Tapentadol Hydrochloride

Drug Abuse of Opium Pain Killer:Tapentadol are used for addiction around the world-Deadly Health effects-{Health Tips-Leadership Club}

ISO Hand . Book Comments 0 February 5, 2020

Tapentadol is used to help relieve moderate to severe short-term pain (such as pain from an injury or after surgery). It belongs to a class of drugs known as Opioid (Narcotic) {The Opioid alkaloids contained in opium extracts (e.g., codeine, morphine, thebaine) are used to synthesize many prescription narcotics (like morphine, codeine, oxycodone, etc.). Heroin is also made from raw materials obtained from the opium poppy plant.} analgesics. It works in the brain to change how your body feels and responds to pain.

Tapentadol Hydrochloride is an orally active, extended-release preparation of the hydrochloride salt of tapentadol with analgesic activity. Tapentadol is a synthetic, centrally acting analgesic with a dual mechanism of action involving mu-opioid receptor agonism and norepinephrine reuptake inhibition.

Tapentadol-MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. The extended-release form of this medicine (Nucynta ER) is for around-the-clock treatment of pain that is not controlled by other medicines. This form of tapentadol is not for use on an as-needed basis for pain.

Tapentadol Hydrochloride

What should I discuss with my healthcare provider before taking tapentadol?

You should not use this medication if you are allergic to tapentadol, or if you have:

  • severe asthma or breathing problems; or
  • a blockage in your digestive tract (stomach or intestines).

Do not use tapentadol if you have taken an MAO(Monoamine oxidase inhibitors) inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

Tell your doctor if you have ever had:

  • any type of breathing problem or lung disease;
  • a head injury, brain tumor, or seizures;
  • drug or alcohol addiction, or mental illness;
  • urination problems;
  • liver or kidney disease; or
  • problems with your gallbladder, pancreas, or thyroid.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks. You should not breast-feed while using this medicine.Do not give tapentadol to a child.

Tapentadol Hydrochloride Tablet

How should I take tapentadol?

Follow the directions on your prescription label and read all medication guides. Never use tapentadol in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Take this medicine with a full glass of water. Tapentadol can be taken with or without food.Stop taking all other around-the-clock narcotic pain medications when you start taking tapentadol extended-release tablets.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.Tapentadol can cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.

Do not stop using tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using tapentadol.

Never crush or break a tapentadol pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of tapentadol and similar prescription drugs.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

What happens if I miss a dose?

Since tapentadol is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not take extra medicine to make up a missed dose. Do not take more than your prescribed dose in a 24-hour period.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, fainting, or coma.

What should I avoid while taking tapentadol?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Opium Derivatives Tapentadol Abuse & Deadly Health Effects

What are the possible side effects of tapentadol?

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • weak or shallow breathing, weak pulse, slow heartbeat;
  • a light-headed feeling, like you might pass out;
  • agitation, feeling hot;
  • seizure (convulsions);
  • severe drowsiness or dizziness, confusion, problems with speech or balance;
  • infertility, missed menstrual periods;
  • impotence, sexual problems, loss of interest in sex; or
  • low cortisol levels — nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

  • constipation, mild nausea, stomach pain;
  • headache, tired feeling; or
  • mild drowsiness or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tapentadol?

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
  • medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
  • other narcotic medications –opioid pain medicine or prescription cough medicine;
  • a sedative like Valium –diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
  • drugs that make you sleepy or slow your breathing –a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
  • drugs that affect serotonin levels in your body –a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about tapentadol.

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.

Deadly Health Effects of Tapentadol

Tapentadol Tablet : COMMON BRAND(S): Nucynta , GENERIC NAME(S): Tapentadol

WARNINGS:

Tapentadol has a risk for abuse and addiction, which can lead to overdose and death. Tapentadol may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of tapentadol that works, and take it for the shortest possible time. The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to take tapentadol and what other drugs you should avoid taking with it. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn’t stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

Danger of Tapentadol Tablet

How to use Tapentadol Tablet

Read the Medication Guide provided by your pharmacist before you start taking tapentadol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).

The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Properly stop the medication when so directed.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Deadly Health Effects of Tapentadol

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your pain does not get better or if it gets worse.

View Video :Opioid (Narcotic) Pain Medications Guide: https://www.webmd.com/pain-management/guide/narcotic-pain-medications#1

Precautions:

Before taking tapentadol, tell your doctor or pharmacist if you are allergic to it; 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: brain disorders (such as seizures, head injury, tumor), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease–COPD), gallbladder disease, kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), disease of the pancreas (pancreatitis), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially slow/shallow breathing, confusion, constipation, dizziness, and drowsiness.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)

It is unknown if this medication passes into breast milk. It may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Drug Interactions:

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy,” St. John’s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, slow heartbeat, seizures, coma.

Notes:

Do not share this medication with others. Sharing it is against the law.This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. For more details, read the Medication Guide, or consult your pharmacist or local waste disposal company.Information last revised October 2019. Copyright(c) 2019 First Databank, Inc.

Centradol Tablet- Tapentadol Hydrochloride in Bangladesh

Tapentadol Hydrochloride Available Brand Names in Bangladesh-Shown Only One strength:

Brand /Trade Name Dosage Form Strength Company Pack Size & Price
Centradol Tablet 75 mg Incepta Pharmaceuticals Limited 10’s pack : ৳ 170.00 (Unit Price : ৳ 17.00)
Cynta Tablet 100 mg Healthcare Pharmacuticals Limited 10’s pack : ৳ 250.00 (Unit Price : ৳ 25.00)
Lopenta Tablet 75 mg ACI Limited 10’s pack : ৳ 200.00 (Unit Price : ৳ 20.00)
Pentadol Tablet 100 mg Square Pharmaceuticals Ltd. 10’s pack : ৳ 250.80 (Unit Price : ৳ 25.08)
Tapendol Tablet 75 mg Opsonin Pharma Limited 20’s pack : ৳ 339.86 (Unit Price : ৳ 16.99)
Tapenta Tablet 100 mg Eskayef Bangladesh Ltd. 10’s pack : ৳ 200.01 (Unit Price : ৳ 20.00)
Tapexia Tablet 75 mg Globe Pharmaceuticals Limited. 20’s pack : ৳ 340.00 (Unit Price : ৳ 17.00)

WHO Reports- The potential for abuse of tapentadol is described to be similar to that of pure, strong μ-opioid analgesics, such as morphine and hydromorphone. Tapentadol is still in the launch or post-launch phase in some countries and not yet commercially available in the majority of countries. It is currently only marketed in countries where sufficient national control measures providing the same control as for schedule I of the United Nations (UN) Single Convention on Narcotic Drugs are applied, a context under which low abuse has been observed. Considering future developments with increased market penetration, Grünenthal proposes international scheduling in schedule I of the UN Single Convention on Narcotic Drugs as a precautionary measure.(Grünenthal is a pharmaceutical company headquartered in Aachen in Germany.Grünenthal is a global leader in pain management and related diseases/Opium pain Killer.) The Food and Drug Administration (FDA or Agency) is providing interested persons with the opportunity to submit comments about the World Health Organization (WHO) recommendations to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances(i.e.Opium Analgesics). The comments received in response to this notice will be considered in preparing the United States’ position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, March 18-22, 2019. This notice is issued under the Controlled Substances Act (CSA).

Appropriate scheduling right from the start is important to avoid a substantial abuse situation that is not easily controllable once present. Possible changes to the abuse situation expected at specific milestones should be considered. An expansion of market share and worldwide market penetration is expected as well as an increase in companies manufacturing and distributing tapentadol, possibly in countries where national control measures might not be in place. Therefore, sufficient international control mechanisms need to be in place to prevent a potential public health problem related to abuse of tapentadol.

Tapentadol Hydrochloride :Brand Names around the World

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