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Instillagel

Instillagel

Manufacturer:

Farco-Pharma

Distributor:

Primal
Full Prescribing Info
Contents
Lidocaine hydrochloride, chlorhexidine digluconate solution.
Description
100ml of Instillagel contains: Lidocaine hydrochloride (B.P) 2090.0mg; Chlorhexidine digluconate solution (B.P) 260.0mg; Methyl-4-hydroxybenzoate (B.P) 63.0mg; Propyl-4 hydroxybenzoate (B.P) 26.0mg.
Instillagel is a combination of lidocaine and chlorhexidine lubricant gel filled in a single-use syringe which is instilled into the urethra before catheterization and instrumentation to achieve lubricant, anesthetic and disinfectant effects.
Instillagel provides a total solution to complications from catheterization.
Instillagel is a prescription drug filled in a single-use syringe for a urethral catheterization procedure.
Action
Combined action of lubricant, mucosal anesthetic and anti-microbial takes place when instilled into the urethra.
Used for catheterization, endoscopies, gynecologic examination and rectum and colon examination.
Complete coverage of the entire urethra with lubricant protects the mucosa and prevents the incidence of such strictures following transurethral instrumentation.
Due to the reduced pain when inserting a catheter, end users have significantly less stress.
Unlike conventional catheterization, the lubricant gel does not get pushed out but instilled thoroughly into the urethra.
Unlike plane lubricant gel, the lubricating film covers the entire urethra during catheterization from one instillation.
No concern about the possible bacterial infection from the gel being put around the catheter before insertion.
The urethra is dilated to provide the maximum pathway for the incoming catheter.
Lubricant: Effective insertion while reducing trauma: The unbroken coating of lubricant reduces the danger of injury to the vulnerable urothelium.
The lubricating film reduces friction between foreign objects (catheters) and the mucosa, and allows the catheter to glide painlessly into the bladder.
The single instillation of Instillagel provides a maximum coverage over the entire urethra.
Since the urethral canal is dilated before insertion, it reduces the actual intubation time.
Instillagel is clear and does not impair visualization during endoscopy.
The viscosity of Instillagel is ideal for the insertion of catheter and other instruments.
Anesthetic: Pain relieving: Pain-free catheterization and internal urethrotomy are possible after the instillation of 2% lidocaine gel into the urethra.
Instillagel provides sufficient urethral anesthesia and reduces the risk of injury as a result of the patient's involuntary defensive movements.
Anesthetic effect occurs 3~5 minutes after the instillation and maintained for 30 minutes.
No side effects attributable to the administration of Instillagel were recorded.
Disinfectant: Antiseptic and against infection: Instillagel prevents the risk of nosocomial infections due to catheterization and cystoscopy.
As Instillagel contains the constituents lidocaine hydrochloride, chlorhexidine digluconate and methyl and propyl 4-hydroxybenzoate it works as a local anaesthetic and an antibacterial agent against all relevant pathogens.
With Saccharomyces cerevisiae, Streptococcus pyogenes, Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa, an entire extinction is obtained by Instillagel already within 5 minutes.
The unbroken coating of lubricant builds a protection against bacteria.
Shown as an effective treatment for urethritis as a local antiseptic therapy.
Antimicrobial action of Instillagel: See table.

Click on icon to see table/diagram/image

Catheter-Associated Urinary Tract Infections (CAUTI): Effective Infection management for CAUTI which takes 30% of the total nosocomial infection: According to the Centers for Disease Control and Prevention (CDC) in the US, the mortality rate from nosocomial infections was ranked 4th following cardiovascular disease, cancer and cerebrovascular disease. This morality rate is higher than accidental death including traffic accidents. Nosocomial infections are causing a large number of deaths even in developed countries alarming the infection control surveillance and management at hospitals.
The nosocomial infection rate is 6~8% out of the total number of patients and the urinary tract infection (UTI) takes up to 40~45% out of the total nosocomial infections. Among that, 70~80% of the infection is catheter-associated (daily incidence rate of 3-10%) and that causes the total CAUTI rate of 30% out of the total nosocomial infections.
The most critical factor of UTI is the indwelling period of a catheter. It has been reported that the infection rate per urethral catheterization is 1%, 10~40% when the indwelling period is less than a week and 100% when indwelling longer than 28 days. There are two commonly known infection courses: When bacteria access form the exterior surface of a catheter (65%); When bacteria ascent along the interior surface of a catheter (35%). (See figure.)

Click on icon to see table/diagram/image

Bacteria from urethral meatus may access to the bladder via a catheter.
The major causative bacteria of CAUTI still is E. coli (25~35%) which is mostly caused from ascending infection during catheterization.
Indications/Uses
Local anesthesia, disinfectant, lubricant for the following procedures: Catheterization, probing, urethral operation, all types of endoscopies, intubation and prevention of iatrogenic injuries to the rectum and colon.
Foley Catheter; Nelatone's Catheter; Prostate biopsy, Endorectal ultrasound; Cystoscopy, HoLEP; Hysteroscopy, IUD, D&C, biopsy, HIFU; Contrast medium for an ultrasonography; Colonoscopy; L-tube insertion; Manual rectal examination; Relieving defecation pain after hemorrhoidectomy; Self-catheterisation.
Dosage/Direction for Use
During catheterisation: Instill 6ml or 11ml. After the usual cleaning of the glans and the external urethral orifice, Instillagel 6ml/11ml is instilled slowly into the urethra and the glans is compressed until the local anaesthetic and antiseptic effect has set in.
During cystoscopy and endoscopy: Instill 11ml, and if necessary an additional 6ml or 11ml. The entire urethra, including the external sphincter, must be covered with the lubricating film and be anesthetised for germ-free and pain less insertion of instruments. A penile clamp should be applied in the region of the coronal sulcus.
In urethral strictures (stricture division, bougienation): Instill 11ml, and if necessary an additional 6ml or 11ml, and apply a penile clamp. The required urethral anesthesia will be achieved after 5-10 minutes.
For disinfection: 6ml or 11ml of gel is spread (instilled) evenly on the mucous membrane.
For other applications: Instill 6 ml or 11 ml slowly into the relevant body orifice and/or spread the gel as evenly as possible on the catheter to be inserted or on the instrument.
Foley Catheter: 11ml for Male, 6ml for Female (apply the remaining gel to the extravaginal area).
Insert a foley catheter after instillation - prevents the urethral infection.
Nelatone's Catheter: 11ml for Male, 6ml for Female.
Insert a nelatone catheter after instillation for an aseptic procedure.
Prostate biopsy, Endorectal ultrasound: Instill 2 syringes of 11ml.
Proceed the procedure 2~3 minutes after the instillation.
Cystoscopy, HoLEP: Proceed the procedures 3~5 minutes after the instillation to maximize the anesthetic effect.
Hysteroscopy, IUD, D&C, biopsy, HIFU: Instill into the operation area using an extension tube (eg. Instillaquill)(11ml x 1).
Pain relieving and disinfecting the affected area after the natural delivery.
Caution For Usage
How to use Instillagel: 1. Instill 6ml for female patients and 11ml for male patients.
2. Clean the glans and the external urethral orifice.
3. Push the syringe against firm resistance (e.g. a tabletop) while gently pressing on the piston rod to release the pressure in the syringe.
4. Remove the cap without touching the tip of the syringe.
5. Apply a drop of the lubricant to the urethral opening.
6. Carefully insert the tip of the syringe into the urethra.
7. Instill Instillagel slowly into the urethra by evenly pushing down on the piston rod.
8. Compress the glans for 3 minutes until the local anaesthetic and antiseptic effect has set in.
Storage
Store below 25 °C and avoid humidity.
ATC Classification
N01BB52 - lidocaine, combinations ; Belongs to the class of amides. Used as local anesthetics.
Presentation/Packing
Gel (disposable syringe) (transparent and almost colorless gel) 6 mL x 10's, 11 mL x 10's.
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