Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Sertraline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Sertraline hydrochloride tablets are not approved for the treatment of major depressive disorder in pediatric patients. (See
WARNINGS
:
Clinical Worsening and Suicide Risk
,
PRECAUTIONS:
Information for Patients
, and
PRECAUTIONS:
Pediatric Use
).
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LORTAB SUMMARY
Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.
Lortab Tablets are indicated for the relief of moderate to moderately severe pain.
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NEWS HIGHLIGHTS
Published Studies Related to Lortab (Hydrocodone / Acetaminophen)
Randomized clinical trial of hydrocodone/acetaminophen versus
codeine/acetaminophen in the treatment of acute extremity pain after emergency
department discharge. [2014]
(DEA) Schedule III narcotics... CONCLUSIONS: Both medications decreased NRS pain scores by approximately 50%.
Hydrocodone/acetaminophen and tramadol chlorhydrate combination tablets for the management of chronic cancer pain: a double-blind comparative trial. [2008.01]
OBJETIVES: The purpose of this study was to compare the analgesic efficacy and tolerability of opioids hydrocodone and tramadol in the relief of cancer pain... CONCLUSIONS: There was no superior analgesic efficacy with the administration of hydrocodone/acetaminophen when compared to patients receiving tramadol in the relief of cancer pain. Tramadol produced more mild side effects than hydrocodone.
Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial. [2007.04]
STUDY OBJECTIVE: This randomized, multicenter study compares the analgesic efficacy and safety of tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo for the treatment of acute musculoskeletal pain caused by ankle sprain... CONCLUSION: One or 2 capsules of 37.5 mg tramadol/325 mg acetaminophen and 1 capsule of 7.5 mg hydrocodone/650 mg acetaminophen were well tolerated, had comparable clinical utility, and were more effective than placebo in the management of acute musculoskeletal pain caused by ankle sprain.
Tramadol/Acetaminophen or Hydrocodone/Acetaminophen for the Treatment of Ankle Sprain: A Randomized, Placebo-Controlled Trial. [2006.11.17]
STUDY OBJECTIVE: This randomized, multicenter study compares the analgesic efficacy and safety of tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo for the treatment of acute musculoskeletal pain caused by ankle sprain... CONCLUSION: One or 2 capsules of 37.5 mg tramadol/325 mg acetaminophen and 1 capsule of 7.5 mg hydrocodone/650 mg acetaminophen were well tolerated, had comparable clinical utility, and were more effective than placebo in the management of acute musculoskeletal pain caused by ankle sprain.
Rofecoxib versus hydrocodone/acetaminophen for postoperative analgesia in functional endoscopic sinus surgery. [2006.04]
OBJECTIVES/HYPOTHESIS: Functional endoscopic sinus surgery (FESS) is less invasive and more tissue sparing than extirpative techniques, with an assumed benefit of diminished postoperative pain. Oral opioids are commonly prescribed after sinus surgery but are associated with adverse effects, including gastrointestinal and neurologic symptoms. Nonopioid analgesics have been suggested to offer similar pain control efficacy with fewer adverse effects. STUDY DESIGN: To investigate postoperative analgesia in FESS, a prospective randomized, double-blinded comparison of hydrocodone/acetaminophen 7.5/750 mg (an opioidderivative) with rofecoxib 50 mg (a cyclooxygenase-2 inhibitor) was performed... CONCLUSIONS: The use of nonopioid analgesics after FESS may provide similar pain control to oral opioids.
Clinical Trials Related to Lortab (Hydrocodone / Acetaminophen)
Post-operative Pain Control After Pediatric Adenotonsillectomy [Recruiting]
Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric
population in the United States. It is generally a well-tolerated procedure with
post-operative bleeding risk ranging from 3-5% in children. Post-operative pain following
adenotonsillectomy has significant morbidity and may result in prolonged hospital stay or
re-admission to the hospital. Post-operative analgesia is most commonly managed with
narcotic-containing pain medication. In recent years however, there is evidence that some
patients may manifest increased sensitivity to narcotics, resulting in life-threatening
respiratory compromise. Though there is a theoretical risk that nonsteroidal
anti-inflammatory drugs (NSAIDs) increase bleeding time by disrupting platelet aggregation,
evidence of detrimental effects (i. e. increased risk of postoperative bleeding) remains
inconclusive for these generally well-tolerated medications. The goal of this study is to
determine the incidence of post-operative bleeding and to determine the efficacy of NSAIDs
in the management of post-operative pain following pediatric adenotonsillectomy, versus more
commonly used narcotic pain medication. The study design will be an initial retrospective
study to collect pilot data on the incidence of postoperative hemorrhage and indicators of
adequate/inadequate pain control in children age 4 to 17 undergoing adenotonsillectomy.
This will be followed by a prospective, randomized, single-blind controlled study in which
orally-administered ibuprofen (test intervention) is compared to acetaminophen-hydrocodone
(control intervention) in the postoperative period following adenotonsillectomy.
Comparison of Tramacet Versus Percocet in Post Surgical Patients [Not yet recruiting]
Opioid naive patients are randomized to receive either TRAMACET or PERCOCET at the time of
discharge following mild to moderate pain risk surgery. The following will be assessed: 1)
Brief pain inventory (BPI) for the month. 2) Post operative pain management satisfaction. 3)
Whether they sought any repeat opioid prescription. 4) Whether they intend to seek repeat
opioid prescription. It is expected that both groups will have similar pain outcomes but
those patients in the Percocet group will be more likely to seek a second prescription.
PK and Safety Study of XARTEMIS� XR (7.5 mg Oxycodone HCl/325 mg APAP) in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain [Recruiting]
Phase 4, multicenter, open-label, multiple-dose study of the pharmacokinetics (PK) and
safety of XARTEMIS XR in postsurgical adolescent subjects aged 12 to 17 years with moderate
to severe acute pain. The study will assess the safety of administering multiple doses of
XARTEMIS XR in this population.
A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain [Recruiting]
The purpose of this study is to explore the clinical characteristics oral MNK155 and Norco®
7. 5mg/325mg when used for the treatment of moderate to severe post operative pain.
Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco [Completed]
This study aims to determine whether the hydrocodone and acetaminophen exposures following
oral dosing of Vycavert are comparable to those following oral dosing of Norco.
Reports of Suspected Lortab (Hydrocodone / Acetaminophen) Side Effects
Headache (27),
Vomiting (27),
Fatigue (21),
Abdominal Pain (19),
Nausea (19),
Malaise (18),
Cognitive Disorder (18),
Drug Ineffective (17),
Anxiety (17),
Pain (15), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 6 ratings/reviews, Lortab has an overall score of 7. The effectiveness score is 9 and the side effect score is 6.33. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Lortab review by 37 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | pain |
| Dosage & duration: | | 10 mg taken one to two tablets every eight hours for the period of still taking it |
| Other conditions: | | neck pain, arm pain, hands numbness |
| Other drugs taken: | | Diazapam | | |
Reported Results |
| Benefits: | | Had surgery on my neck, the lortab reduce the pain.The lortab help relieve th pain upto eight hours so I did not need to take as many pills to find release. This is a good thing because I do not like pills. This medication helped tremedously. |
| Side effects: | | a little nausea. This medication has a high risk of addiction. When you take it be very careful that you do not misuse. The lortab reduces the pain on the first pill however as you take the medication it seems to take more pills as you go along to recieve the same releif as first. |
| Comments: | | take one to two tablets by mouth every 8 hours as needed for pain. |
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| | Lortab review by 23 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | oral surgery |
| Dosage & duration: | | 1-2 tablets taken every 6 hours for the period of 1 week |
| Other conditions: | | none |
| Other drugs taken: | | amoxicillin, ibuprofen | | |
Reported Results |
| Benefits: | | considerably reduced pain, if i experienced any at all. |
| Side effects: | | With two tablets, the main difference was moderate to severe drowsiness. With either dosage, I experienced vibrant dreams/nightmares and/or an elated/lightheaded feeling while awake. Constipation relieved with extra fiber. |
| Comments: | | In my experience with this medication, I've found it moderately addicting and should be taken with caution. I advise to take when in mild-moderate pain because that's what it's for, but hold off taking it every six hours (or as prescribed) if pain is not an issue. |
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| | Lortab review by 37 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | pain from recovering from abdominal surgery |
| Dosage & duration: | | 10 (dosage frequency: every 6 hours) for the period of few weeks |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | treated pain due to an open wound from abdominal surgery |
| Side effects: | | severe nausea, dizziness, lightheaded...I couldn't eat or drink many foods |
| Comments: | | taking pain medication while recovering from surgery...had an open wound with wound vac. The pain was so severe, especially when it came time to change the dressings and clean out the wound in which case I would double up on the medication. It helped with the pain, but also doubled the side effects I was feeling. |
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Page last updated: 2014-11-30
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