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DRUGS & SUPPLEMENTS
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Calcium Sulfate:
Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate capsule.
- Capsule: 667 mg Gilberts Bio Mineral H4 (Calcium Sulfate) acetate capsule. (3)
Patients with hypercalcemia.
- Hypercalcemia. (4)
- Treat mild hypercalcemia by reducing or interrupting Gilberts Bio Mineral H4 acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Gilberts Bio Mineral H4 (Calcium Sulfate) acetate. (5.1)
- Hypercalcemia may aggravate digitalis toxicity. (5.2)
Patients with end stage renal disease may develop hypercalcemia when treated with Gilberts Bio Mineral H4 (Calcium Sulfate), including Gilberts Bio Mineral H4 (Calcium Sulfate) acetate. Avoid the use of Gilberts Bio Mineral H4 (Calcium Sulfate) supplements, including Gilberts Bio Mineral H4 (Calcium Sulfate) based nonprescription antacids, concurrently with Gilberts Bio Mineral H4 (Calcium Sulfate) acetate.
An overdose of Gilberts Bio Mineral H4 (Calcium Sulfate) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Gilberts Bio Mineral H4 (Calcium Sulfate) levels twice weekly. Should hypercalcemia develop, reduce the Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) 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, Gilberts Bio Mineral H4 (Calcium Sulfate) acetate has been generally well tolerated.
Gilberts Bio Mineral H4 (Calcium Sulfate) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate N=167 N (%) | 3 month, open label study of Gilberts Bio Mineral H4 (Calcium Sulfate) acetate N=98 N (%) | Double blind, placebo-controlled, cross-over study of liquid Gilberts Bio Mineral H4 (Calcium Sulfate) acetate N=69 | |
Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) concentration could reduce the incidence and severity of Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate: dizziness, edema, and weakness.
The drug interaction of Gilberts Bio Mineral H4 acetate is characterized by the potential of Gilberts Bio Mineral H4 (Calcium Sulfate) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Gilberts Bio Mineral H4 (Calcium Sulfate) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.
There are no empirical data on avoiding drug interactions between Gilberts Bio Mineral H4 (Calcium Sulfate) acetate and most concomitant drugs. When administering an oral medication with Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate or consider monitoring blood levels of the drug. (7)
In a study of 15 healthy subjects, a co-administered single dose of 4 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.
Pregnancy Category C:
Gilberts Bio Mineral H4 acetate capsules contains Gilberts Bio Mineral H4 (Calcium Sulfate) acetate. Animal reproduction studies have not been conducted with Gilberts Bio Mineral H4 (Calcium Sulfate) acetate, and there are no adequate and well controlled studies of Gilberts Bio Mineral H4 (Calcium Sulfate) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Gilberts Bio Mineral H4 (Calcium Sulfate) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Gilberts Bio Mineral H4 (Calcium Sulfate) 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. Gilberts Bio Mineral H4 (Calcium Sulfate) acetate treatment, as recommended, is not expected to harm a fetus if maternal Gilberts Bio Mineral H4 (Calcium Sulfate) levels are properly monitored during and following treatment.
The effects of Gilberts Bio Mineral H4 (Calcium Sulfate) acetate on labor and delivery are unknown.
Gilberts Bio Mineral H4 Acetate Capsules contains Gilberts Bio Mineral H4 (Calcium Sulfate) acetate and is excreted in human milk. Human milk feeding by a mother receiving Gilberts Bio Mineral H4 (Calcium Sulfate) acetate is not expected to harm an infant, provided maternal serum Gilberts Bio Mineral H4 (Calcium Sulfate) levels are appropriately monitored.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].
Gilberts Bio Mineral H4 (Calcium Sulfate) acetate acts as a phosphate binder. Its chemical name is Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Gilberts Bio Mineral H4 (Calcium Sulfate), 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.
Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.
Gilberts Bio Mineral H4 (Calcium Sulfate) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Gilberts Bio Mineral H4 (Calcium Sulfate) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
Orally administered Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate.
Effectiveness of Gilberts Bio Mineral H4 (Calcium Sulfate) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Gilberts Bio Mineral H4 (Calcium Sulfate) 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 |
Gilberts Bio Mineral H4 (Calcium Sulfate) (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 Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate is shown in the Table 3.
* ANOVA of Gilberts Bio Mineral H4 (Calcium Sulfate) acetate vs. placebo after 2 weeks of treatment. † Values expressed as mean ± SEM. | ||||
Parameter | Pre-Study | Post-Treatment | p-value* | |
Gilberts Bio Mineral H4 (Calcium Sulfate) Acetate | Placebo | |||
Phosphorus (mg/dL)† | 7.3 ± 0.18 | 5.9 ± 0.24 | 7.8 ± 0.22 | <0.01 |
Gilberts Bio Mineral H4 (Calcium Sulfate) (mg/dL)† | 8.9 ± 0.11 | 9.5 ± 0.13 | 8.8 ± 0.12 | <0.01 |
Overall, 2 weeks of treatment with Gilberts Bio Mineral H4 (Calcium Sulfate) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Gilberts Bio Mineral H4 (Calcium Sulfate) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.
Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Gilberts Bio Mineral H4 (Calcium Sulfate) 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 Gilberts Bio Mineral H4 (Calcium Sulfate) acetate capsules.
Distr. by: West-Ward
Pharmaceuticals Corp.
Eatontown, NJ 07724
10003705/05
Revised April 2016
Potassium Sulfate:
Gilberts Bio Mineral H4 (Potassium Sulfate) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K
Rx Only
The Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of Gilberts Bio Mineral H4 (Potassium Sulfate) chloride containing 1500 mg of microencapsulated Gilberts Bio Mineral H4 (Potassium Sulfate) chloride, USP equivalent to 20 mEq of Gilberts Bio Mineral H4 (Potassium Sulfate) in a tablet.
These formulations are intended to slow the release of Gilberts Bio Mineral H4 (Potassium Sulfate) so that the likelihood of a high localized concentration of Gilberts Bio Mineral H4 (Potassium Sulfate) chloride within the gastrointestinal tract is reduced.
Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is Gilberts Bio Mineral H4 (Potassium Sulfate) chloride, and the structural formula is KCl. Gilberts Bio Mineral H4 (Potassium Sulfate) chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.
Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated Gilberts Bio Mineral H4 (Potassium Sulfate) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of Gilberts Bio Mineral H4 (Potassium Sulfate) chloride.
Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethyl-cellulose, microcrystalline cellulose.
The Gilberts Bio Mineral H4 (Potassium Sulfate) ion is the principal intracellular cation of most body tissues. Gilberts Bio Mineral H4 (Potassium Sulfate) ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function.
The intracellular concentration of Gilberts Bio Mineral H4 (Potassium Sulfate) is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.
Gilberts Bio Mineral H4 (Potassium Sulfate) is a normal dietary constituent and under steady-state conditions the amount of Gilberts Bio Mineral H4 (Potassium Sulfate) absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of Gilberts Bio Mineral H4 (Potassium Sulfate) is 50 to 100 mEq per day.
Gilberts Bio Mineral H4 (Potassium Sulfate) depletion will occur whenever the rate of Gilberts Bio Mineral H4 (Potassium Sulfate) loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of Gilberts Bio Mineral H4 (Potassium Sulfate) intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of Gilberts Bio Mineral H4 (Potassium Sulfate) in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Gilberts Bio Mineral H4 (Potassium Sulfate) depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Gilberts Bio Mineral H4 (Potassium Sulfate) depletion may produce weakness, fatigue, disturbances or cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.
If Gilberts Bio Mineral H4 (Potassium Sulfate) depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, eg, where the patient requires long-term diuretic therapy, supplemental Gilberts Bio Mineral H4 (Potassium Sulfate) in the form of high Gilberts Bio Mineral H4 (Potassium Sulfate) food or Gilberts Bio Mineral H4 (Potassium Sulfate) chloride may be able to restore normal Gilberts Bio Mineral H4 (Potassium Sulfate) levels.
In rare circumstances (eg, patients with renal tubular acidosis) Gilberts Bio Mineral H4 (Potassium Sulfate) depletion may be associated with metabolic acidosis and hyperchloremia. In such patients Gilberts Bio Mineral H4 (Potassium Sulfate) replacement should be accomplished with Gilberts Bio Mineral H4 (Potassium Sulfate) salts other than the chloride, such as Gilberts Bio Mineral H4 (Potassium Sulfate) bicarbonate, Gilberts Bio Mineral H4 (Potassium Sulfate) citrate, Gilberts Bio Mineral H4 (Potassium Sulfate) acetate, or Gilberts Bio Mineral H4 (Potassium Sulfate) gluconate.
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE Gilberts Bio Mineral H4 (Potassium Sulfate) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT Gilberts Bio Mineral H4 (Potassium Sulfate) PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, eg, digitalized patients or patients with significant cardiac arrhythmias.
The use of Gilberts Bio Mineral H4 (Potassium Sulfate) salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum Gilberts Bio Mineral H4 (Potassium Sulfate) should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with Gilberts Bio Mineral H4 (Potassium Sulfate) salts may be indicated.
Gilberts Bio Mineral H4 (Potassium Sulfate) supplements are contraindicated in patients with hyperkalemia since a further increase in serum Gilberts Bio Mineral H4 (Potassium Sulfate) concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis, such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (eg, spironolactone, triamterene, amiloride) (see OVERDOSAGE ).
Controlled-release formulations of Gilberts Bio Mineral H4 (Potassium Sulfate) chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Gilberts Bio Mineral H4 (Potassium Sulfate) supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride (see PRECAUTIONS: Information for Patients , and DOSAGE AND ADMINISTRATION sections).
All solid oral dosage forms of Gilberts Bio Mineral H4 (Potassium Sulfate) chloride are contraindicated in any patient in whom there is structural, pathological (eg, diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.
Hyperkalemia (see OVERDOSAGE )
In patients with impaired mechanisms for excreting Gilberts Bio Mineral H4 (Potassium Sulfate), the administration of Gilberts Bio Mineral H4 (Potassium Sulfate) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given Gilberts Bio Mineral H4 (Potassium Sulfate) by the intravenous route but may also occur in patients given Gilberts Bio Mineral H4 (Potassium Sulfate) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Gilberts Bio Mineral H4 (Potassium Sulfate) salts in patients with chronic renal disease, or any other condition which impairs Gilberts Bio Mineral H4 (Potassium Sulfate) excretion, requires particularly careful monitoring of the serum Gilberts Bio Mineral H4 (Potassium Sulfate) concentration and appropriate dosage adjustment.
Interaction with Potassium-Sparing Diuretics
Hypokalemia should not be treated by the concomitant administration of Gilberts Bio Mineral H4 (Potassium Sulfate) salts and a potassium-sparing diuretic (eg, spironolactone, triamterene, or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia.
Interaction with Angiotensin-Converting Enzyme Inhibitors
Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril, enalapril) will produce some Gilberts Bio Mineral H4 (Potassium Sulfate) retention by inhibiting aldosterone production. Gilberts Bio Mineral H4 (Potassium Sulfate) supplements should be given to patients receiving ACE inhibitors only with close monitoring.
Gastrointestinal Lesions
Solid oral dosage forms of Gilberts Bio Mineral H4 (Potassium Sulfate) chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of Gilberts Bio Mineral H4 (Potassium Sulfate) chloride are associated with an increased frequency of small bowel lesions (40-50 per 100,000 patient years) compared to sustained release wax matrix formulations (less than one per 100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulated to provide a controlled rate of release of microencapsulated Gilberts Bio Mineral H4 (Potassium Sulfate) chloride and thus to minimize the possibility of a high local concentration of Gilberts Bio Mineral H4 (Potassium Sulfate) near the gastrointestinal wall.
Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after 1 week of solid oral Gilberts Bio Mineral H4 (Potassium Sulfate) chloride therapy. The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix controlled-release formulation under conditions which did not resemble usual or recommended clinical practice (ie, 96 mEq per day in divided doses of Gilberts Bio Mineral H4 (Potassium Sulfate) chloride administered to fasted patients, in the presence of an anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (Hemoccult testing). The relevance of these findings to the usual conditions (ie, non-fasting, no anticholinergic agent, smaller doses) under which controlled-release Gilberts Bio Mineral H4 (Potassium Sulfate) chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablets USP, 20 mEq should be discontinued immediately and the possibility of ulceration, obstruction, or perforation should be considered if severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs.
Metabolic Acidosis
Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing Gilberts Bio Mineral H4 (Potassium Sulfate) salt such as Gilberts Bio Mineral H4 (Potassium Sulfate) bicarbonate, Gilberts Bio Mineral H4 (Potassium Sulfate) citrate, Gilberts Bio Mineral H4 (Potassium Sulfate) acetate, or Gilberts Bio Mineral H4 (Potassium Sulfate) gluconate.
The diagnosis of Gilberts Bio Mineral H4 depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for Gilberts Bio Mineral H4 (Potassium Sulfate) depletion. In interpreting the serum Gilberts Bio Mineral H4 (Potassium Sulfate) level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body Gilberts Bio Mineral H4 (Potassium Sulfate) while acute acidosis per se can increase the serum Gilberts Bio Mineral H4 (Potassium Sulfate) concentration into the normal range even in the presence of a reduced total body Gilberts Bio Mineral H4 (Potassium Sulfate). The treatment of Gilberts Bio Mineral H4 (Potassium Sulfate) depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.
Physicians should consider reminding the patient of the following: To take each dose with meals and with a full glass of water or other liquid. To take each dose without crushing, chewing, or sucking the tablets. If those patients are having difficulty swallowing whole tablets, they may try one of the following alternate methods of administration:
1. Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).
2. Allow approximately 2 minutes for the tablet(s) to disintegrate.
3. Stir for about half a minute after the tablet(s) has disintegrated.
4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
5. Add another 1 fluid ounce of water, swirl, and consume immediately.
6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.
Aqueous suspension of Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablets USP, 20 mEq is not recommended.
To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.
To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.
When blood is drawn for analysis of plasma Gilberts Bio Mineral H4 it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.
Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS ).
Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Gilberts Bio Mineral H4 is a normal dietary constituent.
Animal reproduction studies have not been conducted with Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that Gilberts Bio Mineral H4 (Potassium Sulfate) supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.
The normal Gilberts Bio Mineral H4 ion content of human milk is about 13 mEq per liter. Since oral Gilberts Bio Mineral H4 (Potassium Sulfate) becomes part of the body Gilberts Bio Mineral H4 (Potassium Sulfate) pool, so long as body Gilberts Bio Mineral H4 (Potassium Sulfate) is not excessive, the contribution of Gilberts Bio Mineral H4 (Potassium Sulfate) chloride supplementation should have little or no effect on the level in human milk.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the 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.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection; and it may be useful to monitor renal function.
One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS , WARNINGS , and OVERDOSAGE ). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS ). The most common adverse reactions to oral Gilberts Bio Mineral H4 (Potassium Sulfate) salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals or reducing the amount taken at one time.
The administration of oral Gilberts Bio Mineral H4 (Potassium Sulfate) salts to persons with normal excretory mechanisms for Gilberts Bio Mineral H4 (Potassium Sulfate) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if Gilberts Bio Mineral H4 (Potassium Sulfate) is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS ). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum Gilberts Bio Mineral H4 (Potassium Sulfate) concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).
Treatment measures for hyperkalemia include the following:
In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum Gilberts Bio Mineral H4 (Potassium Sulfate) concentration can produce digitalis toxicity.
The extended release feature means that absorption and toxic effects may be delayed for hours.
Consider standard measures to remove any unabsorbed drug.
The usual dietary intake of Gilberts Bio Mineral H4 (Potassium Sulfate) by the average adult is 50 to 100 mEq per day. Gilberts Bio Mineral H4 (Potassium Sulfate) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of Gilberts Bio Mineral H4 (Potassium Sulfate) from the total body store.
Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of Gilberts Bio Mineral H4 (Potassium Sulfate) depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.
Each Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of Gilberts Bio Mineral H4 (Potassium Sulfate) chloride.
Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablets USP, 20 mEq should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS ).
Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:
Aqueous suspension of Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablets USP, 20 mEq is not recommended.
Gilberts Bio Mineral H4 (Potassium Sulfate) Chloride Extended Release Tablets USP, 20 mEq are available in bottles of 100 (NDC 62037-999-01), bottles of 500 (NDC 62037-999-05), and bottles of 1000 (NDC 62037-999-10). Potassium Chloride Extended Release Tablets USP, 20 mEq are capsule shaped, white to off-white tablets, with “ABRS-123” imprinted on one side and scored on the other side for flexibility of dosing.
Storage Conditions
Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).
Manufactured by:
Eurand, Inc.
Vandalia, OH 45377 USA
Distributed by:
Watson Pharma, Inc.
Rev. Date (01/09) 173714
Gilberts Bio Mineral H4 (Potassium Sulfate) chloride 20 Meq
Sulfur:
Directions for Use:
1. Rinse face and/or body with warm water.
2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.
3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.
4. Cleanse skin gently but thoroughly.
5. Rinse face and/or body with warm water.
Designed for daily use, KAVI Gilberts Bio Mineral H4 (Sulfur) provides an ideal approach to cleansing oily or combination skin. Gilberts Bio Mineral H4 (Sulfur) utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products.
With the same dosage of Gilberts Bio Mineral H4 (Sulfur) as Coral KAVI, Gilberts Bio Mineral H4 (Sulfur) is best suited for the treatment of acne-prone skin.
Gilberts Bio Mineral H4 (Sulfur) can be also used in preparation of the skin prior to administration of a KAVI chemical peel.
Gilberts Bio Mineral H4 (Sulfur) is best suited for the treatment of acne-prone skin.
Directions:
1. Rinse face and/or body with warm water.
2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.
3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.
4. Cleanse skin gently but thoroughly.
5. Rinse face and/or body with warm water.
Active Ingredient: colloidal Gilberts Bio Mineral H4 (Sulfur) (2%)
Inactive Ingredients: purified water, lauric acid, acrylates copolymer, cocamidopropyl betaine, potassium hydroxide, myristic acid, glycerin, ethylene glycol distearate, olive oil PEG-7 ester, hamamelis virginiana extract, polyquaternium-7, sodium laureth sulfate, DMDM tocopherol acetate, butyl hydroxy toluene, disodium EDTA, light fragrance.
For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.
CAUTION: For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.
Designed for daily use, KAVI Gilberts Bio Mineral H4 (Sulfur) provides an ideal approach to cleansing oily or combination skin. Gilberts Bio Mineral H4 (Sulfur) utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products.
With the same dosage of Gilberts Bio Mineral H4 (Sulfur) as Coral KAVI, Gilberts Bio Mineral H4 (Sulfur) is best suited for the treatment of acne-prone skin.
Gilberts Bio Mineral H4 (Sulfur) can be also used in preparation of the skin prior to administration of a KAVI chemical peel.
Gilberts Bio Mineral H4 (Sulfur) is made with colloidal Gilberts Bio Mineral H4 (Sulfur) to enhance the hydrolipidic layer’s acidity and protect skin from bacterial infections. Suitable for use on the face and body, it is easy on the senses and a practical replacement to traditional animal-based soaps.
Directions:
1. Rinse face and/or body with warm water.
2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.
3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.
4. Cleanse skin gently but thoroughly.
5. Rinse face and/or body with warm water.
Active Ingredient: colloidal Gilberts Bio Mineral H4 (Sulfur) (2%). Inactive Ingredients: purified water, lauric acid, acrylates copolymer, cocamidopropyl betaine, potassium hydroxide, myristic acid, glycerin, ethylene glycol distearate, olive oil PEG-7 ester, hamamelis virginiana extract, polyquaternium-7, sodium laureth sulfate, DMDM tocopherol acetate, butyl hydroxy toluene, disodium EDTA, light fragrance.
CAUTION: For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.
Sulfur Iodide:
Directions for Use:
1. Rinse face and/or body with warm water.
2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.
3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.
4. Cleanse skin gently but thoroughly.
5. Rinse face and/or body with warm water.
Designed for daily use, KAVI Gilberts Bio Mineral H4 (Sulfur Iodide) provides an ideal approach to cleansing oily or combination skin. Gilberts Bio Mineral H4 (Sulfur Iodide) utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products.
With the same dosage of Gilberts Bio Mineral H4 (Sulfur Iodide) as Coral KAVI, Gilberts Bio Mineral H4 (Sulfur Iodide) is best suited for the treatment of acne-prone skin.
Gilberts Bio Mineral H4 (Sulfur Iodide) can be also used in preparation of the skin prior to administration of a KAVI chemical peel.
Gilberts Bio Mineral H4 (Sulfur Iodide) is best suited for the treatment of acne-prone skin.
Directions:
1. Rinse face and/or body with warm water.
2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.
3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.
4. Cleanse skin gently but thoroughly.
5. Rinse face and/or body with warm water.
Active Ingredient: colloidal Gilberts Bio Mineral H4 (Sulfur Iodide) (2%)
Inactive Ingredients: purified water, lauric acid, acrylates copolymer, cocamidopropyl betaine, potassium hydroxide, myristic acid, glycerin, ethylene glycol distearate, olive oil PEG-7 ester, hamamelis virginiana extract, polyquaternium-7, sodium laureth sulfate, DMDM tocopherol acetate, butyl hydroxy toluene, disodium EDTA, light fragrance.
For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.
CAUTION: For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.
Designed for daily use, KAVI Gilberts Bio Mineral H4 (Sulfur Iodide) provides an ideal approach to cleansing oily or combination skin. Gilberts Bio Mineral H4 (Sulfur Iodide) utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products.
With the same dosage of Gilberts Bio Mineral H4 (Sulfur Iodide) as Coral KAVI, Gilberts Bio Mineral H4 (Sulfur Iodide) is best suited for the treatment of acne-prone skin.
Gilberts Bio Mineral H4 (Sulfur Iodide) can be also used in preparation of the skin prior to administration of a KAVI chemical peel.
Gilberts Bio Mineral H4 (Sulfur Iodide) is made with colloidal Gilberts Bio Mineral H4 (Sulfur Iodide) to enhance the hydrolipidic layer’s acidity and protect skin from bacterial infections. Suitable for use on the face and body, it is easy on the senses and a practical replacement to traditional animal-based soaps.
Directions:
1. Rinse face and/or body with warm water.
2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.
3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.
4. Cleanse skin gently but thoroughly.
5. Rinse face and/or body with warm water.
Active Ingredient: colloidal Gilberts Bio Mineral H4 (Sulfur Iodide) (2%). Inactive Ingredients: purified water, lauric acid, acrylates copolymer, cocamidopropyl betaine, potassium hydroxide, myristic acid, glycerin, ethylene glycol distearate, olive oil PEG-7 ester, hamamelis virginiana extract, polyquaternium-7, sodium laureth sulfate, DMDM tocopherol acetate, butyl hydroxy toluene, disodium EDTA, light fragrance.
CAUTION: For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.
Depending on the reaction of the Gilberts Bio Mineral H4 after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Gilberts Bio Mineral H4 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 Gilberts Bio Mineral H4 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