FORTICAL- calcitonin salmon spray, metered

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

calcitonin salmon (UNII: 7SFC6U2VI5) (calcitonin salmon - UNII:7SFC6U2VI5)

Disponível em:

Upsher-Smith Laboratories, Inc.

DCI (Denominação Comum Internacional):

calcitonin salmon

Composição:

calcitonin salmon 2200 [iU] in 1 mL

Via de administração:

NASAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Fortical nasal spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Fracture reduction efficacy has not been demonstrated. Fortical nasal spray should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). - Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see Warnings and Precautions (5.4) ]. - Calcitonin-salmon nasal spray has not been shown to increase spinal bone mineral density in early postmenopausal women. Hypersensitivity to calcitonin-salmon or any of the excipients. Reactions have included anaphylactic shock, anaphylaxis, bronchospasm, and swelling of the tongue or throat [see Warnings and Precautions (5.1) ]. Pregnancy Category C: Risk Summary There are no adequate and well-controlled

Resumo do produto:

How Supplied Fortical® (calcitonin-salmon [rDNA origin]) nasal spray is presented as a metered dose solution in a 3.7 mL fill amber glass bottle with screw-on pump that contains 2200 International Units of calcitonin-salmon per mL. Following priming, the pump will deliver 200 International Units of calcitonin-salmon per activation (0.09 mL per spray). Fortical® nasal spray is provided in individual boxes containing one glass bottle with screw cap and one screw-on pump (NDC# 0245-0008-35). Storage and Handling Store unopened bottle in refrigerator between 2° to 8°C (36° to 46°F). Protect from freezing. After opening, store bottle in use in an upright position at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). Discard the bottle after 30 doses have been used.

Status de autorização:

New Drug Application

Características técnicas

FORTICAL- CALCITONIN SALMON SPRAY, METERED
UPSHER-SMITH LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FORTICAL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FORTICAL.
FORTICAL (CALCITONIN-SALMON [RDNA ORIGIN]) NASAL SPRAY FOR INTRANASAL
USE
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Indications and Usage (1.2)
07/2014
Warnings and Precautions (5.2, 5.4)
07/2014
INDICATIONS AND USAGE
Fortical is a calcitonin indicated for the treatment of postmenopausal
osteoporosis in women greater than 5 years
postmenopause when alternative treatments are not suitable. Fracture
reduction efficacy has not been demonstrated (1.1).
Limitations of Use:
Due to the possible association between malignancy and
calcitonin-salmon use, the need for continued therapy should
be re-evaluated on a periodic basis (1.2, 5.4)
Calcitonin-salmon nasal spray has not been shown to increase bone
mineral density in early postmenopausal women
(1.2)
DOSAGE AND ADMINISTRATION
For intranasal use only: one spray (200 International Units) per day,
alternating nostrils daily (2.1)
Prior to first use, allow the bottle to reach room temperature and
prime the pump (2.2)
Ensure adequate calcium and Vitamin D intake. (2.3)
DOSAGE FORMS AND STRENGTHS
Nasal spray: 2200 International Units per mL of calcitonin-salmon in a
3.7 mL fill glass bottle with screw-on pump. Each
actuation delivers 200 International Units of calcitonin-salmon. (3)
CONTRAINDICATIONS
Hypersensitivity to calcitonin-salmon or any of the excipients (4)
WARNINGS AND PRECAUTIONS
Serious hypersensitivity reactions, including anaphylactic shock have
been reported. Consider skin testing prior to
treatment in patients with suspected hypersensitivity to
calcitonin-salmon. (5.1)
Hypocalcemia has been reported. Ensure adequate intake of calcium and
vitamin D (5.2)
Nasal adverse reactions including severe ulceration can occur.
Periodic nasal examinations are recommended (5.3)
Malignancy: A meta-analy