Prucal

Prucal Uses, Dosage, Side Effects, Food Interaction and all others data.

Allantoin is a substance that is endogenous to the human body and also found as a normal component of human diets . In healthy human volunteers, the mean plasma concentration of allantoin is about 2-3 mg/l. During exercise, the plasma allantoin concentration rapidly increases about two fold and remains elevated . In human muscle, urate is oxidized to allantoin during such exercise . The concentration of allantoin in muscles increases from a resting value of about 5000 ug/kg to about 16000 ug/kg immediately after short-term exhaustive cycling exercise .

More specifically, allantoin is a diureide of glyoxylic acid that is produced from uric acid. It is a major metabolic intermediate in most organisms. Allantoin is found in OTC cosmetic products and other commercial products such as oral hygiene products, in shampoos, lipsticks, anti-acne products, sun care products, and clarifying lotions . Allantoin has also demonstrated to ameliorate the wound healing process in some studies .

There is no well controlled and appropriate data that can formally substantiate the pharmacodynamic properties of allantoin . Nevertheless, ongoing studies suggest that allantoin possesses moisturizing and keratolytic effects, as well as abilities to increase the water content of the extracellular matrix and enhance the desquamation of upper layers of dead skin cells, all of which are activities that can promote cell proliferation and facilitate wound healing .

Glycerin is a hyperosmotic laxative, given rectally, which usually produces a bowel movement within 15 minutes to 1 hour. Hyperosmotic laxatives encourage bowel movements by drawing water into the bowel from surrounding tissues. This produces a softer stool mass and increased bowel action. These products are used for fast, predictable relief of occasional constipation.

Glycerin is commonly classified as an osmotic laxative but may act additionally or alternatively through its local irritant effects; it may also have lubricating and fecal softening actions. Glycerin suppositories usually work within 15 to 30 minutes.

Oil extracted from olives . Consists primarily of the glycerides of the fatty acids linoleic, oleic and palmitic. Used as a source of fatty acids in total parenteral nutrition and as an additive in some cosmetic products .

Provides a source of calories and fatty acids .

Trade Name Prucal
Generic Calamine + Aloe Vera Extract + Allantoin + Wheat Germ Oil + Vitamin E / Tocopherol + Liquid Paraffin + Olive Oil + Glycerin
Weight 8%
Type Lotion
Therapeutic Class
Manufacturer Apex Laboratories Private Limited
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Prucal
Prucal

Uses

Allantoin is an ingredient used in skin care products to relieve irritation and protect minor cuts, scrapes, and burns.

Allantoin is commonly applied in a variety of topical vehicles or applications such as cosmetic creams, toothpastes, mouthwashes, shampoos, lipsticks, anti-acne products, and lotions for the purpose of moisturizing skin, enhancing the smoothness of skin, stimulating the healing of wounds, and soothing irritated skin .

For the relief of occasional constipation

For use in adults as a source of calories and fatty acids in total parenteral nutrition . Sometimes used as an additive in cosmetic products.

Prucal is also used to associated treatment for these conditions: Scarring, Dental cleaning, Skin Lightening, Skin protectionCold Sore, Constipation, Dry Mouth, Dry Skin, Dry throat, Edema of the cerebrum, Hypertension Intracranial, Occasional Constipation, Ocular Discomfort, Ocular Hypertension, Ocular Irritation, Skin Infections, Sore Throat, Mouth soreness, Ocular burning, Bowel preparation therapy, Topical Antisepsis, Skin protectionNutritional supplementation, Total parenteral nutrition therapy

How Prucal works

There is no well controlled data that can formally substantiate the method of action . However, ongoing studies suggest that there may exist a histological wound healing profile induced by allantoin in rats that leads to the amelioration and fastening of the reestablishment of normal skin . This facilitation of wound healing is supported by observations that wounds inflicted to rat subjects to which topical allantoin preparations were applied histologically demonstrated increased vasodilation, presence of inflammatory exudates, number of inflammatory cells, angiogenesis, fibroblast proliferation, and increased collagen deposition when compared to rat subjects with wounds that did not receive any allantoin administration .

When administered rectally, glycerin exerts a hygroscopic and/or local irritant action, drawing water from the tissues into the feces and reflexively stimulating evacuation. Glycerin decreases intraocular pressure by creating an osmotic gradient between the blood and intraocular fluid, causing fluid to move out of the aqueous and vitreous humors into the bloodstream.

Fatty acids act as a substrate in energy production through beta-oxidation as well as important components of cell membrane structures and prescursors for bioactive molecules like prostaglandins .

Dosage

Prucal dosage

Children under 2 years: Consult a physician.

Children (2 to 6 years): only 1 Glycerin 1.15 suppository per 24 hours or as directed by a physician.

Adults and Children (From 6 years): only 1 Glycerin 2.30 suppository per 24 hours or as directed by a physician

Insert suppository well up into rectum. Suppository need to melt completely to produce laxative action.

Side Effects

Glycerin when used rectally may cause rectal discomfort or a burning sensation

Toxicity

No studies on repeated dose toxicity and reproductive toxicity have been submitted. Moreover, studies show that the tumor incidence in allantoin treated animals did not differ largely from that found in untreated controls. As a result, further or additional toxicity, mutagenicity, or carcinogenicity tests are not required in view of the endogenous nature of allantoin and the general lack of overall toxicity .

Finally, as allantoin is a normal component of the diet in humans and is a substance of endogenous origin present in the body of humans, it is generally recognized as being a safe substance for humans .

Glycerol has very low toxicity when ingested ; Rat LD50 (oral)-12600mg/kg Mice LD50 (oral )-4090mg/kg Human TDLo (oral) - 1428mg/kg

Fat overload sydrome is the primary form of toxicity characterized by a sudden deterioration in the patient's condition accompanied by fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, liver fatty infiltration, deteriorating liver function, and central nervous system manifestations such as coma . The precise cause of this is unclear. While it is most likely to occur during overdosage of lipids some occurences have been reported when lipids are administered appropriately. Intraperitoneal LD50 in mice of >50g/kg and intravenous LD50 in rats of 1320mg/kg .

Volume of Distribution

Glycerin is distributed throughout the blood. Although glycerin generally does not appear in ocular fluids, it may enter the orbital sac when the eye is inflamed, with a consequent decrease in osmotic effect.

Elimination Route

In studies on human subjects, a recovery of 19% and 34% of allantoin in the urine was observed but only in two individuals and only after the administration of massive doses of allantoin . After intravenous administration, recovery in the urine was practically quantitative with doses of 75 to 600 mgm in the human model . After 240 mgm, excretion continued for 72 hours in human subjects and the results were similar in regards to subcutaneous injection .

Well absorbed orally, poorly absorbed rectally. Studies in humans and animals indicate glycerol is rapidly absorbed in the intestine and the stomach

Half Life

When studied in cattle, sheep, and horses, the half-life of allantoin is in the range of 1 to 2.5 hours .

30 - 45 minutes

Clearance

Some studies suggest that the average renal clearance of allantoin in normal, healthy human subjects is approximately 123 cc per minute . It is generally agreed upon that exogenously administered allantoin is rapidly excreted .

Elimination Route

Urinary clearance is the predominant excretion route .

Approx 7-14% of dose is excreted unchanged in the urine within 2.5 hr.

Pregnancy & Breastfeeding use

Pregnancy category C. There are no controlled data in human pregnancy

Contraindication

Sensitivity to the ingredients. Do not use unless the patient to be treated is, in fact, constipated.

Storage Condition

Store below 25° C. Protect from moisture.

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