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Minims Lidocaine & Fluorescein


Minims*

Lidocaine and Fluorescein

4% w/v Lidocaine hydrochloride and 0.25% w/v Fluorescein Sodium

About your eye drops

The name of this medicine is Minims Lidocaine & Fluorescein. Each Minims unit contains a solution of 4% w/v Lidocaine hydrochloride with 0.25% w/v fluorescein sodium.

One of the active ingredients in this medicine is lidocaine hydrochloride. This is the new name for lignocaine hydrochloride. The ingredient itself has not changed.

It also contains purified water, povidone and hydrochloric acid. Each Minims unit is a sterile, single-use container which holds approximately 0.5ml of solution. Each carton holds 20 Minims units. Lidocaine is a local anaesthetic which temporarily numbs the surface of the eye. Fluorescein temporarily colours your eyes orange or green and helps your doctor or eye specialist to examine them.

Who makes your eye drops?

Minims Lidocaine and Fluorescein are manufactured by

Laboratoire Chauvin S.A. ZI Ripotier 07200/Aubenas France

The Marketing Authorisations for Minims Lidocaine and Fluorescein (PL 0033/0073 & PA 118/24/1) are held by

Chauvin Pharmaceuticals Ltd. 106 London Road Kingston-Upon-Thames KT2 6TN England What are your eye drops for?

Your eye drops are used to numb and stain the surface of the eye, for a short time only, to allow the doctor or eye specialist to examine your eye.

Most often, your eye drops are used to allow the pressure inside your eyes to be measured.

Before using your eye drops

You should not use this product if you are allergic to fluorescein or Lidocaine and other similar types of local anaesthetic.

This product should be used with care in eyes that are inflamed (red and painful).

Your eye drops are not intended for long term use. Frequent use of local anaesthetic in the eye over long periods of time may affect your eyesight.

Using your eye drops

The doctor or eye specialist will put the drops in for you. You may be asked to press on the inner corners of your eyes for a minute to stop the solution draining into your nose and throat through the tear ducts.

It is important to protect your eye from dust during the time your eye is numb. Your doctor or eye specialist will make sure that your eye is properly protected.

The Minims unit should be thrown away after a single use, even if some solution remains.

It is unlikely that you will suffer an overdose from Minims Lidocaine & Fluorescein, but if you do suddenly feel unwell after receiving the drops, tell your doctor or eye specialist.

Following administration of Minims Lidocaine & Fluorescein you may experience very rare side effects which includes redness and irriatation of the eye, swelling around the eye, rarely difficulty in breathing and symptoms of shock and itchy skin rash with raised red blotches.

After using your eye drops

Tell your doctor or eye specialist if you suffer from any unwanted effects after using Minims Lidocaine & Fluorescein, that are not mentioned in this leaflet.

Storing your eye drops

The expiry date is printed on each Minims unit overwrap and printed on the carton label. Do not use it after this date.

Your eye drops should be stored below 25°C and in original container to protect from light. Do not allow to freeze.

This leaflet applies only to Minims Lidocaine & Fluorescein, but does not contain all the

If you have any questions or are not sure about anything, ask a doctor, eye specialist or pharmacist.

Date of (Partial) Revision of Text:

August 2005.

* Trade Mark

Chauvin Pharmaceuticals Ltd. 106 London Road Kingston-Upon-Thames KT2 6TN England Tel:020 8781 2900 Fax:020 8781 2901

Art. 76441 0504128/4


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Iodopengha


Iodopengha may be available in the countries listed below.

Ingredient matches for Iodopengha Eugenol

Eugenol is reported as an ingredient of Iodopengha in the following countries:

France Lidocaine

Lidocaine is reported as an ingredient of Iodopengha in the following countries:

France

International Drug Name Search


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Petco Lidocaine



Dosage Form: FOR ANIMAL USE ONLY
Drug Facts

    PETCO

   Itch Relief Spray

PETCO Itch Relief is a colorless, odorless, non-sticky, non-staining, water based formula containing the following ingredients which provide temporary relief of pain and itching from minor skin problems:

Lidocaine - An anesthectic to instantly calm pain and itching Aloe Vera and Allantoin - To soothe irritated skin Glycerin - A humectant to help moisturize the skin Denatonium Benzoate - A non-toxic bittering agent to deter chewing and licking of skin irritations
Active Ingredients

2% Lidocaine HCL, 0.01% Benzalkonium Chloride

Uses Provides temporary relief of pain and itching from minor skin problems such as insect bites, cuts, scrapes, and burns.
Warnings

Should irritation develop, persist or increase, discontinue use and consult a veterinarian. Keep this product out of reach of children and pets to avoid unintended consumption.

Directions

For use on dogs over six weeks old. Hold sprayer 6-8 inches from animal and thoroughly wet affected area making sure spray contacts the skin. Avoid spraying in eyes, nose, ears or mouth.

other Information

Store at 20-25C (68-77F)

Inactive Ingredients

Water, glycerin, Aloe Vera, Allantoin, Denatonium Benzoate.

FOR QUESTIONS CALL 1-877-473-8465


PETCO
Itch Relief
Spray
For Dogs
Medicated Spray Helpstemporarily relieve itching Helps aid in the temporary relief of minor skin problems Veterinarian Approved
NET 8 FL. OZ. (236mL)
PETCO 
lidocaine hydrochloride  liquid Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 27102-806 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 4.72 g  in 236 g Inactive Ingredients Ingredient Name Strength Water   GLYCERIN   ALOE VERA LEAF   ALLANTOIN   DENATONIUM BENZOATE   BENZALKONIUM CHLORIDE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 27102-806-07 236 g In 1 BOTTLE, SPRAY None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2001
Labeler - PETCO (028364727) Registrant - United Pet Group (931135730) Establishment Name Address ID/FEI Operations JUNGLE LABORATORIES CORPORATION 032615270 manufacture Revised: 03/2010PETCO

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Pro Pet Dr Jeff



Dosage Form: FOR ANIMAL USE ONLY
Drug Facts Active Ingredient

2% Lidocaine HCL

Uses

Uses: Provides temporary relief of pain and itching from minor skin problems. For use on dogs and cats.

Warnings Should irritation develop, persist, or increase, discontinue use and consult a veterinarian. Do not apply to wounds or damaged skin Do not bandage tightly Keep this product out of reach of children and pets to avoid unintended consumption
Directions For use on dogs over six weeks old Hold sprayer 6-8 inches from animal and thoroughly wet affected area making sure spray contacts the skin Avoid spraying in eyes, nose ears or mouth.
Other Information

Store at 20C-25C (68F-77F)

Inactive Ingredients

Water, Glycerin, Aloe Vera, Allantoin, Denatonium Benzoate.

PRO PET

Skin Relief

Medicated Spray


Relieves minor pain, itching and other skin discomfort With Lidocaine and Aloe Vera Veterinarian Approved      Dr. Jeff Werber, D.V.M.
Net Wt.
8 Fl. oz.
(236 ml)



Skin Relief Medicated Spray

Provides temporary relief from skin discomfort associated with scrapes, insect bites, minor cuts, burns, skin irritations, and sunburn. With Lidocaine, an anesthetic to calm itching and minor pain, and moisturizing conditioners to nourish skin. Bitter taste discourages chewing and licking of irritated area.
PRO PET DR. JEFF 
anti itch spray  spray Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 24730-626 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 4.72 g  in 236 g Inactive Ingredients Ingredient Name Strength Water   ALLANTOIN   ALOE VERA LEAF   BENZALKONIUM CHLORIDE   GLYCERIN   DENATONIUM BENZOATE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 24730-626-07 236 g In 1 BOTTLE, SPRAY None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2001
Labeler - United Pet Group (931135730) Establishment Name Address ID/FEI Operations JUNGLE LABORATORIES CORPORATION 032615270 manufacture Revised: 01/2010United Pet Group

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Exparel



Dosage Form: injection, suspension, liposomal
FULL PRESCRIBING INFORMATION 1. INDICATIONS AND USAGE

Exparel is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated for administration into the surgical site to produce postsurgical analgesia.

Exparel has not been studied for use in patients younger than 18 years of age.

2. DOSAGE AND ADMINISTRATION

Exparel is intended for single-dose administration only. The recommended dose of Exparel is based on the surgical site and the volume required to cover the area.

1Infiltrate 7 mL of Exparel into the tissues surrounding the osteotomy and 1 mL into the subcutaneous tissue. 2Dilute 20 mL of Exparel with 10 mL of saline, for a total of 30 mL, and divide the mixture into six 5 mL aliquots. Perform the anal block by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers. Surgery Dose of Exparel Volume of Exparel Bunionectomy1 106 mg 8 mL Hemorrhoidectomy2 266 mg 20 mL Injection Instructions

Exparel should be injected slowly into soft tissues of the surgical site with frequent aspiration to check for blood and minimize the risk of intravascular injection.

Exparel is intended for single-dose infiltration only. Exparel should be administered with a 25 gauge or larger bore needle. The maximum dosage of Exparel should not exceed 266 mg (20 mL, 1.3% of undiluted drug). Do not administer Exparel if the product is discolored. Do not administer Exparel if it is suspected that the vial has been frozen as reflected by the temperature indicator or exposed to high temperature (greater than 40°C or 104°F) for an extended period. Exparel can be administered undiluted or diluted up to 0.89 mg/mL (i.e. 1:14 dilution by volume) with preservative-free normal (0.9%) sterile saline for injection. Vials of Exparel should be inverted multiple times to re-suspend the particles immediately prior to withdrawal from the vial. Diluted suspensions of Exparel should be used within 4 hours of preparation in a syringe. Administration Precautions

Some physicochemical incompatibilities exist between Exparel and certain other drugs. Direct contact of Exparel with these drugs results in a rapid increase in free (unencapsulated) bupivacaine, altering Exparel characteristics and potentially affecting the safety and efficacy of Exparel. Therefore, admixing Exparel with other drugs prior to administration is not recommended [See Drug Interactions (7)].

Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from Exparel if administered together locally. The administration of Exparel may follow the administration of lidocaine after a delay of 20 minutes or more. Bupivacaine HCl, when injected immediately before Exparel, may impact the pharmacokinetic and/or physicochemical properties of the drugs when the milligram dose of bupivacaine HCl solution exceeds 50% of the Exparel dose. Exparel contains bupivacaine; therefore, coadministration of both drugs will increase the overall exposure to bupivacaine. When a topical antiseptic such as povidone iodine (e.g., Betadine®) is applied, the site should be allowed to dry before Exparel is administered into the surgical site. Exparel should not be allowed to come into contact with antiseptics such as povidone iodine in solution.

Studies conducted with Exparel demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of Exparel any more than they are by saline. None of the materials studied had an adverse effect on Exparel.

When administered in recommended doses and concentrations, bupivacaine HCl does not ordinarily produce irritation or tissue damage and does not cause methemoglobinemia.

Non-Interchangeability with Other Formulations of Bupivacaine

Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to Exparel and vice versa.

Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug's functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute.

Dosing in Special Populations

Exparel has not been studied in patients younger than 18 years of age, pregnant patients or patients who are nursing.

3. DOSAGE FORMS AND STRENGTHS

Exparel (bupivacaine liposome injectable suspension)

10 mL single use vial, 1.3% (13.3 mg/mL) 20 mL single use vial, 1.3% (13.3 mg/mL) 4. CONTRAINDICATIONS

Exparel is contraindicated in obstetrical paracervical block anesthesia. While Exparel has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death.

5. WARNINGS AND PRECAUTIONS Warnings and Precautions for Bupivacaine containing Products

The safety and effectiveness of bupivacaine and other amide-containing products depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. As there is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, any bupivacaine-containing product should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity [See Overdosage (10)].

Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after injection of bupivacaine and other amide-containing products. Restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity.

Bupivacaine and other amide-containing products should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of AV conduction produced by these drugs.

Injection of multiple doses of bupivacaine and other amide-containing products may cause significant increases in plasma concentrations with each repeated dose due to slow accumulation of the drug or its metabolites, or to slow metabolic degradation. Tolerance to elevated blood concentrations varies with the status of the patient.

Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, these drugs should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations.

Central Nervous System Reactions

The incidences of adverse neurologic reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration, and the physical status of the patient. Many of these effects may be related to local anesthetic techniques, with or without a contribution from the drug. Neurologic effects following infiltration of soft tissue may include persistent anesthesia, paresthesias, weakness, and paralysis, all of which may have slow, incomplete, or no recovery.

Central nervous system reactions are characterized by excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision, or tremors may occur, possibly proceeding to convulsions. However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction. This may quickly be followed by drowsiness merging into unconsciousness and respiratory arrest. Other central nervous system effects may be nausea, vomiting, chills, and constriction of the pupils. The incidence of convulsions associated with the use of local anesthetics varies with the procedure used and the total dose administered.

Cardiovascular System Reactions

Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure [See Warnings and Precautions (5.1) and Overdosage (10)].

Allergic Reactions

Allergic-type reactions are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. These reactions are characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly anaphylactoid-like symptoms (including severe hypotension). Cross-sensitivity among members of the amide-type local anesthetic group has been reported. The usefulness of screening for sensitivity has not been definitively established.

Chondrolysis

Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been postmarketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humerol chondrolysis have been described in pediatric patients and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness, and loss of motion can be variable, but may begin as early as the second month after surgery. Currently, there is no effective treatment for chondrolysis; patients who have experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.

Warnings and Precautions Specific for Exparel

As there is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, Exparel should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity [See Overdosage (10)].

Caution should be taken to avoid accidental intravascular injection of Exparel. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amide-containing products.

Using Exparel followed by other bupivacaine formulations has not been studied in clinical trials. Other formulations of bupivacaine should not be administered within 96 hours following administration of Exparel [See Clinical Pharmacology (12.3)].

Exparel has not been evaluated for the following uses and, therefore, is not recommended for these types of analgesia or routes of administration.

epidural intrathecal regional nerve blocks intravascular or intra-articular use

Exparel has not been evaluated for use in the following patient population and, therefore, it is not recommended for administration to these groups.

patients younger than 18 years old pregnant patients nursing patients

The ability of Exparel to achieve effective anesthesia has not been studied. Therefore, Exparel is not indicated for pre-incisional or pre-procedural loco-regional anesthetic techniques that require deep and complete sensory block in the area of administration.

6. ADVERSE REACTIONS General

The most commonly encountered acute adverse experiences to bupivacaine and all amide-type local anesthetics that demand immediate counter-measures are related to the central nervous and cardiovascular systems.

High plasma concentrations of bupivacaine can occur from overdosage, unintended intravascular injection, or accumulation of bupivacaine in plasma secondary to decreased hepatic metabolic degradation of the drug or diminished plasma protein binding capacity due to acidosis, pathologically lowered plasma protein production, or competition with other drugs for protein binding sites. Although rare, some individuals have a lower tolerance to and are supersensitive to bupivacaine and other amide-type local anesthetics and may rapidly develop signs of toxicity at low doses [See Overdosage (10)].

Adverse Reactions Reported in All Wound Infiltration Clinical Studies

Because clinical studies 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 studies of another drug and may not reflect the rates observed in practice.

The safety of Exparel was evaluated in 10 randomized, double-blind, local administration into the surgical site clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 to 532 mg of Exparel. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following Exparel administration were nausea, constipation, and vomiting.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following Exparel administration were pyrexia, dizziness, edema peripheral, anemia, hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain.

The less common/rare adverse reactions (incidence less than 2%) following Exparel administration were chills, erythema, bradycardia, anxiety, urinary retention, pain, edema, tremor, dizziness postural, paresthesia, syncope, incision site edema, procedural hypertension, procedural hypotension, procedural nausea, muscular weakness, neck pain, pruritus generalized, rash pruritic, hyperhidrosis, cold sweat, urticaria, bradycardia, palpitations, sinus bradycardia, supraventricular extrasystoles, ventricular extrasystoles, ventricular tachycardia, hypertension, pallor, anxiety, confusional state, depression, agitation, restlessness, hypoxia, laryngospasm, apnea, respiratory depression, respiratory failure, body temperature increased, blood pressure increased, blood pressure decreased, oxygen saturation decreased, urinary retention, urinary incontinence, vision blurred, tinnitus, drug hypersensitivity, and hypersensitivity.

Neurological and Cardiac Adverse Reactions Reported in All Wound Infiltration Clinical Studies

In the Exparel wound infiltration studies, adverse reactions with an incidence greater than or equal to 1% in the Nervous System Disorders system organ class following Exparel administration were dizziness (6.2%), headache (3.8%), somnolence (2.1%), hypoesthesia (1.5%), and lethargy (1.3%). The adverse reactions with an incidence greater than or equal to 1% in the Cardiac Disorders system organ class following Exparel administration were tachycardia (3.9%) and bradycardia (1.6%).

Adverse Reactions Reported in Placebo-Controlled Wound Infiltration Clinical Studies

Adverse reactions with an incidence greater than or equal to 2% reported by patients in clinical studies comparing 8 mL Exparel 1.3% (106 mg) to placebo and 20 mL Exparel 1.3% (266 mg) to placebo are shown in Table 1.

Table 1: Treatment-Emergent Adverse Reactions (TEAE) with an Incidence Greater than or Equal to 2%: Placebo Controlled Studies a Study 1: Bunionectomy b Study 2: Hemorrhoidectomy At each level of summation (overall, system organ class, preferred term), patients are only counted once.
Preferred terms are included where at least 2% of patients reported the event in any treatment group.
TEAE = treatment-emergent adverse event. STUDY 1a STUDY 2b Exparel Placebo Exparel Placebo System Organ Class
     Preferred Term 8 mL/1.3% (106 mg)
(N=97)
n (%) (N=96)
n (%) 20 mL/1.3% (266 mg)
(N=95)
n (%) (N=94)
n (%)   Any TEAE 53 (54.6) 59 (61.5) 10 (10.5) 17 (18.1)   Gastrointestinal Disorders 41 (42.3) 38 (39.6) 7 (7.4) 13 (13.8)      Nausea 39 (40.2) 36 (37.5) 2 (2.1) 1 (1.1)      Vomiting 27 (27.8) 17 (17.7) 2 (2.1) 4 (4.3)      Constipation 2 (2.1) 1 (1.0) 2 (2.1) 2 (2.1)      Anal Hemorrhage 0 (0.0) 0 (0.0) 3 (3.2) 4 (4.3)      Painful Defecation 0 (0.0) 0 (0.0) 2 (2.1) 5 (5.3)      Rectal Discharge 0 (0.0) 0 (0.0) 1 (1.1) 3 (3.2)   Nervous System Disorders 20 (20.6) 30 (31.3) 0 (0.0) 0 (0.0)      Dizziness 11 (11.3) 25 (26.0) 0 (0.0) 0 (0.0)      Headache 5 (5.2) 8 (8.3) 0 (0.0) 0 (0.0)      Somnolence 5 (5.2) 1 (1.0) 0 (0.0) 0 (0.0)      Syncope 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0)   Skin And Subcutaneous Tissue Disorders 8 (8.2) 7 (7.3) 0 (0.0) 0 (0.0)      Pruritus Generalized 5 (5.2) 6 (6.3) 0 (0.0) 0 (0.0)      Pruritus 3 (3.1) 1 (1.0) 0 (0.0) 0 (0.0)   Investigations 5 (5.2) 3 (3.1) 4 (4.2) 3 (3.2)      Alanine Aminotransferase Increased 3 (3.1) 3 (3.1) 1 (1.1) 0 (0.0)      Aspartate Aminotransferase Increased 3 (3.1) 2 (2.1) 0 (0.0) 0 (0.0)      Blood Creatinine Increased 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0)      Body Temperature Increased 0 (0.0) 0 (0.0) 3 (3.2) 3 (3.2)   General Disorders And Administration Site Conditions 4 (4.1) 0 (0.0) 1 (1.1) 1 (1.1)      Feeling Hot 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0)      Pyrexia 2 (2.1) 0 (0.0) 1 (1.1) 1 (1.1)   Infections And Infestations 2 (2.1) 1 (1.0) 0 (0.0) 0 (0.0)      Fungal Infection 2 (2.1) 1 (1.0) 0 (0.0) 0 (0.0)   Injury, Poisoning And Procedural Complications 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0)      Post Procedural Swelling 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0)   Metabolism And Nutrition Disorders 2 (2.1) 2 (2.1) 0 (0.0) 0 (0.0)      Decreased Appetite 2 (2.1) 2 (2.1) 0 (0.0) 0 (0.0) Drug Interactions

Exparel can be administered undiluted or diluted up to 0.89 mg/mL (i.e., 1:14 dilution by volume) with preservative-free normal (0.9%) sterile saline for injection. Exparel must not be diluted with water or other hypotonic agents as it will result in disruption of the liposomal particles.

Exparel should not be admixed with lidocaine or other non-bupivacaine-based local anesthetics.

Exparel may be locally administered after at least 20 minutes following local administration of lidocaine.

Exparel should not be admixed with other drugs prior to administration.

8. USE IN SPECIFIC POPULATIONS Pregnancy

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women of the effect of bupivacaine on the developing fetus. Exparel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Bupivacaine hydrochloride (HCl) produced developmental toxicity when administered subcutaneously to pregnant rats and rabbits at clinically relevant doses. This does not exclude the use of Exparel at term for analgesia [See Labor and Delivery (8.2)].

Bupivacaine HCl was administered subcutaneously to rats and rabbits during the period of fetal organogenesis. No embryo-fetal effects were observed in rats at the high dose which caused increased maternal lethality. An increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity.

Administration of bupivacaine HCl to rats during pregnancy and lactation resulted in decreased offspring survival.

Labor and Delivery

Bupivacaine hydrochloride is contraindicated for obstetrical paracervical block anesthesia.

Local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity [See Clinical Pharmacology (12.3)]. The incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus, and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function.

Nursing mothers

Bupivacaine has been reported to be excreted to some extent in human milk, suggesting that the nursing infant could be theoretically exposed to a dose of the drug. Because of the potential for serious adverse reactions in nursing infants from bupivacaine, a decision should be made whether to discontinue nursing or not administer Exparel, taking into account the importance of the drug to the mother.

Pediatric use

Safety and effectiveness in pediatric patients below the age of 18 have not been established.

Geriatric use

Of the total number of patients in the Exparel wound infiltration clinical studies (N=823), 171 patients were greater than or equal to 65 years of age and 47 patients were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients. Clinical experience with Exparel has not identified differences in efficacy or safety between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

In clinical studies, differences in various pharmacokinetic parameters have been observed between elderly and younger patients. Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to bupivacaine may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection of Exparel.

Hepatic Impairment

Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, these drugs should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations.

Renal Impairment

Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Care should be taken in dose selection of Exparel.

10. OVERDOSAGE

Acute emergencies from local anesthetics are generally related to high plasma concentrations encountered during therapeutic use of local anesthetics or to unintended intravascular injection of local anesthetic solution [See Warnings and Precautions (5) and Adverse Reactions (6)].

In the clinical study program, maximum plasma concentration (Cmax) values of approximately 34,000 ng/mL were reported and likely reflected inadvertent intravascular administration of Exparel or systemic absorption of Exparel at the surgical site. The plasma bupivacaine measurements did not discern between free and liposomal-bound bupivacaine making the clinical relevance of the reported values uncertain; however, no discernable adverse events or clinical sequelae were observed in these patients.

11. DESCRIPTION

Exparel is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension of multivesicular liposomes (DepoFoam® drug delivery system) containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of Exparel into soft tissue, bupivacaine is released from the multivesicular liposomes over a period of time.

Active Ingredient

Bupivacaine is related chemically and pharmacologically to the amide-type local anesthetics. It is a homologue of mepivacaine and is related chemically to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Chemically, bupivacaine is 1-butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide with a molecular weight of 288.4. Bupivacaine has the following structural formula:

Bupivacaine is present in Exparel at a concentration of 13.3 mg/mL.

Lipid Formulation

The median diameter of the liposome particles ranges from 24 to 31 µm. The liposomes are suspended in a 0.9% sodium chloride solution. Each vial contains bupivacaine at a nominal concentration of 13.3 mg/mL. Inactive ingredients and their nominal concentrations are: cholesterol, 4.7 mg/mL; 1, 2-dipalmitoyl-sn-glycero-3 phospho-rac-(1-glycerol) (DPPG), 0.9 mg/mL; tricaprylin, 2.0 mg/mL; and 1, 2-dierucoylphosphatidylcholine (DEPC), 8.2 mg/mL. The pH of Exparel is in the range of 5.8 to 7.4.

Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug's functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute.

12. CLINICAL PHARMACOLOGY Mechanism of action

Local anesthetics block the generation and the conduction of nerve impulses presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.

Pharmacodynamics

Systemic absorption of local anesthetics produces effects on the cardiovascular and central nervous systems. At blood concentrations achieved with normal therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations depress cardiac conductivity and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. Clinical reports and animal research suggest that these cardiovascular changes are more likely to occur after accidental intravascular injection of bupivacaine.

Following systemic absorption, local anesthetics can produce central nervous system stimulation, depression, or both. Apparent central stimulation is manifested as restlessness, tremors, and shivering progressing to convulsions, followed by depression and coma progressing ultimately to respiratory arrest. However, the local anesthetics have a primary depressant effect on the medulla and on higher centers. The depressed stage may occur without a prior excited state.

Pharmacokinetics

Local infiltration of Exparel results in significant systemic plasma levels of bupivacaine which can persist for 96 hours [See Warnings and Precautions (5.2)]. Systemic plasma levels of bupivacaine following administration of Exparel are not correlated with local efficacy.

Absorption

The rate of systemic absorption of bupivacaine is dependent upon the total dose of drug administered, the route of administration, and the vascularity of the administration site.

Pharmacokinetic parameters of Exparel after local administration were evaluated following surgical procedures. Descriptive statistics of pharmacokinetic parameters of representative Exparel doses in each study are provided in Table 2.

Table 2: Summary of Pharmacokinetic Parameters for Bupivacaine after Administration of Single Doses of Exparel Note: Arithmetic mean (standard deviation) except Tmax (median). Exparel Bunionectomy
106 mg (8 mL) Hemorrhoidectomy
266 mg (20 mL)   (N=26) (N=25)   Cmax (ng/mL) 166 (92.7) 867 (353) Tmax (h) 2 0.5 AUC(0-t) (h?ng/mL) 5864 (2038) 16,867 (7868) AUC(inf) (h?ng/mL) 7105 (2283) 18,289 (7569) t? (h) 34.1 (17.0) 23.8 (39.4)

Distribution

After bupivacaine has been released from Exparel and is absorbed systemically, bupivacaine distribution is expected to be the same as for any bupivacaine HCl solution formulation.

Local anesthetics including bupivacaine are distributed to some extent to all body tissues, with high concentrations found in highly perfused organs such as the liver, lungs, heart, and brain.

Local anesthetics including bupivacaine appear to cross the placenta by passive diffusion. The rate and degree of diffusion is governed by (1) the degree of plasma protein binding, (2) the degree of ionization, and (3) the degree of lipid solubility. Fetal/maternal ratios of local anesthetics appear to be inversely related to the degree of plasma protein binding, because only the free, unbound drug is available for placental transfer. Bupivacaine with a high protein binding capacity (95%) has a low fetal/maternal ratio (0.2 to 0.4). The extent of placental transfer is also determined by the degree of ionization and lipid solubility of the drug. Lipid soluble, non-ionized drugs such as bupivacaine readily enter the fetal blood from the maternal circulation.

Metabolism

Amide-type local anesthetics, such as bupivacaine, are metabolized primarily in the liver via conjugation with glucuronic acid. Pipecolylxylidine (PPX) is the major metabolite of bupivacaine; approximately 5% of bupivacaine is converted to PPX. Elimination of drug depends largely upon the availability of plasma protein binding sites in the circulation to carry it to the liver where it is metabolized.

Various pharmacokinetic parameters of the local anesthetics can be significantly altered by the presence of hepatic disease. Patients with hepatic disease, especially those with severe hepatic disease, may be more susceptible to the potential toxicities of the amide-type local anesthetics.

Excretion

After bupivacaine has been released from Exparel and is absorbed systemically, bupivacaine excretion is expected to be the same as for other bupivacaine formulations.

The kidney is the main excretory organ for most local anesthetics and their metabolites. Only 6% of bupivacaine is excreted unchanged in the urine.

Urinary excretion is affected by urinary perfusion and factors affecting urinary pH. Acidifying the urine hastens the renal elimination of local anesthetics. Various pharmacokinetic parameters of the local anesthetics can be significantly altered by the presence of renal disease, factors affecting urinary pH, and renal blood flow.

Specific Populations

Hepatic Impairment

The effects of decreased hepatic function on bupivacaine pharmacokinetics following administration of Exparel were studied in patients with moderate hepatic impairment. Consistent with the hepatic clearance of bupivacaine, mean plasma concentrations were higher in patients with moderate hepatic impairment than in the healthy control volunteers with approximately 1.5- and 1.6-fold increases in the mean values for Cmax and the area under the curve (AUC), respectively.

Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, these drugs should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations [See Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].

Renal Impairment

Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Care should be taken in dose selection of Exparel [See Use in Specific Populations (8.7)].

Age

Various pharmacokinetic parameters of the local anesthetics such as bupivacaine can be significantly altered by the age of the patient.

In clinical studies, differences in various pharmacokinetic parameters have been observed between elderly and younger patients.

Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection of Exparel [See Use in Specific Populations (8.5)].

13. NONCLINICAL TOXICOLOGY Carcinogenesis, mutagenesis, impairment of fertility

Long-term studies in animals of most local anesthetics, including bupivacaine, to evaluate the carcinogenic potential have not been conducted. Mutagenic potential and the effect on fertility have not been determined. There is no evidence from human data that bupivacaine may be carcinogenic or mutagenic or that it impairs fertility.

14. CLINICAL STUDIES

The efficacy of Exparel was compared to placebo in two multicenter, randomized, double-blinded clinical trials. One trial evaluated the treatments in patients undergoing bunionectomy; the other trial evaluated the treatments in patients undergoing hemorrhoidectomy. Exparel has not been demonstrated to be safe and effective in other procedures.

Bunionectomy

A multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluated the safety and efficacy of 106 mg Exparel in 193 patients undergoing bunionectomy. The mean age was 43 years (range 18 to 72). Study medication was administered directly into the wound at the conclusion of the surgery, prior to wound closure. Pain intensity was rated by the patients on a 0 to 10 numeric rating scale (NRS) out to 72 hours. Postoperatively, patients were allowed rescue medication (5 mg oxycodone/325 mg acetaminophen orally every 4 to 6 hours as needed) or, if that was insufficient within the first 24 hours, ketorolac (15 to 30 mg IV). The primary outcome measure was the area under the curve (AUC) of the NRS pain intensity scores (cumulative pain scores) collected over the first 24 hour period. There was a significant treatment effect for Exparel compared to placebo.

In this clinical study, Exparel demonstrated a significant reduction in pain intensity compared to placebo for up to 24 hours. The difference in mean pain intensity between treatment groups occurred only during the first 24 hours following study drug administration. Between 24 and 72 hours after study drug administration, there was minimal to no difference between Exparel and placebo treatments on mean pain intensity.

Hemorrhoidectomy

A multicenter, random


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Lidocaine Hydrochloride BP Laryngojet 4% (International Medication Systems)


Lidocaine Hydrochloride BP

Laryngojet 4%W/V

Please read this leaflet. It contains important information about your medicine. If you have any questions, please ask your doctor or nurse.

What is this medicine?

This medicine is called Lidocaine Hydrochloride BP Laryngojet 4% w/v. It is a sterile solution which comes in a glass vial and contains 160mg lidocaine hydrochloride in 4ml as the active ingredient. It also contains sodium hydroxide and water.

The active ingredient in this medicine is Lidocaine hydrochloride. This is the new name for Lidocaine (Lignocaine) hydrochloride. The ingredient itself has not changed.

There is one 4ml vial in each carton.

It is a local anaesthetic. It numbs the area it is applied to.

Who makes it? Marketing Authorisation Holder: International Medication Systems (UK) Limited 208 Bath Road Slough Berkshire SL1 3WE UK Manufacturer: International Medication Systems (UK) Ltd. Unit 14 Foster Avenue Woodside Park Dunstable Beds LU5 5TA UK What is it used for?

It is used to numb parts of the body, such as the mouth, throat and lungs, before some medical procedures which would otherwise be uncomfortable or painful. Examples of the kind of procedures lidocaine is used for are putting a breathing tube in during an operation, putting a tube into the lungs to examine them (bronchoscopy), or taking a specimen from the mouth, throat or lungs.

Before you are given lidocaine You should not be given lidocaine and should tell your doctor immediately if: You suffer from porphyria You are allergic to any of the ingredients or to other local anaesthetics You should tell your doctor if: You have epilepsy, any heart problems including heart failure, slow heart beat or delayed heart signals (heart block), very poor breathing, myasthenia gravis, shock, low oxygen levels or low blood volume The area to be anaesthetised is infected or cut You are pregnant, likely to become pregnant, or breast feeding You are taking any other medicines at all, especially ones for your heart (eg. propranolol, and medicines to treat an irregular heartbeat) or ulcers (eg. cimetidine) You are going to have a general anaesthetic where suxamethonium will be used. How much is given?

The lowest dose possible will be given. The usual adult dose is 4ml (160mg). The elderly may need a lower dose. Children can be given up to 3mg for every kg they weigh (so if they weigh 10kg, they could have 3 x 10 = 30mg).

The solution can be sprayed, instilled or applied with a swab to the area to be numbed. It usually works within 5 minutes.

Since this medicine will usually be given to you by a doctor it is unlikely that you will be given too much.

However, if you are worried that you have been given too much, please tell the doctor.

Are there any side effects?

Very rarely, a patient may have an allergic reaction including rashes, swelling (particularly of the lips, face, eyelids, tongue and throat), breathlessness and collapse.

If applied in the mouth it may be difficult to swallow properly until the effect has worn off.

Other side effects may include light headedness, drowsiness, dizziness, mood changes, ringing in your ears, fear, vision difficulties such as blurred or double vision or quivering eyeballs, sickness, sensations of heat, cold or numbness, twitching, fits, shaking, unconsciousness, shallow breathing, stopping breathing, low blood pressure (feeling faint), slow heart beat, collapse including the heart stopping.

If you feel drowsy, dizzy or suffer from blurred or double vision after having lidocaine, do not drive or operate machinery.

The doctor treating you will be watching to see if these effects occur and will have the equipment to treat them.

If you think this medicine has upset you in ANY way, please tell your doctor.

How to store this medicine

Do not use this medicine after the expiry date shown on the carton and vial label.

Do not store above 25°C.

KEEP THIS AND ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN

Date of preparation: January 2004

Further Information

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor (or pharmacist), who will have access to further information.

YOU MAY WANT TO READ THIS LEAFLET AGAIN. PLEASE DO NOT THROW IT AWAY IMMEDIATELY.

This leaflet only applies to Lidocaine Hydrochloride BP Laryngojet 4%w/v

6963001C


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Anbesol Teething Gel


1. Name Of The Medicinal Product

Anbesol Teething Gel

2. Qualitative And Quantitative Composition

Lidocaine hydrochloride

1.0%w/w

Chlorocresol

0.1%w/w

Cetylpyridinium chloride

0.02%w/w

3. Pharmaceutical Form

Gel for oral administration.

4. Clinical Particulars 4.1 Therapeutic Indications

For the temporary relief of pain caused by recurrent mouth ulcers, denture irritation and teething.

4.2 Posology And Method Of Administration

Adults, children and the elderly: Apply a small amount to the affected area with a clean fingertip. Two applications immediately will normally be sufficient to obtain pain relief. Use up to four times a day.

Babies teething: Apply a small amount to the affected area with a clean fingertip. Use up to four times a day.

4.3 Contraindications

In patients with a known history of hypersensitivity or allergic type reactions to any of the constituents of the product.

4.4 Special Warnings And Precautions For Use

The following statements will appear on the packaging:

If symptoms persist for more than 7 days, consult your doctor or dentist.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions required.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

There have been reports of non-specific ulceration following oral cetylpyridinium chloride therapy.

4.9 Overdose

Overdose is extremely unlikely considering the small size of the tube used for sale.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Lidocaine is a local anaesthetic of the amide type which acts by reversible inhibition of nerve impulse generation and transmission.

Chlorocresol: Chlorocresol has a disinfectant action.

Cetylpyridinium chloride: Cetylpyridinium chloride has a disinfectant action.

5.2 Pharmacokinetic Properties

Lidocaine hydrochloride

Absorption and fate: Lidocaine is readily absorbed from mucous membranes and through damaged skin. Lidocaine undergoes first-pass metabolism in the liver and about 90% is dealkylated to form monoethylglycinexylidide and glycinexylidide. Further metabolism occurs and the metabolites are excreted in the urine with less than 10% as unchanged lidocaine.

Chlorocresol

Absorption: There is no significant absorption of chlorocresol through the skin or mucous membranes.

Cetylpyridinium chloride

Absorption: There is no significant absorption of cetylpyridinium chloride through the skin or mucous membranes.

5.3 Preclinical Safety Data

The active ingredients in Anbesol Teething Gel have a well established safety record.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Alcohol 96%

Glycerin

Clove Oil

Sodium Saccharin

Hydroxypropyl Cellulose

Ponceau 4R (E124)

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store at a temperature not exceeding 25°C.

6.5 Nature And Contents Of Container

Membrane sealed lacquered aluminium tubes fitted with plastic caps containing 10g gel.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

UK

8. Marketing Authorisation Number(S)

PL 16853/0126

9. Date Of First Authorisation/Renewal Of The Authorisation

31/01/06

10. Date Of Revision Of The Text

29th July 2011


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Lidocaine Injection BP with Preservative 1 %


Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What your medicine is and what it is used for 2. Before you receive it 3. How it is administered 4. Possible side effects 5. Storing it

Lidocaine Injection with Preservative 1%

The active ingredient in this medicine is lidocaine hydrochloride. This is the new name for lignocaine hydrochloride. The ingredient itself has not changed.

This injection contains the active ingredient lidocaine hydrochloride 1%. Each ml contains 10 mg of lidocaine hydrochloride.

This injection also contains the following inactive ingredients:

Sodium chloride, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216) and water for injections.

Holder of the Marketing Authorisation: hameln pharmaceuticals ltd Gloucester United Kingdom Manufacturer: hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany What your medicine is and what it is used for

Lidocaine Injection with Preservative 1% is a clear, colourless, sterile and isotonic solution supplied in 20 and 50 ml clear glass vials, only intended to be given by injection under your skin (subcutaneously or SC).

Lidocaine is a local anaesthetic of the amide group. When injected into the skin, it causes loss of feeling before or during surgery. Lidocaine allows doctors to sew up cuts in the skin and to undertake operations without any pain even though the patient is awake.

Before you receive your medicine You should tell your doctor if: you think you are allergic to either lidocaine or the preservatives used in this injection. The preservatives are often known just as benzoates or hydroxy-benzoates. (See also section 4. Possible side effects for further information). you suffer from epilepsy or have fits you suffer from heart, lung or breathing disorders you have kidney or liver disease you suffer from myasthenia gravis (loss of muscle function and weakness) you are pregnant, likely to become pregnant or breast-feeding you have inflammation or infection in the area to be injected you are taking cimetidine (for stomach ulcer or heartburn) or beta-blockers, for example, propranolol (for angina, high blood pressure or other heart problems)

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Driving and operating machinery: Depending on where and how lidocaine is used, it may affect your ability to drive or operate machinery. Ask your doctor about when it would be safe to drive or operate machines.

How your medicine is administered

The dose of a local anaesthetic will be different for different patients. Your healthcare professional will decide on the right amount for you, depending on:

Your age; your general physical condition; the reason the local anaesthetic is being given and other medicines you are taking or will receive before or after the local anaesthetic is given.

Adults: As a guide, 20 ml (equivalent to 200 mg) of Lidocaine Injection with Preservative 1% is the usual maximum dose. Your doctor will decide on the most appropriate dose for you. A smaller dose may be used if you are elderly or weak.

Children: A smaller dose is usually used for children depending on their age, physical condition and the procedure to be performed.

Possible side effects

Like all medicines, Lidocaine Injection with Preservative 1% can have side effects:

Lidocaine is generally well tolerated, but along with its needed effects, all medicine can cause unwanted effects. Lidocaine may occasionally cause the following side effects:

pain, inflammation or numbness at the site of injection after the effects of the injection should have worn off nervousness tremor blurred or double vision dizziness or drowsiness convulsions (seizures) nausea or vomiting breathing problems slowed heart beat or low blood pressure

Allergic reactions to lidocaine hydrochloride are rare, but tell your doctor immediately if you get any difficulty with your breathing, a rash or itchy skin.

Methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

For patients going home before the numbness or loss of feeling caused by a local anaesthetic wears off:

During the time that the injected area feels numb, serious injury can occur without your knowing about it. Be especially careful to avoid injury until the anaesthetic wears off or feeling returns to the area.

Storing your medicine

Your doctor will store the vials in the outer carton in order to protect from light, between 10°C and 25°C and out of reach and sight of children.

Use by date

Your doctor will not use the drug after the expiry date shown on the vial and carton.

This leaflet was last updated on July 13th, 2004.

PL 01502/0035

43870/18/04


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Lidocaine Ointment


Pronunciation: LIE-doe-cane
Generic Name: Lidocaine
Brand Name: Generic only. No brands available.
Lidocaine Ointment is used for:

Relieving pain in the mouth and throat. It is also used to temporarily relieve pain and itching associated with minor cuts and skin scrapes, minor burns (including sunburn), minor skin irritation, and insect bites. It may also be used for certain medical procedures or other conditions as determined by your doctor.

Lidocaine Ointment is an anesthetic. It works by preventing nerves from transmitting painful impulses to the brain.

Do NOT use Lidocaine Ointment if: you are allergic to any ingredient in Lidocaine Ointment or other similar medicines (eg, amide-type anesthetics)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lidocaine Ointment:

Some medical conditions may interact with Lidocaine Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a blood infection or severe injury of the mouth, throat, or other area where you are applying Lidocaine Ointment if you have heart, liver, or kidney problems if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any anesthetic medicine

Some MEDICINES MAY INTERACT with Lidocaine Ointment. Tell your health care provider if you are taking any other medicines, especially any of the following:

Amiodarone, beta-adrenergic blockers (eg, metoprolol), cimetidine, or mexiletine because side effects, such as confusion, dizziness, lightheadedness, or tiredness, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lidocaine Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lidocaine Ointment:

Use Lidocaine Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Do not get Lidocaine Ointment in your eyes. Apply a small amount of Lidocaine Ointment to the affected area. Gently rub the medicine in until it is evenly distributed. If applying to broken skin, use a sterile gauze pad to apply the medicine. Wash your hands immediately after using Lidocaine Ointment unless your hands are part of the treated area. If you miss a dose of Lidocaine Ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Lidocaine Ointment.

Important safety information: Lidocaine Ointment may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Lidocaine Ointment with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Tell your doctor or dentist that you take Lidocaine Ointment before you receive any medical or dental care, emergency care, or surgery. Lidocaine Ointment may make it difficult for you to swallow. Do not eat anything for at least 1 hour after Lidocaine Ointment has been applied in the mouth or throat area. Numbness of the tongue may cause you to bite the inside of your mouth accidentally. Do not eat any food or chew gum while your mouth or throat area is numb. Lidocaine Ointment may cause a numbing effect at the application site. Do not scratch, rub, or expose the area to extreme hot or cold temperature until the numbness is gone. Use caution when applying Lidocaine Ointment over large areas. Do not use more medicine, apply it more often, or use it for longer than prescribed. Your condition will not improve faster, but the risk of side effects may be increased. PREGNANCY and BREAST-FEEDING: It is not known if Lidocaine Ointment can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lidocaine Ointment while you are pregnant. It is not known if Lidocaine Ointment is found in breast milk after topical use. If you are or will be breast-feeding while you use Lidocaine Ointment, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Lidocaine Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Redness or swelling at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); choking; confusion; dizziness or lightheadedness; fast breathing; fast, slow, or irregular heartbeat; fever; mood or mental changes; ringing in the ears or hearing changes; seizures; shortness of breath; swelling of the throat; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include apprehension; blurred vision; confusion; difficulty breathing; nervousness; ringing in the ears; seizures; sensations of heat, cold, or numbness; severe dizziness, drowsiness, or lightheadedness; slow or irregular heartbeat; tremor; twitching; unconsciousness; vomiting.

Proper storage of Lidocaine Ointment:

Store Lidocaine Ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Keep Lidocaine Ointment out of the reach of children and away from pets.

General information: If you have any questions about Lidocaine Ointment, please talk with your doctor, pharmacist, or other health care provider. Lidocaine Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lidocaine Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Lidocaine resources Lidocaine Use in Pregnancy & Breastfeeding Lidocaine Support Group 22 Reviews for Lidocaine - Add your own review/rating Compare Lidocaine with other medications Anal Itching Anesthesia Burns, External Hemorrhoids Pain Persisting Pain, Shingles Pruritus Sunburn
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UAD Caine


Generic Name: lidocaine injection (LYE doe kane)
Brand Names: Anestacaine, UAD Caine, Xylocaine HCl, Xylocaine-MPF

What is UAD Caine (lidocaine injection)?

Lidocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Lidocaine injection is used to numb an area of your body to help reduce pain or discomfort caused by invasive medical procedures such as surgery, needle punctures, or insertion of a catheter or breathing tube.

Lidocaine injection is also given in an epidural (spinal block) to reduce the discomfort of contractions during labor.

Lidocaine injection is sometimes used to treat irregular heart rhythms that may signal a possible heart attack.

Lidocaine injection may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about UAD Caine (lidocaine injection)? You should not receive this medication if you are allergic to lidocaine or any other type of numbing medicine.

Before you receive lidocaine 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 lidocaine 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.

Lidocaine can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication What should I discuss with my healthcare provider before receiving UAD Caine (lidocaine injection)? You should not receive this medication if you are allergic to lidocaine or any other type of numbing medicine.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use lidocaine injection:

liver disease; kidney disease;

heart disease;

coronary artery disease, circulation problems; or

a history of malignant hyperthermia.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether lidocaine injection passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How is lidocaine injection given?

Lidocaine is given as an injection through a needle placed into a vein or directly into the body area to be numbed. Your doctor, nurse, or other healthcare provider will give you this injection.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving lidocaine injection in a hospital setting.

To treat irregular heart rhythms, you may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

The LidoPen auto-injector 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 the injection.

Never use the LidoPen auto-injector without first calling your doctor.

Do not use the auto-injector in or near a vein or into your buttocks. Inject the medication only in your upper thigh or upper arm.

With the LidoPen auto-injector you will also receive a CardioBeeper. This device is used to transmit your heart rate and rhythm to your doctor over a telephone. Read all provided instructions and practice using the CardioBeeper so you will be able to quickly use it in an emergency.

Store the LidoPen auto-injector at room temperature away from moisture and extreme hot or cold. What happens if I miss a dose?

Since lidocaine injection is used only when needed, you are not likely to be on a dosing schedule.

Never use the LidoPen auto-injector without first calling your doctor.

What happens if I overdose? Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include drowsiness, confusion, nervousness, ringing in your ears, blurred vision, feeling hot or cold, numbness, muscle twitches, uneven heartbeats, seizure (convulsions), slowed breathing, or respiratory failure (breathing stops).

What should I avoid while receiving UAD Caine (lidocaine injection)? Lidocaine can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication

Avoid eating or chewing within 1 hour after lidocaine injection is used to numb your mouth or throat. You may have trouble swallowing which could lead to choking. You may also accidentally bite the inside of your mouth if you are still numb an hour after treatment with lidocaine injection.

UAD Caine (lidocaine injection) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have any of these serious side effects:

feeling anxious, shaky, dizzy, restless, or depressed;

drowsiness, vomiting, ringing in your ears, blurred vision;

confusion, twitching, seizure (convulsions);

fast heart rate, rapid breathing, feeling hot or cold;

weak or shallow breathing, slow heart rate, weak pulse; or

feeling like you might pass out.

Less serious side effects include:

mild bruising, redness, itching, or swelling where the medication was injected;

mild dizziness;

nausea;

numbness in places where the medicine is accidentally applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect UAD Caine (lidocaine injection)?

There may be other drugs that can interact with lidocaine injection. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More UAD Caine resources UAD Caine Side Effects (in more detail) UAD Caine Use in Pregnancy & Breastfeeding UAD Caine Drug Interactions UAD Caine Support Group 0 Reviews for UAD Caine - Add your own review/rating Lidocaine Aerosol MedFacts Consumer Leaflet (Wolters Kluwer) lidocaine Intradermal Advanced Consumer (Micromedex) - Includes Dosage Information Lidocaine Prescribing Information (FDA) Lidocaine Hydrochloride Monograph (AHFS DI) Lidocaine Hydrochloride (Local Anesthetic) Monograph (AHFS DI) Compare UAD Caine with other medications Anesthesia Arrhythmia Ventricular Fibrillation Ventricular Tachycardia Where can I get more information? Your doctor or pharmacist can provide more information about lidocaine injection.

See also: UAD Caine side effects (in more detail)


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MEDIJEL GEL


1. Name Of The Medicinal Product

MEDIJEL GEL

2. Qualitative And Quantitative Composition Lidocaine Hydrochloride BP 0.66% w/w Aminoacridine Hydrochloride BP 1968 0.05% w/w 3. Pharmaceutical Form

Oral Gel

4. Clinical Particulars 4.1 Therapeutic Indications

The quick, effective relief from the pain of common mouth ulcers, soreness of gums and denture rubbing. Medijel Gel is administered directly onto the affected area with a clean finger or small pad of cotton wool.

4.2 Posology And Method Of Administration

The gel should be applied directly to the affected area(s) with a clean finger or small pad of cotton wool. If necessary application may be repeated after 20 minutes.

Each dose is approximately 300mg, i.e. 2mg of Lidocaine Hydrochloride and 0.15mg of Aminoacridine Hydrochloride. Medijel Gel can be used as directed for adults and children.

4.3 Contraindications

Hypersensitivity to the active substances or to any other of the ingredients.

Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.4 Special Warnings And Precautions For Use

If symptoms persist longer than 7 days following the use of the product a doctor or dentist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

The safety of Medijel Gel during pregnancy and lactation has not been established, but is considered not to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Hypersensitivity reactions to Lidocaine have been reported on rare occasions.

4.9 Overdose

Maximum safe dosage for a 70kg adult is 750mg for Lidocaine (Goodman & Gilman, page 313). A tube of Medijel Gel contains 82.5mg of Lidocaine hydrochloride - overdose is not a problem.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Lidocaine Hydrochloride is well documented in Martindale 28th Edition Page 900-904 and Goodman & Gilman, Chapter 15 and pages 767-770.

Lidocaine Hydrochloride was first introduced in 1948 and is one of the most widely used local anaesthetics, producing more prompt, more intense, longer lasting and more extensive anaesthesia than does an equal concentration of procaine (Peak anaesthesia within 2-5 minutes). Local anaesthetics are drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They have good powers of penetration and their action is reversible. Their use is followed by complete recovery in nerve function with no evidence of structural damage to nerve fibres or cells.

Aminoacridine Hydrochloride is a slow acting disinfectant. It exerts germicidal action against bacteria and fungi. It is also used as a surgical and endodontic irrigant and to treat local infections of the ear, mouth and throat. Its exact mode of action is not known but it involves disruption of certain metabolic pathways.

5.2 Pharmacokinetic Properties

Lidocaine is readily absorbed through mucous membranes. They exert their effects in the form of the non-ionised base. Lidocaine undergoes first-pass metabolism in the liver and bioavailability is low after administration by mouth. It is rapidly de-ethylated to the active metabolite monoethylglycinexylidide and then hydrolysed by amidases to various compounds, including glycineexylidide which has reduced activity but a longer elimination half-life. Less than 10% of a dose is excreted unchanged via the kidneys. The metabolic products are excreted in the urine.

Aminoacridine Hydrochloride if administered systematically is rapidly eliminated through the kidney (0.2 grams being eliminated from the blood in 30 minutes). (Medijel Gel dose 0.15mg Aminoacridine hydrochloride).

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerol , Hydroxypolyethoxydodecane HSE, Alcohol 96% v/v, Carbomer, Sucrose, Saccharin Sodium, Peppermint Oil, Ethyl vanillin, Di-isopropanolamine 90% aqueous, Purified Water

6.2 Incompatibilities

None encountered.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium tube with membrane seal and spiked polyethylene cap.

6.6 Special Precautions For Disposal And Other Handling

N/A

7. Marketing Authorisation Holder

DDD LIMITED

94, Rickmansworth Road, Watford, Hertfordshire, United Kingdom, WDI8 7JJ.

8. Marketing Authorisation Number(S)

PL 0133/5000R

Legal Status: GSL

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of last renewal: 20/05/03

10. Date Of Revision Of The Text

March 2010


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Emla


Generic Name: lidocaine and prilocaine topical (LY doh kayn and PRIL oh kayn TOP ik al)
Brand Names: Emla

What is lidocaine and prilocaine topical?

Lidocaine and prilocaine topical is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Lidocaine and prilocaine topical is used to numb the skin, or surfaces of the penis or vagina, in preparation for a medical procedure or to lessen the pain of inserting a medical instrument such as a tube or speculum.

Lidocaine and prilocaine topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about lidocaine and prilocaine? An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography. Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops). Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of lidocaine and prilocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Do not use lidocaine and prilocaine topical if you have had an allergic reaction to a numbing medicine in the past.

Before lidocaine and prilocaine topical is applied, tell your doctor if you have liver disease, a history of allergic reaction to lidocaine or prilocaine, or a personal or family history of methemoglobinemia, or any genetic enzyme deficiency.

Lidocaine and prilocaine topical is for use only on the surface of your body. Avoid getting this medication in your eyes.

Avoid accidentally injuring treated skin areas while they are numb. Avoid coming into contact with very hot or very cold surfaces.

What should I discuss with my health care provider before using lidocaine and prilocaine topical? An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood.

Overdose is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography. Symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Do not use lidocaine and prilocaine topical if you have a blood cell disorder called methemoglobinemia.

Before lidocaine and prilocaine topical is applied, tell your doctor if you have:

liver disease;

a history of allergic reaction to lidocaine or prilocaine; or

a personal or family history of methemoglobinemia, or any genetic enzyme deficiency.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use lidocaine and prilocaine topical.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Lidocaine and prilocaine topical can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use lidocaine and prilocaine topical?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of lidocaine and prilocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

You should be lying down when lidocaine and prilocaine topical cream is applied.

Your medicine may have been supplied with bandages to cover the cream when it is applied to a small area on your skin. If using a bandage dressing, first apply a thick layer of the cream to the skin, taking care not to spread the cream out. Place the bandage over the cream and smooth down the edges until it is completely sealed around the cream.

Lidocaine and prilocaine topical is usually applied 1 to 2 hours before the start of a procedure that requires the treated area to be numb. Follow your doctor's instructions about the length of time the cream should be left on the skin.

Store lidocaine and prilocaine topical at room temperature away from moisture and heat. Do not allow the cream to freeze. What happens if I miss a dose?

Since lidocaine and prilocaine topical is used as needed, it is not likely that you will be on a dosing schedule.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. An overdose of lidocaine and prilocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops). What should I avoid while taking lidocaine and prilocaine topical? Lidocaine and prilocaine topical is for use only on the surface of your body. Avoid getting this medication in your eyes.

Avoid accidentally injuring treated skin areas while they are numb. Avoid coming into contact with very hot or very cold surfaces.

Lidocaine and prilocaine topical side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using lidocaine and prilocaine topical and call your doctor at once if you have any of these serious side effects:

severe burning, stinging, or sensitivity where the medicine is applied;

swelling or redness;

sudden dizziness or sleepiness after medicine is applied;

bruising or purple appearance of the skin; or

unusual sensations of temperature.

Less serious side effects may include:

mild burning where the medicine is applied;

skin redness; or

changes in skin color where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect lidocaine and prilocaine topical?

Before this medication is applied, tell your doctor if you are using any of the following drugs:

heart rhythm medication such as mexiletine (Mexitil);

acetaminophen (Tylenol);

chloroquine (Aralen);

dapsone;

nitrates or nitrites such as Imdur, Isordil, Monoket;

nitrofurantoin (Furadantin, Macrodantin, Macro-Bid);

phenobarbital (Luminal, Solfoton);

primaquine;

quinine; or

a sulfa drug (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others).

This list is not complete and there may be other drugs that can interact with lidocaine and prilocaine topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Emla resources Emla Side Effects (in more detail) Emla Use in Pregnancy & Breastfeeding Emla Support Group 0 Reviews for Emla - Add your own review/rating Emla Topical Advanced Consumer (Micromedex) - Includes Dosage Information Emla Consumer Overview EMLA Prescribing Information (FDA) EMLA Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Emla with other medications Anesthesia Where can I get more information? Your pharmacist can provide more information about lidocaine and prilocaine topical.

See also: Emla side effects (in more detail)


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Anodesyn Ointment


1. Name Of The Medicinal Product

Anodesyn Ointment

Care Haemorrhoid Relief Ointment

Sainsburys Haemorrhoid Relief Ointment

Tesco Haemorrhoid Relief Ointment

2. Qualitative And Quantitative Composition

Allantoin 0.5% w/w.

Lidocaine Hydrochloride 0.5% w/w.

For excipients, see 6.1

3. Pharmaceutical Form

A soft white translucent ointment.

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic relief of pain and irritation associated with external haemorrhoids.

4.2 Posology And Method Of Administration

Route of administration: For external application.

Adults & the elderly.

For external piles, wash the affected area with tepid water, dry and apply the ointment with gauze or lint.

Repeat as required, do not use for more than 7 days unless advised by your doctor.

Children.

Not recommended for children.

4.3 Contraindications

Hypersensitivity to any of the ingredients, especially lidocaine.

4.4 Special Warnings And Precautions For Use

Anodesyn Ointment / Care Haemorrhoid Relief Ointment / Sainsburys Haemorrhoid Relief Ointment/Tesco Haemorrhoid Relief Ointment is intended for use for short periods and should not be used for longer than 7 days without medical advice. Patients should be instructed to seek medical advice if they experience persistent pain or bleeding from the anus, especially where associated with a change in bowel habit, if the stomach is distended or if they are losing weight.

Avoid contact with the eyes.

The label will state:

Keep all medicines out of the reach and sight of children.

If symptoms persist for more than 7 days consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions known.

4.6 Pregnancy And Lactation

The safety of Anodesyn Ointment / Care Haemorrhoid Relief Ointment / Sainsburys Haemorrhoid Relief Ointment/Tesco Haemorrhoid Relief Ointment in pregnancy and lactation has not been assessed, but it is thought unlikely to constitute a hazard, though caution should be exercised during the first trimester.

Lidocaine crosses the placenta and is distributed into breast milk.

4.7 Effects On Ability To Drive And Use Machines

No or negligible influence.

4.8 Undesirable Effects

Hypersensitivity to any of the ingredients, especially lidocaine.

4.9 Overdose

Accidental ingestion may result in anaesthesia of the upper respiratory tract, nausea, vomiting and abdominal discomfort. Ingestion of very large quantities could result in CNS and cardiovascular toxicity. Treatment should be symptomatic and supportive.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

C05A X - Other antihaemorrhoidals for topical use

Lidocaine has a local anaesthetic action, relieving pain and discomfort in the affected areas.

Allantoin is claimed to promote healing.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

White Soft Paraffin

Wool Fat

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store at or below 25°C.

6.5 Nature And Contents Of Container

A collapsible 25g aluminium tube, internally lacquered with a latex welt and HPDE screw cap. Supplied with a nozzle and packed in a carton.

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0072

9. Date Of First Authorisation/Renewal Of The Authorisation

2 December 2002 / 29 September 2003

10. Date Of Revision Of The Text

23/1/2008

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable


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Lidocaine Hydrochloride Injection BP Minijet 2% (International Medication Systems)


1. Name Of The Medicinal Product

Lidocaine Hydrochloride Injection BP Minijet 2% w/v.

2. Qualitative And Quantitative Composition

Lidocaine Hydrochloride BP 20 mg per ml

3. Pharmaceutical Form

Sterile aqueous solution for infiltration injection or intravenous administration.

4. Clinical Particulars 4.1 Therapeutic Indications

For local anaesthesia by infiltration, intravenous regional anaesthesia and nerve blocks.

By intravenous injection for the emergency management of ventricular arrhythmias, particularly after myocardial infarction and cardiac surgery.

4.2 Posology And Method Of Administration

For local anaesthesia:

The dosage varies depending upon the area to be anaesthetised, vascularity of the tissues, number of neuronal segments to be blocked, individual tolerance and the anaesthetic technique. The lowest dosage needed to provide anaesthesia should be administered.

Adults: the usual dose should not exceed 200 mg.

Children: the usual dose should not exceed 3 mg/kg.

For epidurals, a test dose should be administered at least 5 minutes before total dose to prevent inadvertent intravascular or subarachnoid injection.

For continuous epidural, caudal or paracervical anaesthesia, the maximal dose should not be repeated at intervals under 90 minutes.

For IV regional anaesthesia (Bier's block), the tourniquet should not be released until at least 20 minutes after administration.

For intravenous use in cardiac arrhythmias:

Adults: the usual dose is 50 to 100 mg administered intravenously under ECG monitoring. This dose may be injected at a rate of approximately 25 to 50 mg (2.5 to 5.0 ml 1% solution or 1.25 to 2.5 ml 2% solution) per minute. A sufficient period of time should be allowed to enable a slow circulation to carry the drug to the site of action. If the initial dose of 50 to 100 mg does not produce the desired response, a second dose may be given after 5 minutes. No more than 200 to 300 mg of lidocaine should be administered during a one hour period.

Following a single injection in those patients in whom arrhythmia tends to recur and who are incapable of receiving oral antiarrhythmic therapy, intravenous infusions of lidocaine may be administered at the rate of 1 to 4 mg/minute (20 to 50 mcg/kg/minute). IV infusions must be given under ECG monitoring to avoid potential overdosage and toxicity. The infusion should be terminated as soon as the patient's basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. It should rarely be necessary to continue the infusion beyond 24 hours. As soon as possible, patients should be changed to an oral antiarrhythmic agent for maintenance therapy.

Children: experience with lidocaine is limited. A suggested paediatric dose is a loading dose of 0.8 to 1 mg/kg repeated if necessary up to 3-5 mg/kg, followed by continuous infusion of 10 to 50 mcg/kg/minute.

Elderly: doses may need to be reduced depending on age and physical state.

4.3 Contraindications

Lidocaine is contraindicated in patients with known hypersensitivity to local anaesthetics of the amide type and in patients with porphyria.

4.4 Special Warnings And Precautions For Use

Constant ECG monitoring is necessary during IV administration. Resuscitative equipment and drugs should be immediately available for the management of severe adverse cardiovascular, respiratory or central nervous system effects. If severe reactions occur, lidocaine should be discontinued.

Use with caution in patients with epilepsy, liver disease, congestive heart failure, severe renal disease, marked hypoxia, severe respiratory depression, hypovolaemia or shock and in patients with any form of heart block or sinus bradycardia. Hypokalaemia, hypoxia and disorders of acid-base balance should be corrected before treatment with lidocaine begins.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Propranolol and cimetidine may reduce the renal and hepatic clearance of lidocaine, thus increasing toxicity. The cardiac depressant effects of lidocaine are additive to those of other antiarrhythmic agents. Lidocaine prolongs the action of suxamethonium.

4.6 Pregnancy And Lactation

The safe use of lidocaine has not been established with respect to possible adverse effects upon foetal development. Lidocaine is excreted in breast milk and so should be used with caution in nursing women.

4.7 Effects On Ability To Drive And Use Machines

Not applicable; this preparation is intended for use only in emergencies.

4.8 Undesirable Effects

Adverse effects are usually due to inadvertent intravenous administration or overdosage. Allergic reactions (including anaphylaxis) have been reported rarely.

The following systemic reactions have been reported in association with lidocaine:

Central nervous system: light-headedness, drowsiness, dizziness, apprehension, nervousness, euphoria, tinnitus, blurred or double vision, nystagmus, vomiting, sensations of heat, cold or numbness, twitching, tremors, paraesthesia, convulsions, unconsciousness, respiratory depression and arrest.

Cardiovascular system: hypotension, cardiovascular collapse and bradycardia which may lead to cardiac arrest.

4.9 Overdose

Symptoms: reactions due to overdose with lidocaine (high plasma levels) are systemic and involve the central nervous and cardiovascular systems. Effects include medullary depression, tonic and clonic convulsions and cardiovascular collapse.

Treatment: institute emergency resuscitative procedures and administer the drugs necessary to manage the severe reaction. For severe convulsions, small increments of diazepam or an ultra-short acting barbiturate (thiopentone), or if not available, a short-acting barbiturate (pentobarbitone or quinalbarbitone), or if the patient is under anaesthesia, a short-acting muscle relaxant (suxamethonium) may be given intravenously. Patency of the airway and adequacy of ventilation must be assured.

Should circulatory depression occur vasopressors such as metaraminol may be used.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Lidocaine stabilises the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anaesthetic action. The onset of action is rapid and the blockade may last up to 2 hours.

In the heart, lidocaine reduces automaticity by decreasing the rate of diastolic (phase 4) depolarisation. Lidocaine is considered as a class 1b (membrane stabilising) antiarrhythmic agent. The duration of the action potential is decreased due to blockade of the sodium channel and the refractory period is shortened.

5.2 Pharmacokinetic Properties

Lidocaine is rapidly distributed to all body tissues. About 65% is plasma bound. Lidocaine crosses the placenta and the blood brain barrier. The plasma half life is 1.6 hours. About 80% of the dose is metabolised in the liver; less than 10% is found unchanged in the urine.

5.3 Preclinical Safety Data

Not applicable since lidocaine has been used in clinical practice for many years and its effects in man are well known.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Hydrochloric Acid BP

Sodium Chloride BP

Sodium Hydroxide BP

Water for Injection USP

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

The solution is contained in a USP type I glass vial with an elastomeric closure which meets all the relevant USP specifications. The product is available as a 2% solution in a 5ml vial.

6.6 Special Precautions For Disposal And Other Handling

The container is specially designed for use with the IMS Minijet injector.

7. Marketing Authorisation Holder

International Medication Systems (UK) Ltd

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

8. Marketing Authorisation Number(S)

PL 03265/0006R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date first granted: 28 February 1991

Date renewed: 29 November 1996

10. Date Of Revision Of The Text

June 2004

11. Legal category

POM


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lidocaine Topical


LYE-doe-kane, PRIL-oh-kane

Commonly used brand name(s)

In the U.S.

Oraqix

Available Dosage Forms:

Gel/Jelly

Therapeutic Class: Anesthetic, Amino Amide Combination

Chemical Class: Amino Amide

Uses For lidocaine

Lidocaine and prilocaine periodontal (gingival) gel is used on the gums to cause numbness or loss of feeling during dental procedures. lidocaine contains a mixture of two topical local anesthetics (numbing medicines). It deadens the nerve endings in the gum.

lidocaine is available only with your dentist's prescription.

Before Using lidocaine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For lidocaine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lidocaine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lidocaine and prilocaine periodontal gel in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lidocaine and prilocaine periodontal gel in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving lidocaine and prilocaine periodontal gel.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of lidocaine. Make sure you tell your doctor if you have any other medical problems, especially:

Glucose-6-phosphate dehydrogenase (G6PD) deficiency, history of or Heart disease or Heart rhythm problems—May cause side effects to become worse. Methemoglobinemia (blood disorder), history of—Should not use in patients with this condition. Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of lidocaine

A dentist or other trained health professional will give you lidocaine in an office or clinic setting. The medicine is applied to the gums using a special dispenser.

Precautions While Using lidocaine

It is very important that your dentist check you closely for any problems or unwanted effects that may be caused by lidocaine.

lidocaine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your dentist right away if you have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.

lidocaine may cause a rare, but serious blood problem called methemoglobinemia. Call your dentist right away if you develop a blue or bluish purple color on the lips, fingernails, or skin, or have headaches, dizziness, fainting, sleepiness, or trouble with breathing after you receive lidocaine.

During the time that the gum feels numb, serious injury can occur. Be especially careful to avoid injury until the numbness wears off and you have normal feeling in the area. Avoid foods or liquids that are very hot or very cold. Do not chew gum or food while your mouth feels numb. You may accidentally bite your tongue or the inside of your cheeks.

lidocaine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common Gum numbness that continues gum swelling or irritation nausea Rare Itching hoarseness or trouble with swallowing rash shortness of breath swelling of the eyelids, face, lips, or tongue tightness in the chest trouble with breathing wheezing Incidence not known Blue or blue-purple color of lips, fingernails, mouth, or skin blurred or double vision convulsions dark urine dizziness or drowsiness fainting feeling hot, cold, or numb headache irregular or fast heartbeat muscle twitching or trembling nausea or vomiting ringing or buzzing in the ears shortness of breath or troubled breathing unusual excitement, nervousness, or restlessness unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Bad or bitter taste headache mouth pain or soreness mouth ulcers tiredness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: lidocaine Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More lidocaine Topical resources Lidocaine Topical Side Effects (in more detail) Lidocaine Topical Use in Pregnancy & Breastfeeding Lidocaine Topical Support Group 2 Reviews for Lidocaine Topical - Add your own review/rating Bactine Liquid MedFacts Consumer Leaflet (Wolters Kluwer) LMX 5 Cream MedFacts Consumer Leaflet (Wolters Kluwer) LidaMantle Cream MedFacts Consumer Leaflet (Wolters Kluwer) Lidoderm Consumer Overview Lidoderm Patch MedFacts Consumer Leaflet (Wolters Kluwer) Lidoderm Prescribing Information (FDA) Solarcaine Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer) Xylocaine Jelly Prescribing Information (FDA) Xylocaine Jelly Gel MedFacts Consumer Leaflet (Wolters Kluwer) Xylocaine Viscous Solution MedFacts Consumer Leaflet (Wolters Kluwer) Zingo Prescribing Information (FDA) Zingo System MedFacts Consumer Leaflet (Wolters Kluwer) Zingo Consumer Overview Compare lidocaine Topical with other medications Anesthesia
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LMX4 Lidocaine 4% w / w Cream


1. Name Of The Medicinal Product

LMX 4

Lidocaine 4%w/w Cream

2. Qualitative And Quantitative Composition

Lidocaine 4%w/w

For excipients, see 6.1

3. Pharmaceutical Form

Cream

A white to off-white yellowish cream

4. Clinical Particulars 4.1 Therapeutic Indications

Local anaesthetic for topical use to produce surface anaesthesia of the skin prior to venous cannulation or venipuncture.

4.2 Posology And Method Of Administration

For cutaneous use only.

Adults, including elderly, and children over one month of age.

Apply 1g to 2.5g of cream onto the skin to cover a 2.5cm x 2.5cm (6.25cm2) area where venous cannulation or venipuncture will occur. No more than 1g of cream should be applied to infants below the age of 1 year. 1g of cream equates to approximately 5cm of cream squeezed from the 5g tube or 3.5cm from the 30g tube.

The cream should remain undisturbed and the area can be covered with an occlusive dressing to prevent disturbance or interference by the patient or other external factors. Adequate anaesthesia should be obtained after 30 minutes, but the LMX4 Cream may be applied for up to 5 hours under a dressing. Prior to starting the procedure, the LMX 4 Cream should be removed using a clean gauze swab and the site for venous cannulation or venipuncture prepared in the usual manner. The procedure should be initiated approximately 5 minutes after the cream has been removed. Maximum application time for 1 month upto 3 month infant should not exceed 60 minutes. Maximum application time for 3 month upto 12 month infant should not exceed 4 hours. Maximum application for 12 month infant – adult should not exceed 5 hours.

4.3 Contraindications

Hypersensitivity to the active substance, or any of the amide-type local anaesthetics, or any of the excipients.

4.4 Special Warnings And Precautions For Use

For external use only.

Avoid contact with eyes.

Do not apply to irritated skin or if excessive irritation develops. If condition worsens, or if symptoms persist unaltered for more than seven days or clear up and occur again within only a few days, discontinue use of this product and consult a doctor.

Do not use in large quantities, particularly over raw or blistered areas.

LMX 4 contains propylene glycol which may cause skin irritation.

LMX 4 has not been applied to wounds, mucous membranes or in areas of atopic dermatitis as there are no clinical data in relation to these.

Anaesthetic efficacy during the heel lancing of neonates has not been studied.

Application of lidocaine to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine resulting in serious adverse effects.

Studies in laboratory animals (guinea pigs) have shown that lidocaine has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine in the external auditory canal only showed no abnormality. Lidocaine should not be used in any clinical situation in which its penetration or migration beyond the tympanic membrane into the middle ear is possible.

Dermal application of lidocaine may cause transient local blanching followed by transient erythema.

PRECAUTIONS

General: Repeated doses of lidocaine may increase blood levels of lidocaine. Lidocaine should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine including acutely ill, debilitated, or elderly patients.

Lidocaine coming in contact with the eye should be avoided because animal studies have demonstrated severe eye irritation. Also the loss of protective reflexes can permit corneal irritation and potential abrasion. Absorption of lidocaine in conjunctival tissues has not been determined. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.

Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine; however, lidocaine should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Patients with severe hepatic disease, because of their inability to metabolize local anaesthetics normally, are at greater risk of developing toxic plasma concentrations of lidocaine.

When lidocaine is used, the patient should be aware that the production of dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing, or exposure to extreme hot or cold temperatures until complete sensation has returned.

Lidocaine has bactericidal and antiviral properties in concentrations above 0.5%. For this reason, the results of intra-cutaneous injections of live vaccines (such as BCG vaccination) should be monitored.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lidocaine should be used with caution in patients receiving Class I anti-arrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and generally synergistic.

The risk of additional systemic toxicity should be considered when large doses of LMX 4 are applied to patients already using other local anaesthetics.

4.6 Pregnancy And Lactation

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, lidocaine should be used during pregnancy only if clearly needed.

Lidocaine is not contraindicated in labour and delivery. Should LMX 4 be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered.

Lidocaine can cross the placental barrier.

Lidocaine is excreted in human milk. Therefore, caution should be exercised when LMX 4 is administered to a nursing mother since the milk:plasma ratio of lidocaine is 0.4.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Common side effects (>1/100) can include irritation, redness, itching, or rash.

In rare cases local anaesthetics have been associated with allergic reactions including anaphylactic shock.

Corneal irritation after accidental eye exposure.

4.9 Overdose

Overdose with LMX 4 cream is unlikely but signs of systemic toxicity would be consistent with those of lidocaine.

An indication of systemic toxicity may include blurred vision, dizziness or drowsiness, difficulty breathing, trembling, chest pain, or irregular heartbeat.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Anaesthetics for topical use, lidocaine, ATC Code: D04A B 01

Lidocaine applied to intact skin provides dermal analgesia by a release of lidocaine from the cream into the epidermal and dermal layers of the skin, and by the accumulation of lidocaine in the vicinity of pain receptors and nerve endings. Lidocaine is an amide-type local anaesthetic agent which stabilises neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anaesthetic action. The onset, depth and duration of dermal analgesia provided by lidocaine depend primarily on the duration of application. LMX 4 may cause transient peripheral vasoconstriction followed by transient vasodilation at the application site.

5.2 Pharmacokinetic Properties

The amount of lidocaine systemically absorbed is directly related to both the duration of application and to the area over which it is applied. It is not known if it is metabolized into the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent to that of lidocaine. The metabolite, 2,6-xylidine, has unknown pharmacologic activity but is carcinogenic in rats. Following intravenous administration, MEGX and GX concentrations in serum range from 11 to 36% and from 5 to 11% of concentrations, respectively. The half-life of lidocaine elimination from the plasma following IV administration is approximately 65 to 150 minutes (mean 110, ±24 SD, n=13). This half-life may be increased in cardiac or hepatic dysfunction. More than 98% of an absorbed dose of can be recovered in the urine as metabolites or parent drug. The systemic clearance is 10 to 20 mL/min/kg (mean 13, ±3 SD, n=13).

When applied topically to intact skin, the absorption of lidocaine is very low. Increased absorption is therefore to be expected when applied to mucosa or previously damaged skin.

The maximum plasma level of active ingredient was very low (0.3 µg/ml or less) in a study investigating the application of LMX 4 in children of different ages. It was well below the toxically effective plasma level of ingredients.

5.3 Preclinical Safety Data

The mutagenic potential of lidocaine HCl has been tested in the Ames Salmonella/mammalian microsome test and by analysis of structural chromosome aberrations in human lymphocytes in vitro, and by mouse micronucleus test in vivo. There was no indication in these tests of any mutagenic effects. The mutagenicity of 2,6-xylidine, a metabolite of lidocaine, has been studied in different tests with mixed results. The compound was found to be weakly mutagenic in the Ames test only under metabolic activation conditions. In addition, 2,6-xylidine was observed to be mutagenic at the thymidine kinase locus, with or without activation, and induced chromosome aberrations and sister chromatic exchanges at concentrations at which the drug precipitated out of the solution (1.2 mg/ml). No evidence of genotoxicity was found in the in vivo assays measuring unscheduled DNA synthesis in rat hepatocytes, chromosome damage in polychromatic erythrocytes or preferential killing of DNA repair-deficient bacteria in liver, lung, kidney, testes and blood extracts from mice. However, covalent binding studies of DNA from liver and ethmoid turbinates in rats indicate that 2,6-xylidine may be genotoxic under certain conditions in vivo.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl Alcohol

Carbomers

Cholesterol

Phospholipon 80H (Hydrogenated Soy Lecithin)

Polysorbate 80 (Tween 80)

Propylene Glycol

Trolamine

Vitamin E Acetate

Purified Water

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

Unopened:

Two years

Opened:

3 months

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

The pack sizes are 5g and 30g.

Both packs comprise of an aluminium tube with an epoxyphenolic internal lacquer, fitted with a polypropylene cap.

The following packaging options are approved but not all of these packaging options may be marketed:

1) A carton containing one 5g tube.

2) A carton containing five 5g tubes.

3) A carton containing one 5g tube with two Tegaderm® occlusive dressings.

4) A carton containing five 5g tubes with ten Tegaderm® occlusive dressings.

5) A carton containing one 30g tube.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Ferndale Pharmaceuticals Ltd

12 York Place

Leeds

LS1 2DS

United Kingdom

8. Marketing Authorisation Number(S)

PL 20685/0034

9. Date Of First Authorisation/Renewal Of The Authorisation

20/11/2007

10. Date Of Revision Of The Text

15/03/2011


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Boots Pharmacy Anaesthetic Throat Spray


Boots Pharmacy Anaesthetic Throat Spray

(Lidocaine Hydrochloride)

Specifically to:

Relieve severe sore throat pain

20 ml e

Read all of this carton for full instructions.

A local anaesthetic spray to provide direct and soothing relief from the pain of severe sore throats.

Before you use this medicine Do not use: If you are allergic to any of the ingredients If you have asthma, or difficulty breathing If you are under 12 years of age Talk to your pharmacist or doctor: If you are receiving any medical treatment If you have a high fever, headache, feel sick or are being sick as well as having a sore throat If you are pregnant or breastfeeding

This spray may cause your tongue to become numb. You must take care when eating or drinking hot foods or drinks.

How to use this medicine

Use at the back of the throat only.

Do not breathe in when you use the spray, or get the spray in your eyes.

To spray: Swing the nozzle through 90° and press.

Before first use or after storing the spray for a long time: Press the spray 3 times away from the face into a sink.

Adults and children of 12 years and over
Three sprays at the back of the throat every 3 hours, if you need to.
Don’t use more than 6 times in any 24 hours.

Do not use for children under 12 years.

Do not use more than the amount recommended above.

If you use too much:

Talk to a doctor straight away. Take your medicine with you.

If symptoms do not go away, talk to your doctor.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop using the spray.

See a doctor at once:

Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

If you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the side of the carton.

Active ingredient

This liquid contains Lidocaine Hydrochloride 2% w/v.

Also contains: purified water, ethanol (30 vol %), sorbitol (E420), sodium citrate, saccharin, quinoline yellow (E104), patent blue V (E131), flavours (peppermint, levomenthol, aniseed).

PL00014/0430

P

Text prepared 10/07

Manufactured for the Marketing Authorisation holder Boots Pharmacy Nottingham NG2 3AA

by

The Boots Company PLC Nottingham NG2 3AA

Contains approximately 150 sprays.

If you need more advice ask your pharmacist.

BTC22021 vE 15/05/08


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Lidocaine Hydrochloride Injection BP 1.0% w / v


1. Name Of The Medicinal Product

Lidocaine Hydrochloride Injection BP 1.0% w/v.

2. Qualitative And Quantitative Composition

Each 1ml of solution contains 1.0% w/v of Lidocaine Hydrochloride BP (Lidocaine Hydrochloride).

3. Pharmaceutical Form

Clear, colourless, sterile solution for injection, intended for parenteral administration to human beings.

4. Clinical Particulars 4.1 Therapeutic Indications

Lidocaine is a local anaesthetic of the amide group. The injectable form has a wide range of applications for nerve blockade. It can be used by percutaneous infiltration; to block a major nerve plexus such as the brachial; for epidural anaesthesia; for intravenous regional analgesia.

4.2 Posology And Method Of Administration

The dosage should be adjusted according to the response of the patient and the site of administration. The lowest concentration and smallest dose producing the required effect should be given. The maximum dose for healthy adults should not exceed 200mg.

Children and elderly or debilitated patients require smaller doses, commensurate with age and physical status.

4.3 Contraindications

Known hypersensitivity to anaesthetics of the amide type.

4.4 Special Warnings And Precautions For Use

Lidocaine should be administered by persons with resuscitative skills and equipment. Extreme care should be observed in patients with hypovolaemia, heart block or other conduction disturbances. It should be used with caution in patients with congestive heart failure, bradycardia or respiratory depression, including where agents are known to interact with Lidocaine either to increase its availability or additive effects e.g. phenytoin or prolong its elimination e.g. hepatic or end renal insufficiency where the metabolites of Lidocaine may accumulate.

Intramuscular Lidocaine may increase creatinine phosphokinase concentrations which can interfere with the diagnosis of acute myocardial infarction. The use of Lidocaine for the treatment of ventricular arrhythmias not associated with a myocardial infarction might be hazardous in patients with hypoxia where there is a depression of the cough reflex. Lidocaine has been shown to be porphyrinogenic in animals and should be avoided in persons suffering from porphyria.

The effect of Lidocaine may be reduced if it is injected into inflamed or infected areas. Care should be observed in patients suffering from epilepsy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lidocaine toxicity is enhanced by the co-administration of cimetidine and propranolol. Both drugs decrease hepatic blood flow. Also, cimetidine depresses microsomial activity. Ranitidine produces a small reduction in Lidocaine clearance.

Cardiovascular collapse has been reported following the use of bupivacaine in patients on treatment with verapamil and timolol; Lidocaine is closely related to bupivacaine.

Prenylamine and Lidocaine Infusion may precipitate atrioventricular block and ventricular tachycardia.

Dopamine and 5 hydroxytryptamine reduce the convulsant threshold to Lidocaine.

Narcotics are probably proconvulsants and this would support the evidence that Lidocaine reduces the seizure threshold to fentanyl in man.

Opioid-antiemetic combination sometimes used for sedation in children could reduce the convulsant threshold to Lidocaine and increase the CNS depressant effect.

While adrenaline when used in conjunction with Lidocaine might decrease vascular absorption, it greatly increases the danger of ventricular tachycardia and fibrillation if accidentally injected intravenously.

Hypoxia and acidosis will enhance the cardiovascular and central nervous system toxicity of Lidocaine in animals. In man, such changes commonly accompany convulsions and can be expected to exacerbate cardiac sequelae.

4.6 Pregnancy And Lactation

Lidocaine readily crosses the placental barrier after epidural or intravenous administration to the mother. The ratio of umbilical to maternal venous concentration is 0.5 to 0.6. The foetus appears to be capable of metabolising Lidocaine at term. The elimination half life in the newborn of the drug received in utero is about three hours, compared with 100 minutes in the adult.

Moderate doses of Lidocaine over short periods have been used in mothers receiving antiarrhythmic drugs in late pregnancy. Foetal blood concentrations are about half of the maternal values and by term the foetus is capable of metabolising Lidocaine.

Local anaesthetics are not noted for producing congenital malformations. Foetal bradycardia may occur during extradural analgesia using Lidocaine. This may result from placental drug transfer or it may be secondary to maternal circulatory changes.

Symptoms of overdose will occur in the same order as in the adult. In clinical practice, neonatal effects are generally slight and are largely limited to hypotonia and neonatal depression. Excessive doses can occur following paracervical block probably resulting from direct entry of drug to the placental circulation, or because solution is injected to the head in mistake for the caudal canal or the paracervical region.

Lidocaine is secreted into the breast milk. Although mothers on infusions of Lidocaine could probably continue to breast feed with safety, caution should be exercised. There is a remote possibility of an idiosyncratic or allergic reaction.

4.7 Effects On Ability To Drive And Use Machines

Where major motor nerve block occurs e.g. Brachial plexus, epidural, spinal block. Where there is a loss of sensation resulting from nerve block to areas of muscle co-ordination or balance. Advice is that for general anaesthesia as sedative/hypnotic drugs are often used during nerve blockade.

4.8 Undesirable Effects

Localised nerve damage at the site of injection (very rare).

Prolonged neural blockade following epidural may be due to delayed spread. Permanent neural blockade may be more likely associated with hypotension and cord ischaemia.

Following regional blockade as when Lidocaine is injected intrathecally or extradurally, hypotension, hypoventilation, Horners Syndrome and hypoglycaemia may be seen. The degree of these effects will depend on the dose and the height of the block. Urinary retention may occur following sacral or lumbar epidural block. It should not outlast the duration of the block. Apnoea and coma followed by aphasia and hemiparesis following stellate ganglion block. The probable cause is a direct injection of Lidocaine into the vertebral or carotid arteries.

Profound lethargy and death have been reported following the injection of only 10 - 32mg of Lidocaine for dental blocks.

Diplopia and temporary blindness has been reported following Lidocaine for maxillary block, also respiratory arrest following retrobulbar block.

The major adverse effects on the CNS and CVS are primarily due to the absorption of Lidocaine into the systemic circulation. Lidocaine may also produce methaemoglobinaemia.

The initial CNS toxic effects are demonstrated by a gradual onset of drowsiness or inebriation similar to alcoholic intoxication. Balance is disturbed, circumoral pins and needles, numb tongue, roaring in the ears, visual disturbances, restlessness and twitching may occur. Severe intoxication of rapid onset may immediately lead to convulsions followed by circulatory depression. Major overdosage may depress all systems simultaneously. Psychotic reactions have been reported following infusion for the control of arrhythmia.

Profound hypotension may be associated with B blockade, widespread sympathetic block from spinal or epidural block, intercostal nerve block administration or supine hypotension in pregnancy.

Ventricular fibrillation occurs less frequently than that seen with bupivacaine.

Respiratory Depression

Medullary depression associated with systemic effects, following retrobulbar nerve blockade, high spinal or extradural blocks causing motor block, possible subarachnoid spread following on excessive dose by interscalene brachial plexus block. An increase in extradural pressure may cause transient respiratory depression. Respiratory distress as an allergic response can occur.

Allergic reactions (including anaphylaxis) have been reported rarely.

4.9 Overdose

Systemic toxicity affecting principally the CNS and secondarily the CVS may arise because of acute or cumulative overdosage. Acute toxicity can occur due to excessive doses above that recommended minimum by rapid entry of Lidocaine into the circulation from accidental or deliberate intravenous injection, rapid absorption from a vascular site or transplacental passage. Cumulative toxicity may slow elimination or drug interaction.

Symptoms relating to the central nervous and cardiovascular systems are: gradual onset of drowsiness or inebriation, disturbance in balance, later circumoral pins and needles, numb tongue, roaring in the ears, visual disturbances, restlessness and twitching, progressing to convulsions and coma in severe states. If the overdose is of rapid onset, convulsions may occur closely followed by cardiovascular depression. Major overdosage may depress all symptoms simultaneously.

Psychotic reactions have been reported following I.V. infusions of Lidocaine. Bradycardia and hypotension, the latter being due to sympathetic blockade and vasomotor and cardiac centres depression. In the medulla, cardiac depression, allergic reaction.

Heavy pre-anaesthetic medication should be avoided, which will mask early signs of CNS toxicity, while an anticonvulsant may even suppress seizure activity until circulatory collapse supervenes.

Initially, oxygen should be administered. It may be necessary to give an anticonvulsant. Thiopentone has a more rapid onset of action than diazepam. Both drugs especially thiopentone may seriously exacerbate circulatory and respiratory depression.

Persistent convulsion may require the use of suxamethonium to stop muscle activity and allow for intubation, control of the airway and artificial ventilation. Agents to support the cardiovascular system may also be required. The correction of acidosis is very important.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Lidocaine is used to provide anaesthesia by nerve blockade at various sites in the body and in the control of dysrhythmias. It has a rapid onset of action (about one minute following intravenous injection and fifteen minutes following intramuscular injection) and rapidly spreads through the surrounding tissues. The effect lasts about ten to twenty minutes and about sixty to ninety minutes following intravenous and intramuscular injection respectively.

5.2 Pharmacokinetic Properties

The concentration of Lidocaine in the blood will be determined by its rate of absorption from the site of injection, the rate of tissue distribution and the rate of metabolism and excretion.

The systemic absorption of Lidocaine is determined by the site of injection, the dosage and its pharmacological profile. The maximum blood concentration occurs following intercostal nerve blockade followed in order of decreasing concentration, the lumbar epidural space, brachial plexus site and subcutaneous tissue. The total dose injected regardless of the site is the primary determinant of the absorption rate and blood levels achieved. There is a linear relationship between the amount of Lidocaine injected and the resultant peak anaesthetic blood levels.

The lipid solubility and vasodilator activity will also influence its rate of absorption. This is seen in the epidural space where Lidocaine is absorbed more rapidly than prilocaine.

Lidocaine is distributed throughout the total body water. Its rate of disappearance from the blood can be described by a two or three compartment model. There is a rapid disappearance (alpha) phase which is believed to be related to uptake by rapidly equilibrating tissues (i.e. tissues with a high vascular perfusion). The slower phase is related to distribution, to slowly equilibrating tissues (Betaphase) and to its metabolism and excretion (Gamma phase).

Lidocaine is distributed less rapidly than prilocaine (an amide drug of similar potency and duration of action) but equally as with mepivacaine. Its distribution is throughout all body tissues. In general, the more highly perfused organs will show higher concentrations of Lidocaine. The highest percentage of this drug will be found in skeletal muscle. This is because of the mass of muscle rather than an affinity.

Lidocaine undergoes enzymatic degradation primarily in the liver. Some degradation may take in tissues other than liver. The main pathway involves oxidative de-ethylation to monoethylglycinexylidide followed by a subsequent hydrolysis to xylidine.

The excretion occurs via the kidney with less than 5% in the unchanged form appearing in the urine. The renal clearance is inversely related to its protein binding affinity and the pH of the urine. This suggests by the latter that excretion of Lidocaine occurs by non-ionic diffusion.

5.3 Preclinical Safety Data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium Chloride

Sodium Hydroxide 10% w/v

Dilute Hydrochloric Acid

Water for Injections

6.2 Incompatibilities

Lidocaine has been found to be incompatible when mixed with amphotericin, methohexitone and glyceryl trinitrate. It is not advisable to mix Lidocaine with other agents.

6.3 Shelf Life

4 years (48 months).

If only part of an ampoule is used, the remainder should be discarded.

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep in outer carton.

6.5 Nature And Contents Of Container

2ml, 5ml, 10ml & 20ml clear glass ampoules, glass type 1 Ph.Eur. presented in cardboard cartons to contain 10 x 2ml ampoules; 10 x 5ml ampoules; 10 x 10ml ampoules and 10 x 20ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

For S.C., I.M. or I.V. injection.

Use as directed by the physician.

Keep out of reach of children.

If only part used, discard the remaining solution.

7. Marketing Authorisation Holder

Antigen International Ltd.

Roscrea

Co. Tipperary

Ireland

8. Marketing Authorisation Number(S)

PL 02848/0002R

9. Date Of First Authorisation/Renewal Of The Authorisation

25 November 1986 / 24 June 1992

10. Date Of Revision Of The Text

April 2008


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Xylocaine 10mg Spray


Xylocaine 10 mg Spray

lidocaine

Read all of this leaflet carefully before Xylocaine spray is given to you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, dentist or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or dentist. In this leaflet: 1. What Xylocaine Spray is and what it is used for 2. Before Xylocaine Spray is given to you 3. How Xylocaine Spray is given to you 4. Possible side effects 5. How to store Xylocaine Spray 6. Further information What Xylocaine Spray is and what it is used for

The name of your medicine is ‘Xylocaine 10 mg Spray’. It is referred to as ‘Xylocaine Spray’ in the rest of this leaflet.

Xylocaine Spray contains a medicine called lidocaine. This belongs to a group of medicines called local anaesthetics.

Xylocaine Spray is used to numb (anaesthetise) parts of the body. It stops pain happening during:

Medical examinations and operations of the nose and throat. Childbirth, and after the birth if stitches are needed. Treatment at the dentist. Before Xylocaine Spray is given to you You must not be given Xylocaine Spray if: You are allergic (hypersensitive) to lidocaine or any of the other ingredients of Xylocaine Spray (see Section 6: Further information). You are allergic to any other local anaesthetics of the same class (such as prilocaine or bupivacaine).

You must not be given Xylocaine Spray if any of the above apply to you. If you are not sure, talk to your doctor or dentist before you are given Xylocaine Spray.

Take special care with Xylocaine Spray

Check with your doctor or dentist before having Xylocaine Spray if:

You have any cuts, sores or ulcers in your throat, mouth or nose. You have a chest infection. You have epilepsy. You have heart problems such as a slow heart beat. You have very low blood pressure. You have liver or kidney problems. You have ever been told that you have a rare disease of the blood pigment called ‘porphyria’ or anyone in your family has it.

If you are not sure if any of the above apply to you, talk to your doctor before having Xylocaine Spray.

Taking other medicines

Please tell your doctor or dentist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Xylocaine Spray can affect the way some medicines work and some medicines can have an effect on Xylocaine Spray.

In particular, tell your doctor or dentist if you are taking any of the following medicines:

Medicines used to treat an uneven heart beat (arrhythmia) such as mexiletine. Pregnancy and breast-feeding

Before you are given Xylocaine Spray, tell your doctor or dentist if you are pregnant, planning to get pregnant, or if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines Xylocaine Spray may affect you being able to drive or use tools or machines. This depends on where in the body Xylocaine Spray is used and how much is used. Your doctor or dentist will tell you when it is safe for you to do these activities. Important information about some of the ingredients of Xylocaine Spray Xylocaine Spray contains saccharin. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before using this medicine. The banana flavouring in Xylocaine Spray contains propylene glycol. Propylene glycol may cause skin irritation. How Xylocaine Spray is given to you Xylocaine Spray will usually be given to you by a doctor or dentist. The dose that your doctor or dentist gives you will depend on the type of pain relief that you need. It will also depend on your age and physical condition. If you are given Xylocaine Spray to take home, you must use the dose recommended by your doctor or dentist. Always use Xylocaine Spray exactly as your doctor or dentist has told you. You should check with them if you are not sure. How to use Xylocaine Spray Do not use more than 20 sprays. You should use as few sprays as possible. Do not get the spray in your eyes. The spray nozzle is bent so that it works properly. Do not try to change the shape of the nozzle or it might break. How to use Xylocaine Spray in the mouth and throat When Xylocaine Spray is used in the mouth and throat it causes a loss of feeling. This makes it more likely that food or liquid may go down the wrong way. Also, this may make it difficult to swallow or cause some people to accidentally bite their tongue or cheek. Xylocaine Spray should be used with care in the elderly, in people who are in poor general health and in children. Cleaning the nozzle

Do not shorten the nozzle. Otherwise the spray will not work properly. If you need to clean the nozzle:

Remove the nozzle from the spray bottle. Place the nozzle in boiling water for 5 minutes. Remove the nozzle from the water. Then dry the nozzle and replace it on top of the bottle. If you use more Xylocaine Spray than you should

If you think you have used more Xylocaine Spray than you should, talk to your doctor or dentist immediately.

Possible side effects

Like all medicines, Xylocaine Spray may cause side effects although not everybody gets them.

Severe allergic reactions:

If you have a severe allergic reaction, tell your doctor immediately. The signs may include sudden onset of:

Swelling of your face, lips, tongue or throat. This may make it difficult to swallow. Severe or sudden swelling of your hands, feet and ankles. Difficulty breathing. Severe itching of the skin (with raised lumps). Other possible side effects: Irritation where Xylocaine Spray has been used. Feeling nervous. Feeling dizzy. Feeling sleepy. Loss of consciousness. Sore throat. Hoarse voice or loss of voice. Low blood pressure. This might make you feel dizzy or light-headed. Fits (seizures). Difficulty breathing or slow breathing. Slow heart beat. Stopped breathing or a stopped heart beat.

Do not be concerned by this list of possible side effects. You may not get any of them.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or dentist.

How to store Xylocaine Spray Keep out of the reach and sight of children. Do not use after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. At temperatures below 8°C the spray solution may start to go solid. This will dissolve when the spray solution is warmed up gently to room temperature. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment. Further information What Xylocaine Spray contains

The active ingredient is lidocaine. Each dose of spray contains 10 mg of lidocaine.

The other ingredients are ethanol, levomenthol, macrogol 400, essence of banana (contains propylene glycol), saccharin and purified water.

What Xylocaine Spray looks like and contents of the pack

Xylocaine Spray is a pump spray. It comes in a 50 ml bottle. Each bottle contains about 500 sprays.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Xylocaine Spray is held by

AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU UK

Xylocaine Spray is manufactured by

AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA UK

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Reference Number
Xylocaine Spray 17901/0177

This is a service provided by the Royal National Institute of Blind People.

Leaflet prepared: November 2009.

© AstraZeneca 2009.

Xylocaine is a trade mark of the AstraZeneca group of companies.

PAI 09 0051a

P026382


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LMX 4 Topical


Generic Name: lidocaine and prilocaine (Gingival route)

LYE-doe-kane, PRIL-oh-kane

Commonly used brand name(s)

In the U.S.

Oraqix

Available Dosage Forms:

Gel/Jelly

Therapeutic Class: Anesthetic, Amino Amide Combination

Chemical Class: Amino Amide

Uses For LMX 4

Lidocaine and prilocaine periodontal (gingival) gel is used on the gums to cause numbness or loss of feeling during dental procedures. This medicine contains a mixture of two topical local anesthetics (numbing medicines). It deadens the nerve endings in the gum.

This medicine is available only with your dentist's prescription.

Before Using LMX 4

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lidocaine and prilocaine periodontal gel in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lidocaine and prilocaine periodontal gel in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving lidocaine and prilocaine periodontal gel.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Glucose-6-phosphate dehydrogenase (G6PD) deficiency, history of or Heart disease or Heart rhythm problems—May cause side effects to become worse. Methemoglobinemia (blood disorder), history of—Should not use in patients with this condition. Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of lidocaine

This section provides information on the proper use of a number of products that contain lidocaine. It may not be specific to LMX 4. Please read with care.

A dentist or other trained health professional will give you this medicine in an office or clinic setting. The medicine is applied to the gums using a special dispenser.

Precautions While Using LMX 4

It is very important that your dentist check you closely for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your dentist right away if you have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. Call your dentist right away if you develop a blue or bluish purple color on the lips, fingernails, or skin, or have headaches, dizziness, fainting, sleepiness, or trouble with breathing after you receive this medicine.

During the time that the gum feels numb, serious injury can occur. Be especially careful to avoid injury until the numbness wears off and you have normal feeling in the area. Avoid foods or liquids that are very hot or very cold. Do not chew gum or food while your mouth feels numb. You may accidentally bite your tongue or the inside of your cheeks.

LMX 4 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common Gum numbness that continues gum swelling or irritation nausea Rare Itching hoarseness or trouble with swallowing rash shortness of breath swelling of the eyelids, face, lips, or tongue tightness in the chest trouble with breathing wheezing Incidence not known Blue or blue-purple color of lips, fingernails, mouth, or skin blurred or double vision convulsions dark urine dizziness or drowsiness fainting feeling hot, cold, or numb headache irregular or fast heartbeat muscle twitching or trembling nausea or vomiting ringing or buzzing in the ears shortness of breath or troubled breathing unusual excitement, nervousness, or restlessness unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Bad or bitter taste headache mouth pain or soreness mouth ulcers tiredness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: LMX 4 Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More LMX 4 Topical resources LMX 4 Topical Side Effects (in more detail) LMX 4 Topical Use in Pregnancy & Breastfeeding LMX 4 Topical Support Group 2 Reviews for LMX 4 Topical - Add your own review/rating Compare LMX 4 Topical with other medications Anesthesia
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