Bula do remedy Cibacalcina

the package insert of the medicine Cibacalcina. Therapeutic class of Metabolism Bone. Active principlesCalcitonin Human Synthetic.

Indication of Cibacalcina

what For?

· Osteoporosis of various origins
· Paget’s disease of bone (Osteitis crippling)
· Hypercalcemia induced by tumor

Contraindications

When should I not use?

known Hypersensitivity to calcitonin human synthetic.

Dosage

How to use?

adverse Reactions such as nausea and waves of heat can be minimized by the administration before going to sleep.

· Osteoporosis of various origins
Administer 0.25 mg of Cibacalcina 3 times per week subcutaneously as a continuous treatment in the long term. The preventive effect of Cibacalcina in bone loss remains for several months after the end of treatment. You must use a supplementation adequate calcium. The density of bone mass should be measured before starting treatment and then at regular intervals (approximately 1 time a year) during therapy for chronic.

· Paget’s Disease of bone
The dosage should be individually adapted according to the needs of the patient. As a rule, it is recommended that the treatment starts with a dose of 0.5 mg subcutaneously or intramuscular once a day, for several weeks. According to the patient response, this dosage may later be increased to 0.5 mg twice a day, or reduced for maintenance therapy, for example 0.25 mg daily or 0.5 mg, 2 to 3 times per week.

As an aid in the evaluation of the effectiveness of Cibacalcina, the determination of serum alkaline phosphatase and urinary excretion of hidroxiprolina should be performed before starting therapy, during the first three months and at intervals ( of approximately 3 to 6 months) during the continuous treatment. Adjustments in dosage should be guided by clinical signs and radiological examinations, such as changes in alkaline phosphatase in serum and urinary excretion of hidroxiprolina. The treatment should continue for 6 months or more. If withdrawal of therapy is followed by a prolonged exacerbation (marked by an increase in the biochemical parameters and return of symptoms or signs, radiological), the treatment should be restarted.

· Hypercalcemia induced by tumor
For acute treatment, administer 0.5 mg every 6 hours by intravenous injection slowly, after rehydration prior. The calcium lactate should be measured every 6 hours. The treatment can be discontinued 12 hours after serum calcium levels have returned to normal. The therapeutic effect is usually obtained within the first 24 hours of treatment. In patients with unsatisfactory results, the increase of the dose does not entail a further reduction of calcium in serum. It is observed a new increase in calcium serum in a few days after the discontinuation of the treatment.

Side Effects

What are the evils that can cause me?

gastrointestinal Tract
Frequent: nausea. Occasional: vomiting, diarrhea, abdominal discomfort. Rare: anorexia.

the central nervous System and peripheral
Rare: headache, vertigo, paresthesia including gentleness of the region, palmar and plantar.

the Organs of sense
Rare: taste metallic.

urogenital System
Occasional: urinary frequency increased, polyuria.

Skin/hypersensitivity:
Occasional reaction at the site of application. Rare: skin rashes, urticaria, pruritus, fever, chills and goosebumps. Isolated cases: allergic reactions/anaphylactoid including shock, angioedema, laringoespasmos and dyspnea.

the cardiovascular System
Faq: heat waves, rarely accompanied by hypotension and tachycardia. Isolated cases: hypertension.

the Metabolism
Isolated cases: symptoms of tetania or transient hypocalcemia without clinical importance.

Other
Rare: malaise, asthenia.

The adverse reactions most frequently observed were nausea and waves of heat, being that the majority of patients improve with continued treatment.

Warnings and Precautions

what should I know before using?

Considering that Cibacalcina is a peptide, the possibility of an allergic reaction that is systemic should not be disregarded.