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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 11.04.2022
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Lidocaine (Topla) and Prilocaine (Topla) cream USP, 2.5%/2.5% (a eutectic mixture of Lidocaine (Topla) 2.5% and Prilocaine (Topla) 2.5%) is indicated as a topical anesthetic for use on:
• normal intact skin for local analgesia.
• genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.
Lidocaine (Topla) and Prilocaine (Topla) cream is not recommended in any clinical situation in which penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies.
Lidocaine (Topla) and Prilocaine (Topla) topical cream is used on the skin or in the genital area to cause numbness or loss of feeling before certain medical procedures. It is used to prevent pain caused by an injection, the drawing of blood from a vein, or minor surgeries such as removing warts. Lidocaine (Topla) and Prilocaine (Topla) contains a mixture of two topical local anesthetics (numbing medicines). It deadens the nerve endings in the skin.
Lidocaine (Topla) and Prilocaine (Topla) is available only with your doctor's prescription.
Adult Patients-Intact Skin: A thick layer of Lidocaine (Topla) and Prilocaine (Topla) cream is applied to intact skin and covered with an occlusive dressing.
Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of Lidocaine (Topla) and Prilocaine (Topla) cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using Lidocaine (Topla) and Prilocaine (Topla) cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of Lidocaine (Topla) and Prilocaine (Topla) cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of Lidocaine (Topla) and Prilocaine (Topla) cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of Lidocaine (Topla) and Prilocaine (Topla) cream.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of Lidocaine (Topla) and Prilocaine (Topla) absorbed during the period of application can be estimated from the information in TABLE 2, ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous Membranes: For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of Lidocaine (Topla) and Prilocaine (Topla) cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the Lidocaine (Topla) and Prilocaine (Topla) cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of Lidocaine (Topla) and Prilocaine (Topla) cream.
Pediatric Patients-Intact Skin: The following are the maximum recommended doses, application areas and application times for Lidocaine (Topla) and Prilocaine (Topla) cream based on a child's age and weight:
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of Lidocaine (Topla) and Prilocaine (Topla) cream should be restricted to that which corresponds to the patient's weight.
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of Lidocaine (Topla) and Prilocaine (Topla) cream.
When applying Lidocaine (Topla) and Prilocaine (Topla) cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of Lidocaine (Topla) and Prilocaine (Topla) cream, or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine (Topla) and Prilocaine (Topla) cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents.
When Lidocaine (Topla) and Prilocaine (Topla) cream is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. The amount absorbed in the case of Lidocaine (Topla) and Prilocaine (Topla) cream is determined by the area over which it is applied and the duration of application under occlusion.
Although the incidence of systemic adverse reactions with Lidocaine (Topla) and Prilocaine (Topla) cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure.
INSTRUCTIONS FOR APPLICATION
To measure 1 gram of Lidocaine (Topla) and Prilocaine (Topla) cream, the cream should be gently squeezed out of the tube as a narrow strip that is 1.5 inches (3.8 cm) long and 0.2 inches (5 mm) wide. The strip of Lidocaine (Topla) and Prilocaine (Topla) cream should be contained within the lines of the diagram shown below.
1.5 x 0.2 inches
Use the number of strips that equals your dose, like the examples in the table below.
For adult and pediatric patients, apply ONLY as prescribed by your physician.
If your child is below the age of 3 months or small for their age, please inform your doctor before applying Lidocaine (Topla) and Prilocaine (Topla) cream, which can be harmful, if applied over too much skin at one time in young children.
When applying Lidocaine (Topla) and Prilocaine (Topla) cream to the intact skin of young children, it is important that they be carefully observed by an adult in order to prevent the accidental ingestion of or eye contact with Lidocaine (Topla) and Prilocaine (Topla) cream.
Lidocaine (Topla) and Prilocaine (Topla) cream must be applied to intact skin at least 1 hour before the start of a routine procedure and for 2 hours before the start of a painful procedure. A protective covering of the cream is not necessary for absorption but may be helpful to keep the cream in place. If using a protective covering, your doctor will remove it, wipe off the Lidocaine (Topla) and Prilocaine (Topla) cream, and clean the entire area with an antiseptic solution before the procedure.
The duration of effective skin anesthesia will be at least 1 hour after removal of the protective covering.
PRECAUTIONS:
1. Do not apply near eyes or on open wounds.
2. Keep out of reach of children.
3. If your child becomes very dizzy, excessively sleepy, or develops duskiness of the face or lips after applying Lidocaine (Topla) and Prilocaine (Topla) cream, remove the cream and contact your physician at once.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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What is the most important information I should know about Topla?
Topla™ is contraindicated in patients with a known hypersensitivity to Lidocaine (Topla) or bupivacaine or any local anesthetic agent of the amide type or to other components of Lidocaine (Topla) and/or bupivacaine solutions.
Topla™ should not be used in patients with Stokes-Adams syndrome. Wolff Parkinson-White syndrome, or with severe degrees of sinoatrial atrioventricular, or intraventricular block in the absence of an artificial pacemaker.
Use Topla cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Topla cream. Talk to your pharmacist if you have questions about this information.
- Wash and completely dry the area to be treated. Apply a thick layer of cream to the affected skin. Do not rub Topla cream into the skin.
- Topla cream should only be used on normal, unbroken skin. Do not apply to damaged skin.
- Avoid getting Topla cream in your eyes, nose, or mouth. If you get Topla cream in your eyes, rinse them with plenty of water.
- Wash your hands immediately after using Topla cream.
- Discard unused medicine and packaging in the trash, out of the reach of children and away from pets.
- If you miss a dose of Topla cream, 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 Topla cream.
Increased risk of methemoglobinemia w/ sulpha prep, local anesth or prep that are structurally similar to local anesth, antiarrhythmic drug class III (eg amiodarone).
See also:
What are the possible side effects of Topla?
Localized Reactions: During or immediately after treatment with Lidocaine (Topla) and Prilocaine (Topla) cream on intact skin, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. Rare cases of discrete purpuric or petechial reactions at the application site have been reported. Rare cases of hyperpigmentation following the use of Lidocaine (Topla) and Prilocaine (Topla) cream have been reported. The relationship to Lidocaine (Topla) and Prilocaine (Topla) cream or the underlying procedure has not been established. In clinical studies on intact skin involving over 1,300 Lidocaine (Topla) and Prilocaine (Topla) cream-treated subjects, one or more such local reactions were noted in 56% of patients, and were generally mild and transient, resolving spontaneously within 1 or 2 hours. There were no serious reactions which were ascribed to Lidocaine (Topla) and Prilocaine (Topla) cream.
Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of Lidocaine (Topla) and Prilocaine (Topla) cream.
In patients treated with Lidocaine (Topla) and Prilocaine (Topla) cream on intact skin, local effects observed in the trials included: paleness (pallor or blanching) 37%, redness (erythema) 30%, alterations in temperature sensations 7%, edema 6%, itching 2% and rash, less than 1%.
In clinical studies on genital mucous membranes involving 378 Lidocaine (Topla) and Prilocaine (Topla) cream-treated patients, one or more application site reactions, usually mild and transient, were noted in 41% of patients. The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%).
Allergic Reactions: Allergic and anaphylactoid reactions associated with Lidocaine (Topla) or Prilocaine (Topla) can occur. They are characterized by urticaria, angioedema, bronchospasm, and shock. If they occur they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.
Systemic (Dose Related) Reactions: Systemic adverse reactions following appropriate use of Lidocaine (Topla) and Prilocaine (Topla) cream are unlikely due to the small dose absorbed. Systemic adverse effects of Lidocaine (Topla) and/or Prilocaine (Topla) are similar in nature to those observed with other amide local anesthetic agents including CNS excitation and/or depression (light-headedness, 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). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.
A local anesthetic of the amide type now generally used for surface anesthesia. It is one of the most potent and toxic of the long-acting local anesthetics and its parenteral use is restricted to spinal anesthesia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1006)