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RX ITEM-Budesonide 0.25mg 2ml Res 30X2ml by Cipla Pharma

NDC No. 69097-0318-87 69097-318-87 6909731887 69097031887  UPC/GTIN No. 3-07817-51587-2 307817515872  307817-515872   MPN 751587Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Budesonide 0.25mg 2ml Res 30X2ml by Cipla Pharma

$171.00$49.99

NDC No. 69097-0318-87 69097-318-87 6909731887 69097031887 UPC/GTIN No. 3-07817-51587-2 307817515872 307817-515872 MPN 751587 RX712596/M 712596 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Other Name Pulmicort, Budesonide, Rhinacort, Entocort Therapeutic Cod

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PULMICORT RESPULES- budesonide suspension
AstraZeneca LP

1 INDICATIONS AND USAGE

1.1 Maintenance Treatment of Asthma
PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.



Important Limitations of Use:


PULMICORT RESPULES is NOT indicated for the relief of acute bronchospasm.
2 DOSAGE AND ADMINISTRATION

The recommended starting dose and highest recommended dose of PULMICORT RESPULES, based on prior asthma therapy, are listed in the following table.

Previous Therapy Recommended Starting Dose Highest Recommended Dose
Bronchodilators alone

0.5 mg total daily dose administered either once daily or twice daily in divided doses

0.5 mg total daily dose

Inhaled Corticosteroids

0.5 mg total daily dose administered either once daily or twice daily in divided doses

1 mg total daily dose

Oral Corticosteroids

1 mg total daily dose administered either as 0.5 mg twice daily or 1 mg once daily

1 mg total daily dose

2.1 Dosing Recommendations
Dosing recommendations based on previous therapy are as follows:


Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily

Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily

Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily
In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered. If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a divided dose. In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved.

2.2 Directions for Use
PULMICORT RESPULES should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of PULMICORT RESPULES and, therefore, are NOT recommended.

The effects of mixing PULMICORT RESPULES with other nebulizable medications have not been adequately assessed. PULMICORT RESPULES should be administered separately in the nebulizer [see Patient Counseling Information, Administration with a jet nebulizer (17.1)].

A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver PULMICORT RESPULES to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of PULMICORT RESPULES delivered by other nebulizers and compressors have not been established.

3 DOSAGE FORMS AND STRENGTHS

PULMICORT RESPULES is available in three strengths, each containing 2 mL: 0.25 mg/2 mL, 0.5 mg/2mL, and 1 mg/2 mL. PULMICORT RESPULES is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose RESPULES ampules together with patient instructions for use. There are 30 RESPULES ampules in a carton. Each single-dose RESPULES ampule contains 2 mL of sterile liquid suspension.
CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. In standard in vitro and animal models, budesonide has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol (rat croton oil ear edema assay). As a measure of systemic activity, budesonide is 40 times more potent than cortisol when administered subcutaneously and 25 times more potent when administered orally in the rat thymus involution assay. The clinical significance of these findings is unknown.

NDC No. 69097-0318-87 69097-318-87 6909731887 69097031887  UPC/GTIN No. 3-07817-51587-2 307817515872  307817-515872   MPN 751587
Budesonide 0.25mg 2ml Res 30X2ml by Sand
NDC No. 69097-0318-87 69097-318-87 6909731887 69097031887 UPC/GTIN No. 3-07817-51587-2 307817515872 307817-515872 MPN 751587

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