Bondros

Description

The Cathay Drug Co., Inc.

 

FORMULATION

Each uncoated tablet contains:

Alendronic Acid (as alendronate sodium) …………. 70 mg

 

PHARMACOLOGICAL ACTION

PHARMACODYNAMICS

Alendronate is a bisphosphonate that binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. Alendronate reduces bone resorption with no direct effect on bone formation, although the latter process is ultimately reduced because bone resorption and formation are coupled during bone turnover.

 

MECHANISM OF ACTION

The action of Alendronate on bone tissue is based partly on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Alendronate also targets farnesyl pyrophosphate (FPP) synthase. Nitrogen-containing bisphosphonates (such as pamidronate, alendronate, risedronate, ibandronate and zoledronate) appear to act as analogues of isoprenoid diphosphate lipids, thereby inhibiting FPP synthase, an enzyme in the mevalonate pathway. Inhibition of this enzyme in osteoclasts prevents the biosynthesis of isoprenoid lipids (FPP and GGPP) that are essential for the post-translational farnesylation and geranylgeranylation of small GTPase signalling proteins. This activity inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

 

PHARMACOKINETICS

Absorption and Distribution

The oral mean bioavailability of alendronic acid in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardized breakfast. Bioavailability was decreased similarly to an estimated 0.46% and 0.39% when alendronate was administered one hour or half an hour before a standardized breakfast. In osteoporosis studies, alendronate was effective when administered at least 30 minutes before the first food or beverage of the day.

 

Alendronic acid transiently distributes to soft tissues but is then rapidly redistributed to bone or excreted in the urine.

Metabolism and Excretion

There is no evidence that alendronate is metabolized in humans. Approximately 50% of Alendronic acid is excreted in the urine within 72 hours and recovered in the feces.

 

INDICATIONS

Treatment of postmenopausal osteoporosis and osteoporosis in men.

 

CONTRAINDICATIONS

BONDROS 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
• Hypersensitivity to any component of this product.

 

WARNINGS AND PRECAUTIONS

Alendronic Acid can cause local irritation of the upper gastrointestinal mucosa. Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastrointestinal problems, such as dysphagia or oesophageal disease, gastritis, duodenitis, ulcers or with a recent history (within the previous year) or major gastrointestinal disase such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty. In patients with known Barett’s oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.

 

DOSAGE AND ADMINISTRATION

The Recommended dosage: one (1) 70 mg tablet once weekly.

Or as prescribed by the physician.

 

Important Administration Instructions

Instruct patients to do the following:

• Take BONDROS at least one-half hour before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral

water), food, and some medications are likely to reduce the absorption of BONDROS. Waiting less than 30 minutes, or taking BONDROS with food, beverages (other than plain water) or other medications will lessen the effect of BONDROS by decreasing its absorption into the body.

• Take BONDROS upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a BONDROS tablet should be swallowed with a full glass of water (200 mL).
• Patients should not lie down for at least 30 minutes and until after their first food of the day.
• BONDROS should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences.

 

PREGNANCY AND LACTATION

Alendronic Acid should not be used during pregnancy.

It is not known whether alendronic acid is excreted in human breast milk. Alendronic acid should not be used by breastfeeding women.

 

ADVERSE EFFECTS

Hypersensitivity reactions including urticarial and angioedema, headache, abdominal pain, dyspepsia, constipation, diarrhea, flatulence, oesophageal ulcer, dysphagia, abdominal distension, acid regurgitation.

DRUG INTERACTION

If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of alendronic acid. Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product. No other interactions with medicinal products of clinical significance are anticipated. A number of patients in the clinical trials received oestrogen (intravaginal, transdermal, or oral) while taking alendronic acid. No adverse experiences attributable to their concomitant use were identified.

 

Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.

 

OVERDOSAGE AND ITS TREATMENT

No specific information is available on the treatment of overdosage with alendronate. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright. Dialysis would not be beneficial.

 

STORAGE

Store at temperatures not exceeding 30°C.

Keep out of reach of children.

 

AVAILABILITY

Alendronic Acid (BONDROS) 70 mg Tablet – Alu/Alu Blister Pack x 2’s (Box of 2’s)

 

Manufactured by:
XL Laboratories PVT. Ltd.

E-1223 Phase-I Extn., (Ghatal) RIICO Industrial Area

Bhiwadi-301019, Rajasthan, India

 

Distributed by:
The Cathay Drug Co., Inc.

2/F Vernida I Condominium 120 Amorsolo St.

Legaspi Village, Makati City

 

Date of Revision: November 2018