Microsoft word - compounded tetra- lidocaine.doc

Compounded Tetracaine & Lidocaine

This medication has been prepared by a compounding pharmacy as instructed by your doctor. Both Tetracaine and Lidocaine are components of FDA
approved drugs. Compounded medications are routinely tested in labs for accuracy and purity, but they are not subjected to human clinical trials or to
FDA’s drug approval process.
When deciding to use a medication, the risks of taking the medication must be weighed against its potential benefits. This is a decision you and your
doctor will make. For Tetracaine 6% and Lidocaine 6% the following should be considered: Warning: This medication must be used under the direction
and supervision of a doctor or licensed medical practitioner and only as directed
. Reactions resulting in death have occurred on rare occasions with the
use of topical anesthetics. Excessive doses: Applying too much application on to a large surface area or applying excessive amounts on broken, burned
or damaged skin or mucous membranes will increase the amount of the medication absorbed into your body and may produce serious or fatal reactions.
Existing Medical Conditions: Tell your doctor or licensed medical practitioner about any medical conditions you might have, including but not limited to,
heart disordered, liver problems, blood disorders, enzyme deficiencies or sensitivity to Tetracaine or Lidocaine, and about any unusual reaction to an
anesthetic or any other medications you might have tried in the past.
Other Medications: Tell your doctor about any other prescription or over-the-counter drugs that you are currently taking before using this medication. Do
not use this medication before consulting your doctor if you are taking drugs to control a rapid heart rate (antiarrhythmic drugs). Do not use this
medication if you are using any other topical anesthetic drug products.
Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to local anesthetics, especially when applied to the skin or other areas of
your body. Also tell your doctor if you are allergic to any other substances, such as foods, preservatives, or dyes, especially amino benzoic acid (also
called para amino benzoic acid (PABA), or to parbens (preservatives).
Pregnancy and Breast Feeding: There is insufficient information about the use of this medication during pregnancy or breast-feeding, Do not use if
pregnant or breast-feeding.
Children: Keep out of the reach of children. For use on adults only.
Older Adults There is no specific information comparing use of topical anesthetics in the elderly with use in other age groups.
Proper Use of This Medication
Warning: this medication must be used under the direction and supervision of a doctor or licensed medical practitioner and only as directed. Reactions resulting in death have occurred on rare occasions with the use of topical anesthetics. Apply according to your doctor’s instructions at the doctor’s office, clinic or hospital, 30-90 minutes before a scheduled procedure. Keep in mind that no studies have been completed to determine the safe amount of this compounded medication to apply or the safe maximum surface area. A commercially available product containing 7% Tetracaine and 7% Lidocaine limits the applications to 400 square centimeters (approximately the surface area of the face). Apply a coat of this medication to clean, intact skin and rub in like you would regular skin lotion. Apply a second layer and leave a visible coat of this medication on the skin. Do not cover with occlusive barriers such as plastic wrap unless specifically directed to do so by your doctor or practitioner. Use gloves for the application of the medication and dispose of the gloves, along with used tubes, in allocation that prevents accidental ingestion by children or pets. Do not let this medication come in contact with eyes, nose, mouth or unintended areas of skin. This medication should be used only for the treatment specified by your doctor. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Precautions While Using This Medication
Stop using this medication and check with your doctor: If the skin you are treating becomes infected. If you notice a skin rash burning, stinging, swelling or any other sign of irritation that was not present when you began using this medication. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Possible Side Effects of This Medication
Along with its desired effects, a medication may cause some unwanted effects. Use of this medication might result in temporary skin discoloration or mild swelling at the site of application. Use of this medication may also result in the blocking of all sensation in the treated area. Therefore, avoid scratching, rubbing or exposing the treated area to extreme hot or cold temperatures or to extreme sunlight until full sensation has returned. Stop using this medication and call your doctor immediately if any of the following side effects occurs: Large swellings that look like hives on the skin or in the mouth or throat. Blurred or double vision; confusion; convulsions (seizures); dizziness or light-headedness; nausea; drowsiness; feeling hot, cold or numb; headache; increased sweating; ringing or buzzing in the ears; shivering or trembling; slow or irregular heartbeat; trouble breathing; unusual anxiety, excitement, nervousness or restlessness; unusual paleness; unusual tiredness or weakness. This information is not intended to cover all possible uses, side effects, precautions and warnings, or drug interactions between this medication and other drugs. If you notice other side effects or have any questions, please check with your doctor immediately. I have read and understand the above information and agree to be treated with this topical compound. I understand there are certain risks associated with it.


Microsoft word - cervical

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Microsoft word - lawsuits hlep guarantee drug safety.doc

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