Limifen Uses

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What is Limifen?

Limifen injection is given together with other medicines to relieve pain during surgery. It is also used as a primary anesthesia (numbing medicine) for patients undergoing general surgery.

Limifen is to be given only by or under the direct supervision of a doctor.

Limifen indications

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Limifen HCl injection is indicated:

as an analgesic adjunct given in incremental doses in the maintenance of anesthesia with barbiturate/nitrous oxide/oxygen.
as an analgesic administered by continuous infusion with nitrous oxide/oxygen in the maintenance of general anesthesia.
as a primary anesthetic agent for the induction of anesthesia in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required.
as the analgesic component for monitored anesthesia care (MAC).

Uses of Limifen in details

Use: Labeled Indications

Analgesia: Analgesic adjunct for the maintenance of anesthesia with barbiturate/nitrous oxide/oxygen; analgesic with nitrous oxide/oxygen in the maintenance of general anesthesia; analgesic component for monitored anesthesia care.

Anesthetic: Primary anesthetic for induction of anesthesia in general surgery when endotracheal intubation and mechanical ventilation are required.

Limifen description

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A short-acting opioid anesthetic and analgesic derivative of fentanyl. It produces an early peak analgesic effect and fast recovery of consciousness. Limifen is effective as an anesthetic during surgery, for supplementation of analgesia during surgical procedures, and as an analgesic for critically ill patients. [PubChem]

Limifen dosage

The dosage of Limifen should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anaesthesia.

The initial dose should be reduced in the elderly and in debilitated patients. In children, it should be increased. The effect of the initial dose should be taken into account in determining supplemental doses.

To avoid bradycardia, it is recommended to administer a small IV dose of an anticholinergic agent just before induction. Droperidol may be given to prevent nausea and vomiting.

For Use as an Induction Agent: An IV bolus dose of ≥120 mcg/kg (17 mL/70 kg) Limifen will induce hypnosis and analgesia while maintaining good cardiovascular stability in patients with adequate muscle relaxation.

For Short Procedures and Use in Outpatients: Small doses of Limifen are most useful for minor, short but painful surgical procedures and for outpatients, provided good monitoring equipment is available.

An IV bolus dose of 7-15 mcg/kg (1-2 mL/70 kg) will suffice for procedures lasting <10 min. Should the duration of the procedure exceed 10 min, further increments of 7-15 mcg/kg (1-2 mL/70 kg) should be given 10-15 min or as required.

Spontaneous respiration may be maintained in most instances with a dose of 7 mcg/kg (1 mL/70 kg) or less, slowly injected; suggested increments with this technique are 3.5 mcg/kg (0.5 mL/70 kg).

It is preferable not to administer droperidol or benzodiazepines to outpatients as these drugs may lengthen the recovery period. In outpatients, a preferred technique consists of an anticholinergic agent, a short-acting induction hypnotic, Limifen and N2O/O2.

When postoperative nausea occurs, it is of relatively short duration and easily controlled by conventional measures.

For Procedures of Medium Duration: The dose of initial IV bolus should be adapted to the expected duration of the surgical procedure as follows. See Table 1.

When surgery is more prolonged or more aggressive, analgesia can be maintained by either increments of 15 mcg/kg (2 mL/70 kg) Limifen when required (to avoid postoperative respiratory depression, no Limifen should be administered during the last 10 min of surgery; or a Limifen infusion at a rate of 1 mcg/kg/min (0.14 mL/70 kg/min) until 5-10 min before the completion of surgery.

Periods of very painful stimuli can easily be overcome by a small dose increments or by temporarily increasing the infusion rate. When Limifen is used without N2O/O2 or another inhalation anaesthetic, a higher maintenance dose of Limifen is required.

For Long Procedures: Limifen may be used as the analgesic component of anaesthesia for long lasting surgical procedures especially when rapid extubation is indicated. Optimum analgesia and stable autonomic condition are maintained through an individually adapted initial IV dose and by adjusting the infusion rate to the severity of the surgical stimuli and the reactions of the patients.

Limifen interactions

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Drugs Modifying the Effect of Limifen: Drugs eg, barbiturates, benzodiazepines, neuroleptics, halogenic gases and other, nonselective CNS depressants (eg, alcohol) may potentiate the respiratory depression of narcotics.

When patients have received such drugs, the dose of Limifen required will be less than usual. Likewise, following the administration of Limifen, the dose of other CNS-depressant drugs should be reduced.

Limifen is metabolized mainly via the human cytochrome P-450 3A4 enzyme. In vitro data suggest that potent cytochrome P-450 3A4 enzyme inhibitors (eg, ketoconazole, itraconazole, ritonavir) may inhibit the metabolism of Limifen. Available human pharmacokinetic data indicate that the metabolism of Limifen is inhibited by fluconazole, voriconazole, erythromycin, diltiazem and cimetidine (known cytochrome P-450 3A4 enzyme inhibitors). This could increase the risk of prolonged or delayed respiratory depression. The concomitant use of such drugs requires special patient care and observation; in particular, it may be necessary to lower the dose of Limifen.

It is usually recommended to discontinue MAO inhibitors 2 weeks prior to any surgical or anaesthetic procedure.

Effect of Limifen on the Metabolism of Other Drugs: In combination with Limifen, the blood concentrations of propofol are 17% higher than in the absence of Limifen. The concomitant use of Limifen and propofol may require a lower dose of Limifen.

Incompatibilities: The injectable solution must not be mixed with other products. If desired, Limifen may be mixed with sodium chloride or glucose IV infusions. Such dilutions are compatible with plastic infusion sets. These should be used within 24 hrs of preparation.

Limifen side effects

See also:
What are the possible side effects of Limifen?

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Clinical Trial Data: The safety of Limifen was evaluated in 1157 subjects who particpiated in 18 clinical trials. Limifen was administered as an anaesthetic induction agent or as an analgesic/anaesthesia adjuvant to regional and general anaesthesia, in short, medium and long surgical procedures. These subjects took at least 1 dose of Limifen and provided safety data. Adverse Drug Reactions (ADRs) that were reported for ≥1% of Limifen-treated subjects in these trials are shown in Table 2.

Additional ADRs that occurred in <1% of Limifen-treated subjects in the 18 clinical trials are listed in Table 3.

Post-Marketing Data: Adverse drug reactions first identified during post-marketing experience with Limifen are included in Table 4. In the table, the frequencies are provided according to the following convention: Very common ≥1/10; common ≥1/100, <1/10; uncommon ≥1/1000, <1/100; rare ≥1/10,000, <1/1000; very rare <1/10,000, including isolated reports.

In Table 4, ADRs are presented by frequency category based on spontaneous reporting rates.

Limifen contraindications

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.

Active ingredient matches for Limifen:

Alfentanil in Spain.


List of Limifen substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Injectable; Injection; Alfentanil Hydrochloride 0.5 mg / ml
Alfenta 500 mcg/ml ampul$ 5.26
Alfentanil injection 500 ug/mL (Akorn, Inc. (US))
Injectable; Injection; Alfentanil Hydrochloride 0.5 mg / ml (Janssen)
Rapifen 0.5 mg/1 mL x 2 mL x 10's (Janssen)$ 1510.00
Rapifen 0.5 mg/1 mL x 2 mL x 5's (Janssen)
Rapifen / amp 0.5 mg/1 mL x 2 mL x 1's (Janssen)
Rapifen 0.5 mg/1 mL x 10 mL x 1's (Janssen)
Rapifen inj 0.5 mg/mL / amp 2 mL x 5 x 1's (Janssen)
Injectable; Injection; Alfentanil Hydrochloride 5 mg / ml

References

  1. PubChem. "ALFENTANIL". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "ALFENTANIL". http://www.drugbank.ca/drugs/DB00802 (accessed September 17, 2018).
  3. MeSH. "Anesthetics, Intravenous". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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