Idrofos Kit (31 Tab)

IDROFOS KIT (31 TAB)

IDROFOS KIT is a combination medication developed by SUN PHARMACEUTICAL IND.LTD.. It is designed to support bone health by providing essential nutrients and a bone-strengthening agent.

Composition Each IDROFOS KIT contains a combination of three active ingredients:

• Ibandronic Acid: 150 mg
• Elemental Calcium: 225 mg
• Vitamin D3 (Cholecalciferol): 800 IU

Ibandronic acid is a bisphosphonate that works by slowing down osteoclast-mediated bone resorption, thus reducing the rate of bone breakdown and maintaining bone density. Elemental calcium is crucial for building and maintaining strong bones. Vitamin D3 enhances the absorption of calcium from the gastrointestinal tract and regulates calcium metabolism, which is vital for optimal bone health.

Uses IDROFOS KIT is primarily used for the treatment and prevention of osteoporosis (weakening of bones). It is particularly beneficial for postmenopausal women and patients at high risk of fractures. The kit helps to increase bone mineral density (BMD), strengthen bones, and minimize the risk of vertebral and hip fractures. It also aids in treating conditions associated with low blood calcium levels, such as Vitamin D deficiency, hypoparathyroidism, latent tetany, rickets, and osteomalacia.

Dosage and Administration The typical dosage involves one Ibandronic Acid 150 mg tablet taken once monthly on the same date. Additionally, two tablets of Calcium 225 mg and Vitamin D3 800 IU are usually recommended per day, taken in divided doses (morning and evening after a meal). For the Ibandronic Acid tablet:

• Take it on an empty stomach with a full glass of plain water at least 60 minutes before the first food, drink (other than water), or any oral medication/supplementation.
• Swallow the tablet whole; do not chew or suck it.
• Remain standing or sitting upright for at least 60 minutes after taking the tablet to prevent irritation to the esophagus.

For the Calcium and Vitamin D3 tablets:

• Take one in the morning and one in the evening after a meal, following the order on the blister strip. It is crucial to adhere strictly to the prescribed dosage and duration as advised by a healthcare professional.

Side Effects Common side effects of IDROFOS KIT may include:

• Abdominal pain, dyspepsia (indigestion), nausea
• Musculoskeletal pain, back pain, arthralgia (joint pain)
• Headache, dizziness
• Flu-like symptoms
• Diarrhea, constipation, flatulence

Serious side effects, though less common, can include:

• Severe and occasionally incapacitating bone, joint, and/or muscle pain
• Osteonecrosis (primarily in the jaw)
• Chest pain, difficulty or pain when swallowing, new or worsening heartburn
• Numbness or heavy feeling in the jaw, painful urination, feeling short of breath
• Allergic reactions like rash, itching, swelling, or trouble breathing.

Precautions

• Hypocalcemia: Correct low blood calcium levels before initiating therapy.
• Gastrointestinal Issues: Use with caution in patients with active upper gastrointestinal problems (e.g., Barrett's esophagus, dysphagia, ulcers) due to potential local irritation.
• Liver/Kidney Impairment: Consult a doctor if you have liver or kidney health issues.
• Pregnancy and Breastfeeding: Not recommended for pregnant or breastfeeding women without medical consultation.
• Children: IDROFOS KIT is not recommended for children under 18 years.
• Older Patients: Elderly patients should take this medicine under medical supervision due to increased susceptibility to side effects.
• Drug Interactions:
  • Calcium supplements and antacids can reduce the absorption of ibandronic acid; they should be taken at least 60 minutes after the ibandronic acid dose.
  • NSAIDs (e.g., aspirin, ibuprofen) may increase the risk of gastrointestinal side effects when taken concurrently.
  • Dairy products should be avoided for at least 60 minutes after taking the ibandronic acid tablet as they can decrease absorption.
• Alcohol: Limit alcohol consumption as it may increase the risk of stomach side effects.

Storage Store IDROFOS KIT in a cool, dry place, below 30°C, and out of the sight and reach of children.

Here are frequently asked questions about IDROFOS KIT (31 TAB) by SUN PHARMACEUTICAL IND.LTD.:

What is IDROFOS KIT used for?

IDROFOS KIT is a prescription medicine primarily used to prevent and treat osteoporosis in postmenopausal women and high-fracture-risk patients. It helps strengthen bones, increase bone mineral density, and reduce the risk of fractures. This kit may also be used to supplement calcium and vitamin D levels and manage certain bone diseases.

How does IDROFOS KIT work?

IDROFOS KIT contains three active ingredients: Ibandronic Acid, Elemental Calcium, and Vitamin D3 (Cholecalciferol).

• Ibandronic Acid is a bisphosphonate that works by slowing down osteoclast-mediated bone resorption, which is the process of bone loss. By reducing the rate of bone breakdown, it helps maintain and increase bone density.
• Elemental Calcium is essential for building and maintaining strong bones. It helps to strengthen bones and counteract calcium loss.
• Vitamin D3 (Cholecalciferol) boosts the absorption of calcium from the gastrointestinal tract and regulates calcium metabolism, which is crucial for proper calcium utilization and optimal bone health.

What is the usual dosage for IDROFOS KIT?

The recommended dose of Ibandronic acid, a component of Idrofos Kit, for treatment is one 150 mg film-coated tablet once a month, preferably taken on the same date each month. To maximize absorption and clinical benefit, the tablet should be taken 60 minutes before the first food, drink (other than plain water), or any other oral medication or supplement (including calcium) of the day. It should be swallowed whole with a full glass of plain water (180 to 240 ml) while sitting or standing upright, and patients should not lie down for 60 minutes after taking it.

What are the possible side effects of IDROFOS KIT?

Common side effects of IDROFOS KIT may include back pain, headache, dizziness, nausea or upset stomach, diarrhea, abdominal pain, muscle aches, and flu-like symptoms. More serious, though rare, side effects can include chest pain, difficulty or pain when swallowing, new or worsening heartburn, numbness or heavy feeling in the jaw (osteonecrosis of the jaw), painful urination, or feeling short of breath. If you experience any severe or persistent side effects, you should consult your doctor.

Is IDROFOS KIT safe during pregnancy or breastfeeding?

IDROFOS KIT should generally be used with caution during pregnancy, and it's recommended to consult your doctor, as animal studies have shown potential harmful effects on the developing baby. It is generally not recommended during breastfeeding, as it is unknown if it is excreted in human milk and could potentially affect the infant. Your doctor will weigh the benefits against potential risks if prescribing during these times.

Can IDROFOS KIT be taken with other medications?

It is important to inform your doctor about all medications, vitamins, and herbal supplements you are taking, as they may interact with IDROFOS KIT. Calcium supplements and antacids, as well as some oral medications containing multivalent cations (like aluminum, magnesium, iron), can interfere with the absorption of Ibandronic acid and should be taken at least 60 minutes after IDROFOS KIT. Non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin or ibuprofen, when used concurrently with IDROFOS KIT, may increase the risk of gastrointestinal side effects.

What precautions should be taken?

Before starting IDROFOS KIT, any conditions like hypocalcemia (low blood calcium levels) and other disturbances of bone and mineral metabolism should be effectively treated. Adequate intake of calcium and vitamin D is important. Orally administered bisphosphonates can cause irritation of the upper gastrointestinal mucosa, so caution is advised for patients with active upper gastrointestinal problems (e.g., Barrett's esophagus, dysphagia, gastritis, ulcers). Patients should remain upright for at least 60 minutes after taking the tablet to facilitate delivery to the stomach and reduce the potential for esophageal irritation. Limiting alcohol intake is also advised as it can affect calcium absorption and cause bone loss. Caution should be exercised in patients with severe kidney impairment.

What happens if a dose is missed?

If a once-monthly dose of IDROFOS KIT is missed and the next scheduled dose is more than 7 days away, take the missed tablet in the morning following the date it is remembered. Then, return to the original monthly schedule. If the next scheduled dose is within 7 days, skip the missed dose and wait until the next regularly scheduled dose, then continue taking one tablet once a month as originally scheduled. Do not take two 150 mg tablets within the same week.

How should it be stored?

IDROFOS KIT should be stored below 30°C temperature, away from light and moisture. It should be kept out of the reach of children. Do not freeze the medicine unless specifically required by the package insert.