"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
(pentazocine hydrochloride and naloxone hydrochloride, USP)
Analgesic for Oral Use Only
WARNING: TALWIN® NX (pentazocine and naloxone) is intended for oral use only. Severe, potentially lethal, reactions may result from misuse of TALWIN® NX (pentazocine and naloxone) by injection either alone or in combination with other substances. (See Drug Abuse and Dependence section.)
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:
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:
Inactive Ingredients: Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, D&C Yellow #10, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Starch.
What are the possible side effects of naloxone and pentazocine (Talwin NX)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
- weak or shallow breathing, slow heartbeats;
- confusion, hallucinations, unusual thoughts or behavior;
- severe weakness or dizziness;
- seizure (convulsions);
- feeling like you might pass out; or
- severe skin reaction -- fever, sore throat, swelling in your face or...
What are the precautions when taking pentazocine and naloxone (Talwin Nx)?
Before taking this product, tell your doctor or pharmacist if you are allergic to pentazocine or naloxone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung disease (such as asthma, chronic obstructive pulmonary disease-COPD), a certain spinal problem (kyphoscoliosis), breathing problems (such as slow/shallow breathing, sleep apnea), certain heart problems (irregular heartbeat), personal or family history of regular use/abuse of drugs/alcohol, brain disorders (such as seizures, head injury, tumor, increased intracranial...
Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.
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