ABD - İngilizce - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. - primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of testosterone topical solution in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. - safety and efficacy of testosterone topical solution in males <18 years old have not been established [see use in specific populations (8.4)]. - testosterone topical solution is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see warnings and precautions(5.1)]. - testosterone topical solution is contraindicated in women who are, or who may become pregnant, or who are breastfeeding. testosterone topical solution may cause fetal harm when administered to a pregnant woman. testosterone topical solution may cause serious adverse reactions in nursing infants. if a pregnant woman is exposed to testosterone topical solution, she should be apprised of the potential hazard to the fetus. [see use in specific populations (8.1, 8.3)]. pregnancy category x [see contraindications (4)] — testosterone topical solution is contraindicated during pregnancy or in women who may become pregnant. testosterone is teratogenic and may cause fetal harm. exposure of a female fetus to androgens may result in varying degrees of virilization. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. although it is not known how much testosterone transfers into human milk, testosterone topical solution is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. testosterone and other androgens may adversely affect lactation. [see contraindications (4)] . safety and efficacy of testosterone topical solution has not been established in males <18 years of age. improper use may result in acceleration of bone age and premature closure of epiphyses. there have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone topical solution to determine whether efficacy in those over 65 years of age differs from younger patients. of the 155 patients enrolled in the pivotal clinical study utilizing testosterone topical solution, 21 were over 65 years of age. additionally, there were insufficient long-term safety data in these patients utilizing testosterone topical solution to assess a potential incremental risk of cardiovascular disease and prostate cancer. no formal studies were conducted involving patients with renal impairment. no formal studies were conducted involving patients with hepatic impairment. safety and efficacy of testosterone topical solution in males with bmi >35 kg/m2 has not been established. testosterone topical solution contains testosterone, a schedule iii controlled substance in the controlled substances act. drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. abuse and misuse of testosterone are seen in male and female adults and adolescents. testosterone, often in combination with other anabolic androgenic steroids (aas), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. there have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. abuse-related adverse reactions serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. the following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. the following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. the following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. behaviors associated with addiction continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: -   taking greater dosages than prescribed -   continued drug use despite medical and social problems due to drug use -   spending significant time to obtain the drug when supplies of the drug are interrupted -   giving a higher priority to drug use than other obligations -   having difficulty in discontinuing the drug despite desires and attempts to do so -   experiencing withdrawal symptoms upon abrupt discontinuation of use physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

ABD - İngilizce - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - bosentan (unii: q326023r30) (bosentan anhydrous - unii:xul93r30k2) - bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): ·         in adults  to improve exercise ability and to decrease clinical worsening. studies establishing effectiveness included predominantly patients with who functional class ii-iv symptoms and etiologies of idiopathic or heritable pah (60%), pah associated with connective tissue diseases (21%), and pah associated with congenital heart disease with left-to-right shunts (18%) [see clinical studies (14.1)] . use of bosentan tablets are contraindicated in females who are or may become pregnant. to prevent pregnancy, females of reproductive potential must use two reliable forms of contraception during treatment and for one month after stopping bosentan tablets [see boxed warning, warnings and precautions (5.2), drug interactions (7.2), use in specific populations (8.1)] . co-administration of cyclosporine a and bosentan resulted in markedly increased plasma concentrations of bosentan. therefore, concomitant

ABD - İngilizce - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg - itraconazole capsules    are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. blastomycosis, pulmonary and extrapulmonary 2. histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non- meningeal histoplasmosis, and 3. aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin b therapy. specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before 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, antiinfective therapy should be adjusted accordingly. itraconazole capsules    are also indicated for the treatment of the following fungal infections in non-immunocompromised patients:  1. onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and 2. onychomycosis of the fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (see clinical pharmacology: special populations, contraindications, warnings, and adverse reactions: post-marketing experience for more information.) description of clinical studies: blastomycosis: analyses were conducted on data from two open-label, non-concurrently controlled studies (n=73 combined) in patients with normal or abnormal immune status. the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. histoplasmosis: analyses were conducted on data from two open-label, non-concurrently controlled studies (n=34 combined) in patients with normal or abnormal immune status (not including hiv-infected patients). the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. histoplasmosis in hiv-infected patients: data from a small number of hiv-infected patients suggested that the response rate of histoplasmosis in hiv-infected patients is similar to that of non-hiv-infected patients. the clinical course of histoplasmosis in hiv-infected patients is more severe and usually requires maintenance therapy to prevent relapse. aspergillosis: analyses were conducted on data from an open-label, “single-patient-use” protocol designed to make itraconazole available in the u.s. for patients who either failed or were intolerant of amphotericin b therapy (n=190). the findings were corroborated by two smaller open-label studies (n=31 combined) in the same patient population. most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin b therapy. onychomycosis of the toenail: analyses were conducted on data from three double-blind, placebo-controlled studies (n=214 total; 110 given itraconazole capsules    in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules   once daily for 12 consecutive weeks. results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative koh plus negative culture, in 54% of patients. thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). the mean time to overall success was approximately 10 months. twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of koh or culture from negative to positive). onychomycosis of the fingernail: analyses were conducted on data from a double-blind, placebo-controlled study (n=73 total; 37 given itraconazole capsules   in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules   b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules   b.i.d. results demonstrated mycologic cure in 61% of patients. fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. the mean time to overall success was approximately 5 months. none of the patients who achieved overall success relapsed. congestive heart failure: itraconazole capsules   should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (chf) or a history of chf. (see boxed warnings, warnings, precautions: drug interactions-calcium channel blockers, adverse reactions: post-marketing experience, and clinical pharmacology: special populations.) drug interactions: coadministration of a number of cyp3a4 substrates are contraindicated with itraconazole. some examples of drugs for which plasma concentrations increase are: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride,naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. in addition, coadministration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and coadministration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of cyp2d6 and in subjects taking strong or moderate cyp2d6 inhibitors. (see precautions: drug interactions section for specific examples.) this increase in drug concentrations caused by coadministration with itraconazole may increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs. for example, increased plasma concentrations of some of these drugs can lead to qt prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes , a potentially fatal arrhythmia. some specific examples are listed in precautions: drug interactions. coadministration with venetoclax is contraindicated in patients with cll/sll during the dose initiation and ramp-up phase of venetoclax due to the potential for an increased risk of tumor lysis syndrome.   itraconazole should not be administered for the treatment of onychomycosis to pregnant patients or to women contemplating pregnancy. itraconazole are contraindicated for patients who have shown hypersensitivity to itraconazole. there is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents. caution should be used when prescribing itraconazole to patients with hypersensitivity to other azoles.

ABD - İngilizce - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - lidocaine ointment usp, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. it is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of lidocaine ointment 5%.

ABD - İngilizce - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for ucb, inc.'s levetiracetam tablets and oral solution. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam.

ABD - İngilizce - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - acetazolamide (unii: o3fx965v0i) (acetazolamide - unii:o3fx965v0i) - for adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angleclosure glaucoma where delay of surgery is desired in order to lower intraocular pressure. acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent. hypersensitivity to acetazolamide or any excipients in the formulation. since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible. acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis. it is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy. long-term administration of acetazolamide extended-release capsules

ABD - İngilizce - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - midodrine hydrochloride (unii: 59jv96ytxv) (midodrine - unii:6ye7pbm15h) - midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (oh). because midodrine hydrochloride tablets  can cause marked elevation of supine blood pressure (bp>200 mmhg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. the indication is based on midodrine’s effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. at present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. after initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptom

ABD - İngilizce - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - hydrochlorothiazide 12.5 mg - hydrochlorothiazide capsules, usp  are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ace inhibitors. usage in pregnancy: the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. dependent edema in pregnancy resulting from restriction of venous return by the exp

ABD - İngilizce - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - nadolol (unii: fen504330v) (nadolol - unii:fen504330v) - angina pectoris nadolol tablets are indicated for the long-term management of patients with angina pectoris. hypertension nadolol tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with nadolol tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see warnings ).

ABD - İngilizce - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 250 mg - symptomatic trichomoniasis. metronidazole tablets usp are indicated for the treatment of t. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). asymptomatic trichomoniasis. metronidazole tablets usp are indicated in the treatment of asymptomatic t. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. treatment of asymptomatic sexual partners. t. vaginalis infection is a venereal disease. therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. the decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. in making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. in any event, the sexual partner should be treated with metronidazole tablets usp in cases of reinfection. amebiasis. metronidazole tablets usp are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. in amebic liver abscess, metronidazole tablet usp therapy does not obviate the need for aspiration or drainage of pus. anaerobic bacterial infections. metronidazole tablets usp are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. indicated surgical procedures should be performed in conjunction with metronidazole tablets usp therapy. in a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets usp. intra-abdominal infections, including peritonitis, intra-abdominal abscess, and liver abscess, caused by bacteroides species including the b. fragilis group (b. fragilis, b. distasonis, b. ovatus, b. thetaiotaomicron, b. vulgatus ), clostridium species, eubacterium species, peptococcus species, and peptostreptococcus species. skin and skin structure infections caused by bacteroides species including the b. fragilis group, clostridium species, peptococcus species, peptostreptococcus species, and fusobacterium species. gynecologic infections, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by bacteroides species including the b. fragilis group, clostridium species, peptococcus species, peptostreptococcus species, and fusobacterium species. bacterial septicemia caused by bacteroides species including the b. fragilis group and clostridium species. bone and joint infections, (as adjunctive therapy), caused by bacteroides species including the b. fragilis group. central nervous system (cns) infections, including meningitis and brain abscess, caused by bacteroides species including the b. fragilis group. lower respiratory tract infections, including pneumonia, empyema, and lung abscess, caused by bacteroides species including the b. fragilis group. endocarditis caused by bacteroides species including the b. fragilis group. to reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets usp and other antibacterial drugs, metronidazole tablets usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. hypersensitivity metronidazole tablets are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. in patients with trichomoniasis, metronidazole tablets are contraindicated during the first trimester of pregnancy (see precautions ). psychotic reaction with disulfiram use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see precautions, drug interactions ). interaction with alcohol use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see precautions, drug interactions ). cockayne syndrome metronidazole tablets are contraindicated in patients with cockayne syndrome. severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with cockayne syndrome (see adverse reactions) .