Rhinocort Inhaler and Spray

Rhinocort is inhaled glucocorticosteroids, which has a local anti-inflammatory, anti-allergic and antiexudative effect. It is used for Crohn’s disease, bronchial asthma and chronic obstructive pulmonary diseases treatment.

Rhinocort Inhaler

International name: Budesonide
Pharmacotherapeutic group: inhaled glucocorticosteroid
Active substance: budesonide

Composition

Each dose contains 0,2 mg of active substance – budesonide.
Excipient: lactose monohydrate – 7,8 mg

Pharmaceutical Form

Rhinocort is released in the form of dosed powder for inhalation. One dose contains 200 mcg (0,2 mg) of budesonide. Carton box contains 1 inhaler made of polymeric material and 200 doses in laminated packages made of aluminum foil.

Pharmacokinetics

When inhaled 30 – 35% of dose gets into bronchial tubes. Bioavailability when entering lings is about 73%. 25 – 30% get into digestive tract. Bioavailability when taken orally is 10,7%. Rhinocort is rapidly cleared from the body. After oral administration in special dosage form about 90% of the drug is metabolized at «first passage» through liver, and only about 10% is system availability. Binding to blood plasma proteins is at average 85 – 90%. Rhinocort undergoes extensive biotransformation in liver with metabolites formation with low glucocorticoid activity. Glucocorticoid activity of major metabolites (6beta-hydroxy-budesonide and 16alfa-hydroxy-prednisolone) does not exceed 1% of budesonide activity. Rhinocort metabolism is predominantly mediated by CYP3A isoenzymes. Elimination rate is limited by extent of budesonide absorption.

Therapeutic Effect

Budesonide has local antiexudative, immunosuppressive, anti-allergic and anti-inflammatory action on respiratory tract mucosa. The drug improves bronchial asthma control. Asthma attacks may occur within 24 hours after this drug therapy beginning. Maximal therapeutic effect is achieved after several weeks of continuous drug use.

Indications

The drug is indicated for mild, moderately severe and severe bronchial asthma. Inhaler is used as basic therapy, with little effect of beta2-adrenoceptor agonists and ketotifen, as well as to reduce oral glucocorticosteroids dosage.

Rhinocort Inhaler is taken for chronic obstructive pulmonary disease treatment.

Intranasal drug administration is carried out for seasonal or year-round allergic rhinitis treatment.

Contraindications

• hypersensitivity or idiosyncrasy to active substance, lactose and other drug’s excipients;
• respiratory diseases of fungal origin;
• tuberculosis at active stage;
• children under 6 years old.

With utmost caution and only under medical recommendation the drug is prescribed at:

• hepatic cirrhosis;
• glaucoma;
• hypothyroidism;
• lip and eye herpes;
• osteoporosis;
• diabetes;
• viral respiratory tract infections;
• hypertrophic obstructive cardiomyopathy;
• ischemic heart disease;
• chronic decompensated heart failure;
• severe hypertension;
• lactation period;
• all pregnancy stages;
• aneurysm;
• tachyarrhythmia;
• expressed pheochromocytoma.

Pregnancy and Lactation Period

Rhinocort Inhaler use during pregnancy is possible if expected benefits to the mother outweigh potential risk to the fetus. If drug administration is necessary breastfeeding should be stopped, due to lack of data on budesonide excretion with breast milk.

Oral administration during pregnancy and lactation period is contraindicated.

Rhinocort for Children

Efficacy and safety of the drug for children under the age of 7 years has not been studied.

Instruction for Use

Dosage scheme is determined by specialist depending on disease type and patient’s age.

Usually Rhinocort Inhaler at adults is used in dosage of 200 – 800 mg a day in 2 – 4 inhalations. Children older than 6 years, take 1 inhalation (200 mcg) a day, maximal allowed dosage is 2 inhalations a day.

Rhinocort Inhaler application basic rules:

1. open the package, store container in protective cover;
2. shake container and make a test nebulisation spray of the powder before using it for intended purpose;
3. standing or sitting it is necessary to inhale deeply and actively through the mouthpiece (for required dose of substance entering bronchi);
4. do not exhale through mouthpiece, but if this happens, you need to hit container softly on hard surface;
5. close protective cup after using inhaler;
6. often clean mouthpiece dry tissue. It is strictly prohibited to use water for cleaning the device.

Precautions and Recommendations

During Rhinocort treatment special instructions must be observed:

• avoid product contact with eyes;
• children should take the drug with caution and under doctor’s supervision, because high doses can cause growth retardation and hydrocortisone reduction. These parameters are recommended to monitor;
• after using Rhinocort it is recommended to rinse mouth with water to reduce oral candidiasis risk;
• when missing doses, inhalation must be applies as soon as possible, the remaining doses should be used at the same day, sharing dividing into regular intervals;
• Rhinocort should not be exposed to direct sunlight or freezing. Comply with all rules of using container and its utilization;
• In case of cylinder cooling it is recommended to get it from polymer shell and warm in hands, because low temperature drug effectiveness decreases;
• after drug discontinuation long-term monitoring of the patient and his respiratory function is necessary.

Side Effects

In most cases Rhinocort is well tolerated by the body, but there are data about the following adverse reaction:

• tachycardia;
• tremor;
• muscle cramps;
• cough;
• headaches and dizziness;
• mouth and throat irritation;
• oral candidiasis;
• anxiety;
• hoarseness;
• nausea;
• sleep disorders;
• in case of hypersensitivity to drug composition bruises and extravasations appeared;
• in rare cases – itching, bronchospasm, depression, rash, cataracts, urticaria fever, increased ocular tension, growth retardation at children.

If you are disturbed by above symptoms, you should immediately discontinue treatment with Rhinocort and seek for medical advice.

Overdose

Toxic reactions at an Rhinocort overdose are observed extremely rare. However, chronic drug administration in high doses can cause systemic reaction to glucocorticosteroids:

• susceptibility to infection;
• hypercorticoidism development;
• adrenal function reduction;
• adrenal cortex atrophy.

Drug Interactions

Cimetidine and omeprazole has no clinically significant effect on Rhinocort pharmacokinetic parameters when administered together. However, under cimetidine influence Rhinocort metabolism in liver may be slowed down.

Rhinocort is characterized by lower systemic bioavailability compared to other glucocorticosteroids, so drug interactions may be less pronounced in comparison with many other drugs of this class.

Drug interactions risk may be increased at elderly people and patients with renal or hepatic dysfunction.

Storage Conditions and Shelf-Life Period

Rhinocort Inhaler should be stored in a dry place away from children. Air temperature must not exceed 30 degrees. The drug must be protected from freezing or direct sunlight. Shelf life period is 3 years from date of issue, after first drug application it should be used within 6 months.

Rhinocort Spray

Clinical Pharmacological Group

Vasoconstrictor drugs for local application in an ENT-practice

Release Form, Composition and Packing

Metered nasal spray (for children) 0.05% as a clear, colorless solution.
1 ml contains Xylometazoline hydrochloride 500 mcg.

Additive agents: citric acid monohydrate, sodium citrate dihydrate, glycerol 85%, water for injection.

15 ml – vials of dark glass with a metering device and a nozzle for nose, packs are made from cardboard.

Nasal spray metered dose 0.1% as a clear, colorless solution.
1 ml contains Xylometazoline hydrochloride 1 mg

Additive agents: citric acid monohydrate, sodium citrate dihydrate, glycerol 85%, water for injection.

15 ml – vials of dark glass with a metering device and a nozzle for the nose, packs are made from cardboard.

Indications for Use

Rhinocort Spray is used as symptomatic treatment for the following diseases and conditions:

• acute viral or bacterial rhinitis;
• acute allergic rhinitis;
• acute sinusitis and chronic sinusitis exacerbation;
• acute otitis media (to reduce swelling of mucous membrane of Eustachian tube);
• patient’s preparation for diagnostic procedures in the nasal passages.

Dosage

1. Adults and children over 10 years are prescribed by generic Rhinicort nasal spray 0.1% to 1 dose (1 pressing) in each nostril no more than 3 times / day.
2. Children aged 2 to 10 years are designated Rhinicort nasal spray online for children 0.05% for 1 dose (1 pressing) in each nostril no more than 3 times / day.
3. The maximum dose is not more than 7 times / day. The interval between drug administration should not be less than 6 hours.
4. The amount of fluid entering patient’s nasal stroke (one dose), is equal to 0.14 ml.
5. To avoid complications in a symptoms’ resumption after continuous drug use duration should not exceed 7 days.
6. Before using product you should dispose nasal passages out of discharge. During administration you should make an easy breath through the nose.

Overdose

Symptoms: in rare cases of overdose it occurs predominantly in children, who may experience arrhythmia, increased blood pressure, in some cases – loss of consciousness.

Treatment: symptomatic therapy is shown under surveillance. In severe cases, it can be used non-selective alpha-blockers to lower blood pressure, as well as intubation and mechanical ventilation. Vasoconstrictor drugs are contraindicated. If you accidentally take moderate or large amounts of drug, you should take activated charcoal and laxative (eg, sodium sulphate) to carry out gastric lavage.

Side Effects

• Local reactions: burning sensation, nasal mucosa dryness; rare – irritation of nose, mouth and throat mucous membranes.
• CNS (central nervous system): rarely – headache; very rare (
• Cardiovascular system: very rare (
• Other: rarely – nausea; very rare (

Contraindications

• atrophic rhinitis;
• angle-closure glaucoma;
• state after hypophysectomy;
• simultaneous reception of MAO inhibitors and tricyclic antidepressants;
• children under 2 years of age (spray for children);
• children under the age of 10 years (spray for adults);
• hypersensitivity to xylometazoline or other preparation’s components.

It should be used with care in patients with:

• hypertension;
• severe heart disease;
• hyperthyroidism;
• diabetes mellitus;
• patients taking bromocriptine.

Drug Interactions

Simultaneous treatment with tri- or tetracyclic antidepressants may increase systemic exposure of xylometazoline.
At the same time taking the drug with MAO inhibitors can increase the risk of arterial blood pressure.

Pregnancy and Lactation

The drug should not be taken during pregnancy. With caution drug should be used during breastfeeding.

Special Instructions

Effects on ability to drive a car and transport management of machines and mechanisms were observed.

Application in Childhood

Children aged 2 to 10 years are designated generic Rhinocort nasal spray for children 0.05% for 1 dose (1 pressing) in each nostril no more than 3 times / day.

Adults and children over 10 years are prescribed online Rhinocort nasal spray 0.1% to 1 dose (1 pressing) in each nostril no more than 3 times / day.

Terms and Conditions of Storage

The drug should be stored out of reach of children at or above 25 ° C. Shelf life is 3 years, after first application – 1 year.

Conditions of Dispensing from Pharmacy

The drug is approved for use as a means of OTC and can be bought via Asthma Inhalers Online (https://onlineasthmainhalers.com).