Salost DR Tablet (Delayed Release)

Your body is constantly breaking down old bone and making new bone tissue. If you have osteoporosis, your body breaks down more bone than it forms so gradually bone loss occurs and your bones become thinner and fragile. This is especially common in women after menopause (change of life). Many people with osteoporosis have no symptoms and you may not even know that you have it. However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists.

Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, Risedronat inhibits osteoclasts. The osteoclasts adhere normally to the bone surface but show evidence of reduced active resorption.

Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures: The recommended dose is Risedronate Sodium 5 mg once daily or Risedronate Sodium 35 mg once weekly on the same day each week or Risedronate Sodium 150 mg once monthly. 

Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis: The recommended dose is Risedronate Sodium 5 mg once daily. 

To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months): Systemic corticosteroid treatment at doses 7.5 mg/day prednisone or equivalent. The recommended dose is Risedronate Sodium 5 mg once daily. 

Treatment of osteoporosis in men at high risk of fractures: The recommended dose is Risedronate Sodium 35 mg once weekly. The tablet should be taken on the same day each week.

The absorption of Risedronate Sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate tablets at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. In the particular instances that before breakfast dosing is not practical, Risedronate 5 mg tablet can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Risedronate Sodium tablet is taken on an empty stomach-Between meals:

Risedronate Sodium tablet should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water). In the evening:

Risedronate Sodium tablet should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. If a dose is missed: Risedronate 5 mg tablet: If an occasional dose is missed, Risedronate 5 mg tablet can be taken before breakfast, between meals, or in the evening according to the instructions above.

Risedronate 35 mg tablet: Patients should be instructed that if a dose is missed, just take one Risedronate 35 mg tablet on the morning after remember. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day.

Risedronate 150 mg tablet: Patient should be instructed that if a dose is missed and the next month’s schedule dose is more than 7 days away, then should take the missed tablet in the morning after the day it is remembered. Patients should then return to taking one tablet once a month normally taken.The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Risedronate tablet is to be taken while in an upright position with a glass of plain water (120 ml or more). Patients should not lie down for 30 minutes after taking the tablet. Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription specially aspirin or other NSAIDs. Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs Salost DR. If you use these other medicines, do not take them for at least 30 minutes after taking a Salost DR tablet.

Risedronate Sodium tablet is contraindicated in patients with known hypersensitivity to Risedronate Sodium and in patients with hypocalcaemia, severe renal impairment (creatinine clearance lower than 30 ml/min), during pregnancy and lactation.

Serious side effects:

• chest pain;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• new or worsening heartburn;
• severe joint, bone, or muscle pain; or
• jaw pain, numbness, or swelling.

Less serious side effects:

• mild heartburn or stomach upset;
• diarrhea, gas,or constipation;
• mild joint or back pain;
• headache.

Risedronate Sodium is meant for use only in postmenopausal women. Therefore, Risedronate Sodium should not be taken during pregnancy. If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor. Risedronate Sodium is meant for use only in postmenopausal women. Therefore, breast-feeding women should not take this medicine. If you take it by accident during breast-feeding, stop taking it straight away and talk to your doctor.

Take special care with Salost DR if you:

• Have low blood calcium (hypocalcemia)
• Cannot sit or stand up for 30 minutes
• Have kidneys that work poorly
• Have an allergy to Salost DR

Before taking Salost DR talk to doctor if you:

• Are pregnant or may become pregnant. We do not know if Salost DR can harm your unborn child.
• Are breast-feeding or plan to breast-feed. We do not know if Salost DR can passthrough your milk and if it can harm your baby.
• Have kidney problems Salost DR may not be right for you.
• Salost DR is not intended for use in children.

During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must stop taking Salost DR and seek medical advice immediately. If you have stopped treatment due to hypersensitivity reactions you should not re-start therapy with Salost DR.

Pediatric use: The safety and efficacy of Salost DR tablets have not been established in children and adolescents.

Elderly: No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (60 years of age or older) compared to younger subjects. This has also been shown in the very elderly, 75 years old and above postmenopausal population. 

Renal impairment: No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of Salost DR is contra-indicated in patients with severe renal impairment (Creatinine clearance lower than 30ml/min).

No specific information is available on the treatment of overdose with Salost DR. Decreases in serum calcium following substantial overdose may be expected. Signs and symptoms of hypocalcaemia may also occur in some of these patients. Milk or antacids containing magnesium, calcium or aluminium should be given to bind Salost DR and reduce absorption of Salost DR. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed Salost DR.

Bisphosphonate preparations

Store in a cool and dry place. Protect from light & moisture. Keep out of the reach of children.