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risedronate sodium

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Overview

What is Atelvia?

Atelvia (risedronate sodium) delayed-release tablets contain a pH-sensitive enteric coating and a chelating agent (EDTA).

Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Atelvia tablet for oral administration contains the equivalent of 35 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 •2.5 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:

      Molecular Weight:

      Anhydrous:       305.10

      Hemi-pentahydrate:       350.13

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.



What does Atelvia look like?



What are the available doses of Atelvia?

Delayed-release tablets: 35 mg ()

What should I talk to my health care provider before I take Atelvia?

Atelvia is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min) (, , ) 

Atelvia is not indicated for use in pediatric patients ()

How should I use Atelvia?

Atelvia is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures

[see

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The recommended regimen is:


What interacts with Atelvia?

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What are the warnings of Atelvia?

Sorry No Records found


What are the precautions of Atelvia?

Sorry No Records found


What are the side effects of Atelvia?

Sorry No records found


What should I look out for while using Atelvia?

Atelvia 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. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis , have been reported [see ]


What might happen if I take too much Atelvia?

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 sodium immediate- release and reduce absorption of the drug, the impact of this intervention for Atelvia delayed-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. 

Lethality after single oral doses of risedronate 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 human Paget’s disease dose of 30 mg/day based on surface area (mg/m). 


How should I store and handle Atelvia?

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Atelvia (risedronate sodium) delayed-release tablets are:35 mg, yellow, oval-shaped, and engraved with EC 35 on one side.NDC 0430-0979-03       Dosepak of 4 tabletsStore at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].Atelvia (risedronate sodium) delayed-release tablets are:35 mg, yellow, oval-shaped, and engraved with EC 35 on one side.NDC 0430-0979-03       Dosepak of 4 tabletsStore at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].Atelvia (risedronate sodium) delayed-release tablets are:35 mg, yellow, oval-shaped, and engraved with EC 35 on one side.NDC 0430-0979-03       Dosepak of 4 tabletsStore at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].Atelvia (risedronate sodium) delayed-release tablets are:35 mg, yellow, oval-shaped, and engraved with EC 35 on one side.NDC 0430-0979-03       Dosepak of 4 tabletsStore at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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

Non-Clinical Toxicology
Atelvia 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. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis , have been reported [see ]

See Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin. Misoprostol has no clinically significant effect on the kinetics of diclofenac or ibuprofen.

Prostaglandins such as misoprostol may augment the activity of oxytocic agents, especially when given less than 4 hours prior to initiating oxytocin treatment. Concomitant use is not recommended.

Atelvia contains the same active ingredient found in Actonel. A patient being treated with Actonel should not receive Atelvia.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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