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DRUGS & SUPPLEMENTS
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What is the dose of the medication you are taking? |
Calcitriol:
Calgrow-C (Calcitriol) is the most potent metabolite of vitamin D available. The administration of Calgrow-C (Calcitriol) to patients in excess of their daily requirements can cause hypercalcemia, hypercalciuria, and hyperphosphatemia. Therefore, pharmacologic doses of vitamin D and its derivatives should be withheld during Calgrow-C (Calcitriol) treatment to avoid possible additive effects and hypercalcemia. If treatment is switched from ergocalciferol (vitamin D2) to Calgrow-C (Calcitriol), it may take several months for the ergocalciferol level in the blood to return to the baseline value (see OVERDOSAGE ).
Calgrow-C (Calcitriol) increases inorganic phosphate levels in serum. While this is desirable in patients with hypophosphatemia, caution is called for in patients with renal failure because of the danger of ectopic calcification. A non-aluminum phosphate-binding compound and a low-phosphate diet should be used to control serum phosphorus levels in patients undergoing dialysis.
Magnesium-containing preparations (eg, antacids) and Calgrow-C (Calcitriol) should not be used concomitantly in patients on chronic renal dialysis because such use may lead to the development of hypermagnesemia.
Studies in dogs and rats given Calgrow-C (Calcitriol) for up to 26 weeks have shown that small increases of Calgrow-C (Calcitriol) above endogenous levels can lead to abnormalities of calcium metabolism with the potential for calcification of many tissues in the body.
Should hypercalcemia develop, treatment with Calgrow-C (Calcitriol) should be stopped immediately. During periods of hypercalcemia, serum calcium and phosphate levels must be determined daily. When normal levels have been attained, treatment with Calgrow-C (Calcitriol) can be continued, at a daily dose 0.25 mcg lower than that previously used. An estimate of daily dietary calcium intake should be made and the intake adjusted when indicated. Calgrow-C (Calcitriol) should be given cautiously to patients on digitalis, because hypercalcemia in such patients may precipitate cardiac arrhythmias.
Immobilized patients, eg, those who have undergone surgery, are particularly exposed to the risk of hypercalcemia.
In patients with normal renal function, chronic hypercalcemia may be associated with an increase in serum creatinine. While this is usually reversible, it is important in such patients to pay careful attention to those factors which may lead to hypercalcemia. Calgrow-C (Calcitriol) therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of the serum calcium. An estimate of daily dietary calcium intake should be made and the intake adjusted when indicated.
Patients with normal renal function taking Calgrow-C (Calcitriol) should avoid dehydration. Adequate fluid intake should be maintained.
The effectiveness of Calgrow-C (Calcitriol) therapy is predicated on the assumption that each patient is receiving an adequate daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. RDA for calcium in adults is 800 mg to 1200 mg.
Pregnancy Category C. Calgrow-C (Calcitriol) has been found to be teratogenic in rabbits when given at doses of 0.08 and 0.3 mcg/kg (approximately 2 and 6 times the maximum recommended dose based on mg/m2). All 15 fetuses in 3 litters at these doses showed external and skeletal abnormalities. However, none of the other 23 litters (156 fetuses) showed external and skeletal abnormalities compared with controls.
Teratogenicity studies in rats at doses up to 0.45 mcg/kg (approximately 5 times maximum recommended dose based on mg/m2) showed no evidence of teratogenic potential. There are no adequate and well-controlled studies in pregnant women. Calgrow-C (Calcitriol) capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects
In the rabbit, dosages of 0.3 mcg/kg/day (approximately 6 times maximum recommended dose based on surface area) administered on days 7 to 18 of gestation resulted in 19% maternal mortality, a decrease in mean fetal body weight and a reduced number of newborn surviving to 24 hours. A study of perinatal and postnatal development in rats resulted in hypercalcemia in the offspring of dams given Calgrow-C (Calcitriol) at doses of 0.08 or 0.3 mcg/kg/day (approximately 1 and 3 times the maximum recommended dose based on mg/m2), hypercalcemia and hypophosphatemia in dams given Calgrow-C (Calcitriol) at a dose of 0.08 or 0.3 mcg/kg/day, and increased serum urea nitrogen in dams given Calgrow-C (Calcitriol) at a dose of 0.3 mcg/kg/day. In another study in rats, maternal weight gain was slightly reduced at a dose of 0.3 mcg/kg/day (approximately 3 times the maximum recommended dose based on mg/m2) administered on days 7 to 15 of gestation. The offspring of a woman administered 17 mcg/day to 36 mcg/day of Calgrow-C (Calcitriol) (approximately 17 to 36 times the maximum recommended dose), during pregnancy manifested mild hypercalcemia in the first 2 days of life which returned to normal at day 3.
Oral doses of Calgrow-C (Calcitriol) ranging from 10 to 55 ng/kg/day have been shown to improve calcium homeostasis and bone disease in pediatric patients with chronic renal failure for whom hemodialysis is not yet required (predialysis). Long-term Calgrow-C (Calcitriol) therapy is well tolerated by pediatric patients. The most common safety issues are mild, transient episodes of hypercalcemia, hyperphosphatemia, and increases in the serum calcium times phosphate (Ca x P) product which are managed effectively by dosage adjustment or temporary discontinuation of the vitamin D derivative.
The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include:
Early: weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia, abdominal pain or stomach ache.
Late: polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT (AST) and SGPT (ALT), ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.
In clinical studies on hypoparathyroidism and pseudohypoparathyroidism, hypercalcemia was noted on at least one occasion in about 1 in 3 patients and hypercalciuria in about 1 in 7 patients. Elevated serum creatinine levels were observed in about 1 in 6 patients (approximately one half of whom had normal levels at baseline).
In concurrent hypercalcemia and hyperphosphatemia, soft-tissue calcification may occur; this can be seen radiographically (see WARNINGS ).
In patients with normal renal function, chronic hypercalcemia may be associated with an increase in serum creatinine (see PRECAUTIONS: General ).
Hypersensitivity reactions (pruritus, rash, urticaria, and very rarely severe erythematous skin disorders) may occur in susceptible individuals. One case of erythema multiforme and one case of allergic reaction (swelling of lips and hives all over the body) were confirmed by rechallenge.
Call your doctor for medical advice about side effects. You may report side effects to Strides Pharma Inc. at 1-877-244-9825 or go to www.stridesshasun.com
The effectiveness of Calgrow-C (Calcitriol) capsule therapy is predicated on the assumption that each patient is receiving an adequate but not excessive daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. RDA for calcium in adults is 800 mg to 1200 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.
Because of improved calcium absorption from the gastrointestinal tract, some patients on Calgrow-C (Calcitriol) capsule may be maintained on a lower calcium intake. Patients who tend to develop hypercalcemia may require only low doses of calcium or no supplementation at all.
During the titration period of treatment with Calgrow-C (Calcitriol), serum calcium levels should be checked at least twice weekly. When the optimal dosage of Calgrow-C (Calcitriol) has been determined, serum calcium levels should be checked every month (or as given below for individual indications). Samples for serum calcium estimation should be taken without a tourniquet.
Patients with normal or only slightly reduced serum calcium levels may respond to Calgrow-C (Calcitriol) capsules doses of 0.25 mcg every other day. Most patients undergoing hemodialysis respond to doses between 0.5 and 1 mcg/day.
Oral Calgrow-C (Calcitriol) capsules may normalize plasma ionized calcium in some uremic patients, yet fail to suppress parathyroid hyperfunction. In these individuals with autonomous parathyroid hyperfunction, oral Calgrow-C (Calcitriol) may be useful to maintain normocalcemia, but has not been shown to be adequate treatment for hyperparathyroidism.
Most adult patients and pediatric patients age 6 years and older have responded to dosages in the range of 0.5 mcg to 2 mcg daily. Pediatric patients in the 1 to 5 year age group with hypoparathyroidism have usually been given 0.25 mcg to 0.75 mcg daily. The number of treated patients with pseudohypoparathyroidism less than 6 years of age is too small to make dosage recommendations.
Malabsorption is occasionally noted in patients with hypoparathyroidism; hence, larger doses of Calgrow-C (Calcitriol) capsules may be needed.
For pediatric patients less than 3 years of age, the recommended initial dosage of Calgrow-C (Calcitriol) is 10 to 15 ng/kg/day.
Capsules: 0.5 mcg Calgrow-C (Calcitriol) in soft gelatin, orange, oblong capsules, imprinted with 674; bottles of 100 (64380-724-06).
Calgrow-C (Calcitriol) Capsules should be protected from light.
Store at 20° to 25°C (68° to 77°C F)
Manufactured by:
Strides Shasun Limited
Bengaluru - 560076, India
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
Revised: 05/2016
Calcium Citrate Maleate:
Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) acetate capsule.
- Capsule: 667 mg Calgrow-C (Calcium Citrate Maleate) acetate capsule. (3)
Patients with hypercalcemia.
- Hypercalcemia. (4)
- Treat mild hypercalcemia by reducing or interrupting Calgrow-C acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Calgrow-C (Calcium Citrate Maleate) acetate. (5.1)
- Hypercalcemia may aggravate digitalis toxicity. (5.2)
Patients with end stage renal disease may develop hypercalcemia when treated with Calgrow-C (Calcium Citrate Maleate), including Calgrow-C (Calcium Citrate Maleate) acetate. Avoid the use of Calgrow-C (Calcium Citrate Maleate) supplements, including Calgrow-C (Calcium Citrate Maleate) based nonprescription antacids, concurrently with Calgrow-C (Calcium Citrate Maleate) acetate.
An overdose of Calgrow-C (Calcium Citrate Maleate) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Calgrow-C (Calcium Citrate Maleate) levels twice weekly. Should hypercalcemia develop, reduce the Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) 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, Calgrow-C (Calcium Citrate Maleate) acetate has been generally well tolerated.
Calgrow-C (Calcium Citrate Maleate) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) acetate N=167 N (%) | 3 month, open label study of Calgrow-C (Calcium Citrate Maleate) acetate N=98 N (%) | Double blind, placebo-controlled, cross-over study of liquid Calgrow-C (Calcium Citrate Maleate) acetate N=69 | |
Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) concentration could reduce the incidence and severity of Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) acetate: dizziness, edema, and weakness.
The drug interaction of Calgrow-C acetate is characterized by the potential of Calgrow-C (Calcium Citrate Maleate) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Calgrow-C (Calcium Citrate Maleate) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.
There are no empirical data on avoiding drug interactions between Calgrow-C (Calcium Citrate Maleate) acetate and most concomitant drugs. When administering an oral medication with Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) acetate or consider monitoring blood levels of the drug. (7)
In a study of 15 healthy subjects, a co-administered single dose of 4 Calgrow-C (Calcium Citrate Maleate) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.
Pregnancy Category C:
Calgrow-C acetate capsules contains Calgrow-C (Calcium Citrate Maleate) acetate. Animal reproduction studies have not been conducted with Calgrow-C (Calcium Citrate Maleate) acetate, and there are no adequate and well controlled studies of Calgrow-C (Calcium Citrate Maleate) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Calgrow-C (Calcium Citrate Maleate) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Calgrow-C (Calcium Citrate Maleate) 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. Calgrow-C (Calcium Citrate Maleate) acetate treatment, as recommended, is not expected to harm a fetus if maternal Calgrow-C (Calcium Citrate Maleate) levels are properly monitored during and following treatment.
The effects of Calgrow-C (Calcium Citrate Maleate) acetate on labor and delivery are unknown.
Calgrow-C Acetate Capsules contains Calgrow-C (Calcium Citrate Maleate) acetate and is excreted in human milk. Human milk feeding by a mother receiving Calgrow-C (Calcium Citrate Maleate) acetate is not expected to harm an infant, provided maternal serum Calgrow-C (Calcium Citrate Maleate) levels are appropriately monitored.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].
Calgrow-C (Calcium Citrate Maleate) acetate acts as a phosphate binder. Its chemical name is Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Calgrow-C (Calcium Citrate Maleate), 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.
Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.
Calgrow-C (Calcium Citrate Maleate) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Calgrow-C (Calcium Citrate Maleate) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
Orally administered Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) acetate.
Effectiveness of Calgrow-C (Calcium Citrate Maleate) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Calgrow-C (Calcium Citrate Maleate) 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 |
Calgrow-C (Calcium Citrate Maleate) (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 Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) acetate is shown in the Table 3.
* ANOVA of Calgrow-C (Calcium Citrate Maleate) acetate vs. placebo after 2 weeks of treatment. † Values expressed as mean ± SEM. | ||||
Parameter | Pre-Study | Post-Treatment | p-value* | |
Calgrow-C (Calcium Citrate Maleate) Acetate | Placebo | |||
Phosphorus (mg/dL)† | 7.3 ± 0.18 | 5.9 ± 0.24 | 7.8 ± 0.22 | <0.01 |
Calgrow-C (Calcium Citrate Maleate) (mg/dL)† | 8.9 ± 0.11 | 9.5 ± 0.13 | 8.8 ± 0.12 | <0.01 |
Overall, 2 weeks of treatment with Calgrow-C (Calcium Citrate Maleate) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Calgrow-C (Calcium Citrate Maleate) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.
Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Calgrow-C (Calcium Citrate Maleate) 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 Calgrow-C (Calcium Citrate Maleate) acetate capsules.
Distr. by: West-Ward
Pharmaceuticals Corp.
Eatontown, NJ 07724
10003705/05
Revised April 2016
Depending on the reaction of the Calgrow-C after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Calgrow-C 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 Calgrow-C 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