Lehigh Valley Technologies, Inc.

Lehigh Valley Technologies, Inc. Drugs

• Potassium Chloride
  

  ×

  Potassium Chloride

  

  ---

  2.1 Administration and Monitoring

  If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation.

  Monitoring

  Monitor serum potassium and adjust dosages accordingly. For treatment of hypokalemia, monitor potassium levels daily or more often depending on the severity of hypokalemia until they return to normal. Monitor potassium levels monthly to biannually for maintenance or prophylaxis.

  The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms and the clinical status of the patient. Correct volume status, acid-base balance and electrolyte deficits as appropriate.

  Administration

  Dilute the potassium chloride for oral solution with at least 4 ounces of cold water [see Warnings and Precautions (5.1)].

  Take with meals or immediately after eating.

  2.2 Adult Dosing

  Treatment of hypokalemia:

  Daily dose range from 40 to 100 mEq. Give in 2 to 5 divided doses: limit doses to 40 mEq per dose. The total daily dose should not exceed 200 mEq in a 24 hour period.

  Maintenance or Prophylaxis

  Typical dose is 20 mEq per day. Individualize dose based upon serum potassium levels.

  Studies support the use of potassium replacement in digitalis toxicity. When alkalosis is present, normokalemia and hyperkalemia may obscure a total potassium deficit. The advisability of use of potassium replacement in the setting of hyperkalemia is uncertain.

  2.3 Pediatric Dosing

  Treatment of hypokalemia:

  Pediatric patients aged birth to 16 years old: The initial dose is 2 to 4 mEq/kg/day in divided doses; do not exceed as a single dose 1 mEq/kg or 40 mEq, whichever is lower; maximum daily doses should not exceed 100 mEq. If deficits are severe or ongoing losses are great, consider intravenous therapy.

  Maintenance or Prophylaxis

  Pediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day.

  Close
  More Info
• Potassium Chloride Solu...
  

  ×

  Potassium Chloride Solution

  

  ---

  2.1 Administration and Monitoring

  Monitoring

  Monitor serum potassium and adjust dosages accordingly. For treatment of hypokalemia, monitor potassium levels daily or more often depending on the severity of hypokalemia until they return to normal. Monitor potassium levels monthly to biannually for maintenance or prophylaxis.

  The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms and the clinical status of the patient. Correct volume status, acid-base balance and electrolyte deficits as appropriate.

  Administration

  Dilute the potassium chloride solution with at least 4 ounces of cold water [see Warnings and Precautions (5.1)].

  Take with meals or immediately after eating.

  If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation.

  2.2 Adult Dosing

  Treatment of hypokalemia

  Daily dose range from 40 to 100 mEq. Give in 2 to 5 divided doses: limit doses to 40 mEq per dose. The total daily dose should not exceed 200 mEq in a 24 hour period.

  Maintenance or Prophylaxis

  Typical dose is 20 mEq per day. Individualize dose based upon serum potassium levels.

  Studies support the use of potassium replacement in digitalis toxicity. When alkalosis is present, normokalemia and hyperkalemia may obscure a total potassium deficit. The advisability of use of potassium replacement in the setting of hyperkalemia is uncertain.

  2.3 Pediatric Dosing

  Treatment of hypokalemia

  Pediatric patients aged birth to 16 years old: The initial dose is 2 to 4 mEq/kg/day in divided doses; do not exceed as a single dose 1 mEq/kg or 40 mEq, whichever is lower; maximum daily doses should not exceed 100 mEq. If deficits are severe or ongoing losses are great, consider intravenous therapy.

  Maintenance or Prophylaxis

  Pediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day.

  Close
  More Info
• Oxycodone Hydrochloride...
  

  ×

  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-Naive 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.

  Close
  More Info
• Nystatin Suspension
  

  ×

  Nystatin Suspension

  

  ---

  Infants

  2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes).

  NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

  Children and Adults

  4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.

  Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.

  Close
  More Info
• Hydrocodone Bitartrate ...
  

  ×

  Hydrocodone Bitartrate And Acetaminophen Solution

  

  ---

  Dosage should be adjusted according to severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

  The usual adult dosage is one tablespoonful every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 6 tablespoonfuls.

  The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.27 mL/kg of hydrocodone bitartrate and acetaminophen oral solution (providing 0.135 mg/kg of hydrocodone bitartrate and 5.85 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.

  Body Weight Approximate Age Dose every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE(6 doses per day) 12 to 15 kg27 to 34 lbs. 2 to 3 years ¾ teaspoonful = 3.75 mL 4½ teaspoonfuls =22.5 mL 16 to 22 kg35 to 50 lbs 4 to 6 years 1 teaspoonful = 5 mL 6 teaspoonfuls = 30 mL 23 to 31 kg51 to 69 lbs 7 to 9 years 1½ teaspoonfuls = 7.5 mL 9 teaspoonfuls = 45 mL 32 to 45 kg70 to 100 lbs. 10 to 13 years 2 teaspoonfuls = 10 mL 12 teaspoonfuls = 60 mL 46 kg and up101 lbs. and up 14 years to adult 1 Tablespoonful = 15 mL 6 Tablespoonfuls = 90 mL

  The total daily dosage for children should not exceed 6 doses per day.

  It is of utmost importance that the dose of hydrocodone bitartrate and acetaminophen oral solution be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that caregivers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage.

  Close
  More Info
• Phenytoin Suspension
  

  ×

  Phenytoin Suspension

  

  ---

  Serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid form. The free acid form of phenytoin is used in Phenytoin Oral Suspension, USP. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa.

  General

  Dosage should be individualized to provide maximum benefit. In some cases serum blood level determinations may be necessary for optimal dosage adjustments—the clinically effective serum level is usually 10–20 mcg/mL. With recommended dosage, a period of seven to ten days may be required to achieve steady-state blood levels with phenytoin and changes in dosage (increase or decrease) should not be carried out at intervals shorter than seven to ten days.

  Adult Dose

  Patients who have received no previous treatment may be started on one teaspoonful (5 mL) of Phenytoin Oral Suspension, USP three times daily, and the dose is then adjusted to suit individual requirements. An increase to five teaspoonfuls daily may be made, if necessary.

  Dosing in Special Populations

  Patients with Renal or Hepatic Disease

  Due to an increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia, the interpretation of total phenytoin plasma concentrations should be made with caution. Unbound phenytoin concentrations may be more useful in these patient populations.

  Elderly Patients

  Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required.

  Pediatric

  Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over 6 years and adolescents may require the minimum adult dose (300 mg/day).

  Close
  More Info
• Oxycodone Hydrochloride...
  

  ×

  Oxycodone Hydrochloride Solution

  

  ---

  Oxycodone Hydrochloride Oral Solution is available in two concentrations: 5 mg per 5 mL and 100 mg per 5 mL (20 mg per mL). 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 per 5 mL (20 mg per 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 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 oral solution, 5 mg per 5 mL strength. Oxycodone HCl Oral Solution: 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 tolerability of the oxycodone by the patient.

  The 100 mg per 5 mL (20 mg per 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.

  Instruct patients how to measure and take the correct dose of Oxycodone Hydrochloride Oral Solution. Advise patients to always use the enclosed oral syringe when administering Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL) to ensure the dose is measured and administered accurately.

  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 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 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, 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.

  2.4 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.

  Close
  More Info