САЩ - английски - NLM (National Library of Medicine)

glenmark pharmaceuticals inc.,usa - phendimetrazine tartrate (unii: 6985ip0t80) (phendimetrazine - unii:ab2794w8kv) - phendimetrazine tartrate tablets, usp is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (bmi) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient’s weight in kilograms (kg), divided by the patient’s height, in meters (m), squared. metric conversions are as follow: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. body mass index (bmi), kg/m2 height (feet, inches)   phendimetrazine tartrate is indicated for the use as monotherapy only. known hypersensitivity or idiosyncratic reactions to sympathomimetics. advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism, and glaucoma. highly nervous or agitated patients. patients with a history o

САЩ - английски - NLM (National Library of Medicine)

glenmark pharmaceuticals inc. usa - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). risk summary available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity. administration of eszopiclone to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; the lowest dose wa

САЩ - английски - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate emulsion foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. risk summary there are no available data on clobetasol propionate emulsion foam use in pregnant women to inform of a drug associated risk for adverse developmental outcomes. published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women of the potential risk to a fetus and to use clobetasol propionate emulsion foam on the smallest area of skin and for the shortest duration possible (see data ). in animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. no comparison of animal exposure with human exposure was computed. 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 human data multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. however, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants (adjusted rr, 7.74 [95% ci, 1.49 to 40.11]). in addition, a small cohort study, in which 28 sub-saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. the majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month [range, 12 to 170 g]) over long periods of time. animal data embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg. malformations seen included cleft palate and skeletal abnormalities. risk summary there is no information regarding the presence of clobetasol propionate in breast milk or its effects on the breastfed infant or on milk production. systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of clobetasol propionate could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clobetasol propionate emulsion foam and any potential adverse effects on the breastfed infant from clobetasol propionate emulsion foam or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use clobetasol propionate emulsion foam on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply clobetasol propionate emulsion foam directly to the nipple and areola to avoid direct infant exposure. use in pediatric patients younger than 12 years is not recommended because of the risk of hpa axis suppression. after two weeks of twice-daily treatment with clobetasol propionate emulsion foam, 7 of 15 subjects (47%) aged 6 to 11 years demonstrated hpa axis suppression. the laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post-treatment. in 92 subjects aged 12 to 17 years, safety was similar to that observed in the adult population. based on these data, no adjustment of dosage of clobetasol propionate emulsion foam in adolescent patients aged 12 to 17 years is warranted [see warnings and precautions (5.1)]. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing’s syndrome when they are treated with topical corticosteroids. they are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. hpa axis suppression, cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles (in infants), headaches, and bilateral papilledema. administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of children. adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children. a limited number of subjects aged 65 years or older have been treated with clobetasol propionate emulsion foam (n = 58) in u.s. clinical trials. while the number of subjects is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger subjects. based on available data, no adjustment of dosage of clobetasol propionate emulsion foam in geriatric patients is warranted. clobetasol propionate (kloe bay’ ta sol proe’ pee oh nate) foam important information: clobetasol propionate emulsion foam is for use on the skin only. do not get clobetasol propionate emulsion foam in your eyes, mouth, or vagina; if contact happens, rinse well with water. how to apply clobetasol propionate emulsion foam figure a step 1 : before applying clobetasol propionate emulsion foam for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle. (see figure a). figure b step 2 : shake the can of clobetasol propionate emulsion foam before use. (see figure b). figure c step 3 : turn the can of clobetasol propionate emulsion foam upside down and press the nozzle. see figure c. figure d step 4 : press down on the actuator to dispense a small amount of clobetasol propionate emulsion foam into the palm of your hand. (see figure d). figure e step 5 : apply a thin layer of clobetasol propionate emulsion foam to cover the affected area. gently rub the foam into the affected area until the foam disappears. (see figure e). step 6 : wash your hands after applying clobetasol propionate emulsion foam. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: glenmark pharmaceuticals limited aurangabad, maharashtra 431154, india manufactured for: glenmark pharmaceuticals inc., usa mahwah, nj 07430 questions? 1 (888) 721-7115 www.glenmarkpharma-us.com january 2022

САЩ - английски - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topiramate extended-release capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate extended-release capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as topiramate extended-release capsules, during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy.

САЩ - английски - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate gel is indicated in the treatment of acne vulgaris. in view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see contraindications, warnings and adverse reactions). clindamycin phosphate gel is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

САЩ - английски - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride extended-release capsules (twice-a-day dosage) are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensive medications, such as diuretics. diltiazem hydrochloride is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree av block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

САЩ - английски - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - chlorpromazine hydrochloride (unii: 9wp59609j6) (chlorpromazine - unii:u42b7vya4p) - for the management of manifestations of psychotic disorders. for the treatment of schizophrenia. to control nausea and vomiting. for relief of restlessness and apprehension before surgery. for acute intermittent porphyria. as an adjunct in the treatment of tetanus. to control the manifestations of the manic type of manic-depressive illness. for relief of intractable hiccups. for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance. do not use in patients with known hypersensitivity to phenothiazines. do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.).

САЩ - английски - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - theophylline anhydrous (unii: 0i55128jyk) (theophylline anhydrous - unii:0i55128jyk) - theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. theophylline extended-release tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

САЩ - английски - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - bisoprolol fumarate (unii: ur59kn573l) (bisoprolol - unii:y41js2nl6u), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension. bisoprolol fumarate and hydrochlorothiazide tablets are contraindicated in patients in cardiogenic shock, overt cardiac failure (see warnings), second or third degree av block, marked sinus bradycardia, anuria, and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.

САЩ - английски - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - i. stable angina nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. ii. hypertension nicardipine hydrochloride capsules are indicated for the treatment of hypertension. nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. in administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see dosage and administration). nicardipine hydrochloride capsules are contraindicated in patients with hypersensitivity to the drug. because part of the effect of nicardipine hydrochloride capsules are secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.