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

vacation inc. - avobenzone (3%), homosalate (5%), octisalate (3%), octocrylene (10%) - sunscreen - helps prevent sunburn - if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

prometheus laboratories inc. - allopurinol (unii: 63cz7gjn5i) (allopurinol - unii:63cz7gjn5i) - allopurinol 100 mg - this is not an innocuous drug. it is not recommended for the treatment of asymptomatic hyperuricemia. zyloprim reduces serum and urinary uric acid concentrations. its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see clinical pharmacology, contraindications, warnings, and precautions). zyloprim is indicated in: - the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). - the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. treatment with zyloprim should be discontinued when the potential for overproduction of uric acid is no longer present. - the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. therapy in suc

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

salix pharmaceuticals, inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 375 mg - apriso ® is indicated for the maintenance of remission of ulcerative colitis in adults. apriso is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of apriso capsules [see warnings and precautions ( 5.3), adverse reactions ( 6.2), description ( 11)] . risk summary published data from meta-analyses, cohort studies and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes ( see data) . in animal reproduction studies, there were no adverse developmental outcomes with administration of oral mesalamine during organogenesis to pregnant rats and rabbits at doses 1.7 and 5.4 times, respectively, the maximum recommended human dose ( see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. data human data published data from meta-analyses, cohort studies and case series on the use of mesalamine during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes. there is no clear evidence that mesalamine exposure in early pregnancy is associated with an increased risk in major congenital malformations, including cardiac malformations. published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products. animal data reproduction studies with mesalamine during organogenesis have been performed in rats at oral doses up to 320 mg/kg/day (about 1.7 times the recommended human dose based on a body surface area comparison) and rabbits at doses up to 495 mg/kg/day (about 5.4 times the recommended human dose based on a body surface area comparison) and have revealed no evidence of harm to the fetus due to mesalamine. risk summary data from published literature report the presence of mesalamine and its metabolite, n-acetyl 5-aminosalicylic acid in human milk in small amounts with relative infant doses (rid) of 2% or less ( see data) . there are case reports of diarrhea in breastfed infants exposed to mesalamine (see clinical considerations) . there is no information on the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of apriso to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for apriso and any potential adverse effects on the breastfed child from apriso or from the underlying maternal condition. clinical considerations advise the caregiver to monitor the breastfed infant for diarrhea. data in published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 4.8 g daily. the average concentration of mesalamine in milk ranged from non-detectable to 0.5 mg/l. the average concentration of the n-acetyl-5-aminosalicylic acid in milk ranged from 0.2 to 9.3 mg/l. based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.075 mg/kg/day (rid 0 to 0.1%) of mesalamine and 0.03 to 1.4 mg/kg/day of n-acetyl-5-aminosalicylic acid. safety and effectiveness of apriso in pediatric patients have not been established. clinical studies of apriso did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia and pancytopenia) in patients who were 65 years or older compared to younger patients taking mesalamine-containing products such as apriso. monitor complete blood cell counts and platelet counts in elderly patients during treatment with apriso. in general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing apriso [see use in specific populations ( 8.6)]. mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on apriso therapy. monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. discontinue apriso if renal function deteriorates while on therapy [see warnings and precautions (5.1), adverse reactions (6.2), drug interactions (7.2)].

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

salix pharmaceuticals, inc - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 1.1 g - giazo is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. limitations of use: giazo is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates or their metabolites, or to any of the components of giazo tablets [see description (11)]. risk summary published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of giazo, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see clinical considerations) . in animal reproduction studies, there were no adverse developmental effects observed after oral administration of balsalazide disodium in pregnant rats and rabbits during organogenesis at doses up to 2.4 and 4.7 times, respectively, the maximum recommended

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

avpak - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. safety and effectiveness of balsalazide beyond 8 weeks in children (ages 5 to 17 years) and 12 weeks in adults have not been established. patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium capsules or balsalazide metabolites. hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction. pregnancy category b. reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether balsalazide disodium is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when balsalazide is administered to a nursing woman. use of balsalazide disodium in pediatric and adolescent patients 5 to 17 years of age for the treatment of mildly to moderately active ulcerative colitis is supported by: - extrapolation of results from clinical studies that supported the approval of balsalazide disodium for adults. - a clinical trial of 68 patients ages 5 to 17 years comparing two doses of balsalazide disodium (6.75 g/day and 2.25 g/day), and - a pharmacokinetic study performed on a subset of the pediatric study population. [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)]. based on the limited data available, dosing can be initiated at either 6.75 or 2.25 g/day. safety and efficacy of balsalazide disodium in pediatric patients below the age of 5 years have not been established.

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

nivagen pharmaceuticals, inc - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 10 mg - piroxicam capsules usp is indicated: -   for relief of the signs and symptoms of osteoarthritis. -   for relief of the signs and symptoms of rheumatoid arthritis. piroxicam capsules usp is contraindicated in the following patients: -   known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see warnings and precautions (5.7 , 5.9)] -   history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7 , 5.8)] -   in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] pregnancy category c prior to 30 weeks gestation; category d starting at 30 weeks gestation. risk summary use of nsaids, including piroxicam capsules usp, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosu

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

rebel distributors corp - thyroid (unii: 0b4fdl9i6p) (thyroid - unii:0b4fdl9i6p) - thyroid 15 mg - armour thyroid tablets are indicated: - as replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. this category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (see warnings). - as pituitary tsh suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic iymphocytic thyroiditis (hashimoto's), multinodular goiter, and in the management of thyroid cancer. thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected

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

omp, inc. - hydroquinone (unii: xv74c1n1ae) (hydroquinone - unii:xv74c1n1ae) - hydroquinone 40 mg in 1 ml - the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. - helps prevent sunburn - if used as directed with other sun protection measures (see directions ), decreases the risk of skin cancer and early skin aging caused by the sun

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

cvs - trolamine salicylate (unii: h8o4040bhd) (salicylic acid - unii:o414pz4lpz) - trolamine salicylate 10 g in 100 g - trolamine salicylate - 10%                topical analgesic ​uses ​temporarily reliefs minor pain associated with • arthritis • simple backache •muscle strains • bruises • cramps allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. ​when using this product • use only as directed • avoid taking a bath or shower within 1 hour before or after applying • do not bandage tightly or use with a heating pad • avoid contact with eyes or muscous membranes • do not apply to wounds or damaged skin stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops if pregnant or breast-feeding , ask a health professional before use. keep out of reach of the children . if product is swallowed, get medical help or contact a poison control center right away

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

amneal pharmaceuticals of new york llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 5 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see warnings ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - have not been tolerated or are not expected to be tolerated, - have not provided adequate analgesia or are not expected to provide adequate analgesia hydrocodone bitartrate and acetaminophen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see warnings , adverse reactions ] hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a schedule ii controlled substance. hydrocodone bitartrate and acetaminophen tablets contains hydrocodone, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings ]. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of hydrocodone bitartrate and acetaminophen tablets increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of hydrocodone bitartrate and acetaminophen tablets with alcohol and other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of hydrocodone bitartrate and acetaminophen tablets abuse include those with a history of prolonged use of any opioid, including products containing hydrocodone, those with a history of drug or alcohol abuse, or those who use hydrocodone bitartrate and acetaminophen tablets in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. hydrocodone bitartrate and acetaminophen tablets, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of hydrocodone bitartrate and acetaminophen tablets abuse of hydrocodone bitartrate and acetaminophen tablets poses a risk of overdose and death. the risk is increased with concurrent use of hydrocodone bitartrate and acetaminophen tablets with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue hydrocodone bitartrate and acetaminophen tablets in a patient physically dependent on opioids. rapid tapering of hydrocodone bitartrate and acetaminophen tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing hydrocodone bitartrate and acetaminophen tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of hydrocodone bitartrate and acetaminophen tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see dosage and administration, and warnings ]. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see pregnancy ].