DYCLOPRO Topical solution Ref.[10046] Active ingredients: Dyclonine

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.

Proctology

Apply pledgets of cotton or sponges moistened with the Dyclonine HCl Topical Solution, USP 0.5% to postoperative wounds for the relief of discomfort and pain.

Gynecology

Apply Dyclonine HCl Topical Solution, USP 0.5% as wet compresses or as a spray to relieve the discomfort of episiotomy or perineorrhaphy wounds.

Oncology-Radiology

Apply Dyclonine HCl Topical Solution, USP 0.5% as a rinse or swab to inflamed or ulcerated mucous membrane of the mouth caused by anti-neoplastic chemotherapy or radiation therapy. In lesions of the esophagus, 5-15 mL of the anesthetic may be swallowed to relieve pain and allow more comfortable deglutition.

Otorhinolaryngology

To suppress the gag reflex and to facilitate examination of the posterior pharynx or larynx, apply Dyclonine HCl Topical Solution, USP, 0.5% as a spray or gargle.

Dyclonine HCl Topical Solution, USP, 0.5% may be applied as a rinse or swab to relieve the discomfort of aphthous stomatitis, herpetic stomatitis, or other painful oral lesions.

Dentistry

Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic is useful to suppress the gag reflex in the positioning of x-ray films, making prosthetic impressions, and doing surgical procedures in the molar areas. It is also useful as a preinjection mucous membrane anesthetic or applied to the gums prior to scaling (prophylaxis). The anesthetic can be applied as a mouthwash or gargle and the excess spit out.

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 (LD₅₀) of Dyclonine HCl Topical Solution, USP administered orally to female rats is 176 mg/kg and 90 mg/kg in female mice. Intraperitoneally the LD₅₀ in female rats is 31 mg/kg and 43 mg/kg in female mice.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep upright and preserve in tight and light-resistant container. Avoid excessive heat (temperatures above 40ºC [104ºF]). Subject to damage by freezing.