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

avpak - docusate sodium (unii: f05q2t2ja0) (docusate - unii:m7p27195ag) - stool softener - for the relief of occasional constipation. - helps to prevent dry, hard stools. - this product generally produces a bowel movement within 12 to 72 hours. if you notice a sudden change in bowel habits that persists over a period of two weeks. if you have rectal bleeding or you fail to have a bowel movement after use.

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

avpak - midodrine hydrochloride (unii: 59jv96ytxv) (midodrine - unii:6ye7pbm15h) - midodrine hydrochloride is indicated for the treatment of symptomatic orthostatic hypotension (oh). because midodrine hydrochloride can cause marked elevation of supine blood pressure (bp>200 mmhg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. the indication is based on midodrine hydrochloride 's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. at present, however, clinical benefits of midodrine hydrochloride, principally improved ability to perform life activities, have not been established. further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride . after initiation of treatment, midodrine hydrochloride should be continued only for patients who report significant symptomatic improvement. m idodrine hydrochloride is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. m idodrine hydrochloride should not be used in patients with persistent and excessive supine hypertension.

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

avpak - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - malaria hydroxychloroquine sulfate tablets are indicated for the treatment of uncomplicated malaria due to p. falciparum, p. malariae, p. ovale , and p. vivax. hydroxychloroquine sulfate tablets are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. limitations of use in malaria - hydroxychloroquine sulfate tablets are not recommended for the treatment of complicated malaria. - hydroxychloroquine sulfate tablets are not effective against chloroquine or hydroxychloroquine- resistant strains of plasmodium species (see clinical pharmacology – microbiology ). - hydroxychloroquine sulfate tablets are not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the plasmodium species has not been identified. hydroxychloroquine sulfate tablets are not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs. - hydroxychloroquine sulfate tablets does not prevent relapses of p. vivax or p. ovale because it is not active against the hypnozoite forms of these parasites. for radical cure of p. vivax and p. ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see clinical pharmacology – microbiology ). prior to prescribing hydroxychloroquine sulfate tablets for the treatment or prophylaxis of malaria, consult the centers for disease control and prevention (cdc) malaria website   ( http://www.cdc.gov/malaria ).   lupus erythematosus hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults. rheumatoid arthritis hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults. use of hydroxychloroquine sulfate tablets is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.

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

avpak - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole sodium delayed-release tablets, usp are indicated for: pantoprazole is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole is indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. - pantoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. hypersensitivity reactions may includ

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

avpak - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - - ursodiol capsules are indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. safety of use of ursodiol capsules beyond 24 months is not established. - ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. - ursodiol will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. hence, patients with such stones are not candidates for ursodiol therapy. - patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for ursodiol therapy. - allergy to bile acids.

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

avpak - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. - diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder. diclofenac sodium topical gel is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [ see warnings and precautions ( 5.7, 5.9 )] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions ( 5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.

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

avpak - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. venlafaxine hydrochloride extended-release capsules is indicated for the treatment of generalized anxiety disorder (gad). efficacy was established in two 8-week and two 26-week placebo-controlled trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of social anxiety disorder (sad), also known as social phobia. efficacy was established in four 12-week and one 26-week, placebo-controlled trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation the use of maois (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules are contraindicated because of an increased risk of serotonin syndrome. the use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an maoi (intended to treat psychiatric disorders) is also contraindicated [see dosage and administration (2.9), warnings and precautions (5.2), and drug interactions (7.2)]. starting venlafaxine hydrochloride extended-release capsules in a patient who is being treated with an maoi such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome [ see dosage and administration (2.9), warnings and precautions (5.2), and drug interactions (7.3) ]. teratogenic effects – pregnancy category c venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily dose on a mg/m 2 basis. however, in rats, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. the cause of these deaths is not known. these effects occurred at 2.5 times (mg/m 2 ) the maximum human daily dose. the no effect dose for rat pup mortality was 0.25 times the human dose on a mg/m 2 basis. in reproductive developmental studies in rats and rabbits with o-desmethylvenlafaxine (odv), the major human metabolite of venlafaxine, evidence of teratogenicity was not observed at exposure margins of 13 in rats and 0.3 in rabbits. there are no adequate and well-controlled studies in pregnant women. venlafaxine hydrochloride extended-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. non-teratogenic effects neonates exposed to venlafaxine hydrochloride extended-release capsules, other snris, or ssris, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these features are consistent with either a direct toxic effect of ssris and snris, or possibly a drug discontinuation syndrome. it should be noted, that in some cases the clinical picture is consistent with serotonin syndrome [ see warnings and precautions (5.2) and drug interactions (7.3) ]. when treating a pregnant woman with venlafaxine hydrochloride extended-release capsules during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. the effect of venlafaxine on labor and delivery in humans is unknown. venlafaxine and odv have been reported to be excreted in human milk. because of the potential for serious adverse reactions in nursing infants from venlafaxine hydrochloride extended-release capsules a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. two placebo-controlled trials in 766 pediatric patients with mdd and two placebo-controlled trials in 793 pediatric patients with gad have been conducted with venlafaxine hydrochloride extended-release capsules and the data were not sufficient to support a claim for use in pediatric patients. anyone considering the use of venlafaxine hydrochloride extended-release capsules in a child or adolescent must balance the potential risks with the clinical need [ see boxed warning, warnings and precautions ( 5.1, 5.10, 5.11) and adverse reactions (6.4) ]. although no studies have been designed to primarily assess venlafaxine hydrochloride extended-release capsules impact on the growth, development, and maturation of children and adolescents, the studies that have been done suggest that venlafaxine hydrochloride extended-release capsules may adversely affect weight and height (see warnings and precautions (5.10). should the decision be made to treat a pediatric patient with venlafaxine hydrochloride extended-release capsules regular monitoring of weight and height is recommended during treatment, particularly if treatment is to be continued long-term [ see warnings and precautions ( 5.10, 5.11) ]. the safety of venlafaxine hydrochloride extended-release capsules treatment for pediatric patients has not been systematically assessed for chronic treatment longer than six months in duration. in the studies conducted in pediatric patients (ages 6-17), the occurrence of blood pressure and cholesterol increases considered to be clinically relevant in pediatric patients was similar to that observed in adult patients. consequently, the precautions for adults apply to pediatric patients [ see warnings and precautions ( 5.3, 6.3) ]. the percentage of patients in clinical studies for venlafaxine hydrochloride extended-release capsules for mdd,gad,sad, and pd who were 65 years of age or older are shown in table 15. a in addition, in the premarketing assessment of venlafaxine hydrochloride (immediate release), 12% (357/2,897) of patients were ≥ 65 years of age. no overall differences in effectiveness or safety were observed between geriatric patients and younger patients, and other reported clinical experience generally has not identified differences in response between the elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out. ssris and snris, including venlafaxine hydrochloride extended-release capsules have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [ see warnings and precautions (5.9) ]. the pharmacokinetics of venlafaxine and odv are not substantially altered in the elderly [ see clinical pharmacology (12.3) and (see figure 3)]. no dose adjustment is recommended for the elderly on the basis of age alone, although other clinical circumstances, some of which may be more common in the elderly, such as renal or hepatic impairment, may warrant a dose reduction [ see dosage and administration (2.6) ]. a population pharmacokinetic analysis of 404 venlafaxine hydrochloride tablets-treated patients from two studies involving both twice daily and three times daily regimens showed that dose-normalized trough plasma levels of either venlafaxine or odv were unaltered by age or gender differences. dosage adjustment based on the age or gender of a patient is generally not necessary [ see dosage and administration (2.6) ] (see table 15). figure 3: pharmacokinetics of venlafaxine and its metabolite o-desmethylvenlafaxine (odv) in special populations. abbreviations: odv, o-desmethylvenlafaxine; auc, area under the curve; c max , peak plasma concentrations;  *similar effect is expected with strong cyp2d6 inhibitors venlafaxine hydrochloride extended-release capsules is not a controlled substance. while venlafaxine has not been systematically studied in clinical studies for its potential for abuse, there was no indication of drug-seeking behavior in the clinical studies. however, it is not possible to predict on the basis of premarketing experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine (e.g., development of tolerance, incrementation of dose, drug-seeking behavior). in vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (pcp), or n-methyl-d-aspartic acid (nmda) receptors. venlafaxine was not found to have any significant cns stimulant activity in rodents. in primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. discontinuation effects have been reported in patients receiving venlafaxine [ see dosage and administration (2.8) ].

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

avpak - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 15 years of age and older.   tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients  of age and older. because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with   reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients  15 years of age and older. because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with  allergic rhinitis [see warnings and precautions (5.1)],  reserve use for patients who have an inadequate response or intolerance to alternative therapies. • hypersensitivity to any component of this product. risk summary available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see data]. in animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (mrhdod) based on aucs [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly or moderately controlled asthma in pregnancy increases the maternal risk of perinatal adverse outcomes such as preeclampsia and infant prematurity, low birth weight, and small for gestational age. data human data published data from prospective and retrospective cohort studies have not identified an association with montelukast sodium use during pregnancy and major birth defects. available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups. animal data in embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the auc in humans at the mrhdod, respectively). risk summary a published clinical lactation study reports the presence of montelukast in human milk. data available on the effects of the drug on infants, either directly [see use in specific populations (8.4)]  or through breast milk, do not suggest a significant risk of adverse events from exposure to montelukast sodium. the effects of the drug on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for montelukast sodium and any potential adverse effects on the breastfed infant from montelukast sodium or from the underlying maternal condition. the safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established. of the total number of subjects in clinical studies of montelukast, 3.5% were 65 years of age and over, and 0.4% were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetic profile and the oral bioavailability of a single 10 mg oral dose of montelukast are similar in elderly and younger adults. the plasma half-life of montelukast is slightly longer in the elderly. no dosage adjustment in the elderly is required. no dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency [see clinical pharmacology ( 12.3)]. no dosage adjustment is recommended in patients with renal insufficiency [see clinical pharmacology (12.3)].

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

avpak - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence.   triple therapy omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults.   dual therapy omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults.   among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resi

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

avpak - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence.   triple therapy omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults.   dual therapy omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults.   among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resi