Rhinocort Aqua 64MCG/Astrazeneca nasal

Dosage form Bottle
Specifications Budesonide

Ingredient

Composition information	Content
Budesonide	64mcg

Uses

Indications

Rhinocort Aqua 64 mcg/dose is indicated in the following cases:

The treatment of allergic rhinitis all year round and seasonal allergic rhinitis, vascular rhinitis.

prevent recurrent nasal polyps after polyp surgery.

Treatment of nasal polyps.

ATC code: R01ADO5.

Budesonid is a glucocorticoid with strong local anti -inflammatory effect. The exact mechanism of action of glucocorticoid in the treatment of rhinitis has not been fully understood. Anti -inflammatory effects such as inhibiting the release of intermediate substances that cause inflammation and inhibition of immune response through cytokin are important. The activity of Budesonid is measured by its affinity for glucocorticoid receptors about 15 times higher than the activity of Prednisolon. When using backup before stimulating the nose, Budesonid proves to protect against the penetration of eosinophilia and hypersensitivity.

With the treatment dose, Rhinocort Aqua does not cause any clinical changes at the basic concentration of cortisol in plasma as a response to ACTH's stimulation. However, the decrease in the amount of cortisol in plasma and urine related to the dose has been recorded in healthy volunteers after a short time using Rhinocort Aqua.

Do not record the response relationship - dose through clinical trials in children with seasonal allergic or year -round or in adults with allergic rhinitis all year round.

pharmacokinetic

absorption

Budesonid's systemic bioavailability in Rhinocort Aqua is 33%.

Dynamic pharmacokinetics in doses at clinical doses, in adults, maximum plasma concentrations achieved after using 256 microgram budesonid in Rhinocort Aqua is 0.64 nmol/l within 0.7 hours. The area under the curve shows the drug concentration over time (AUC) after using 256 microgram budesonid from Rhinocort Aqua is 2.7 nmol x hour/l in adults and 5.5 nmol x o'clock/l in children, this shows that in children, the body contact with glucocorticosteroid is higher.

Distribution and metabolism

Budesonid has an integral distribution of about 3 l/kg. Combined with plasma protein is 85 - 90%. Budesonid metabolizes the first phase through strong liver (~ 90%) into low metabolites with low glucocorticoid activity. The main metabolites 6-α-hydroxybudesonid and 16-β-β-hydroxyprednisolon have glucocorticoid activity lower than 1% of this activity of Budesonid. Budesonid is not inactivated at the nose.

Elimination

Budesonid is eliminated by metabolism that is mainly catalyzed by CYP3A4 enzyme. The metabolites are excreted through the kidneys in a constant form and a combination form. Only an insignificant amount of Budesonid is unchanged found in urine. Budesonid has a high system clearance (0.9 - 1.4 liters/minute), and the semi -cancellation time in plasma after an average intravenous injection is about 2-3 hours.

Before taking Rhinocort Aqua 64MCG/Astrazeneca nasal

How to use

Instructions for use correctly Rhinocort Aqua

The guidance for patients to carefully read the "User Guide, Processing and Delete Rhinocort Aqua" section is very important.

Instructions for use, processing and throwing away Rhinocort Aqua

Note: Before the Rhinocort Aqua spray bottle is first used, the drug must be loaded into the nose. Shake the bottle and spray into the air until a homogeneous spray is reached. This effect lasts 24 hours. If after 24 hours to use the next dose, the drug must be reloaded. This time, just spraying once into the air is enough.

Clean nose. Shake the bottle. Open the brown protective lid.

Hold the bottle straight up.

Put the top of the bottle into the nostril and pump according to the prescribed dose. Similarly, pump the drug on the other nose.

Cover the brown protective lid. Do not use rhinocort aqua more than the specified dose.

Children: Children should only use Rhinocort Aqua under the guidance of adults to ensure the right use and the right dose of prescribed prescription.

Rinse: Wash the plastic parts regularly. Open the brown protective lid and remove the part of the white nose. Wash these plastic parts in warm water. Let the plastic parts dry completely in the air before covering.

Dosage

Need to adjust the dose suitable for each individual.

Rhinitis

adults and children aged 6 and older

The recommended starting dose is 256 micrograms/day. Can be used only once every morning or divided into 2 mornings and evening. This means that 128 micrograms (2 x 64 micrograms) each nose in the morning or 64 micrograms on each side of the nose in the morning and evening.

Not to show more effective daily dose than 256 micrograms.

Dosage for elderly patients is like adult dose. When the efficiency is achieved, it is necessary to reduce the lowest doses and still control symptoms. Clinical trials show that for some patients, the 32 micrograms on each nose in the morning are effective enough.

Some patients will reduce symptoms for 5-7 hours after the beginning of treatment. The full effect is only achieved after a few days of treatment (rarely more than 2 weeks). Therefore, if possible, it is recommended to start treating seasonal rhinitis before contact with allergens.

In case of severe nasal congestion, may need additional medication.

Sometimes additional treatment is needed to handle visual symptoms caused by allergies.

Symptomatic treatment and nasal polyp prevention. The recommended dose is 256 micrograms per day. The dose can be used immediately in the morning or divided into 2 doses of light and evening. After achieving the desired clinical effect, the maintenance dose should be gradually reduced until the lowest dose needed to control symptoms.

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 overdose? When using high doses of Rhinocort Aqua for a long time, the effect of systemic glucocorticoids such as adrenal energy and adrenal pulp is likely to occur.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not use double the prescribed dose.

Side Effects

When using Rhinocort Aqua 64 mcg/dose, you may experience unwanted effects (ADR).

About 5% of patients taking drugs may have side effects in the form of local irritation.

In the table below, adultery effects are listed according to the organ system and frequency

Common (≥1/100,

Respiratory, chest and mediastinum disorders.

Common.

On -site irritation, mild nasal bleeding, nosebleeds.

Very rare.

puncture nasal septum, mucosal ulcer.

immune system disorders.

Less.

Thiche. Hres, dermatitis, rash, itching.

Very rare.

Anaphylactic reaction.

Very rare cases may occur mucosal ulcer and puncture the nasal septum. The causes of these side effects (due to steroids, potential diseases or other factors) are not clear.

Notify the doctor with unwanted effects when using the drug.

Instructions on how to handle ADR

Can greatly reduce the rate of hoarseness or mouth -to -mouth Candida - Throat with measures to reduce the amount of pills sticking to the oral cavity, such as gargling and throat after pumping the drug.

can reduce ADR ratio in long -term treatment by periodic trying to stop using inhaled corticosteroids in well -controlled patients.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Rhinocort Aqua 64 mcg/dose contraindicated in the following cases:

Previously was sensitive to Budesonid or any excipients of the drug.

Caution when using

When long -term use in high doses, the systemic effect of glucocorticosteroids such as adrenal energy, adrenal pulp and/or growth retardation in children may occur.

Not yet established a long -term effect of nasal steroids in children. Cortison -containing drug treatment can lead to developmental retardation. Should regularly monitor the development of children and adolescents regularly when long -term treatment with corticosteroids, regardless of the route. If there is a suspected retardation, medication must be reviewed. The benefits of treatment with glucocorticosteroid must be placed in a new correlation with the risk of development inhibitors.

Be cautious when treating patients with fungal infections or nasal herpes infection.

Be cautious when treating patients from glucocorticosteroid -acting to the body to use Rhinocort Aqua when suspected to have hypothalamic shaft disorders - pituitary - adrenal glands. In these patients, the system of systemic steroids should be carefully reduced and consider the test of the function of the hill - pituitary - adrenal gland. Patients may also need to use more systemic steroids in stress stages such as surgery, injury.

Severe liver function will affect the pharmacokinetics of Budesonid oral, reducing the rate of excretion and increasing body biodegrades. Pay attention to the body effects that may occur.

Need to be particularly cautious in tuberculosis patients.

Should avoid exposure to Rhinocort Aqua with the eyes. If Rhinocort Aqua is in contact with the eyes, should be washed immediately with water.

Should avoid simultaneously with ketoconazole or other powerful CYP3A4 inhibitors. If used combined, the distance of Budesonid and these drugs as far as possible (see the interaction with other drugs and other types of interactions).

The ability to drive and operate machinery

Rhinocort Aqua does not affect the ability to drive and operate the machine.

Pregnancy

Data from more than 2000 pregnant women does not show an increased risk of malformations in children for pregnant women treated with Rhinocort Aqua.

Comparison with the prediction rate, the slight increase of the frequency of small defects in the heart has been discovered in children where the mother is exposed to Rhinocort Aqua in the early stages of pregnancy, but it does not seem to have relationships with concentrations and contact time. During pregnancy, the purpose is to use the lowest doses effectively and shorten the maximum time for Rhinocort Aqua.

Breastfeeding period

Budesonid is secreted through breast milk. However, in Rhinocort's treatment doses, unpredictable effects on children. Rhinocort can be used carefully during breastfeeding.

Medicinal interaction

Ketoconazole 200 mg orally once a day, increasing the plasma concentration of oral budesonid (3 mg of only dose) neutral than simultaneously used. When Ketoconazole is used after 12 hours of using budesonid, the concentration of budesonid increases by an average of 3 times. There is no information on this interaction for the nasal budesonid, but the concentration of plasma increases significantly also expected in such cases.

Avoid combining use because there is no data that allows the doses to recommend the nose. If the combination must be used, the distance used by Budesonid and Ketoconazole is as far as possible. It is also advisable to consider reducing the dose of Budesonid. Other powerful CYP3A4 inhibitors can significantly increase the concentration of budesonid in plasma.

Storage

Do not store over 30 ° C. Do not be frozen.

Expiry date: 24 months from the date of manufacture. Do not use overdue drugs stated on the packaging.

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