NDC 00173-0859 Breo Ellipta. 2021 ICD-10-CM and ICD-10-PCS CODING HANDBOOK. ×. The handbook's format and style of presentation follows that of previous editions inspired by the Faye Brown approach to coding instruction. The handbook is authored by Nelly Leon-Chisen, RHIA, Director of Coding and Classification at the AHA.
Z77-Z99 Persons with potential health hazards related to family and personal history and certain conditions influencing health status
A type 2 excludes note represents "not included here". A type 2 excludes note indicates that the condition excluded is not part of the condition it is excluded from but a patient may have both conditions at the same time. When a type 2 excludes note appears under a code it is acceptable to use both the code ( Z79.84) and the excluded code together.
The 2022 edition of ICD-10-CM Z79.84 became effective on October 1, 2021.
T50- Poisoning by, adverse effect of and underdosing of diuretics and other and unspecified drugs, medicaments and biological substances
Underdosing of unspecified drugs, medicaments and biological substances 1 T50.906 should not be used for reimbursement purposes as there are multiple codes below it that contain a greater level of detail. 2 Short description: Underdosing of unsp drug/meds/biol subst 3 The 2021 edition of ICD-10-CM T50.906 became effective on October 1, 2020. 4 This is the American ICD-10-CM version of T50.906 - other international versions of ICD-10 T50.906 may differ.
Poisoning by, adverse effect of and underdosing of drugs, medicaments and biological substances. Code First. , for adverse effects, the nature of the adverse effect, such as:
Use secondary code (s) from Chapter 20, External causes of morbidity, to indicate cause of injury. Codes within the T section that include the external cause do not require an additional external cause code. Type 1 Excludes.
The 2022 edition of ICD-10-CM T50.906 became effective on October 1, 2021.
The 2022 edition of ICD-10-CM Z79.3 became effective on October 1, 2021.
Z77-Z99 Persons with potential health hazards related to family and personal history and certain conditions influencing health status
T48- Poisoning by, adverse effect of and underdosing of agents primarily acting on smooth and skeletal muscles and the respiratory system
Underdosing of antiasthmatics, initial encounter 1 T48.6X6A is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes. 2 The 2021 edition of ICD-10-CM T48.6X6A became effective on October 1, 2020. 3 This is the American ICD-10-CM version of T48.6X6A - other international versions of ICD-10 T48.6X6A may differ.
The 2022 edition of ICD-10-CM T48.6X6A became effective on October 1, 2021.
BREO ELLIPTA is supplied as a disposable light grey and pale blue plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters for the institutional pack). One strip contains fluticasone furoate (100 or 200 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). A blister from each strip is used to create 1 dose. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs: NDC 0173-0859-10 BREO ELLIPTA 100/25 30 inhalations (60 blisters) NDC 0173-0859-14 BREO ELLIPTA 100/25 14 inhalations (28 blisters), institutional pack NDC 0173-0882-10 BREO ELLIPTA 200/25 30 inhalations (60 blisters) NDC 0173-0882-14 BREO ELLIPTA 200/25 14 inhalations (28 blisters), institutional packStore at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.BREO ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard BREO ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
BREO ELLIPTANo studies of carcinogenicity , mutagenicity, or impairment of fertility were conducted with BREO ELLIPTA; however, studies are available for the individual components, fluticasone furoate and vilanterol, as described below.Fluticasone FuroateFluticasone furoate produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at inhaled doses up to 9 and 19 mcg/kg/day, respectively (approximately 0.5 times the MRHDID in adults on a mcg/m2 basis). Fluticasone furoate did not induce gene mutation in bacteria or chromosomal damage in a mammalian cell mutation test in mouse lymphoma L5178Y cells in vitro. There was also no evidence of genotoxicity in the in vivo micronucleus test in rats.No evidence of impairment of fertility was observed in male and female rats at inhaled fluticasone furoate doses up to 29 and 91 mcg/kg/day, respectively (approximately 3 and 8 times, respectively, the MRHDID based on AUC) [see Use in Specific Populations (8.1)].VilanterolIn a 2-year carcinogenicity study in mice, vilanterol caused a statistically significant increase in ovarian tubulostromal adenomas in females at an inhalation dose of 29,500 mcg/kg/day (approximately 8,750 times the MRHDID in adults on an AUC basis). No increase in tumors was seen at an inhalation dose of 615 mcg/kg/day (approximately 530 times the MRHDID in adults on an AUC basis).In a 2-year carcinogenicity study in rats, vilanterol caused statistically significant increases in mesovarian leiomyomas in females and shortening of the latency of pituitary tumors at inhalation doses greater than or equal to 84.4 mcg/kg/day (greater than or equal to approximately 45 times the MRHDID in adults on an AUC basis). No tumors were seen at an inhalation dose of 10.5 mcg/kg/day (approximately 2 times the MRHDID in adults on an AUC basis). These tumor findings in rodents are similar to those reported previously for other beta-adrenergic agonist drugs. The relevance of these findings to human use is unknown.Vilanterol tested negative in the following genotoxicity assays: the in vitro Ames assay, in vivo rat bone marrow micronucleus assay, in vivo rat unscheduled DNA synthesis (UDS) assay, and in vitro Syrian hamster embryo (SHE) cell assay. Vilanterol tested equivocal in the in vitro mouse lymphoma assay. No evidence of impairment of fertility was observed in male and female rats at inhaled vilanterol doses up to 31,500 and 37,100 mcg/kg/day, respectively (approximately 5,490 times the MRHDID based on AUC).
Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of BREO ELLIPTA. Discontinue BREO ELLIPTA if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of other powder medications containing lactose; therefore, patients with severe milk protein allergy should not use BREO ELLIPTA [see Contraindications (4)].
BREO ELLIPTA should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD or asthma. BREO ELLIPTA has not been studied in subjects with acutely deteriorating COPD or asthma. The initiation of BREO ELLIPTA in this setting is not appropriate.COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If BREO ELLIPTA 100/25 no longer controls symptoms of bronchoconstriction; the patient’s inhaled, short-acting, beta2-agonist becomes less effective; or the patient needs more short-acting beta2-agonist than usual, these may be markers of deterioration of disease. In this setting a reevaluation of the patient and the COPD treatment regimen should be undertaken at once. For COPD, increasing the daily dose of BREO ELLIPTA 100/25 is not appropriate in this situation.Increasing use of inhaled, short-acting beta2-agonists is a marker of deteriorating asthma. In this situation, the patient requires immediate reevaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of BREO ELLIPTA with a higher strength, adding additional ICS, or initiating systemic corticosteroids. Patients should not use more than 1 inhalation once daily of BREO ELLIPTA.BREO ELLIPTA should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. BREO ELLIPTA has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.When beginning treatment with BREO ELLIPTA, patients who have been taking oral or inhaled, short-acting beta2-agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs and to use them only for symptomatic relief of acute respiratory symptoms. When prescribing BREO ELLIPTA, the healthcare provider should also prescribe an inhaled, short-acting beta2-agonist and instruct the patient on how it should be used.
BREO ELLIPTA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA).Important Limitation of UseBREO ELLIPTA is NOT indicated for the relief of acute bronchospasm.
BREO ELLIPTA, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines. Doses of the related beta2-adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
TERMS OF USE: Eligible patients who present a Free Trial Offer together with a valid 30-day prescription for BREO at participating pharmacies can receive a free 30-day supply of BREO. This Free Trial Offer may not be redeemed on prescriptions written for longer than 30 days. Patient is responsible for applicable taxes, if any. This offer is limited to one per patient and is nontransferable. The Free Trial Offer cannot be combined with any other coupon, free trial, or similar offer. No substitutions are permitted. Your acceptance of this offer must be consistent with the terms of any drug benefit plan provided to you by your health insurer. You agree to report your use of this coupon to your health insurer if required.
for COPD. Once-daily BREO 100/25 is a prescription medicine used long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups. BREO is not used to relieve sudden breathing problems and won't replace a rescue inhaler.
ELIGIBILITY: Patients may be eligible for this offer if they have commercial insurance and insurance does not cover the full cost of the prescription or if they are not insured and are responsible for the cost of their prescriptions.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Call your healthcare provider or get medical care right away if your breathing problems get worse, if you need your rescue inhaler more often than usual or it does not work as well to relieve your symptoms, or if your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
Duplicates of this uniquely coded offer are invalid and not redeemable at the pharmacy. This offer is not conditioned on any past, present, or future purchase, including refills. This offer expires on 06/30/2020.
BREO contains vilanterol. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. BREO contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.