MarinCal-Kit Tablet

Indications

Osteoporosis therapy and prevention are the goals of this kit. It boosts bone mineral density (BMD) and lowers the risk of vertebral fractures.

Pharmacology

Ibandronate Sodium Monohydrate (Ibandronate) is a nitrogen-containing bisphosphonate that prevents bone resorption caused by osteoclasts. Ibandronate's impact on bone tissue is based on its affinity for hydroxyapatite, which is a component of bone's mineral matrix. Ibandronate lowers bone resorption and turnover by inhibiting osteoclast activity. It lowers the high rate of bone turnover in postmenopausal women, resulting in a net gain in bone mass on average.

Calcium Carbonate with modest amounts of Magnesium and other Trace elements make up the Coral Calcium and Cholecalciferol combo. Due to its chemical structure, which is very comparable to the makeup of human bone Calcium Carbonate, coral Calcium provides higher absorption than Calcium from other Calcium Carbonate sources. Vitamin D increases calcium absorption from the GI tract and helps the body maintain calcium equilibrium.

Dosage & Administration

One tablet of Ibandronic Acid 150 mg once monthly on the same date of each month is recommended. To maximize the clinical benefit of Ibandronic acid, two tablets of Calcium 500 mg and Vitamin D3 200 IU per day are usually recommended in divided dosage or as directed by the physician.

Day 1: Take the Ibandronic Acid tablet on an empty stomach at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation including Calcium, Antacid,s and/or Vitamins

Swallow the tablet whole with a glass of plain water while standing or sitting in an upright position

Avoid lying down for 60 minutes

Do not chew or suck the tablet

Day 2-31: One tablet of Calcium and Vitamin D should be taken at the morning and at the evening after meal

Tablets should be taken in order as directed on the blister strip for ease of dose tracking.

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

Interaction

Ibandronate absorption is likely to be hampered by calcium and other multivalent cations (such as aluminum, magnesium, and iron), which can be found in milk, food, and antacids. In multiple clinical trials, it was discovered to interact with H2 blockers like Ranitidine.

Calcium (Coral) and Vitamin D: Oral calcium can impair the absorption of tetracycline and fluoride preparations, hence a minimum of 3 hours between ingestions is recommended. Calcium excretion is reduced by thiazide diuretics. Vitamin D metabolism can be induced by phenytoin, barbiturates, and glucocorticoids. Certain foods, such as spinach, cereals, milk, and its derivatives, may limit calcium absorption in the intestine when consumed together.

Contraindications

Ibandronic Acid is contraindicated in the following conditions: esophageal abnormalities that delay esophageal emptying, such as stricture or achalasia; esophageal abnormalities that delay esophageal emptying, such as stricture or achalasia; esophageal abnormalities that delay esophageal emptying, such as strict Inability to sit or stand upright for more than 60 minutes, Hypocalcemia with a history of Ibandronic Acid hypersensitivity.

Hypersensitivity to any component in this formulation, including calcium and vitamin D3. Hypercalcemia, hyperparathyroidism, hypercalciuria, nephrolithiasis, severe renal insufficiencies, concomitant Digoxin therapy (which necessitates careful monitoring of serum calcium levels), renal calculi, and Zollinger Ellison syndrome are all contraindications.

Side Effects

Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Localized Osteoarthritis, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bronchitis, Urinary Tract Infection, Upper Respiratory Tract Infection, Headache, Dizziness, Skin rash, Insomnia, and others are some of the most common side

Flatulence, diarrhea, constipation, upper GI discomfort, and other side effects are the most common. Hypercalciuria and hypercalcemia have been observed seldom as a result of prolonged use.

Pregnancy & Lactation

Category C pregnancy. In pregnant women, there are no sufficient and well-controlled trials. Only if the possible benefit outweighs the risk to the mother and fetus should this kit be used during pregnancy.

It is unknown whether this kit is secreted in human milk by nursing mothers. Because many medications are secreted in human milk, care should be used while administering this kit to a nursing mother.

Precautions & Warnings

Upper Gastrointestinal Adverse Reactions to Ibandronic Acid: Ibandronic acid, like other bisphosphonates, can cause local irritation of the upper gastrointestinal mucosa when taken orally. Because of these potential irritating effects, patients with active upper gastrointestinal disorders (such as Barrett's esophagus, dysphagia, other esophageal illnesses, gastritis, duodenitis, or ulcers) should be given Ibandronic acid with caution.

Hypocalcemia and Mineral Metabolism: Before starting therapy, treat hypocalcemia and other bone and mineral metabolism disturbances.

Musculoskeletal Pain: Patients taking Ibandronic acid and other bisphosphonates have reported severe and sometimes incapacitating bone, joint, and/or muscle pain.

Osteonecrosis of the Jaw: Osteonecrosis of the jaw has been documented in bisphosphonate-treated patients. The majority of occurrences have happened in cancer patients undergoing dental treatments, although there have also been incidences in people with postmenopausal osteoporosis and other diseases.

Storage Conditions

Do not store above 30°C. Keep away from light and out of the reach of children.