Dyclonine

FDA label, Septodont Inc, topical, effective 2024-11-28. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

DOSAGE AND ADMINISTRATION: As with all local anesthetics, the dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. A maximum dose of 30 mL of Dyclonine HCl Topical Solution, USP 1% topical anesthetic (300 mg of dyclonine HCl) may be used, although satisfactory anesthesia is usually produced within the range of 4 to 20 mL.

For specific techniques and procedures refer to standard textbooks. Although as much as 300 mg of Dyclonine HCl Topical Solution USP (as a 1% solution) have been tolerated, this dosage as a 0.5% solution has not been administered primarily because satisfactory anesthesia in endoscopic procedures can usually be produced by lesser amounts.

For specific techniques for endoscopic procedures refer to standard textbooks. Dyclonine HCl Topical Solution, USP can be used for a period of 7 days after open.

Contraindications

CONTRAINDICATIONS: Dyclonine HCl Topical Solution, USP is contraindicated in patients known to be hypersensitive (allergic) to the local anesthetic or to other components of Dyclonine HCl Topical Solution, USP .

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for dyclonine. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with dyclonine hydrochloride. It is also not known whether dyclonine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dyclonine hydrochloride should be given to pregnant women only if clearly needed.

Lactation

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dyclonine is administered to a nursing woman.

Breastfeeding (LactMed)

No information is available on the use of dyclonine during breastfeeding. Topical dyclonine products should be wiped off thoroughly prior to nursing if they are applied to the breast or nipple area. Topical dyclonine is relatively safe, but allergic contact dermatitis has been reported following dyclonine use, so it is best kept away from the infant’s skin.

Source: LactMed: Dyclonine (NICHD, public domain)Revised Nov 16, 2020

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Price ladder

Not the price at the counter
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