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Adverse events have been observed in animal reproduction studies. Lithium crosses the placenta in concentrations similar to those in the maternal plasma (Newport 2005). Cardiac malformations in the infant, including Ebstein anomaly, are associated with use of lithium during the first trimester of pregnancy. Other adverse events including polyhydramnios, fetal/neonatal cardiac arrhythmias, hypoglycemia, diabetes insipidus, changes in thyroid function, premature delivery, floppy infant syndrome, or neonatal lithium toxicity are associated with lithium exposure when used later in pregnancy (ACOG 2008). The incidence of adverse events may be associated with higher maternal doses (Newport 2005).


1: 13 of the 143 were receiving tacrine when evaluated.
2: 41 of the 172 were not receiving tacrine when evaluated.
 
The first column of the table is based on all patients participating in the study. The proportion provides an estimate of the likelihood that a patient entering the study will (1) still be on his or her assigned treatment at week 30 and (2) will improve 7 or more ADAS cognitive points over his or her baseline score. The estimate of response derived in this manner is conservative because the rules under which the 30-week study was conducted required the withdrawal of patients with relatively low (>3 X ULN), asymptomatic, transaminase elevations. In actual clinical practice under the conditions of treatment recommended in the Dosage and Administration Section, a larger fraction of these patients would be able to remain on tacrine and the proportion of those improving 7 or more points on tacrine would be expected, therefore, to be increased (the third column illustrates this).
 
The second column of the table presents the proportion of 7 unit responders based on the number of patients who (1) were able to complete the full 30 weeks of the study and (2) attained an ADAS cognitive score at week 30 that was 7 or more points better than their baseline score. This analysis provides an optimistic estimate of tacrine's effects because it reflects experience gained only with the minority of patients who were able to remain on treatment to the study's end. The comparison between the proportions of placebo and 160 mg patients attaining a 7 or more point improvement is complicated further by the fact that a larger proportion of tacrine assigned patients withdrew prematurely.
 
The third column of the table presents the proportion of patients who had evaluations made at 30 weeks and had a 7-point or greater response. The analysis includes data from patients still on their assigned treatment at week 30 as well as patients who withdrew from the study prior to that time, but were retrieved for a week 30 evaluation. Because patients who withdrew prior to week 30 were permitted to receive tacrine under "open label” conditions, retrieved patients included in this analysis could be receiving either no treatment or treatment with tacrine. In this analysis, patients are considered under the treatment to which they were randomized, regardless of the treatment they were actually receiving at week 30. Thus, some placebo patients could have received tacrine and some tacrine patients could have been receiving no tacrine. Like the analysis based on percent randomized (column I), this analysis, therefore, tends to provide a conservative view of the expected effects of tacrine treatment.

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© Janssen Pharmaceuticals, Inc. 2018. All Rights Reserved. Your use of the information on this site is subject to the terms of our Legal Notice. Please see our Privacy Policy. This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. Capitalized product names are trademarks of Janssen Pharmaceuticals, Inc. This information is intended for use by our customers, patients, and healthcare professionals in the United States only. Janssen Pharmaceuticals, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The prescribing information included here may not be appropriate for use outside the United States. Last Updated: March 10, 2018

Haldol decanoate 150 mg

haldol decanoate 150 mg

© Janssen Pharmaceuticals, Inc. 2018. All Rights Reserved. Your use of the information on this site is subject to the terms of our Legal Notice. Please see our Privacy Policy. This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. Capitalized product names are trademarks of Janssen Pharmaceuticals, Inc. This information is intended for use by our customers, patients, and healthcare professionals in the United States only. Janssen Pharmaceuticals, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The prescribing information included here may not be appropriate for use outside the United States. Last Updated: March 10, 2018

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