Momate nasal spray 50mcg Glenmark for allergic rhinitis (60 doses)
Dosage form Box
Specifications Mometasone Furoate
Ingredient
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| Composition information | Content |
| Mometasone Furoate | 50mcg |
Uses
Indications
Momate Nasal Spray Glenmark 60DOSES is indicated in the following cases:
allergic rhinitis treatment
Mometason Furoat Monohydrate 50 mcg nasal spray is indicated to treat seasonal allergic rhinitis and year -round allergic rhinitis in adults and children 2 years and older.
Treatment of seasonal nasal congestor for allergic rhinitis
Mometason Furoat Monohydrate 50 mcg nasal spray is specified to mitigate the nasal congestion due to seasonal allergic rhinitis in adults and children 2 years old and older.
Prevention of seasonal allergic rhinitis
Mometason Furoat Monohydrate 50 mcg nasal spray is indicated to prevent seasonal allergic rhinitis symptoms in adults and children 12 years or older.
Treatment of small tumors in the nose (polyp)
Mometason Furoat Monohydrate 50 mcg nasal spray is assigned to treat nasal polyps for patients aged 18 and over.
Pharmacy
Mometason Furoat Monohydrate is a corticosteroid with strong anti -inflammatory effect. The exact mechanism of corticosteroids on unknown allergic rhinitis, but corticosteroids have shown to have the effects of widening on different types of cells (for example, moisturizing, acidic leukocytes, neutrophils, macrophages, cell lymphocytes) and intermediate substances (for example, histamine, eicosanoid, leukotrien and cytokin) related to inflammation.
In two clinical studies checking antigen challenge in the nose, Mometason Furoat Monohydrate 50 mcg nasal spray reduces some manifestations of an early and late allergic reaction. These observations include a decrease (compared to placebo) histamine concentrations, and acid -preferred cation protein (compared to standard values) of acidic leukemia, neutrophils, and protein -mounted epithelial cells. The clinical significance of these findings is unclear.
The effect of Mometason Furoat Monohydrate 50 mcg nasal spray on the nasal mucosa after 12 months of treatment has been tested in patients with allergic rhinitis. No evidence of acid atrophy and acidic leukemia, and reducing inflammatory cell infection (such as acidic leukemia, cell lymphocytes, large single cell leukemia, neutrophils, and cytoplasm).
pharmacokinetic
absorption
Mometason Furoat Monohydrate is used in the form of a very low nasal spray mixture. When using sensitive quantitative magazine with a quantitative limit (LOQ) 0.25 PCG/ml is only found
Distribution
The ratio of the protein of Mometason Furoat in the laboratory is reported from 98% to 99% in the concentration range from 5 to 500 ng/ml.
Metabolism
Studies have shown that any part of the Mometason Furoat dose has been swallowed and absorbed is strongly metabolized into different metabolites, but no major metabolites are detected in plasma. When in the laboratory, one of the secondary metabolites, formed as 6β-hydroxymumetason furoat. In human liver microorganisms, the formation of metabolites is adjusted by Cytochrom P450 3A4 (CYP3A4).
Elimination
After using intravenous tract, the effective sale time in the plasma of Mometason Furoat is 5.8 hours. Any amount of drugs that have been absorbed is excreted in the form of metabolites mostly through bile and a little through urine.
Special population
Hepatic impairments: Use a single 400 mcg Mometason Furoat inhaler in mild, medium and severe patients with only one or 2 objects in each group of patients with Mometason Fuoat peak concentration in plasma can be detected (about 50 to 150 pcg/ml). The correlation peak concentration seems to increase according to the severity of the liver failure, however, only a few people have an increase in detection.
Person of renal failure: The effect of renal failure on the kineticness of Mometason Furoat has not been fully studied.
Children: Mometason Furoat pharmacokinetics in the population of children have not been studied.
Sex: The impact of gender on the pharmacokinetics of Mometason Furoat has not been fully studied.
Race: The influence of race on the pharmacokinetics of Mometason Furoat has not been fully studied.
Before taking Momate nasal spray 50mcg Glenmark for allergic rhinitis (60 doses)
How to use
Mometason Furoat Monohydrate nasal spray is indicated to spray in the nose. Before starting to use Mometason Furoat Monohydrate nasal spray, 50 mcg must activate the pump by pressing the pump 10 times or until the smooth rays of the drug shot out. Once activated, the unused pump can be stored within a week without having to activate it. If you do not use more than a week, you must activate it twice or until it is shot out smoothly.
Instructions for patients using Mometason Furoat Monohydrate nasal spray
Remove the plastic lid.
When using the Mometason Furoat monohydrate nasal spray for the first time, it is necessary to activate the pump by using the index finger and the middle finger on the shoulders of the shoulder of the white spray, the thumb support the bottom of the jar and press down.
Do not puncture the spray head. Press down and release 10 times or until firing smooth rays. Do not shot into the eyes. The pump is now ready to use. The pump can tell the air force for a week without having to activate it. If not used for a week, it must be activated twice or until the ray is smooth.
Spray nasal gently to clean the two nasal cavities. Squeeze one side of the nose. Tilting his head slightly forward, holding the vial upwards, carefully putting the head to the side of the nostrils opened. Do not spray directly on one nasal wall (partition between two nostrils). Then exhale through the mouth.
repeat the spray into the 2nd nostril.
wipe the nasal spray with a clean towel and close the plastic lid.
Instructions for patients to clean the spray head
To clean the nasal spray head, remove the plastic cap.
Pull the white nose spray tip up to remove.
Dip the nasal spray tip into the cold faucet, scrub both ends of this part and dry.
Do not try to clear the nasal spray with other pins or sharp objects because this will damage the spray head and make the dosage incorrectly.
Wash the plastic lid under cold water and dry.
Install the spray head back to the original position to ensure the stem pump the cage tightly into the middle hole of the spray head.
Activate the pump by using the index and middle finger to the shoulder of the shoulder of the white spray, the thumb support the bottom of the jar. Press down and release twice or until firing smooth rays. Do not shot into the eyes. The pump is now ready to use. Can be stored not used for a week without having to be activated. If not used for a week, it must be triggered twice or until the smooth rays shot out.
Close the plastic lid.
Dosage
allergic rhinitis treatment
Adults and children aged 12 and older
recommended dose for treating seasonal allergic rhinitis and allergic rhinitis year -round is 2 spray (50 mcg mometason furoat each spray) in each nostril once a day (total daily dose is 200 mcg).
Children from 2 to 11 years old
recommended dose for the treatment of seasonal or year -round allergic rhinitis is 1 spray (50 mcg mometason furoat each spray) in each nostril once a day (total daily dose is 100 mcg).
Seasonal nasal congestive treatment for allergic rhinitis
Adults and children aged 12 and older
recommended dose to treat nasal congestion caused by seasonal allergic rhinitis is 2 sprays (50 mcg mometason furoat each spray) in each nostril once a day (total daily dose is 200 mcg).
Children from 2 to 11 years old
recommended dose for treating nasal congestion caused by seasonal allergic rhinitis is 1 spray (50 mcg mometason furaat each spray in each nostril once a day (total daily dose is 100 mcg).
Prevention of seasonal allergic rhinitis
Adults and children aged 12 and older
recommended dose for the prevention of seasonal allergic rhinitis is 2 spray (50 mcg mometason fursat each spray) in each nostril once a day (total daily dose is 200 mcg).
In patients who know this seasonal and allergic allergies, it is expected to cause seasonal allergic rhinitis symptoms, which are recommended by Mometason Furoat Monohydrate, 50 mcg (200 mcg/day) 2 to 4 weeks before starting pollen season.
nasal polyps
Patients aged 18 and over
The recommended dose for the treatment of nasal polyps is 2 spray (50 mcg mometason furoat each spray) in each nostril, 2 times a day (total daily dose is 400 mcg).
Some patients take a dose of 2 sprays (50 mcg mometason furoat each spray) in each nostril 1 time a day (total daily dose is 200 mc) is also effective.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when using overdose? Because of the low bioavailability and no findings in clinical studies on acute systemic reactions, overdose is almost no occurrence and requires any treatment. Used in the nose 1600 mcg (4 times the recommended dose of the Mometason Furoat 50 mcg nasal spray to treat nasal polyps in patients aged 18 and older) every day, for 29 days, for a healthy volunteer has shown not to increase the incidence of unwanted reactions.
Studies used in single -dose nose up to 4000 mcg and oral inhalation dose up to 8000 mcg on volunteers do not detect unwanted reactions. Overdose for a long time any corticosteroids can lead to signs or symptoms of the excess steroid in the body (hypercorticism). Excessive overdose with this form of preparation does not occur because each bottle of nasal spray Mometason Furoat Monohydrate 50 mcg contains about 8500 mcg mometason furoat.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Momate Nasal Spray Glenmark, you may experience unwanted effects (ADR).
The unwanted effects of Mometason Furoat nasal spray, related to the treatment of allergic rhinitis
Common, 1/00 The unwanted effects of Mometason Furoat nasal spray, related to nasal polyps In patients with nasal polyps, the incidence of unwanted reactions can be compared with placebo and similar to observable reactions to patients with allergic rhinitis. Unwanted reactions related to treatment above 1% of patients with nasal polyps in clinical studies are as follows: at a dose of 200 mcg, once/day Common, 1/00 Gastrointestinal disorders: stimulating throat. At the dose of 200 mcg, twice a day Very common, ADR> 1/10: Common, 1/00 Uncommon, ADR The undesirable effects of Mometason Furoat nasal spray, related to acute sinusitis The rate of nosebleeds with Mometason Furoat is 3.3% compared to 2.6% of the placebo and similar to the group of patients treating allergic rhinitis. The instantaneous hypersensitivity reactions including bronchospasm and shortness of breath can occur after use in the tip of Mometason Furoat Monohydrate are rare. Hypersensitivity reactions and Quincke edema have reported but very rare. The systemic effects of CDC corticosteroids for the nose can also occur, especially when prescribing high doses in prolonged treatments. post -commercial experience The following unwanted reactions have been determined during the post -commercial period for Mometason Furoat Monohydrate 50 mcg: burning nose, nasal irritation, hypersensitivity reactions, quicke edema, taste disorders, sense of smell and partition. Because these reactions are voluntarily reported from the population with uncertain scale, it is not always possible to estimate frequency reliability or establish a cause and effect association with the drug used. Instructions on how to handle ADR Notify the doctor the unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Momate Nasal Spray Glenmark 60DOSES FOR contraindications in the following cases:
Precautions when using
Effect at the nose
nosebleeds
In clinical studies, nosebleeds often occur in patients with allergic rhinitis treated with Mometason Furoat Monohydrate nasal spray compared to the fake group.
Candida infection
Clinical studies with Mometason Furoat Monohydrate nasal sprays 50 mcg, showing the development of Candida albican infection in the nose and pharyngeal. When such an infection is developed, Mometason Furoat monohydrate nasal spray must be stopped and 50 mcg and if it is necessary to replace it with local or appropriate body treatment.
Perpiring nasal septum
There have been a number of reports on the puncture of the nasal septum after using corticosteroids in the nose. Like any long -term nasal cavity treatment, patients use Mometason Furoat Monohydrate nasal spray 50 mcg for months or longer need to be checked periodically about possible changes in the nasal mucosa.
The wound has not healed
Because of the inhibitory effect of corticosteroids on wound healing, the patient has a new nasal septal ulcer, nose surgery, or a nose injury, should not use corticosteroids until the wound has healed.
glaucoma and cataract disease
Corticosteraids used in the nose and inhalation may cause glaucoma and cataract. Therefore, closely monitoring in patients with vision changes or a history of increased intraocular pressure, glaucoma and/or cataract.
Hypersensitivity reactions
Hypersensitivity reactions such as wheezing may occur after using the Mometason Furoat monohydrate nose. If such reactions occur, Mometason should be stopped.
immunodeficiency
Those who are taking drugs inhibit the immune system are more susceptible to infections than healthy people, for example, for children who are not vaccinated or adults who are using corticosteroids that suffer from chickenpox, measles may worse or even die. Therefore, children or adults are using corticosteroids without having these diseases must also be particularly cautious to avoid exposure.
Do not know the dose, sugar, how to use corticosteroids affects the risk of spreading bacterial infections. It is not known the effect of potential disease and/or corticosteroid treatment earlier on this risk. If exposed to chickenpox, it is possible to prevent preventing Varicella Zoster immune globulin (Vzig). If exposed to measles, it is possible to prescribe preventive treatment with immune globulin (IG) intramuscularly.
If chickenpox is developed, it is possible to consider treatment with antiviral drugs.
Corticosteroids should be used carefully in patients with respiratory tuberculosis or silent, or systemic virus infection, bacterial infection, incomplete fungal infection or herpes simplex infection because the potential of these diseases becomes worse.
works on the hypothalamus - pituitary - adrenal
adrenal and adrenal insufficiency
When the steroid dose is used in the nose in excess of the recommended dose or in the recommended individuals, the recommended dose may appear effects of systemic corticosteroids such as adrenal strength and adrenal insufficiency. If such changes occur, the nasal spray should be slowly stopped with the Mometason Furoat Monohydrate, suitable for accepted procedures for oral corticosteroid treatment.
affect children's development
Corticosteroids may reduce the growth rate of pediatric patients. It is necessary to regularly monitor the development of children with Mometason Furoat Monohydrate nasal spray to minimize the body effect of corticosteroids including Mometason Furoat Monohydrate nasal spray, lowest dose alignment but still effectively control symptoms.
used for special population
used for children
Safety and effectiveness of Mometason Furoat Monohydrate 50 mcg to treat allergic rhinitis for children 12 years old or older has been established. The use of Mometason Furoat Monohydrate nasal spray 50 mcg to treat allergic rhinitis for children 2 to 11 years old based on safety and effectiveness from clinical research data.
Safety and effectiveness of Mometason Furoat Monohydrate 50 mcg to treat allergic rhinitis for children under 2 years old as well as the safety and effectiveness of Mometason Furoat Monohydrate 50 mcg to treat nasal polyps for children under 18 years old. Controlled clinical studies have shown that corticostreroids used in the nose may slow down the growth rate in children's patients.
also cannot exclude the potential of Mometason Furoat Monohydrate 50 mcg nasal sprays that inhibit development in sensitive patients or high doses.
Used for the elderly
According to the reports, the type and extent of harmful reactions in the elderly population are similar to younger patients.
Patients with liver failure
The concentration of Mometason Furoat seems to increase according to the severity of the liver failure.
The ability to drive and operate machinery
No report.
Pregnancy
There is no complete and well -controlled study in pregnant women. Mometason Furoat Monohydrate 50 mcg as well as other corticosteroids for pregnant women only when potential benefits surpassing the potential risk for the fetus.
Experience using oral corticosteroids since being treated in the form of pharmacological doses, in contrast to the physiological doses, shows that the monster effect of corticosteroids in rodents is more in humans. In addition, because when pregnant, the production of natural corticosteroids increases, most women require external corticosteroid dose and many people do not need to treat corticosteroids during pregnancy.
Agreement of adrenal gland activity can occur in children born from women who use Cortisteroids during pregnancy. These children need to be carefully monitored.
breastfeeding period
It is not known whether the Mometason Furoat will be secreted into breast milk, but because other corticosteroids have secretion into breast milk, it is cautious when using Mormetason Furoat Monohydrate 50 mcg for breastfeeding women.
Drug interaction
There is no official research on drug-drug interactions conducted with Mometason Furoat Monohydrate nasal spray of 50 mcg.
Cytochrom P450 3A4 inhibitors
Ketoconazole: Studies have shown that the Mometason Furoat is mainly and strongly metabolized in the liver of all researches and creates many different metabolites. The laboratory studies have confirmed the main role of Cytochrom CYP 3A4 during the metabolism of Mometason Furoat, so when used simultaneously with Ketoconazole, a powerful CYP 3A4 inhibitor, can increase the plasma concentration of Mometason Furoat.
Loratadin: There is no interaction detected when studying clinical interactions with loratadin.
Storage
Store at temperatures below 30 ° C. Do not freeze.
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