Pregna
Pregna 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 .
Evening primrose oil comes from the extraction from Oenothera biennis seeds and it is commonly used as an alternative source for omega-6 essential fatty acids. In its composition it presents some fatty acids such as Linolenic acid and Gamolenic acid. Evening primrose oil has been filled for the FDA by Humanetics Corporation on April 2000 to be a new dietary ingredient but its current status is "Inadequate basis for expectation of safety". By Health Canada, evening primrose oil is approved in over-the-counter combination dietary supplements. By the EMA, evening primrose oil is approved in herbal preparations.
The effectivity of evening primrose oil is debatable as the evidence is very limited. Evening primrose oil improves the essential fatty acid content in plasma, erythrocyte, and platelet lipids. It has also been registered to increase alpha-tocopherol levels in non-diabetic and type I diabetic patients. Evening primrose oil affects the fatty acid composition of serum lipids and adipose tissue as well as it helps maintain normal cellular structures and it serves as a prostaglandin precursor. Administration of evening primrose oil is part of long-term therapy and thus, immediate results are never expected.
Magnesium is the second most plentiful cation of the intracellular fluids. It is essential for the activity of many enzyme systems and plays an important role with regard to neurochemical transmission and muscular excitability. Deficits are accompanied by a variety of structural and functional disturbances.
Magnesium sulfate is a small colorless crystal used as an anticonvulsant, a cathartic, and an electrolyte replenisher in the treatment of pre-eclampsia and eclampsia. It causes direct inhibition of action potentials in myometrial muscle cells. Excitation and contraction are uncoupled, which decreases the frequency and force of contractions. Magnesium sulfate is gaining popularity as an initial treatment in the management of various dysrhythmias, particularly torsades de pointes, and dyrhythmias secondary to TCA overdose or digitalis toxicity.
Sodium citrate is the sodium salt of citric acid. It is white, crystalline powder or white, granular crystals, slightly deliquescent in moist air, freely soluble in water,practically insoluble in alcohol. Like citric acid, it has a sour taste.From the medical point of view, it is used as alkalinizing agent. It works by neutralizing excess acid in the blood and urine. It has been indicated for the treatment of metabolic acidosis.
Citrate prevents activation of the clotting cascade by chelating calcium ions. Citrate neutralizes acid in the stomach and urine, raising the pH .
A metallic element of atomic number 30 and atomic weight 65.38. It is a necessary trace element in the diet, forming an essential part of many enzymes, and playing an important role in protein synthesis and in cell division. Zinc deficiency is associated with anemia, short stature, hypogonadism, impaired wound healing, and geophagia. It is identified by the symbol Zn .
A newer study suggests implies that an imbalance of zinc is associated with the neuronal damage associated with traumatic brain injury, stroke, and seizures .
Understanding the mechanisms that control brain zinc homeostasis is, therefore, imperative to the development of preventive and treatment regimens for these and other neurological disorders .
| Trade Name | Pregna |
| Generic | Allantoin + Aloe Vera Extract + Ascorbic Acid [vit C] + Calendula Officinalis + Evening Primrose Oil + Magnesium Sulfate + Menthol + Pantothenic Acid [vit B5] + Sodium Citrate + Tocopherol [vit E] + Zinc |
| Type | Cream |
| Therapeutic Class | |
| Manufacturer | Meyer Organics Pvt Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
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 .
Evening primrose oil is used as part of over-the-counter dietary supplements.
It is also used for the treatment of systemic inflammatory diseases and for women's health conditions such as cyclical mastalgia. These indications do not have sufficient evidence of their effectiveness. It was used for the treatment of atopic dermatitis in the United Kingdom but it is currently withdrawn due to lack of evidence of effectiveness.
Magnesium sulfate injection is used for the following conditions:
Convulsions (treatment) - Intravenous Magnesium sulfate injection is used for immediate control of life-threatening convulsions in the treatment of severe toxemias (pre-eclampsia and eclampsia) of pregnancy and in the treatment of acute nephritis in children.
Hypomagnesemia (prophylaxis and treatment) - Magnesium sulfate injection is used for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those of hypocalcemia.
Magnesium sulfate injection is also used to prevent or treat magnesium deficiency in patients receiving total parenteral nutrition.
Tetany, uterine (treatment) - Magnesium sulfate injection is used for uterine tetany as a myometrial relaxant.
Sodium citrate is an ingredient used for the anticoagulation of whole blood as part of automated apheresis procedures.
Used as an anticoagulant during plasmophoresis as well as a neutralizing agent in the treatment of upset stomach and acidic urine .
Zinc is an essential element commonly used for the treatment of patients with documented zinc deficiency.
Zinc can be used for the treatment and prevention of zinc deficiency/its consequences, including stunted growth and acute diarrhea in children, and slowed wound healing. It is also utilized for boosting the immune system, treating the common cold and recurrent ear infections, as well as preventing lower respiratory tract infections .
Pregna is also used to associated treatment for these conditions: Scarring, Dental cleaning, Skin Lightening, Skin protectionDietary supplementationConstipation, Convulsions, Hypomagnesemia, Torsades de Pointes, Barium poisoning, Severe Exacerbation of asthma, Bowel preparation therapy, Soaking aid for minor sprains and bruisesAcidosis, Allergic cough, Allergies, Asthma, Asthma Chronic, Cough, Common Cold, Cough, Coughing caused by Bronchitis, Dehydration, Gouty Arthritis, Heartburn, Metabolic Acidosis, Phlegm, Airway secretion clearance therapy, Oral rehydration therapy, Plasmapheresis, Urine alkalinization therapy, Fluid and electrolyte maintenance therapy, Irrigation during surgical procedures, Irrigation of the ocular surface therapyCandidiasis, Common Cold, Diaper Dermatitis, Diaper Rash, Eye redness, Iron Deficiency (ID), Ocular Irritation, Skin Irritation, Sunburn, Wilson's Disease, Zinc Deficiency, Dietary and Nutritional Therapies, Dietary supplementation
How Pregna 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 .
Evening primrose oil presents a content of 74% Linolenic acid and 9% Gamolenic acid from which the later seems to be the key active ingredient of this oil. These major essential fatty acids are required for the normal structure of cell membranes and they are not synthesized endogenously. The therapeutic activity of evening primrose oil is attributed to the direct action of its essential fatty acids on immune cells as well as to an indirect effect on the synthesis of eicosanoids. The actions of highly unsaturated fatty acids in tissues and eicosanoids are thought to be implicated in inflammatory and immunologic pathogeneses.
The essential fatty acids found in evening primrose oil are involved in the biosynthesis of prostaglandin. For this activity, the main involved component is the Gamolenic acid. The presence of this essential fatty acid allows the synthesis of anti-inflammatory substances such as 15-hydroxy-eicosatrienoic acid and prostaglandin E1.
Magnesium is the second most plentiful cation of the intracellular fluids. It is essential for the activity of many enzyme systems and plays an important role with regard to neurochemical transmission and muscular excitability. Magnesium sulfate reduces striated muscle contractions and blocks peripheral neuromuscular transmission by reducing acetylcholine release at the myoneural junction. Additionally, Magnesium inhibits Ca2+ influx through dihydropyridine-sensitive, voltage-dependent channels. This accounts for much of its relaxant action on vascular smooth muscle.
Citrate chelates free calcium ions preventing them from forming a complex with tissue factor and coagulation factor VIIa to promote the activation of coagulation factor X . This inhibits the extrinsic initiation of the coagulation cascade. Citrate may also exert an anticoagulant effect via a so far unknown mechanism as restoration of calcium concentration does not fully reverse the effect of citrate . Citrate is a weak base and so reacts with hydrochloric acid in the stomach to raise the pH. It it further metabolized to bicarbonate which then acts as a systemic alkalizing agent, raising the pH of the blood and urine . It also acts as a diuretic and increases the urinary excretion of calcium.
Zinc has three primary biological roles: catalytic, structural, and regulatory. The catalytic and structural role of zinc is well established, and there are various noteworthy reviews on these functions. For example, zinc is a structural constituent in numerous proteins, inclusive of growth factors, cytokines, receptors, enzymes, and transcription factors for different cellular signaling pathways. It is implicated in numerous cellular processes as a cofactor for approximately 3000 human proteins including enzymes, nuclear factors, and hormones .
Zinc promotes resistance to epithelial apoptosis through cell protection (cytoprotection) against reactive oxygen species and bacterial toxins, likely through the antioxidant activity of the cysteine-rich metallothioneins .
In HL-60 cells (promyelocytic leukemia cell line), zinc enhances the up-regulation of A20 mRNA, which, via TRAF pathway, decreases NF-kappaB activation, leading to decreased gene expression and generation of tumor necrosis factor-alpha (TNF-alpha), IL-1beta, and IL-8 .
There are several mechanisms of action of zinc on acute diarrhea. Various mechanisms are specific to the gastrointestinal system: zinc restores mucosal barrier integrity and enterocyte brush-border enzyme activity, it promotes the production of antibodies and circulating lymphocytes against intestinal pathogens, and has a direct effect on ion channels, acting as a potassium channel blocker of adenosine 3-5-cyclic monophosphate-mediated chlorine secretion. Cochrane researchers examined the evidence available up to 30 September 2016 .
Zinc deficiency in humans decreases the activity of serum thymulin (a hormone of the thymus), which is necessary for the maturation of T-helper cells. T-helper 1 (Th(1)) cytokines are decreased but T-helper 2 (Th(2)) cytokines are not affected by zinc deficiency in humans [A342417].
The change of Th(1) to Th(2) function leads to cell-mediated immune dysfunction. Because IL-2 production (Th(1) cytokine) is decreased, this causes decreased activity of natural-killer-cell (NK cell) and T cytolytic cells, normally involved in killing viruses, bacteria, and malignant cells [A3424].
In humans, zinc deficiency may lead to the generation of new CD4+ T cells, produced in the thymus. In cell culture studies (HUT-78, a Th(0) human malignant lymphoblastoid cell line), as a result of zinc deficiency, nuclear factor-kappaB (NF-kappaB) activation, phosphorylation of IkappaB, and binding of NF-kappaB to DNA are decreased and this results in decreased Th(1) cytokine production .
In another study, zinc supplementation in human subjects suppressed the gene expression and production of pro-inflammatory cytokines and decreased oxidative stress markers [A3424]. In HL-60 cells (a human pro-myelocytic leukemia cell line), zinc deficiency increased the levels of TNF-alpha, IL-1beta, and IL-8 cytokines and mRNA. In such cells, zinc was found to induce A20, a zinc finger protein that inhibited NF-kappaB activation by the tumor necrosis factor receptor-associated factor pathway. This process decreased gene expression of pro-inflammatory cytokines and oxidative stress markers .
The exact mechanism of zinc in acne treatment is poorly understood. However, zinc is considered to act directly on microbial inflammatory equilibrium and facilitate antibiotic absorption when used in combination with other agents. Topical zinc alone as well as in combination with other agents may be efficacious because of its anti-inflammatory activity and ability to reduce P. acnes bacteria by the inhibition of P. acnes lipases and free fatty acid levels .
Dosage
Pregna dosage
Intramuscular:Adults and older children: For severe hypomagnesemia, 1 to 5 g (2 to 10 mLof 50% solution) daily in divided doses; administration is repeated daily until serum levels have returned to normal. If deficiency is not severe, 1 g (2 mL of 50% solution) can be given once or twice daily. Serum magnesium levels should serve as a guide to continued dosage.
Intravenous:1 to 4 g magnesium sulfate (magnesium sulfate (magnesium sulfate injection) injection) may be given intravenously in 10% to 20% solution, but only with great caution; the rate should not exceed 1.5 mL of 10% solution or equivalent per minute until relaxation is obtained.
Intravenous Infusion:4 g in 250 mL of 5% Dextrose Injection at a rate not exceeding 3 mL per minute.
Usual Dose Range:1 to 40 g daily.
Electrolyte Replenisher:Intramuscular 1 to 2 g in 50% solution four times a day until serum magnesium is within normal limits.
Usual Pediatric Dose:Intramuscular 20 to 40 mg per kg of body weight in a 20% solution repeated as necessary.
For Eclampsia:Initially 1 to 2 g in 25% or 50% solution is given intramuscularly. Subsequently, 1 g is given every 30 minutes until relief is obtained. The blood pressure should be monitored after each injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Side Effects
Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor and ultimately, respiratory depression.
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 .
Evening primrose oil seems to have little toxicological effect in humans. The reported LD50 values in the mouse are 3.12 x 10^4 mcg/kg. The toxicological effects are very minimal and it has proven to not have an effect on tumor incidence nor to present effects on fertility studies.
LD50 = 1200 mg/kg (rat, subcutaneous). May be harmful if swallowed. May act as an irritant. Adverse reactions include hypotension, ECG changes, diarrhea, urinary retention, CNS depression and respiratory depression.
Overdose toxicity is mainly due to alkalosis as well as tetany or depressed heart function due to lack of free calcium .
According to the Toxnet database of the U.S. National Library of Medicine, the oral LD50 for zinc is close to 3 g/kg body weight, more than 10-fold higher than cadmium and 50-fold higher than mercury .
The LD50 values of several zinc compounds (ranging from 186 to 623 mg zinc/kg/day) have been measured in rats and mice .
Precaution
Renal impairment, myasthaenia gravis, digitalised patients; pregnancy. Monitor serum-magnesium concentrations.
Volume of Distribution
No pharmacokinetic data available.
19-39L .
A pharmacokinetic study was done in rats to determine the distribution and other metabolic indexes of zinc in two particle sizes. It was found that zinc particles were mainly distributed to organs including the liver, lung, and kidney within 72 hours without any significant difference being found according to particle size or rat gender .
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 .
The pharmacokinetics of evening primrose oil is mainly studied by analyzing its active ingredient Gamolenic acid. After administration, Gamolenic acid is rapidly absorbed and converted directly to Dihomo-gamma-linolenic acid and other precursors. When orally administered, the tmax was directly dependent to the time of administration, being of 2.7 hours in the evening and 4.4 hours in the morning. The Cmax and AUC were registered to be approximately 21 mcg/ml and 274 mcg.h/ml. The bioavailability of Gamolenic acid acid is influenced by triglyceride composition, cellular kinetics of phospholipases and acyltransferases.
Tmax of 98-130min .
Zinc is absorbed in the small intestine by a carrier-mediated mechanism . Under regular physiologic conditions, transport processes of uptake do not saturate. The exact amount of zinc absorbed is difficult to determine because zinc is secreted into the gut. Zinc administered in aqueous solutions to fasting subjects is absorbed quite efficiently (at a rate of 60-70%), however, absorption from solid diets is less efficient and varies greatly, dependent on zinc content and diet composition .
Generally, 33% is considered to be the average zinc absorption in humans . More recent studies have determined different absorption rates for various populations based on their type of diet and phytate to zinc molar ratio. Zinc absorption is concentration dependent and increases linearly with dietary zinc up to a maximum rate [L20902].
Additionally zinc status may influence zinc absorption. Zinc-deprived humans absorb this element with increased efficiency, whereas humans on a high-zinc diet show a reduced efficiency of absorption .
Half Life
When studied in cattle, sheep, and horses, the half-life of allantoin is in the range of 1 to 2.5 hours .
No pharmacokinetic data available.
43.2 hours (for newborns)
18-54 min
The half-life of zinc in humans is approximately 280 days .
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 .
No pharmacokinetic data available.
Total clearance of 313-1107mL/min .
In one study of healthy patients, the clearance of zinc was found to be 0.63 ± 0.39 μg/min .
Elimination Route
Urinary clearance is the predominant excretion route .
The major components of the primrose oil are highly metabolized and the majority of the generated metabolites are excreted in the urine.
Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.
Largely eliminated through hepatic metabolism with very little cleared by the kidneys .
The excretion of zinc through gastrointestinal tract accounts for approximately one-half of all zinc eliminated from the body .
Considerable amounts of zinc are secreted through both biliary and intestinal secretions, however most is reabsorbed. This is an important process in the regulation of zinc balance. Other routes of zinc excretion include both urine and surface losses (sloughed skin, hair, sweat) .
Zinc has been shown to induce intestinal metallothionein, which combines zinc and copper in the intestine and prevents their serosal surface transfer. Intestinal cells are sloughed with approximately a 6-day turnover, and the metallothionein-bound copper and zinc are lost in the stool and are thus not absorbed .
Measurements in humans of endogenous intestinal zinc have primarily been made as fecal excretion; this suggests that the amounts excreted are responsive to zinc intake, absorbed zinc and physiologic need .
In one study, elimination kinetics in rats showed that a small amount of ZnO nanoparticles was excreted via the urine, however, most of the nanoparticles were excreted via the feces .
Pregnancy & Breastfeeding use
Pregnancy category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Contraindication
Heart block, severe renal impairment, myocardial damage.
Acute Overdose
Symptoms of hypermagnesaemia are: respiratory depression and loss of deep tendon reflexes due to neuromuscular blockade; nausea, vomiting, flushing, thirst, hypotension, drowsiness, confusion, slurred speech, double vision, bradycardia and muscle weakness.
Treatment in adults should include IV administration of 5-10 mEq of 10% calcium gluconate. Artificial respiration may be required.
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