PENTAZOCINE-NALOXONE HCL (pentazocine hcl/naloxone hcl)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Acute asthma attack

There are 31 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Alcohol intoxication
Alcohol withdrawal delirium
Benign prostatic hyperplasia
Bradycardia
Cardiac arrhythmia
Coma
Cor pulmonale
Debilitation
Dehydration
Drug abuse
Exacerbation of chronic obstructive pulmonary disease
Familial dysautonomia
Gastrointestinal tract surgery
History of opioid overdose
Hypotension
Inflammatory bowel disease
Intracranial hypertension
Morbid obesity
Neoplasm of brain
Primary adrenocortical insufficiency
Pulmonary emphysema
Respiratory depression
Seizure disorder
Shock
Sleep apnea
Suicidal ideation
Systemic mastocytosis
Toxic psychosis
Ulcerative colitis
Urethral stricture
Urinary retention

There are 8 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Acute abdominal pain
Biliary spasm
Constipation
Disease of liver
Gallbladder disease
Kidney disease with reduction in glomerular filtration rate (GFr)
Mood changes
Untreated hypothyroidism

There are 22 severe adverse reactions.

More Frequent	Less Frequent
None.	Allergic dermatitis Angioedema Hypertension Tachycardia Urticaria

Rare/Very Rare
Accidental fall Acute cognitive impairment Adrenocortical insufficiency Agranulocytosis Anaphylaxis Biliary spasm Depression Drug dependence Dyspnea Erythema multiforme Hallucinations Intracranial hypertension Respiratory depression Seizure disorder Stevens-johnson syndrome Toxic epidermal necrolysis Urinary retention

There are 41 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Dizziness Drowsy Euphoria Hyperhidrosis Nausea Sedation Vomiting	Blurred vision Constipation Flushing Headache disorder Hypotension Irritability Nightmares Paresthesia Pruritus of skin Skin rash Syncope Visual changes Xerostomia

Rare/Very Rare
Androgen deficiency Anorexia Chills Erectile dysfunction Excitement Gastrointestinal irritation General weakness Infertility Injection site sequelae Insomnia Libido changes Nystagmus Opioid induced allodynia Opioid induced hyperalgesia Orthostatic hypotension Palpitations Sleep apnea Tinnitus Tremor Vasodilation of blood vessels

Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome. There are no available data with pentazocine/naloxone in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, pentazocine administered subcutaneously to pregnant hamsters during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) at 2.6

times the maximum daily dose (MDD). In pregnant rats administered pentazocine/naloxone during organogenesis, there were increased incidences of resorptions and extra ribs at 0.2 times the MDD.

There was no evidence of malformations in rats or rabbits. Based on animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight.

The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly. Opioids cross the placenta and may produce respiratory depression and psycho physiologic effects in neonates.

An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Pentazocine/naloxone is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including pentazocine/naloxone, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions.

However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

Pentazocine is excreted in human milk. Caution should be exercised when pentazocine/naloxone is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pentazocine/naloxone and any potential adverse effects on the breastfed infant from the drugs or from the underlying maternal condition.

Infants exposed to pentazocine/naloxone through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.

Elderly patients (aged 65 years or older) may have increased sensitivity to pentazocine/naloxone. In general, use caution when selecting a dosage for an elderly patient, 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. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid tolerant or when opioids were co-administered with other agents that depress respiration.

Titrate the dosage of pentazocine/naloxone slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression. Pentazocine and naloxone are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.