Calcitonina Salmón Sintética

Uses

Each ml Calcitonina Salmón Sintética injection contains-

• 50 or 100 I.U. salcatonin (present as Polyacetate polyhydrate)
• Sodium acetate 0.2%
• Glacial acetic acid 0.2%
• Sodium chloride 0.75%

Calcitonina Salmón Sintética contains 32 amino-acids in linear sequence with a disulphide bridge at position 1 and 7 and a molecular weight of 3431.9 (free peptide). Salcatonin is a white or grey-tinged white amorphous powder. It is very soluble in water and very slightly soluble in alcohol.

Calcitonina Salmón Sintética is used for Active Paget's disease in patients who do not respond to alternative treatments or for whom such treatments are not suitable; Hypercalcaemia.

Naturally-occurring calcitonin is synthesised by parafollicular cells in the thyroid gland of mammals and the ultimobranchial gland of birds and fish. The potency of salmon calcitonin is standardised according to its ability to lower plasma calcium levels of rats as compared to the International Reference standard.

Calcitonina Salmón Sintética is also used to associated treatment for these conditions: Hypercalcemia, Osteoporosis, Paget’s Disease, Symptomatic Paget's disease

How Calcitonina Salmón Sintética works

Calcitonin binds to the calcitonin receptor (found primarily in osteoclasts) which then enhances the production of vitamin D producing enzymes (25-hydroxyvitamine D-24-hydroxylase), leading to greater calcium retention and enhanced bone density. Binding of calcitonin to its receptor also activates adenylyl cyclase and the phosphatidyl-inositol-calcium pathway.

Dosage

Calcitonina Salmón Sintética dosage

Intravenous (Adult)-

• Emergency treatment of hypercalcaemia: Up to 10 u/kg in 500 mL of sodium chloride 0.9% by slow IV infusion over at least 6 hr.

Parenteral (Adult)-

• Adjunct in hypercalcaemia: SC/IM: 4 u/kg 12 hrly, may increase after 1-2 days to 8 u/kg 12 hrly to max 8 u/kg 6 hrly after 2 days. Alternatively, 100 u every 6-8 hr, increased after 1-2 days to max 400 u every 6-8 hr.
• Paget's disease of bone: SC/IM: 50 u 3 times wkly to 100 u/day.

Nasal (Adult)-

• Nasal postmenopausal osteoporosis: 200 u/day, alternation nostrils everyday.

Side Effects

GI disturbances, dizziness, flushing, tingling of the hands, unpleasant taste, skin rash, abdominal pain, urinary frequency, tremor, inj site inflammation. Rarely, diabetogenic effect.

Toxicity

Salmon calcitonin was shown to inhibit lactation in animals and is not recommend in nursing mothers. While research in animals have shown a decrease in fetal weight, no studies have yet shown similar results in humans. It is recommended however to proceed carefully when administering salmon calcitonin to pregnant women and consider if the benefits outweigh the risks. Because of its protein nature, salmon calcitonin may provoke an allergy reaction (bronchospams and swelling of the tongue/throat) that can turn into a full-blown anaphylactic response. The manufacturer also reports an increase in the risk of malignancies from oral route (0.7%) to intranasal route (2.4%) compared to placebo. The same may apply to IV, IM and SC routes since the systemic exposure is higher in those cases. Nausea is noticeable in some patients but tends to decrease with continued administration. Rhinitis, headaches and back pain have also been reported among others.

Precaution

Skin test should be done before initiating therapy. Heart failure; renal impairment. Pregnancy, lactation, childn.

Interaction

Concurrent use wth cardiac glycosides (e.g. digitalis) or Ca-channel blockers requires dosage adjustments of these drugs. May decrease serum concentration of lithium.

Food Interaction

• Administer calcium supplement. Individuals who are taking salmon calcitonin for the treatment of postmenopausal osteoporosis should ingest at least 1000mg of elemental calcium daily (by food or through supplementation).
• Administer vitamin supplements. Individuals who are taking salmon calcitonin for the treatment of postmenopausal osteoporosis should take at least 400 international units of vitamin D daily.

Volume of Distribution

0.15 to 0.3 L/kg

Elimination Route

Salmon calcitonin is rapidly absorbed with bioavailability of 71% following subcutaneous injection and 66% following intramuscular injection in humans. Via the nasal route, the bioavailability varies between 3 to 5% relative to IM.

Half Life

Half-life elimination (terminal): I.M. 58 minutes; SubQ 59 to 64 minutes; Nasal: ~18 to 23 minutes

Elimination Route

Urine. Studies with injectable calcitonin show increases in the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption in the kidney.

Pregnancy & Breastfeeding use

Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Contraindication

Hypersensitivity. Patients with hypocalcaemia.

Special Warning

Renal Impairment: Dosage adjustment needed.

Acute Overdose

Symptoms: Flushing, nausea, vomiting and dizziness.

Management: Symptomatic and supportive treatment.

Storage Condition

Store between 2-8° C.

Innovators Monograph

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