Limifen Side effects

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What are the possible side effects of Limifen?

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 or nurse immediately if any of the following side effects occur:

More common

Rare Incidence not known

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:

More common

Rare

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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Side effects of Limifen in details

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The most common adverse reactions of opioids are respiratory depression and skeletal muscle rigidity, particularly of the truncal muscles. Limifen may produce muscular rigidity that involves the skeletal muscles of the neck and extremities. See CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS on the management of respiratory depression and skeletal muscle rigidity.

The adverse experience profile from 696 patients receiving Limifen for Monitored Anesthesia Care (MAC) is similar to the profile established with Limifen during general anesthesia. Respiratory events reported during MAC included hypoxia, apnea, and bradypnea. Other adverse events reported by patients receiving Limifen for MAC, in order of decreasing frequency, were nausea, hypotension, vomiting, pruritus, confusion, somnolence and agitation.

The following adverse reaction information is derived from controlled and open clinical trials in 785 patients who received intravenous Limifen during induction and maintenance of general anesthesia. The controlled trials included treatment comparisons with fentanyl, thiopental sodium, enflurane, saline placebo and halothane. The incidence of certain side effects is influenced by the type of use, e.g., chest wall rigidity has a higher reported incidence in clinical trials of Limifen induction, and by the type of surgery, e.g., nausea and vomiting have a higher reported incidence in patients undergoing gynecologic surgery. The overall reports of nausea and vomiting with Limifen were comparable to fentanyl.

Incidence Greater than 1% - Probably Causally Related (Derived from clinical trials)

*Incidence 3% to 9%

All others 1% to 3%

Gastrointestinal: nausea (28%),
vomiting (18%)
Cardiovascular: arrhythmia, bradycardia (14%),
hypertension (18%),
hypotension (10%),
tachycardia (12%)
Musculoskeletal: chest wall rigidity (17%),
skeletal muscle movements*
Respiratory: apnea*, postoperative respiratory depression
Central Nervous
System: blurred vision, dizziness*, sleepiness/postoperative sedation

Incidence Less than 1% - Probably Causally Related (Derived from clinical trials)

Adverse events reported in post-marketing surveillance, not seen in clinical trials, are italicized.

*Incidence 0.3% to 1%

Body as a whole: anaphylaxis
Central Nervous
System: headache*, myoclonic movements, postoperative confusion*, postoperative euphoria*, shivering*
Dermatological: itching*, urticaria*
Injection Site: pain*
Musculoskeletal: skeletal muscle rigidity of neck and extremities
Respiratory: bronchospasm, hypercarbia*, laryngospasm*

Limifen contraindications

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Hypersensitivity (eg, anaphylaxis) to Limifen or any component of the formulation.

Canadian labeling: Additional contraindication (not in US labeling): Suspected surgical abdomen (eg, acute appendicitis or pancreatitis); mild pain that can be managed with other pain medications; acute or severe bronchial asthma, chronic obstructive airway, status asthmaticus; acute respiratory depression, hypercapnia, cor pulmonale; acute alcoholism, delirium tremens, and convulsive disorders; severe CNS depression, increased cerebrospinal or intracranial pressure and head injury; concurrent use or use within 14 days of an MAO inhibitor; women who are nursing, pregnant, or during labor and delivery

Documentation of allergenic cross-reactivity for opioids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity can not be ruled out with certainty.

References

  1. HSDB. "ALFENTANIL". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
  2. NCIt. "Alfentanil: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
  3. NIST. "Propanamide, N-(1-(2-(4-ethyl-4,5-dihydro-5-oxo-1H-tetrazol-1-yl)ethyl)-4-(methoxymethyl)-4-piperidinyl)-N-phenyl-". http://www.nist.gov/srd/nist1a.cfm (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Limifen are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Limifen. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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