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Apicaine-X

Generic Name: lidocaine
Dosage Form: ointment

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENTS

Lidocaine 5%

INDICATION AND USAGE

Apicaine-X is a topical anesthetic ointment contains 5% lidocaine used for
temporary relief of minor aches and pains associated with arthritis,
simple backache, strain, muscle soreness, stiffness,
rectal itch or ulcers (anal fissures, piles),
numbing gums in dentistry and
the relief of sore nipples in nursing mothers

It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.

It can be applied topically for production of anesthesia of accessible mucous membranes of the oropharynx.

WARNINGS:

For topical use only.

Excessive dosage, or short intervals between doses, can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines.

Lidocaine Ointment 5% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.

When using this product,
• Avoid contact with eyes
• Do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor or pharmacist if,
• Allergic reaction occurs
• Redness, irritation, swelling, pain or other symptoms begin or increase
• Taking other medicines - cimetidine for stomach problems, propranolol for high blood pressure, anxiety or heart problems.

Keep out of reach of children,
If swallowed, get medical help or contact a Poison Control Center right away

Pregnancy and breast-feeding,
If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking any medicine.

Driving and using machines,
Lidocaine Ointment may cause drowsiness if it enters your blood stream. If affected, DO NOT drive or operate machinery.

PRECAUTIONS:

Lidocaine Ointment 5% should be used with caution in patients with known drug sensitivities.

When topical anesthetics are used in the mouth, the patient should be aware that the production of topical anaesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not be ingested for 60 minutes following the use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating.

Numbness of the tongue or buccal mucosa may enhance the danger of unintentional biting trauma. Food and chewing gum should not be taken while the mouth or throat area is anesthetized.

The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug and/or its metabolites.

Lidocaine should also be used with caution in patients with severe shock or heart block.

Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful outcome 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).

ADVERSE REACTIONS:

To report SUSPECTED ADVERSE REACTIONS, contact Medicap Laboratories LLC. at 1-800-494-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Adverse effects are very rare and dose-related, mostly result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.

The following types are those most commonly reported:
Central nervous system - CNS manifestations are excitatory and/or depressant and may be characterized by light-headedness, drowsiness, nervousness, apprehension, euphoria, confusion, dizziness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest.

Drowsiness is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.

An allergic reaction may occur (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives). This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

DOSAGE AND ADMINISTRATION:

Always use Apicaine-X Ointment exactly as prescribed by your doctor. Otherwise, follow the instructions below. If you are not sure how to use this medicine, talk to your doctor or pharmacist.

Directions:
Clean area with mild soap and warm water. Rinse and dry thoroughly.
Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day.
Children under 12 years of age: Consult a doctor.

Adult Dose:
A single application should not exceed 5 g of Lidocaine Ointment 5%, containing 250 mg of lidocaine base (equivalent chemically to approximately 300 mg of lidocaine hydrochloride).
In a 70 kg adult this dose equals 3.6 mg/kg (1.6 mg/lb) loidocaine base. No more than one-third of a jar, approximately 17-20 g of ointment or 850-1000 mg lidocaine base should be administered in any one day.

Dosage for children:
The maximum dose for children may be determined by the application of one of the standard pediatric drug formulas (e.g. Clark's rule). For example a child of five years weighing 50 lbs., the dose of lidocaine should not exceed 75-100 mg when calculated according to Clark's rule.
In any case, the maximum amount of lidocaine administered should not exceed 4.5 mg/kg (2 mg/lb) of body weight. No more than 3 doses should be administered within 24 hours.

Administration:
• In dentistry, apply to previously dried oral mucosa. Subsequent removal of excess saliva with cotton rolls or saliva ejector minimizes dilution of the ointment, permits maximum penetration, and minimizes the possibility of swallowing the topical ointment.
For use in connection with the insertion of new dentures, apply to all denture surfaces contacting mucosa.
Nursing mothers
Apply to the nipples using a small piece of lint or gauze, wash off immediately before the next feed

HOW SUPPLIED:

Lidocaine Ointment, 5% is available in 50 g (1.76 oz) Jar.

STORAGE AND HANDLING:

Store at controlled room temperature 20° - 25° C (68° - 77° F).
Do not permit to freeze.

QUESTIONS?

Call us at 1-800-494-7449

PRINCIPAL DISPLAY PANEL

Apicaine-X 
polyethylene glycol 400, polyethylene glycol 3350, propylene glycol, glycerin, menthol ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69589-006
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 0.05 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400  
POLYETHYLENE GLYCOL 3350  
PROPYLENE GLYCOL  
GLYCERIN  
MENTHOL  
Packaging
# Item Code Package Description
1 NDC:69589-006-05 50 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/12/2015
Labeler - Medicap laboratories Inc. (078798864)
Establishment
Name Address ID/FEI Operations
Medicap laboratories Inc. 078798864 wholesale drug distributor(69589-006)
Revised: 12/2015
 
Medicap laboratories Inc.



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