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alvogen, inc - gadopentetate dimeglumine (unii: rh248g8v27) (gadopentetate - unii:v7ok6j19hq) - gadopentetate dimeglumine 469.01 mg in 1 ml - gadopentetate dimeglumine injection is indicated for use with magnetic resonance imaging (mri) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. gadopentetate dimeglumine injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors. gadopentetate dimeglumine is indicated for use with mri in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck. gadopentetate dimeglumine injection is indicated for use in mri in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body (excluding the heart). gadopentetate dimeglumine is contraindicated in patients with:

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alvogen inc. - nitrofurantoin (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l), nitrofurantoin monohydrate (unii: e1qi2cqq1i) (nitrofurantoin - unii:927ah8112l) - nitrofurantoin 25 mg - nitrofurantoin capsules (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of escherichia coli or staphylococcus saprophyticus . 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 capsules (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (monohydrate/macrocrystals) 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 agents

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alvogen inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - butalbital 50 mg - butalbital and acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit forming and potentially abusable. this product is contraindicated under the following conditions: - hypersensitivity or intolerance to any component of this product. - patients with porphyria. abuse and dependence: butalbital: barbiturates may be habit-forming: tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. the average daily dose for the barbiturate addict is usually about 1500 mg. as tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. as this occurs, the margin b

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

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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

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

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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.