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

prasco laboratories - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s), glimepiride (unii: 6ky687524k) (glimepiride - unii:6ky687524k) - pioglitazone 30 mg - pioglitazone and glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see clinical studies (14)] . important limitations of use pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone and glimepiride tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.5)]. - initiation in patients with established nyha class iii or iv heart failure [see boxed warning] . - use in patients with known hypersensitivity to pioglitazone, glimepiride or any other component of pioglitazone and glimepiride tablets [see warnings and precautions (5.3)] . - use in patients with known history of an alle

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

prasco laboratories - teriparatide (unii: 10t9csu89i) (teriparatide - unii:10t9csu89i) - teriparatide injection is indicated: - for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. in postmenopausal women with osteoporosis, teriparatide injection reduces the risk of vertebral and nonvertebral fractures. - to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. - for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. teriparatide injection is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. hypersensitivity reactions have included angioedema and anaphylaxis [see adverse reactions (6.3)] . risk summary there are no available data on teriparatide injection use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. consider discontinuing teriparatide injection when pregnancy is recognized. in animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m2 ), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. the background risk in the us general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in animal reproduction studies, pregnant mice received teriparatide during organogenesis at subcutaneous doses equivalent to 8 to 267 times the human dose (based on body surface area, mcg/m2 ). at subcutaneous doses ≥60 times the human dose, the fetuses showed an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib). when pregnant rats received teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings. in a perinatal/postnatal study in pregnant rats dosed subcutaneously from organogenesis through lactation, mild growth retardation was observed in female offspring at doses ≥120 times the human dose. mild growth retardation in male offspring and reduced motor activity in both male and female offspring were observed at maternal doses of 540 times the human dose. there were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively. risk summary it is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant. avoid teriparatide injection use in women who are breastfeeding. the safety and effectiveness of teriparatide injection have not been established in pediatric patients. pediatric patients are at higher baseline risk of osteosarcoma because of open epiphyses [see warnings and precautions (5.1)] . of the patients who received teriparatide injection in the osteoporosis trial of 1637 postmenopausal women, 75% were 65 years of age and older and 23% were 75 years of age and older. of the patients who received teriparatide injection in the trial of 437 men with primary or hypogonadal osteoporosis, 39% were 65 years of age and over and 13% were 75 years of age and over. of the 214 patients who received teriparatide injection in the glucocorticoid induced osteoporosis trial, 28% were 65 years of age and older and 9% were 75 years of age and older. no overall differences in safety or effectiveness of teriparatide injection have been observed between patients 65 years of age and older and younger adult patients. no studies have been performed in patients with hepatic impairment [see clinical pharmacology (12.3)] . in 5 patients with severe renal impairment (crcl<30 ml/minute), the auc and t1/2 of teriparatide were increased by 73% and 77%, respectively. maximum serum concentration of teriparatide was not increased. it is unknown whether teriparatide injection alters the underlying metabolic bone disease seen in chronic renal impairment [see clinical pharmacology (12.3)] . teriparatide [ter-i-par-a-tide] injection user manual important: first read the medication guide that comes inside your teriparatide carton. before you use your new teriparatide delivery device, please read the entire front and back of this user manual completely. follow the directions carefully when using the teriparatide delivery device. do not share your delivery device or needles because infection or disease can be spread from one person to another. the teriparatide delivery device contains 28 days of medicine. throw away the teriparatide delivery device after 28 days, even if it is not completely empty. do not inject more than one dose of teriparatide in the same day. do not transfer teriparatide to a syringe. wash your hands before every injection. prepare the injection site as your healthcare provider instructed. for more information, or if you have any questions, turn to the back of this page. - if you have already injected, do not inject yourself a second time on the same day. - remove the needle. - attach a new needle, pull off the large needle cover and save it. - pull out the black injection button until it stops. check to make sure the red stripe shows. - pull off the small needle protector and throw away. - point the needle down into an empty container. push in the black injection button until it stops. hold it in and slowly count to five. you may see a small stream or drop of fluid. when you have finished, the black injection button should be all the way in. - if you still see the yellow shaft showing, contact eli lilly and company (see contact information below) or your healthcare provider. - put the large needle cover on needle. unscrew the needle all the way by giving the needle cover 3 to 5 counter-clockwise turns. pull off the covered needle and throw away as instructed by your healthcare provider. push the white cap back on, and put your teriparatide delivery device in the refrigerator. - wipe the outside of the teriparatide delivery device with a damp cloth. - do not place the teriparatide delivery device in water, or wash or clean it with any liquid. - after each use, refrigerate the teriparatide delivery device right away. read and follow the instructions in the medication guide section “how should i store teriparatide?”. - do not store the teriparatide delivery device with a needle attached. doing this may cause air bubbles to form in the medicine cartridge. - store the teriparatide delivery device with the white cap on. - do not freeze teriparatide. if the teriparatide delivery device has been frozen, throw the device away and use a new teriparatide delivery device. - if the teriparatide delivery device has been left out of the refrigerator, do not throw the delivery device away. place the delivery device back in the refrigerator and call eli lilly and company at 1-866-436-7836. - the teriparatide delivery device contains 28 days of medicine. - do not transfer teriparatide to a syringe. this may result in you taking the wrong dose of medicine. - read and follow the instructions in the user manual so that you use your teriparatide delivery device the right way. - check the teriparatide delivery device label to make sure you have the right medicine and that it has not expired. - do not use the teriparatide delivery device if it looks damaged. look at the teriparatide medicine in the cartridge. if the medicine is not clear and colorless, or if it has particles, do not use it. call eli lilly and company if you notice any of these (see contact information ). - use a new needle for each injection. - during injection, you may hear one or more clicks – this is normal. - the teriparatide delivery device is not recommended for use by the blind or by those who have vision problems without help from a person trained in the proper use of the device. - keep your teriparatide delivery device and needles out of the reach of children. - before throwing away the teriparatide delivery device, be sure to remove the pen needle. - throw away your teriparatide delivery device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies. literature revised october 3, 2019 ter-0002-ifu-20191003

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

prasco laboratories - omeprazole magnesium (unii: 426qfe7xlk) (omeprazole - unii:kg60484qx9) - omeprazole magnesium for delayed-release oral suspension is indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy omeprazole magnesium for delayed-release oral suspension in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. dual therapy omeprazole magnesium for delayed-release oral suspension in combination with clarithromycin is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, omeprazole magnesium for delayed-release oral suspension with clarithromycin is more likely to be associated with the development of clarithromyci

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

prasco laboratories - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 7.5 mg in 1 g - metronidazole topical gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. metronidazole topical gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

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

prasco laboratories - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 20 mg - pantoprazole sodium  delayed-release tablets are indicated for: pantoprazole sodium  delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium  delayed-release tablets may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium  delayed-release tablets are indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium  delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. - pantoprazole sodium delayed-release tablets are contra

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

prasco laboratories - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 20 mg - duloxetine delayed-release capsules are indicated for the treatment of: - major depressive disorder [see clinical studies (14.1)] - generalized anxiety disorder [see clinical studies (14.2)] - diabetic peripheral neuropathy [see clinical studies (14.3)] - chronic musculoskeletal pain [see clinical studies (14.5)] monoamine oxidase inhibitors (maois) — the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)] . starting duloxetine delayed-release capsules in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of seroto

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

prasco laboratories - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets, usp are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] . raloxifene hydrochloride tablets, usp are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . raloxifene hydrochloride tablets, usp are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)] . twenty-seven percent of the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ

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

prasco laboratories - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate 200 mg - malaria hydroxychloroquine sulfate tablets are indicated for the treatment of uncomplicated malaria due to p. falciparum, p. malariae, p. ovale, and p. vivax . hydroxychloroquine sulfate tablets are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. limitations of use in malaria - hydroxychloroquine sulfate tablets are not recommended for the treatment of complicated malaria. - hydroxychloroquine sulfate tablets are not effective against chloroquine or hydroxychloroquine-resistant strains of plasmodium species (see clinical pharmacology – microbiology ). hydroxychloroquine sulfate tablets are not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the plasmodium species has not been identified. - hydroxychloroquine sulfate tablets are not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs. - hydroxychloroquine sulfate tablets do not prevent relapses

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

prasco laboratories - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 7.5 mg in 1 g - metronidazole topical lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. metronidazole topical lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.

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

prasco laboratories - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole topical cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. metronidazole topical cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.