Airon tablets

Airon

  • Active Ingredient: Montelukast
  • 10 mg, 5 mg, 4 mg
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What is Airon?

The active ingredient of Airon brand is montelukast. Montelukast is a leukotriene (loo-koe-TRY-een) inhibitor. Leukotrienes are chemicals your body releases when you breathe in an allergen (such as pollen). These chemicals cause swelling in your lungs and tightening of the muscles around your airways, which can result in asthma symptoms.

Used for

Airon is used to treat diseases such as: Allergic Rhinitis, Asthma, Asthma, Maintenance, Bronchospasm Prophylaxis, COPD.

Side Effect

Possible side effects of Airon include: upper right abdominal or stomach pain; hives or welts; flu-like symptoms; anxiety; blurred vision; skin rash, encrusted, scaly and oozing; swollen joints.

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What are the side effects of Airon?

The most common side effects with Airon are:

Other important side effects include:

Elevated liver enzymes, suicidal behavior, fluid retention, depression, and hallucinations have also been reported.

Phenobarbital, which induces hepatic metabolism, decreased the area under the plasma concentration curve (AUC) of Airon approximately 40% following a single 10-mg dose of Airon. No dosage adjustment for SINGULAIR is recommended. It is reasonable to employ appropriate clinical monitoring when potent CYP enzyme inducers, such as phenobarbital or rifampin, are co-administered with SINGULAIR.

Nursing Mothers

Studies in rats have shown that Airon is excreted in milk. It is not known if Airon is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SINGULAIR is given to a nursing mother.

SINGULAIR has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. In drug-interaction studies, the recommended clinical dose of Airon did not have clinically important effects on the pharmacokinetics of the following drugs: theophylline, prednisone, and prednisolone.

Airon at a dose of 10 mg once daily dosed to pharmacokinetic steady state, did not cause clinically significant changes in the kinetics of a single intravenous dose of theophylline . Airon at doses of ≥ 100 mg daily dosed to pharmacokinetic steady state, did not cause any clinically significant change in plasma profiles of prednisone or prednisolone following administration of either oral prednisone or intravenous prednisolone.

How to store Airon

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

What Are Side Effects Associated with Using Airon?

Some adverse drug reactions vary by age group

Common side effects of Airon include:

Less common side effects of Airon include:

Postmarketing side effects of Airon reported include:

  • Hematologic: Increased bleeding tendency, thrombocytopenia
  • Immunologic: Hypersensitivity reactions (e.g., anaphylaxis, hepatic eosinophilic infiltration)
  • Psychiatric: Agitation, including aggressive behavior or hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, irritability, restlessness, sleepwalking, suicidal thinking and behavior (including suicide), tremor
  • Neurologic: Drowsiness, numbness and tingling, reduced sense of touch, seizures
  • Cardiac: Palpitations
  • Respiratory, thoracic, mediastinal: nosebleed, pulmonaryeosinophilia
  • Gastrointestinal: Diarrhea, indigestion, nausea, pancreatitis, vomiting
  • Hepatobiliary: Cases of cholestatic hepatitis, hepatocellular liver injury, and mixed-pattern liver injury have been reported, mostly occurring in combination with other confounding factors (e.g., use of other medications, administration to patients who had underlying potential for liver disease )
  • Dermatologic: Skin swelling, bruising, erythema multiforme, erythema nodosum, itching, hives
  • Musculoskeletal: Jointpain, muscle pain (including muscle cramps)
  • General: Swelling (edema)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

How it works

Airon belongs to a class of drugs called leukotriene receptor antagonists. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Leukotriene receptor antagonists help decrease inflammation and nasal congestion. This can help prevent reactions to triggers by keeping the airways to your lungs open. This helps improve symptoms of asthma as well as seasonal and year-round allergies. It also helps prevent breathing problems during or after exercise.

Airon oral tablet doesn’t cause drowsiness, but it can cause other side effects.

Hepatotoxicity

In clinical trials, mild elevations in serum aminotransferase levels were found in 1% to 2% of patients taking Airon chronically, but similar rates are reported in matched placebo recipients. The ALT abnormalities were usually mild, asymptomatic and self limited. Clinically apparent liver injury from Airon is rare; but more than a dozen cases reported in the literature. In these cases, the latency to onset of injury was highly variable, ranging from a few days to several years. Patients presented with anorexia, nausea, right upper quadrant pain, dark urine, and jaundice. The pattern of enzyme elevation was usually mixed, but both hepatocellular or cholestatic patterns have been reported. Allergic features and autoantibody formation were rare. Eosinophilia was often reported, but this may have been due to the underlying allergic condition rather than the liver injury. The injury usually resolved within 1 to 4 months of stopping the drug.

Likelihood score: B (rare but likely cause of clinically apparent liver injury).

Q: Does Singulair cause weight gain, moodiness, and anxiety? Can you tell me the symptoms that I may experience?

A: Singulair (Airon) (//www.everydayhealth.com/drugs/singulair) is a leukotriene inhibitor. Leukotrienes are chemicals that the body releases when allergies are breathed in. Singulair is indicated for the treatment of asthma and allergies. Common side effects reported with Singulair include headache, upset stomach, nausea and diarrhea, tiredness, sore throat and cough. A search of prescribing information for Singulair did not specifically list weight gain as a side effect. (//www.everydayhealth.com/allergies/guide/). Drugs can cause weight gain in several different ways. Some can increase appetite or make you crave certain types of foods like those high in carbohydrates or fat. Other medications may slow down metabolism or cause fluid retention. However, the effect of prescription drugs on body weight is complex. Some drugs have no effect on weight, while others cause weight gain or weight loss. Also, the same medications can cause weight gain in certain individuals and weight loss in others. There are also drugs that initially cause weight loss and then lead to weight gain with long-term use. Most prescription medications associated with changes in body weight affect the central nervous system. These include antidepressants like monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, and selective serotonin reuptake inhibitors (SSRIs). Mood stabilizers (lithium, valproic acid), antipsychotics, and anticonvulsants have also been linked with weight gain. Other drugs that have been reported to cause weight gain include diabetes medications (insulin, sulfonylureas, and thiazolidinediones), antihypertensive drugs, certain hormonal contraceptives, corticosteroids, antihistamines, some chemotherapy regimens, and antiretroviral protease inhibitors. If you think a drug you are taking is causing weight gain, tell your health care provider. Do not stop any medication or change the dose without first talking to your provider. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Kimberly Hotz, PharmD

Pharmacodynamics

Airon causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD4 in asthmatics. Doses as low as 5 mg cause substantial blockage of LTD4-induced bronchoconstriction. In a placebo-controlled, crossover study (n=12), SINGULAIR inhibited early- and late-phase bronchoconstriction due to antigen challenge by 75% and 57%, respectively.

The effect of SINGULAIR on eosinophils in the peripheral blood was examined in clinical trials. In patients with asthma aged 2 years and older who received SINGULAIR, a decrease in mean peripheral blood eosinophil counts ranging from 9% to 15% was noted, compared with placebo, over the doubleblind treatment periods. In patients with seasonal allergic rhinitis aged 15 years and older who received SINGULAIR, a mean increase of 0.2% in peripheral blood eosinophil counts was noted, compared with a mean increase of 12.5% in placebo-treated patients, over the double-blind treatment periods; this reflects a mean difference of 12.3% in favor of SINGULAIR. The relationship between these observations and the clinical benefits of Airon noted in the clinical trials is not known .

Warnings

  • This medication contains Airon
  • Do not take Singulair if you are allergic to Airon or any ingredients contained in this drug
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Q: Are there alternative medications to Singulair?

A: Inhibition of leukotrienes, fatty compounds produced by the immune system that cause inflammation, potentially plays a role in the treatment of asthma and other allergic conditions such as allergic rhinitis, atopic dermatitis, and chronic urticaria. Leukotriene inhibitors are either leukotriene receptor antagonists or leukotriene synthesis inhibitors, which act by blocking 5-lipoxygenase activity. The leukotriene receptor antagonists include zafirlukast (Accolate) and Airon (Singulair); zileuton (Zyflo) is the only leukotriene synthesis inhibitor. Airon is used to treat asthma, and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma. Zafirlukast and zileuton are used to treat asthma. Accolate is approved for treatment of asthma in patients seven years or older. The most common side effects reported with Accolate include pharyngitis, headache, rhinitis, and gastritis. Zyflo is approved for treatment of chronic asthma in patients 12 years or older. The most common side effects reported with Zyflo include dyspepsia, abdominal pain, and nausea. Leukotriene inhibitors have been shown to be more effective than placebo but less effective than inhaled corticosteroids in treating persistent asthma. However, leukotriene inhibitors are less effective than inhaled corticosteroids or long-acting beta2 agonists against asthma. For exercise-induced asthma, leukotriene inhibitors are as effective as long-acting beta2-agonist bronchodilators and are superior to placebo; they have not been compared with short-acting bronchodilators. Leukotriene inhibitors are as effective as antihistamines but are less effective than intranasal steroids for the treatment of allergic rhinitis. The use of leukotriene inhibitors in treating atopic dermatitis, aspirin-intolerant asthma, and chronic idiopathic urticaria appears promising but has not been studied thoroughly.

Q: What is Singulair?

A: Singulair (Airon) is a leukotriene receptor blocker used to help control symptoms of asthma in adults and children 12 months and older, and for relief of symptoms of indoor and outdoor allergies (outdoor allergies in adults and children as young as 2 years, and indoor allergies in adults and children as young as 6 months). In clinical studies of patients with asthma, those who took a placebo were compared with those who were treated with Singulair. Patients on Singulair had less usage of fast-acting inhalers, fewer daily asthma symptoms, fewer awakenings at night due to asthma symptoms, fewer asthma attacks, and more days that asthma was controlled. The most common side effects with Singulair include stomach pain, stomach or intestinal upset, heartburn, tiredness, fever, stuffy nose, cough, flu, upper respiratory infection, dizziness, headache, and rash. Singulair may cause serious side effects. Behavior and mood-related changes have been reported: agitation including aggressive behavior or hostility, bad or vivid dreams, depression, disorientation (confusion), feeling anxious, hallucinations (seeing or hearing things that are not really there), irritability, restlessness, sleepwalking, suicidal thoughts and actions (including suicide), tremor, and trouble sleeping. Patients should be advised to take Singulair once daily in the evening as prescribed, even when they are asymptomatic, as well as during periods of worsening asthma. Singulair is not for the treatment of acute asthma attacks.

Generic Names

  • Airon (OS: BAN)
  • Montélukast (OS: DCF)
  • Airon Sodium (OS: USAN, BANM, JAN)
  • L 706631 (Merck) (IS)
  • MK 0476 (Merck) (IS)
  • MK 476 (Merck) (IS)
  • Montélukast sodique (PH: Ph. Eur. 9)
  • Airon Sodium (PH: BP 2018, USP 41)
  • Airon sodium (PH: JP XVII, Ph. Eur. 9.1)
  • Airon-Natrium (PH: Ph. Eur. 9.1)
  • Aironum natricum (PH: Ph. Eur. 9.1)

Q: I stopped taking Singulair as of yesterday. How long does it take before the drug is completely out of your system? I can't seem to find a definitive answer on the internet and it is so hard to get hold of the doctor who prescribed it.

A: A medication's half-life is the time it takes for the plasma concentration of a drug to reach half of its original concentration. More simply put, the half-life of a drug is how long it takes for half of it to be eliminated from the bloodstream. The half-life of Singulair (Airon) is approximately 5.5 hours in healthy adults. The full amount of medication will be out of your system in 30 hours at the most. Lori Poulin, PharmD

Outcome and Management

Liver injury from Airon is self limited and resolves in 1 to 4 months. Rechallenge with Airon may lead to recurrence and should be avoided. Use of other leukotriene receptor antagonists has been reported to be safe, but should be done with caution.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all patients taking this medicine (Airon tablets):

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs or symptoms of depression, suicidal thoughts, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life.
  • Signs of a very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
  • Hallucinations (seeing or hearing things that are not there).
  • Memory problems or loss.
  • Feeling confused, not able to focus, or change in behavior.
  • Strange or odd dreams.
  • Trouble sleeping.
  • Trouble speaking.
  • Restlessness.
  • Sleepwalking.
  • Shakiness.
  • Trouble controlling body movements.
  • Seizures.
  • Trouble breathing that is new or worse.
  • Fever.
  • Flu-like signs.
  • Sinus pain.
  • Chest pain.
  • A heartbeat that does not feel normal.
  • Any unexplained bruising or bleeding.
  • A burning, numbness, or tingling feeling that is not normal.
  • Ear pain.
  • Muscle or joint pain.
  • Swelling.

What are some things I need to know or do while I take Airon Tablets?

For all uses of this medicine (Airon tablets):

  • Tell all of your health care providers that you take this medicine (Airon tablets). This includes your doctors, nurses, pharmacists, and dentists.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

For breathing problems:

  • Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
  • If you take this medicine (Airon tablets) for asthma or allergy, do not take another dose to prevent exercise-induced breathing problems.
  • If you have asthma and taking aspirin makes it worse, keep avoiding aspirin and NSAIDs while you take this medicine (Airon tablets).
  • If you are switching to this medicine (Airon tablets) from a steroid, do not stop taking the steroid all of a sudden. The dose of the steroid may need to be slowly lowered to avoid side effects. Talk with the doctor.

Asthma

SINGULAIR should be taken once daily in the evening. The following doses are recommended:

For adults and adolescents 15 years of age and older: one 10-mg tablet.

For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.

For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg oral granules.

For pediatric patients 12 to 23 months of age: one packet of 4-mg oral granules.

Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.

There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of Airon are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when Airon was administered in the evening without regard to time of food ingestion.


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