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bayshore pharmaceuticals, llc - etodolac (unii: 2m36281008) (etodolac - unii:2m36281008) - carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). etodolac tablets are indicated: - for acute and long-term use in the management of signs and symptoms of the following: osteoarthritis rheumatoid arthritis - osteoarthritis - rheumatoid arthritis - for the management of acute pain etodolac tablets are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac tablets. etodolac tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions and precautions, pre-existing asthma ). - in the setting of coronary artery bypass graft (cabg) surg

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bayshore pharmaceuticals llc - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - methocarbamol tablets usp, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. methocarbamol does not directly relax tense skeletal muscles in man. methocarbamol tablets usp, 500 mg and 750 mg are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

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bayshore pharmaceuticals, llc - diphenoxylate hydrochloride (unii: w24od7yw48) (diphenoxylate - unii:73312p173g), atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in: - pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (cns) depression (see warnings ). - patients with diarrhea associated with pseudomembranous enterocolitis (clostridium difficile ) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (gi) complications, including sepsis (see warnings ). - patients with known hypersensitivity to diphenoxylate or atropine. - patients with obstructive jaundice. diphenoxylate hydrochloride and atropine sulfate tablets are classified as a schedule v controlled substance by federal regulation. diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine. in doses used for the treatment of diarrhea, whether acute or chronic, diphenoxylate has not produced addiction. diphenoxylate hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. at high doses it exhibits codeine-like subjective effects. the dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects. the insolubility of diphenoxylate hydrochloride in commonly available aqueous media precludes intravenous self-administration. a dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets, administered to humans for 40 to 70 days, produced opiate withdrawal symptoms. since addiction to diphenoxylate hydrochloride is possible at high doses, the recommended dosage should not be exceeded.

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bayshore pharmaceuticals llc (nj) - benztropine mesylate (unii: wmj8tl7510) (benztropine - unii:1nhl2j4x8k) - benztropine mesylate 0.5 mg - for use as an adjunct in the therapy of all forms of parkinsonism. useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see precautions ) due to neuroleptic drugs (e.g., phenothiazine's). hypersensitivity to benztropine mesylate tablets. because of its atropine-like side effects, this drug is contraindicated in pediatric patients under three years of age, and should be used with caution in older pediatric patients. because of the atropine-like side effects, benztropine mesylate should be used with caution in pediatric patients over three years of age (see contraindications ).

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bayshore pharmaceuticals llc - pindolol (unii: bj4hf6iu1d) (pindolol - unii:bj4hf6iu1d) - pindolol tablets are indicated in the management of hypertension. it may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic. pindolol tablets are contraindicated in: 1) bronchial asthma; 2) overt cardiac failure; 3) cardiogenic shock; 4) second and third degree heart block; 5) severe bradycardia. (see warnings.)

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bayshore pharmaceuticals llc - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol af are indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (afib/afl)] in patients with symptomatic afib/afl who are currently in sinus rhythm. because sotalol af can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom afib/afl is highly symptomatic. patients with paroxysmal afib whose afib/afl that is easily reversed (by valsalva maneuver, for example) should usually not be given sotalol af (see warnings ). in general, antiarrhythmic therapy for afib/afl aims to prolong the time in normal sinus rhythm. recurrence is expected in some patients (see clinical studies ). sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name betapace® (sotalol hydrochloride) . sotalol hydrochloride tablets, however, must not be substituted for sotalol hydrochloride tablets (af) because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information). sotalol af is contraindicated in patients with sinus bradycardia (<50 bpm during waking hours), sick sinus syndrome or second and third degree av block (unless a functioning pacemaker is present), congenital or acquired long qt syndromes, baseline qt interval >450 msec, cardiogenic shock, uncontrolled heart failure, hypokalemia (<4 meq/l), creatinine clearance <40 ml/min, bronchial asthma and previous evidence of hypersensitivity to sotalol. the safety and effectiveness of sotalol af in children have not been established. however, the class iii electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (qtc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old. (see clinical pharmacology .)

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bayshore pharmaceuticals llc - metolazone (unii: tz7v40x7vx) (metolazone - unii:tz7v40x7vx) - metolazone tablets, usp, are indicated for the treatment of salt and water retention including: - edema accompanying congestive heart failure; - edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. metolazone tablets, usp, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. mykrox  tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. a dose titration is necessary if mykrox  tablets are to be substituted for metolazone tablets, usp, in the treatment of hypertension. see package circular for mykrox  tablets. 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 evidence that they are useful in the treatment of developed toxemia.

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bayshore pharmaceuticals, llc - primaquine phosphate (unii: h0982hf78b) (primaquine - unii:mvr3634gx1) - primaquine 15 mg - primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria. severe glucose-6-phosphate dehydrogenase (g6pd) deficiency (see warnings). pregnant women (see warnings, usage in pregnancy). primaquine phosphate is contraindicated in acutely ill patients suffering from systemic disease manifested by tendency to granulocytopenia, such as rheumatoid arthritis and lupus erythematosus. the drug is also contraindicated in patients receiving concurrently other potentially hemolytic drugs or depressants of myeloid elements of the bone marrow. because quinacrine hydrochloride appears to potentiate the toxicity of antimalarial compounds which are structurally related to primaquine, the use of quinacrine in patients receiving primaquine is contraindicated. similarly, primaquine should not be administered to patients who have received quinacrine recently, as toxicity is increased.

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bayshore pharmaceuticals llc - methscopolamine bromide (unii: rtn51lk7wl) (methscopolamine - unii:vdr09vtq8u) - methscopolamine bromide 2.5 mg - adjunctive therapy for the treatment of peptic ulcer. methscopolamine bromide has not been shown to be effective in contributing to the healing of peptic ulcer, decreasing the rate of recurrence or preventing complications. glaucoma; obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (e.g., pyloroduodenal stenosis); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. methscopolamine bromide tablets, usp 2.5 mg and 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. not applicable.

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bayshore pharmaceuticals llc - cyproheptadine hydrochloride (unii: nj82j0f8qc) (cyproheptadine - unii:2yhb6175do) - perennial and seasonal allergic rhinitis vasomotor rhinitis allergic conjunctivitis due to inhalant allergens and foods mild, uncomplicated allergic skin manifestations of urticaria and angioedema. amelioration of allergic reactions to blood or plasma cold urticaria dermatographism as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. this drug should not be used in newborn or premature infants. because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. hypersensitivity to cyproheptadine and other drugs of similar chemical structure. monoamine oxidase inhibitor therapy (see drug interactions .) angle-closure glaucoma stenosing peptic ulcer symptomatic prostatic hypertrophy bladder neck obstruction pyloroduodenal obstruction elderly, debilitated patients