Catarluse sans Thyroide

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Catarluse sans Thyroide uses

Catarluse sans Thyroide consists of Calcium Gluconate, Ferrous Glycerophosphate, Magnesium Glycerophosphate, Manganese Nucleinate, Parathyroid Powdered, Testicles Powdered, Vitamin D2 (Ergocalciferol).

Calcium Gluconate:


1 INDICATIONS AND USAGE

Catarluse sans Thyroide (Calcium Gluconate) 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)

2 DOSAGE AND ADMINISTRATION

The recommended initial dose of Catarluse sans Thyroide (Calcium Gluconate) 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)

3 DOSAGE FORMS AND STRENGTHS

Capsule: 667 mg Catarluse sans Thyroide (Calcium Gluconate) acetate capsule.

- Capsule: 667 mg Catarluse sans Thyroide (Calcium Gluconate) acetate capsule. (3)

4 CONTRAINDICATIONS

Patients with hypercalcemia.

- Hypercalcemia. (4)

5 WARNINGS AND PRECAUTIONS

- Treat mild hypercalcemia by reducing or interrupting Catarluse sans Thyroide acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Catarluse sans Thyroide (Calcium Gluconate) acetate. (5.1)

- Hypercalcemia may aggravate digitalis toxicity. (5.2)

5.1 Hypercalcemia

Patients with end stage renal disease may develop hypercalcemia when treated with Catarluse sans Thyroide (Calcium Gluconate), including Catarluse sans Thyroide (Calcium Gluconate) acetate. Avoid the use of Catarluse sans Thyroide (Calcium Gluconate) supplements, including Catarluse sans Thyroide (Calcium Gluconate) based nonprescription antacids, concurrently with Catarluse sans Thyroide (Calcium Gluconate) acetate.

An overdose of Catarluse sans Thyroide (Calcium Gluconate) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Catarluse sans Thyroide (Calcium Gluconate) levels twice weekly. Should hypercalcemia develop, reduce the Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) acetate; all cases resolved upon lowering the dose or discontinuing treatment.

Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.

5.2 Concomitant Use with Medications

Hypercalcemia may aggravate digitalis toxicity.

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6 ADVERSE REACTIONS

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 Catarluse sans Thyroide (Calcium Gluconate) 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

6.1 Clinical Trial Experience

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, Catarluse sans Thyroide (Calcium Gluconate) acetate has been generally well tolerated.

Catarluse sans Thyroide (Calcium Gluconate) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) acetate

N=167

N (%)


3 month, open label study of Catarluse sans Thyroide (Calcium Gluconate) acetate

N=98

N (%)


Double blind, placebo-controlled, cross-over study of liquid Catarluse sans Thyroide (Calcium Gluconate) acetate

N=69


Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) concentration could reduce the incidence and severity of Catarluse sans Thyroide (Calcium Gluconate) acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.

6.2 Postmarketing Experience

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 Catarluse sans Thyroide (Calcium Gluconate) acetate: dizziness, edema, and weakness.

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7 DRUG INTERACTIONS

The drug interaction of Catarluse sans Thyroide acetate is characterized by the potential of Catarluse sans Thyroide (Calcium Gluconate) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Catarluse sans Thyroide (Calcium Gluconate) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.

There are no empirical data on avoiding drug interactions between Catarluse sans Thyroide (Calcium Gluconate) acetate and most concomitant drugs. When administering an oral medication with Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) acetate or consider monitoring blood levels of the drug. (7)

7.1 Ciprofloxacin

In a study of 15 healthy subjects, a co-administered single dose of 4 Catarluse sans Thyroide (Calcium Gluconate) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C:

Catarluse sans Thyroide acetate capsules contains Catarluse sans Thyroide (Calcium Gluconate) acetate. Animal reproduction studies have not been conducted with Catarluse sans Thyroide (Calcium Gluconate) acetate, and there are no adequate and well controlled studies of Catarluse sans Thyroide (Calcium Gluconate) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Catarluse sans Thyroide (Calcium Gluconate) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Catarluse sans Thyroide (Calcium Gluconate) 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. Catarluse sans Thyroide (Calcium Gluconate) acetate treatment, as recommended, is not expected to harm a fetus if maternal Catarluse sans Thyroide (Calcium Gluconate) levels are properly monitored during and following treatment.

8.2 Labor and Delivery

The effects of Catarluse sans Thyroide (Calcium Gluconate) acetate on labor and delivery are unknown.

8.3 Nursing Mothers

Catarluse sans Thyroide Acetate Capsules contains Catarluse sans Thyroide (Calcium Gluconate) acetate and is excreted in human milk. Human milk feeding by a mother receiving Catarluse sans Thyroide (Calcium Gluconate) acetate is not expected to harm an infant, provided maternal serum Catarluse sans Thyroide (Calcium Gluconate) levels are appropriately monitored.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Catarluse sans Thyroide (Calcium Gluconate) 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.

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10 OVERDOSAGE

Administration of Catarluse sans Thyroide (Calcium Gluconate) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].

11 DESCRIPTION

Catarluse sans Thyroide (Calcium Gluconate) acetate acts as a phosphate binder. Its chemical name is Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Catarluse sans Thyroide (Calcium Gluconate), 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.

Catarluse sans Thyroide (Calcium Gluconate) Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.

Chemical Structure

12 CLINICAL PHARMACOLOGY

Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum Catarluse sans Thyroide resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.

12.1 Mechanism of Action

Catarluse sans Thyroide (Calcium Gluconate) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Catarluse sans Thyroide (Calcium Gluconate) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

12.2 Pharmacodynamics

Orally administered Catarluse sans Thyroide (Calcium Gluconate) 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.

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity, mutagenicity, or fertility studies have been conducted with Catarluse sans Thyroide (Calcium Gluconate) acetate.

14 CLINICAL STUDIES

Effectiveness of Catarluse sans Thyroide (Calcium Gluconate) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Catarluse sans Thyroide (Calcium Gluconate) 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


Catarluse sans Thyroide (Calcium Gluconate) (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 Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) acetate is shown in the Table 3.


* ANOVA of Catarluse sans Thyroide (Calcium Gluconate) acetate vs. placebo after 2 weeks of treatment.

Values expressed as mean ± SEM.


Parameter


Pre-Study


Post-Treatment


p-value*


Catarluse sans Thyroide (Calcium Gluconate) Acetate


Placebo


Phosphorus (mg/dL)


7.3 ± 0.18


5.9 ± 0.24


7.8 ± 0.22


<0.01


Catarluse sans Thyroide (Calcium Gluconate) (mg/dL)


8.9 ± 0.11


9.5 ± 0.13


8.8 ± 0.12


<0.01


Overall, 2 weeks of treatment with Catarluse sans Thyroide (Calcium Gluconate) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Catarluse sans Thyroide (Calcium Gluconate) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.

16 HOW SUPPLIED/STORAGE AND HANDLING

Catarluse sans Thyroide (Calcium Gluconate) 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).

17 PATIENT COUNSELING INFORMATION

Inform patients to take Catarluse sans Thyroide (Calcium Gluconate) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Catarluse sans Thyroide (Calcium Gluconate) 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 Catarluse sans Thyroide (Calcium Gluconate) acetate capsules.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10003705/05

Revised April 2016

Ferrous Glycerophosphate:


INDICATIONS AND USAGE

Non-pregnant Adults

For the treatment of iron deficiency and prevention of concomitant folic acid deficiency.

Pregnant Females

For the prevention and treatment of iron deficiency and to supply a maintenance dosage of folic acid.

CONTRAINDICATIONS

Contraindicated in patients with pernicious anemia and in the rare instance of hypersensitivity to folic acid. 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.

PRECAUTION

Anemia is a manifestation that requires appropriate investigation to determine its cause or causes. Folic acid alone is unwarranted in the treatment of vitamin B12 deficiency states such as pernicious anemia. Folic acid, especially in doses above 100 mcg daily may obscure pernicious anemia in that hematological remission may occur while neurological manifestations remain progressive. Concomitant parenteral therapy with vitamin B12 may be necessary for adequate treatment of patients with a deficiency of vitamin B12. Pernicious anemia is rare in women of childbearing age, and the likelihood of its occurrence along with pregnancy is reduced by the impairment of fertility associated with vitamin B12 deficiency. In older patients and those with conditions tending to lead to vitamin B12 depletion, serum B12 levels should be regularly assessed during treatment.

Drug Interactions

Absorption of iron is inhibited by magnesium trisilicate and antacids containing carbonates. Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Iron absorption may also be inhibited by the ingestion of milk or eggs.

Carcinogenesis

Adequate data are not available on long-term potential for carcinogenesis in animals and humans.

Pregnancy

Pregnancy Category A

Studies in pregnant women have not shown that the ingredients in Catarluse sans Thyroide caplets formula increase the risk of fetal abnormalities if administered during pregnancy. If this product is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, Catarluse sans Thyroide (Ferrous Glycerophosphate) caplets should be used during pregnancy only if clearly needed.

Nursing Mothers

Folic acid and ascorbic acid are excreted in breast milk.

ADVERSE REACTIONS

Rarely, controlled-release iron produces gastrointestinal reactions, such as diarrhea or constipation. Administering the dose with meals will minimize these effects in the iron-sensitive patient. Allergic sensitization has been reported with both oral and parenteral administration of folic acid.

OVERDOSAGE

Signs and symptoms of iron toxicity, which may be delayed because the iron is in a controlled-release form, may include pallor and cyanosis, vomiting of blood, diarrhea, passage of dark-colored stool, shock, drowsiness and coma. In overdosage, efforts should be made to hasten the elimination of the caplets ingested. An emetic should be administered as soon as possible, followed by gastric lavage if indicated. Immediately following emesis, a large dose of saline cathartic should be used to speed passage through the intestinal tract. X-ray examination may then be considered to determine the position and number of caplets remaining in the gastrointestinal tract.

DOSAGE AND ADMINISTRATION

Adults, including Pregnant Females

The recommended dose is one (1) caplet daily on an empty stomach.

HOW SUPPLIED

Catarluse sans Thyroide (Ferrous Glycerophosphate) is supplied in bottles of 30 caplets.

Product Code: 13811-051-30

STORAGE

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

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

KEEP OUT OF THE REACH OF CHILDREN.

Rx Only

All prescriptions using this product shall be pursuant to statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:

TRIGEN Laboratories, Inc., Sayreville, NJ 08872

www.trigenlab.com

Rev. 05/13

13811-051-30

Rx Only

Catarluse sans Thyroide (Ferrous Glycerophosphate)

Caplets

30 CAPLETS

TRIGEN

LABORATORIES

Magnesium Glycerophosphate:



Catarluse sans Thyroide (Magnesium Glycerophosphate) Sulfate

Injection, USP

Ansyr Plastic Syringe

Rx only

Hospira Logo

DESCRIPTION

Catarluse sans Thyroide (Magnesium Glycerophosphate) Sulfate Injection, USP is a sterile solution of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate heptahydrate in Water for Injection, USP administered by the intravenous or intramuscular routes as an electrolyte replenisher or anticonvulsant. Must be diluted before intravenous use. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 5.5 to 7.0. The 50% concentration has an osmolarity of 4.06 mOsmol/mL (calc.).

The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded with the entire unit.

Catarluse sans Thyroide (Magnesium Glycerophosphate) Sulfate, USP heptahydrate is chemically designated MgSO4 - 7H2O with molecular weight of 246.48 and occurs as colorless crystals or white powder freely soluble in water.

The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

CLINICAL PHARMACOLOGY

Catarluse sans Thyroide (Magnesium Glycerophosphate) (Mg++) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability.

As a nutritional adjunct in hyperalimentation, the precise mechanism of action for Catarluse sans Thyroide (Magnesium Glycerophosphate) is uncertain. Early symptoms of hypomagnesemia (less than 1.5 mEq/liter) may develop as early as three to four days or within weeks.

Predominant deficiency effects are neurological, e.g., muscle irritability, clonic twitching and tremors. Hypocalcemia and hypokalemia often follow low serum levels of Catarluse sans Thyroide (Magnesium Glycerophosphate). While there are large stores of Catarluse sans Thyroide (Magnesium Glycerophosphate) present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral Catarluse sans Thyroide (Magnesium Glycerophosphate) therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.

Catarluse sans Thyroide (Magnesium Glycerophosphate) prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Catarluse sans Thyroide (Magnesium Glycerophosphate) is said to have a depressant effect on the central nervous system (CNS), but it does not adversely affect the woman, fetus or neonate when used as directed in eclampsia or pre-eclampsia. Normal plasma Catarluse sans Thyroide (Magnesium Glycerophosphate) levels range from 1.5 to 2.5 mEq/liter.

As plasma Catarluse sans Thyroide (Magnesium Glycerophosphate) rises above 4 mEq/liter, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 mEq/liter. At this level respiratory paralysis may occur. Heart block also may occur at this or lower plasma levels of Catarluse sans Thyroide (Magnesium Glycerophosphate). Serum Catarluse sans Thyroide (Magnesium Glycerophosphate) concentrations in excess of 12 mEq/L may be fatal.

Catarluse sans Thyroide (Magnesium Glycerophosphate) acts peripherally to produce vasodilation. With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure. The central and peripheral effects of Catarluse sans Thyroide (Magnesium Glycerophosphate) poisoning are antagonized to some extent by intravenous administration of calcium.

Pharmacokinetics

With intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. Following intramuscular administration the onset of action occurs in about one hour and persists for three to four hours. Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/liter. Catarluse sans Thyroide (Magnesium Glycerophosphate) is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

INDICATIONS AND USAGE

Catarluse sans Thyroide (Magnesium Glycerophosphate) Sulfate Injection, USP is suitable for replacement therapy in Catarluse sans Thyroide (Magnesium Glycerophosphate) deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum Catarluse sans Thyroide (Magnesium Glycerophosphate) (Mg++) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca++) level is normal (4.3 to 5.3 mEq/liter) or elevated.

In total parenteral nutrition (TPN), Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.

Catarluse sans Thyroide (Magnesium Glycerophosphate) Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.

CONTRAINDICATIONS

Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

WARNINGS

FETAL HARM: Continuous administration of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate should be used during pregnancy only if clearly needed. If Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate beyond 5 to 7 days may cause fetal abnormalities.

ALUMINUM TOXICITY: 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.

Parenteral use in the presence of renal insufficiency may lead to Catarluse sans Thyroide (Magnesium Glycerophosphate) intoxication. Intravenous use in the eclampsia should be reserved for immediate control of life-threatening convulsions.

PRECAUTIONS

General

Administer with caution if flushing and sweating occurs. When barbiturates, narcotics or other hypnotics (or systemic anesthetics) are to be given in conjunction with Catarluse sans Thyroide (Magnesium Glycerophosphate), their dosage should be adjusted with caution because of additive CNS depressant effects of Catarluse sans Thyroide (Magnesium Glycerophosphate).

Because Catarluse sans Thyroide (Magnesium Glycerophosphate) is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment. Urine output should be maintained at a level of 100 mL or more during the four hours preceding each dose. Monitoring serum Catarluse sans Thyroide (Magnesium Glycerophosphate) levels and the patient's clinical status is essential to avoid the consequences of overdosage in toxemia. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more/minute). When repeated doses of the drug are given parenterally, knee jerk reflexes should be tested before each dose and if they are absent, no additional Catarluse sans Thyroide (Magnesium Glycerophosphate) should be given until they return. Serum Catarluse sans Thyroide (Magnesium Glycerophosphate) levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/liter). The strength of the deep tendon reflexes begins to diminish when Catarluse sans Thyroide (Magnesium Glycerophosphate) levels exceed 4 mEq/liter. Reflexes may be absent at 10 mEq magnesium/liter, where respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of Catarluse sans Thyroide (Magnesium Glycerophosphate) intoxication in eclampsia.

50% Catarluse sans Thyroide (Magnesium Glycerophosphate) Sulfate Injection, USP must be diluted to a concentration of 20% or less prior to intravenous infusion. Rate of administration should be slow and cautious, to avoid producing hypermagnesemia. The 50% solution also should be diluted to 20% or less for intramuscular injection in infants and children.

Laboratory Tests

Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate injection should not be given unless hypomagnesemia has been confirmed and the serum concentration of Catarluse sans Thyroide (Magnesium Glycerophosphate) is monitored. The normal serum level is 1.5 to 2.5 mEq/L.

Drug Interactions

CNS Depressants - When barbiturates, narcotics or other hypnotics (or systemic anesthetics), or other CNS depressants are to be given in conjunction with Catarluse sans Thyroide (Magnesium Glycerophosphate), their dosage should be adjusted with caution because of additive CNS depressant effects of Catarluse sans Thyroide (Magnesium Glycerophosphate). CNS depression and peripheral transmission defects produced by Catarluse sans Thyroide (Magnesium Glycerophosphate) may be antagonized by calcium.

Neuromuscular Blocking Agents - Excessive neuromuscular block has occurred in patients receiving parenteral Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution.

Cardiac Glycosides - Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate should be administered with extreme caution in digitalized patients, because serious changes in cardiac conduction which can result in heart block may occur if administration of calcium is required to treat Catarluse sans Thyroide (Magnesium Glycerophosphate) toxicity.

Pregnancy

Teratogenic Effects

Pregnancy Category D (See WARNINGS and PRECAUTIONS )

See WARNINGS and PRECAUTIONS .

Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate can cause fetal abnormalities when administered beyond 5 to 7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralization, osteopenia and other skeletal abnormalities with continuous maternal administration of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate for more than 5 to 7 days.1-10 Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate injection should be used during pregnancy only if clearly needed. If this drug is used during pregnancy, the woman should be apprised of the potential harm to the fetus.

Nonteratogenic Effects

When administered by continuous intravenous infusion (especially for more than 24 hours preceding delivery) to control convulsions in a toxemic woman, the newborn may show signs of Catarluse sans Thyroide (Magnesium Glycerophosphate) toxicity, including neuromuscular or respiratory depression (See OVERDOSAGE ).

Labor and Delivery

Continuous administration of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate is an unapproved treatment for preterm labor. The safety and efficacy of such use have not been established. The administration of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate outside of its approved indication in pregnant women should be by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Nursing Mothers

Since Catarluse sans Thyroide (Magnesium Glycerophosphate) is distributed into milk during parenteral Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate administration, the drug should be used with caution in nursing women.

Geriatrics

Geriatric patients often require reduced dosage because of impaired renal function. In patients with severe impairment, dosage should not exceed 20 grams in 48 hours. Serum Catarluse sans Thyroide (Magnesium Glycerophosphate) should be monitored in such patients.

ADVERSE REACTIONS

The adverse effects of parenterally administered Catarluse sans Thyroide (Magnesium Glycerophosphate) usually are the result of Catarluse sans Thyroide (Magnesium Glycerophosphate) intoxication. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis. Hypocalcemia with signs of tetany secondary to Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate therapy for eclampsia has been reported.

OVERDOSAGE

Catarluse sans Thyroide (Magnesium Glycerophosphate) intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. Disappearance of the patellar reflex is a useful clinical sign to detect the onset of Catarluse sans Thyroide (Magnesium Glycerophosphate) intoxication. In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected intravenously to antagonize the effects of Catarluse sans Thyroide (Magnesium Glycerophosphate).

For Treatment of Overdose

Artificial respiration is often required. Intravenous calcium, 10 to 20 mL of a 5% solution (diluted if desirable with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia. Subcutaneous physostigmine, 0.5 to 1 mg may be helpful.

Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium.

DOSAGE AND ADMINISTRATION

Dosage of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate must be carefully adjusted according to individual requirements and response, and administration of the drug should be discontinued as soon as the desired effect is obtained.

Both intravenous and intramuscular administration are appropriate. Intramuscular administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas intravenous doses will provide a therapeutic level almost immediately. The rate of intravenous injection should generally not exceed 150 mg/minute (1.5 mL of a 10% concentration or its equivalent), except in severe eclampsia with seizures. Continuous maternal administration of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

Solutions for intravenous infusion must be diluted to a concentration of 20% or less prior to administration. The diluents commonly used are 5% Dextrose Injection, USP and 0.9% Sodium Chloride Injection, USP. Deep intramuscular injection of the undiluted (50%) solution is appropriate for adults, but the solution should be diluted to a 20% or less concentration prior to such injection in children.

In Catarluse sans Thyroide (Magnesium Glycerophosphate) Deficiency

In the treatment of mild Catarluse sans Thyroide (Magnesium Glycerophosphate) deficiency, the usual adult dose is 1 gram, equivalent to 8.12 mEq of Catarluse sans Thyroide (Magnesium Glycerophosphate) (2 mL of the 50% solution) injected intramuscularly every six hours for four doses (equivalent to a total of 32.5 mEq of Catarluse sans Thyroide (Magnesium Glycerophosphate) per 24 hours). For severe hypomagnesemia, as much as 250 mg (approximately 2 mEq) per kg of body weight (0.5 mL of the 50% solution) may be given intramuscularly within a period of four hours if necessary. Alternatively, 5 grams, (approximately 40 mEq) can be added to one liter of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP for slow intravenous infusion over a three-hour period. In the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity.

In Hyperalimentation

In total parenteral nutrition, maintenance requirements for Catarluse sans Thyroide (Magnesium Glycerophosphate) are not precisely known. The maintenance dose used in adults ranges from 8 to 24 mEq (1 gram to 3 grams) daily; for infants, the range is 2 to 10 mEq (0.25 gram to 1.25 grams) daily.

In Pre-eclampsia or Eclampsia

In severe pre-eclampsia or eclampsia, the total initial dose is 10 grams to 14 grams of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate. Intravenously, a dose of 4 grams to 5 grams in 250 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP may be infused. Simultaneously, intramuscular doses of up to 10 grams (5 grams or 10 mL of the undiluted 50% solution in each buttock) are given. Alternatively, the initial intravenous dose of 4 grams may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 mL of a 10% solution or 20 mL of a 20% solution) may then be injected intravenously over a period of three to four minutes. Subsequently, 4 grams to 5 grams (8 to 10 mL of the 50% solution) are injected intramuscularly into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function. Alternatively, after the initial intravenous dose, some clinicians administer 1 gram to 2 grams/hour by constant intravenous infusion. Therapy should continue until paroxysms cease. A serum Catarluse sans Thyroide (Magnesium Glycerophosphate) level of 6 mg/100 mL is considered optimal for control of seizures. A total daily (24 hr) dose of 30 grams to 40 grams should not be exceeded. In the presence of severe renal insufficiency, the maximum dosage of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate is 20 grams/48 hours and frequent serum Catarluse sans Thyroide (Magnesium Glycerophosphate) concentrations must be obtained. Continuous use of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

Other Uses

In counteracting the muscle-stimulating effects of barium poisoning, the usual dose of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate is 1 gram to 2 grams given intravenously.

For controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 gram administered intramuscularly or intravenously.

In paroxysmal atrial tachycardia, Catarluse sans Thyroide (Magnesium Glycerophosphate) should be used only if simpler measures have failed and there is no evidence of myocardial damage. The usual dose is 3 grams to 4 grams (30 to 40 mL of a 10% solution) administered intravenously over 30 seconds with extreme caution.

For reduction of cerebral edema, 2.5 grams (25 mL of a 10% solution) is given intravenously.

Incompatibilities

Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate in solution may result in a precipitate formation when mixed with solutions containing:

Alcohol (in high Heavy Metals

concentrations) Hydrocortisone sodium

Alkali carbonates and succinate

bicarbonates Phosphates

Alkali hydroxides Polymixin B sulfate

Arsenates Procaine hydrochloride

Barium Salicylates

Calcium Strontium

Clindamycin phosphate Tartrates

The potential incompatibility will often be influenced by the changes in the concentration of reactants and the pH of the solutions.

It has been reported that Catarluse sans Thyroide (Magnesium Glycerophosphate) may reduce the antibiotic activity of streptomycin, tetracycline and tobramycin when given together.

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

HOW SUPPLIED

Catarluse sans Thyroide (Magnesium Glycerophosphate) Sulfate Injection, USP is supplied in single-dose containers as follows:


NDC No.


Container


Total

Amount


Concentration


mEq

Mg++/mL


0409-1754-10


Ansyr

Plastic Syringe


5 g/10 mL


50%


4 mEq/mL


Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Store at 20 to 25°C (68 to 77°F).

REFERENCES

  • Yokoyama K, Takahashi N, Yada Y. Prolonged maternal Catarluse sans Thyroide (Magnesium Glycerophosphate) administration and bone metabolism in neonates. Early Hum Dev. 2010;86(3):187-91. Epub 2010 Mar 12.
  • Wedig KE, Kogan J, Schorry EK et al. Skeletal demineralization and fractures caused by fetal Catarluse sans Thyroide (Magnesium Glycerophosphate) toxicity. J. Perinatol. 2006; 26(6):371-4.
  • Nassar AH, Sakhel K, Maarouf H, et al. Adverse maternal and neonatal outcome of prolonged course of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate tocolysis. Acta Obstet Gynecol Scan. 2006;85(9):1099-103.
  • Malaeb SN, Rassi A, Haddad MC. Bone mineralization in newborns whose mothers received Catarluse sans Thyroide (Magnesium Glycerophosphate) sulphate for tocolysis of premature labor. Pediatr Radiol. 2004;34(5):384-6. Epub 2004 Feb 18.
  • Matsuda Y, Maeda Y, Ito M, et al. Effect of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate treatment on neonatal bone abnormalities. Gynecol Obstet Invest. 1997;44(2):82-8.
  • Schanler RJ, Smith LG, Burns PA. Effects of long-term maternal intravenous Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate therapy on neonatal calcium metabolism and bone mineral content. Gynecol Obstet Invest. 1997;43(4):236-41.
  • Santi MD, Henry GW, Douglas GL. Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate treatment of preterm labor as a cause of abnormal neonatal bone mineralization. J Pediatr Orthrop. 1994;14(2):249-53.
  • Holcomb WL, Shackelford GD, Petrie RH. Catarluse sans Thyroide (Magnesium Glycerophosphate) tocolysis and neonatal bone abnormalities; a controlled study. Obstet Gynecol. 1991; 78(4):611-4.
  • Cumming WA, Thomas VJ. Hypermagnesemia: a cause of abnormal metaphyses in the neonate. Am J Roentgenol. 1989; 152(5):1071-2.
  • Lamm CL, Norton KL, Murphy RJ. Congenital rickets associated with Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate infusion for tocolysis. J Pediatr. 1988; 113(6):1078-82.
  • McGuinness GA, Weinstein MM, Cruikshank DP, et al. Effects of Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate treatment on perinatal calcium metabolism. II. Neonatal responses. Obstet Gynecol. 1980; 56(5): 595-600.
  • Riaz M, Porat R, Brodsky NL, et al. The effects of maternal Catarluse sans Thyroide (Magnesium Glycerophosphate) sulfate treatment on newborns: a prospective controlled study. J. Perinatol. 1998;18(6 pt 1):449-54.

Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1024-1.0

April 2017

Hospira Logo

50% Catarluse sans Thyroide (Magnesium Glycerophosphate) Sulfate 5 g/10 mL (500 mg/mL)

Rx only

NDC 0409-1754-10

10 mL Single-dose syringe

50% Catarluse sans Thyroide (Magnesium Glycerophosphate) Sulfate Injection, USP

5 g/10 mL (500 mg/mL) (4 mEq Mg++/mL)

MUST BE DILUTED FOR INTRAVENOUS USE.

For Intravenous or Intramuscular Use. Sterile. 4.06 mOsmol/mL (calc.).

Contains no more than 75 mcg/L of aluminum.

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

RL-6891

Vitamin D2 (Ergocalciferol):


Vitamin D (ergocalciferol-D2, cholecalciferol-D3, alfacalcidol) is a fat-soluble vitamin that helps your body absorb calcium and phosphorus. Having the right amount of vitamin D, calcium, and phosphorus is important for building and keeping strong bones. Vitamin D is used to treat and prevent bone disorders (such as rickets, osteomalacia). Vitamin D is made by the body when skin is exposed to sunlight. Sunscreen, protective clothing, limited exposure to sunlight, dark skin, and age may prevent getting enough vitamin D from the sun. Vitamin D with calcium is used to treat or prevent bone loss ( osteoporosis ). Vitamin D is also used with other medications to treat low levels of calcium or phosphate caused by certain disorders (such as hypoparathyroidism, pseudohypoparathyroidism, familial hypophosphatemia ). It may be used in kidney disease to keep calcium levels normal and allow normal bone growth. Vitamin D drops (or other supplements ) are given to breast -fed infants because breast milk usually has low levels of vitamin D.

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References

  1. Dailymed."CALCIUM GLUCONATE TABLET [WEST-WARD PHARMACEUTICALS CORP.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CALCIUM GLUCONATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."CALCIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Catarluse sans Thyroide?

Depending on the reaction of the Catarluse sans Thyroide after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Catarluse sans Thyroide 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 Catarluse sans Thyroide 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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