Aphanate 70

Aphanate 70
Alendronate (as sodium)
70 mg Tablet
This medicine has been prescribed for your current condition. Therefore, avoid using it in similar cases or recommending it to others.

General Guidelines:
Consult your doctor before taking this medicine in the following cases:
• In case of allergy to this medicine or other medicines, or any other substances such as foods, preservatives, dyes, etc.

Use in Pregnancy and Lactation:
Alendronate should not be used during pregnancy and lactation unless advised by a specialist.

Warnings:
• The duration of alendronate use is determined by a specialist. The duration of use is usually 3 to 5 years.
• Alendronate can cause local irritation of the upper gastrointestinal mucosa. To prevent the worsening of the underlying disease, caution should be exercised when prescribing alendronate to patients with upper gastrointestinal problems such as dysphagia, esophageal diseases, gastritis, and gastric or duodenal ulcers.
• Osteonecrosis of the external auditory canal has been reported in association with long-term therapy. It is more commonly seen in individuals undergoing steroid therapy and chemotherapy, and/or with risk factors such as infection or trauma. Consult a doctor if symptoms such as pain, discharge, or chronic ear infection occur.
• In rare cases, the use of alendronate sodium may cause osteonecrosis of the jaw. Symptoms of this condition include pain, numbness, redness and swelling of the gums, tooth loss, or delayed healing after dental procedures.
• Musculoskeletal pain may occur with the use of this medicine; these pains may start days or months after initiating the drug.
• Atypical bone fractures have been primarily reported in patients receiving long-term alendronate therapy for osteoporosis. During treatment, patients should be advised to report any thigh, hip, or groin pain, and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
• Alendronate is not recommended for patients with renal impairment whose creatinine clearance is less than 35 mL/min.
• Alendronate sodium prevents bone resorption of calcium and inhibits osteoclast function, and by this mechanism, it prevents osteoporosis. Therefore, hypocalcemia must be corrected before initiating alendronate therapy. Other disorders affecting mineral metabolism (such as hypocalcemia, vitamin D deficiency, and hypoparathyroidism) must also be treated before starting this medicinal product.
• It is recommended not to take any other medicine containing calcium, vitamins, or antacids for at least 30 minutes after taking alendronate.
• Bone mineral density should be monitored frequently during the course of alendronate therapy.

Dosage:
The dosage of the medicine is determined by the attending physician for each patient. However, the usual dose of the medicine is as follows:
For the treatment of osteoporosis in postmenopausal women and to increase bone mass in men:
The recommended dose is one 70 mg tablet once a week.
Studies have shown no difference in the efficacy of this medicine in older individuals; therefore, no dosage adjustment is necessary for the elderly.

Method of Administration:
The medicine should be taken in the morning on an empty stomach with plenty of water. It is best to avoid eating for up to 30 minutes after taking the medicine.
After taking the medicine, it is best for the patient to sit upright or stand for up to 30 minutes.
If the alendronate tablet is taken once a week, it is best for the patient to take it on a specific day of the week.
In case of a missed dose, you should take it on the morning of the day after you remember, and if it is close to the next dose, skip the missed dose and do not double the dose.
Avoid stopping the medicine abruptly.

Side Effects:
Every medicine, along with its desired therapeutic effects, may also cause some unwanted side effects. Inform your doctor if any of the following side effects occur.
Important side effects that require notifying a doctor if they occur:
Common or very common: Gastrointestinal disorders, joint swelling, dizziness
Uncommon: Bleeding
Rare or very rare: Stress fracture of the femur, oropharyngeal ulcer, photosensitivity reaction, severe skin reactions

Storage Conditions:
• Store the medicine at a temperature below 30°C, away from light and moisture.
• Keep the medicine out of the reach of children.
• To protect the environment, do not dispose of any medicines in wastewater or non-recyclable waste.
• Avoid using expired medicine.

Dosage Forms and Packaging:
This medicine is produced and supplied as tablets containing 70 mg of alendronate (as sodium) in boxes of 10 by Afashimi Pharmaceutical Company.

USP DI
pdr.net
BNF 2020