Adult Dosing
Mild-to-moderate pain relief
- 1 tab [650 mg/25 mg] PO q4 hrs PRN
- Max: 6 tabs [3900 mg/150 mg]/day
Note:
- Taper dose gradually when discontinuing therapy after long-term use
Pediatric Dosing
Mild-to-moderate pain relief
- Children >12 yrs
- 1 tab [650 mg/25 mg] PO q4 hrs PRN
- Max: 6 tabs [3900 mg/150 mg]/day
Note:
- Safety and effectiveness in pediatric patients <12 yrs have not been established
- Taper dose gradually when discontinuing therapy after long-term use
[Outline]
See Supplemental Patient Information
- Cases of acute liver failure, occasionally resulting in liver transplant and death, have been reported with acetaminophen. These events are mostly associated with acetaminophen doses >4000 mg/day and often involve more than one acetaminophen-containing product. Individuals with underlying liver disease and those who ingest alcohol during therapy are at a greater risk for developing acute liver failure [US Black Box Warning]
- Pentazocine may cause a physical and psychological dependence, particularly in patients with a history of drug abuse
- Pentazocine component of this combination drug is associated with elevation of cerebrospinal fluid pressure. Respiratory depressant effects of pentazocine may be markedly exaggerated in the presence of head injury, intracranial lesions, or a preexisting increase in intracranial pressure. Also, pentazocine may obscure the clinical course of patients with head injuries. Use this drug with extreme caution and only if its use is deemed essential in such patients
- Hallucinations (usually visual), disorientation, and confusion may occur during therapy. Closely observe such patients and check their vital signs. Exercise caution during re-institution of this drug as acute CNS manifestations may recur
- Pentazocine may have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs, which may result in CNS depression, respiratory depression, hypotension, profound sedation, coma or death
- Cases of dependence and withdrawal symptoms have been reported during therapy. Rarely, there have been reports of possible abstinence syndromes in newborns after long-term use of pentazocine during pregnancy
- Avoid abrupt cessation of therapy; gradually taper the dose to discontinue in order to prevent signs and symptoms of withdrawal in patients receiving therapy for an extended period of time
- Opioid abstinence symptoms may be precipitated during therapy in patients receiving courses of opiates for pain relief
- Physicians should undertake precautions to avoid increases in dose by the patient while prescribing this combination drug for chronic use
- Accentuation of side effects may occur in patients with extensive liver disease. Consider the safety for use of this combination drug in patients with liver disease
- Seizures may occur in certain susceptible patients in association with the use of this combination drug
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- CV disease
- Patients with MI having nausea or vomiting
- Hypotension
- CNS depression
- Impaired pulmonary function
- Severe bronchial asthma
- Cor pulmonale
- Chronic obstructive pulmonary disease
- Cyanosis
- Severely limited respiratory reserve
- Hypoxia
- Hypercapnia
- Preexisting respiratory depression
- Opioid dependence
- Head injury
- Increased ICP
- Seizure disorder
- Inflammatory bowel disease
- Obstructive GI disease
- Acute abdominal syndrome
- Biliary disease
- Pancreatitis
- Cholecystitis
- Porphyria
- Prostate hypertrophy
- Hypothyroidism
- Adrenocortical insufficiency
- Substance abuse
- Acute alcohol intoxication
- Use of CNS depressants
- Debilitated patients
- Geriatric patients
- Delirium tremens
Supplemental Patient Information
- Advise patients receiving treatment to refrain from any hazardous activity such as driving a motor vehicle or operating machinery until it is confirmed that they are not adversely affected
- Instruct patients to avoid concomitant use of this drug with alcohol or other CNS depressants
- Instruct patients not to take acetaminophen >4000 mg/day or use more than one product that contains acetaminophen
- Inform patients regarding the potential for severe constipation during therapy; provide appropriate laxatives and/or stool softeners and other appropriate treatments during acetaminophen/pentazocine therapy
- Advise patients to discontinue treatment and promptly consult their physician if they develop signs or symptoms of allergy including rash, hives, itching, swelling of the face or mouth, vomiting, or difficulty breathing
Pregnancy Category:C
Breastfeeding: Acetaminophen component of this combination drug is a good choice for analgesia and for fever reduction in nursing mothers. Amounts excreted in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare. Since no information is available regarding the use of pentazocine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT). Maternal medication of acetaminophen is usually compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting the compound. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 23 June, 2011). Manufacturer advises caution.
US Trade Name(s)
US Availability
acetaminophen/pentazocine (generic)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Drug Name: Acetaminophen 650 MG / Pentazocine 25 MG Oral Tablet
Ingredient(s): Acetaminophen mixture with Pentazocine
Imprint: 396;25;650;WATSON
Color(s): Blue
Shape: Oval
Size (mm): 19.00
Score: 2
Inactive Ingredient(s): colloidial silicon dioxide / crospovidone / d&c yellow no.10 aluminum lake / fd & c blue no. 1 aluminum lake / microcrystalline cellulose / povidone / pregelatinized starch / sodium starch gylcolate / stearic acid
Drug Label Author:
Watson Laboratories, Inc.
DEA Schedule:
CIV
Drug Name: Talacen (acetaminophen 650 MG / pentazocine 25 MG) Oral Tablet
Ingredient(s): Acetaminophen mixture with Pentazocine
Imprint: Winthrop;T37
Color(s): Blue
Shape: Oval
Size (mm): 3.00
Score: 2
Inactive Ingredient(s): colloidal silicon dioxide / fd&c blue #1 / gelatin / microcrystalline cellulose / potassium sorbate / pregelatinized starch / sodium lauryl sulfate / sodium metabisulfite / sodium starch glycolate / stearic acid
Drug Label Author:
sanofi-aventis U.S. LLC
DEA Schedule:
CIV