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glenmark pharmaceuticals inc., usa - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - adults esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed ee in adults. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of esomeprazole magnesium delayed-release capsules may be considered. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of ee in pediatric patients 12 years to 17 years of age. esomeprazole magnesium delayed-release capsules delayed-release capsules are indicated for the maintenance of healing of ee in adults. controlled studies do not extend beyond 6 months. adults esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with gerd in adults. pediatric patients 12 years to 17 years of age esomeprazole magnes

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glenmark pharmaceuticals inc., usa - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. fingolimod capsules are contraindicated in patients who have: risk summary based on findings from animal studies, fingolimod may cause fetal harm when administered to a pregnant woman. data from prospective reports to the fingolimod pregnancy registry are currently not sufficient to allow for an adequate assessment of the drug-associated risk for birth defects and miscarriage in humans. in oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. in rats, the highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m2 ) basis. the most common fetal visceral malformations in rats were pe

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glenmark pharmaceuticals inc., usa - sodium phenylbutyrate (unii: nt6k61736t) (phenylbutyric acid - unii:7wy7ybi87e) - sodium phenylbutyrate tablets are indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (cps), ornithine transcarbamylase (otc), or argininosuccinic acid synthetase (as). it is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). it is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. it is important that the diagnosis be made early and treatment initiated immediately to improve survival. any episode of acute hyperammonemia should be treated as a life-threatening emergency. sodium phenylbutyrate tablets must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation (see nutritional supplementation subsection of the dosage and administration section). previously, neonatal-onset disease was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or their nitrogen-free analogs. however, with hemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate, and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in newborns diagnosed after birth but within the first month of life is almost 80%. most deaths have occurred during an episode of acute hyperammonemic encephalopathy. patients with neonatal-onset disease have a high incidence of mental retardation. those who had iq tests administered had an incidence of mental retardation as follows: ornithine transcarbamylase deficiency, 100% (14/14 patients tested); argininosuccinic acid synthetase deficiency, 88% (15/17 patients tested); and carbamylphosphate synthetase deficiency, 57% (4/7 patients tested). retardation was severe in the majority of the retarded patients. in patients diagnosed during gestation and treated prior to any episode of hyperammonemic encephalopathy, survival is 100%, but even in these patients, most subsequently demonstrate cognitive impairment or other neurologic deficits. in late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recover from hyperammonemic encephalopathy and are then treated chronically with sodium phenylbutyrate and dietary protein restriction, the survival rate is 98%. the two deaths in this group of patients occurred during episodes of hyperammonemic encephalopathy. however, compliance with the therapeutic regimen has not been adequately documented to allow evaluation of the potential for sodium phenylbutyrate tablets and dietary protein restriction to prevent mental deterioration and recurrence of hyperammonemic encephalopathy if carefully adhered to. the majority of these patients tested (30/46 or 65%) have iq’s in the average to low average/borderline mentally retarded range. reversal of preexisting neurologic impairment is not likely to occur with treatment and neurologic deterioration may continue in some patients. even on therapy, acute hyperammonemic encephalopathy recurred in the majority of patients for whom the drug is indicated. sodium phenylbutyrate tablets may be required lifelong unless orthotopic liver transplantation is elected. (see clinical pharmacology, pharmacodynamics subsection for the biochemical effects of sodium phenylbutyrate tablets). sodium phenylbutyrate tablets should not be used to manage acute hyperammonemia, which is a medical emergency.

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glenmark pharmaceuticals inc., usa - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 300 mg - lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of bipolar disorder. bipolar disorder, manic (dsm-iv) is equivalent to manic depressive illness, manic, in the older dsm-ii terminology. lithium carbonate extended-release tablets are also indicated as a maintenance treatment for individuals with a diagnosis of bipolar disorder. maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. when given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.

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glenmark pharmaceuticals inc., usa - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - healing of erosive esophagitis esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered. maintenance of healing of erosive esophagitis esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. controlled studies do not extend beyond 6 months. symptomatic gastroesophageal reflux disease esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with gerd in adults and children 1 year or older. esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous nsaid therapy

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glenmark pharmaceuticals inc., usa - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (bsa) in patients 18 years of age or older. patients should be instructed to use clobetasol propionate spray, 0.05% for the minimum amount of time necessary to achieve the desired results [see dosage and administration (2) ]. use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of hpa axis suppression were seen with other clobetasol propionate topical formulations formulations [see use in specific populations (8.4)]. clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin. clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis. none. risk summary there are no available data on clobetasol propionate spray use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topical corticosteroids (see data ). advise pregnant women that clobetasol propionate spray may increase the risk of having a low birth weight infant and to use clobetasol propionate spray on the smallest area of skin and for the shortest duration possible. animal reproduction studies have not been conducted with clobetasol propionate spray. in an animal reproduction study, subcutaneous administration of clobetasol propionate to pregnant rats at doses greater than 12.5 mcg/kg/day during the period of organogenesis caused an increase in malformations (increased incidence of umbilical hernia) (see data ). the available data do not allow calculation of relevant comparisons between the systemic exposure of clobetasol propionate in animal studies to the systemic exposure that would be expected in humans after topical use of clobetasol propionate spray. 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. however, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. animal data clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it caused malformations in both the rabbit and the mouse. clobetasol propionate has greater potential for adverse developmental effects than steroids that are less potent. the effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 mcg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. the maternal no-observed-adverse-effect-level (noael) for clobetasol propionate was less than 12.5 mcg/kg/day due to reduced body weight gain and feed consumption during the gestation period. the reproductive noael in the dams was 25 mcg/kg/day based on prolonged delivery at 50 mcg/kg/day. the noael for viability and growth in the offspring was 12.5 mcg/kg/day based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. the weights of the epididymides and testes were significantly reduced at higher dosages. despite these changes, there were no effects on the mating and fertility of the offspring. risk summary there is no information regarding the presence of clobetasol propionate in human milk or its effects on the breastfed infant or on milk production. 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 spray and any potential adverse effects on the breastfed infant from clobetasol propionate spray or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use clobetasol propionate spray on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply clobetasol propionate spray directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4) ]. use in patients under 18 years of age is not recommended, because safety has not been established and because numerically high rates of hpa axis suppression were seen with other clobetasol propionate topical formulations. safety and effectiveness in pediatric patients treated with clobetasol propionate spray, 0.05% have not been established [see warnings and precautions (5.1) ]. because of 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 glucocorticosteroid insufficiency during and/or after withdrawal of treatment. adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. 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 absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. clinical studies of clobetasol propionate spray, 0.05% did not include sufficient numbers of patients aged 65 and over to adequately determine whether they respond differently than younger patients. in two randomized, vehicle controlled clinical trials, 21 of the 240 patients (9%) were over the age of 65. in general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. clobetasol propionate (kloh-bay-tuh-sall proh-pee-uh-nate) spray important: for use on skin only. do not get clobetasol propionate spray near or in your eyes, mouth or vagina. read the instructions for use that comes with clobetasol propionate spray before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking with your doctor about your medical condition or your treatment. parts of clobetasol propionate spray (see figure a). when you receive clobetasol propionate spray the directional spray nozzle is in the “locked” position with the nozzle pointing downwards (see figure b). how to apply clobetasol propionate spray: step 1: to unlock the directional spray nozzle, hold the clobetasol propionate spray bottle and sides of the pump top with one hand. use your other hand to turn the directional spray nozzle to either the right or the left (see figure c). the spray will come out through the opening at the end of the directional spray nozzle. step 2: to apply clobetasol propionate spray, point the directional spray nozzle to the affected area. to spray, push down on the pump top. apply clobetasol propionate spray to the affected area as instructed by your doctor (see figure d) . step 3: spray only enough clobetasol propionate spray to cover the affected area, for example, the elbow (see figure e). rub in clobetasol propionate spray gently and completely. step 4: after applying clobetasol propionate spray, return the directional spray nozzle to the “locked” position (see figure g). step 5: wash your hands after applying clobetasol propionate spray. this patient information and instructions for use have been approved by the u.s. food and drug administration. manufactured by: glenmark pharmaceuticals limited baddi, himachal pradesh 173205, india manufactured for: glenmark pharmaceuticals inc., usa mahwah, nj 07430 questions? 1 (888) 721-7115 www.glenmarkpharma-us.com september 2020

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glenmark pharmaceuticals inc., usa - trandolapril (unii: 1t0n3g9crc) (trandolaprilat - unii:rr6866vl0o), verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - trandolapril 4 mg - trandolapril and verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension. this fixed combination drug is not indicated for the initial therapy of hypertension (see dosage and administration ). in using trandolapril and verapamil hydrochloride extended-release tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have similar risk (see warnings - neutropenia/agranulocytosis ). trandolapril and verapamil hydrochloride extended-release tablets are contraindicated in patients who are hypersensitive to any ace inhibitor or verapamil. because of the verapamil component, trandolapril and verapamil hydrochloride extended-release tablets are contraindicated in: because of the trandolapril component, trandolapril and verapamil hydrochloride extended-release tablets are contraindicated in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme (ace) inhibitor. do not co-administer aliskiren with trandolapril and verapamil hydrochloride extended-release tablets in patients with diabetes (see precautions - drug interactions ). trandolapril and verapamil hydrochloride extended-release tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer trandolapril and verapamil hydrochloride extended-release tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see warnings ).

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glenmark pharmaceuticals inc., usa - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.4 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. % of women experiencing an accidental pregnancy in the first year of continuous use method lowest expected* typical** (no contraception) (85) (85) oral contraceptives combined 0.1 3*** progestin only 0.5 3*** diaphragm with spermicidal cream or jelly 6 18 spermicides alone (foam, creams, jellies and vaginal suppositories) 3 21 vaginal sponge nulliparous 6 18 multiparous 9 28 iud 0.8-2.0 3# condom without spermicides 2 12 periodic abstinence (all methods) 1-9 20 injectable progestogen 0.3-0.4 0.3-0.4 implants 6 capsules 0.04 0.04 2 rods 0.03 0.03 female sterilization 0.2 0.4 male sterilization 0.1 0.15 reproduced with permission of the population counsil from j. trusell, et. al: contraceptive failure in the united states: an update. studies in family planning, 21(1), january-february 1990. * the authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any reason other than pregnancy. ** this term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any reason other than pregnancy. *** combined typical rate for both combined and progestin only. # combined typical rate for both medicated and nonmedicated iud. briellyn is contraindicated in females who are known to have or develop the following conditions:

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glenmark pharmaceuticals inc., usa - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 90 ug - levonorgestrel and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective for pregnancy prevention. table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and implants, depend upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year3 method (1) typical use1  (2) perfect use2  (3) (4) chance4 85 85 spermicides5 26 6 40 periodic abstinence 25 63    calendar 9    ovulation method 3    sympto-thermal6 2    post-ovulation 1 cap7    parous women 40 26 42    nulliparous women 20 9 56 sponge    parous women 40 20 42    nulliparous women 20 9 56 diaphragm7 20 6 56 withdrawal 19 4 condom8    female (realitytm ) 21 5 56    male 14 3 61 pill 5 71    progestin only 0.5    combined 0.1 iud    progesterone t 2 1.5 81    copper t380a 0.8 0.6 78    lng 20 0.1 0.1 81 depo-provera® 0.3 0.3 70 levonorgestrel implants (norplant®) 0.05 0.05 88 female sterilization 0.5 0.5 100 male sterilization 0.15 0.10 100 emergency contraceptive pills: the fda has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 lactation amenorrhea method: lam is a highly effective, temporary method of contraception.10 source: trussell j. contraceptive efficacy. in: hatcher ra, trussell j, stewart f, cates w, stewart gk, kowel d, guest f. contraceptive technology: seventeenth revised edition. new york ny: irvington publishers; 1998. the efficacy and safety of levonorgestrel and ethinyl estradiol were studied in 2 one-year clinical trials of subjects age 18 to 49. there were no exclusions for body mass index (bmi), weight, or bleeding history. the primary efficacy and safety study (313-na) was a one-year open-label clinical trial that treated 2,134 subjects in north america. of these subjects 1,213 (56.8%) discontinued prematurely, including 102 (4.8%) discontinued by the sponsor for early study closure. the mean weight of subjects in this study was 70.38 kg. the efficacy of levonorgestrel and ethinyl estradiol was assessed by the number of pregnancies that occurred after the onset of treatment and within 14 days of the last dose. among subjects 35 years or less, there were 23 pregnancies (4 of these occurred during the interval 1 to 14 days after the last day of pill use) during 12,572 28-day pill packs of use. the resulting total pearl index was 2.38 (95% ci: 1.51, 3.57) and the one-year life table pregnancy rate was 2.39 (95% ci: 1.57, 3.62). pill pack cycles during which subjects used back-up contraception or were not sexually active were not included in these calculations. among women 35 years or less who took the pills completely as directed, there were 15 pregnancies (method failures) resulting in a pearl index of 1.55 (95% ci: 0.87, 2.56) and the one-year life table pregnancy rate was 1.59 (95% ci: 0.95 to 2.67). in a second supportive study conducted in europe (315-eu), 641 subjects were randomized to levonorgestrel and ethinyl estradiol (n=323) or the cyclic comparator of 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol (n=318). the mean weight of subjects in this study was 63.86 kg. the efficacy analysis among women 35 years or less included 2,756 levonorgestrel and ethinyl estradiol pill packs and 2,886 cyclic comparator pill packs. there was one pregnancy in the levonorgestrel and ethinyl estradiol group that occurred within 14 days following the last dose. there were three pregnancies in the cyclic comparator group. the bleeding profile for subjects in study 313-na also was assessed. women with a history of unscheduled bleeding and/or spotting were not excluded from the study. in those subjects who provided complete bleeding data, the percentage of patients who were amenorrheic in a given cycle and remained amenorrheic through cycle 13 (cumulative amenorrhea rate) was determined (figure 2). figure 2: percentage of subjects with cumulative amenorrhea for each pill pack through pill pack 13 when prescribing levonorgestrel and ethinyl estradiol, the convenience of having no scheduled menstrual bleeding should be weighed against the inconvenience of unscheduled bleeding and spotting (see warnings, 11 ). levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions : thrombophlebitis or thromboembolic disorders history of deep-vein thrombophlebitis or thromboembolic disorders cerebrovascular or coronary artery disease (current or past history) valvular heart disease with thrombogenic complications thrombogenic rhythm disorders hereditary or acquired thrombophilias major surgery with prolonged immobilization diabetes with vascular involvement headaches with focal neurological symptoms such as aura uncontrolled hypertension current diagnosis of, or history of, breast cancer, which may be hormone-sensitive carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia undiagnosed abnormal genital bleeding cholestatic jaundice of pregnancy or jaundice with prior pill use hepatic adenomas or carcinomas, or active liver disease known or suspected pregnancy hypersensitivity to any of the components of levonorgestrel and ethinyl estradiol. are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations (see warnings, risk of liver enzyme elevations with concomitant hepatitis c treatment) .

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glenmark pharmaceuticals inc., usa - fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy) - fluconazole 50 mg - fluconazole tablets are indicated for the treatment of: prophylaxis: fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. fluconazole tablets are contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. there is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles. coadministration of other drugs known to prol