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Propoxyphene and Acetaminophen (Propoxyphene Hydrochloride / Acetaminophen) - Indications and Dosage

 
 



INDICATION

Propoxyphene napsylate and acetaminophen tablets, USP are indicated for the relief of mild to moderate pain.

DOSAGE AND ADMINISTRATION

Propoxyphene napsylate and acetaminophen tablets are intended for the management of mild to moderate pain. The dose should be individually adjusted according to severity of pain, patient response and patient size.

Propoxyphene napsylate and acetaminophen tablets 100 mg/650 mg
The usual dosage is one tablet every 4 hours orally as needed for pain. The maximum dose of propoxyphene napsylate and acetaminophen tablets 100 mg/650 mg is 6 tablets per day. Do not exceed the maximum daily dose.

Propoxyphene napsylate and acetaminophen tablets 50 mg/325 mg
The usual dosage is two tablets every 4 hours orally as needed for pain. The maximum dose of propoxyphene napsylate and acetaminophen tablets 50 mg/325 mg is 12 tablets per day. Do not exceed the maximum daily dose.

Patients receiving propoxyphene and any CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted.

Consideration should be given to a reduced total daily dosage in elderly patients and in patients with hepatic or renal impairment.

Cessation of Therapy

For patients who used propoxyphene napsylate and acetaminophen on a regular basis for a period of time, when therapy with propoxyphene napsylate and acetaminophen is no longer needed for the treatment of their pain, it may be useful to gradually discontinue the propoxyphene napsylate and acetaminophen 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  for 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 titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.

HOW SUPPLIED

Propoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mg are available as follows:

Orange film coated, unscored, capsule shaped tablets, debossed "5111" over "V" on one side and plain on the reverse side.

Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mg are available as follows:

Orange film coated, unscored, capsule shaped tablets, debossed "5112" over "V" on one side and plain on the reverse side.

White film coated, unscored, capsule shaped tablets, debossed "5113" over "V" on one side and plain on the reverse side.

Pink film coated, unscored, capsule shaped tablets, debossed "5114" over "V" on one side and plain on the reverse side.

They are supplied by Keltman Pharmaceuticals Inc. as follows:

NDC Strength Quantity/Form Color Source Prod. Code
68387-100-10 100 mg / 650 mg 10 Tablets in a Plastic Bottle PINK 0603-5468
68387-100-15 100 mg / 650 mg 15 Tablets in a Plastic Bottle PINK 0603-5468
68387-100-30 100 mg / 650 mg 30 Tablets in a Plastic Bottle PINK 0603-5468
68387-100-40 100 mg / 650 mg 40 Tablets in a Plastic Bottle PINK 0603-5468
68387-100-50 100 mg / 650 mg 50 Tablets in a Plastic Bottle PINK 0603-5468
68387-100-60 100 mg / 650 mg 60 Tablets in a Plastic Bottle PINK 0603-5468
68387-100-90 100 mg / 650 mg 90 Tablets in a Plastic Bottle PINK 0603-5468
68387-100-12 100 mg / 650 mg 120 Tablets in a Plastic Bottle PINK 0603-5468

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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