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DRUGS & SUPPLEMENTS
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Calcium (Calcium Phosphate):
Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
- Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1)
The recommended initial dose of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.
- Starting dose is 2 capsules with each meal. (2)
- Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 capsules with each meal. (2)
Capsule: 667 mg Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate capsule.
- Capsule: 667 mg Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate capsule. (3)
Patients with hypercalcemia.
- Hypercalcemia. (4)
- Treat mild hypercalcemia by reducing or interrupting Multivitamines, Mineraux Junior Regulier ) acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate. (5.1)
- Hypercalcemia may aggravate digitalis toxicity. (5.2)
Patients with end stage renal disease may develop hypercalcemia when treated with Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)), including Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate. Avoid the use of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) supplements, including Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) based nonprescription antacids, concurrently with Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate.
An overdose of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) levels twice weekly. Should hypercalcemia develop, reduce the Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia
More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate therapy.
Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well.
Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long term effect of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate on the progression of vascular or soft tissue calcification has not been determined.
Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3 month study of solid dose formulation of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate; all cases resolved upon lowering the dose or discontinuing treatment.
Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.
Hypercalcemia may aggravate digitalis toxicity.
Hypercalcemia is discussed elsewhere [see Warnings and Precautions ].
- The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. (6.1)
- In clinical studies, patients have occasionally experienced nausea during Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate therapy. (6)
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical studies, Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate has been generally well tolerated.
Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.
Preferred Term | Total adverse reactions reported for Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate N=167 N (%) | 3 month, open label study of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate N=98 N (%) | Double blind, placebo-controlled, cross-over study of liquid Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate N=69 | |
Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate N (%) | Placebo N (%) | |||
Nausea | 6 (3.6) | 6 (6.1) | 0 (0) | 0 (0) |
Vomiting | 4 (2.4) | 4 (4.1) | 0 (0) | 0 (0) |
Hypercalcemia | 21 (12.6) | 16 (16.3) | 5 (7.2) | 0 (0) |
Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) concentration could reduce the incidence and severity of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.
The following additional adverse reactions have been identified during post-approval of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate: dizziness, edema, and weakness.
The drug interaction of Multivitamines, Mineraux Junior Regulier ) acetate is characterized by the potential of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.
There are no empirical data on avoiding drug interactions between Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate and most concomitant drugs. When administering an oral medication with Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate.
- Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones. (7)
- When clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate or consider monitoring blood levels of the drug. (7)
In a study of 15 healthy subjects, a co-administered single dose of 4 Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.
Pregnancy Category C:
Multivitamines, Mineraux Junior Regulier ) acetate capsules contains Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate. Animal reproduction studies have not been conducted with Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate, and there are no adequate and well controlled studies of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate treatment, as recommended, is not expected to harm a fetus if maternal Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) levels are properly monitored during and following treatment.
The effects of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate on labor and delivery are unknown.
Multivitamines, Mineraux Junior Regulier ) Acetate Capsules contains Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate and is excreted in human milk. Human milk feeding by a mother receiving Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate is not expected to harm an infant, provided maternal serum Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) levels are appropriately monitored.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses 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.
Administration of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].
Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate acts as a phosphate binder. Its chemical name is Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is:
Each white opaque/blue opaque capsule contains 667 mg of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)), polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.
Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.
Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum Multivitamines, Mineraux Junior Regulier ) resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.
Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
Orally administered Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.
No carcinogenicity, mutagenicity, or fertility studies have been conducted with Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate.
Effectiveness of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate solid oral dosage form.
Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1 week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.
The patients received Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.
The data presented in Table 2 demonstrate the efficacy of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) levels are also presented.
* Ninety-one patients completed at least 6 weeks of the study. † ANOVA of difference in values at pre-study and study completion. ‡ Values expressed as mean ± SE. | |||||
Parameter | Pre-Study | Week 4* | Week 8 | Week 12 | p-value† |
Phosphorus (mg/dL)‡ | 7.4 ± 0.17 | 5.9 ± 0.16 | 5.6 ± 0.17 | 5.2 ± 0.17 | ≤0.01 |
Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) (mg/dL)‡ | 8.9 ± 0.09 | 9.5 ± 0.10 | 9.7 ± 0.10 | 9.7 ± 0.10 | ≤0.01 |
There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) increased 9% during the study mostly in the first month of the study.
Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.
The phosphate binding effect of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate is shown in the Table 3.
* ANOVA of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate vs. placebo after 2 weeks of treatment. † Values expressed as mean ± SEM. | ||||
Parameter | Pre-Study | Post-Treatment | p-value* | |
Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) Acetate | Placebo | |||
Phosphorus (mg/dL)† | 7.3 ± 0.18 | 5.9 ± 0.24 | 7.8 ± 0.22 | <0.01 |
Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) (mg/dL)† | 8.9 ± 0.11 | 9.5 ± 0.13 | 8.8 ± 0.12 | <0.01 |
Overall, 2 weeks of treatment with Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.
Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) Acetate Capsules
667 mg capsule is supplied as a white opaque/blue opaque capsule, imprinted with “54 215” on the cap and body.
NDC 0615-2303-39: Blistercards of 30 Capsules
NDC 0615-2303-30: Unit-dose Boxes of 30 Capsules
STORAGE
Store at 20° to 25°C (68° to 77°F).
Inform patients to take Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ].
Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after Multivitamines, Mineraux Junior Regulier (Calcium (Calcium Phosphate)) acetate capsules.
Distr. by: West-Ward
Pharmaceuticals Corp.
Eatontown, NJ 07724
10003705/05
Revised April 2016
Folic Acid:
Multivitamines, Mineraux Junior Regulier (Folic Acid)® is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.
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. |
Multivitamines, Mineraux Junior Regulier (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.
Allergic sensitization has been reported following both oral and parenteral administration of Multivitamines, Mineraux Junior Regulier (Folic Acid) acid.
One tablet daily with or without food or as prescribed by a licensed healthcare provider with prescribing authority.
Multivitamines, Mineraux Junior Regulier (Folic Acid)® tablets are supplied in child-resistant bottles of 90 tablets (NDC 0037-6885-90)
KEEP OUT OF REACH OF CHILDREN.
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.
Multivitamines, Mineraux Junior Regulier (Folic Acid) and the BIFERA logo are registered trademarks and the Multivitamines, Mineraux Junior Regulier (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
Vitamin A (Retinol Acetate):
One tablet daily or as directed by a physician.
Supplement Facts | ||
---|---|---|
Serving Size 1 Tablet Servings Per Container 100 | ||
Amount Per Serving | % Daily Value | |
Multivitamines, Mineraux Junior Regulier (Vitamin A (Retinol Acetate)) | 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 | |
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, Multivitamines, Mineraux Junior Regulier (Vitamin A (Retinol Acetate)) acetate, vitamin B12 and vitamin E acetate.
Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.
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.
Multivitamines, Mineraux Junior Regulier (Vitamin A (Retinol Acetate)) 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:
Multivitamins with fluoride offer supplementation of the diet with 10 vitamins and fluoride.
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.
The suggested dose of Multivitamines, Mineraux Junior Regulier (Vitamin A (Retinol Acetate)) Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before recommending Multivitamines, Mineraux Junior Regulier (Vitamin A (Retinol Acetate)) Tablets
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.
One tablet daily or as directed by a physician.
Multivitamines, Mineraux Junior Regulier ) Tablets 0.25 mg are available as orange, red and purple chewable tablets imprinted with "151" in 100 tablet bottles.
Multivitamines, Mineraux Junior Regulier (Vitamin A (Retinol Acetate)) Tablets 0.5 mg are available as orange, red and purple chewable tablets imprinted with "152" in 100 tablet bottles.
Multivitamines, Mineraux Junior Regulier (Vitamin A (Retinol Acetate)) Tablets 1.0 mg are available as orange, red and purple chewable tablets imprinted with "153" in 100 tablet bottles.
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 B12:
Multivitamines, Mineraux Junior Regulier refers to a group of water-soluble vitamins. It has high biological activity. Multivitamines, Mineraux Junior Regulier (Vitamin B12) is necessary for normal hematopoiesis (promotes maturation of erythrocytes). Involved in the processes of transmethylation, hydrogen transport, synthesis of methionine, nucleic acids, choline, creatine. Contributes to the accumulation in erythrocytes of compounds containing sulfhydryl groups. Has a beneficial effect on liver function and the nervous system. Activates the coagulation of blood in high doses causes an increase in the activity of thromboplastin and prothrombin.
After oral administration Multivitamines, Mineraux Junior Regulier (Vitamin B12) absorbed from the gastrointestinal tract. Metabolized in the tissues, becoming a co-enzyme form - adenosylcobalamin which is the active form of cyanocobalamin. Excreted in bile and urine.
Anemia due to B12-deficiency conditions; in the complex therapy for iron and posthemorrhagic anemia; aplastic anemia caused by toxic substances and drugs; liver disease (hepatitis, cirrhosis); funicular myelosis; polyneuritis, radiculitis, neuralgia, amyotrophic lateral sclerosis; children cerebral palsy, Down syndrome, peripheral nerve injury; skin diseases (psoriasis, photodermatosis, herpetiformis dermatitis, neurodermatitis); to prevent and treat symptoms of deficiency of Multivitamines, Mineraux Junior Regulier (Vitamin B12) (including the application of biguanide, PASA, vitamin C in high doses); radiation sickness.
Multivitamines, Mineraux Junior Regulier is used as injections SC, IV, IM, intralumbar, and also oral. With anemia associated with Multivitamines, Mineraux Junior Regulier (Vitamin B12) deficiency is introduced on 100-200 mcg in 2 days. In anemia with symptoms of funicular myelosis and megalocytic anemia with diseases of the nervous system - 400-500 micrograms in the first 7 days daily, then 1 time every 5-7 days. In the period of remission in the absence of events funicular myelosis maintenance dose - 100 mcg 2 times a month, in the presence of neurological symptoms - at 200-400 mcg 2-4 times a month. In acute post-hemorrhagic anemia and iron anemia by 30-100 mcg 2-3 times a week. When aplastic anemia (especially in children) - 100 micrograms before clinical improvement. When nutritional anemia in infants and preterm - 30 mcg / day during 15 days.
In diseases of the central and peripheral nervous system and neurological diseases with a pain syndrome is administered in increasing doses - 200-500 mcg, with the improvement in the state - 100 mcg / day. The course of treatment with Multivitamines, Mineraux Junior Regulier (Vitamin B12) is 2 weeks. In traumatic lesions of peripheral nervous system - at 200-400 mcg every other day for 40-45 days.
When hepatitis and cirrhosis - 30-60 mcg / day or 100 mg every other day for 25-40 days.
Dystrophy in young children, Down syndrome and cerebral palsy - by 15-30 mcg every other day.
When funicular myelosis, amyotrophic lateral sclerosis can be introduced into the spinal canal at 15-30 mcg, gradually increasing the dose of 200-250 micrograms.
In radiation sickness, diabetic neuropathy, sprue - by 60-100 mcg daily for 20-30 days.
When deficiency of Multivitamines, Mineraux Junior Regulier (Vitamin B12) to prevent - IV or IM for 1 mg 1 time a month; for treatment - IV or IM for 1 mg daily for 1-2 weeks, the maintenance dose is 1-2 mg IV or IM from 1 per week, up to 1 per month. Duration of treatment is determined individually.
CNS: rarely - a state of arousal.
Cardiovascular system: rarely - pain in the heart, tachycardia.
Allergic reactions: rarely - urticaria.
Thromboembolism, erythremia, erythrocytosis, increased sensitivity to cyanocobalamin.
Cyanocobalamin can be used in pregnancy according to prescriptions.
When stenocardia should be used with caution in a single dose of Multivitamines, Mineraux Junior Regulier 100 mcg. During treatment should regularly monitor the blood picture and coagulation. It is unacceptable to enter in the same syringe with cyanocobalamin solutions of thiamine and pyridoxine.
In an application of Multivitamines, Mineraux Junior Regulier (Vitamin B12) with hormonal contraceptives for oral administration may decrease the concentration of cyanocobalamin in plasma.
In an application with anticonvulsant drugs decreased cyanocobalamin absorption from the gut.
In an Multivitamines, Mineraux Junior Regulier (Vitamin B12) application with neomycin, aminosalicylic acid, colchicine, cimetidine, ranitidine, drugs potassium decreased cyanocobalamin absorption from the gut.
Cyanocobalamin may exacerbate allergic reactions caused by thiamine.
When parenteral application of chloramphenicol may decrease the hematopoietic effects of cyanocobalamin with anemia.
Pharmaceutical incompatibility
Contained in the molecule of cyanocobalamin cobalt ion contributes to the destruction of ascorbic acid, thiamine bromide, riboflavin in one solution.
Vitamin C:
Ascorbic acid is essential for the formation of intracellular collagen, is required to strengthen the structure of teeth, bones, and the capillary walls. Multivitamines, Mineraux Junior Regulier (Vitamin C) participates in redox reactions, the metabolism of tyrosine, converting folic acid into folinic acid, metabolism of carbohydrates, the synthesis of lipids and proteins, iron metabolism, processes of cellular respiration. Reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid, enhances the body's resistance to infections; enhances iron absorption, contributing to its sequestration in reduced form. Multivitamines, Mineraux Junior Regulier (Vitamin C) has antioxidant properties.
With intravaginal application of ascorbic acid lowers the vaginal pH, inhibiting the growth of bacteria and helps to restore and maintain normal pH and vaginal flora (Lactobacillus acidophilus, Lactobacillus gasseri).
After oral administration ascorbic acid is completely absorbed from the gastrointestinal tract. Widely distributed in body tissues.
The concentration of ascorbic acid in blood plasma in normal amounts to approximately 10-20 mg / ml.
The concentration of ascorbic acid in white blood cells and platelets is higher than in erythrocytes and plasma. When deficient state of concentration in leucocytes is reduced later and more slowly and is regarded as the best criterion for evaluating the deficit than the concentration in plasma.
Plasma protein binding is about 25%.
Ascorbic acid is reversibly oxidized to form dehydroascorbic acid, is metabolized with the formation of ascorbate-2-sulphate which is inactive and oxalic acid which is excreted in the urine.
Ascorbic acid taken in excessive quantities is rapidly excreted unchanged in urine, it usually happens when exceeding a daily dose is 200 mg.
For systemic use of Multivitamines, Mineraux Junior Regulier (Vitamin C) Kimia Farma: prevention and treatment of hypo- and avitaminosis of Multivitamines, Mineraux Junior Regulier (Vitamin C); providing increased need for Multivitamines, Mineraux Junior Regulier (Vitamin C) during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.
For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.
This medication administered orally, IM, IV, intravaginally.
For the prevention of deficiency conditions Multivitamines, Mineraux Junior Regulier dose is 25-75 mg / day, for the treatment - 250 mg / day or more in divided doses.
For intravaginal used ascorbic acid drugs in appropriate dosage forms.
CNS: headache, fatigue, insomnia.
Digestive system: stomach cramps, nausea and vomiting.
Allergic reaction: describes a few cases of skin reactions and manifestations of the respiratory system.
Urinary system: when used in high doses - hyperoxaluria and the formation of kidney stones of calcium oxalate.
Local reactions: with intravaginal application - a burning or itching in the vagina, increased mucous discharge, redness, swelling of the vulva. Other: sensation of heat.
Increased sensitivity to ascorbic acid.
The minimum daily requirement of ascorbic acid in the II and III trimester of pregnancy is about 60 mg.
Ascorbic acid crosses the placental barrier. It should be borne in mind that the fetus can adapt to high doses of ascorbic acid, which takes a pregnant woman, and then a newborn baby may develop the ascorbic disease as the reaction of cancel. Therefore, during pregnancy should not to take ascorbic acid in high doses, except in cases where the expected benefit outweighs the potential risk.
The minimum daily requirement during lactation is 80 mg. Ascorbic acid is excreted in breast milk. A mother's diet that contains adequate amounts of ascorbic acid, is sufficient to prevent deficiency in an infant. It is unknown whether dangerous to the child's mother use of ascorbic acid in high doses. Theoretically it is possible. Therefore, it is recommended not to exceed the maximum daily nursing mother needs to ascorbic acid, except when the expected benefit outweighs the potential risk.
Multivitamines, Mineraux Junior Regulier (Vitamin C) is used with caution in patients with hyperoxaluria, renal impairment, a history of instructions on urolithiasis. Because ascorbic acid increases iron absorption, its use in high doses can be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia.
Patients with high content body iron should apply ascorbic acid in minimal doses.
Multivitamines, Mineraux Junior Regulier (Vitamin C) is used with caution in patients with deficiency of glucose-6-phosphate dehydrogenase.
The use of ascorbic acid in high doses can cause exacerbation of sickle cell anemia.
Data on the diabetogenic action of ascorbic acid are contradictory. However, prolonged use of ascorbic acid should periodically monitor your blood glucose levels.
It is believed that the use of ascorbic acid in patients with rapidly proliferating and widely disseminated tumors may worsen during the process. It should therefore be used with caution in ascorbic acid in patients with advanced cancer.
Absorption of ascorbic acid decreased while use of fresh fruit or vegetable juices, alkaline drinking.
In an application with barbiturates, primidone increases the excretion of ascorbic acid in the urine.
With the simultaneous use of oral contraceptives reduces the concentration of ascorbic acid in blood plasma.
In an application of Multivitamines, Mineraux Junior Regulier (Vitamin C) with iron preparations ascorbic acid, due to its regenerative properties, transforms ferric iron in the bivalent, which improves its absorption.
Ascorbic acid in high doses can decrease urine pH that while the application reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.
With the simultaneous use of aspirin reduces the absorption of ascorbic acid by about a third.
Multivitamines, Mineraux Junior Regulier (Vitamin C) in an application with warfarin may decrease effects of warfarin.
With the simultaneous application of ascorbic acid increases the excretion of iron in patients receiving deferoxamine. In the application of ascorbic acid at a dose of 500 mg / day possibly left ventricular dysfunction.
In an application with tetracycline is increased excretion of ascorbic acid in the urine.
There is a described case of reducing the concentration of fluphenazine in plasma in patients treated with ascorbic acid 500 mg 2 times / day.
May increase the concentration of ethinyl estradiol in the blood plasma in its simultaneous application in the oral contraceptives.
Symptoms: long-term use of large doses (more than 1 g) - headache, increased CNS excitability, insomnia, nausea, vomiting, diarrhea, gastritis giperatsidnyh, ultseratsiya gastrointestinal mucosa, inhibition of the function insular apparatus of the pancreas (hyperglycemia, glycosuria), hyperoxaluria, nephrolithiasis (calcium oxalate), damage to the glomerular apparatus of the kidneys, moderate thamuria (when receiving a dose of 600 mg / day).
Decrease capillary permeability (possibly deteriorating trophic tissues, increased blood pressure, hypercoagulability, the development of microangiopathy).
When IV administration in high doses - the threat of termination of pregnancy (due to estrogenemia), hemolysis of red blood cells.
Depending on the reaction of the Multivitamines, Mineraux Junior Regulier after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Multivitamines, Mineraux Junior Regulier not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Multivitamines, Mineraux Junior Regulier addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology