pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Sodium Channel Interactions.

Indications

Sourced from openFDA
  • Dyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures. Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic may also be used to block the gag reflex, to relieve the pain of oral ulcers or stomatitis and to relieve pain associated with ano-genital lesions.

Contraindications

Sourced from openFDA
  • 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 .contraindicated

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

Sourced from openFDA

IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS, RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHENEVER LOCAL ANESTHETIC AGENTS, SUCH AS DYCLONINE, ARE ADMINISTERED TO MUCOUS MEMBRANES. Dyclonine HCl Topical Solution, USP should not be injected into tissue or used in the eyes because of highly irritant properties. Dyclonine HCl Topical Solution, USP should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application since under such conditions there is the potential for rapid systemic absorption.

Adverse reactions

Sourced from openFDA

Adverse experiences following the administration of dyclonine are similar in nature to those observed with other local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central nervous system: CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of dyclonine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular system: Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic: Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions.

Use in specific populations

Sourced from openFDA

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.

Overdosage

Sourced from openFDA

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (See ADVERSE REACTIONS, WARNINGS and PRECAUTIONS ). Management of local anesthetic emergencies: The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic administration. The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously.

Approval history

Sourced from openFDA
  • Nov 20, 2018ANDAANDA200480Septodont

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
107 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Infection7065%
  2. 2Arthralgia6561%
  3. 3White Blood Cell Count Decreased4542%
  4. 4Productive Cough4441%
  5. 5Platelet Count Decreased4340%
  6. 6Blood Magnesium Decreased4037%
  7. 7Clostridium Difficile Infection4037%
  8. 8Febrile Neutropenia4037%
  9. 9Heart Rate Abnormal4037%
  10. 10Hypotension4037%
  11. 11Muscle Twitching4037%
  12. 12Thrombosis4037%
  13. 13Arthritis3028%
  14. 14Peripheral Swelling3028%
  15. 15Joint Swelling2927%

Clinical trials

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The 6 most recently updated of 6 ClinicalTrials.gov registrations naming Dyclonine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Dyclonine work?
Mechanism-of-action class: Sodium Channel Interactions.
What is Dyclonine used for?
According to FDA labeling, Dyclonine carries indications including: Dyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures. Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic may also be used to block the gag reflex, to relieve the pain of oral ulcers or stomatitis and to relieve pain associated with ano-genital lesions.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dyclonine?
Dyclonine is classified as Anesthetics, local, Other local anesthetics, Sodium Channel Interactions, Analgesia, Decreased Sensory-Somatic Nervous System Organized Electrical Activity.
What are the brand names for Dyclonine?
Dyclonine is marketed under brand names including Dyclopro, Sucrets, Sucrets Complete, Sucrets Sore Throat.
What are the contraindications for Dyclonine?
Dyclonine labeling lists contraindications including: 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 .. Always consult the full prescribing information and a clinician.
Note. Data for dyclonine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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