NUMBEX Cream 50gm

INTRODUCTION

NUMBEX CREAM is a combination of Lignocaine and Prilocaine which belongs to the group of medicines called Local Anesthetic agents. It is used to cause temporary numbness (loss of pain sensation) of the normal intact skin and genital mucosal membranes when applied topically.

It is primarily used to abolish pain signals prior to surgical and diagnostic procedures on the skin and genital areas (such as during insertion of needles or catheters, during certain painful vaccinations (such as MMR, flu, hepatitis, DPT), during minor surgeries of genital areas (such as removal of foreskin around the penis) and during laser treatment or other cosmetic procedures involving the skin surface).

NUMBEX CREAM can also be used to temporarily numb skin before injecting an anesthetic solution and can be used to abolish pain signals while removing dead and damaged skin/cells among patients with leg ulcers. It also provides relief from the symptoms of atopic dermatitis (red, itchy skin) in adults.

NUMBEX CREAM is suitable for use both in adults and in children (including infants and newborns). It should be used only under careful medical supervision. It will be applied to you only by a doctor or nurse at skin surfaces where loss of sensation is required.

Before NUMBEX CREAM is applied onto your skin, inform your doctor if you have any genetic disorders (like G6PD deficiency) or blood problems (such as methemoglobinemia). You must also inform your doctor if you are pregnant or breastfeeding before this medicine is given to you as a precaution.

NUMBEX CREAM is not suitable for use in patients with problems in ear drum. The most common side effects of using NUMBEX CREAM are paleness, redness, swelling, mild burning sensation, itching or warmth at the treated area. Consult your doctor if it bothers you.

USES OF NUMBEX CREAM

Used as topical anesthesia prior to surgical and diagnostic procedures to:

• Cause temporary numbness of normal intact skin or genital mucous membrane
• Provide temporary relief from the symptoms of atopic dermatitis (such as skin rash, itching)

HOW NUMBEX CREAM WORKS

NUMBEX CREAM is a local anesthetic medication. When applied topically, it blocks the flow of certain ions (sodium ions) through the nerves that causes pain sensation. As a result, it limits the transfer of pain signals from the peripheral part of the body (i.e., face, hands, legs, abdomen, pelvis, genitals or where the medicine has been applied) to the brain which ultimately leads to loss of sensation.

DIRECTIONS FOR USE

NUMBEX CREAM should be used only under careful medical supervision. It is strictly for external use only. It will be applied to you only by a doctor or nurse at skin surfaces where loss of sensation is required.

Avoid accidental contact of this medicine with your eyes, nose, ears, mouth or anus and with damaged skin surfaces including minor cuts on the skin.

Your doctor will decide the correct dose for you depending upon your age, body weight, health condition and sites where numbness is required in the body.

SIDE EFFECTS OF NUMBEX CREAM

HOW TO MANAGE SIDE EFFECTS

Application Site Reactions

This side effect is usually temporary and disappears after few minutes of application. Additionally, you can also follow a few measures that can prevent your skin condition from worsening. This includes, avoiding hot showers or using irritant soaps or cosmetics (such as chemical peelings) on the treated skin surface. Do not use vaginal wash or other solutions if your genital areas are treated. Consult your doctor if this symptom is persistent for a prolonged period or worsens.

WARNING & PRECAUTIONS

PREGNANCY

Use with Caution

NUMBEX CREAM should be used with caution among pregnant women. Therefore, inform your doctor before application.

BREASTFEEDING

Use with Caution

NUMBEX CREAM should be used with caution among breastfeeding women. Therefore, inform your doctor before application.

DRIVING AND USING MACHINES

Safe

NUMBEX CREAM is unlikely to affect your ability for driving or handling heavy tools or machines.

ALLERGY

Contraindicated

Talk to your doctor before NUMBEX CREAM is applied onto your skin, if you are allergic to lignocaine, prilocaine or to any other local anesthetic agents (such as bupivacaine).

USE IN PEDIATRICS

Consult your doctor

NUMBEX CREAM can be used in children and adolescents (aged below 18 years) if prescribed by the physician. However, it should not be used on the genital areas of children aged below 12 years. Therefore, consult your doctor for advice before application.

USE IN GERIATRICS

Use with Caution

NUMBEX CREAM should be used with caution in the elderly patients. Therefore, consult your doctor for advice before application.

INTERACTIONS

A. Drug-Drug interactions:

Before NUMBEX CREAM is applied onto your skin, inform your doctor if you are taking any of the following medicines such as:

• medicines used to treat irregular heartbeat (such as digoxin, amiodarone procainamide)
• live vaccines (such as BCG, MMR)
• anti-epileptic agents (used to treat fits) Ex. phenytoin, sodium valproate, phenobarbital
• nitrofurantoin (a medicine used to treat urinary tract infections)
• sulphonamides (used to treat bacterial infections) such as sulfasalazine
• cimetidine (a medicine used to treat stomach ulcers)
• beta-blockers such as atenolol, propranolol, bisoprolol (used to treat high blood pressure)
• other local anesthetic agents (such as bupivacaine, proparacaine, ropivacaine, mepivacaine, procaine, tetracaine)

Overdosage:

NUMBEX CREAM will be applied to you only by a doctor or a nurse onto the skin. Therefore, it is unlikely to receive an overdose. However, if you experience any unusual side effects such as dizziness, blurred vision, tingling sensation around the mouth, numbness of tongue, abnormal taste or ringing in the ears, contact your doctor or visit the nearby hospital immediately.

SYNOPSIS

MORE INFORMATION

• Keep NUMBEX CREAM out of reach of children
• Store NUMBEX CREAM at room temperature

FAQs ABOUT NUMBEX CREAM

Q: Can NUMBEX CREAM be used on the face?

A: NUMBEX CREAM is used on the facial skin surface to cause temporary numbness prior to laser treatment/cosmetic surgeries (such as removal of skin tags, moles, scars, etc.).

Q: Can NUMBEX CREAM be used for cosmetic procedures?

A: NUMBEX CREAM is used for performing minor cosmetic procedures such as laser hair removal, microblading, micro-needling, lip/facial fillers, Botox filler, PRP injection etc.  It is also used to numb skin before tattooing.

Q: Is NUMBEX CREAM safe for use in pregnant women?

A: NUMBEX CREAM should be used with caution among pregnant women. Therefore, inform your doctor before application.

Q: How long will it take for NUMBEX CREAM to induce numbness?

A: It may take around 3-5 minutes for NUMBEX CREAM to create numbness. However, this period may vary from person-to-person based on the dose and amount of NUMBEX CREAM that is administered.

Q: How long does the effects of NUMBEX CREAM lasts long in the body?

A: The effects of NUMBEX CREAM may last between 15-30 minutes after application. However, the recovery period may vary from person-to-person based on the dose and amount of the NUMBEX CREAM applied.

Q: What is the use of NUMBEX CREAM?

A: NUMBEX CREAM is used to cause temporary numbness (loss of pain sensation) of the normal intact skin and genital mucosal membranes when applied topically. It is primarily used to abolish pain signals prior to surgical and diagnostic procedures on the skin and genital areas.

Q: How to use NUMBEX CREAM?

A: NUMBEX CREAM should be used only under careful medical supervision. It is strictly for external use only. It will be applied to you only by a doctor or nurse at skin surfaces where loss of sensation is required.

Q: Can NUMBEX CREAM be used in children?

A: NUMBEX CREAM can be used in children and adolescents (aged below 18 years) if prescribed by the physician. However, it should not be used on the genital areas of children aged below 12 years. Therefore, consult your doctor for advice before application.

Q: Can NUMBEX CREAM be used in infants?

A: NUMBEX CREAM can be used in newborns and infants (aged between 0-11 months) if prescribed by the doctor. It is not recommended for use in preterm infants. Therefore, consult your doctor for advice.

Q: What if I have accidental exposure of NUMBEX CREAM to the eye?

A: Use lukewarm water to gently wash the outer surface of the eye in case of accidental contact with NUMBEX CREAM. If the discomfort in the eye persists, contact your doctor, or visit a nearby hospital immediately.

Q: What are the side effects of NUMBEX CREAM?

A: The most common side effects of using NUMBEX CREAM are paleness, redness, swelling, mild burning sensation, itching or warmth at the treated area. Consult your doctor if it bothers you.

REFERENCES

1. KD. Tripathi. Local Anesthetics. Essentials of medical pharmacology. 7th Edition. 2013. Page – 366.

2. Adnan I. Qureshi, Muhammad A. Saleem, Nishath Naseem, Emrah Aytac, Cetin Kursad Akpinar, and Shawn S. Wallery. Effectiveness of Topical Lidocaine-Prilocaine Cream for Pain Control During Femoral Artery Catheterization in Adult Patients. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. June 2018. [Accessed on 14th December 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5999301/

3. Aspen Pharma Trading Limited. EMLA Cream 5%. Electronic Medicines Compendium (EMC). [Revised in February 2021]. [Accessed on 14th December 2022] https://www.medicines.org.uk/emc/files/pil.871.pdf

4. Astra Pharmaceuticals, L.P. EMLA Cream. U.S Food and Drug Administration. [Accessed on 14th December 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19941s11lbl.pdf

5. Aspen Pharmacare Canada Inc. Topical Anesthetic for Dermal Analgesia, Emla Cream. [Revised in August 2017] [Accessed on 14th December 2022] https://pdf.hres.ca/dpd_pm/00040608.PDF

6. Akorn pharmaceuticals. U.S. National Library of Medicine. lidocaine and prilocaine cream. [Revised in March 2022] [Accessed on 14th December 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=9378d186-5b25-49bc-8563-a659fa1194c2&type=display

7. Aspen Pharma UK Limited. Emla Cream. [Accessed on 14th December 2022] https://www.emla.co.uk/

8. Central Drugs Standard Control Organization. Lidocaine 2%+Prilocaine 2.5% w/w cream. May 1999. [Accessed on 14th December 2022] https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadApprovalNewDrugs/dciApprovedfdc.pdf

AUTHOR DETAILS

Written By Srilekha. R, B.Pharm
Last updated on 16 Mar 2023 | 03:37 PM(IST)