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Zucapsaicin (United States: Not available): Drug information

Zucapsaicin (United States: Not available): Drug information
(For additional information see "Zucapsaicin (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • Zuacta [DSC]
Pharmacologic Category
  • Analgesic, Topical;
  • Topical Skin Product;
  • Transient Receptor Potential Vanilloid 1 (TRPV1) Agonist
Dosing: Adult
Pain relief in osteoarthritis of knee

Pain relief in osteoarthritis of knee: Topical: Apply a pea-sized amount to 3 locations around affected knee 3 times daily; allow at least 4 hours between applications (maximum: 3 applications/day). Therapy should be limited to ≤3 months.

Missed dose: Apply the dose as soon as possible, but not within four hours of the next dose.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment does not appear to be necessary since there is no systemic absorption following topical administration of zucapsaicin.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment does not appear to be necessary since there is no systemic absorption following topical administration of zucapsaicin.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

>10%: Local: Application-site burning (35%; including severe burning skin [6% to 10%])

1% to 10%:

Dermatologic: Burning sensation of skin (2%)

Local: Application-site reaction (4%; including application-site edema [<1%], application-site erythema [<1%], application-site irritation [1%], application-site pain [<1%], application-site pruritus [1%], application-site rash [1%], local dryness of skin [<1%], sensation of cold [<1%]), localized numbness (3%), localized warm feeling (6%)

Ophthalmic: Eye irritation (1%)

Respiratory: Cough (2%), sneezing (1%)

<1%:

Cardiovascular: Flushing

Dermatologic: Skin blister, skin discoloration, skin photosensitivity, skin rash

Nervous system: Headache

Respiratory: Dyspnea, nasal congestion, nasal mucosa irritation, throat irritation

Contraindications

Hypersensitivity to zucapsaicin or any component of the formulation; application to broken or irritated skin or areas with a compromised skin barrier

Warnings/Precautions

Concerns related to adverse effects:

• Cough: May induce cough; do not apply to the face. Wash hands thoroughly after each application.

Other warnings/precautions:

• Appropriate use: For external use only. Avoid contact with eyes, lips, genital areas, broken or irritated skin or on areas with a compromised skin barrier Avoid application of other topical products to zucapsaicin treated areas. Do not use under occlusive dressings. Avoid hot baths or showers just prior to or right after application to avoid a possible burning sensation. Safety and efficacy have only been evaluated in the treatment of osteoarthritis of the knee; has not been evaluated and is not recommended for use in other arthritic, inflammatory, or painful musculoskeletal conditions, in severe neurological or vascular disease, and/or in osteoarthritis of the knee secondary to other pathological processes

Product Availability

Not available in the US

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Zuacta: 0.075% ([DSC]) [contains benzyl alcohol, cetyl alcohol, peg-100 stearate]

Administration: Adult

Topical: For external use only on intact skin; do not apply to broken or irritated skin. Gently rub in a circular motion into affected knee until no residue is left on skin. Do not cover treated area with occlusive dressing. Wash hands thoroughly after application. Avoid taking a hot bath or shower immediately before or after administration (may cause burning sensation). Avoid contact with eyes, lips, and genital area. Avoid concomitant application of other topical medications to treated areas.

Use: Labeled Indications

Note: Not approved in the US

Osteoarthritis of the knee: In conjunction with an oral NSAID or COX-2 inhibitor for short-term (≤3 months) treatment of severe pain associated with osteoarthritis of the knee that is not controlled by NSAID or COX-2 inhibitor monotherapy

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Zucapsaicin is not absorbed systemically following topical administration. Use during pregnancy is not expected to result in significant exposure to the fetus.

Breastfeeding Considerations

It is not known if zucapsaicin is excreted in breast milk. The manufacturer recommends that caution be exercised when administering zucapsaicin to nursing women.

Mechanism of Action

Actions are thought to be similar to other capsaicinoids, such as capsaicin, which is a transient receptor potential vanilloid 1 receptor (TRPV1) agonist, that activates TRPV1 ligand-gated cation channels on nociceptive nerve fibers, resulting in depolarization, initiation of action potential, and pain signal transmission to the spinal cord; capsaicin exposure results in subsequent desensitization of the sensory axons, depletion of proinflammatory neuropeptides (eg, calcitonin gene-related peptide, substance P) and inhibition of pain transmission initiation. In arthritis, capsaicin induces release of substance P, the principal chemomediator of pain impulses from the periphery to the CNS, from peripheral sensory neurons; after repeated application, capsaicin depletes the neuron of substance P and prevents reaccumulation. The functional link between substance P and the capsaicin receptor, TRPV1, is not well understood.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Systemic absorption is negligible

  1. Zuacta (zucapsaicin cream 0.075%) [product monograph]. Laval, Quebec, Canada: Sanofi-aventis Canada Inc; November 2010
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