WARNING: FETAL TOXICITY When pregnancy is detected, discontinue losartan potassium as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [ see Warnings and Precautions (5.1 )]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue losartan potassium as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume or salt depletion prior to administration of losartan potassium. ( 5.2 ) Monitor renal function and potassium in susceptible patients. ( 5.3 , 5.4 ) 5.1 Fetal Toxicity Losartan potassium can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria,hypotension, renal failure, and death. When pregnancy is detected, discontinue losartan potassium as soon as possible [ see Use in Specific Populations (8.1) ]. 5.2 Hypotension in Volume- or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with losartan potassium. Correct volume or salt depletion prior to administration of losartan potassium [ see Dosage and Administration (2.1) ]. 5.3 Renal Function Deterioration Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on losartan potassium. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on losartan potassium [ see Drug Interactions (7.3) and Use in Specific Populations (8.7) ]. 5.4 Hyperkalemia Monitor serum potassium periodically and treat appropriately. Dosage reduction or discontinuation of losartan potassium may be required [ see Adverse Reactions (6.1) ]. Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia [ see Drug Interactions (7.1) ].
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication): TABLE 1. Gabapentin Capsules Dosage Based on Renal Function TID = Three times a day; BID = Two times a day; QD = Single daily dose a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table. Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen (mg) ≥ 60 900 to 3600 300 TID 400 TID 600 TID 800 TID 1200 TID > 30 to 59 400 to 1400 200 BID 300 BID 400 BID 500 BID 700 BID > 15 to 29 200 to 700 200 QD 300 QD 400 QD 500 QD 700 QD 15 a 100 to 300 100 QD 125 QD 150 QD 200 QD 300 QD Post-Hemodialysis Supplemental Dose (mg) Hemodialysis 125 b 150 b 200 b 250 b 350 b Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault: The use of gabapentin capsules in patients less than 12 years of age with compromised renal function has not been studied. 6.2 Postmarketing Experience The following additional adverse reactions have been reported in postmarketing experience with losartan potassium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: Digestive: Hepatitis. General Disorders and Administration Site Conditions: Malaise. Hematologic: Thrombocytopenia. Hypersensitivity: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported. Anaphylactic reactions have been reported. Metabolic and Nutrition: Hyponatremia. Musculoskeletal: Rhabdomyolysis. Nervous System Disorders: Dysgeusia. Skin: Erythroderma.
adverse reactions table
<table width="100%" ID="ID16" styleCode="Noautorules"><caption>TABLE 1. Gabapentin Capsules Dosage Based on Renal Function</caption><colgroup><col width="14%"/><col width="15%"/><col width="13%"/><col width="14%"/><col width="14%"/><col width="14%"/><col width="14%"/></colgroup><tfoot><tr><td align="left" colspan="7"><paragraph>TID = Three times a day; BID = Two times a day; QD = Single daily dose</paragraph></td></tr><tr><td align="left" colspan="7"><paragraph><sup>a</sup>For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). </paragraph></td></tr><tr><td align="left" colspan="7"><paragraph><sup>b</sup>Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table. </paragraph></td></tr></tfoot><tbody><tr><td align="center" styleCode="Lrule Toprule Botrule Rrule" valign="top">Renal Function Creatinine Clearance (mL/min) </td><td align="center" styleCode="Toprule Botrule Rrule" valign="top">Total Daily Dose Range (mg/day) </td><td align="center" colspan="5" styleCode="Toprule Botrule Rrule">Dose Regimen (mg)</td></tr><tr><td align="center" styleCode="Lrule Botrule Rrule" valign="top">≥ 60</td><td align="center" styleCode="Botrule Rrule" valign="top">900 to 3600</td><td align="center" styleCode="Botrule Rrule" valign="top">300 TID</td><td align="center" styleCode="Botrule Rrule" valign="top">400 TID</td><td align="center" styleCode="Botrule Rrule" valign="top">600 TID</td><td align="center" styleCode="Botrule Rrule" valign="top">800 TID</td><td align="center" styleCode="Botrule Rrule" valign="top">1200 TID</td></tr><tr><td align="center" styleCode="Lrule Botrule Rrule" valign="top">> 30 to 59</td><td align="center" styleCode="Botrule Rrule" valign="top">400 to 1400</td><td align="center" styleCode="Botrule Rrule" valign="top">200 BID</td><td align="center" styleCode="Botrule Rrule" valign="top">300 BID</td><td align="center" styleCode="Botrule Rrule" valign="top">400 BID</td><td align="center" styleCode="Botrule Rrule" valign="top">500 BID</td><td align="center" styleCode="Botrule Rrule" valign="top">700 BID</td></tr><tr><td align="center" styleCode="Lrule Botrule Rrule" valign="top">> 15 to 29</td><td align="center" styleCode="Botrule Rrule" valign="top">200 to 700</td><td align="center" styleCode="Botrule Rrule" valign="top">200 QD</td><td align="center" styleCode="Botrule Rrule" valign="top">300 QD</td><td align="center" styleCode="Botrule Rrule" valign="top">400 QD</td><td align="center" styleCode="Botrule Rrule" valign="top">500 QD</td><td align="center" styleCode="Botrule Rrule" valign="top">700 QD</td></tr><tr><td align="center" styleCode="Lrule Botrule Rrule" valign="top">15 <sup>a</sup></td><td align="center" styleCode="Botrule Rrule" valign="top">100 to 300</td><td align="center" styleCode="Botrule Rrule" valign="top">100 QD</td><td align="center" styleCode="Botrule Rrule" valign="top">125 QD</td><td align="center" styleCode="Botrule Rrule" valign="top">150 QD</td><td align="center" styleCode="Botrule Rrule" valign="top">200 QD</td><td align="center" styleCode="Botrule Rrule" valign="top">300 QD</td></tr><tr><td align="center" colspan="7" styleCode="Lrule Botrule Rrule" valign="top">Post-Hemodialysis Supplemental Dose (mg)</td></tr><tr><td align="center" colspan="2" styleCode="Lrule Botrule Rrule" valign="top">Hemodialysis</td><td align="center" styleCode="Botrule Rrule" valign="top">125 <sup>b</sup></td><td align="center" styleCode="Botrule Rrule" valign="top">150 <sup>b</sup></td><td align="center" styleCode="Botrule Rrule" valign="top">200 <sup>b</sup></td><td align="center" styleCode="Botrule Rrule" valign="top">250 <sup>b</sup></td><td align="center" styleCode="Botrule Rrule" valign="top">350 <sup>b</sup></td></tr></tbody></table>