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

mikart, llc - methazolamide (unii: w733b0s9sd) (methazolamide - unii:w733b0s9sd) - methazolamide tablets usp is indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery. methazolamide therapy is contraindicated in situations in which sodium and/or potassium serum levels are depressed, in cases of marked kidney or liver disease or dysfunction, in adrenal gland failure, and in hyperchloremic acidosis. in patients with cirrhosis, use may precipitate the development of hepatic encephalopathy. long-term administration of methazolamide is contraindicated in patients with angle-closure glaucoma, since organic closure of the angle may occur in spite of lowered intraocular pressure.

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kmm pharmaceuticals, llc - ergotamine tartrate (unii: mru5xh3b48) (ergotamine - unii:pr834q503t), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - ergotamine tartrate and caffeine tablets are 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 tartrate and caffeine tablets was coadministered, at least one resulting in death. because of the increased risk of 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 ). ergotamine tartrate and caffeine tablets may cause fetal

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

akorn - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 10 mg in 15 ml - lortab elixir 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 lortab elixir 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 lortab elixir is 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 ] lortab elixir contains hydrocodone, a schedule ii controlled substance.

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

mikart, llc - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate 5 mg in 5 ml - dextroamphetamine sulfate oral solution is indicated in: narcolepsy attention deficit disorder with hyperactivity: as an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotionally lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympa

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

aidarex pharmaceuticals llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 2.5 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a schedule iii controlled substance. hydrocodone bitartrate and acetaminophen tablets, and other opioids, used in analgesia can be abused and are subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a treatable disease utilizing a multidisciplinary approach, bu

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amneal pharmaceuticals ny llc - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)] . emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)] .  emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary data on the use of emtricitabine and tenofovir disoproxil fumarate during pregnancy from observational studies have shown no increased risk of major birth defects. available data from the apr show no significant difference in the overall risk of major birth defects with first trimester exposure for emtricitabine (ftc) (2.3%) or tenofovir disoproxil fumarate (tdf) (2.1%) compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data) . the rate of miscarriage for individual drugs is not reported in the apr. in the u.s. general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15% to 20%. in animal reproduction studies, no adverse developmental effects were observed when the components of emtricitabine and tenofovir disoproxil fumarate tablet were administered separately at doses/exposures ≥60 (ftc), ≥14 (tdf) and 2.7 (tenofovir) times those of the recommended daily dose of emtricitabine and tenofovir disoproxil fumarate (see data ). clinical considerations disease-associated maternal and/or embryo/fetal risk hiv-1 prep: published studies indicate an increased risk of hiv-1 infection during pregnancy and an increased risk of mother to child transmission during acute hiv-1 infection. in women at risk of acquiring hiv-1, consideration should be given to methods to prevent acquisition of hiv, including continuing or initiating emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep, during pregnancy. data human data emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep: in an observational study based on prospective reports to the apr, 78 hiv-seronegative women exposed to emtricitabine and tenofovir disoproxil fumarate during pregnancy delivered live-born infants with no major malformations. all but one were first trimester exposures, and the median duration of exposure was 10.5 weeks. there were no new safety findings in the women receiving emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep compared with hiv-1 infected women treated with other antiretroviral medications. emtricitabine: based on prospective reports to the apr of exposures to ftc-containing regimens during pregnancy resulting in live births (including over 3,300 exposed in the first trimester and  over 1,300 exposed in the second/third trimester), the prevalence of major birth defects in live births was 2.6% (95% ci: 2.1% to 3.2%) and 2.3% (95% ci: 1.6% to 3.3%) following first and second/third trimester exposure, respectively, to ftc-containing regimens. tenofovir disoproxil fumarate: based on prospective reports to the apr of exposures to tdf-containing regimens during pregnancy resulting in live births (including over 4,000 exposed in the first trimester and over 1,700 exposed in the second/third trimester), the prevalence of major birth defects in live births was  2.4% (95% ci: 2.0% to 2.9%) and 2.4% (95% ci: 1.7% to 3.2%) following first and second/third trimester exposure, respectively, to tdf-containing regimens. methodologic limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at <20 weeks gestation. additionally, published observational studies on emtricitabine and tenofovir exposure in pregnancy have not shown an increased risk for major malformations.   animal data emtricitabine: ftc was administered orally to pregnant mice (at 0, 250, 500, or 1,000 mg/kg/day), and rabbits (at 0, 100, 300, or 1,000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively). no significant toxicological effects were observed in embryo-fetal toxicity studies performed with ftc in mice at exposures (auc) approximately 60 times higher and in rabbits at approximately 120 times higher than human exposures at the recommended daily dose. in a pre/postnatal development study in mice, ftc was administered orally at doses up to 1,000 mg/kg/day; no significant adverse effects directly related to drug were observed in the offspring exposed daily from before birth (in utero ) through sexual maturity at daily exposures (auc) of approximately 60 times higher than human exposures at the recommended daily dose. tenofovir disoproxil fumarate: tdf was administered orally to pregnant rats (at 0, 50, 150, or 450 mg/kg/day) and rabbits (at 0, 30, 100, or 300 mg/kg/day) through organogenesis (on gestation days 7 through 17, and 6 through 18, respectively). no significant toxicological effects were observed in embryo-fetal toxicity studies performed with tdf in rats at doses up to 14 times the human dose based on body surface area comparisons and in rabbits at doses up to 19 times the human dose based on body surface area comparisons. in a pre/postnatal development study in rats, tdf was administered orally through lactation at doses up to 600 mg/kg/day; no adverse effects were observed in the offspring at tenofovir exposures of approximately 2.7 times higher than human exposures at the recommended daily dose of emtricitabine and tenofovir disoproxil fumarate. risk summary based on published data, ftc and tenofovir have been shown to be present in human breast milk (see data). it is not known if the components of emtricitabine and tenofovir disoproxil fumarate tablet affect milk production or have effects on the breastfed child. treatment of hiv-1 infection: the centers for disease control and prevention recommend that hiv-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1. because of the potential for: (1) hiv transmission (in hiv-negative infants); (2) developing viral resistance (in hiv-positive infants); and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking emtricitabine and tenofovir disoproxil fumarate for the treatment of hiv-1. hiv-1 prep: in hiv-uninfected women, the developmental and health benefits of breastfeeding and the mother’s clinical need for emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep should be considered along with any potential adverse effects on the breastfed child from emtricitabine and tenofovir disoproxil fumarate and the risk of hiv-1 acquisition due to nonadherence and subsequent mother to child transmission. women should not breastfeed if acute hiv-1 infection is suspected because of the risk of hiv-1 transmission to the infant. data hiv-1 prep: in a study of 50 breastfeeding women who received emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep between 1 and 24 weeks postpartum (median 13 weeks), after 7 days of treatment, tenofovir was undetectable but ftc was detectable in the plasma of most infants. in these infants, the average ftc plasma concentration was less than 1% of the ftc cmax observed in hiv-infected infants (up to 3 months of age) receiving the therapeutic dose of ftc (3 mg/kg/day). there were no serious adverse events. two infants (4%) had an adverse event of mild diarrhea which resolved. treatment of hiv-1 infection no pediatric clinical trial was conducted to evaluate the safety and efficacy of emtricitabine and tenofovir disoproxil fumarate in patients with hiv-1 infection. data from previously conducted trials with the individual drug products, ftc and tdf, were relied upon to support dosage recommendations for emtricitabine and tenofovir disoproxil fumarate. for additional information, consult the prescribing information for emtriva and viread. emtricitabine and tenofovir disoproxil fumarate tablet should only be administered to hiv-1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a tablet. because it is a fixed-dose combination tablet, emtricitabine and tenofovir disoproxil fumarate cannot be adjusted for patients of lower weight [see warnings and precautions (5.5), adverse reactions (6.1) and clinical pharmacology (12.3)] . emtricitabine and tenofovir disoproxil fumarate is not approved for use in pediatric patients weighing less than 17 kg. hiv-1 prep the safety and effectiveness of emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep in at-risk adolescents weighing at least 35 kg is supported by data from adequate and well-controlled studies of emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep in adults with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, ftc and tdf, in hiv-1 infected adults and pediatric subjects [see dosage and administration (2.5), adverse reactions (6.1), clinical pharmacology (12.3  and 12.4), and clinical studies (14.3  and 14.4)]. safety, adherence, and resistance were evaluated in a single-arm, open-label clinical trial (atn113) in which 67 hiv-1 uninfected at-risk adolescent men who have sex with men received emtricitabine and tenofovir disoproxil fumarate once daily for hiv-1 prep. the mean age of subjects was 17 years (range 15 to 18 years); 46% were hispanic, 52% black, and 37% white. the safety profile of emtricitabine and tenofovir disoproxil fumarate in atn113 was similar to that observed in the adult hiv-1 prep trials [see adverse reactions (6.1)] . in the atn113 trial, hiv-1 seroconversion occurred in 3 subjects. tenofovir diphosphate levels in dried blood spot assays indicate that these subjects had poor adherence. no tenofovir- or ftc-associated hiv-1 resistance substitutions were detected in virus isolated from the 3 subjects who seroconverted [see microbiology (12.4)]. adherence to study drug, as demonstrated by tenofovir diphosphate levels in dried blood spot assays, declined markedly after week 12 once subjects switched from monthly to quarterly visits, suggesting that adolescents may benefit from more frequent visits and counseling [see warnings and precautions (5.2)]. safety and effectiveness of emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep in pediatric patients weighing less than 35 kg have not been established.   clinical trials of ftc, tdf, or emtricitabine and tenofovir disoproxil fumarate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. treatment of hiv-1 infection the dosing interval for emtricitabine and tenofovir disoproxil fumarate should be modified in hiv-infected adult individuals with estimated creatinine clearance of 30 to 49 ml/min. emtricitabine and tenofovir disoproxil fumarate is not recommended in individuals with estimated creatinine clearance below 30 ml/min and in individuals with end-stage renal disease requiring dialysis [see dosage and administration (2.6)] . hiv-1 prep emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep is not recommended in hiv-1 uninfected individuals with estimated creatinine clearance below 60 ml/min. if a decrease in estimated creatinine clearance is observed in uninfected individuals while using emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep, evaluate potential causes and re-assess potential risks and benefits of continued use [see dosage and administration (2.6)] .

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

amneal pharmaceuticals ny llc - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)] . emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)] .  emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary data on the use of emtricitabine and tenofovir disoproxil fumarate during pregnancy from observational studies have shown no increased risk of major birth defects. available data from the apr show no significant difference in the overall risk of major birth defects with first trimester exposure for emtricitabine (ftc) (2.3%) or tenofovir disoproxil fumarate (tdf) (2.1%) compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data) . the rate of miscarriage for individual drugs is not reported in the apr. in the u.s. general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15% to 20%. in animal reproduction studies, no adverse developmental effects were observed when the components of emtricitabine and tenofovir disoproxil fumarate tablet were administered separately at doses/exposures ≥60 (ftc), ≥14 (tdf) and 2.7 (tenofovir) times those of the recommended daily dose of emtricitabine and tenofovir disoproxil fumarate (see data ). clinical considerations disease-associated maternal and/or embryo/fetal risk hiv-1 prep: published studies indicate an increased risk of hiv-1 infection during pregnancy and an increased risk of mother to child transmission during acute hiv-1 infection. in women at risk of acquiring hiv-1, consideration should be given to methods to prevent acquisition of hiv, including continuing or initiating emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep, during pregnancy. data human data emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep: in an observational study based on prospective reports to the apr, 78 hiv-seronegative women exposed to emtricitabine and tenofovir disoproxil fumarate during pregnancy delivered live-born infants with no major malformations. all but one were first trimester exposures, and the median duration of exposure was 10.5 weeks. there were no new safety findings in the women receiving emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep compared with hiv-1 infected women treated with other antiretroviral medications. emtricitabine: based on prospective reports to the apr of exposures to ftc-containing regimens during pregnancy resulting in live births (including over 3,300 exposed in the first trimester and  over 1,300 exposed in the second/third trimester), the prevalence of major birth defects in live births was 2.6% (95% ci: 2.1% to 3.2%) and 2.3% (95% ci: 1.6% to 3.3%) following first and second/third trimester exposure, respectively, to ftc-containing regimens. tenofovir disoproxil fumarate: based on prospective reports to the apr of exposures to tdf-containing regimens during pregnancy resulting in live births (including over 4,000 exposed in the first trimester and over 1,700 exposed in the second/third trimester), the prevalence of major birth defects in live births was  2.4% (95% ci: 2.0% to 2.9%) and 2.4% (95% ci: 1.7% to 3.2%) following first and second/third trimester exposure, respectively, to tdf-containing regimens. methodologic limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at <20 weeks gestation. additionally, published observational studies on emtricitabine and tenofovir exposure in pregnancy have not shown an increased risk for major malformations.   animal data emtricitabine: ftc was administered orally to pregnant mice (at 0, 250, 500, or 1,000 mg/kg/day), and rabbits (at 0, 100, 300, or 1,000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively). no significant toxicological effects were observed in embryo-fetal toxicity studies performed with ftc in mice at exposures (auc) approximately 60 times higher and in rabbits at approximately 120 times higher than human exposures at the recommended daily dose. in a pre/postnatal development study in mice, ftc was administered orally at doses up to 1,000 mg/kg/day; no significant adverse effects directly related to drug were observed in the offspring exposed daily from before birth (in utero ) through sexual maturity at daily exposures (auc) of approximately 60 times higher than human exposures at the recommended daily dose. tenofovir disoproxil fumarate: tdf was administered orally to pregnant rats (at 0, 50, 150, or 450 mg/kg/day) and rabbits (at 0, 30, 100, or 300 mg/kg/day) through organogenesis (on gestation days 7 through 17, and 6 through 18, respectively). no significant toxicological effects were observed in embryo-fetal toxicity studies performed with tdf in rats at doses up to 14 times the human dose based on body surface area comparisons and in rabbits at doses up to 19 times the human dose based on body surface area comparisons. in a pre/postnatal development study in rats, tdf was administered orally through lactation at doses up to 600 mg/kg/day; no adverse effects were observed in the offspring at tenofovir exposures of approximately 2.7 times higher than human exposures at the recommended daily dose of emtricitabine and tenofovir disoproxil fumarate. risk summary based on published data, ftc and tenofovir have been shown to be present in human breast milk (see data). it is not known if the components of emtricitabine and tenofovir disoproxil fumarate tablet affect milk production or have effects on the breastfed child. treatment of hiv-1 infection: the centers for disease control and prevention recommend that hiv-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1. because of the potential for: (1) hiv transmission (in hiv-negative infants); (2) developing viral resistance (in hiv-positive infants); and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking emtricitabine and tenofovir disoproxil fumarate for the treatment of hiv-1. hiv-1 prep: in hiv-uninfected women, the developmental and health benefits of breastfeeding and the mother’s clinical need for emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep should be considered along with any potential adverse effects on the breastfed child from emtricitabine and tenofovir disoproxil fumarate and the risk of hiv-1 acquisition due to nonadherence and subsequent mother to child transmission. women should not breastfeed if acute hiv-1 infection is suspected because of the risk of hiv-1 transmission to the infant. data hiv-1 prep: in a study of 50 breastfeeding women who received emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep between 1 and 24 weeks postpartum (median 13 weeks), after 7 days of treatment, tenofovir was undetectable but ftc was detectable in the plasma of most infants. in these infants, the average ftc plasma concentration was less than 1% of the ftc cmax observed in hiv-infected infants (up to 3 months of age) receiving the therapeutic dose of ftc (3 mg/kg/day). there were no serious adverse events. two infants (4%) had an adverse event of mild diarrhea which resolved. treatment of hiv-1 infection no pediatric clinical trial was conducted to evaluate the safety and efficacy of emtricitabine and tenofovir disoproxil fumarate in patients with hiv-1 infection. data from previously conducted trials with the individual drug products, ftc and tdf, were relied upon to support dosage recommendations for emtricitabine and tenofovir disoproxil fumarate. for additional information, consult the prescribing information for emtriva and viread. emtricitabine and tenofovir disoproxil fumarate tablet should only be administered to hiv-1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a tablet. because it is a fixed-dose combination tablet, emtricitabine and tenofovir disoproxil fumarate cannot be adjusted for patients of lower weight [see warnings and precautions (5.5), adverse reactions (6.1) and clinical pharmacology (12.3)] . emtricitabine and tenofovir disoproxil fumarate is not approved for use in pediatric patients weighing less than 17 kg. hiv-1 prep the safety and effectiveness of emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep in at-risk adolescents weighing at least 35 kg is supported by data from adequate and well-controlled studies of emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep in adults with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, ftc and tdf, in hiv-1 infected adults and pediatric subjects [see dosage and administration (2.5), adverse reactions (6.1), clinical pharmacology (12.3 and 12.4), and clinical studies (14.3 and 14.4)]. safety, adherence, and resistance were evaluated in a single-arm, open-label clinical trial (atn113) in which 67 hiv-1 uninfected at-risk adolescent men who have sex with men received emtricitabine and tenofovir disoproxil fumarate once daily for hiv-1 prep. the mean age of subjects was 17 years (range 15 to 18 years); 46% were hispanic, 52% black, and 37% white. the safety profile of emtricitabine and tenofovir disoproxil fumarate in atn113 was similar to that observed in the adult hiv-1 prep trials [see adverse reactions (6.1)] . in the atn113 trial, hiv-1 seroconversion occurred in 3 subjects. tenofovir diphosphate levels in dried blood spot assays indicate that these subjects had poor adherence. no tenofovir- or ftc-associated hiv-1 resistance substitutions were detected in virus isolated from the 3 subjects who seroconverted [see microbiology (12.4)]. adherence to study drug, as demonstrated by tenofovir diphosphate levels in dried blood spot assays, declined markedly after week 12 once subjects switched from monthly to quarterly visits, suggesting that adolescents may benefit from more frequent visits and counseling [see warnings and precautions (5.2)]. safety and effectiveness of emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep in pediatric patients weighing less than 35 kg have not been established.   clinical trials of ftc, tdf, or emtricitabine and tenofovir disoproxil fumarate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. treatment of hiv-1 infection the dosing interval for emtricitabine and tenofovir disoproxil fumarate should be modified in hiv-infected adult individuals with estimated creatinine clearance of 30 to 49 ml/min. emtricitabine and tenofovir disoproxil fumarate is not recommended in individuals with estimated creatinine clearance below 30 ml/min and in individuals with end-stage renal disease requiring dialysis [see dosage and administration (2.6)] . hiv-1 prep emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep is not recommended in hiv-1 uninfected individuals with estimated creatinine clearance below 60 ml/min. if a decrease in estimated creatinine clearance is observed in uninfected individuals while using emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep, evaluate potential causes and re-assess potential risks and benefits of continued use [see dosage and administration (2.6)] .

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

golden state medical supply, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 150 mg - 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 tablets are 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 tablets 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 evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks’ gestation. the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15% to 20%. the background risk for major birth defects and miscarriage for the indicated population is unknown. in animal reproduction studies, oral administration of lamivudine to pregnant rabbits during organogenesis resulted in embryolethality at systemic exposure (auc) similar to the recommended clinical dose; however, no adverse development effects were observed with oral administration of lamivudine to pregnant rats during organogenesis at plasma concentrations (c max ) 35 times the recommended clinical dose (see data).  data human data based on prospective reports to the apr of over 11,000 exposures to lamivudine during pregnancy resulting in live births (including over 4,500 exposed in the first trimester), there was no difference between  the overall risk of birth defects for lamivudine compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of defects in live births was 3.1% (95% ci: 2.6% to 3.6%) following first trimester exposure to lamivudine-containing regimens and 2.8% (95% ci: 2.5% to 3.3%) following second/third trimester exposure to lamivudine-containing regimens. lamivudine pharmacokinetics were studied in pregnant women during 2 clinical trials conducted in south africa. the trials assessed pharmacokinetics in 16 women at 36 weeks’ gestation using 150 mg lamivudine twice daily with zidovudine, 10 women at 38 weeks’ gestation using 150 mg lamivudine twice daily with zidovudine, and 10 women at 38 weeks’ gestation using lamivudine 300 mg twice daily without other antiretrovirals. these trials were not designed or powered to provide efficacy information. lamivudine concentrations were generally similar in maternal, neonatal, and umbilical cord serum samples. in a subset of subjects, amniotic fluid specimens were collected following natural rupture of membranes and confirmed that lamivudine crosses the placenta in humans.  based on limited data at delivery, median (range) amniotic fluid concentrations of lamivudine were 3.9 (1.2 to 12.8)–fold greater compared with paired maternal serum concentration (n = 8). animal data lamivudine was administered orally to pregnant rats (at 90, 600, and 4,000 mg per kg per day) and rabbits (at 90, 300, and 1,000 mg per kg per day and at 15, 40, and 90 mg per kg per day) during organogenesis (on gestation days 7 through 16 [rat] and 8 through 20 [rabbit]). no evidence of fetal malformations due to lamivudine was observed in rats and rabbits at doses producing plasma concentrations (c max ) approximately 35 times higher than human exposure at the recommended daily dose. evidence of early embryolethality was seen in the rabbit at system exposures (auc) similar to those observed in humans, but there was no indication of this effect in the rat at plasma concentrations (c max ) 35 times higher than human exposure at the recommended daily dose. studies in pregnant rats showed that lamivudine is transferred to the fetus through the placenta. in the fertility/pre-and postnatal development study in rats, lamivudine was administered orally at doses of 180, 900, and 4,000 mg per kg per day (from prior to mating through postnatal day 20). in the study, development of the offspring, including fertility and reproductive performance, was not affected by maternal administration of lamivudine. risk summary the centers for disease control and prevention recommends that hiv-1-infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. lamivudine is present in human milk. there is no information on the effects of lamivudine on the breastfed infant or the effects of the drugs on milk production. because of the potential for (1) hiv-1 transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants), and (3) adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving lamivudine. the safety and effectiveness of lamivudine tablets in combination with other antiretroviral agents have been established in pediatric patients aged 3 months and older. lamivudine scored tablet is the preferred formulation for hiv-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate because pediatric subjects who received lamivudine oral solution had lower rates of virologic suppression, lower plasma lamivudine exposure, and developed viral resistance more frequently than those receiving lamivudine tablets in the arrow trial [see dosage and administration ( 2.2), warnings and precautions ( 5.6), adverse reactions ( 6.1), clinical pharmacology ( 12.3), clinical studies ( 14.2)] . clinical trials of lamivudine tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, caution should be exercised in the administration of lamivudine in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see dosage and administration ( 2.3), clinical pharmacology ( 12.3)]. reduction of the dosage of lamivudine tablets are recommended for patients with impaired renal function [ see dosage and administration ( 2.3), clinical pharmacology ( 12.3)] .

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

avion pharmaceuticals, llc - pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204), calcium carbonate (unii: h0g9379fgk) (calcium cation - unii:2m83c4r6zb), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8) - pyridoxine hydrochloride 75 mg - description: prenate ® am is a yellow, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with "prenate" on one side and "am" on the other.

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

amneal pharmaceuticals llc - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 0.5 mg - entecavir tablets are indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. none. pregnancy exposure registry there is a  pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir 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 apr are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. entecavir use during pregnancy has been evaluated in a limited number of individuals reported to the apr and the number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population. the estimated background rate for major birth defects is 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp). the rate of miscarriage is not reported in the apr. 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 miscarriage in clinically recognized pregnancies is 15% to 20%. in animal reproduction studies, no adverse developmental effects were observed with entecavir at clinically relevant exposures. no developmental toxicities were observed at systemic exposures (auc) approximately 25 (rats) and 200 (rabbits) times the exposure at the maximum recommended human dose (mrhd) of 1 mg/day (see data ). data animal data entecavir was administered orally to pregnant rats (at 2, 20, and 200 mg per kg per day) and rabbits (at 1, 4, and 16 mg per kg per day) during organogenesis (on gestation days 6 through 15 [rat] and 6 through 18 [rabbit]).  in rats, embryofetal toxicity  including post-implantation loss, resorptions, tail and vertebral malformations, skeletal variations including reduced ossification (vertebrate, sternebrae, and phalanges) and extra lumbar vertebrae and ribs, and lower fetal body weights were observed at systemic exposures (auc) 3,100 times those in humans at the mrhd. maternal toxicity was also observed at this dose level. in rabbits, embryofetal toxicity including post implantation loss, resorptions and skeletal variations, including reduced ossification (hyoid) and increased incidence of 13th rib, were observed at systemic exposures (auc) 883 times those in humans at the mrhd. there were no signs of embryofetal toxicity when pregnant animals received oral entecavir at 28 (rat) and 212 (rabbit) times the human exposure (auc) at the mrhd. in a pre/postnatal development study, entecavir was administered orally to pregnant rats at 0.3, 3, and 30 mg per kg per day from gestation day 6 to lactation/post-partum day 20. no adverse effects on the offspring occurred at up to the highest dose evaluated, resulting in exposures (auc) greater than 94 times those in humans at the mrhd. risk summary it is not known whether entecavir is present in human breast milk, affects human milk production, or has effects on the breastfed infant. when administered to lactating rats, entecavir was present in milk (see data ). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for entecavir and any potential adverse effects on the breastfed infant from entecavir or from the underlying maternal condition. data entecavir was excreted into the milk of lactating rats following a single oral dose of 10 mg per kg on lactation day 7. entecavir in milk was approximately 25% that in maternal plasma (based on auc). entecavir was evaluated in two clinical trials of pediatric subjects 2 years of age and older with hbeag-positive chronic hbv infection and compensated liver disease. the exposure of entecavir in nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric subjects 2 years of age and older with hbeag-positive chronic hbv infection and compensated liver disease receiving 0.015 mg/kg (up to 0.5 mg once daily) or 0.03 mg/kg (up to 1 mg once daily), respectively, was evaluated in study ai463028. safety and efficacy of the selected dose in treatment-naïve pediatric subjects were confirmed in study ai463189, a randomized, placebo-controlled treatment trial [see indications and usage (1), dosage and administration (2.3), adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.2)] . there are limited data available on the use of entecavir in lamivudine-experienced pediatric patients; entecavir should be used in these patients only if the potential benefit justifies the potential risk to the child. since some pediatric patients may require long-term or even lifetime management of chronic active hepatitis b, consideration should be given to the impact of entecavir on future treatment options [see microbiology (12.4)] . the efficacy and safety of entecavir have not been established in patients less than 2 years of age. use of entecavir in this age group has not been evaluated because treatment of hbv in this age group is rarely required. clinical studies of entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. entecavir is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.4)] . there are no significant racial differences in entecavir pharmacokinetics. the safety and efficacy of entecavir 0.5 mg once daily were assessed in a single-arm, open-label trial of hbeag-positive or -negative, nucleoside-inhibitor-naïve, black/african american (n=40) and hispanic (n=6) subjects with chronic hbv infection. in this trial, 76% of subjects were male, the mean age was 42 years, 57% were hbeag-positive, the mean baseline hbv dna was 7.0 log10 iu/ml, and the mean baseline alt was 162 u/l. at week 48 of treatment, 32 of 46 (70%) subjects had hbv dna <50 iu/ml (approximately 300 copies/ml), 31 of 46 (67%) subjects had alt normalization (≤1 × uln), and 12 of 26 (46%) hbeag-positive subjects had hbe seroconversion. safety data were similar to those observed in the larger controlled clinical trials. because of low enrollment, safety and efficacy have not been established in the us hispanic population. dosage adjustment of entecavir is recommended for patients with creatinine clearance less than 50 ml/min, including patients on hemodialysis or capd [see dosage and administration (2.4)  and clinical pharmacology (12.3) ] . the safety and efficacy of entecavir were assessed in a single-arm, open-label trial in 65 subjects who received a liver transplant for complications of chronic hbv infection. eligible subjects who had hbv dna less than 172 iu/ml (approximately 1,000 copies/ml) at the time of transplant were treated with entecavir 1 mg once daily in addition to usual post-transplantation management, including hepatitis b immune globulin. the trial population was 82% male, 39% caucasian, and 37% asian, with a mean age of 49 years; 89% of subjects had hbeag-negative disease at the time of transplant. four of the 65 subjects received 4 weeks or less of entecavir (2 deaths, 1 re-transplantation, and 1 protocol violation) and were not considered evaluable. of the 61 subjects who received more than 4 weeks of entecavir, 60 received hepatitis b immune globulin post-transplant. fifty-three subjects (82% of all 65 subjects treated) completed the trial and had hbv dna measurements at or after 72 weeks treatment post-transplant. all 53 subjects had hbv dna <50 iu/ml (approximately 300 copies/ml). eight evaluable subjects did not have hbv dna data available at 72 weeks, including 3 subjects who died prior to study completion. no subjects had hbv dna values ≥50 iu/ml while receiving entecavir (plus hepatitis b immune globulin). all 61 evaluable subjects lost hbsag post-transplant; 2 of these subjects experienced recurrence of measurable hbsag without recurrence of hbv viremia. this trial was not designed to determine whether addition of entecavir to hepatitis b immune globulin decreased the proportion of subjects with measurable hbv dna post-transplant compared to hepatitis b immune globulin alone. if entecavir treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function must be carefully monitored both before and during treatment with entecavir [see dosage and administration (2.4) and clinical pharmacology (12.3)] .