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blenheim pharmacal, inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 mg - topiramate tablets usp are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies (14.1) ]. topiramate tablets usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies (14.1) ] none. [see warnings and precautions (5.6)] topiramate can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero

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

blenheim pharmacal, inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 10 mg - fluoxetine capsules, usp are indicated for the treatment of: - acute and maintenance treatment of major depressive disorder [see clinical studies (14.1)] . - acute and maintenance treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) [see clinical studies (14.2)] . - acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa [see clinical studies (14.3)] . - acute treatment of panic disorder, with or without agoraphobia [see clinical studies (14.4)] . fluoxetine capsules, usp and olanzapine in combination are indicated for the treatment of: - acute treatment of depressive episodes associated with bipolar i disorder. fluoxetine capsules, usp monotherapy is not indicated for the treatment of depressive episode

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

blenheim pharmacal, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 400 mg - gabapentin capsules, usp are indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin capsules, usp are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy category c : there are no adequate and well-controlled studies in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pregnant mice received oral doses of gabapentin (500 mg, 1000 mg, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no

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

blenheim pharmacal, inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 500 mg - ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by escherichia coli , klebsiella pneumoniae , enterobacter cloacae , serratia marcescens , proteus mirabilis , providencia rettgeri , morganella morganii , citrobacter koseri , citrobacter freundii , pseudomonas aeruginosa , methicillin-susceptible staphylococcus epidermidis , staphylococcus saprophyticus , or enterococcus faecalis . ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by escherichia coli or staphylococcus saprophyticus. ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by escherichia coli or proteus mirabilis. ciprofloxacin tablets are indicated in adult patients for treatment of lower r

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

blenheim pharmacal, inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 250 mg - ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. please see dosage and administration for specific recommendations. urinary tract infections caused by escherichia coli, klebsiella pneumoniae, enterobacter cloacae, serratia marcescens, proteus mirabilis, providencia rettgeri, morganella morganii, citrobacter diversus, citrobacter freundii, pseudomonas aeruginosa, methicillin-susceptible staphylococcus epidermidis, staphylococcus saprophyticus, or enterococcus faecalis. acute uncomplicated cystitis in females caused by escherichia coli or staphylococcus saprophyticus. chronic bacterial prostatitis caused by escherichia coli or proteus mirabilis. lower respiratory tract infections caused by escherichia coli, klebsiella pneumoniae, enterobacter cloacae, proteus mirabilis, pseudomonas aeruginosa, haemophilus influenzae, haemophilus parainfluenzae, or penicillin-suscept

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

blenheim pharmacal, inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 500 mg

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

blenheim pharmacal, inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 10 mg - fluoxetine capsules usp are indicated for the treatment of: - acute and maintenance treatment of major depressive disorder [see clinical studies ( 14.1)] . - acute and maintenance treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) [see clinical studies ( 14.2)]. - acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa [see clinical studies ( 14.3)] . - acute treatment of panic disorder, with or without agoraphobia [see clinical studies ( 14.4)]. fluoxetine capsules usp and olanzapine in combination are indicated for the treatment of: - acute treatment of depressive episodes associated with bipolar i disorder. fluoxetine capsules usp monotherapy is not indicated for the treatment of depressive episodes associated with bipolar i disorder.

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

blenheim pharmacal, inc. - metaxalone (unii: 1nma9j598y) (metaxalone - unii:1nma9j598y) - metaxalone 800 mg - metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. the mode of action of this drug has not been clearly identified, but may be related to its sedative properties. metaxalone does not directly relax tense skeletal muscles in man. known hypersensitivity to any components of this product. known tendency to drug induced, hemolytic, or other anemias. significantly impaired renal or hepatic function.

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

blenheim pharmacal, inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride is indicated for the management of moderate to moderately severe pain in adults. tramadol hydrochloride should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. tramadol hydrochloride is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. tramadol hydrochloride may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride tablets can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. drug addiction is characterized by behaviors that include one or more of the following: impaired control over d

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

blenheim pharmacal, inc. - hydroxyzine hydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - hydroxyzine hydrochloride 25 mg - for symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. as a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. atropine and other belladonna alkaloids are not affected by the drug. hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. the effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. the physician should reassess periodically the usefulness of the drug for the individual patient. hydroxyzine, when administered t