Rexall Pain Relief

Rexall Pain Relief Manufacturers

• Dolgencorp, Llc
  

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  Rexall Pain Relief | Dolgencorp, Llc

  

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  do not take more than directed (see Liver warning) adults and children 12 years and over

   

  take 2 tablets every 6 hours as needed do not take more than 8 tablets in 24 hours children under 12 years do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

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• Dolgencorp Inc
  

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  Rexall Pain Relief | Teva Pharmaceuticals Usa Inc

  

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  2.1 Important Administration Instructions

  Quetiapine tablets can be taken with or without food.

  2.2 Recommended Dosing

  The recommended initial dose, titration, dose range and maximum quetiapine tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].

  Table 1: Recommended Dosing for Quetiapine Tablets * N/A Not applicable

  Indication

  Initial Dose and Titration

  Recommended

  Dose

  Maximum Dose

  Schizophrenia-Adults

  Day 1: 25 mg twice daily.

  Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.

  Further adjustments can be made in

  increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.

  150 to 750

  mg/day

  750 mg/day

  Schizophrenia-

  Adolescents (13 to 17 years)

  Day 1: 25 mg twice daily.

  Day 2: Twice daily dosing totaling 100 mg.

  Day 3: Twice daily dosing totaling 200 mg.

  Day 4: Twice daily dosing totaling 300 mg.

  Day 5: Twice daily dosing totaling 400 mg.

  Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day.

  Based on response and tolerability, may be administered three times daily.

  400 to 800 mg/day

  800 mg/day

  Schizophrenia-

  Maintenance

  N/A*

  400 to 800

  mg/day

  800 mg/day

  Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex

  Day 1: Twice daily dosing totaling 100 mg.

  Day 2: Twice daily dosing totaling 200 mg.

  Day 3: Twice daily dosing totaling 300 mg.

  Day 4: Twice daily dosing totaling 400 mg.

  Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.

  400 to 800

  mg/day

  800 mg/day

  Bipolar Mania-Children and Adolescents
  (10 to 17 years),

  Monotherapy

  Day 1: 25 mg twice daily.

  Day 2: Twice daily dosing totaling 100 mg.

  Day 3: Twice daily dosing totaling 200 mg.

  Day 4: Twice daily dosing totaling 300 mg.

  Day 5: Twice daily dosing totaling 400 mg.

  Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.

  Based on response and tolerability, may be administered three times daily.

  400 to 600

  mg/day

  600 mg/day

  Bipolar Depression-

  Adults

  Administer once daily at bedtime.

  Day 1: 50 mg

  Day 2: 100 mg

  Day 3: 200 mg

  Day 4: 300 mg

  300 mg/day

  300 mg/day

  Bipolar I Disorder

  Maintenance Therapy- Adults

  Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex.

  Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.

  400 to 800

  mg/day

  800 mg/day

  Maintenance Treatment for Schizophrenia and Bipolar I Disorder

  Maintenance Treatment—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].

  2.3 Dose Modifications in Elderly Patients

  Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.

  Elderly patients should be started on quetiapine tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.

  2.4 Dose Modifications in Hepatically Impaired Patients

  Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.

  2.5 Dose Modifications when used with CYP3A4 Inhibitors

  Quetiapine tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].

  2.6 Dose Modifications when used with CYP3A4 Inducers

  Quetiapine tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].

  2.7 Reinitiation of Treatment in Patients Previously Discontinued

  Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.

  2.8 Switching from Antipsychotics

  There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.

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• Dolgencorp, Llc
  

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  Rexall Pain Relief | Dolgencorp, Llc

  

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  • do not take more than directed (see overdose warning)

  adults and children

  12 years and over

  • take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor

  children under

  12 years

  ask a doctor

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