Brondilat tablets

Brondilat

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

The active ingredient of Brondilat 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

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

Side Effect

Possible side effects of Brondilat include: headache; swollen joints; blurred vision; fast, irregular, pounding, or racing heartbeat or pulse; change in near or distance vision; pain or tenderness around the eyes and cheekbones; muscle aching or cramping.

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What Is Brondilat and How Does It Work?

Brondilat is used regularly to prevent the wheezing and shortness of breath caused by asthma and decrease the number of asthma attacks. Brondilat is also used before exercise to prevent breathing problems. This medication can help decrease the number of times you need to use your rescue inhaler. This medication is also used to relieve symptoms of hay fever and allergic rhinitis (such as sneezing, stuffy/runny/itchy nose).

This drug works by blocking certain natural substances (leukotrienes) that may cause or worsen asthma and allergies. It helps make breathing easier by reducing swelling (inflammation) in the airways.

Brondilat is available under the following different brand names: Singulair.

Dosages of Brondilat:

Dosage Forms & Strengths

Dosage Considerations – Should be Given as Follows:

  • Adult: 10 mg (single 10-mg tablet) orally once daily in evening
  • Children under 12 months: Safety and efficacy not established
  • Children 12-24 months: 4 mg (granules) orally once daily in evening
  • Children 2-6 years: 4 mg (chewable tablet or granules) orally once daily in evening
  • Children 6-15 years: 5 mg (chewable tablet) orally once daily in evening
  • Children over 15 years: 10 mg (conventional tablet) orally once daily in evening

  • 7.5 mg/day orally at bedtime; increase by 7.5-15 mg/day no more frequently than every 1-2 weeks; not to exceed 60 mg/day

  • Adult: 10 mg orally 2 hours before exercise; do not take additional dose within 24 hours
  • Children 6-15 years: 5 mg (chewable tablet) orally 2 hours before exercise; do not take additional dose within 24 hours
  • Children over 15 years: 10 mg orally 2 hours before exercise; do not take additional dose within 24 hours
  • If taking drug for another indication, do not take additional dose to prevent EIB

Allergic or Perennial Rhinitis

  • Adult: 10 mg (single 10-mg tablet) orally once daily
  • Children under 6 months: Safety and efficacy not established
  • Children 6-24 months: 4 mg (granules) orally once daily
  • Children 2-6 years: 4 mg (chewable tablet or granules) orally once daily
  • Children 6-15 years: 5 mg (chewable tablet) orally once daily
  • Children over 15 years: 10 mg (conventional tablet) orally once daily

Seasonal Allergic Rhinitis, Pediatric

  • Children under 2 years: Safety and efficacy not established
  • Children 2-6 years: 5 mg (chewable tablet) or 4 mg (granules) orally once daily
  • Children 6-15 years: 5 mg (chewable tablet) orally once daily
  • Children over 15 years: 10 mg (conventional tablet) orally once daily

  • Patients aged 12 years and older with both asthma and allergic rhinitis: 1 dose orally at bedtime
  • Patients with allergic rhinitis: Dosing time may be individualized to patient needs
  • Granules may be taken directly; mixed in applesauce, carrots, rice, or ice cream; or dissolved in 5 mL of breast milk or baby formula (administer within 15 minutes of opening)

  • Appropriate use warning: You should not use this drug if you have a sudden asthma attack. Also, don’t use it to treat status asthmaticus. This is a severe asthma attack that doesn’t respond to treatment with an inhaler. It’s a medical emergency. This drug should also not be used in place of inhaled or oral corticostero >

Brondilat is a prescription drug. It comes as a tablet that can be swallowed whole, or as a chewable tablet. It’s also available as granules that can be dissolved in liquid or soft food.

Brondilat oral tablet is available as the brand-name drug Singulair. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications.

No teratogenicity was observed at oral doses up to 400 mg/kg/day and 300 mg/kg/day in rats and rabbits, respectively. These doses were approximately 100 and 110 times the maximum recommended daily oral dose in adults, respectively, based on AUCs. Brondilat crosses the placenta following oral dosing in rats and rabbits .

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Brondilat – Generic, Singulair®

Product labeling at DailyMed, National Library of Medicine, NIH

Mechanism of Liver Injury

The cause of hepatotoxicity from Brondilat is not known, but the rare incidence, absence of immunoallergic features and long latency period suggest that it is not due to hypersensitivity but rather to altered metabolism. Brondilat is metabolized by the cytochrome P450 system, predominantly by CYP 2C8 but also by CYP 3A4 and 2C9, but it appears to have few clinically significant drug-drug interactions. Nevertheless, the rare instances of hepatotoxicity attributed to Brondilat may be caused by formation of toxic or immunogenic intermediates during its metabolism.

Q: Can Singulair cause you to have a cough and hoarseness?

A: Singulair (Brondilat) is a medication used to treat asthma. Cough is not listed as a side effect, but since hoarseness is, the hoarseness itself may lead to a cough. It is recommended that you contact your doctor if you experience these side effects, as this medication may not be right for you. Other common side effects may include headache, dizziness, heartburn, stomach pain, and tiredness. This is not a complete list of the side effects associated with Singulair. 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. When your doctor prescribes a new medication, be sure to discuss all your prescription and over-the-counter drugs, including dietary supplements, vitamins, botanicals, minerals, and herbals, as well as the foods you eat. Always keep a current list of the drugs and supplements you take and review it with your health care providers and your pharmacist. If possible, use one pharmacy for all your prescription medications and over-the-counter products. This allows your pharmacist to keep a complete record of all your prescription drugs and to advise you about drug interactions and side effects. Tell your health care provider about any negative side effects from prescription drugs. You can also report them to the U.S. Food and Drug Administration by visiting www.fda.gov/medwatch or by calling 1-800-FDA-1088. 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. Patti Brown, PharmD

In the US, Brondilat (Brondilat systemic) is a member of the drug class leukotriene modifiers and is used to treat Allergic Rhinitis, Asthma, Asthma - Maintenance, Bronchospasm Prophylaxis and COPD.

Can Brondilat cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains the most common ones associated with Brondilat. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Allergic Rhinitis

For allergic rhinitis, SINGULAIR should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when Brondilat was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.

The following doses for the treatment of symptoms of seasonal allergic rhinitis 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.

Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.

The following doses for the treatment of symptoms of perennial allergic rhinitis 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 6 to 23 months of age: one packet of 4-mg oral granules.

Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.

Brondilat is rapidly absorbed following oral administration. After administration of the 10-mg filmcoated tablet to fasted adults, the mean peak Brondilat plasma concentration (Cmax) is achieved in 3 to 4 hours (Tmax). The mean oral bioavailability is 64%. The oral bioavailability and Cmax are not influenced by a standard meal in the morning.

For the 5-mg chewable tablet, the mean Cmax is achieved in 2 to 2.5 hours after administration to adults in the fasted state. The mean oral bioavailability is 73% in the fasted state versus 63% when administered with a standard meal in the morning.

For the 4-mg chewable tablet, the mean Cmax is achieved 2 hours after administration in pediatric patients 2 to 5 years of age in the fasted state.

The 4-mg oral granule formulation is bioequivalent to the 4-mg chewable tablet when administered to adults in the fasted state. The co-administration of the oral granule formulation with applesauce did not have a clinically significant effect on the pharmacokinetics of Brondilat. A high fat meal in the morning did not affect the AUC of Brondilat oral granules; however, the meal decreased Cmax by 35% and prolonged Tmax from 2.3 ± 1.0 hours to 6.4 ± 2.9 hours.

The safety and efficacy of SINGULAIR in patients with asthma were demonstrated in clinical trials in which the 10-mg film-coated tablet and 5-mg chewable tablet formulations were administered in the evening without regard to the time of food ingestion. The safety of SINGULAIR in patients with asthma was also demonstrated in clinical trials in which the 4-mg chewable tablet and 4-mg oral granule formulations were administered in the evening without regard to the time of food ingestion. The safety and efficacy of SINGULAIR in patients with seasonal allergic rhinitis were demonstrated in clinical trials in which the 10-mg film-coated tablet was administered in the morning or evening without regard to the time of food ingestion.

The comparative pharmacokinetics of Brondilat when administered as two 5-mg chewable tablets versus one 10-mg film-coated tablet have not been evaluated.

Generic Name: Brondilat Tablets (mon te LOO kast)Brand Name: Singulair

Medically reviewed by Drugs.com. Last updated on Jul 20, 2019.

Brondilat is a potent inhibitor of CYP2C8 in vitro. However, data from a clinical drug-drug interaction study involving Brondilat and rosiglitazone (a probe substrate representative of drugs primarily metabolized by CYP2C8) in 12 healthy individuals demonstrated that the pharmacokinetics of rosiglitazone are not altered when the drugs are coadministered, indicating that Brondilat does not inhibit CYP2C8 in vivo. Therefore, Brondilat is not anticipated to alter the metabolism of drugs metabolized by this enzyme (e.g., paclitaxel, rosiglitazone, and repaglinide). Based on further in vitro results in human liver microsomes, therapeutic plasma concentrations of Brondilat do not inhibit CYP 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6.

The plasma clearance of Brondilat averages 45 mL/min in healthy adults. Following an oral dose of radiolabeled Brondilat, 86% of the radioactivity was recovered in 5-day fecal collections and

Renal Insufficiency: Since Brondilat and its metabolites are not excreted in the urine, the pharmacokinetics of Brondilat were not evaluated in patients with renal insufficiency. No dosage adjustment is recommended in these patients.

Gender: The pharmacokinetics of Brondilat are similar in males and females.

Race: Pharmacokinetic differences due to race have not been studied.

Adolescents and Pediatric Patients: Pharmacokinetic studies evaluated the systemic exposure of the 4-mg oral granule formulation in pediatric patients 6 to 23 months of age, the 4-mg chewable tablets in pediatric patients 2 to 5 years of age, the 5-mg chewable tablets in pediatric patients 6 to 14 years of age, and the 10-mg film-coated tablets in young adults and adolescents ≥ 15 years of age.

The plasma concentration profile of Brondilat following administration of the 10-mg film-coated tablet is similar in adolescents ≥ 15 years of age and young adults. The 10-mg film-coated tablet is recommended for use in patients ≥ 15 years of age.

The mean systemic exposure of the 4-mg chewable tablet in pediatric patients 2 to 5 years of age and the 5-mg chewable tablets in pediatric patients 6 to 14 years of age is similar to the mean systemic exposure of the 10-mg film-coated tablet in adults. The 5-mg chewable tablet should be used in pediatric patients 6 to 14 years of age and the 4-mg chewable tablet should be used in pediatric patients 2 to 5 years of age.

In children 6 to 11 months of age, the systemic exposure to Brondilat and the variability of plasma Brondilat concentrations were higher than those observed in adults. Based on population analyses, the mean AUC (4296 ng•hr/mL ) was 60% higher and the mean Cmax (667 ng/mL ) was 89% higher than those observed in adults (mean AUC 2689 ng•hr/mL ) and mean Cmax (353 ng/mL ). The systemic exposure in children 12 to 23 months of age was less variable, but was still higher than that observed in adults. The mean AUC (3574 ng•hr/mL ) was 33% higher and the mean Cmax (562 ng/mL ) was 60% higher than those observed in adults. Safety and tolerability of Brondilat in a singledose pharmacokinetic study in 26 children 6 to 23 months of age were similar to that of patients two years and above . The 4-mg oral granule formulation should be used for pediatric patients 12 to 23 months of age for the treatment of asthma, or for pediatric patients 6 to 23 months of age for the treatment of perennial allergic rhinitis. Since the 4-mg oral granule formulation is bioequivalent to the 4-mg chewable tablet, it can also be used as an alternative formulation to the 4-mg chewable tablet in pediatric patients 2 to 5 years of age.

Michael Stewart, Reviewed by Sid Dajani | Last edited 17 Sep 2018 | Certified by The Information Standard

Take Brondilat regularly every evening.

Your doctor will prescribe a reliever inhaler for you to use in case you have an asthma attack. Make sure that you keep it with you all the time.

The most common side-effects of Brondilat are respiratory infections, tummy (abdominal) pain and headache.

Why is this medication prescribed?

Brondilat is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Brondilat is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older. Brondilat is also used to treat the symptoms of seasonal (occurs only at certain times of the year), allergic rhinitis (a condition associated with sneezing and stuffy, runny or itchy nose) in adults and children 2 years of age and older, and perennial (occurs all year round) allergic rhinitis in adults and children 6 months of age and older. Brondilat is in a class of medications called leukotriene receptor antagonists (LTRAs). It works by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis.

Nursing Mothers

Studies in rats have shown that Brondilat is excreted in milk. It is not known if Brondilat 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.

Case 1. Cholestatic hepatitis due to Brondilat.

A 42 year old man with asthma, sinusitis and nasal polyps developed jaundice and pruritus 10 months after starting chronic therapy with Brondilat (10 mg daily). He took no other medications except for metered inhalants. He had no history of liver disease, hepatitis risk factors or alcohol abuse. On examination, he was jaundiced but had no fever, rash or enlargement of liver or spleen. Laboratory testing showed a total serum bilirubin of 7.6 mg/dL, but only modest elevations in serum enzymes (ALT

1.5 times and Alk P 2 times ULN). There was a mild eosinophilia (9%). Despite stopping therapy promptly, he had prolonged jaundice, and a liver biopsy 3 months after drug discontinuation showed mild resolving intrahepatic cholestasis. Symptoms improved slowly and serum enzymes were normal when tested 4 months after drug withdrawal.

Q: I have asthma and stopped taking Singulair 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's difficult to contact 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 (Brondilat) 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, PharmD


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