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

alvogen inc. - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) - oseltamivir acid 6 mg in 1 ml - oseltamivir phosphate for oral suspension is 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 for oral suspension is indicated for the prophylaxis of influenza a and b in patients 1 year and older. - oseltamivir phosphate for oral suspension is 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 for oral suspension [see microbiology (12.4)] . - ose

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

alvogen inc. - methenamine hippurate (unii: m329791l57) (methenamine - unii:j50oix95qv) - methenamine hippurate 1 g - to reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate tablets and other antibacterial drugs, methenamine hippurate tablets 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. methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. this drug should only be used after eradication of the infection by other appropriate antimicrobial agents. methenamine hippurate tablets are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. it should not be used

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

alvogen, inc. - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - minocycline 50 mg - minocycline hydrochloride capsules, usp are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: minocycline hydrochloride capsules, usp are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: when penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: in acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides. in severe acne , minocycline may be useful adjunctive therapy. oral minocycline is indicated in the treatment of asymptomatic carriers of neisseria  meningitidis to eliminate meningococci from the nasopharynx. in order to preserve the usefulness of minocycline

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

alvogen inc. - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate 67 mg

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

alvogen inc. - paclitaxel (unii: p88xt4is4d) (paclitaxel - unii:p88xt4is4d) - paclitaxel 30 mg in 5 ml - paclitaxel injection, usp is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. as first-line therapy, paclitaxel is indicated in combination with cisplatin. paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. in the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptornegative tumors (see clinical studies, breast carcinoma ). paclitaxel injection, usp is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. prior therapy should have included an anthracycline unless clinica

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

alvogen inc. - mesna (unii: nr7o1405q9) (2-mercaptoethanesulfonic acid - unii:vhd28s0h7f) - mesna 100 mg in 1 ml - mesna injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. limitation of use : mesna injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. mesna injection is contraindicated in patients known to be hypersensitive to mesna or to any of the excipients [see warnings and precautions (5.1)]. pregnancy category b. risk summary there are no studies of mesna in pregnant women. reproduction studies performed in rats and rabbits at oral doses approximately 10 times the maximum recommended total daily intravenous-oral-oral human dose on a body surface area basis (1000 mg/kg in rabbits and 2000 mg/kg in rats) revealed no evidence of harm to the fetus due to mesna. the incidence of malformations in human pregnancies has not been established for mesna.  all pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations and 15 to 20% for pregnancy loss.

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

alvogen inc. - labetalol hydrochloride (unii: 1gev3baw9j) (labetalol - unii:r5h8897n95) - labetalol hydrochloride 100 mg - labetalol hydrochloride tablets are indicated in the management of hypertension. labetalol hydrochloride tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. labetalol hydrochloride tablets are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see warnings). beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

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

alvogen inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml

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

alvogen inc. - carboplatin (unii: bg3f62ond5) (carboplatin - unii:bg3f62ond5) - carboplatin 10 mg in 1 ml - initial treatment of advanced ovarian carcinoma carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. one established combination regimen consists of carboplatin and cyclophosphamide. two randomized controlled studies conducted by the ncic and swog with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (seeclinical studies ). there is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup. secondary treatment of advanced ovarian carcinoma carboplatin injection is indicated for the palliative treatment of

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

alvogen inc. - rocuronium bromide (unii: i65mw4ofhz) (rocuronium - unii:wre554rfez) - rocuronium bromide 10 mg in 1 ml - rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see warnings and precautions (5.2)] . developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats. inhibition of neuromuscular function was the endpoint for high-dose selection. the maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15% to 30% of human intubation dose of 0.6 to 1.2 mg/kg based on the body surface unit of mg/m2 ) from day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from day 6 to 18 of pregnancy. high-dose treatment caused acute symptoms