Montelukast Sandoz

Montelukast Sandoz

montelukast

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Contents
Montelukast sodium.
Description
Excipients/Inactive Ingredients: Chewable Tablet 4- and 5-mg: Mannitol, microcrytalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, cherry flavour, cherry durarome TD0990B [contains the colouring agent allura red (E129)], aspartame (E951), red ferric oxide and magnesium stearate.
Film-Coated Tablet 10-mg: Core: Lactose monohydrate, hydroxyproplycellulose type EF, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. Coating: Hypromellose 6 cps, titanium dioxide (E171), macrogol 400, ferric oxide yellow (E172), ferric oxide red (E172).
Oral Granules: Mannitol, hydroxypropyl cellulose and magnesium stearate.
Action
Asthma is a long-term disease.
Asthma includes: Difficulty breathing because of narrowed airways (this narrowing of airways worsens and improves in response to various conditions); sensitive airways that react to many things eg, cigarette smoke, pollen, cold air or exercise; swelling (inflammation) in the lining of the airways.
Symptoms of Asthma: Coughing, wheezing and chest tightness.
Pharmacology: Montelukast sodium is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, montelukast sodium improves asthma symptoms and helps control asthma.
Indications/Uses
Chewable Tablet 4-mg and Oral Granules: Children 6 months to 5 years: Treatment for inadequately controlled medication as an additional therapy.
Children 2-5 years: Alternative treatment to inhaled corticosteroids for patients who have not recently taken oral corticosteroids for asthma and as a substitute to inhaled corticosteroids.
Children ≥2 years: Prevention of narrowing of airways triggered by exercise.
Chewable Tablet 5-mg: Children 6 to 14 years: Treatment for inadequately controlled medication as an additional therapy.
Children 6-14 years: Alternative treatment to inhaled corticosteroids for patients who have not recently taken oral corticosteroids for asthma and as a substitute to inhaled corticosteroids.
Children ≥6 years: Prevention of narrowing of airways triggered by exercise.
Film-Coated Tablet 10-mg: Treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom "as-needed" short acting beta-agonists provide inadequate clinical control of asthma. In those asthmatic patients in whom Montelukast Sandoz is indicated in asthma, Montelukast Sandoz Film-Coated Tab 10 mg can also provide symptomatic relief of seasonal allergic rhinitis.
Prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.
Montelukast Sandoz Film-Coated Tab 10 mg is indicated in adults and adolescents from the age of 15 years.
Dosage/Direction for Use
Chewable Tablet 4-mg: Children 2 to 5 years: One 4 mg chewable tablet daily to be taken in the evening. Montelukast Sandoz Chewable Tablet 4 mg should not be taken immediately with food. It should be taken at least 1 hour before or 2 hours after a meal.
Montelukast Sandoz Chewable Tablets 4 mg are not recommended in children below 2 years of age.
Chewable Tablet 5-mg: Children 6 to 14 years: One 5 mg chewable tablet daily to be taken in the evening. Montelukast Sandoz Chewable Tablet 5 mg should not be taken immediately with food. It should be taken at least 1 hour before or 2 hours after a meal.
Montelukast Sandoz Chewable Tablets 5 mg are not recommended in children below 6 years of age.
Film-Coated Tablet 10-mg: Asthma or Asthma and Concomitant Seasonal Allergic Rhinitis: Adults and Adolescents ≥15 years: One 10-mg tablet daily to be taken in the evening.
Oral Granules: Children 6 months to 5 years: 1 sachet each evening.
Missed Dose: Resume the usual schedule of 1 tablet/sachet once daily. Do not give double dose to make up for a missed dose.
Administration: For oral use.
Chewable Tablets: It should be given to a child under adult supervision. It should be taken even when the child has no symptoms or if he/she has an acute asthma attack.
If the child is taking Montelukast Sandoz Chewable Tablet, be sure that he/she does not take any other medicines that contain the same active ingredient, i.e. montelukast.
If the child takes more Montelukast Sandoz Chewable Tablet than he/she should, contact the child’s physician immediately for advice.
Discontinuation of Treatment: Montelukast Sandoz Chewable Tablet can treat the child’s asthma only if the child continues taking it. It is important for the child to continue taking Montelukast Sandoz Chewable Tablet for as long as the physician prescribes. It will help control the child’s asthma.
Film-Coated Tablet 10-mg: The therapeutic effect of Montelukast Sandoz Film-Coated Tab 10 mg on parameters of asthma control occurs within one day. Montelukast Sandoz Film-Coated Tab 10 mg may be taken with or without food. Patients should be advised to continue taking Montelukast Sandoz even if asthma is under control, as well as during periods of worsening asthma.
Montelukast Sandoz Film-Coated Tab 10 mg should not be used concomitantly with other products containing the same active ingredient, montelukast.
No dosage adjustment is necessary for the elderly or for the patients with renal insufficiency or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients.
Therapy with Montelukas Sandoz Film-Coated Tab 10 mg in relation to other treatment for asthma. It can be added to a patient's existing treatment regimen.
Inhaled Corticosteroids: Treatment with Montelukast Sandoz Film-Coated Tab 10 mg can be used as add-on therapy in patients when inhaled corticosteroids plus "as needed" short-acting β-agonist provide inadequate clinical control. Montelukast Sandoz Film-Coated Tab 10 mg should not be subtituted for inhaled corticosteriods (see Precautions).
Montelukast Sandoz Film-Coated Tab 10 mg should not be used in children <15 years due to the high content of active substance.
Other dosage forms with appropriate strengths are available for young children.
Oral Granules: Montelukast Sandoz can be given either directly in the mouth or mixed with a spoonful of cold or room temperature soft food (eg, applesauce, ice cream, carrots and rice).
Do not dissolve granules in water. However, the patient may take liquids after swallowing the granules.
Overdosage
No specific information is available on the treatment of overdose with montelukast. In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to patients for 22 weeks and in short-term studies, up to 900 mg/day to patients for approximately 1 week without clinically important adverse experiences.
There have been reports of acute overdose in post-marketing and clinical studies with montelukast. These includes reports in adults and children with a dose as high as 1,000 mg (approximately 61 mg/kg in a 42-month old child). The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients. There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity.
It is not known whether montelukast is dialyzable by peritoneal or hemodialysis.
Contraindications
Hypersensitivity to montelukast or to any excipients of Montelukast Sandoz.
Special Precautions
Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available. If an acute attack occurs, a short-acting inhaled β-agonist should be used. Patients should seek the physician's advice as soon as possible if more inhalations of short-acting β-agonists than usual.
Montelukast should not be substituted for inhaled or oral corticosteroids.
There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.
In rare cases, patients on therapy with antiasthma agents including 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. These cases usually, not always, have been associated with the reduction or withdrawal of oral corticosteroid therapy. The possibility that leukotriene receptor antagonists may be associated with emergence of Churg-Strauss syndrome can neither be excluded nor established. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications and/or neuropathy presenting in patients. Patients who develop these symptoms should be reassessed and the treatment regimens evaluated.
Treatment with montelukast does not alter the need for patients with aspirin-sensitive asthma to avoid taking aspirin and other nonsteroidal anti-inflammatory drugs.
Chewable Tablet 4- and 5-mg: If the child’s asthma or breathing gets worse, tell the physician immediately.
Montelukast Sandoz Chewable Tablet is not meant to treat acute asthma attacks. If an attack occurs, follow the physician’s instructions. Always have the inhaled rescue medicine for asthma attacks with the child.
It is important that the child takes all asthma medications prescribed by the physician. Montelukast Sandoz Chewable Tablet should not be used instead of other asthma medications the physician has prescribed for the child. If the child is on anti-asthma medicines, be aware that if he/she develops a combination of symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, the physician should be consulted.
The child should not take acetyl-salicylic acid or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.
Montelukast Sandoz Chewable Tablets contain aspartame, a source of phenylalanine. Can be harmful for people with phenylketonuria (a rare, hereditary disorder of the metabolism) .
Montelukast Sandoz Chewable Tablet contains phenylalanine (0.593 mg phenylalanine per one 4 mg chewable tablet and 0.674 mg phenylalanine per one 5 mg chewable tablet) .
Montelukast Sandoz Chewable Tablet chewable tablets contain colouring agent Allura red (E129) which may cause allergic reactions.
Film-Coated Tablet 10-mg: Montelukast Sandoz film-coated tablet contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on the Ability to Drive or Operate Machinery: Montelukast is not expected to affect the patient's ability to drive a car or operate machinery. However, in very rare cases, individuals have reported drowsiness or dizziness.
Use in Children: Chewable Tablet 4-mg: Not recommended in children <2 years. Chewable Tablet 5-mg: Not recommended in children <6 years. Film-Coated Tablet 10-mg: Should not be used in children <15 years. Oral Granules: Not recommended in children <6 months.
Use In Pregnancy & Lactation
Use in Pregnancy: Animal studies do not indicate harmful effects with respect to effects on pregnancy or embryonal/fetal development. Limited data from available pregnancy database do not suggest a causal relationship between Montelukast Sandoz and malformations (ie, limb defects) that have been rarely reported in worldwide post-marketing experience.
Montelukast Sandoz Film-Coated Tab 10 mg may be used during pregnancy only if it is considered to be clearly essential.
Use in Lactation: It is not known if Montelukast Sandoz appears in breast milk. Consult the physician before taking Montelukast Sandoz if the patient is breast-feeding or intend to breast-feed. Studies in rats have shown that montelukast is excreted in milk. It is not known if montelukast is excreted in human milk. Montelukast Sandoz Film-Coated Tab 10 mg may be used in nursing mothers only if it is considered to be clearly essential.
Adverse Reactions
Chewable Tablet 4- and 5-mg: Like all medicines, Montelukast Sandoz Chewable Tablet can cause side effects, although not everybody gets them.
In clinical studies with Montelukast Sandoz Chewable Tablet 4 mg, the most commonly reported side effects (occurring in 1 to 10 out of 100 patients) thought to be related to montelukast were abdominal pain and thirst.
In clinical studies with Montelukast Sandoz Chewable Tablet 5 mg, the most commonly reported side effects (affects 1 to 10 users in 100) thought to be related to montelukast was headache.
These were usually mild and occurred at a greater frequency in patients treated with montelukast than placebo (a tablet containing no medication).
Additionally, while the medicine has been on the market, the following have been reported: Increased bleeding tendency; allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing; behaviour and mood related changes [dream abnormalities, including nightmares, hallucinations, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, tremor, depression, trouble sleeping, sleep walking, suicidal thoughts and actions (in very rare cases)]; dizziness, drowsiness, pins and needles/numbness, epileptic seizure; palpitations (rapid, pounding heartbeat); nosebleed; diarrhoea, dry mouth, indigestion, nausea, vomiting; inflammation of the liver; bruising, itching, hives, tender red lumps under the skin most commonly on your shins (erythema nodosum); joint or muscle pain, muscle cramps; tiredness, feeling unwell, swelling, fever.
In asthmatic patients treated with montelukast, very rare cases (in less than 1 out of 10,000 patients) of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported. Tell the physician right away if the child gets one or more of these symptoms.
Ask the physician or pharmacist for more information about side effects. If any of the side effects gets serious, or if any side effects is noticed, tell the child’s doctor or pharmacist.
Film-Coated Tablet 10-mg: Montelukast has been evaluated in clinical studies as follows: 10-mg film-coated tablet in approximately 4,000 adult asthmatic patients ≥15 years.
10-mg film-coated tablet in approximately 400 adult asthmatic patients with seasonal allergic rhinitis ≥15 years.
5-mg chewable tablet in approximately 1,750 pediatric asthmatic patients 6-14 years.
The following drug-related adverse reactions in clinical studies were reported commonly (≥1/100 to <1/10) in asthmatic patients treated with montelukast and at a greater incidence than in patients treated with placebo. (See Table 1.)

Click on icon to see table/diagram/image

With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults, and up to 12 months for paediatric patients 6-14 years, the safety profile did not change.
Post-Marketing Experience: Adverse reactions reported in post-marketing use are listed by system organ class and specific adverse experience term as follows (see Table 2). Frequency categories were estimated based on relevant clinical trials.

Click on icon to see table/diagram/image

Oral Granules: Montelukast Sandoz Oral Granules can cause side effects, although not everybody gets them. In clinical studies with montelukast, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to montelukast were diarrhoea, hyperactivity, asthma, scaly and itchy skin and rash.
Drug Interactions
Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: Theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
The area under the plasma concentration curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of phenobarbital. Since montelukast is metabolised by CYP 3A4, caution should be exercised, particularly in children, when montelukast is co-administered with inducers of CYP 3A4 e.g., phenytoin, phenobarbital and rifampicin.
In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8. However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of drugs primarily metabolized by CYP 2C8) demonstrated that montelukast does not inhibit CYP 2C8 in vivo. Therefore, montelukast is not anticipated to markedly alter the metabolism of drugs metabolized by this enzyme (e.g., paclitaxel, rosiglitazone and repaglinide).
Montelukast Sandoz Chewable Tablet should not be taken immediately with food. They should be taken at least 1 hour before or 2 hours after a meal.
Caution For Usage
Instructions for Use, Storage and Handling: Sachet: Do not open the sachet until ready to use.
Mix the granules into a spoonful of cold or room temperature soft food. The entire dose must be mixed with the food.
Be sure the child is given the entire spoonful of the granule/food mixture immediately (within 15 min). Never store any granule/food mixture for use at a later time.
Montelukast Sandoz oral granules are not intended to be dissolved in liquid. However, the child may take liquids after swallowing the granules. It can be taken without regard to the timing of food intake.
Do not dispose via wastewater or household waste.
Storage
Protect from light and moisture.
ATC Classification
R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
Presentation/Packing
Chewable tab 4 mg (oval pink to slightly speckled pink tablet with odour of cherry, debossed with "4" on one side) x 28's. 5 mg (round pink to slightly speckled pink tablet with odour of cherry, debossed with "5" on one side) x 28's. FC tab 10 mg (beige, squared, biconvex, encoded "10" on one side) x 28's. Oral granules (white to off-white granules, sachet) 4 mg x 28's.
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