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alvogen, inc. - rasagiline mesylate (unii: lh8c2ji290) (rasagiline - unii:003n66ts6t) - rasagiline tablets are indicated for the treatment of parkinson’s disease (pd). rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene, and mao inhibitors (maois), including other selective mao-b inhibitors, because of risk of serotonin syndrome [see warnings and precautions (5.2)] . at least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications. rasagiline is contraindicated for use with st. john’s wort and with cyclobenzaprine. rasagiline is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. risk summary there are no adequate data on the developmental risks associated with the use of rasagiline in pregnant women. in animal studies, oral administration of rasagiline to rats during gestation and lactation resulted in decreased survival and reduced body weight in the offspring at doses similar to those used clinically. when administered to pregnant animals in com

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

alvogen inc. - pyrimethamine (unii: z3614qox8w) (pyrimethamine - unii:z3614qox8w) - treatment of toxoplasmosis: pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination. use of pyrimethamine is contraindicated in patients with known hypersensitivity to pyrimethamine or to any component of the formulation. use of the drug is also contraindicated in patients with documented megaloblastic anemia due to folate deficiency.

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

alvogen inc. - exemestane (unii: ny22hmq4bx) (exemestane - unii:ny22hmq4bx) - exemestane 25 mg - exemestane is indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy [see clinical studies ( 14.1 )] . exemestane is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see clinical studies ( 14.2 )] . exemestane tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients. risk summary based on findings in animal studies and its mechanism of action, exemestane can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited human data from case reports are insufficient to inform a drug-associated risk. in animal reproduction studies, administration of exemestane to pregnant rats and rabbits caused increased incidence of abo

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

alvogen inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.  limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):  • have not been tolerated, or are not expected to be tolerated, • have not provided adequate analgesia, or are not expected to provide adequate analgesia  hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: • significant respiratory depression [see warnings ] • acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] • known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] • hypersensitivity to hydrocodone o

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

alvogen inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin 500 mg in 10 ml - vancomycin hydrochloride for injection, usp is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. it is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. vancomycin hydrochloride for injection, usp is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. vancomycin hydrochloride for injection, usp is effective in the treatment of staphylococcal endocarditis. its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. when staphylococcal infecti

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. - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. do not use nitroglycerin sublingual tablets in patients who are taking pde-5 inhibitors, such as avanafil, sildenafil, tadalafil, vardenafil hydrochloride. concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see drug interactions (7.1)]. do not use nitroglycerin sublingual tablets in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. concomitant use can cause hypotension. nitroglycerin sublingual tablets are contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). nitroglycerin sublingual tablets may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e.g., cerebral hemorrhage or traumatic brain injury). nitr

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

alvogen, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.025 mg in 1 d -     when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.     when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered. the estradiol transdermal system is contraindicated in women with any of the following conditions: the estradiol transdermal system should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as oral contraceptives inadvertently during early pregnancy. the estradiol transdermal system should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectable amounts of estrogens have been identified in the b

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

alvogen inc. - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane 500 mg in 50 ml - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2)] . do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. pregnancy category d risk summary dexrazoxane for injection can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5)]. animal data dexrazoxane res

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

alvogen inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin 125 mg - vancomycin hydrochloride capsules are indicated for the treatment of clostridioides difficile -associated diarrhea. vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. limitations of use • parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections. • orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. to reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride 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 considere