Lidocaine 3%/hc 0.5% Cream 28.3gm
It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Anorectal agent, local anesthetic, corticosteroid
Pharmacologic Class
Amide local anesthetic; Topical corticosteroid (low potency)
Pregnancy Category
Category C
FDA Approved
Sep 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
This cream contains two medicines: Lidocaine, which is a numbing medicine to relieve pain and itching, and Hydrocortisone, which is a steroid to reduce swelling and inflammation. It's used to treat discomfort from conditions like hemorrhoids or anal fissures.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. This medication is designed for rectal use only and should not be taken orally. Avoid getting the medication in your eyes or nose, as it may cause burning. Wash your hands thoroughly before and after using the medication. Unless directed by your doctor, do not apply the medication to cuts, scrapes, or damaged skin.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding freezing. Keep all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush medications down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
Managing Missed Doses
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. This medication is designed for rectal use only and should not be taken orally. Avoid getting the medication in your eyes or nose, as it may cause burning. Wash your hands thoroughly before and after using the medication. Unless directed by your doctor, do not apply the medication to cuts, scrapes, or damaged skin.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding freezing. Keep all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush medications down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
Managing Missed Doses
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Maintain good hygiene in the affected area.
- Avoid straining during bowel movements; consider a high-fiber diet and adequate fluid intake to prevent constipation.
- Avoid prolonged sitting or standing.
- Do not use for longer than prescribed without consulting your doctor, especially for hydrocortisone component.
Available Forms & Alternatives
Available Strengths:
- Lidocaine 4% Top Soln 50ml
- Lidocaine 2% Visc Oral Solution
- Lidocaine 1% Inj, 10ml
- Lidocaine 2% Inj, 2ml
- Lidocaine 4% Injection, 5ml
- Lidocaine 1% Inj, 5ml
- Lidocaine 1% Inj, 20ml
- Lidocaine 2% Inj, 20ml
- Lidocaine 1% Inj, 2ml
- Lidocaine 1% Inj, 50ml
- Lidocaine 2% Inj, 5ml
- Lidocaine 2% Inj, 10ml
- Lidocaine 1% Inj, 30ml
- Lidocaine 2% Inj, 50ml
- Lidocaine 2% Inj, 5ml
- Lidocaine 10mg/ml Inj, 5ml
- Lidocaine 3% Cream 28.35gm
- Lidocaine 3% Cream 85gm
- Lidocaine 2% Topical Jelly 5ml
- Lidocaine 2% Topical Jelly 10ml
- Lidocaine 2% Topical Jelly 20ml
- Lidocaine 20mg/ml Inj, 5ml
- Lidocaine 2% Jelly Gel (uro-Jet)5ml
- Lidocaine 0.5% Inj, 50ml
- Lidocaine 5% Patch
- Lidocaine 5% Topical Ointment 30gm
- Lidocaine 5% Topical Oint 35.44gm
- Lidocaine 5% Topical Ointment 50gm
- Lidocaine 1.5% Inj, 1 Ampule
- Lidocaine 5% Top/oral Oint 50gm
- Lidocaine 4% Cream 15gm
- Lidocaine 4% Cream 30gm
- Lidocaine 4% Cream 5gm
- Lidocaine 3% Cream 85gm
- Lidocaine Pain Relief 4% Patch
- Lidocaine 5% Top/oral Oint (sprmt)
- Lidocaine 5% Anorectal Cream
- Lidocaine 4% Cream 15gm
- Lidocaine 5% Topical Ointment 30gm
- Lidocaine 5% Anorectal Cream 15gm
- Lidocaine Pain Relief 4% Patch
- Lidocaine 5% Cream 30gm
- Lidocaine 2% Inj 25ml
- Lidocaine 5% Ointment 50gm
- Lidocaine 4% Cream 15gm
- Lidocaine 4% Topical Pain Patch
- Lidocaine 3%/hc 0.5% Cream 28.3gm
- Lidocaine 2% Topical Jelly 30ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected area 3 to 4 times daily, or as directed by a physician.
Condition-Specific Dosing:
anorectalDisorders:
Apply externally to the perianal area and/or apply internally using an applicator, 3 to 4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with extreme caution due to risk of systemic absorption and adrenal suppression)
Child:
Not established (use with extreme caution due to risk of systemic absorption and adrenal suppression)
Adolescent:
Not established (consult physician; generally, adult dosing may be considered with caution)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use; however, monitor for systemic effects if extensive use or impaired skin barrier.
Dialysis:
No specific adjustment needed for topical use; monitor for systemic effects if extensive use.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use; however, monitor for systemic effects (especially lidocaine toxicity) if extensive use or impaired skin barrier, as lidocaine is metabolized by the liver.
Confidence:
Medium
Pharmacology
Mechanism of Action
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Hydrocortisone is a corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It induces phospholipase A2 inhibitory proteins, thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
Pharmacokinetics
Absorption:
Bioavailability:
Low (topical); Systemic absorption varies with skin integrity, area of application, duration of exposure, and occlusion. For lidocaine, up to 36% can be absorbed from intact skin, higher from mucous membranes or denuded skin. For hydrocortisone, systemic absorption is generally low but can increase with extensive use or damaged skin.
Tmax:
Variable (topical); For lidocaine, systemic peak concentrations typically occur within 1-4 hours after topical application.
FoodEffect:
Not applicable (topical formulation)
Distribution:
Vd:
Not applicable for topical use; for systemic lidocaine, approximately 0.7-2.7 L/kg.
ProteinBinding:
Lidocaine: 60-80% (primarily to alpha-1-acid glycoprotein); Hydrocortisone: ~90% (to corticosteroid-binding globulin and albumin).
CnssPenetration:
Limited (for topical application; significant systemic absorption could lead to CNS effects for lidocaine).
Elimination:
HalfLife:
Lidocaine: Approximately 1.5-2 hours (systemic); Hydrocortisone: Approximately 1.5-2 hours (systemic, but biological half-life is longer).
Clearance:
Not applicable for topical use; for systemic lidocaine, approximately 10-20 mL/min/kg.
ExcretionRoute:
Renal (primarily as metabolites for both lidocaine and hydrocortisone)
Unchanged:
Lidocaine: Less than 10% (systemic); Hydrocortisone: Less than 10% (systemic)
Pharmacodynamics
OnsetOfAction:
Lidocaine: Rapid (within 3-5 minutes for local anesthetic effect); Hydrocortisone: Variable (anti-inflammatory effects may take hours to days).
PeakEffect:
Lidocaine: Variable, depends on absorption; Hydrocortisone: Variable.
DurationOfAction:
Lidocaine: 30-60 minutes (local anesthetic effect); Hydrocortisone: Several hours to days (anti-inflammatory effect).
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of methemoglobinemia: blue or gray discoloration of the lips, nails, or skin, irregular heartbeat, seizures, severe dizziness or fainting, severe headache, excessive sleepiness, fatigue, or shortness of breath. This rare condition can be life-threatening if left untreated.
Signs of skin infection: oozing, heat, swelling, redness, or pain.
Irritation at the site of application.
Severe rectal bleeding or rectal pain.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging sensations.
Redness.
* Changes in skin color.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of methemoglobinemia: blue or gray discoloration of the lips, nails, or skin, irregular heartbeat, seizures, severe dizziness or fainting, severe headache, excessive sleepiness, fatigue, or shortness of breath. This rare condition can be life-threatening if left untreated.
Signs of skin infection: oozing, heat, swelling, redness, or pain.
Irritation at the site of application.
Severe rectal bleeding or rectal pain.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging sensations.
Redness.
* Changes in skin color.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or irritation at the application site.
- Rash, hives, or signs of an allergic reaction (swelling of face/tongue, difficulty breathing).
- Signs of infection (pus, fever, worsening pain).
- Dizziness, drowsiness, confusion, or unusual tiredness.
- Blurred vision or ringing in the ears.
- Numbness or tingling around the mouth.
- Tremors or muscle twitching.
- Slow or irregular heartbeat.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Fungal infections of the skin
+ Tuberculosis (TB) infections of the skin
+ Viral infections of the skin
* If you currently have a cold sore or are experiencing a genital herpes outbreak
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Fungal infections of the skin
+ Tuberculosis (TB) infections of the skin
+ Viral infections of the skin
* If you currently have a cold sore or are experiencing a genital herpes outbreak
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using any other medications or products on your skin, such as soaps, consult with your doctor to ensure safe use.
While using this medication, avoid scratching or rubbing the treated skin area, as it may be numb. Additionally, protect the area from extreme temperatures, avoiding exposure to very hot or very cold conditions.
Do not exceed the recommended duration of use for this medication, as prescribed by your doctor. In the event of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center, as this medication can be harmful if swallowed.
There is a risk of developing a severe blood disorder called methemoglobinemia associated with this type of medication. This risk may be increased in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, pre-existing heart or lung problems, or when taking certain other medications. Infants under 6 months of age may also be at a higher risk. If you have a history of methemoglobinemia, inform your doctor.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. Similarly, if you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
While using this medication, avoid scratching or rubbing the treated skin area, as it may be numb. Additionally, protect the area from extreme temperatures, avoiding exposure to very hot or very cold conditions.
Do not exceed the recommended duration of use for this medication, as prescribed by your doctor. In the event of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center, as this medication can be harmful if swallowed.
There is a risk of developing a severe blood disorder called methemoglobinemia associated with this type of medication. This risk may be increased in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, pre-existing heart or lung problems, or when taking certain other medications. Infants under 6 months of age may also be at a higher risk. If you have a history of methemoglobinemia, inform your doctor.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. Similarly, if you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe dizziness or lightheadedness
- Nausea, vomiting
- Tremors, muscle twitching, seizures
- Difficulty breathing
- Slow or irregular heartbeat
- Low blood pressure
- Coma
What to Do:
Immediately wash off the cream with soap and water. Seek emergency medical attention or call Poison Control at 1-800-222-1222. Management is supportive, focusing on maintaining airway, breathing, and circulation, and controlling seizures if present.
Drug Interactions
Moderate Interactions
- Antiarrhythmics (Class I antiarrhythmics like tocainide, mexiletine): Increased risk of additive cardiac effects if significant systemic lidocaine absorption occurs.
- Beta-blockers (e.g., propranolol): May reduce lidocaine clearance, increasing systemic levels if significant absorption occurs.
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): May increase systemic levels of hydrocortisone if significant absorption occurs, leading to potential for systemic corticosteroid effects.
- Other local anesthetics: Increased risk of systemic toxicity if used concurrently with other lidocaine-containing products or other local anesthetics.
Monitoring
Baseline Monitoring
Assessment of affected area (e.g., hemorrhoids, anal fissures)
Rationale: To establish baseline severity and identify any contraindications (e.g., infection, open wounds).
Timing: Prior to initiation of therapy.
Patient history (allergies, cardiac conditions, liver disease)
Rationale: To identify potential risks for systemic toxicity or hypersensitivity reactions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom improvement (pain, itching, inflammation)
Frequency: Daily during treatment
Target: Reduction in severity of symptoms
Action Threshold: Lack of improvement after 7 days, or worsening symptoms, warrants re-evaluation by physician.
Local adverse reactions (e.g., irritation, burning, rash, atrophy)
Frequency: Daily during treatment
Target: Absence or mild, transient reactions
Action Threshold: Persistent or severe local reactions, or signs of allergic contact dermatitis, require discontinuation.
Signs of systemic toxicity (CNS: dizziness, drowsiness, confusion, seizures; CV: bradycardia, hypotension; Adrenal suppression: fatigue, weight loss)
Frequency: Periodically, especially with extensive or prolonged use, or use on broken skin.
Target: Absence of systemic signs/symptoms
Action Threshold: Any signs of systemic toxicity require immediate medical attention and discontinuation.
Symptom Monitoring
- Worsening of pain or itching
- Increased redness or swelling
- Development of rash or hives
- Unusual burning or stinging at application site
- Signs of infection (pus, fever)
- Dizziness, lightheadedness, drowsiness
- Blurred vision, ringing in ears
- Numbness or tingling around the mouth
- Tremors or muscle twitching
- Slow or irregular heartbeat
- Unusual fatigue or weakness
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lidocaine is Pregnancy Category B, but topical corticosteroids are generally Category C. Systemic absorption is low with proper topical use, but extensive use or use on broken skin could increase risk.
Trimester-Specific Risks:
First Trimester:
Avoid if possible, or use with caution, due to general concerns with drug exposure during organogenesis.
Second Trimester:
Use with caution; monitor for systemic effects if extensive use.
Third Trimester:
Use with caution; monitor for systemic effects. Prolonged or extensive use of corticosteroids near term may theoretically affect fetal adrenal development.
Lactation
Use with caution. Lidocaine is excreted in breast milk in small amounts; hydrocortisone is also excreted in breast milk. The amount absorbed systemically from topical application is generally low, making infant exposure minimal. However, avoid applying to areas where the infant may ingest the cream.
Infant Risk:
Low risk with proper, limited topical use. Monitor infant for unusual drowsiness or feeding difficulties (for lidocaine) or signs of adrenal suppression (for hydrocortisone), though unlikely.
Pediatric Use
Not recommended for routine use in children, especially infants, without specific medical guidance. Children have a larger skin surface area to body weight ratio and less developed skin barrier, increasing the risk of systemic absorption of both lidocaine (leading to CNS/cardiac toxicity) and hydrocortisone (leading to adrenal suppression, growth retardation). Use lowest effective dose for shortest duration if absolutely necessary.
Geriatric Use
No specific dose adjustments are typically needed. However, elderly patients may have thinner skin, which could increase systemic absorption. Monitor for systemic adverse effects, especially if extensive or prolonged use. Use with caution in patients with pre-existing cardiac or hepatic conditions.
Clinical Information
Clinical Pearls
- Advise patients to apply a thin layer and rub in gently, avoiding excessive application.
- Emphasize that this product is for external or anorectal use only and should not be ingested.
- Instruct patients to wash hands thoroughly before and after application.
- Caution against using occlusive dressings or tight clothing over the treated area, as this can increase systemic absorption.
- If symptoms do not improve within 7 days or worsen, advise patients to consult their physician.
- Prolonged use of topical corticosteroids can lead to skin atrophy, striae, or telangiectasias; limit duration of use as directed by physician.
Alternative Therapies
- Topical anesthetics (e.g., benzocaine, pramoxine)
- Topical corticosteroids (e.g., hydrocortisone cream 1%)
- Astringents (e.g., witch hazel pads)
- Protectants (e.g., zinc oxide, petrolatum)
- Sitz baths
- Dietary modifications (fiber supplements, stool softeners)
Cost & Coverage
Average Cost:
$50 - $200+ per 28.3gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may vary by plan and specific brand/generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.