Provair ODT Tablet 5mg

Product Information

PROVAIR

Provair®

Montelukast

Presentation

Provair 4 oral granules : Each sachet contains Montelukast Sodium USP equivalent to Montelukast 4mg.

Provair 4 tablet : Light orange, barrel shaped, chewable tablet; each tablet contains Montelukast Sodium USP equivalent to

Montelukast 4mg.

Provair 5 tablet : Light green, barrel shaped, chewable tablet; each tablet contains Montelukast Sodium USP equivalent to

Montelukast 5mg.

Provair 10 tablet : Gray, barrel shaped, film coated tablet; each tablet contains Montelukast Sodium USP equivalent to Montelukast

10mg.

Indications

Montelukast (Provair) is indicated for the prophylaxis and chronic treatment of asthma and for the relief of symptoms of seasonal

allergic rhinitis in adults and paediatric patients 6 months of age and older.

Dosage and administration

Adults and adolescents with asthma or seasonal allergic rhinitis: The dosage for adults and adolescents 15 years of age and older

is Montelukast 10mg (one Provair 10 tablet) once daily.

Paediatric patients with asthma or seasonal allergic rhinitis: The dosage for paediatric patients 6 to 14 years of age is

Montelukast 5mg (one Provair 5 tablet) once daily. The dosage for paediatric patients 2 years to 5 years of age is Montelukast 4mg

(one Provair 4 tablet) once daily. The dosage for paediatric patients 6 months to 5 years of age is Montelukast 4mg (one Provair 4

oral granules can be administered either directly in the mouth, or mixed with a spoonful of cold water or soft food at room

temperature) once daily

Contra-indications, warnings etc.

Contra-indication: Montelukast is contra-indicated in patients with hypersensitivity to it.

Precautions: Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status

asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with Montelukast can be continued

during acute exacerbations of asthma. While the dose of inhaled corticosteroid may be reduced gradually under medical supervision,

Montelukast should not be abruptly substituted for inhaled or oral corticosteroids. Montelukast should not be used as monotherapy

for the treatment and management of exercise induced bronchospasm. Patients with known aspirin sensitivity should continue

avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Montelukast. Although Montelukast is effective in

improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor

response to aspirin and other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients.

Drug interactions: 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, prednisone,

prednisolone, oral contraceptives (norethindrone 1mg/ethinyl estradiol 35mcg), 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 evidence of clinical adverse interactions. These medications included thyroid

hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines and decongestants. Phenobarbital, which

induces hepatic metabolism, decreased the AUC of Montelukast approximately 40% following a single 10mg 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.

Use in pregnancy and lactation: 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. Because many drugs are excreted in human milk,

caution should be exercised when Montelukast  is given to a nursing mother.

Use in paediatric patient: Safety and efficacy of Montelukast have been established in adequate and well-controlled studies in

paediatric patients with asthma 6 months to 14 years of age. Safety and efficacy profiles in this age group are similar to those

seen in adults.

Side effects: Gastro-intestinal disturbances, dry mouth, thirst; hypersensitivity reactions including anaphylaxis, angioedema and

skin reactions; asthenia, dizziness, irritability, restlessness, headache, sleep disorders (insomnia, drowsiness, abnormal dreams,

nightmares); upper respiratory tract infection, fever; arthralgia, myalgia; increased bleeding tendency, oedema and seizures.

Pharmaceutical precaution

Store in a cool and dry place, protected from light.

Package quantities

Provair 4 oral granules : Cartons containing 30 sachets.

Provair 4 tablet : Cartons containing 30 tablets in alu-alu blister.

Provair 5 tablet : Cartons containing 30 tablets in alu-alu blister.

Provair 10 tablet : Cartons containing 30 tablets in alu-alu blister.

Manufactured by

UniMed & UniHealth Manufacturers Ltd.

B K Bari, Gazipur, Bangladesh

® Registered Trademark