Calcitonin Sandoz Uses

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What is Calcitonin Sandoz?

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

Calcitonin Sandoz injection is used to treat Paget's disease of bone, or high levels of calcium in the blood (hypercalcemia). Calcitonin Sandoz injection is also used to treat osteoporosis in postmenopausal women.

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

Calcitonin Sandoz indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Treatment of Paget’s Disease of Bone

Calcitonin Sandoz injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of Calcitonin Sandoz-salmon is beneficial in asymptomatic patients. Calcitonin Sandoz injection should be used only in patients who do not respond to alternative treatments or for whom such 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).

Treatment of Hypercalcemia

Calcitonin Sandoz injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents.

Treatment of Postmenopausal Osteoporosis

Calcitonin Sandoz injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for Calcitonin Sandoz-salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Calcitonin Sandoz injection 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).

Important Limitations of Use

Due to the possible association between malignancy and Calcitonin Sandoz-salmon use, the need for continued therapy should be re-evaluated on a periodic basis.

How should I use Calcitonin Sandoz?

To make sure you are not allergic to Calcitonin Sandoz, your doctor may perform an allergy skin test before your first dose.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Calcitonin Sandoz is injected under the skin or into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Use Calcitonin Sandoz regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Calcitonin Sandoz injection is not a cure for Paget's disease. You may have a relapse, especially if your body forms antibodies and you become immune to Calcitonin Sandoz.

Call your doctor if your symptoms do not improve, or if they get worse while using Calcitonin Sandoz.

Your doctor may want you to take extra calcium and vitamin D while you are using Calcitonin Sandoz. Take only the amounts of calcium and vitamin D your doctor has prescribed.

Store in the refrigerator, do not freeze.

Uses of Calcitonin Sandoz in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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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 Sandoz works by slowing bone loss to help maintain strong bones and reduce your risk of fractures.

This product has been withdrawn from the Canadian market due to safety problems.

How to use Calcitonin Sandoz (salmon) nasal

Read the patient and product information sheets if available from your pharmacist before you start using Calcitonin Sandoz 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. It is recommended to use this medication at the lowest effective dosage and for the shortest possible duration to treat your condition. Patients treated long-term with this medication have shown a rare risk of developing cancer. Discuss the benefits and risks of long term treatment with this medication.

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.

Calcitonin Sandoz description

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Calcitonin Sandoz also contains the following excipients: Nasal Spray: Benzalkonium chloride, sodium chloride, hydrochloric acid (for pH adjustment) and purified water. Ampoule: Acetic acid, sodium acetate trihydrate, sodium chloride and water for injections.

One (1) IU corresponds to 0.2 mcg of synthetic salmon Calcitonin Sandoz.

Nasal spray solution in bottles fitted with a metering pump delivering at least 14 doses of 200 IU salmon Calcitonin Sandoz per actuation.

Calcitonin Sandoz dosage

Calcitonin Sandoz Dosage

Generic name: Calcitonin Sandoz SALMON 200[iU] in 1mL

Dosage form: injection, solution

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The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Paget’s Disease of Bone

The recommended dose of Calcitonin Sandoz injection for treatment of symptomatic Paget’s disease of bone is 100 International Units (0.5 mL) per day administered subcutaneously or intramuscularly.

Hypercalcemia

The recommended starting dose of Calcitonin Sandoz injection for early treatment of hypercalcemia is 4 International Units/kg body weight every 12 hours by subcutaneous or intramuscular injection. If the response to this dose is not satisfactory after one or two days, the dose may be increased to 8 International Units/kg every 12 hours. If the response remains unsatisfactory after two more days, the dose may be further increased to a maximum of 8 International Units/kg every 6 hours.

Postmenopausal Osteoporosis

The recommended dose of Calcitonin Sandoz injection for treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause is 100 International Units (0.5 mL) per day administered subcutaneously or intramuscularly. The minimum effective dose of Calcitonin Sandoz injection for the prevention of vertebral bone mineral density loss has not been established.

Preparation and Administration

Visually inspect Calcitonin Sandoz vials. Calcitonin Sandoz injection is a clear, colorless, solution. If the solution is not clear and colorless, or contains any particles, or if the vial is damaged, do not administer the solution.

If the volume of Calcitonin Sandoz injection to be injected exceeds 2 mL, intramuscular injection is preferable and the total dose should be distributed across multiple sites of injection.

Instruct patients to use sterile injection technique when administering Calcitonin Sandoz injection, and to dispose of needles properly.

Recommendations for Calcium and Vitamin D Supplementation

Patients who use Calcitonin Sandoz injection for treatment of postmenopausal osteoporosis should receive adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day).

More about Calcitonin Sandoz (Calcitonin Sandoz)

Consumer resources

Professional resources

Other formulations

Related treatment guides

Calcitonin Sandoz interactions

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What other drugs will affect Calcitonin Sandoz?

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Nasal Spray: Formal studies designed to evaluate drug interactions with Calcitonin Sandoz (salmon) have not been done. No drug interaction studies have been performed with Calcitonin Sandoz (salmon) nasal spray ingredients.

Currently, no drug interactions with Calcitonin Sandoz (salmon) have been observed. The effects of prior use of diphosphonates in postmenopausal osteoporosis patients have not been assessed; however, in patients with Pagets Disease prior diphosphonate use appears to reduce the anti-resorptive response to Calcitonin Sandoz (salmon) nasal spray.

Calcitonin Sandoz side effects

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What are the possible side effects of Calcitonin Sandoz?

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Calcitonin Sandoz-salmon injection was assessed in open-label trials several months to two years in duration. The most common adverse reactions are discussed below.

Nausea

Nausea with or without vomiting has been noted in about 10% of patients treated with Calcitonin Sandoz-salmon. It is most evident when treatment is first initiated and tends to decrease or disappear with continued administration.

Dermatologic Reactions

Local inflammatory reactions at the site of subcutaneous or intramuscular injection have been reported in about 10% of patients. Flushing of face or hands occurred in about 2%–5% of patients. Skin rashes and pruritus of the ear lobes have also been reported.

Other Adverse Reactions

Nocturia, feverish sensation, pain in the eyes, poor appetite, abdominal pain, pedal edema, and salty taste have been reported in patients treated with Calcitonin Sandoz-salmon injection.

Malignancy

A meta-analysis of 21 randomized, controlled clinical trials with Calcitonin Sandoz-salmon (nasal spray or investigational oral formulations) was conducted to assess the risk of malignancies in Calcitonin Sandoz-salmon-treated patients compared to placebo-treated patients. The trials in the meta-analysis ranged in duration from 6 months to 5 years and included a total of 10883 patients (6151 treated with Calcitonin Sandoz-salmon and 4732 treated with placebo). The overall incidence of malignancies reported in these 21 trials was higher among Calcitonin Sandoz-salmon-treated patients (254/6151 or 4.1%) compared with placebo-treated patients (137/4732 or 2.9%). Findings were similar when analyses were restricted to the 18 nasal spray only trials [Calcitonin Sandoz-salmon 122/2712 (4.5%); placebo 30/1309 (2.3%)].

The meta-analysis results suggest an increased risk of overall malignancies in Calcitonin Sandoz-salmon-treated patients compared to placebo-treated patients when all 21 trials are included and when the analysis is restricted to the 18 nasal spray only trials. It is not possible to exclude an increased risk when Calcitonin Sandoz-salmon is administered by the subcutaneous, intramuscular, or intravenous route because these routes of administration were not investigated in the meta-analysis. The increased malignancy risk seen with the meta-analysis was heavily influenced by a single large 5-year trial, which had an observed risk difference of 3.4% [95% CI (0.4%, 6.5%)]. Imbalances in risks were still observed when analyses excluded basal cell carcinoma; the data were not sufficient for further analyses by type of malignancy. A mechanism for these observations has not been identified. Although a definitive causal relationship between Calcitonin Sandoz-salmon use and malignancies cannot be established from this meta-analysis, the benefits for the individual patient should be carefully evaluated against all possible risks.

Table 1: Risk Difference for Malignancies in Calcitonin Sandoz-Salmon-Treated Patients Compared with Placebo-Treated Patients

Patients Malignancies Risk DifferenceThe corresponding 95% confidence interval for the overall adjusted risk difference also based on MH fixed-effect method.

Postmarketing Experience

Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported during post-approval use of Calcitonin Sandoz injection.

Allergic / Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported in patients receiving Calcitonin Sandoz-salmon injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis.

Skin and subcutaneous tissue disorders: Urticaria

Hypocalcemia: Hypocalcemia with tetany (i.e. muscle cramps, twitching) and seizure activity have been reported.

Body as a Whole: influenza-like symptoms, fatigue, edema (facial, peripheral, and generalized)

Musculoskeletal: arthralgia, musculoskeletal pain

Cardiovascular: hypertension

Gastrointestinal: abdominal pain, diarrhea

Urinary System: polyuria

Nervous System: dizziness, headache, paresthesia, tremor

Vision: visual disturbance

Immunogenicity

Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Calcitonin Sandoz may trigger the development of anti-Calcitonin Sandoz antibodies. Circulating antibodies to Calcitonin Sandoz-salmon after 218 months of treatment have been reported in about one-half of the patients with Paget's disease in whom antibody studies were done. In some cases, high antibody titers are found; these patients usually will have a loss of response to treatment.

The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of a positive antibody test result may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of antibodies among different Calcitonin Sandoz-salmon products may be misleading.

Calcitonin Sandoz contraindications

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What is the most important information I should know about Calcitonin Sandoz?

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

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

Calcitonin Sandoz injection is not a cure for Paget's disease and you may have a relapse, especially if your body forms antibodies and you become immune to Calcitonin Sandoz. Talk with your doctor at any time if you think the medication is not working as well as it did before.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your urine may also need to be tested. Do not miss any scheduled appointments.

Calcitonin Sandoz injection can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

It is important to use Calcitonin Sandoz injection regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Active ingredient matches for Calcitonin Sandoz:

Calcitonin in Germany.


List of Calcitonin Sandoz substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Calcitrin 1000+100+4 Tablet (Influx Pharmaceuticals)$ 0.05
Calco 50 IU/1 dose x 7 puffs (Lisapharma)
Calco 100 IU/1 dose x 7 puffs (Lisapharma)
Calco 100 IU/1 dose x 14 puffs (Lisapharma)
Calco 100 IU/1 dose x 28 puffs (Lisapharma)
Calco 200 IU/1 dose x 12 puffs (Lisapharma)
Calco 200 IU/1 dose x 14 puffs (Lisapharma)
Calco 50 IU x 5's (Lisapharma)
Calco 100 IU x 5's (Lisapharma)
Calco 50 IU/1 mL x 5 tube (Lisapharma)
Calco 100 IU/1 mL x 5 tube (Lisapharma)
Calco 50 IU x 1 mL x 5's (Lisapharma)
Calco 100 IU x 1 mL x 5's (Lisapharma)
Calco 50 IU/1 dose x 11 doses (Lisapharma)
Calco inj 100 IU 5 x 1's (Lisapharma)
Calco inj 50 IU 5 x 1's (Lisapharma)
Calco nasal spray 100 IU/dose 7 puff x 1's (Lisapharma)
Calco nasal spray 100 IU/dose 14 puff x 1's (Lisapharma)
Calco nasal spray 100 IU/dose 28 puff x 1's (Lisapharma)
Calco nasal spray 200 IU/dose 12 puff x 1's (Lisapharma)
Calco nasal spray 200 IU/dose 14 puff x 1's (Lisapharma)
Calco nasal spray 50 IU/dose 7 puff x 1's (Lisapharma)

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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