Venelex Ointment 56.7gm

Manufacturer STRATUS Active Ingredient Balsam Peru and Castor Oil(BAL sam pe RUE & KAS tor oyl) Pronunciation BAL-sam peh-ROO and KAS-tor oyl
It is used to promote healing of skin ulcers and wounds.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Wound healing agent; Skin protectant
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Pharmacologic Class
Emollient; Skin protectant; Mild stimulant; Mild antiseptic
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Pregnancy Category
Not formally assigned; generally considered low risk for topical use.
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This ointment contains natural ingredients, Balsam Peru and Castor Oil, that work together to help wounds heal. Castor oil keeps the wound moist and protected, while Balsam Peru helps new skin grow. It's used for various skin conditions and wounds, including pressure sores, surgical wounds, and burns.
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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 as directed.

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.
Before applying the medication, clean the affected area and dry it thoroughly.
Apply a thin layer of the medication to the affected skin.
Wash your hands before and after applying the medication, unless your hand is the area being treated. If your hand is the treated area, do not wash it after application.
You may need to cover the treated area with a bandage or dressing; consult with your doctor for guidance.

Storage and Disposal

To store this medication properly:
Keep it at room temperature.
Do not freeze the medication.
Protect it from heat sources.
Store it in a dry place, avoiding bathrooms.

Missing a Dose

If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Keep the wound clean and dry before applying the ointment.
  • Wash hands thoroughly before and after applying the ointment.
  • Avoid getting the ointment in eyes or on mucous membranes.
  • Do not use on deep or puncture wounds, animal bites, or serious burns without consulting a doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected area 1 to 3 times daily.
Dose Range: 1 - 3 mg

Condition-Specific Dosing:

wound_care: Cleanse the affected area thoroughly before application. Apply a thin layer directly to the wound or to a dressing.
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Pediatric Dosing

Neonatal: Not established, consult pediatrician.
Infant: Apply a thin layer to the affected area 1 to 3 times daily, or as directed by a healthcare professional. Commonly used for diaper rash.
Child: Apply a thin layer to the affected area 1 to 3 times daily.
Adolescent: Apply a thin layer to the affected area 1 to 3 times daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (topical application, minimal systemic absorption).
Moderate: No adjustment needed (topical application, minimal systemic absorption).
Severe: No adjustment needed (topical application, minimal systemic absorption).
Dialysis: No specific considerations (topical application, minimal systemic absorption).

Hepatic Impairment:

Mild: No adjustment needed (topical application, minimal systemic absorption).
Moderate: No adjustment needed (topical application, minimal systemic absorption).
Severe: No adjustment needed (topical application, minimal systemic absorption).

Pharmacology

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Mechanism of Action

Castor Oil acts as an emollient and skin protectant, forming a protective barrier that helps maintain a moist wound environment conducive to healing. It promotes granulation tissue formation and epithelialization. Balsam Peru is believed to stimulate capillary growth, promote fibroblast proliferation, and possess mild antiseptic and anti-inflammatory properties, aiding in tissue regeneration and wound closure.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption
Tmax: Not applicable (topical)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (topical)
ProteinBinding: Not applicable (topical)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (topical)
Clearance: Not applicable (topical)
ExcretionRoute: Not applicable (topical)
Unchanged: Not applicable (topical)
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Pharmacodynamics

OnsetOfAction: Gradual, as part of the wound healing process (effects observed over days to weeks)
PeakEffect: Not quantifiable in terms of a single peak effect; continuous with application and wound healing progression.
DurationOfAction: Continuous with regular application; effects persist as long as the wound healing process continues.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:

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
Severe skin irritation

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 that bother you or do not go away, contact your doctor:

* Stinging

Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Increased redness, swelling, or pain around the wound
  • Pus or foul-smelling discharge from the wound
  • Fever or chills
  • Rash, itching, or severe irritation at the application site (signs of allergic reaction)
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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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor promptly. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Topical overdose is unlikely to cause systemic effects due to minimal absorption.
  • Excessive application may lead to maceration of skin or increased local irritation.

What to Do:

If swallowed, call a Poison Control Center immediately (1-800-222-1222). For excessive topical application, gently wipe off excess ointment. If severe local irritation occurs, discontinue use and wash the area with mild soap and water. Seek medical attention if symptoms persist or worsen.

Drug Interactions

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Contraindicated Interactions

  • Known hypersensitivity to Balsam Peru, Castor Oil, or any other component of the formulation.
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Minor Interactions

  • Other topical preparations: Concurrent use with other topical medications on the same area may alter absorption or efficacy, or increase local irritation. Separate application times if possible.

Monitoring

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Baseline Monitoring

Wound assessment (size, depth, exudate, presence of necrotic tissue)

Rationale: To establish a baseline for evaluating healing progress and identify any contraindications or need for debridement.

Timing: Prior to first application

Skin integrity around the wound

Rationale: To assess for pre-existing irritation or infection.

Timing: Prior to first application

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Routine Monitoring

Wound healing progress (reduction in size, healthy granulation tissue, epithelialization)

Frequency: Daily to weekly, depending on wound severity

Target: Progressive improvement

Action Threshold: Lack of improvement, worsening of wound, or signs of infection (redness, swelling, increased pain, purulent discharge)

Signs of local irritation or allergic reaction (redness, itching, rash, swelling)

Frequency: With each dressing change/application

Target: Absence of irritation

Action Threshold: Presence of irritation or allergic reaction; discontinue use and consult healthcare provider.

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Symptom Monitoring

  • Increased pain at wound site
  • Increased redness or warmth around the wound
  • Swelling around the wound
  • Fever or chills (systemic infection)
  • Pus or foul odor from the wound
  • Rash or itching at the application site

Special Patient Groups

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Pregnancy

Generally considered low risk for topical use due to minimal systemic absorption. However, consult a healthcare professional before use, especially for extensive or prolonged application.

Trimester-Specific Risks:

First Trimester: Low risk, but caution advised.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Generally considered low risk for topical use. Avoid applying to areas where the infant may ingest the ointment (e.g., breast area).

Infant Risk: Low risk of adverse effects to the infant due to minimal systemic absorption by the mother. Ensure infant does not ingest the product.
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Pediatric Use

Safe for use in children, including infants for conditions like diaper rash, under medical supervision. Dosage and frequency are similar to adults. Ensure proper wound cleaning and monitor for irritation.

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Geriatric Use

No specific dose adjustments or precautions are generally needed for geriatric patients. Monitor for skin sensitivity or pre-existing dermatological conditions.

Clinical Information

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Clinical Pearls

  • Always clean the wound thoroughly before applying the ointment to prevent trapping bacteria.
  • Apply a thin layer; excessive application does not improve efficacy and may lead to maceration.
  • This product is often used for chronic wounds (e.g., pressure ulcers, diabetic ulcers) due to its ability to promote granulation.
  • Be aware of potential allergic reactions to Balsam Peru, especially in individuals with fragrance allergies or a history of contact dermatitis.
  • If no improvement is seen within 1-2 weeks, or if the wound worsens, consult a healthcare professional to re-evaluate the wound care plan.
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Alternative Therapies

  • Hydrocolloid dressings
  • Alginate dressings
  • Foam dressings
  • Silver-impregnated dressings (for infected wounds)
  • Topical antibiotics (for specific infections)
  • Growth factors (e.g., becaplermin for diabetic ulcers)
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Cost & Coverage

Average Cost: $10 - $30 per 56.7gm tube
Generic Available: Yes
Insurance Coverage: Often OTC, may be covered by some insurance plans with a prescription or as a medical supply.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.