Pentazocine and naloxone

TALWIN NX (pentazocine and naloxone hydrochlorides, USP) 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 (pentazocine and naloxone) is an analgesic for oral administration.

Chemically, pentazocine hydrochloride is (2R*,6R*,11R*)-l,2,3,4,5,6-Hexahydro-6,ll-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:

C19H27NO·HCl............M.W. 321.88

Chemically, naloxone hydrochloride is Morphinan-6-one,4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, hydrochloride, (5α)-. It is a slightly off-white powder, and is soluble in water and dilute acids, and has the following structural formula:

C19H21NO4·HCl..............M.W.=363.84

Inactive Ingredients: Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, D&C Yellow #10, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Starch.

You should not use this medication if you are allergic to naloxone (Narcan, Suboxone) or pentazocine (Talacen).

To make sure you can safely take naloxone and pentazocine, tell your doctor if you have any of these other conditions:

• asthma, COPD, sleep apnea, or other breathing disorders;
• liver or kidney disease;
• heart disease or history of heart attack;
• underactive thyroid;
• a blockage in your digestive tract (stomach or intestines);
• a history of head injury or brain tumor;
• epilepsy or other seizure disorder;
• Addison's disease or other adrenal gland disorder;
• low blood pressure;
• gallbladder or pancreas problems:
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• enlarged prostate, urination problems;
• mental illness;
• a history of drug or alcohol addiction; or
• if you have recently received other narcotic pain medicine or methadone.

Naloxone and pentazocine may be habit forming and should be used only by the person for whom it was prescribed. Never share naloxone and pentazocine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether naloxone and pentazocine will harm an unborn baby. Naloxone and pentazocine may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using naloxone and pentazocine.

Naloxone and pentazocine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Naloxone and pentazocine should not be given to a child younger than 12 years old.

• It is used to ease pain.

• If you have an allergy to pentazocine, naloxone, or any other part of pentazocine and naloxone.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take pentazocine and naloxone with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use pentazocine and naloxone as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

• If you take this medicine on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times pentazocine and naloxone is taken on an as needed basis. Do not take more often than told by the doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, oral: Pentazocine 50 mg and naloxone 0.5 mg

• Analgesic, Opioid
• Analgesic, Opioid Partial Agonist

Pentazocine: Agonist of kappa opiate receptors and partial agonist of mu opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; produces analgesia, respiratory depression and sedation similar to opioids.

Naloxone: Pure opioid antagonist that competes for and displaces opioids at opioid receptor sites in CNS. Lacks pharmacologic activity following oral administration (low dose: 0.5 mg) due to poor systemic absorption. Inhibits the actions of pentazocine when administered parenterally.

Pain management: Oral: One tablet (pentazocine 50 mg/naloxone 0.5 mg) every 3 to 4 hours; may increase to 2 tablets (pentazocine 100 mg/naloxone 1 mg) if needed. Maximum daily dose: 12 tablets (pentazocine 600 mg/naloxone 6 mg) per day.

Discontinuation of therapy: For patients on long term opioid therapy, decrease dose gradually; monitor carefully for signs/symptoms of withdrawal.