Glydo
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Questions & Answers
Side Effects & Adverse Reactions
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 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 also ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION.)
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
GLYDO (lidocaine HCl jelly USP, 2%) 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).
History
There is currently no drug history available for this drug.
Other Information
GLYDO (lidocaine HCl jelly USP, 2%) is a sterile aqueous product that contains a local anesthetic agent and is administered topically. (See INDICATIONS for specific uses.)
GLYDO (lidocaine HCl jelly USP, 2%) contains lidocaine HCl which is chemically designated as acetamide, 2-(diethyl-amino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula:
GLYDO (lidocaine HCl jelly USP, 2%) also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use.
GLYDO (lidocaine HCl jelly USP, 2%) is available in 6 mL and 11 mL single-use prefilled syringes. Each mL contains 20 mg of lidocaine HCl. The formulation also contains hypromellose, and sodium hydroxide to adjust pH to 6.0 to 7.0.
Sources
Glydo Manufacturers
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Sagent Pharmaceuticals
![Glydo (Lidocaine Hydrochloride) Jelly [Sagent Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Glydo | Sagent Pharmaceuticals
When GLYDO 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 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 UrethraThe 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 instilled for adequate anesthesia. Prior to sounding or cystoscopy, a penile clamp should be applied for 5 to 10 minutes to obtain adequate anesthesia. A total dose of 30 mL (i.e., 600 mg) is usually required to fill and dilate the male urethra. Prior to catheterization, smaller volumes of 5 to 10 mL (100-200 mg) are usually adequate for lubrication.
For Surface Anesthesia of the Female Adult UrethraSlowly instill 3 to 5 mL (60 to 100 mg of lidocaine HCl) of the jelly into the urethra. If desired, some jelly may be deposited on a cotton swab and introduced into the urethra. In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures.
Lubrication for Endotracheal IntubationApply a moderate amount of jelly to the external surface of the endotracheal tube shortly before use. Care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate endotracheal stylettes. See WARNINGS and ADVERSE REACTIONS concerning rare reports of inner lumen occlusion. It is also recommended that use of endotracheal tubes with dried jelly on the external surface be avoided for lack of lubricating effect.
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