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

arrotex pharmaceuticals pty ltd - dimethyl fumarate, quantity: 240 mg - capsule, enteric - excipient ingredients: croscarmellose sodium; gelatin; purified talc; magnesium stearate; iron oxide yellow; silicified microcrystalline cellulose; triethyl citrate; titanium dioxide; brilliant blue fcf; methacrylic acid copolymer; colloidal anhydrous silica; iron oxide black; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide - dimethyl fumarate enteric coated capsules are indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

arrotex pharmaceuticals pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, enteric - excipient ingredients: croscarmellose sodium; gelatin; purified talc; magnesium stearate; iron oxide yellow; silicified microcrystalline cellulose; triethyl citrate; titanium dioxide; brilliant blue fcf; methacrylic acid copolymer; colloidal anhydrous silica; iron oxide black; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide - dimethyl fumarate enteric coated capsules are indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

shionogi inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg in 5 ml - methylin is indicated for the treatment of: - attention deficit hyperactivity disorder (adhd) in adults and pediatric patients 6 years of age and older - narcolepsy methylin is contraindicated in patients: - with known hypersensitivity to methylphenidate or other components of methylin. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6)] . - receiving concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylin, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychostimulants at 1-866-961-2388. risk summary published studies

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

general injectables & vaccines, inc - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - methylene blue 10 mg in 1 ml - drug induced methemoglobinemia. methylene blue can cause fetal harm when administered to a pregnant woman. an association exists between the use of methylene blue in amniocentesis and atresia of the ileum and jejunum, ileal occlusions and other adverse effects in the neonate. (2, 3) methylene blue is contraindicated in women who are or may become pregnant. 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 the fetus. intraspinal and subcutaneous injections are contraindicated. methylene blue is contraindicated in patients with a known hypersensitivity to the drug.

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

physicians total care, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 18 mg - methylphenidate hcl extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see clinical studies (14)] . 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 effort; loses things; e

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

trigen laboratories, llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 54 mg - methylphenidate hydrochloride extended-release tablets usp is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see clinical studies (14)] . 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 effort; lo

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

mylan pharmaceuticals inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 18 mg - methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see  clinical studies (14)] . 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 effort; lose

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

lannett company, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 18 mg - methylphenidate hcl extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see clinical studies (14)] . 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 effort; loses things; e

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

mayne pharma - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 20 mg - methylphenidate hydrochloride extended-release capsules (la) are indicated for the treatment of attention deficit hyperactivity disorder (adhd). the efficacy of methylphenidate hydrochloride extended-release capsules (la) in the treatment of adhd was established in 1 controlled trial of children aged 6 to 12 who met dsm-iv criteria for adhd (see clinical pharmacology). 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 2 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 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor

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

teva pharmaceuticals usa, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 20 mg - methylphenidate hydrochloride extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd), in pediatric patients 6 to 12 years of age [see clinical studies (14)] . - hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [ s ee adverse reactions (6.1)]. - concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [ see drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride extended-release capsules during pregnancy. healthcare providers are encouraged to register patients by calling the national pregna