Lycobal Forte

L-Arginine:

• Lycobal Forte (L-Arginine) reviews

Indication: Used for nutritional supplementation, also for treating dietary shortage or imbalance.

Studies have shown that is has improved immune responses to bacteria, viruses and tumor cells; promotes wound healing and regeneration of the liver; causes the release of growth hormones; considered crucial for optimal muscle growth and tissue repair.

Selenium (D-Selenium Monomethionine):

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Lycobal Forte (Selenium (D-Selenium Monomethionine)) reviews

Rx Only

TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION

DESCRIPTION

Lycobal Forte (Selenium (D-Selenium Monomethionine)) Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN).

Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental Lycobal Forte (Selenium (D-Selenium Monomethionine)) 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.

CLINICAL PHARMACOLOGY

Lycobal Forte (Selenium (D-Selenium Monomethionine)) is part of glutathione peroxidase which protects cell components from oxidative damage due to peroxides produced in cellular metabolism.

Prolonged TPN support in humans has resulted in Lycobal Forte (Selenium (D-Selenium Monomethionine)) deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with Lycobal Forte (Selenium (D-Selenium Monomethionine)).

Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of Lycobal Forte (Selenium (D-Selenium Monomethionine)). The conditions are endemic to geographical areas with low Lycobal Forte (Selenium (D-Selenium Monomethionine)) soil content. Dietary supplementation with Lycobal Forte (Selenium (D-Selenium Monomethionine)) salts has been reported to reduce the incidence of the conditions among affected children.

Normal blood levels of Lycobal Forte (Selenium (D-Selenium Monomethionine)) in different human populations have been found to vary and depend on the Lycobal Forte (Selenium (D-Selenium Monomethionine)) content of the food consumed. Results of surveys carried out in some countries are tabulated below:

Plasma Lycobal Forte (Selenium (D-Selenium Monomethionine)) levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.

Lycobal Forte (Selenium (D-Selenium Monomethionine)) is eliminated primarily in urine. However, significant endogenous losses through feces also occur. The rate of excretion and the relative importance of two routes varies with the chemical form of Lycobal Forte (Selenium (D-Selenium Monomethionine)) used in supplementation. Ancillary routes of elimination are lungs and skin.

INDICATIONS AND USAGE

Lycobal Forte (Selenium (D-Selenium Monomethionine)) Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of Lycobal Forte (Selenium (D-Selenium Monomethionine)) in TPN solutions helps to maintain plasma Lycobal Forte (Selenium (D-Selenium Monomethionine)) levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

CONTRAINDICATIONS

Lycobal Forte (Selenium (D-Selenium Monomethionine)) Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.

WARNINGS

Lycobal Forte (Selenium (D-Selenium Monomethionine)) Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with Lycobal Forte (Selenium (D-Selenium Monomethionine)) should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma Lycobal Forte (Selenium (D-Selenium Monomethionine)) levels during TPN support and close medical supervision is recommended.

Lycobal Forte (Selenium (D-Selenium Monomethionine)) Injection is a hypotonic solution and should be administered in admixtures only.

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

As Lycobal Forte ) is eliminated in urine and feces, Lycobal Forte (Selenium (D-Selenium Monomethionine)) supplements may be adjusted, reduced or omitted in renal dysfunction and/or gastrointestinal malfunction. In patients receiving blood transfusions, contribution from such transfusions should also be considered. Frequent Lycobal Forte (Selenium (D-Selenium Monomethionine)) plasma level determinations are suggested as a guideline.

In animals, Lycobal Forte (Selenium (D-Selenium Monomethionine)) has been reported to enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium and arsenic.

Pregnancy

Teratogenic Effects

Pregnancy Category C: Lycobal Forte (Selenium (D-Selenium Monomethionine)) at high dose levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however, no adequate and wellcontrolled studies in pregnant women. Lycobal Forte (Selenium (D-Selenium Monomethionine)) Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.

Presence of Lycobal Forte (Selenium (D-Selenium Monomethionine)) in placenta and umbilical cord blood has been reported in humans.

ADVERSE REACTIONS

The amount of Lycobal Forte (Selenium (D-Selenium Monomethionine)) present in Lycobal Forte (Selenium (D-Selenium Monomethionine)) Injection is small. Symptoms of toxicity from Lycobal Forte (Selenium (D-Selenium Monomethionine)) are unlikely to occur at the recommended dosage level.

OVERDOSAGE

Chronic toxicity in humans resulting from exposure to Lycobal Forte (Selenium (D-Selenium Monomethionine)) in industrial environments, intake of foods grown in seleniferous soils, use of selenium-contaminated water, and application of cosmetics containing Lycobal Forte (Selenium (D-Selenium Monomethionine)) has been reported in literature. Toxicity symptoms include hair loss, weakened nails, dermatitis, dental defects, gastrointestinal disorders, nervousness, mental depression, metallic taste, vomiting, and garlic odor of breath and sweat. Acute poisoning due to ingestion of large amounts of Lycobal Forte (Selenium (D-Selenium Monomethionine)) compounds has resulted in death with histopathological changes including fulminating peripheral vascular collapse, internal vascular congestion, diffusely hemorrhagic, congested and edematus lungs, brick-red color gastric mucosa. The death was preceded by coma.

No effective antidote to Lycobal Forte (Selenium (D-Selenium Monomethionine)) poisoning in humans is known. Animal studies have shown casein and linseed oil in feeds, reduced glutathione, arsenic, magnesium sulfate, and bromobenzene to afford limited protection.

DOSAGE AND ADMINISTRATION

Lycobal Forte (Selenium (D-Selenium Monomethionine)) Injection provides 40 mcg selenium/mL. For metabolically stable adults receiving TPN, the suggested additive dosage level is 20 to 40 mcg selenium/day. For pediatric patients, the suggested additive dosage level is 3 mcg/kg/day.

In adults, Lycobal Forte (Selenium (D-Selenium Monomethionine)) deficiency states resulting from long-term TPN support, Lycobal Forte (Selenium (D-Selenium Monomethionine)) as selenomethionine or selenious acid, administered intravenously at 100 mcg/day for a period of 24 and 31 days, respectively, has been reported to reverse deficiency symptoms without toxicity.

Aseptic addition of Lycobal Forte (Selenium (D-Selenium Monomethionine)) Injection to the TPN solution under laminar flow hood is recommended. Lycobal Forte (Selenium (D-Selenium Monomethionine)) is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma Lycobal Forte (Selenium (D-Selenium Monomethionine)) levels is suggested as a guideline for subsequent administration. The normal whole blood range for Lycobal Forte (Selenium (D-Selenium Monomethionine)) is approximately 10 to 37 mcg/100 mL.

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

HOW SUPPLIED

Lycobal Forte (Selenium (D-Selenium Monomethionine)) Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental Lycobal Forte (Selenium (D-Selenium Monomethionine)) 40 mcg/mL).

NDC 0517-6510-25 10 mL Single Dose Vial Packaged in boxes of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

IN6510

Rev. 11/15

PRINCIPAL DISPLAY PANEL - Container

NDC 0517-6510-25

Lycobal Forte (Selenium (D-Selenium Monomethionine)) INJECTION

Lycobal Forte (Selenium (D-Selenium Monomethionine)) 400 mcg/10 mL

(40 mcg/mL)

10 mL

SINGLE DOSE VIAL

Trace Element Additive

FOR IV USE AFTER DILUTION

PRESERVATIVE FREE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL - Carton

Lycobal Forte (Selenium (D-Selenium Monomethionine)) INJECTION

Lycobal Forte (Selenium (D-Selenium Monomethionine)) 400 mcg/10 mL

(40 mcg/mL)

Trace Element Additive

NDC 0517-6510-25

25 x 10 mL

SINGLE DOSE VIALS

FOR INTRAVENOUS USE AFTER DILUTION PRESERVATIVE FREE Rx Only

Each mL contains: Selenious Acid 65.4 mcg, Water for Injection q.s.

pH adjusted with Nitric Acid. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION. Store at 20°-25°C (68°-77°F); excursions

permitted to 15°-30°C (59°-86°F).

Directions for Use: See Package Insert.

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

Container Carton

Vitamin E (D-Alpha Tocopherol):

• Lycobal Forte (Vitamin E (D-Alpha Tocopherol)) reviews

Indication: Lycobal Forte (Vitamin E (D-Alpha Tocopherol)), known for its antioxidant activities, is protective against cardiovascular disease and some forms of cancer and has also demonstrated immune-enhancing effects. It may be of limited benefit in some with asthma and rheumatoid arthritis. It may be helpful in some neurological diseases including Alzheimer's, some eye disorders including cataracts, and diabetes and premenstrual syndrome. It may also help protect skin from ultraviolet irradiation although claims that it reverses skin aging, enhances male fertility and exercise performance are poorly supported. It may help relieve some muscle cramps.

Lycobal Forte (Vitamin E (D-Alpha Tocopherol)) has antioxidant activity. It may also have anti-atherogenic, antithrombotic, anticoagulant, neuroprotective, antiviral, immunomodulatory, cell membrane-stabilizing and antiproliferative actions. Lycobal Forte (Vitamin E (D-Alpha Tocopherol)) is a collective term used to describe eight separate forms, the best-known form being alpha-tocopherol. Lycobal Forte (Vitamin E (D-Alpha Tocopherol)) is a fat-soluble vitamin and is an important antioxidant. It acts to protect cells against the effects of free radicals, which are potentially damaging by-products of the body's metabolism. Lycobal Forte (Vitamin E (D-Alpha Tocopherol)) is often used in skin creams and lotions because it is believed to play a role in encouraging skin healing and reducing scarring after injuries such as burns. There are three specific situations when a Lycobal Forte (Vitamin E (D-Alpha Tocopherol)) deficiency is likely to occur. It is seen in persons who cannot absorb dietary fat, has been found in premature, very low birth weight infants (birth weights less than 1500 grams, or 3½ pounds), and is seen in individuals with rare disorders of fat metabolism. A Lycobal Forte (Vitamin E (D-Alpha Tocopherol)) deficiency is usually characterized by neurological problems due to poor nerve conduction. Symptoms may include infertility, neuromuscular impairment, menstrual problems, miscarriage and uterine degradation. Preliminary research has led to a widely held belief that Lycobal Forte (Vitamin E (D-Alpha Tocopherol)) may help prevent or delay coronary heart disease. Antioxidants such as Lycobal Forte (Vitamin E (D-Alpha Tocopherol)) help protect against the damaging effects of free radicals, which may contribute to the development of chronic diseases such as cancer. It also protects other fat-soluble vitamins (A and B group vitamins) from destruction by oxygen. Low levels of Lycobal Forte (Vitamin E (D-Alpha Tocopherol)) have been linked to increased incidence of breast and colon cancer.

Zinc Ascorbate:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• Lycobal Forte (Zinc Ascorbate) reviews

INDICATIONS AND USAGE

Lycobal Forte (Zinc Ascorbate) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Lycobal Forte (Zinc Ascorbate) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Lycobal Forte (Zinc Ascorbate) 1 mg/mL (Zinc Chloride Injection, USP) 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 Lycobal Forte (Zinc Ascorbate) doses because these elements are primarily eliminated in the urine.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL 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 Lycobal Forte (Zinc Ascorbate) from a bolus injection. Administration of Lycobal Forte (Zinc Ascorbate) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Lycobal Forte (Zinc Ascorbate) are suggested as a guideline for subsequent Lycobal Forte (Zinc Ascorbate) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Lycobal Forte 1 mg/mL (Zinc Chloride Injection, USP) 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 Lycobal Forte (Zinc Ascorbate) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with Lycobal Forte chloride. It is also not known whether Lycobal Forte (Zinc Ascorbate) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Lycobal Forte (Zinc Ascorbate) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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 Lycobal Forte (Zinc Ascorbate) 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 (94.2° F) on the fourth day were accompanied by a serum Lycobal Forte (Zinc Ascorbate) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Lycobal Forte (Zinc Ascorbate) 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 Lycobal Forte (Zinc Ascorbate) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Lycobal Forte (Zinc Ascorbate) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Lycobal Forte (Zinc Ascorbate) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Lycobal Forte (Zinc Ascorbate) toxicity.

DOSAGE AND ADMINISTRATION

Lycobal Forte (Zinc Ascorbate) 1 mg/mL (Zinc Chloride Injection, USP) 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 Lycobal Forte (Zinc Ascorbate) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Lycobal Forte (Zinc Ascorbate).

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.

HOW SUPPLIED

Lycobal Forte (Zinc Ascorbate) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004

© Hospira 2004 EN-0488 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

Lycobal Forte (Zinc Ascorbate)

1 mg/mL

Lycobal Forte (Zinc Ascorbate) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA