Drugs Details

Drugs Info of Nasalcrom, Nasalcrom Child
Drugs Details
  • Drugs Type  : Multum
  • Date : 23rd Feb 2015 02:53 am
  • Brand Name : Nasalcrom, Nasalcrom Child
  • Generic Name : cromolyn sodium (nasal) (Pronunciation: KRO mo lin SO dee um)
Descriptions

Chemically, cromolyn sodium is the disodium salt of 1,3-bis (2-carboxychromon-5-yloxy)-2-hydroxypropane. The empirical formula is C23H14Na2O11; the molecular weight is 512.34.

Ingredient

Active ingredient (per spray) Purpose
Cromolyn sodium 5.2 mg Nasal allergy symptom controller

Inactive ingredients
benzalkonium chloride, edetate disodium, purified water

What are the possible side effects of cromolyn sodium nasal (Nasalcrom, Nasalcrom Child)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives or itching; difficulty breathing; severe dizziness; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor if you have any of these serious side effects:

  • severe burning, stinging, or irritation in your nose;
  • nosebleeds, sinus pain, or sores in your nose;
  • wheezing, tight feeling in your chest; or
  • fever, green or yellow mucus from the nose.

Less serious side effects may include...

Read All Potential Side Effects and See Pictures of Nasalcrom »

What are the precautions when taking cromolyn sodium (Nasalcrom)?

Before using this medication, tell your doctor or pharmacist if you are allergic to cromolyn; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: asthma, growths in the nose (nasal polyps).

If you are using this medication for self-treatment, tell your doctor before using this medication if you have any of the following symptoms: fever, yellow/green/discolored fluid from the nose, sinus pain, wheezing.

During pregnancy, this medication should be used only when clearly needed....

Read All Potential Precautions of Nasalcrom »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Uses

Nasalcrom® (cromolyn sodium) Nasal Spray is used to prevent and relieve nasal symptoms of hay fever and other nasal allergies:

  • runny/itchy nose
  • sneezing
  • allergic stuffy nose

Dosage Administration

Nasal Solution

Nasalcrom (cromolyn sodium) is available in bottles of 13 mL and 26 mL (0.44 and 0.88 FL OZ.). Each fully assembled unit consists of a pump unit and actuator with cover in position on the bottle of nasal solution. The amount of cromolyn sodium in each bottle is: 13 ml - 520 mg (40 mg/ml); 26 ml - 1040 mg (40 mg/ml).

Nasalcrom (cromolyn sodium) should be stored between 20°-25°C (68°-77°F). Protect from light. Keep carton and package insert. They contain important instructions

This monograph has been modified to include the generic and brand name in many instances.

How Supplied

Nasal Solution

Nasalcrom (cromolyn sodium) is available in bottles of 13 mL and 26 mL (0.44 and 0.88 FL OZ.). Each fully assembled unit consists of a pump unit and actuator with cover in position on the bottle of nasal solution. The amount of cromolyn sodium in each bottle is: 13 ml - 520 mg (40 mg/ml); 26 ml - 1040 mg (40 mg/ml).

Nasalcrom (cromolyn sodium) should be stored between 20°-25°C (68°-77°F). Protect from light. Keep carton and package insert. They contain important instructions

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Nasal Solution

The most frequent adverse reactions occurring in the 430 patients included in the clinical trials with cromolyn sodium nasal solution were sneezing (1 in 10 patients), nasal stinging (1 in 20), nasal burning (1 in 25), and nasal irritation (1 in 40). Headaches and bad taste were reported in about 1 in 50 patients. Epistaxis, postnasal drip, and rash were reported in less than one percent of the patients. One patient in the clinical trials developed anaphylaxis.

Adverse reactions which have occurred in the use of other cromolyn sodium formulations for inhalation include angioedema, joint pain and swelling, urticaria, cough, and wheezing. Other reactions reported rarely are serum sickness, periarteritic vasculitis, polymyositis, pericarditis, photodermatitis, exfoliative dermatitis, peripheral neuritis, and nephrosis.

Read the Nasalcrom (cromolyn sodium) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Drug Interaction During Pregnancy

Cromolyn sodium and isoproterenol were studied following subcutaneous injections in pregnant mice. Cromolyn sodium alone in doses of 60 to 540 mg/kg (38 to 338 times the human dose) did not cause significant increases in resorptions or major malformations. Isoproterenol alone at a dose of 2.7 mg/kg (90 times the human dose) increased both resorptions and malformations. The addition of cromolyn sodium (338 times the human dose) to isoproterenol (90 times the human dose) appears to have increased the incidence of both resorptions and malformations.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Do not use if you are allergic to any of the ingredients.

Precautions

Nasal Solution: Some patients may experience transient nasal stinging and/or sneezing immediately following instillation of cromolyn sodium nasal solution. Except in rare occurrences, these experiences have not caused discontinuation of therapy.

Ask a doctor before use if you have:

  • fever
  • discolored nasal discharge
  • sinus pain
  • wheezing

Information for the Patient

Please read the drug facts label.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long term studies in mice (12 months intraperitoneal treatment followed by 6 months observation), hamsters (12 months intraperitoneal treatment followed by 12 months observation), and rats (18 months subcutaneous treatment) showed no neoplastic effect of cromolyn sodium.

No evidence of chromosomal damage or cytotoxicity was obtained in various mutagenesis studies.

No evidence of impaired fertility was shown in laboratory animal reproduction studies.

Pregnancy

Pregnancy Category B

Reproduction studies with cromolyn sodium administered parenterally to pregnant mice, rats, and rabbits in doses up to 338 times the human clinical dose produced no evidence of fetal malformations. Adverse fetal effects (increased resorptions and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pediatric Use

Nasal Solution: Safety and effectiveness in children below the age of 6 years have not been established.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

There is no clinical syndrome associated with an overdosage of cromolyn sodium. Acute toxicity testing in a wide variety of species has demonstrated an extremely low order of toxicity for cromolyn sodium, regardless of whether administration was parenteral, oral or by inhalation. Parenteral administration in mice, rats, guinea pigs, hamsters and rabbits demonstrated an LD50 in the region of 4000 mg/kg. Intravenous administration in monkeys also indicated a similar order of toxicity. The highest dose administered by the oral route in rats and mice was 8000 mg/kg and at this dose level no deaths occurred. By inhalation, even in long term studies, it proved impossible to achieve toxic dose levels of cromolyn sodium in a range of mammalian species.

ContrainDications

Nasal Solution: Cromolyn sodium nasal solution is contraindicated in those patients who have shown hypersensitivity to any of the ingredients.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Nasal Solution

In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Cromolyn sodium inhibits the release of histamine and SRS-A (the slow-acting substance of anaphylaxis). Rhinitis induced by the inhalation of specific antigens can be inhibited to varying degrees by pretreatment with cromolyn sodium nasal solution.

Another activity demonstrated in vitrois the capacity of cromolyn sodium to inhibit the degranulation of non-sensitized rat mast cells by phospholipase A and the subsequent release of chemical mediators. An additional in vitro study showed that cromolyn sodium did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.

Cromolyn sodium has no intrinsic bronchodilator, antihistaminic or anti-inflammatory activity.

Cromolyn sodium is poorly absorbed from the gastrointestinal tract. After instillation of cromolyn sodium nasal solution, less than 7% of the total dose administered is absorbed and is rapidly excreted unchanged in the bile and urine. The remainder of the dose is expelled from the nose, or swallowed and excreted via the alimentary tract.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Drug Facts Label

Ask a doctor before use if you have

  • fever
  • discolored nasal discharge
  • sinus pain
  • wheezing

When using this product

  • it may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks.
  • brief stinging or sneezing may occur right after use
  • do not use it to treat sinus infection, asthma, or cold symptoms
  • do not share this bottle with anyone else as this may spread germs

Stop use and ask a doctor if

  • shortness of breath, wheezing, or chest tightness occurs
  • hives or swelling of the mouth or throat occurs
  • your symptoms worsen
  • you have new symptoms
  • your symptoms do not begin to improve within two weeks
  • you need to use for more than 12 weeks

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • see package insert on how to use pump
  • parent or care provider must supervise the use of this product by young children
  • adults and children 2 years and older:
  • spray once into each nostril. Repeat 3-4 times a day (every 4-6 hours). If needed, may be used up to 6 times a day.
  • use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust).
  • to prevent nasal allergy symptoms, use before contact with the cause of your allergies. For best results, start using up to one week before contact.
  • if desired, you can use this product with other medicines, including other allergy medicines.
  • children under 2 years: Do not use unless directed by a doctor

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

CROMOLYN - NASAL

 

(CROW-mow-lin)

 

COMMON BRAND NAME(S): Nasalcrom

 

USES: This medication is used to prevent allergic symptoms in the nose. It reduces stuffy/runny nose, mucus dripping into the back of the throat, itching, and sneezing caused by seasonal allergies (hay fever) and other allergens (e.g., dust mites, pet dander). This medication is not an antihistamine and does not provide immediate relief from allergic symptoms. It should be used before contact with the allergen.

Cromolyn is known as a mast cell stabilizer. It works by preventing the release of certain natural substances (histamine, SRS-A) made by the body that cause allergy symptoms.

Do not use this medication to treat sinus infection, asthma, or cold symptoms.

 

HOW TO USE: Follow all directions on the product package, or use as directed by your doctor. If you are uncertain about any of the information, consult your doctor or pharmacist.

Use 1 spray in each nostril, usually every 4 to 6 hours (3 to 4 times a day) or as directed by your doctor. Do not use more than 6 times a day. Use every day you are around allergens (e.g., during pollen season).

Gently blow your nose before using this drug. If nasal passages are blocked, a nasal decongestant may be used first to open the passages. Use your finger to close the nostril on the side not receiving the medication. While keeping your head upright, place the spray tip into the open nostril. Spray the medication into the open nostril as you breathe in through your nose. Sniff hard a few times to be sure the medication reaches deep into the nose. Repeat these steps for the other nostril.

Avoid spraying the medication into your eyes. Rinse the spray tip with hot water or wipe with a clean tissue after each use. Make sure that water does not get inside the container. Replace cap after each use.

This medication does not work immediately. It must be used regularly to be most effective. It may take 1 to 2 weeks of regular use to get the full benefit. If your condition persists or worsens after 2 weeks, or if you think you may have a serious medical problem, stop using this medication and seek immediate medical attention. Talk with your doctor if you are still using this medication after 12 weeks.

Consumer Overview Side Effect

SIDE EFFECTS: This medication may cause brief stinging/sneezing right after use. If these effects persist or worsen, tell your doctor promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop using this medication and tell your doctor immediately if any of these rare but very serious side effects occur: frequent nosebleeds, sores in the nose, wheezing/chest tightness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Nasalcrom (cromolyn sodium) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to cromolyn; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: asthma, growths in the nose (nasal polyps).

If you are using this medication for self-treatment, tell your doctor before using this medication if you have any of the following symptoms: fever, yellow/green/discolored fluid from the nose, sinus pain, wheezing.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: If you are using this product under your doctor's direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others. Doing so may cause the spread of germs.

Avoid allergens that may be the cause of your allergies. Some common allergens include molds, pollen, grasses, weeds, dust mites, and pet dander. This medication works better if started a week before you expect to be exposed to allergens (e.g., a week before your seasonal allergy symptoms usually start).

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Refer to storage information printed on the package. Store at room temperature between 68-77 degrees F (20-25 degrees C) away from moisture and sunlight. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Nasalcrom, Nasalcrom Child

Generic Name: cromolyn sodium (nasal) (Pronunciation: KRO mo lin SO dee um)

  • What is cromolyn sodium nasal (Nasalcrom)?
  • What are the possible side effects of cromolyn sodium nasal (Nasalcrom)?
  • What is the most important information I should know about cromolyn sodium nasal (Nasalcrom)?
  • What should I discuss with my healthcare provider before using cromolyn sodium nasal (Nasalcrom)?
  • How should I use cromolyn sodium nasal (Nasalcrom)?
  • What happens if I miss a dose (Nasalcrom)?
  • What happens if I overdose (Nasalcrom)?
  • What should I avoid while using cromolyn sodium nasal (Nasalcrom)?
  • What other drugs will affect cromolyn sodium nasal (Nasalcrom)?
  • Where can I get more information?

What is cromolyn sodium nasal (Nasalcrom)?

Cromolyn sodium is an anti-inflammatory medication. It works by preventing the release of substances in the body that cause inflammation.

Cromolyn sodium nasal is used to prevent allergy symptoms such as runny nose, stuffy nose, sneezing, itching, and post-nasal drip.

Cromolyn sodium nasal will not treat allergy symptoms that have already begun. The medication works best if used at least 1 week before you come into contact with things you are allergic to (pollen, dust, pets, etc).

Cromolyn sodium nasal will not treat the symptoms of asthma, sinus infections, or the common cold.

Cromolyn sodium nasal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of cromolyn sodium nasal (Nasalcrom)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives or itching; difficulty breathing; severe dizziness; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor if you have any of these serious side effects:

  • severe burning, stinging, or irritation in your nose;
  • nosebleeds, sinus pain, or sores in your nose;
  • wheezing, tight feeling in your chest; or
  • fever, green or yellow mucus from the nose.

Less serious side effects may include mild burning or stinging inside your nose after use.

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.

Read the Nasalcrom (cromolyn sodium) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about cromolyn sodium nasal (Nasalcrom)?

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

Before you use cromolyn sodium nasal, tell your doctor if you have asthma, drug allergies, or polyps in your nose.

Cromolyn sodium nasal will not treat allergy symptoms that have already begun. The medication works best if used at least 1 week before you come into contact with things you are allergic to (pollen, dust, pets, etc).

Stop using this medication and call your doctor if you have severe burning, stinging, or irritation in your nose, nosebleeds, sinus pain, sores in your nose, wheezing, chest tightness, fever, or green/yellow mucus from your nose.

Do not use cromolyn sodium nasal more than 6 times in a 24-hour period. Do not use this medication for longer than 12 weeks unless your doctor has told you to.

Side Effects Centers
  • Nasalcrom

Patient Detailed How Take

What should I discuss with my healthcare provider before using cromolyn sodium nasal (Nasalcrom)?

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

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

  • asthma;
  • drug allergies; or
  • polyps in your nose.

FDA pregnancy category B. This medication is not expected to 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 cromolyn sodium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use cromolyn sodium nasal (Nasalcrom)?

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.

This medicine is usually given as 1 spray into each nostril every 4 to 6 hours during allergy season or within 1 week before you will be exposed to an allergen. Follow your doctor's instructions.

Do not use cromolyn sodium nasal more than 6 times in a 24-hour period. Do not use this medication for longer than 12 weeks unless your doctor has told you to.

To use the nasal spray:

  • Blow your nose gently before each use.
  • Keeping your head upright, insert just the tip of the spray bottle into your nostril. Hold your other nostril closed with one finger. Spray the medicine into the nostril while inhaling, then sniff deeply a few times to make sure the medicine gets up into your nasal passages.
  • Repeat these steps in your other nostril.
  • After using the nasal spray, rinse the tip with hot water or wipe it with a clean tissue and recap. Avoid getting water into the nasal spray tip.

It may take up to 2 weeks of using this medicine before you get the full effect. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 2 weeks of treatment.

Store cromolyn sodium at room temperature away from moisture, heat, and light. Keep the bottle capped when not in use.

Side Effects Centers
  • Nasalcrom

Patient Detailed Avoid Taking

What happens if I miss a dose (Nasalcrom)?

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

What happens if I overdose (Nasalcrom)?

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

What should I avoid while using cromolyn sodium nasal (Nasalcrom)?

Avoid getting this medication in your eyes. If this does happen, rinse with water.

What other drugs will affect cromolyn sodium nasal (Nasalcrom)?

There may be other drugs that can interact with cromolyn sodium nasal. 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 cromolyn sodium 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 1996-2011 Cerner Multum, Inc. Version: 5.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers
  • Nasalcrom

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI