Risedronate

For preventing osteoporosis in women who are past menopause, the recommended dose of risedronate is 5 mg once daily or 35 mg once weekly.

For treating osteoporosis in women who are past menopause, there are multiple schedules for taking risedronate. It may be taken 5 mg once daily, 35 mg once weekly, 75 mg on 2 consecutive days per month on the same calendar days each month, or 150 mg once a month on the same calendar day each month.

For treating osteoporosis in men, the recommended dose of risedronate is 35 mg once weekly.

For treating and preventing osteoporosis caused by treatment with corticosteroids, the recommended dose of risedronate is 5 mg daily.

For treating Paget's disease, the recommended dose is 30 mg once daily for 2 months.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Risedronate exactly as prescribed by your doctor.

The tablet should be taken with plain water at least 30 minutes before the first food or drink of the day. It may also be taken at least 2 hours after any food or drink other than plain water. Do not eat or drink for 2 hours before and for at least 30 minutes after taking the tablet.

All strengths of risedronate should be taken while sitting in an upright position and swallowed whole (not chewed) with at least a half glass of water (i.e., at least 120 mL). Do not lie down for at least 30 minutes after taking the medication to prevent any irritation to your esophagus (the tube connecting the mouth and stomach).

If you are taking calcium supplements or aluminum-, iron-, or magnesium-containing medications (e.g., antacids and mineral supplements), you should take them at a different time of day. When taken together with risedronate, they will decrease the amount of risedronate that is delivered from your stomach into your body and reduce the effectiveness of the risedronate.

If you are taking Risedronate on a once-daily schedule and then miss a dose, do not take it later in the day. Resume your usual schedule the next morning. Do not take 2 doses at the same time.

If you are taking Risedronate on a once-weekly basis and you forget to take it on the regularly scheduled day, take one tablet on the day you first remember. Then, return to taking one tablet once a week on your regularly scheduled day. Do not take 2 tablets on the same day.

If you are taking Risedronate on a twice-monthly basis (schedule of 2 doses on 2 consecutive days per month) and miss a dose and the next month's scheduled doses are more than 7 days away, take the missed tablet in the morning after the day it is remembered. If both tablets are missed, take one tablet in the morning after the day it is remembered and the second tablet on the next consecutive morning. If you remember the missed dose and are within 7 days of the next month's scheduled doses, skip the missed dose(s), and wait until the next month's scheduled dose to continue.

If you are taking Risedronate on a once-monthly basis and miss a dose and the next month's scheduled dose is more than 7 days away, take the missed dose in the morning after the day it is remembered. If a dose is missed within 7 days of the next month's scheduled dose, skip the missed dose and wait until the next month's scheduled dose to continue.

Store Risedronate at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause diarrhea; it may cause bone pain; it may cause indigestion; it may cause spots or redness of the skin; it may cause nausea or, rarely, vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each oval, orange-coated tablet debossed with "RS" on one side and "35" on the other contains the equivalent of 35 mg of anhydrous risedronate sodium in the form of the hemipentahydrate with small amounts of monohydrate. Nonmedicinal ingredients: colloidal silicon dioxide, red iron oxide, iron oxide yellow, maltodexterin, mannitol, polyvinyl alcohol-polyethylene glycol graft copolymer, povidone, pregelatinized starch, sodium starch glycolate, sodium stearyl fumarate, sucrose, talc, titaniun dioxide, and triethyl citrate.

Do not take risedronate if you:

• are allergic to risedronate or any ingredients of Risedronate
• have low levels of calcium in the blood

There may be an interaction between risedronate and any of the following:

• aminoglycoside antibiotics (e.g., Amikacin, gentamicin, tobramycin)
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• Deferasirox
• H2 antagonists (e.g., Famotidine, Ranitidine)
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• systemic angiogenesis inhibitors (e.g., Axitinib, Bevacizumab, Lenalidomide, Pazopanib, Regorafenib, Vandetanib)
• supplements containing minerals such as aluminum, calcium, iron, and magnesium

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Risedronate. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Risedronate.

Atypical femur fracture: There is evidence that long-term use of this class of medication may contribute to a type of rare fracture of the long bone in the thigh (femur) without any form of trauma.

If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.

Bone, joint, and muscle problems: On rare occasions, people taking Risedronate experience severe bone, joint, or muscle pain. This pain usually goes away when the medication is stopped.

Calcium and vitamin D: Calcium and vitamin D are important contributors to bone growth and strength. It may be necessary to take calcium or vitamin D supplements to get the best effect from risedronate if you are not getting enough from your diet. Your doctor may test you for low calcium levels or vitamin D deficiency before you start taking risedronate.

Effects on the esophagus: Risedronate can cause irritation or ulcers of the esophagus (the passage from the throat to the stomach). In some cases, these effects have been severe and have required hospitalization. Stop taking the medication and contact your doctor immediately if you suddenly experience problems swallowing, find it painful to swallow, develop pain behind the sternum (breastbone), or have new or worsening heartburn.

To reduce the risk of irritation of the esophagus, swallow Risedronate with a full glass of plain water first thing in the morning when you get up. Do not lie down until 30 minutes have passed and you have eaten your first food of the day. Do not chew or suck on the tablet, as this may lead to ulcers in the mouth or throat. Do not take Risedronate at bedtime or before getting up for the day.

Effects on the stomach and intestines: Rarely, people taking Risedronate have developed ulcers of the stomach or intestines. Get immediate medical attention if you have symptoms of a stomach or intestinal ulcer, such as nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood.

If you have a history of ulcer or other stomach problems, discuss with your doctor how Risedronate may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Risedronate, and whether any special monitoring is needed.

Inflammation of the eye: Conditions of eye inflammation have been reported by people using risedronate. If you experience changes to your vision, red eyes, or eye pain, contact your doctor as soon as possible.

Jaw problems: Rarely, risedronate can cause severe jaw problems associated with delayed healing and infection, especially in people with cancer or after tooth extractions. Your doctor may ask you to see your dentist before you start taking Risedronate. Any necessary dental procedures should be completed before starting treatment with risedronate. It is important that you take good care of your teeth and gums while taking Risedronate. If you experience any mouth sores or pain in the jaw or teeth, contact your doctor as soon as possible.

Kidney function: Risedronate is removed from the body by the kidneys. Decreased kidney function may cause an increase in the amount of medication in the body, causing side effects. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Risedronate may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Risedronate, and whether any special monitoring is needed.

Risedronate is not recommended for use by people with severely reduced kidney function.

People who cannot stand or sit upright for at least 30 minutes: Risedronate can cause irritation or ulcers of the esophagus (the tube connecting the mouth and stomach). People who cannot stand or sit upright for at least 30 minutes should use risedronate only if the benefits outweigh the risks.

Pregnancy: Risedronate is not intended for use during pregnancy. If you become pregnant while taking Risedronate, contact your doctor immediately.

Breast-feeding: It is not known if risedronate passes into breast milk. Risedronate is not intended for use by women who are breast-feeding. If you are a breast-feeding mother and are taking Risedronate, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Risedronate have not been established for children.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. Because it may cause esophageal irritation, this product must be swallowed with a large glass of water. Avoid lying down for at least 30 minutes after taking it. It is not advisable to split, chew or crush this medication since it may irritate your mouth and gastrointestinal tract. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. This medication must be taken in the morning on an empty stomach, at least 30 minutes before eating. It must be taken with plain water only, even orange juice or coffee can decrease its absorption. To ensure effectiveness, avoid taking milk, dairy products, antacids or mineral supplements (calcium, iron, magnesium or zinc) for at least 30 minutes after taking this medication.