GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Alendronate Sodium Tablets USP 5mg
B) Alendronate Sodium Tablets USP 10mg
C) Alendronate Sodium Tablets USP 35mg
D) Alendronate Sodium Tablets USP 70mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Alendronate Sodium Tablets USP 5mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………5mg
Excipients……………………………………..q.s.

B) Alendronate Sodium Tablets USP 10mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………5mg
Excipients……………………………………..q.s.

C) Alendronate Sodium Tablets USP 35mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………35mg
Excipients……………………………………..q.s.

D) Alendronate Sodium Tablets USP 70mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………70mg
Excipients……………………………………..q.s.

THERAPEUTIC INDICATIONS:

Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use. KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician
Attach dispensing label as per end country.

Alendronate Sodium Tablets USP 70mg Technical Specification:

Product Name:Alendronate Sodium Tablets USP
Brand Name:Generic
Strength:5mg, 10mg, 35mg, 70mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antiosteoporotic
Indication: Alendronate is also used to treat osteoporosis in men and women who are taking corticosteroids.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • A) Alendronate Sodium Tablets USP 5mg
  • B) Alendronate Sodium Tablets USP 10mg
  • C) Alendronate Sodium Tablets USP 35mg
  • D) Alendronate Sodium Tablets USP 70mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • A) Alendronate Sodium Tablets USP 5mg
    Each uncoated tablet contains:
    Sodium Alendronate USP
    Equivalent to Alendronic Acid………5mg
    Excipients……………………………………..q.s.
  • B) Alendronate Sodium Tablets USP 10mg
    Each uncoated tablet contains:
    Sodium Alendronate USP
    Equivalent to Alendronic Acid………5mg
    Excipients……………………………………..q.s.
  • C) Alendronate Sodium Tablets USP 35mg
    Each uncoated tablet contains:
    Sodium Alendronate USP
    Equivalent to Alendronic Acid………35mg
    Excipients……………………………………..q.s.
  • D) Alendronate Sodium Tablets USP 70mg
    Each uncoated tablet contains:
    Sodium Alendronate USP
    Equivalent to Alendronic Acid………70mg
    Excipients……………………………………..q.s.

THERAPEUTIC INDICATIONS:

Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily.

CAUTION & WARNING:

CAUTION: Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container.

Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

Elevate Your Osteoporosis Treatment with Taj Pharmaceuticals’ Alendronate Sodium Tablets
In the pursuit of optimal bone health, the choice of a pharmaceutical provider is paramount. Taj Pharmaceuticals proudly presents Alendronate Sodium Tablets, a cornerstone in the management of osteoporosis. Here’s why you should consider us for your osteoporosis treatment needs:

  • Proven Expertise: With a rich history in the pharmaceutical industry, Taj Pharmaceuticals brings decades of experience to the forefront. Our Alendronate Sodium Tablets are the product of meticulous research, stringent quality control, and an unwavering commitment to delivering safe and effective bone health solutions.
  • Quality Assurance: At Taj Pharmaceuticals, quality is our foundation. Our Alendronate Sodium Tablets undergo rigorous testing and quality control processes, adhering to international standards. This guarantees that each tablet meets the highest benchmarks of safety and efficacy.
  • Effective Osteoporosis Management: Alendronate is a well-established medication for treating osteoporosis. Our Alendronate Sodium Tablets offer the necessary potency to strengthen bones, reduce the risk of fractures, and enhance overall bone health.
  • Patient-Centric Approach: We recognize the importance of accessible and affordable treatments for osteoporosis. Taj Pharmaceuticals is dedicated to ensuring that effective bone health solutions are within reach, without compromising on quality.
  • Medical Collaboration: Taj Pharmaceuticals collaborates closely with healthcare professionals to ensure that our medications align with the latest advancements in osteoporosis management. By choosing our Alendronate Sodium Tablets, you benefit from a treatment option backed by collective medical expertise.
  • Comprehensive Bone Care: Our Alendronate Sodium Tablets integrate seamlessly into a holistic approach to bone health. They are a crucial component of a comprehensive strategy to prevent fractures and improve the quality of life for individuals with osteoporosis.
  • Global Reach: Taj Pharmaceuticals’ global presence ensures that our Alendronate Sodium Tablets are accessible to patients and healthcare providers worldwide. Regardless of your location, you can rely on our commitment to advancing bone health on a global scale.

What are Alendronate Sodium Tablets and their uses?

Alendronate Sodium Tablets is a medication used in the treatment of osteoporosis and certain other bone conditions. Here’s an overview of Alendronate Sodium Tablets and their uses:

Alendronate Sodium Tablets: Alendronate is the active ingredient in these tablets, and it belongs to a class of drugs called bisphosphonates. Bisphosphonates are used to treat bone-related conditions because they help to increase bone density and reduce the risk of fractures.

Uses: Alendronate Sodium Tablets are primarily prescribed for the following conditions:

  • Osteoporosis: Osteoporosis is a medical condition characterized by the weakening of bones, which become fragile and prone to fractures. Alendronate Sodium Tablets are often used to treat postmenopausal osteoporosis, as well as osteoporosis in men.
  • Preventing Fractures: These tablets are effective at reducing the risk of fractures, particularly in postmenopausal women who have osteoporosis. By increasing bone density, they can make bones stronger and less likely to break.
  • Paget’s Disease of Bone: Alendronate Sodium Tablets can also be used to treat Paget’s disease of bone, a condition characterized by abnormal bone remodeling. It helps to reduce bone pain and prevent deformities in patients with this condition.

Dosage and Administration: The dosage of Alendronate Sodium Tablets can vary depending on the specific condition being treated. Typically, they are taken orally, usually once a week or as prescribed by a healthcare provider. It’s crucial to follow the dosing instructions and any dietary recommendations provided by the healthcare professional.

Important Considerations:

  • Alendronate Sodium Tablets should be taken with a full glass of plain water, typically in the morning before eating or drinking.
  • Patients should remain upright (sitting or standing) for at least 30 minutes after taking the tablet to reduce the risk of oesophageal irritation.
  • These tablets are not suitable for individuals who cannot sit or stand upright for an extended period.
  • Calcium and vitamin D supplements may also be recommended along with Alendronate to support bone health.

How do Alendronate Sodium Tablets work?

Alendronate Sodium Tablets work by inhibiting the activity of osteoclasts, which are specialized cells responsible for breaking down and resorbing bone tissue. This action helps to increase bone density and reduce the risk of fractures, making Alendronate an effective treatment for conditions like osteoporosis and Paget’s disease of bone. Here’s how Alendronate Sodium Tablets work in more detail:

  • Normal Bone Remodeling: In healthy bone, there is a continuous process of bone remodeling, which involves the removal of old or damaged bone tissue by osteoclasts and the formation of new bone tissue by osteoblasts. This dynamic balance ensures that bones remain strong and structurally sound.
  • Role of Osteoclasts: Osteoclasts are cells that play a crucial role in bone resorption. They secrete enzymes and acids that break down the mineralized bone matrix and release calcium and phosphate into the bloodstream. This process is necessary for maintaining calcium homeostasis in the body and for the repair and renewal of bone tissue.
  • Alendronate’s Mechanism: Alendronate Sodium Tablets contain alendronate, which is a type of bisphosphonate. When a person takes Alendronate, it is absorbed into the bloodstream and then preferentially binds to the surfaces of bone, especially in areas where bone resorption is occurring.
  • Inhibition of Osteoclast Activity: Alendronate specifically targets osteoclasts by binding to their surfaces. It interferes with the function of osteoclasts, disrupting their ability to break down bone tissue effectively. This inhibition of osteoclast activity leads to a decrease in bone resorption.
  • Resultant Increase in Bone Density: As bone resorption is reduced, the balance between bone resorption and bone formation shifts in favor of bone formation. Osteoblasts, the cells responsible for building new bone tissue, continue to deposit new bone matrix. This gradual accumulation of bone tissue increases bone density and overall bone strength.
  • Reduction in Fracture Risk: The increase in bone density and the improvement in bone quality make bones less prone to fractures. This is particularly important for individuals with conditions like osteoporosis, where bones are fragile and at an increased risk of fractures.

Benefits of Alendronate Sodium Tablets:

  • Increased Bone Density: Alendronate Sodium Tablets are effective in increasing bone density, making them a valuable treatment option for conditions like osteoporosis. This increased bone density can reduce the risk of fractures and improve overall bone strength.
  • Fracture Risk Reduction: By enhancing bone density and quality, these tablets significantly reduce the risk of fractures, especially in postmenopausal women with osteoporosis. This benefit is crucial for maintaining mobility and quality of life.
  • Treatment of Paget’s Disease: Alendronate Sodium Tablets can effectively treat Paget’s disease of bone, a condition characterized by abnormal bone remodeling. They help reduce bone pain and prevent deformities associated with this condition.
  • Convenience of Oral Administration: Alendronate is typically administered orally, making it a convenient treatment option for many patients. It is available in tablet form, often taken once a week, which simplifies the medication regimen.

Common Side Effects of Alendronate Sodium Tablets:

  • Gastrointestinal Distress: Common side effects include abdominal pain, nausea, heartburn, and indigestion. To minimize these effects, patients are often advised to take the medication with a full glass of water and remain upright for at least 30 minutes after ingestion.
  • Esophageal Irritation: Alendronate Sodium Tablets can sometimes cause irritation or inflammation of the esophagus (the tube that connects the mouth to the stomach). This can lead to symptoms like difficulty swallowing or chest pain.
  • Musculoskeletal Pain: Some individuals may experience musculoskeletal pain, including joint or muscle pain, during or after starting treatment with Alendronate. These symptoms are usually temporary and resolve with continued use or discontinuation of the medication.
  • Rare Side Effects: In rare cases, Alendronate use has been associated with severe side effects such as osteonecrosis of the jaw (a condition where the jawbone deteriorates) and atypical femur fractures (unusual fractures in the thigh bone). These side effects are exceptionally rare but require prompt medical attention if suspected.
  • Hypocalcemia: In some instances, Alendronate can lower calcium levels in the blood (hypocalcemia). This can lead to symptoms such as muscle cramps, twitching, or numbness and tingling. It’s essential to monitor calcium levels during treatment.

Frequently Asked Questions About Alendronate Sodium Tablets:

Certainly, here are some frequently asked questions (FAQs) about Alendronate Sodium Tablets:

What are Alendronate Sodium Tablets used for?

Alendronate Sodium Tablets are primarily used to treat conditions like osteoporosis and Paget’s disease of bone. They help increase bone density, reduce the risk of fractures, and manage bone-related conditions.

How do I take Alendronate Sodium Tablets?

Typically, Alendronate Sodium Tablets are taken once a week. It’s crucial to follow the dosing instructions provided by your healthcare provider. Take the tablet with a full glass of water and remain upright (sitting or standing) for at least 30 minutes after taking it to minimize the risk of oesophageal irritation.

Can I crush or chew Alendronate Sodium Tablets if I have difficulty swallowing pills?

No, Alendronate Sodium Tablets should not be crushed, chewed, or dissolved. They should be swallowed whole. If you have difficulty swallowing pills, discuss alternative dosage forms or medications with your healthcare provider.

Are there any dietary restrictions when taking these tablets?

While taking Alendronate, it’s important to maintain an adequate intake of calcium and vitamin D through your diet or supplements, as recommended by your healthcare provider. Additionally, it’s best to avoid consuming food, beverages (other than water), or medications for at least 30 minutes after taking the tablet.

How long do I need to take Alendronate Sodium Tablets?

The duration of treatment with Alendronate can vary depending on your specific condition and response to the medication. Your healthcare provider will determine the appropriate treatment duration for you.

Can I drink alcohol while taking Alendronate Sodium Tablets?

Moderate alcohol consumption is generally acceptable while taking Alendronate Sodium Tablets. However, excessive alcohol intake should be avoided, as it can negatively impact bone health.

What should I do if I miss a dose of Alendronate Sodium Tablets?

If you miss a dose, take it as soon as you remember, unless it’s close to the time for your next scheduled dose. Do not take two doses at the same time to make up for a missed one. Follow your regular dosing schedule.

Can Alendronate Sodium Tablets cause side effects, and how can they be managed?

Yes, Alendronate can cause side effects, including gastrointestinal symptoms, esophageal irritation, and musculoskeletal pain. To manage these side effects, take the tablet as directed, with a full glass of water while remaining upright. Discuss any side effects with your healthcare provider.

Can I discontinue Alendronate Sodium Tablets on my own if I feel better?

Do not discontinue Alendronate without consulting your healthcare provider, even if you start to feel better. Your healthcare provider will determine the appropriate duration of treatment based on your specific condition and needs.

Are there any long-term effects or risks associated with Alendronate Sodium Tablets?

Your healthcare provider will assess the risks and benefits of long-term treatment with Alendronate based on your individual situation. Regular follow-up visits and discussions with your healthcare provider are important to monitor your bone health and treatment progress.

As Alendronate Sodium Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Alendronate Sodium Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Alendronate Sodium Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Alendronate Sodium Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274