Diclofenac Sodium And Misoprostol

Diclofenac Sodium And Misoprostol Manufacturers

• American Health Packaging
  

  ×

  Diclofenac Sodium And Misoprostol | American Health Packaging

  

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  Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with diclofenac sodium and misoprostol delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

  For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is given below.

  Diclofenac sodium and misoprostol delayed-release tablets are administered as diclofenac sodium and misoprostol delayed-release tablets (50 mg diclofenac sodium/0.2 mg misoprostol) or as diclofenac sodium and misoprostol delayed-release tablets (75 mg diclofenac sodium/0.2 mg misoprostol).

  Note: See SPECIAL DOSING CONSIDERATIONS section below.

  Osteoarthritis: The recommended dosage for maximal GI mucosal protection is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

   

   OA
  regimen

   Diclofenac sodium
  (mg/day)

   Misoprostol
  (mcg/day)

  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 50 mg/0.2 mg

   tid
   bid

   150
   100

   600
   400

  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 75 mg/0.2 mg

   bid

   150

   400

  Rheumatoid Arthritis: The recommended dosage is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid or qid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

   

   RA
  regimen

   Diclofenac sodium
  (mg/day)

   Misoprostol
  (mcg/day)

  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 50 mg/0.2 mg

   qid
   tid
   bid

   200
   150
   100

   800
   600
   400

  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 75 mg/0.2 mg

   bid

   150

   400

  SPECIAL DOSING CONSIDERATIONS: Diclofenac sodium and misoprostol delayed-release tablets contain misoprostol, which provides protection against gastric and duodenal ulcers (see CLINICAL STUDIES). For gastric ulcer prevention, the 200 mcg qid and tid regimens are therapeutically equivalent, but more protective than the bid regimen. For duodenal ulcer prevention, the qid regimen is more protective than the tid or bid regimens. However, the qid regimen is less well tolerated than the tid regimen because of usually self-limited diarrhea related to the misoprostol dose (see ADVERSE REACTIONS — Gastrointestinal), and the bid regimen may be better tolerated than tid in some patients.

  Dosages may be individualized using the separate products (misoprostol and diclofenac), after which the patient may be changed to the appropriate dose of diclofenac sodium and misoprostol delayed-release tablets. If clinically indicated, misoprostol co-therapy with diclofenac sodium and misoprostol delayed-release tablets, or use of the individual components to optimize the misoprostol dose and/or frequency of administration, may be appropriate. The total dose of misoprostol should not exceed 800 mcg/day, and no more than 200 mcg of misoprostol should be administered at any one time. Doses of diclofenac higher than 150 mg/day in osteoarthritis or higher than 225 mg/day in rheumatoid arthritis are not recommended.

  For additional information, it may be helpful to refer to the package inserts for Cytotec® tablets and Voltaren® tablets.

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• Preferred Pharmaceuticals, Inc.
  

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  Diclofenac Sodium And Misoprostol | Preferred Pharmaceuticals, Inc.

  

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  Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with diclofenac sodium and misoprostol delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

  For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is given below.

  Diclofenac sodium and misoprostol delayed-release tablets are administered as diclofenac sodium and misoprostol delayed-release tablets (50 mg diclofenac sodium/0.2 mg misoprostol) or as diclofenac sodium and misoprostol delayed-release tablets (75 mg diclofenac sodium/0.2 mg misoprostol).

  Note: See SPECIAL DOSING CONSIDERATIONS section below.

  Osteoarthritis: The recommended dosage for maximal GI mucosal protection is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

   

   OA
  regimen

   Diclofenac sodium
  (mg/day)

   Misoprostol
  (mcg/day)

   Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 50 mg/0.2 mg

   tid
  bid

   150
  100

   600
  400

   Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 75 mg/0.2 mg

   bid

   150

   400

  Rheumatoid Arthritis: The recommended dosage is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid or qid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

   

   RA
  regimen

   Diclofenac sodium
  (mg/day)

   Misoprostol
  (mcg/day)

   Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 50 mg/0.2 mg

   qid
  tid
  bid

   200
  150
  100

  800
  600
  400

   Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 75 mg/0.2 mg

   bid

   150

   400

  SPECIAL DOSING CONSIDERATIONS: Diclofenac sodium and misoprostol delayed-release tablets contain misoprostol, which provides protection against gastric and duodenal ulcers (see CLINICAL STUDIES). For gastric ulcer prevention, the0.2 mg qid and tid regimens are therapeutically equivalent, but more protective than the bid regimen. For duodenal ulcer prevention, the qid regimen is more protective than the tid or bid regimens. However, the qid regimen is less well tolerated than the tid regimen because of usually self-limited diarrhea related to the misoprostol dose (see ADVERSE REACTIONS — Gastrointestinal), and the bid regimen may be better tolerated than tid in some patients.

  Dosages may be individualized using the separate products (misoprostol and diclofenac), after which the patient may be changed to the appropriate dose of diclofenac sodium and misoprostol delayed-release tablets. If clinically indicated, misoprostol co-therapy with diclofenac sodium and misoprostol delayed-release tablets, or use of the individual components to optimize the misoprostol dose and/or frequency of administration, may be appropriate. The total dose of misoprostol should not exceed 800 mcg/day, and no more than 200 mcg of misoprostol should be administered at any one time. Doses of diclofenac higher than 150 mg/day in osteoarthritis or higher than 225 mg/day in rheumatoid arthritis are not recommended.

  For additional information, it may be helpful to refer to the package inserts for Cytotec® tablets and Voltaren® tablets.

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• Direct Rx
  

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  Diclofenac Sodium And Misoprostol | Direct Rx

  

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  Carefully consider the potential benefits and risks of diclofenac sodium/misoprostol tablets and other treatment options before deciding to use diclofenac sodium/misoprostol tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with diclofenac sodium/misoprostol tablets, the dose and frequency should be adjusted to suit an individual patient's needs.

  For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is given below.

  Diclofenac sodium/misoprostol tablets are administered as diclofenac sodium/misoprostol 50 (50 mg diclofenac sodium/200 mcg misoprostol) or as diclofenac sodium/misoprostol 75 (75 mg diclofenac sodium/200 mcg misoprostol).

  Note: See SPECIAL DOSING CONSIDERATIONS section below.

  Osteoarthritis

  The recommended dosage for maximal GI mucosal protection is diclofenac sodium/misoprostol 50 tid. For patients who experience intolerance, diclofenac sodium/misoprostol 75 bid or diclofenac sodium/misoprostol 50 bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium/misoprostol tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

  OA regimen Diclofenac sodium
  (mg/day) Misoprostol
  (mcg/day) Diclofenac sodium/misoprostol 50 tid
  bid 150
  100 600
  400 Diclofenac sodium/misoprostol 75 bid 150 400

  Rheumatoid Arthritis

  The recommended dosage is diclofenac sodium/misoprostol 50 tid or qid. For patients who experience intolerance, diclofenac sodium/misoprostol 75 bid or diclofenac sodium/misoprostol 50 bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium/misoprostol tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

  RA regimen Diclofenac sodium
  (mg/day) Misoprostol
  (mcg/day) Diclofenac sodium/misoprostol 50 qid
  tid
  bid 200
  150
  100 800
  600
  400 Diclofenac sodium/misoprostol 75 bid 150 400

  SPECIAL DOSING CONSIDERATIONS

  Diclofenac sodium/misoprostol tablets contain misoprostol, which provides protection against gastric and duodenal ulcers (see CLINICAL STUDIES). For gastric ulcer prevention, the 200 mcg qid and tid regimens are therapeutically equivalent, but more protective than the bid regimen. For duodenal ulcer prevention, the qid regimen is more protective than the tid or bid regimens. However, the qid regimen is less well tolerated than the tid regimen because of usually self-limited diarrhea related to the misoprostol dose (see ADVERSE REACTIONS —Gastrointestinal), and the bid regimen may be better tolerated than tid in some patients.

  Dosages may be individualized using the separate products (misoprostol and diclofenac), after which the patient may be changed to the appropriate dose of diclofenac sodium/misoprostol tablets. If clinically indicated, misoprostol co-therapy with diclofenac sodium/misoprostol tablets, or use of the individual components to optimize the misoprostol dose and/or frequency of administration, may be appropriate. The total dose of misoprostol should not exceed 800 mcg/day, and no more than 200 mcg of misoprostol should be administered at any one time. Doses of diclofenac higher than 150 mg/day in osteoarthritis or higher than 225 mg/day in rheumatoid arthritis are not recommended.

  For additional information, it may be helpful to refer to the package inserts for Cytotec® tablets and Voltaren® tablets.

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• Avkare, Inc.
  

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  Diclofenac Sodium And Misoprostol | Avkare, Inc.

  

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  Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with diclofenac sodium and misoprostol delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

  For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is given below.

  Diclofenac sodium and misoprostol delayed-release tablets are administered as diclofenac sodium and misoprostol delayed-release tablets (50 mg diclofenac sodium/0.2 mg misoprostol) or as diclofenac sodium and misoprostol delayed-release tablets (75 mg diclofenac sodium/0.2 mg misoprostol).

  Note: See SPECIAL DOSING CONSIDERATIONS section below.

  Osteoarthritis: The recommended dosage for maximal GI mucosal protection is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

     OA
  regimen  Diclofenac sodium
  (mg/day)  Misoprostol
  (mcg/day)  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 50 mg/0.2 mg  tid
  bid  150
  100  600
  400  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 75 mg/0.2 mg  bid  150  400

  Rheumatoid Arthritis: The recommended dosage is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid or qid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

     RA
  regimen  Diclofenac sodium
  (mg/day)  Misoprostol
  (mcg/day)  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 50 mg/0.2 mg  qid
  tid
  bid  200
  150
  100  800
  600
  400  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 75 mg/0.2 mg  bid  150  400

  SPECIAL DOSING CONSIDERATIONS: Diclofenac sodium and misoprostol delayed-release tablets contain misoprostol, which provides protection against gastric and duodenal ulcers (see CLINICAL STUDIES). For gastric ulcer prevention, the 200 mcg qid and tid regimens are therapeutically equivalent, but more protective than the bid regimen. For duodenal ulcer prevention, the qid regimen is more protective than the tid or bid regimens. However, the qid regimen is less well tolerated than the tid regimen because of usually self-limited diarrhea related to the misoprostol dose (see ADVERSE REACTIONS— Gastrointestinal), and the bid regimen may be better tolerated than tid in some patients.

  Dosages may be individualized using the separate products (misoprostol and diclofenac), after which the patient may be changed to the appropriate dose of diclofenac sodium and misoprostol delayed-release tablets. If clinically indicated, misoprostol co-therapy with diclofenac sodium and misoprostol delayed-release tablets, or us e of the individual components to optimize the misoprostol dose and/or frequency of administration, may be appropriate. The total dose of misoprostol should not exceed 800 mcg/day, and no more than 200 mcg of misoprostol should be administered at any one time. Doses of diclofenac higher than 150 mg/day in osteoarthritis or higher than 225 mg/day in rheumatoid arthritis are not recommended.

  For additional information, it may be helpful to refer to the package inserts for Cytotec® tablets and Voltaren® tablets.

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• Watson Laboratories, Inc.
  

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  Diclofenac Sodium And Misoprostol | Actavis Pharma, Inc.

  

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  Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with diclofenac sodium and misoprostol delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

  For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is given below.

  Diclofenac sodium and misoprostol delayed-release tablets are administered as diclofenac sodium and misoprostol delayed-release tablets (50 mg diclofenac sodium/0.2 mg misoprostol) or as diclofenac sodium and misoprostol delayed-release tablets (75 mg diclofenac sodium/0.2 mg misoprostol).

  Note: See SPECIAL DOSING CONSIDERATIONS section below.

  Osteoarthritis: The recommended dosage for maximal GI mucosal protection is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

     OA
  regimen  Diclofenac sodium
  (mg/day)  Misoprostol
  (mcg/day)  Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 50 mg/0.2 mg  tid
  bid  150
  100  600
  400  Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 75 mg/0.2 mg  bid  150  400

  Rheumatoid Arthritis: The recommended dosage is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid or qid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

     RA
  regimen  Diclofenac sodium
  (mg/day)  Misoprostol
  (mcg/day)  Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 50 mg/0.2 mg  qid
  tid
  bid  200
  150
  100 800
  600
  400  Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 75 mg/0.2 mg  bid  150  400

  SPECIAL DOSING CONSIDERATIONS: Diclofenac sodium and misoprostol delayed-release tablets contain misoprostol, which provides protection against gastric and duodenal ulcers (see CLINICAL STUDIES). For gastric ulcer prevention, the0.2 mg qid and tid regimens are therapeutically equivalent, but more protective than the bid regimen. For duodenal ulcer prevention, the qid regimen is more protective than the tid or bid regimens. However, the qid regimen is less well tolerated than the tid regimen because of usually self-limited diarrhea related to the misoprostol dose (see ADVERSE REACTIONS — Gastrointestinal), and the bid regimen may be better tolerated than tid in some patients.

  Dosages may be individualized using the separate products (misoprostol and diclofenac), after which the patient may be changed to the appropriate dose of diclofenac sodium and misoprostol delayed-release tablets. If clinically indicated, misoprostol co-therapy with diclofenac sodium and misoprostol delayed-release tablets, or use of the individual components to optimize the misoprostol dose and/or frequency of administration, may be appropriate. The total dose of misoprostol should not exceed 800 mcg/day, and no more than 200 mcg of misoprostol should be administered at any one time. Doses of diclofenac higher than 150 mg/day in osteoarthritis or higher than 225 mg/day in rheumatoid arthritis are not recommended.

  For additional information, it may be helpful to refer to the package inserts for Cytotec® tablets and Voltaren® tablets.

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• Bluepoint Laboratories
  

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  Diclofenac Sodium And Misoprostol | Teva Parenteral Medicines, Inc.

  

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  Note: Contact of the undiluted concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted paclitaxel injection solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.

  All patients should be premedicated prior to paclitaxel injection administration in order to prevent severe hypersensitivity reactions. Such premedication may consist of dexamethasone 20 mg PO administered approximately 12 and 6 hours before paclitaxel injection, diphenhydramine (or its equivalent) 50 mg IV 30 to 60 minutes prior to paclitaxel injection, and cimetidine (300 mg) or ranitidine (50 mg) IV 30 to 60 minutes before paclitaxel injection.

  For patients with carcinoma of the ovary, the following regimens are recommended (see CLINICAL STUDIES, Ovarian Carcinoma):

  1. For previously untreated patients with carcinoma of the ovary, one of the following recommended regimens may be given every 3 weeks. In selecting the appropriate regimen, differences in toxicities should be considered (see TABLE 11 in ADVERSE REACTIONS, Disease-Specific Adverse Event Experiences). 1.%2. Paclitaxel injection administered intravenously over 3 hours at a dose of 175 mg/m 2 followed by cisplatin at a dose of 75 mg/m 2; or 2.%2. Paclitaxel injection administered intravenously over 24 hours at a dose of 135 mg/m 2 followed by cisplatin at a dose of 75 mg/m 2. 2. In patients previously treated with chemotherapy for carcinoma of the ovary, paclitaxel injection has been used at several doses and schedules; however, the optimal regimen is not yet clear (see CLINICAL STUDIES, Ovarian Carcinoma). The recommended regimen is paclitaxel injection 135 mg/m 2 or 175 mg/m 2 administered intravenously over 3 hours every 3 weeks.

  For patients with carcinoma of the breast, the following is recommended
  (see CLINICAL STUDIES, Breast Carcinoma):

  1. For the adjuvant treatment of node-positive breast cancer, the recommended regimen is paclitaxel injection, at a dose of 175 mg/m 2 intravenously over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy. The clinical trial used 4 courses of doxorubicin and cyclophosphamide (see CLINICAL STUDIES, Breast Carcinoma). 2. After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, paclitaxel injection at a dose of 175 mg/m 2 administered intravenously over 3 hours every 3 weeks has been shown to be effective.

  For patients with non-small cell lung carcinoma, the recommended regimen, given every 3 weeks, is paclitaxel injection administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin, 75 mg/m2.

  For patients with AIDS-related Kaposi’s sarcoma, paclitaxel injection administered at a dose of 135 mg/m2 given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m2 given intravenously over 3 hours every 2 weeks is recommended (dose intensity 45 to 50 mg/m2/week). In the 2 clinical trials evaluating these schedules (see CLINICAL STUDIES, AIDS-Related Kaposi’s Sarcoma), the former schedule (135 mg/m2 every 3 weeks) was more toxic than the latter. In addition, all patients with low performance status were treated with the latter schedule (100 mg/m2 every 2 weeks).

  Based upon the immunosuppression in patients with advanced HIV disease, the following modifications are recommended in these patients:

  1. Reduce the dose of dexamethasone as 1 of the 3 premedication drugs to 10 mg PO (instead of 20 mg PO); 2. Initiate or repeat treatment with paclitaxel injection only if the neutrophil count is at least 1000 cells/mm 3; 3. Reduce the dose of subsequent courses of paclitaxel injection by 20% for patients who experience severe neutropenia (neutrophil < 500 cells/mm 3 for a week or longer); and 4. Initiate concomitant hematopoietic growth factor (G-CSF) as clinically indicated.

  For the therapy of patients with solid tumors (ovary, breast, and NSCLC), courses of paclitaxel injection should not be repeated until the neutrophil count is at least 1500 cells/mm3 and the platelet count is at least 100,000 cells/mm3. Paclitaxel injection should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline or subsequent neutrophil count is less than 1000 cells/mm3. Patients who experience severe neutropenia (neutrophil < 500 cells/mm3 for a week or longer) or severe peripheral neuropathy during paclitaxel injection therapy should have dosage reduced by 20% for subsequent courses of paclitaxel injection. The incidence of neurotoxicity and the severity of neutropenia increase with dose.

  Preparation and Administration Precautions

  Paclitaxel is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised in handling paclitaxel. The use of gloves is recommended. If paclitaxel solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning and redness. If paclitaxel contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported.

  Hepatic Impairment

  Patients with hepatic impairment may be at increased risk of toxicity, particularly grade III–IV myelosuppression (see CLINICAL PHARMACOLOGY and PRECAUTIONS, Hepatic). Recommendations for dosage adjustment for the first course of therapy are shown in TABLE 17 for both 3 and 24 hour infusions. Further dose reduction in subsequent courses should be based on individual tolerance. Patients should be monitored closely for the development of profound myelosuppression.

  TABLE 17: RECOMMENDATIONS FOR DOSING IN PATIENTS WITH HEPATIC IMPAIRMENT BASED ON CLINICAL TRIAL DATAa

  Degree of Hepatic Impairment

   Recommended Paclitaxel Injection
  Dosec

  Transaminase Levels

   

  Bilirubin Levelsb

  24 hour infusion

  < 2 × ULN

  and

  ≤ 1.5 mg/dL

  135 mg/m2

  2 to < 10 × ULN

  and

  ≤ 1.5 mg/dL

  100 mg/m2

  < 10 × ULN

  and

  1.6 to 7.5 mg/dL

  50 mg/m2

  ≥ 10 × ULN

  or

  > 7.5 mg/dL

  Not recommended

  3 hour infusion

  < 10 × ULN

  and

  ≤ 1.25 × ULN

  175 mg/m2

  < 10 × ULN

  and

  1.26 to 2 × ULN

  135 mg/m2

  < 10 × ULN

  and

  2.01 to 5 × ULN

  90 mg/m2

  ≥ 10 × ULN

  or

  > 5 × ULN

  Not recommended

  a These recommendations are based on dosages for patients without hepatic impairment of 135 mg/m2 over 24 hours or 175 mg/m2 over 3 hours; data are not available to make dose adjustment recommendations for other regimens (e.g., for AIDS-related Kaposi’s sarcoma).

  b Differences in criteria for bilirubin levels between the 3 and 24 hour infusion are due to differences in clinical trial design.

  c Dosage recommendations are for the first course of therapy; further dose reduction in subsequent courses should be based on individual tolerance.

  Preparation and Administration Precautions

  Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1–4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing paclitaxel injection. If paclitaxel injection solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning, and redness. If paclitaxel injection contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported.

  Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration (see PRECAUTIONS, Injection Site Reaction).

  Preparation for Intravenous Administration

  Paclitaxel injection must be diluted prior to infusion. Paclitaxel injection should be diluted in 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection, USP; or 5% Dextrose in Ringer’s Injection to a final concentration of 0.3 to 1.2 mg/mL. The solutions are physically and chemically stable for up to 27 hours at ambient temperature (approximately 25°C) and room lighting conditions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle. No significant losses in potency have been noted following simulated delivery of the solution through IV tubing containing an in-line (0.22 micron) filter.

  Data collected for the presence of the extractable plasticizer DEHP [di-(2-ethylhexyl)phthalate] show that levels increase with time and concentration when dilutions are prepared in PVC containers. Consequently, the use of plasticized PVC containers and administration sets is not recommended. Paclitaxel injection solutions should be prepared and stored in glass, polypropylene, or polyolefin containers. Non-PVC containing administration sets, such as those which are polyethylene-lined, should be used.

  Paclitaxel injection should be administered through an in-line filter with a microporous membrane not greater than 0.22 microns. Use of filter devices such as IVEX-2® filters which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP.

  The Chemo Dispensing Pin™ device or similar devices with spikes should not be used with vials of paclitaxel injection since they can cause the stopper to collapse resulting in loss of sterile integrity of the paclitaxel injection solution.

  Stability

  Unopened vials of paclitaxel injection are stable until the date indicated on the package when stored between 20° to 25°C (68° to 77°F), in the original package. Neither freezing nor refrigeration adversely affects the stability of the product. Upon refrigeration, components in the paclitaxel injection vial may precipitate, but will redissolve upon reaching room temperature with little or no agitation. There is no impact on product quality under these circumstances. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded. Solutions for infusion prepared as recommended are stable at ambient temperature (approximately 25°C) and lighting conditions for up to 27 hours.

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• Bryant Ranch Prepack
  

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  Diclofenac Sodium And Misoprostol | Bryant Ranch Prepack

  

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  Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with diclofenac sodium and misoprostol delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

  For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is given below.

  Diclofenac sodium and misoprostol delayed-release tablets are administered as diclofenac sodium and misoprostol delayed-release tablets (50 mg diclofenac sodium/0.2 mg misoprostol) or as diclofenac sodium and misoprostol delayed-release tablets (75 mg diclofenac sodium/0.2 mg misoprostol).

  Note: See SPECIAL DOSING CONSIDERATIONS section below.

  Osteoarthritis: The recommended dosage for maximal GI mucosal protection is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

     OA
  regimen  Diclofenac sodium
  (mg/day)  Misoprostol
  (mcg/day)  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 50 mg/0.2 mg  tid
  bid  150
  100  600
  400  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 75 mg/0.2 mg  bid  150  400

  Rheumatoid Arthritis: The recommended dosage is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid or qid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

     RA
  regimen  Diclofenac sodium
  (mg/day)  Misoprostol
  (mcg/day)  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 50 mg/0.2 mg  qid
  tid
  bid  200
  150
  100 800
  600
  400  Diclofenac Sodium and Misoprostol Delayed-Release Tablets 75 mg/0.2 mg  bid  150  400

  SPECIAL DOSING CONSIDERATIONS: Diclofenac sodium and misoprostol delayed-release tablets contain misoprostol, which provides protection against gastric and duodenal ulcers (see CLINICAL STUDIES). For gastric ulcer prevention, the0.2 mg qid and tid regimens are therapeutically equivalent, but more protective than the bid regimen. For duodenal ulcer prevention, the qid regimen is more protective than the tid or bid regimens. However, the qid regimen is less well tolerated than the tid regimen because of usually self-limited diarrhea related to the misoprostol dose (see ADVERSE REACTIONS— Gastrointestinal), and the bid regimen may be better tolerated than tid in some patients.

  Dosages may be individualized using the separate products (misoprostol and diclofenac), after which the patient may be changed to the appropriate dose of diclofenac sodium and misoprostol delayed-release tablets. If clinically indicated, misoprostol co-therapy with diclofenac sodium and misoprostol delayed-release tablets, or use of the individual components to optimize the misoprostol dose and/or frequency of administration, may be appropriate. The total dose of misoprostol should not exceed 800 mcg/day, and no more than 200 mcg of misoprostol should be administered at any one time. Doses of diclofenac higher than 150 mg/day in osteoarthritis or higher than 225 mg/day in rheumatoid arthritis are not recommended.

  For additional information, it may be helpful to refer to the package inserts for Cytotec® tablets and Voltaren® tablets.

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• Greenstone Llc
  

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  Diclofenac Sodium And Misoprostol | Dupuy Oxygen & Supply Company, Inc.

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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• Blenheim Pharmacal, Inc.
  

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  Diclofenac Sodium And Misoprostol | Blenheim Pharmacal, Inc.

  

  ---

  Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with diclofenac sodium and misoprostol delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

  For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is given below.

  Diclofenac sodium and misoprostol delayed-release tablets are administered as diclofenac sodium and misoprostol delayed-release tablets (50 mg diclofenac sodium/0.2 mg misoprostol) or as diclofenac sodium and misoprostol delayed-release tablets (75 mg diclofenac sodium/0.2 mg misoprostol).

  Note: See SPECIAL DOSING CONSIDERATIONS section below.

  Osteoarthritis: The recommended dosage for maximal GI mucosal protection is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

      OA
  regimen   Diclofenac sodium
  (mg/day)   Misoprostol
  (mcg/day)  Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 50 mg/0.2 mg  tid
  bid  150
  100  600
  400  Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 75 mg/0.2 mg  bid  150  400

  Rheumatoid Arthritis: The recommended dosage is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid or qid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

      RA
  regimen   Diclofenac sodium
  (mg/day)   Misoprostol
  (mcg/day)  Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 50 mg/0.2 mg  qid
  tid
  bid  200
  150
  100 800
  600
  400  Diclofenac Sodium
   and Misoprostol
   Delayed-Release
   Tablets 75 mg/0.2 mg  bid  150  400

  SPECIAL DOSING CONSIDERATIONS: Diclofenac sodium and misoprostol delayed-release tablets contain misoprostol, which provides protection against gastric and duodenal ulcers (see CLINICAL STUDIES). For gastric ulcer prevention, the0.2 mg qid and tid regimens are therapeutically equivalent, but more protective than the bid regimen. For duodenal ulcer prevention, the qid regimen is more protective than the tid or bid regimens. However, the qid regimen is less well tolerated than the tid regimen because of usually self-limited diarrhea related to the misoprostol dose (see ADVERSE REACTIONS — Gastrointestinal), and the bid regimen may be better tolerated than tid in some patients.

  Dosages may be individualized using the separate products (misoprostol and diclofenac), after which the patient may be changed to the appropriate dose of diclofenac sodium and misoprostol delayed-release tablets. If clinically indicated, misoprostol co-therapy with diclofenac sodium and misoprostol delayed-release tablets, or use of the individual components to optimize the misoprostol dose and/or frequency of administration, may be appropriate. The total dose of misoprostol should not exceed 800 mcg/day, and no more than 200 mcg of misoprostol should be administered at any one time. Doses of diclofenac higher than 150 mg/day in osteoarthritis or higher than 225 mg/day in rheumatoid arthritis are not recommended.

  For additional information, it may be helpful to refer to the package inserts for Cytotec ® tablets and Voltaren ® tablets.

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