Talwin NX

Name: Talwin NX

Indications

TALWIN NX (pentazocine and naloxone hydrochlorides, USP) is indicated for the relief of moderate to severe pain.

TALWIN NX (pentazocine and naloxone) is indicated for oral use only.

Overdose

Manifestations

For pentazocine alone in single doses above 60 mg there have been reports of the occurrence of nalorphine-like psychotomimetic effects such as anxiety, nightmares, strange thoughts, and hallucinations. Somnolence, marked respiratory depression associated with hypertension and tachycardia have also resulted as have seizures, hypotension, dizziness, nausea, vomiting, lethargy, and paresthesias. The respiratory depression is antagonized by naloxone (see Treatment). Circulatory failure and deepening coma may occur in more severe cases, particularly in patients who have also ingested other CNS depressants such as alcohol, sedative/hypnotics, or antihistamines.

Treatment

Adequate measures to maintain ventilation and general circulatory support should be employed. Assisted or controlled ventilation, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Consideration should be given to gastric lavage and gastric aspiration. For respiratory depression due to overdosage or unusual sensitivity to pentazocine, parenteral naloxone is a specific and effective antagonist. Initial doses of 0.4 to 2.0 mg of naloxone are recommended, repeated at 2-3 minute intervals, if needed, up to a total of 10 mg. Anti-convulsant therapy may be necessary.

Clinical pharmacology

Pentazocine is a Schedule IV opioid analgesic which when administered orally in a 50 mg dose appears equivalent in analgesic effect to 60 mg of codeine.

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.

Onset of significant analgesia usually occurs between 15 and 30 minutes after oral administration, and duration of action is usually three hours or longer.

Pentazocine is well absorbed from the gastrointestinal tract. Concentrations in plasma coincide closely with the onset, duration, and intensity of analgesia. The time to mean peak concentration in 24 normal volunteers was 1.7 hours (range 0.5 to 4 hours) after oral administration and the mean plasma elimination half-life was 3.6 hours (range 1.5 to 10 hours).

Pentazocine is metabolized in the liver and excreted primarily in the urine. The products of the oxidation of the terminal methyl groups and glucuronide conjugates are excreted by the kidney. Elimination of approximately 60% of the total dose occurs within 24 hours. 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 antagonist to pentazocine and a pure antagonist to narcotic analgesics.

TALWIN NX (pentazocine and naloxone) is a potent analgesic when administered orally. However, the presence of naloxone in TALWIN NX (pentazocine and naloxone) is intended to 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.

What is the most important information i should know about naloxone and pentazocine (talwin nx)?

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

Never crush a naloxone and pentazocine tablet to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of pentazocine and similar prescription drugs.

Naloxone and pentazocine may be habit-forming and should be used only by the person for whom it was prescribed. Keep this medication in a secure place where others cannot get to it.

Never take naloxone and pentazocine in larger amounts, or for longer than recommended by your doctor. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not drink alcohol while you are using this medication. Dangerous side effects or death can occur when alcohol is combined with naloxone and pentazocine. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how naloxone and pentazocine will affect you.

Do not stop using naloxone and pentazocine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using naloxone and pentazocine.

Where can i get more information?

Your pharmacist can provide more information about naloxone and pentazocine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Talwin NX Overview

Talwin NX is a brand name medication included in the following groups of medications: Antidotes, Benzomorphan derivatives. For more information about Talwin NX see its generics Naloxone, Pentazocine

Talwin NX Drug Class

Talwin NX is part of the drug classes:

  • Antidotes

  • Benzomorphan derivatives

Uses For Talwin NX

Pentazocine and naloxone combination is used to relieve moderate to severe pain.

Pentazocine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

Naloxone is an opioid antagonist. It acts on the CNS to block the effects of narcotics, especially the "high'' feeling that makes you want to use them. It will not produce any narcotic-like effects or cause mental or physical dependence.

When pentazocine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Precautions While Using Talwin NX

It is very important that your doctor check the progress of you or your child while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before you or your child take any of the medicines listed above while you are using this medicine.

This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you or your child have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Talwin NX Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
  • Black, tarry stools
  • chest pain
  • chills
  • cough or hoarseness
  • difficult or troubled breathing
  • fever
  • fever with or without chills
  • general feeling of tiredness or weakness
  • irregular, fast or slow, or shallow breathing
  • lower back or side pain
  • painful or difficult urination
  • pale or blue lips, fingernails, or skin
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • trembling or shaking of the hands or feet
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • confusion
  • decrease in the frequency of urination
  • diarrhea
  • difficulty in passing urine (dribbling)
  • difficulty with swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast, slow, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • headache
  • hives
  • itching
  • joint or muscle pain
  • loss of bladder control
  • loss of consciousness
  • nervousness
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid breathing
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of the face, neck, arms, and occasionally, upper chest
  • skin rash
  • sweating
  • swelling of the lower legs or arms
  • swelling of the face
  • tightness in the chest
  • total body jerking
  • upper abdominal or stomach pain
  • weight gain
  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Seeing, hearing, or feeling things that are not there
  • seizures (convulsions)
  • sleepiness or unusual drowsiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare
  • Abdominal or stomach distress
  • hives or welts
  • redness of the skin
Incidence not known
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • confusion about identity, place, and time
  • constipation
  • constricted, pinpoint, or small pupils (black part of the eye)
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cracked, dry, or scaly skin
  • depression
  • difficulty in focusing the eyes
  • disturbed dreams
  • drowsiness
  • dry mouth
  • excitement
  • false or unusual sense of well-being
  • hearing loss
  • irritability
  • lightheadedness
  • loss of appetite
  • mood or mental changes
  • nausea
  • relaxed and calm feeling
  • trouble with sleeping
  • unable to sleep
  • vomiting
  • weakness
  • weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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