Xylogel Gel 30gm

Product Information

XYLOGEL

Xylogel® 2% Jelly

Lidocaine HCl

Presentation

Xylogel 2% Jelly: Transparent jelly; each gram jelly contains Lidocaine HCl USP 20mg.

Indications

Xylogel (Lidocaine HCl) 2% jelly is indicated for prevention and control of pain in male and female urethra during cystoscope,

catheterization, exploration by sound and other endourethral operations; for topical treatment of painful urethritis; for adequate

analgesia in endoscopy and as an anesthetic lubricant for endotracheal intubation (oral and nasal).

Dosage and administration

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, elderly and debilitated patients.

For Surface Anesthesia of the Male Adult Urethra: Sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to

the tube. Slowly instill approximately 15 gm (300 mg of lidocaine HCl) jelly into the urethra or until the patient has a feeling

of tension. A penile clamp is then applied for several minutes. An additional dose of not more than 15 gm (300 mg) 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 gm (600 mg) is usually required to fill and dilate the male urethra. Prior to catheterization, smaller volumes of 5-10 gm

(100-200 mg) are usually adequate for lubrication.

For Surface Anesthesia of the Female Adult Urethra: Sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to

the tube. Slowly instill 3-5 gm (60-100 mg) 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 Intubation: Apply 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.

Contraindications, warnings etc

Contraindications: Lidocaine HCl jelly is contraindicated in patients with a known history of hypersensitivity to local

anaesthetics of the amide type.

Precautions & warnings: If Lidocaine HCl jelly is used concomitantly with other products containing lidocaine, the total dose

contributed by all formulations must be kept in mind. No more than 600 mg of lidocaine HCl should be given in any 12 hour period.

Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. Lidocaine HCl jelly

should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application. Food

should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area because topical

anesthesia may impair swallowing and thus enhance the danger of aspiration. This is particularly important in children because of

their frequency of eating. Lidocaine HCl should also be used with caution in patients with severe shock or heart block.

Excessive dosage, or short intervals between doses, can result in high plasma levels and serious adverse effects.

Drug interactions: Lidocaine HCl should be used with caution in patients receiving antiarrhythmic drugs, such as tocainide, since

the toxic effects are additive.

Use in pregnancy and lactation: There is no, or inadequate, evidence of safety of the drug in human pregnancy but it has been in

wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy, this drug can be used if there

is no safer alternative. Lidocaine HCl enters the mother’s milk, but in such small quantities that there is generally no risk of

affecting the child at therapeutic dose levels.

Side effects: Aaphylactoid reactions such as cutaneous lesion, urticaria and oedema; drowsiness , nervousness, dizziness, blurred

vision, tremors, convulsions, unconsciousness,   respiratory arrest, hypotension, myocardial depression, bradycardia and  cardiac

arrest.

Overdosage: Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic

use of local anesthetics. If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia,

acidosis, bradycardia, arrhythmias, and cardiac arrest. If cardiac arrest occurs, standard cardiopulmonary resuscitative measures

should be instituted.

Pharmaceutical precautions

Store in a cool and dry place, protected from light. 

Packaging quantity

Xylogel® 2% Jelly: Cartons containing 30gm jelly in alu tube.

Manufactured by

UniMed & UniHealth Manufacturers Ltd.

B K Bari, Gazipur, Bangladesh.

®Registered Trademark