Actonel

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Risedronate tablets come in different strengths (number of milligrams per pill). Some tablets are taken once each day. Some tablets are taken once each week, or only 1 or 2 times each month.

Your dosing schedule will depend on the tablet strength your doctor has prescribed. If you change tablet strengths, you may also need to change your schedule. Follow the directions on your prescription label.

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

Take the Atelvia tablet just after breakfast, with at least 4 ounces of water.

Use only plain water (not mineral water) when taking a risedronate tablet.

After taking a risedronate tablet, carefully follow these instructions:

• Do not lie down or recline for at least 30 minutes after taking risedronate.

• Do not eat or drink anything other than plain water.

• Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking risedronate. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

Do not take two different strengths of risedronate tablet at the same time.

If you take risedronate only once a week, take it on the same day and time each week.

Do not crush, chew, or suck the risedronate tablet. Swallow it whole. The pill has a special coating to protect your stomach. Breaking the pill will damage this coating.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate. You may need to stop using the medicine for a short time.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. You may not need to take risedronate for longer than 3 to 5 years if you take it for osteoporosis.

Risedronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Avoid taking any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking a risedronate tablet. Some medicines can make it harder for your body to absorb risedronate.

Osteoporosis in Postmenopausal Women

Used alone or with calcium carbonate for prevention of osteoporosis in postmenopausal women.1 17 33 Risk factors for osteoporosis include premature ovarian failure; family history of osteoporosis; a small, slim body frame; cigarette smoking; excessive alcohol use; low dietary calcium intake; sedentary lifestyle; and Caucasian or Asian race.1 17

Used alone or with calcium carbonate for treatment of osteoporosis in postmenopausal women.1 5 6 7 33

Osteoporosis in Men

Treatment of osteoporosis in men.1 60

Corticosteroid-induced Osteoporosis

Prevention of corticosteroid-induced osteoporosis in men and women initiating therapy with corticosteroids (daily dosage ≥7.5 mg of prednisone or equivalent).1 8 10

Treatment of corticosteroid-induced osteoporosis in men and women receiving corticosteroids (daily dosage ≥7.5 mg of prednisone or equivalent).1 4 9 10 11

American College of Rheumatology (ACR) currently recommends use of one of several bisphosphonates (i.e., alendronate, risedronate, or zoledronic acid) in conjunction with lifestyle modification and calcium and vitamin D supplementation for the prevention and treatment of corticosteroid-induced osteoporosis in select postmenopausal women and men ≥50 years of age who are initiating or currently receiving corticosteroid therapy.57

ACR recommendations based on a risk-stratification approach in which an individual’s clinical risk for developing a fracture is determined based on variables such as gender, age, race/ethnicity, and femoral neck density57 and the individual’s preexisting or anticipated corticosteroid dosage.57

ACR states that because of limited data, use of bisphosphonates for prevention or treatment of corticosteroid-induced osteoporosis in premenopausal women and men <50 years of age can be recommended only in those who have a history of fragility fracture.57

Paget’s Disease of Bone

Treatment of Paget’s disease of bone (osteitis deformans).1 2 13 1

• 5 mg film-coated, oval, yellow tablet with RSN on 1 face and 5 mg on the other.
• 30 mg film-coated, oval, white tablet with RSN on 1 face and 30 mg on the other.
• 35 mg film-coated, oval, orange tablet with RSN on 1 face and 35 mg on the other.
• 75 mg film-coated, oval, pink tablet with RSN on 1 face and 75 mg on the other.
• 150 mg film-coated, oval, blue tablet with RSN on 1 face and 150 mg on the other.

No specific drug-drug interaction studies were performed. Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450).

Calcium Supplements/Antacids

Co-administration of Actonel and calcium, antacids, or oral medications containing divalent cations will interfere with the absorption of Actonel.

Hormone Replacement Therapy

One study of about 500 early postmenopausal women has been conducted to date in which treatment with Actonel 5 mg daily plus estrogen replacement therapy was compared to estrogen replacement therapy alone. Exposure to study drugs was approximately 12 to 18 months and the primary endpoint was change in BMD. If considered appropriate, Actonel may be used concomitantly with hormone replacement therapy.

Aspirin/Nonsteroidal Anti-Inflammatory Drugs

Of over 5700 patients enrolled in the Actonel Phase 3 osteoporosis studies, aspirin use was reported by 31% of patients, 24% of whom were regular users (3 or more days per week). Forty-eight percent of patients reported NSAID use, 21% of whom were regular users. Among regular aspirin or NSAID users, the incidence of upper gastrointestinal adverse experiences in placebo-treated patients (24.8%) was similar to that in Actonel-treated patients (24.5%).

H2 Blockers and Proton Pump Inhibitors (PPIs)

Of over 5700 patients enrolled in the Actonel Phase 3 osteoporosis studies, 21% used H2 blockers and/or PPIs. Among these patients, the incidence of upper gastrointestinal adverse experiences in the placebo-treated patients was similar to that in Actonel-treated patients.

Mechanism of Action

Actonel has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, Actonel inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (for example, lack of ruffled border). Histomorphometry in rats, dogs, and minipigs showed that Actonel treatment reduces bone turnover (activation frequency, that is, the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites.

Pharmacodynamics

Actonel treatment decreases the elevated rate of bone turnover that is typically seen in postmenopausal osteoporosis. In clinical trials, administration of Actonel to postmenopausal women resulted in decreases in biochemical markers of bone turnover, including urinary deoxypyridinoline/creatinine and urinary collagen cross-linked N-telopeptide (markers of bone resorption) and serum bone-specific alkaline phosphatase (a marker of bone formation). At the 5 mg dose, decreases in deoxypyridinoline/creatinine were evident within 14 days of treatment. Changes in bone formation markers were observed later than changes in resorption markers, as expected, due to the coupled nature of bone resorption and bone formation; decreases in bone-specific alkaline phosphatase of about 20% were evident within 3 months of treatment. Bone turnover markers reached a nadir of about 40% below baseline values by the sixth month of treatment and remained stable with continued treatment for up to 3 years. Bone turnover is decreased as early as 14 days and maximally within about 6 months of treatment, with achievement of a new steady-state that more nearly approximates the rate of bone turnover seen in premenopausal women. In a 1-year study comparing daily versus weekly oral dosing regimens of Actonel for the treatment of osteoporosis in postmenopausal women, Actonel 5 mg daily and Actonel 35 mg once-a-week decreased urinary collagen cross-linked N-telopeptide by 60% and 61%, respectively. In addition, serum bone-specific alkaline phosphatase was also reduced by 42% and 41% in the Actonel 5 mg daily and Actonel 35 mg once-a-week groups, respectively. When postmenopausal women with osteoporosis were treated for 1 year with Actonel 5 mg daily or Actonel 75 mg two consecutive days per month, urinary collagen cross-linked N-telopeptide was decreased by 54% and 52%, respectively, and serum bone-specific alkaline phosphatase was reduced by 36% and 35%, respectively. In a 1–year study comparing Actonel 5 mg daily versus Actonel 150 mg once-a-month in women with postmenopausal osteoporosis, urinary collagen cross-linked N-telopeptide was decreased by 52% and 49%, respectively, and serum bone-specific alkaline phosphatase was reduced by 31% and 32%, respectively.

Osteoporosis in Men

In a 2-year study of men with osteoporosis, treatment with Actonel 35 mg once-a-week resulted in a mean decrease from baseline compared to placebo of 16% (placebo 20%; Actonel 35 mg 37%) for the bone resorption marker urinary collagen cross-linked N-telopeptide, 45% (placebo -6%; Actonel 35 mg 39%) for the bone resorption marker serum C-telopeptide, and 27% (placebo -2%; Actonel 35 mg 25%) for the bone formation marker serum bone-specific alkaline phosphatase.

Glucocorticoid-Induced Osteoporosis

Osteoporosis with glucocorticoid use occurs as a result of inhibited bone formation and increased bone resorption resulting in net bone loss. Actonel decreases bone resorption without directly inhibiting bone formation.

In two 1-year clinical trials in the treatment and prevention of glucocorticoid-induced osteoporosis, Actonel 5 mg decreased urinary collagen cross-linked N-telopeptide (a marker of bone resorption), and serum bone-specific alkaline phosphatase (a marker of bone formation) by 50% to 55% and 25% to 30%, respectively, within 3 to 6 months after initiation of therapy.

Paget’s Disease

Paget’s disease of bone is a chronic, focal skeletal disorder characterized by greatly increased and disordered bone remodeling. Excessive osteoclastic bone resorption is followed by osteoblastic new bone formation, leading to the replacement of the normal bone architecture by disorganized, enlarged, and weakened bone structure.

In pagetic patients treated with Actonel 30 mg daily for 2 months, bone turnover returned to normal in a majority of patients as evidenced by significant reductions in serum alkaline phosphatase (a marker of bone formation), and in urinary hydroxyproline/creatinine and deoxypyridinoline/creatinine (markers of bone resorption).

Pharmacokinetics

Absorption

Based on simultaneous modeling of serum and urine data, peak absorption after an oral dose is achieved at approximately 1 hour (Tmax) and occurs throughout the upper gastrointestinal tract. The fraction of the dose absorbed is independent of dose over the range studied (single dose, from 2.5 mg to 30 mg; multiple dose, from 2.5 mg to 5 mg). Steady-state conditions in the serum are observed within 57 days of daily dosing. Mean absolute oral bioavailability of the 30 mg tablet is 0.63% (90% CI: 0.54% to 0.75%) and is comparable to a solution.

Food Effect

The extent of absorption of a 30 mg dose (three 10 mg tablets) when administered 0.5 hours before breakfast is reduced by 55% compared to dosing in the fasting state (no food or drink for 10 hours prior to or 4 hours after dosing). Dosing 1 hour prior to breakfast reduces the extent of absorption by 30% compared to dosing in the fasting state. Dosing either 0.5 hours prior to breakfast or 2 hours after dinner (evening meal) results in a similar extent of absorption. Actonel is effective when administered at least 30 minutes before breakfast.

Distribution

The mean steady-state volume of distribution for risedronate is 13.8 L/kg in humans. Human plasma protein binding of drug is about 24%. Preclinical studies in rats and dogs dosed intravenously with single doses of [14C] risedronate indicate that approximately 60% of the dose is distributed to bone. The remainder of the dose is excreted in the urine. After multiple oral dosing in rats, the uptake of risedronate in soft tissues was in the range of 0.001% to 0.01%.

Metabolism

There is no evidence of systemic metabolism of risedronate.

Excretion

In young healthy subjects, approximately half of the absorbed dose of risedronate was excreted in urine within 24 hours, and 85% of an intravenous dose was recovered in the urine over 28 days. Based on simultaneous modeling of serum and urine data, mean renal clearance was 105 mL/min (CV = 34%) and mean total clearance was 122 mL/min (CV = 19%), with the difference primarily reflecting nonrenal clearance or clearance due to adsorption to bone. The renal clearance is not concentration dependent, and there is a linear relationship between renal clearance and creatinine clearance. Unabsorbed drug is eliminated unchanged in feces. In osteopenic postmenopausal women, the terminal exponential half-life was 561 hours, mean renal clearance was 52 mL/min (CV = 25%), and mean total clearance was 73 mL/min (CV = 15%).

Specific Populations

Pediatric: Actonel is not indicated for use in pediatric patients [see Pediatric Use (8.4)].

Gender: Bioavailability and pharmacokinetics following oral administration are similar in men and women.

Geriatric: Bioavailability and disposition are similar in elderly (greater than 60 years of age) and younger subjects. No dosage adjustment is necessary.

Race: Pharmacokinetic differences due to race have not been studied.

Renal Impairment: Risedronate is excreted unchanged primarily via the kidney. As compared to persons with normal renal function, the renal clearance of risedronate was decreased by about 70% in patients with creatinine clearance of approximately 30 mL/min. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min) because of lack of clinical experience. No dosage adjustment is necessary in patients with a creatinine clearance greater than or equal to 30 mL/min.

Hepatic Impairment: No studies have been performed to assess risedronate’s safety or efficacy in patients with hepatic impairment. Risedronate is not metabolized in rat, dog, and human liver preparations. Insignificant amounts (less than 0.1% of intravenous dose) of drug are excreted in the bile in rats. Therefore, dosage adjustment is unlikely to be needed in patients with hepatic impairment.

Drug Interactions: No specific drug-drug interaction studies were performed. Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (Cytochrome P450) [see Drug Interactions (7)].

See FDA-approved patient labeling (Medication Guide)

Instruct patients to read the Medication Guide before starting therapy with Actonel and to re-read it each time the prescription is renewed.

Instruct patients that Atelvia and Actonel contain the same active ingredient and if they are taking Atelvia, they should not take Actonel [see Warnings and Precautions (5.1)].

Instruct patients to pay particular attention to the dosing instructions as clinical benefits may be compromised by failure to take the drug according to instructions. Specifically, Actonel should be taken at least 30 minutes before the first food or drink of the day other than water.

Instruct patients to take Actonel while in an upright position (sitting or standing) with a full glass of plain water (6 to 8 ounces) to facilitate delivery to the stomach, and thus reduce the potential for esophageal irritation.

Instruct patients not to lie down for 30 minutes after taking the medication [see Warnings and Precautions (5.1)].

Instruct patients not to chew or suck on the tablet because of a potential for oropharyngeal irritation.

Instruct patients that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or severe persistent or worsening heartburn) they should consult their physician before continuing Actonel.

Instruct patients about missing Actonel doses as follows:

• If a dose of Actonel 35 mg once-a-week is missed, they should take 1 tablet on the morning after they remember and return to taking 1 tablet once-a-week, as originally scheduled on their chosen day. Patients should not take 2 tablets on the same day.
• If one or both tablets of Actonel 75 mg on two consecutive days per month are missed, and the next month’s scheduled doses are more than 7 days away, the patient should be instructed as follows:
  • If both tablets are missed, take one Actonel 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning.
  • If only one Actonel 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered.
  • Patients should then return to taking their Actonel 75 mg on two consecutive days per month as originally scheduled. Patients should not take more than two 75 mg tablets within 7 days. 
• If one or both tablets of Actonel 75 mg on two consecutive days per month are missed, and the next month's scheduled doses are within 7 days, patients should wait until their next month’s scheduled doses and then continue taking Actonel 75 mg on two consecutive days per month as originally scheduled.
• If the dose of Actonel 150 mg once-a-month is missed, and the next month’s scheduled dose is more than 7 days away, the patient should be instructed to take the missed tablet in the morning after the day it is remembered. Patients should then return to taking their Actonel 150 mg once-a-month as originally scheduled. Patients should not take more than one 150 mg tablet within 7 days.
• If the dose of Actonel 150 mg once-a-month is missed, and the next month's scheduled dose is within 7 days, patients should wait until their next month’s scheduled dose and then continue taking Actonel 150 mg once-a-month as originally scheduled.

Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [see Warnings and Precautions (5.3)]. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as excessive cigarette smoking, and/or alcohol consumption, if these factors exist.

Instruct patients to take calcium supplements or calcium-, aluminum-, and magnesium-containing medications at a different time of the day than Actonel as these medications may interfere with the absorption of Actonel.

Remind patients to give all of their healthcare providers an accurate medication history. Instruct patients to tell all of their healthcare providers that they are taking Actonel. Patients should be instructed that any time they have a medical problem they think may be from Actonel, they should talk to their doctor.

Actonel is a prescription medicine that is used:

•  to prevent and treat osteoporosis in postmenopausal women (women that have gone through the "end of periods" or "change of life")
•  to increase bone mass in men with osteoporosis (a condition in which bones weaken and break easily)
•  to prevent and treat osteoporosis in men and women that is caused by treatment with steroid medicines such as prednisone
•  to treat Paget’s disease (a condition in which bones are soft, weak, deformed, painful, or easily broken) of bone in men and women

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

The following instructions apply to all patients taking Actonel:

• Take Actonel exactly as prescribed by your healthcare provider.
• Take Actonel first thing in the morning before you eat or drink anything except plain water.
• Take Actonel while you are sitting up or standing.
• Take Actonel with 6 to 8 ounces (about 1 cup) of plain water. Do not take it with any other drink besides plain water. Do not eat or drink anything for 30 minutes after taking Actonel.
• Swallow Actonel whole. Do not chew the tablet or keep it in your mouth to melt or dissolve it.

After taking Actonel you must wait at least 30 minutes before:

• lying down. You may sit, stand, or do normal activities like read the newspaper or take a walk.
• eating or drinking anything except plain water.
• taking vitamins, calcium, or antacids. It is best to take vitamins, calcium, and antacids at a different time of the day from when you take Actonel.

If you miss a dose of Actonel, do not take it later in the day. Take your missed dose the next morning and then return to your normal schedule. Do not take 2 doses at the same time.

If you miss more than 2 doses of Actonel in a month, call your doctor for instructions.

If you take too much Actonel, call your doctor. Do not try to vomit. Do not lie down.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room 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.

Applies to risedronate: oral delayed release tablet, oral tablet

General

Abdominal and musculoskeletal pain were commonly reported adverse effects.[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 10.5%)
Common (1% to 10%): Arrhythmia (2%) in men with osteoporosis
Frequency not reported: Syncope, vasodilation[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 12.9%), diarrhea (up to 10.8%), dyspepsia (up to 10.8%), nausea (up to 10.5%)
Common (1% to 10%): Abdominal pain, vomiting, abdominal upper pain, gastritis, gastroesophageal reflux disease, gastroenteritis
Uncommon (0.1% to 1%): Duodenitis, glossitis
Rare (less than 0.1%): Esophageal stricture
Postmarketing reports: Esophagitis, esophageal or gastric ulcers[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 11.1%)
Common (1% to 10%): Nocturia (1.6%), cystitis, hemorrhoids, Hiatus hernia, urinary disorders, reproductive system and breast disorders[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 23.7%)
Common (1% to 10%): Back pain, pain in extremity, musculoskeletal pain, bone pain, muscle spasms, myalgia, neck pain, arthritis, traumatic bone fracture, join disorder, leg cramps, myasthenia (1.6%), osteoarthritis, tendonitis
Rare (less than 0.1%): Severe or incapacitating bone, join, or muscle pain; osteonecrosis of the jaw (ONJ); atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
Frequency not reported: Muscle spasms[Ref]

Other

Very common (10% or more): Accidental injury (up to 16.9%), pain (up to 14.1%), flu syndrome (up to 11.6%)
Common (1% to 10%): Tinnitus (1.6%), asthenia, peripheral edema, contusion, herpes zoster (1% to 2.6%), ear and labyrinth disorders, vertigo[Ref]

Respiratory

Very common (10% or more): Bronchitis (up to 10%)
Common (1% to 10%): Influenza, upper respiratory infection, chest pain, sinusitis, rhinitis, pharyngitis, increased cough, apnea (1.6%)
Postmarketing reports: Asthma exacerbations[Ref]

Dermatologic

Common (1% to 10%): Rash
Frequency not reported: Pruritus[Ref]

Endocrine

Common (1% to 10%): Elevated levels of parathyroid hormone (PTH), endocrine disorders[Ref]

Hematologic

Common (1% to 10%): Anemia (1% to 2.6%), blood and lymphatic system disorders[Ref]

Hepatic

In most of the postmarketing reported cases the patients were also treated with other products known to cause hepatic disorders.[Ref]

Common (1% to 10%): Colitis (1.6%), hepatobiliary disorders
Rare (less than 0.1%): Abnormal liver function test
Postmarketing reports: Serious hepatic disorders[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reactions
Postmarketing reports: Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis, anaphylactic reactions[Ref]

Immunologic

Common (1% to 10%): Immune system disorders[Ref]

Metabolic

Common (1% to 10%): Decreased weight, hypocalcemia (1.6%), transient decreases from baseline of serum calcium and phosphate, hypercholesterolemia[Ref]

Transient decreases from baseline in serum calcium (less than 1%) and serum phosphate (less than 3%) were observed within 6 months in patients in osteoporosis clinical trials treated with doses of 5 mg daily immediate-release.[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, insomnia, sciatica (0.6% to 2.3%)[Ref]

Ocular

Common (1% to 10%): Cataract; amblyopia, corneal lesion and dry eye (1.6%)
Uncommon (0.1% to 1%): Iritis
Rare (less than 0.1%): Eye inflammation including uveitis[Ref]

Oncologic

Common (1% to 10%): Benign prostatic hyperplasia (5%) in men with osteoporosis; neoplasms benign, malignant and unspecified (including cysts and polyps)[Ref]

Psychiatric

Common (1% to 10%): Depression, psychiatric disorders[Ref]

Renal

Common (1% to 10%): Nephrolithiasis (3%) in men with osteoporosis, renal disorders[Ref]

Some side effects of Actonel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

• Actonel is used in the treatment and prevention of osteoporosis in postmenopausal women and men. It is also used to treat glucocorticoid-induced osteoporosis and to treat Paget's disease of the bone.
• Bisphosphonates may also be used to treat adverse skeletal effects caused by some cancers.
• Depending on the condition being treated, Actonel may be taken once daily, once weekly, or monthly.

• Take Actonel at least 30 minutes before eating or drinking any food or beverages (other than water), or taking any other medication, including calcium, antacids or vitamins for the day.
• Take Actonel with a full glass of water and remain upright for at least 30 minutes after taking Actonel. Do not lie down.
• Avoid eating, drinking (other than water) or taking other medications for 30 minutes after taking Actonel.
• You may need to take supplementary calcium or vitamin D if your dietary intake is inadequate. Your doctor will advise you on this. If you are taking supplemental calcium, iron, magnesium, or antacids, take them at a different time of day to Actonel (for example at lunchtime), as they may interfere with the absorption of Actonel.
• Talk to both your dentist and doctor if you require dental surgery or a tooth extraction and you have been on Actonel long-term. Your doctor may advise discontinuation of Actonel.
• Tell your doctor if you experience any thigh or groin pain, severe or debilitating muscle pain, eye inflammation, or any other adverse effects of concern while you are taking Actonel.

UK: Use is contraindicated. AU, US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Excreted into animal milk: Unknown Comments: The effects in the nursing infant are unknown.

Substance Name

Risedronate

CAS Registry Number

105462-24-6

Drug Class

Bisphosphonates

Bone Density Conservation Agents

Diphosphonates