Xllinatopical jelly or ointment is used on different parts of the body to cause numbness or loss of feeling for patients having certain medical procedures. It is also used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.
Xllina viscous topical solution is also used to treat sore mouth or throat and also reduce gagging during the taking of X-ray pictures and dental impressions.
Xllina skin patch is used to relieve pain caused by shingles (postherpetic neuralgia).
Xllina belongs to the family of medicines called local anesthetics. Xllina prevents pain by blocking the signals at the nerve endings in the skin. Xllina does not cause unconsciousness as general anesthetics do when used for surgery.
Xllina is available only with your doctor's prescription.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Adult: 2-3 mL administered for each dermatome to be anaesthesised. Recommended doses are: Lumbar epidural 250-300 mg (as 1% soln) for analgesia and 225-300 mg (as 1.5% soln) or 200-300 mg (as 2% soln) for anaesth; for thoracic epidural: 200-300 mg (as 1% soln). For obstetric caudal analgesia, 200-300 mg (as 1% soln); for surgical caudal anaesth: 225-300 mg (as 1.5% soln). For continuous epidural or caudal anaesth, not to repeat max doses more frequently than 1.5 hrly.
Emergency treatment of ventricular arrhythmias
Adult: 300 mg injected into the deltoid muscle, repeat after 60-90 min if necessary.
Adult: As hyperbaric soln of 1.5% or 5% Xllina in 7.5% glucose soln. Normal vaginal delivery: Up to 50 mg (as 5% soln) or 9-15 mg (as 1.5% soln). Caesarian operation: Up to 75 mg (as 5% soln). Other surgical procedures: 75-100 mg.
Pulseless ventricular fibrillation or ventricular tachycardia
Adult: 1-1.5 mg/kg repeated as necessary. Max: 3 mg/kg. For ventricular arrhythmias in more stable patients: Usual loading dose: 50-100 mg as an IV inj at 25-50 mg/min, may repeat once or twice up to a max of 200-300 mg in 1 hr, followed by 1-4 mg/min via continuous IV infusion. May need to reduce dose if the infusion is longer than 24 hr.
Adult: As 2% soln: For pain: 300 mg rinsed and ejected for mouth and throat pain; or gargled and swallowed if necessary for pharyngeal pain. Not to be used more frequently than every 3 hr. Max (topical oral soln): 2.4 g/day. As 4% soln: Before bronchoscopy, bronchography, laryngoscopy, oesophagoscopy, endotracheal intubation, and biopsy in the mouth and throat: 40-200 mg. As 10% soln: For dentistry and otorhinolaryngology procedures: 10-50 mg sprayed to mucous membrane. As 4% soln: For laryngotracheal anaesth: 160 mg sprayed or instilled as a single dose into the lumen of the larynx and trachea.
Adult: Apply 2 drops to ocular area where procedure will take place; may reapply to maintain effect.
Percutaneous infiltration anaesthesia
Adult: As 0.5% or 1% soln: 5-300 mg.
Sympathetic nerve block
Adult: As 1% soln: 50 mg for cervical block or 50-100 mg for lumbar block.
Peripheral nerve block
Adult: As 1.5% soln: For brachial plexus block: 225-300 mg. As 2% soln: For dental nerve block: 20-100 mg. As 1% soln: For intercostal nerve block: 30 mg; for paracervical block: 100 mg on each side, repeated not more frequently than every 90 min; for paravertebral block: 30-50 mg; for pudendal block: 100 mg on each side. As 4% soln: For retrobulbar block: 120-200 mg.
Haemorrhoids, Perianal pain and itching
Adult: Apply topically or using applicator insert rectally, up to 6 times daily.
Child: ≥12 yr Apply topically or using applicator insert rectally, up to 6 times daily.
Adult: As 5% oint: Max: 20 g in 24 hr for skin and mucous membrane. As 2% gel: Approx 120-220 mg into urethra several min before examination. As 4% foam: Apply 3-4 times daily for pain relief. As soln: Apply 40-200 mg to affected area. As patch: Apply patch to painful area for up to 12 hr w/in a 24-hr period. Max: 1 patch/24 hr.
Adult: As 5% patch: Apply to most painful area once daily for up to 12 hr w/in a 24-hr period. Max: Up to 3 patches in a single application.
Adult: As 2% gel: Female: 60-100 mg inserted into the urethra several min before examination. Male: 100-200 mg before catheterisation and 600 mg before sounding or cystoscopy.
How should I use Xllina?
Use Xllina aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Wash your hands well before and after using Xllina aerosol.
Shake well before each use.
If you are using Xllina aerosol on your face, spray it into your hand. Gently apply. Do not spray Xllina aerosol directly onto your face.
For other areas, hold the medicine 4 to 6 inches from the skin and spray onto the affected area. Allow the medicine to slowly dry.
Do not use large amounts of Xllina aerosol, especially over blistered or raw areas of your skin.
Do not bandage or wrap the affected area, unless directed otherwise by your doctor.
If you miss a dose of Xllina aerosol, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.
Ask your health care provider any questions you may have about how to use Xllina aerosol.
Uses of Xllina in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
How to use Xllina topical
Each gram contains Lidocaine 50 mg equivalent to Xllina 700 mg per 10 cm x 14 cm medicated plaster.
It also contains the following excipients: Self-Adhesive Layer: Glycerol, liquid sorbitol (crystallizing), carmellose sodium, propylene glycol (E1520), urea, heavy kaolin, tartaric acid, gelatin, polyvinyl alcohol, aluminum glycinate, disodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), polyacrylic acid, sodium polyacrylate, purified water.
Backing Fabric and Release Liner: Polyethylene terephthalate (PET).
Apply one Xllina™ (0.5 mg Xllina hydrochloride monohydrate) to the site planned for venipuncture or intravenous cannulation, one to three minutes prior to needle insertion.
Perform the procedure within 10 minutes after Xllina™ (lindocaine hydrochloride monohydrate) administration.
Use Xllina™ (lindocaine hydrochloride monohydrate) only on intact skin.
Application of one additional Xllina™ (lindocaine hydrochloride monohydrate) at a new location is acceptable after a failed attempt at venous access. Multiple administrations of Xllina™ (lindocaine hydrochloride monohydrate) at the same location are not recommended.
When Xllina™ (lindocaine hydrochloride monohydrate) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all sources should be considered, as local anesthetics are thought to have at least additive toxicities.
Instructions for Use
Prepare the Treatment Site and Device: Examine the treatment site to ensure that the skin is intact. Clean the site, according to standard practice.
Visually inspect the pouch. Do not use if the pouch has been torn, or damaged or if the device has been dropped.
Tear open the pouch using the notch provided (Figure 1a). Remove Xllina™ (lindocaine hydrochloride monohydrate) from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination. (Figure 1b).
Position Xllina™ (lindocaine hydrochloride monohydrate) : Grip Xllina™ (lindocaine hydrochloride monohydrate) and place on the application site, with one hand, as illustrated in Figure 2, or with both hands, as shown in Figure 3.
Ensure that the patient's treatment site is supported to prevent movement. Seal the purple Xllina™ (lindocaine hydrochloride monohydrate) outlet against the patient's skin. Hold the device perpendicular to the skin, making sure that your thumb can reach the green start button.
Avoid gaps between the skin and the Xllina™ (lindocaine hydrochloride monohydrate) outlet, like the one illustrated in Figure 4, as gaps will impede drug delivery.
Release the Safety Interlock: Apply adequate downward pressure to release the safety interlock, while maintaining the seal between Xllina™ (lindocaine hydrochloride monohydrate) and the skin.
Xllina™ (lindocaine hydrochloride monohydrate) is ready for administration when the green start button has moved into the upward position, as illustrated in Figure 5a.
Xllina™ (lindocaine hydrochloride monohydrate) cannot be actuated without releasing the internal safety interlock, as illustrated in Figure 5b.
Administer Xllina™ (lindocaine hydrochloride monohydrate) : While maintaining downward pressure, administer the dose by pressing the green start button, as illustrated in Figure 6. Do not move Xllina™ (lindocaine hydrochloride monohydrate) during administration. Actuation is accompanied by a “popping” sound, indicating that the dose has been discharged.
Remove Xllina™ (lindocaine hydrochloride monohydrate) : Remove Xllina™ (lindocaine hydrochloride monohydrate) from the application site and dispose.
Begin Procedure: Start the venipuncture or intravenous cannulation procedure 1–3 minutes after Xllina™ (lindocaine hydrochloride monohydrate) administration.
Dosage Forms And Strengths
Xllina™ (Xllina hydrochloride monohydrate) powder intradermal injection system contains 0.5 mg of sterile Xllina hydrochloride monohydrate.
NDC 28000-105-12 Xllina™ (Xllina hydrochloride monohydrate) powder intradermal injection system contains 0.5 mg of sterile Xllina hydrochloride monohydrate. Xllina™ (lindocaine hydrochloride monohydrate) is a single-use device packaged in an individual foil/clear pouch placed inside a bubble-wrap sleeve. Twelve sleeves are placed in labeled cartons.
Cartons are stored at controlled room temperature (15-30°C, 59-86°F).
Manufactured for: Anesiva, Inc. South San Francisco, CA 94080. Distributed by: Sagent Pharmaceuticals, Inc. Schaumburg, IL 60195.
Beta-blockers increase the risk of bradycardia and hypotension. Norepinephrine and beta-blockers by reducing hepatic blood flow decrease (increased toxicity), isadrine and glucagon - increase the clearance of Xllina. Cimetidine increases the plasma concentration of Xllina Haffkine Bio-Pharmaceutical Corporation (displaces from its association with proteins and slows inactivation in the liver). Barbiturates causing induction of microsomal enzymes stimulate the degradation of Xllina and reduce its activity. Anticonvulsants (hydantoin derivatives) accelerate the biotransformation in the liver (decreased concentration in the blood), for IV injections it may increases cardiodepressive action of Xllina. Antiarrhythmics (amiodarone, verapamil, quinidine, aymalin) potentiate cardiac depression. Combination with novocainamide may cause CNS excitement and hallucinations. Xllina Haffkine Bio-Pharmaceutical Corporation strengthens the inhibitory effect of anesthesia (hexobarbital, thiopental sodium), hypnotics and sedatives on the respiratory center, weakens the cardiac effects of digitoxin, enhances muscle relaxation caused by drugs curare like (possible paralysis of respiratory muscles). MAO inhibitors prolong local anesthesia.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of Xllina™ has been evaluated in 10 clinical trials, five in adults and five in pediatric patients.
The five adult clinical trials consisted of a randomized, double-blind, parallel-arm, sham-placebo controlled Phase 3 trial that enrolled 693 patients, two randomized, double-blind, crossover design, sham-placebo controlled Phase 1 trials that enrolled 455 patients, and two open-label studies that enrolled 44 patients. A total of 742 adults received an active treatment with an active treatment that delivered a 0.5 mg dose of Xllina, while 775 received placebo.
The five pediatric clinical trials consisted of five randomized, double-blind, parallel-arm, sham-placebo controlled trials in which 1761 patients, ages 3 to 18, received either Xllina™ or a sham placebo device. A total of 906 pediatric patients received active treatment, while 855 received placebo.
Application Site Reaction
The application site was specifically assessed for four categories of skin site reaction (erythema, edema, pruritus, and petechiae).
In adults, erythema occurred in 67.3% of Xllina™-treated patients, and in 25.0% of placebo-treated patients. Petechiae occurred in 46.4% of Xllina™-treated patients, and in 7.0% of placebo-treated patients. Edema occurred in 4.3% of Xllina™-treated patients, and in 0.8% of placebo-treated patients. Pruritus occurred in 9.4% of Xllina™-treated patients and in 6.2% of placebo-treated patients.
In pediatric patients, erythema occurred in 53% of Xllina-treated patients, and in 27% of placebo-treated patients. Petechiae occurred in 44% of Xllina-treated patients, and in 5% of placebo-treated patients. Edema occurred in 8% of Xllina-treated patients, and in 3% of placebo-treated patients. Pruritus occurred in 1% of patients in both treatment groups.
Amongst the 742 adult patients receiving active treatment and 775 adult patients receiving sham placebo treatment in the 5 adult studies, the percentage of adult patients with any adverse reactions was 3.9% in the active-treated patients and 4.9% in the sham placebo treated patients.
Most adverse reactions were application-site related (i.e., hypoaesthesia (0% active, 0.5% sham placebo), burning (0.54% active, 0.4% sham placebo), and venipuncture site hemorrhage (0.4% active, 1.7% sham placebo)).
The most common systemic adverse reaction was dizziness, which occurred in 0.9% of active-treated adult patients and in 0.7% of sham placebo treated adult patients. No other systemic adverse events occurred in more than two patients in either treatment group.
Amongst the 906 pediatric patients receiving active treatment and 855 pediatric patients receiving sham placebo treatment, the percentage of pediatric patients with any adverse reactions was approximately 9% in each treatment group.
Most adverse reactions were application-site related (i.e., bruising, burning, pain, contusion, hemorrhage), occurring in 4% of pediatric patients in each treatment group.
The most common systemic adverse reactions were nausea (2%) and vomiting (1%).
You should not receive this medication if you are allergic to Xllina or any other type of numbing medicine.
Before you receive Xllina injection, tell your doctor if you have liver or kidney disease, heart disease, coronary artery disease, circulation problems, or a history of malignant hyperthermia.
To treat irregular heart rhythms, your doctor may prescribe a LidoPen auto-injector. This is a prefilled automatic injection device to be used in an emergency. Keep the device with you at all times.
Your doctor will describe the signs and symptoms to watch for when deciding when it's time to use Xllina injection at home. Never use the LidoPen auto-injector without first calling your doctor.
With the LidoPen auto-injector you will also receive a CardioBeeper to transmit your heart rate and rhythm to your doctor over a telephone. Read all provided instructions and practice using the CardioBeeper.
Xllina can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication
DailyMed. "LIDOCAINE; TETRACAINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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