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Montelukast

INFORMATION FOR USE OF A MEDICALPRACTITIONER, HOSPITAL OR LABORATORY MONTELUKAST Available CompositionASMA LU

Each film-coated tablets contains Montelukast sodium…10 mg

PHARMACOLOGICAL CLASSIFICATIONBronchodilator (Leukotriene receptor antagonist)

MECHANISM OF ACTION ASMA LU is a potent, orally active compound that significantly improves parameters of asthmatic inflammation. Based on biochemical and pharmacological bioassays, it binds with high affinity and selectivity to the CysLT₁ receptor (in preference to other pharmacologically important airway receptors such as the prostanoid, cholinergic, or b-adrenergic receptor). Montelukast potently inhibits physiologic actions of LTC₄, LTD₄, and LTE₄at the CysLT₁ receptor without any agonist activity.

PHARMACOKINETICS

Peak plasma concentrations of ASMA LU are achieved in 2 to 4 hours after oral administration. The mean oral bioavailability is 64%. ASMA LU is more than 99 % bound to plasma proteins. It is extensively metabolized in the liver by Cytochrome P450 isoenzymes CYP3A4, CYP2A6, and CYP2C9, and is excreted principally in the faeces via the bile. Metabolism was reduced and the elimination half life prolonged in patients with mild to moderate hepatic impairment.

INDICATIONS

ASMA LU is indicated for the treatment of: · Asthma· Prevention of exercise-induced asthma· Allergic Rhinitis PATIENT INFORMATION: BEFORE YOU TAKE ASMALUMake sure you have told your doctor if you:- have ever had an allergic reaction to montelukast Tablets, ASMALU or any of the ingredients in the tablet. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. - are pregnant, plan to become pregnant or are breast feeding. - Have liver problem- have renal problem

HOW TO TAKE ASMA LU
You must take your medicine as the doctor tells you. It is important to take ASMALU Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness. The usual doses for: For asthma -Take once daily in the evening:· One 10-mg tablet for adults and adolescents 15 years of age and older. Asmalu 10 mg may be taken with or without food.For exercise-induced asthma - Take at least 2 hours before exercise, but not more than once daily:
One 10-mg tablet for adults and adolescents 15 years of age and older. Asmalu 10 mg may be taken with or without food.
For allergic rhinitis -Take once daily at about the same time each day:
One 10-mg tablet for adults and adolescents 15 years of age and older, Asmalu 10 mg may be taken with or without food.

IF YOU MISS A DOSEIf it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally. Do not take a double dose to make up for the dose that you missed. If you miss more than one dose, or you are not sure what to do, ask your doctor or pharmacist.

WHAT TO DO IF AN OVERDOSE IS TAKEN

In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department.Symptoms of overdose may include: · stomach pain · sleepiness · thirst · headache · vomiting · restlessness or agitation TAKING OTHER MEDICINE Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including those obtained without a prescription.Tell your doctor if you are taking the following medicines before starting ASMA LU:· Phenobarbital (used for treatment of epilepsy) · Phenytoin (used for treatment of epilepsy) · Rifampicin (used to treat tuberculosis and some other infections) SIDE EFFECTS Like all medicines, ASMALU can sometimes cause unwanted side effects.The most common side effects include: stomach pain, stomach or intestinal upset, heartburn, tiredness, fever, stuffy nose, cough, upper respiratory infection, dizziness, headache, rash.Less common side effects include: increased bleeding tendency, allergic reactions [including swelling of the face, lips, tongue, and/or throat, behavior and mood related changes [agitation including aggressive behavior, bad/vivid dreams, depression, feeling anxious, hallucinations, irritability, restlessness, suicidal thoughts and actions, tremor, trouble sleeping, palpitations, drowsiness, pins and needles/numbness, seizures,STORINGDo not use the tablets after the expiry date shown on the product packaging. Keep the tablets stored below 25°C in a dry place and in the original packaging. Keep them in a secure place where children cannot get at or see them.

Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice.