Pentazocine Hcl And Naloxone Hcl
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
INDICATIONS AND USAGE
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| Pentazocine and naloxone hydrochlorides tablets are intended for oral use only. Severe, potentially lethal, reactions may result from misuse of pentazocine and naloxone hydrochlorides tablets by injection either alone or in combination with other substances. (See DRUG ABUSE AND DEPENDENCE section.) | |
Pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain.
Pentazocine and naloxone hydrochlorides tablets are indicated for oral use only.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION
Pentazocine and naloxone hydrochlorides tablets USP contain pentazocine hydrochloride USP, equivalent to 50 mg base, a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride USP, equivalent to 0.5 mg base.
Pentazocine and naloxone hydrochlorides tablets are an analgesic for oral administration.
Chemically, pentazocine hydrochloride is (2R*, 6R*, 11R*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions. It has the following structural formula:
PENTAZOCINE STRUCTURE IMAGE
Chemically, naloxone hydrochloride is 17-AIlyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids. It has the following structural formula:
NALOXONE STRUCTURE IMAGE
Each tablet, for oral administration, contains pentazocine hydrochloride USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride USP, equivalent to 0.5 mg of naloxone. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D and C Yellow No. 10 Al-lake, FD and C Blue No. 1 Al-lake, FD and C Yellow No. 6 Al-lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate.
Sources
Pentazocine Hcl And Naloxone Hcl Manufacturers
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Stat Rx Usa Llc
![Pentazocine Hcl And Naloxone Hcl (Pentazocine Hydrochloride And Naloxone Hydrochloride) Tablet [Stat Rx Usa Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pentazocine Hcl And Naloxone Hcl | Stat Rx Usa Llc
DOSAGE AND ADMINISTRATIONAdults. The usual initial adult dose is 1 tablet every three or four hours. This may be increased to 2 tablets when needed. Total daily dosage should not exceed 12 tablets.
When anti-inflammatory or antipyretic effects are desired in addition to analgesia, aspirin can be administered concomitantly with this product.
Pediatric Patients. Since clinical experience in pediatric patients under 12 years of age is limited, administration of this product in this age group is not recommended.
Duration of Therapy. Patients with chronic pain who receive pentazocine and naloxone hydrochlorides tablets orally for prolonged periods have only rarely been reported to experience withdrawal symptoms when administration was abruptly discontinued (see WARNINGS). Tolerance to the analgesic effect of pentazocine has also been reported only rarely. However, there is no long-term experience with the oral administration of pentazocine and naloxone hydrochlorides tablets.
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