Important: This page is general information, not medical advice. It does not recommend or prescribe any treatment. Always consult your doctor or pharmacist before starting, stopping or changing any medicine.
Quick facts
- How it is given
- topical
- Type
- human prescription drug
- Brand names
- DycloPro
- RxNorm ID
- 1048281
We do not publish dosing. How much of this medicine to take, how often, and for how long depends on your age, weight, kidney and liver function, other conditions and other medicines. That is a decision for the person who prescribes or dispenses it. Follow the directions on your own pack and ask your pharmacist if anything is unclear.
What it is used to treat
INDICATIONS AND USAGE: 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.
About this medicine
Description: DycloPro (Dyclonine Hydrochloride Topical Solution, USP, 0.5% and 1%) topical anesthetics contain a local anesthetic agent and are administered topically. See INDICATIONS for specific uses. DycloPro (Dyclonine Hydrochloride Topical Solution, USP, 0.5% and 1%) contain dyclonine HCl, which is chemically designated as 4’-butoxy-3-piperidinopropiophenone HCl. Dyclonine HCl is a white crystalline powder that is sparingly soluble in water and has the following structural formula: Structural Formula
Who should not take it
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 .
Warnings
WARNINGS: 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.
Reported side effects
ADVERSE REACTIONS: 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. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to the other ingredients used in this formulation. Allergic reactions, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. Local reactions include irritation, stinging, urethritis with and without bleeding.
If too much is taken
OVERDOSAGE: 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. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine). If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. The median lethal dose (LD 50 ) of Dyclonine HCl Topical Solution, USP administered orally to female rats is 176 mg/kg and 90 mg/kg in female mice. Intraperitoneally the LD 50 in female rats is 31 mg/kg and 43 mg/kg in female mice.
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This page is built from the openFDA record of the U.S. Food and Drug Administration's approved labelling for this product, effective 28 November 2024. Label text has been shortened and reformatted for readability; safety wording has not been altered in meaning. FDA labelling describes products approved in the United States — brand names, strengths, formulations and approved uses may differ in your country. Always read the leaflet that comes with your own pack. PocketsInfo is not affiliated with, and is not endorsed by, the FDA. Retrieved 2026-07-30.