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alvogen inc. - nitrofurantoin (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l) - nitrofurantoin 25 mg - nitrofurantoin macrocrystals capsules is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of escherichia coli, enterococci, staphylococcus aureus , and certain susceptible strains of klebsiella and enterobacter species. nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules 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. nitrofurantoins lack the broader tissue distribution of other therapeutic

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alvogen inc. - melphalan (unii: q41or9510p) (melphalan - unii:q41or9510p) - melphalan 2 mg - melphalan tablets usp are indicated for the palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary. melphalan tablets usp should not be used in patients whose disease has demonstrated a prior resistance to this agent. patients who have demonstrated hypersensitivity to melphalan should not be given the drug.

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alvogen inc. - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) - oseltamivir carboxylate 30 mg - oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza a and b infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. oseltamivir phosphate capsules are indicated for the prophylaxis of influenza a and b in patients 1 year and older. - oseltamivir phosphate capsules are not a substitute for early influenza vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices. - influenza viruses change over time. emergence of resistance substitutions could decrease drug effectiveness. other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate capsules [see microbiology (12.4)]. -  oseltamivir phosphate capsules are not recom

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alvogen, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide capsules (enteric coated)  are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon. pediatric use information is approved for perrigo pharma international dac’s entocort ec (budesonide) capsules. however, due to perrigo pharma international dac’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). serious hypersensitivity reactions, including anaphylaxis have occurred  [see adverse reactions (6.2)]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insuffici

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alvogen, inc. - primaquine phosphate (unii: h0982hf78b) (primaquine - unii:mvr3634gx1) - primaquine 26.3 mg

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alvogen inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 7.7 mg in 1 g - superficial dermatophyte infections ciclopirox gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to trichophyton rubrum, trichophyton mentagrophytes, or epidermophyton floccosum . seborrheic dermatitis ciclopirox gel is indicated for the topical treatment of seborrheic dermatitis of the scalp. ciclopirox gel is contraindicated in individuals who have shown hypersensitivity to any of its components.

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alvogen, inc. - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 1 ug - paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or - vitamin d toxicity [see warnings and precautions (5.1) ]. pregnancy category c. paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times a human dose of 14 mcg or 0.24 mcg/kg (based on body surface area, mcg/m2 ), and when administered to rats at a dose two times the 0.24 mcg/kg human dose (based on body surface area, mcg/m2 ). at the highest dose tested, 20 mcg/kg administered three times per week in rats (13 times the 14 mcg human dose based on surface area, mcg/m2 ), there was a significant i

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alvogen inc. - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam 5 mg in 1 ml - midazolam injection, usp is indicated: injectable midazolam hydrochloride is contraindicated in patients with a known hypersensitivity to the drug. benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction with midazolam hydrochloride; patients with glaucoma have not been studied. midazolam hydrochloride is not intended for intrathecal or epidural administration due to the presence of the preservative benzyl alcohol in the dosage form. midazolam hydrochloride is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see warnings and precautions, pediatric use ). midazolam hydrochloride contains midazolam, a schedule iv control substance. midazolam was actively self-administered in primate models used to assess the positive

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alvogen inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid 100 mg in 1 ml - tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. tranexamic acid injection is contraindicated: • in patients with subarachnoid hemorrhage. anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. • in patients with active intravascular clotting [see warnings and precautions (5.1)]. • in patients with hypersensitivity to tranexamic acid or any of the ingredients [see warnings and precautions (5.3)]. risk summary available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. there are 2 (0.02%) infant cases with structural abnormalities that

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

alvogen, inc. - pyridostigmine bromide (unii: kvi301na53) (pyridostigmine - unii:19qm69hh21) - pyridostigmine bromide 180 mg - pyridostigmine bromide extended release tablets is contraindicated in mechanical intestinal or urinary obstruction, and particular caution should be used in its administration to patients with bronchial asthma. care should be observed in the use of atropine for counteracting side effects, as discussed below.