glydo 20 mg/mL
lidocaine hydrochloride · JELLY · Sagent Pharmaceuticals
Glydo is a topical lidocaine jelly applied directly to the skin or mucous membranes to numb and relieve pain in the treated area. It works by blocking nerve signals that transmit pain sensations.
Key Facts
- Brand Name
- glydo
- Generic Name
- lidocaine hydrochloride
- NDC Code (Product)
25021-673- Manufacturer
- Sagent Pharmaceuticals
- Strength
- 20 mg/mL
- Dosage Form
- JELLY
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA201094
- Marketing Start
- 09/15/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
GLYDO 2% Jelly is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).
Dosage & Administration
When GLYDO 2% Jelly is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind. 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. Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with GLYDO 2% Jelly is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered. For Surface Anesthesia of the Male Adult Urethra The outer orifice is washed and disinfected. The plastic tip is introduced into the orifice, where it is firmly held in position. The jelly is instilled by an easy syringe-like action, until the patient has a feeling of tension or until about 15 mL (i.e., 300 mg of lidocaine hydrochloride) is instilled. A penile clamp is then applied for several minutes at the corona and then additional jelly (about 15 mL) can be in…
Warnings
EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS. GLYDO 2% Jelly 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. When used for endotracheal tube lubrication care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate the endotracheal stylettes. If allowed into the inner lumen, the jelly may dry on the inner surface leaving a residue which tends to clump with flexion, narrowing the lumen. There have been rare reports in which this residue has caused the lumen to occlude (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION). Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all pati…
Contraindications
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO 2% Jelly.
Adverse Reactions
Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide 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: There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube (see WARNINGS and DOSAGE AND ADMINISTRATION). 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 m…
Frequently Asked Questions
What is glydo used for?
Glydo is a topical lidocaine jelly applied directly to the skin or mucous membranes to numb and relieve pain in the treated area. It works by blocking nerve signals that transmit pain sensations.
Is glydo a controlled substance?
glydo is not classified as a controlled substance by the DEA.
What is the generic name for glydo?
The generic name for glydo is lidocaine hydrochloride. There are 12 other brand versions of lidocaine hydrochloride.
What is the NDC code for glydo 20 mg/mL?
The NDC (National Drug Code) for glydo 20 mg/mL is 25021-673, listed by Sagent Pharmaceuticals.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)