Monkast tablets

Monkast

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

The active ingredient of Monkast 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

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

Side Effect

Possible side effects of Monkast include: breathing problems; pains in the stomach, side, or abdomen, possibly moving to the back; belching; flu-like symptoms; swollen joints; dreams that are unusual; pain.

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How to use Singulair

Read the Patient Information Leaflet if available from your pharmacist before you start taking Monkast and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. The dosage is based on your medical condition and response to treatment. When Monkast is started - or when the dosage is increased - watch closely for side effects. There is a greater chance of mental/mood changes during these times (see also Side Effects section).

If you are using the chewable tablets, chew them thoroughly before swallowing. If your child cannot safely chew and swallow them, consult the doctor or pharmacist for advice.

Take this medication at the same time each day. If you are taking this medication for asthma or for both asthma and allergies, take your dose in the evening. If you are taking Monkast to prevent only allergies, take your dose either in the morning or the evening.

If you are taking this medication to prevent breathing problems during exercise, take your dose at least 2 hours before exercise. Do not take more than one dose in 24 hours. Do not take a dose before exercise if you are already taking this medication daily for asthma or allergies. Doing so may increase the risk of side effects.

Do not increase or decrease your dose or stop using this medication without consulting your doctor. Continue to use this medication regularly to keep your asthma under control, even during sudden asthma attacks or periods when you have no asthma symptoms. Continue to also take other medications for asthma as directed by your doctor. This medication works over time and is not meant to relieve sudden attacks of asthma. Therefore, if an asthma attack or other breathing problem occurs, use your quick-relief inhaler as prescribed. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details.

Get medical help right away if your asthma symptoms worsen and your quick-relief inhaler is not helping. Tell your doctor promptly if asthma symptoms, breathing problems, allergy symptoms, number of times you use your rescue inhaler persist or worsen.

Q: Does Singular cause bloating?

A: Singulair (Monkast) is a medication used to treat asthma and seasonal allergies, and does not list the side effect of bloating. Possible side effects include stomach pain and/or upset, heartburn, nausea, headache, dizziness, and tiredness. This is not a complete list of the side effects associated with Singulair (Monkast). Patti Brown, PharmD

What are some other side effects of Monkast Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

What Other Drugs Interact with Monkast?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of Monkast include:

Serious Interactions of Monkast include:

Monkast has moderate interactions with at least 21 different drugs.

Monkast has mild interactions with at least 73 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

DESCRIPTION

Monkast sodium, the active ingredient in SINGULAIR, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.

Monkast sodium is described chemically as -1-phenyl]-3-propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt.

The empirical formula is C35H35ClNNaO3S, and its molecular weight is 608.18. The structural formula is:

Monkast sodium is a hygroscopic, optically active, white to off-white powder. Monkast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile.

Each 10-mg film-coated SINGULAIR tablet contains 10.4 mg Monkast sodium, which is equivalent to 10 mg of Monkast, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The film coating consists of: hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, red ferric oxide, yellow ferric oxide, and carnauba wax.

Each 4-mg and 5-mg chewable SINGULAIR tablet contains 4.2 and 5.2 mg Monkast sodium, respectively, which are equivalent to 4 and 5 mg of Monkast, respectively. Both chewable tablets contain the following inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, red ferric oxide, croscarmellose sodium, cherry flavor, aspartame, and magnesium stearate.

Each packet of SINGULAIR 4-mg oral granules contains 4.2 mg Monkast sodium, which is equivalent to 4 mg of Monkast. The oral granule formulation contains the following inactive ingredients: mannitol, hydroxypropyl cellulose, and magnesium stearate.

Asthma

SINGULAIR should be taken once daily in the evening. The following doses 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 12 to 23 months of age: one packet of 4-mg oral granules.

Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.

There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of Monkast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when Monkast was administered in the evening without regard to time of food ingestion.

What Are Side Effects Associated with Using Monkast?

Some adverse drug reactions vary by age group

Common side effects of Monkast include:

Less common side effects of Monkast include:

Postmarketing side effects of Monkast reported include:

  • Hematologic: Increased bleeding tendency, thrombocytopenia
  • Immunologic: Hypersensitivity reactions (e.g., anaphylaxis, hepatic eosinophilic infiltration)
  • Psychiatric: Agitation, including aggressive behavior or hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, irritability, restlessness, sleepwalking, suicidal thinking and behavior (including suicide), tremor
  • Neurologic: Drowsiness, numbness and tingling, reduced sense of touch, seizures
  • Cardiac: Palpitations
  • Respiratory, thoracic, mediastinal: nosebleed, pulmonaryeosinophilia
  • Gastrointestinal: Diarrhea, indigestion, nausea, pancreatitis, vomiting
  • Hepatobiliary: Cases of cholestatic hepatitis, hepatocellular liver injury, and mixed-pattern liver injury have been reported, mostly occurring in combination with other confounding factors (e.g., use of other medications, administration to patients who had underlying potential for liver disease )
  • Dermatologic: Skin swelling, bruising, erythema multiforme, erythema nodosum, itching, hives
  • Musculoskeletal: Jointpain, muscle pain (including muscle cramps)
  • General: Swelling (edema)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Q: Why should Singulair be taken at bedtime? Will it make me sleepy, or is it for some other reason? Can I take it earlier in the day instead of at bedtime?

A: According to the prescribing information for the medication, Singulair (Monkast) should be dosed once daily in the evening with or without food, when it is used for asthma. When being tested for effectiveness in asthma, Singulair was dosed in the evening. There were no clinical trials in patients with asthma to compare the effectiveness of Singulair when used in the morning compared to the evening. For allergies, Singulair can be given at any time of day to suit the person's needs, but should be taken at the same time each day. Singulair was shown to be effective if given in the morning or the evening with or without food. Singulair is in a class of medications known as leukotriene inhibitors. Singulair is used for the treatment of asthma and allergies. Singulair is also used as a pre-exercise treatment for people who experience bronchoconstriction during exercise. Some of the common side effects of Singulair include: upper respiratory infections, fever, headache, pharyngitis, cough, abdominal pain, and diarrhea. Please consult your health care provider regarding the most appropriate time for you to take Singulair.

Q: Does Singulair cause weight gain, moodiness, and anxiety? Can you tell me the symptoms that I may experience?

A: Singulair (Monkast) (//www.everydayhealth.com/drugs/singulair) is a leukotriene inhibitor. Leukotrienes are chemicals that the body releases when allergies are breathed in. Singulair is indicated for the treatment of asthma and allergies. Common side effects reported with Singulair include headache, upset stomach, nausea and diarrhea, tiredness, sore throat and cough. A search of prescribing information for Singulair did not specifically list weight gain as a side effect. (//www.everydayhealth.com/allergies/guide/). Drugs can cause weight gain in several different ways. Some can increase appetite or make you crave certain types of foods like those high in carbohydrates or fat. Other medications may slow down metabolism or cause fluid retention. However, the effect of prescription drugs on body weight is complex. Some drugs have no effect on weight, while others cause weight gain or weight loss. Also, the same medications can cause weight gain in certain individuals and weight loss in others. There are also drugs that initially cause weight loss and then lead to weight gain with long-term use. Most prescription medications associated with changes in body weight affect the central nervous system. These include antidepressants like monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, and selective serotonin reuptake inhibitors (SSRIs). Mood stabilizers (lithium, valproic acid), antipsychotics, and anticonvulsants have also been linked with weight gain. Other drugs that have been reported to cause weight gain include diabetes medications (insulin, sulfonylureas, and thiazolidinediones), antihypertensive drugs, certain hormonal contraceptives, corticosteroids, antihistamines, some chemotherapy regimens, and antiretroviral protease inhibitors. If you think a drug you are taking is causing weight gain, tell your health care provider. Do not stop any medication or change the dose without first talking to your provider. 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. Kimberly Hotz, PharmD

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

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

Gender: The pharmacokinetics of Monkast 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 Monkast 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 Monkast and the variability of plasma Monkast 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 Monkast 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.

Q: Are drugs like Singulair causes/contributors to osteoporosis?

A: Singulair (Monkast) is a medication that is used to treat asthma and allergies. It is in a group of medications called leukotriene modifiers. Leukotrienes are chemicals produced by the body in response to allergens and other conditions, that cause irritation and swelling in the airways and constriction of the muscles of the respiratory tract. Singulair works by blocking leukotriene receptors, preventing these chemicals from causing allergy or asthma symptoms. The prescribing information on Singulair does not associate this medication with contributing to osteoporosis. The most common side effects are: headaches, flu-like symptoms, abdominal pain, indigestion and cough. Some rare and potentially serious side effects that should be brought to the attention of your physician are: worsening of asthma, depression, hallucinations, and signs of liver damage (dark urine, yellowing of the eyes or skin, and upper abdominal pain). For more specific information, consult with your doctor for guidance based on your health status and current medications, particularly before taking any action. Lori Poulin, PharmD


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