Fortical (Calcitonin-Salmon (rDNA origin))
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Fortical (Calcitonin-Salmon (rDNA origin))

FORTICAL®
(calcitonin-salmon rDNA origin) Nasal Spray

For Intranasal Use Only

DRUG 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:

FORTICAL® (calcitonin-salmon) Amino acid sequence - Illustration

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.

What are the possible side effects of calcitonin nasal (Fortical, Miacalcin Nasal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting; or
  • severe nasal irritation.

Less serious side effects may include:

  • bleeding from your nose;
  • runny or stuffy nose;
  • dryness, itching, tenderness, or general discomfort of your nose;
  • crusting, scabs, or sores inside your...

Read All Potential Side Effects and See Pictures of Fortical »

What are the precautions when taking calcitonin-salmon (rdna origin) (Fortical)?

Before taking calcitonin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication is used mainly in women after menopause. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this...

Read All Potential Precautions of Fortical »

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Postmenopausal Osteoporosis

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 increases lumbar vertebral BMD relative to baseline and relative to placebo in osteoporotic women who were greater than 5 years postmenopause. Calcitonin-salmon nasal spray produced statistically significant increases in lumbar vertebral BMD compared to placebo as early as 6 months after initiation of therapy with persistence of this level for up to 2 years of observation.

No effects of calcitonin-salmon nasal spray on cortical bone of the forearm or hip were demonstrated. However, in one study, BMD of the hip showed a statistically significant increase compared with placebo in a region composed of predominantly trabecular bone after 1 year of treatment changing to a trend at 2 years that was no longer statistically significant.

DOSAGE AND ADMINISTRATION

The recommended dose of FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray in postmenopausal osteoporotic patients is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily. Each bottle, filled with 3.7 mL of solution, contains enough medication for 30 doses. Drug effect may be monitored by periodic measurements of lumbar vertebral bone mass to document stabilization of bone loss or increases in bone density. Effects of calcitonin-salmon nasal spray on biochemical markers of bone turnover have not been consistently demonstrated in studies in postmenopausal osteoporosis. Therefore, these parameters should not be solely utilized to determine clinical response to calcitonin-salmon nasal spray therapy in these patients.

Priming (Activation) of Pump

Before the first dose and administration, allow the bottle to reach room temperature. Remove the protective cap and clip from the bottle of FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray. To prime the pump, hold the bottle upright and depress the two white side arms of the pump toward the bottle at least 5 times until a full spray is produced. The pump is primed once the first full spray is emitted. To administer, the nozzle should be carefully placed into the nostril with the head in the upright position and the pump firmly depressed toward the bottle. The pump should NOT be primed before each daily use.

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. 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# 0245-0008-35).

Store and Dispense

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.

Distributed by: Upsher-Smith Laboratories, Inc. Minneapolis, MN USA 55447-4709. Revised 0411

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The incidence of adverse reactions reported in studies involving postmenopausal osteoporotic patients chronically exposed to calcitonin-salmon nasal spray (N=341) and to placebo nasal spray (N=131), and reported in greater than 3% of calcitonin-salmon nasal spray treated patients are presented in the following table. Most adverse reactions were mild to moderate in severity. Nasal adverse events were most common with 70% mild, 25% moderate, and 5% severe in nature (placebo rates were 71% mild, 27% moderate, and 2% severe).

Adverse Reactions Occurring in at Least 3% of Postmenopausal Patients Treated Chronically

Adverse Reaction Calcitonin-Salmon Nasal Spray
N=341
% of Patients
Placebo
N=131
% of Patients
Rhinitis 12.0 6.9
Symptom of Nose† 10.6 16.0
Back Pain 5.0 2.3
Arthralgia 3.8 5.3
Epistaxis 3.5 4.6
Headache 3.2 4.6
†Symptom of nose includes: nasal crusts, dryness, redness or erythema, nasal sores, irritation, itching, thick feeling, soreness, pallor, infection, stenosis, runny/blocked, small wound, bleeding wound, tenderness, uncomfortable feeling and sore across bridge of nose.

In addition, the following adverse events were reported in fewer than 3% of patients during chronic therapy with calcitonin-salmon nasal spray. Adverse events reported in 1%-3% of patients are identified with an asterisk(*). The remainder occurred in less than 1% of patients. Other than flushing, nausea, possible allergic reactions, and possible local irritative effects in the respiratory tract, a relationship to calcitonin-salmon nasal spray has not been established.

Body as a whole – General Disorders: influenza-like symptoms*, fatigue*, edema (facial, peripheral, and generalized), fever

Integumentary: erythematous rash*, skin ulceration, eczema, alopecia, pruritus, increased sweating

Musculoskeletal/Collagen: arthrosis*, myalgia*, arthritis, polymyalgia rheumatica, stiffness

Respiratory/Special Senses: sinusitis*, upper respiratory tract infection*, bronchospasm*, pharyngitis, bronchitis, pneumonia, coughing, dyspnea, taste perversion, parosmia, nasal congestion, sneezing, allergic rhinitis, nasal odor, mucosal excoriation, rhinitis ulcerative

Cardiovascular: hypertension*, angina pectoris*, tachycardia, palpitation, bundle branch block, myocardial infarction

Gastrointestinal: dyspepsia*, constipation*, abdominal pain*, nausea*, diarrhea*, vomiting, flatulence, increased appetite, gastritis, dry mouth

Liver/Metabolic: cholelithiasis, hepatitis, thirst, weight increase

Endocrine: goiter, hyperthyroidism

Urinary System: cystitis*, pyelonephritis, hematuria, renal calculus

Central and Peripheral Nervous System: dizziness*, paresthesia*, vertigo, migraine, neuralgia, agitation

Hearing/Vestibular: tinnitus, hearing loss, earache

Vision: abnormal lacrimation*, conjunctivitis*, blurred vision, vitreous floater, visual disturbance

Vascular: flushing, cerebrovascular accident, thrombophlebitis

Hematologic/Resistance Mechanisms: lymphadenopathy*, infection*, anemia

Psychiatric: depression*, insomnia, anxiety, anorexia

Immune System Disorders: hypersensitivity, anaphylaxis and anaphylactic shock

Common adverse reactions associated with the use of injectable calcitonin-salmon occurred less frequently in patients treated with calcitonin-salmon nasal spray than in those patients treated with injectable calcitonin. Nausea, with or without vomiting, which occurred in 1.8% of patients treated with the nasal spray (and 1.5% of those receiving placebo nasal spray) occurs in about 10% of patients who take injectable calcitonin-salmon. Flushing, which occurred in less than 1% of patients treated with the nasal spray, occurs in 2-5% of patients treated with injectable calcitonin-salmon. Although the administered dosages of injectable and nasal spray calcitonin-salmon are comparable (50-100 units daily of injectable versus 200 units daily of nasal spray), the nasal dosage form has a mean bioavailability of about 3% (range 0.3%-30.6%) and therefore provides less drug to the systemic circulation, possibly accounting for the decrease in frequency of adverse reactions.

The collective foreign marketing experience with calcitonin-salmon nasal spray does not show evidence of any notable difference in the incidence profile of reported adverse reactions when compared with that seen in the clinical trials.

Read the Fortical (calcitonin-salmon (rdna origin)) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Formal studies designed to evaluate drug interactions with calcitonin-salmon have not been done.

Concomitant use of calcitonin and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may need to be adjusted.

The effects of prior use of diphosphonates in postmenopausal osteoporosis patients have not been assessed; however, in patients with Paget's disease prior diphosphonate use appears to reduce the anti-resorptive response to calcitonin-salmon nasal spray.

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Allergic Reactions

Because calcitonin is a polypeptide, the possibility of a systemic allergic reaction exists. A few cases of serious allergic-type reactions have been reported in patients receiving calcitonin-salmon nasal spray, including cases of anaphylaxis and anaphylactic shock. With injectable calcitonin-salmon there have been a few reports of serious allergic-type reactions (e.g. bronchospasm, swelling of the tongue or throat, anaphylactic shock), including very rare reports of death attributed to anaphylaxis. The usual provisions should be made for emergency treatment if such a reaction should occur. Allergic reactions should be differentiated from generalized flushing and hypotension.

For patients with suspected sensitivity to calcitonin, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of a calcitonin-salmon injectable product. Physicians may wish to refer patients who require skin testing to an allergist. A detailed skin testing protocol is available from Upsher-Smith Laboratories, Inc. by calling toll-free at 1-800-6542299.

PRECAUTIONS

Periodic Nasal Examinations

Periodic nasal examinations with visualization of the nasal mucosa, turbinates, septum and mucosal blood vessel status are recommended.

The development of mucosal alterations or transient nasal conditions have been reported in up to 9% of patients who received a calcitonin-salmon nasal spray and in up to 12% of patients who received placebo nasal spray in studies in postmenopausal women. The majority of patients (approximately 90%) in whom nasal abnormalities were noted also reported nasally related complaints/symptoms as adverse events. Therefore, a nasal examination should be performed prior to start of treatment with nasal calcitonin and at any time nasal complaints occur.

In all postmenopausal patients treated with a calcitonin-salmon nasal spray, the most commonly reported nasal adverse events included rhinitis (12%), epistaxis (3.5%), and sinusitis (2.3%). Smoking was shown not to have any contributory effect on the occurrence of nasal adverse events. One patient (0.3%) treated with a calcitonin-salmon nasal spray who was receiving 400 International Units daily developed a small nasal wound. In clinical trials in another disorder (Paget's disease), 2.8% of patients developed nasal ulcerations.

If severe ulceration of the nasal mucosa occurs, as indicated by ulcers greater than 1.5 mm in diameter or penetrating below the mucosa, or those associated with heavy bleeding, calcitonin-salmon nasal spray should be discontinued. Although smaller ulcers often heal without withdrawal of calcitonin-salmon nasal spray, medication should be discontinued temporarily until healing occurs.

Carcinogenicity, Mutagenicity, Impairment of Fertility

An increased incidence of non-functioning pituitary adenomas has been observed in 1-year toxicity studies in Sprague-Dawley and Fischer 344 Rats administered (subcutaneously) calcitonin-salmon at dosages of 80 International Units per kilogram per day (16-19 times the recommended human parenteral dose and about 130-160 times the human intranasal dose based on body surface area).

The findings suggest that calcitonin-salmon reduced the latency period for development of the pituitary adenomas that do not produce hormones, probably through the perturbation of physiologic processes involved in the evolution of this commonly occurring endocrine lesion in the rat. Although administration of calcitonin-salmon reduces the latency period of the development of nonfunctional proliferative lesions in rats, it did not induce the hyperplastic/neoplastic process.

Calcitonin-salmon was tested for mutagenicity using four strains of Salmonella typhimurium and two strains of Escherichia coli, with and without rat liver metabolic activation, and found to be non-mutagenic. The drug was also not mutagenic in a chromosome aberration test in Chinese Hamster ovary cells in vitro .

Laboratory Tests

Urine sediment abnormalities have not been reported in ambulatory volunteers treated with calcitonin-salmon nasal spray. Coarse granular casts containing renal tubular epithelial cells were reported in young adult volunteers at bed rest who were given injectable calcitonin-salmon to study the effect of immobilization on osteoporosis. There was no evidence of renal abnormality and the urine sediment became normal after calcitonin was stopped. Periodic examinations of urine sediment should be considered.

Pregnancy

Teratogenic Effects - Category C

Calcitonin-salmon has been shown to cause a decrease in fetal birth weights in rabbits when given by injection in doses 8-33 times the parenteral dose and 70-278 times the intranasal dose recommended for human use based on body surface area.

Since calcitonin does not cross the placental barrier, this finding may be due to metabolic effects on the pregnant animal. There are no adequate and well-controlled studies in pregnant women with calcitonin-salmon. FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray is not indicated for use in pregnancy.

Nursing Mothers

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on this drug since many drugs are excreted in human milk. Calcitonin has been shown to inhibit lactation in animals.

Pediatric Use

There are no data to support the use of FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray in children. Disorders of bone in children referred to as idiopathic juvenile osteoporosis have been reported rarely. The relationship of these disorders to postmenopausal osteoporosis has not been established and experience with the use of calcitonin in these disorders is limited.

Geriatric Use

In a large 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 and over. Compared to subjects less than 65 years old, the incidence of nasal adverse events (rhinitis, irritation, erythema, and excoriation) was higher in patients over the age of 65, particularly those over the age of 75. Most events were mild in intensity. 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.

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No instances of overdose with calcitonin-salmon nasal spray have been reported and no serious adverse reactions have been associated with high doses. There is no known potential for drug abuse for calcitonin-salmon.

Single doses of calcitonin-salmon nasal spray up to 1600 International Units, doses up to 800 International Units per day for 3 days and chronic administration of doses up to 600 International Units per day have been studied without serious adverse effects. A 1000 International Units dose of calcitonin-salmon injectable product given subcutaneously may produce nausea and vomiting. A 32 International Units per kg per day dose of calcitonin-salmon injectable product for 1or 2 days demonstrated no additional adverse effects.

There have been no reports of hypocalcemic tetany. However, the pharmacologic actions of FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray suggest that this could occur in overdose. Therefore, provisions for parenteral administration of calcium should be available for the treatment of overdose.

CONTRAINDICATIONS

Clinical allergy to calcitonin-salmon.

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

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 discovered in osteoclasts and osteoblasts.

Single injections of calcitonin cause a marked transient inhibition of the ongoing bone resorptive process. With prolonged use, there is a persistent, smaller decrease in the rate of bone resorption. Histologically, this is associated with a decreased number of osteoclasts and an apparent decrease in their resorptive activity. In vitro studies have shown that calcitonin-salmon causes inhibition of osteoclast function with loss of the ruffled osteoclast border responsible for resorption of bone. This activity resumes following removal of calcitonin-salmon from the test system. There is some evidence from in vitro studies that bone formation may be augmented by calcitonin through increased osteoblastic activity.

Animal studies indicate that endogenous calcitonin, primarily through its action on bone, participates with parathyroid hormone in the homeostatic regulation of blood calcium. Thus, high blood calcium levels cause increased secretion of calcitonin which, in turn, inhibits bone resorption. This reduces the transfer of calcium from bone to blood and tends to return blood calcium towards the normal level. The importance of this process in humans has not been determined. In normal adults, who have a relatively low rate of bone resorption, the administration of exogenous calcitonin results in only a slight decrease in serum calcium in the limits of the normal range. In normal children and in patients with Paget's disease in whom bone resorption is more rapid, decreases in serum calcium are more pronounced in response to calcitonin.

Bone biopsy and radial bone mass studies at baseline and after 26 months of daily injectable calcitonin indicate that calcitonin therapy results in the formation of normal bone.

Postmenopausal Osteoporosis

Osteoporosis is a disease characterized by low bone mass and architectural deterioration of bone tissue leading to enhanced bone fragility and a consequent increase in fracture risk as patients approach or fall below a bone mineral density associated with increased frequency of fracture. The most common type of osteoporosis occurs in postmenopausal women. Osteoporosis is a result of a disproportionate rate of bone resorption compared to bone formation, which disrupts the structural integrity of bone, rendering it more susceptible to fracture. The most common sites of these fractures are the vertebrae, hip, and distal forearm (Colles' fracture). Vertebral fractures occur with the highest frequency and are associated with back pain, spinal deformity and a loss of height.

Calcitonin, given by the intranasal route, has been shown to increase spinal bone mass in postmenopausal women with established osteoporosis but not in early postmenopausal women.

Calcium Homeostasis

In two clinical studies designed to evaluate the pharmacodynamic response to calcitonin-salmon nasal spray, administration of 100-1600 International Units to healthy volunteers resulted in rapid and sustained small decreases (but still within the normal range) in both total serum calcium and serum ionized calcium. Single doses greater than 400 International Units did not produce any further biological response to the drug. The development of hypocalcemia has not been reported in studies in healthy volunteers or postmenopausal women.

Kidney

Studies with injectable calcitonin show increases in the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption. Comparable studies have not been conducted with FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray.

Gastrointestinal Tract

Some evidence from studies with injectable preparations suggests that calcitonin may have significant actions on the gastrointestinal tract. Short-term administration of injectable calcitonin results in marked transient decreases in the volume and acidity of gastric juice and in the volume and the trypsin and amylase content of pancreatic juice. Whether these effects continue to be elicited after each injection of calcitonin during chronic therapy has not been investigated. These studies have not been conducted with FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray.

Pharmacokinetics and Drug Metabolism

The pharmacokinetic properties of FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray after multiple dose administration were shown to be similar to that of a commercially available calcitonin-salmon product in healthy volunteers. FORTICAL® Nasal Spray is absorbed rapidly by the nasal mucosa. In normal volunteers approximately 3% (range 0.3%-30.6%) of a nasally administered dose is bioavailable compared to the same dose administered by intramuscular injection. Peak plasma concentrations of drug appear approximately 10 minutes after nasal administration. The terminal half-life (t½) of calcitonin-salmon is calculated to be about 23 minutes. There is no accumulation of the drug on repeated nasal administration at 10 hour intervals for up to 15 days. Absorption of FORTICAL® Nasal Spray has not been studied in postmenopausal women.

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Careful instructions on pump assembly, priming of the pump and nasal introduction of FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray should be given to the patient. Although instructions for patients are supplied with the individual bottle, procedures for use should be demonstrated to each patient. Patients should notify their physician if they develop significant nasal irritation.

Get emergency medical help right away if you have any of the following symptoms of a serious allergic reaction:

Patients should be advised of the following:

  • Store new, unassembled bottles in the refrigerator between 36-46oF (2-8oC).
  • Protect the product from freezing.
  • Keep the bottle of Fortical® Nasal Spray away from light.
  • Before priming the pump and using a new bottle, allow it to reach room temperature.
  • After opening a new bottle of Fortical® Nasal Spray, store bottle in use with pump attached at room temperature, 68°F to 77°F (20°C to 25°C), in an upright position. Each bottle contains enough medicine for 30 doses.
  • Throw away the empty bottle of Fortical® Nasal Spray after you have used 30 doses.
  • See DOSAGE AND ADMINISTRATION, Priming (Activation) of Pump for complete instructions on priming the pump and administering FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray.

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Careful instructions on pump assembly, priming of the pump and nasal introduction of FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray should be given to the patient. Although instructions for patients are supplied with the individual bottle, procedures for use should be demonstrated to each patient. Patients should notify their physician if they develop significant nasal irritation.

Get emergency medical help right away if you have any of the following symptoms of a serious allergic reaction:

Patients should be advised of the following:

  • Store new, unassembled bottles in the refrigerator between 36-46oF (2-8oC).
  • Protect the product from freezing.
  • Keep the bottle of Fortical® Nasal Spray away from light.
  • Before priming the pump and using a new bottle, allow it to reach room temperature.
  • After opening a new bottle of Fortical® Nasal Spray, store bottle in use with pump attached at room temperature, 68°F to 77°F (20°C to 25°C), in an upright position. Each bottle contains enough medicine for 30 doses.
  • Throw away the empty bottle of Fortical® Nasal Spray after you have used 30 doses.
  • See DOSAGE AND ADMINISTRATION, Priming (Activation) of Pump for complete instructions on priming the pump and administering FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray.

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Fortical Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CALCITONIN SPRAY - NASAL

(KAL-si-TOE-nin)

COMMON BRAND NAME(S): Fortical, Miacalcin

USES: This medication is used to treat brittle bone disease (osteoporosis) in women who are at least 5 years past "the change of life" (menopause). Calcitonin works by slowing bone loss to help maintain strong bones and reduce your risk of fractures.

HOW TO USE: Read the patient and product information sheets if available from your pharmacist before you start using calcitonin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

This medication is for use in the nose as directed, usually one spray in one nostril each day, alternating nostrils daily.

Remove a new bottle from the refrigerator and allow it to reach room temperature. Follow the instructions on how to prime the pump the first time you use a new bottle. Once the pump is primed, it does not have to be reprimed if the bottle is properly stored in an upright position. Consult your pharmacist if you have any questions.

To use the nasal spray, remove the protective cap, keep your head upright and insert the tip into a nostril. Press down firmly on the pump to deliver the medication. Replace the protective cap. Use the other nostril the next day.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

Disclaimer

Fortical Consumer (continued)

SIDE EFFECTS: Runny nose, nose bleeds, nasal irritation, dry nose with crusting, headache, dizziness, nausea, flushing of the face, or back pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this unlikely but serious side effect occurs: nasal sores.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Fortical (calcitonin-salmon (rdna origin)) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking calcitonin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication is used mainly in women after menopause. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this product.

Disclaimer

Fortical Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: lithium.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.

Laboratory and/or medical tests (e.g., bone density tests, nasal exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store unopened bottles in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze.

For US products: Once the bottle is opened and the pump is primed, store at room temperature between 59-86 degrees F (15-30 degrees C) in an upright position away from light and moisture. Discard the unused portion after the number of days noted on the package. If you are unsure when to discard your brand, ask your pharmacist.

For Canadian products: Once the bottle is opened and the pump is primed, store at room temperature below 77 degrees F (25 degrees C) in an upright position away from light and moisture. Discard the unused portion after 4 weeks.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Fortical Patient Information Including Side Effects

Brand Names: Fortical, Miacalcin Nasal

Generic Name: calcitonin nasal (Pronunciation: kal si TOE nin)

What is calcitonin nasal (Fortical)?

Calcitonin is a man-made form of a hormone that occurs naturally in the thyroid gland.

Calcitonin nasal is used to treat osteoporosis in women who have been in menopause for at least 5 years.

Calcitonin nasal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of calcitonin nasal (Fortical)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting; or
  • severe nasal irritation.

Less serious side effects may include:

  • bleeding from your nose;
  • runny or stuffy nose;
  • dryness, itching, tenderness, or general discomfort of your nose;
  • crusting, scabs, or sores inside your nose;
  • redness in or around your nose;
  • warmth, redness, or tingly feeling under your skin;
  • headache;
  • back pain; or
  • nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Fortical (calcitonin-salmon (rdna origin)) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about calcitonin nasal (Fortical)?

To make sure you are not allergic to this medication, your doctor may perform an allergy skin test before your first dose of calcitonin nasal.

Before using calcitonin nasal, tell your doctor if you have any nasal or sinus problems such as nasal deformities, a chronic infection, or nasal pain.

Avoid using any other nasal sprays or medicines at the same time you use calcitonin nasal unless your doctor has told you to.

Call your doctor at once if you have any type of severe irritation of your nose, or if you feel light-headed or faint.

Less serious nasal irritation is more likely to occur, such as minor bleeding, redness, itching, tenderness, dryness, crusting, scabs, or nasal congestion.

To be sure this medication is not causing harmful side effects to the inside of your nose, your doctor may want to check your nasal passages on a regular basis. Do not miss any scheduled visits to your doctor.

Side Effects Centers

Fortical Patient Information including How Should I Take

What should I discuss with my healthcare provider before using calcitonin nasal (Fortical)?

Do not use this medication if you are allergic to salmon calcitonin.

Before using calcitonin nasal, tell your doctor if you have any nasal or sinus problems such as nasal deformities, a chronic infection, or nasal pain.

FDA pregnancy category C. It is not known whether calcitonin nasal is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether calcitonin nasal passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use calcitonin nasal (Fortical)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

To make sure you are not allergic to this medication, your doctor may perform an allergy skin test before your first dose of calcitonin nasal.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Store unopened calcitonin nasal in the refrigerator but do not allow it to freeze.

Once you put the bottle and pump assembly together, you may keep the medicine at room temperature, away from light and heat. Keep the bottle upright while stored. Throw away any unused medicine after 35 days.

Before your first use of the assembled bottle and pump, you must prime the spray. Allow the medicine to reach room temperature before priming.

To prime calcitonin nasal, spray the medicine into the air and away from your face, until a fine mist appears. You will need to prime the pump only before your first use of the newly assembled bottle.

Calcitonin nasal is usually given as one spray per day into only one of your nostrils. Use the other nostril the next day and continue alternating back and forth for each daily dose.

Before each use, gently blow your nose to clear your nostrils.

Hold the nasal spray upright with your first and second fingers on each side of the pump and your thumb on the bottom of the bottle.

Gently insert the sprayer tip into the nostril but not far into your nose. Bend your head forward to aim the spray toward the back of your nose. Pump the spray unit firmly to spray the medicine into your nostril. You do not need to sniff or inhale deeply.

Calcitonin nasal spray delivers a fine mist into the nose. Even if you do not feel the spray while using it, the medication is still being absorbed by your nasal passages.

Avoid blowing your nose for several minutes after using this medication.

Each bottle contains 30 doses of calcitonin nasal. Throw away the medicine after 30 uses, even if there is still medicine left in the bottle.

To be sure this medication is not causing harmful side effects to the inside of your nose, your doctor may want to check your nasal passages on a regular basis. Do not miss any scheduled visits to your doctor.

Side Effects Centers

Fortical Patient Information including If I Miss a Dose

What happens if I miss a dose (Fortical)?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Fortical)?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of calcitonin nasal is not likely to produce life-threatening side effects.

What should I avoid while using calcitonin nasal (Fortical)?

Avoid using any other nasal sprays or nasal medications at the same time you use calcitonin nasal unless your doctor has told you to.

What other drugs will affect calcitonin nasal (Fortical)?

There may be other drugs that can interact with calcitonin nasal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about calcitonin nasal.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2011 Cerner Multum, Inc. Version: 3.11. Revision date: 12/15/2010.

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