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tersera therapeutics, llc - ergotamine tartrate (unii: mru5xh3b48) (ergotamine - unii:pr834q503t) - ergomar® is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called "histaminic cephalalgia". coadministration of ergotamine with potent cyp 3a4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities (see precautions: drug interactions ), with some cases resulting in amputation. there have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine was coadministered, at least one resulting in death. because of the increased risk for ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of cyp 3a4 (e.g., ketoconazole, itraconazole) (see warnings: cyp 3a4 inhibitors ). ergomar® sublingual tablets may cause fetal harm when administered to pregnant women. ergomar® subli

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mikart, llc - carbinoxamine maleate (unii: 02o55696wh) (carbinoxamine - unii:982a7m02h5) - carbinoxamine maleate is effective for the symptomatic treatment of: seasonal and perennial allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angioedema. dermatographism. as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. amelioration of the severity of allergic reactions to blood or plasma. carbinoxamine maleate is contraindicated in children younger than 2 years of age. carbinoxamine maleate is contraindicated in nursing mothers. carbinoxamine maleate is contraindicated in patients who are hypersensitive to the drug or on monoamine oxidase inhibitor therapy (see drug interactions ).

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merck sharp & dohme llc - doravirine (unii: 913p6lk81m) (doravirine - unii:913p6lk81m) - pifeltro® is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 35 kg: - with no prior antiretroviral treatment history; or - to replace the current antiretroviral regimen in those who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine [see clinical studies (14)] . pifeltro is contraindicated when co-administered with drugs that are strong cytochrome p450 (cyp)3a enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of pifeltro [see warnings and precautions (5.1), drug interactions (7.1), and clinical pharmacology (12.3)] . these drugs include, but are not limited to, the following: - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the androgen receptor inhibitor enzalutamide - the antimycobacterials rifampin, rifapentine - the cytotoxic agent mitotane - st. john's wort (hypericum perforatum) pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to pifeltro during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary no adequate human data are available to establish whether or not pifeltro poses a risk to pregnancy outcomes. in animal reproduction studies, no adverse developmental effects were observed when doravirine was administered at exposures ≥8 times the exposure in humans at the recommended human dose (rhd) of pifeltro (see data ). the background rate of major birth defects is 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp). the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in the clinically recognized pregnancies in the u.s. general population is 15-20%. methodological limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates individuals and infants from the limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation. data animal data doravirine was administered orally to pregnant rabbits (up to 300 mg/kg/day on gestation days (gd) 7 to 20) and rats (up to 450 mg/kg/day on gd 6 to 20 and separately from gd 6 to lactation/postpartum day 20). no significant toxicological effects on embryo-fetal (rats and rabbits) or pre/post-natal (rats) development were observed at exposures (auc) approximately 9 times (rats) and 8 times (rabbits) the exposure in humans at the rhd. doravirine was transferred to the fetus through the placenta in embryo-fetal studies, with fetal plasma concentrations of up to 40% (rabbits) and 52% (rats) that of maternal concentrations observed on gd 20. risk summary the centers for disease control and prevention recommend that hiv-1-infected mothers in the united states not breastfeed their infants to avoid risking potential transmission of hiv-1 infection. it is unknown whether doravirine is present in human milk, affects human milk production, or has effects on the breastfed infant. doravirine is present in the milk of lactating rats (see data ). because of the potential for (1) hiv-1 transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants), and (3) serious adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving pifeltro. data doravirine was excreted into the milk of lactating rats following oral administration (450 mg/kg/day) from gd 6 to lactation day 14, with milk concentrations approximately 1.5 times that of maternal plasma concentrations observed 2 hours post dose on lactation day 14. the safety and efficacy of pifeltro for the treatment of hiv-1 infection have been established in pediatric patients weighing at least 35 kg [see indications and usage (1) and dosage and administration (2.1)]. use of pifeltro in this group is supported by evidence from adequate and well-controlled trials in adults and an open-label trial in virologically-suppressed or treatment-naïve pediatric subjects 12 to less than 18 years of age. the safety, efficacy, and exposure of doravirine in these pediatric subjects were similar to that in adults. [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.3).] safety and efficacy of pifeltro in pediatric patients weighing less than 35 kg have not been established. clinical trials of pifeltro did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. in general, caution should be exercised in the administration of pifeltro in elderly patients, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)] . no dosage adjustment of pifeltro is required in patients with mild, moderate, or severe renal impairment. pifeltro has not been adequately studied in patients with end-stage renal disease and has not been studied in dialysis patients [see clinical pharmacology (12.3)] . no dosage adjustment of pifeltro is required in patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment. pifeltro has not been studied in patients with severe hepatic impairment (child-pugh class c) [see clinical pharmacology (12.3)] .

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mikart, llc - chlorzoxazone (unii: h0de420u8g) (chlorzoxazone - unii:h0de420u8g) - chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of this drug has not been clearly identified, but may be related to its sedative properties. chlorzoxazone does not directly relax tense skeletal muscles in man. chlorzoxazone is contraindicated in patients with known intolerance to the drug.

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mayne pharma - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - butalbital and acetaminophen capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit-forming and potentially abusable. this product is contraindicated under the following conditions: - hypersensitivity or intolerance to any component of this product. - patients with porphyria. abuse and dependence butalbital barbiturates may be habit-forming : tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. the average daily dose for the barbiturate addict is usually about 1500 mg. as tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. as this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. the lethal dose of a barbiturate is far less if alcohol is also ingested. major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. one method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

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eci pharmaceuticals llc - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. limitations of use: - the dosage of this product is for hiv-1 and not for hbv. lamivudine is contraindicated in patients with previous hypersensitivity reaction to lamivudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry at 1-800-258-4263. risk summary available data from the antiretroviral pregnancy registry show no difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% in the us reference population of the metropolitan atlanta congenital defects program (macdp). lamivudine produced embryonic toxicity in rabbits at a dose that produced similar human exposure

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el dorado distributors llc - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tencon (butalbital and acetaminophen) tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit-forming and potentially abusable. this product is contraindicated under the following conditions: - hypersensitivity or intolerance to any component of this product. - patients with porphyria. butalbital : barbiturates may be habit-forming: tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. the average daily dose for the barbiturate addict is usually about 1500 mg. as tolerance to barbiturates develops, the amount neededto maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. as this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. the lethal dose of a barbiturate is far less ifalcohol is also ingested. major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. one method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

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amneal pharmaceuticals llc - ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. - when co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. - ritonavir tablets are contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (ten) or stevens-johnson syndrome) to ritonavir or any of its ingredients. - ritonavir is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see drug interactions (7.1) and clinical pharmacology (12.3)] . alpha 1- adrenoreceptor antagonist: alfuzosin antianginal: ranolazine antiarrhythmics: amiodarone, dronedarone, flecainide, propafenone, quinidine antifungal: voriconazole anti-gout: colchicine antipsychotics: lurasidone, pimozide ergot derivatives: dihydroergotamine, ergotamine, methylergonovine gi motility agent: cisapride hmg-coa reductase inhibitors: lovastatin, simvastatin microsomal triglyceride transfer protein (mttp) inhibitor: lomitapide pde5 inhibitor: sildenafil (revatio® ) when used for the treatment of pulmonary arterial hypertension sedative/hypnotics: triazolam, orally administered midazolam - alpha 1- adrenoreceptor antagonist: alfuzosin - antianginal: ranolazine - antiarrhythmics: amiodarone, dronedarone, flecainide, propafenone, quinidine - antifungal: voriconazole - anti-gout: colchicine - antipsychotics: lurasidone, pimozide - ergot derivatives: dihydroergotamine, ergotamine, methylergonovine - gi motility agent: cisapride - hmg-coa reductase inhibitors: lovastatin, simvastatin - microsomal triglyceride transfer protein (mttp) inhibitor: lomitapide - pde5 inhibitor: sildenafil (revatio® ) when used for the treatment of pulmonary arterial hypertension - sedative/hypnotics: triazolam, orally administered midazolam - ritonavir is contraindicated with drugs that are potent cyp3a inducers where significantly reduced ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross-resistance [see drug interactions (7.2) and clinical pharmacology (12.3)] . - anticancer agents: apalutamide - herbal products: st. john's wort (hypericum perforatum) when co-administering ritonavir with other protease inhibitors, see the full prescribing information for the co-administered protease inhibitor including important information for use in special populations. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ritonavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the antiretroviral pregnancy registry (apr) are not sufficient to adequately assess the risk of birth defects or miscarriage. available data from the apr show no difference in the rate of overall birth defects for ritonavir compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp) [see data] . in animal reproduction studies, no evidence of adverse developmental outcomes was observed with oral administration of ritonavir to pregnant rats and rabbits. during organogenesis in the rat and rabbit, systemic exposure (auc) was approximately 1/3 lower than human exposure at the recommended daily dose. in the rat pre- and post-natal developmental study, maternal systemic exposure to ritonavir was approximately 1/2 of the exposure in humans at the recommended daily dose, based on a body surface area conversion factor [see data] . ritonavir oral solution is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy [see clinical considerations, dosage and administration (2.3) and warnings and precautions (5.2)] . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 dose adjustments during pregnancy and the postpartum period ritonavir oral solution contains alcohol and propylene glycol and is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy [see dosage and administration (2.3)  and warnings and precautions (5.2)] . human data based on prospective reports to the apr of approximately 6100 live births following exposure to ritonavir-containing regimens (including over 2800 live births exposed in the first trimester and over 3200 live births exposed in the second and third trimesters), there was no difference in the rate of overall birth defects for ritonavir compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.3% (95% ci: 1.7% to 2.9%) following first-trimester exposure to ritonavir-containing regimens and 2.9% (95% ci: 2.3% to 3.5%) following second and third trimester exposure to ritonavir-containing regimens. while placental transfer of ritonavir and fetal ritonavir concentrations are generally low, detectable levels have been observed in cord blood samples and neonate hair. animal data ritonavir was administered orally to pregnant rats (at 0, 15, 35, and 75 mg/kg/day) and rabbits (at 0, 25, 50, and 110 mg/kg/day) during organogenesis (on gestation days 6 through 17 and 6 through 19, respectively). no evidence of teratogenicity due to ritonavir was observed in rats and rabbits at doses producing systemic exposures (auc) equivalent to approximately 1/3 lower than human exposure at the recommended daily dose. developmental toxicity observed in rats (early resorptions, decreased fetal body weight and ossification delays and developmental variations) occurred at a maternally toxic dose, at an exposure equivalent to approximately 1/3 lower than human exposure at the recommended daily dose. a slight increase in the incidence of cryptorchidism was also noted in rats (at a maternally toxic dose) at an exposure approximately 1/5 lower than human exposure at the recommended daily dose. developmental toxicity was observed in rabbits (resorptions, decreased litter size and decreased fetal weights) at maternally toxic doses approximately 1.8 times higher than the recommended daily dose, based on a body surface area conversion factor. in pre-and postnatal development study in rats, ritonavir was administered at doses of 0, 15, 35, and 60 mg/kg/day from gestation day 6 through postnatal day 20. at doses of 60 mg/kg/day, no developmental toxicity was noted with ritonavir dosage equivalent to 1/2 of the recommended daily dose, based on a body surface area conversion factor. risk summary the centers for disease control and prevention recommend that hiv-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv. limited published data reports that ritonavir is present in human milk. there is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. because of the potential for (1) hiv transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants) and (3) serious adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving ritonavir. contraception use of ritonavir may reduce the efficacy of combined hormonal contraceptives. advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception [see drug interactions (7.2)] . in hiv-infected patients age greater than 1 month to 21 years, the antiviral activity and adverse event profile seen during clinical trials and through postmarketing experience were similar to that for adult patients. clinical studies of ritonavir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting 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. no dose adjustment of ritonavir is necessary for patients with either mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment. no pharmacokinetic or safety data are available regarding the use of ritonavir in subjects with severe hepatic impairment (child-pugh class c), therefore, ritonavir is not recommended for use in patients with severe hepatic impairment [see warnings and precautions (5.3), clinical pharmacology (12.3)] .

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akorn operating company llc - aminocaproic acid (unii: u6f3787206) (aminocaproic acid - unii:u6f3787206) - aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. in life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (see warnings ). aminocaproic acid should not be used when there is evidence of an

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arise pharmaceuticals llc - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. limitations of use: - the dosage of this product is for hiv-1 and not for hbv. lamivudine is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the overall risk of birth defects for lamivudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defects program (macdp) reference population (see data). the apr uses the macdp as the u.s. reference population for birth defects in the general population. the macdp evaluate