Retrovir

Retrovir Manufacturers

• Viiv Healthcare Company
  

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  Retrovir | Amneal Pharmaceuticals Of New York, Llc

  

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  Table 1. Recommended Daily Dosage by Indication    Initial Dose  Titration
  (Increments)  Target Dose  Effective DoseRange  Schizophrenia: adults(2.1)  2 mg  1 to 2 mg  4 to 8 mg  4 to 16 mg  Schizophrenia:adolescents(2.2)  0.5 mg  0.5 to 1 mg  3 mg  1 to 6 mg  Bipolar mania: adults(2.2)  2 to 3 mg  1mg  1 to 6mg  1 to 6 mg  Bipolar mania:children andadolescents(2.2)  0.5 mg  0.5 to 1mg  1 to 2.5 mg  1 to 6 mg  Irritability in autisticdisorder (2.3)  0.25 mgCan increase to0.5 mg by Day 4:(body weight lessthan 20 kg)
  
  0.5 mgCan increase to1 mg by Day 4:(body weightgreater than orequal to 20 kg)  After Day 4, atintervals of > 2weeks:0.25 mg(body weight lessthan 20 kg)
  
  0.5 mg:(body weightgreater than orequal to 20 kg)  0.5 mg:(body weight lessthan 20 kg)
  
  1 mg:(body weightgreater than or equal to 20 kg)  0.5 to 3 mg

  Severe Renal and Hepatic Impairment in Adults: use a lower starting dose of 0.5 mg twice daily.

  May increase to dosages above 1.5 mg twice daily at intervals of one week or longer.

  2.1 Schizophrenia

  Adults

  Usual Initial Dose

  Risperidone oral solution, USP can be administered once or twice daily. Initial dosing is 2 mg/day. May increase the dose at intervals of 24 hours or greater, in increments of 1 to 2 mg per day, as tolerated, to a recommended dose of 4 to 8 mg perday. In some patients, slower titration may be appropriate. Efficacy has been demonstrated in a range of 4 to 16 mg perday. However, doses above 6 mg per day for twice daily dosing were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are generally not recommended. In a single study supporting once-daily dosing, the efficacy results were generally stronger for 8 mg than for 4 mg. The safety of doses above 16 mg perday has not been evaluated in clinical trials [see Clinical Studies (14.1)].

  Adolescents

  The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg perday, as tolerated, to a recommended dose of 3 mg per day. Although efficacy has been demonstrated in studies of adolescent patients with schizophrenia at doses between 1 mg and 6 mg per day, no additional benefit was observed above 3 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied.

  Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.

  Maintenance Therapy

  While it is unknown how long a patient with schizophrenia should remain on risperidone oral solution, USP, the effectiveness of risperidone oral solution, USP 2 mg per day to 8 mg per day at delaying relapse was demonstrated in a controlled trial in adult patients who had been clinically stable for at least 4 weeks and were then followed for a period of 1 to 2 years [see Clinical Studies (14.1)]. Both adult and adolescent patients who respond acutely should generally be maintained on their effective dose beyond the acute episode. Patients should be periodically reassessed to determine the need for maintenance treatment.

  Reinitiation of Treatment in Patients Previously Discontinued

  Although there are no data to specifically address reinitiation of treatment, it is recommended that after an interval off risperidone oral solution, USP, the initial titration schedule should be followed.

  Switching From Other Antipsychotics

  There are no systematically collected data to specifically address switching schizophrenic patients from other antipsychotics to risperidone oral solution, USP, or treating patients with concomitant antipsychotics.

  2.2 Bipolar Mania

  Usual Dose

  Adults

  The initial dose range is 2 mg to 3 mg per day. The dose may be adjusted at intervals of 24 hours or greater, in increments of 1 mg per day. The effective dose range is 1 mg to 6 mg per day, as studied in the short-term, placebo-controlled trials. In these trials, short-term (3-week) anti-manic efficacy was demonstrated in a flexible dosage range of 1 mg to 6 mg per day [see Clinical Studies (14.2,14.3)]. Risperidone oral solution, USP doses higher than 6 mg per day were not studied.

  Pediatrics

  The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg per day, as tolerated, to the recommended target dose of 1 mg to 2.5 mg per day. Although efficacy has been demonstrated in studies of pediatric patients with bipolar mania at doses between 0.5 and 6 mg per day, no additional benefit was observed above 2.5 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied.

  Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.

  Maintenance Therapy

  There is no body of evidence available from controlled trials to guide a clinician in the longer-term management of a patient who improves during treatment of an acute manic episode with risperidone oral solution, USP. While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no systematically obtained data to support the use of risperidone oral solution, USP in such longer-term treatment (i.e., beyond 3 weeks). The physician who elects to use risperidone oral solution, USP for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

  2.3 Irritability Associated with Autistic Disorder – Pediatrics (Children and Adolescents)

  The safety and effectiveness of risperidone oral solution, USP in pediatric patients with autistic disorder less than 5 years of age have not been established.

  The dosage of risperidone oral solution, USP should be individualized according to the response and tolerability of the patient. The total daily dose of risperidone oral solution, USP can be administered once daily, or half the total daily dose can be administered twice daily.

  For patients with body weight less than 20 kg, initiate dosing at 0.25 mg per day. For patients with body weight greater than or equal to 20 kg, initiate dosing at 0.5 mg per day. After a minimum of four days, the dose may be increased to the recommended dose of 0.5 mg per day for patients less than 20 kg and 1 mg per day for patients greater than or equal to 20 kg. Maintain this dose for a minimum of 14 days. In patients not achieving sufficient clinical response, the dose may be increased at intervals of 2 weeks or greater, in increments of 0.25 mg per day for patients less than 20 kg, or increments of 0.5 mg per day for patients greater than or equal to 20 kg. The effective dose range is 0.5 mg to 3 mg per day. No dosing data are available for children who weigh less than 15 kg.

  Once sufficient clinical response has been achieved and maintained, consider gradually lowering the dose to achieve the optimal balance of efficacy and safety. The physician who elects to use risperidone oral solution, USP for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

  Patients experiencing persistent somnolence may benefit from a once-daily dose administered at bedtime or administering half the daily dose twice daily, or a reduction of the dose.

  2.4 Dosage in Patients with Severe Renal or Hepatic Impairment

  For patients with severe renal impairment (CLcr < 30 mL/min) or hepatic impairment (10 to 15 points on Child Pugh System), the initial starting dose is 0.5 mg twice daily. The dose may be increased in increments of 0.5 mg or less, administered twice daily. For doses above 1.5 mg twice daily, increase in intervals of one week or greater [see Use in Specific Populations (8.6 and 8.7)].

  2.5 Dose Adjustments for Specific Drug Interactions

  When risperidone oral solution, USP is co-administered with enzyme inducers (e.g., carbamazepine), the dose of risperidone oral solution, USP should be increased up to double the patient’s usual dose. It may be necessary to decrease the risperidone oral solution, USP dose when enzyme inducers such as carbamazepine are discontinued [see Drug Interactions (7.1)]. Similar effect may be expected with co-administration of risperidone oral solution, USP with other enzyme inducers (e.g., phenytoin, rifampin, phenobarbital).

  When fluoxetine or paroxetine is co-administered with risperidone oral solution, USP, the dose of risperidone oral solution, USP should be reduced. The risperidone oral solution, USP dose should not exceed 8 mg per day in adults when co-administered with these drugs. When initiating therapy, risperidone oral solution, USP should be titrated slowly. It may be necessary to increase the risperidone oral solution, USP dose when enzyme inhibitors such as fluoxetine or paroxetine are discontinued [see Drug Interactions (7.1)].

  2.6 Administration of Risperidone Oral Solution

  Risperidone oral solution, USP can be administered directly from the calibrated pipette, or can be mixed with a beverage prior to administration. Risperidone oral solution, USP is compatible in the following beverages: water, coffee, orange juice, and low-fat milk; it is NOT compatible with either cola or tea.

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• Viiv Healthcare Company
  

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  Retrovir | Viiv Healthcare Company

  

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  Adults:

  The recommended intravenous dose is 1 mg/kg infused over 1 hour. This dose should be administered 5 to 6 times daily (5 to 6 mg/kg daily). The effectiveness of this dose compared with higher dosing regimens in improving the neurologic dysfunction associated with HIV disease is unknown. A small randomized trial found a greater effect of higher doses of RETROVIR on improvement of neurological symptoms in subjects with pre-existing neurological disease.

  Patients should receive RETROVIR IV Infusion only until oral therapy can be administered. The intravenous dosing regimen equivalent to the oral administration of 100 mg every 4 hours is approximately 1 mg/kg intravenously every 4 hours.

  Maternal-Fetal HIV Transmission:

  The recommended dosing regimen for administration to pregnant women (>14 weeks of pregnancy) and their neonates is:

  Maternal Dosing: 100 mg orally 5 times per day until the start of labor. During labor and delivery, intravenous RETROVIR should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.

  Neonatal Dosing: Start neonatal dosing within 12 hours after birth and continue through 6 weeks of age. Neonates unable to receive oral dosing may be administered RETROVIR intravenously. See Table 9. (See PRECAUTIONS if hepatic disease or renal insufficiency is present.)

  Table 9. Recommended Neonatal Dosages of RETROVIR

  Route

  Total Daily Dose

  Dose and Dosage Regimen

  Oral

  8 mg/kg/day

  2 mg/kg every 6 hours

  IV

  6 mg/kg/day

  1.5 mg/kg infused over 30 minutes, every 6 hours

  Monitoring of Patients:

  Hematologic toxicities appear to be related to pretreatment bone marrow reserve and to dose and duration of therapy. In patients with poor bone marrow reserve, particularly in patients with advanced symptomatic HIV disease, frequent monitoring of hematologic indices is recommended to detect serious anemia or neutropenia (see WARNINGS). In patients who experience hematologic toxicity, reduction in hemoglobin may occur as early as 2 to 4 weeks, and neutropenia usually occurs after 6 to 8 weeks.

  Dose Adjustment:

  Anemia: Significant anemia (hemoglobin of <7.5 g/dL or reduction of >25% of baseline) and/or significant neutropenia (granulocyte count of<750 cells/mm3 or reduction of >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed (see WARNINGS). In patients who develop significant anemia, dose interruption does not necessarily eliminate the need for transfusion. If marrow recovery occurs following dose interruption, resumption in dose may be appropriate using adjunctive measures such as epoetin alfa at recommended doses, depending on hematologic indices such as serum erythropoetin level and patient tolerance.

  For patients experiencing pronounced anemia while receiving chronic coadministration of zidovudine and some of the drugs (e.g., fluconazole, valproic acid) listed in Table 4, zidovudine dose reduction may be considered.

  End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis (CrCl <15 mL/min), recommended dosing is 1 mg/kg every 6 to 8 hours (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

  Hepatic Impairment: There are insufficient data to recommend dose adjustment of RETROVIR in patients with mild to moderate impaired hepatic function or liver cirrhosis. Since RETROVIR is primarily eliminated by hepatic metabolism, a reduction in the daily dose may be necessary in these patients. Frequent monitoring of hematologic toxicities is advised (see CLINICAL PHARMACOLOGY: Pharmacokinetics and PRECAUTIONS: General).

  Method of Preparation:

  RETROVIR IV Infusion must be diluted prior to administration. The calculated dose should be removed from the 20-mL vial and added to 5% Dextrose Injection solution to achieve a concentration no greater than 4 mg/mL. Admixture in biologic or colloidal fluids (e.g., blood products, protein solutions, etc.) is not recommended.

  After dilution, the solution is physically and chemically stable for 24 hours at room temperature and 48 hours if refrigerated at 2° to 8°C (36° to 46°F). Care should be taken during admixture to prevent inadvertent contamination. As an additional precaution, the diluted solution should be administered within 8 hours if stored at 25°C (77°F) or 24 hours if refrigerated at 2° to 8°C to minimize potential administration of a microbially contaminated solution.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Should either be observed, the solution should be discarded and fresh solution prepared.

  Administration:

  RETROVIR IV Infusion is administered intravenously at a constant rate over 1 hour. Rapid infusion or bolus injection should be avoided. RETROVIR IV Infusion should not be given intramuscularly.

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