Alendronic Acid

Cipla Ltd ,

Zydus Cadila

Osteofos 35mg Tablet 4s ,

Stoplos A Plus Tablet Lemon 4s

Osteoporosis ,

Paget Disease

DRUG STATUS

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Approvals

US. FDA / uk mhra / ema / pdma

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Essential Medicine

WHO / India

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Use in Pregnancy

Not Advised / Caution

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Pharmaceutical Class

ama / pdma

Summary

  • Alendronic Acid is used to treat and prevent osteoporosis, particularly in postmenopausal women. It's also used to manage Paget's disease of bone, prevent bone loss in people taking corticosteroid medications, and reduce the risk of fractures in men with osteoporosis.

  • Alendronic Acid works by inhibiting the activity of osteoclasts, cells that break down bone tissue. This reduces bone resorption, allowing bone-building cells to function more effectively, which strengthens bones.

  • The usual dosage for osteoporosis is typically 10 mg daily or 70 mg weekly. For Paget's disease, the usual dose is 40 mg daily for 6 months. It should be taken in the morning, on an empty stomach, with a full glass of plain water.

  • Common side effects include gastrointestinal issues like nausea, abdominal pain, heartburn, and esophageal irritation. Serious, but rare, side effects include esophageal ulcers, jaw osteonecrosis, and atypical femur fractures.

  • Alendronic Acid should not be used by people with esophageal abnormalities, severe renal impairment, or those unable to stand or sit upright for at least 30 minutes. It should be used cautiously in individuals with low blood calcium levels or vitamin D deficiency. It's also contraindicated in pregnant and breastfeeding women.

Indications and Purpose

How does Alendronic Acid work?

Alendronic acid works by inhibiting the activity of osteoclasts, the cells responsible for breaking down bone tissue. This action helps to reduce bone resorption, allowing the bone-building cells (osteoblasts) to function more effectively, which in turn strengthens bones. It is a bisphosphonate that slows down bone loss, making it especially beneficial in conditions like osteoporosis and Paget's disease, where bone resorption outpaces bone formation.

 

 

How does one know if Alendronic Acid is working?

The benefit of alendronic acid is evaluated through regular monitoring of bone mineral density (BMD) using dual-energy X-ray absorptiometry (DXA) scans. Additionally, fracture rates (both clinical and radiographic) are assessed to determine its effectiveness in preventing fractures. Blood tests may also be used to monitor markers of bone turnover, helping to assess the drug’s impact on bone health over time.

 

 

Is Alendronic Acid effective?

Evidence supporting alendronic acid's effectiveness comes from multiple clinical trials and studies. It has been shown to significantly reduce the risk of fractures, particularly in people with osteoporosis, by improving bone mineral density and reducing bone turnover. Studies demonstrate its ability to decrease both vertebral and hip fractures in postmenopausal women and individuals with Paget's disease, confirming its role in strengthening bones and reducing fracture risk.

 

 

What is Alendronic Acid used for?

Alendronic acid is primarily indicated for the following conditions:

  1. Osteoporosis: To prevent and treat osteoporosis in postmenopausal women and men, reducing the risk of fractures.
  2. Paget's disease of bone: To manage this chronic condition where bones become enlarged and deformed.
  3. Glucocorticoid-induced osteoporosis: To prevent bone loss in people taking corticosteroid medications.
  4. Bone loss prevention in men: To reduce the risk of fractures in men with osteoporosis.

 

 

Directions for Use

How do I take Alendronic Acid?

Instructions for using Alendronic Acid:

  • Take on an empty stomach: Alendronic Acid should be taken first thing in the morning, at least 30 minutes before eating, drinking, or taking any other medications.
  • No food or drink: Do not consume any food, drink, or medications other than plain water during the first 30 minutes after taking the tablet.
  • Take with a full glass of water: Swallow the tablet whole with a full glass of plain water. Avoid mineral water or other beverages.
  • Remain upright: After taking the tablet, remain upright (sitting or standing) for at least 30 minutes to help prevent esophageal irritation.

 

How long does it take for Alendronic Acid to start working?

Alendronic acid typically starts working within a few weeks to a few months to help strengthen bones, but noticeable benefits, such as a reduction in bone fractures, may take several months to years of treatment. The medication works gradually, improving bone density and reducing the risk of fractures over time, so immediate effects might not be evident.

 

 

How should I dispose of Alendronic Acid?

If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of the medicines properly so they don't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag and throw it away.

How should I store Alendronic Acid?

Store the medication between 68° to 77°F. Keep it in a container that is sealed shut to keep out light and has a childproof cap.

What are the consequences to stopping Alendronic Acid?

Stopping Alendronic acid abruptly may reduce its effectiveness in preventing bone loss and fractures. Over time, without continued use, bone density can decrease, potentially increasing the risk of fractures. If treatment is discontinued, your doctor may recommend alternative therapies or monitoring to manage bone health. Always consult your doctor before stopping or altering the dosage of this medication.

 

 

What is Alendronic Acid’s dose and duration?

The usual dosage for Alendronic Acid in adults for osteoporosis is typically 10 mg once daily or 70 mg once weekly. For Paget’s disease, the usual dose is 40 mg once daily for 6 months.

Administration instructions:

  • Alendronic Acid should be taken first thing in the morning on an empty stomach, at least 30 minutes before eating, drinking, or taking any other medications.
  • The tablet should be swallowed whole with a full glass of plain water (not mineral water or any other beverage).
  • After taking it, remain upright (sitting or standing) for at least 30 minutes to help prevent irritation of the esophagus.
  • Do not chew or suck the tablet to avoid throat irritation.

 

What should I do if I miss a dose of Alendronic Acid?

If you forget to take your alendronate sodium tablet, don't take it later that day. Instead, take it the next morning and continue with your regular schedule. Never take two tablets on the same day.

Warnings and Precautions

Can Alendronic Acid be taken safely while breastfeeding?

Alendronic acid is excreted in breast milk in small amounts, but the effects on a breastfeeding infant are not well studied. Since it is poorly absorbed from the gastrointestinal tract, the risk to a nursing infant is considered low. However, it is generally advised to avoid using alendronic acid while breastfeeding, or to consult a healthcare provider to assess potential risks and benefits.

 

 

Can Alendronic Acid be taken safely while pregnant?

Alendronic acid is classified as a Category C drug during pregnancy by the FDA, meaning that animal studies have shown some risks to the fetus, but there are no well-controlled human studies. The potential risks include skeletal malformations seen in animal studies at high doses. Therefore, it is recommended to avoid alendronic acid during pregnancy unless the benefits clearly outweigh the risks to the fetus.

 

 

Can Alendronic Acid be taken safely while trying to conceive?

There is limited information on the direct effects of alendronic acid on fertility in both men and women. Animal studies have shown no adverse effects on fertility. However, due to a lack of comprehensive human studies, it is recommended to consult a healthcare provider before using alendronic acid if planning to conceive.

 

 

Can I take Alendronic Acid with other prescription drugs?

Alendronic acid may interact with several prescription medications, including:

  1. Nonsteroidal anti-inflammatory drugs (NSAIDs): May increase the risk of gastrointestinal issues such as ulcers or bleeding.
  2. Proton pump inhibitors (PPIs): These can reduce the absorption of alendronic acid, making it less effective.
  3. Antibiotics like tetracycline: Can also reduce the absorption of alendronic acid.
  4. Calcium supplements and H2 blockers: These may interfere with alendronic acid absorption if taken concurrently.

 

Can I take Alendronic Acid with vitamins or supplements?

Alendronic acid can interact with calcium, iron, magnesium, and multivitamins containing these minerals, as they can reduce its absorption. It is advised to take these supplements at least 30 minutes after alendronic acid to avoid interference. Vitamin D supplementation is recommended to support calcium absorption and bone health, particularly in individuals with osteoporosis or low vitamin D levels.

 

 

What are Alendronic Acid possible harms and risks?

Common side effects of alendronic acid include gastrointestinal issues like nausea, abdominal pain, heartburn, and esophageal irritation. Serious adverse effects, though rare, include esophageal ulcers, jaw osteonecrosis, and atypical femur fractures. Additionally, it may cause low blood calcium levels (hypocalcemia) or bone, joint, and muscle pain. Severe allergic reactions, though uncommon, can also occur.

 

 

Who should avoid taking Alendronic Acid?

Alendronic acid should not be used by people with esophageal abnormalities, severe renal impairment, or those unable to stand or sit upright for at least 30 minutes. It should be used cautiously in individuals with low blood calcium levels or vitamin D deficiency. Warnings include the potential for gastrointestinal issues, osteonecrosis of the jaw, and atypical femur fractures. It’s also contraindicated in pregnant and breastfeeding women.

 

 

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