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DRUGS & SUPPLEMENTS
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Cobanerve Plus Capsules
How is the drug helping you? |
Cobanerve Plus Capsules uses
Cobanerve Plus Capsules consists of Alpha-Lipoic Acid, Chromium (Chromium Chloride), Folic Acid, Methylcobalamin, Selenium (Selenium Dioxide), Vitamin A, Vitamin B1, Vitamin B5 (Calcium Pantothenate), Vitamin B6, Vitamin E.Folic Acid:
- Indications and usage
- Contraindications
- Precautions
- Adverse reactions
- Dosage and administration
- How supplied
- Storage
INDICATIONS AND USAGE
Cobanerve Plus Capsules (Folic Acid)® is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.
| WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. |
PRECAUTIONS
Cobanerve Plus Capsules (Folic Acid) acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of Cobanerve Plus Capsules (Folic Acid) acid.
DOSAGE AND ADMINISTRATION
One tablet daily with or without food or as prescribed by a licensed healthcare provider with prescribing authority.
HOW SUPPLIED
Cobanerve Plus Capsules (Folic Acid)® tablets are supplied in child-resistant bottles of 90 tablets (NDC 0037-6885-90)
KEEP OUT OF REACH OF CHILDREN.
STORAGE
Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F).
Dispense in a tight, light-resistant container to protect from light and moisture.
To report SUSPECTED ADVERSE REACTIONS contact Meda Pharmaceuticals Inc. at 1-888-349-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch
Distributed by:
Meda Pharmaceuticals Inc.
Somerset New Jersey 08873-4120
© 2014 Meda Pharmaceuticals Inc.
U.S. Patent Nos. 7,585,527 and 8,080,520
Proferrin® is a registered trademark of Colorado BioLabs, Inc., Cozad, NE.
Cobanerve Plus Capsules (Folic Acid) and the BIFERA logo are registered trademarks and the Cobanerve Plus Capsules (Folic Acid) logo is a trademark of Alaven Pharmaceutical LLC, used under license by Meda Pharmaceuticals Inc.
MEDA PHARMACEUTICALS mark and logo are trademarks of Meda AB.
IN-6885-02 Rev 6/2014
Selenium (Selenium Dioxide):
- Description
- Clinical pharmacology
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
Rx Only
TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION
DESCRIPTION
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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 Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.
CLINICAL PHARMACOLOGY
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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 Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with Cobanerve Plus Capsules (Selenium (Selenium Dioxide)).
Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of Cobanerve Plus Capsules (Selenium (Selenium Dioxide)). The conditions are endemic to geographical areas with low Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) soil content. Dietary supplementation with Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) salts has been reported to reduce the incidence of the conditions among affected children.
Normal blood levels of Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) in different human populations have been found to vary and depend on the Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) content of the food consumed. Results of surveys carried out in some countries are tabulated below:
| COUNTRY | Number of Samples | Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) (mcg/100 mL) (a) | ||
| Whole Blood | Blood Cells | Plasma/ Serum | ||
| (a) Mean values with or without standard deviation in parentheses, all other ranges. | ||||
| (b) Age group unknown. | ||||
| (c) Three children recovered from Kwashiorkor and the other six under treatment for other diseases. | ||||
| (d) Low selenium-content soil area. | ||||
| (e) Well nourished children, three recovered from Kwashiorkor and the other six under treatment for other diseases. | ||||
| (f) Mean values from seven subjects. | ||||
| Canada | 254 Adults | (37.9 ± 7.8) | (23.6 ± 6.0) | (14.4 ± 2.9) |
| England | 8 (b) | 26-37 (32) | -- | -- |
| Guatemala & Southern USA | 10 Adults 9 Children (c) | 19-28 (22) (23 ± 5) | -- (36 ± 12) | -- (15 ± 5) |
| New Zealand (d) | 113 Adults | (5.4 ± 0.1) | (6.6 ± 0.3) | (4.3 ± 0.1) |
| Thailand | 3 Adults 9 Children (e) | 14.4-20.2 (12.0 ± 3.6) (f) | 17.8-35.8 (19.5 ± 8.2) | 8.1-12.5 (8.3 ± 2.2) |
| USA | 210 Adults | 15.7-25.6 (20.6) | -- | -- |
Plasma Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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 Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) used in supplementation. Ancillary routes of elimination are lungs and skin.
INDICATIONS AND USAGE
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) in TPN solutions helps to maintain plasma Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
CONTRAINDICATIONS
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.
WARNINGS
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) levels during TPN support and close medical supervision is recommended.
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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 Cobanerve Plus Capsules ) is eliminated in urine and feces, Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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 Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) plasma level determinations are suggested as a guideline.
In animals, Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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: Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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. Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.
Presence of Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) in placenta and umbilical cord blood has been reported in humans.
ADVERSE REACTIONS
The amount of Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) present in Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) Injection is small. Symptoms of toxicity from Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) are unlikely to occur at the recommended dosage level.
OVERDOSAGE
Chronic toxicity in humans resulting from exposure to Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) in industrial environments, intake of foods grown in seleniferous soils, use of selenium-contaminated water, and application of cosmetics containing Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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 Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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 Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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, Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) deficiency states resulting from long-term TPN support, Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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 Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) Injection to the TPN solution under laminar flow hood is recommended. Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) levels is suggested as a guideline for subsequent administration. The normal whole blood range for Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) INJECTION
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) INJECTION
Cobanerve Plus Capsules (Selenium (Selenium Dioxide)) 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 A:
- Dosage and administration
- Warning
- Clinical pharmacology
- Dietary supplementation
- Warnings
- Precautions
- Adverse reactions
- Dosage and administration
- How supplied
DOSAGE AND ADMINISTRATION
One tablet daily or as directed by a physician.
| Supplement Facts | ||
|---|---|---|
| Serving Size 1 Tablet Servings Per Container 100 | ||
| Amount Per Serving | % Daily Value | |
| Cobanerve Plus Capsules (Vitamin A) | 2500 IU | 50% |
| Vitamin C | 60 mg | 100% |
| Vitamin D | 400 IU | 100% |
| Vitamin E | 15 IU | 50% |
| Thiamine | 1.05 mg | 70% |
| Riboflavin | 1.2 mg | 70% |
| Niacinamide | 13.5 mg | 68% |
| Vitamin B6 | 1.05 mg | 53% |
| Folic Acid | 0.3 mg | 75% |
| Vitamin B12 | 4.5 mcg | 75% |
| Fluoride | 0.25 mg | |
WARNING
KEEP OUT OF THE REACH OF CHILDREN.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Other Ingredients: Artificial cherry flavor, artificial grape flavor, ascorbic acid, cholecalciferol, compressible sugar, D&C Red #7 calcium lake, FD&C Blue #1 aluminum lake, FD&C Yellow #6 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, natural and artificial orange flavor, niacinamide, polyethylene glycol, pyridoxine HCl, riboflavin, sodium ascorbate, sodium fluoride, stearic acid, sucralose, thiamine HCl, Cobanerve Plus Capsules (Vitamin A) acetate, vitamin B12 and vitamin E acetate.
Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.
CLINICAL PHARMACOLOGY
Significant decrease in the incidence of dental caries can be linked to the fluoridation of the water supply (1ppm fluoride) during the period of tooth development.
Cobanerve Plus Capsules (Vitamin A) Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the Hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite.
The reaction may be expressed by the equation:
| Ca10(PO4)6(OH2) + 2F- | Ca10 (PO4)6F2 + 2OH- |
| (Hydroxyapatite) | (Fluorapatite) |
Three stages of fluoride deposition in tooth enamel can be distinguished:
- Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
- After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
- After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts of saliva.
DIETARY SUPPLEMENTATION
Multivitamins with fluoride offer supplementation of the diet with 10 vitamins and fluoride.
WARNINGS
AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN. This tablet should be chewed. This product, as with all chewable tablets are not recommended for children under the age of 4 due to risk of choking.
PRECAUTIONS
The suggested dose of Cobanerve Plus Capsules (Vitamin A) Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before recommending Cobanerve Plus Capsules (Vitamin A) Tablets
- Determine the fluoride content of the drinking water from all major sources
- Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste
- Periodically check to make sure that the child does not develop significant dental fluorosis.
ADVERSE REACTIONS
Allergic rash and other idiosyncrasies have been rarely reported.
To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma, LLC at 1 (866) 592-6438 or FDA at 1 (800) 332-1088 or via the web at www.fda.gov/medwatch/index.html for voluntary reporting of adverse reactions.
DOSAGE AND ADMINISTRATION
One tablet daily or as directed by a physician.
HOW SUPPLIED
Cobanerve Plus Capsules Tablets 0.25 mg are available as orange, red and purple chewable tablets imprinted with "151" in 100 tablet bottles.
Cobanerve Plus Capsules (Vitamin A) Tablets 0.5 mg are available as orange, red and purple chewable tablets imprinted with "152" in 100 tablet bottles.
Cobanerve Plus Capsules (Vitamin A) Tablets 1.0 mg are available as orange, red and purple chewable tablets imprinted with "153" in 100 tablet bottles.
STORAGE
Store at controlled room temperature 20ºC-25ºC (68º-77ºF), excursions permitted between 15º-30ºC (59º-86ºF).
Distributed by:
H2-Pharma, LLC
2010 Berry Chase Place
Montgomery, AL 36117
www.h2-pharma.com
1067084
61269-151-01
MultiVitamin
with Fluoride
Chewable Tablets
Rx
0.25 mg
MultiVitamin and Fluoride Supplement
Dietary Supplement
100 Tablets
H2pharma
Vitamin E:
A generic descriptor for all tocopherols and tocotrienols that exhibit alpha-tocopherol activity. By virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus, these compounds exhibit varying degree of antioxidant activity, depending on the site and number of methyl groups and the type of isoprenoids.
Indication: Cobanerve Plus Capsules (Vitamin E), 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.
Cobanerve Plus Capsules (Vitamin E) has antioxidant activity. It may also have anti-atherogenic, antithrombotic, anticoagulant, neuroprotective, antiviral, immunomodulatory, cell membrane-stabilizing and antiproliferative actions. Cobanerve Plus Capsules (Vitamin E) is a collective term used to describe eight separate forms, the best-known form being alpha-tocopherol. Cobanerve Plus Capsules (Vitamin E) 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. Cobanerve Plus Capsules (Vitamin E) 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 Cobanerve Plus Capsules (Vitamin E) 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 Cobanerve Plus Capsules (Vitamin E) 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 Cobanerve Plus Capsules (Vitamin E) may help prevent or delay coronary heart disease. Antioxidants such as Cobanerve Plus Capsules (Vitamin E) 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 Cobanerve Plus Capsules (Vitamin E) have been linked to increased incidence of breast and colon cancer.
Cobanerve Plus Capsules pharmaceutical active ingredients containing related brand and generic drugs:
Cobanerve Plus Capsules available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.