Embeda

Embeda Manufacturers

• Stat Rx Usa Llc
  

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  Embeda | Stat Rx Usa Llc

  

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  2 DOSAGE AND ADMINISTRATION

  Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Physicians should 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 and Federation of State Medical Boards Model Guidelines.

  Care should be taken to use low initial doses of EMBEDA in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications.

  The 100 mg/4 mg capsules are for use only in opioid-tolerant patients.

  EMBEDA is to be swallowed whole or the contents of the capsules sprinkled on apple sauce and taken by mouth. The pellets in the capsules are not to be crushed, dissolved, or chewed before swallowing.

  2.1 Initiating Therapy with EMBEDA

  It is critical to 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 EMBEDA, attention should be given to:

  1) the total daily dose, potency, and kind of opioid the patient has been taking previously;
  2) the reliability of the relative potency estimate used to calculate the equivalent dose of morphine needed (Note: potency estimates may vary with the route of administration);
  3) the patient's degree of opioid experience and opioid tolerance;
  4) the general condition and medical status of the patient;
  5) concurrent medication;
  6) the type and severity of the patient's pain.

  The following dosing recommendations can be considered approaches to what is actually a series of clinical decisions over time in the management of the pain of an individual patient:

  Use of EMBEDA as the First Opioid Analgesic

  The lowest dose of EMBEDA should be used as the initial opioid analgesic in patients with chronic pain. Patients may subsequently be titrated to a once or twice a day dosage which adequately manages their pain.

  Conversion from Other Oral Morphine Formulations to EMBEDA

  Patients on other oral morphine formulations may be converted to EMBEDA by administering one-half of the patient's total daily oral morphine dose as EMBEDA every 12 hours (twice-a-day) or by administering the total daily oral morphine dose as EMBEDA every 24 hours (once-a-day). EMBEDA should not be given more frequently than every 12 hours.

  Conversion from Oral Opioids, Parenteral Morphine, or Other Parenteral Opioids to EMBEDA

  EMBEDA can be administered to patients previously receiving treatment with parenteral morphine or other opioids. While there are useful tables of oral and parenteral equivalents in cancer analgesia, there is substantial inter-patient variation in the relative potency of different opioid drugs and formulations. For these reasons, it is better to underestimate the patient's 24-hour oral morphine requirement and provide rescue medication than to overestimate and manage an adverse event. The following general points should be considered:

  Parenteral to Oral Morphine Ratio: It may take anywhere from 2-6 mg of oral morphine to provide analgesia equivalent to 1 mg of parenteral morphine. A dose of oral morphine three times the daily parenteral morphine requirement may be sufficient in chronic use settings. Other Oral or Parenteral Opioids to Oral Morphine Sulfate: There is lack of systematic evidence bearing on these types of analgesic substitutions. Therefore, specific recommendations are not possible. Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safest to give half of the estimated daily morphine demand as the initial dose and to manage inadequate analgesia by supplementation with immediate-release morphine.

  The first dose of EMBEDA may be taken with the last dose of any immediate-release (short-acting) opioid medication due to the extended-release characteristics of EMBEDA.

  2.2 Individualization of Dosage

  Patients may develop some degree of tolerance, requiring dosage adjustment until they have achieved their individual balance between effective analgesia and opioid side effects such as confusion, sedation, and constipation.

  EMBEDA should be titrated no more frequently than every-other-day to allow patients to stabilize before escalating the dose. If breakthrough pain occurs, the dose may be supplemented with a small dose (less than 20% of the total daily dose) of a short-acting analgesic. Patients who exhibit signs of excessive opioid side effects such as sedation should have their dose reduced. Patients who experience inadequate analgesia on once-daily dosing should be switched to twice-a-day. EMBEDA should not be dosed more frequently than every 12 hours.

  During periods of changing analgesic requirements including initial titration, frequent communication is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family.

  2.3 Alternative Methods of Administration

  Patients who have difficulty swallowing whole capsules or tablets may benefit from an alternative method of administration. EMBEDA pellets may be sprinkled over apple sauce. Other foods have not been tested and should not be substituted for apple sauce.

  Sprinkle the pellets onto a small amount of apple sauce and use immediately. The patient must be cautioned not to chew the pellets [see WARNINGS AND PRECAUTIONS (5)]. Rinse mouth to ensure all pellets have been swallowed. Patients should consume entire portion and should not divide apple sauce into separate doses.

  Do not administer EMBEDA pellets through a nasogastric or gastric tubes.

  2.4 Maintenance of Therapy

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control 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), the continued need for the use of opioid analgesics should be re-assessed as appropriate.

  2.5 Cessation of Therapy

  In general, EMBEDA should not be abruptly discontinued. However, EMBEDA, like other opioids, can be safely discontinued without the development of withdrawal symptoms by slowly tapering the daily dose.

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• Pfizer Laboratories Div Pfizer Inc
  

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  Embeda | Proficient Rx Lp

  

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  Cephalexin is administered orally.

  Adults

  The adult dosage ranges from 1 to 4 g daily in divided doses. The 333 mg and 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

  Pediatric Patients

  The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

  Cephalexin Suspension

  Weight

  125 mg/5 mL

  250 mg/5 mL

  10 kg (22 lb)

  1/2 to 1 tsp q.i.d.

  1/4 to 1/2 tsp q.i.d.

  20 kg (44 lb)

  1 to 2 tsp q.i.d.

  1/2 to 1 tsp q.i.d.

  40 kg (88 lb)

  2 to 4 tsp q.i.d.

  1 to 2 tsp q.i.d.

  Or

  Weight

  125 mg/5 mL

  250 mg/5 mL

  10 kg (22 lb)

  1 to 2 tsp b.i.d.

  1/2 to 1 tsp b.i.d

  20 kg (44 lb)

  2 to 4 tsp b.i.d.

  1 to 2 tsp b.i.d.

  40 kg (88 lb)

  4 to 8 tsp b.i.d.

  2 to 4 tsp b.i.d.

  In severe infections, the dosage may be doubled.

  In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.

  In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.

  Directions for Mixing

  250 mg per 5 mL (200 mL when mixed): Prepare suspension at time of dispensing. Add to the bottle a total of 140 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 250 mg cephalexin in each 5 mL (teaspoonful).

  * After mixing, store in refrigerator. May be kept for 14 days without significant loss of potency.

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