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Albuterol/Ipratropium 2.5-0.5mg/3ml Ampoules 30X3 ml Unit Dose Package By Sandoz

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Albuterol/Ipratropium 2.5-0.5mg/3ml Ampoules 30X3 ml Unit Dose Package By Sandoz

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Albuterol/Ipratropium 2.5-0.5mg/3ml Ampoules 30X3 ml Unit Dose Package By Sandoz This Item Requires A Valid Order From A Physician Licensed in USA. Item No.: RXD3992831/RXB10038962 Generic Duoneb
NDC No. 00185732230 MPN no. 732230
Generic Name: Albuterol/Ipratropium
Additional Description: 6X5Ud Inhl
Strength: 2.5-0.5mg/3ml Form Ampolues size 30X3ml
Unit of Measure ml Unit of Sale Cn Unit Dose Ud
Schedule No. 0 Private Label 999 Multi-Source Y

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Contraindications

Ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to Ipratropium bromide, or to atropine and its derivatives.
Warnings

The use of Ipratropium Bromide Inhalation Solution as a single agent for the relief of bronchospasm in acute COPD exacerbation has not been adequately studied. Drugs with faster onset of action may be preferable as initial therapy in this situation. Combination of Ipratropium bromide and beta agonists has not been shown to be more effective than either drug alone in reversing the bronchospasm associated with acute COPD exacerbation.

Immediate hypersensitivity reactions may occur after administration of Ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.
Precautions
General

Ipratropium bromide should be used with caution in patients with narrow angle glaucoma, prostatic hypertrophy or bladder neck obstruction.
Information for Patients

Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if the solution comes into direct contact with the eyes. Use of a nebulizer with a mouthpiece rather than face mask may be preferable, to reduce the likelihood of the nebulizer solution reaching the eyes. Patients should be advised that Ipratropium Bromide Inhalation Solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established. Patients should be reminded that Ipratropium Bromide Inhalation Solution should be used consistently as prescribed throughout the course of therapy.
Drug Interactions

Ipratropium bromide has been shown to be a safe and effective bronchodilator when used in conjunction with beta adrenergic bronchodilators. Ipratropium bromide has also been used with other pulmonary medications, including methylxanthines and corticosteroids, without adverse drug interactions.
Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic potential at dietary doses up to 6 mg/kg/day of Ipratropium bromide.

Results of various mutagenicity studies (Ames test, mouse dominate lethal test, mouse micronucleus test and chromosome aberration of bone marrow in Chinese hamsters) were negative.

Fertility of male or female rats at oral doses up to 50 mg/kg/day was unaffected by Ipratropium bromide administration. At doses above 90 mg/kg, increased resorption and decreased conception rates were observed.