Aminovel-600

Uses

Amino Acids is used for a source of amino acids for protein synthesis in patients needing intravenous nutrition. It is particularly suitable for a patient with basal amino acid requirements. Amino Acids is also used for faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of Cancer.

Vitamin C is used for prevention and treatment of scurvy. It may be used for pregnancy, lactation, infection, trauma, burns, cold exposure, following surgery, fever, stress, peptic ulcer, cancer, methaemoglobinaemia and in infants receiving unfortified formulas. It is also prescribed for haematuria, dental caries, pyorrhea, acne, infertility, atherosclerosis, fractures, leg ulcers, hay fever, vascular thrombosis prevention, levodopa toxicity, succinyl-choline toxicity, arsenic toxicity etc. To reduce the risk of stroke in the elderly, long-term supplementation with Vitamin C is essential.

Inositol is an ingredient found in a variety of nutritional products.

Inositol may be used in food without any limitation. As a drug, inositol is used as a nutrient supplement in special dietary foods and infant formula. As it presents a relevant role in ensuring oocyte fertility, inositol has been studied for its use in the management of polycystic ovaries. Inositol is also being researched for the treatment of diabetes, prevention of metabolic syndrome, aid agent for weight loss, treatment of depression, psychiatric disorder and anxiety disorder and for prevention of cancer.

Nicotinamide is an ingredient found in a variety of cosmetic products.

Management of acidosis in cardiac arrest.

Management of metabolic acidosis in:

• Severe renal disease
• Uncontrolled diabetes
• Circulatory insufficiency from shock or dehydration
• Severe primary lactic acidosis

Alkalinization of urine.

Sorbitol is a product that can be used as a laxative to relieve constipation, and also as a urologic irrigating fluid. May also be used as a pharmaceutical sweetener.

Used as a non-stimulant laxative via an oral suspension or enema.

Aminovel-600 is also used to associated treatment for these conditions: Creatinine Clearance 5-15 mL/min, Uremia, Nutritional Support, Parenteral Nutrition, Total parenteral nutrition therapyCommon Cold, Deficiency, Vitamin A, Deficiency, Vitamin D, Fever, Flu caused by Influenza, Folate deficiency, Iron Deficiency (ID), Iron Deficiency Anemia (IDA), Oral bacterial infection, Scurvy, Vitamin C Deficiency, Vitamin Deficiency, Nutritional supplementation, Vitamin supplementationGastrointestinal insufficiency, Hepatic Insufficiency, Macrocytic anemia, Secondary anemia, Vitamin Deficiency, Severe debilitation, Dietary and Nutritional Therapies, Nutritional supplementation, Dietary supplementationAcid indigestion, Barbiturate intoxication, Breast Cancer, Constipation, Dental Decay, Duodenal Ulcer, Dyspepsia, Gastro-esophageal Reflux Disease (GERD), Gingival Bleeding, Heartburn, Helicobacter Infections, Hyperkalemia, Ischaemia, Metabolic Acidosis, Myocardial Infarction, Plaque, Dental, Pruritis of the skin, Skin Irritation, Upset stomach, Zollinger-Ellison Syndrome, Abdominal bloating, Benign, active Gastric Ulcer, Methyl alcohol poisoning, Prophylaxis of Contrast-induced nephropathy, Salicylate poisoning, Severe Diarrhea, Swelling of the gums, Bowel preparation therapyConstipation, Constipation caused by Pregnancy, Occasional Constipation, Bladder irrigation therapy, Bowel preparation therapy, Preparation for rectoscopic or sigmoidoscopic examination

How Aminovel-600 works

In humans, an exogenous source of ascorbic acid is required for collagen formation and tissue repair by acting as a cofactor in the posttranslational formation of 4-hydroxyproline in -Xaa-Pro-Gly- sequences in collagens and other proteins. Ascorbic acid is reversibly oxidized to dehydroascorbic acid in the body. These two forms of the vitamin are believed to be important in oxidation-reduction reactions. The vitamin is involved in tyrosine metabolism, conversion of folic acid to folinic acid, carbohydrate metabolism, synthesis of lipids and proteins, iron metabolism, resistance to infections, and cellular respiration.

The mechanism of action of inositol in brain disorders is not fully understood but it is thought that it may be involved in neurotransmitter synthesis and it is a precursor to the phosphatidylinositol cycle. The change that occurs in the cycle simulates when the postsynaptic receptor is activated but without activating the receptor. This activity provokes a fake activation which regulated the activity of monoamines and other neurotransmitters.

Reports have shown that insulin resistance plays a key role in the clinical development of PCOS. The presence of hyperinsulinemia can induce an excess in androgen production by stimulating ovaries to produce androgens and by reducing the sex hormone binding globulin serum levels. One of the mechanisms of insulin deficiency is thought to be related to a deficiency in inositol in the inositolphosphoglycans. The administration of inositol allows it to act as a direct messenger of the insulin signaling and improves glucose tissue uptake. This mechanism is extrapolated to its functions in diabetes treatment, metabolic syndrome, and weight loss.

In cancer, the mechanism of action of inositol is not fully understood. It is hypothesized that the administration of inositol increases the level of lower-phosphate inositol phosphates why can affect cycle regulation, growth, and differentiation of malignant cells. On the other hand, the formation of inositol hexaphosphate after administration of inositol presents antioxidant characteristics by the chelation of ferric ions and suppression of hydroxyl radicals.

Sodium bicarbonate is a systemic alkalizer, which increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis. It is also a urinary alkalizer, increasing the excretion of free bicarbonate ions in the urine, thus effectively raising the urinary pH. By maintaining an alkaline urine, the actual dissolution of uric acid stones may be accomplished. Sodium bicarbonate acts as an antacid and reacts chemically to neutralize or buffer existing quantities of stomach acid but has no direct effect on its output. This action results in increased pH value of stomach contents, thus providing relief of hyperacidity symptoms. [PharmGKB]

Sorbitol exerts its laxative effect by drawing water into the large intestine, thereby stimulating bowel movements.

Dosage

Aminovel-600 dosage

Adults:

The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).

No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day,

Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day,

Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day.

The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino Acids/kg/day.

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino Acids may be infused intravenously per 24 hours. Amino Acids should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

Infants and Children:

In children and infants, the rate of infusion is 28-35 ml/kg body wt/day is recommended, with a stepwise increment in the rate of administration during the first week of treatment.

vitamin C is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.

For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.

The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.

To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively and postoperatively are generally considered adequate, although considerably larger amounts have been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For severe burns, daily doses of 1 to 2 g are recommended. In other conditions in which the need for vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Oral: The usual dose is 300 mg to 2 grams, 1 to 4 times daily.

Intravenous (Severe metabolic acidosis):

• Adult: By slow inj of a hypertonic solution of up to 8.4% (1000 mmol/L), or by continuous infusion of a weaker solution, usually 1.26% (150 mmol/L). For correction of acidosis during advanced cardiac life support procedures, 50 ml of an 8.4% solution may be given.
• Elderly: Dosage adjustments may be required.

Side Effects

Amino Acids is usually well tolerated. Yet nausea, vomiting, flushing and sweating have been observed during infusion of Amino Acids at rates exceeding the recommended maximal rate. Hypersensitivity reactions have been reported. Like all hypertonic infusion solution, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If it is infused to severely ill patients, premature infants, hyperphenylalaninemia may occur.

Ascorbic acid does not seem to have any important adverse effects at dosages less than 4 mg/day. Larger dose may cause diarrhoea or formation of renal calculi of calcium oxalate in patients with renal impairment. Ingestion of more than 600 mg daily have a diuretic action.

This medication is generally well tolerated. However, high doses may cause headache, nausea or irritability. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: muscle weakness, slow reflexes, confusion, swelling of the feet or ankles, black tar-like stools, coffee-ground vomit. If you notice other effects not listed above, contact your doctor or pharmacist.

Toxicity

Consumption of high doses of inositol is reported to only cause some gastrointestinal effects.

Acute oral toxicity (LD50): 15900 mg/kg [Rat].

Precaution

Hyperphenylalaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine levels is recommended and the infusion rate adjusted as needed.

Do not use if the solution is turbid or contains particles. Discard any unused portion.

Ingestion of megadose (more than 1000 mg daily) of vitamin C during pregnancy has resulted in scurvy in neonates. Vitamin C in mega-doses has been contraindicated for patients with hyperoxaluria. Vitamin C itself is a reactive substance in the redox system and can give rise to false positive reactions in certain analytical tests for glucose, uric acid, creatine and occult blood.

Pre-existing heart disease, kidney disease, liver disease, high blood pressure, any allergies.

Interaction

Potentially hazardous interactions: Ascorbic acid is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin sodium, conjugated oestrogen, sodium bicarbonate, sulphafurazole diethanolamine, chloramphenicol sodium succinate, chlorthiazide sodium and hydrocortisone sodium succinate.

Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.

This medication has the potential to interact with many medications. Should not take any other medication within 1 to 2 hours of taking an antacid. Potentially hazardous interactions with Corticosteroids and Corticotropin, Alkalis, Calcium, Diuretics and Potassium.

Volume of Distribution

The pharmacokinetic profile of inositol was studied in preterm infants and the estimated volume of distribution was reported to be 0.5115 L/kg.

Elimination Route

70% to 90%

Inositol is absorbed from the small intestine. In patients with inositol deficiency, the maximal plasma concentration after oral administration of inositol is registered to be of 4 hours. Inositol is taken up by the tissues via sodium-dependent inositol co-transporter which also mediates glucose uptake. Oral ingestion of inositol is registered to generate a maximal plasma concentration of 36-45 mcg.

Half Life

16 days (3.4 hours in people who have excess levels of vitamin C)

The pharmacokinetic profile of inositol was studied in preterm infants and the estimated elimination half-life was reported to be of 5.22 hours.

Clearance

The pharmacokinetic profile of inositol was studied in preterm infants and the estimated clearance rate was reported to be 0.0679 L.kg/h.

Elimination Route

Most of the administered dose is excreted in urine.

Sorbitol will either be excreted in the urine by the kidneys, or metabolized to carbon dioxide and dextrose.

Pregnancy & Breastfeeding use

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino Acids.

The drug is safe in normal doses in pregnant women, but a daily intake of 5 gm or more is reported to have caused abortion. The drug may be taken safely during lactation.

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Contraindication

Amino acid is contraindicated in patients with inborn errors of amino acids metabolism, irreversible liver damage and severe uremia when dialysis facilities are not available.

This drug is contraindicated in hypoventilatory states, chloride depletion owing to continuous gastric fluid loss, metabolic and/or respiratory alkalosis, hypocalcemia and diuretics known to produce hypochloremic alkalosis.

Special Warning

In children and infants, the rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step wise increase in the rate of administration during the first week.

Acute Overdose

If alkalosis results, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indication in severe alkalosis.

Storage Condition

Protect from light and store between 15-25 °C temperature. Avoid freezing. Keep medicament's out of reach of children.

Should be stored in a dry place below 30˚C.

Store in a cool & dry place protected from light. Keep out of reach of children.

Innovators Monograph

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