Rinodex with phenylephrine nasal spray 15ml №1

Name:
Rinodex with phenylephrine
Description:
Colorless to light yellow transparent liquid. The main active ingredient is Dexamethasone + Neomycin + Polymyxin B + Phenylephrine. Release form Nasal spray 10 ml, 15 ml or 20 ml in a polyethylene bottle, sealed with a polypropylene nasal spray nozzle. Each vial, together with the leaflet, is placed in a cardboard box. Pharmacological action Rinodex with phenylephrine is a combined anti-inflammatory drug for topical use in otolaryngology. It consists of the antibiotics neomycin sulfate and polymyxin B sulfate, the steroidal anti-inflammatory drug dexamethasone, and the alpha1-agonist phenylephrine hydrochloride. Neomycin is an antibiotic of the aminoglycoside group of the 1st generation. It has a bacteriostatic and bactericidal effect (in high concentrations). Neomycin is active against both gram-negative and gram-positive microorganisms. Resistance to neomycin in microorganisms develops slowly. Neomycin is not active against pathogenic fungi, anaerobic microflora, viruses. Resistant to neomycin clostridia, fungi, protozoa, most strains of Pseudomonas aeruginosa. There is cross-resistance with kanamycin, framycetin, paromomycin. Polymyxin B Polymyxins have a bactericidal effect on the microbial cell. It is active against pathogens that are in the stage of both reproduction and rest, but they act only on extracellularly located microorganisms. Active against most Gram-negative bacteria. Serratia marcescens, Providencia spp., Bacteroides fragilis are usually resistant. Not active against Proteus spp., Neisseria spp., obligate anaerobic and gram-positive bacteria. It has cross-resistance with colistin. Dexamethasone is a synthetic glucocorticosteroid. As part of the combined drug Rinodex with phenylephrine, it has a pronounced anti-inflammatory effect, reducing swelling of the nasal mucosa, which helps to restore airway patency. Phenylephrine – decongestant; alpha1-agonist with a predominant effect on alpha-adrenergic receptors. When applied topically, it has a pronounced vasoconstrictive effect on the mucous membrane of the nasal cavity. When applied topically to an intact mucosa, absorption of the drug into the systemic circulation is practically absent. Indications for use Inflammatory and infectious diseases of the nasal cavity, pharynx, paranasal sinuses: – Acute and chronic rhinitis. – Acute and chronic nasopharyngitis. – Sinusitis. Dosage and administrationAdults: one injection in each nostril 3-5 times a day. Children aged 2.5 to 18 years: one injection in each nostril 3 times a day. The duration of treatment is 5-10 days. Thoroughly clean the nose (for example, by blowing the nose) before using Rinodex nasal spray. When using the spray, the following procedure must be observed: 1. Remove the protective cap. 2. Before the very first use, press the spray nozzle several times to activate the microdosing device; For the following applications, you do not need to repeat this operation: the microdosing device will always be ready for use. 3. Hold the sprayer vertically with the tip up. 4. Keep your head straight, do not tilt. 5. Insert the tip of the spray nozzle into the nostril, press the spray nozzle once with a short sharp movement and at the same time take a shallow breath through the nose for optimal distribution of the drug over the surface of the nasal cavity. 6. After removing the tip from the nostril, open the atomizer. 7. Repeat steps #3-#5 on the other nostril. 8. Close the tip of the spray nozzle with a protective cap. Use during pregnancy and lactation Precautions Do not use for washing the paranasal sinuses. Do not use in patients with renal insufficiency. The drug is used with caution in patients with arterial hypertension, coronary artery disease, hyperthyroidism. To the attention of athletes: the drug contains components that can give a positive effect during doping control. Avoid getting the drug in the eyes. In case of accidental contact with the eyes and other mucous membranes, rinse immediately with plenty of water. When using the bottle should be kept in an upright position with the spray up. Clear nasal passages before use. It is not recommended to use the same vial by several people in order to avoid the spread of infection. The drug should not be used for more than 10 consecutive days. If symptoms persist for more than 10 days, you should consult a doctor. Prolonged use of the drug (more than 2 weeks) can cause tachyphylaxis and drug-induced rhinitis, and can also lead to the development of a systemic vasoconstrictor effect. Recommended doses should not be exceeded, as systemic effects may develop. RINODEX WITH PHENYLEPHRYNE should not be sprayed into the eyes as it causes irritation. In case of accidental contact, it is recommended to rinse the eye with plenty of water. Do not use the drug in the presence of extensive damage to the mucous membrane or perforation of the nasal septum. Patients using corticosteroids have the potential to have a reduced immune response and should be warned about the increased risk of infection if they come into contact with patients with infectious diseases (eg, chickenpox), as well as the need to consult a doctor if this occurs. Systemic effects may occur with the use of nasal corticosteroids, and may differ in different patients, as well as with the use of different corticosteroid agents. Potential systemic effects may include Cushing’s syndrome, Cushingoid symptoms, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and, less commonly, psychiatric and behavioral disorders including psychomotor agitation, hyperactivity, sleep disturbance, anxiety, depression, or aggression (especially in children). After the use of intranasal corticosteroids, cases of increased intraocular pressure have been reported. Treatment with doses higher than those recommended may result in clinically significant adrenal suppression. Long-term use of the drug can cause the growth of bacteria and fungi that are insensitive to neomycin and polymyxin B, as well as allergic reactions to neomycin and polymyxin B, tachyphylaxis and drug-induced rhinitis, lead to systemic vasoconstrictor reactions, arterial hypertension. In the case of infections caused by bacteria or fungi resistant to neomycin and polymyxin B, it is necessary to prescribe appropriate systemic antibacterial or antifungal therapy. Use with caution in patients with hypersensitivity to sympathomimetics, manifested by insomnia, dizziness, tremors, cardiac arrhythmias and increased blood pressure. Patients with renal insufficiency: not recommended. Patients with hepatic insufficiency, elderly patients: it is recommended to reduce the dose and duration of use. Contraindications Hypersensitivity to the active and excipients of the drug, including aminoglycoside antibiotics, pulmonary tuberculosis, systemic viral, bacterial or fungal infections, dry rhinitis, ozena, violation of the integrity of the nasal mucosa, condition after transsphenoidal hypophysectomy or other interventions affecting the dura mater shell, suspected angle-closure glaucoma, diabetes mellitus, diseases of the cardiovascular system (CHD, arterial hypertension), prostatic hyperplasia, kidney disease accompanied by albuminuria, taking MAO inhibitors (simultaneously or in the previous 14 days), simultaneous use with oto- and nephrotoxic drugs, a history of convulsive syndrome, children under 2.5 years of age, pregnancy and lactation. Active ingredients: – Neomycin sulfate – 6500 IU – Polymyxin B sulfate – 10000 IU – Dexamethasone sodium metasulfobenzoate – 0.25 mg – Phenylephrine hydrochloride – 2.5 mg Excipients: – Methyl parahydroxybenzoate, lithium chloride, citric acid, lithium hydroxide (in the form lithium hydroxide monohydrate), macrogol 400, polysorbate 80, purified water. Overdose Due to phenylephrine: Toxic dose in children 3 mg/kg body weight orally, in adults from 300 mg orally. Overdose when applied topically can lead to systemic effects such as fatigue, headache, tachycardia, increased blood pressure, abdominal pain, vomiting, agitation, insomnia, pallor. There is no specific antidote, treatment is symptomatic. Hypertension caused by phenylephrine can be eliminated by the administration of an alpha-blocker. Caused by dexamethasone: May be manifested by the systemic action of corticosteroids (see section “Side effects”) Side effects The frequency of side effects is estimated according to the following scheme: very often (≥1 / 10); often (≥1/100 to <1/10); infrequently (≥1/1000 to <1/100); rarely (≥1/10000 to <1/1000); very rare (<1/10000), not known: the frequency cannot be determined from the available data. Due to the action of dexamethasone: On the part of the organs of vision Very rarely (<1/10000) increased intraocular pressure, glaucoma. General disorders Very rare (<1/10000) With prolonged use, as well as with overdose: Local side effects, as well as atrophy, damage and dryness of the nasal mucosa, perforation of the nasal septum. Systemic side effects: increased blood sugar levels. Growth disorders in children cannot be ruled out. Due to the action of phenylephrine: Central nervous system: Very rare: anxiety, insomnia, fatigue (drowsiness, sedation), headache, hallucinations (mainly in children). Cardiovascular system: Rare: palpitations, tachycardia, arterial hypertension. Very rare: sleep apnea in young children and newborns. Musculoskeletal system: Very rare: convulsions (especially in children). Immune system: Infrequently: hypersensitivity reaction (Quincke's edema, rash, itching). Caused by the action of neomycin and polymyxin B: Local action of neomycin and polymyxin can cause irritation of the nasal mucosa or skin, with prolonged use - contact allergies. Systemic absorption of neomycin with prolonged use or when applied to a damaged surface may be manifested by nephro- and ototoxic effects. Prolonged use of the drug can lead to the growth of strains of bacteria and fungi. If you experience these side effects, as well as reactions not mentioned in this section of the package insert, you should consult a doctor. Storage conditionsStore at a temperature not exceeding 25ºС. Keep out of the reach of children. Buy Rinodex with phenylephrine nasal spray 15ml №1 Price for Rinodex with phenylephrine nasal spray 15ml №1