Stany Zjednoczone - angielski - NLM (National Library of Medicine)

prasco laboratories - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 10 mg in 1 g - metronidazole gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. metronidazole gel, 1% is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. risk summary available data have not established an association with metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. no fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. the available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of metronidazole gel, 1%. the 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 2-4% and 15-20%, respectively. risk summary it is not known whether metronidazole is present in human milk after topical administration. published literature reports the presence of metronidazole in human milk after oral administration. there are no data on the effects of metronidazole on milk production. because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with metronidazole gel, 1%. safety and effectiveness of metronidazole gel, 1% have not been established in pediatric patients. sixty-six subjects aged 65 years and older were treated with metronidazole gel, 1% in the clinical study. 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.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

prasco laboratories - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

prasco laboratories - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - augmented betamethasone dipropionate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. augmented betamethasone dipropionate ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on augmented betamethasone dipropionate ointment use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that augmented betamethasone dipropionate ointment may increase the risk of having a low birthweight infant and to use augmented betamethasone dipropionate ointment on the smallest

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

prasco laboratories - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 225 mg - propafenone hydrochloride extended-release (sr) capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (af) in patients with episodic (most likely paroxysmal or persistent) af who do not have structural heart disease. usage considerations: propafenone hydrochloride extended-release (sr) capsules are contraindicated in the following circumstances:   risk summary there are no studies of propafenone hydrochloride extended-release (sr) capsules in pregnant women. available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride extended-release (sr) capsules in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. untreated arrhythmias during pregnancy may pose a risk to the pregnant woman and fetus (see clinical considerations). propafenone and its metabolite, 5-oh-propafenone, cross the placenta in humans. in animal studies, propafenone was

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

prasco laboratories - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters 900 mg - omega-3-acid ethyl esters is indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (greater than or equal to 500 mg per dl) hypertriglyceridemia (htg). usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters and should continue this diet during treatment with omega-3-acid ethyl esters. laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. limitations

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

prasco laboratories - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 30 mg - the components in lansoprazole/amoxicillin/clarithromycin are indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence (see clinical studies and dosage and administration) . to reduce the development of drug-resistant bacteria and maintain the effectiveness of lansoprazole/amoxicillin/clarithromycin and other antibacterial drugs, lansoprazole/amoxicillin/clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. lansoprazole/amoxicillin/clarithromycin is contraindicated in p

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

prasco laboratories - desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3), ethinyl estradiol (unii: 423d2t571u) (estradiol - unii:4ti98z838e) - kit - 0.1 mg - cesia® (desogestrel/ethinyl estradiol) tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and implants, depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. oral contraceptives should not be used in women who currently have the following conditions: - thrombophlebitis or thromboembolic disorders - a past history of deep vein thrombophlebitis or thromboembolic disorders - cerebral vascular or coronary artery disease (current or history) - valvular heart disease with thrombogenic complications - severe hypertension - diabetes with vascular involvement - headaches with focal neurological symptoms - major surgery w

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

prasco laboratories - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone 750 mg in 5 ml - atovaquone oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx). atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx. clinical experience with atovaquone oral suspension for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do2 ] ≤45 mm hg). treatment of more severe episodes of pcp with atovaquone oral suspension has not been studied. the efficacy of atovaquone oral suspension in subjects who are failing therapy with tmp-smx has also not been studied. atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or to any component of the

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

prasco laboratories - phenoxybenzamine hydrochloride (unii: x1ieg24ohl) (phenoxybenzamine - unii:0ttz664r7z) - phenoxybenzamine hydrochloride 10 mg - conditions where a fall in blood pressure may be undesirable; hypersensitivity to the drug or any of its components.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

prasco laboratories - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i), tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - dutasteride 0.5 mg - dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer. dutasteride and tamsulosin hydrochloride capsules are contraindicated for use in: pregnancy category x. there are no adequate and well-controlled studies in pregnant women with the fixed-dose formulation of dutasteride and tamsulosin hydrochloride capsules or its individual components. dutasteride dutasteride is contraindicated for use in women of childbearing potential and during pregnancy. dutasteride is a 5-alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (dht), a hormone necessary for normal development of male genitalia. in animal reproduction and developmental toxicity studies, dutasteride inhibited normal development of external genitalia in male fetuses. therefore, dutasteride may