Complete SPL Sections
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
5 mg film-coated, round, yellow tablets debossed ‘5’ on one side and ‘S’ on other side. 30 mg film-coated, round, white tablets debossed ‘667’ on one side and ‘S’ on other side. 35 mg film-coated, round, brown tablets debossed ‘668’ on one side and ‘S’ on other side. 75 mg film-coated, round, pink tablets debossed ‘727’ on one side and ‘S’ on other side. 150 mg film-coated, round, blue tablets debossed ‘928’ on one side and ‘S’ on other side.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Risedronate sodium tablets are 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 tablets 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)]
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
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).
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
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 1,703 mg/kg. The minimum lethal dose in mice and rabbits was 4,000 mg/kg and 1,000 mg/kg, respectively. These values represent 320 to 620 times the 30 mg human dose based on surface area (mg/m 2 ).
11 DESCRIPTION
DESCRIPTION SECTION
Risedronate sodium tablets are pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5 mg, 30 mg, 35 mg, 75 mg, or 150 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate. The molecular formula for risedronate sodium hemi-pentahydrate, USP 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: Risedronate sodium 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: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized maize starch, talc, titanium dioxide. Dose strength-specific ingredients include: 5 mg—iron oxide yellow; 35 mg— iron oxide red, iron oxide yellow; 75 mg— iron oxide red; 150 mg—FD&C blue #2 aluminum lake. For 75 mg and 150 mg strengths - FDA approved dissolution test specifications differ from USP.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Risedronate sodium tablets, USP are available as follows: 5 mg film-coated, round, yellow tablets debossed ‘5’ on one side and ‘S’ on other side. Bottles of 30 with Child-resistant cap, NDC 47335-666-83 Bottles of 100 with Child-resistant cap, NDC 47335-666-88 Bottles of 100, NDC 47335-666-08 Bottles of 1000, NDC 47335-666-18 30 mg film-coated, round, white tablets debossed ‘667’ on one side and ‘S’ on other side. Bottles of 30 with Child-resistant cap, NDC 47335-667-83 Bottles of 100 with Child-resistant cap, NDC 47335-667-88 Bottles of 100, NDC 47335-667-08 Bottles of 1000, NDC 47335-667-18 35 mg film-coated, round, brown tablets debossed ‘668’ on one side and ‘S’ on other side. Unit-dose blister package of 4……………………..… NDC 47335-668-68 Unit-dose blister package of 12……………………… NDC 47335-668-62 75 mg film-coated, round, pink tablets debossed ‘727’ on one side and ‘S’ on other side. Unit-dose blister package of 2…………………..…… NDC 47335-727-98 150 mg film-coated, round, blue tablets debossed ‘928’ on one side and ‘S’ on other side. Unit-dose blister package of 1..……………………… NDC 47335-928-60 Unit-dose blister package of 3..……………………… NDC 47335-928-67 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers as defined in USP.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
See FDA-approved patient labeling (Medication Guide) Instruct patients to read the Medication Guide before starting therapy with risedronate sodium tablets and to re-read it each time the prescription is renewed. Instruct patients that risedronate sodium delayed-release tablets and risedronate sodium tablets contain the same active ingredient and if they are taking risedronate sodium delayed-release tablets, they should not take risedronate sodium tablets [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 tablets 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 tablets 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 tablets. Instruct patients about missing risedronate sodium tablets doses as follows: If a dose of risedronate sodium tablet 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 tablet 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 tablets 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 tablet 75 mg on two consecutive days per month as originally scheduled. If the dose of risedronate sodium tablet 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 risedronate sodium tablets 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 risedronate sodium tablet 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 risedronate sodium tablet 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 risedronate sodium tablets as these medications may interfere with the absorption of risedronate sodium tablets. 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 tablets. Patients should be instructed that any time they have a medical problem they think may be from risedronate sodium tablets, they should talk to their doctor. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India. 5269850 Revised: 02/2026
Medication Guide
SPL MEDGUIDE SECTION
Risedronate Sodium (RIS-e-DROE-nate SOE-dee-um) Tablets, USP 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 : Esophagus problems Low calcium levels in your blood (hypocalcemia) Severe jaw bone problems (osteonecrosis) Bone, joint, or muscle pain 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 are a prescription medicine used to: Treat or prevent osteoporosis in women after menopause. Risedronate sodium tablets help increase bone mass and help 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 work 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 take risedronate sodium tablets if you: Have certain problems with your esophagus, the tube that connects your mouth with your stomach Cannot stand or sit upright for at least 30 minutes Have low levels of calcium in your blood Are allergic to risedronate sodium tablets or any of its ingredients. A list of ingredients is at the end of this leaflet. What should I tell my doctor before taking risedronate sodium tablets? Before you start risedronate sodium tablets, be sure to talk to your doctor if you: Have problems with swallowing Have stomach or digestive problems Have low blood calcium Plan to have dental surgery or teeth removed Have kidney problems Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome) Are pregnant, plan to become pregnant, or suspect that you are pregnant. If you become pregnant while taking risedronate sodium tablets, stop taking it and contact your doctor. It is not known if risedronate sodium tablets can harm your unborn baby. Are breastfeeding or plan to breastfeed. It is not known if risedronate sodium passes into your milk and may harm your baby. Especially tell your doctor if you take: antacids aspirin Nonsteroidal Anti-Inflammatory (NSAID) medicines Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Certain medicines may affect how risedronate sodium tablets work. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine. How should I take risedronate sodium tablets? Take risedronate sodium tablets exactly as your doctor tells you. Your doctor may change your dose of risedronate sodium tablets if needed. Risedronate sodium tablets work only if taken on an empty stomach. Take 1 risedronate sodium tablet, after you get up for the day and before taking your first food, drink, or other medicine. Take risedronate sodium tablet while you are sitting or standing. Do not chew or suck on a tablet of risedronate sodium. Swallow risedronate sodium tablet with a full glass (6 to 8 ounces) of plain water only. Do not take risedronate sodium tablet with mineral water, coffee, tea, soda, or juice. After swallowing risedronate sodium tablet, wait at least 30 minutes: Before you lie down. You may sit, stand or walk, and do normal activities like reading. Before you take your first food or drink except for plain water. Before you take other medicines, including antacids, calcium, and other supplements and vitamins. Do not lie down for at least 30 minutes after you take risedronate sodium tablets and after you eat your first food of the day. If you miss a dose of risedronate sodium tablets, 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 risedronate sodium tablets in a month, call your doctor for instructions. If you take too many risedronate sodium tablets, call your doctor. Do not try to vomit. Do not lie down. What are the possible side effects of risedronate sodium tablets? Risedronate sodium tablets may cause serious side effects : See “What is the most important information I should know about risedronate sodium tablets?” The most common side effects of risedronate sodium tablets are: pain, including back and joint pain stomach area (abdominal) pain heartburn You may get allergic reactions, such as hives, swelling of your face, lips, tongue, or throat. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of risedronate sodium tablets. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088. How should I store risedronate sodium tablets? Store risedronate sodium tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° an...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-666-83 Risedronate Sodium Tablets, USP 5 mg Rx only 30 Tablets Sun Pharma PHARMACIST: Dispense with Medication Guide to each patient.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-667-83 Risedronate Sodium Tablets, USP 30 mg Rx only 30 Tablets Sun Pharma PHARMACIST: Dispense with Medication Guide to each patient.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-668-68 Once-a-Week Risedronate Sodium Tablets, USP 35 mg 4 Week Supply 4 Tablets Rx only Sun Pharma PHARMACIST: Dispense with Medication Guide to each patient.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-727-98 Two Consecutive Days-a-Month Risedronate Sodium Tablets, USP 75 mg Rx only One Month Pack 2 Tablets Sun Pharma PHARMACIST: Dispense with Medication Guide to each patient.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-928-60 Once-a-Month Risedronate Sodium Tablet, USP 150 mg Rx only One Month Pack 1 Tablet Sun Pharma PHARMACIST: Dispense with Medication Guide to each patient.