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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Allium Sat, Aloe, Arsenicum Alb, Berber Vulg, Calc Phos, Ceanothus, Chelidonium Maj, Cholesterinum, Clematis Erecta, Condurango, Gambogia, Hamamelis, Kali Brom, Kali Phos, Lycopodium, Nat Carb, Passiflora, Senna, Silicea, Solidago, Spigelia Anth, Spongia, Veratrum Vir
Brand Name
Day And Night Vitals
Generic Name
Allium Sat, Aloe, Arsenicum Alb, Berber Vulg, Calc Phos, Ceanothus, Chelidonium Maj, Cholesterinum, Clematis Erecta, Condurango, Gambogia, Hamamelis, Kali Brom, Kali Phos, Lycopodium, Nat Carb, Passiflora, Senna, Silicea, Solidago, Spigelia Anth, Spongia, Veratrum Vir
Active Ingredient
Aloe Vera LeafCategory
Non-Standardized Food Allergenic Extract [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 12 [hp_X]/59mL | LIQUID | ORAL | 61626-0100 |
Detailed information about Day And Night Vitals
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Day And Night Vitals, you must consult a qualified healthcare professional.
Aloe Vera Leaf is a botanical substance used primarily as a non-standardized food allergenic extract for diagnostic purposes, as well as in various topical and oral formulations under clinical supervision.
Dosage for Aloe Vera Leaf varies significantly based on the indication and the specific part of the plant used. For its role as a Non-Standardized Food Allergenic Extract, the dosage is not measured in milligrams but in standardized dilutions (e.g., 1:10 or 1:20 w/v) used for skin prick testing. A single drop of the extract is typically applied to the skin, followed by a puncture.
For topical dermatological use (e.g., for psoriasis or minor burns), a cream or gel containing 0.5% to 70% aloe vera may be applied to the affected area three times daily. In clinical studies for psoriasis, a 0.5% aloe vera extract cream was used for 4 weeks.
Regarding oral intake, there is no standardized FDA-approved dose. Historically, for constipation, 50-200 mg of aloe latex was used once daily for no more than 10 days. However, due to safety concerns, most clinicians recommend avoiding oral latex altogether. If using decolorized (purified) whole-leaf extract, doses of 100-200 mL per day have been used in research settings, but this must be done under strict medical supervision.
Aloe Vera Leaf is generally not recommended for oral use in children under the age of 12. The risk of severe abdominal cramping, dehydration, and electrolyte imbalances is significantly higher in pediatric populations.
For topical use, such as treating minor skin irritations, aloe gel is generally considered safe for children when applied sparingly. However, parents should perform a patch test first to rule out allergic contact dermatitis. As a pediculicide, follow the specific product labeling, which usually involves applying the solution to dry hair for a specified duration (e.g., 10-30 minutes) before rinsing.
Oral use of Aloe Vera Leaf (especially the latex) is contraindicated in patients with renal impairment. The potential for electrolyte disturbances, specifically hypokalemia (low potassium), can exacerbate underlying kidney disease and increase the risk of acute kidney injury.
While there are no specific dosage adjustments for topical use, oral whole-leaf extracts should be used with caution. Rare cases of hepatotoxicity (liver injury) have been reported with long-term oral ingestion of aloe supplements.
Geriatric patients are at a significantly higher risk for the adverse effects of oral aloe, particularly dehydration and potassium depletion. Clinicians typically recommend lower doses or alternative therapies for this population. Monitoring of serum electrolytes is essential if oral use is deemed necessary.
If you miss a dose of a topical application, apply it as soon as you remember. If it is almost time for the next application, skip the missed dose. For oral supplements, do not double the dose to catch up, as this increases the risk of severe abdominal pain and diarrhea.
Signs of an oral overdose include severe abdominal cramping, profuse watery diarrhea, hematuria (blood in the urine), and extreme muscle weakness (due to potassium loss). In the event of an overdose, seek emergency medical attention or contact a Poison Control Center immediately. Treatment is supportive, focusing on fluid and electrolyte replacement.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or start oral aloe therapy without medical guidance, as the risks of toxicity are substantial with whole-leaf products.
When applied topically, the most common side effect is a transient stinging or burning sensation upon application. This typically lasts for only a few minutes as the gel dries. Some patients may also experience mild skin redness or itching.
When taken orally, common side effects include abdominal pain and cramping. This is caused by the anthraquinones stimulating the smooth muscle of the intestines. Additionally, diarrhea is a frequent occurrence, which may be accompanied by a feeling of urgency. These symptoms usually resolve once the substance is discontinued, but they can be distressing during the first few days of use.
> Warning: Stop taking Aloe Vera Leaf and call your doctor immediately if you experience any of these serious adverse events:
Prolonged oral ingestion of non-decolorized Aloe Vera Leaf extract has been linked to more serious long-term consequences. The National Toxicology Program (NTP) conducted a 2-year study in which rats were given non-decolorized whole-leaf aloe vera extract in their drinking water. The results showed a significant increase in the incidence of adenomas and carcinomas of the large intestine (colon cancer). While these results have not been definitively replicated in humans, they serve as a critical warning regarding the long-term safety of non-purified oral aloe products.
Furthermore, chronic use of stimulant laxatives like aloe latex can lead to 'lazy bowel syndrome,' where the colon becomes dependent on the stimulant to function, leading to chronic, worsening constipation.
There are currently no FDA-mandated black box warnings specifically for Aloe Vera Leaf as an allergenic extract. However, the FDA has issued strong safety communications regarding the use of aloe in OTC laxative products, effectively banning them from the OTC market due to safety concerns. Patients should treat the lack of a black box warning not as a sign of absolute safety, but as a reflection of its status as a non-standardized botanical product.
Report any unusual symptoms to your healthcare provider. Monitoring of liver enzymes and electrolytes may be required for those using aloe products long-term.
Aloe Vera Leaf is not a 'simple' herbal remedy; it contains potent chemical compounds that can interfere with normal physiological processes. The most critical safety point is the distinction between the inner gel (generally safe for topical use) and the whole-leaf extract or latex (potentially toxic when ingested). Patients must ensure they know exactly which part of the plant is contained in their product. Furthermore, because aloe is often sold as a dietary supplement, products may not be standardized, leading to significant variability in the concentration of active ingredients like aloin.
No FDA black box warnings for Aloe Vera Leaf. However, clinicians are advised to follow the safety guidelines for allergenic extracts, which include the risk of systemic allergic reactions during administration.
If a patient is under a clinical protocol involving oral Aloe Vera Leaf, the following monitoring is recommended:
Aloe Vera Leaf generally does not affect the central nervous system. However, if a patient experiences severe abdominal cramping or dizziness due to dehydration from aloe-induced diarrhea, they should avoid driving or operating heavy machinery until symptoms resolve.
Alcohol can exacerbate the gastrointestinal irritation caused by aloe anthraquinones. Furthermore, both alcohol and aloe can have diuretic effects; combining them increases the risk of severe dehydration and electrolyte depletion.
When stopping long-term use of aloe as a laxative, patients may experience 'rebound constipation.' It is often necessary to taper the dose while simultaneously increasing dietary fiber and fluid intake to allow the bowel to regain its natural rhythm. Sudden discontinuation after chronic use does not typically cause a withdrawal syndrome in the traditional sense, but it can lead to significant GI discomfort.
> Important: Discuss all your medical conditions, especially any history of intestinal disease or kidney problems, with your healthcare provider before starting Aloe Vera Leaf.
For each major interaction, the management strategy involves either avoiding the combination or performing frequent lab monitoring. For example, if a patient must take a diuretic, a potassium supplement may be required if they are also using aloe products under medical supervision.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. Botanical-drug interactions are often under-reported and can be clinically significant.
Aloe Vera Leaf must NEVER be used in the following circumstances:
Conditions requiring careful risk-benefit analysis by a physician include:
Patients with known hypersensitivity to plants in the Liliaceae family (including onions, garlic, chives, asparagus, and hyacinths) should avoid Aloe Vera Leaf. There is a high rate of cross-reactivity where the immune system recognizes similar proteins across these species, potentially leading to contact dermatitis or systemic allergic reactions.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of 'silent' GI issues, before prescribing or recommending Aloe Vera Leaf products.
FDA Category: Avoid Oral Use. While topical aloe gel is generally considered safe for use on small areas of the skin during pregnancy, the oral ingestion of Aloe Vera Leaf (especially the latex) is strictly contraindicated. Anthraquinones like aloin can cause potent uterine contractions, which may lead to miscarriage or premature birth. There is no established safe dose for oral aloe during any trimester of pregnancy. Furthermore, animal studies have raised concerns about potential teratogenicity (birth defects) when high doses are consumed, although human data is lacking.
Components of Aloe Vera Leaf, particularly the anthraquinones, can pass into breast milk. This can cause severe diarrhea and abdominal cramping in the nursing infant. Therefore, oral use of aloe products is not recommended for breastfeeding mothers. Topical use on the breasts should also be avoided to prevent the infant from accidentally ingesting the gel during feeding.
Aloe Vera Leaf is not approved for oral use in children under 12 years of age. In older children, its use should be limited to short-term topical applications for minor skin issues. The use of aloe as a pediculicide in children must be done strictly according to the product's age-specific labeling, usually for children 2 years and older. Growth effects have not been formally studied, but the potential for chronic malabsorption (if used orally) could theoretically impact nutritional status.
Older adults are particularly vulnerable to the adverse effects of Aloe Vera Leaf. Age-related declines in renal function mean that the kidneys are less able to handle the electrolyte imbalances caused by aloe-induced diarrhea. There is also a significant concern regarding polypharmacy; elderly patients are more likely to be on Digoxin, diuretics, or blood thinners, all of which interact dangerously with aloe. Clinicians should monitor geriatric patients for signs of dehydration, confusion, and muscle weakness.
In patients with a GFR (Glomerular Filtration Rate) below 30 mL/min, Aloe Vera Leaf should be avoided. The risk of acute kidney injury (AKI) is heightened because the anthraquinones can act as direct irritants to the renal parenchyma when the kidneys are already compromised. For those on dialysis, aloe is not effectively cleared and can complicate the management of fluid and electrolyte balance.
Patients with Child-Pugh Class B or C hepatic impairment should avoid oral aloe products. Since there have been reports of aloe-induced hepatitis, those with pre-existing liver disease may have a reduced capacity to recover from such an insult. Topical use remains generally safe, provided the skin is intact.
> Important: Special populations require individualized medical assessment. Never assume a botanical product is safe for these vulnerable groups without consulting a specialist.
The pharmacology of Aloe Vera Leaf is multifaceted. As a Non-Standardized Food Allergenic Extract, it acts as an antigen that triggers an IgE-mediated response in sensitized individuals.
Therapeutically, the inner gel contains acemannan, which binds to mannose receptors on macrophages, activating them and increasing their phagocytic activity. This enhances the release of growth factors that stimulate fibroblasts to produce collagen and proteoglycans, accelerating tissue repair.
The latex contains C-glycosides such as aloin. Once in the colon, these are hydrolyzed by bacterial β-glycosidases into aloe-emodin anthrone. This compound inhibits the Na+/K+-ATPase pump in the intestinal wall and opens chloride channels, leading to an influx of water and electrolytes into the bowel lumen, while simultaneously stimulating prostaglandin E2 (PGE2) production, which increases intestinal contractions.
| Parameter | Value |
|---|---|
| Bioavailability | Low for polysaccharides; Moderate for anthraquinone metabolites |
| Protein Binding | 80-90% (for aloe-emodin) |
| Half-life | Approximately 10-12 hours (metabolites) |
| Tmax | 8-12 hours (for colonic metabolite peak) |
| Metabolism | Intestinal bacteria (primary); Hepatic glucuronidation (secondary) |
| Excretion | Fecal (main); Renal (<10%) |
Aloe Vera Leaf belongs to the class of Anthraquinone Stimulant Laxatives (when referring to the latex) and Botanical Allergenic Extracts (when used for diagnostics). It is related to other stimulant laxatives like Senna and Cascara Sagrada.
Common questions about Day And Night Vitals
Aloe Vera Leaf has several distinct clinical uses depending on how it is prepared. Most officially, it is used as a Non-Standardized Food Allergenic Extract to help doctors diagnose specific plant allergies through skin testing. Topically, it is widely utilized to soothe minor burns, sunburns, and skin irritations like psoriasis due to its anti-inflammatory properties. In some specialized products, it also serves as a pediculicide to treat head lice. Historically, it was used as an oral laxative, though this is no longer recommended by the FDA for over-the-counter use due to safety concerns. Always consult a healthcare provider to determine the appropriate form for your needs.
The side effects of Aloe Vera Leaf depend on whether it is used on the skin or taken by mouth. When applied topically, many people experience a brief stinging or redness, and some may develop an itchy allergic rash. If taken orally, the most common issues are significant abdominal cramping and watery diarrhea. Long-term oral use can also lead to a harmless but visible darkening of the colon's lining called pseudomelanosis coli. More serious side effects, though rare, include kidney strain and liver inflammation. You should stop use and contact a doctor if you experience severe pain or signs of an allergic reaction.
It is generally advised to avoid or strictly limit alcohol consumption if you are taking Aloe Vera Leaf orally. Both alcohol and the active compounds in aloe (anthraquinones) can irritate the lining of the stomach and intestines, potentially worsening cramping and diarrhea. Additionally, both substances can have a diuretic effect, which increases the risk of becoming severely dehydrated. This dehydration can lead to a dangerous imbalance of electrolytes like potassium. If you are only using aloe topically for a minor burn, alcohol is unlikely to cause a direct interaction, but you should still consult your pharmacist. Always prioritize hydration if you are using any botanical supplement.
Oral use of Aloe Vera Leaf is considered unsafe and is strictly contraindicated during pregnancy. The yellow latex found in the leaf contains chemicals that can act as a powerful uterine stimulant, potentially leading to miscarriage or premature labor. There are also concerns about these compounds causing birth defects based on animal studies. While applying small amounts of pure aloe gel topically for a skin irritation is generally thought to be low-risk, it should still be discussed with an obstetrician. Breastfeeding mothers should also avoid oral aloe, as the active laxative components can pass into breast milk and cause diarrhea in the infant. Safety for the developing fetus is the primary concern.
The onset of action for Aloe Vera Leaf depends on the desired effect. For topical application on a burn or irritated skin, the cooling and soothing sensation is almost immediate, though healing of the skin may take several days of consistent use. When used as an allergenic extract for skin testing, a reaction usually appears within 15 to 20 minutes. If taken orally for its laxative effect, it typically takes between 6 and 12 hours to work. This delay occurs because the active compounds must travel to the large intestine and be converted into their active forms by gut bacteria. You should not take a second dose if you don't see immediate results.
If you have been using Aloe Vera Leaf topically or for a short-term diagnostic test, you can stop using it suddenly without any withdrawal symptoms. However, if you have been using oral aloe products chronically as a laxative, stopping suddenly may result in 'rebound constipation.' This happens because the bowel can become dependent on the stimulant effect of the aloe to move. In such cases, it is better to gradually reduce the dose while increasing your intake of water and dietary fiber. This allows your digestive system to regain its natural function. Always seek medical advice before ending a long-term supplement regimen.
If you miss a dose of a topical aloe vera product, simply apply it as soon as you remember and then continue with your regular schedule. If it is nearly time for your next application, skip the missed one entirely. For oral aloe products, if you miss a dose, skip it and wait for your next scheduled time. Never take two doses at once to make up for a missed one, as this significantly increases the risk of severe stomach cramps and diarrhea. Because aloe is often used on an 'as needed' basis for skin relief, missing a dose is usually not a clinical emergency. Consistency is most important for conditions like psoriasis.
There is no clinical evidence to suggest that Aloe Vera Leaf causes weight gain. In fact, because oral aloe latex acts as a potent stimulant laxative, its misuse can lead to temporary weight loss through the loss of water and stool. However, this is not a safe or effective method for fat loss and can lead to dangerous dehydration and electrolyte imbalances. Some people may experience temporary bloating or gas when first starting oral aloe juice, which could feel like weight gain, but this is usually transient. If you notice sudden or unusual weight changes while using aloe, you should discuss this with your healthcare provider. Focus on a balanced diet rather than supplements for weight management.
Aloe Vera Leaf has several significant drug interactions that require caution. It should never be taken with Digoxin, as the potassium loss caused by aloe can lead to life-threatening heart rhythm problems. It also interacts with 'water pills' (diuretics) and steroid medications, which further deplete potassium levels. If you are taking blood thinners like Warfarin, aloe may increase your risk of bleeding. Additionally, because aloe can lower blood sugar, it may cause problems for those taking diabetes medications. Always provide your doctor with a full list of your current medications and supplements before starting any form of oral aloe vera to ensure your safety.
Aloe Vera Leaf is a botanical substance and is not a 'brand name' drug in the traditional sense, so it is widely available in many generic forms. You can find it as a generic topical gel, an ingredient in various skincare products, and as a dietary supplement in health food stores. However, because it is a botanical product, the quality and concentration can vary wildly between different manufacturers. For clinical uses, such as allergenic extracts for testing, these are specialized products produced by biological laboratories. When buying aloe products, look for those certified by the International Aloe Science Council (IASC) to ensure purity and quality. Always choose products based on your doctor's specific recommendation.
Other drugs with the same active ingredient (Aloe Vera Leaf)