Our chosen pharmacy partner is designed and operated to meet cGMP standards. Furthermore, our pharmacy partner adheres to the guidance provided by under section 503B of The Drug Quality and Security Act. We are regularly inspected by the State Boards of Pharmacy, DEA, and FDA to assure compliance. The key to providing safe sterile compounded products resides in using the principles of aseptic technique throughout the compounding process. This allows us to maintain the highest degree of supply chain integrity and compliance with state and federal regulations.
cGMP refers to the Current Good Manufacturing Practices enforced by the US Food and Drug Administration (FDA). cGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to cGMP regulations assures the identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations and maintaining validated testing methods. This formal system of controls, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures and errors.
If irritation develops, this medicine should be discontinued. This medication contains a corticosteroid, your physician may periodically monitor you for HPA axis suppression if prolonged therapy is needed. Your physician needs to know if you experience severe or troublesome adverse reactions, become pregnant or intend to become pregnant, or intend to breastfeed.
Do not share or take anyone else’s medication. Talk with your healthcare provider before starting any new medication, including over-the-counter, natural products, or vitamins. This medication was compounded specifically for you. This patient information summarizes the most important information about your medication; if you would like more information, talk with your doctor.
You should not take this medication if you have any hypersensitivities to dyclonine, acyclovir, or triamcinolone. You should not use this medicine if you have an active fungal or bacterial infection of the mouth or throat. A reduced dosage of dyclonine may be required in elderly patients and children. Inform your doctor if you have known renal impairment; a dose adjustment may be required.
Burning; itching; irritation; dryness; erythema; pain; stinging; blistering or peeling not present prior to therapy; perioral dermatitis; allergic contact dermatitis; maceration of the oral mucosa; hives; aphthous ulcers; secondary infection; atrophy of the oral mucosa; HPA axis suppression with systemic absorption; cardiovascular events with high plasma levels of dyclonine hydrochloride upon excessive dosage or rapid absorption; myocardium depression; hypotension; hypertension; bradycardia; cardiac arrest; drowsiness; convulsions; apprehension; euphoria; confusion; tinnitus; double vision; vomiting; twitching; sensations of heat; respiratory depression; respiratory arrest; nervousness, with excessive dosing; dizziness; blurred vision; tremors; diarrhea; nausea; sore gums; and vomiting.