Risedronate Sodium (Atelvia)

Trade Name : Atelvia

Allergan, Inc.

TABLET, DELAYED RELEASE

Strength 30.14.9 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 (Atelvia) which is also known as Atelvia and Manufactured by Allergan, Inc.. It is available in strength of 30.1; 4.9 mg/1; mg/1 per ml. Read more

Risedronate Sodium (Atelvia) 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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  • Atelvia is a bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis ()
  • Limitations ofu00a0Use
  • 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 ()
  • One 35u00a0mg delayed-release tablet once-a-week ()
  • Instruct patients to:
  • Take Atelviau00a0in the morning immediately u00a0with at least 4 ounces of plain water ()u00a0n
  • Avoid lying down for 30 minutes after taking Atelviau00a0()n
  • Take supplemental calcium and vitamin D if dietary intake is inadequate ()
  • Delayed-release tablets: 35u00a0mg, yellow, oval-shaped, and engraved with EC 35 on one side.
  • Delayed-release tablets: 35u00a0mg ()
  • Atelvia is contraindicated in patients with the following conditions:
  • u2022 Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia n n u00a0
  • u2022 Inability to stand or sit upright for at least 30 minutes n n n n n
  • u2022 Hypocalcemia n n n
  • u2022 Known hypersensitivity to any component of this product. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis , have been reported [see ]
  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (, ) n
  • Inability to stand or sit upright for at least 30 minutes (, )n
  • Hypocalcemia (, )n
  • Known hypersensitivity to any component of this product (, )
  • No data
  • Products Containing Same Active Ingredient
  • Upper Gastrointestinal Adverse Reactions
  • Hypocalcemia
  • Osteonecrosis of the n- Jn- aw
  • Severe n- Bn- one, n- Jn- oint, n- Mn- uscle n- Pn- ainn- u00a0
  • 5.5n- 6.2
  • Atypical n- Fn- emur n- Fn- ractures
  • Most common adverse reactions (greater than 5%)u00a0include: diarrhea, influenza, arthralgia, back pain, and abdominal pain ()
  • Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely ()
  • Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450).
  • Calcium supplements, antacids,u00a0proton pump inhibitors (PPIs), H blockers, magnesium-based supplements or laxatives, and iron preparations interfere with the absorption of Atelviau00a0(, )
  • Atelviau00a0is not recommended for use in patients with severe renal impairment (creatinine clearance less thanu00a030 mL/min) (, , )u00a0
  • Atelviau00a0is 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. While milk or antacids containing calcium may be given to bind risedronate sodiumu00a0immediate- releaseu00a0and reduce absorption of the drug, the impact of this intervention for Atelviau00a0delayed-release tablets has not been evaluated.
  • 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.u00a0
  • Lethality after single oral doses of risedronate was seen in female rats at 903u00a0mg/kg and male rats at 1703u00a0mg/kg. The minimum lethal dose in mice and rabbits was 4000u00a0mg/kg and 1000u00a0mg/kg, respectively. These values represent 320 to 620 times the human Pagetu2019s diseaseu00a0dose of 30 mg/day based on surface area (mg/m).u00a0
  • Atelviau00a0(risedronate sodium) delayed-release tablets contain a pH-sensitive enteric coatingu00a0and a chelating agent (EDTA).
  • Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Atelviau00a0tablet for oral administration contains the equivalent of 35u00a0mg 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:
  • nttu00a0u00a0u00a0u00a0u00a0ntMolecular Weight:
  • nttu00a0u00a0u00a0u00a0u00a0ntAnhydrous:nttu00a0u00a0u00a0u00a0u00a0nt305.10
  • nttu00a0u00a0u00a0u00a0u00a0ntHemi-pentahydrate:nttu00a0u00a0u00a0u00a0u00a0nt350.13
  • 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
  • Edetate disodium, ferric oxide yellow, magnesium stearate, methacrylic acid copolymer, polysorbate 80, silicified microcrystalline cellulose (ProSolv SMCC90), simethicone, sodium starch glycolate, stearic acid, talc, and triethyl citrate.
  • No data
  • No data
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  • Atelvia (risedronate sodium)u00a0delayed-release tablets are:
  • 35u00a0mg,u00a0yellow, oval-shaped, and engraved with EC 35 on oneu00a0side.
  • NDC 0430-0979-03nttu00a0u00a0u00a0u00a0u00a0ntDosepak of 4 tablets
  • Store at controlled room temperature 20u00b0 to 25u00b0u00a0C (68u00b0 to 77u00b0u00a0F) [see USP].
  • See FDA-approved patient labeling ()
  • Instruct patients to read the Medication Guide before starting therapy with Atelviau00a0and to re-read it each time the prescription is renewed.
  • Instruct patients that Atelviau00a0and Actonelu00a0contain the same active ingredient and if they are taking Actonel, they should not take Atelviau00a0[u00a0].
  • Instruct patientsu00a0to pay particular attention to the dosing instructions as clinical benefits may be compromised by failure to take the drug according to instructions.
  • Instruct patients to take Atelviau00a0in the morning, while in an upright position (sitting or standing) with at least 4 ounces of plain water immediately following breakfast. Atelviau00a0should not be taken before breakfast.u00a0
  • Instruct patients to swallow Atelviau00a0tablets whole. Patients should not chew, cut, or crush the tablet because of a potential for oropharyngeal irritation, and because the tablet coating is an important part of the delayed-release formulation.u00a0Patients should not lie down for 30 minutes after taking the medication.u00a0
  • 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 Atelviau00a0[u00a0].
  • If a dose of Atelviau00a035u00a0mg once-a-week is missed, instruct the patient to take one tablet on the morning after they remember and return to taking one tablet once-a-week, as originally scheduled on their chosen day. Patients should not take 2 tablets on the same day.
  • Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [u00a0].u00a0
  • Instruct patients to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day because they interfere with the absorption of Atelvia.u00a0
  • 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 Atelvia. Patients should be instructed that any time they have a medical problem they think may be from Atelviau00a0they should talk to their doctor.
  • Distributed by: Allergan USA, Inc.Irvine CA, 92612
  • For all medical inquiries contact:Allergan Medical Communications1-800-678-1605
  • u00a9 2018 Allergan. All rights reserved.ATELVIAu00ae is a registered trademark ofAllergan Pharmaceuticals International Limited.Allerganu00ae and its design are trademarks of Allergan, Inc.
  • Content Updated: March 2015
  • 73166US11
  • Medication Guiden- Atelvian- Arrayn- (uh-TEL-v-uh) n- (risedronate sodium) n- dn- elayedn- -n- release tablets
  • Read this Medication Guide that comes with Atelviau00a0before you start takingu00a0it 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 Atelvia, there may be new information about it.u00a0
  • What is the most important information I should know about n- Atelvian- ?
  • Atelvian- can cause serious side effects including
  • 1. Esophagus problems.
  • Some people who take n- Atelvian- 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).
  • Atelviau00a0may lower the calcium levels in your blood. If you have low blood calcium before you start taking Atelvia, it may get worse during treatment. Your low blood calcium must be treated before you take Atelvia. 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 are taking Atelvia. 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 Atelvia. Your doctor should examine your mouth before you start Atelvia. Your doctor may tell you to see your dentist before you start Atelvia. It is important for you to practice good mouth care during treatment with Atelvia.
  • 4. Bone, joint, or muscle pain.
  • Some people who take Atelviau00a0develop 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 is n- Atelvian- ?
  • Atelviau00a0is a prescription medicine used to treat osteoporosis in women after menopause.
  • It is not known how long Atelviau00a0works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if Atelviau00a0is still right for you.
  • Atelviau00a0is not for use in children.
  • Who should not take n- Atelvian- ?
  • Do not take n- Atelvian- if youn- :
  • What should I tell my healthcare provider before taking n- Atelvian- ?
  • Before you take n- Atelvian- , tn- ell your n- healthcare provider n- ifn- youn- :
  • Tell your doctor n- about all the medicines you take,
  • Especially tell your doctor if you take
  • Ask your doctor or pharmacist for a list of these medications, if you are not sure.
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
  • How should I take n- Atelvian- ?
  • After swallowing Atelviau00a0wait at least 30 minutes:
  • Do not lie down for at least 30 minutes after you take n- Atelvian- .
  • If you miss your weekly Atelviau00a0dose, take Atelviau00a0the morning after you remember then return to your normal schedule. Do not take 2 doses at the same time.
  • You should take calcium and vitamin D as directed by your doctor.
  • If you take too much Atelvia, call your doctor. Do not try to vomit. Do not lie down.
  • What are the possible side effects of n- Atelvian- ?
  • Atelviau00a0may cause serious side effects:
  • The most common side effects of Atelvia include:
  • 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 Atelvia. 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 n- Atelvian- ?
  • Keep n- Atelvian- and all medicines out of the reach of children.
  • General information about n- the safe and effective use of n- Atelvia
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Atelviau00a0for a condition for which it was not prescribed. Do not give Atelviau00a0to other people, even if they have the same symptoms you have. It may harm them.
  • This Medication Guide summarizes the most important information about Atelvia. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Atelviau00a0that is written for health professionals.
  • For more information, go to n n or call 1-800-678-1605.u00a0u00a0
  • What are the ingredients n- inn- u00a0n- Atelvian- ?
  • Active ingredient: risedronate sodium
  • Inactive ingredients:u00a0Edetate disodium, ferric oxide yellow, magnesium stearate, methacrylic acid copolymer, polysorbate 80, silicified microcrystalline cellulose (ProSolv SMCC90), simethicone, sodium starch glycolate, stearic acid, talc, and triethyl citrate.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Distributed by: Allergan USA, Inc.Irvine, CA, 92612
  • For all medical inquiries contact:Allergan Medical Communications1-800-678-1605
  • u00a9 2018 Allergan. All rights reserved.
  • ATELVIAu00ae is a registered trademark ofAllergan Pharmaceuticals International Limited.Allerganu00ae and its design are trademarks of Allergan, Inc.n
  • Content Updated: March 2015
  • 73166US11
  • PRINCIPAL DISPLAY PANEL
  • NDC 0430-0979-03Atelvia 35 mg(risedronate sodium) delayed-release tabletsOnce-a-Week4 tabletsRx Only

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