Glenmark Generics Inc
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Glenmark Generics Inc Drugs
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![Oxycodone Hydrochloride Capsule [Glenmark Generics, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=566ef74d-5c0b-49bf-9619-e757d16431ef&name=oxycodone-02.jpg)
Oxycodone Hydrochloride
Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.
2.1 Individualization of Dosage
As with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of oxycodone hydrochloride, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.
During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family.
2.2 Initiation of Therapy in Opioid-Naïve Patients
Start patients who have not been receiving opioid analgesics on oxycodone hydrochloride in the following dosing range using Oxycodone Hydrochloride Capsules, 5 mg strength:
Oxycodone Hydrochloride Capsules: 5 to 15 mg every 4 to 6 hours as needed for pain.
Titrate the dose based upon the individual patient's response to their initial dose of oxycodone hydrochloride. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the oxycodone by the patient.
2.3 Conversion to Oral Oxycodone Hydrochloride
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of oxycodone hydrochloride. It is better to underestimate a patient's 24-hour oral oxycodone hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral oxycodone hydrochloride dose and manage an adverse experience of overdose.
Consider the following general points regarding opioid conversions.
Conversion From other Non-Oxycodone Opioids to Oral Oxycodone Hydrochloride.
In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.
Conversion From Controlled-Release Oral Oxycodone to Oral Oxycodone Hydrochloride.
The relative bioavailability of Oxycodone Hydrochloride Capsule compared to controlled-release oxycodone is unknown. The extended duration of release of oxycodone hydrochloride from controlled-release tablets results in reduced maximum and increased minimum plasma oxycodone hydrochloride concentrations than with shorter acting oxycodone hydrochloride products. Conversion from controlled-release tablets could lead to excessive sedation at peak serum levels. Therefore, dose adjustment with close observation is necessary.
Conversion From Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone
The relative bioavailability of Oxycodone Hydrochloride Capsules compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.4 Maintenance of Therapy
Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.
2.5 Cessation of Therapy
When a patient no longer requires therapy with oxycodone hydrochloride gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.
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![Oxycodone Hydrochloride Solution [Glenmark Generics, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7290eb06-641a-43df-9a23-74288ca1e25d&name=oxycodone-03.jpg)
Oxycodone Hydrochloride Solution
Take care when prescribing and administering Oxycodone Hydrochloride Oral Solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated oral syringe when administering Oxycodone Hydrochloride Oral Solution, 100 mg/5 mL (20 mg/mL), to ensure the dose is measured and administered accurately.
Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.
2.1 Individualization of Dosage
As with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of oxycodone hydrochloride, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.
During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family.
2.2 Conversion to Oral Oxycodone Hydrochloride
The 100 mg/5 mL (20 mg/mL) oral solution formulation is for use in opioid-tolerant patients only who have already been receiving opioid therapy. Use this strength only for patients that have already been titrated to a stable analgesic regimen using lower strengths of oxycodone hydrochloride and who can benefit from use of a smaller volume of oral solution.
There is inter-patient variability in the potency of opioid drugs and opioid formulations.
Therefore, a conservative approach is advised when determining the total daily dose of Oxycodone Hydrochloride. It is better to underestimate a patient's 24-hour oral Oxycodone Hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral Oxycodone Hydrochloride dose and manage an adverse experience of overdose.
Consider the following general points regarding opioid conversions.
Conversion From Non-Oxycodone Opioids to Oral Oxycodone Hydrochloride.
In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.
Conversion From Controlled-Release Oral Oxycodone to Oral Oxycodone Hydrochloride.
The relative bioavailability of Oxycodone Hydrochloride Oral Solution compound to controlled-release oxycodone is unknown. The extended duration of release of oxycodone hydrochloride from controlled-release tablets results in reduced maximum and increased minimum plasma oxycodone hydrochloride concentrations than with shorter acting oxycodone hydrochloride products. Conversion from controlled-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.
Conversion From Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone
The relative bioavailability of Oxycodone Hydrochloride Oral Solution compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.3 Maintenance of Therapy
Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.
2.4 Cessation of Therapy
When a patient no longer requires therapy with oxycodone hydrochloride gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.
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![Heather (Norethindrone) Tablet [Glenmark Generics Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=bac27291-bf77-4545-ad48-772eb780aa66-06.jpg)
Heather
To achieve maximum contraceptive effectiveness, HEATHER must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See PATIENT LABELING for detailed instructions.
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![Atovaquone And Proguanil Hydrochloride Pediatric (Atovaquone And Proguanil Hydrochloride) Tablet, Film Coated [Glenmark Generics Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=88061724-7578-4f74-b1ab-5ad3519778e2&name=ato-prog-spl-graphic-03.jpg)
Atovaquone And Proguanil Hydrochloride Pediatric
The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.
Prevention of Malaria
Prophylactic treatment with atovaquone and proguanil hydrochloride should be started 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.
Pediatric Patients
The dosage for prevention of malaria in pediatric patients is based upon body weight (Table 5).
Table 5. Dosage for Prevention of Malaria in Pediatric PatientsWeight
(kg)
Atovaquone/
Proguanil HCl
Total Daily Dose
Dosage Regimen
11-20
62.5 mg/25 mg
1 Atovaquone and Proguanil Hydrochloride Pediatric Tablet daily
21-30
125 mg/50 mg
2 Atovaquone and Proguanil Hydrochloride Pediatric Tablets as a single dose daily
31-40
187.5 mg/75 mg
3 Atovaquone and Proguanil Hydrochloride Pediatric Tablets as a single dose daily
>40
250 mg/100 mg
1 Atovaquone and Proguanil Hydrochloride Tablet (adult strength) as a single dose daily
See prescribing information for Atovaquone and Proguanil Hydrochloride Tablets (adult strength).
Treatment of Acute Malaria
Pediatric Patients
The dosage for treatment of acute malaria in pediatric patients is based upon body weight (Table 6).
Table 6. Dosage for Treatment of Acute Malaria in Pediatric PatientsWeight
(kg)
Atovaquone/
Proguanil HCl
Total Daily Dose
Dosage Regimen
5-8
125 mg/50 mg
2 Atovaquone and Proguanil Hydrochloride Pediatric Tablets daily for 3 consecutive days
9-10
187.5 mg/75 mg
3 Atovaquone and Proguanil Hydrochloride Pediatric Tablets daily for 3 consecutive days
11-20
250 mg/100 mg
1 Atovaquone and Proguanil Hydrochloride Tablet (adult strength) daily for 3 consecutive days
21-30
500 mg/200 mg
2 Atovaquone and Proguanil Hydrochloride Tablets (adult strength) as a single dose daily for 3 consecutive days
31-40
750 mg/300 mg
3 Atovaquone and Proguanil Hydrochloride Tablets (adult strength) as a single dose daily for 3 consecutive days
>40
1 g/400 mg
4 Atovaquone and Proguanil Hydrochloride Tablets (adult strength) as a single dose daily for 3 consecutive days
See prescribing information for Atovaquone and Proguanil Hydrochloride Tablets (adult strength).
Atovaquone and proguanil hydrochloride tablets may be crushed and mixed with condensed milk just prior to administration for children who may have difficulty swallowing tablets.
Patients With Renal Impairment
Atovaquone and proguanil hydrochloride tablets should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). Atovaquone and proguanil hydrochloride tablets may be used with caution for the treatment of malaria in patients with severe renal impairment (creatinine clearance <30 mL/min), only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure (see CLINICAL PHARMACOLOGY: Special Populations: Renal Impairment). No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 50 mL/min) renal impairment (see CLINICAL PHARMACOLOGY: Special Populations).
Patients With Hepatic Impairment
No dosage adjustments are needed in patients with mild to moderate hepatic impairment. No studies have been conducted in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations: Hepatic Impairment).
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