Risedronate Sodium (Risedronate Sodium)

Trade Name : risedronate sodium

Actavis Pharma, Inc.

TABLET, FILM COATED

Strength 12921 mg/1mg/1

RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE Bisphosphonate [EPC],Diphosphonates [CS],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 Actavis Pharma, Inc.. It is available in strength of 129; 21 mg/1; 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Risedronate sodium tabletsu00a0is a bisphosphonate indicated for:
  • Limitations of UseOptimal 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 () nn
  • Treatment to increase bone mass in men with osteoporosis () nn
  • Treatment and prevention of glucocorticoid-induced osteoporosis () nn
  • 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 daynn
  • Avoid lying down for 30 minutes ()nn
  • Take supplemental calcium and vitamin D if dietary intake is inadequate ()
  • Tablets: 5, 30, 35, 75, and 150 mg
  • u200bu200bu200bu200bu200bu200bu200bu200bu200bu200bRisedronate sodium tablets is contraindicated in patients with the following conditions:
  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (, )nn
  • Inability to stand or sit upright for at least 30 minutes (, )nn
  • Hypocalcemia (, )nn
  • Known hypersensitivity to any component of this product (, )
  • No data
  • Products Containing Same Active Ingredient
  • Upper Gastrointestinal Adverse Reactions
  • Hypocalcemia
  • Osteonecrosis
  • Severe Bone, Joint, Muscle Pain
  • Atypical Femur Fractures
  • 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 ()Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely ()
  • 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 ()
  • Risedronate sodium tabletsu00a0is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min) (, , )Risedronate sodium tablets 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 sodiumu00a0tablets 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/m2).
  • Risedronate sodium tabletsu00a0(risedronate sodium)u00a0is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is CHNOPNa u20222.5 HO. 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:
  • Inactive Ingredientsn
  • No data
  • No data
  • No data
  • Risedronate sodium tablets is available as follows:
  • 5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0591-2102-30 bottle of 30
  • 30 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0591-2109-30 bottle of 30
  • 35 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0591-2075-04 dose pack of 4NDC 0591-2075-39 dose pack of 12
  • 75 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0591-2067-02 dose pack of 2
  • 150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0591-2044-54 dose pack of 1NDC 0591-2044-03 dose pack of 3
  • Store at controlled room temperature 20u00b0 to 25u00b0 C (68u00b0 to 77u00b0 F) [see USP].
  • 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 Atelvia and risedronate sodium tablets contain the same active ingredient and if they are taking Atelvia, they should not take risedronate sodium tabletsu00a0[].
  • 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 lie down for 30 minutes after taking the medication [n u200b].
  • Instruct patients not 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:
  • Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [n u200b]. 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.u00a0Patients 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.
  • Content updated:u00a0October 2014
  • Medication GuideRisedronate Sodium Tablets(ris-ed-ro-nate so-di-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 sodiumu00a0tablets 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).
  • 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).n
  • 4. Bone, joint, or muscle pain.n
  • 5. Unusual thigh bone fractures. n
  • Call your doctor right away if you have any of these side n- effects.
  • What is risedronate sodium tablets?n
  • 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 is still right for you.
  • Risedronate sodium tablets is not for use in children.
  • Who should not take risedronate sodium tablets?n n- Do not take risedronate sodium tablets if you:
  • Arrayn- odium 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 tablets, 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 much 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 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 n- 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 it was not prescribed. Do not give risedronate sodium tablets to other people, even if they have the same symptoms you have. It 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 1-800-272-5525
  • What are the ingredients in risedronate sodium tablets?
  • Active ingredient: risedronate sodium
  • Inactive ingredients in all dose strengths: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide.
  • Inactive ingredients specific to a dose strength: 5 mgu2014ferric oxide yellow, lactose monohydrate; 30 mgu2014lactose monohydrate; 35 mgu2014ferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mgu2014ferric oxide red; 150 mgu2014FD&C blue #2 aluminum lake.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured By:Norwich Pharmaceuticals, Inc.,North Norwich, NY 13814
  • For all medical inquiries contact: ACTAVIS Medical CommunicationsParsippany NJ 070541-800-272-5525
  • Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • Content Updated:u00a0October 2014
  • Risedronate Sodium Tablets 5 mgBottle label x 30 tabletsNDC 0591-2102-30
  • Risedronate Sodium TabletsBottle label x 30 tabletsNDC 0591-2109-30
  • Risedronate Sodium Tablets35 mg x 4 week supplyNDC 0591-2075-04
  • Risedronate Sodium Tablets35 mg xu00a012 week supplyNDC 0591-2075-39
  • u00a0Risedronate Sodium Tablets150 mg x 1 month packNDC 0591-2044-54
  • Risedonate Sodium Tablets150 mg xu00a03 month packNDC 0591-2044-03

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