Nevirapine
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Side Effects & Adverse Reactions
DO NOT DILUTE THIS PRODUCT
DO NOT RETURN TEAT DIP LEFT IN THE TEAT DIPPER TO STORAGE CONTAINER
ENSURE THAT DIPPED TEATS ARE DRY BEFORE EXPOSING THE ANIMALS TO WEATHER CONDITIONS WHICH MAY CAUSE DAMAGE TO THE TEATS.
PROTECT THIS PRODUCT FROM FREEZING.
CAUTION: KEEP OUT OF REACH OF CHILDREN.
AVOID CONTACT WITH FOOD. DO NOT TAKE INTERNALLY.
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
GENERAL RECOMMENDATIONS
1. Use teat dip applicators made of plastic or other non-corrosive materials. Do not use cups made of aluminum.
2. When solution in the teat dip cup becomes dirty and/or noticeably loses color, discard remaining contents and refill cup with fresh teat dip.
3. Do not use this product for cleaning or sanitizing equipment
4. Wash Teat Dip cups after each milking.
RECOMMENDED PROCEDURES FOR TEAT SANITATION
A. PRE-MILKING (PRE-DIPPING)
1. REMOVE VISIBLE SOILS FROM THE TEATS.
2. OBSERVE FOREMILK BY STRIPPING TWO OR THREE STREAMS OF MILK INTO A STRIP CUP.
3. DIP OR SPRAY THE COW'S TEATS FULL LENGTH WITH QUADRA-PLEX TEAT DIP.
4 WAIT APPROXIMATELY 30 SECONDS.
5. REMOVE ALL TEAT DIP BY THOROUGHLY DRYING THE TEATS AND TEAT ORIFICES WITH A CLEAN, SINGLE SERVICE PAPER TOWEL(S).
6. ATTACH MILKING UNIT
B.POST-MILKING (POST DIPPING)
Immediately after milking dip all teats full length with QUADRA-PLEX Teat Dip Ensure good coverage of all sides of the teats and teat orifices.
History
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Sources
Nevirapine Manufacturers
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State Of Florida Doh Central Pharmacy
![Nevirapine Tablet [State Of Florida Doh Central Pharmacy]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Nevirapine | Iba Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Mylan Pharmaceuticals Inc.
Nevirapine | Sandoz Inc
Each 50 mL glass vial contains 50 mg argatroban (1 mg/mL); and, as supplied, is ready for intravenous infusion. Dilution is not required.
Argatroban Injection is a clear, colorless to pale yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if solution is cloudy, contains precipitates, or if the white flip top cap is not intact.
Vial may be inverted for use with a medical infusion set.
2.1 Dosing in Patients with Heparin-Induced ThrombocytopeniaInitial Dosage:
Before administering argatroban, discontinue heparin therapy and obtain a baseline aPTT. The recommended initial dose of Argatroban for adult patients without hepatic impairment is 2 mcg/kg/min, administered as a continuous infusion (see Table 1).
Table 1. Recommended Doses and Infusion Rates for 2 mcg/kg/min Dose of Argatroban for Patients With HIT* and Without Hepatic Impairment (1 mg/mL Concentration)*with or without thrombosis
Body Weight (kg) Dose (mcg/min) Infusion Rate (mL/hr) 50 100 6 60 120 7 70 140 8 80 160 10 90 180 11 100 200 12 110 220 13 120 240 14 130 260 16 140 280 17Monitoring Therapy:
For use in HIT, therapy with Argatroban Injection is monitored using the aPTT with a target range of 1.5 to 3 times the initial baseline value (not to exceed 100 seconds). Tests of anticoagulant effects (including the aPTT) typically attain steady-state levels within 1 to 3 hours following initiation of Argatroban Injection. Check the aPTT 2 hours after initiation of therapy and after any dose change to confirm that the patient has attained the desired therapeutic range.
Dosage Adjustment:
After the initiation of Argatroban Injection, adjust the dose (not to exceed 10 mcg/kg/min) as necessary to obtain a steady state aPTT in the target range [see Clinical Studies (14.1)].
2.2 Dosing in Patients Undergoing Percutaneous Coronary InterventionInitial Dosage:
Initiate an infusion of Argatroban Injection at 25 mcg/kg/min and administer a bolus of 350 mcg/kg via a large bore intravenous line over 3 to 5 minutes (see Table 2). Check an activated clotting time (ACT) 5 to 10 minutes after the bolus dose is completed. The PCI procedure may proceed if the ACT is greater than 300 seconds.
Dosage Adjustment:
If the ACT is less than 300 seconds, an additional intravenous bolus dose of 150 mcg/kg should be administered, the infusion dose increased to 30 mcg/kg/min, and the ACT checked 5 to 10 minutes later (see Table 2).
If the ACT is greater than 450 seconds, the infusion rate should be decreased to 15 mcg/kg/min, and the ACT checked 5 to 10 minutes later (Table 3).
Continue titrating the dose until a therapeutic ACT (between 300 and 450 seconds) has been achieved; continue the same infusion rate for the duration of the PCI procedure.
In case of dissection, impending abrupt closure, thrombus formation during the procedure, or inability to achieve or maintain an ACT over 300 seconds, additional bolus doses of 150 mcg/kg may be administered and the infusion dose increased to 40 mcg/kg/min. Check the ACT after each additional bolus or change in the rate of infusion.
Table 2. Recommended Starting and Maintenance Doses (Within the Target ACT Range) of Argatroban Injection in Patients Undergoing PCI Without Hepatic Impairment (1 mg/mL Concentration)NOTE: 1 mg = 1000 mcg; 1 kg = 2.2 lbs
Body Weight (kg) Starting Bolus Dose (350 mcg/kg) Starting Maintenance Continuous
Infusion Dosing For ACT 300-450 seconds 25 mcg/kg/min Bolus Dose (mcg) Bolus
Volume
(mL) Continuous
Infusion Dose
(mg/min) Continuous
Infusion Rate
(mL/hr) 50 17500 18 1250 75 60 21000 21 1500 90 70 24500 25 1750 105 80 28000 28 2000 120 90 31500 32 2250 135 100 35000 35 2500 150 110 38500 39 2750 165 120 42000 42 3000 180 130 45500 46 3250 195 140 49000 49 3500 210 Table 3. Recommended Dose Adjustments of Argatroban Injection for Patients Outside of ACT Target Range Undergoing PCI Without Hepatic Impairment (1 mg/mL Concentration)NOTE: 1 mg = 1000 mcg; 1 kg – 2.2 lbs
† Additional intravenous bolus dose of 150 mcg/kg should be administered if ACT less than 300 seconds.
* No bolus dose is given if ACT greater than 450 seconds.
Body
Weight
(kg) If ACT Less than 300 seconds
Dosage Adjustment†
30 mcg/kg/min If ACT
Greater than 450 seconds Dosage Adjustment* 15 mcg/kg/min Additional
Bolus Dose
(mcg) Bolus
Volume
(mL) Continuous
Infusion
Dose
(mcg/min) Continuous
Infusion Rate
(mL/hr) Continuous
Infusion
Dose
(mcg/min) Continuous
Infusion Rate
(mL/hr) 50 7500 8 1500 90 750 45 60 9000 9 1800 108 900 54 70 10500 11 2100 126 1050 63 80 12000 12 2400 144 1200 72 90 13500 14 2700 162 1350 81 100 15000 15 3000 180 1500 90 110 16500 17 3300 198 1650 99 120 18000 18 3600 216 1800 108 130 19500 20 3900 234 1950 117 140 21000 21 4200 252 2100 126Monitoring therapy:
For use in PCI, therapy with Argatroban Injection is monitored using ACT. Obtain ACTs before dosing, 5 to 10 minutes after bolus dosing, following adjustments in the infusion rate, and at the end of the PCI procedure. Obtain additional ACTs every 20 to 30 minutes during a prolonged procedure.
Continued Anticoagulation after PCI:
If a patient requires anticoagulation after the procedure, Argatroban Injection may be continued, but at a rate of 2 mcg/kg/min and adjusted as needed to maintain the aPTT in the desired range [see Dosage and Administration (2.1)].
2.3 Dosing in Patients with Hepatic ImpairmentFor adult patients with HIT and moderate or severe hepatic impairment (based on Child-Pugh classification), an initial dose of 0.5 mcg/kg/min is recommended, based on the approximately 4-fold decrease in argatroban clearance relative to those with normal hepatic function. Monitor the aPTT closely, and adjust the dosage as clinically indicated.
Monitoring Therapy:
Achievement of steady state aPTT levels may take longer and require more dose adjustments in patients with hepatic impairment compared to patients with normal hepatic function.
For patients with hepatic impairment undergoing PCI who have HIT or are at risk for HIT, carefully titrate argatroban until the desired level of anticoagulation is achieved. Use of Argatroban in PC patients with clinically significant hepatic disease or AST/ALT levels ≥ 3 times the upper limit of normal should be avoided. [see Warnings and Precautions (5.2)].
2.4 Dosing in Pediatric Patients With Heparin-Induced Thrombocytopenia/Heparin-Induced Thrombocytopenia and Thrombosis SyndromeInitial Dosage:
Initial argatroban infusion doses are lower for seriously ill pediatric patients compared to adults with normal hepatic function [see Use in Specific Populations (8.4)].
Monitoring Therapy:
In general, therapy with argatroban is monitored using the aPTT. Tests of anticoagulant effects (including the aPTT) typically attain steady-state levels within one to three hours following initiation of argatroban in patients without hepatic impairment [see Warnings and Precautions (5.2)]. Dose adjustment may be required to attain the target aPTT. Check the aPTT two hours after initiation of therapy and after any dose change to confirm that the patient has attained the desired therapeutic range.
Dosage Adjustment: [see Use in Specific Populations (8.4)]
2.5 Conversion to Oral Anticoagulant TherapyInitiating Oral Anticoagulant Therapy
When converting patients from Argatroban to oral anticoagulant therapy, consider the potential for combined effects on the International Normalized Ratio (INR). To avoid prothrombotic effects and to ensure continuous anticoagulation when initiating warfarin, overlap Argatroban Injection and warfarin therapy. There are insufficient data available to recommend the duration of the overlap. Initiate therapy using the expected daily dose of warfarin. A loading dose of warfarin should not be used.
The relationship between INR and bleeding risk is altered when argatroban and warfarin are coadministered. The combination of argatroban and warfarin does not cause further reduction in the vitamin-K dependent factor Xa activity than that which is seen with warfarin alone. The relationship between INR obtained on combined therapy and INR obtained on warfarin alone is dependent on both the dose of argatroban and the thromboplastin reagent used. The INR value on warfarin alone (INRw) can be calculated from the INR value on combination argatroban and warfarin therapy [see Drug Interactions (7.2) and Clinical Pharmacology (12.2)].
Co-Administration of Warfarin and Argatroban Injection at Doses up to 2 mcg/kg/min: Measure INR daily while Argatroban Injection and warfarin are co-administered. In general, with doses of Argatroban Injection up to 2 mcg/kg/min, Argatroban Injection can be discontinued when the INR is greater than 4 on combined therapy. After Argatroban Injection is discontinued, repeat the INR measurement in 4 to 6 hours. If the repeat INR is below the desired therapeutic range, resume the infusion of Argatroban Injection and repeat the procedure daily until the desired therapeutic range on warfarin alone is reached.
Co-Administration of Warfarin and Argatroban Injection at Doses Greater than 2 mcg/kg/min: For doses greater than 2 mcg/kg/min, the relationship of INR between warfarin alone to the INR on warfarin plus argatroban is less predictable. In this case, in order to predict the INR on warfarin alone, temporarily reduce the dose of Argatroban Injection to a dose of 2 mcg/kg/min. Repeat the INR on Argatroban Injection and warfarin 4 to 6 hours after reduction of the Argatroban Injection dose and follow the process outlined above for administering Argatroban Injection at doses up to 2 mcg/kg/min.
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Breckenridge Pharmaceutical, Inc.
Nevirapine |
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Cipla Limited
Nevirapine | Cipla Limited
2.1 Adult PatientsThe recommended dose for nevirapine is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer's recommended dosage and monitoring should be followed.
2.2 Pediatric PatientsThe recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
2.3 Monitoring of patientsIntensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment [ see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
2.4 Dosage Adjustment Patients with RashDiscontinue nevirapine if a patients experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warnings, Warnings and Precautions (5.2) ]. Do not increase nevirapine dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.
Patients with Hepatic EventsIf a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine. Do not restart nevirapine after recovery [see Warnings and Precautions (5.1)].
Patients with Dose InterruptionFor patients who interrupt nevirapine dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).
Patients with Renal ImpairmentPatients with CrCL greater than or equal to 20 mL per min do not require an adjustment in nevirapine dosing.The pharmacokinetics of Nevirapine have not been evaluated in patients with CrCl less than 20 mL per min. An additional 200 mg dose of nevirapine following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3) ].
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Camber Pharmaceuticals, Inc.
Nevirapine | Aplicare, Inc.
Directions
Apply locally as needed.
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Golden State Medical Supply, Inc.
Nevirapine | Golden State Medical Supply, Inc.
2.1 AdultsThe recommended dose for Nevirapine is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.
2.2 Pediatric PatientsThe recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
2.3 Monitoring of PatientsIntensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with Nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout Nevirapine treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
2.4 Dosage AdjustmentPatients with Rash
Discontinue nevirapine tablets if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning, Warnings and Precautions (5.2), and Patient Counseling Information (17.1)]. Do not increase nevirapine tablets dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2) and Patient Counseling Information (17.1)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.
Patients with Hepatic Events
If a clinical (symptomatic) hepatic event occurs, permanently discontinued nevirapine tablets. Do not restart nevirapine tablets after recovery [see Warnings and Precautions (5.1)].
Patients with Dose Interruption
For patients who interrupt nevirapine tablets dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).
Patients with Renal Impairment
Patients with CrCL greater than or equal to 20 mL per min do not require an adjustment in nevirapine tablets dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. An additional 200 mg dose of nevirapine tablets following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)]. -
Aurobindo Pharma Limited
Nevirapine | Aurobindo Pharma Limited
2.1 Adult PatientsThe recommended dose for nevirapine tablets is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.
2.2 Pediatric PatientsThe recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
2.3 Monitoring of PatientsIntensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine tablets. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine tablets treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
2.4 Dosage AdjustmentPatients with Rash
Discontinue nevirapine tablets if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning and Warnings and Precautions (5.2)] . Do not increase nevirapine tablets dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.
Patients with Hepatic Events
If a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine tablets. Do not restart nevirapine tablets after recovery [see Warnings and Precautions (5.1)].
Patients with Dose Interruption
For patients who interrupt nevirapine tablets dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).
Patients with Renal Impairment
Patients with CrCL greater than or equal to 20 mL per min do not require an adjustment in nevirapine tablets dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. An additional 200 mg dose of nevirapine tablets following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)]. -
Apotex Corp
Nevirapine | Apotex Corp
2.1 General Dosing ConsiderationsNevirapine extended-release tablets must be swallowed whole and must not be chewed, crushed, or divided.
Nevirapine extended-release tablets can be taken with or without food.
Pediatric use information is approved for Boehringer Ingelheim Pharmaceuticals, Inc.’s Viramune XR® (nevirapine) extended-release tablets. However, due to Boehringer Ingelheim Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
2.2 Adult Patients Patients not currently taking immediate-release nevirapine tabletsPatients must initiate therapy with one 200 mg tablet of immediate-release nevirapine tablets daily for the first 14 days in combination with other antiretroviral agents (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 400 mg tablet of nevirapine extended-release tablets once daily.
Switching Patients from immediate-release nevirapine tablets to nevirapine extended-release tabletsPatients already on a regimen of immediate-release nevirapine tablet twice daily in combination with other antiretroviral agents can be switched to nevirapine extended-release tablets 400 mg once daily in combination with other antiretroviral agents without the 14-day lead-in period of immediate-release nevirapine tablets.
2.3 Pediatric PatientsPediatric use information is approved for Boehringer Ingelheim Pharmaceuticals, Inc.’s Viramune XR® (nevirapine) extended-release tablets. However, due to Boehringer Ingelheim Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
2.4 Monitoring of PatientsIntensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests prior to beginning the 14-day lead-in period with immediate-release nevirapine tablets, prior to initiation of nevirapine extended-release tablets, and at two weeks after initiation of nevirapine extended-release tablets therapy. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine extended-release tablets treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
Patients already on a regimen of immediate-release nevirapine tablets twice daily who switch to nevirapine extended-release tablets once daily should continue with their ongoing clinical and laboratory monitoring.
2.5 Dosage Adjustment Patients with RashDiscontinue nevirapine if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning and Warnings and Precautions (5.2)].Do not initiate therapy with nevirapine extended-release tablet if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of immediate-release nevirapine tablets until the rash has resolved [see Warnings and Precautions (5.2)].The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.
Patients with Hepatic EventsIf a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine. Do not restart nevirapine after recovery [see Warnings and Precautions (5.1)].
Patients with Dose InterruptionFor patients who interrupt nevirapine extended-release tablets dosing for more than 7 days, restart the recommended lead-in dosing with immediate-release nevirapine tablets, using one 200 mg tablet daily for the first 14 days.
Patients with Renal ImpairmentPatients with CrCL greater than or equal to 20 mL per min and not requiring dialysis do not require an adjustment in dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. An additional 200 mg dose of immediate-release nevirapine tablets following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)]. Nevirapine extended-release tablets have not been studied in patients with renal dysfunction.
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State Of Florida Doh Central Pharmacy
Nevirapine | State Of Florida Doh Central Pharmacy
2.1 AdultsThe recommended dose for nevirapine tablets is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.
Nevirapine extended-release tablets (400 mg once daily) are also available for use after the lead-in period. Patients must never take more than one form of nevirapine at the same time.
2.2 Pediatric PatientsThe recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
Table 1 Calculation of the Volume of Nevirapine Oral Suspension (50 mg/5 mL) Required for Pediatric Dosing Based on Body Surface and a Dose of 150 mg/m2 BSA range (m2) Volume (mL) 0.06 to 0.12 1.25 0.12 to 0.25 2.5 0.25 to 0.42 5 0.42 to 0.58 7.5 0.58 to 0.75 10 0.75 to 0.92 12.5 0.92 to 1.08 15 1.08 to 1.25 17.5 1.25+ 20Nevirapine suspension should be shaken gently prior to administration. It is important to administer the entire measured dose of suspension by using an oral dosing syringe or dosing cup. An oral dosing syringe is recommended, particularly for volumes of 5 mL or less. If a dosing cup is used, it should be thoroughly rinsed with water and the rinse should also be administered to the patient.
2.3 Monitoring of PatientsIntensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine tablets. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
2.4 Dosage Adjustment Patients with RashDiscontinue nevirapine tablets if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning, Warnings and Precautions (5.2) and Patient Counseling Information (17.1)]. Do not increase nevirapine dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2) and Patient Counseling Information (17.1)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.
Patients with Hepatic EventsIf a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine tablets. Do not restart nevirapine tablets after recovery [see Warnings and Precautions (5.1)].
Patients with Dose InterruptionFor patients who interrupt nevirapine dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).
Patients with Renal ImpairmentPatients with CrCL greater than or equal to 20 mL/min do not require an adjustment in nevirapine dosing. An additional 200 mg dose of nevirapine tablets following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)].
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Apotex Corp
Nevirapine | Apotex Corp
2.1 Adult PatientsThe recommended dose for nevirapine tablets is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.
2.2 Pediatric PatientsThe recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
2.3 Monitoring of PatientsIntensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
2.4 Dosage AdjustmentPatients with Rash
Discontinue nevirapine if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning and Warnings and Precautions (5.2)]. Do not increase nevirapine dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.
Patients with Hepatic Events
If a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine. Do not restart nevirapine after recovery [see Warnings and Precautions (5.1)].
Patients with Dose Interruption
For patients who interrupt nevirapine dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).
Patients with Renal Impairment
Patients with CrCL greater than or equal to 20 mL per min do not require an adjustment in nevirapine dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. An additional 200 mg dose of nevirapine following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)].
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Amneal-agila, Llc
Nevirapine | Amneal-agila, Llc
2.1 AdultsThe recommended dose for Nevirapine tablets, USP is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.
2.2 Pediatric PatientsThe recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
2.3 Monitoring of PatientsIntensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with Nevirapine tablets, USP. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout Nevirapine tablets, USP treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
2.4 Dosage AdjustmentPatients with Rash
Discontinue Nevirapine tablets, USP if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning, Warnings and Precautions (5.2), and Patient Counseling Information (17.1)]. Do not increase Nevirapine tablets, USP dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2) and Patient Counseling Information (17.1)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.
Patients with Hepatic Events
If a clinical (symptomatic) hepatic event occurs, permanently discontinue Nevirapine tablets, USP. Do not restart Nevirapine tablets, USP after recovery [see Warnings and Precautions (5.1)].
Patients with Dose Interruption
For patients who interrupt Nevirapine tablets, USP dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).
Patients with Renal Impairment
Patients with CrCL greater than or equal to 20 mL/min do not require an adjustment in Nevirapine tablets, USP dosing. An additional 200 mg dose of Nevirapine tablets, USP following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine tablets, USP metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)].
-
Sandoz Inc
Nevirapine | Sandoz Inc
2.1 General Dosing Considerations • Nevirapine extended-release tablets must be swallowed whole and must not be chewed, crushed, or divided. • Nevirapine extended-release tablets can be taken with or without food.Pediatric use information is approved for BoehringerIngelheim Pharmaceuticals, Inc.’s Viramune XR® (nevirapine) extended-release tablets. However, due to BoehringerIngelheim Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
2.2 Adult PatientsPatients Not Currently Taking Immediate-Release Nevirapine
Patients must initiate therapy with one 200 mg tablet of immediate-release nevirapine daily for the first 14 days in combination with other antiretroviral agents (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 400 mg tablet of nevirapine extended-release tablets once daily.
Switching Patients From Immediate-Release Nevirapine to Nevirapine Extended-Release Tablets
Patients already on a regimen of immediate-release nevirapine twice daily in combination with other antiretroviral agents can be switched to nevirapine extended-release tablets 400 mg once daily in combination with other antiretroviral agents without the 14-day lead-in period of immediate-release nevirapine.
2.3 Pediatric PatientsPediatric use information is approved for BoehringerIngelheim Pharmaceuticals, Inc.’s Viramune XR® (nevirapine) extended-release tablets. However, due to BoehringerIngelheim Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
2.4 Monitoring of PatientsIntensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests prior to beginning the 14-day lead-in period with immediate-release nevirapine, prior to initiation of nevirapine extended-release tablets, and at two weeks after initiation of nevirapine extended-release tablets therapy. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine extended- release tablets treatment [see WARNINGS AND PRECAUTIONS (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
Patients already on a regimen of immediate-release nevirapine twice daily who switch to nevirapine extended-release tablets once daily should continue with their ongoing clinical and laboratory monitoring.
2.5 Dosage AdjustmentPatients with Rash
Discontinue nevirapine if a patient experiences severe rash or any rash accompanied by constitutional findings[seeBOXED WARNING and WARNINGS AND PRECAUTIONS (5.2). Do not initiate therapy with nevirapine extended-release tablets if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of immediate-release nevirapine until the rash has resolved[see WARNINGS AND PRECAUTIONS (5.2)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.
Patients with Hepatic Events
If a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine. Do not restart nevirapine after recovery[see WARNINGS AND PRECAUTIONS (5.1)].
Patients with Dose Interruption
For patients who interrupt nevirapine extended-release tablets dosing for more than 7 days, restart the recommended lead-in dosing with immediate-release nevirapine, using one 200 mg tablet daily for the first 14 days.
Patients with Renal Impairment
Patients with CrCL greater than or equal to 20 mL per min and not requiring dialysis do not require an adjustment in dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. An additional 200 mg dose of immediate-release nevirapine following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see CLINICAL PHARMACOLOGY (12.3)]. Nevirapine extended-release tablets have not been studied in patients with renal dysfunction.
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Alvogen Inc.
Nevirapine | Alvogen Inc.
2.1 Adults PatientsThe recommended dose for nevirapine is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.
2.2 Pediatric PatientsThe recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
2.3 Monitoring of PatientsIntensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
2.4 Dosage AdjustmentPatients with Rash
Discontinue nevirapine if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning, Warnings and Precautions (5.2), and Patient Counseling Information (17.1)]. Do not increase nevirapine dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2) and Patient Counseling Information (17.1)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.Patients with Hepatic Events
If a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine. Do not restart nevirapine after recovery [see Warnings and Precautions (5.1)].Patients with Dose Interruption
For patients who interrupt nevirapine dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).Patients with Renal Impairment
Patients with CrCL greater than or equal to 20 mL/min do not require an adjustment in nevirapine dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. An additional 200 mg dose of nevirapine following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)]. -
Amneal Pharmaceuticals Of New York, Llc
Nevirapine | Amneal Pharmaceuticals Of New York, Llc
2.1 AdultsThe recommended dose for Nevirapine tablets, USP is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.
2.2 Pediatric PatientsThe recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
2.3 Monitoring of PatientsIntensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with Nevirapine tablets, USP. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout Nevirapine tablets, USP treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
2.4 Dosage AdjustmentPatients with Rash
Discontinue Nevirapine tablets, USP if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning, Warnings and Precautions (5.2), and Patient Counseling Information (17.1)]. Do not increase Nevirapine tablets, USP dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2) and Patient Counseling Information (17.1)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.
Patients with Hepatic Events
If a clinical (symptomatic) hepatic event occurs, permanently discontinue Nevirapine tablets, USP. Do not restart Nevirapine tablets, USP after recovery [see Warnings and Precautions (5.1)].
Patients with Dose Interruption
For patients who interrupt Nevirapine tablets, USP dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).
Patients with Renal Impairment
Patients with CrCL greater than or equal to 20 mL/min do not require an adjustment in Nevirapine tablets, USP dosing. An additional 200 mg dose of Nevirapine tablets, USP following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine tablets, USP metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)].
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