Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1335
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Talwin Nx (Tablet)
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| dailymed-instance:dosage |
Adults: 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.<br/>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.<br/>Duration of Therapy: Patients with chronic pain who receive TALWIN Nx orally for prolonged periods have only rarely been reported to experience withdrawal symptoms when administration was abruptly discontinued . Tolerance to the analgesic effect of pentazocine has also been reported only rarely. However, there is no long-term experience with the oraladministration of TALWIN Nx.
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| dailymed-instance:descripti... |
TALWIN Nx contains pentazocine hydrochloride, USP, equivalent to 50 mg base and is a member of the benzazocine series (also known as the benzomorphan series), and Naloxone hydrochloride, USP, equivalent to 0.5 mg base. TALWIN Nx is an analgesic for oral administration. Chemically, pentazocine hydrochloride is 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, and has the following structural formula: Chemically, naloxone hydrochloride is Morphinan-6-one,4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, hydrochloride, (5��)-. It is a slightly off-white powder, and is soluble in water and dilute acids, and has the following structural formula: Inactive Ingredients: Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, D&C Yellow #10, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Starch.
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| dailymed-instance:clinicalP... |
Pentazocine is a potent analgesic which when administered orally in a 50 mg dose appears equivalent in analgesic effect to 60 mg (1 grain) of codeine. Onset of significant analgesia usually occurs between 15 and 30 minutes after oral administration, and duration of action is usually three hours or longer. Onset and duration of action and the degree of pain relief are related both to dose and the severity of pretreatment pain. Pentazocine weakly antagonizes the analgesic effects of morphine and meperidine; in addition, it produces incomplete reversal of cardiovascular, respiratory, and behavioral depression induced by morphine and meperidine. Pentazocine has about 1/50 the antagonistic activity of nalorphine. It also has sedative activity. Pentazocine is well absorbed from the gastrointestinal tract. Concentrations in plasma coincide closely with the onset, duration, and intensity of analgesia; peak values occur 1 to 3 hours after oral administration. The half-life in plasma is 2 to 3 hours. Pentazocine is metabolized in the liver and excreted primarily in the urine. Pentazocine passes into the fetal circulation. Naloxone when administered orally at 0.5 mg has no pharmacologic activity. Naloxone hydrochloride administered parenterally at the same dose is an effective antagonist to pentazocine and a pure antagonist to narcotic analgesics. TALWIN Nx is a potent analgesic when administered orally. However, the presence of naloxone in TALWIN Nx will prevent the effect of pentazocine if the product is misused by injection. Studies in animals indicate that the presence of naloxone does not affect pentazocine analgesia when the combination is given orally. If the combination is given by injection the action of pentazocine is neutralized.
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TALWIN Nx should not be administered to patients who are hypersensitive to either pentazocine or naloxone. TALWIN Nx is intended for oral use only. Severe, potentially lethal, reactions may result from misuse of TALWIN Nx by injection either alone or in combination with other substances.
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| dailymed-instance:supply |
Tablets (oblong), yellow, scored, each containing pentazocine hydrochloride equivalent to 50 mg base and naloxone hydrochloride equivalent to 0.5 mg base. Bottles of 100 (NDC 0024-1951-04). Store at 25��C (77��F); excursions permitted between 15�����30��C (59��F to 86��F).
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| dailymed-instance:boxedWarn... |
TALWIN Nx is intended for oral use only. Severe, potentially lethal, reactions may result from misuse of TALWIN Nx by injection either alone or in combination with other substances.
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... |
dailymed-ingredient:Colloidal_Silicon_Dioxide,
dailymed-ingredient:D&C_Yellow_#10,
dailymed-ingredient:Dibasic_Calcium_Phosphate,
dailymed-ingredient:FD&C_Yellow_#6,
dailymed-ingredient:Magnesium_Stearate,
dailymed-ingredient:Microcrystalline_Cellulose,
dailymed-ingredient:Sodium_Lauryl_Sulfate,
dailymed-ingredient:Starch
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| dailymed-instance:precautio... |
CNS Effect: Caution should be used when pentazocine is administered to patients prone to seizures; seizures have occurred in a few such patients in association with the use of pentazocine though no cause and effect relationship has been established.<br/>Impaired Renal or Hepatic Function: Decreased metabolism of pentazocine by the liver in extensive liver disease may predispose to accentuation of side effects. Although laboratory tests have not indicated that pentazocine causes or increases renal or hepatic impairment, the drug should be administered with caution to patients with such impairment. In prescribing pentazocine for long-term use, the physician should take precautions to avoid increases in dose by the patient.<br/>Biliary Surgery: Narcotic drug products are generally considered to elevate biliary tract pressure for varying periods following their administration. Some evidence suggests that pentazocine may differ from other marketed narcotics in this respect (i.e., it causes little or no elevation in biliary tract pressures). The clinical significance of these findings, however, is not yet known.<br/>Information for Patients: Since sedation, dizziness, and occasional euphoria have been noted, ambulatory patients should be warned not to operate machinery, drive cars, or unnecessarily expose themselves to hazards. Pentazocine may cause physical and psychological dependence when taken alone and may have additive CNS depressant properties when taken in combination with alcohol or other CNS depressants.<br/>Myocardial Infarction: As with all drugs, pentazocine should be used with caution in patients with myocardial infarction who have nausea or vomiting.<br/>Drug Interactions: Usage with Alcohol: See WARNINGS.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies in animals to test for carcinogenesis have been performed with the components of TALWIN Nx.<br/>Pregnancy Category C: Animal reproduction studies have not been conducted with TALWIN Nx. It is also not known whether TALWIN Nx can cause fetal harm when administered to pregnant women or can affect reproduction capacity. TALWIN Nx should be given to pregnant women only if clearly needed. However, animal reproduction studies with pentazocine have not demonstrated teratogenic or embryotoxic effects.<br/>Labor and Delivery: Patients receiving pentazocine during labor have experienced no adverse effects other than those that occur with commonly used analgesics. TALWIN Nx should be used with caution in women delivering premature infants. The effect of TALWIN Nx on the mother and fetus, the duration of labor or delivery, the possibility that forceps delivery or other intervention or resuscitationof the newborn may be necessary, or the effect of TALWIN Nx on the later growth, development, and functional maturation of the child are unknown at the present time.<br/>Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TALWIN Nx is administered to a nursing woman.<br/>Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 years have not been established.<br/>Geriatric Use: Controlled clinical studies of TALWIN Nx did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses or effectiveness in analgesic activity between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, 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.
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| dailymed-instance:overdosag... |
Manifestations: Clinical experience of overdosage with this oral medication has been insufficient to define the signs of this condition.<br/>Treatment: Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. For respiratory depression due to overdosage or unusual sensitivity to pentazocine, parenteral naloxone is a specific and effective antagonist. TALWIN' Nx is intended for oral use only. Severe, potentially lethal, reactions may result from misuse of TALWIN' Nx by injection either alone or in combination with other substances.
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| dailymed-instance:genericMe... |
pentazocine hydrochloride and naloxone hydrochloride
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| dailymed-instance:fullName |
Talwin Nx (Tablet)
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| dailymed-instance:adverseRe... |
Cardiovascular. Hypotension, tachycardia, syncope. Respiratory. Rarely, respiratory depression. Acute CNS Manifestations. Patients receiving therapeutic doses of pentazocine have experienced hallucinations (usually visual), disorientation, and confusion which have cleared spontaneously within a period of hours. The mechanism of this reaction is not known. Such patients should be closely observed and vital signs checked. If the drug is reinstituted it should be done with caution since these acute CNS manifestations may recur. Other CNS Effects. Dizziness, lightheadedness, hallucinations, sedation, euphoria, headache, confusion, disorientation; infrequently weakness, disturbed dreams, insomnia, syncope, visual blurring and focusing difficulty, depression; and rarely tremor, irritability, excitement, tinnitus. Autonomic. Sweating; infrequently flushing; and rarely chills. Gastrointestinal. Nausea, vomiting, constipation, diarrhea, anorexia, rarely abdominal distress. Allergic. Edema of the face; dermatitis, including pruritus; flushed skin, including plethora; infrequently rash, and rarely urticaria. Ophthalmic. Visual blurring and focusing difficulty. Hematologic. Depression of white blood cells (especially granulocytes), which is usually reversible, moderate transient eosinophilia. Other. Headache, chills, insomnia, weakness, urinary retention, paresthesia, serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
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| dailymed-instance:indicatio... |
TALWIN Nx is intended for oral use only. Severe, potentially lethal, reactions may result from misuse of TALWIN Nx by injection either alone or in combination with other substances. TALWIN Nx is indicated for the relief of moderate to severe pain. TALWIN Nx is indicated for oral use only.
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| dailymed-instance:name |
Talwin Nx
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