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Risedronate Sodium 5 mg Tablet, Film Coated, 2,000-count — NDC 33342-0107-49 package photo

Risedronate Sodium 5 mg Tablet, Film Coated, 2,000-count

by Macleods Pharmaceuticals Limited · 2000 TABLET, FILM COATED in 1 CONTAINER (33342-107-49)
NDC 33342-0107-49
🏷️ FDA NDC (as labeled) 33342-107-49 billing pads the product segment with a zero
This package
Contains2,000-count Pack sizes3 compare ↓
Also priced by: Part D plans $2.90/unit — full pricing hub ↓
Also comes in: 10 tablets 33342-0107-06 30 tablets 33342-0107-07
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Past resolved recalls for this product (1)
Class III · Mar 10, 2022 · Terminated — FAILED CONTENT UNIFORMITY SPECIFICATIONS (Macleods Pharma Usa Inc) · FDA recall D-0762-2022

🆔 Identity & classification

FDA NDC (as labeled) 33342-107-49
Product NDC 33342-107
11-digit billing NDC 33342010749
RxCUI 905024, 905032, 905041, 905092, 905100
UNII OFG5EXG60L
Application # ANDA203533
SPL Set ID 62aff8d6-a2f7-4c7e-a102-c70105ac3792
Established class (EPC) Bisphosphonate
Chemical class Diphosphonates
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-12-09
Route ORAL
Dosage form TABLET, FILM COATED
Substance RISEDRONATE SODIUM
GPI-14 30042065100305
GPI class Risedronate Sodium
GCN Seq No 045102
GCN 92238
HICL code 018565
Ingredient (HICL) Risedronate Sodium
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P4
Therapeutic class — intermediate (HIC2) Parathyroid/Bone Resorption Drugs
HIC3 code P4L
Therapeutic class — specific (HIC3) Bone Resorption Inhibitors
AHFS code 92:24.00.00
AHFS class Bone Resorption Inhibitors
FDB label name RISEDRONATE SODIUM 5 MG TABLET
FDB brand name Risedronate Sodium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 33342-107-49 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 33342-0107-49. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerMacleods Pharmaceuticals Limited
Application holderMACLEODS PHARMACEUTICALS LTD
FDA applicationANDA203533 (ANDA)
Labeler code33342
First marketedDec 2015
Product typeHuman Prescription Drug
Portfolio381 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name RISEDRONATE SODIUM 5 MG TABLET Ingredient Risedronate Sodium
📖 What it is MedlinePlus · NLM

Risedronate is used to prevent and treat osteoporosis (a condition in which the bones become thin and weak and break easily) and Paget's disease of bone (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Risedronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Risedronate works by slowing down the cells in your body that break bone down. Normally your bones are constantly being broken down and rebuilt, but in conditions like osteoporosis...
  • What exactly does risedronate do for my bones?
  • It really does matter — this is one of the most important things to get right. If you're taking the regular tablet, you need to take it first thing in the morning, at least 30 minu...
  • Does it matter when I take risedronate, or can I just take it whenever?
📖 Read our full Risedronate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow / White / Orange
ShapeRound
ImprintCL92
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $2.90 $5,806.40 / 2000 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Risedronate Sodium 5 mg 00093-3099-56 Teva 30 tablets $1.498 AB Availability likely —
Risedronate Sodium 5 mgthis 33342-0107-49 Macleods 2000 tablets — AB FDA listed —
risedronate sodium 5 mg 47335-0666-08 Sun 100 tablets — AB FDA listed —
Risedronate Sodium 5 mg 65862-0517-22 Aurobindo 2000 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
On the market since
Dec 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets33342-0107-07 133 Rx · $8,947
10 tablets33342-0107-06 No Medicaid data
2000 tablets this page33342-0107-49 No Medicaid data
Drug total (last 4 qtrs): 133 Rx · 5,460 units · $8,947 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Risedronate Sodium — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Risedronate Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.96M
Claims incl. refills
73K
Beneficiaries
57.5K
Spend / beneficiary
$68.80
Spend / claim
$54.19
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
33342-0107-06 3 BLISTER PACK in 1 CARTON (33342-107-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK — — 2015-12-09 Active
33342-0107-07 30 TABLET, FILM COATED in 1 CONTAINER (33342-107-07) $1.50 / ea $44.93 2015-12-09 Active
33342-0107-49 You're viewing this 2000 TABLET, FILM COATED in 1 CONTAINER (33342-107-49) — — 2015-12-09 Active

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 33342-0107-49?
NDC 33342-0107-49 is a 2,000-count package — 2000 tablet, film coated in 1 container.
What is the difference between NDC 33342-0107-49 and NDC 33342-0107-07?
Both are Risedronate Sodium 5 mg Tablet, Film Coated — the drug itself is identical. NDC 33342-0107-49 is the 2,000-count package, while NDC 33342-0107-07 is the 30 tablets package.
What NDC number is used to bill for this package of Risedronate Sodium 5 mg Tablet, Film Coated?
Bill NDC 33342-0107-49 — the 11-digit billing format is 33342010749. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 33342-107-49, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 33342-0107-49, written without dashes as 33342010749. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 33342-0107-49, the first segment (33342) is the labeler code FDA assigned to Macleods Pharmaceuticals Limited; the middle segment (0107) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (49) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Macleods Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 tablets (33342-0107-06), 30 tablets (33342-0107-07). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Macleods Pharmaceuticals Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS & USAGE Risedronate sodium tablet, USP is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) Treatment of Paget's disease ( 1.4 ) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ( 1.5 )

1.1Postmenopausal Osteoporosis Risedronate sodium tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets, USP reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [ see Clinical Studies ( 14.1 , 14.2 ) ].

1.2Osteoporosis in Men Risedronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis.

1.3Glucocorticoid-Induced Osteoporosis Risedronate sodium tablets, USP are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

1.4Paget's Disease Risedronate sodium tablets, USP are indicated for treatment of Paget's disease of bone in men and women.

1.5Important Limitations of Use The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets, USP for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.

Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE & ADMINISTRATION Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week, 75 mg two consecutive days each month ( 2.1 ) Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week ( 2.2 ) Men with Osteoporosis: 35 mg once-a-week ( 2.3 ) Glucocorticoid-Induced Osteoporosis: 5 mg daily ( 2.4 ) Paget's Disease: 30 mg daily for 2 months ( 2.5 ) Instruct patients to: • Swallow tablet whole with 6 to 8 ounces of plain water, at least 30 minutes before the first food, beverage, or medication of the day • Avoid lying down for 30 minutes ( 2 ) • Take supplemental calcium and vitamin D if dietary intake is inadequate ( 2.7 )

2.1Treatment of Postmenopausal Osteoporosis [see Indications and Usage (1.1)] The recommended regimen is: • one 5 mg tablet orally, taken daily or • one 35 mg tablet orally, taken once-a-week or • one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month

2.2Prevention of Postmenopausal Osteoporosis [see Indications and Usage (1.1)] The recommended regimen is: • one 5 mg tablet orally, taken daily or • one 35 mg tablet orally, taken once-a-week or • alternatively, one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be considered

2.3Treatment to Increase Bone Mass in Men with Osteoporosis [see Indications and Usage (1.2)] The recommended regimen is: one 35 mg tablet orally, taken once-a-week

2.4Treatment and Prevention of Glucocorticoid-Induced Osteoporosis [see Indications and Usage (1.3)] The recommended regimen is: • one 5 mg tablet orally, taken daily

2.5Treatment of Paget's Disease [see Indications and Usage (1.4)] The recommended treatment regimen is 30 mg orally once daily for 2 months. Retreatment may be considered (following post-treatment observation of at least 2 months) if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase. For retreatment, the dose and duration of therapy are the same as for initial treatment.

No data are available on more than 1 course of retreatment.

2.6Important Administration Instructions Instruct patients to do the following: Take risedronate sodium tablets at least 30 minutes before the first food or drink of the day other than water, and before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, [ see Drug Interactions ( 7.1 ) ]. Avoid the use of water with supplements, including mineral water, because they may have a higher concentration of calcium. Swallow risedronate sodium tablets whole with a full glass of plain water (6 to 8 ounces).

Avoid lying down for 30 minutes after taking the medication [ see Warnings and Precautions ( 5.1 ) ]. Do not chew or suck the tablet because of a potential for oropharyngeal ulceration. Do not eat or drink anything except plain water, or take other medications for at least 30 minutes after taking risedronate sodium tablets.

2.7Recommendations for Calcium and Vitamin D Supplementation Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate; and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of risedronate sodium tablets.

2.8Administration Instructions for Missed Doses Instruct patients about missing risedronate sodium tablets doses as follows: • If a dose of risedronate sodium tablet 35 mg once-a-week is missed: ○ 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. ○ Do not take 2 tablets on the same day. • If one or both tablets of risedronate sodium 75 mg on two consecutive days per month are missed, and the next month’s scheduled doses are more than 7 days away: ○ If both tablets are missed, take one risedronate sodium 75 mg tablet in the morning after the day it is…

💊 Dosage Forms and Strengths 82 words ▾

3 DOSAGE FORMS & STRENGTHS • 5 mg yellow coloured, circular, biconvex, film coated tablet debossed with "CL 90" on one side and plain on other side. • 30 mg white to off white, circular, biconvex, film coated tablet debossed with "CL 91" on one side and plain on other side • 35 mg orange coloured, circular, biconvex, film coated tablet debossed with "CL 92" on one side and plain on the other side Tablets: 5, 30, 35 mg ( 3 )

⛔ Contraindications 152 words ▾

4 CONTRAINDICATIONS Risedronate sodium is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions ( 5.1 )] Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 )] Hypocalcemia [see Warnings and Precautions ( 5.2 )] Known hypersensitivity to risedronate sodium or any of its excipients. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported [see Adverse Reactions ( 6.2 )] • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia ( 4 , 5.1 ) • Inability to stand or sit upright for at least 30 minutes ( 4 , 5.1 ) • Hypocalcemia ( 4 , 5.3 ) • Known hypersensitivity to any component of this product ( 4 , 6.2 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Products Containing Same Active Ingredient: Patients receiving Atelvia should not be treated with risedronate sodium tablets ( 5.1 ) • Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur ( 5.2 ) • Hypocalcemia may worsen and must be corrected prior to use ( 5.3 ) • Osteonecrosis of the Jaw has been reported ( 5.4 ) • Severe Bone, Joint, Muscle Pain may occur.

Discontinue use if severe symptoms develop ( 5.5 , 6.2 ) • Atypical Fractures Including Femoral Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered ( 5.6 )

5.1Drug Products with the Same Active Ingredient Risedronate sodium tablet contains the same active ingredient found in Atelvia ® . A patient being treated with Atelvia should not receive risedronate sodium tablets.

5.2Upper Gastrointestinal Adverse Reactions Risedronate sodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when risedronate sodium is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers) [ see Contraindications ( 4 ), Adverse Reactions ( 6.1 ), Information for Patients ( 17.1 ) ].

Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue risedronate sodium and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6 to 8 ounces) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient [ see Dosage and Administration ( 2 ) ]. In patients who cannot comply with dosing instructions due to mental disability, therapy with risedronate sodium should be used under appropriate supervision.

There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.

5.3Mineral Metabolism Hypocalcemia has been reported in patients taking risedronate sodium. Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting risedronate sodium therapy. Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate.

Adequate intake of calcium and vitamin D is important in all patients, especially in patients with Paget’s disease in whom bone turnover is significantly elevated [ see Contraindications ( 4 ), Adverse Reactions ( 6.1 ), Information for Patients ( 17 ) ].

5.4Jaw Osteonecrosis Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including risedronate sodium. Known risk factors for…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are described elsewhere in the labeling: • Drug Products with the Same Active Ingredient [see Warnings and Precautions ( 5.1 )] • Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Mineral Metabolism [see Warnings and Precautions ( 5.3 )] • Jaw Osteonecrosis [see Warnings and Precautions ( 5.4 )] • Musculoskeletal Pain [see Warnings and Precautions ( 5.5 )] • Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.6 )] • Renal Impairment [see Warnings and Precautions ( 5.7 )] • Glucocorticoid-Induced Osteoporosis [see Warnings and Precautions ( 5.8 )] • Laboratory Test Interactions [see Warnings and Precautions ( 5.9 )] Most common adverse reactions reported in greater than 10% of patients treated with risedronate sodium tablets and with a higher frequency than placebo are: back pain,arthralgia, abdominal pain, and dyspepsia ( 6.1 ) Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210, or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Treatment of Postmenopausal Osteoporosis Daily Dosing The safety of risedronate sodium 5 mg once daily in the treatment of postmenopausal osteoporosis was assessed in four randomized, double-blind, placebo-controlled multinational trials of 3232 women aged 38 to 85 years with postmenopausal osteoporosis.

The duration of the trials was up to three years, with 1619 patients exposed to placebo and 1613 patients exposed to risedronate sodium 5 mg. Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors, and H 2 antagonists were included in these clinical trials. All women received 1000 mg of elemental calcium plus vitamin D supplementation up to 500 international units per day if their 25-hydroxyvitamin D 3 level was below normal at baseline.

The incidence of all-cause mortality was 2.0% in the placebo group and 1.7% in the risedronate sodium 5 mg daily group. The incidence of serious adverse events was 24.6% in the placebo group and 27.2% in the risedronate sodium 5 mg group. The percentage of patients who withdrew from the study due to adverse events was 15.6% in the placebo group and 14.8% in the risedronate sodium 5 mg group.

The most common adverse reactions reported in greater than 10 percent of subjects were: back pain, arthralgia, abdominal pain and dyspepsia. Table 1 lists adverse events from the Phase 3 postmenopausal osteoporosis trials reported in greater than or equal to 5% of patients. Adverse events are shown without attribution of causality.

Table 1 Adverse Events Occurring at a Frequency greater than or equal to 5% in Either Treatment Group Combined Phase 3 Postmenopausal Osteoporosis Treatment Trials Body System Placebo N = 1619 % 5 mg Risedronate Sodium N = 1613 % Body as a Whole Infection 29.9

31.1Back Pain 26.1

28.0Accidental Injury 16.8

16.9Pain 14.0

14.1Abdominal Pain 9.9

12.2Flu Syndrome 11.6

10.5Headache 10.8

9.9Asthenia 4.5

5.4Neck Pain 4.7

5.4Chest Pain 5.1

5.0Allergic Reaction 5.9

3.8Cardiovascular System Hypertension 9.8

10.5Digestive System Constipation 12.6

12.9Diarrhea 10.0

10.8Dyspepsia 10.6

10.8Nausea 11.2

10.5Metabolic & Nutritional Disorders Peripheral Edema 8.8

7.7Musculoskeletal System Arthralgia 22.1

23.7Arthritis 10.1

9.6Traumatic Bone Fracture 12.3

9.3Joint Disorder 5.3 7…

🔄 Drug Interactions ~1 min read ▾

7 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 (for example, Cytochrome P450). Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of risedronate sodium tablets ( 7.1 )

7.1Calcium Supplements/Antacids Co-administration of risedronate sodium and calcium, antacids, or oral medications containing divalent cations will interfere with the absorption of risedronate sodium.

7.2Hormone Replacement Therapy One study of about 500 early postmenopausal women has been conducted to date in which treatment with risedronate sodium 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, risedronate sodium may be used concomitantly with hormone replacement therapy.

7.3Aspirin/Nonsteroidal Anti-Inflammatory Drugs Of over 5700 patients enrolled in the risedronate sodium 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 risedronate sodium-treated patients (24.5%).

7.4H 2 Blockers and Proton Pump Inhibitors (PPIs) Of over 5700 patients enrolled in the risedronate sodium Phase 3 osteoporosis studies, 21% used H 2 blockers and/or PPIs. Among these patients, the incidence of upper gastrointestinal adverse experiences in the placebo-treated patients was similar to that in risedronate sodium-treated patients.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Discontinue when pregnancy is recognized ( 8.1 ) Risedronate sodium tablet is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min) ( 5.6 , 8.6 , 12.3 ) Risedronate sodium tablet is not indicated for use in pediatric patients ( 8.4 )

8.1Pregnancy Risk Summary Available data on the use of risedronate sodium tablets in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue risedronate sodium tablets when pregnancy is recognized. In animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommended human daily dose of 30 mg (based on body surface area, mg/m 2 ).

A low incidence of cleft palate was observed in fetuses of dams treated at doses approximately equal to the 30 mg human daily dose. Delayed skeletal ossification was observed in fetuses of dams treated at approximately 2.5 to 5 times the 30 mg human daily dose. Periparturient mortality due to maternal hypocalcemia occurred in dams and neonates upon daily oral administration of risedronate to pregnant rats during mating and/or gestation starting at doses equivalent to the 30 mg daily human dose.

Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone and available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate use. Consequently, based on the mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.

The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been studied. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 - 4% and 15 - 20%, respectively. Data Animal Data In animal studies, pregnant rats received risedronate sodium during organogenesis at doses equivalent to 1 to 26 times the 30 mg human daily dose (based on body surface area, mg/m2). Survival of neonates was decreased in dams treated during gestation with oral doses approximately 5 times the human dose, and body weight was decreased in neonates of dams treated with approximately 26 times the human dose.

A low incidence of cleft palate was observed in fetuses of dams treated with oral doses approximately equal to the human dose. The number of fetuses exhibiting incomplete ossification of sternebrae or skull of dams treated with approximately 2.5 times the human dose was significantly increased compared to controls. Both incomplete ossification and unossified sternebrae were increased in fetuses of dams treated with oral doses approximately 5 times the human dose.

No significant ossification effects were seen in fetuses of rabbits treated with oral doses approximately 7 times the human dose (the highest dose tested). However, 1 of 14 litters were aborted and 1 of 14 litters were delivered prematurely. Periparturient mortality due to maternal hypocalcemia occurred in dams and neonates when pregnant rats were treated daily during mating and/or gestation with oral doses equivalent to the human dose or higher.

8.2Lactation Risk Summary There are no data on the presence of risedronate in human milk, the effects on the breastfed infant, or the effects on milk produ…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data on the use of risedronate sodium tablets in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue risedronate sodium tablets when pregnancy is recognized. In animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommended human daily dose of 30 mg (based on body surface area, mg/m 2 ).

A low incidence of cleft palate was observed in fetuses of dams treated at doses approximately equal to the 30 mg human daily dose. Delayed skeletal ossification was observed in fetuses of dams treated at approximately 2.5 to 5 times the 30 mg human daily dose. Periparturient mortality due to maternal hypocalcemia occurred in dams and neonates upon daily oral administration of risedronate to pregnant rats during mating and/or gestation starting at doses equivalent to the 30 mg daily human dose.

Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone and available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate use. Consequently, based on the mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.

The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been studied. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 - 4% and 15 - 20%, respectively. Data Animal Data In animal studies, pregnant rats received risedronate sodium during organogenesis at doses equivalent to 1 to 26 times the 30 mg human daily dose (based on body surface area, mg/m2). Survival of neonates was decreased in dams treated during gestation with oral doses approximately 5 times the human dose, and body weight was decreased in neonates of dams treated with approximately 26 times the human dose.

A low incidence of cleft palate was observed in fetuses of dams treated with oral doses approximately equal to the human dose. The number of fetuses exhibiting incomplete ossification of sternebrae or skull of dams treated with approximately 2.5 times the human dose was significantly increased compared to controls. Both incomplete ossification and unossified sternebrae were increased in fetuses of dams treated with oral doses approximately 5 times the human dose.

No significant ossification effects were seen in fetuses of rabbits treated with oral doses approximately 7 times the human dose (the highest dose tested). However, 1 of 14 litters were aborted and 1 of 14 litters were delivered prematurely. Periparturient mortality due to maternal hypocalcemia occurred in dams and neonates when pregnant rats were treated daily during mating and/or gestation with oral doses equivalent to the human dose or higher.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Risedronate sodium is not indicated for use in pediatric patients. The safety and effectiveness of risedronate was assessed in a one-year, randomized, double-blind, placebo-controlled study of 143 pediatric patients (94 received risedronate) with osteogenesis imperfecta (OI). The enrolled population was predominantly patients with mild osteogenesis imperfecta (85% Type-I), aged 4 to less than 16 years, 50% male and 82% Caucasian, with a mean lumbar spine BMD Z-score of -2.08 (2.08 standard deviations below the mean for age-matched controls).

Patients received either a 2.5 mg (less than or equal to 30 kg body weight) or 5 mg (greater than 30 kg body weight) daily oral dose. After one year, an increase in lumbar spine BMD in the risedronate group compared to the placebo group was observed. However, treatment with risedronate did not result in a reduction in the risk of fracture in pediatric patients with osteogenesis imperfecta.

In risedronate sodium-treated subjects, no mineralization defects were noted in paired bone biopsy specimens obtained at baseline and month 12. The overall safety profile of risedronate in OI patients treated for up to 12 months was generally similar to that of adults with osteoporosis. However, there was an increased incidence of vomiting compared to placebo.

In this study, vomiting was observed in 15% of children treated with risedronate and 6% of patients treated with placebo. Other adverse events reported in greater than or equal to 10% of patients treated with risedronate and with a higher frequency than placebo were: pain in the extremity (21% with risedronate versus 16% with placebo), headache (20% versus 8%), back pain (17% versus 10%), pain (15% versus 10%), upper abdominal pain (11% versus 8%), and bone pain (10% versus 4%).

🧓 Geriatric Use 150 words ▾

8.5Geriatric Use Of the patients receiving risedronate sodium in postmenopausal osteoporosis studies [see Clinical Studies ( 14 )] , 47% were between 65 and 75 years of age, and 17% were over 75. The corresponding proportions were 26% and 11% in glucocorticoid-induced osteoporosis trials, and 40% and 26% in Paget’s disease trials. No overall differences in efficacy between geriatric and younger patients were observed in these studies.

In the male osteoporosis trial, 28% of patients receiving risedronate sodium were between 65 and 75 years of age and 9% were over 75. The lumbar spine BMD response for risedronate sodium compared to placebo was 5.6% for subjects less than 65 years and 2.9% for subjects greater than or equal to 65 years. No overall differences in safety between geriatric and younger patients were observed in the risedronate sodium trials, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 147 words ▾

10 OVERDOSAGE Decreases in serum calcium and phosphorus following substantial overdose may be expected in some patients. Signs and symptoms of hypocalcemia may also occur in some of these patients. Milk or antacids containing calcium should be given to bind risedronate sodium and reduce absorption of the drug.

In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed drug. Standard procedures that are effective for treating hypocalcemia, including the administration of calcium intravenously, would be expected to restore physiologic amounts of ionized calcium and to relieve signs and symptoms of hypocalcemia. Lethality after single oral doses was seen in female rats at 903 mg/kg and male rats at 1703 mg/kg.

The minimum lethal dose in mice and rabbits was 4000 mg/kg and 1000 mg/kg, respectively. These values represent 320 to 620 times the 30 mg human dose based on surface area (mg/m 2 ).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Risedronate sodium has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, risedronate sodium 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 risedronate sodium treatment reduces bone turnover (activation frequency, that is, the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites.

12.2Pharmacodynamics Risedronate sodium treatment decreases the elevated rate of bone turnover that is typically seen in postmenopausal osteoporosis. In clinical trials, administration of risedronate sodium 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 risedronate sodium for the treatment of osteoporosis in postmenopausal women, risedronate sodium 5 mg daily and risedronate sodium 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 risedronate sodium 5 mg daily and risedronate sodium 35 mg once-a-week groups, respectively. When postmenopausal women with osteoporosis were treated for 1 year with risedronate sodium 5 mg daily or risedronate sodium 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.

Osteoporosis in Men In a 2-year study of men with osteoporosis, treatment with risedronate sodium 35 mg once-a-week resulted in a mean decrease from baseline compared to placebo of 16% (placebo 20%; risedronate sodium 35 mg 37%) for the bone resorption marker urinary collagen cross-linked N-telopeptide, 45% (placebo-6%; risedronate sodium 35 mg 39%) for the bone resorption marker serum C-telopeptide, and 27% (placebo -2%; risedronate sodium 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. Risedronate sodium decreases bone resorption without directly inhibiting bone formation. In two 1-year clinical trials in the treatment and prevention of glucocorticoid-induced osteoporosis, risedronate sodium 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 remodelin…

🧬 Mechanism of Action 82 words ▾

12.1Mechanism of Action Risedronate sodium has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, risedronate sodium 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 risedronate sodium treatment reduces bone turnover (activation frequency, that is, the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites.

📦 How Supplied / Storage and Handling 152 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Risedronate sodium tablets, USP are available as follows: 5 mg yellow coloured, circular, biconvex, film-coated tablet debossed with "CL 90" on one side and plain on other side. NDC 33342-107-07 bottle of 30 NDC 33342-107-49 bottle of 2000 NDC 33342-107-06 Unit dose tablets pack of 30 (3 x 10) 30 mg white to off white, circular, biconvex, film-coated tablet debossed with "CL 91" on one side and plain on other side. NDC 33342-108-07 bottle of 30 NDC 33342-108-15 bottle of 500 NDC 33342-108-06 Unit dose tablets pack of 30 (3 x 10) 35 mg orange coloured, circular, biconvex, film-coated tablet debossed with "CL 92" on one side and plain on the other side.

NDC 33342-109-37 dose pack of 4 NDC 33342-109-50 dose pack of 12 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

📋 Description 171 words ▾

11 DESCRIPTION Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablets, USP for oral administration contains the equivalent of 5, 30 and 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The molecular formula for risedronate sodium hemi-pentahydrate is C 7 H 10 NO 7 P 2 Na •2.5 H 2 O.

The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following: Molecular Weight: Anhydrous: 305.10 Hemi-pentahydrate: 350.13 Risedronate sodium anhydrous is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents.

Inactive Ingredients All dose strengths contain: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. Dose strength-specific ingredients include: 5 mg-ferric oxide yellow, lactose anhydrous; 30 mg- lactose anhydrous; 35 mg-ferric oxide red, ferric oxide yellow, lactose anhydrous. srtuct

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide) Instruct patients to read the Medication Guide before starting therapy with risedronate sodium and to re-read it each time the prescription is renewed. Instruct patients that Atelvia and risedronate sodium contain the same active ingredient and if they are taking Atelvia, they should not take risedronate sodium [ 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, risedronate sodium should be taken at least 30 minutes before the first food or drink of the day other than water. Instruct patients to take risedronate sodium 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 risedronate sodium. Instruct patients about missing risedronate sodium doses as follows: • If a dose of risedronate sodium 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 risedronate sodium 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 risedronate sodium 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 risedronate sodium 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 risedronate sodium 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 risedronate sodium 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 risedronate sodium 75 mg on two consecutive days per 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 risedronate sodium as these medicatiosn may interfere with the absorption of risedronate sodium. 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 risedronate sodium. Patients should be instructed that any time they have a medical problem they think may be from risedronate sodium, they should talk to their doctor. Manufactured for : Macleods Pharma USA, Inc.

Princeton, NJ 08540 Manufactured by : Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, 174101, INDIA Medication Guide available at: www.macleodspharma.com/usa All other trademarks are the properties of their respective…

💬 Medication Guide ~3 min read ▾

SPL MEDGUIDE SECTION Risedronate Sodium tablets, USP (RIS-e-DROE-nate SOE-dee-um) Read the Medication Guide that comes with risedronate sodium tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

Talk to your doctor if you have any questions about risedronate sodium tablets, there may be new information about it. What is the most important information I should know about risedronate sodium tablets? Risedronate sodium tablets can cause serious side effects including: 1.

Esophagus problems 2. Low calcium levels in your blood (hypocalcemia) 3. Severe jaw bone problems (osteonecrosis) 4.

Bone, joint, or muscle pain 5. Unusual breaks in thigh and other bones. 1.

Esophagus problems. Some people who take risedronate sodium tablets may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed. • It is important that you take risedronate sodium tablets exactly as prescribed to help lower your chance of getting esophagus problems.

(See the section “How should I take risedronate sodium tablets?”) • Stop taking risedronate sodium tablets and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow. 2. Low calcium levels in your blood (hypocalcemia).

Risedronate sodium tablets may lower the calcium levels in your blood. If you have low blood calcium before you start taking Risedronate sodium tablets, it may get worse during treatment. Your low blood calcium must be treated before you take risedronate sodium tablets.

Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as: • Spasms, twitches, or cramps in your muscles • Numbness or tingling in your fingers, toes, or around your mouth Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take risedronate sodium tablets. Take calcium and vitamin D as your doctor tells you to.

3. Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take risedronate sodium tablets.

Your doctor should examine your mouth before you start risedronate sodium tablets. Your doctor may tell you to see your dentist before you start risedronate sodium tablets. It is important for you to practice good mouth care during treatment with risedronate sodium tablets.

4. Bone, joint, or muscle pain. Some people who take risedronate sodium tablets develop severe bone, joint, or muscle pain.

5. Unusual breaks in thigh and other bones. Some people have had unusual bone breaks, including the thigh bone, when taking risedronate sodium tablets.

A break in the thigh bone can feel like a new pain in your hip, groin, or thigh. People taking risedronate sodium tablets can also have breaks in other bones. Call your doctor right away if you have any of these side effects.

What are risedronate sodium tablets? Risedronate sodium tablets is a prescription medicine used to: • Treat or prevent osteoporosis in women after menopause. Risedronate sodium tablet helps increase bone mass and helps reduce the chance of having a spinal or non-spinal fracture (break). • Increase bone mass in men with osteoporosis. • Treat or prevent osteoporosis in either men or women who are taking corticosteroid medicines. • Treat certain men and women who have Paget’s disease of the bone.

It is not known how long risedronate sodium tablets works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if risedronate sodium tablets are still right for you. Risedronate sodium tablets are not for use in children.

Who should not take risedronate sodium tablets? Do not tak…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 33342-0106-07 · Macleods 33342-0108-06 · Macleods →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.