Astringent

For most inflammatory skin conditions, Aluminum Sulfate Tetradecahydrate is used as a wet dressing, compress, or soak. The dosage is determined by the concentration of the final solution:

• Standard Dilution (1:40 ratio): Dissolve one packet or one tablet in 16 ounces (1 pint) of cool or lukewarm water. This is the most common concentration for general skin irritation.
• Stronger Dilution (1:20 ratio): Dissolve two packets or two tablets in 16 ounces of water. This may be used for more severe 'weeping' or as directed by a physician.
• Maximum Strength (1:10 ratio): Dissolve four packets or four tablets in 16 ounces of water. This concentration is typically reserved for severe athlete's foot or under strict medical guidance.

Aluminum Sulfate Tetradecahydrate is generally safe for use in children when used as a topical soak. However, the following guidelines apply:

• Children 2 years and older: Use the standard adult dilution (1 packet per 16 oz) unless otherwise directed by a pediatrician.
• Infants and Children under 2 years: Consult a healthcare provider before use. While not contraindicated, the delicate nature of infant skin requires professional assessment to avoid over-drying.
• Diaper Rash: Use only as a brief soak (5-10 minutes) and ensure the area is thoroughly dried afterward. Do not use under occlusive (airtight) plastic pants unless directed.

Renal Impairment

While systemic absorption is minimal, patients with severe renal impairment (kidney failure) should exercise caution when applying aluminum-based products to large areas of broken skin, as the kidneys are responsible for clearing any absorbed aluminum.

Hepatic Impairment

No dosage adjustments are required for patients with liver disease, as the drug is not metabolized by the liver.

Elderly Patients

Elderly patients often have thinner, more fragile skin (atrophic skin). It is recommended to start with the most dilute solution (1:40) to prevent excessive dryness or skin cracking.

This medication is for EXTERNAL USE ONLY. Do not swallow the tablets, powder, or solution.

1. 1Preparation: Prepare the solution fresh for each use. Use a clean container and stir until the powder or tablet is completely dissolved. The solution should be clear or slightly cloudy depending on the formulation.
2. 2Compress/Wet Dressing: Soak a clean, soft cloth (such as gauze or a washcloth) in the solution. Wring out excess liquid so it is not dripping. Apply the cloth to the affected area for 15 to 30 minutes.
3. 3Soaking: For hands or feet, submerge the affected area directly in the solution for 15 to 30 minutes.
4. 4Frequency: Repeat the application every 6 to 8 hours (3 to 4 times a day) or as directed by your doctor.
5. 5Storage: Store the dry packets or tablets at room temperature (59°F to 86°F). Keep away from moisture and heat.

If you miss an application, apply it as soon as you remember. If it is almost time for the next application, skip the missed dose and resume your regular schedule. Do not use extra solution to 'make up' for a missed treatment.

Accidental Ingestion: If a child or adult swallows the tablets or powder, contact a Poison Control Center (1-800-222-1222) or seek emergency medical help immediately. Symptoms of ingestion may include gastrointestinal irritation, nausea, or vomiting.

Topical Overuse: Excessive use can lead to severe skin drying, cracking, or irritation. If this occurs, discontinue use and apply a mild moisturizer after consulting your doctor.

> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or concentration without medical guidance.

Most patients tolerate Aluminum Sulfate Tetradecahydrate very well when used as directed. However, because it is an astringent, the most common side effects involve the skin's reaction to the drying process:

• Skin Dryness: The most frequent report is a sensation of tightness or visible flaking of the skin. This is a direct result of the medication's mechanism of action in removing excess moisture.
• Mild Stinging: A brief stinging or 'pins and needles' sensation may occur immediately upon application, especially if the skin is raw or broken.
• Temporary Redness: The area may appear slightly pinker immediately after a soak due to increased localized blood flow from the temperature of the water.

• Skin Irritation: Some patients may develop localized irritation that persists beyond the application time.
• Pruritus (Itching): While the drug is intended to stop itching, occasionally the drying effect can cause a secondary itch as the skin becomes dehydrated.
• Maceration: If a wet dressing is left on for too long (over 30 minutes) or covered with plastic, the skin may become overly soft and white, which can delay healing.

• Contact Dermatitis: Rarely, a patient may be hypersensitive to the aluminum salts themselves, resulting in an itchy, red rash at the site of application.
• Severe Skin Cracking: In patients with already dry skin, the astringent effect may lead to painful fissures (cracks) in the skin.

> Warning: Stop taking Aluminum Sulfate Tetradecahydrate and call your doctor immediately if you experience any of these.

• Allergic Reaction (Anaphylaxis): Symptoms include hives, swelling of the face, lips, or tongue, and difficulty breathing. While extremely rare for topical aluminum, it is a medical emergency.
• Severe Skin Blistering: If the medication causes new blisters or significant skin peeling, it may indicate a chemical burn or severe hypersensitivity.
• Signs of Systemic Absorption: Although unlikely, if you experience confusion, muscle weakness, or bone pain after using this product over very large areas of broken skin for a long time, seek medical advice.
• Worsening Infection: If the skin becomes increasingly hot, swollen, or develops pus, the underlying condition may have progressed to a bacterial infection (cellulitis) requiring antibiotics.

Aluminum Sulfate Tetradecahydrate is intended for short-term use (usually no more than 7 days). Prolonged use can lead to:

1. 1Chronic Xerosis: Permanent or long-lasting skin dryness and loss of natural oils.
2. 2Delayed Wound Healing: While it stops 'weeping,' over-drying a wound can prevent the migration of new skin cells across the wound bed.
3. 3Aluminum Accumulation: In patients with severe kidney disease, using aluminum soaks on open wounds for weeks or months could theoretically contribute to aluminum toxicity, though this is not documented with standard OTC use.

No FDA black box warnings are currently issued for Aluminum Sulfate Tetradecahydrate. It is considered safe for its intended over-the-counter use when applied topically and for limited durations.

Report any unusual symptoms to your healthcare provider. If skin irritation increases or persists for more than 7 days, discontinue use and consult a physician.

Aluminum Sulfate Tetradecahydrate is for external use only. It must never be ingested, injected, or used in the eyes. If the solution comes into contact with the eyes, flush immediately with large amounts of cool water for at least 15 minutes and seek medical attention if irritation persists.

There are no FDA black box warnings for Aluminum Sulfate Tetradecahydrate. It has a long history of safe use as a topical astringent.

• Allergic Reactions: Patients with a known history of sensitivity to aluminum salts or any components of the formulation (such as calcium acetate) should avoid this product. Anaphylaxis is rare but possible.
• Deep Wounds and Punctures: This product is intended for minor skin irritations. Do not use on deep puncture wounds, animal bites, or serious burns without consulting a healthcare professional.
• Extensive Body Surface Area: Avoid applying the solution to more than 20% of the body surface area at one time, especially if the skin is not intact. Large-scale application increases the risk of systemic absorption.
• Occlusive Dressings: Do not cover the wet dressing with plastic or other airtight materials. This can cause the skin to become overly macerated (soggy) and may lead to skin breakdown or increased absorption.

For standard OTC use, no specific laboratory monitoring is required. However, if a healthcare provider prescribes this for a chronic condition or for a patient with renal impairment:

• Skin Assessment: Regular visual inspection of the treated area to ensure the condition is resolving and not becoming overly dry.
• Renal Function: In patients with Stage 4 or 5 Chronic Kidney Disease (CKD), a doctor may occasionally check serum aluminum levels if the drug is used on large open wounds, though this is rare.

There are no known effects of Aluminum Sulfate Tetradecahydrate on the ability to drive or operate heavy machinery. It does not cause drowsiness or impairment of motor skills.

There are no documented interactions between topical Aluminum Sulfate Tetradecahydrate and alcohol consumption. However, alcohol can dehydrate the skin and body, potentially worsening the skin conditions for which this medication is being used.

You should stop using Aluminum Sulfate Tetradecahydrate if:

1. 1The skin condition clears up (usually within 1-3 days).
2. 2The condition worsens or symptoms persist for more than 7 days.
3. 3Severe irritation or a new rash develops.

There is no withdrawal syndrome associated with stopping this medication, and tapering is not required.

> Important: Discuss all your medical conditions with your healthcare provider before starting Aluminum Sulfate Tetradecahydrate, particularly if you have kidney disease or sensitive skin.

There are no known systemic drug-drug contraindications for topical Aluminum Sulfate Tetradecahydrate because it is not significantly absorbed into the bloodstream. However, chemical incompatibilities exist for the prepared solution:

• Alkaline Substances: Mixing the solution with strong bases (like ammonia or lye) will neutralize the acidity and cause the aluminum to precipitate out of the solution, making it ineffective.
• Lead Salts: Aluminum sulfate reacts with lead salts to form insoluble lead sulfate.

• Topical Collagenase (Santyl): Some astringents and metal-containing solutions can interfere with the enzymatic activity of collagenase ointments used for wound debridement. If you are using a prescription debriding agent, consult your doctor before using an aluminum soak.
• Other Topical Medications: Applying other creams, lotions, or ointments immediately before or after the soak may prevent the other medication from being absorbed. The astringent effect 'closes' the skin surface, which may reduce the efficacy of steroid creams or antibiotics applied afterward.

• Skin Cleansers: Harsh or medicated soaps used just before the soak may increase the risk of skin irritation. It is best to use a mild, non-soap cleanser and rinse thoroughly before applying the Aluminum Sulfate solution.

There are no known interactions between topical Aluminum Sulfate Tetradecahydrate and food, including grapefruit, dairy, or high-fat meals. Because the drug is not absorbed systemically, diet does not affect its performance.

There are no documented interactions with herbal supplements such as St. John's Wort or Ginkgo Biloba. However, if you are using topical herbal preparations (like tea tree oil or aloe vera) on the same area, the Aluminum Sulfate may alter their absorption or cause increased irritation.

Aluminum Sulfate Tetradecahydrate does not typically interfere with standard blood or urine laboratory tests. However, if significant systemic absorption occurs (rare), it could potentially interfere with:

• Serum Aluminum Levels: May be falsely elevated.
• Bone Scans: High levels of aluminum can sometimes interfere with the uptake of technetium-99m in bone imaging.

For each interaction, the primary management strategy is to separate the application of Aluminum Sulfate from other topical treatments by at least 2 to 4 hours. Always rinse the skin with plain water between different topical treatments.

> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, even those applied to the skin.

Aluminum Sulfate Tetradecahydrate must NEVER be used in the following circumstances:

• Hypersensitivity: If you have a known allergy to aluminum sulfate, aluminum acetate, or any other aluminum-containing salts. An allergic reaction can lead to contact dermatitis or, in severe cases, systemic hypersensitivity.
• Ophthalmic Use: This medication is highly irritating to the mucous membranes of the eyes. It must never be used in or near the eyes.
• Ingestion: The concentrated powder or tablets are toxic if swallowed. They can cause severe gastrointestinal distress and potential aluminum toxicity if large amounts are consumed.

Conditions requiring careful risk-benefit analysis by a healthcare provider include:

• Severe Renal Failure: Patients with end-stage renal disease (ESRD) have a reduced ability to clear aluminum from the body. While topical use is generally safe, use on large areas of broken skin should be supervised by a physician to prevent aluminum accumulation in the bones and brain.
• Extremely Dry Skin (Xerosis): Patients with naturally very dry or cracked skin may find that the astringent effect worsens their condition, leading to painful fissures.
• Deep or Puncture Wounds: Astringents are not appropriate for deep tissue injuries as they can 'trap' bacteria inside the wound by sealing the surface too quickly.

Patients who react to Aluminum Chlorohydrate (found in many deodorants) or Aluminum Zirconium may also experience sensitivity to Aluminum Sulfate Tetradecahydrate. If you have ever had a rash from a deodorant or antiperspirant, test the solution on a very small area of healthy skin before applying it to an inflamed area.

> Important: Your healthcare provider will evaluate your complete medical history, including any history of kidney disease or skin allergies, before prescribing or recommending Aluminum Sulfate Tetradecahydrate.

Pregnancy Category: Not Formally Assigned (Typically considered Category C or safe for limited topical use).

There are no adequate and well-controlled studies of Aluminum Sulfate Tetradecahydrate in pregnant women. However, because systemic absorption is negligible when applied to intact skin, the risk to the developing fetus is considered extremely low. According to the FDA, topical astringents are generally acceptable for use during pregnancy for short durations. It is always recommended that pregnant women consult their obstetrician before using any medication, especially on large areas of the body.

It is not known whether aluminum from topical application passes into breast milk in significant quantities. However, since systemic levels remain very low, it is unlikely to affect a nursing infant.

Precaution: If applying the solution to the chest or breast area, ensure the medication is thoroughly washed off before breastfeeding to prevent the infant from accidentally ingesting the solution or coming into contact with it.

Aluminum Sulfate Tetradecahydrate is widely used in pediatric medicine for conditions like poison ivy and diaper rash.

• Approved Age: Generally safe for children 2 years and older.
• Infants: Use under 2 years of age should be directed by a pediatrician.
• Safety: Avoid application to the face or hands of infants to prevent accidental eye contact or ingestion (hand-to-mouth behavior).

Clinical studies have not identified significant differences in responses between the elderly and younger patients. However, elderly patients are more likely to have:

• Thinning Skin: Increased risk of irritation or over-drying.
• Renal Insufficiency: While systemic absorption is low, the elderly should avoid long-term use over large areas to ensure no aluminum accumulation occurs.
• Fall Risk: If used as a foot soak, ensure the feet are dried completely before walking, as the solution can make the skin slippery.

In patients with a GFR (Glomerular Filtration Rate) below 30 mL/min, use with caution. The kidneys are the primary route for the elimination of any absorbed aluminum. While topical use is unlikely to cause toxicity, these patients should avoid applying the product to large, open, or severely denuded skin surfaces for more than a few days.

No adjustments are necessary for patients with liver disease. The liver does not play a role in the clearance or processing of aluminum sulfate.

> Important: Special populations require individualized medical assessment. Always inform your doctor if you are pregnant, nursing, or have chronic kidney issues.

Aluminum Sulfate Tetradecahydrate functions as a topical astringent through the action of the trivalent aluminum ion ($Al^{3+}$). When the salt is dissolved in water, it dissociates into aluminum ions and sulfate ions. The aluminum ions react with the proteins (such as albumin and globulins) present in the skin's extracellular fluid and cell membranes. This reaction results in the formation of insoluble albuminate complexes (protein precipitation). This process effectively 'tans' the skin, causing the tissue to contract, reducing the size of skin pores, and coagulating surface proteins to form a protective layer that stops the leakage of fluids (exudate).

• Onset of Action: The astringent effect is almost immediate upon contact with the skin. The cooling and anti-itch effects begin as soon as the wet dressing is applied and the water begins to evaporate.
• Duration of Effect: The tissue-contracting effect lasts for several hours after the soak is completed. Repeated applications (every 6-8 hours) are necessary to maintain the therapeutic effect in 'weeping' conditions.
• Tolerance: There is no known pharmacological tolerance to the astringent effects of aluminum sulfate.

| Parameter | Value |

|---|---|

| Bioavailability | <0.1% (on intact skin) |

| Protein Binding | High (localized to skin proteins) |

| Half-life | N/A (Topical action) |

| Tmax | N/A (Immediate local effect) |

| Metabolism | None (Inorganic salt) |

| Excretion | Renal (for any absorbed fraction) |

• Molecular Formula: $Al_2(SO_4)_3 \cdot 14H_2O$
• Molecular Weight: Approximately 594.4 g/mol (for the tetradecahydrate form).
• Solubility: Highly soluble in water; insoluble in alcohol.
• Structure: The tetradecahydrate form consists of two aluminum atoms, three sulfate groups, and fourteen molecules of water of crystallization. It appears as a white, crystalline powder or granules.

Aluminum Sulfate Tetradecahydrate is classified as a Topical Astringent and Skin Protectant. It is related to other aluminum salts such as Aluminum Acetate (Burow's Solution), Aluminum Chloride (used in antiperspirants), and Aluminum Hydroxide (used as an antacid). Within the therapeutic area of dermatology, it is considered a 'wet-to-dry' therapy for acute inflammatory dermatoses.