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Film coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and talc . The position of the various presentations may vary from one country to another. We remend you consult the information provided by your local supplier. Important information 9650 This medicine contains lactose.

If your doctor has told you have an intolerance to some sugars, contact him before taking. Before taking the drug 9650 Do not use tadalafil If you are allergic (hypersensitive) to the active substance tadalafil or any of the other ingredients of the medicinal product prescribed to you . If you think you may be allergic, ask your doctor. Allergy symptoms may include: - Asthma attacks with shortness of breath, audible wheezing or rapid breathing. - More or less sudden swelling of face, lips, tongue or elsewhere in the body. It is especially critical if it affects the vocal cords. - Hives, itching, rash - Anaphylactic shock (loss of consciousness, paleness, sweating, etc.). Nor you should take this medicine: - If you have severe heart disease or have recently had a heart attack , - If you have recently had a stroke, - If you have low blood pressure or uncontrolled high blood pressure , - If you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition sometimes described as stroke of the eye . Take special care with tadalafil Be aware that sexual activity carries a possible risk to patients with heart problems, due to the extra demands placed on it. If you have a heart problem, tell your doctor.

There are some reasons why the drug tadalafil may not be suitable for you, which are listed below. If you are in any of these cases, tell your doctor before taking this medicine: - If you have sickle cell anemia (an abnormality of red blood cells), multiple myeloma (cancer of bone marrow), leukemia (cancer of blood cells) or any deformation of the penis . - If you have a serious liver problem - If you have a severe kidney problem . It is not known if tadalafil is effective in patients undergoing surgery in the pelvic area or has been subjected to an operation in which has removed the prostate (radical prostatectomy without preservation of neurovascular bundles). If you experience sudden decrease or loss of vision, stop taking tadalafil and contact your doctor immediately . Tadalafil should not be used in women or adolescents under 18 . If in doubt, consult your doctor. Taking other medicines Tell your doctor or pharmacist if you are taking or have recently taken any medications, even those without a prescription or herbal remedies. This is particularly important if you are being treated with nitrates since you should not take tadalafil. Sometimes, to treat high blood pressure and enlarged prostate are used a type of medicines called alpha blockers .

Tell your doctor if you are being treated for any of these conditions or if you use other medications to treat high blood pressure . If you are taking medicines that can inhibit an enzyme called CYP3A4 (eg ketoconazole or protease inhibitors for treatment of AIDS (HIV)) since an increase in the frequency of adverse effects may occur. Do not take tadalafil with other medicines if your doctor has told you not to do it. It is advised not to take this substance together with any other treatment for erectile dysfunction . Remember that your doctor has prescribed this medicine only for you. Never give it to someone else. Use with food and beverages You can take this medicine with or without food Special physiological situations Always consult your doctor or pharmacist before taking any medicine during pregnancy or lactation. Pregnancy and lactation: This medicine is not appropriate for use during pregnancy or lactation Tadalafil is not indicated for children. Driving and using machines Some men who took tadalafil in clinical studies have reported dizziness.

Check carefully how you react to the medicines before driving or operating machinery . Consult your doctor or pharmacist before taking any medicine. How to use tadalafil 9650 Follow exactly instructions of use of tadalafil provided by your doctor. Consult your doctor or pharmacist when in doubt. Follow the instructions of the physician in preference to those given in this website, which may be different. Ask your doctor to explain any aspect that you do not understand, contained in the instruction leaflet that es with the medicine.

Daily administration of this drug may be useful in men who maintain sexual activity two or more times per week. The remended dose is one tablet of 5 mg once daily, at the same time each day. Your doctor may adjust the dose to 2.5 mg based on your response. Tadalafil tablets are administered orally. Swallow the tablet whole with some water. You can take it with or without food. Tadalafil administered daily allows you to get an erection at any time, 24 hours a day, whenever there is sexual stimulation. It is important to warn that tadalafil has no effect if there is no sexual stimulation. So you and your partner should act in the same way as if you were not taking a medicine for erectile dysfunction. Drinking alcohol may affect your ability to have an erection and may temporarily lower your blood pressure.

If you have taken or are planning to take tadalafil, avoid excessive drinking (blood alcohol level of 0.08 or more), because it can increase the risk of dizziness when standing up . You do not take tadalafil more than once a day. If you think the effect of the medicine is too strong or too weak, consult your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. While you take tadalafil 9650 If a doctor prescribes another medicine . tell you are taking tadalafil.

Check with your doctor regularly developments of disorder that motivates the use of tadalafil. Maybe there is some reason that prevented you properly receive the indicated doses and induce your doctor to erroneous conclusions about treatment. Do not restart treatment with tadalafil at your own risk without first talking to your doctor, nor encourage its use by another person, even if have the same symptoms you have. Nor is it advisable to interrupt or reduce the dose without considering the opinion of your doctor. Consult your doctor or go to the nearest hospital carrying the box with the rest of the drug you have not consumed. If you forget a dose: Do not take a double dose to make up for forgotten individual doses. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Side Effects of tadalafil 9650 Very mon side effects (affect more than 1 in 10 patients): - Headache - Indigestion . mon side effects (affect 1 in 10-100 patients): - Backaches, muscle aches. - Allergic reactions including rashes and hives, blurred vision, swelling of the eyelids, face, lips (angioedema). eye pain. red eyes, - Increased sweating, - Nose bleeding, - Fast heartbeat (tachycardia). high blood pressure. low blood pressure and chest pain. If it appears chest pain during or after sexual activity you should NOT use nitrates and should contact your doctor immediately . Rare side effects (affect at least 1 in 10.000 patients): - Fainting - Migraine - Swelling of the face .

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Lidocaine

LidocaineLidocaine-HC topical This bination medication is used to treat irritation, soreness, and itchiness from certain skin conditions (e. g. scrapes, minor burns, eczema. insect bites ). It can also be used to treat minor disfort and itching caused by hemorrhoids and other problems of the anal area (e. g. anal fissures ). This medication contains lidocaine. an anesthetic that works to decrease pain by temporarily numbing the area.

This product also contains hydrocortisone. a corticosteroid that reduces redness, itching. and swelling. How to use Lidocaine-HC topical Wash your hands before applying the medication. Clean and dry the area to be treated. Apply a thin layer of medication to the affected area of skin 2 or 3 times daily or as directed by your doctor. If you are using the medicated pads, use each pad only once and discard the pad after one use. Do not save used pads for later.

To apply this medication to the outside of the anus. apply a small amount to the affected area and rub in gently. Do not apply this medication inside the anus. Dosage is based on your medical condition and response to therapy. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Do not use on large areas of the body, apply heat or cover the area with waterproof bandages or plastic unless directed to do so by your doctor. If used in the diaper area on an infant. do not use tight-fitting diapers or plastic pants. These may increase the risk of serious side effects.

Wash hands immediately after use unless you are treating an area on the hands. Avoid getting the product in your eyes. nose, ears, or mouth. If the medication gets in these areas, rinse the area immediately with clean water. Do not use more of this product, use it more often, or keep using it longer than prescribed by your doctor. If you have been using this medication for a long time or in high doses, do not suddenly stop using it without your doctors approval. Some conditions may bee worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Inform your doctor if your condition does not improve or if it worsens after 1 to 2 weeks. Side Effects Redness, swelling, or temporary numbness at the treated area may occur. If any of these effects persist or worsen, notify your doctor. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: change in skin appearance (e. g. color, stretch marks. thinning skin), skin redness/tenderness/pus or other signs of infection.

Tell your doctor right away if any of these rare but very serious side effects occur: slow/shallow breathing, slow/irregular heartbeat. signs of serious infection (e. g. fever, persistent sore throat ), seizures . A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction.

rash. itching/swelling (especially of the face/tongue /throat), severe dizziness. trouble breathing . This is not a plete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at fda. gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions Before using this product, tell your doctor or pharmacist if you are allergic to lidocaine or to other amide anesthetics (e. g. bupivacaine, prilocaine) or to hydrocortisone or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes. eye problems. current/recent infections (such as tuberculosis. chickenpox, herpes ), skin sores/infections (such as fungal infections), liver disease, stomach /intestinal problems. If there is an infection or sore in the area to be treated, do not use this medication without consulting your doctor first.

Children may be more sensitive to the effects of too much corticosteroid medication. Consult your doctor for more details. During pregnancy. this medication should be used only when clearly needed. It should not be used for long periods of time or in large amounts.

Discuss the risks and benefits with your doctor. Lidocaine passes into breast milk. It is unknown if hydrocortisone passes into breast milk. Consult your doctor before breast-feeding. This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case. Missed Dose If you miss a dose, use it as soon as you remember unless it is almost time for the next dose.

In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Store at room temperature between 59-86 degrees F (15-30 degrees C). Do not refrigerate. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal pany for more details about how to safely discard your product. Information last revised October 2015. Copyright(c) 2015 First Databank, Inc./media/kcms/gbs/research/images/2013/05/02/10/56/globalnav-patientcare.

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jpg / Give to Mayo Clinic Help set a new world standard in care for people everywhere. Give now. What Is Lidocaine Lidocaine, sold under the brand names Akten, Glydo, and Lidoderm, relieves pain when applied to the skin via cream, gel, or patch. Lidocaine can also be given through the veins before surgical procedures to numb the surrounding area where medication is being administered and to help with irregular heartbeat. Lidocaine belongs to group of drugs known antiarrhythmics, which work by preventing sodium being pumped out of the cells of the heart to help the heart beat normally. Physicians may give lidocaine to people during heart surgery to help prevent irregular heartbeat. Doctors may also prescribe lidocaine off-label for premature babies who have irregular heartbeats. Lidocaine Warnings You should not take lidocaine if you have any of the following: Heart conditions like Adams-Stokes syndrome or heart blocks without a pacemaker Congestive heart failure (CHF) or heart shock Talk to your doctor before taking lidocaine if you are taking drugs called beta-blockers, including Inderal (propranolol), Bystolic (nebivolol), Lopressor (metoprolol tartrate), and Toprol XL (metoprolol succinate).

To date, whether lidocaine can help prevent a heart attack remains much-debated. If you have any concerns about this issue, talk to your doctor. Lidocaine Warnings In 2014, the Food and Drug Administration (FDA) issued a black-box warning for lidocaine because of its danger in small children. The FDA warns that lidocaine should not be used to relieve tooth pain in teething babies, because lidocaine is easily absorbed into the bloodstream and may cause death. Pregnancy and Lidocaine Lidocaine is an FDA Pregnancy Category B drug, which means it is generally safe to use during pregnancy because there is low risk of harm for your developing baby. Regardless, you should tell your doctor if you are pregnant or plan to bee pregnant before taking this medication.

You should also alert your physician if you are breastfeeding or plan to breastfeed before using lidocaine. DRUG DESCRIPTION Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection. See INDICATIONS for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Epinephrine is (-) -3, 4-Dihydroxy-alpha-(methylamino) methyl benzyl alcohol and has the molecular wt. 183.21. Epinephrine (C 9 H 13 NO 3 ) has the following structural formula: Dosage forms listed as Xylocaine (lidocaine) - MPF indicate single dose solutions that are Methyl Paraben Free (MPF). Xylocaine (lidocaine) MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.

Xylocaine (lidocaine) in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0ndash7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine (lidocaine) MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer. Xylocaine (lidocaine) with Epinephrine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 4.5 (3.3ndash5.5) with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen.

What are the possible side effects of lidocaine injection (Anestacaine, UAD Caine, Xylocaine HCl, Xylocaine-MPF) 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. 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. lidocaine topical Generic Name: lidocaine topical (LYE doe kane TOP i kal) Brand Name: AneCream, AneCream with Tegaderm, Bactine, LidaMantle, Lidocream, Lidoderm, LidoRx, LMX 4, LMX 4 with Tegaderm, Medi-Quik Spray, RadiaGuard, RectiCare, Regenecare HA Spray, Solarcaine Aloe Extra Burn Relief, Xylocaine Topical What is lidocaine topical Lidocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body. Lidocaine topical (for use on the skin) is used to reduce pain or disfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches, or burns. Lidocaine topical is also used to treat rectal disfort caused by hemorrhoids.

Lidocaine topical may also be used for purposes not listed in this medication guide. What is the most important information I should know about lidocaine topical An overdose of numbing medicine can cause fatal side effects if too much of the medicine is absorbed through your skin. Overdose symptoms may include uneven heartbeats, seizure (convulsions), slowed breathing, a, or respiratory failure (breathing stops). Use the smallest amount of this medicine needed to numb the skin or relieve pain. Do not use large amounts of lidocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Keep both used and unused lidocaine skin patches out of the reach of children or pets. The amount of lidocaine in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows the patch.

Seek emergency medical attention if this happens. What should I discuss with my healthcare provider before using lidocaine topical You should not use lidocaine topical if you are allergic to any type of numbing medicine. Fatal overdoses have occurred when numbing medicines were used 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. Be aware that many cosmetic procedures are performed without a medical doctor present. To make sure lidocaine topical is safe for you, tell your doctor if you have: liver disease or if you take a heart rhythm medicine. FDA pregnancy category B. Lidocaine topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to bee pregnant during treatment.

It is not known whether lidocaine topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. How should I use lidocaine topical Lidocaine topical es in many different forms (gel, spray, cream, lotion, ointment, liquid, skin patch). Use this medicine exactly as directed on the label, or as it has been prescribed by your doctor. Do not apply this medicine in larger amounts than remended. Do not take by mouth. Lidocaine topical is for use only on the skin. If this medicine gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Your body may absorb too much of this medicine 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. Do not apply this medicine to swollen skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion. Do not cover treated skin unless your doctor has told you to. Lidocaine topical may be applied with your finger tips or a cotton swab. If your medicine es with patient instructions for safe and effective use, follow these directions carefully.

Ask your doctor or pharmacist if you have any questions. Store at room temperature away from moisture and heat. Keep both used and unused lidocaine topical skin patches out of the reach of children or pets. The amount of lidocaine in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows the patch. Seek emergency medical attention if this happens. What happens if I miss a dose Since lidocaine topical is used when needed, you may not be on a dosing schedule.

If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. What happens if I overdose Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of numbing medicine can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood.

Symptoms may include uneven heartbeats, seizure (convulsions), slowed breathing, a, or respiratory failure (breathing stops). Lidocaine applied to the skin is not likely to cause an overdose unless you apply more than the remended dose. Improper use of lidocaine topical may result in death. What should I avoid while using lidocaine topical Do not allow this medicine to e into contact with your eyes. If it does, rinse with water. Avoid touching the sticky side of a lidocaine skin patch while applying it. Avoid accidentally injuring treated skin areas while they are numb. Avoid ing into contact with very hot or very cold surfaces. Lidocaine 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. Call your doctor at once if you have: severe burning, stinging, or irritation where the medicine was applied unusual sensations of temperature.

This is not a plete 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. Lidocaine topical dosing information Usual Adult Dose for Anesthesia: 2 viscous solution: Gargle 15 mL, undiluted, and spit out or swallow, no less than every 3 hours Maximum dose: 300 mg for normal healthy adult - not to exceed 4.5 mg/kg (2 mg/lb), or 8 doses in 24 hours - Adjust dose based on patients age, weight, and physical condition. - Topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx - Reducing gagging during dental x-rays and impressions Endotracheal intubation: Apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before insertion Maximum dose: 600 mg in any 12 hour period - Avoid introducing jelly into tube lumen due to possibility of inner lumen occlusion. - Do not use the jelly to lubricate endotracheal stylettes. - Avoid use of endotracheal tubes with dried jelly on the external surface due to lack of lubricating effect. 4 solution: Spray 1 to 5 mL (40 to 200 mg) to the desired area. May also be applied with cotton applicators or by instillation Maximum dose: 300 mg for normal healthy adult - not to exceed 4.5 mg/kg (2 mg/lb) - When spraying, transfer solution to an atomizer.

- Dosage varies and depends on the area to be anesthetized, vascularity of the tissues, individual tolerance, and technique. - Reduce dose for elderly and debilitated patients. 5 ointment: Apply topically for adequate control of symptoms. Apply to the tube prior to intubation Maximum dose: 5 g per single application (approximately 6 inches of ointment squeezed from the tube) 20 g total in any day - Adjust dose based on patients age, weight, and physical condition. - In dentistry, apply to previously dried oral mucosa subsequent saliva removal with cotton rolls or saliva ejector minimizes dilution, permits maximum penetration, and minimizes swallowing of the drug. - For insertion of new dentures, apply to all denture surfaces contacting mucosa patients should consult a dentist at least every 48 hours throughout the fitting period. - Production of anesthesia of accessible mucous membranes of the oropharynx - Anesthetic lubricant for endotracheal intubation (oral and nasal) Usual Adult Dose for Gastrointestinal Tract Examination: 2 viscous solution: Gargle 15 mL, undiluted, and spit out or swallow, no less than every 3 hours Maximum dose: 300 mg for normal healthy adult - not to exceed 4.5 mg/kg (2 mg/lb), or 8 doses in 24 hours - Adjust dose based on patients age, weight, and physical condition. - Topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx - Reducing gagging during dental x-rays and impressions Endotracheal intubation: Apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before insertion Maximum dose: 600 mg in any 12 hour period - Avoid introducing jelly into tube lumen due to possibility of inner lumen occlusion. - Do not use the jelly to lubricate endotracheal stylettes.

- Avoid use of endotracheal tubes with dried jelly on the external surface due to lack of lubricating effect. 4 solution: Spray 1 to 5 mL (40 to 200 mg) to the desired area. May also be applied with cotton applicators or by instillation Maximum dose: 300 mg for normal healthy adult - not to exceed 4.5 mg/kg (2 mg/lb) - When spraying, transfer solution to an atomizer. - Dosage varies and depends on the area to be anesthetized, vascularity of the tissues, individual tolerance, and technique. - Reduce dose for elderly and debilitated patients. 5 ointment: Apply topically for adequate control of symptoms.

Apply to the tube prior to intubation Maximum dose: 5 g per single application (approximately 6 inches of ointment squeezed from the tube) 20 g total in any day - Adjust dose based on patients age, weight, and physical condition. - In dentistry, apply to previously dried oral mucosa subsequent saliva removal with cotton rolls or saliva ejector minimizes dilution, permits maximum penetration, and minimizes swallowing of the drug. - For insertion of new dentures, apply to all denture surfaces contacting mucosa patients should consult a dentist at least every 48 hours throughout the fitting period. - Production of anesthesia of accessible mucous membranes of the oropharynx - Anesthetic lubricant for endotracheal intubation (oral and nasal) Usual Adult Dose for Pain: Lidocaine 0.5 spray: Apply a thin film to affected area up to 3 to 4 times daily as needed 3 lotion or cream: Apply a thin film to affected area 2 to 3 times daily as needed 3 gel: Apply a thin film to affected area 2 to 3 times daily as needed Maximum dose: A single application should not exceed 4 pumps do not exceed 12 pumps in 24 hours 4 cream, gel, solution: Apply a thin film to affected area 3 to 4 times daily as needed 5 ointment: Apply topically for adequate control of symptoms Maximum dose: 5 gm per single application (approximately 6 inches of ointment squeezed from the tube) 20 gm total in any day - Adjust dose based on patients age, weight, and physical condition. - To apply spray to face, spray in palm of hand and gently apply. - Do not use in large quantities, particularly over raw or blistered areas.

Uses: Relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness, and disfort due to pruritus ani, pruritus vulvae, anal fissures, and similar conditions of the skin and mucous membranes. Usual Adult Dose for Pruritus: Lidocaine 0.5 spray: Apply a thin film to affected area up to 3 to 4 times daily as needed 3 lotion or cream: Apply a thin film to affected area 2 to 3 times daily as needed 3 gel: Apply a thin film to affected area 2 to 3 times daily as needed Maximum dose: A single application should not exceed 4 pumps do not exceed 12 pumps in 24 hours 4 cream, gel, solution: Apply a thin film to affected area 3 to 4 times daily as needed 5 ointment: Apply topically for adequate control of symptoms Maximum dose: 5 gm per single application (approximately 6 inches of ointment squeezed from the tube) 20 gm total in any day - Adjust dose based on patients age, weight, and physical condition. - To apply spray to face, spray in palm of hand and gently apply. - Do not use in large quantities, particularly over raw or blistered areas. Uses: Relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness, and disfort due to pruritus ani, pruritus vulvae, anal fissures, and similar conditions of the skin and mucous membranes. Usual Adult Dose for Burns - External: Lidocaine 0.5 spray: Apply a thin film to affected area up to 3 to 4 times daily as needed 3 lotion or cream: Apply a thin film to affected area 2 to 3 times daily as needed 3 gel: Apply a thin film to affected area 2 to 3 times daily as needed Maximum dose: A single application should not exceed 4 pumps do not exceed 12 pumps in 24 hours 4 cream, gel, solution: Apply a thin film to affected area 3 to 4 times daily as needed 5 ointment: Apply topically for adequate control of symptoms Maximum dose: 5 gm per single application (approximately 6 inches of ointment squeezed from the tube) 20 gm total in any day - Adjust dose based on patients age, weight, and physical condition. - To apply spray to face, spray in palm of hand and gently apply. - Do not use in large quantities, particularly over raw or blistered areas.

Uses: Relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness, and disfort due to pruritus ani, pruritus vulvae, anal fissures, and similar conditions of the skin and mucous membranes. Usual Adult Dose for Hemorrhoids: 3 lotion or cream: Apply a thin film to affected area 2 to 3 times daily as needed 3 gel: Apply a thin film to affected area 2 to 3 times daily as needed Maximum dose: A single application should not exceed 4 pumps do not exceed 12 pumps in 24 hours 4, 5 lotion or cream: Apply a thin film to affected area up to 6 times daily as needed - When practical, cleanse the affected area before applying medication. - Gently dry by patting or blotting with toilet tissue or a soft cloth before application of product. - Onset of action is 3 to 5 minutes. - Use with caution in ill, elderly, or debilitated patients who may be more sensitive to systemic effects. - If irritation or sensitivity occurs, or infection appears, discontinue treatment and institute appropriate therapy. - Do not use on traumatized mucosa or in the presence of secondary bacterial infection in the area of proposed application. - Temporary relief of local itching and disfort associated with hemorrhoids - Temporary relief of pain, soreness, and burning - Relief of disfort due to pruritus ani, and anal fissures Usual Adult Dose for Postherpetic Neuralgia: 5 patch: Apply patch(es) to intact skin to cover the most painful area for up to 12 hours in a 24 hour period Maximum dose: 3 patches, 12 out of 24 hours - Apply only to intact skin. - May cut patches to smaller sizes with scissors prior to removal of release liner, if needed.

- Clothing may be worn over patches. - Smaller areas of treatment are remended in debilitated patients or patients with impaired elimination. - If irritation or burning sensations occur, remove patches and do not reapply until irritation subsides. - Placing heat sources (electric blankets, heating pads, etc.) over the patches is not remended. Use: Relief of pain associated with post-herpetic neuralgia Usual Pediatric Dose for Hemorrhoids: 3 lotion or cream: Apply a thin film to affected area 2 to 3 times daily as needed.

Maximum dose: 4.3 mg/kg (2 mg/lb) 3 gel: Apply to affected area 2 to 3 times daily as needed Maximum dose: A single application should not exceed 4 pumps do not exceed 12 pumps in 24 hours 4, 5 lotion or cream: Children 12 years and older: Apply thin film to affected area up to 6 times daily as needed - When practical, cleanse the affected area before applying medication. - Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. - The onset of action is 3 to 5 minutes. - Use with caution children may be more sensitive to systemic effects. - Reduce dose in pediatric patients mensurate with age, body weight, and physical condition. - Children under 10 years with normal lean body mass and development: determine maximum dose using one of the standard pediatric drug formulas (e. g. Clarks rule). - If irritation or sensitivity occurs, or infection appears, discontinue treatment and institute appropriate therapy. - Do not use on traumatized mucosa or in the presence of secondary bacterial infection in the area of application.

- Temporary relief of local itching and disfort associated with hemorrhoids. - Temporary relief of pain, soreness, and burning, - Relief of disfort due to pruritus ani, and anal fissures. Usual Pediatric Dose for Pain: Lidocaine 0.5 spray: 2 years and older: Apply thin film to affected area up to 3 to 4 times daily as needed 3 lotion or cream: Apply a thin film to affected area 2 to 3 times daily as needed 3 gel: Apply thin film to affected area 2 to 3 times daily as needed Maximum dose: 12 pumps in 24 hours 4 cream, gel, solution: Apply thin film to affected area 3 to 4 times daily as needed Maximum dose: 4.5 mg/kg (2 mg/lb) 5 ointment: Apply topically for adequate control of symptoms. Maximum dose: 4.5 mg/kg (2 mg/lb) - Adjust dose based on patients age, weight, and physical condition. - It is difficult to remend a maximum dose of any drug for children since this varies as a function of age and weight. - Children under ten years with normal lean body mass and development determine the maximum dose by the applying of one of the standard pediatric drug formulas (e. g. Clarks rule). - To apply spray to face, spray in palm of hand and gently apply.

- Do not use in large quantities, particularly over raw or blistered areas. Uses: Relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness, and disfort due to pruritus ani, pruritus vulvae, anal fissures, and similar conditions of the skin and mucous membranes. Usual Pediatric Dose for Pruritus: Lidocaine 0.5 spray: 2 years and older: Apply thin film to affected area up to 3 to 4 times daily as needed 3 lotion or cream: Apply a thin film to affected area 2 to 3 times daily as needed 3 gel: Apply thin film to affected area 2 to 3 times daily as needed Maximum dose: 12 pumps in 24 hours 4 cream, gel, solution: Apply thin film to affected area 3 to 4 times daily as needed Maximum dose: 4.5 mg/kg (2 mg/lb) 5 ointment: Apply topically for adequate control of symptoms. Maximum dose: 4.5 mg/kg (2 mg/lb) - Adjust dose based on patients age, weight, and physical condition. - It is difficult to remend a maximum dose of any drug for children since this varies as a function of age and weight.

- Children under ten years with normal lean body mass and development determine the maximum dose by the applying of one of the standard pediatric drug formulas (e. g. Clarks rule). - To apply spray to face, spray in palm of hand and gently apply. - Do not use in large quantities, particularly over raw or blistered areas. Uses: Relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness, and disfort due to pruritus ani, pruritus vulvae, anal fissures, and similar conditions of the skin and mucous membranes. Usual Pediatric Dose for Burns - External: Lidocaine 0.5 spray: 2 years and older: Apply thin film to affected area up to 3 to 4 times daily as needed 3 lotion or cream: Apply a thin film to affected area 2 to 3 times daily as needed 3 gel: Apply thin film to affected area 2 to 3 times daily as needed Maximum dose: 12 pumps in 24 hours 4 cream, gel, solution: Apply thin film to affected area 3 to 4 times daily as needed Maximum dose: 4.5 mg/kg (2 mg/lb) 5 ointment: Apply topically for adequate control of symptoms. Maximum dose: 4.5 mg/kg (2 mg/lb) - Adjust dose based on patients age, weight, and physical condition.

- It is difficult to remend a maximum dose of any drug for children since this varies as a function of age and weight. - Children under ten years with normal lean body mass and development determine the maximum dose by the applying of one of the standard pediatric drug formulas (e. g. Clarks rule). - To apply spray to face, spray in palm of hand and gently apply. - Do not use in large quantities, particularly over raw or blistered areas.

Uses: Relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness, and disfort due to pruritus ani, pruritus vulvae, anal fissures, and similar conditions of the skin and mucous membranes. Usual Pediatric Dose for Anesthesia: 2 Oral solution (viscous): Infants and children less than 3 years: One quarter teaspoon applied to area with a cotton tipped applicator no more frequently than every 3 hours Maximum dose: 4 doses per 12 hour period Children 3 years and older: No more than 4.5 mg/kg/dose (or 300 mg/dose), swished in the mouth and spit out no more frequently than every 3 hours - Do not use for teething pain. - Adjust dose based on patients age, weight, and physical condition. - Children under ten years with normal lean body mass and development determine the maximum dose by the applying of one of the standard pediatric drug formulas (e. g. Clarks rule). - Topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. - Reducing gagging during dental x-rays and impressions Pediatric LTA(R) 2 spray: For laryngoscopy, bronchoscopy, and endotracheal intubation: Spray pharynx with 1 to 5 mL Maximum dose: 4.5 mg/kg (2 mg/lb) - Dosage in children should be reduced, mensurate with age, body weight and physical condition. - Children under ten years with normal lean body mass and development determine the maximum dose by the applying of one of the standard pediatric drug formulas (e. g. Clarks rule).

Endotracheal intubation: Apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before insertion Maximum dose: 4.5 mg/kg (2 mg/lb) - Avoid introducing jelly into tube lumen due to possibility of inner lumen occlusion. - Do not use the jelly to lubricate endotracheal stylettes. - Avoid use of endotracheal tubes with dried jelly on the external surface due to lack of lubricating effect. 2, 4, or 5 solution: Spray on the desired area.

May also be applied with cotton applicators or by instillation Maximum Dose: 4.5 mg/kg (2 mg/lb) - When spraying, transfer solution to an atomizer. - Dosage varies and depends on the area to be anesthetized, vascularity of the tissues, individual tolerance, and technique. - Reduce dose in children mensurate with age, body weight and physical condition. - Children under ten years with normal lean body mass and development: determine the maximum dose by the applying of one of the standard pediatric drug formulas (e. g. Clarks rule). 5 ointment: Apply topically for adequate control of symptoms. Apply to the tube prior to intubation - Adjust dose based on patients age, weight, and physical condition. - In dentistry, apply to previously dried oral mucosa subsequent saliva removal with cotton rolls or saliva ejector minimizes dilution, permits maximum penetration, and minimizes swallowing of the drug. - For insertion of new dentures, apply to all denture surfaces contacting mucosa patients should consult a dentist at least every 48 hours throughout the fitting period.

- Production of anesthesia of accessible mucous membranes of the oropharynx. - Anesthetic lubricant for endotracheal intubation (oral and nasal). Usual Pediatric Dose for Gastrointestinal Surgery: 2 Oral solution (viscous): Infants and children less than 3 years: One quarter teaspoon applied to area with a cotton tipped applicator no more frequently than every 3 hours Maximum dose: 4 doses per 12 hour period Children 3 years and older: No more than 4.5 mg/kg/dose (or 300 mg/dose), swished in the mouth and spit out no more frequently than every 3 hours - Do not use for teething pain. - Adjust dose based on patients age, weight, and physical condition. - Children under ten years with normal lean body mass and development determine the maximum dose by the applying of one of the standard pediatric drug formulas (e. g. Clarks rule). - Topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. - Reducing gagging during dental x-rays and impressions Pediatric LTA(R) 2 spray: For laryngoscopy, bronchoscopy, and endotracheal intubation: Spray pharynx with 1 to 5 mL Maximum dose: 4.5 mg/kg (2 mg/lb) - Dosage in children should be reduced, mensurate with age, body weight and physical condition.

- Children under ten years with normal lean body mass and development determine the maximum dose by the applying of one of the standard pediatric drug formulas (e. g. Clarks rule). Endotracheal intubation: Apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before insertion Maximum dose: 4.5 mg/kg (2 mg/lb) - Avoid introducing jelly into tube lumen due to possibility of inner lumen occlusion. - Do not use the jelly to lubricate endotracheal stylettes. - Avoid use of endotracheal tubes with dried jelly on the external surface due to lack of lubricating effect.

2, 4, or 5 solution: Spray on the desired area. May also be applied with cotton applicators or by instillation Maximum Dose: 4.5 mg/kg (2 mg/lb) - When spraying, transfer solution to an atomizer. - Dosage varies and depends on the area to be anesthetized, vascularity of the tissues, individual tolerance, and technique. - Reduce dose in children mensurate with age, body weight and physical condition. - Children under ten years with normal lean body mass and development: determine the maximum dose by the applying of one of the standard pediatric drug formulas (e. g. Clarks rule).

5 ointment: Apply topically for adequate control of symptoms. Apply to the tube prior to intubation - Adjust dose based on patients age, weight, and physical condition. - In dentistry, apply to previously dried oral mucosa subsequent saliva removal with cotton rolls or saliva ejector minimizes dilution, permits maximum penetration, and minimizes swallowing of the drug. - For insertion of new dentures, apply to all denture surfaces contacting mucosa patients should consult a dentist at least every 48 hours throughout the fitting period. - Production of anesthesia of accessible mucous membranes of the oropharynx. - Anesthetic lubricant for endotracheal intubation (oral and nasal). Usual Pediatric Dose for Local Anesthesia: 0.5 powder injection system: Ages 3 to 18 years: Apply one 0.5 mg lidocaine topical to the site of intact skin planned for venipuncture or peripheral intravenous cannulation, 1 to 3 minutes prior to needle insertion - Perform procedure within 10 minutes after administration.

- Use only on intact skin. - Perform procedure within 10 minutes after administration. - One additional application at a new location may be used after a failed attempt at venous access. - Multiple administrations at the same location are not remended. Use: Topical anesthesia prior to venipuncture or peripheral intravenous cannulation in children ages 3 to 18. What other drugs will affect lidocaine topical It is not likely that other drugs you take orally or inject will have an effect on topically applied lidocaine. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products. wiseGEEK: What is Lidocaine Lidocaine, pronounced LYE-doe-kane, is a local or topical anesthetic that can be applied to the skin or to mucous membranes to reduce the immediate feeling of pain and produce numbness. Lidocaine has been in the market since 1948, and is available over the counter, which means no doctor prescription is needed to buy it or use it. Lidocaine is used for a variety of medical conditions, and is often one of the drugs included in first-aid kits in the form of a bination antibiotic /pain relieving cream.

Sprays for treating sunburn, insect bites, or poison ivy often include lidocaine as the main ingredient. Lidocaine gel is often used in dental procedures as a way of numbing the area before applying an injection, or to reduce pain after the procedure is finished. For Infiltration and Nerve Block Including Caudal and Epidural Use. Lidocaine Description Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS for specific uses . Lidocaine hydrochloride injection, USP contains Lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight 270.8. Lidocaine hydrochloride (C 14 H 22 N 2 O HCl) has the following structural formula: Mechanism of Action Lidocaine hydrochloride stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic action. Hemodynamics Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. With central neural blockade these changes may be attributable to block of autonomic fibers, a direct depressant effect of the local anesthetic agent on various ponents of the cardiovascular system, and/or the beta-adrenergic receptor stimulating action of epinephrine when present.

The net effect is normally a modest hypotension when the remended dosages are not exceeded. Pharmacokinetics and Metabolism Information derived from diverse formulations, concentrations and usages reveals that Lidocaine hydrochloride is pletely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors such as the site of administration and the presence or absence of a vasoconstrictor agent. Except for intravascular administration, the highest blood levels are obtained following intercostal nerve block and the lowest after subcutaneous administration. The plasma binding of Lidocaine hydrochloride is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg of free base per mL 60 to 80 percent of Lidocaine hydrochloride is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein.

Lidocaine hydrochloride crosses the blood-brain and placental barriers, presumably by passive diffusion. Lidocaine hydrochloride is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of Lidocaine hydrochloride.

Approximately 90 of Lidocaine hydrochloride administered is excreted in the form of various metabolites, and less than 10 is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline. The elimination half-life of Lidocaine hydrochloride following an intravenous bolus injection is typically 1.5 to 2 hours. Because of the rapid rate at which Lidocaine hydrochloride is metabolized, any condition that affects liver function may alter Lidocaine hydrochloride kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect Lidocaine hydrochloride kinetics but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of Lidocaine hydrochloride required to produce overt systemic effects. Objective adverse manifestations bee increasingly apparent with increasing venous plasma levels above 6 mcg free base per mL. In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for convulsive activity.

Indications and Usage for Lidocaine Contraindications Lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Lidocaine HYDROCHLORIDE INJECTION, USP FOR INFILTRATION AND NERVE BLOCK SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES. (See also ADVERSE REACTIONS and PRECAUTIONS .) DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH. 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-humeral chondrolysis have been described in pediatric 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 2 nd month after surgery. Currently, there is no effective treatment for chondrolysis patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.

To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected. The needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not guarantee that intravascular injection has been avoided. Precautions The safety and effectiveness of Lidocaine hydrochloride depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Standard textbooks should be consulted for specific techniques and precautions for various regional anesthetic procedures. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use. (See WARNINGS and ADVERSE REACTIONS .

) The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Syringe aspirations should also be performed before and during each supplemental injection when using indwelling catheter techniques. During the administration of epidural anesthesia, it is remended that a test dose be administered initially and that the patient be monitored for central nervous system toxicity and cardiovascular toxicity, as well as for signs of unintended intrathecal administration, before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions that contain epinephrine for the test dose because circulatory changes patible with epinephrine may also serve as a warning sign of unintended intravascular injection.

An intravascular injection is still possible even if aspirations for blood are negative. Repeated doses of Lidocaine hydrochloride may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses mensurate with their age and physical condition. Lidocaine hydrochloride should also be used with caution in patients with severe shock or heart block. Lumbar and caudal epidural anesthesia should be used with extreme caution in persons with the following conditions: existing neurological disease, spinal deformities, septicemia, and severe hypertension. Local anesthetic solutions containing a vasoconstrictor should be used cautiously and in carefully circumscribed quantities in areas of the body supplied by end arteries or having otherwise promised blood supply. Patients with peripheral vascular disease and those with hypertensive vascular disease may exhibit exaggerated vasoconstrictor response. Ischemic injury or necrosis may result.

Preparations containing a vasoconstrictor should be used with caution in patients during or following the administration of potent general anesthetic agents, since cardiac arrhythmias may occur under such conditions. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patientrsquos state of consciousness should be acplished after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression or drowsiness may be early warning signs of central nervous system toxicity. Since amide-type local anesthetics are metabolized by the liver, Lidocaine hydrochloride injection, USP should be used with caution in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations. Lidocaine hydrochloride injection, USP should also be used with caution in patients with impaired cardiovascular function since they may be less able to pensate for functional changes associated with the prolongation of A-V conduction produced by these drugs.

Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia. Since it is not known whether amide-type local anesthetics may trigger this reaction and since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for the management of malignant hyperthermia should be available. Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful oute is dependent on early diagnosis, prompt discontinuance of the suspect triggering agent(s) and institution of treatment, including oxygen therapy, indicated supportive measures and dantrolene (consult dantrolene sodium intravenous package insert before using). Proper tourniquet technique, as described in publications and standard textbooks, is essential in the performance of intravenous regional anesthesia. Solutions containing epinephrine or other vasoconstrictors should not be used for this technique. Lidocaine hydrochloride should be used with caution in persons with known drug sensitivities. Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to Lidocaine hydrochloride. Use in the Head and Neck Area Small doses of local anesthetics injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses.

Confusion, convulsions, respiratory depression and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage remendations should not be exceeded.

(See DOSAGE AND ADMINISTRATION. ) Information for Patients When appropriate, patients should be informed in advance that they may experience temporary loss of sensation and motor activity, usually in the lower half of the body, following proper administration of epidural anesthesia. Clinically Significant Drug Interactions The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs (for the treatment of hypotension related to obstetric blocks) and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.

Drug/Laboratory Test Interactions The intramuscular injection of Lidocaine hydrochloride may result in an increase in creatine phosphokinase levels. Thus, the use of this enzyme determination, without isoenzyme separation, as a diagnostic test for the presence of acute myocardial infarction may be promised by the intramuscular injection of Lidocaine hydrochloride. Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category B Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by Lidocaine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering Lidocaine hydrochloride to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. Labor and Delivery Local anesthetics rapidly cross the placenta and when used for epidural, paracervical, pudendal or caudal block anesthesia, can cause varying degrees of maternal, fetal and neonatal toxicity.

(See CLINICAL PHARMACOLOGY: Pharmacokinetics. ) The potential for toxicity depends 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. Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves.

Elevating the patientrsquos legs and positioning her on her left side will help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Epidural, spinal, paracervical, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. In one study, paracervical block anesthesia was associated with a decrease in the mean duration of first stage labor and facilitation of cervical dilation. However, spinal and epidural anesthesia have also been reported to prolong the second stage of labor by removing the parturientrsquos reflex urge to bear down or by interfering with motor function. The use of obstetrical anesthesia may increase the need for forceps assistance. The use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. The long-term significance of these observations is unknown. Fetal bradycardia may occur in 20 to 30 percent of patients receiving paracervical nerve block anesthesia with the amide-type local anesthetics and may be associated with fetal acidosis.

Fetal heart rate should always be monitored during paracervical anesthesia. The physician should weigh the possible advantages against risks when considering a paracervical block in prematurity, toxemia of pregnancy, and fetal distress. Careful adherence to remended dosage is of the utmost importance in obstetrical paracervical block. Failure to achieve adequate analgesia with remended doses should arouse suspicion of intravascular or fetal intracranial injection. Cases patible with unintended fetal intracranial injection of local anesthetic solution have been reported following intended paracervical or pudendal block or both.

Babies so affected present with unexplained neonatal depression at birth, which correlates with high local anesthetic serum levels, and often manifest seizures within six hours. Prompt use of supportive measures bined with forced urinary excretion of the local anesthetic has been used successfully to manage this plication. Case reports of maternal convulsions and cardiovascular collapse following use of some local anesthetics for paracervical block in early pregnancy (as anesthesia for elective abortion) suggest that systemic absorption under these circumstances may be rapid. The remended maximum dose of each drug should not be exceeded. Injection should be made slowly and with frequent aspiration. Allow a 5-minute interval between sides. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lidocaine hydrochloride is administered to a nursing woman. Pediatric Use Dosages in children should be reduced, mensurate with age, body weight and physical condition.

(See DOSAGE AND ADMINISTRATION .) Adverse Reactions Adverse experiences following the administration of Lidocaine hydrochloride are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most monly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of Lidocaine hydrochloride is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular System Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions.

Allergic reactions may occur as a result of sensitivity to local anesthetic agents. Allergic reactions as result of sensitivity to Lidocaine hydrochloride are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. Neurologic The incidences of adverse 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. In a prospective review of 10,440 patients who received Lidocaine hydrochloride for spinal anesthesia, the incidences of adverse reactions were reported to be about 3 percent each for positional headaches, hypotension and backache 2 percent for shivering and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision.

Many of these observations may be related to local anesthetic techniques, with or without a contribution from the local anesthetic. In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the amount of drug administered subdurally. These may include spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months) or inplete recovery have been reported in rare instances when caudal or lumbar epidural block has been attempted.

Backache and headache have also been noted following use of these anesthetic procedures. There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration. Overdosage Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (see ADVERSE REACTIONS. WARNINGS. and PRECAUTIONS ). Management of Local Anesthetic Emergencies The first consideration is prevention best acplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patientrsquos state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered. The first step in the management of convulsions, as well as underventilation or apnea due to unintended subarachnoid injection of drug solution, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask.

Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e. g. ephedrine). If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. Underventilation or apnea due to unintentional subarachnoid injection of local anesthetic solution may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated. Dialysis is of negligible value in the treatment of acute overdosage with Lidocaine hydrochloride.

The oral LD 50 of Lidocaine hydrochloride in non-fasted female rats is 459 (346 to 773) mg/kg (as the salt) and 214 (159 to 324) mg/kg (as the salt) in fasted female rats. Lidocaine Dosage and Administration Table 1 (Remended Dosages) summarizes the remended volumes and concentrations of Lidocaine hydrochloride injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required, only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated. There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.

Lidocaine hydrochloride injection, USP is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION ). These remended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given.

Dosages should be reduced for children and for the elderly and debilitated patients and patients with cardiac and/or liver disease. The onset of a

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