Ertina-XT

Ferrous Ascorbate, Folic Acid Vitamin B12 & Zinc Tablets

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Folic Acid

IN HUMANS, AN EXOGENOUS SOURCE OF FOLIC ACID IS REQUIRED FOR NUCLEOPROTEIN SYNTHESIS AND THE MAINTENECE OF NORMAL ERYTHROPOIESIS.

Dose :

THE USUAL DOSE :- 1 MG DAILY, MAINTENENCE DOSE - 0.1 MG FOR INFANTS AND 0.3 MG FOR CHILDREN UNDER 4 YEARS OF AGE, 0.4 MG FOR ADULTS AND CHILDREN OVER 4 YEARS OF AGE AND 0.8 MG FOR PREGNANT AND LACTATING MOTHERS.

Monograph

Folic Acid Indications: Anemia, megaloblastic DESCRIPTION: Folic Acid, N-(p(((2-Amino-4-hydroxy-6-pteridinyl)-methyl)Amino)benzoyl) glutamic acid, is a complex organic compound present in liver, yeast and other substances, and which may be prepared synthetically. Tablets: 1 mg folic acid Parenteral: Each ml of folic acid-solution contains sodium folate equivalent to 5 mg of folic acid. Inactive ingredients: Sequestrene sodium 0.2% and water for injection qs 100%. Sodium hydroxide to approx. pH 9. Preservative: Benzyl alcohol 1.5%. CLINICAL PHARMACOLOGY: In man, an exogenous source of folate is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid, whether given by mouth or parenterally, stimulates specifically the production of red blood cells, white blood cells, and platelets in persons suffering from certain megaloblastic anemias. INDICATIONS AND USAGE: Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or non-tropical sprue, in anemias of nutritional origin, pregnancy, infancy, or childhood. WARNINGS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. PRECAUTIONS: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. DOSAGE AND ADMINISTRATION: Oral Administration: Folic acid is well absorbed and may be administered orally with satisfactory results except in severe instances of intestinal malabsorption. Parenteral Administration: Intramuscular, intravenous, and subcutaneous routes may be used if the disease is exceptionally severe, or if gastrointestinal absorption may be, or is known to be, impaired. Usual Therapeutic Dosage: Adults and children regardless of age, up to 1.0 mg daily. Resistant cases may require larger doses. Maintenance Level: When clinical symptoms have subsided and the blood picture has become normal, a maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under four years of age, 0.4 mg for adults and children four or more years of age, and 0.8 mg for pregnant and lactating women, per day, but never less than 0.1 mg per day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.

Zinc

ZINC IS AN ESSENTIAL ELEMENT OF NUTRITION. IT PLAYS AN IMPORTANT ROLE IN VARIOUS BIOLOGICAL ACTIVITIES PARTICULARLY IN NUMEROUS ENZYMATIC PATHWAYS INCLUDING SYNTHESIS OF NUCLEIC ACIDS AND METABOLISM OF PROTEINS, CARBOHYDRATES AND LIPIDS. IT ALSO HELPS IN THE DEVELOPMENT OF CELL MEDIATED IMMUNITY.

Dose :

THE USUAL DOSE :- 50 MG THREE TIMES DAILY. WHEN I.V SUPPLIMENTS ARE REQUIRED, ZINC CHLORIDE OR ZINC SULPHATE MAY BE GIVEN, SUGGESTED DOSE-6.5 MG OF ELEMENTAL ZINC (100 MICRO MOL) DAILY.

Monograph :

Zinc Indications: Nutritional support DESCRIPTION: Zinc chloride injection is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (TPN). Each ml of solution contains 2.09 mg zinc chloride and 9 mg sodium chloride. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and sodium hydroxide for pH adjustment. The osmolarity is 0.354 m0smoL/ml (calc.). Zinc chloride is chemically designated ZnCl2, a white crystalline compound freely soluble in water. Sodium chloride is chemically designated NaCl, a white crystalline compound freely soluble in water. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration. CLINICAL PHARMACOLOGY: Zinc is an essential nutritional requirement and serves as a cofactor for more than 70 different enzymes including carbonic anhydrase, alkaline phosphatase, lactic dehydrogenase, and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration, and the senses of taste and smell. Zinc resides in muscle, bone, skin, kidney, liver, pancreas, retina, prostate and particularly in the red and white blood cells. Zinc binds to plasma albumin, alpha2-macroglobulin, and some plasma amino acids including histidine, cysteine, threonine, glycine, and asparagine. Ingested zinc is excreted mainly in the stool (approximately 90%), and to a lesser extent in the urine and in perspiration. Providing Zinc Helps Prevent Development of Deficiency Symptoms Such as: Parakeratosis, hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth retardation and hepatosplenomegaly. The initial manifestations of hypozincemia in TPN are diarrhea, apathy and depression. At plasma levels below 20 mcg zinc/100 ml dermatitis followed by alopecia has been reported for TPN patients. Normal zinc plasma levels are 100 ñ 12 mcg/100 ml. INDICATIONS AND USAGE: Zinc chloride injection is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain zinc serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms. Zinc deficiency in diabetics aggravates insulin resistance and alters immune functions. CONTRAINDICATIONS: None known. WARNINGS: Direct intramuscular or intravenous injection of zinc chloride injection is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation. Severe kidney disease may make it necessary to reduce or omit chromium and zinc doses because these elements are primarily eliminated in the urine. PRECAUTIONS: General Do not use unless the solution is clear and the seal is intact. Zinc chloride injection should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed. Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of zinc from a bolus injection. Administration of zinc in the absence of copper may cause a decrease in serum copper levels. Laboratory Tests Periodic determinations of serum copper as well as zinc are suggested as a guideline for subsequent zinc administration. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies to evaluate the carcinogenic potential of zinc chloride injection have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when zinc chloride injection is administered to a nursing woman. Pediatric Use See DOSAGE AND ADMINISTRATION. Safety and effectiveness in children have not been established. Pregnancy Category C Animal reproduction studies have not been conducted with zinc chloride. It is also not known whether zinc chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Zinc chloride should be given to a pregnant woman only if clearly needed. ADVERSE REACTIONS: None known. DRUG ABUSE AND DEPENDENCE: None known. OVERDOSAGE: Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg zinc was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2øF) on the fourth day were accompanied by a serum zinc concentration of 207 mcg/dl. Symptoms abated within three hours. Hyperamylasemia may be a sign of impending zinc overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310). Death resulted from an overdosage in which 1683 mg zinc was delivered intravenously over the course of 60 hours to a 72 year old patient. Symptoms of zinc toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum zinc level of 4184 mcg/dl. Calcium supplements may confer a protective effect against zinc toxicity. DOSAGE AND ADMINISTRATION: Zinc chloride injection contains 1 mg zinc/ml and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 ml. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 ml/day). An additional 2 mg zinc/day (2 ml/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 ml/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 ml/kg of stool or ileostomy output) is recommended. Frequent monitoring of zinc blood levels is suggested for patients receiving more than the usual maintenance dosage level of zinc. For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 ml/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 ml/kg/day) is suggested. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.) Zinc status in human immunodeficiency virus type I infection and illicit drug use. BaumMK, Campa A, LaiS, LaiH, Page JB. Florida International University, College of Health and Urban Affairs, University Park, Rm. HLS 337, Miami, FL 33199, USA. baumm@fiu.edu Zinc deficiency is the most prevalent micronutrient abnormality seen in human immunodeficiency virus (HIV) infection. Low levels of plasma zinc predict a 3-fold increase in HIV-related mortality, whereas normalization has been associated with significantly slower disease progression and a decrease in the rate of opportunistic infections. Studies in Miami, Florida, indicated that HIV-positive users of illicit drugs are at risk for developing zinc deficiency, at least partially because of their poor dietary intake. Zinc deficiency characterized by low plasma zinc levels over time enhances HIV- associated disease progression, and low dietary zinc intake is an independent predictor of mortality in HIV-infected drug users. The amount of zinc supplementation in HIV infectiol appears to be critical, because deficiency, as well as excessive dietary intake of zinc. has been linked with declining CD4 cell counts and reduced survival. More research is needed to determine the optimal zinc supplementation level in HIV-infected patients, to prevent further burden on an already compromised immune system Zinc deficiency, DNA damage and cancer risk. HoE. Department of Nutrition and Food Management and Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA. emily.ho@oregonstate.edu A large body of evidence suggests that a significant percentage of deaths resulting from cancer in the United States could be avoided through greater attention to proper and adequate nutrition. Although many dietary compounds have been suggested to contribute to the prevention of cancer, there is strong evidence to support the fact that zinc, a key constituent or cofactor of over 300 mammalian proteins, may be of particular importance in host defense against the initiation and progression of cancer. Remarkably, 10% of the U.S. population consumes less than half the recommended dietary allowance for zinc and are at increased risk for zinc deficiency. Zinc is known to be an essential component of DNA-binding proteins with zinc fingers, as well as copper/zinc superoxide dismutase an( several proteins involved in DNA repair. Thus, zinc plays an important role in transcription factor function, antioxidant defense and DNA repair. Dietary deficiencies ir zinc can contribute to single- and double-strand DNA breaks and oxidative modification? to DNA that increase risk for cancer development. This review will focus on potential mechanisms by which zinc deficiency impairs host protective mechanisms designed to protect against DNA damage, enhances susceptibility to DNA-damaging agents and ultimately increases risk for cancer. Suitable nutrients necessary in early years and its later consequences. Wania M. King Baudouin Foundation Kenya. There is compelling evidence that micronurtrient deficiency of zinc, magnesium selenium and manganese, vitamins A& B and E can profoundly affect Health and immunity in human being. In Kenya this is a major problem because of overcooking of vegetable and consumption of overpolished grains eg, wheat, rice and maize and poor consumption of fruits. Commercial supplements are alarmingly expensive to an average Kenyan or even one living under the poverty line. Our organisation has therefore been advising the whole community on how to use locally available food sources rich in vitamins A, B complex, C, D, E and minerals like zinc, alluminium, magnesium and selenium as part of the daily intake. The method has proved to be highly effective and successful in reducing both micro nutrient and macro nutrient deficiencies. The King Baudouin foundation (Kenya)- health promotion through infection control program has developed a health meal using locally available grains to counter problems like eliminating fatigue (both mental and physical), control of opportunistic infection, eliminating indigestion, muscle and joint pain, reducing skin infection and allergy control and finally promotion of nerve sensitivity(neuralgia).