Drug Facts

Type of Drug:

Respiratory inhalant.

How the Cromolyn Sodium Works:

Cromolyn sodium is an antiasthmatic, antiallergic stabilizer of mast cells, which release histamine and slow-reacting substances of anaphylaxis. The decreased release of these and other chemicals assist in preventing constriction (narrowing) of the breathing airways in asthma and allergy attacks.

Uses of The Cromolyn Sodium:

Cromolyn Sodium and Intal: To prevent symptoms in the management of bronchial asthma, exercise-induced bronchospasm (spasm of breathing airways in the lungs), and acute bronchospasm due to environmental pollution and known allergens (chemicals that may produce an asthmatic or allergic reaction).

Nasalcrom: To prevent or treat symptoms of allergic rhinitis (eg, runny, itchy, stuffy nose; sneezing).

Unlabeled Uses: Oral use of cromolyn is being evaluated in patients with food allergies, eczema, ulcers, hives (chronic), and postexercise-induced bronchospasms.

Precautions:

Pregnancy: Safety for use during pregnancy has not been established. Use only if clearly needed and potential benefits to the mother outweigh the possible hazards to the fetus.

Breastfeeding: It is not known if cromolyn appears in breast milk. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness for use in children under 6 (nasal solution), 5 (aerosol), or 2 (nebulizer) years of age have not been established.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or if you are planning to take any over-the-counter or prescription medications or dietary supplements while taking cromolyn. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. Isoproterenol interacts with this medicine.

Side Effects of Cromolyn Sodium:

Every drug is capable of producing side effects. Many patients experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy, and individual susceptibility. Possible side effects include:

Aerosol: Dizziness; dry or irritated throat; joint swelling and pain; painful or difficult urination; urinary frequency; hives; skin inflammation; excessive eye tearing; swollen parotid gland.

Nasal Solution: Nasal stinging; nasal burning; postnasal drip.

Nebulizer Solution: Drowsiness; serum sickness; stomach ache.

Other: Headache; nausea; cough; wheezing; nasal irritation; sneezing; nosebleed; bad taste in mouth; rash.

Guidelines for Use:

• Use exactly as prescribed.
• Not for the treatment of an existing asthma attack. Only use when an asthma attack is under control and you can breathe well.
• Notify your doctor if coughing, wheezing, or other unusual symptoms Occur.
• Blow your nose before administering the nasal solution. If congested, use a shortacting topical decongestant before the solution. Nasal solution may cause mild stinging or sneezing, but this rarely requires stop­ping therapy.
• Instructions for use of inhalation devices accompany each product.
• Use continuously. Effectiveness depends on regularity of use. Do not stop therapy suddenly. Consult your doctor before stopping the drug.
• To prevent exercise-induced bronchospasm - Administer no longer than 1 hour before beginning exercise.
• If a dose is missed, inhale it as soon as possible. If several hours have passed or it is nearing time for the next dose, do not double the dose to catch up, unless advised to do so by your doctor. If more than one dose is missed or it is necessary to establish a new dosage schedule, contact your doctor or pharmacist.
• Improvement ordinarily occurs within the first 4 weeks of use. Improvement should be apparent by a decrease in the severity of symptoms and the need for other therapy (eg, oral steroids, inhaled bronchodilators).
• Long-term use is justified if cromolyn produces a significant reduction in frequency or severity of symptoms, permits reduction of doses Dr elimination of oral steroids, or improves management of patients experiencing intolerable side effects from other asthma drugs.
• If allergic rhinitis (eg, runny nose) is seasonal, continue treatment throughout exposure period. If it is year-round, continuous use may be necessary. Cromolyn use may decrease or eliminate the need for anti­histamines or decongestants.
• Store nebulizer solution, aerosol, and nasal solution at room temperature, away from light. Do not use nebulizer solution if it is discolored or contains particles. Do not puncture the aerosol container or store near heat, cold, or open flame. Keep away from children.

Type of Drug:

Nasal corticosteroids; anti-inflammatory agents.

How the Drug Works:

Intranasal steroids for inhalation shrink swollen and irritated nasal tissue primarily by reducing inflammation, but also by constricting blood vessels of the nasal mucosa.

Uses:

To relieve nasal symptoms of seasonal or perennial allergic rhinitis (eg, hay fever), which involves inflammation of the mucous membranes of the nasal passages. Symptoms of allergic rhinitis include itching of the nose and eyes, runny nose, postnasal drip, nasal congestion, and sneezing.

Budesonide and beclomethasone (spray): Used to treat non allergic perennial rhinitis in adults.

Precautions:

Changing from other dosage forms: Patients on long-term oral corticosteroids may lose their body’s natural ability to produce corticosteroid hormones. Switching or lessening current doses may cause symptoms of withdrawal (eg, joint or muscle pain, tiredness, depression). Therefore, taper dosage of oral steroid gradually and only with the instruction of a doctor.

Intranasal steroids: Intranasal steroids are absorbed into the blood stream.

Using higher than recommended doses may interfere with normal adrenal functions.

Nasal decongestants: In the presence of excessive nasal congestion, the drug may fail to reach the site of intended action. In such cases, use a nasal decongestant spray just before use during the first 2 to 3 days of therapy. Do not use a nasal decongestant spray for more than 3 consecutive days.

Pregnancy: Adequate studies have not been done in pregnant women. Use only if clearly needed and potential benefits outweigh the possible hazards to the fetus.

Breastfeeding: It is not known whether these drugs are excreted in breast milk. Other corticosteroids do appear in breast milk. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness in children under 3 years of age (mometasone), under 4 years of age (fluticasone), or under 6 years of age (beclomethasone, budesonide, flunisolide, triamcinolone) have not been established. Use is not recommended. May Suppress growth in children and teenagers with extended use.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or planning to take any over­ the-counter or prescription medications or dietary supplements while taking these drugs. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. The following drugs or drug classes interacts with these drugs:

• Cytochrome P-450 3A4 inhibitors (eg, erythromycin, ketoconazole, ritonavir)
• Glucocorticoids (eg, prednisone)
• Immunosuppressants (eg, methotrexate)

Side Effects:

Every drug is capable of producing side effects. Many patients experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy, and individual susceptibility. Possible side effects include:

Nervous System: Headache; light-headedness; dizziness; nervousness.

Digestive Tract: Nausea; vomiting; dry mouth; indigestion; diarrhea; stomach pain.

Eyes or Ocular: Watery eyes; eye disorders; eye infection; cataracts; dry or irritated eyes; glaucoma; blurred vision.

Respiratory System: Nasal or throat irritation; stinging; burning; dryness; nosebleed; runny nose; sneezing (especially in children); blood in nasal mucus; congestion; asthma; increased cough; sore throat; thrush or sores in nose or throat; nasal pain; difficulty breathing; wheezing.

Other: Joint or muscle pain; weakness; depression; sense of smell or taste changes; earache; ringing in ears; painful menstruation; fever; flu-like symptoms; aches and pains; herpes simplex; hoarseness; infection; voice changes; facial swelling; hives; rash; itching.

Guidelines for Use:

• Dosage is individualized. Take exactly as prescribed.
• Do not stop taking or change the dose, unless instructed by your doctor. Do not exceed the recommended dosage.
• Read and follow patient instructions provided with these products.
• If a dose is missed, take it as soon as possible. If several hours have passed or it is nearing time for the next dose, do not double the dose to catch up, unless instructed by your doctor. If more than one dose is missed, or it is necessary to establish a new dosage schedule, contact your doctor or pharmacist.
• Effects are not immediate. Product requires daily use, and improvement usually occurs in a few days. Improvement time varies with each patient. Consult your doctor if condition does not improve or worsens after 3 weeks of daily use.
• May cause irritation and drying of nasal mucosa. Contact your doctor if symptoms do not improve, if the condition worsens, if sneezing or nasal irritation occurs, or if symptoms do not improve within 3 weeks.
• Report any unusual fever, muscle or joint pain, weakness, sneezing, dizziness, nasal irritation, depression, or fluid retention to your doctor.
• Clear nasal passages prior to use by blowing the nose. If nasal pas­sages are congested or blocked, use a decongestant nasal spray just before use to ensure adequate penetration of the spray. Do not use the decongestant nasal spray for more than 3 consecutive days.

• Clean outer portion of the nose with a damp tissue and wash hands with soap and water after drug administration.
• Infection of the nose and throat by a fungus (Candida albicans) has been associated with chronic use. Such infection (thrush) may require stop­ping the intranasal steroid to treat the infection.
• Avoid exposure to chickenpox, measles, or other infections. Consult your doctor immediately if exposed.
• Nasal polyps - Treatment may have to be continued for several weeks or more before results can be fully assessed. Recurrence of symptoms due to polyps can occur after stopping treatment, depending on the severity of the disease.
• Inform your doctor if you are pregnant, become pregnant, planning to become pregnant, or are breastfeeding.
• Lab tests may be required if you are using this medicine for several months. Be sure to keep appointments.
• Beclomethasone - Beneficial effects may decrease when the aerosol canister is cold. This medicine comes in different strengths and dos­age forms. Products and use may not be interchangeable.
• Budesonide - Store with valve upward. After opening aluminum pouch, use within 6 months. Avoid storage in areas of high humidity.
• Fluticasone - Do not exceed more than 2 sprays per nostril per day. Adolescents and children should start at one spray per nostril per day.
• Mometasone -In patients with known seasonal allergies, preventive use is recommended 2 to 4 weeks prior to the start of pollen season. Store at room temperature (59° to 86°F) in a dry place. Store mometasone at 36° to 77° F. Protect from light and moisture.

Type of Drug:

Anti-asthma drug.

How the Drug Works:

Zileuton inhibits the formation of certain chemicals (leukotrienes) that are responsible for causing some forms of asthma. Montelukast and zafirlukast block the action of certain chemicals (leukotrienes) that are responsible for causing some forms of asthma.

These drugs are useful for controlling or preventing some forms of asthma but do not help during an acute asthma attack.

Uses:

For the prevention and chronic treatment of asthma in adult and children 2 years of age and older (montelukast), 7 years of age and older (zafirlukast), and 12 years of age and older (zileuton).

Precautions:

Phenylketonuria: Montelukast chewable tablets contain phenylalanine. Consult your doctor or pharmacist.

Pregnancy: There are no adequate and well controlled studies in pregnant women. Use only if clearly needed and potential benefits to the mother outweigh the possible hazards to the fetus.

Breastfeeding: Zafirlukast appears in breast milk. Do not breastfeed while taking zafirlukast. It is not known if zileuton or montelukast appear in breast milk. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness for use in children younger than 12 years of age (zileuton), younger than 5 years of age (zafirlukast), and younger than 2 years of age (montelukast) are not established.

Elderly: Patients older than 65 years of age are more likely to experience infections while taking zafirlukast. These infections are usually mild to moderate and mostly affect the respiratory tract.

Lab Tests: Lab tests may be required to monitor therapy. Tests may include breathing tests. Liver enzymes will be monitored with zileuton therapy.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or planning to take any over­the-counter or prescription medications or dietary supplements while taking a leukotriene receptor antagonist or formation inhibitor. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. The following drugs and drug classes may interact with leukotriene receptor antagonists or formation inhibitors:

• Aspirin (zafirlukast only)
• Calcium channel blockers (eg, nifidipine) (zafirlukast and zileuton only)
• Cyclosporine (eg, Sandimmune) (zafirlukast and zileuton only)
• Erythromycin (eg, E-Mycin) (zafirlukast only)
• Propranolol (eg, Inderal) (zileuton only)
• Theophylline (eg, Thea-Our) (zafirlukast and zileuton only)
• Warfarin (eg, Caumadin) (zafirlukast and zileuton only)

Side Effects:

Every drug is capable of producing side effects. Many equestrienne receptor antagonist or formation inhibitor users experience no, or minor, side effects. The frequency or severity of side effects depend on many factors including dose, duration of therapy, and individual susceptibility. Possible side effects include:

Nervous System: Headache; weakness; dizziness; sleeplessness; nervousness; drowsiness; fatigue.

Digestive Tract: Nausea; vomiting; diarrhea; stomach pain; indigestion; gas; constipation.

Other: Infection; accidental injury; generalized pain; muscle, chest, joint, leg, or back pain; fever; eye inflammation; stiffness; swollen lymph nodes; general body discomfort; neck pain; itching; urinary tract infection; inflammation of the vagina; flu; cough; nasal congestion; dental pain; rash; laryngitis; sore throat; ear pain or inflammation; sinus inflammation; viral infection; thirst; sneezing; hives; pus in the urine.

Guidelines for Use:

• Dosage is individualized. Take exactly as prescribed.
• These medicines are used for long-term control or prevention of asthma and should be taken regularly as prescribed, even during symptom­free periods. They should also be continued during acute exacerbations of asthma.
• Do not decrease the dose or stop taking any other asthma medications unless instructed by your doctor.
• Take affiliate 2 times a day on an empty stomach, at least 1 hour before or 2 hours after meals.
• Take zileuton 4 times a day with meals and at bedtime.
• Take montelukast once a day in the evening without regard to meals. Take with food if stomach upset occurs.
• If a dose is missed, take it as soon as possible. If several hours have passed or it is nearing time for the next dose, do not double the dose to catch up, unless advised by your doctor. If more than one dose is missed or it is necessary to establish a new dosage schedule, contact your doctor or pharmacist.
• May cause dizziness. Use caution when driving or performing other tasks requiring alertness, coordination or physical dexterity.
• These medicines are not broncobusters and should not be used as “rescue medicines” to treat acute episodes of asthma.
• Do not breastfeed while taking zafirlukast.
• Contact your doctor if you need your short acting broncobusters (”rescue medicines”) more often than usual.
• Contact your doctor if you are taking zileuton and experience right upper quadrant pain, nausea, tiredness, unconsciousness, itchiness, yellowing of the skin or the whites of the eyes, “flu-like” symptoms, or unusually dark urine.
• Lab tests may be required to monitor therapy. Be sure to keep appointments.
• Store at controlled room temperature (68° to 77°F). Protect from light and moisture.