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ACTONEL

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Overview

What is ACTONEL?

ACTONEL (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each ACTONEL 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 •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:

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: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide.

Dose strength-specific ingredients include: 5 mg—ferric oxide yellow, lactose monohydrate; 30 mg—lactose monohydrate; 35 mg—ferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mg—ferric oxide red; 150 mg—FD&C blue #2 aluminum lake.



What does ACTONEL look like?



What are the available doses of ACTONEL?

Tablets: 5, 30, 35, 75, and 150 mg ()

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

ACTONEL is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min) (, , ).

ACTONEL is not indicated for use in pediatric patients ().

How should I use ACTONEL?

ACTONEL is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ACTONEL reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [].

ACTONEL should be taken at least 30 minutes before the first food or drink of the day other than water.

To facilitate delivery to the stomach, ACTONEL should be swallowed while the patient is in an upright position and with a full glass of plain water (6 to 8 oz). Patients should not lie down for 30 minutes after taking the medication [ ].

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate [ ]. Calcium supplements and calcium-, aluminum-, and magnesium-containing medications may interfere with the absorption of ACTONEL and should be taken at a different time of the day. ACTONEL is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min). No dosage adjustment is necessary in patients with a creatinine clearance ≥30 mL/min or in the elderly.


What interacts with ACTONEL?

Sorry No Records found


What are the warnings of ACTONEL?

Sorry No Records found


What are the precautions of ACTONEL?

Sorry No Records found


What are the side effects of ACTONEL?

Sorry No records found


What should I look out for while using ACTONEL?

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 (, )


What might happen if I take too much ACTONEL?

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 ACTONEL 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).


How should I store and handle ACTONEL?

StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].ACTONEL is available as follows:5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.NDC 0149-0471-01 bottle of 30NDC 0149-0471-03 bottle of 200030 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.NDC 0149-0470-01 bottle of 3035 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.NDC 0149-0472-01 dose pack of 4NDC 0149-0472-04 dose pack of 1275 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.NDC 0149-0477-01 dose pack of 2150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.NDC 0149-0478-01 dose pack of 1NDC 0149-0478-03 dose pack of 3Store at controlled room temperature 20° to 25°C (68° to 77°F) [ USP].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

ACTONEL has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, ACTONEL inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (e.g., lack of ruffled border). Histomorphometry in rats, dogs, and minipigs showed that ACTONEL treatment reduces bone turnover (activation frequency, i.e., the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites.

Non-Clinical Toxicology
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 (, )

ACTONEL, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when ACTONEL is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers) [ ].

Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue ACTONEL and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6-8 oz) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient []. In patients who cannot comply with dosing instructions due to mental disability, therapy with ACTONEL should be used under appropriate supervision.

There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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