Product Name

MNTK
4, 5 & 10mg Tablets
Composition
Each Tablet Contains: Montelukast Sodium 4, 5 & 10 mg


Pack
14's


INDICATION & USAGE

Montelukast sodium (MNTK) is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
Montelukast sodium (MNTK) is also indicated for the relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adults and pediatric patients 6 months of age and older).



DOSAGE AND ADMINISTRATION

Montelukast sodium (MNTK) should be taken once daily. For asthma, the dose should be taken in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs.

Tablets & Chewable Tablets
Patients with both asthma and allergic rhinitis should take only one tablet daily in the evening.

Adults and Adolescents 15 Years of Age and Older with Asthma or
Allergic Rhinitis

The dosage for adults and adolescents 15 years of age and older is one 10 mg tablet daily.
Pediatric Patients 6 to 14 Years of Age with Asthma or Allergic Rhinitis
The dosage for pediatric patients 6 to 14 years of age is one 5 mg chewable tablet daily. No dosage adjustment within this age group is necessary.
Pediatric Patients 2 to 5 Years of Age with Asthma or Allergic Rhinitis
The dosage for pediatric patients 2 to 5 years of age is one 4 mg chewable tablet daily.

Pediatric Patients 12 to 23 Months of Age with Asthma
The dosage for pediatric patients 12 to 23 months of age is 4 mg daily to be taken in the evening.

Pediatric Patients 6 to 23 Months of Age with Perennial Allergic Rhinitis
The dosage for pediatric patients 6 to 23 months of age 4 mg daily.

CONTRAINDICATIONS
Hypersensitivity to any component of this product.

ADVERSE EFFECTS
Body as a whole asthenia/fatigue, fever, pain, abdominal, trauma digestive system disorders dyspepsia, gastroenteritis, infectious, pain, dental nervous system psychiatric dizziness, headache, respiratory system disorders congestion, nasal, cough, influenza, skin/skin Appendages disorder rash.

WARNINGS AND PRECAUTIONS
Pregnancy
Pregnancy Category B

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, MNTK should be used during pregnancy only if clearly needed.
Nursing Mothers
Because many drugs are excreted in human milk, caution should be exercised when montelukast is given to a nursing mother.
Hepatic Impairment
No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency. The pharmacokinetics of Montelukast sodium (MNTK) in patients with more severe hepatic impairment or with hepatitis have not been evaluated.
Renal Insufficiency
Since montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast were not evaluated in patients with renal insufficiency. No dosage adjustment is recommended in these patients.
INTERACTIONS
Montelukast sodium (MNTK) 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, prednisone, prednisolone, oral contraceptives (norethindrone 1 mg/ethinyl estradiol 35 mcg), terfenadine, digoxin, and warfarin.

OVERDOSAGE
In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast sodium (MNTK) and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis.

STORAGE
Store at room temperature. Protect from heat, light and moisture. Keep all medicines out of the reach of children.

PRESENTATION
MNTK 10 mg tablets blister of 14’s
MNTK 5 mg chewable tablets blister of 2 x 7’s
MNTK 4 mg chewable tablets blister of 2 x 7’s


 
 
 
 
 
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