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strides pharma science limited - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). in pediatric patients, ibuprofen oral suspension is indicated: - for reduction of fever in patients aged 6 months up to 2 years of age. - for relief of mild to moderate pain in patients aged 6 months up to 2 years of age. - for relief of signs and symptoms of juvenile arthritis. in adults, ibuprofen oral suspension is indicated: - for treatment of primary dysmenorrhea. - for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended. (see precautions –  drug interactions ). ibuprofen or

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strides pharma science limited - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or candida infections. ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. drug interactions coadministration of a number of cyp3a4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with ketoconazole tablets. coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to s

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strides pharma science limited - methoxsalen (unii: u4vj29l7bq) (methoxsalen - unii:u4vj29l7bq) - methoxsalen 10 mg - photochemotherapy (methoxsalen with long wave uva radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation. a.    patients exhibiting idiosyncratic reactions to psoralen compounds. b.     patients possessing a specific history of light sensitive disease states should not initiate methoxsalen therapy except under special circumstances. diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism. c.     patients with melanoma or with a history of melanoma. d.    patients with invasive squamous cell carcinomas. e.     patients with aphakia, because of the significantly increased risk of retinal damage due to the abse

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

strides pharma science limited - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reac

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strides pharma science limited - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin capsules are indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin capsules during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/ . risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmen

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strides pharma science limited - flucytosine (unii: d83282dt06) (flucytosine - unii:d83282dt06) - flucytosine capsules are indicated only in the treatment of serious infections caused by susceptible strains of candida and/or cryptococcus . candida: septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. limited trials in pulmonary infections justify the use of flucytosine. cryptococcus: meningitis and pulmonary infections have been treated effectively. studies in septicemias and urinary tract infections are limited, but good responses have been reported. flucytosine capsules should be used in combination with amphotericin b for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to flucytosine capsules (see microbiology ). flucytosine capsule is contraindicated in patients with a known hypersensitivity to the drug. flucytosine capsule is contraindicated in patients with known complete dihydropyrimidine dehydrogenase (dpd) enzyme deficiency (see warnings ).

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strides pharma science limited - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablet is 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 tablets 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 tablets 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 tablets 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 15–20%. in animal reproduction studies, no adverse developmental effects were observed when the components of emtricitabine and tenofovir disoproxil fumarate tablets 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 tablets (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 tablets for hiv-1 prep, during pregnancy. data human data emtricitabine and tenofovir disoproxil fumarate tablets  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 tablets 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 tablets 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 tablets. 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 tablets 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 tablets 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 tablets for hiv-1 prep should be considered along with any potential adverse effects on the breastfed child from emtricitabine and tenofovir disoproxil fumarate tablets 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 tablets 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 tablets 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 tablets. for additional information, consult the prescribing information for emtriva and viread. emtricitabine and tenofovir disoproxil fumarate tablets 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 tablets 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 tablets 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 tablets 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 tablets 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 tablets 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 tablets 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 tablets 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 tablets 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 tablets should be modified in hiv-infected adult individuals with estimated creatinine clearance of 30–49 ml/min. emtricitabine and tenofovir disoproxil fumarate tablet 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 tablets 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 tablets for hiv-1 prep, evaluate potential causes and re-assess potential risks and benefits of continued use [see dosage and administration (2.6)] .

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strides pharma science limited - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsule is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older. pediatric use information is approved for novartis pharmaceuticals corporation's gilenya (fingolimod) capsules. however, due to novartis pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information. fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, tia, decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1)] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with clas

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strides pharma science limited - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast tablets are indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. the use of roflumilast is contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology (12.3) and use in specific populations (8.6)] . risk summary there are no randomized clinical studies of roflumilast in pregnant women. in animal reproductive toxicity studies, roflumilast administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest roflumilast dose in these studies was approximately 30 and 26 times, respectively, the maximum recommended human dose (mrhd). roflumilast induced post-implantation loss in rats at doses greater than or equal to approximately 10 times the mrhd

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strides pharma science limited - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablets, usp is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets, usp is not recommended to be initiated, unless the benefit outweighs the risk, in: -   adult females with cd4+ cell counts greater than 250 cells/mm3 or -   adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)] . nevirapine tablets, usp are contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)] - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)] . pregnancy exposure registry th