PROVENTIL HFA Inhalation aerosol (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

A-S Medication Solutions

Λέξεις κλειδιά

50090-4326

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1. Description

The active component of PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, USP racemic α1 [(tert-Butylamino)methyl]-4-hydroxy-mxyleneα,α'-diol sulfate ...

2. Clinical Pharmacology

Mechanism of Action In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2-adrenergic receptors compared with ...

3. Indications and Usage

PROVENTIL HFA Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention ...

4. Contraindications

PROVENTIL HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other PROVENTIL HFA components.

5. Warnings

Paradoxical Bronchospasm: Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, PROVENTIL HFA Inhalation Aerosol should ...

6.1. General

Albuterol sulfate, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in ...

6.2. Information for Patients

See illustrated Patients Instructions for Use. SHAKE WELL BEFORE USING. Patients should be given the following information: It is recommended to prime the inhaler before using for the first time and in ...

6.4. Drug Interactions

Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as PROVENTIL HFA Inhalation Aerosol, but may produce severe bronchospasm in asthmatic ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year study in SPRAGUE-DAWLEY rats, albuterol sulfate caused a dose-related increase in the incidence of benign leiomyomas of the mesovarium at the above dietary doses of 2 mg/kg (approximately 15 ...

6.7. Pregnancy

Teratogenic Effects Albuterol sulfate has been shown to be teratogenic in mice. A study in CD-1 mice given albuterol sulfate subcutaneously showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 ...

6.8. Labor and Delivery

Because of the potential for beta-agonist interference with uterine contractility, use of PROVENTIL HFA Inhalation Aerosol for relief of bronchospasm during labor should be restricted to those patients ...

6.9. Nursing Mothers

Plasma levels of albuterol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of PROVENTIL HFA Inhalation Aerosol are excreted in human ...

6.10. Pediatric Use

The safety and effectiveness of PROVENTIL HFA Inhalation Aerosol in pediatric patients below the age of 4 years have not been established.

6.11. Geriatric Use

PROVENTIL HFA Inhalation Aerosol has not been studied in a geriatric population. As with other beta2-agonists, special caution should be observed when using PROVENTIL HFA Inhalation Aerosol ...

7. Adverse Reactions

Adverse reaction information concerning PROVENTIL HFA Inhalation Aerosol is derived from a 12-week, double-blind, double-dummy study which compared PROVENTIL HFA Inhalation Aerosol, a CFC 11/12 propelled ...

9. Overdosage

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, ...

10. Dosage and Administration

For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age and older is two inhalations repeated every 4 to 6 hours. More ...

11. How Supplied

Product: 50090-4326 NDC: 50090-4326-0 200 AEROSOL, METERED in a CANISTER / 1 in a CARTON NDC: 50090-4326-1 200 AEROSOL, METERED in a CANISTER / 1 in a CARTON