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hf acquisition co. llc, dba health first - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin lingual spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. 4.1 pde-5-inhibitors and sgc-stimulators do not use nitroglycerin lingual spray in patients who are taking pde-5-inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see drug interactions (7.1)]. do not use nitroglycerin lingual spray in patients who are taking soluble guanylate cyclase (sgc) stimulators, such as riociguat. concomitant use can cause hypotension. 4.2 severe anemia nitroglycerin lingual spray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). 4.3 increased intracranial pressure nitroglycerin lingual spray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e. g. cer

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 32 ug - rhinocort aqua nasal spray is indicated for the treatment of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older. rhinocort aqua nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.2) ]. teratogenic effects: pregnancy category b. the impact of budesonide on human pregnancy outcomes has been evaluated through assessments of birth registries linked with maternal usage of inhaled budesonide (i.e., pulmicort turbuhaler) and intranasally administered budesonide (i.e., rhinocort aqua nasal spray). the results from population-based prospective cohort epidemiological studies reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995- 2001 (i.e., swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for overall congenital malformations from the use of inhaled or intranasal budeso

United States - English - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin lingual spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. 4.1 pde-5-inhibitors and sgc-stimulators do not use nitroglycerin lingual spray in patients who are taking pde-5-inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see drug interactions ( 7-7.1)]. do not use nitroglycerin lingual spray in patients who are taking soluble guanylate cyclase (sgc) stimulators, such as riociguat. concomitant use can cause hypotension. 4.2 severe anemia nitroglycerin lingual spray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). 4.3 increased intracranial pressure nitroglycerin lingual spray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e. g

United States - English - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin lingual spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. 4.1 pde-5-inhibitors and sgc-stimulators do not use nitroglycerin lingual spray in patients who are taking pde-5-inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see drug interactions]. do not use nitroglycerin lingual spray in patients who are taking soluble guanylate cyclase (sgc) stimulators, such as riociguat. concomitant use can cause hypotension. 4.2 severe anemia nitroglycerin lingual spray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). 4.3 increased intracranial pressure nitroglycerin lingual spray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e. g. cerebral hemorrhage or traumatic brain injury). 4.4 hypersensitivity nitroglycerin lingual spray is contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient. 4.5 circulatory failure and shock nitroglycerin lingual spray is contraindicated in patients with acute circulatory failure or shock. 8.1 pregnancy risk summary limited published data on the use of nitroglycerin are insufficient to determine a drug associated risk of major birth defects or miscarriage. in animal reproduction studies, there were no adverse developmental effects when nitroglycerin was administered intravenously to rabbits or intraperitoneally to rats during organogenesis at doses greater than 64-times the human dose [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively. data animal data no embryotoxic or postnatal development effects were observed with transdermal application in pregnant rabbits and rats at doses up to 240 mg/kg/day for 13 days, at intraperitoneal doses in pregnant rats up to 20 mg/kg/day for 11 days, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day for 13 days. 8.2 lactation risk summary sublingual nitroglycerin has not been studied in lactating women. it is not known if nitroglycerin is present in human milk or if nitroglycerin has effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for nitroglycerin and any potential adverse effects on the breastfed child from nitroglycerin or from the underlying maternal condition. 8.4 pediatric use safety and effectiveness of nitroglycerin in pediatric patients have not been established. 8.5 geriatric use clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between elderly (greater than or equal to 65 years) and younger (less than 65 years) patients. in general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

United States - English - NLM (National Library of Medicine)

sunovion pharmaceuticals inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 37 ug - zetonna® (ciclesonide) nasal aerosol is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. zetonna is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of zetonna [see warnings and precautions (5.3) ]. teratogenic effects : pregnancy category c. there are no adequate and well-controlled trials in pregnant women. zetonna should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. oral administration of ciclesonide in rats at approximately 120 times the maximum recommended human daily intranasal dose (mrhdid) in adults (on a mcg/m2 basis at a maternal dose of 900 mcg/kg/day) produced no teratogenicity or other fetal

United States - English - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - ipratropium bromide anhydrous 21 ug - ipratropium bromide nasal solution 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ipratropium bromide 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. ipratropium bromide nasal solution 0.03% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. ipratropium bromide nasal solution, 0.03% nasal spray, 21mcg/spray read complete instructions carefully before using. in order to ensure proper dosing, do not attempt to change the size of the spray opening.   ipratropium bromide nasal solution, 0.03% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ipratropium bromide nasal solution, 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. read complete instructions carefully and use only as directed. to use: figure 1 figure 1 figure 2 figure 2 figure 3 figure 3 to clean: if the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. hold the nasal tip under running, warm tap water (figure 4) for about a minute. dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip. figure 4 figure 4 caution: ipratropium bromide nasal solution, 0.03% is intended to relieve your rhinorrhea (runny nose) with regular use. it is therefore important that you use ipratropium bromide nasal solution, 0.03% as prescribed by your physician. for most patients, some improvement in runny nose is usually apparent during the first full day of treatment with ipratropium bromide nasal solution, 0.03% some patients may require up to two weeks of treatment to obtain maximum benefit. do not spray ipratropium bromide nasal solution, 0.03% in your eyes. should this occur, immediately flush your eye with cool tap water for several minutes. if you accidentally spray ipratropium bromide nasal solution, 0.03% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. should acute eye pain or blurred vision occur, contact your doctor. should you experience excessive nasal dryness or episodes of nasal bleeding contact your doctor. if you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using ipratropium bromide nasal solution, 0.03% if you are pregnant or you are breast feeding your baby, be sure to tell your physician prior to using ipratropium bromide nasal solution, 0.03% storage store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] avoid freezing. keep out of reach of children. address medical inquiries to hikma pharmaceuticals usa inc. at 1-800-962-8364. distributed by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 c50000619/01 revised july 2022

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - butorphanol tartrate (unii: 2l7i72ruhn) (butorphanol - unii:qv897jc36d) - butorphanol tartrate 10 mg in 1 ml - butorphanol tartrate nasal spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see warnings), reserve butorphanol tartrate nasal spray for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) butorphanol tartrate nasal spray is contraindicated in: butorphanol tartrate nasal spray contains butorphanol, a schedule iv controlled substance. butorphanol tartrate nasal spray contains butorphanol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. butorphanol tartrate nasal spray can be abused and is subject to misuse, addiction, and criminal diversion (see warnings). all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of

United States - English - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin lingual spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. 4.1 pde-5-inhibitors and sgc-stimulators do not use nitroglycerin lingual spray in patients who are taking pde-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see drug interactions (7.1)]. do not use nitroglycerin lingual spray in patients who are taking the soluble guanylate cyclase (sgc) stimulator riociguat. concomitant use can cause hypotension. 4.2 severe anemia nitroglycerin lingual spray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). 4.3 increased intracranial pressure nitroglycerin lingual spray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e. g. cerebral

United States - English - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin lingual spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. 4.1 pde-5-inhibitors and sgc-stimulators do not use nitroglycerin lingual spray in patients who are taking pde-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see drug interactions (7.1)]. do not use nitroglycerin lingual spray in patients who are taking the soluble guanylate cyclase (sgc) stimulator riociguat. concomitant use can cause hypotension. 4.2 severe anemia nitroglycerin lingual spray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). 4.3 increased intracranial pressure nitroglycerin lingual spray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e. g. cerebral

United States - English - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals inc. - tiotropium bromide monohydrate (unii: l64sxo195n) (tiotropium - unii:0eb439235f), olodaterol hydrochloride (unii: 65r445w3v9) (olodaterol - unii:vd2ysn1afd) - tiotropium 3.124 ug - stiolto respimat is a combination of tiotropium and olodaterol indicated for long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. important limitations of use - stiolto respimat is not indicated to treat acute deteriorations of copd [see warnings and precautions (5.2)]. - stiolto respimat is not indicated to treat asthma. the safety and effectiveness of stiolto respimat in asthma have not been established. use of a laba, including stiolto respimat, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)] . stiolto respimat is not indicated for the treatment of asthma. stiolto respimat is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product [see warnings and precautions (5.4)] . in clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, inc