Edenbridge Pharmaceuticals, Llc

Edenbridge Pharmaceuticals, Llc Drugs

• Bumetanide
  

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  Bumetanide

  

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  Dosage should be individualized with careful monitoring of patient response.

  Oral Administration

  The usual total daily dosage of bumetanide tablets is 0.5 mg to 2 mg and in most patients is given as a single dose.

  If the diuretic response to an initial dose of bumetanide tablets is not adequate, in view of its rapid onset and short duration of action, a second or third dose may be given at 4- to 5-hour intervals up to a maximum daily dose of 10 mg. An intermittent dose schedule, whereby bumetanide tablets is given on alternate days or for 3 to 4 days with rest periods of 1 to 2 days in between, is recommended as the safest and most effective method for the continued control of edema. In patients with hepatic failure, the dosage should be kept to a minimum and, if necessary, dosage increased very carefully.

  Because cross-sensitivity with furosemide has rarely been observed, bumetanide can be substituted at approximately a 1:40 ratio of bumetanide in proportion to furosemide in patients allergic to furosemide.

  Parenteral Administration

  Bumetanide injection may be administered parenterally (IV or IM) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical.

  Parenteral treatment should be terminated and oral treatment instituted as soon as possible.

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• Opium Tincture Deodoriz...
  

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  Opium Tincture Deodorized

  

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  Usual Adult Dose – 0.6 mL orally 4 times a day.

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• Stavudine
  

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  Stavudine

  

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  The interval between doses of stavudine should be 12 hours. Stavudine may be taken with or without food.

  2.1 Recommended Adult Dosage

  The recommended adult dosage is based on body weight as follows:

  For patients weighing less than 60 kg: 30 mg every 12 hours. For patients weighing at least 60 kg: 40 mg every 12 hours.

  2.2 Recommended Pediatric Dosage

  For newborns from birth to 13 days old: 0.5 mg/kg given every 12 hours. For pediatric patients at least 14 days old and weighing less than 30 kg: 1 mg/kg given every 12 hours. For pediatric patients weighing at least 30 kg: use the recommended adult dosage.

  2.3 Dosage Adjustment

  Renal Impairment

  Adult Patients: Stavudine may be administered to adult patients with impaired renal function with an adjustment in dosage as shown in Table 1.

  Table 1: Recommended Dosage Adjustment for Adult Patients with Renal Impairment Creatinine Clearance Recommended Stavudine Dose by Patient Weight (mL/min) At least 60 kg Less than 60 kg * Administered after the completion of hemodialysis on dialysis days and at the same time of day on non-dialysis days. greater than 50 40 mg every 12 hours 30 mg every 12 hours 26 – 50 20 mg every 12 hours 15 mg every 12 hours 10 – 25 20 mg every 24 hours 15 mg every 24 hours Hemodialysis 20 mg every 24 hours* 15 mg every 24 hours*

  Pediatric Patients: Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, the clearance of stavudine may be altered in children with renal impairment. There are insufficient data to recommend a specific dose adjustment of stavudine in this patient population.

  2.4 Method of Preparation for Oral Solution

  Prior to dispensing, the pharmacist must constitute the dry powder with purified water to a concentration of 1 mg stavudine per mL of solution, as follows:

  Add 200 mL of purified water to the container. Shake container vigorously until the powder dissolves completely. Constitution in this way produces 200 mL (deliverable volume) of 1 mg/mL stavudine solution. The solution may appear slightly hazy. Dispense solution in original container with measuring cup provided. Instruct patient to shake the container vigorously prior to measuring each dose and to store the tightly closed container in a refrigerator, 2°C to 8°C (36°F to 46°F). Discard any unused portion after 30 days.

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• Zidovudine
  

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  Zidovudine

  

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  2.1 Treatment of HIV-1 Infection

  Adults: The recommended oral dose of zidovudine is 600 mg/day in divided doses in combination with other antiretroviral agents.

  Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of Zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

  Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.

  Before prescribing Zidovudine capsules, children should be assessed for the ability to swallow capsules. If a child is unable to reliably swallow a Zidovudine capsule, the Zidovudine syrup formulation should be prescribed.

  The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets or capsules are not appropriate.

  Table 1: Recommended Pediatric Dosage of Zidovudine Body Weight (kg) Total Daily Dose Dosage Regimen and Dose Twice Daily Three Times Daily 4 to <9 24 mg/kg/day 12 mg/kg 8 mg/kg ≥ 9 to <30 18 mg/kg/day 9 mg/kg 6 mg/kg ≥ 30 600 mg/day 300 mg 200 mg

  Alternatively, dosing for zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

  2.2 Prevention of Maternal-Fetal HIV-1 Transmission

  The recommended dosage 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 [see Clinical Studies (14.3)]. During labor and delivery, intravenous Zidovudine 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: 2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours.

  2.3 Patients With Severe Anemia and/or Neutropenia

  Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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.

  2.4 Patients With Renal Impairment

  End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].

  2.5 Patients With Hepatic Impairment

  There are insufficient data to recommend dose adjustment of Zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.

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• Methenamine Mandelate
  

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  Methenamine Mandelate

  

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  The average adult dose is 4 grams daily given as 1 gram after each meal and at bedtime. Children 6 to 12 should receive half the adult dose, and children under 6 years of age should receive 250 mg per 30 lb body weight, four times daily. (See chart) Since an acid urine is essential for antibacterial activity, with maximum efficacy occurring at pH 5.5 or below, restriction of alkalinizing foods and medication is thus desirable. If testing of urine pH reveals the need, supplemental acidification should be given.

  Dosages Dosage Adults PediatricPatients Tablets Tablets 1000mg 1 tablet qid  - 500mg 2 tablets qid (Ages 6-12)1 tablet qid

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• Zidovudine Syrup
  

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  Zidovudine Syrup

  

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  2.1 Treatment of HIV-1 Infection

  Adults: The recommended oral dose of zidovudine is 600 mg/day in divided doses in combination with other antiretroviral agents.

  Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of Zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

  Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.

  Before prescribing Zidovudine Capsules or Tablets, children should be assessed for the ability to swallow capsules or tablets. If a child is unable to reliably swallow a Zidovudine Capsule or Tablet, the Zidovudine oral solution should be prescribed.

  The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine oral solution should be used to provide accurate dosage when whole tablets or capsules are not appropriate.

  Table 1: Recommended Pediatric Dosage of Zidovudine Body Weight (kg) Total Daily Dose Dosage Regimen and Dose Twice Daily Three Times Daily 4 to <9 24 mg/kg/day 12 mg/kg 8 mg/kg ≥9 to <30 18 mg/kg/day 9 mg/kg 6 mg/kg ≥30 600 mg/day 300 mg 200 mg

  Alternatively, dosing for zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

  2.2 Prevention of Maternal-Fetal HIV-1 Transmission

  The recommended dosage 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 [see Clinical Studies (14.3)]. During labor and delivery, intravenous zidovudine 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 zidovudine intravenously. See Table 2.

  Table 2. Recommended Neonatal Dosages of Zidovudine 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

  2.3 Patients With Severe Anemia and/or Neutropenia

  Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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.

  2.4 Patients With Renal Impairment

  End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].

  2.5 Patients With Hepatic Impairment

  There are insufficient data to recommend dose adjustment of zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.

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• Limencin Patch
  

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  Limencin Patch

  

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  Strongyloidiasis

  The recommended dosage of ivermectin Tablets for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg of ivermectin per kg of body weight. See Table 1 for dosage guidelines. Patients should take tablets on an empty stomach with water (See CLINICAL PHARMACOLOGY, Pharmacokinetics). In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection (See CLINICAL PHARMACOLOGY, Clinical Studies).

  Table 1: Dosage Guidelines for Ivermectin Tablets for Strongyloidiasis Body Weight (kg) Single Oral DoseNumber of 3-mg Tablets 15 to 24 1 tablet 25 to 35 2 tablets 36 to 50 3 tablets 51 to 65 4 tablets 66 to 79 5 tablets ≥80 200 mcg/kg

  Onchocerciasis

  The recommended dosage of ivermectin Tablets for the treatment of onchocerciasis is a single oral dose designed to provide approximately 150 mcg of ivermectin per kg of body weight. See Table 2 for dosage guidelines. Patients should take tablets on an empty stomach with water (See CLINICAL PHARMACOLOGY, Pharmacokinetics). In mass distribution campaigns in international treatment programs, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.

  Table 2: Dosage Guidelines for Ivermectin Tablets for Onchocerciasis Body Weight (kg) Single Oral DoseNumber of 3-mg Tablets 15 to 25 1 tablet 26 to 44 2 tablets 45 to 64 3 tablets 65 to 84 4 tablets ≥85 150 mcg/kg

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