FORTICAL- calcitonin salmon spray, metered

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Physicians Total Care, Inc.

INN (Међународно име):

CALCITONIN SALMON

Састав:

CALCITONIN SALMON 2200 [iU] in 1 mL

Пут администрације:

NASAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass relative to healthy premenopausal women. Use of FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and Vitamin D (400 International Units per day) intake to retard the progressive loss of bone mass. The evidence of efficacy for calcitonin-salmon is based on increases in spinal bone mineral density (BMD) observed in clinical trials. Two randomized, placebo-controlled trials were conducted in 325 postmenopausal women (227 treated with calcitonin-salmon nasal spray and 98 treated with placebo) with spinal, forearm or femoral BMD at least one standard deviation below the normal value for healthy premenopausal women. These studies conducted over two years demonstrated that 200 International Units daily of calcitonin-salmon nasal spray

Резиме производа:

FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray is presented as a metered dose solution in a 3.7 mL fill amber glass bottle. It is available in a dosage strength of 200 International Units per activation (0.09 mL). A screw-on pump is provided. Following priming, the pump will deliver solution containing 200 International Units of calcitonin-salmon per activation. FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray contains 2200 International Units/mL calcitonin-salmon and is provided in individual boxes containing one glass bottle with screw cap and one screw-on pump (NDC# 54868-5499-0 ). Store unopened bottle in refrigerator between 36°F to 46°F (2°C to 8 °C). Protect from freezing. After opening, store bottle in use in an upright position at 68°F to 77°F (20°C to 25 °C). Excursions permitted to 15°C to 30°C (59°F to 86°F). Throw away the empty bottle of Fortical® Nasal Spray after you have used 30 doses.

Статус ауторизације:

New Drug Application

Карактеристике производа

FORTICAL - CALCITONIN SALMON SPRAY, METERED
PHYSICIANS TOTAL CARE, INC.
----------
FORTICAL
CALCITONIN-S ALMON
(RDNA ORIGIN)
NASAL SPRAY
FOR INTRANASAL USE ONLY
RX ONLY
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.
The active ingredient in FORTICAL calcitonin-salmon (rDNA origin)
Nasal Spray is a polypeptide of
32 amino acids manufactured by recombinant DNA technology and is
identical to calcitonin-salmon
produced by chemical synthesis.
This is shown by the following graphic formula:
It is provided in a 3.7 mL fill glass bottle as a solution for
intranasal administration with sufficient
medication for at least 30 doses. Each spray delivers 200
International Units calcitonin-salmon in a
volume of 0.09 mL.
_Active Ingredient_: Calcitonin-salmon 2200 International Units/mL,
corresponding to 200 International
Units per actuation (0.09 mL).
_Inactive Ingredients_: Sodium Chloride USP, Citric Acid USP,
Phenylethyl Alcohol USP, Benzyl
Alcohol NF, Polysorbate 80 NF, Hydrochloric Acid NF or Sodium
Hydroxide NF (added as necessary
to adjust pH) and Purified Water USP.
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 the 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 d