Formonide 200 HFA Cadila Cadila Cadila Treatment (120 doses)

Dosage form Box
Specifications Budesonide, Formoterol Fumarate

Ingredient

Composition information	Content
Budesonide	200mcg
Formoterol fumarate	6mcg

Uses

Indications

Formonide drugs are indicated in the following cases:

Long-term treatment for asthma asthma for patients aged 12 and older when the combination of inhaled corticosteroids and the prolonged condderic beneficiary is appropriate. Other asthma treatment (for example, when using low-doses to medium corticosteroids inhaled) or patients with asthma severe severe severe treatment when treated with 2 treatments.

Pharmacy

Formonide Inhaler contains Formoterol and Budesonide, these substances have different ways of impact and show a combination effect that reduces asthma play (asthma). The mechanism of action of these two substances will be mentioned below:

budesonide

Budesonide inhaled at recommended doses for anti -inflammatory effects of glucocorticoids in the lungs, reduces symptoms and asthma drama and has little adverse effects compared to the use of systemic corticosteroids. The exact mechanism for this anti -inflammatory effect has not been known.

formoterol

Formoterol is a selective beta-2, causing bronchodilatoma in patients with recovery respiratory obstruction. The bronchodilator effect is achieved quickly within 1-3 minutes after inhalation and lasts 12 hours after the single dose.

budesonide and formoterol

In adult clinical trials, the addition of formoterol to Budesonide improves asthma symptoms and lung function and reduces asthma play. In two 12 -week studies, the impact on the lung function of the inhaler formonide is equivalent to the impact of products containing Budesonide and Formoterol and is more effective than the impact of budesonide used separately. There are no signs of decline in asthma treatment when prolonged use.

pharmacokinetic

absorption

In a single -dose study, bronchial asthma patients are used for high doses of combined aerospm of Budesonide and Formoterol, Budesonide's peak in plasma concentration is 4.5 nmol/l after 20 minutes and Fomoterol is 10 minutes after taking the drug. About 8% of the formoterol dose is found in urine in the form of unchanged. Budesonide's systemic effect when used in the form of aerosol combined with formoterol is about 30% lower than when using Budesonide in the form of aerosol powder (DPI) separately. Budesonide waste time is 4.7 hours and of Formoterol is 7.9 hours.

In the study when the dose was repeated, the healthy patient had an average level of bronchial asthma that was taken within 1 week with the highest doses recommended for Budesonide and Formoterol. The peak concentration of Budesonide and Formoterol respectively is 1.2 nmol/l and 28 PMOL/L after 21 and 10 minutes. And the peak concentration of Budesonide and Formoterol is about 30-40% higher in healthy people than people with asthma.

There is no research on the absorption of drugs on the elderly.

Children: Plasma drug concentrations are evaluated after using Budesonide and Formoterol in the study of single -dose of children with bronchial asthma aged 6 - 11 years old. Budesonide concentration is 1.4 mmol/l achieved after 20 minutes after taking the drug. About 3.5% of the Formoterol dose is found in urine in the form of formoterol. Budesonide's systemic effect when used in the form of aerosol combined with formoterol is about 30% lower than when using Budesonide in the form of aerospm (DPI).

Distribution and metabolism

Plasma protein cohesion is about 50% for formoterol and 90% for Budesonide. The distribution volume is about 4 l/kg for formoterol and 3 l/kg for budesonide. Formoterol is inactivated through conjugated reactions (O-Metyl and Formyl reduction substances are formed, but they are found mainly in the non-active combination form). Budesonide through a strong biological shift (about 90%) when the first time through the liver into low -active metabolites glucocorticosteroids. Glucocorticosteroid activity of main metabolites (6B-Hydroxy-Budesonide and 16A-Hydroxy-Prednisolone) is 1% less than that activity of Budesonide. There is no information on any metabolic interaction or a shift reaction between formoterol and budesonide.

Elimination

Most of the formoterol dose is metabolized through the liver and then excreted the kidneys. After inhalation, 8 - 13% of the formoterol's release dose is excreted in the form of non -metabolized urine. Formoterol has a high body clearance (about 1.4 l/min) and the average last phase waste time is 17 hours.

Budesonide is eliminated by metabolism mainly by catalyst by CYP3A4. Budesonide metabolites are secreted in a free or combined form. Only a significant amount of Budesonide is found in the urine. Budesonide has a high body clearance (about 1.2 l/min) and the sale time after the average intravenous injection is 4 hours.

pharmacokinetics of Budesonide or Formoterol in patients with renal failure is still unknown. The impact of budesonide and formoterol may increase in patients with liver disease.

Before taking Formonide 200 HFA Cadila Cadila Cadila Treatment (120 doses)

How to use

Before using the Formonide drug for the first time or after not use for 1 week to try before taking the drug. Shake the vial carefully, spray one by the air.

Use aerosol tube:

To use 1 dose, follow the following instructions:

1. Turn and remove the protective lid. Check the cleanliness of the vial.

2. Shake the bottle well.

3. Hold the tube vertically between your thumb and index finger. Breathe out gently, put the tip of the inhaler between the teeth and seal the lips.

4. Slightly tilted his head back, breathing slowly through the mouth and pressing hard to get a dose of the drug while continuing to breathe evenly and deep.

5. Before exhaling, take the vial out of the mouth, keep breathing for 10 seconds or until you feel comfortable, exhale gently.

6. Inhalation in a strong and deep mouth. Do not chew or bite hard.

7. If you need additional dose, repeat from step 2 to step 5.

8. Close the lid.

9. Rinse mouth with water. Do not swallow.

Dosage

recommended dose: Use 2 inhales/time x 2 times daily (in the morning and evening), only inhaled through the mouth. Garges after each medication.

If the signs of bronchial asthma have been fully controlled with the recommended dose, it should be considered for a 1 -time/day reduction.

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? Symptoms recorded from special cases such as heart rate, hyperglycemia, hypokalemia, prolonged QTC segment, arrhythmia, nausea and vomiting. Supporting and symptomatic treatment can be appointed. The dose of 90 mcg used in 3 hours in patients with acute bronchial obstruction also does not need to be safe. Overdose of Budesonide, even when using excessive doses, is not a clinical problem. When long -term use of excessive doses, the effects of systemic glucocorticosteroids can occur as adrenal energy and adrenal inhibition.

What to do when forgetting 1 dose?

Not recorded.

Side Effects

When using formonide, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Central nervous system: headache

cardiovascular system: tachycardia.

Muscle system: muscle contraction.

Central nervous system: agitation, restlessness, impatience, nausea, dizziness, sleep disorders.

Skin: Skin bruise.

Instructions on how to handle ADR

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

Formonide drugs contraindicated in the following cases:

Not used for patients with initial treatment of asthma or acute manifestations of asthma when required emergency measures.

Hypersensitivity (allergies to Budesonide, Formoterol inhaled).

Precautions when used

Dosage should be gradually reduced when stopped treatment and should not stop the drug suddenly.

If the patient feels that the treatment is ineffective or need to increase the dose, there must be a doctor's monitoring. The increase in the use of bronchodilators shows that the progression is worse in the background disease and need to re -evaluate asthma treatment. Sudden and progressive decline in controlling asthma can be life -threatening and patients should be evaluated in terms of medical immediately. In this situation, it is advisable to consider the need to increase the dose of corticosteroids or combine anti -inflammatory therapy as a corticosteroids or oral antibiotic treatment if there is an infection.

There is no data on the use of inhaler formonide in the treatment of acute asthma attacks. It is necessary to advise patients to always carry bronchodilators quickly.

Patients should remember to use formonide inhaler daily as prescribed even without symptoms.

Do not start treatment when the patient is in a asthma play.

As well as other inhaled sugars, bronchospasm of drama can occur with a sudden increase in wheezing symptoms after inhalation. At that time, it should be discontinued should re -evaluate the treatment and replacement with other therapy if necessary.

Systemic effects may occur when using any inhaled corticosteroids, especially when taking high doses for a long time. These effects are rarely occurring when using inhaled corticosteroids compared to oral corticosteroids. The body's effects may occur include: inhibiting adrenal glands, developing retarded in children and minors, reducing bone minerals, cataracts and glaucoma.

The height of children being treated long -term with inhaled corticosteroids is recommended for regular monitoring. If there is a retardation, the treatment should be re -evaluated for the purpose of reducing the dose of inhaled corticosteroids. The benefits of corticosteroid treatment and the risk of growth are possible to be carefully considered. In addition, it is necessary to consider instructing patients to pediatric respiratory specialists.

A few data from long -term studies suggested that most children and minors are treated with the last inhaled corticosteroids will achieve the target height as adults. However, it was noted that there was a slight and temporary decline in development (about 1 cm). This usually happens during the first year of treatment.

Long -term studies on Budesonide inhaled lines on children at an average dose of 400 mcg (titration dose) or adults at an average dose of 800 mcg (titration dose) did not show any significant impact on the mineral density of the bone.

If there is a retardation and to minimize the risk of the whole body possible, the review of therapeutic and adjusting the dose of corticosteroids inhaled to the lowest dose and still maintaining the effective control is very important.

The benefits of inhaled budesonide treatment are often minimizing oral steroids, but in patients moving from oral steroids may still have the risk of adrenal reserves in a significant time. Patients who need to use high doses of corticosteroids before or when using high doses of inhaled corticosteroids for a long time, especially when the recommended dose may still be at risk. The use of additional corticosteroids should be considered during stress or selective surgery.

To minimize the risk of Candida infection with throat, patients should be instructed to gargle with water and then spit after each inhalation.

Should avoid simultaneous treatment with ketoconazole or strong CYP3A4 inhibitors. If it cannot be avoided, the distance between the use of drugs interact with each other should last as long as possible.

Formonide Inhaler should be used carefully for patients with armor toxicity, chromium skin tumor, diabetes, untreated potassium potassium, obstructive hypertrophic cardiomyopathy, underground aortic stenosis, severe hypertension, aneurysm or other serious cardiovascular disorders such as local anemia heart disease, fast heart rate or severe heart failure.

Precautions when treating in patients has a long period of QTC. Formoterol itself can extend the QTC time.

Reassessment of the need and dose of inhaled corticosteroids in patients with pulmonary tuberculosis progresses or hidden, fungal infections and respiratory viruses.

The ability to lower severe blood potassium may occur when high doses of beta-2 owner. Simultaneous use of beta-2 shipping owners with drugs that cause or hypoglycemia such as Xanthine derivatives, steroids and diuretics can increase the impact of hypotension due to the use of concrete-2-substances. Should be especially cautious in unstable asthma patients taking different doses of bronchodilators, in acute severe asthma patients and coordinated risks may increase due to oxygen decrease and other patients with other conditions when the possibility of adultery reactions lowering potassium. Should monitor serum potassium level throughout these conditions.

The ability to drive and operate machinery

Formonide inhaler does not affect or negligible effect on the ability to drive and operate the machine.

Pregnancy

There is no clinical data on the combination of formoterol and budesonide in pregnant women. Has not conducted studies on toxic animals on reproduction when using combined drugs.

There is no adequate data on the use of formoterol for pregnant women. In animal studies, in very high doses, formoterol causes adverse effects in reproductive studies.

The data on about 2000 pregnant women use drugs shows that there is no risk of teratogenicity associated with the use of inhaled budesonide. Animal studies show that glucocorticosteroids cause deformities. This is not related to people when using the recommended doses.

Animal studies also show that there is an excessive prenatal glucocorticoid use and increased risks such as uterine retardation, adult cardiovascular disease, long -term changes in glucocorticoid receptors, neurotransmitter and behaviors when exposure under the limit of teratogenic doses.

During pregnancy, the drug should only be taken when considering the outstanding effect. The lowest lowest dose of Budesonide should be used to maintain good asthma (asthma) control.

Breastfeeding period

still do not know whether the formoterol or budesonide will be in breast milk or not. On the mouse, a small amount of formoterol was discovered in breast milk. The use of formonide inhaler for breastfeeding women should only be considered if the benefits for mothers are higher than the risks that may occur for children.

Medicinal interaction

Ketoconazole 200 mg, 1 time/day increases the plasma concentration of oral budesonide (single dose of 3 mg) on average 6 times when used simultaneously. When Ketoconazole is used 12 hours after using Budesonide, the average budesonide level increases by 3 times. There is no information on this interaction for inhaled Budesonide, but it is thought to have a clear increase in drug concentration in plasma. Because there is no information about the dose, avoid combining the above drugs. If inevitable, the distance between the use of ketoconazole and budesonide should last as long as possible. It is also advisable to consider reducing the dose of Budesonide. Other powerful CYP3A4 inhibitors also increase the budesonide level in plasma.

Betel blockers may reduce or inhibit the effects of formoterol. Therefore, formonide inhaler should not be used with beta blockers (including eye drops) unless there is a convincing reason.

Concentrated with Quinidine, Disopyramide, Procainamide, Phenothiazine, antihistamine (Terfenadine), IMAO and 3 -round antidepressants can extend QTC and increase the risk of ventricular arrhythmia. Moreover, L-Dopa, L-Thyroxine, Oxytocin and alcohol can affect the tolerance of the heart for the sympathetic drug in beta-2. Simultaneous use with imao including agents with characteristics similar to Furazolidone and Procarbazine can promote hypertension reactions.

Increased risk of arrhythmia in patients who are emotionless with Halogenization hydrocarbon.

Concentrated with other condaluic drugs may have a strong plus effect.

Hemoto reduction may increase the tendency to arrhythmia in patients treated with cardiac glycosides.

Budesonide does not show interactive with other drugs used to treat asthma (asthma).

Storage

Storage below 30 ° C.

Other drugs

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