Risedronate Sodium + Calcium

Uses

• • to prevent and treat osteoporosis in postmenopausal women.
• • to increase bone mass in men with osteoporosis.
• • to prevent and treat osteoporosis in men and women that is caused by treatment with steroid medicines such as prednisolone.
• • to treat Paget’s disease of bone in men and women

Risedronate Sodium + Calcium is also used to associated treatment for these conditions: Calcium Deficiency, Deficiency, Vitamin D, Osteodystrophy, Osteomalacia, Osteoporosis, Chronic Hypocalcemia, Chronic Hypocalcemia caused by anticonvulsant medications, Care of the Joint, Mineral supplementation, Nutritional supplementation

How Risedronate Sodium + Calcium works

Calcium plays a vital role in the anatomy, physiology and biochemistry of organisms and of the cell, particularly in signal transduction pathways. More than 500 human proteins are known to bind or transport calcium. The skeleton acts as a major mineral storage site for the element and releases Ca2+ ions into the bloodstream under controlled conditions. Circulating calcium is either in the free, ionized form or bound to blood proteins such as serum albumin. Parathyroid hormone (secreted from the parathyroid gland) regulates the resorption of Ca2+ from bone. Calcitonin stimulates incorporation of calcium in bone, although this process is largely independent of calcitonin. Although calcium flow to and from the bone is neutral, about 5 mmol is turned over a day. Bone serves as an important storage point for calcium, as it contains 99% of the total body calcium. Low calcium intake may also be a risk factor in the development of osteoporosis. The best-absorbed form of calcium from a pill is a calcium salt like carbonate or phosphate. Calcium gluconate and calcium lactate are absorbed well by pregnant women. Seniors absorb calcium lactate, gluconate and citrate better unless they take their calcium supplement with a full breakfast. The currently recommended calcium intake is 1,500 milligrams per day for women not taking estrogen and 800 milligrams per day for women on estrogen. There is close to 300 milligrams of calcium in one cup of fluid milk. Calcium carbonate is currently the best and least expensive form of calcium supplement available.

Dosage

Risedronate Sodium + Calcium dosage

WHAT RisedonTM Plus IS AND WHAT IT IS USED FOR?

RisedonTM Plus is a co-package product containing 1 tablet of Risedronate Sodium INN 35 mg for once weekly dosing and 6 tablets of Calcium Carbonate BP equivalent to 500 mg Calcium for daily dosing of the remaining 6 days of the week. Risedronate is in a group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. It slows bone loss while increasing bone mass, which may prevent bone fractures.

HOW RisedonTM Plus WORKS?

Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, Risedronate inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption. Calcium suppresses parathyroid hormone (PTH) secretion and decreases bone turnover. Increased levels of PTH are known to contribute to age-related bone loss, especially at cortical sites, while increased bone turnover is an independent risk factor of fractures.

HOW TO TAKE RisedonTM Plus TABLET?

The following instructions are applicable to all patients taking Risedon tablet: • Take Risedon tablet exactly as prescribed by your healthcare provider • At first take Risedon tabletin the morning before you eat or drink anything except plain water. • Take Risedon tablet while you are sitting up or standing. • Take a Risedon tablet with 1 glass of plain water. Do not take it with any other drink besides plain water. • Swallow whole Risedon tablet. Do not chew the tablet or keep it in your mouth to melt or dissolve. • After taking Risedon tablet you must wait at least 30 minutes before: 1. lying down. You may sit, stand, or do normal activities. 2. eating or drinking anything except plain water. 3. taking vitamins, calcium, or antacids. • Take vitamins, calcium, & antacids at a different time of the day from when you take Risedon tablet. • Keep taking Risedon tablet for as long as your healthcare provider tells you.

WHAT IS MY RisedonTM Plus SCHEDULE?

One Risedon tablet should be taken orally once a week (Day 1 of the 7-day treatment cycle). One calcium 500 mg tablet should be taken orally with food daily on each of the remaining six days (Days 2 through 7 of the 7-day treatment cycle).

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, jaw pain, numbness, or swelling, mild heartburn or stomach upset, diarrhea, gas, or constipation, mild joint or back pain, headache.

Precaution

Take special care with if you:

• • have low blood calcium (hypocalcemia).
• • cannot sit or stand up for 30 minutes.
• • have kidneys that work poorly.
• • have an allergy to Risedronate Sodium.
• • are pregnant or may become pregnant.
• • are breast-feeding or plan to breast-feed.
• • have kidney problems, Risedronate Sodium may not be right for you.

Interaction

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 Risedronate Sodium. If you use these other medicines, do not take them for at least 30 minutes after taking a Risedronate Sodium tablet.

Elimination Route

The kidney excretes 250 mmol a day in urine, and resorbs 245 mmol, leading to a net loss in the urine of 5 mmol/d.

Pregnancy & Breastfeeding use

PREGNANCY It should not be taken during pregnancy. If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor.

LACTATION 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.

FOR RENAL IMPAIRED PATIENTS Risedronate Sodium is not recommended for use in patients with severe renal impairment (creatinine clearance <30 ml/min). No dosage adjustment is necessary in patients with a creatinine clearance >30 ml/min or in the elderly

Contraindication

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.

Special Warning

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 Risedronate Sodium is contra-indicated in patients with severe renal impairment (Creatinine clearance lower than 30ml/min).

Acute Overdose

Seek emergency medical attention if you think you have used too much of this medicine. Drink a full glass of milk right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

Interaction with other Medicine

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 the absorption of Risedronate Sodium. If you use these other medicines, do not take these for at least 30 minutes after taking a Risedronate Sodium tablet.

Storage Condition

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

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