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

orchidpharma inc - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 20 mg - pantoprazole sodium delayed-release tablets are indicated for: pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. for those adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison syndrome pantoprazole is contraindicated in patients with known

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

orchidpharma inc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole orally disintegrating tablets are indicated for the treatment of: - schizophrenia [see clinical studies (14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole during pregnancy.healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk su

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

orchidpharma inc - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 1 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6 week study (adults only), at the end of both 2 week studies (elderly only) and at the end of the 6 month study (adults only). - eszopiclone is contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone [see warnings and precautions (5.1) ]. - eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3) ]. risk summary available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth

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

orchidpharma inc - zaleplon (unii: s62u433rmh) (zaleplon - unii:s62u433rmh) - zaleplon capsules are indicated for the short-term treatment of insomnia. zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see clinical trials under clinical pharmacology ). it has not been shown to increase total sleep time or decrease the number of awakenings. the clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. the final formal assessments of sleep latency were performed at the end of treatment. zaleplon is contraindicated in patients: - who have experienced complex sleep behaviors after taking zaleplon (see warnings ). - with hypersensitivity to zaleplon or any excipients in the formulation (see precautions ). zaleplon is classified as a schedule iv controlled substance by federal regulation. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoa

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

orchidpharma inc - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use in osa, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. if continuous positive airway pressure (cpap) is the treatment of choice for a patient, a maximal effort to treat with cpap for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness. modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . teratogenic effects pregnancy category c there are no adequate and well-controlled studies of modafinil in pregnant women. intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of r- and s-modaf

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

orchidpharma inc - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (koh) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in patients with: - chronic or active liver disease [see warnings and precautions (5.1)] - history of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see adverse reactions (6.2)] ​ risk summary available data from postmarketing cases on the use of terbinafine tablets in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, terbinafine did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at oral doses

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

orchidpharma inc - cephalexin (unii: obn7uds42y) (cephalexin anhydrous - unii:5sff1w6677) - cephalexin anhydrous 125 mg in 5 ml - cephalexin for oral suspension is indicated for the treatment of respiratory tract infections caused by susceptible isolates of streptococcus pneumoniae and streptococcus pyogenes . cephalexin for oral suspension is indicated for the treatment of otitis media caused by susceptible isolates of streptococcus pneumoniae , haemophilus influenzae , staphylococcus aureus , streptococcus pyogenes , and moraxella catarrhalis . cephalexin for oral suspension is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus and streptococcus pyogenes . cephalexin for oral suspension is indicated for the treatment of bone infections caused by susceptible isolates of staphylococcus aureus and proteus mirabilis. cephalexin for oral suspension is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of escherichia coli , proteus mirabilis , and klebsiella p

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

orchidpharma inc - cefpodoxime proxetil (unii: 2tb00a1z7n) (cefpodoxime - unii:7r4f94tvgy) - cefpodoxime 100 mg - cefpodoxime proxetil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. recommended dosages, durations of therapy, and applicable patient populations vary among these infections. please see dosage and administration for specific recommendations. acute otitis media caused by streptococcus pneumoniae (excluding penicillin-resistant strains), streptococcus pyogenes, haemophilus influenzae (including beta- lactamase-producing strains), or moraxella (branhamella) catarrhalis (including beta- lactamase-producing strains). pharyngitis and/or tonsillitis caused by streptococcus pyogenes . note: only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. cefpodoxime proxetil tablets are generally effective in the eradication of streptococci from the oropharynx. however, data establishing the efficacy of cefpodoxime pro

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

orchidpharma inc - cefdinir monohydrate (unii: 6e7sn358se) (cefdinir - unii:ci0fao63wc) - cefdinir 125 mg in 5 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. cefdinir for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. adults and adolescents community-acquired pneumonia caused by haemophilus influenzae (including β-lactamase producing strains), haemophilus parainfluenzae (including β-lactamase producing strains), streptococcus pneumoniae (penicillin-susceptible strains only), and moraxella catarrhalis (inclu

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

orchidpharma inc - cefdinir monohydrate (unii: 6e7sn358se) (cefdinir - unii:ci0fao63wc) - cefdinir 300 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. adults and adolescents community-acquired pneumonia caused by haemophilus influenzae (including β-lactamase producing strains), haemophilus parainfluenzae (including β-lactamase producing strains), streptococcus pneumoniae (penicillin-susceptible strains only), and moraxella catarrhalis (including β-lac