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alvogen, inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg - moxifloxacin hydrochloride is indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]),  haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies (14.3 )] . mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin hydrochloride is indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or streptococcus pyogenes [see clinical studies (14.4 )]. moxifloxacin hydrochloride is indicated in

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

alvogen inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 60 mg - fluoxetine tablets are indicated for the treatment of: the use of maois intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. the use of fluoxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.6) and warnings and precautions (5.2)] . starting fluoxetine 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 serotonin syndrome [see dosage and administration ( 2.7 ) and warnings and precautions (5.2 )] . the use of fluoxetine is contraindicated with the following: pimozide and thioridazine prolong the qt interval. fluoxetine can increase the levels of pimozide and thioridazine through inhibition of cyp2d6. fluoxetine can also prolong the qt interval. pregnancy category c —fluoxetine should be used duri

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

alvogen, inc. - acarbose (unii: t58msi464g) (acarbose - unii:t58msi464g) - acarbose 25 mg - acarbose is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. acarbose is contraindicated in patients with known hypersensitivity to the drug. acarbose is contraindicated in patients with diabetic ketoacidosis or cirrhosis. acarbose is also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction. in addition, acarbose is contraindicated in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine.

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

alvogen inc. - amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e), dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - amphetamine aspartate monohydrate 1.25 mg - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. attention deficit hyperactivity disorder (adhd) a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental eff

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

alvogen inc. - nifedipine (unii: i9zf7l6g2l) (nifedipine - unii:i9zf7l6g2l) - nifedipine 30 mg - nifedipine extended-release tablets are indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive agents. concomitant administration with strong p450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (see precautions, drug interactions .)  nifedipine must not be used in cases of cardiogenic shock. nifedipine is contraindicated in patients with a known hypersensitivity to any component of the tablet.

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

alvogen, inc. - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin 0.1 mg in 1 h - transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. the onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack. nitroglycerin is contraindicated in patients who are allergic to it. allergy to the adhesives used in nitroglycerin patches has also been reported, and it similarly constitutes a contraindication to the use of this product. do not use nitroglycerin transdermal infusion system in patients who are taking phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil) for erectile dysfunction or pulmonary arterial hypertension. concomitant use can cause severe drops in blood pressure. do not use nitroglycerin transdermal infusion system in patients who are taking the soluble guanylate cyclase stimulator riociguat. concomitant use can cause hypotension.

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alvogen inc. - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 150 mg - ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. ibandronate sodium increases bone mineral density (bmd) and reduces the incidence of vertebral fractures. the optimal duration of use has not been determined. the safety and effectiveness of ibandronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate sodium is contraindicated in patients with the following conditions: • abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see warnings and precautions [5.1]) • inability to stand or sit upright for at least 60 minutes (see dosage

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

alvogen, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 7.5 mg - oxycodone and acetaminophen tablets is indicated for the relief of moderate to moderately severe pain. oxycodone and acetaminophen tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. oxycodone is contraindicated in the setting of suspected or known paralytic ileus. oxycodone and acetaminophen tablets are a schedule ii controlled substance. oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical, psyc

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

alvogen, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 7.5 mg - oxycodone and acetaminophen tablets is 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, , which can occur at any dosage or duration [see warnings ] , reserve oxycodone 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 oxycodone and acetaminophen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. oxycodone and acetaminophen tablets is contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitor