Соединенные Штаты - английский - NLM (National Library of Medicine)

prasco laboratories - doxycycline (unii: n12000u13o) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 40 mg - doxycycline 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. no meaningful effect was demonstrated for generalized erythema (redness) of rosacea. this formulation of doxycycline has not been evaluated in the treatment or prevention of infections. do not use doxycycline 40 mg for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. to reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, doxycycline 40 mg should be used only as indicated. doxycycline 40 mg has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. this drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any other tetracyclines. risk summary doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [see warnings and precautions (5.1 and 5.2) ]. available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. avoid use of doxycycline 40 mg during the second and third trimester of pregnancy. 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 2–4% and 15–20%, respectively. data human data published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects. the use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). this adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. animal data results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues. risk summary based on available published data, doxycycline is likely to be present in human breast milk but the specific concentration in breastmilk is not clear. there is no information on the effects of doxycycline on the breastfed infant or the effects on milk production. because there are other antibacterial drug options available to treat rosacea in lactating women and because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with doxycycline 40 mg and for 5 days after the last dose. doxycycline 40 mg should not be used in infants and children less than 8 years of age [see warnings and precautions (5.1) ]. doxycycline 40 mg has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended. clinical studies of doxycycline 40 mg did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between elderly and younger patients. 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 concomitant disease or other drug therapy.

Соединенные Штаты - английский - NLM (National Library of Medicine)

prasco laboratories - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 0.31 mg in 3 ml - levalbuterol hcl inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol hcl inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol hcl inhalation solution, during pregnancy. to enroll in mothertobaby pregnancy studies' asthma & pregnancy study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoing-study/asthma. risk summary there are no adequate and well-controlled studies of levalbuterol hcl inhalation solution in pregnant women. there are clinical con

Соединенные Штаты - английский - NLM (National Library of Medicine)

prasco laboratories - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone 250 mg - atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated p. falciparum malaria. atovaquone and proguanil hydrochloride have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance. risk summary available data from published literature and postmarketing experience with use of atovaquone and proguanil hydrochloride in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. the proguanil component of atovaquone and proguanil hydrochloride tablets acts to inhibit parasitic dihydrofolate reductase; however, pregnant women and females of reproductive potential should continue fola

Соединенные Штаты - английский - NLM (National Library of Medicine)

prasco, llc - zileuton (unii: v1l22wve2s) (zileuton - unii:v1l22wve2s) - zileuton 600 mg - zileuton extended-release tablets is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. zileuton extended-release tablets is not indicated for use in the reversal of bronchospasm in acute asthma attacks.  therapy with zileuton extended-release tablets can be continued during acute exacerbations of asthma. the use of zileuton extended-release tablets is contraindicated in patients with: - active liver disease or persistent hepatic function enzyme elevations greater than or equal to 3 times the upper limit of normal (≥3xuln) [see warnings and precautions (5), and use in specific populations (8.7) ]. - a history of allergic reaction to zileuton or any of the ingredients of zileuton extended-release tablets (e.g., rash, eosinophilia, etc.). information on specific populations is based on studies conducted with zileuton immediate-release tablets and is applicable to zileuton extended-release tablets. risk summary there are no adequate human data on zileu

Соединенные Штаты - английский - NLM (National Library of Medicine)

prasco laboratories - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid 650 mg - tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding [see clinical studies (14) ]. prior to prescribing tranexamic acid tablets, exclude endometrial pathology that can be associated with heavy menstrual bleeding. do not prescribe tranexamic acid tablets to women who are - using combination hormonal contraception - known to have any of the following conditions: active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) a history of thrombosis or thromboembolism, including retinal vein or artery occlusion an intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy) - active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) - a history of thrombosis or thromboembolism, including retinal vein or artery occlusion - an intrinsic risk of thrombosis or thromboembolism (e.g.,

Соединенные Штаты - английский - NLM (National Library of Medicine)

prasco llc - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 10 mg

Соединенные Штаты - английский - NLM (National Library of Medicine)

prasco laboratories - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - calcipotriene 50 ug in 1 g - calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. the safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. calcipotriene cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. it should not be used by patients with demonstrated hypercalcemia or evidence of vitamin d toxicity. calcipotriene cream should not be used on the face.

Соединенные Штаты - английский - NLM (National Library of Medicine)

prasco laboratories - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 30 mg in 1.5 ml

Соединенные Штаты - английский - NLM (National Library of Medicine)

prasco laboratories - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 100 mg - lamivudine tablets (hbv) are indicated for the treatment of chronic hepatitis b virus (hbv) infection associated with evidence of hepatitis b viral replication and active liver inflammation [see clinical studies (14.1, 14.2)]. the following points should be considered when initiating therapy with lamivudine tablets (hbv): lamivudine tablets (hbv) 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 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 substantial difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% reported in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp). the

Соединенные Штаты - английский - NLM (National Library of Medicine)

prasco laboratories - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg