Risedronate Sodium (Actonel)

Trade Name : Actonel

Allergan, Inc.

TABLET, FILM COATED

Strength 25.84.2 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 (Actonel) which is also known as Actonel and Manufactured by Allergan, Inc.. It is available in strength of 25.8; 4.2 mg/1; mg/1 per ml. Read more

Risedronate Sodium (Actonel) 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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About GNH

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
  • ACTONELu00a0is 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 () n
  • Treatment to increase bone mass in men with osteoporosis () n
  • Treatment and prevention of glucocorticoid-induced osteoporosis () n
  • 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 dayn
  • Avoid lying down for 30 minutes ()n
  • Take supplemental calcium and vitamin D if dietary intake is inadequate ()
  • Tablets: 5, 30, 35, 75, and 150u00a0mg ()
  • ACTONELu00a0is contraindicated in patients with the following conditions:
  • 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
  • Osteonecrosisn- of the n- Jn- aw
  • Sn- evere n- Bn- one, n- Jn- ointn- , n- Mn- uscle n- Pn- ainn- u00a0
  • 5.5n- 6.2
  • Atypical n- Fn- emur n- Fn- ractures
  • Most common adverse reactions reported in greater than 10% of patients treated with ACTONELu00a0and with a higher frequency than placebo are:u00a0back pain, arthralgia, abdominal pain, and dyspepsiau00a0()u00a0
  • Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis),u00a0and eye inflammation (iritis, uveitis) have been reported rarelyu00a0()
  • 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,u00a0Cytochrome P450).
  • Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of ACTONELu00a0()
  • No data
  • Pregnancy: Discontinue when pregnancy is recognized ()n
  • ACTONEL is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min) (,u00a0, )n
  • ACTONEL 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 ACTONELu00a0and 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).
  • ACTONELu00a0(risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each ACTONELu00a0tablet for oral administration contains the equivalent of 5, 30, 35,u00a075, 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:
  • 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
  • All dose strengths contain: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide.
  • Dose strength-specific ingredients include: 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.
  • No data
  • No data
  • No data
  • ACTONEL is available as follows:
  • 5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.
  • NDC 0430-0471-15nttu00a0u00a0u00a0u00a0u00a0ntbottle of 30
  • 30 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.
  • NDC 0430-0470-15nttu00a0u00a0u00a0u00a0u00a0ntbottle of 30
  • 35 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.
  • NDC 0430-0472-03nttu00a0u00a0u00a0u00a0u00a0ntdose pack of 4
  • NDC 0430-0472-07nttu00a0u00a0u00a0u00a0u00a0ntdose pack of 12
  • 75 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.
  • NDC 0430-0477-02nttu00a0u00a0u00a0u00a0u00a0ntdose pack of 2
  • 150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.
  • NDC 0430-0478-01nttu00a0u00a0u00a0u00a0u00a0ntdose pack of 1
  • NDC 0430-0478-02nttu00a0u00a0u00a0u00a0u00a0ntdose pack of 3
  • Store at controlled room temperature 20u00b0 to 25u00b0u00a0C (68u00b0 to 77u00b0u00a0F) [see USP].
  • See FDA-approved patient labeling ()u00a0
  • Instruct patients to read the Medication Guide before starting therapy with ACTONELu00a0and to re-read it each time the prescription is renewed.
  • Instruct patients that Atelviau00a0and ACTONELu00a0contain the same active ingredient and if they are taking Atelvia, they should not take ACTONELu00a0[u00a0n n ].
  • 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, ACTONELu00a0should be taken at least 30 minutes before the first food or drink of the day other than water.
  • Instruct patientsu00a0to take ACTONELu00a0while in an upright position (sitting or standing) with a full glass of plain water (6 to 8 ounces)u00a0to 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 [u00a0n n ].
  • 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 ACTONEL.
  • Instruct patientsu00a0about missing ACTONELu00a0doses as follows:
  • Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [u00a0n n ]. 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 ACTONEL as these medicationsu00a0may interfere with the absorption of ACTONEL.
  • 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 ACTONEL. Patients should be instructed that any time they have a medical problem they think may be from ACTONEL, they should talk to their doctor.
  • Distributed by:
  • Allergan USA, Inc.
  • Madison, NJ 07940
  • u00a9 2019 Allergan.u00a0All rights reserved.
  • All trademarks are the property of their respective owners.
  • v1.0USPI0471
  • Medication Guide
  • ACTONELn- Arrayn- (n- AKn- -n- tohn- -n- neln- )
  • (n- risedronate sodiumn- )
  • Tabletsn- u00a0
  • Read theu00a0Medication Guide that comes with ACTONELu00a0before 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 ACTONEL, there may be new information about it.u00a0
  • What is the most important information I should know about ACTONEL?
  • ACTONELn- u00a0n- cann- cause serious side effects including
  • 1. Esophagus problems.
  • Some people who take n- ACTONELn- u00a0n- mayn- 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).
  • ACTONEL may lower the calcium levels in your blood. If you have low blood calcium before you start taking ACTONEL, it may get worse during treatment. Your low blood calcium must be treated before you take ACTONEL. 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 ACTONEL. 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 ACTONEL. Your doctor should examine your mouth before you start ACTONEL. Your doctor may tell you to see your dentist before you start ACTONEL. It is important for you to practice good mouth care during treatment with ACTONEL.
  • 4. Bone, joint, or muscle pain.
  • Some people who take ACTONEL 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 is n- ACTONELn- ?
  • ACTONELu00a0is a prescription medicine used to:
  • It is not known how long ACTONEL works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if ACTONEL is still right for you.
  • ACTONEL is not for use in children.
  • Who should not take n- ACTONELn- ?
  • Do not take n- ACTONELn- u00a0n- ifn- youn- :
  • What should I tell my doctor before taking n- ACTONELn- ?
  • Before you start n- ACTONELn- , be sure to talk to your doctor n- ifn- youn- :
  • Especially tell your doctor if you take:
  • Tell your doctor n- 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 n- ACTONELn- ?
  • After swallowing ACTONELu00a0tablet, wait at least 30 minutes:
  • Do not lie down for at least 30 minutes after you take n- ACTONELn- u00a0n- and after you eat your first food of the day.
  • If you miss a dose of ACTONEL, do not 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 ACTONELu00a0in a month, call your doctor for instructions.
  • If you take too much ACTONEL, call your doctor. Do not try to vomit. Do not lie down.
  • What are the possible side effects of n- ACTONELn- ?
  • ACTONELu00a0may cause serious side effects:
  • The most common side effects of n- ACTONELn- u00a0n- 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 ACTONEL. 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- ACTONELn- ?
  • Safely throw away medicine that is out of date or no longer needed.
  • Keep n- ACTONELn- u00a0n- and all medicines out of the reach of children.
  • General information about n- the safe and effective use of n- ACTONELn- .
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACTONELu00a0for a condition for which it was not prescribed. Do not give ACTONELu00a0to other people, even if they have the same symptoms you have. It may harm them.
  • This Medication Guide summarizes the most important information about ACTONEL. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ACTONELu00a0that 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- ACTONELn- ?
  • Active ingredient: risedronate sodium
  • Inactive ingredients in all dose strengths: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. u00a0
  • Inactive ingredients specific to a dose strength: 5 mgu2014ferric oxide yellow, lactose monohydrate; 30u00a0mgu2014lactose 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.
  • Distributed by:
  • Allergan USA, Inc.
  • Madison, NJ 07940
  • u00a9 2019 Allergan.u00a0All rights reserved.
  • All trademarks are the property of their respective owners.
  • Revised: 11/2019
  • v1.0MG0471
  • PRINCIPAL DISPLAY PANEL
  • Rx OnlyNDC 0430-0471-15Actonel(risedronate sodium) tablets5 mg30 Tablets
  • PRINCIPAL DISPLAY PANEL
  • Rx OnlyNDC 0430-0470-15Actonel(risedronate sodium) tablets30 mg30 Tablets
  • PRINCIPAL DISPLAY PANEL
  • NDC 0430-0472-03Actonel(risedronate sodium) tablets35 mg4 Week Supply(4 tablets)Rx Only
  • PRINCIPAL DISPLAY PANEL
  • NDC 0430-0472-07Actonel(risedronate sodium) tablets35 mg12 Week SupplyRx Only
  • PRINCIPAL DISPLAY PANEL
  • NDC 0430-0477-02Actonel(risedronate sodium) tablets75 mgOne Month Pack(2 tablets)Rx Only
  • PRINCIPAL DISPLAY PANEL
  • NDC 0430-0478-01Actonel(risedronate sodium) tablets150 mgOne Month Pack(1 tablet)Rx Only
  • PRINCIPAL DISPLAY PANEL
  • NDC 0430-0478-02Actonel(risedronate sodium) tablets150 mg3 Month PackRx Only

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