Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

keltman pharmaceuticals inc. - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine hydrochloride 4 mg - tizanidine hydrochloride is a short-acting drug for the management of spasticity. because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see dosage and administration). concomitant use of tizanidine with fluvoxamine or with ciprofloxacin, potent inhibitors of cyp1a2, is contraindicated. significant alterations of pharmacokinetic parameters of tizanidine including increased auc, t1/2 , cmax , increased oral bioavailability and decreased plasma clearance have been observed with concomitant administration of either fluvoxamine or ciprofloxacin. this pharmacokinetic interaction can result in potentially serious adverse events (see warnings and clinical pharmacology: drug interactions). tizanidine tablets are contraindicated in patients with known hypersensitivity to tizanidine or its ingredients. abuse potential was not evaluated in human studies. rats were able to distinguish tizanidine from saline in

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - desvenlafaxine succinate (unii: zb22enf0xr) (desvenlafaxine - unii:ng99554anw) - desvenlafaxine 50 mg - desvenlafaxine extended-release tablets are indicated for the treatment of adults with major depressive disorder (mdd) [see clinical studies (14) ] . there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185. there are no published studies on desvenlafaxine extended-release tablets in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes (see data) . there are risks associated with untreated depression in pregnancy and with exposure to snris and ssris, including desvenlafaxine extended-release tablets, during pregnancy (see clinical considerations). in reproductive developmental studies in rats and rabbits treated with desvenlafaxine succinate, there was no evidence of

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 75 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)]. pregnancy category c risk summary data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. no clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately equal to the maxim

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

kremers urban pharmaceuticals inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 10 mg - methylphenidate hcl extended-release capsules cd is contraindicated in patients with marked anxiety, tension and agitation, since the drug may aggravate these symptoms. methylphenidate hcl extended-release capsules cd is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product. methylphenidate hcl extended-release capsules cd contains sucrose. therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. methylphenidate hcl extended-release capsules cd is contraindicated in patients with glaucoma. methylphenidate hcl extended-release capsules cd is contraindicated in patients with motor tics or with a family history or diagnosis of tourette's syndrome (see adverse reactions). methylphenidate hcl extended-release capsules cd is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discon

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 30 mg - duloxetine is indicated for the treatment of: monoamine oxidase inhibitors (maois) -the use of maois intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)] . starting duloxetine 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 (2.9) and warnings and precautions (5.4)]. pregnancy category c risk summary — there are no adequate and well-controlled studies of duloxetine administration in pregnant women. in animal studies with duloxetine, fetal weights were decreased but there was no evidence of teratogenicity in pregnant rats and rabbits at oral do

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 20 mg - duloxetine delayed-release capsules are indicated for the treatment of: monoamine oxidase inhibitors (maois) the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)]. starting duloxetine delayed-release capsules 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 (2.9) and warnings and precautions (5.4)] . pregnancy category c   risk summary there are no adequate and well-controlled studies of duloxetine administration in pregnant women. in animal studie

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

keltman pharmaceuticals inc. - metaxalone (unii: 1nma9j598y) (metaxalone - unii:1nma9j598y) - metaxalone 800 mg - metaxalone tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. the mode of action of this drug has not been clearly identified, but may be related to its sedative properties. metaxalone does not directly relax tense skeletal muscles in man. known hypersensitivity to any components of this product. known tendency to drug induced, hemolytic or other anemias. significantly impaired renal or hepatic function. deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants and have been reported with this class of drug in combination with alcohol. when determining the ld50 in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased. in dogs, no ld50 could be determined as the higher doses produced an emetic action in 15 to 30 minutes. treatment gastric lavage and supportive therapy.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

altura pharmaceuticals, inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg - carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see dosage and administration (2) ]. carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reactions to a carbamate such as meprobamate there are no data on the use of carisoprodol tablets during human pregnancy. animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. the primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increase

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

keltman pharmaceuticals inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital 50 mg - butalbital, acetaminophen, and caffeine 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,

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

keltman pharmaceuticals inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tramadol hydrochloride 37.5 mg - tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, are indicated for the short-term (five days or less) management of acute pain. tramadol hydrochloride and acetaminophen tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, any other component of this product or opioids. tramadol hydrochloride and acetaminophen tablets are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. tramadol hydrochloride and acetaminophen tablets may worsen central nervous system and respiratory depression in these patients. tramadol may induce psychic and physical dependence of the morphine-type (µ-opioid). (see warnings. ) dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with a prior history of opioid