European Union - English - EMA (European Medicines Agency)

bene-arzneimittel gmbh - pentosan polysulfate sodium - cystitis, interstitial - urologicals - elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition.,

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

sigmapharm laboratories, llc - acitretin (unii: lch760e9t7) (acitretin - unii:lch760e9t7) - acitretin 10 mg - acitretin capsules, usp are indicated for the treatment of severe psoriasis in adults. because of significant adverse effects associated with its use, acitretin capsules, usp should be prescribed only by those knowledgeable in the systemic use of retinoids. in females of reproductive potential, acitretin capsules, usp should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed contraindications and warnings — acitretin capsules, usp can cause severe birth defects). most patients experience relapse of psoriasis after discontinuing therapy. subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy. pregnancy category x:  ( see boxed contraindications and warnings. ) acitretin is con

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

sigmapharm laboratories, llc - protriptyline hydrochloride (unii: 44665v00o8) (protriptyline - unii:4ndu154t12) - protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. its activating properties make it particularly suitable for withdrawn and anergic patients. protriptyline hydrochloride tablets are contraindicated in patients who have shown prior hypersensitivity to it. it should not be given concomitantly with a monoamine oxidase inhibiting compound. hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. when it is desired to substitute protriptyline for a monoamine oxidase inhibitor, a minimum of 14 days should be allowed to elapse after the latter is discontinued. protriptyline should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. protriptyline is contraindicated in patients taking cisapride because of the possibility of adverse cardiac interaction

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

sigmapharm laboratories, llc - dofetilide (unii: r4z9x1n2nd) (dofetilide - unii:r4z9x1n2nd) - dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [af/afl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. in general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. recurrence is expected in some patients (see clinical studies ). dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation. dofetilide is contraindicated in patients with congenital or acquired long qt syndromes. dof

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

sigmapharm laboratories, llc - flucytosine (unii: d83282dt06) (flucytosine - unii:d83282dt06) - flucytosine capsules, usp are indicated only in the treatment of serious infections caused by susceptible strains of candida and/or cryptococcus . candida: septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. limited trials in pulmonary infections justify the use of flucytosine. cryptococcus: meningitis and pulmonary infections have been treated effectively. studies in septicemias and urinary tract infections are limited, but good responses have been reported. flucytosine capsules, usp should be used in combination with amphotericin b for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to flucytosine capsules, usp (see  microbiology). flucytosine capsules, usp should not be used in patients with a known hypersensitivity to the drug.

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

sigmapharm laboratories, llc - ambrisentan (unii: hw6nv07qec) (ambrisentan - unii:hw6nv07qec) - ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): - to improve exercise ability and delay clinical worsening. - in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening pah, and to improve exercise ability [ see clinical studies (14.2) ]. studies establishing effectiveness included predominantly patients with who functional class ii-iii symptoms and etiologies of idiopathic or heritable pah (60%) or pah associated with connective tissue diseases (34%). ambrisentan may cause fetal harm when administered to a pregnant female. ambrisentan is contraindicated in females who are pregnant. ambrisentan was consistently shown to have teratogenic effects when administered to animals. 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

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

sigmapharm laboratories, llc - griseofulvin (unii: 32hrv3e3d5) (griseofulvin - unii:32hrv3e3d5) - griseofulvin is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: tinea corporis tinea pedis tinea cruris tinea barbae tinea capitis tinea unguium when caused by one or more of the following species of fungi: epidermophyton floccosum microsporum audouinii microsporum canis microsporum gypseum trichophyton crateriform trichophyton gallinae trichophyton interdigitalis trichophyton megnini trichophyton mentagrophytes trichophyton rubrum trichophyton schoenleini trichophyton sulphureum trichophyton tonsurans trichophyton verrucosum note: prior to therapy, a dermatophyte should be identified as responsible for the infection. prior to initiating treatment, appropriate specimens for laboratory testing (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis. griseofulvin is not effective in the following: bacterial infections candidiasis (moniliasis) histoplasmosis actinomycosis spo

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

sigmapharm laboratories, llc - griseofulvin (unii: 32hrv3e3d5) (griseofulvin - unii:32hrv3e3d5) - ultramicrosize griseofulvin tablets, usp are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: trichophyton rubrum, trichophyton tonsurans, trichophyton mentagrophytes, trichophyton interdigitalis, trichophyton verrucosum, trichophyton megnini, trichophyton gallinae, trichophyton crateriform, trichophyton sulphureum, trichophyton schoenleini, microsporum audouini, microsporum canis, microsporum gypseum and epidermophyton floccosum . note: prior to therapy, the type of fungi responsible for the infection should be identified. the use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. griseofulvin is not effective in

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

sigmapharm laboratories, llc - disulfiram (unii: tr3mlj1uai) (disulfiram - unii:tr3mlj1uai) - disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. disulfiram is not a cure for alcoholism. when used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking pattern of the chronic alcoholic. patients who are receiving or have recently received metronidazole, paraldehyde, alcohol, or alcohol-containing preparations, e.g., cough syrups, tonics and the like, should not be given disulfiram. disulfiram is contraindicated in the presence of severe myocardial disease or coronary occlusion, psychoses, and hypersensitivity to disulfiram or to other thiuram derivatives used in pesticides and rubber vulcanization.

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

sigmapharm laboratories, llc - ergocalciferol (unii: vs041h42xc) (ergocalciferol - unii:vs041h42xc) - ergocalciferol 1.25 mg - ergocalciferol capsules, usp, are a synthetic calcium regulator for oral administration. ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. it is affected by air and by light. ergosterol or provitamin d2 is found in plants and yeast and has no antirachitic activity. there are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin d or antirachitic activity. one usp unit of vitamin d2 is equivalent to one international unit (iu), and 1 mcg of vitamin d2 is equal to 40 iu. each capsule contains 1.25 mg (50,000 international units vitamin d) of ergocalciferol, usp, in an edible vegetable oil. ergocalciferol, also called vitamin d2, is 9, 10-secoergosta-5, 7, 10 (19), 22-tetraen-3-ol,(3β,5z,7e,22e)-; (c28h44o) with a molecular weight of 396.65, and has the following structural formula: