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

burel pharmaceuticals, llc - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - oral olanzapine tablets are indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial [see clinical studies (14.1)] . when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions (5.5)] . monotherapy — oral olanzapine tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patie

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

burel pharmaceuticals, llc - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - butalbital and acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit-forming and potentially abusable. this product is contraindicated under the following conditions: - hypersensitivity or intolerance to any component of this product. - patients with porphyria abuse and dependence: butalbital: barbiturates may be habit-forming: tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. the average daily dose for the barbiturate addict is usually about 1500 mg. as tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. as this occurs, the margin

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

burel pharmaceuticals, llc - triamcinolone acetonide (unii: f446c597ka) (triamcinolone acetonide - unii:f446c597ka) - triamcinolone acetonide dental paste, usp 0.1% is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma. triamcinolone acetonide dental paste is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

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

burel pharmaceuticals, llc - haloperidol (unii: j6292f8l3d) (haloperidol - unii:j6292f8l3d) - haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. haloperidol tablets are indicated for the control of tics and vocal utterances of tourette's disorder in children and adults. haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). haloperidol tablets are also effective 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. haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any caus

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

burel pharmaceuticals, llc - haloperidol (unii: j6292f8l3d) (haloperidol - unii:j6292f8l3d) - haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. haloperidol tablets are indicated for the control of tics and vocal utterances of tourette's disorder in children and adults. haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). haloperidol tablets are also effective 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. haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any caus

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

burel pharmaceuticals, llc - haloperidol (unii: j6292f8l3d) (haloperidol - unii:j6292f8l3d) - haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. haloperidol tablets are indicated for the control of tics and vocal utterances of tourette's disorder in children and adults. haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). haloperidol tablets are also effective 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. haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any caus

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

burel pharmaceuticals, llc - 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 hydrochloride 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.

Philippines - English - FDA (Food And Drug Administration)

ambicare pharmaceuticals inc.; distributor: ambica international corporation - human albumin - solution for intravenous infusion - 20 % (0.2 g/ml)

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

direct rx - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or candida infections. ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. drug interactions coadministration of a number of cyp3a4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with ketoconazole tablets. coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to s

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

burel pharmaceuticals llc - sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o) - a dental caries preventive; for once daily self-applied topical use. it is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4  sodium fluoride 1.1% dental gel in a squeeze-tube is easily applied onto a toothbrush. this prescription dental gel should be used once daily following use of your regular toothpaste unless otherwise instructed by your dental professional. may be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (see warnings for exception.) do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.