Gemcal
Gemcal Uses, Dosage, Side Effects, Food Interaction and all others data.
Calcitonin is a polypeptide hormone produced by the ultimobranchial gland in non-mammalian vertebrates or by the mammalian thyroid parafollicular cells. It inhibits osteoclastic bone resorption and reduces bone turnover. It decreases tubular reabsorption and promotes renal excretion of Ca, Cl, Na, Mg, K and phosphate.
Calcitonin inhibits bone resorption by osteoclasts (bone remodeling cells) and promotes bone formation by osteoblasts. This leads to a net increase in bone mass and a reduction in plasma calcium levels. It also promotes the renal excretion of ions such as calcium, phosphate, sodium, magnesium, and potassium by decreasing tubular reabsorption. In consequence, there is an increase in the jejunal secretion of water, sodium, potassium, and chloride.
| Trade Name | Gemcal |
| Generic | Salmon Calcitonin |
| Salmon Calcitonin Other Names | Calcitonin (Salmon Synthetic), Calcitonin salmon, Calcitonin salmon recombinant, Calcitonin-salmon, Calcitonin, salmon, Calcitonina salmón sintética, Recombinant salmon calcitonin, Salmon calcitonin |
| Weight | 0.25mcg |
| Type | Nasal Spray, Syrup, Capsule |
| Formula | C145H240N44O48S2 |
| Weight | 3431.853 Da |
| Protein binding | Protein binding is about 30 to 40%. |
| Groups | Approved, Investigational |
| Therapeutic Class | Hormone in bone formation by Inhibiting bone resorption |
| Manufacturer | Alkem Laboratories Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Each ml Gemcal 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%
Gemcal 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.
Gemcal 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.
Gemcal is also used to associated treatment for these conditions: Hypercalcemia, Osteoporosis, Paget’s Disease, Symptomatic Paget's disease
How Gemcal 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
Gemcal 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
You find simplified version here Gemcal
FAQ
What is Gemcal used for?
Gemcal used to treat osteoporosis in women who are at least 5 years past menopause and cannot or do not want to take estrogen products.
How safe is Gemcal?
Gemcal is reserved for the treatment of postmenopausal osteoporosis in women when other treatments for osteoporosis are ineffective, not tolerated, or not desired.
How does Gemcal work?
Gemcal is a human hormone that is also found in salmon. It works by preventing bone breakdown and increasing bone density.
How long does it take Gemcal to work?
Gemcal nasal spray is rapidly absorbed with a maximum time to peak effect of 13 minutes. It has a short half-life 18 minutes.
What are the common side effects of Gemcal?
The common side effects of Gemcal are include:
- runny nose.
- nosebleed.
- sinus pain.
- nose symptoms such as crusts, dryness, redness, or swelling.
- back pain.
- joint pain.
- upset stomach.
- flushing (feeling of warmth)
Is Gemcal safe during pregnancy?
Gemcal has not been studied in pregnant women and may not be safe for use during pregnancy. This medication is not approved for women who are premenopausal, including pregnant women.Gemcal does not cross the placenta and is considered safe for the mother and fetus 2.
Is Gemcal safe during breastfeeding?
Gemcal is not known calcitonin whether nasal passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Can I drink alcohol with Gemcal?
Intranasal Gemcal had no affect on alcohol drinking.
How long should I take Gemcal?
Gemcal is used as a short-term treatment (for 2–4 weeks) to help prevent bone loss if you're immobilised following an osteoporotic fracture.
How does Gemcal affect the kidneys?
Gemcal and phosphorus are prevented from being lost in urine by reabsorption in the kidney tubules. Gemcal inhibits tubular reabsorption of these two ions, leading to increased rates of their loss in urine.
Does Gemcal increase bone deposition?
A hormone produced by the thyroid gland that lowers the levels of calcium and phosphate in the blood and promotes the formation of bone.
What happens if you have too much Gemcal?
If too much Gemcal is found in the blood, it may be a sign of a type of thyroid cancer called medullary thyroid cancer.
Does Gemcal help with pain?
Gemcal has been demonstrated to decrease pain and improve the level of activity in patients with acute vertebral osteoporotic compression fractures when administered within the first 5 days of onset of pain.
Does Gemcal increase osteoclast activity?
Gemcal lowers blood calcium levels by suppressing osteoclast activity in the bones and increasing the amount of calcium excreted in the urine.
What should I do if I forget a dose?
Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.
Who should not take Gemcal?
May cause changes in urine in bedridden people. Has not been shown to increase bone mineral density in early postmenopausal women, which is why use is restricted to women who are at least five years postmenopausal. It should never be used in women with reproductive potential.
Is Gemcal a pain medication?
Gemcal is considered an effective analgesic in many patients unable of tolerating Gemcal and narcotics.
Is Gemcal a steroid?
Gemcal also called thyrocalcitonin, a protein hormone synthesized and secreted in humans and other mammals primarily by parafollicular cells (C cells) in the thyroid gland.
Does Gemcal decrease phosphate?
Gemcal also lowers blood phosphorus levels when they rise above normal.
