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concordia pharmaceuticals inc. - zonisamide (unii: 459384h98v) (zonisamide - unii:459384h98v) - zonisamide 25 mg - zonegran is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. zonegran is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide. the abuse and dependence potential of zonegran has not been evaluated in human studies (see warnings, cognitive/neuropsychiatric adverse events subsection). in a series of animal studies, zonisamide did not demonstrate abuse liability and dependence potential. monkeys did not self-administer zonisamide in a standard reinforcing paradigm. rats exposed to zonisamide did not exhibit signs of physical dependence of the cns-depressant type. rats did not generalize the effects of diazepam to zonisamide in a standard discrimination paradigm after training, suggesting that zonisamide does not have abuse potential of the benzodiazepine-cns depressant type.

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concordia pharmaceuticals inc. - tranylcypromine sulfate (unii: 7zat6es870) (tranylcypromine - unii:3e3v44j4z9) - tranylcypromine 10 mg - parnate is indicated for the treatment of major depressive disorder (mdd) in adult patients who have not responded adequately to other antidepressants. parnate is not indicated for the initial treatment of mdd due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions [see contraindications (4), warnings and precautions (5), and drug interactions (7)] . concomitant use of parnate or use in rapid succession with the products in table 1 is contraindicated. such use may cause severe or life-threatening reactions such as hypertensive crises or serotonin syndrome [see drug interactions (7.1)]. medication-free periods between administration of parnate and contraindicated agents are recommended [ see dosage and administration (2.2) and drug interactions (7.1) ]. table 1: products contraindicated with the use of parnate - other monoamine oxidase inhibitors (maois) - selective serotonin reuptake inhibitors (ssris) and serotonin and norepinephrine reuptake inh

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

concordia pharmaceuticals inc. - alitretinoin (unii: 1ua8e65kdz) (alitretinoin - unii:1ua8e65kdz) - panretin® gel is indicated for topical treatment of cutaneous lesions in patients with aids-related kaposi’s sarcoma. panretin® gel is not indicated when systemic anti-ks therapy is required (e.g., more than 10 new ks lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary ks, or symptomatic visceral involvement). there is no experience to date using panretin® gel with systemic anti-ks treatment. panretin® gel is contraindicated in patients with a known hypersensitivity to retinoids or to any of the ingredients of the product.

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

concordia pharmaceuticals inc. - phenobarbital (unii: yqe403bp4d) (phenobarbital - unii:yqe403bp4d), hyoscyamine sulfate (unii: f2r8v82b84) (hyoscyamine - unii:px44xo846x), atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i), scopolamine hydrobromide (unii: 451ifr0gxb) (scopolamine - unii:dl48g20x8x) - phenobarbital 16.2 mg in 5 ml - - glaucoma; - obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); - obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); - paralytic ileus, intestinal atony of the elderly or debilitated patient; - unstable cardiovascular status in acute hemorrhage; - severe ulcerative colitis especially if complicated by toxic megacolon; - myasthenia gravis; - hiatal hernia associated with reflux esophagitis; - in patients with known hypersensitivity to any of the ingredients. phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement. phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs (see warnings ). in patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

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

concordia pharmaceuticals inc. - pilocarpine hydrochloride (unii: 0ww6d218xj) (pilocarpine - unii:01mi4q9di3) - salagen® tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with sjogren's syndrome. salagen® tablets are contraindicated in patients with uncontrolled asthma, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.

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

concordia pharmaceuticals inc. - phenobarbital (unii: yqe403bp4d) (phenobarbital - unii:yqe403bp4d), hyoscyamine sulfate (unii: f2r8v82b84) (hyoscyamine - unii:px44xo846x), atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i), scopolamine hydrobromide (unii: 451ifr0gxb) (scopolamine - unii:dl48g20x8x) - phenobarbital 16.2 mg - - glaucoma; - obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); - obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); - paralytic ileus, intestinal atony of the elderly or debilitated patient; - unstable cardiovascular status in acute hemorrhage; - severe ulcerative colitis especially if complicated by toxic megacolon; - myasthenia gravis; - hiatal hernia associated with reflux esophagitis; - in patients with known hypersensitivity to any of the ingredients. phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement. phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs (see warnings ). in patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

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

concordia pharmaceuticals inc. - nilutamide (unii: 51g6i8b902) (nilutamide - unii:51g6i8b902) - nilutamide 150 mg - nilandron tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (stage d2 ). for maximum benefit, nilandron treatment must begin on the same day as or on the day after surgical castration. nilandron tablets are contraindicated: - in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment) - in patients with severe respiratory insufficiency - in patients with hypersensitivity to nilutamide or any component of this preparation.

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

concordia pharmaceuticals inc. - triamterene (unii: ws821z52lq) (triamterene - unii:ws821z52lq) - triamterene 50 mg - dyrenium (triamterene) is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism. dyrenium may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. it also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism. 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 (however, see preca

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

concordia pharmaceuticals inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - kapvay® (clonidine hydrochloride) extended-release is indicated for the treatment of attention deficit hyperactivity disorder (adhd) as monotherapy and as adjunctive therapy to stimulant medications [see clinical studies (14)] . kapvay is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. reactions have included generalized rash, urticaria, and angioedema [see adverse reactions (6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including kapvay, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. risk summary prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not iden

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

concordia pharmaceuticals inc. - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 0.125 mg - lanoxin is indicated for the treatment of mild to moderate heart failure in adults. lanoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, lanoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. lanoxin increases myocardial contractility in pediatric patients with heart failure. lanoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. lanoxin is contraindicated in patients with: - ventricular fibrillation [see warnings and precautions (5.1)] - known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). a hypersensitivity reaction to other digitalis preparations usually constitutes a co