Australia - English - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - oxycodone hydrochloride, quantity: 5 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium starch glycollate type a; silicon dioxide; lactose monohydrate; maize starch; stearic acid - mayne pharma oxycodone ir is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Australia - English - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - itraconazole, quantity: 50 mg - capsule - excipient ingredients: silicon dioxide; magnesium stearate; sodium starch glycollate type a; hypromellose phthalate; gelatin; brilliant blue fcf; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - superficial mycoses: lozanoc is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and pityriasis versicolor. systemic mycoses: lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see pharmacology).

Australia - English - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - itraconazole, quantity: 50 mg - capsule - excipient ingredients: sodium starch glycollate type a; titanium dioxide; brilliant blue fcf; hypromellose phthalate; silicon dioxide; magnesium stearate; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - superficial mycoses: lozanoc is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and pityriasis versicolor. systemic mycoses: lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see pharmacology).

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets, usp is indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets usp in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. the efficacy of venlafaxine tablets usp in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see clinical trials). nevertheless, the physician who elects to use venlafaxine tablets, usp / venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation. the use of maois intended to treat psychiatric disorders with venlafaxine hydrochloride or within 7 days of stopping treatment with venlafaxine hydrochloride is contraindicated because of an increased risk of serotonin syndrome. the use of venlafaxine hydrochloride within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration). starting venlafaxine hydrochloride 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 warnings and dosage and administration). venlafaxine hydrochloride is not a controlled substance. in vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (pcp), or n-methyl-d-aspartic acid (nmda) receptors. venlafaxine was not found to have any significant cns stimulant activity in rodents. in primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. discontinuation effects have been reported in patients receiving venlafaxine (see dosage and administration ). while venlafaxine hydrochloride has not been systematically studied in clinical trials for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. however, it is not possible to predict on the basis of premarketing experience the extent to which a cns active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine hydrochloride (e.g., development of tolerance, incrementation of dose, drug- seeking behavior).

Australia - English - Department of Health (Therapeutic Goods Administration)

noumed pharmaceuticals pty ltd - ibuprofen, quantity: 20 mg/ml - oral liquid, suspension - excipient ingredients: saccharin sodium; purified water; sodium benzoate; sodium citrate dihydrate; sodium propyl hydroxybenzoate; maltitol solution; polysorbate 80; xanthan gum; sodium methyl hydroxybenzoate; citric acid monohydrate; flavour; microcrystalline cellulose; carmellose sodium - pharmacy choice ibuprofen children's suspension may be used for the temporary relief of pain and discomfort resulting from headaches, teething, earache and muscle sprains. pharmacy choice ibuprofen children's suspension reduces fever and relieves the discomfort of cold and flu symptoms. pharmacy choice ibuprofen children's suspension may be used to reduce fever after childhood vaccinations.

Australia - English - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - erythromycin, quantity: 250 mg - capsule, enteric - excipient ingredients: povidone; monobasic potassium phosphate; lactose monohydrate; gelatin; carbon black; sunset yellow fcf; shellac; indigo carmine; purified water; cellacefate; erythrosine; diethyl phthalate - mayne pharma erythromycin is indicated in children and adults for the treatment of the following conditions: upper respiratory tract infections of mild to moderate degree caused by streptococcus pyogenes (group a beta haemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae). lower respiratory tract infections of mild to moderate severity caused by streptococcus pyogenes (group a beta hemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae), acute and chronic bronchitis, pneumonia. sinusitis caused by streptococcus pneumoniae, streptococcus pyogenes. otitis media due to streptococcus pneumoniae, streptococcus pyogenes. respiratory tract infections due to mycoplasma pneumonia (eaton's agent). skin, and skin structure infections of mild to moderate severity caused by streptococcus pyogenes and staphylococcus aureus (resistant staphylococci may emerge during treatment). bordetella pertussis: erythromycin produces early elimination of the causative organism from the nasopharynx although the clinical course of the disease is not altered; therapeutic doses should be continued for at least 10 days. diphtheria: as an adjunct to antitoxin infections due to corynebacterium diphtheriae, to prevent establishment of carriers and to eradicate the organism in carriers. erythrasma: in the treatment of infections due to corynebacterium minutissimum. infections due to listera monocytogenes. non-gonococcal urethritis: chlamydia trachomatis and ureaplasma urealyticum have been shown to be sensitive to erythromycin and clinical studies have demonstrated its efficacy in urethritis due to these organisms. a minimum of 10 days therapy appears to be required. chlamydia trachomatis infection (excluding non-gonococcal urethritis): erythromycin has been shown to be effective in the treatment of trachoma or inclusion-body conjunctivitis and pneumonia in infants caused by chlamydia trachomatis. campylobacter fetus (subspecies) jejuni: infections due to this organism when antibiotic therapy is indicated. primary syphilis caused by treponema pallidum: erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. in the treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the followup after therapy. legionnaires' disease caused by legionella pneumophila: although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating legionnaires' disease. prevention of initial attacks of rheumatic fever: penicillin is considered by the american heart association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of group a beta - haemolytic streptococcal infections of the upper respiratory tract e.g. tonsillitis or pharyngitis). erythromycin is indicated for the treatment of penicillin allergic patients. a therapeutic dose should be administered for 10 days. prevention of recurrent attacks of rheumatic fever: penicillin or sulphonamides are considered by the american heart association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. in patients who are allergic to penicillin and sulphonamides, oral erythromycin is recommended by the american heart association in the long term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever). prevention of bacterial endocarditis: although no controlled clinical efficacy trials have been conducted, oral erythromycin has been suggested by the american heart association and the american dental association in a regimen for prophylaxis against bacterial endocarditis in patients sensitive to penicillin who have congenital heart disease, or rheumatic or other acquired valvular heart disease when they undergo dental or surgical procedures of the upper respiratory tract. erythromycin is not suitable prior to genitourinary or gastrointestinal tract surgery.

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals 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 tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1,5.2, 5.3)]. 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-modafinil) and armodafinil (the r-enantiomer of modafinil). although the pharmacology of modafinil is not identical to that of the sympathomimetic amines, it does share some pharmacologic properties with this class. certain of these drugs have been associated with intrauterine growth restriction and spontaneous abortions. whether the cases reported with modafinil are drug-related is unknown. in studies of modafinil and armodafinil conducted in rats (modafinil, armodafinil) and rabbits (modafinil), developmental toxicity was observed at clinically relevant plasma exposures. modafinil tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. modafinil (50, 100, or 200 mg/kg/day) administered orally to pregnant rats throughout organogenesis caused, in the absence of maternal toxicity, an increase in resorptions and an increased incidence of visceral and skeletal variations in the offspring at the highest dose tested. the higher no-effect dose for embryofetal developmental toxicity in rats (100 mg/kg/day) was associated with a plasma modafinil auc less than that in humans at the recommended human dose (rhd) of modafinil tablets (200 mg/day). however, in a subsequent study of up to 480 mg/kg/day of modafinil, no adverse effects on embryofetal development were observed. oral administration of armodafinil (60, 200, or 600 mg/kg/day) to pregnant rats throughout organogenesis resulted in increased incidences of fetal visceral and skeletal variations and decreased fetal body weight at the highest dose tested. the highest no-effect dose for embryofetal developmental toxicity in rats (200 mg/kg/day) was associated with a plasma armodafinil auc less than that in humans at the rhd of modafinil tablets. modafinil administered orally to pregnant rabbits throughout organogenesis at doses of up to 100 mg/kg/day had no effect on embryofetal development; however, the doses used were too low to adequately assess the effects of modafinil on embryofetal development. in a subsequent developmental toxicity study evaluating doses of 45, 90, and 180 mg/kg/day in pregnant rabbits, the incidences of fetal structural alterations and embryofetal death were increased at the highest dose. the highest no-effect dose for developmental toxicity (100 mg/kg/day) was associated with a plasma modafinil auc similar to that in humans at the rhd of modafinil tablets. modafinil administration to rats throughout gestation and lactation at oral doses of up to 200 mg/kg/day resulted in decreased viability in the offspring at doses greater than 20 mg/kg/day, a dose resulting in a plasma modafinil auc less than that in humans at the rhd of modafinil tablets. no effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring. it is not known whether modafinil or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when modafinil tablets are administered to a nursing woman. safety and effectiveness in pediatric patients have not been established. modafinil tablets are not approved in this population for any indication. serious skin rashes, including erythema multiforme major (emm) and stevens - johnson syndrome (sjs) have been associated with modafinil use in pediatric patients [see warnings and precautions (5.1)]. in a controlled 6-week study, 165 pediatric patients (aged 5-17 years) with narcolepsy were treated with modafinil (n=123), or placebo (n=42). there were no statistically significant differences favoring modafinil over placebo in prolonging sleep latency as measured by mslt, or in perceptions of sleepiness as determined by the clinical global impression-clinician scale (cgi-c). in the controlled and open-label clinical studies, treatment emergent adverse reactions of the psychiatric and nervous system included tourette’s syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations, and suicidal ideation. transient leukopenia, which resolved without medical intervention, was also observed. in the controlled clinical study, 3 of 38 girls, ages 12 or older, treated with modafinil experienced dysmenorrhea compared to 0 of 10 girls who received placebo. there were three 7 to 9 week, double-blind, placebo-controlled, parallel group studies in children and adolescents (aged 6-17 years) with attention-deficit hyperactivity disorder (adhd). two of the studies were flexible-dose studies (up to 425 mg/day), and the third was a fixed-dose study (340 mg/day for patients <30 kg and 425 mg/day for patients ≥30 kg). although these studies showed statistically significant differences favoring modafinil over placebo in reducing adhd symptoms as measured by the adhd-rs (school version), there were 3 cases of serious rash including one case of possible sjs among 933 patients exposed to modafinil in this program. modafinil is not approved for use in treating adhd. in clinical trials, experience in a limited number of modafinil-treated patients who were greater than 65 years of age showed an incidence of adverse reactions similar to other age groups. in elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. therefore, consideration should be given to the use of lower doses and close monitoring in this population [see dosage and administration (2.4) and clinical pharmacology (12.3)]. in patients with severe hepatic impairment, the dose of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function [see dosage and administration (2.3) and clinical pharmacology (12.3)]. modafinil tablets contains modafinil, a schedule iv controlled substance. in humans, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other cns stimulants. in in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. in some studies, modafinil was also partially discriminated as stimulant-like. physicians should follow patients closely, especially those with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) abuse. patients should be observed for signs of misuse or abuse (e.g., incrementation of doses or drug-seeking behavior). the abuse potential of modafinil (200, 400, and 800 mg) was assessed relative to methylphenidate (45 and 90 mg) in an inpatient study in individuals experienced with drugs of abuse. results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled cns stimulants (methylphenidate). in one placebo-controlled clinical trial, the effects of modafinil withdrawal were monitored following 9 weeks of modafinil use. there were no reported withdrawal symptoms with modafinil during 14 days of observation, although sleepiness returned in narcoleptic patients.

New Zealand - English - Medsafe (Medicines Safety Authority)

arrotex pharmaceuticals (nz) limited - atomoxetine hydrochloride 11.43mg equivalent to atomoxetine 10mg - capsule - 10 mg - active: atomoxetine hydrochloride 11.43mg equivalent to atomoxetine 10mg excipient: colloidal silicon dioxide croscarmellose sodium gelatin   magnesium stearate opacode black s-1-277002 starch titanium dioxide   - treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

New Zealand - English - Medsafe (Medicines Safety Authority)

arrotex pharmaceuticals (nz) limited - atomoxetine hydrochloride 114.3mg equivalent to atomoxetine 100mg - capsule - 100 mg - active: atomoxetine hydrochloride 114.3mg equivalent to atomoxetine 100mg excipient: colloidal silicon dioxide croscarmellose sodium gelatin   iron oxide black   iron oxide red   iron oxide yellow   magnesium stearate opacode black s-1-277002 starch titanium dioxide   - treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

New Zealand - English - Medsafe (Medicines Safety Authority)

arrotex pharmaceuticals (nz) limited - atomoxetine hydrochloride 20.574mg equivalent to atomoxetine 18mg - capsule - 18 mg - active: atomoxetine hydrochloride 20.574mg equivalent to atomoxetine 18mg excipient: colloidal silicon dioxide croscarmellose sodium gelatin   iron oxide yellow magnesium stearate opacode black s-1-277002 starch titanium dioxide   - treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.