Budecort Rotacaps (budesonide Inhalation Powder)

Generic Pulmicort Flexhaler (Budesonide Inhalation Powder) - Product Information

Generic Pulmicort Flexhaler (Budesonide Inhalation Powder) is used for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients five years of age or older. It is also used to treat patients that require treatment with oral corticosteroid for asthma. Budecort Rotacaps must not be used for the relief of acute bronchospasm. Budecort Rotacaps are manufactured by Cipla Ltd. in the strengths of 200 mcg. Another medication which is used to prevent or reduce the frequency and seriousness of asthma attacks is Generic Flovent HFA (Flohale Inhaler).

We also have in stock Budecort Inhaler (Generic Pulmicort) which is used for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older.

Name of the Drug

We supply original Budecort rotacaps manufactured by Cipla Ltd. Each Budecort 200 mcg rotacap capsule contains 200 mcg of Budesonide in the form of a dry inhalation powder.

Manufacturer of Budecort Rotacaps

Cipla Ltd. 
Website: cipla.com

Active Ingredient present in Budecort Rotacaps

The active ingredient present in Budecort Rotacaps is Budesonide. Each Budecort 200 mcg capsule contains 200 mcg of Budesonide in the form of a dry inhalation powder.

Uses of Generic Pulmicort Flexhaler (Budesonide Powder For Inhalation)

Generic Pulmicort Flexhaler is used to prevent asthma attacks and not to treat an asthma attack that has already begun. Budecort Rotacaps works by decreasing irritation and swelling in the airways, which helps to control or prevent asthma symptoms. It contains Budesonide which is a corticosteroid. Budesonide prevents the release of substances in the body that cause inflammation.

Budecort Rotacaps - Dosage

The dosage of Budecort Rotacaps (Generic Pulmicort Flexhaler) is given below:
Adults (including elderly) and children over 12 years:
200 mcg to 1,600 mcg daily, in divided doses.
200 mcg twice daily, in the morning and in the evening. During periods of severe asthma the daily dosage can be increased up to 1600 mcg.
In patients with well controlled asthma, the daily dose can be reduced below 400 mcg but should not go below 200 mcg.
Patients should be maintained on the lowest dose that will effectively control symptoms.

Children (5 years to 12 years):
200 mcg to 800 mcg daily, in divided doses.
The dose should be reduced to the minimum necessary to maintain good asthma control. The patient should be transferred to once daily dosing at the same equivalent total daily dose. The dose should subsequently be reduced to the minimum needed to maintain good asthma control.
Patients must be instructed to take the once daily dose in the evening. It is important that the dose is taken consistently and at the same time every evening.
Patients, specially those receiving once daily treatment, should be advised that if their asthma deteriorates (e.g. increased frequency of bronchodilator use or persistent respiratory symptoms) they should double their steroid dose, by administering it twice daily, and must contact their doctor as soon as possible.
In patients where an increased therapeutic effect is required, an increased dose of Budesonide rotacaps (Budesonide Powder for inhalation) is recommended because of the lower risk of systemic effects as compared with a combined treatment with oral glucocorticosteroids.
Budecort Rotacaps should only be inhaled with the Cipla Rotahaler device (Generic Handihaler). Budecort Rotacaps must not be swallowed.

How to Use Cipla Rotahaler(Generic Handihaler) to administer Budecort Rotacaps

Read the leaflet supplied with the RotaHaler device and follow these instructions:
• Do not swallow the capsules
• Use the RotaHaler to take the medicine
• Do not use the RotaHaler device to take any other medicine
• The medicine comes as a powder in a capsule that fits into the RotaHaler device. Each capsule contains only a small amount of powder equal to one full dose of medicine.
• Take one of the capsules from the packaging and insert into the Rotahaler. Twist the RotaHaler to pierce open the capsule.
• After the capsule is pierced, take a complete dose of the medicine by breathing in the powder by mouth two times, using the RotaHaler device.
• Throw away any capsules that are not used right away after it is taken out of the package. Do not leave the capsules open to air; they may not work as well.

The RotaHaler comes with a pictogram of the above procedure making it very easy to follow and understand.

 

Budecort Rotacaps Contraindications

Budecort Rotacaps are contraindicated in patients with a history of hypersensitivity to Budesonide or any of the inactive ingredients present in this medicine. Budecort Rotacaps (Budesonide Powder for inhalation) is also contraindicated in the primary treatment of status asthmaticus (a severe condition in which asthma attacks follow one another without a break) or other acute episodes of asthma where intensive measures are necessary.

Budecort Rotacaps Side effects

The most common side effects of Budecort Rotacaps (Generic Pulmicort Flexhaler) with an incidence rate of 1% and more common than placebo in the clinical trials are: Mild irritation in the throat, Candida infection in the oropharynx, hoarseness, coughing, nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, nausea, viral gastroenteritis, otitis media, oral candidiasis, respiratory infection, sinusitis, headache, pain, back pain, fever, neck pain, syncope, abdominal pain, dry mouth, vomiting, weight gain, fracture, myalgia, hypertonia, migraine, ecchymosis, insomnia, infection, taste perversion, voice alteration, asthenia, dyspepsia, arthralgia, increased cough and rhinitis.


Seek medical attention right away in case any of these severe side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); ear infection; fainting; increased wheezing; infection (fever, chills, sore throat); mental/mood changes; severe dizziness; shortness of breath after using Budesonide Inhalation Powder; sinus infection; sudden weight loss; tightness in the lungs; vomiting; white patches in mouth or on throat.

Other Less serious side effects of Generic Pulmicort Inhaler (Budecort Inhaler) may include:
• white patches or sores inside your mouth or on your lips
• runny or stuffy nose, sneezing
• sore throat, cough
• nausea, vomiting, diarrhea, stomach pain
• nosebleed
• headache

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Budecort Rotacaps Storage Instructions

Store Budecort Rotacaps at controlled room temperature (59°F to 86°F, 15°C to 30°C). Protect from light.

Warnings & Precautions When Using Budecort Rotacaps (Generic Pulmicort Flexhaler))

You should not use Budecort Rotacaps (Generic Pulmicort Flexhaler) if you are having an acute asthma attack.The other warnings and precautions are:

• Treatment with the recommended doses of Budesonide Rotacaps usually gives a therapeutic benefit within 10 days. However, certain patients may have an excessive collection of mucous secretion in the bronchi. In these cases, a short course of oral corticosteroids (usually 1 to 2 weeks) must be administered in addition to the aerosol. After the course of the oral drug, the inhaler alone should be sufficient therapy.
• Transfer of patients on oral steroids to treatment with budesonide inhaler demands special care, mainly due to the slow restitution of the disturbed hypothalamic-pituitary-adrenal (HPA) axis function, caused by extended treatment with oral corticosteroids. When the Budesonide Rotacaps treatment is initiated, the patient should be in a relatively stable phase. Budesonide Rotacaps is then given in combination with the previously used oral steroid dose for about 10 days.
• Budecort Rotacaps are not intended for rapid relief of acute episodes of asthma or symptoms of asthma. In these situations an inhaled short-acting bronchodilator is required. Patients should be advised to have such 'rescue' medication with them at all times.
• The main route of metabolism of Budesonide, as well as other corticosteroids, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a potent inhibitor of CYP3A4, the mean plasma concentration of orally administered Budesonide increased. Concomitant administration of other known inhibitors of CYP3A4 (eg, itraconazole, clarithromycin, erythromycin, etc.) may inhibit the metabolism of, and increase the systemic exposure to, Budesonide.
• Reduced liver function may affect the elimination of glucocorticosteroids. The plasma clearance following an intravenous dose of Budesonide however was similar in cirrhotic patients and in healthy subjects. After oral ingestion systemic availability of Budesonide was increased by compromised liver function due to decreased first pass metabolism.
• No overall differences in safety were observed between these patients and younger patients. Clinical studies did not include sufficient numbers of patients aged 65 years and over to determine differences in efficacy between elderly and younger patients. Other reported clinical or medical surveillance experience has not identified differences in responses between the elderly and younger patients.

Budecort Inhaler During Pregnancy

Budesonide (Budecort Rotacaps) is classified by the US FDA as Pregnancy Category B.
Several studies of pregnant women and from worldwide post marketing experience, have not shown increased teratogenic risk associated with inhaled Budesonide during pregnancy.
In animal studies, glucocorticosteroids have been shown to induce malformations. This is unlikely to be relevant for humans given recommended doses, but therapy with inhaled Budesonide must be regularly reviewed and maintained at the lowest effective dose.
Hypoadrenalism can occur in infants born of mothers receiving corticosteroids during pregnancy. Such babies should be carefully observed.
Use of Budecort Rotacaps (Budesonide Powder for inhalation) during pregnancy requires that the benefits for the mother be weighed against the risks for the foetus. Budecort Rotacaps should only be used during pregnancy if the expected benefits outweigh the potential risks. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Budecort Rotacaps During Breastfeeding

Budesonide, like other corticosteroids, is secreted in human milk. Studies with Budesonide delivered via dry powder inhaler indicates that the total daily oral dose of Budesonide available in breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by the mother. Use of Budecort Rotacaps immediately after breastfeeding to maximize the time interval between dosing and breastfeeding to minimize infant exposure.
Do not use this medicine without telling your doctor if you are breastfeeding a baby. This medicine can affect the growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Buy Generic Pulmicort Flexhaler 200 mcg (Budesonide Powder For Inhalation) Online at Only $0.19 per capsule

You can buy Generic Pulmicort Flexhaler online from Clear Sky Pharmacy at a cheap price. Budecort 200 mcg Rotacaps, manufactured by Cipla Ltd., India are supplied in a bottle of 30 capsules. Budecort Rotacaps (Budesonide Powder for inhalation 200 mcg) costs only $0.19 per unit when you place an order for 600 capsules.

Disclaimer

The above information is provided to the best of our knowledge and in good faith, it is without a warrant of any kind, expressed or implied.

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