Asmatab Tablet

Asmatab Tablet is manufactured by Veritas Pharmaceuticals Ltd. Asmatab Tablet contains 10 mg Montelukast Sodium. It is Leukotriene receptor antagonists class drug.

Montelukast is a selective leukotriene receptor antagonist that inhibits the effects of cysteinyl leukotrienes in the airways. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma, including airway oedema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Uses

Montelukast is used for- 

  • The prophylaxis and chronic treatment of asthma in adults and paediatric patients 12 months of age and older.
  • The relief of symptoms of seasonal allergic rhinitis in adults and paediatric patients 2 years of age and older.
Brand Name: Asmatab
Generic: Montelukast Sodium
Weight: 10 mg
Type: Tablet
Therapeutic Class: Leukotriene receptor antagonists
Manufacturer: Veritas Pharmaceuticals Ltd
Price: 14.04
Last Updated: June 9, 2021 at 3:00 pm

Dosage

Asmatab contains Montelukast Sodium 10 mg. Asmatab Dosage:

General information: Montelukast should be taken once daily. For asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualised to suit patients needs. Patients with both asthma and seasonal allergic rhinitis should take only one tablet daily in the evening.

Adults and adolescents 15 years of age and older with asthma or seasonal allergic rhinitis: The dosage is one 10 mg tablet daily.

Paediatric patients 6 to 14 years of age with asthma or seasonal allergic rhinitis: The dosage is one 5 mg tablet daily. No dosage adjustment within this age group is necessary.

Paediatric patients 2 to 5 years of age with asthma or seasonal allergic rhinitis: The dosage is one 4 mg tablet daily.

Paediatric patients 12 to 23 months of age with asthma: The dosage is one 4 mg tablet daily to be taken in the evening. Safety and effectiveness in paediatric patients younger than 12 months of age have not been established.

 

Side Effects

Adolescents and Adults 15 years of age and older: In placebo-controlled clinical trials, Montelukast has been evaluated for safety in approximately 2600 adolescent and adult patients of 15 years and older, the following adverse experiences reported with Montelukast occurred in greater than or equal to 1% of patients. 

  • General: Asthenia/fatigue, Fever, Pain
  • Gastrointestinal: Dyspepsia, Gastroenteritis; Nervous 
  • System/Psychiatric: Dizziness, Headache
  • Respiratory System: Congestion, Cough, Influenza
  • Skin: Rash; Laboratory adverse experiences: ALT increase, AST increase, Pyuria.

Paediatric patients 6 to 14 years of age: In paediatric patients receiving montelukast, the following events occurred with a frequency 2% are diarrhoea, laryngitis, pharyngitis, nausea, otitis, sinusitis, and viral infection. With prolonged treatment, the adverse profile did not change significantly.

Precaution

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks (in case of status asthmaticus). Patients with known aspirin sensitivity should continue avoidance of aspirin or other NSAID, while taking Montelukast.

In rare cases, patients on therapy with Montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with churg-strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. Physician should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between Montelukast and these underlying conditions has not been established.

Asmatab

Interaction

Montelukast 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 montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: Theophylline, Prednisolone, oral contraceptives (Norethindrone 1 mg/Ethinyl Oestradiol 35 mg), Terfenadine, Digoxin, and Warfarin.

Although additional specific interaction studies were not performed, Montelukast was used concomitantly with a wide range of commonly prescribed drugs in clinical studies without clinically evident adverse interactions. These medications included thyroid hormones, sedative hypnotic, non-steroidal anti-inflammatory agents, benzodiazepines, and decongestants.

Phenobarbital, which induces hepatic metabolism, decreased the AUC of Montelukast approximately 40% following a single 10 mg dose of Montelukast. No dosage adjustment for Montelukast is recommended. It is reasonable to employ appropriate clinical monitoring when potent cytochrome P450 enzyme inducers, such as Phenobarbital or Rifampin, are co-administered with Montelukast.

Pregnancy Lactation use

Pregnancy: Montelukast crosses the placenta following oral dosing in rats and rabbits. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Montelukast should be used during pregnancy only if clearly needed.

Lactation: It is not known if Montelukast is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Montelukast is given to a nursing mother.

Contraindication

Montelukast is contraindicated to patients with hypersensitivity to any component of this product.

Special Warning

Paediatric use: Safety and efficacy of Montelukast has been established in adequate and well controlled studies in paediatric patients with asthma and allergic rhinitis between age 1 to 14 years. Long term trials evaluatingthe effect of chronic administration of Montelukast on linear growth in paediatric patients have not been conducted.

Geriatric use: Of the total number of subjects in clinical studies of Montelukast, 3.5% were 65 years of age and over and 0.4% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. But greater sensitivity of some older individuals cannot be ruled out.

Acute Overdose

Symptoms: Abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. 

Management: Supportive and symptomatic treatment. If indicated, unabsorbed material should be removed from the GI tract.

Interaction with other Medicine

 

Storage Condition

Store at 25° C. Protect from moisture and light.

FAQ

What does Asmatab used for?

Asmatab helps stop your airways from narrowing (caused by inflammation). This makes breathing easier and prevents asthma attacks. Most people take Asmatab once a day in the evening. If you take it for asthma, it's important to take it even when you have no symptoms.

What is Montelukast?

Montelukast is a medication that can be used for the treatment of asthma, allergic rhinitis, and exercise-induced bronchoconstriction in the pill form. It is an anti-inflammatory agent that inhibits the leukotriene pathway by blocking receptors located in the cell walls of the lungs, preventing smooth muscle contraction, respiratory inflammation, and edema. These leukotrienes are also released from the nasal mucosa after allergen exposure, and Montelukast may inhibit symptoms associated with allergic rhinitis.

Does Asmatab a steroid?

Asmatab is a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and inflammation of the lining of the nose (allergic rhinitis). Asmatab does not contain a steroid.

Does Asmatab make me sleepy?

Asmatab doesn't cause drowsiness, but it can cause other side effects.

What are side effects of Asmatab?

Common side effects of Asmatab include upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache or ear infection, flu, runny nose, and sinus infection.

How safe is Asmatab?

Asmatab is generally safe and well tolerated; headache and gastrointestinal symptoms are the most commonly reported side effects. Other side effects include hypersensitivity reactions, sleep disorders, drowsiness, increased bleeding tendency, hallucination, and possible mood changes and suicidal thoughts.

Can I take Asmatab in the morning?

There were no statistical differences between taking the drug in the morning or evening.

Can Asmatab cause anxiety?

Taking Asmatab who exhibit mood changing behaviors should immediately report symptoms to a healthcare provider. These can include bad or vivid dreams, depression, disorientation or confusion, feeling anxious, hallucinations, irritability, restlessness, stuttering, and uncontrolled muscle movements.

Does Asmatab affect the liver?

Asmatab is an orally available leukotriene receptor antagonist which is widely used for the prophylaxis and chronic treatment of asthma and has been linked to rare cases of clinically apparent liver injury.

Does Asmatab used for itching?

Asmatab is also used to prevent exercise-induced bronchoconstriction (EIB) and treat symptoms of allergic rhinitis (hay fever), including seasonal (short-term) or perennial (long-term) allergic rhinitis, such as sneezing, runny nose, itching, or wheezing.

Does Asmatab help with allergies?

Asmatab can help decrease the number of times you need to use your quick relief inhaler. Asmatab is also used to relieve symptoms of hay fever and allergic rhinitis (such as sneezing, stuffy/runny/itchy nose).

What should I avoid while taking Asmatab?

Avoid situations or activities that may trigger an asthma attack. If your asthma symptoms get worse when you take aspirin, avoid taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs) while you are taking Asmatab.

What time should Asmatab be taken?

Asmatab is usually taken once a day with or without food. When Asmatab is used to treat asthma, it should be taken in the evening. When Asmatab is used to prevent breathing difficulties during exercise, it should be taken at least 2 hours before exercise.

How long does it take for Asmatab side effects to go away?

Asmatab will be in your system for approximately 30.3 hours. The mean plasma half-life of montelukast ranges from 2.7 to 5.5 hours in healthy young adults. This is the time it takes for your body to reduce the plasma levels by half.

Can I take Asmatab during pregnancy?

Asmatab can be taken in pregnancy only if your doctor considers it appropriate for you after assessing the benefits over risks. But consult your doctor before you start the medication.

Can I take Asmatab while breastfeeding?

It is safe to give Asmatab in breastfeeding women as it has shown no side effects on the infant.

Can I drive if I take Asmatab?

Asmatab does not affect your ability to drive a vehicle. If you feel dizzy or drowsiness after taking Asmatab, avoid driving or using machinery.

How Does Asmatab Work?

Asmatab blocks chemicals called leukotrienes in the body. These leukotrienes cause allergy symptoms, narrowing and swelling of the airways in the lungs. Thus by preventing these, Asmatab improves asthma symptoms and improves seasonal allergy symptoms.

What drugs interact with Asmatab?

Interactions with other medicines

  • Theophylline derivatives like Aminophylline
  • Anticonvulsant like Phenobarbital, Phenytoin
  • Anti-tubercular medicines like Rifampicin
  • Lipid-lowering medicine like Gemfibrozil

What is Asmatab used for?

Asmatab is used to control and prevent symptoms caused by asthma (such as wheezing and shortness of breath). It is also used before exercise to prevent breathing problems during exercise (bronchospasm). This medication can help decrease the number of times you need to use your quick relief inhaler.

Asmatab usually prescribed when asthma is mild and can stop it from getting worse. It can also help people with asthma who have breathing difficulties when they exercise (exercise-induced asthma) and seasonal allergies, such as sneezing, itchiness and a blocked or runny nose (allergic rhinitis).

Is Asmatab a steroid?

Asmatab is a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and inflammation of the lining of the nose (allergic rhinitis). Asmatab does not contain a steroid.

Why is Asmatab taken at night?

Asmatab is recommended to be taken in the evening. The effectiveness of this drug to prevent exercise-induced bronchoconstriction (EIB) in children was already evaluated.

What are the side effects of Asmatab?

The more common side effects that can occur with use of Asmatab:

  • upper respiratory infection (infection in the nose or throat)
  • fever
  • headache
  • sore throat
  • cough
  • stomach pain
  • diarrhea
  • earache or ear infection
  • flu
  • runny nose
  • sinus infection
  • bed-wetting in children

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

What are the long term side effects of Asmatab?

  • memory problems.
  • obsessive-compulsive symptoms.
  • restlessness.
  • sleepwalking.
  • stuttering.
  • suicidal thoughts and actions.
  • tremor or shakiness.
  • trouble sleeping.

Can I just stop taking Asmatab?

Do not stop taking these medicines and do not reduce the dose, even if your asthma seems better, unless you or your child are told to do so by your doctor. Talk to your doctor or get medical care right away if: Your or your child's symptoms do not improve after using this medicine or if they become worse.

What can you not take with Asmatab?

If your asthma symptoms get worse when you take aspirin, avoid taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs) while you are taking montelukast. NSAIDs include ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Is Asmatab safe during pregnancy?

Asmatab during pregnancy does not appear to increase the risk of major malformations above the 1% to 3% baseline in the general population. It is important that women are treated effectively for asthma during pregnancy to ensure the best outcome for the mothers.

Is Asmatab safe during breastfeeding?

Very low levels of Asmatab appear in breastmilk. Asmatab is approved for use in children as young as 6 months of age and has been used in neonates in dosages far greater than the amounts in breastmilk. Amounts ingested by the infant would not be expected to cause any adverse effects in breastfed infants.

How safe is Asmatab?

Asmatab oral tablet is used for long-term treatment. It comes with risks if you don't take it as prescribed. If you stop taking the drug suddenly or don't take it at all: You increase your risk of more frequent and more severe asthma attacks. Asthma that is not treated can lead to increased lung damage.

Who should not take Asmatab?

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Asmatab in children 1 year of age and older with asthma, children 6 years of age and older with exercise-induced bronchoconstriction, children 2 years of age and older with seasonal allergic.