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LABELS · 671a0224-c38b-4f2e-a132-fa38aa1a0797

Duraclon

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2021-03-17
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  2. NOTE: Duraclon ® (epidural clonidine) is not recommended for obstetrical, post-partum, or peri-operative pain management. The risk of hemodynamic instability, especially hypotension and bradycardia, from epidural clonidine may be unacceptable in these patients. However, in a rare obstetrical, post-partum or peri-operative patient, potential benefits may outweigh the possible risks.

Indications and usage: exact source text

  1. INDICATIONS AND USAGE Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials ). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS ).
Full extracted label fields
application numbers
  1. NDA020615
boxed warning exact
  2. NOTE: Duraclon ® (epidural clonidine) is not recommended for obstetrical, post-partum, or peri-operative pain management. The risk of hemodynamic instability, especially hypotension and bradycardia, from epidural clonidine may be unacceptable in these patients. However, in a rare obstetrical, post-partum or peri-operative patient, potential benefits may outweigh the possible risks.
brand names
  1. Duraclon
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8c126bb8-732a-4949-8754-2f50b5543638
generic names
  1. CLONIDINE HYDROCHLORIDE
id
671a0224-c38b-4f2e-a132-fa38aa1a0797
indications and usage exact
  1. INDICATIONS AND USAGE Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials ). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS ).
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Mylan Institutional LLC
    matched search terms
    1. cancer
    package ndcs
    1. 67457-218-10
    product ndcs
    1. 67457-218
    product types
    1. HUMAN PRESCRIPTION DRUG
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      meta
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        2. Appl No
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          Submission Class Code ID
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          Submission No
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        6. Appl No
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        1. Active Ingredient
          CLONIDINE HYDROCHLORIDE
          Appl No
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          Drug Name
          DURACLON
          Form
          INJECTABLE;INJECTION
          Product No
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          Reference Drug
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          Reference Standard
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          1MG/10ML (0.1MG/ML)
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        2. Active Ingredient
          CLONIDINE HYDROCHLORIDE
          Appl No
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          Drug Name
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          Product No
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          Reference Drug
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          Reference Standard
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          Strength
          5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
          marketing status
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      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

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      INDICATIONS AND USAGE Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials ). The safety of this drug product has only been established in
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          INDICATIONS AND USAGE Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone.
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          INDICATIONS AND USAGE Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials ). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is n
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                s that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials ). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS ).
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                            1. CLONIDINE HYDROCHLORIDE
                            id
                            ind-span-c66aa09d9f65d5cae256
                            label id
                            671a0224-c38b-4f2e-a132-fa38aa1a0797
                            positive predicate support span
                            Source null
                            qualifier mentions
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                source defined aliases
                                  source span
                                  end
                                  624
                                  end exclusive
                                  true
                                  exact text
                                  In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS ).
                                  label id
                                  671a0224-c38b-4f2e-a132-fa38aa1a0797
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  9c9f5b41172f071f75c65a7b5726738fdb2370d95b7263af470389cde3f679ea
                                  start
                                  537
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%22671a0224-c38b-4f2e-a132-fa38aa1a0797%22
                                  spl effective date
                                  2021-03-17
                                  spl set id
                                  8c126bb8-732a-4949-8754-2f50b5543638
                                  spl version
                                  10
                                  structured fields status
                                  not_extracted_no_values_inferred_from_mentions
                                  structured indication
                                  age
                                  Source null
                                  approval pathway
                                  Source null
                                  biomarker and test
                                  Source null
                                  disease stage
                                  Source null
                                  limitations
                                  Source null
                                  line
                                  Source null
                                  prior therapy
                                  Source null
                                  regimen
                                  Source null
                                  tumor histology
                                  Source null
                                  use intent
                                  not_applicable

                                  Preserved source evidence · Not medical advice