Intal

Keep this medication in the container it came in, tightly closed, and out of reach of children. Keep unused vials of nebulizer solution in the foil pouch until you are ready to use them. Store nebulizer vials at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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

Although there is no specific information comparing the use of cromolyn in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. The inhalation solution form of this medicine should not be used in children younger than 2 years of age, and the inhalation aerosol should not be used in children younger than 5 years of age.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of cromolyn inhalation in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Heart disease or
• Irregular heartbeat—The propellants used to deliver the medicine in the aerosol inhaler may worsen these conditions

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

Cromolyn oral inhalation is used to help prevent symptoms of asthma or bronchospasm (wheezing or difficulty in breathing). Cromolyn will not relieve an asthma or a bronchospasm attack that has already started. It is important to use cromolyn at regular times as directed by your doctor.

Use cromolyn inhalation only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

Cromolyn inhalation usually comes with patient directions. Read them carefully before using this medicine. If you do not understand the directions that come with the inhaler or if you are not sure how to use the inhaler, ask your health care professional to show you how to use it. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

For patients using cromolyn inhalation aerosol:

• The cromolyn aerosol canister provides about 112 or 200 inhalations, depending on the size of the canister your doctor ordered. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike some other aerosol canisters, cannot be floated in water to test its fullness.
• When you use the inhaler for the first time, or if you have not used it in a while, the inhaler may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, test or prime it.
• To test or prime the inhaler:
  • Insert the medicine container (canister) firmly into the clean mouthpiece according to the manufacturer's directions. Check to make sure the canister is placed properly into the mouthpiece.
  • Take the cap off the mouthpiece and shake the inhaler three or four times.
  • Hold the inhaler well away from you at arm's length and press the top of the canister, spraying the medicine one time into the air. The inhaler will now be ready to provide the right amount of medicine when you use it.
• To use the inhaler:
  • Using your thumb and one or two fingers, hold the inhaler upright, with the mouthpiece end down and pointing toward you.
  • Take the cap off the mouthpiece. Check the mouthpiece to make sure it is clear. Do not use the inhaler with any other mouthpieces.
  • Gently shake the inhaler three or four times.
  • Hold the mouthpiece away from your mouth and breathe out slowly and completely to the end of a normal breath.
  • Use the inhalation method recommended by your doctor.
    • Open-mouth method: Place the mouthpiece about 1 to 2 inches (2 fingerwidths) in front of your widely opened mouth. Make sure the inhaler is aimed into your mouth so the spray does not hit the roof of your mouth or your tongue. Avoid spraying in eyes.
    • Closed-mouth method: Place the mouthpiece in your mouth between your teeth and over your tongue with your lips closed tightly around it. Make sure your tongue or teeth are not blocking the opening.
  • Tilt your head back a little. Start to breathe in slowly through your mouth. At the same time, press the top of the canister once to get one puff of medicine. Continue to breathe in slowly for 3 to 4 seconds until you have taken a full deep breath. It is important to press down on the canister and breathe in slowly at the same time so the medicine gets into your lungs. This step may be difficult at first. If you are using the closed-mouth method and you see a fine mist coming from your mouth or nose, the inhaler is not being used correctly.
  • Hold your breath as long as you can up to 10 seconds (count slowly to ten). This gives the medicine time to settle into your airways and lungs.
  • Take the mouthpiece away from your mouth and breathe out slowly.
  • If your doctor has told you to inhale more than 1 puff of medicine at each dose, wait about 1 minute between puffs. Then, gently shake the inhaler again, and take the second puff following exactly the same steps you used for the first puff. Breathe in only one puff at a time.
  • When you are finished using the inhaler, wipe off the mouthpiece and replace the cap.
  • Keep track of the number of sprays you have used from the inhaler, and discard the inhaler after the labeled maximum number of sprays has been used.

Your doctor may want you to use a spacer device with the inhaler. A spacer makes the inhaler easier to use. It allows more of the medicine to reach your lungs, rather than staying in your mouth and throat.

• To use a spacer device with the inhaler:
  • Attach the spacer to the inhaler according to the manufacturer's directions. There are different types of spacers available, but the method of breathing remains the same with most spacers.
  • Gently shake the inhaler and spacer well.
  • Hold the mouthpiece of the spacer away from your mouth and breathe out slowly and completely.
  • Place the mouthpiece of the spacer into your mouth between your teeth and over your tongue with your lips closed around it.
  • Press down on the canister top once to release one puff of medicine into the spacer. Then, within 1 or 2 seconds, begin to breathe in slowly and deeply through your mouth for 5 to 10 seconds. Count the seconds while inhaling.
  • Hold your breath as long as you can up to 10 seconds (count slowly to 10).
  • Breathe out slowly.
  • Wait a minute between puffs. Then, gently shake the inhaler and spacer again and take the second puff, following exactly the same steps you used for the first puff. Do not spray more than one puff at a time into the spacer.
  • When you are finished using the inhaler, remove the spacer device from the inhaler and replace the cap.

Clean the inhaler, mouthpiece, and spacer at least once a week.

• To clean the inhaler:
  • Remove the canister from the inhaler and set the canister aside. Do not get the canister wet.
  • Wash the mouthpiece, cap, and the spacer in warm soapy water. Rinse well with warm, running water.
  • Shake off the excess water and let the inhaler parts air dry completely before putting the inhaler back together.

For patients using cromolyn capsules for inhalation :

• Do not swallow the capsules. The medicine will not work if you swallow it.
• This medicine is used with a special inhaler, either the Spinhaler or the Halermatic. If you do not understand the directions that come with the inhaler or if you are not sure how to use the inhaler, ask your health care professional to show you how to use it. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.
• If you are using cromolyn capsules for inhalation with the Spinhaler:
  • To load the Spinhaler:
    • Make sure your hands are clean and dry.
    • Insert the capsule into the inhaler just before using this medicine.
    • Hold the inhaler upright with the mouthpiece pointing down. Unscrew the body of the inhaler from the mouthpiece.
    • Keep the mouthpiece pointing down and the propeller on the spindle. Remove the foil from the capsule and insert the colored end of the cromolyn capsule firmly into the cup of the propeller. Avoid too much handling of the capsule, because moisture from your hands may make the capsule soft.
    • Make sure the propeller moves freely.
    • Screw the body of the inhaler back into the mouthpiece and make certain that it is fastened well.
    • While keeping the inhaler upright with the mouthpiece pointing down, slide the grey outer sleeve down firmly until it stops. This will puncture the capsule. Then slide the sleeve up as far as it will go. This step may be repeated a second time to make sure the capsule is punctured.
  • To use the Spinhaler:
    • Check to make sure the mouthpiece is properly attached to the body of the inhaler.
    • Hold the inhaler away from your mouth and breathe out slowly to the end of a normal breath.
    • Place the mouthpiece in your mouth, close your lips around it, and tilt your head back. Do not block the mouthpiece with your teeth or tongue.
    • Take a deep and rapid breath. You should hear and feel the vibrations of the rotating propeller as you breathe in.
    • Take the inhaler from your mouth and hold your breath for a few seconds or as long as possible.
    • Hold the inhaler away from your mouth and breathe out slowly and completely to the end of a normal breath. Do not breathe out through the inhaler because this may prevent the inhaler from working properly.
    • Keep taking inhalations of this medicine until all the powder from the capsule is inhaled. A light dusting of powder remaining in the capsule is normal and is not a sign that the inhaler is not working properly.
    • Throw away the empty capsule. Then return the inhaler to the container and replace the lid on the container.
  • To clean the Spinhaler:
    • At least once a week, brush off any powder left sticking to the propeller.
    • Take the inhaler apart and wash the parts of the inhaler with clean, warm water.
    • Wash the inside of the propeller shaft by moving the propeller on and off the steel spindle under water.
    • Shake out the excess water.
    • Allow all parts of the inhaler to dry completely before putting it back together.
    • The Spinhaler should be replaced after 6 months.
• If you are using cromolyn capsules for inhalation with the Halermatic:
  • To load the Halermatic:
    • Make sure your hands are clean and dry.
    • Insert the capsule cartridge into the inhaler just before using this medicine.
    • Remove the mouthpiece cover. Then pull off the mouthpiece.
    • Push a cromolyn capsule cartridge firmly down to the bottom of the slot.
    • Slide the mouthpiece back on the body of the inhaler. Push down slowly as far as the mouthpiece will go. This punctures the capsule cartridge and lifts it into the rotation chamber. Do not repeat this step because the capsule cartridge needs to be punctured only once.
  • To use the Halermatic:
    • Hold the inhaler away from your mouth and breathe out slowly to the end of a normal breath.
    • Place the mouthpiece in your mouth, close your lips around it, and tilt your head back. Do not block the flow of medicine into the lungs with your teeth or tongue.
    • Breathe in quickly and steadily through the mouthpiece.
    • Hold your breath for a few seconds to keep the medicine in the lungs as long as possible. Then take the inhaler away from your mouth.
    • Hold the inhaler well away from your mouth and breathe out to the end of a normal breath. Do not breathe out through the inhaler because this may prevent the inhaler from working properly.
    • Keep taking inhalations of this medicine until all the powder from the capsule is inhaled. A light dusting of powder remaining in the capsule is normal and is not a sign that the inhaler is not working properly.
    • Throw away the empty capsule cartridge.
  • To clean the Halermatic:
    • Brush away powder deposits each day with a brush.
    • When powder deposits build up, wipe them away with a slightly damp cloth.
    • The mouthpiece may be washed separately if necessary. However, do not wet the blue-based body of the inhaler. Be sure the mouthpiece grid is dry before putting the inhaler back together.
    • The Halermatic should be replaced every 6 months.

For patients using cromolyn inhalation solution:

• Cromolyn inhalation solution comes in a small glass container called an ampul. The ampul must be broken gently to empty the contents. If you do not understand the manufacturer's directions, ask your health care professional to show you what to do.
• Do not use the solution in the ampul if it is cloudy or contains particles.
• To break and empty the ampul:
  • The glass ampul is weak at each end so the ends can be broken easily by hand.
  • Hold the ampul away from the nebulizer and your face when you break it. Hold the ampul at an angle and carefully break off the lower end. No solution will come out.
  • Turn the ampul over so the open end faces up. Place a forefinger carefully over the open end.
  • Keep your finger firmly in place and break off the lower end of the ampul.
  • To empty the ampul, hold it over the bowl of the nebulizer unit and remove your finger to let the solution flow out.
  • Throw away any solution left in the nebulizer after you have taken your treatment.
• Use this medicine only in a power-operated nebulizer that has an adequate flow rate and is equipped with a face mask or mouthpiece. Your doctor will advise you on which nebulizer to use. Make sure you understand exactly how to use it. Hand-squeezed bulb nebulizers cannot be used with this medicine. If you have any questions about this, check with your doctor.

For patients using cromolyn oral inhalation regularly (for example, every day):

• In order for cromolyn to work properly, it must be inhaled every day in regularly spaced doses as ordered by your doctor. Up to 4 weeks may pass before you feel the full effects of the medicine.

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 inhalation aerosol dosage form:
  • For prevention of asthma symptoms:
    • Adults and children 5 years of age or older—2 inhalations (puffs) taken four times a day with doses spaced four to six hours apart.
    • Children up to 5 years of age—Cromolyn inhalation aerosol should not be used in children younger than 5 years of age.
  • For prevention of bronchospasm caused by exercise or a condition or substance:
    • Adults and children 5 years of age or older—2 inhalations (puffs) taken at least ten to fifteen (but not more than sixty) minutes before exercise or exposure to any condition or substance that may cause an attack.
    • Children up to 5 years of age—Cromolyn inhalation aerosol should not be used in children younger than 5 years of age.
• For capsule for inhalation dosage form:
  • For prevention of asthma symptoms:
    • Adults and children 2 years of age or older—20 mg (contents of 1 capsule) used in an inhaler, taken four times a day with doses spaced four to six hours apart.
    • Children up to 2 years of age—The capsule for inhalation should not be used in children younger than 2 years of age.
  • For prevention of bronchospasm caused by exercise or a condition or substance:
    • Adults and children 2 years of age or older—20 mg (contents of 1 capsule) used in an inhaler, taken at least ten to fifteen (but not more than sixty) minutes before exercise or exposure to any condition or substance that may cause an attack.
    • Children up to 2 years of age—The capsule for inhalation should not be used in children younger than 2 years of age.
• For inhalation solution dosage form:
  • For prevention of asthma symptoms:
    • Adults and children 2 years of age or older—20 mg (contents of 1 ampul) used in a nebulizer. This medicine should be used four times a day with doses spaced four to six hours apart. Use a new ampul of solution for each dose.
    • Children up to 2 years of age—Cromolyn inhalation solution should not be used in children younger than 2 years of age.
  • For prevention of bronchospasm caused by exercise or a condition or substance:
    • Adults and children 2 years of age or older—20 mg (contents of 1 ampul) used in a nebulizer. This medicine should be used at least ten to fifteen (but not more than sixty) minutes before exercise or exposure to any condition or substance that may cause an attack. Use a new ampul of solution for each dose.
    • Children up to 2 years of age—Cromolyn inhalation solution should not be used in children younger than 2 years of age.

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.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

If your symptoms do not improve within 4 weeks or if your condition becomes worse after you begin using cromolyn, check with your doctor.

If you are also taking a corticosteroid or a bronchodilator for your asthma along with this medicine, do not stop taking the corticosteroid or bronchodilator even if your asthma seems better, unless you are told to do so by your doctor.

Dryness of the mouth or throat or throat irritation may occur after you use this medicine. Gargling and rinsing your mouth or taking a drink of water after each dose may help prevent these effects.

Intal Inhaler is a prophylactic agent indicated in the management of patients with bronchial asthma.

In patients whose symptoms are sufficiently frequent to require a continuous program of medication, Intal Inhaler is given by inhalation on a regular daily basis. (See DOSAGE AND ADMINISTRATION.) The effect of Intal Inhaler is usually evident after several weeks of treatment, although some patients show an almost immediate response.

If improvement occurs, it will ordinarily occur within the first 4 weeks of administration as manifested by a decrease in the severity of clinical symptoms of asthma, or in the need for concomitant therapy, or both.

In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, known antigens, etc., IntalInhaler should be used shortly before exposure to the precipitating factor, i.e., within 10 to 15 minutes but not more than 60 minutes. (See DOSAGE AND ADMINISTRATION.) Intal Inhaler may be effective in relieving bronchospasm in some, but not all, patients with exercise induced bronchospasm.

Intal Inhaler has no role in the treatment of an acute attack of asthma, especially status asthmaticus. Severe anaphylactic reactions can occur after cromolyn sodium administration. The recommended dosage should be decreased in patients with decreased renal or hepatic function. Intal Inhaler should be discontinued if the patient develops eosinophilic pneumonia (or pulmonary infiltrates with eosinophilia). Because of the propellants in this preparation, it should be used with caution in patients with coronary artery disease or a history of cardiac arrhythmias.

There is no clinical syndrome associated with an overdosage of cromolyn sodium. In several animal species acute toxicity with cromolyn sodium occurs only with very high exposure levels. No deaths occurred at the highest oral doses tested in mice, 8000 mg/kg (approximately 5100 and 2700 times the maximum recommended daily inhalation doses in adults and children, respectively, on a mg/m2 basis) or in rats, 8000 mg/kg (approximately 10,000 and 5400 times the maximum recommended daily inhalation doses in adults and children, respectively, on a mg/m2 basis).

Applies to cromolyn: oral capsule, oral solution

Other dosage forms:

• inhalation aerosol liquid, inhalation aerosol powder, inhalation capsule, inhalation solution

Along with its needed effects, cromolyn (the active ingredient contained in Intal) 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 while taking cromolyn:

• Coughing
• difficulty in swallowing
• hives or itching of skin
• swelling of face, lips, or eyelids
• wheezing or difficulty in breathing

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

• Skin rash

Some side effects of cromolyn 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:

• Diarrhea
• headache

Note: If the above side effects occur in patients with mastocytosis, they are usually only temporary and could be symptoms of the disease.

• Abdominal pain
• irritability
• muscle pain
• nausea
• trouble in sleeping

Applies to cromolyn: compounding powder, inhalation aerosol with adapter, inhalation solution, nasal spray, oral capsule, oral solution

General

Adverse reactions following use of this drug are rare; headache and diarrhea have been reported following oral use, while cough, nasal congestion, sneezing and wheezing have been reported with oral inhalation.[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis, laryngeal edema[Ref]

Respiratory

Frequency not reported: Pharyngitis, dyspnea, cough, nasal congestion, sneezing, wheezing, nasal itching, nose bleed, nose burning
Postmarketing reports: Bronchospasm, pulmonary infiltrates with eosinophilia, hoarseness[Ref]

Hematologic

Frequency not reported: Polycythemia, neutropenia, pancytopenia
Postmarketing reports: Anemia[Ref]

Genitourinary

Postmarketing reports: Dysuria, urinary frequency[Ref]

Dermatologic

Rare (less than 0.1%): Pruritus, rash
Frequency not reported: Urticaria/angioedema, erythema/burning, photosensitivity, purpura
Postmarketing reports: Photodermatitis, exfoliative dermatitis[Ref]

Gastrointestinal

Rare (0.01% to 0.1%): Abdominal pain, nausea,
Frequency not reported: Diarrhea, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, oesophagospasm, unpleasant taste, stomachache, mild throat irritation
Postmarketing reports: Swollen parotid gland[Ref]

Hepatic

Frequency not reported: Abnormal hepatic function test[Ref]

Cardiovascular

Frequency not reported: Flushing, tachycardia, premature ventricular contractions, palpitations, chest pain
Postmarketing reports: Periarteritic vasculitis, pericarditis[Ref]

Musculoskeletal

Rare (less than 0.1%): Myalgia
Frequency not reported: Arthralgia, stiffness/weakness of legs, lupus erythematosus syndrome
Postmarketing reports: Joint swelling and pain, polymyositis[Ref]

Nervous system

Rare (0.01% to 0.1%): Headache
Frequency not reported: Dizziness, hypoesthesia, paresthesia, migraine, convulsions
Postmarketing reports: Peripheral neuritis[Ref]

Psychiatric

Frequency not reported: Psychosis, anxiety, depression, hallucinations, behavior change, insomnia, nervousness[Ref]

Other

Frequency not reported: Fatigue, malaise, tinnitus
Postmarketing reports: Vertigo[Ref]

Ocular

Postmarketing reports: Lacrimation[Ref]

Some side effects of Intal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.