Abstract  Following the article by Kerkkamp et al. (1985; 2353-6)two questions came up. The first concerns calcium administered intravenously. In 1943 I had a lot to do with treatment of diphtheria and with minor accidents for which tetanus prevention was deemed necessary at the time: both with the respective serum. As a reaction, urticaria was often seen: type 1; they were called "serum sickness." This was treated with calcium gluconate iv with spectacular results: the patient had an enormous feeling of heat and a rapid regression of the severe itching. Later I saw one more time at the consultation hour (in between) a young man of about 23 years who had acutely got an attack of urticaria with a large bronchospasmus: the whole looked rather worrisome. Anamnestic there was no cause to be found. Also in this case, I have taken to the calcium gluconate with a fast result: after half an hour in the waiting room as a hiding place (what a horrible word) he could go home on his own feet. Question: does this product deserve a place in the therapeutic arsenal listed in the article? I am also curious about the frequency of these reactions: if I read this story like this, I would not dare to do even the smallest wound attachment under local anesthesia outside the hospital. In response to the comments from my colleague Van Beek, I would like to mention the following. The treatment of an anaphylactic reaction with calcium gluconate does not seem useful. In view of the severity, it is necessary to use an agent that is directly effective and treats threatening circulatory and respiratory symptoms. The means of first choice is adrenalin. 1 In theory, the administration of calcium is contraindicated, since calcium ions are necessary for the release of mediators from the manure and basophil cells. 2 A low serum calcium level reduces the release of the mediators from the manure and basophilic cells. 3 The patients described by colleague Van Beek probably did not have a type 1 allergic reaction. Serum serum is often seen when the serum is injected, which belongs to type III (complex-mediated). In the last patient described, no causative factors (antigens) can be identified, although there is still a histamine-induced reaction. A possible explanation for the beneficial effect after administration of calcium gluconate in the described patients might be due to the fact that with an acute rise in serum calcium levels the concentrations of the hormones aldosterone and cortisol and of the neurotransmitter ACTH in the serum are increased. 4 The frequency of type 1 reaction (anaphylaxis) when using local anesthetics of the amide type is extremely rare; no exact figures are given in the literature. The allergic reactions with the ester type are considerably more common. Only 1 of all reactions in the use of local anesthetics are allergic, 80 to 90 of type IV. 5 Use of local anesthetics is therefore justified, provided that the maximum doses are not exceeded. However, one must always realize that an anaphylactic reaction can occur, for which the therapeutic drugs must be available.

Abstract  Morphologic evidence for calcium salts within the brains of severely stressed neonates at autopsy correlated to the mean daily parenteral dose of calcium gluconate (P less than 0.01). Survival analysis indicated that parenteral administration of calcium contributed a negative effect to predicted survival (P less than 0.05).

Abstract  Changes in serum and urine biochemical indices have been studied in ten normal subjects in the four hours following the ingestion of four proprietary calcium supplements. Each was taken in a dose containing 1 gram of elemental calcium. The four preparations were ranked according to the amount of calcium absorbed in the order Spar-Cal and Calcium Sandoz greater than Os-Cal greater than Ossopan. There were no significant differences between the four preparations in the changes in parathyroid hormone (PTH) and urine hydroxyproline levels. For this reason, the four results from each subject were averaged. Following the calcium load there was a reduction in mean PTH from 0.16 +/- 0.01 to 0.10 +/- 0.02 micrograms/l (p less than 0.001) and a decline in urine hydroxyproline/creatinine ratio from 20 +/- 1 to 17 +/- 1 (p less than 0.02), suggesting that bone resorption responds immediately to dietary calcium intake. There was a rise in urine sodium excretion which correlated with the indices of calcium absorption (r = 0.63, p less than 0.01) but not with the sodium content of the calcium preparations. This effect could be important, particularly in elderly patients on borderline sodium intakes.

Abstract  Teratological test results are reported in four species of laboratory animals. Portions of these documents are not fully legible.

Abstract  Transplacental 45Ca and 32P flux was measured across the in situ perfused guinea-pig placenta under conditions of acute maternal hypocalcaemia and hypercalcaemia. Maternal hypercalcaemia induced acutely by calcium gluconate infusion caused an increase in maternal-to-fetal 45Ca flux which was proportional to the increase in maternal plasma ionized calcium concentration. Acute maternal hypocalcaemia was induced by EGTA infusion and resulted in a decrease in maternal plasma ionized calcium concentration proportional to a corresponding decrease in transplacental 45Ca transfer. A bolus of calcium gluconate caused a transient decrease in 32P flux, whereas EGTA administration was without significant effect on transplacental 32P transfer. Calcium transport across the placenta is not saturated under conditions of maternal normocalcaemia and may be altered according to acute changes in maternal plasma calcium concentration. Thus, control of maternal-to-fetal calcium transfer does not appear to be at the placental level. This suggests that fetal calcium homeostasis may be regulated by the fetus itself.

Abstract  Compound FDA 71-72, glucono-delta-lactone, was not genetically active, either directly or in the presence of organ homogenates, in any of the in vitro assays employed in this evaluation.

Abstract  On May 16, 2016 Fresenius Kabi submitted a New Drng Application (NDA) for Calcium Gluconate Injection under Section 505(b) (2) of the Federal Food, Drug, and Cosmetic Act.

Abstract  The effects of commercially available calcium supplements (calcium carbonate, calcium gluconate, oyster shell preparation and bovine bone preparation) and gluconic acid on the absorption of calcium and magnesium were evaluated for 30 days in male Wistar rats. There were no differences in the apparent absorption ratio of calcium among rats fed each calcium supplement; however the rats fed the calcium gluconate diet had a higher apparent absorption ratio of magnesium than the rats fed the other calcium supplements. Dietary gluconic acid also more markedly stimulated magnesium absorption than the calcium carbonate diet, and the bone (femur and tibial magnesium contents of rats fed the gluconic acid diet were significantly higher than those of the rats fed the calcium carbonate diet. Furthermore, the weight of cecal tissue and the concentrations of acetic acid and butyric acid in cecal digesta of rats fed the calcium gluconate diet or the gluconic acid diet were significantly increased. We speculate that the stimulation of magnesium absorption in rats fed the calcium gluconate diet is a result of the gluconic acid component and the effect of gluconic acid on magnesium absorption probably results from cecal hypertrophy, magnesium solubility in the large intestine and the effects of volatile fatty acids on magnesium absorption.

Abstract  In order to compare the effects of several experimental renal calcium oxalate stones formation models in rats and to find a simple and convenient model with significant effect of calcium oxalate crystals deposition in the kidney, several rat models of renal calcium oxalate stones formation were induced by some crystal-inducing drugs (CID) including ethylene glycol (EG), ammonium chloride (AC), vitamin D(3)[1alpha(OH)VitD(3), alfacalcidol], calcium gluconate, ammonium oxalate, gentamicin sulfate, L-hydroxyproline. The rats were fed with drugs given singly or unitedly. At the end of experiment, 24-h urines were collected and the serum creatinine (Cr), blood urea nitrogen (BUN), the extents of calcium oxalate crystal deposition in the renal tissue, urinary calcium and oxalate excretion were measured. The serum Cr levels in the stone-forming groups were significantly higher than those in the control group except for the group EG+L-hydroxyproline, group calcium gluconate and group oxalate. Blood BUN concentration was significantly higher in rats fed with CID than that in control group except for group EG+L-hydroxyproline and group ammonium oxalate plus calcium gluconate. In the group of rats administered with EG plus Vitamin D(3), the deposition of calcium oxalate crystal in the renal tissue and urinary calcium excretion were significantly greater than other model groups. The effect of the model induced by EG plus AC was similar to that in the group induced by EG plus Vitamin D(3). EG plus Vitamin D(3) or EG plus AC could stably and significantly induced the rat model of renal calcium oxalate stones formation.

Abstract  A single oral dose of 4-46 mmol calcium gluconate at pH 5-6 was administered intragastrically to 15 male volunteers without gastrointestinal disease. There was a significant rise in acid output from 30-90 minutes after the calcium was given compared with the basal hourly collection. The serum gastrin level 30 minutes after calcium administration was significantly raised, but no correlation could be demonstrated between the acid and gastrin responses. Serum calcium levels were unchanged throughout. An equimolar dose of magnesium sulphate had no such effects. This study suggests that the intragastric administration of calcium results in independent release of gastric acid and gastrin from the gastric mucosa.

Abstract  Microcrystalline calcium hydroxyapatite compound (MCHC) was given orally together with small doses of dihydrotachysterol (DHT) to a number of patients with osteogenesis imperfecta (OI). Serial calcium and phosphate balances in three patients representing wide variations in severity of OI are presented over periods from eight months to two years. The combination of MCHC and DHT resulted in an immediate positive calcium balance which was maintained throughout the period of assessment in 2 cases. However, no radiological improvement could be demonstrated. Substituting calcium gluconate for MCHC resulted in a reduction of positive balance. No adverse effects were noted. The reasons why MCHC with DHT should result in increased calcium retention are discussed. This combination of MCHC and DHT could be of benefit in many common situations of bone demineralization, such as osteoporosis.

Abstract  The report, by a group of scientists designated the Select Committee on GRAS Substances (SCOGS), provides an independent evaluation of the safety of food ingredients, when used in food at present or projected levels of use.

Abstract  During the past 10 years, we have had the opportunity of observing and treating approximately 250 patients ill with industrial lead poisoning. In several instances, irreversible reactions due to the effects of lead upon the peripheral nervous system, occurred as a result of active mobilization of lead by the continued use of high calcium therapy after removal of the individual from the occupational hazard. In this communication, we are calling attention to the danger of the prolonged use of high calcium therapy in the treatment of lead poisoning. Four cases in which the prolonged use of large amounts of calcium was responsible for permanent and irreversible damage to the nervous system are being cited.

Abstract  The results of the new study of acute toxicity provided no evidence of toxicity in rats given single doses of 500, 1000, or 2000 mg/kg bw sodium gluconate. In two new four-week studies in rats, sodium gluconate was administered orally either by gavage at doses of 0, 500, 1000, or 2000 mg/kg bw per day or by feeding at doses of 0, 1, 1.25, 2.5, or 5% w/w (equal to 1000, 2000, and 4100 mg/kg bw per day). A further group received 1.35% w/w sodium chloride (equal to 1100 mg/kg bw per day), equivalent to the concentration of sodium in 5% sodium gluconate. After gavage, a significant increase in the relative weight of the kidneys (unilateral) was seen in males at 1000 or 2000 mg/kg bw per day. No treatment-related or dose-related effect was observed on any of the other parameters examined in this study. The effects observed in the feeding study, i.e. increased water intake, increased prothrombin time, and increased relative kidney weights, were not dose-related. Qualitative urine analyses revealed effects in both four-week studies that were considered by the Committee to be related to the high sodium intake arising from the sodium gluconate. Evaluation. On the basis of a re-evaluation of data previously considered by the Committee and new-data on the short-term toxicity of sodium gluconate, the Committee extended the previous ADI `not specified' for glucono-delta-lactone to a group ADI for glucono-delta-lactone and the calcium, magnesium, potassium, and sodium salts of gluconic acid..