Risedronate Sodium (Risedronate Sodium)

Trade Name : Risedronate Sodium

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 150 mg/1

RISEDRONATE SODIUM MONOHYDRATE Bisphosphonate [EPC],Diphosphonates [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Risedronate Sodium (Risedronate Sodium) which is also known as Risedronate Sodium and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 150 mg/1 per ml. Read more

Risedronate Sodium (Risedronate Sodium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Risedronate sodium tablets are a bisphosphonate indicated for:
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. ()

Treatment and prevention of postmenopausal osteoporosis ()
Treatment to increase bone mass in men with osteoporosis ()
Treatment and prevention of glucocorticoid-induced osteoporosis ()
Treatment of Pagetu2019s disease ()

Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week, 75 mg two consecutive days each month, 150 mg once-a-month ()Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week ()Men with Osteoporosis: 35 mg once-a-week ()Glucocorticoid-Induced Osteoporosis: 5 mg daily ()Pagetu2019s Disease: 30 mg daily for 2 months ()
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 ()
Take supplemental calcium and vitamin D if dietary intake is inadequate ()

Tablets: 150 mg ()

Risedronate sodium is contraindicated in patients with the following conditions:

Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (, )
Inability to stand or sit upright for at least 30 minutes (, )
Hypocalcemia (, )
Known hypersensitivity to any component of this product (, )

No data

Products Containing Same Active Ingredient:
Upper Gastrointestinal Adverse Reactions
Hypocalcemia
Osteonecrosis of the Jaw
Severe Bone, Joint, Muscle Pain
Atypical Femur Fractures

Most common adverse reactions reported in greater than 10% of patients treated with risedronate and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia ()
Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely ()
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 ()

No data

Pregnancy: Discontinue when pregnancy is recognized )
Risedronate is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min) (, , )
Risedronate is not indicated for use in pediatric patients ()

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 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).

Risedronate Sodium Tablets USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Risedronate Sodium Tablet USP for oral administration contains the equivalent of 150 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following:
CHNOPNau2022HOu00a0 u00a0 M.W. Monohydrate: 323.10u00a0u00a0u00a0u00a0 Anhydrous: 305.10
Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents.
Inactive Ingredients
Colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinized corn starch, sodium stearyl fumarate, talc and titanium dioxide.

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Risedronate Sodium Tablets USP are available as:
150 mg: white, film-coated, convex, round, unscored tablets, debossed with u201c93u201d on one side of the tablet and u201c7771u201d on the other side, in blister packages of 1 x 1 card in a carton (NDC 0093-7771-79) and 1 x 3 cards in a carton (NDC 0093-7771-13).
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].

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 Atelviau00a0and risedronate sodium tablets contain the same active ingredient and if they are taking Atelvia, they should not take risedronate sodium tablets [].
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 [].
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.
Instruct patients about missing risedronate sodium tablets doses as follows:
Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate []. 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.
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. Patients should be instructed that any time they have a medical problem they think may be from risedronate, they should talk to their doctor.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
Distributed By:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. D 1/2020

Risedronate Sodium (ris ed' roe nate soe' dee um)
Tablets
Read the Medication Guide that comes with risedronate sodium tablets before you start taking them 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.
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.
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:
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 thigh bone fractures.
Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.
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:
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:
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:
Especially tell your doctor if you take:
Tell your doctor about all the medicines you take,
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?
After swallowing risedronate sodium tablet, wait at least 30 minutes:
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, 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:
The most common side effects of risedronate sodium tablets are:
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?
Safely throw away medicine that is out of date or no longer needed.
Keep risedronate sodium tablets and all medicines out of the reach of children.
General information about the safe and effective use of risedronate sodium tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use risedronate sodium tablets for a condition for which they were not prescribed. Do not give risedronate sodium tablets to other people, even if they have the same symptoms you have. They may harm them.
This Medication Guide summarizes the most important information about risedronate sodium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about risedronate sodium tablets that is written for health professionals. For more information, call 1-888-838-2872.
What are the ingredients in risedronate sodium tablets?
Active ingredient: risedronate sodium
Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinized corn starch, sodium stearyl fumarate, talc and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed By:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. D 1/2020

NDCu00a0n- -7771-n- 1 Tablet
Once-a-Monthn- Risedronate Sodium Tablets USPn- 150 mg
PHARMACIST: Dispense the enclosed Medication Guide to each patient.Each film-coated tablet contains the equivalent of 150 mg of anhydrousrisedronate sodium, USP in the form of the monohydrate.
Usual Dosage:
Rx only
1 Month Pack (1 Tablet)
TEVA

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Risedronate Sodium (Risedronate Sodium)

Trade Name : Risedronate Sodium

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Risedronate Sodium (Risedronate Sodium)

Trade Name : Risedronate Sodium

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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