications and side effects and the precautions to be taken.

FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is

difficult, give oxygen. Get medical help.

RETURN WITH 25 PSIG.

TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY

AUTHORIZED BY INO Therapeutics

Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs).

DO NOT REMOVE THIS PRODUCT LABEL.

Store at 25°C (77°F)

[see USP Controlled Room Temperature].

Volume 1963 Liters

IKARIA™

1060 Allendale Dr.

Port Allen, LA 70767 USA

For Product Inquiry 1-877-KNOW INO

(566-9466)

UN 1956

COMPRESSED GAS, N.O.S.

(NITRIC OXIDE, NITROGEN)

2.2

Net Weight: 2.5 Kg

NDC 64693-002-02

MADE IN USA

AIR ELIGIBLE

Label No. SPC-0060 V:4.0

PRINCIPAL DISPLAY PANEL - 100 PPM Size 88 Cylinder

Inomax®

nitric oxide FOR INHALATION

100 PPM

CAUTION: Federal Law Prohibits Dispensing without Prescription.

CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment

rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve

after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE MSDS.

WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the

supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and is familiar

with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards,

contraindications and side effects and the precautions to be taken.

FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is

difficult, give oxygen. Get medical help.

RETURN WITH 25 PSIG.

TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY

AUTHORIZED BY INO Therapeutics

Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs).

DO NOT REMOVE THIS PRODUCT LABEL .

Store at 25°C (77°F)

[see USP Controlled Room Temperature].

Volume 1963 Liters

IKARIA™

1060 Allendale Dr.

Port Allen, LA 70767 USA

For Product Inquiry 1-877-KNOW INO

(566-9466)

UN 1956

COMPRESSED GAS, N.O.S.

(NITRIC OXIDE, NITROGEN)

2.2

Net Weight: 2.5 Kg

NDC 64693-001-02

MADE IN USA

AIR ELIGIBLE

Label No. SPC-0059 V:4.0

Inomax  nitric oxide  gas

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64693-002 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength nitric oxide (nitric oxide) nitric oxide 0.98 mg  in 1 L

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64693-002-02 1 CYLINDER In 1 CARTON contains a CYLINDER 1 1918 L In 1 CYLINDER This package is contained within the CARTON (64693-002-02) 2 64693-002-01 1 CYLINDER In 1 CARTON contains a CYLINDER 2 344 L In 1 CYLINDER This package is contained within the CARTON (64693-002-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020845	12/23/1999

Inomax  nitric oxide  gas

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64693-001 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength nitric oxide (nitric oxide) nitric oxide 0.123 mg  in 1 L

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64693-001-02 1 CYLINDER In 1 CARTON contains a CYLINDER 1 1918 L In 1 CYLINDER This package is contained within the CARTON (64693-001-02) 2 64693-001-01 1 CYLINDER In 1 CARTON contains a CYLINDER 2 344 L In 1 CYLINDER This package is contained within the CARTON (64693-001-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020845	12/23/1999

Labeler - INO Therapeutics (090546628)

Establishment
Name	Address	ID/FEI	Operations
INO Therapeutics		011121840	MANUFACTURE

Revised: 07/2011INO Therapeutics

Allegra

Generic Name: fexofenadine (Oral route)

fex-oh-FEN-a-deen

Commonly used brand name(s)

In the U.S.

• Allegra


• Allegra ODT

Available Dosage Forms:

• Tablet


• Tablet, Disintegrating


• Capsule


• Suspension

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Antihistamine, Less-Sedating

Chemical Class: Butyrophenone

Uses For Allegra

Fexofenadine is an antihistamine. It is used to relieve the symptoms of hay fever (seasonal allergic rhinitis) and hives of the skin (chronic idiopathic urticaria) .

Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Also, in some people histamine can close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Histamine can also cause some people to have hives, with severe itching of the skin .

This medicine is available only with your doctor's prescription .

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Allegra

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fexofenadine in children below 6 months of age. Safety and efficacy have not been established .

Do not give any cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

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

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

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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.

• Droperidol

Using this medicine 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.

• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• St John's Wort

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Apple Juice


• Grapefruit Juice


• Orange Juice

Other Medical Problems

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

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

• Phenylketonuria—Use with caution. The oral disintegrating tablets contain phenylalanine .

Proper Use of fexofenadine

This section provides information on the proper use of a number of products that contain fexofenadine. It may not be specific to Allegra. Please read with care.

You should always take this medicine with water. Do not take it with juice such as grapefruit, orange, or apple juice .

You should NOT take antacids that contain aluminum or magnesium hydroxide within 15 minutes of taking this medicine. If you are uncertain about this, ask your doctor or pharmacist .

For patients using the oral disintegrating tablet form of this medicine:

• Make sure your hands are dry.


• Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.


• Immediately place the tablet on top of the tongue. Do not chew or break the tablet.


• The tablet will dissolve in seconds, and you may swallow it with your saliva. You may drink a glass of water after the tablet has dissolved.


• Always take this tablet on an empty stomach .

Shake the oral liquid well before using it. Measure the liquid with a marked measuring spoon, oral syringe, or medicine cup .

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For symptoms of hay fever:
  
  • For oral dosage form (capsules, tablets):
    
    • Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day.
    
    
    • Children 6 to 11 years of age—30 mg two times a day.
    
    
    • Children 4 to 6 years of age—Use and dose must be determined by your doctor .
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  
  • For oral dosage form (disintegrating tablets):
    
    • Children 6 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach.
    
    
    • Children 4 to 6 years of age—Use and dose must be determined by your doctor .
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  
  • For oral dosage form (suspension):
    
    • Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day.
    
    
    • Children younger than 4 years of age—Use and dose must be determined by your doctor .
    
    
  
  

• For symptoms of chronic hives:
  
  • For oral dosage form (capsules, tablets):
    
    • Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day.
    
    
    • Children 4 to 11 years of age—30 mg two times a day.
    
    
    • Children younger than 4 years of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For oral dosage form (disintegrating tablets):
    
    • Children 4 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach.
    
    
    • Children younger than 4 years of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For oral dosage form (suspension):
    
    • Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day.
    
    
    • Children 6 months to 4 years of age—15 mg or 2.5 mL two times a day.
    
    
    • Children younger than 6 months of age—Use and dose must be determined by your doctor .
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Allegra

It is important that your doctor check your progress at regular visits to allow for changes in your dose and to help reduce any side effects .

Allegra 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:

Rare

• Chest tightness


• feeling of warmth, redness of the face, neck, arms and occasionally, upper chest


• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• shortness of breath, difficult or labored breathing

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:

More common

• Vomiting

Less common

• Back pain


• body aches or pain


• chills


• coughing


• diarrhea


• difficulty with moving


• dizziness


• ear congestion


• earache


• fever


• headache


• joint pain


• loss of voice


• muscle aching or cramping


• muscle pains or stiffness


• nasal congestion


• nausea


• pain in arms or legs


• pain or tenderness around eyes or cheekbones


• painful menstrual bleeding


• redness or swelling in ear


• ringing or buzzing in ears


• runny or stuffy nose


• sleepiness or unusual drowsiness


• sneezing


• sore throat


• stomach upset


• swollen joints


• unusual feeling of tiredness or weakness


• viral infection (such as cold and flu)

Rare

• Nervousness


• rash


• sleeplessness


• terrifying dreams


• trouble sleeping

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.

See also: Allegra side effects (in more detail)

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More Allegra resources

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

• Allegra Prescribing Information (FDA)


• Allegra Monograph (AHFS DI)


• Allegra Consumer Overview


• Allegra MedFacts Consumer Leaflet (Wolters Kluwer)


• Fexofenadine Prescribing Information (FDA)


• Allegra ODT Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Allegra with other medications

• Hay Fever
• Urticaria