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Ipratropium Bromide and Albuterol Sulfate

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Overview

What is Ipratropium Bromide and Albuterol Sulfate?

The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β-adrenergic bronchodilator chemically described as α-[(-Butylamino) methyl]-4-hydroxy--xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (CHNO)• HSO. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol.

Chemical Structure of Ipratropium Bromide

Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is CHBrNO• HO. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons.

Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4.

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor system, under conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).



What does Ipratropium Bromide and Albuterol Sulfate look like?



What are the available doses of Ipratropium Bromide and Albuterol Sulfate?

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What should I talk to my health care provider before I take Ipratropium Bromide and Albuterol Sulfate?

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How should I use Ipratropium Bromide and Albuterol Sulfate?

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.

The recommended dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is one 3 mL vial administered 4 times per day via nebulization with up to 2 additional 3 mL doses allowed per day, if needed. Safety and efficacy of additional doses or increased frequency of administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution beyond these guidelines has not been studied and the safety and efficacy of extra doses of albuterol sulfate or ipratropium bromide in addition to the recommended doses of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution have not been studied.

The use of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. If a previously effective regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of worsening COPD, which would require reassessment of therapy.

A Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor was used to deliver Ipratropium Bromide and Albuterol Sulfate Inhalation Solution to each patient in one U.S. clinical study. The safety and efficacy of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution delivered by other nebulizers and compressors have not been established.

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask.


What interacts with Ipratropium Bromide and Albuterol Sulfate?

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What are the warnings of Ipratropium Bromide and Albuterol Sulfate?

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What are the precautions of Ipratropium Bromide and Albuterol Sulfate?

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What are the side effects of Ipratropium Bromide and Albuterol Sulfate?

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What should I look out for while using Ipratropium Bromide and Albuterol Sulfate?

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.


What might happen if I take too much Ipratropium Bromide and Albuterol Sulfate?

The effects of overdosage with Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are expected to be related primarily to albuterol sulfate, since ipratropium bromide is not well absorbed systemically after oral or aerosol administration. The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmia, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, and exaggeration of pharmacological effects listed in ADVERSE REACTIONS. Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. Treatment consists of discontinuation of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 540 times the maximum recommended daily inhalation dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution on a mg/mbasis). The subcutaneous median lethal dose of albuterol sulfate in mature rats and small young rats is approximately 450 and 2000 mg/kg, respectively (approximately 240 and 1100 times the maximum recommended daily inhalation dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution on a mg/mbasis, respectively). The inhalation median lethal dose has not been determined in animals. The oral median lethal dose of ipratropium bromide in mice, rats and dogs is greater than 1000 mg/kg, approximately 1700 mg/kg and approximately 400 mg/kg, respectively (approximately 1400, 4600, and 3600 times the maximum recommended daily inhalation dose in adults on a mg/mbasis, respectively).


How should I store and handle Ipratropium Bromide and Albuterol Sulfate?

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is supplied as a 3 mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store vials in pouch until time of use. Supplied in cartons as listed below.Overbagged with 5 vials per bag (1 vial per foil pouch), NDC 55154-4357-5Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is supplied as a 3 mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store vials in pouch until time of use. Supplied in cartons as listed below.Overbagged with 5 vials per bag (1 vial per foil pouch), NDC 55154-4357-5


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a combination of the β-adrenergic bronchodilator, albuterol sulfate, and the anticholinergic bronchodilator, ipratropium bromide.

Non-Clinical Toxicology
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.

Adverse reaction information concerning Ipratropium Bromide and Albuterol Sulfate Inhalation Solution was derived from the 12-week controlled clinical trial.

Additional adverse reactions reported in more than 1% of patients treated with Ipratropium Bromide and Albuterol Sulfate Inhalation Solution included constipation and voice alterations.

In the clinical trial, there was a 0.3% incidence of possible allergic-type reactions, including skin rash, pruritis, and urticaria.

Additional information derived from the published literature on the use of albuterol sulfate and ipratropium bromide singly or in combination includes precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, mydriasis, paradoxical bronchospasm, wheezing, exacerbation of COPD symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain, sore throat and metabolic acidosis.  Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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