Bula do remedy Sigmatriol

the package insert of the medicine Sigmatriol. Active principles Calcitriol.

what For?

Sigmatriol is indicated for: Osteoporosis; renal Osteodystrophy in patients with chronic renal failure, particularly those undergoing hemodialysis; Hypoparathyroidism post-operative Hypoparathyroidism idiopático; Pseudo-hypoparathyroidism; Rickets dependent on vitamin D; Rickets hipofosfatêmico resistant to vitamin D.


When should I not use?

Tell your doctor about any medicine you are using, before the beginning or during the treatment. Sigmatriol is contraindicated in all diseases associated with hypercalcemia. The use of
Sigmatriol, is also contraindicated in patients with known hypersensitivity to the components of the formula, or to drugs in the same therapeutic class.

The risk-benefit ratio should be evaluated in the presence of pregnancy, lactation, renal dysfunction or heart and arteriosclerosis.
This medicine should not be used by pregnant women without medical advice.


How to use?

dosing schedule general:
The recommended daily dose of Sigmatriol should be carefully determined in function of the level of serum calcium of each patient. The treatment with Sigmatriol should be always started with the lowest doses possible and increase only with strict control of calcium in serum. Once you’ve determined the ideal dosage of Sigmatriol should be controlled on a monthly basis the serum calcium levels (or as specified below for the individual nominations). Samples for analysis of serum calcium should be collected without the aid of a tourniquet. As soon as these levels are projected at 1 mg/100 ml (250 mcmol/l) above normal (9-11 mg/100 ml or 2,25 – 2,75 mcmol/l), or serum creatinine increase to > 120 mcmol/l, the dose of Sigmatriol should be substantially reduced or treatment stopped until it is achieved normocalcemia.

During periods of hypercalcemia must measure daily serum levels of calcium and phosphate. After normalization of the values could be to continue with the administration of Sigmatriol, however, in a daily dose less than 0.25 mcg to the previous dose. You should calculate the daily intake of approximately calcium with the diet and, if necessary, adjust the intake. The adequate intake of calcium – but not excessive – at the beginning of the treatment (adults: 800 mg daily, approximately) is an essential prerequisite for better effectiveness of the Sigmatriol. If there is a need, one should prescribe calcium supplement. Thanks to the better absorption of gastrointestinal calcium with the use of calcitriol, in some patients can reduce their contribution. Those with a propensity for hypercalcemia, are sufficient, on some occasions, only low doses of calcium or, even, eliminate supplementation. The daily intake of total calcium (from foods and, when necessary, drugs) should be approximately 800 mg, and not exceed 1,000 mg.

Schemas posológicos special:
Osteoporosis: The recommended dose of Sigmatriol is 0.25 mcg twice daily. The serum levels of calcium and creatinine should be determined every 4 weeks, 3 months and 6 months and subsequently at intervals of 6 months;
Renal osteodystrophy (dialysis patients): The initial dose is 0.25 mcg. For patients normocálcicos or with hypercalcemia rims are sufficient 0,25 mcg every two days. If it is not observed a satisfactory response of clinical parameters, and biochemical, within two to four weeks, it will raise the dosage by 0.25 mcg daily at intervals of 2 to 4 weeks. During this period should be determined by the serum calcium levels at least twice a week. The majority of patients on hemodialysis respond to a dose of 0.5 to 1.0 mcg daily;
Hypoparathyroidism and rickets: The recommended initial dose of Sigmatriol is 0.25 mcg/day, administered in the morning. If you do not observe an influence of satisfactory in the biochemical parameters, the dose may be increased at intervals of two to four weeks. During this period, the serum calcium levels should be determined at least twice weekly and, if hypercalcemia is noted, Sigmatriol should be immediately discontinued until normocalcemia is restored. Many adult patients, pediatric patients (over 6 years) and older patients responded better to a dosage of 0.5 mcg to 2 mcg daily;
Dosage for the elderly: No dosage adjustment is necessary for elderly patients. It must, however, observe the recommendations for the control of serum calcium levels and creatinine.

Follow the guidance of your doctor, always respecting the schedules, doses and duration of treatment.

The capsules should be taken with a little liquid, preferably in the morning or at the discretion of your doctor.

do Not stop treatment without the knowledge of your doctor.

Side Effects

What are the evils that can cause me?

once that calcitriol exerts an effect of vitamin D, the side effects that may occur in the case of
overdose are similar to those of the hipervitaminosis D, that is: the syndrome of hypercalcemia or poisoning by calcium (depending on the severity and duration of hypercalcemia). Symptoms of acute occasional include anorexia, headache, vomiting, and constipation. Chronic effects may include dystrophy, sensory disturbances, and sometimes fever with thirst, polyuria, dehydration, apathy, disruption of growth and infections of the urinary tract.

The incidence of adverse effects reported with clinical use of calcitriol over a period of 15 years, in all therapeutic indications, is extremely low in relation to each individual effect, including hypercalcemia, occurring at a ratio of 0.001% or less. The concomitant hypercalcemia and hipofosfatemia (> 6 mg/100 ml, equivalent to 1.9 mmol/l) can lead to calcification of soft tissues, visible to X-ray radiation In patients with normal renal function, hypercalcemia chronic can be associated with an increase in serum creatinine. The investigations all have shown that, due to the average life short of calcitriol, the serum calcium levels excessively high standard a few days after discontinuation of the medication, or reduction of the dose, that is, more quickly than after a treatment with preparations containing vitamin D.

Tell your doctor the appearance of reactions unpleasant.

Warnings and Precautions

what should I know before using?

There is a marked correlation between treatment with calcitriol and the development of hypercalcemia. In studies conducted in patients with osteoarthritis urêmica, we observed hypercalcemia in up to 40% of patients treated with calcitriol. A sudden increase in calcium intake as a result of changes in diet (for example, high consumption of dairy products) or ingestion uncontrolled preparations with a basis of calcium can lead to hypercalcemia. It is absolutely necessary, therefore, that the patients to follow strictly the recommendations of the doctor about the diet, the fact that relatives must also have knowledge, and who are instructed about how to recognize the symptoms of hypercalcemia. In patients with normal renal function, hypercalcemia, chronic may be associated with an increase in serum creatinine.

Patients immobilized, for example, undergoing surgery, are particularly exposed to the risk of hypercalcemia. Calcitriol increases serum concentrations of phosphate and inorganic. Although this is desirable in patients with hipofosfatemia, caution is advised in patients with renal insufficiency because of the risk of calcification ectopic. In such cases, the serum concentration should be maintained within normal levels (2-5 mg/100 ml or 0,65-1,62 mmol/litre) by the oral administration of agents, fixers, and phosphate-poor diet of phosphates. The patients with rickets resistant vitamin D (hipofosfatemia family), that they are being treated with calcitriol, need to continue treatment with phosphate orally. However, one should take into consideration that calcitriol can stimulate their intestinal absorption, for which reason it vary the additional needs of the phosphates.

The laboratory investigations required include determinations of serum calcium, phosphorus, magnesium and alkaline phosphatase and the content of calcium and phosphate in the urine collected in 24 hours. During the phase of standardisation of the treatment with Sigmatriol, the serum calcium levels should be checked at least two times per week (see Dosage). Being the calcitriol, the principal metabolite of vitamin D, other medications based on vitamin D should not be administered concomitantly to calcitriol, with the goal of preventing hipervitaminosis D. If the patient is receiving ergocalciferol (vitamin D2), and switch to calcitriol, it may take several months for the level of ergocalciferol in the blood flow to resume to normal values (see Overdosage). Patients with normal renal function treated with calcitriol should drink adequate amounts of fluids to avoid dehydration. Hypersensitivity reactions may occur in patients sensitive.

Tell your doctor the occurrence of pregnancy during treatment or after its termination.

Inform your doctor if you are breast-feeding. Do not breastfeed during treatment with Sigmatriol.



what to do if someone use a larger amount than is recommended?

Treatment of hypercalcemia asymptomatic: since calcitriol is a derivative of vitamin D, the symptoms of overdose are the same as those of this vitamin. The ingestion of high doses of calcium and phosphate together with calcitriol may give rise to similar symptoms. A high concentration of calcium in the patient subjected to dialysis may contribute to hypercalcemia;
Symptoms of acute intoxication by vitamin D are: Anorexia, headache, vomiting, constipation;
Symptoms of chronic intoxication by vitamin D: Dystrophy (weakness, loss of weight), sensory disturbances, fever associated with thirst, polyuria, dehydration, apathy, disruption of growth and infections of the urinary tract.

Occurs hypercalcemia with metastatic calcification of the renal cortex, myocardium, lungs and pancreas. In case of overdose accidental can be adopted, the following therapeutic measures: immediate gastric lavage, provocation of vomiting to prevent a greater uptake and administration of mineral oil to promote the elimination of fecal matter. It is advisable to make repeated determinations of the calcium in serum. If you still hypercalcemia serum may proceed to the administration of bifosfonados and corticosteroids and induce a diuresis forced appropriate.