Kle 2, Inc.

Kle 2, Inc. Drugs

• Quazepam
  

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  Quazepam

  

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  Use the lowest dose effective for the patient, as important adverse effects of QUAZEPAM are dose related.

  The recommended initial dose is 7.5 mg. The 7.5 mg dose can be increased to 15 mg if necessary for efficacy.

  The 7.5 mg dose can be achieved by splitting the 15 mg tablet along the score line.

  2.1 Special Populations

  Elderly and debilitated patients may be more sensitive to benzodiazepines.

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• Hydrocodone Bitartate A...
  

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  Hydrocodone Bitartate And Acetaminophen

  

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  Dosage should be adjusted according to the 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 or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.

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• Pitocin
  

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  Pitocin

  

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  For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).

  Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).

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• Fenoprofen
  

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  Fenoprofen

  

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  Carefully consider the potential benefits and risks of Fenoprofen Calcium and other treatment options before deciding to use Fenoprofen Calcium. 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 Fenoprofen Calcium, the dose and frequency should be adjusted to suit an individual patient's needs.

  Analgesia

  For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed.

  Rheumatoid Arthritis and Osteoarthritis

  For the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis the recommended dose is 400 to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Dosage adjustments may be made after initiation of drug therapy or during exacerbations of the disease. Total daily dosage should not exceed 3,200 mg.

  Fenoprofen Calcium may be administered with meals or with milk. Although the total amount absorbed is not affected, peak blood levels are delayed and diminished.

  Patients with rheumatoid arthritis generally seem to require larger doses of Fenoprofen Calcium than do those with osteoarthritis. The smallest dose that yields acceptable control should be employed.

  Although improvement may be seen in a few days in many patients, an additional 2 to 3 weeks may be required to gauge the full benefits of therapy.

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• Tramadol Hydrochloride
  

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  Tramadol Hydrochloride

  

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  2.1 General Dosing Considerations

  Tramadol Hydrochloride Extended-Release is an extended-release formulation intended for once a day dosing in adults aged 18 years and older. The tablets must be swallowed whole with liquid and must not be split, chewed, dissolved or crushed. Chewing, crushing or splitting the tablet could result in the uncontrolled delivery of tramadol, in overdose and death [see WARNINGS AND PRECAUTIONS ( 5.11), DRUG ABUSE AND DEPENDENCE ( 9), and OVERDOSE ( 10.1)].

  Do not administer Tramadol Hydrochloride Extended-Release at a dose exceeding 300 mg per day. Do not use Tramadol Hydrochloride Extended-Release more than once daily or concomitantly with other tramadol products [see WARNINGS AND PRECAUTIONS ( 5.12)].

  2.2 Patients Not Currently on Tramadol Immediate-Release Products

  Initiate treatment with Tramadol Hydrochloride Extended-Release at a dose of 100 mg once daily and titrated up as necessary to 150 mg, 200 mg and 300 mg every five days to achieve a balance between relief of pain and tolerability.

  2.3 Patients Currently on Tramadol Immediate-Release Products

  Calculate the 24-hour tramadol IR dose and initiate a total daily dose of Tramadol Hydrochloride Extended-Release rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with Tramadol Hydrochloride Extended-Release, some patients maintained on tramadol IR products may not be able to convert to Tramadol Hydrochloride Extended-Release.

  2.4 Patients 65 Years of Age and Older

  Initiate dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Tramadol Hydrochloride Extended-Release should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.

  2.5 Patients with Renal Impairment

  The limited availability of dose strengths and once daily dosing of Tramadol Hydrochloride Extended-Release do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with creatinine clearance less than 30 mL/min [see USE IN SPECIFIC POPULATIONS ( 8.6) and CLINICAL PHARMACOLOGY ( 12.3) ].

  2.6 Patients with Hepatic Impairment

  The limited availability of dose strengths and once daily dosing of tramadol hydrochloride extended-release capsules do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with severe hepatic impairment (Child-Pugh Class C) [see USE IN SPECIFIC POPULATIONS ( 8.7) and CLINICAL PHARMACOLOGY ( 12.3) ].

  2.7 Discontinuation of Treatment

  Withdrawal symptoms may occur if Tramadol Hydrochloride Extended-Release is discontinued abruptly. Clinical experience with tramadol suggests that withdrawal symptoms may be reduced by tapering Tramadol Hydrochloride Extended-Release [see WARNINGS AND PRECAUTIONS ( 5.10) and DRUG ABUSE AND DEPENDENCE ( 9.3)] .

  2.8 Food Effects

  Tramadol Hydrochloride Extended-Release may be taken without regard to food [see CLINICAL PHARMACOLOGY ( 12.3)].

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