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

prasco laboratories - prasugrel hydrochloride (unii: g89jq59i13) (prasugrel - unii:34k66tbt99) - prasugrel 5 mg

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

prasco laboratories - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 10 mg in 1 g - metronidazole gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. metronidazole gel, 1% is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. risk summary available data have not established an association with metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. no fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. the available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of metronidazole gel, 1%. 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. risk summary it is not known whether metronidazole is present in human milk after topical administration. published literature reports the presence of metronidazole in human milk after oral administration. there are no data on the effects of metronidazole on milk production. because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with metronidazole gel, 1%. safety and effectiveness of metronidazole gel, 1% have not been established in pediatric patients. sixty-six subjects aged 65 years and older were treated with metronidazole gel, 1% in the clinical study. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

prasco laboratories - phenoxybenzamine hydrochloride (unii: x1ieg24ohl) (phenoxybenzamine - unii:0ttz664r7z) - phenoxybenzamine hydrochloride 10 mg - conditions where a fall in blood pressure may be undesirable; hypersensitivity to the drug or any of its components.

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

prasco laboratories - nitrofurantoin (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l) - nitrofurantoin 25 mg in 5 ml

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

prasco laboratories - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 30 mg - the components in lansoprazole/amoxicillin/clarithromycin are indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence (see clinical studies and dosage and administration) . to reduce the development of drug-resistant bacteria and maintain the effectiveness of lansoprazole/amoxicillin/clarithromycin and other antibacterial drugs, lansoprazole/amoxicillin/clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. lansoprazole/amoxicillin/clarithromycin is contraindicated in p

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

prasco laboratories - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone 750 mg in 5 ml - atovaquone oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx). atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx. clinical experience with atovaquone oral suspension for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do2 ] ≤45 mm hg). treatment of more severe episodes of pcp with atovaquone oral suspension has not been studied. the efficacy of atovaquone oral suspension in subjects who are failing therapy with tmp-smx has also not been studied. atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or to any component of the

United States - English - 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.,

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

prasco laboratories - ibuprofen lysine (unii: n01orx9d6s) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 10 mg in 1 ml - ibuprofen lysine is indicated to close a clinically significant patent ductus arteriosus (pda) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. the clinical trial was conducted among infants with an asymptomatic pda. however, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant pda. ibuprofen lysine is contraindicated in: - preterm infants with proven or suspected infection that is untreated; - preterm infants with congenital heart disease in whom patency of the pda is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of fallot, severe coarctation of the aorta); - preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; - preterm infants with thrombocytopenia; - preterm infants with coagulation defects; - preterm infants with or who are suspected of having necrotizing enterocolitis; - preterm infants with significant impairment of renal function. safety and effectiveness have only been established in premature infants.

United States - English - 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 known to have 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) venous and arterial thrombosis or thromboembolism, as well as cases of retinal artery and retinal vein occlusions, have been reported with tranexamic acid. do not prescribe tranexamic acid tablets to women with known hypersensitivity to tranexamic acid [see warnings and precautions (5.2) and adverse reactions (6.1) ]. tranexamic

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

prasco laboratories - benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) -  acne medication - for the treatment of acne