Calci-10

Calci-10

calcitonin

Manufacturer:

Pharmathen

Distributor:

Cosma Medical
Full Prescribing Info
Contents
Calcitonin salmon.
Description
Each nasal spray contains calcitonin salmon 200 IU per dose.
Excipients/Inactive Ingredients: Sodium chloride, sodium methylparaben E 219, sodium propylparaben E 217, disodium edetate, water purified.
Action
Pharmacotherapeutic Group: Anti-parathyroid hormone. ATC Code: H05BA01 (calcitonin salmon).
Pharmacology: Pharmacodynamics: Calcitonin is a hormone that possesses effects on calcium metabolism and inhibits bone resorption with direct action on osteoclasts. By inhibiting osteoclastic activity, salmon calcitonin reduces bone resorption.
Salmon calcitonin significantly reduces the rate of bone resorption in cases with an increased rate of bone resorption such as osteoporosis.
In pharmacological studies, calcitonin salmon seems to exhibit an analgesic action in animal models.
Intranasal calcitonin provokes clinically relevant biological response in humans, as it appears by the increase in calcium, phosphate and natrium excretion in the urine (reduction in their reuptake at the renal tubes) and by the reduction of hydroxyproline excretion in the urine. Long lasting administration of intranasal calcitonin significantly reduces the biochemical indexes of bone resorption such as serum C­ telopeptides (CTX) and skeletal isoenzymes of alkaline phosphatase.
Intranasal calcitonin results in a statistically important increase of 1-2% in bone mineral density (BMD) of the spinal column's lumbar pars, which is obvious from the 1st year and is preserved for up to 5 years. BMD for the ischium remains stable.
In a 5-year study in women after menopause (PROOF study), the administration of 200 IU of intranasal calcitonin salmon resulted in the reduction in the relevant risk of spinal fracture development by 33%. The relevant risk of spinal fracture development in comparison to placebo (treatment with only vitamin D and calcium) for all patients who received daily doses of 200 IU was 0.67 (95% CI: 0.47-0.97).
The absolute risk of fracture development during the 5 years was reduced from 25.9% in the placebo group to 17.8% in the 200 IU group. No reduction in ischium fractures has been proved. The recommended dose of intranasal calcitonin for the treatment of established post-menopausal osteoporosis is 200 IU once daily. Higher doses did not prove to be more effective.
Pharmacokinetics: The pharmacokinetic properties of intranasal calcitonin salmon are difficult to evaluate quantitatively because of inadequate sensitivity and non-certain speciality of the available immunologic tests that were used in the studies that have been conducted until today. Bioavailability of a 200 IU dose that has been administered parenterically varies from 2 to 15%. Intranasal calcitonin is rapidly absorbed via the nasal mucous membrane and maximum plasma concentrations are achieved within the first hour from administration. Elimination half-life has been calculated at approximately 16 to 43 minutes and after multiple administrations, no signs of concentration were observed. Doses higher than the recommended ones result in higher blood levels (as proved by the increase in AUC) but the relevant bioavailability does not increase. As in the case of other polypeptide hormones, the monitoring of plasma calcitonin salmon levels is of no particular value since these levels do not directly represent its therapeutic response. Therefore, calcitonin's action should be evaluated with the use of clinical parameters regarding activity.
Binding with plasma proteins is of 30 to 40%.
Toxicology: Preclinical Safety Data: Conventional long lasting studies in toxicity, reproduction and mutagenicity have been conducted on guinea pigs. Moreover, tolerance of the nose has been investigated in dogs and apes.
Calcitonin salmon lacks embryotoxic, teratogenic and mutagenic action.
Increased incidence of hypophysis adenoma was reported in rats that were receiving synthetic calcitonin salmon for 1 year. This effect is considered special to the species and of no clinical importance. Calcitonin salmon cannot cross the placenta barrier. 
In animals that were receiving calcitonin during lactation, suppression in the production of milk was noted. Calcitonin is excreted in the milk.
Analysis of all available calcitonin trials showed an increased risk of cancer. In long-term clinical trials the risk of developing cancer was 0.7% to 2.4% higher in patients receiving calcitonin-containing medicines compared to those patients receiving placebo, with the higher rates seen in trials with intranasal calcitonin.
Indications/Uses
Treatment of established post-menopausal osteoporosis for the reduction of spinal fractures. Reduction in fractures of the ischium has not been proved.
Bone pain with osteoporosis; Paget's disease; neurodystrophic disorders (Sudeck's disease).
Dosage/Direction for Use
The recommended dose of the intranasal calcitonin for the treatment of established post-menopausal osteoporosis is 200 ID once daily. The use of intranasal calcitonin is recommended in combination with adequate calcium and vitamin D. Administration of the therapeutic treatment should be long lasting (see Pharmacology: Pharmacodynamics under Actions).
Use in Elderly Patients and Patients with Hepatic and Renal Failure: Extensive experience in the use of intranasal calcitonin in elderly patients has showed no reduced tolerance or need for dose adjustment. The same applies in the case of patients with disturbed renal or hepatic function.
Use in Children: Since intranasal calcitonin is indicated in post-menopausal women, its use in children is not appropriate.
Overdosage
Nausea, vomit, flush and dizziness are known as dose-dependant symptoms when calcitonin is administered parenterically. Single doses of injectable calcitonin salmon (up to 10,000 IU) have been administered with no other undesirable effects except for nausea, vomit and intensification of the pharmacological actions. Such symptoms should therefore be expected with overdose of intranasal calcitonin.
However, intranasal calcitonin administered as a single dose of up to 1600 IU and also of up to 800 IU daily for three days has not caused any serious undesirable effects. Treatment should be symptomatic in case symptoms of overdose appear.
Contraindications
Hypersensitivity to calcitonin (see Adverse Reactions) or any of the composition's excipients (see Description).
Calcitonin is also contraindicated in patients with hypocalcemia.
Special Precautions
Prior to the treatment's initiation and in case of nasal disturbances, a nasal examination should be performed. In case of severe ulceration of the nasal mucous membrane (e.g. penetration under the mucous membrane or correlation with severe hemorrhage), intranasal calcitonin should be discontinued. In case of mild ulceration, treatment should be temporarily discontinued until healing.
Since calcitonin is a peptide, there is a possibility of systemic allergic reactions. In patients receiving intranasal calcitonin, allergic type reactions have been reported, including isolated cases of anaphylactic shock. In patients with a suspicion of sensitivity to calcitonin, a dermal test should be performed before their treatment with calcitonin.
Treatment in this condition should normally be limited to 3 months.
Effects on the ability to drive and use machines: There are no data regarding the effect of intranasal calcitonin on the ability to drive and use machines. Intranasal calcitonin may provoke transient dizziness (see Adverse Reactions) that may reduce the patient's reactions. Patients should therefore be warned regarding the possibility of transient dizziness, so as not to drive or use machines.
Use In Pregnancy & Lactation
Since intranasal calcitonin is indicated in post-menopausal women, no studies have been conducted on pregnant or lactating women. For this reason, intranasal calcitonin should not be administered in these patients. However, studies in animals have showed no embryotoxic or teratogenic action. It seems that in the case of animals, calcitonin salmon cannot cross the placenta barrier.
It is not known whether the substance is excreted in human milk. In animals, calcitonin salmon has been proved to reduce lactation and to be excreted in the milk.
Adverse Reactions
Categories based on incidence: Very often >1/10, often (>1/100, <1/10), unusual (>1/1000, <1/100), rare (>1/10000, <1/1000), very rare (<1/10000), including isolated reports. Gastrointestinal disorders: Usual: Nausea, diarrhea and abdominal pain.
Unusual: Vomit.
Vascular disorders: Usual: Flushing.
Unusual: Hypertension.
Respiratory disorders: Very often: Rhinitis (including dry nose, nasal edema, nasal congestion, sneezing, allergic rhinitis), non-specialized symptoms by the nose (e.g. irritation of the nasal route, papular exanthema, erythema, excoriation).
Usual: Ulcer rhinitis, nasosinusitis, epistaxis and pharyngitis.
Unusual: Cough.
These symptoms are generally mild (approximately 80% of the cases reported) and require treatment discontinuation in less than 5% of the cases.
Disorders of the nervous system: Usual: Dizziness, headache and dysgeusia.
Disorders of the sensory organs: Unusual: Vision disorder.
Disorders of the skin and of the subcutaneous tissue: Unusual: Edema (facial edema, peripheral edema and edema of the flesh).
Disorders of the immune system: Unusual: Hypersensitivity reactions such as generalized skin reactions, flush, edema (facial edema, peripheral edema and edema of the flesh), hypertension, arthralgia and itching.
Very rare: Allergic and anaphylactic type reactions such as tachycardia, hypotension, circulatory shock and anaphylactic shock.
Examination: Rare: Development of antibodies that inactivate calcitonin. The development of these antibodies does not usually relate to the loss of clinical effectiveness, although their presence in a small percentage of patients after long lasting treatment at high doses of calcitonin may result in reduced response to the product. The presence of antibodies seems not to relate to allergic reactions, which are rare. Downregulation of calcitonin receptors may result in reduced clinical response in a small percentage of patients after long lasting treatment at high doses.
General disturbances: Usual: Fatigue.
Unusual: Disease similar to flu.
Drug Interactions
No interactions have been reported regarding the use of intranasal calcitonin with other drugs.
Caution For Usage
Incompatibilities: Not mentioned.
Storage
Special precautions for storage: Keep at temperatures of 2°-8°C. After the initial opening of the package, the product may be kept for 30 days at ambient temperature (up to 25°C). The product must be kept away from children.
Shelf-Life: 36 months.
ATC Classification
H05BA01 - calcitonin (salmon synthetic) ; Belongs to the class of anti-parathyroid hormones, calcitonin preparations. Used in the management of calcium homeostasis.
Presentation/Packing
Nasal spray solution 200 IU/dose x 14 doses.
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