Calembic Kit

Calembic Kit Uses, Dosage, Side Effects, Food Interaction and all others data.

Osteoporosis causes the body to remove more bone than it replaces. This means that bones get weaker. Weak bones are more likely to break. Osteoporosis is a bone disease that is quite common in women after menopause. It also affects men. At first, osteoporosis has no symptoms, but people with osteoporosis may develop loss of height and are more likely to break (fracture) their bones, especially the back (spine), wrist, and hip bones. Osteoporosis can be prevented, and with proper therapy it can be treated.

Ibandronic acid inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to a progressive gain in bone mass. The absorption of ibandronate occurs in the upper gastrointestinal tract. After absorption, ibandronate either rapidly binds to bone or is excreted unchanged into urine.

Ibandronate is a nitrogen containing bisphosphonate used to treat and prevent osteoporosis in postmenopausal women. The therapeutic index is wide as overdoses are not especially toxic, and the duration of action is long as the half life can be up to 157 hours. Patients should be counselled regarding the risk of upper GI adverse reactions, hypocalcemia, musculoskeletal pain, osteonecrosis of the jaw, atypical fractures of the femur, and severe renal impairment.

Calembic Kit
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Calembic Kit
Generic	Vitamin D3 / Cholecalciferol + Ibandronate + Elemental Calcium
Weight	800iu
Type	Tablet
Therapeutic Class
Manufacturer	Alembic Pharmaceuticals
Available Country	India
Last Updated:	September 19, 2023 at 7:00 am

Uses

Ibandronic Acid is used for the:

Treatment of osteoporosis in women (specially postmenopausal)
Prevention of osteoporosis in women (specially postmenopausal)
Prevention and treatment of osteoporosis in men

Calembic Kit is also used to associated treatment for these conditions: Bone Metastases, Hypercalcemia of Malignancy, Osteoporosis

How Calembic Kit works

Bisphosphonates are taken into the bone where they bind to hydroxyapatite. Bone resorption by osteoclasts causes local acidification, releasing the bisphosphonate, which is taken into the osteoclast by fluid-phase endocytosis. Endocytic vesicles become acidified, releasing bisphosphonates into the cytosol of osteoclasts where they act.

Osteoclasts mediate resorption of bone. When osteoclasts bind to bone they form podosomes, ring structures of F-actin. Disruption of the podosomes causes osteoclasts to detach from bones, preventing bone resorption.

Nitrogen containing bisphosphonates such as ibandronate are known to induce apoptosis of hematopoietic tumor cells by inhibiting the components of the mevalonate pathway farnesyl diphosphate synthase, farnesyl diphosphate, and geranylgeranyl diphosphate. These components are essential for post-translational prenylation of GTP-binding proteins like Rap1. The lack of prenylation of these proteins interferes with their function, and in the case of Rap1, leads to apoptosis. ibandronate also activated caspase-3 which contribute to apoptosis.

Dosage

Calembic Kit dosage

Intravenous (Adult)-

Hypercalcaemia of malignancy:2-4 mg as a single infusion over 2 hr. Max: 6 mg.
Postmenopausal osteoporosis: 3 mg by inj over 15-30 seconds once every 3 mth. Missed dose: Give inj as soon as possible; then re-schedule next inj 3 mth from this inj; should not be given more frequently than once every 3 mth.
Prophylaxis of skeletal events in patients with breast cancer and bone metastases: 6 mg by infusion over at least 15 min 3-4 wkly.

Oral (Adult)-

Prophylaxis of skeletal events in patients with breast cancer and bone metastases: 50 mg tablet daily
Postmenopausal osteoporosis, Prophylaxis of postmenopausal osteoporosis: 150 mg tablet once-a-month on the same date each month, alternatively, 2.5 mg daily. Missed once-monthly dose: If next scheduled dose is >7 days away: Take dose the next morning and return to original schedule; if next dose is<7 days away: Wait until the next scheduled dose; 2 tabs must not be taken w/in the same wk.

Oral Administrations-

The tablet should preferably be taken on the same date each month.
To maximize absorption and clinical benefit, Ibandronic acid should be taken at least 60 minutes before the first food or drink or any oral medication or supplementation (including calcium).
To facilitate delivery to the stomach and reduce the potential for esophageal irritation, Ibandronic acid should be swallowed whole with a full glass of plain water.
The tablet should not be chewed or sucked.
Patients should not lie down for 60 minutes after takin Ibandronic acid . However, patients can sit down, walk, exercise or do the regular activities.
If the once-monthly dose is missed and the patient’s next scheduled Ibandronic acid day is more than 7 days away, the patient should be instructed to take one Ibandronic acid 150 mg tablet in the morning following the date that it is remembered. Then the patient should return to the original schedule.
If the next scheduled dose is within 7 days, patients should wait until the next dose? and then continue taking one tablet once-a-month as originally scheduled. Two 150 mg tablets should not be taken within the same week.

Side Effects

In a one-year study in patients with osteoporosis treated with ibandronate 150 mg once monthly, the majority of adverse drug reactions observed, were mild to moderate in intensity, and most cases did not lead to cessation of therapy. Common adverse reactions include dyspepsia, nausea, diarrhoea, constipation, abdominal pain, myalgia, headache, mild flu-like symptoms, dizziness, skin rash.

Toxicity

Patients experiencing an overdose may present with hypocalcemia, hypophosphatemia, upset stomach, dyspepsia, esophagitis, and uclers. Oral overdose can be managed by giving patients milk or antacids to bind excess unabsorbed ibandronate. Overdoses can be managed by providing intravenous electrolytes and dialysis is not expected to remove excess drug from serum.

Precaution

Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting therapy with Ibandronic Acid. Adequate intake of calcium and vitamin D is important in all patients.

Interaction

It is likely that products containing calcium and other multivalent cations (such as aluminium, magnesium, iron) including milk, food, and antacids are likely to interfere with absorption of ibandronate. Therefore, patients must wait 60 minutes after taking Ibandronic Acid before taking other oral medications.

Volume of Distribution

The apparent terminal volume of distribution of ibandronate is 90-368L in headlthy subjects and 103L in postmenopausal women with osteopenia.

Elimination Route

Oral ibandronate is 0.63% bioavailable. In a study of healthy males, a 10mg oral dose had a T_max of 1.1±0.6h and a C_max of 4.1±2.6ng/mL. The T_max is approximately 1 hour, while C_max varies depending on dose.

A 2mg intravenous dose of ibandronate has an AUC of 316ng*h/mL, a 4mg intravenous dose of ibandronate has an AUC of 581ng*h/mL, and a 6mg intravenous dose of ibandronate has an AUC of 908ng*h/mL.

Half Life

The half life of ibandronate in postmenopausal women ranges from 37-157 hours.

Clearance

The total clearance of ibandronate is 84-160mL/min.

Elimination Route

Ibandronate is predominantly eliminated in the urine and the unabsorbed drug is eliminated unchanged in the feces.

Pregnancy & Breastfeeding use

Use in pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Use in nursing mothers: It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing woman.

Contraindication

Ibandronic Acid is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients, hypocalcemia and inability to stand or sit upright for at least 1 hour.

Special Warning

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Patients: No dose adjustment is necessary in the elderly.

Patients with Hepatic Impairment: No dose adjustment is necessary.

Patients with Renal Impairment: No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal to or greater than 30 ml/min.

Acute Overdose

No specific information is available on the treatment of overdose with ibandronic acid. However, oral overdose may result in hypocalcemia, hypophosphatemia, upset stomach, dyspepsia, esophagitis, gastritis. Milk or antacids should be given to bind Ibandronic Acid