Apicaine-X

Name: Apicaine-X

Active ingredients

Lidocaine 5%

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.

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.

Questions?

Call us at 1-800-494-7449

For the Consumer

Applies to lidocaine topical: topical application aerosol liquid, topical application cream, topical application dressing, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment, topical application pad, topical application patch extended release, topical application powder, topical application solution, topical application spray

Along with its needed effects, lidocaine topical (the active ingredient contained in Apicaine-X) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lidocaine topical:

Rare
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • cough
  • cracked, dry, or scaly skin
  • fast heartbeat
  • fever
  • hives or welts, itching, or skin rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
Incidence not known
  • Blistering, bruising, burning, discoloration, itching, redness, or swelling at the application site
  • blurred vision
  • chest pain or discomfort
  • cold, clammy, or pale skin
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness or dizziness
  • false or unusual sense of well-being
  • fear or nervousness
  • irregular, fast or slow, or shallow breathing
  • lethargy
  • no blood pressure or pulse
  • pale or blue lips, fingernails, or skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • shakiness in the legs, arms, hands, or feet
  • slow heart rate
  • slow or irregular heartbeat
  • stopping of heart
  • trembling or shaking of the hands or feet
  • twitching
  • unconsciousness
  • unusual tiredness or weakness
  • weakness

Some side effects of lidocaine topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Bad, unusual, or unpleasant (after) taste
  • change in taste
  • cold or numbness
  • confusion about identity, place, and time
  • continuing ringing or buzzing or other unexplained noise in the ears
  • double vision
  • headache
  • hearing loss
  • heat sensation
  • lack or loss of strength
  • metallic taste
  • sleepiness or unusual drowsiness

For Healthcare Professionals

Applies to lidocaine topical: intradermal device, mucous membrane solution, mucous membrane spray, topical cream, topical film, topical gel, topical gel with applicator, topical kit, topical liquid, topical lotion, topical ointment, topical solution, topical spray, topical stick

General

The most common adverse events were administration site reactions: burning, dermatitis, erythema, pruritus, rash, skin irritation, and vesicles.[Ref]

Dermatologic

Very common (10% or more): Erythema (up to 67.3%), petechiae (up to 46.4%)
Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Skin lesion, skin injury
Frequency not reported: Flushing, cutaneous lesions, urticaria, dermatitis[Ref]

Local

Very common (10% or more): Administration site reactions
Common (1% to 10%): Irritation, redness, itching, application site erythema, application site burning, application site pain, application site pruritus, edema
Uncommon (0.1% to 1%): Venipuncture site hemorrhage, burning sensation
Frequency not reported: Locus of abnormal sensation, paleness (pallor or blanching), alteration in temperature sensation, blisters, bruising, depigmentation, dermatitis, discoloration, exfoliation, papules, petechiae, vesicles, application site dermatitis, application site vesicles, skin irritation[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness
Frequency not reported: Lightheadedness, nervousness, apprehension, euphoria, confusion, drowsiness, tinnitus, nystagmus, headache, nausea, vomiting, sensations of heat, cold or numbness, twitching, tremors, paraesthesia, convulsions, unconsciousness, respiratory depression and arrest, pain and/or dysesthesia in the buttocks or legs, unconsciousness
Postmarketing reports: Headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, somnolence, taste alteration[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting[Ref]

Immunologic

Common (1% to 10%): Nasopharyngitis[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reaction, hypersensitivity
Frequency not reported: Anaphylactoid reactions, anaphylactic shock, angioedema, bronchospasm, shock, dyspnea, laryngospasm[Ref]

Cardiovascular

Frequency not reported: Bradycardia, hypotension, arrhythmia, cardiovascular collapse, cardiac arrest, AV block, myocardial depression[Ref]

Hematologic

Frequency not reported: Methemoglobinemia[Ref]

Ocular

Frequency not reported: Corneal irritation, blurred or double vision
Postmarketing reports: Visual disturbances[Ref]

Respiratory

Rare (less than 0.1%): Endotracheal tube occlusion
Frequency not reported: Sore throat, hoarseness, loss of voice[Ref]

Psychiatric

Frequency not reported: Confusion, psychosis, disorientation, dizziness[Ref]

Other

Postmarketing reports: Open wound, asthenia, pain exacerbated[Ref]

Some side effects of Apicaine-X may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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