CALCITONIN SANDOZ SPRAY ® is a drug based on salmon calcitonin
THERAPEUTIC GROUP: Drugs that affect bone metabolism
Indications CALCITONIN SANDOZ SPRAY ® - Salmon Calcitonin
CALCITONIN SANDOZ SPRAY ® has been shown to be effective in reducing the incidence of vertebral bone fractures following postmenopausal osteoporosis.
Mechanism of action CALCITONIN SANDOZ SPRAY ® - Salmon calcitonin
CALCITONIN SANDOZ SPRAY ® is a drug that allows the intake of synthetic calcitonin, generally administered parenterally, by the nasal route.
Once administered intranasally, it is easily absorbed by the nasal mucosa reaching maximum plasma concentrations within one hour of intake.
Despite the low bioavailability, made such by the action of the various proteases present in the respiratory tree, inhaled calcitonin is able to act effectively by improving calcium metabolism and preventing, as demonstrated in various studies, the incidence of vertebral fractures.
This very important therapeutic effect is guaranteed by particularly complex mechanisms of action which see the aforementioned hormone involved in the renal level in facilitating the excretion of calcium, in the intestinal level in reducing the absorption of this mineral but above all in the bone level, inhibiting the " osteo-absorbent activity of osteoclasts, responsible for the demineralization observed in pathologies such as osteoporosis.
Studies carried out and clinical efficacy
1. BIOAVAILABILITY OF CALCITONIN BY THE ENDONASAL ROUTE
Pharm Res. 2008 Jul; 25: 1583-90. Epub 2008 Feb 21.
A comparison of the pulmonary bioavailability of powder and liquid aerosol formulations of salmon calcitonin.
Clark A, Kuo MC, Newman S, Hirst P, Pitcairn G, Pickford M.
Although research in the pharmaceutical field has proposed numerous forms of synthetic salmon calcitonin for intranasal use, at the moment all are equivalent in pharmacokinetic terms, failing to overcome the major limit of bioavailability.
2. CALCITONIN OF SALMON AND OSTEOPOROSIS
BioDrugs. 1998 Oct; 10: 295-300.
Efficacy and tolerability of calcitonin in the prevention and treatment of osteoporosis.
Halkin V, Reginster JY.
Interesting work that demonstrates how salmon calcitonin, even when taken intranasally, can be effective in reducing the incidence of vertebral fractures in women suffering from postmenopausal osteoporosis. This treatment was particularly effective also in patients for whom the "estrogen intake was poorly indicated
3. RESEARCH EFFORTS IN IMPROVING THE PHARMACOKINETIC PROPERTIES OF CALCITONIN
J Pharm Sci. 2009 Oct; 98: 3691-706.
Development of Calcitonin Salmon Nasal Spray: similarity of peptide formulated in chlorobutanol compared to benzalkonium chloride as preservative.
Costantino HR, Culley H, Chen L, Morris D, Houston M, Roth S, Phoenix MJ, Foerder C, Philo JS, Arakawa T, Eidenschink L, Andersen NH, Brandt G, Quay SC.
Yet another effort in pharmaceutical research in the development of alternative formulations of intranasal salmon calcitonin capable of improving its bioavailability. In addition to the choice of excipients, genetic engineering and molecular biology could be important in defining peptides with the same activity as calcitonin but resistant to the proteolotic action of proteases.
Method of use and dosage
CALCITONIN SANDOZ SPRAY ®
Nasal Spray: 200 IU doses of synthetic salmon calcitonin:
the treatment of postmenopausal osteoporosis should include the intake of calcitonin in the most severe cases, also that of vitamin D and calcium, in order to optimize the phases of bone mineralization.
Generally speaking, the most widely used dosage schedule provides for the intake of 200 I.U. once a day.
In any case, the correct dosage and the relative therapeutic procedure must necessarily be established by a specialist doctor.
Warnings CALCITONIN SANDOZ SPRAY ® - Salmon calcitonin
Given the particular route of administration, treatment with CALCITONIN SANDOZ SPRAY ® should be preceded by a "careful medical examination useful to evaluate the patency and integrity of the respiratory tract and in particular of the nasal mucosa, seat of absorption of the active ingredient.
Treatment should therefore be discontinued immediately following the appearance of respiratory diseases or allergic manifestations.
For this reason, before starting the intake of synthetic salmon calcitonin, it would be indicated to undergo allergy tests.
The presence of benzalkonium chloride as a preservative could increase the risk of irritation and edema of the nasal mucosa.
Long-term administration of calcitonin has in some cases been associated with the appearance of antibodies to calcitonin, responsible for reducing the therapeutic efficacy of the drug.
PREGNANCY AND BREASTFEEDING
Despite the studies carried out on calcitonin taken intranasally, have not shown the presence of embryotoxicity or fetal teratogenicity, the intake of CALCITONIN SANDOZ SPRAY ® remains contraindicated during pregnancy and breastfeeding due to the absence of therapeutic indications and significant clinical trials. .
Interactions
At the moment there are no known active ingredients whose concomitant intake could lead to significant pharmacokinetic and pharmacodynamic changes in synthetic salmon calcitonin.
Contraindications CALCITONIN SANDOZ SPRAY ® - Salmon calcitonin
The use of CALCITONIN SANDOZ SPRAY ® is contraindicated in patients with hypersensitivity to the active substance or to one of its excipients and in case of hypocalcemia.
Undesirable Effects - Side Effects
Intake of synthetic salmon calcitonin intranasally may be responsible for side effects concentrated at the level:
- Gastrointestinal with nausea, vomiting, diarrhea and abdominal pain;
- Cutaneous with the appearance of rash and hypersensitivity reactions;
- Respiratory with rhinitis, alterations in the sense of smell, epistaxis, sinusitis and pharyngitis;
- Nervous with the onset of headache and motor instability.
More rarely, the intake of CALCITONIN SANDOZ SPRAY ® has resulted in the onset of systemic adverse reactions such as edema, musculoskeletal pain and vasomotor symptoms.
Note
CALCITONIN SANDOZ SPRAY ® can only be sold under strict medical prescription.
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