Verenigde Staten - Engels - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - oral contraceptives 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 i lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization and the iud, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. table i: percentage of women experiencing an unintended pregnancy during the first year of use of a contraceptive method na - not available levonorgestrel and ethinyl estradiol tablet is contraindicated in females who are known to have or develop the following conditions: thrombophlebitis or thromboembolic disorders a past history of deep-vein-thrombophlebitis or thromboembolic disorders. cerebral-vascular or coronary-artery disease. current diagnosis or history of breast cancer, which may be hormone sensitive. undiagnosed abnormal genital bleeding. cholestatic jaundice of pregnancy or jaundice with prior pill use. hepatic adenomas and carcinomas. known or suspected pregnancy. women who are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (alt) elevations (see warnings, risk of liver enzyme elevations with concomitant hepatitis c treatment ).

Verenigde Staten - Engels - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets, usp in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology —clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets, usp in hospitalized depressed patients have not been adequately studie

Verenigde Staten - Engels - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. the clinical trials performed in support of efficacy were up to 3 months in duration. doxepin tablets are contraindicated in individuals who have shown hypersensitivity to doxepin hcl, any of its inactive ingredients, or other dibenzoxepines. serious side effects and even death have been reported following the concomitant use of certain drugs with mao inhibitors. do not administer doxepin tablets if patient is currently on maois or has used maois within the past two weeks. the exact length of time may vary depending on the particular maoi dosage and duration of treatment. doxepin tablets are contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention. available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see data) . there are risks of poor neonatal adaptation with

Verenigde Staten - Engels - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine tablets, usp and other treatment options before deciding to use ketorolac tromethamine tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. acute pain in adult patients ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with ketorolac tromethamine-iv or im and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine-iv/im and ketorolac tromethamine tablets is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administra

Verenigde Staten - Engels - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other albuterol sulfate inhalation aerosol components. instructions for use albuterol sulfate (al-byoo-ter-ole) inhalation aerosol with dose indicator read this instructions for use before you start using albuterol sulfate inhalation aerosol and eachtime you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or treatment. your doctor should show you how your child should use albuterol sulfate inhalation aerosol. important information: albuterol sulfate inhalation aerosol comes as a canister with a dose indicator. the dose indicator is located on the top of the canister that fits into an actuator (see error! hyperlink reference not valid. ). the dose indicator display window will show you how many puffs of medicine you have left. a puff of medicine is released each time you press the center of the dose indicator. figure a before you use albuterol sulfate inhalation aerosol for the first time make sure that the pointer on the dose indicator is pointing to the right of the “200” inhalation mark in the dose indicator display window (see error! hyperlink reference not valid.) . each canister of albuterol sulfate inhalation aerosol contains 200 puffs of medicine. this does not include the sprays of medicine used for priming your inhaler. figure b before using your albuterol sulfate inhalation aerosol for the first time, you should prime your inhaler. if you do not use your albuterol sulfate inhalation aerosol for more than 2 weeks , you should re-prime it before use. using your albuterol sulfate inhalation aerosol inhaler: step 1: shake the inhaler well before each use. remove the cap from the mouthpiece ( see error! hyperlink reference not valid. ). check inside the mouthpiece for objects before use. make sure the canister is fully inserted into the actuator. figure c step 2: breathe out as fully as you comfortably can through your mouth. hold the inhaler in the upright position with the mouthpiece pointing towards you and place the mouthpiece fully into the mouth ( see error! hyperlink reference not valid. ). close your lips around the mouthpiece. figure d step 3: while breathing in deeply and slowly, press down on the center of the dose indicator with your index finger until the canister stops moving in the actuator and a puff of medicine has been released ( see error! hyperlink reference not valid. ). then stop pressing the dose indicator. step 4: hold your breath as long as you comfortably can, up to 10 seconds. remove the inhaler from your mouth, and then breathe out. step 5: if your doctor has prescribed additional puffs of albuterol sulfate inhalation aerosol , wait 1 minute then shake the inhaler well. repeat steps 3 through 5 in the section “ error! hyperlink reference not valid.”. step 6: replace the cap right away after use. cleaning your albuterol sulfate inhalation aerosol inhaler: it is very important that you keep the mouthpiece clean so that medicine will not build up and block the spray through the mouthpiece. clean the mouthpiece 1 time each week or if your mouthpiece becomes blocked ( see error! hyperlink reference not valid. ). step 1: remove the canister from the actuator and take the cap off the mouthpiece. do not clean the metal canister or let it get wet. step 2: wash the mouthpiece through the top and bottom with warm running water for 30 seconds ( see error! hyperlink reference not valid. ). figure e step 3 : shake off as much water from the mouthpiece as you can. step 4: look in the mouthpiece to make sure any medicine buildup has been completely washed away. if the mouthpiece is blocked with buildup, little to no medicine will come out of the mouthpiece ( see error! hyperlink reference not valid. ). if there is any buildup, repeat steps 2 through 4 in the section “ error! hyperlink reference not valid.”. figure f step 5: let the mouthpiece air-dry such as overnight ( figure g ). do not put the canister back into the actuator if it is still we figure g step 6: when the mouthpiece is dry, put the canister back in the actuator and put the cap on the mouthpiece. note: if you need to use your albuterol sulfate inhalation aerosol inhaler before it is completely dry, put the canister back in the actuator and shake the inhaler well. press down on the center of the dose indicator 2 times to release a total of 2 sprays into the air, away from your face. take your dose as prescribed then clean and air-dry your inhaler as described in the section “ error! hyperlink reference not valid.”. how should i store albuterol sulfate inhalation aerosol? developed and manufactured by:  kindeva drug delivery l.p. northridge, ca 91324, usa distributed by: sandoz inc. princeton, nj 08540 copyright © 1996, 2011, 2012, 2017, 2018, 2020all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised: 12/2020          34-8726-6023-7 relabeled by: preferred pharmaceuticals inc.

Verenigde Staten - Engels - NLM (National Library of Medicine)

yiling pharmaceutical, inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine is indicated in adults for the treatment of: - major depressive disorder (mdd) - obsessive compulsive disorder (ocd) - panic disorder (pd) - social anxiety disorder (sad) - generalized anxiety disorder (gad) - posttraumatic stress disorder (ptsd) paroxetine is contraindicated in patients: - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7)] . - taking thioridazine because of risk of qt prolongation [see warnings and precautions (5.3) and drug interactions (7)] - taking pimozide because of risk of qt prolongation [see warnings and precautions (5.3), drug interactions (7)] . - with known hypersensitivity (e.g., anaphylaxis, angioedema, stevens-johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine tablets [see adverse reactions (6.1), (6.2)] . risk summary based on data from published observational studies, exposure to ssris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions (5.5) and clinical considerations] . epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations. if paroxetine is used during pregnancy, or if the patient becomes pregnant while taking paroxetine, advise the patient of the potential hazard to the fetus. clinical considerations unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing paroxetine therapy or switching to another antidepressant [see warnings and precautions (5.7)] . for - a study based on swedish national registry data demonstrated that infants exposed to paroxetine during pregnancy (n = 815) had an increased risk of cardiovascular malformations (2% risk in paroxetine-exposed infants) compared to the entire registry population (1% risk), for an odds ratio (or) of 1.8 (95% confidence interval 1.1 to 2.8). no increase in the risk of overall congenital malformations was seen in the paroxetine-exposed infants. the cardiac malformations in the paroxetine-exposed infants were primarily ventricular septal defects (vsds) and atrial septal defects (asds). septal defects range in severity from those that resolve spontaneously to those which require surgery. - a separate retrospective cohort study from the united states (united healthcare data) evaluated 5,956 infants of mothers dispensed antidepressants during the first trimester (n = 815 for paroxetine). this study showed a trend towards an increased risk for cardiovascular malformations for paroxetine (risk of 1.5%) compared to other antidepressants (risk of 1%), for an or of 1.5 (95% confidence interval 0.8 to 2.9). of the 12 paroxetine-exposed infants with cardiovascular malformations, 9 had vsds. this study also suggested an increased risk of overall major congenital malformations including cardiovascular defects for paroxetine (4% risk) compared to other (2% risk) antidepressants (or 1.8; 95% confidence interval 1.2 to 2.8). - two large case-control studies using separate databases, each with >9,000 birth defect cases and >4,000 controls, found that maternal use of paroxetine during the first trimester of pregnancy was associated with a 2- to 3-fold increased risk of right ventricular outflow tract obstructions. in one study the or was 2.5 (95% confidence interval, 1.0 to 6.0, 7 exposed infants) and in the other study the or was 3.3 (95% confidence interval, 1.3 to 8.8, 6 exposed infants). other studies have found varying results as to whether there was an increased risk of overall, cardiovascular, or specific congenital malformations. a meta-analysis of epidemiological data over a 16-year period (1992 to 2008) on first trimester paroxetine use in pregnancy and congenital malformations included the above-noted studies in addition to others (n = 17 studies that included overall malformations and n = 14 studies that included cardiovascular malformations; n = 20 distinct studies). while subject to limitations, this meta-analysis suggested an increased occurrence of cardiovascular malformations (prevalence odds ratio [por] 1.5; 95% confidence interval 1.2 to 1.9) and overall malformations (por 1.2; 95% confidence interval 1.1 to 1.4) with paroxetine use during the first trimester. it was not possible in this meta-analysis to determine the extent to which the observed prevalence of cardiovascular malformations might have contributed to that of overall malformations, nor was it possible to determine whether any specific types of cardiovascular malformations might have contributed to the observed prevalence of all cardiovascular malformations. unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing paroxetine therapy or switching to another antidepressant [see warnings and precautions (5.7)] . for women who intend to become pregnant or are in their first trimester of pregnancy, paroxetine should only be initiated after consideration of the other available treatment options [see warnings and precautions (5.4)] . treatment of pregnant women during their third trimester : neonates exposed to ssris or serotonin and norepinephrine reuptake inhibitors (snris), including paroxetine, 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)]. exposure to ssris in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (pphn). pphn occurs in 1 – 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. in a retrospective case-control study of 377 women whose infants were born with pphn and 836 women whose infants were born healthy, the risk for developing pphn was approximately six-fold higher for infants exposed to ssris after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. there have also been postmarketing reports of premature births in pregnant women exposed to paroxetine or other ssris. when treating a pregnant woman with paroxetine during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment . a prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy. the women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication. maternal adverse reactions use of paxil in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions (5.5)]. animal findings reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. these doses are approximately 6 (rat) and less than 2 (rabbit) times the maximum recommended human dose (mrhd – 75 mg) on an mg/m 2 basis. these studies have revealed no evidence of developmental effects. however, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. this effect occurred at a dose of 1 mg/kg/day which is than the mrhd on an mg/m2 basis. the no-effect dose for rat pup mortality was not determined. the cause of these deaths is not known. like many other drugs, paroxetine is secreted in human milk. because of the potential for serious adverse reactions in nursing infants from paroxetine, a decision should be made whether to discontinue nursing infants or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of paroxetine in pediatric patients have not been established [see box warning]. effectiveness was not demonstrated in three placebo-controlled trials in 752 paroxetine - treated pediatric patients with mdd. antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see boxed warning, warnings and precautions (5.1)] . decreased appetite and weight loss have been observed in association with the use of ssris. in placebo-controlled clinical trials conducted with pediatric patients, the following adverse reactions were reported in at least 2% of pediatric patients treated with paroxetine and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self- harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation. adverse reactions upon discontinuation of treatment with paroxetine in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients and at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain. in premarketing clinical trials with paroxetine, 17% of patients treated with paroxetine (approximately 700) were 65 years of age or older. pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended;, however, no overall differences in safety or effectiveness were observed between elderly and younger patients [see dosage and administration (2.4), clinical pharmacology (12.3)]. ssris including paroxetine, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions (5.7)]. increased plasma concentrations of paroxetine occur in patients with renal and hepatic impairment. the initial dosage of paroxetine should be reduced in patients with severe renal impairment and in patients with severe hepatic impairment [see dosage and administration (2.4), clinical pharmacology (12.3)].

Filipijnen - Engels - FDA (Food And Drug Administration)

golden dale pharma corp. - carbocisteine , zinc - film coated tablet - 500mg / 5mg (equivalent to 13.720mg zinc sulfate monohydrate)

Verenigde Staten - Engels - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - vigabatrin (unii: gr120krt6k) (vigabatrin - unii:gr120krt6k) - vigabatrin for oral solution is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see warnings and precautions (5.1)] . vigabatrin for oral solution is not indicated as a first line agent for complex partial seizures. vigabatrin for oral solution is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see warnings and precautions (5.1)]. none. pregnancy exposure registry   there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, including vigabatrin, during pregnancy. encourage women who are taking vigabatrin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the to

Verenigde Staten - Engels - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam tablets usp are indicated for treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam tablets usp are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets usp are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-233

Filipijnen - Engels - FDA (Food And Drug Administration)

daily grace unlimited inc.; importer: n/a; distributor: n/a - ascorbic acid (as calcium ascorbate) , zinc (as zinc gluconate) - capsule - 500 mg (equivalent to 605.2 mg calcium ascorbate)/ 4.3 mg (equivalent to 30 mg zinc gluconate)