Osteofos 35 Tablet

Here is a detailed product description for OSTEOFOS 35 TABLET:

OSTEOFOS 35 TABLET by CIPLA HEALTH LTD

Name

• Brand Name: OSTEOFOS 35 TABLET
• Common Name: Alendronic Acid (Alendronate)

Composition Each uncoated tablet contains Sodium Alendronate IP equivalent to Alendronic Acid 35 mg.

Uses OSTEOFOS 35 TABLET is a bisphosphonate medication primarily used to prevent and treat bone weakening conditions.

• Osteoporosis: Prevention and treatment in postmenopausal women and men.
• Glucocorticoid-induced Osteoporosis: Management in both men and women.
• Paget's Disease of Bone: Treatment of this disorder where bone replacement is disrupted, leading to weak, thin, and easily fractured bones.

Dosage and Administration OSTEOFOS 35 TABLET is typically administered once weekly.

• It should be taken on the same day each week.
• Swallow the tablet whole with a full glass of plain water (6-8 ounces) upon arising for the day, at least 30 minutes before the first food, beverage, or other medication.
• Do not crush, chew, or allow the tablet to dissolve in the mouth due to the potential for oropharyngeal ulceration.
• Remain upright (sitting, standing, or walking) for at least 30 minutes after taking the tablet and until after your first food of the day to reduce the risk of oesophageal irritation.
• Do not take at bedtime or before arising for the day.

Side Effects

• Common Side Effects: Abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, headache, dizziness, musculoskeletal (bone, muscle or joint) pain, indigestion, and heartburn/acid regurgitation. These are usually mild and temporary.
• Serious Side Effects: Oesophageal adverse experiences (such as oesophagitis, ulcers, erosions, occasionally with bleeding), osteonecrosis of the jaw (jaw pain), kidney problems, and low calcium levels in the blood (hypocalcaemia). Seek immediate medical attention if these occur.

Precautions

• Oesophageal Abnormalities: Avoid if you have certain oesophageal abnormalities or conditions that delay oesophageal emptying.
• Hypocalcemia: Not recommended for patients with decreased calcium levels; calcium and vitamin D levels should be checked before starting therapy.
• Kidney Disease: Use with extreme caution in patients with kidney impairment and is not recommended for severe kidney impairment.
• Interactions: Calcium supplements, antacids, and other oral medications containing multivalent cations can interfere with alendronate absorption; wait at least 30 minutes after taking OSTEOFOS before taking other oral medications.
• Dental Health: Maintaining good oral hygiene and informing your dentist about treatment is advised, especially if undergoing dental procedures, due to the risk of osteonecrosis of the jaw.
• Pregnancy and Breastfeeding: Generally contraindicated during pregnancy and caution is advised during breastfeeding; consult a doctor.
• Alcohol and Smoking: Avoid excessive alcohol consumption and smoking as they can negatively impact bone health.

Storage Store OSTEOFOS 35 TABLET in a well-closed container at room temperature, ideally below 25°C, protected from moisture and heat. Keep out of reach and sight of children.

What is OSTEOFOS 35 TABLET used for?

OSTEOFOS 35 TABLET contains alendronic acid (alendronate), which belongs to a class of medicines called bisphosphonates. It is primarily used to prevent and treat osteoporosis, a condition that causes bones to become weak and brittle, making them more susceptible to fractures. It can be prescribed for postmenopausal women, men, and individuals with glucocorticoid-induced osteoporosis. It is also used to treat Paget's disease of the bone, a disorder where old bone cells are replaced abnormally by new bone cells.

How does OSTEOFOS 35 TABLET work?

Alendronic acid works by slowing down the natural breakdown of bone, a process carried out by cells called osteoclasts. By suppressing the activity of these bone-resorbing cells, OSTEOFOS helps to maintain and increase bone density, thereby strengthening bones and reducing the risk of fractures.

What is the usual dosage for OSTEOFOS 35 TABLET?

For the prevention of osteoporosis, the usual dosage of OSTEOFOS 35 TABLET is one tablet (35 mg) once weekly. Your doctor will determine the appropriate dose and duration of treatment based on your condition.

How should I take OSTEOFOS 35 TABLET?

It is crucial to follow specific instructions to ensure effectiveness and minimize side effects:

• Take OSTEOFOS 35 TABLET upon arising for the day, at least 30 minutes before your first food, drink (other than plain water), or any other medication.
• Swallow the tablet whole with a full glass of plain water (6-8 ounces). Do not chew, crush, or suck on the tablet, as this can cause irritation or ulceration of the esophagus or mouth.
• After taking the tablet, remain fully upright (sitting, standing, or walking) for at least 30 minutes and until after your first food of the day. Do not lie down.
• Do not take it at bedtime or before arising for the day.

What are the possible side effects of OSTEOFOS 35 TABLET?

Common side effects may include headache, musculoskeletal (bone, muscle, or joint) pain, indigestion, heartburn, nausea, stomach pain, constipation, and diarrhea. These are usually mild and temporary.

More serious, but rare, side effects can occur, such as severe esophageal irritation or ulcers (especially if dosing instructions are not followed), low calcium levels (hypocalcemia), jaw pain (osteonecrosis of the jaw), severe bone/joint/muscle pain, and atypical femur fractures. You should seek immediate medical attention if you experience severe symptoms like chest pain, difficulty or pain when swallowing, new or unusual hip/thigh/groin pain, or severe jaw pain.

Is OSTEOFOS 35 TABLET safe during pregnancy or breastfeeding?

OSTEOFOS 35 TABLET is generally not recommended during pregnancy due to potential harm to the developing baby, as indicated by animal studies. It is primarily intended for use in postmenopausal women. If you are pregnant or think you might be, or are breastfeeding, you should consult your doctor. While some sources suggest it might be safe during breastfeeding with monitoring, others advise caution due to unknown passage into breast milk.

Can OSTEOFOS 35 TABLET be taken with other medications?

It is important to inform your doctor about all medications, herbal preparations, and supplements you are taking. You should avoid consuming any food, beverages (other than plain water), calcium supplements, antacids, or other medications for at least 30 minutes after taking OSTEOFOS, as they can significantly reduce its absorption and effectiveness. Non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin or ibuprofen, when taken with alendronic acid, may increase the risk of gastrointestinal side effects.

What precautions should be taken while using OSTEOFOS 35 TABLET?

• Inform your doctor if you have any esophageal disorders (like stricture or achalasia), low calcium levels (hypocalcemia must be corrected before starting treatment), kidney disease, jaw problems, or if you are planning any dental procedures.
• Ensure adequate intake of calcium and vitamin D through diet or supplements, as these are crucial for bone health and the effectiveness of the medicine. Your doctor may recommend supplements.
• Maintain good oral hygiene and have regular dental check-ups, particularly if you have risk factors for jaw problems.
• Avoid smoking and excessive alcohol consumption, as these can negatively impact bone health.
• If you experience dizziness or severe bone, muscle, or joint pain, your ability to drive or operate machinery may be affected.

What happens if a dose of OSTEOFOS 35 TABLET is missed?

If you miss a once-weekly dose of OSTEOFOS 35 TABLET, take it on the morning after you remember. Do not take two doses on the same day. You should then return to taking one dose once a week, as originally scheduled on your chosen day.

How should OSTEOFOS 35 TABLET be stored?

Store OSTEOFOS 35 TABLET in a well-closed container at room temperature (between 20°C to 25°C or 68°F to 77°F), away from excessive heat, moisture, and direct light. Keep it out of reach of children.