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Is Nucynta A Controlled Substance?

Is Nucynta A Controlled Substance?

 

Nucynta is formulated with Tapentadol, a Schedule II controlled substance, as its active compound. 

Schedule II drugs are medicines with high potency for addiction, misuse, and abuse, thus leading to both psychological and physical dependency. Therefore, Tapentadol or Nucynta is a prescription medication retailed with strict regulations and restrictions. 

 

 

Nucynta, the brand name of Tapentadol, is a centrally acting that relieves moderate to severe body pain in adults. It is classified as “opioid medicine,” thus having a potential risk for abuse and dependency. Thus, making people wonder if Nucynta is a controlled substance.

If you are prescribed Nucynta by your healthcare expert, or you are thinking of taking the Tapentadol pain medicine without a prescription, it is essential to know about its benefits and potential health risks. 

This article aims to explore Nucynta or Tapentadol as a controlled substance, including its legal status and prescription regulations. 

 

Nucynta Controlled Substance- An Overview Of Nucynta And Controlled Substances 

Tapentadol is an FDA-approved treatment for severe chronic pain patients over 18 years old. Nucynta manufacturer has marketed this analgesic as an improved version of the currently available opioid analgesics with an improved tolerability and safety profile. 

Tapentadol is available in immediate-release form (Nucynta IR), approved for treating severe acute pain in adults. The extended-release form (Nucynta ER) is prescribed for moderate to chronic pain [1]. 

Clinical studies indicate its efficacy similar to oxycodone, with a lesser risk of experiencing side effects such as vomiting, nausea, and constipation [2]. 

 

What are controlled substances?

Controlled substances are medicines or compounds tightly controlled and regulated by the government for their potential risk of causing abuse and dependency [3]. The regulations apply to the compound's manufacturing, usage, retailing, storage, and distribution. Some of the commonly controlled substances include depressants, opioids, stimulants, anabolic steroids, and hallucinogens. 

Medical use of such controlled substances is only done after consulting a medical professional. They are not available over the counter and are retailed only through prescription from a licensed medical professional [3]. 

 

Points To Know Before Starting Controlled Substances- 

  • Long-term use of Controlled substances requires medical monitoring. 

  • Storing such medicines correctly is essential to prevent misuse. 

  • If you experience any side effects, it is crucial to consult a doctor immediately. 

  • As these medications have a high risk of abuse, any changes in the dose should be made after consulting a doctor. 

  • If your friends and family have similar symptoms as you, do not share your prescription-controlled drug with them. 

 

 

Is Nucynta a controlled substance?

Tapentadol, the active compound of Nucynta, is a Schedule II controlled substance [4]. 

drug-schedules

Drug Schedule is determined by the following factors listed in Section 201 (c) of the Controlled Substances Act (CSA) [5]. 

  • The abuse potential of the drug.

  • If there is any known scientific evidence of its pharmacology. 

  • The current state of the scientific knowledge available about the particular medicine. 

  • The history and the current pattern of abuse. 

  • The duration and severity of abuse. 

  • If there are any potential health risks for the public. 

  • If it causes any physiological dependence.

  • If the compound is an immediate precursor of a substance that is already a controlled substance. 

Schedule II Drug Information

  • This Schedule includes medicines and substances with high potency for abuse.

  • They may lead to severe physical and psychological dependency [6]. 

  • These medicines are currently used in the United States with severe restrictions [7]. 

 

Tapentadol or Nucynta Abuse Potential 

A study published in 2015 suggests that the risk of addiction to Tapentadol is comparatively lesser than other compounds [8]. It also states that Tapentadol IR abuse prevalence is significantly lower than all its comparators. Tapentadol ER abuse risk is lower than most comparators except hydromorphone ER. 

According to a medical journal published in the year 2015, Recreational abusers online seem to be less interested in abusing Tapentadol compared to other opioid medicines [9]. 

 

Who Makes Nucynta- What Are Schedule Drug Manufacturing Regulations?

Tapentadol or Nucynta manufacturer is Cadila Pharmaceuticals. 

Controlled substances such as Tapentadol (except Schedule I drugs) can be legally manufactured, distributed, and possessed in the United States when used for medical conditions approved by the FDA [11]. 

All drug companies, pharmacies, and distributors should follow the FDA and DEA regulations before retailing any scheduled drug. 

 

Nucynta Prescribing And Refilling Regulations

 

nucynta-prescribing-and-refilling-regulations

 

Physicians should have a registration with the DEA for prescribing Scheduled Drugs, including Nucynta pills [11]. Medical practitioners such as physicians, veterinarians, dentists, and mid-level practitioners can prescribe Nucynta or Tapentadol 100 mg tablets. 

The following information should be considered when writing a medical prescription for Tapentadol. 

  • Patient's Name and Address.

  • The physician's name, address, and registration number with DEA.

  • Name of the medicine. 

  • Strength of the drug. 

  • Dosage of the medication.

  • Quantity.

  • How to take these medicines. 

  • Number of authorized refills. 

Schedule II drugs can only be refilled by consulting a doctor. A new prescription is needed every time you need a refill for your medication in most places. So, to make it easier, many online pharmacies let you buy Tapentadol without a prescription. However, proper administration guidelines should be followed in such cases to avoid any health risks.

 

Tapentadol Schedule II Prescription Regulation Based On The States Of USA- 

The DEA sets the Schedule II prescription regulations. However, individual states may have additional restrictions. Some of these regulations bases on the states are mentioned below. 

  • Many states of the USA, including New York, Florida, California, and Texas, follow additional Prescription Drug Monitoring Programs (PDMPs) on prescribing Tapentadol pills and other Schedule II medications [12]. 

  • The use of opioids such as Tapentadol has quality limits in Massachusetts, Maine, Rhode Island, and Vermont. 

  • Hand-written prescriptions for Nucynta or Tapentadol pills should be done on tamper-resistant prescription pads or electronically transmitted in states like Florida, New York, and California [13]. 

 

 

Legal Status of Nucynta

The legal status of Tapentadol may vary between countries and jurisdictions. The classification of Tapentadol under the law in a few countries is listed below [14]. 

  • Australia (AU)-     

  • AU: S8 (Controlled drug)

  • Canada (CA)- Schedule I

  • Germany (DE)-  Anlage III (Special prescription form required)

  • UK- Class A (Schedule II)

  • US- Schedule II

 

What Medication Is Similar To Nucynta?

Other Schedule II analgesics with similar efficacy in relieving body pain are Hydromorphone, Oxycodone, Codeine, and Methadone.

It is, however, essential to note that studies suggest that Tapentadol abuse is less frequent than most Schedule II pain medications [10]. 

 

Is Nucynta A Controlled Substance- Our Final Thought On Its Safety Profile 

Nucynta, or Generic Tapentadol, is classified as a Schedule II controlled substance in the USA by the Drug Enforcement Administration (DEA). It indicates the potency of the opioid analgesic to cause abuse and dependency if administered incorrectly or taken for an extended period. 

Tapentadol is thus a prescription drug and is not available over the counter. However, online pharmacies such as Health Naturo offers Tapentadol 100 mg without a prescription. 

It is essential to note that Health Naturo retails and ships Tapentadol tablets in compliance with all the regulations and restrictions to ensure that the medicine is delivered on time.

However, while buying Tapentadol 100 mg or other Schedule II drugs, you must be aware of its prescription regulation in your country. 


FAQ's

No, Tapenadol is not considered under India's Narcotic Drugs and Psychotropic Substances Act.

Nucynta, or Tapentadol, is an Opioid analgesic that treats acute and severe chronic pain.

  • People below 18 and above 65 years.

  • People with kidney, liver, and heart disorders.

  • If you are taking any other treatment or medications.

Tapentadol is a Schedule II drug.

Tapentadol does not come under the NDPS (The Narcotic Drugs and Psychotropic Substances Act, 1985).

Yes, it is safe if Nucynta is taken in the correct dosage.

It is advisable not to take more than 600 mg of Nucynta in a day.

The use of Tapentadol has a risk of causing side effects and dependence. Thus, any change in the dosage should be done after consulting a doctor.


References-

  1. Tapentadol (Nucynta) for Treatment of Pain, aafp.org. 

  2. Tapentadol for pain; enoxaparin after prosthetic valve replacement, journals.lww.com.

  3. Controlled substance, cancer.gov.

  4. Mechanism of Action - Nucynta ER

  5. The Controlled Substances Act, dea.gov. 

  6. Controlled Substance Schedules, deadiversion.usdoj.gov.

  7. List of Schedule II drugs (US), Wikipedia.

  8. Tapentadol abuse potential: a postmarketing evaluation using a sample of individuals evaluated for substance abuse treatment, pubmed.

  9. Assessing Abuse Potential of New Analgesic Medications Following Market Release: An Evaluation of Internet Discussion of Tapentadol Abuse, academic.oup.com. 

  10. Tapentadol Abuse Potential: A Postmarketing Evaluation Using a Sample of Individuals Evaluated for Substance Abuse Treatment, academic.oup.com.

  11. DEA Drug Schedules, drugrehab. 

  12. Prescription Drug Monitoring Program, NCBI. 

  13. Tamper-Resistant Prescription Form Requirements, cdc.gov. 

  14. Tapentadol, Wikipedia.