Egalet Us Inc.

Egalet Us Inc. Drugs

• Sprix
  

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  Sprix

  

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  2.1 Limitations of Use

  The total duration of use of SPRIX alone or sequentially with other formulations of ketorolac (IM/IV or oral) must not exceed 5 days because of the potential for increasing the frequency and severity of adverse reactions associated with the recommended doses [see Warnings and Precautions (5.1)]. Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with SPRIX.

  Do not use SPRIX concomitantly with other formulations of ketorolac or other NSAIDs [see Warnings and Precautions (5.1)].

  SPRIX has not been shown to be safe and effective in pediatric patients 17 years of age and younger.

  2.2 Administration

  SPRIX is not an inhaled product. Do not inhale when administering this product.

  Instruct patients to administer as follows:

  1. First hold the finger flange with fingers, and remove the clear plastic cover with opposite hand; then remove the blue plastic safety clip. Keep the clear plastic cover; and throw away the blue plastic safety clip.

  2. Before using the bottle for the FIRST time, activate the pump. To activate the pump, hold the bottle at arm’s length away from the body with index finger and middle finger resting on the top of the finger flange and thumb supporting the base.

  Press down evenly and release the pump 5 times. Patient may not see a spray the first few times he/she presses down.

  The bottle is now ready to use. There is no need to activate the pump again if more doses are used from the bottle.

  3. It’s important to get the medication to the correct place in the nose so it will be most effective.

      - Blow nose gently to clear nostrils.    - Sit up straight or stand.  Tilt head slightly forward.    - Insert the tip of the container into your right nostril.      - Point the container away from the center of your nose.     - Hold your breath and spray once into your right nostril, pressing down evenly on both sides.    - Immediately after administration, resume breathing through mouth to reduce expelling the product.  Also pinch the nose to help retain the spray if it starts to drip.

      If only one spray per dose is prescribed, administration is complete; skip to Step 5 below.

  4. If a dose of 2 sprays is prescribed, repeat the process in Step 3 for the left nostril. Again, be sure to point the spray away from the center of nose. Spray once into the left nostril.

  5. Replace the clear plastic cover and place the bottle in a cool, dry location out of direct sunlight, such as inside a medication cabinet. Keep out of reach of children.

  2.3 Adult Patients < 65 Years of Age

  The recommended dose is 31.5 mg SPRIX (one 15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily dose is 126 mg (four doses).

  2.4 Reduced Doses for Special Populations

  For patients ≥ 65 years of age, renally impaired patients, and adult patients less than 50 kg (110 lbs), the recommended dose is 15.75 mg SPRIX (one 15.75 mg spray in only one nostril) every 6 to 8 hours. The maximum daily dose is 63 mg (four doses) [see Warnings and Precautions (5.2, 5.4)].

  2.5 Discard Used SPRIX Bottle after 24 Hours

  Do not use any single SPRIX bottle for more than one day as it will not deliver the intended dose after 24 hours. Therefore, the bottle must be discarded no more than 24 hours after taking the first dose, even if the bottle still contains some liquid.

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• Mucus Relief D
  

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  Mucus Relief D

  

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  Selection of patients for treatment with OXAYDO should be governed by the same principles that apply to the use of other potent opioid analgesics. Opioid analgesics given on a fixed-dosage schedule have a narrow therapeutic index in certain patient populations, especially when combined with other drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Healthcare providers should individualize treatment in every case, using non-opioid analgesics, opioids and/or combination products when necessary, and chronic opioid therapy with drugs such as OXAYDO in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Health Care Policy and Research, and the American Pain Society.

  OXAYDO must be swallowed whole. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)]. OXAYDO is not amenable to crushing and dissolution. Do not administer OXAYDO via nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.

  2.1 Individualization of Dose

  The dose of OXAYDO should be individually adjusted according to severity of pain, and the patient’s response, weight, age, and prior analgesic treatment experience. Although it is not possible to list every condition that is important to the selection of the initial dose of OXAYDO, attention must be given to:

  the daily dose, potency and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously the reliability of the relative potency estimate to calculate the dose of oxycodone HCl needed the degree of opioid tolerance the general condition and medical status of the patient the balance between pain management and adverse reactions the type and severity of the patient’s pain risk factors for abuse or addiction, including a prior history of abuse or addiction

  2.2 Initiation of Therapy

  Patients who have not been receiving opioid analgesics should be started on OXAYDO in a dosing range of 5 mg to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient’s response to their initial dose of OXAYDO.

  Patients with chronic pain may need to be dosed at the lowest dosage level that will achieve acceptable analgesia and tolerable adverse reactions, on an around-the-clock basis rather than on an as needed basis.

  Hepatic Impairment

  Since oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. Dose initiation in such patients should follow a conservative approach. Dosages should be adjusted according to the clinical situation [see Use in Specific Populations (8.6)].

  Renal Impairment

  Published data reported that elimination of oxycodone was impaired in patients with end-stage renal failure. The mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance.

  Dose initiation in such patients should follow a conservative approach. Dosages should be adjusted according to the clinical situation [see Use in Specific Populations (8.7)].

  2.3 Conversion to OXAYDO

  Conversion from Fixed-Ratio Oral Opioid/Non-Opioid Combinations

  When converting patients from fixed-ratio opioid/non-opioid drug regimens to OXAYDO, determine whether or not to continue the non-opioid analgesic. Titrate the dose of OXAYDO in response to the level of analgesia and adverse reactions afforded by the dosing regimen regardless of whether the non-opioid is continued.

  Conversion from Other Oral Opioid Therapy to OXAYDO

  If a patient has been receiving opioid-containing medications prior to taking OXAYDO, factor the potency of the prior opioid relative to oxycodone into the selection of the total daily dose of oxycodone.

  In converting patients from other opioids to OXAYDO, close observation and adjustment of dosage based upon the patient's response to OXAYDO is imperative.

  2.4 Maintenance of Therapy

  Continual re-evaluation of the patient receiving OXAYDO is important, with special attention to the maintenance of pain management and the relative incidence of adverse reactions associated with therapy. If the level of pain increases, effort should be made to identify the source of the 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 must be re-assessed as appropriate.

  2.5 Cessation of Therapy

  When a patient no longer requires therapy with OXAYDO after chronic use, it is important that therapy be gradually tapered over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal [see Drug Abuse and Dependence (9.3) for a description of the signs and symptoms of withdrawal]. If the patient develops these signs or symptoms, the dose should be raised to the previous level and tapered more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of OXAYDO that treatment may be discontinued without risk of the opioid abstinence syndrome occurring.

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