drug for the treatment of COPD during labor should be restricted to those patients in whom the benefits clearly outweigh risk; serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol Animal data Animal studies are available with its individual components, ipratropium bromide and albuterol sulfate Based on oral reproduction studies, no evidence of structural alterations was observed when ipratropium bromide was administered to pregnant mice, rats, and rabbits during organogenesis at doses approximately 340, 68,000 and 17,000 times, respectively, the maximum recommended human daily inhalation dose (MRHDID) in adults on a mg/m2 basis When albuterol was administered to pregnant mice during organogenesis there was evidence of cleft palate at doses approximately equivalent to maximum recommended human daily inhalation Lactation There are no available data on presence of drug, or components, ipratropium bromide or albuterol, in human milk, effects on breastfed infant, or on milk production; although lipid-insoluble quaternary cations pass into breast milk, ipratropium concentrations in plasma after inhaled therapeutic doses are low Plasma levels of albuterol after inhaled therapeutic doses are low in humans; therefore, ipratropium and albuterol concentrations in human breast milk are likely to be correspondingly low; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for albuterol and any potential adverse effects on breastfed child from albuterol or from underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Albuterol: Beta2-adrenergic bronchodilator Ipratropium: Anticholinergic (parasympatholytic) agent; inhibits vagally mediated reflexes by antagonizing acetylcholine action; prevents increase in intracellular calcium concentration caused by interaction of acetylcholine with muscarinic receptors on bronchial smooth muscle Absorption Peak plasma time: Albuterol, 3 hr (from portion swallowed) Peak plasma concentration: Albuterol, 419-802 pg/mL (from portion swallowed) Distribution Protein bound: Ipratropium, 0-9% Metabolism Albuterol: Conjugatively metabolized to albuterol 4'-O-sulfate Ipratropium: Partially metabolized to inactive ester hydrolysis products Elimination Half-life: Albuterol, 3.6 hr (after 30-min infusion of 1.5 mg); ipratropium, 2 hr (after inhalation or IV administration) Mean clearance: Albuterol, 439 mL/min/1.73 m² Excretion: Albuterol, urine (27%); ipratropium, urine (4%) Instructions See individual package inserts for instructions on use Avoid freezing Aerosol metered-dose inhalers Insert cartridge into metered-dose inhaler, and prime unit before initial use; actuate inhaler toward ground until aerosol cloud is visible, then repeat 3 more times If inhaler has not been used for >3 days, actuate it once before using it again If inhaler has not been used for ≥21 days, repeat priming process for initial use (ie, actuate until aerosol cloud is observed, then repeat 3 more times) Nebulizer solution Administer via jet nebulizer connected to air compressor with adequate air flow Equip with mouthpiece or suitable air mask No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. 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