CALCITONIN SALMON spray, metered

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

CALCITONIN SALMON (UNII: 7SFC6U2VI5) (CALCITONIN SALMON - UNII:7SFC6U2VI5)

MAH:

Physicians Total Care, Inc.

INN:

CALCITONIN SALMON

composition:

CALCITONIN SALMON 200 [iU] in 0.09 mL

administration_route:

NASAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Calcitonin-Salmon Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. Calcitonin-Salmon Nasal Spray should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Use of Calcitonin-Salmon Nasal Spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (400 I.U. per day) intake to retard the progressive loss of bone mass. The evidence of efficacy is based on increases in spinal bone mineral density observed in clinical trials. Two randomized, placebo controlled trials were conducted in 325 postmenopausal females [227 Calcitonin-Salmon Nasal Spray treated and 98 placebo treated] with spinal, forearm or femoral bone mineral density (BMD) at least one standard deviation below normal for healthy premenopausal females. These studies conducted over two years demonstrated that 2

leaflet_short:

Available as a metered dose clear solution in a 3.7 mL fill clear glass bottle. It is available in a dosage strength of 200 I.U. per activation (0.09 mL/spray). A screw-on pump is provided. The pump, following priming, will deliver 0.09 mL of solution. Calcitonin-Salmon Nasal Spray contains 2200 I.U./mL calcitonin-salmon and is provided in an individual box containing one glass bottle and one screw-on pump (NDC 54868-6323-0). Store unopened bottle in refrigerator between 2°C-8°C (36°F-46°F). Protect from freezing. Store bottle in use at room temperature between 20°C-25°C (68°F-77°F) in an upright position, for up to 35 days. Each bottle contains at least 30 doses.

authorization_status:

Abbreviated New Drug Application

SPC

CALCITONIN SALMON - CALCITONIN SALMON SPRAY, METERED
PHYSICIANS TOTAL CARE, INC.
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CALCITONIN-SALMON
NASAL SPRAY, USP
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Calcitonin is a polypeptide hormone secreted by the parafollicular
cells of the thyroid gland in
mammals and by the ultimobranchial gland of birds and fish.
Calcitonin-Salmon Nasal Spray is a synthetic polypeptide of 32 amino
acids in the same linear sequence
that is found in calcitonin of salmon origin. This is shown by the
following graphic formula:
It is provided in 3.7 mL fill glass bottles as a solution for nasal
administration. This is sufficient
medication for at least 30 doses.
_Active Ingredient:_calcitonin-salmon, 2200 I.U. per mL (corresponding
to 200 I.U. per 0.09 mL
actuation).
_Inactive Ingredients:_sodium chloride, chlorobutanol, hydrochloric
acid (added as necessary to adjust
pH), purified water and nitrogen.
The activity of Calcitonin-Salmon Nasal Spray is stated in
International Units based on bioassay in
comparison with the International Reference Preparation of
calcitonin-salmon for Bioassay, distributed
by the National Institute of Biologic Standards and Control, Holly
Hill, London.
CLINICAL PHARMACOLOGY
Calcitonin acts primarily on bone, but direct renal effects and
actions on the gastrointestinal tract are
also recognized. Calcitonin-salmon appears to have actions essentially
identical to calcitonins of
mammalian origin, but its potency per mg is greater and it has a
longer duration of action.
The information below, describing the clinical pharmacology of
calcitonin, has been derived from
studies with _injectable_ calcitonin. The mean bioavailability of
Calcitonin-Salmon Nasal Spray is
approximately 3% of that of injectable calcitonin in normal subjects
and, therefore, the conclusions
concerning the clinical pharmacology of this preparation may be
different.
The actions of calcitonin on bone and its role in normal human bone
physiology are still not completely
elucidated, although calcitonin receptors have been discovered