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lupin pharmaceuticals,inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg in 5 ml - methylphenidate hydrochloride oral solution is indicated for the treatment of: -   attention deficit hyperactivity disorder (adhd) in adults and pediatric patients 6 years of age and older -   narcolepsy methylphenidate hydrochloride oral solution is contraindicated in patients: - with known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution. 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 methylphenidate hydrochloride oral solution, 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 and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy (see clinical considerations ). no effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 12 and 19 times, respectively, the maximum recommended human dose (mrhd) of 60 mg/day given to adults on a mg/m2 basis. however, spina bifida was observed in rabbits at a dose 65 times the mrhd given to adults. a decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 7 times the mrhd given to adults (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions cns stimulants, such as methylphenidate hydrochloride oral solution, can cause vasoconstriction and thereby decrease placental perfusion. no fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. data animal data in embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 65 times the mrhd of 60 mg/day given to adults on a mg/m2 basis. the no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (19 times the mrhd given to adults on a mg/m2 basis). there was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (12 times the mrhd of 60 mg/day given to adults on a mg/m2 basis), which was also maternally toxic. the no effect level for embryo-fetal development in rats was 25 mg/kg/day (4 times the mrhd on a mg/m2 basis). when methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (7 times the mrhd of 60 mg/day given to adults on a mg/m2 basis), but no other effects on postnatal development were observed. the no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the mrhd given to adults on a mg/m2 basis). risk summary limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight- adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. there are no reports of adverse effects on the breastfed infant and no effects on milk production. long-term neurodevelopmental effects on infants from stimulant exposure are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for methylphenidate hydrochloride oral solution and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride oral solution or from the underlying maternal condition. clinical considerations monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. the safety and effectiveness of methylphenidate hydrochloride oral solution for the treatment of adhd have been established in pediatric patients six years of age and older. the safety and effectiveness of methylphenidate hydrochloride oral solution in pediatric patients under six years of age have not been established. the long-term efficacy of methylphenidate in pediatric patients has not been established. long-term suppression of growth growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride oral solution. pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.6)]. juvenile animal toxicity data in a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10). when these animals were tested as adults (postnatal weeks 13 -14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the mrhd of 60 mg/day given to children on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the mrhd given to children on a mg/m2 basis). the no effect level for juvenile neurobehavioral development in rats (5 mg/kg/day) is less than the mrhd given to children on a mg/m2 basis. the clinical significance of the long-term behavioral effects observed in rats is unknown. methylphenidate hydrochloride oral solution has not been studied in the geriatric population. methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride, a schedule ii controlled substance. methylphenidate hydrochloride oral solution has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1)]. methylphenidate hydrochloride oral solution can be diverted for nonmedical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including methylphenidate hydrochloride oral solution, can result in overdose and death [see overdosage (10)] , and this risk is increased with higher doses and or unapproved methods of administration, such as snorting or injection. physical dependence methylphenidate hydrochloride oral solution may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including methylphenidate hydrochloride oral solution include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance methylphenidate hydrochloride oral solution may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

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amneal pharmaceuticals of new york llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 10 mg - methylphenidate hydrochloride extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in pediatric patients 6 to 15 years of age. methylphenidate hydrochloride extended-release capsules are contraindicated in patients with: - known hypersensitivity to methylphenidate or other component of methylphenidate hydrochloride extended-release capsules. angioedema has been reported in patients treated with methylphenidate hydrochloride extended-release capsules. anaphylactic reactions have been reported in patients treated with other methylphenidate products [see adverse reactions (6)] . - concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crisis [see drug interactions (7)] . - methylphenidate hydrochloride extended-release capsules contain sucrose. therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorpti

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american sales company - eucalyptol, menthol, methyl salicylate, thymol - antigingivitis, antiplaque helps control plaque that leads to gingvitis if you have painful or swollen gums, pus from the fum line, loose teeth or increased spacing between the teeth.  see your dentist immediately.  these may be signs of periodontitis, a serious form of gum disease. gingivitis, bleeding, or redness persists for more than 2 weeks

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stat rx usa llc - methylprednisolone (unii: x4w7zr7023) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone 4 mg - methylprednisolone tablets are indicated in the following conditions: 1.endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2.rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode orexacerbation) in: rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis synovitis of osteoarthritis acute nonspecific tenosynovitis post-traumatic osteoarthritis psoriatic arthritis epicondylitis acute gouty arthritis 3.collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythema

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par pharmaceutical, inc. - methylprednisolone (unii: x4w7zr7023) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone 4 mg - methylprednisolone tablets are indicated in the following conditions: 1. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis synovitis of osteoarthritis acute nonspecific tenosynovitis post-traumatic osteoarthritis psoriatic arthritis epicondylitis acute gouty arthritis 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematos

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greenstone llc - methylprednisolone (unii: x4w7zr7023) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone 4 mg - methylprednisolone tablets are indicated in the following conditions: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis synovitis of osteoarthritis acute nonspecific tenosynovitis post-traumatic osteoarthritis psoriatic arthritis epicondylitis acute gouty arthritis during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus systemic dermatomyositis (polymyositis) acute rheumatic carditis bullous dermatitis herpetiformis severe erythema multiforme (stevens-johnson syndrome) severe seborrheic dermatitis exfoliative dermatitis mycosis fungoides pemphigus severe psoriasis control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis drug hypersensitivity reactions serum sickness contact dermatitis bronchial asthma atopic dermatitis severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic corneal marginal ulcers herpes zoster ophthalmicus anterior segment inflammation diffuse posterior uveitis and choroiditis sympathetic ophthalmia keratitis optic neuritis allergic conjunctivitis chorioretinitis iritis and iridocyclitis symptomatic sarcoidosis berylliosis loeffler's syndrome not manageable by other means fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired (autoimmune) hemolytic anemia erythroblastopenia (rbc anemia) congenital (erythroid) hypoplastic anemia for palliative management of: leukemias and lymphomas in adults acute leukemia of childhood to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. to tide the patient over a critical period of the disease in: ulcerative colitis regional enteritis acute exacerbations of multiple sclerosis tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. trichinosis with neurologic or myocardial involvement. systemic fungal infections and known hypersensitivity to components.

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sandoz inc - methylprednisolone (unii: x4w7zr7023) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone 4 mg - methylprednisolone tablets are indicated in the following conditions: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoids supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis synovitis of osteoarthritis acute nonspecific tenosynovitis post-traumatic osteoarthritis psoriatic arthritis epicondylitis acute gouty arthritis during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus systemic dermatomyositis (polymyositis) acute rheumatic cardit

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actavis pharma, inc. - methylprednisolone (unii: x4w7zr7023) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone 4 mg - methylprednisolone tablets, usp are indicated in the following conditions: - endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer - rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis synovitis of osteoarthritis acute nonspecific tenosynovitis post-traumatic osteoarthritis psoriatic arthritis epicondylitis acute gouty arthritis - collagen diseases during an exacerbation or as maintenance therapy in selected cases o

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

preferred pharmaceuticals, inc. - methylprednisolone (unii: x4w7zr7023) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone 4 mg - methylprednisolone tablets are indicated in the following conditions: systemic fungal infections and known hypersensitivity to components.

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

american health packaging - methylprednisolone (unii: x4w7zr7023) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone 4 mg - methylprednisolone tablets are indicated in the following conditions: - endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer - rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis synovitis of osteoarthritis acute nonspecific tenosynovitis post-traumatic osteoarthritis psoriatic arthritis epicondylitisacute gouty arthritis - collagen diseases during