CALCITONIN SALMON spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotex Corp.

INN (International Name):

CALCITONIN SALMON

Composition:

CALCITONIN SALMON 200 [iU]

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Calcitonin Salmon (synthetic origin) Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Fracture reduction efficacy has not been demonstrated. Calcitonin Salmon (synthetic origin) 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 (synthetic origin) 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)] . Risk Summary Calcitonin salmon nasal spray is not indicated for use in females of reproductive potential. There are no data with the use of calcitonin salmon nasal spray in pregnant women. In an animal reproduction study, subcutaneous administration of calcitonin-salmon to pregnant rabbits during organogenesis at 418 times the recommended parenteral human dose caused a decrease in fetal birth weights. No adverse developmental outcome was observed in the rat with subcutaneous administration of calcitonin-salmon at 9 times the recommended human parenteral dose based on body surface area (see Data).   Data Animal Data Calcitonin salmon has been shown to cause a decrease in fetal birth weights in rabbits when given by subcutaneous injection in doses 4 to 18 times the parenteral dose (of 54 International Units/m2 ) and 70 to 278 times the intranasal dose recommended for human use based on body surface area.   No embryo/fetal toxicities related to calcitonin salmon nasal spray were reported from maternal subcutaneous daily doses in rats up to 80 International Units/kg/day from gestation day 6 to 15. Risk Summary Calcitonin salmon nasal spray is not indicated for use in females of reproductive potential. There is no information on the presence of calcitonin-salmon in human milk, the effects on the breastfed child, or the effects on milk production. Calcitonin has been shown to inhibit lactation in rats. Safety and effectiveness in pediatric patients have not been established. In a multi-centered, double-blind, randomized clinical study of calcitonin salmon nasal spray, 279 patients were less than 65 years old, while 467 patients were 65 to 74 years old and 196 patients were 75 years old and older. Compared to subjects less than 65 years old, the incidence of nasal adverse reactions (rhinitis, irritation, erythema, and excoriation) was higher in patients over the age of 65, particularly among those over the age of 75. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Calcitonin Salmon (synthetic origin) (kal" si toe' nin) Nasal Spray For Nasal Use Only. Important information about your Calcitonin Salmon (synthetic origin) Nasal Spray: - A single spray of Calcitonin Salmon (synthetic origin) Nasal Spray contains 1 daily dose of medicine. - Each Calcitonin Salmon (synthetic origin) Nasal Spray bottle contains the right amount of medicine. The bottle may not be completely filled to the top. This is normal. - This package contains 1 bottle of Calcitonin Salmon (synthetic origin) Nasal Spray with attached pump. - Store unopened bottles of Calcitonin Salmon (synthetic origin) Nasal Spray in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. - After you open your bottle of Calcitonin Salmon (synthetic origin) Nasal Spray, store it at room temperature between 20°C to 25°C (68°F to 77°F) in an upright position. Do not shake the bottle. - To make sure you get the right dose of Calcitonin Salmon (synthetic origin) Nasal Spray medicine you must prime each new bottle and pump before you use it for the first time. - Check to see if the bottle and pump has already been primed by pressing on the pump 1 time. See Figure 2. - If you see a full spray from the pump, the bottle and pump has already been primed for you. - If you do not see a full spray, you must prime the bottle and pump. - Hold the bottle upright with your pointer finger and middle finger on the 2 side arms of the pump, and your thumb on the bottom of the bottle. Firmly press down on the arms of the pump and press down again if needed until you see a full spray of medicine. See Figure 2. - Now your Calcitonin Salmon (synthetic origin) Nasal Spray is ready for you to use. - Do not prime the pump before you use it each day because this will waste your medicine. - Keep your head upright. Carefully tilt the bottle and place the nose spray pump into 1 side of your nose. - Give 1 spray of Calcitonin Salmon (synthetic origin) Nasal Spray, 1 time daily, in 1 side of your nose (nostril). Spray your medicine in a different side of your nose each day. - You do not need to breathe or inhale while you are giving your dose. - You may not feel the spray inside your nose. - Some of the medicine may drip out of your nose. This is normal, and you are still getting all of the medicine you need. - Dry the nose spray pump with a clean cloth. - Be careful not to push down on the pump while you are putting the cap back on it. - Do not refrigerate Calcitonin Salmon (synthetic origin) Nasal Spray between doses. - Store Calcitonin Salmon (synthetic origin) Nasal Spray upright. - Do not shake the bottle. When should I throw away Calcitonin Salmon (synthetic origin) Nasal Spray? - Unopened, refrigerated bottles can be used until the expiration date stamped on the bottle and box. - Throw away Calcitonin Salmon (synthetic origin) Nasal Spray after you use 14 doses (2 mL fill) or 30 doses (3.7 mL fill) (sprays). - Throw away Calcitonin Salmon (synthetic origin) Nasal Spray bottles left at room temperature (opened or unopened) for more than 30 days (2 mL fill) or 35 days (3.7 mL fill). For more information on Calcitonin Salmon (synthetic origin) Nasal Spray, call Apotex Corp. at 1-800-706-5575. This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration. APOTEX INC. CALCITONIN SALMON (SYNTHETIC ORIGIN) NASAL SPRAY Revised: November 2017

Product summary:

How Supplied Calcitonin Salmon (synthetic origin) Nasal Spray is available as a metered dose clear solution in a 2 mL or 3.7 mL fill clear glass bottle that contains 2,200 USP Calcitonin Salmon Units calcitonin salmon per mL. A pump is attached to the bottle. After priming, the pump will deliver 200 USP Calcitonin Salmon Units per activation (0.09 mL per spray) (2 mL fill: NDC 60505-0823-0; 3.7 mL fill: NDC 60505-0823-6). Storage and Handling Store unopened bottle in refrigerator between 2°C to 8°C (36°F to 46°F). Protect from freezing. Store bottle in use at room temperature between 20°C to 25°C (68°F to 77°F) in an upright position, for up to 30 days (2 mL fill) or 35 days (3.7 mL fill). Each bottle contains at least 14 doses (2 mL fill) or 30 doses (3.7 mL fill). Discard bottle after 14 doses (2 mL fill) or 30 doses (3.7 mL fill).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCITONIN SALMON- CALCITONIN SALMON SPRAY, METERED
APOTEX CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCITONIN SALMON
NASAL SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR CALCITONIN
SALMON NASAL SPRAY.
CALCITONIN SALMON NASAL SPRAY
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
Calcitonin Salmon (synthetic origin) Nasal Spray 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 USP Calcitonin Salmon 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 USP Calcitonin Salmon Units per mL of calcitonin
salmon in a 2 mL or 3.7 mL fill glass
bottle with attached pump. Each actuation delivers 200 USP Calcitonin
Salmon 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-analysis of 21 clinical trials suggests an
increa