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

amneal pharmaceuticals llc - methylprednisolone sodium succinate (unii: lec9gky20k) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone 40 mg in 1 ml - when oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of methylprednisolone sodium succinate for injection is indicated as follows: allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. dermatologic diseases: bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (stevens-johnson syndrome). endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. gastrointestinal diseases: to tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. hematologic disorders: acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (diamond-blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. miscellaneous: trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. neoplastic diseases: for the palliative management of leukemias and lymphomas. nervous system: acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. ophthalmic diseases: sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. renal diseases: to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. respiratory diseases: berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). for the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus. methylprednisolone sodium succinate is contraindicated: - in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. the methylprednisolone sodium succinate, 40 mg presentation includes lactose monohydrate produced from cow’s milk. this presentation is therefore contraindicated in patients with a known or suspected hypersensitivity to cow’s milk or its components or other dairy products because it may contain trace amounts of milk ingredients. - for intrathecal administration. reports of severe medical events have been associated with this route of administration. intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. after mixing as directed, methylprednisolone contains benzyl alcohol. the use of methylprednisolone, reconstituted with benzyl alcohol, is contraindicated for use in premature infants (see warnings and precautions, pediatric use ).

Ireland - English - HPRA (Health Products Regulatory Authority)

beacon pharmaceuticals ltd - methylprednisolone sodium succinate - pdr+solv for soln for inf/inj - 1000 milligram - glucocorticoids

Malta - English - Medicines Authority

g. r. lane health products limited - peppermint oil; cajuput oil; eucalyptus oil; clove oil; methyl salicylate; juniper berry oil; levomenthol - inhalation vapour, liquid - peppermint oil 35.45 % (w/w); cajuput oil 18.5 % (w/w); eucalyptus oil 35.45 % (w/w); clove oil 0.1 % (w/w); methyl salicylate 3.7 % (w/w); juniper berry oil 2.7 % (w/w); levomenthol 4.1 % (w/w) - cough and cold preparations

Kenya - English - Pharmacy and Poisons Board

the mentholatum co. ltd. the mentholatum co. ltd. 1 redwood avenue peel - methyl salicylate menthol camphor - ointment - methyl salicylate 0.33%w/w menthol 1.35%w/w… - other topical products for joint and muscular pain

Philippines - English - FDA (Food And Drug Administration)

philusa corporation - methyl salicylate , camphor , menthol , eucalyptol - liniment - per 100ml contains: methyl salicylate 19g; camphor 7g; menthol 6g; eucalyptol 1g

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

u-cap jempol tropiks sdn. bhd. - methyl salicylate; camphor; oleoresin capsicum; clove oil; turpentine oil; peppermint oil -

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: n/a; distributor: n/a - peppermint oil , methyl salicylate , camphor - ointment - formulation: each 100 g contains: peppermint oil 10.5 g methyl salicylate 1 g camphor 0.5 g

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: n/a; distributor: n/a - peppermint oil , methyl salicylate , camphor - ointment stick - formulation: each 100 g contains: peppermint oil 10.5 g methyl salicylate 1 g camphor 0.5 g

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

new hope au pty ltd - peppermint oil, quantity: 1000 mg/g (equivalent: menthol, qty 10 mg/g) - essential oil - excipient ingredients: - traditionally used in aromatherapy to maintain/support general health and wellbeing ; traditionally used in western herbal medicine to maintain/support healthy appetite ; traditionally used in western herbal medicine to aid/assist expulsion of intestinal gas ; traditionally used in western herbal medicine to decrease/reduce/relieve flatulence/carminative ; traditionally used in western herbal medicine to maintain/support healthy digestion ; traditionally used in western herbal medicine to decrease/reduce/relieve abdominal pain/discomfort ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of indigestion/dyspepsia ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of nervous indigestion (linked indication:relieve digestive discomfort); traditionally used in aromatherapy to decrease/reduce/relieve muscle pain/ache/soreness ; traditionally used in aromatherapy to helps decrease/reduce/relieve symptoms of mild tension headache ; traditionally used in aromatherapy to decrease/reduce/relieve mild nerve pain/neuralgia ; traditionally used in aromatherapy to decrease/reduce/relieve symptoms of common colds and flu ; traditionally used in aromatherapy to decrease/reduce/relieve mild upper respiratory tract congestion ; traditionally used in aromatherapy to loosen respiratory tract mucous ; traditionally used in aromatherapy to decrease/reduce/relieve cough ; traditionally used in aromatherapy to antipruritic/relieves itchy skin

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

neos therapeutics brands, llc - methylphenidate (unii: 207zz9qz49) (methylphenidate - unii:207zz9qz49) - methylphenidate 8.6 mg - cotempla xr-odt is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in pediatric patients 6 to 17 years of age [see clinical studies (14)]. cotempla xr-odt is contraindicated in patients with: - known hypersensitivity to methylphenidate or other components of cotempla xr-odt. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products [see adverse reactions (6.2)] . - concomitant treatment with monoamine oxidase inhibitors (maois), and also within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor because of the risk of hypertensive crisis [see drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to cotempla xr-odt 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 are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes [see data] . there are risks to the fetus associated with the use of central nervous system (cns) stimulants during pregnancy [see clinical considerations]. no teratogenic effects were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses 4 and 18 times, respectively, the maximum recommended human dose (mrhd) of 51.8 mg (as base). however, spina bifida was observed in rabbits at a dose 60 times the mrhd [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 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions cns stimulants, such as cotempla xr-odt, 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 human data a limited number of pregnancies have been reported in published observational studies and postmarketing reports describing methylphenidate use during pregnancy. due to the small number of methylphenidate-exposed pregnancies with known outcomes, these data cannot definitely establish or exclude any drug-associated risk during pregnancy. methodological limitations of these observational studies include small sample size, concomitant use of other medications, lack of detail regarding dose and duration of exposure to methylphenidate and non-generalizability of the enrolled populations. animal data in 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. teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 60 times the maximum recommended human dose (mrhd) of 51.8 mg (as base) for adolescents on a mg/m 2 basis. the no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (18 times the mrhd for adolescent on a mg/m 2 basis). there was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (11 times the mrhd on a mg/m 2 basis for adolescent), 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/m 2 basis for adolescent). risk summary limited published literature, based on breast milk sampling from five 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 cotempla xr-odt and any potential adverse effects on the breastfed child from cotempla xr-odt 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 cotempla xr-odt have been established in pediatric patients 6 to 17 years of age in one adequate and well-controlled study in pediatric patients 6 to 12 years, pharmacokinetic data in adolescents, and safety information from other methyphenidate-containing products [see clinical pharmacology (12) and clinical studies (14)] . the safety and effectiveness of cotempla xr-odt in pediatric patients below 6 years of age have not been established. the long-term efficacy of methylphenidate in pediatric patients has not been establisted. long term suppression growth growth should be monitored during treatment with stimulants, including cotempla xr-odt. children who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.7)] . juvenile animal toxicity data rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. a deficit in acquisition of a specific learning task was observed in females only. the doses at which these findings were observed are at least 6 times the maximum recommended human dose (mrhd) of 51.8 mg (as base) for pediatric patients on a mg/m 2 basis. in the 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 6 times the mrhd of 51.8 mg (as base) on a mg/m 2 basis] or greater, and a deficit in the acquisition of a specific learning task was observed in females exposed to the highest dose (12 times the mrhd on a mg/m 2 basis). the no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the mrhd on a mg/m 2 basis). the clinical significance of the long-term behavioral effects observed in rats is unknown. cotempla xr-odt has not been studied in patients over the age of 65 years. cotempla xr-odt contains methylphenidate, a schedule ii controlled substance. cotempla xr-odt 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)] . cotempla xr-odt can be diverted for non-medical 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 health care 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 cotempla xr-odt, can result in overdose and death [see overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. physical dependence cotempla xr-odt 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 cotempla xr-odt include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance cotempla xr-odt 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).