O-Cal Kit 150 mg & 400 mg Tablet

O-Cal Kit 150 mg & 400 mg Tablet

COMPOSITION

Each Kit contains:

a) 1 Tablet of Ibandronic Acid Each film-coated tablet contains Ibandronate Monosodium Monohydrate INN equivalent to Ibandronic Acid 150 mg

b) 60 Tablet of Calcium Orotate Each film-coated tablet contains Calcium Orotate Dihydrate INN equivalent to Calcium Orotate 740 mg.

INDICATIONS

O-Cal Kit is indicated for the treatment and prevention of osteoporosis in women (especially after menopause) & men. It increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

DOSAGE & ADMINISTRATION

One tablet of Ibandronic Acid 150 mg once monthly of the same date of each month is recommended. To maximize clinical benefit of Ibandronic Acid, two tablets of Calcium

Orotate 740 mg per day are usually recommended in divided dosage.

 To maximize absorption and clinical benefit, Ibandronic Acid tablet of O-Cal Kit should be taken 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, antacids, or vitamins.

 To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, Ibandronic Acid tablet should be swallowed whole with a full glass of plain water (250 ml) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking Ibandronic Acid tablet.

 Ibandronic Acid 150 mg tablet of O-Cal Kit should be taken on the same date of each month (i.e., the patients Ibandronic Acid day)

 If the once monthly dose is missed, and the patients 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. The patient should then return to taking one Ibandronic Acid 150 mg tablet every month in the morning of their chosen day, according to their original schedule.

 If the once monthly dose is missed, and the patients next scheduled Ibandronic Acid day is only 1 to 7 days away, the patient must wait until the subsequent month’s scheduled Ibandronic Acid day to take their tablet. The patient should then return to taking one Ibandronic Acid 150 mg tablet every month in the morning of their chosen day according to their original schedule.

 The Patient must not take two Ibandronic Acid 150 mg tablets within the same week.

 Start taking Calcium Orotate tablets from the next day of Ibandronic Acid day (from day-2 and onwards)

OR AS DIRECTED BY PHYSICIAN.

SIDE EFFECTS

Ibandronic Acid

Common side effects include Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Localized Osteoarthritis, Myalgia, Muscle Cramp, Influenza,

Nasopharyngitis, Bonchitis, Urinary Tract Infection, Upper Respiratory Tract Infection, Headache, Dizziness, Skin Rash, Insomnia etc.

Calcium Orotate

Bloating and swelling in the abdomen are common side effects of Calcium Orotate, loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, mood changes, bone/muscle pain, headache, increased thirst/urination, weakness, unusual tiredness, formation of kidney stones may occur infrequently.

CONTRAINDICATIONS

Ibandronic Acid is contraindicated in conditions like:

Abnormalities of the esophagus, hypocalcemia, known hypersensitivity to Ibandronic Acid or any of its components.

Calcium Orotate is contraindicated in conditions like:  Incomplete bowel movements, Kidney stone, Kidney disease and lung disease.

PRECAUTIONS

Ibandronic Acid

 Ibandronic Acid of O-Cal Kit may cause local irritation of the upper gastrointestinal mucosa.

 Adequate intake of Calcium is important in all patient hypocalcaemia

 Severe and occasionally incapacitating bone joint, and/or muscle pain has been reported in patients taking ibandronic Acid.

 Ibandronic Acid is not recommended for use in patients with severe renal impairment (Creatinine clearance of <30 ml/min)

Calcium Orotate

Before taking Calcium Orotate, precaution is needed if the patient is allergic to Calcium Orotate. Any Calcium supplement taken without food may increase the risk of kidney stones.

Therefore, it is advisable that Calcium Orotate be taken with food.

PREGNANCY, LACTATION AND PEDIATRIC USE:

 There are no adequate and well controlled studies in pregnant women for O-Cal Kit . O-Cal Kit should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

 It is not known whether O-Cal Kit is excreted in human milk. Caution should be exercised when O-Cal Kit is administered to a nursing woman.

 Safety and effectiveness in pediatric patients have not been established.

DRUG INTERACTIONS

Ibandronic Acid

Products containing calcium and other multivalent cautions (such as aluminium, magnesium, iron) are likely to interfere with absorption of Ibandronic Acid. Ibandronic Acid should be taken at least 60 minutes before any oral medications. Aspirin,

NSAIDs, and bisphosphonates are all associated with gasrointestinal irritation, caution should be exercised in the concomitant use of aspirin of NSNADs with Ibandronic Acid.

Calcium Orotate

Calcium can decrease the absorption of the other drugs such as bisphosphonates (e.g., alendronate/risedronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotic (e.g., doxycycline, levofloxacin).

SUPPLY

O-Cal Kit : Each box contains one kit. Each kit contains 1 tablet of Ibandronic Acid 150 mg and 60 tablets of Calcium Orotate 740 mg in one calendar strip.