Orocal Kit

Presentation: A kit containing two types of tablets in a single pack:

• Ibandronic Acid Tablet: Each kit contains 1 film-coated tablet of Ibandronate Monosodium Monohydrate INN equivalent to Ibandronic Acid 150 mg.
• Calcium Orotate Tablet: Each kit contains 60 film-coated tablets of Calcium Orotate Dihydrate INN equivalent to either Calcium Orotate 400 mg (Orocal Kit) or 740 mg (Orocal Kit 740). The tablets are arranged in a calendar strip for easy tracking.

Indications: Indicated for the treatment and prevention of osteoporosis in women after menopause and in men. It increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

Dosage and Administration:

• Ibandronic Acid: One tablet of 150 mg is taken once monthly, on the same date each month. To maximize absorption, it should be taken at least 60 minutes before the first food, drink (other than water), or any other oral medication or supplement (including calcium, antacids, or vitamins) of the day. Swallow the tablet whole with a full glass (250 ml) of plain water while standing or sitting upright. Patients should not lie down for 60 minutes after taking the Ibandronic Acid tablet.
• If a monthly dose is missed and the next scheduled dose is more than 7 days away, take one 150 mg tablet the morning after remembering. Then return to the original monthly schedule.
• If the next scheduled dose is only 1 to 7 days away, wait until the next scheduled dose and continue the regular monthly schedule. Do not take two 150 mg tablets within the same week.
• Calcium Orotate: Start taking Calcium Orotate tablets from the day after taking the Ibandronic Acid tablet. The usual recommendation is two tablets per day in divided doses (e.g., one in the morning and one in the evening), or as directed by a physician. It is generally recommended to take Calcium Orotate tablets with or just after meals.

Side Effects:

• Ibandronic Acid: Common side effects may include hypertension, dyspepsia, nausea, diarrhea, abdominal pain, arthralgia, back pain, localized osteoarthritis, myalgia, muscle cramps,¹ influenza-like symptoms, nasopharyngitis, bronchitis, urinary tract infection, upper respiratory tract infection, headache, dizziness, skin rash, and insomnia.
• Calcium Orotate: Common side effects may include bloating and swelling in the abdomen. Infrequent side effects may include loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, increased thirst/urination, weakness, unusual tiredness,² and the formation of kidney stones.

Precautions:

• Ibandronic Acid: Contraindicated in patients with abnormalities of the esophagus that delay esophageal emptying (such as stricture or achalasia),³ inability to stand or sit upright for at least 60 minutes, hypocalcemia,⁴ or known hypersensitivity to ibandronic acid or any of its components. Caution should be exercised in patients with active upper gastrointestinal problems. Adequate calcium intake is important to prevent hypocalcemia. Severe bone, joint, and/or muscle pain has been reported. Not recommended for use in patients with severe renal impairment.
• Products containing calcium and other multivalent cations (like aluminum, magnesium, iron) are likely to interfere with the absorption of Ibandronic Acid. Avoid taking them within 60 minutes before or after taking Ibandronic Acid.
• Calcium Orotate: Contraindicated in conditions like incomplete or infrequent bowel movements, kidney stones, kidney disease, increased activity of the parathyroid gland, high amounts of calcium in urine or blood, and extreme loss of body water. Calcium can decrease the absorption of certain drugs (e.g., bisphosphonates, quinolone and tetracycline antibiotics, levothyroxine, phenytoin). Thiazide diuretics may increase the risk of hypercalcemia and hypercalciuria.
• The safety of Ibandronic Acid and Calcium Orotate combination during pregnancy has not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the⁵ mother and fetus. Caution should be exercised when administered to⁶ a nursing woman.

Storage: Store in a cool and dry place, protected from light. Keep all medicines out of reach of children.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.