Momezal nasal spray 50mcg/dose 140 doses #1

Name:
Momezal.
Description:
White or almost white opaque suspension. The main active ingredient is mometasone furoate. Release form: Dosed nasal spray. Dosage 50 mcg / 1 dose 140 doses. Special instructionsPharmacological groupDecongestants and other drugs for topical use in diseases of the nasal cavity. Corticosteroids. Pharmacodynamics Mometasone furoate is a synthetic topical corticosteroid that has an anti-inflammatory effect. This action is manifested in doses at which there are no systemic effects. The anti-allergic and anti-inflammatory effect of mometasone furoate is associated with its ability to inhibit the release of mediators of allergic reactions. Mometasone furoate significantly inhibits the release of leukotrienes from the leukocytes of patients with allergic diseases. In 28% of patients with seasonal allergic rhinitis, mometasone furoate demonstrated a clinical effect within 12 hours of the first dose. On average (50%) improvement occurred within 35.9 hours. In a study of 1954 patients using 200 mcg of mometasone furoate twice daily, there was a significant reduction in the severity of symptoms associated with acute rhinosinusitis compared with placebo, when assessed by the symptom severity scale (MSS) (pain in the area face, sinus pressure, pain on pressure, sinus pain, rhinorrhea, mucus drip down the back of the throat and nasal congestion) during the treatment period – 15 days (P02683 p < 0.001; P02692 p - 0.038). When conducting a clinical placebo-controlled study in which children (n = 49) took mometasone furoate at a daily dose of 100 mcg for one year, growth retardation in children was not observed. There are limited data on the safety and efficacy of mometasone furoate when used in children aged 3 to 5 years, therefore an appropriate dose range cannot be established. In a study involving 48 children aged 3 to 5 years who were prescribed mometasone furoate intranasally, at doses of 50,100 or 200 mcg per day for 14 days, there was no significant difference, compared with the placebo group, in the average change in cortisol levels in plasma during a test with stimulation with tetracosactrin. Pharmacokinetics With intranasal use of mometasone furoate, its systemic bioavailability is ≤ 0.1%, while mometasone furoate is practically not detected in blood plasma, even when using highly sensitive detection methods with a sensitivity threshold of 50 pg / ml; therefore, there are no relevant pharmacokinetic data for this dosage. The suspension of mometasone furoate is very poorly absorbed in the gastrointestinal tract, and a small amount that can be swallowed by the patient and which can be absorbed is actively biotransformed during the "primary passage" in the liver before excretion in the urine and bile. Indications for use Treatment of seasonal and perennial allergic rhinitis in adults and children over 2 years of age. Preventive treatment of moderate and severe allergic rhinitis in adults and children from 12 years of age (it is recommended to start 2-4 weeks before the expected start of the dusting season). Treatment of symptoms of acute rhinosinusitis without evidence of severe bacterial infection in adults and children 12 years of age and older. Treatment of nasal polyps and related symptoms, including nasal congestion and loss of smell, in patients 18 years of age or older. Method of application and doses Treatment of seasonal or year-round allergic rhinitis: for adults (including the elderly) and adolescents over the age of 12 years, the recommended preventive and therapeutic dose of the drug is two injections (50 mcg each) in each nostril 1 time per day (total daily dose - 200 mcg). After achieving a therapeutic effect for maintenance therapy, it is advisable to reduce the dose to 1 injection in each nostril 1 time per day (total daily dose - 100 mcg). If the symptoms of the disease cannot be relieved by using the drug at the recommended therapeutic dose, the daily dose can be increased to the maximum: 4 injections in each nostril 1 time per day (total daily dose - 400 mcg). After easing the symptoms of the disease, a dose reduction is recommended. In some patients with seasonal allergic rhinitis, this drug has demonstrated a clinically significant onset of action within 12 hours after the first dose. However, the full benefit of the treatment cannot be obtained in the first 48 hours, so the patient must continue regular use to achieve the full therapeutic effect. Treatment with Momezal Nasal Spray may be initiated a few days before the onset of pollination season in patients with a history of moderate to severe seasonal allergic rhinitis. For children aged 2-11 years, the recommended therapeutic dose is an injection (50 mcg each) in each nostril 1 time per day (total daily dose - 100 mcg). Acute rhinosinusitis: for adults (including the elderly) and children aged 12 years and older, the recommended therapeutic dose is 2 injections (50 mcg) in each nostril 2 times a day (total daily dose - 400 mcg). Nasal polyps: for patients over the age of 18 years (including the elderly), the recommended dose is 2 injections (50 mcg) in each nostril 1 time per day (total daily dose - 200 mcg). If after 5-6 weeks of treatment there is no improvement in the symptoms of the disease, the dose can be increased to injections into each nostril 2 times a day (total daily dose - 400 mcg). The dose should be gradually reduced to a lower dose that provides effective control of the symptoms of the disease. If after 5-6 weeks of treatment there is no improvement in the symptoms of the disease, the patient's condition should be reviewed and alternative methods of treatment should be considered. Preparing the nasal spray for use Momezal nasal spray has a dust cap that protects the sprayer and keeps it clean. Don't forget to take it off before spraying and put it back on after use. Before the first use, it is necessary to “calibrate” the spray by 10 clicks of the dosing device until the spray begins to spray. Shake the vial carefully. Place your index and middle fingers on either side of the atomizer and your thumb under the vial. Do not pierce the nasal applicator. Point the sprayer away from you and then press down with your fingers 10 times until the spray begins to spray. If the nasal spray has not been used for 14 days or more, a re- "calibration" is necessary, which is carried out by pressing the dosing device 2 times until the spray appears. After using the indicated number of doses in a vial or after 2 months from the date of first use, the vial should be discarded. How to use the nasal spray Gently shake the bottle and remove the dust cap. Clean your nose carefully. Close one nostril and place the nebulizer in the other nostril as shown. Tilt your head slightly forward while holding the bottle upright. Start inhaling gently and slowly through the nose and at the same time inject the spray into the nostril with a single press on the dosing device. Exhale through your mouth. Repeat step 4 to spray a second time in the same nostril, if applicable. Pull the nebulizer out of that nostril and exhale through your mouth. Repeat steps 3 and 6 for the second nostril. (Figure 3). Wipe the sprayer thoroughly with a clean handkerchief or tissue after using the spray, put on the dust cap. Cleaning the nasal spray It is important to clean your nasal spray regularly, otherwise it will not work properly. Remove the dust cap and carefully remove the atomizer. Wash the atomizer and dust cap with warm water and then rinse under running water. Do not attempt to clean the dosing device with a needle or other sharp object, as this may damage the device and result in incorrect dosing of the medicinal substance. Dry the atomizer and dust cap in a warm place. Place the sprayer on the spray bottle and put on the dust cap. After cleaning, re-"calibrate" by pressing the dosing device 2 times before use. If you have taken more Momezal than prescribed Tell your doctor if you have accidentally taken more than what was prescribed for you. Using steroids for a long time or in large amounts can sometimes affect some of your hormones. In children, it can affect growth and development. If you forget to use Momezal If you forget to use the nasal spray at the right time, use it as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten dose. If during treatment it seems to the patient that the effect of the drug is too strong or weak, he should consult a doctor. Use during pregnancy and lactation If the patient is pregnant, breastfeeding, suspects that she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using the drug. Controlled studies of the safety and efficacy of the drug in pregnant women have not been conducted. After intranasal use of the drug at the maximum therapeutic dose, mometasone is not detected in the blood plasma, even at the minimum concentration; therefore, the effect of the drug on the fetus can be expected to be negligible, and the potential reproductive toxicity very low. As with other nasal corticosteroids, Momezal should not be used during pregnancy or lactation unless the potential benefit to the woman justifies the potential risk to the mother, fetus or newborn. Children whose mothers used corticosteroids during pregnancy should be carefully examined for possible hypofunction of the adrenal glands. Influence on the ability to drive vehicles or maintain mechanisms Mometasone does not affect the ability to drive and control mechanisms. Precautions It is necessary to consult a doctor, even if the above warnings apply to situations observed in the past. Immunosuppression Mometasone furoate should be used with caution, in particular in patients with active or latent tuberculosis infection of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or Herpes simplex infections with eye involvement. Patients taking immunosuppressive corticosteroids have the potential to have reduced immune reactivity and should be warned about the risk of contracting certain infections (eg, chickenpox, measles) and the need for medical attention if such infections occur. Local effect on the nasal cavity After treatment with mometasone furoate for 12 months, there were no signs of atrophy of the nasal mucosa; also in the study of biopsy specimens of the nasal mucosa, the normalization of the histological picture was established. However, patients who have used Momezal for several months or more should undergo regular examination of the nasal mucosa. With the development of a local bacterial or fungal infection of the nose or pharynx, it is recommended to stop treatment with the drug or start appropriate therapy. Irritation of the mucous membrane of the nose and pharynx, which persists for a long time, is an indication for stopping treatment with Momezal. Mometasone is not recommended for patients with perforation of the nasal septum (see section "Side effects"). Nosebleeds usually stopped on their own and were not severe; they occurred with a slightly higher frequency than with placebo (see section "Side Effects"). The drug contains benzalkonium chloride, which can cause irritation of the nasal mucosa. Systemic effects of corticosteroids Systemic effects of nasal corticosteroids can occur, in particular, when high doses are taken over a long period. The occurrence of such an effect is much less likely than with oral corticosteroids and may vary in individual patients, as well as depending on the type of corticosteroids. Potential systemic effects may include Cushing's syndrome, Cushingoid symptoms, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and, less commonly, signs of a psychological or behavioral disorder, including psychomotor hyperactivity, insomnia, anxiety, depression, or aggression ( mostly in children). It was reported about the occurrence of episodes of increased intraocular pressure with the use of intranasal corticosteroids (see "Side Effects"). Patients who switch to nasal spray treatment after long-term treatment with systemic corticosteroids should be closely monitored. Discontinuation of systemic corticosteroids in such patients can lead to adrenal insufficiency for several months until the functions of the hypothalamic-pituitary-adrenal system are fully restored. If these patients present with signs and symptoms of adrenal insufficiency (eg, joint and/or muscle pain, fatigue, depression), regardless of nasal symptoms, restart systemic corticosteroids and other treatments, and take appropriate action. A change in therapy may also reveal allergic conditions (such as allergic conjunctivitis and eczema) that developed earlier and were masked by systemic corticosteroid therapy. Therapy with doses that exceed those recommended may cause clinically significant depression of adrenal function. If the patient is known to have received higher than recommended doses, the need for additional systemic corticoid support during periods of stress or surgery should be considered. Nasal polyps Studies of the safety and efficacy of mometasone furoate in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that have completely blocked the nasal cavities have not been conducted. Unilateral polyps that are unusual or irregular in appearance, especially if ulcerated or bleeding, should be carefully examined. Effects on Growth in Pediatric Patients Regular monitoring of growth and development in children receiving long-term treatment with nasal corticosteroids is recommended. If the child's growth is retarded, treatment should be reviewed to reduce the dose of nasal corticosteroids, if possible, to the lowest dose at which therapeutic effect is maintained. In addition, the patient should be advised to consult a pediatrician. Other organ symptoms Although mometasone nasal spray can relieve nasal symptoms in almost all patients, concomitant use of appropriate adjunctive therapy may help control other organ symptoms, especially ocular symptoms. . Visual disturbances Visual disturbances may result from systemic and local exposure to glucocorticoids. If the patient develops symptoms of decreased visual acuity or other ocular symptoms, they should see an optometrist to diagnose possible causes, which may include cataracts, glaucoma, or rare diseases such as central retinal chorioretinopathy (CRRS), which was diagnosed after systemic and topical application of corticosteroids. Interactions with other drugs The doctor or pharmacist should be informed about all drugs currently or recently used, as well as the drugs that the patient plans to use. If the patient is taking other anti-allergic drugs by mouth or by injection, the attending physician may recommend that they be discontinued while taking Momezal. In some patients, after discontinuation of other corticosteroid drugs for internal and parenteral use, side effects may occur: muscle and joint pain, general weakness and depression. In this case, it is necessary to consult a doctor who will decide on the further use of a nasal spray. If other allergic symptoms appear, such as itching, lacrimation or hyperemia, you should consult a doctor. A clinical interaction study with loratadine has been conducted. No interaction found. Simultaneous use with CYP3A inhibitors, including drugs containing cobiscitate, increases the risk of systemic adverse reactions. The concomitant use of these drugs should be avoided unless the benefit outweighs the risk of systemic side effects. In such cases, additional monitoring is required for the development of systemic pernicious effects of glucocorticoids. Contraindications Do not take Momezal: if the patient has hypersensitivity to the active substance or to any excipient of the drug. if there are any signs of infection in the nasal cavity, you should refrain from using a nasal spray and start using it only after the end of the treatment of the inflammatory process. if the patient has recently undergone surgery in the nose or there has been a trauma to the nose, the drug should be used only after the wound has completely healed. Composition Active ingredient: each dose contains 50 mcg of mometasone furoate (in the form of monohydrate). Excipients: microcrystalline cellulose and carmellose sodium (Avicel CL-611), glycerin, polysorbate 80, sodium citrate, citric acid monohydrate, benzalkonium chloride, water for injection. Overdose In case of using the drug Momezal in a dose greater than prescribed, you should immediately consult a doctor. Mometasone furoate has a low (≤ 0.1%) systemic bioavailability, so it is unlikely that overdose will require any special measures other than monitoring the patient and then prescribing the drug at the recommended dose. Oral use of high doses of corticosteroids or their use by inhalation can lead to depression of the hypothalamic-pituitary-adrenal system. Side effects Like all medicines, Momezal can have side effects, although not everybody gets them. Safety Summary Nosebleeds usually resolve spontaneously and are not severe; they occurred at a frequency slightly higher than with placebo (5%), but equal to or less than with intranasal corticosteroids, which were used as active controls (up to 15%). The incidence of other side effects was comparable to that of placebo. In patients treated for nasal polyps, the incidence of side effects was the same as in patients treated for allergic rhinitis. Side effects associated with the ongoing therapy of allergic rhinitis and nasal polyposis, obtained during clinical trials, as well as in the period of post-marketing research, regardless of the indications, are presented below. Side effects are grouped by frequency, organs and systems according to the MedDRA classification Very common (≥ 1/10); often (≥ 1/100, < 1/10); infrequently (≥ 1/1000, < 1/100); rarely (≥ 1/10000, < 1/1000); very rare (< 1/10000), unknown (frequency cannot be established based on available data). Infections and parasitic infestations Common: Pharyngitis, upper respiratory tract infections† Immune system disorders Not known: Hypersensitivity reactions including anaphylactic reactions, angioedema, bronchospasm, and breathing difficulties Nervous system disorders Common: Headache Eye disorders Unknown : glaucoma, increased intraocular pressure, cataracts, decreased visual acuity Respiratory, thoracic and mediastinal disorders Very common: epistaxis* Common: epistaxis, nasal burning, irritation of the nasal mucosa, ulceration of the nasal mucosa Not known: perforation of the nasal septum Gastrointestinal tract disorders Common: Throat irritation* Not known: Taste and smell disturbances side effects in children. In children, the incidence of adverse events was comparable to that of placebo, such as epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%). If you experience any of the above or other adverse events not listed in this package leaflet, you should inform your doctor about them. Storage conditionsStore at a temperature not exceeding 25°C. Keep out of the reach of children. Medicines must not be flushed down the drain or thrown into the wastebasket. You should ask the pharmacist what to do with unused medicines. This is important for the environment. Buy Momezal nasal spray 50mcg/dose 140 doses #1 Price for Momezal nasal spray 50mcg/dose 140 doses #1