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

mayne pharma commercial llc - methamphetamine hydrochloride (unii: 997f43z9cv) (methamphetamine - unii:44ral3456c) - methamphetamine hydrochloride 5 mg - methamphetamine hydrochloride tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. in patients known to be hypersensitive to amphetamine, or other components of methamphetamine hydrochloride tablets. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetami

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

mayne pharma inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive age to prevent pregnancy. do not prescribe levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets to women who are known to have the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)]. have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)]. have cerebrovascular disease [see warnings and precautions (5.1)]. have coronary artery disease [see warnings and precautions (5.1)]. have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)]. have inherited or acquired h

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

mayne pharma inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide is contraindicated in patients who have a history of hypersensitivity reaction (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, and stevens-johnson syndrome) to any of its components. temozolomide is also contraindicated in patients who have a history of hypersensitivity to dacarbazine (dtic), since both drugs are metabolized to 5-(3- methyltriazen-1-yl)-imidazole-4-carboxamide (mtic). pregnancy category d. see warnings and precautions section. temozolomide can cause fetal harm when administered to a pregnant woman. five consecutive days of oral temozolo

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

mayne pharma inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - amethiatm lo (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. do not prescribe amethia lo to women who are known to have the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 have deep vein thrombosis or pulmonary embolism, now or in the past have cerebrovascular disease have coronary artery disease have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) have hypercoagulopathies have uncontrolled hypertension have diabetes with vascular disease have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 - smoke, if over age 35 - have deep vein thrombosis or pulmonary embolism, now or in the past - have cerebrovascular disease - have coronary artery disease - have thrombogenic valvular o

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

mayne pharma inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. hydrocodone bitartrate and acetaminophen tablets should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a schedule ii controlled substance. hydrocodone bitartrate and acetaminophen, and other opioids, used in analgesia can be abused and are subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a treatable disease utilizing a mul

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

mayne pharma inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) as monotherapy and as adjunctive therapy to stimulant medications [see clinical studies (14)] . clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. reactions have included generalized rash, urticaria, and angioedema [see adverse reactions (6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including clonidine hydrochloride extended-release tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. risk summary prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled

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

mayne pharma inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil cream is recommended for the topical treatment of multiple actinic or solar keratoses. in the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. safety and efficacy in other indications have not been established. the diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. with isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. the success rate with fluorouracil cream is approximately 93%, based on 113 lesions in 54 patients. eighty-eight lesions treated with the cream produced 7 failures. fluorouracil cream may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. one birth defe

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

mayne pharma inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. adapalene and benzoyl peroxide gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide gel. risk summary available pharmacovigilance data with adapalene and benzoyl peroxide gel use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with the combination gel. adapalene gel, 0.3% available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during or

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

mayne pharma inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - zarah® (drospirenone/ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. do not prescribe zarah to women who are known to have the following: - renal impairment - adrenal insufficiency - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and precautions (5.6)] have diabetes mellitus

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

mayne pharma inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide capsules (enteric coated) are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)] . risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations ]. in animal reproduction studies with pregnant rats and rabbits, administration of