Description

FORMULA:

Montelukast: 10 mg

Mannitol; Avicel; PVP, Magnesium Stearate; Erythrosine lake, cherry flavorings

INDICATIONS:

Franlucat is to be used in the following cases:

– Prevention and treatment of chronic asthma in adults and children over 6 months of age.

– Prevention of bronchial spasms in asthma patients due to physical exertions.

– Reduce the symptoms of allergic rhinitis:

• Seasonal allergic rhinitis in adults and children over 2 years old
• Year-round allergic rhinitis in adults and children over 6 months old.

CONTRAINDICATIONS:

– Hypersensitivity to any component of the medication.

ADVERSE EFFECTS:

– Montelukast is generally well tolerated, and adverse events are generally mild and usually do not require discontinuation of therapy. May experience: edema, anxiety and restlessness, allergic reactions (anaphylaxis, angioedema, pruritus, rash , urticaria), palpitations, dizziness, joint pain, increased bleeding capacity

Inform your doctor of any adverse effects when encountered.

PRECAUTION:

– No conclusive evidence on the effects of taking Montelukast in treating acute asthma, so do not use Franlucat to treat acute asthma.

– Be cautious and closely monitor clinically when reducing whole-body Corticosteroid doses for Franlucat users. Do not replace Corticosteroids (inhaled or oral) abruptly with Franlucat

INTERACTIONS:

– Franlucat can be used with other commonly used drugs in the prevention and treatment of chronic asthma and allergic rhinitis.

– The area under the curve (AUC) of Montelukast reduces by approximately 40% in users concurrently using Phenobarbital, yet there is no needs to adjust dosage of Montelukast.

– Studies in vitro showed Montelukast is CYP2C8 inhibitor. However, the clinical data showed no inhibition of CYP2C8 by Montelukast in vivo. Thus, Montelukast does not alter the metabolism of drugs metabolized by this enzyme (paclitaxel, rosiglitazone, Repaglinide)

DOSAGE AND USAGE:

• Dosage:

– Adults and children over 15 years of age: 10 mg per day

– Children from 6-14 years of age: 5 mg per day

– Children from 6 months to 5 years of age: 4 mg per day

• Usage

With chewable tablet, chew the tablets with a little water.

– Asthma in children over 12 months of age: 1 dose of Franlucat/Day in the evening.

– Preventing bronchial spasms caused by physical exertions in asthma patients over 15 years old: Take 1 dose of Franlucat at least 2 hours before physical exercises.

– Allergic rhinitis: 1 dose of Franlucat/day, the exact time depends on the patient’s needs

Drugs to be used only under a physician’s prescription

Use in pregnancy and breastfeeding women:

– Pregnancy: There are no adequate controlled studies on pregnant women, only use Montelukast in pregnancy if clearly needed.

– Breastfeeding women: No information on drug excretion in breast milk, so breastfeeding should stop when taking the drug.

Effects on ability to drive and use machines:

No proven evidence showing Montelukast affects the ability to drive and operate machinery.

Overdose:

– In a study on chronic asthma, using Montelukast with daily doses up to 200mg for adults in 22 weeks and a short study with a dose of  900mg every day, in a week, shows no significant clinical responses.

– In the majority of overdose reports, there were no adverse reactions. The most common reactions are similar to data on safety attributes, including abdominal pain, sleepiness, thirst, headache, vomiting and increased agitation.

– There is no specific information about the treatment of overdose on Montelukast.

Pharmacology: 

Montelukast is a selective antagonist of the receptor Leucotrien.

Cysteinyl Leucotrien (LTC4, LTD4, LTE4) are metabolized products of acid Archidonic and are released from many cell types, including Mast cells, and eosinophils. These substances associate with cysteinyl Repceptor Leucotrien (CysLT).

CysLT1 can be found in the human’s airway (including smooth muscle cells and macrophages of the respiratory tract) and in other inflammatory cells (including eosinophils and marrow stem cells)

CysLT are related to the pathophysiology of asthma and allergic rhinitis: In asthma, Leucotrien intermediates cause edema, bronchial smooth muscle contraction and change cell activity associated with the inflammatory processes.

In allergic rhinitis, after inhalation of allergen, the CysLTs are released from the nasal mucosa in both early and late phase, causing increased mucus secretion, increased vascular permeability and are combined with the symptoms of rhinitis allergic reaction (difficulty breathing, nasal congestion).

Montelukast is an oral effective ingredient, with high affinity and selective antagonists against receptor CysLT1 (more dominant compared to other respiratory receptors). Montelukast inhibits physiologic activities of LTD4 in CysLT1 without other receptor agonist activity

Pharmacokinetics:

Montelukast is rapidly absorbed in the gastrointestinal tracts, peak plasma concentrations are reached after 2-2.5 hours after taking of 10 mg chewable tablet.

The bioavailability of 10 mg chewable tablet in adult vegetarians are 75% and 63% when taken at breakfast with a standard meal.

The effectiveness of treatment with Montelukast (Example: Improve asthma symptoms, improve inspection results of lung function, reduce the use of bronchodilator blockers β) can be seen after the first dose and lasts for at least 24 hours.

Studies on rats showed that only the minimum amount of radio-labeled material is present in all tissues in the body, and a minimal amount pass through the mouse’s brain blood barrier.

Over 99% Montelulast is associated with protein plasma.

Montelukast is primarily metabolized in the intestines and stomach or liver, with biliary excretion. Some metabolic pathways were identified, including: the acylation of glucuronide, oxidation by some cytochrome P-450 isoenzym. After oral doses of treatment, metabolite concentration in plasma at equilibrium is lower than the perceived limit.

In adults between 19-48 years of age, the half-life is 2.7 – 5.5 hours, and the average plasma clearance index was 45 ml/minute. children 6-14 years of age, the half-life is 3.4 – 4.2 hours.

After drinking, Montelukast is primarily excreted via the bile as unchanged drug and metabolites.

SHELF LIFE: 24 months from date of manufacture.

Do not exceed the time limit on the package.

STORAGE: Place dry, at temperature below 30⁰C, protect from light.

Specification: Manufacture’s standard.