Filipina - Inggris - FDA (Food And Drug Administration)

eon pharmatek inc.; distributor: eon pharmatek inc. - piperacillin (as sodium) , tazobactam (as sodium) - powder for iv injection - 4 g/500 mg

Amerika Serikat - Inggris - NLM (National Library of Medicine)

mutual pharmaceutical - sotalol (unii: a6d97u294i) (sotalol - unii:a6d97u294i) - tablet - 80 mg - sotalol hydrochloride tablets (af) are indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (afib/afl)] in patients with symptomatic afib/afl who are currently in sinus rhythm. because sotalol hydrochloride tablets (af) can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom afib/afl is highly symptomatic. patients with paroxysmal afib/afl that is easily reversed (by valsalva maneuver, for example) should usually not be given sotalol hydrochloride tablets (af) (see warnings ). in general, antiarrhythmic therapy for afib/afl aims to prolong the time in normal sinus rhythm. recurrence is expected in some patients (see clinical studies ). sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name betapace® (sotalol hydrochloride). betapace® , however, must not be substituted for sotalol hydrochloride tablets (af) because of signifi

Amerika Serikat - Inggris - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - lubiprostone (unii: 7662kg2r6k) (lubiprostone - unii:7662kg2r6k) - lubiprostone 8 ug - amitiza® is indicated for the treatment of chronic idiopathic constipation (cic) in adults. amitiza is indicated for the treatment of opioid-induced constipation (oic) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. limitations of use: effectiveness of amitiza in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see clinical studies (14.2)] amitiza is indicated for the treatment of irritable bowel syndrome with constipation (ibs-c) in women at least 18 years old. amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction [see warnings and precautions (5.5)] . risk summary following oral administration, concentrations of lubiprostone in plasma are below the level of quantitation; however, one of the metabolites, m3, has measurable systemic concentrations [see clinical pharmacology (12.3)] . limited available data with lubiprostone use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. animal reproduction studies did not show an increase in structural malformations. although a dose dependent increase in fetal loss was observed in pregnant guinea pigs that received lubiprostone (doses equivalent to 0.2 to 6 times the maximum recommended human dose (mrhd) based on body surface area (mg/m2 )), these effects were probably secondary to maternal toxicity and occurred after the period of organogenesis (see data) . the 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. data animal data in developmental toxicity studies, pregnant rats and rabbits received oral lubiprostone during organogenesis at doses up to approximately 338 times (rats) and approximately 34 times (rabbits) the maximum recommended human dose (mrhd) based on body surface area (mg/m2 ). maximal animal doses were 2000 mcg/kg/day (rats) and 100 mcg/kg/day (rabbits). in rats, there were increased incidences of early resorptions and soft tissue malformations (situs inversus , cleft palate) at the 2000 mcg/kg/day dose; however, these effects were probably secondary to maternal toxicity. a dose-dependent increase in fetal loss occurred when guinea pigs received lubiprostone after the period of organogenesis, on days 40 to 53 of gestation, at daily oral doses of 1, 10, and 25 mcg/kg/day (approximately 0.2, 2 and 6 times the mrhd based on body surface area (mg/m2 )); however, these effects were probably secondary to maternal toxicity. the potential of lubiprostone to cause fetal loss was also examined in pregnant rhesus monkeys. monkeys received lubiprostone post-organogenesis on gestation days 110 through 130 at daily oral doses of 10 and 30 mcg/kg/day (approximately 3 and 10 times the mrhd based on body surface area (mg/m2 )). fetal loss was noted in one monkey from the 10-mcg/kg dose group, which is within normal historical rates for this species. there was no drug-related adverse effect seen in monkeys. risk summary there are no data available on the presence of lubiprostone in human milk or the effect of lubiprostone on milk production. there are limited data available on the effect of lubiprostone on the breastfed infant. neither lubiprostone nor its active metabolite (m3) were present in the milk of lactating rats. when a drug is not present in animal milk, it is likely that the drug will not be present in human milk. if present, lubiprostone may cause diarrhea in the breastfed infant (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for amitiza and any potential adverse effects on the breastfed infant from amitiza or from the underlying maternal condition. clinical considerations infants of nursing mothers being treated with amitiza should be monitored for diarrhea. safety and effectiveness have not been established in pediatric patients with ibs-c, pediatric functional constipation (pfc), and oic. efficacy was not demonstrated for the treatment of pfc in patients 6 years of age and older in a 12 week, randomized, double-blind, placebo-controlled trial conducted in 606 patients 6 to 17 years with pfc comparing amitiza to placebo. the primary efficacy endpoint was an overall response based on spontaneous bowel movement frequency over the duration of the trial; the treatment difference from placebo was not statistically significant. in this age group, adverse reactions to amitiza were similar to those reported in adults. in a 36-week, long-term safety extension trial after approximately 9 months of treatment with amitiza, a single case of reversible elevation of alt (17-times upper limit of normal [uln]), ast (13-times uln), and ggt (9-times [uln]) was observed in a child with baseline elevated values (less than or equal to 2.5-times uln). juvenile animal toxicity data in a 13-week oral toxicity study in juvenile rats, a significant decrease in total bone mineral density was observed in female pups at 0.5 mg/kg/day; in male pups, a significantly lower cortical thickness at the tibial diaphysis was observed at 0.5 mg/kg. the 0.5 mg/kg/day dose is approximately 101 times the maximum recommended adult dose of 48 mcg/day, based on body surface area (mg/m2 ). chronic idiopathic constipation the efficacy of amitiza 24 mcg twice daily in the elderly (at least 65 years of age) subpopulation with cic was consistent with the efficacy in the overall study population. of the total number of patients treated in the dose-finding, efficacy, and long-term studies of amitiza, 16% were at least 65 years of age, and 4% were at least 75 years of age. elderly patients taking amitiza experienced a lower rate of associated nausea compared to the overall study population taking amitiza (19% vs. 29%, respectively). opioid-induced constipation the safety profile of amitiza in the elderly (at least 65 years of age) subpopulation with oic (9% were at least 65 years of age and 2% were at least 75 years of age) was consistent with the safety profile in the overall study population. clinical studies of amitiza did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. irritable bowel syndrome with constipation the safety profile of amitiza in the elderly (at least 65 years of age) subpopulation with ibs-c (8% were at least 65 years of age and 2% were at least 75 years of age) was consistent with the safety profile in the overall study population. clinical studies of amitiza did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. patients with moderate hepatic impairment (child-pugh class b) and severe hepatic impairment (child-pugh class c) experienced markedly higher systemic exposure of lubiprostone active metabolite m3, when compared to subjects with normal hepatic function [ see clinical pharmacology (12.3)] . clinical safety results demonstrated an increased incidence and severity of adverse events in subjects with greater severity of hepatic impairment. adjust the dosage of amitiza in patients with severe hepatic impairment for all indications. dosage adjustment is also needed for patients with moderate hepatic impairment treated for cic, and oic [ see dosage and administration (2.1)] . no dosing adjustment is required in patients with mild hepatic impairment (child-pugh class a).

Inggris - Inggris - MHRA (Medicines & Healthcare Products Regulatory Agency)

almus pharmaceuticals ltd - sertraline hydrochloride - oral tablet - 100mg

Amerika Serikat - Inggris - NLM (National Library of Medicine)

zydus pharmaceuticals usa 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 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.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - trimethobenzamide hydrochloride (unii: wdq5p1sx7q) (trimethobenzamide - unii:w2x096qy97) - trimethobenzamide hydrochloride 300 mg - trimethobenzamide hydrochloride capsules are indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. limitation of use: trimethobenzamide hydrochloride capsules are not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (cns) effects, and the risk of exacerbation of the underlying disease in pediatric patients with reye’s syndrome or other hepatic impairment. trimethobenzamide hydrochloride capsules are contraindicated in patients with known hypersensitivity to trimethobenzamide [see adverse reactions (6) ]. risk summary the limited available data with trimethobenzamide in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. no adverse developmental effect was observed in animal reproduction studies with administration of trimethobenzamide hydrochloride during organogenesis in pregnant rats at doses 0.16 a

Amerika Serikat - Inggris - NLM (National Library of Medicine)

lannett company, inc. - prednisone (unii: vb0r961hzt) (prednisone - unii:vb0r961hzt) - prednisone 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 hypercalcemia associated with cancer nonsuppurative thyroiditis 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post-traumatic osteoarthritis synovitis of osteoarthritis epicondylitis 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupu

Amerika Serikat - Inggris - NLM (National Library of Medicine)

lannett company, inc. - prednisone (unii: vb0r961hzt) (prednisone - unii:vb0r961hzt) - prednisone 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 hypercalcemia associated with cancer nonsuppurative thyroiditis 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post-traumatic osteoarthritis synovitis of osteoarthritis epicondylitis 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupu

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

takeda pharmaceuticals australia pty ltd - lanadelumab, quantity: 300 mg - injection, solution - excipient ingredients: citric acid monohydrate; water for injections; dibasic sodium phosphate dihydrate; polysorbate 80; histidine; sodium chloride - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (c1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - lubiprostone (unii: 7662kg2r6k) (lubiprostone - unii:7662kg2r6k) - lubiprostone is indicated for the treatment of chronic idiopathic constipation (cic) in adults. lubiprostone is indicated for the treatment of opioid-induced constipation (oic) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. limitations of use: effectiveness of lubiprostone in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see clinical studies (14.2)] lubiprostone is indicated for the treatment of irritable bowel syndrome with constipation (ibs-c) in women at least 18 years old. lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction [see warnings and precautions (5.5)] . risk summary following oral administration, concentrations of lubiprostone in plasma are below the level of quantitation; however, one of the