Neo-Synalar 0.35-0.025% Cream 60gm
It is used to treat certain skin problems when a skin infection is present.
Drug Class
Topical corticosteroid with anti-infective
Pharmacologic Class
Corticosteroid; Aminoglycoside antibiotic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Neo-Synalar Cream is a medicine applied to the skin. It contains two active ingredients: a steroid (fluocinolone) that helps reduce redness, swelling, and itching, and an antibiotic (neomycin) that helps treat bacterial skin infections. It's used for skin conditions like eczema or dermatitis that are also infected with bacteria.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this may increase the amount of medication absorbed into the body.
Hygiene and Application Tips
Wash your hands before and after applying the medication. However, if your hand is the treated area, do not wash it after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Continuing Treatment
Continue using the medication as directed, even if your symptoms improve.
Storage and Disposal
Store the medication at room temperature, away from heat sources, and do not freeze.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this may increase the amount of medication absorbed into the body.
Hygiene and Application Tips
Wash your hands before and after applying the medication. However, if your hand is the treated area, do not wash it after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Continuing Treatment
Continue using the medication as directed, even if your symptoms improve.
Storage and Disposal
Store the medication at room temperature, away from heat sources, and do not freeze.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Wash your hands before and after applying the cream.
- Apply a thin layer of cream only to the affected skin area.
- Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use this cream for longer than prescribed, especially on the face, groin, or armpits, or in children, due to increased risk of side effects.
- Do not use on large areas of the body or on broken skin unless directed by a doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected skin area two to four times daily.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
generalUse:
Apply thinly to affected area.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to increased systemic absorption risk)
Infant:
Not established (use with extreme caution due to increased systemic absorption risk)
Child:
Apply a thin film to the affected skin area two to four times daily. Limit duration of therapy and amount used due to increased risk of systemic absorption and adrenal suppression.
Adolescent:
Apply a thin film to the affected skin area two to four times daily.
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.
Dialysis:
No specific adjustment needed for topical 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.
Confidence:
Medium
Pharmacology
Mechanism of Action
Fluocinolone acetonide is a corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. It is thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Neomycin sulfate is an aminoglycoside antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, leading to misreading of the mRNA and premature termination of protein synthesis. It is bactericidal.
Pharmacokinetics
Absorption:
Bioavailability:
Limited systemic absorption (topical)
Tmax:
Not applicable (topical)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not well-defined (topical)
ProteinBinding:
Not well-defined (topical)
CnssPenetration:
Limited (topical)
Elimination:
HalfLife:
Not well-defined (topical)
Clearance:
Not well-defined (topical)
ExcretionRoute:
Fluocinolone: Renal (metabolites); Neomycin: Renal (unchanged, if absorbed)
Unchanged:
Not well-defined (topical)
Pharmacodynamics
OnsetOfAction:
Within hours to days (local effect)
PeakEffect:
Within days (local effect)
DurationOfAction:
Varies with application frequency (local effect)
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 signs or symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Irritation where the medication was applied
Changes in hearing
Difficulty urinating or changes in urine output
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
* Dry skin
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 signs or symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Irritation where the medication was applied
Changes in hearing
Difficulty urinating or changes in urine output
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
* Dry skin
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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:
- Skin irritation, burning, itching, or redness that worsens after applying the cream.
- Signs of a new infection (e.g., pus, fever, spreading redness).
- Skin thinning, easy bruising, stretch marks (striae), or changes in skin color.
- Allergic reaction symptoms: rash, hives, swelling of the face/lips/tongue, difficulty breathing (seek immediate medical attention).
- Unusual weight gain, swelling in the face or body, increased thirst or urination, or muscle weakness (rare signs of systemic steroid absorption).
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 to this medication, its components, or other substances, including foods and drugs. Be sure to describe the allergic reaction and its symptoms.
If a large area of your body needs to be treated with this medication.
If you are using this medication in your ear and have a ruptured eardrum. Do not use this medication in your ear if you have a ruptured eardrum.
This medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your health problems, including any pre-existing conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication with all your other drugs and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Be sure to describe the allergic reaction and its symptoms.
If a large area of your body needs to be treated with this medication.
If you are using this medication in your ear and have a ruptured eardrum. Do not use this medication in your ear if you have a ruptured eardrum.
This medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your health problems, including any pre-existing conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication with all your other drugs and health conditions.
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. Avoid applying this drug to cuts, scrapes, or damaged skin. Do not use this medication for a longer period than prescribed by your doctor.
When using this medication in children, exercise caution, as the risk of certain side effects may be increased in this population. In some cases, this drug may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, notify your doctor. You and your doctor will need to weigh the benefits and risks of using this medication to ensure the best outcome for both you and your baby.
When using this medication in children, exercise caution, as the risk of certain side effects may be increased in this population. In some cases, this drug may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, notify your doctor. You and your doctor will need to weigh the benefits and risks of using this medication to ensure the best outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use, especially on large areas or under occlusion, can lead to systemic absorption of the corticosteroid, potentially causing Cushing's syndrome, hyperglycemia, and glucosuria.
- Systemic absorption of neomycin is rare but could lead to ototoxicity (hearing loss, dizziness) or nephrotoxicity (kidney damage) in susceptible individuals or with very high doses/prolonged use on compromised skin.
What to Do:
If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (type of lesion, extent, signs of infection)
Rationale: To assess the severity of the dermatosis and presence of bacterial infection, and to establish a baseline for treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of infection and inflammation
Frequency: Daily to weekly, as clinically indicated
Target: Improvement in redness, swelling, itching, and signs of bacterial infection (e.g., pus, crusting)
Action Threshold: Lack of improvement or worsening of symptoms after 7 days may indicate treatment failure, resistant organism, or allergic reaction.
Local skin reactions (e.g., atrophy, striae, burning, itching, irritation)
Frequency: At each follow-up visit
Target: Absence of adverse skin changes
Action Threshold: Development of significant local adverse effects warrants discontinuation or change in therapy.
Signs of systemic corticosteroid absorption (rare with appropriate topical use)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings
Target: Absence of Cushing's syndrome symptoms, adrenal suppression
Action Threshold: Any signs of systemic absorption (e.g., weight gain, moon face, fatigue) require immediate medical evaluation.
Symptom Monitoring
- Worsening of skin rash or infection
- Increased redness, swelling, pain, or pus at the application site
- Development of new skin lesions or changes in skin texture (thinning, bruising, striae)
- Severe itching or burning sensation
- Signs of allergic reaction (e.g., widespread rash, hives, difficulty breathing)
- Unusual fatigue, weakness, weight gain, or changes in mood (signs of systemic absorption)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical corticosteroids have shown teratogenic effects in animal studies. Systemic absorption is generally low, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption is low.
Second Trimester:
Generally considered safer than first trimester, but still use with caution.
Third Trimester:
No specific increased risk, but continued caution regarding systemic absorption.
Lactation
Use with caution. It is not known whether topically administered corticosteroids or neomycin are excreted in human milk. Systemic absorption is generally low. If used, avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with appropriate topical use, but monitor for potential adverse effects.
Pediatric Use
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects (e.g., hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, intracranial hypertension, growth retardation) than adult patients. Use the smallest effective amount for the shortest duration possible. Avoid use on large surface areas or under occlusive dressings.
Geriatric Use
No specific dosage adjustments are typically required. However, elderly patients may have thinner skin, which could potentially increase the risk of local adverse effects (e.g., skin atrophy) or systemic absorption. Monitor for skin integrity and adverse reactions.
Clinical Information
Clinical Pearls
- Neo-Synalar is for external use only. Do not ingest.
- Avoid prolonged use, especially on the face, groin, or axillae, or in children, due to increased risk of skin atrophy and systemic effects.
- Discontinue use if irritation or sensitization develops. Neomycin is a known contact sensitizer.
- Do not use for viral (e.g., herpes, varicella) or fungal skin infections, as corticosteroids can worsen these conditions.
- If no improvement is seen after 7 days, re-evaluate the diagnosis and treatment plan.
Alternative Therapies
- Topical corticosteroids alone (e.g., fluocinolone acetonide cream) for inflammation without infection.
- Topical antibiotics alone (e.g., mupirocin, fusidic acid) for bacterial skin infections without significant inflammation.
- Oral antibiotics for more severe or widespread bacterial infections.
- Other anti-inflammatory agents for dermatoses (e.g., calcineurin inhibitors).
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic versions)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.