SALMON .1 g/mL
SALMO SALAR · INJECTION, SOLUTION · ALK-Abello, Inc.
Salmon (Salmo Salar) is an over-the-counter injectable solution administered through the skin. This product is derived from salmon and is available in a 0.1 g/mL strength formulation.
Key Facts
- Brand Name
- SALMON
- Generic Name
- SALMO SALAR
- NDC Code (Product)
0268-6212- Manufacturer
- ALK-Abello, Inc.
- Strength
- .1 g/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- PERCUTANEOUS
- Marketing Status
- Application #
- BLA103753
- Marketing Start
- 02/23/1998
Recall History
Endo Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Apotex Corp.
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Calcitonin salmon injection, synthetic is a calcitonin, indicated for the following conditions: Treatment of symptomatic Paget's disease of bone when alternative treatments are not suitable ( 1.1 ) Treatment of hypercalcemia ( 1.2 ) Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) 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 ( 1.4 , 5.3 ) 1.1 Treatment of Paget’s Disease of Bone Calcitonin salmon 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 salmon is beneficial in asymptomatic patients. Calcitonin salmon 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 co…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Symptomatic Paget's disease of bone: 100 USP Units daily. Ensure adequate calcium and vitamin D intake ( 2.1 , 2.5 ) Hypercalcemia: start with 4 USP Units/kg body weight every 12 hours. Increase to 8 USP Units/kg every 12 hours if no improvement in 1-2 days. Increase further to 8 USP Units/kg every 6 hours if no improvement after 2 more days ( 2.2 ) Postmenopausal osteoporosis: 100 USP Units daily. Ensure adequate calcium and vitamin D intake ( 2.3 , 2.5 ) 2.1 Paget’s Disease of Bone The recommended dose of Calcitonin salmon injection for treatment of symptomatic Paget's disease of bone is 100 USP Units (0.5 mL) per day administered subcutaneously or intramuscularly. 2.2 Hypercalcemia The recommended starting dose of Calcitonin salmon injection for early treatment of hypercalcemia is 4 USP 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 USP 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 USP Units/kg every 6 hours. 2.3 Postmenopausal …
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to calcitonin salmon or any of the excipients. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see Warnings and Precautions ( 5.1 )]. Hypersensitivity to calcitonin salmon or any of the excipients ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No formal drug interaction studies have been performed with calcitonin salmon injection. Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment. Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity Reactions, including anaphylaxis [see Warnings and Precautions ( 5.1 )] Hypocalcemia [see Warnings and Precautions ( 5.2 )] Malignancy [see Warnings and Precautions ( 5.3 )] Most common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%) ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 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 salmon.…
Frequently Asked Questions
What is SALMON used for?
Salmon (Salmo Salar) is an over-the-counter injectable solution administered through the skin. This product is derived from salmon and is available in a 0.1 g/mL strength formulation.
Is SALMON a controlled substance?
SALMON is not classified as a controlled substance by the DEA.
What is the generic name for SALMON?
The generic name for SALMON is SALMO SALAR. There are 1 other brand versions of SALMO SALAR.
What is the NDC code for SALMON .1 g/mL?
The NDC (National Drug Code) for SALMON .1 g/mL is 0268-6212, listed by ALK-Abello, Inc..