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ETC / RX - Bone calcium regulators - Forcimax 70

COMPOSITION:

Each caplet contains:

Active ingredient: Alendronic acid (as alendronate sodium) 70 mg.

Excipients: Lactose DC, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, opadry II white.


DESCRIPTION OF PRODUCT:

Oval shaped film-coated caplet, white or ivory-white, smooth on one side, and debossed with shape of bone on the other side.


PHARMACODYNAMICS:

Alendronate, a synthetic aminobisphosphonate analog of pyrophosphate, is a highly selective inhibitor of bone resorption. Unlike pyrophosphate but like etidronate and pamidronate, alendronate is resistant to enzymatic hydrolysis by phosphatases.


PHARMACOKINETICS:

Alendronate is poorly absorbed after oral doses. Absorption is decreased by food, especially by products containing calcium or other polyvalent cations. Bioavailability is about 0.4% when taken half an hour before food; absorption is negligible when taken up to 2 hours after a meal. Plasma protein binding is about 78%. Bisphosphonates do not appear to be metabolised. About half of the absorbed portion is excreted in the urine; the remainder is sequestered to bone for a prolonged period.


INDICATIONS:

  • Treatment and prevention of osteoporosis in postmenopausal women.
  • Treatment to increase bone mass in men with osteoporosis.

ADMINISTRATION AND DOSAGE:

  • For treatment of postmenopausal osteoporosis: 70 mg once weekly.
  • For treatment to increase bone mass in men with osteoporosis: 70 mg once weekly; if you forget to take Alendronic acid 70 mg caplets, take the caplet in the morning after you remember. Do not take two caplets on the same day.
  • For prevention of postmenopausal osteoporosis: 35 mg once weekly.

Note: No dosage adjustment is necessary for the elderly or renal impairment patients from mild to moderate (creatinine clearance 35-60 ml/min).

Alendronic acid is not recommended for patients with severe renal impairment (creatinine clearance less than 35 ml/min), due to lack of experience.

Note: Swallow the caplets whole. You must take this product immediately after you get out of bed in the morning. You should take it with 180-240 ml plain water (never take with mineral water). Taken at least 30 minutes before the first food or medication of day, sit or stand upright until at least 30 minutes. Never take this medicine with tea, coffee, juice, or any liquid other than plain water.


CONTRAINDICATIONS:

  • Hypersensitivity to any component of this product and phosphonate
  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
  • Hypocalcemia
  • Inability to stand or sit upright for at least 30 minutes
  • Pregnancy
  • Severe renal impairment

WARNINGS AND PRECAUTIONS:

  • Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding have been reported in patients receiving treatment with alendronate. Therefore, you must stop taking alendronate or tell your doctor if you have difficulty swallowing, odynophagia, retrosternal pain.
  • Patients have digestion problems such as: difficulty swallowing, esophageal disease, gastritis, duodenitis or ulcer.
  • Pre-existent hypocalcemia must be corrected before initiating alendronate therapy.
  • Adequate intake of calcium and vitamin D are essential.
  • Alendronate is not recommended for patients with renal insufficiency (creatinine clearance less than 35 mL/min).
  • It is not known whether alendronate is excreted in human milk. Caution should be exercised when alendronate is administered to nursing women.
  • Alendronate is not indicated for use in children.

Pregnancy and Lactation:

  • It is contraindicated to pregnancy.
  • It is not known whether alendronate is excreted into human breast milk, thus, cautions should be exercised.

Effects on ability to drive and use machines: None reported.


SIDE EFFECTS:

Common, ADR above 1/100:

Central Nervous System: Headache.

Digestion: Flatulence, acid regurgitation, esophageal ulcer, dysphagia, tympania, diarrhea.

Uncommon, ADR from 1/1000 to below 1/100:

Skin: Rash, erythema (rare).

Gastrointestinal: Gastritis.

Rarely, ADR below 1/1000:

Allergy to alendronate in particular and bisphosphonat in general.

Auditory hallucination, visual disturbance. Osteonecrosis of the jaw, jaw joint damage. Maybe femur fracture when taking for a long period.

In case of an unexpected reaction, consult your physician.


INTERACTIONS:

  • Administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60%.
  • Estrogen: Concomitant use of hormone replacement therapy and alendronate for postmenopausal women is not recommended since safety and efficacy of this combination has not been determined.
  • Concomitant administration of oral alendronate with antacids and calcium supplements and some oral medications may interfere with absorption of alendronate. Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medications.
  • Nonsteroidal anti-inflammatory drugs usually cause gastrointestinal irritation; caution should be used during concomitant use with alendronate.
  • Aspirin: Increased incidence of adverse GI effects when alendronate is used in patients taking aspirin-containing products.
  • Intravenous ranitidine increases the oral bioavailability of alendronate.
  • Iron: Reduces the absorption of alendronate.
  • Aminoglycosyde antibiotics: Increased risk of hypocalcemia if used simultaneously.

OVERDOSAGE:

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.


PRESENTATION:

Box of 1 blister x 1 coated caplets.

Box of 2 blisters x 2 coated caplets.

Booklet of 2 coated caplets.

Booklet of 4 coated caplets.

Storage: Store at temperature below 300C, in a dry place, protected from light.

Shelf-life: 36 months from manufacturing date. Do not use after expiry date.