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| Subject: Re: Roxicet Oral Solution directions use and comparison | |
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Author: percocet kingpin |
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Date Posted: 07:02:49 08/11/11 Thu In reply to: percocet kingpin 's message, "Roxicet Oral Solution directions use and comparison" on 07:01:59 08/11/11 Thu in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose. In patients who are physically dependent on any opioid agonist including oxycodone, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use. Gastric emptying and/or lavage may be useful in removing unabsorbed drug. This procedure is recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. After lavage and/or emesis, administration of activated charcoal, as a slurry, is beneficial, if less than three hours have passed since ingestion. Charcoal adsorption should not be employed prior to lavage and emesis. If an acetaminophen overdose is suspected, the stomach should be promptly emptied by lavage. A serum acetaminophen assay should be obtained as soon as possible, but no sooner than 4 hours following ingestion. Liver function studies should be obtained initially and repeated at 24-hour intervals. The antidote N-acetylcysteine (NAC) should be administered as early as possible, preferably within 16 hours of the overdose ingestion, but in any case within 24 hours. As a guide to treatment of acute ingestion, the acetaminophen level can be plotted against time since ingestion on a nomogram (Rumack-Matthew). The upper toxic line on the nomogram is equivalent to 200 mcg/mL at 4 hours while the lower line is equivalent to 50 mcg/mL at 12 hours. If serum level is above the lower line, and entire course of N-acetylcysteine treatment should be instituted. NAC therapy should be withheld if the acetaminophen level is below the lower line. The toxicity of oxycodone and acetaminophen in combination is unknown. Roxicet Oral Solution Dosage and Administration Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. ROXICET is given orally. ROXICET Tablets: The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. (Maximum daily dose is 12 tablets.) Roxicet Oral Solution: The usual adult dosage is 5 mL (one teaspoonful) every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. (Maximum daily dose is 12 teaspoonfuls or 60 mL.) Cessation of Therapy In patients treated with ROXICET for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient. How is Roxicet Oral Solution Supplied ROXICET™ Tablets, Oxycodone and Acetaminophen Tablets, USP (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg) White, round, scored tablets (Identified 54 543) NDC 0054-8650-24: Unit dose, 25 tablets per card (reverse numbered), 4 cards per shipper. NDC 0054-4650-25: Bottles of 100 tablets. NDC 0054-4650-29: Bottles of 500 tablets. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight light-resistant container, as defined in the USP/NF. ROXICET™ Oral Solution, Oxycodone and Acetaminophen Oral Solution (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg Oral Solution per 5 mL) Clear, dark red solution NDC 0054-8648-16: Unit dose Patient Cups™ filled to deliver 5 mL (Oxycodone Hydrochloride 5 mg, Acetaminophen 325 mg), ten 5 mL Patient Cups™ per shelf pack, four shelf packs per shipper. NDC 0054-3686-63: Bottles of 500 mL. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight light-resistant container, as defined in the USP/NF. DEA Order Form Required. 4073402//03 Revised May 2008 ©RLI, 2008 Package Label - ROXICET™ Tablets, Oxycodone and Acetaminophen Tablets, USP (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg) NDC 0054-8650-24: Unit dose Rx Only Roxane Laboratories, Inc. NDC 0054-4650-25: Bottles of 100 tablets. Rx Only Roxane Laboratories, Inc. NDC 0054-4650-29: Bottles of 500 tablets. Rx Only Roxane Laboratories, Inc. Package Label - ROXICET™ Oral Solution, Oxycodone and Acetaminophen Oral Solution (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg Oral Solution per 5 mL) NDC 0054-8648-16: Unit dose Patient Cups™ Rx Only Roxane Laboratories, Inc. NDC 0054-3686-63: Bottles of 500 mL. Rx Only Roxane Laboratories, Inc. ROXICET oxycodone and acetaminophen tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0054-4650 Route of Administration ORAL DEA Schedule CII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 5 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE STEARIC ACID Product Characteristics Color WHITE Score 2 pieces Shape ROUND (biconvex) Size 11mm Flavor Imprint Code 54;543 Contains Packaging # NDC Package Description Multilevel Packaging 1 0054-4650-25 100 TABLET In 1 BOTTLE, PLASTIC None 2 0054-4650-29 500 TABLET In 1 BOTTLE, PLASTIC None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA087003 02/01/1991 ROXICET oxycodone and acetaminophen solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0054-3686 Route of Administration ORAL DEA Schedule CII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 5 mg in 1 mL ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg in 5 mL Inactive Ingredients Ingredient Name Strength ALCOHOL CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C RED NO. 40 FRUCTOSE POLYETHYLENE GLYCOL POTASSIUM SORBATE SACCHARIN SODIUM WATER Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 0054-3686-63 500 mL In 1 BOTTLE, PLASTIC None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089351 12/03/1986 ROXICET oxycodone and acetaminophen tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0054-8650 Route of Administration ORAL DEA Schedule CII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 5 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE STEARIC ACID Product Characteristics Color WHITE Score 2 pieces Shape ROUND (biconvex) Size 11mm Flavor Imprint Code 54;543 Contains Packaging # NDC Package Description Multilevel Packaging 1 0054-8650-24 4 BLISTER PACK In 1 BOX contains a BLISTER PACK 1 25 TABLET In 1 BLISTER PACK This package is contained within the BOX (0054-8650-24) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA087003 03/11/1987 ROXICET oxycodone and acetaminophen solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0054-8648 Route of Administration ORAL DEA Schedule CII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 5 mg in 1 mL ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg in 5 mL Inactive Ingredients Ingredient Name Strength ALCOHOL CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C RED NO. 40 FRUCTOSE POLYETHYLENE GLYCOL POTASSIUM SORBATE SACCHARIN SODIUM WATER Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 0054-8648-16 10 CUP In 1 CARTON contains a CUP, UNIT-DOSE 1 5 mL In 1 CUP, UNIT-DOSE This package is contained within the CARTON (0054-8648-16) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089351 01/17/1991 Labeler - Roxane Laboratories, Inc. (058839929) Registrant - Roxane Laboratories, Inc. (058839929 [ Next Thread | Previous Thread | Next Message | Previous Message ] |
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