JAMP ALENDRONATE / VITAMIN D3 2800 UNIT — DIN 02519828

What is JAMP ALENDRONATE / VITAMIN D3?

JAMP ALENDRONATE / VITAMIN D3 2800 UNIT contains VITAMIN D3 : 2800 UNIT ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE) : 70 MG. It is listed in the Health Canada Drug Product Database under DIN 02519828, held by JAMP PHARMA CORPORATION, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 13-Jun-2023. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is JAMP ALENDRONATE / VITAMIN D3 used for?

JAMP Alendronate / Vitamin D3 (Alendronic Acid and Cholecalciferol Tablets) is indicated for: • The treatment of osteoporosis in postmenopausal women. • The treatment of osteoporosis in men. For the treatment of osteoporosis, the alendronate sodium component of JAMP Alendronate / Vitamin D3 increases bone mass and can prevent fractures, including those of the hip and spine (vertebral compression fractures). Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2.5 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture. Patients suffering from osteoporosis are at an increased risk for vitamin D insufficiency, especially those over the age of 70 years, home bound, or chronically ill, and may need to receive vitamin D supplementation in addition to that provided in JAMP Alendronate / Vitamin D3. Those living in high latitudes (including most of Canada) may also need additional supplementation. An adequate calcium intake is also required. Patients with gastrointestinal malabsorption may not adequately absorb vitamin D3 and will also require further supplementation. JAMP Alendronate / Vitamin D3 alone should not be used to treat vitamin D deficiency (commonly defined as 25- hydroxyvitamin D <22.5 nmol/L or 9 ng/mL). Important limitations of use: The optimal duration of use has not been determined. Patients should have the need for continued therapy re-evaluated on a periodic basis.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

The recommended dosage is one tablet of JAMP Alendronate / Vitamin D3 (70 mg/2800 IU) or JAMP Alendronate / Vitamin D3 (70 mg/5600 IU) once weekly. The appropriate dosage of JAMP Alendronate / Vitamin D3 must be determined by the health professional based on the patient's vitamin D requirement. All patients must receive supplemental calcium and/or vitamin D, if intake is inadequate. Health Professionals should consider the vitamin D intake from vitamins and dietary supplements. Patients at increased risk for vitamin D insufficiency (e.g. over the age of 70 years, home bound, or chronically ill) should receive JAMP Alendronate / Vitamin D3 (70 mg/5600 IU) and may also need additional vitamin D supplementation. For patients fifty years and over, the recommended dose is at least 800 IU per day. Those living in high latitudes (including most of Canada) may also need additional supplementation. JAMP Alendronate / Vitamin D3 must be taken 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 known to reduce the absorption of alendronate. Waiting less than 30 minutes will lessen the effect of JAMP Alendronate / Vitamin D3 by decreasing its absorption into the body. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, JAMP Alendronate / Vitamin D3 should only be swallowed upon arising for the day with a full glass of water (200-250 mL) and patients should not lie down for at least 30 minutes and until after their first food of the day. JAMP Alendronate / Vitamin D3 should not be taken at bedtime or before arising for the day. JAMP Alendronate / Vitamin D3 tablets should not be chewed, sucked, cut, or crushed. Missed Dose: If a dose is missed, take one tablet on the morning after remembering. Do not take two tablets on the same day but return to taking one tablet once a week, as originally scheduled.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

JAMP Alendronate / Vitamin D3 is contraindicated in patients with: • hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. • abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. • the inability to stand or sit upright for at least 30 minutes. • hypocalcemia. • renal insufficiency with creatinine clearance <0.58 mL/s (<35 mL/min).

Warnings and precautions

General: Patients should swallow each tablet with a full glass of water (200-250 mL) and not lie down for at least 30 minutes and until after their first food of the day. Do not chew or suck on the tablet due to potential for oropharyngeal ulceration. Do not take at bedtime or before arising for the day. Failure to follow instructions may increase risk of esophageal problems. If symptoms of esophageal disease (difficulty/pain upon swallowing, retrosternal pain, new/worsening heartburn) develop, discontinue and consult physician. Causes of osteoporosis other than estrogen deficiency, aging, and glucocorticoid use should be considered. Driving and Operating Machinery: May affect ability to drive or operate machinery due to adverse reactions like dizziness, vertigo, visual disturbances, and severe bone, muscle or joint pain. Endocrine and Metabolism: Hypocalcemia must be corrected before initiating therapy. Other mineral metabolism disorders (e.g., Vitamin D deficiency) should be treated. Serum calcium and symptoms of hypocalcemia should be monitored. Patients should report symptoms of hypocalcemia (paresthesias, muscle spasms). Small, asymptomatic decreases in serum calcium and phosphate may occur. JAMP Alendronate / Vitamin D3 alone should not be used to treat vitamin D deficiency. Gastrointestinal: May cause local irritation of upper gastrointestinal mucosa. Esophageal adverse experiences (esophagitis, ulcers, erosions, stricture, perforation) have been reported, some severe. Discontinue and seek medical attention if dysphagia, odynophagia, retrosternal pain, or new/worsening heartburn occur. Risk is greater if patients lie down after taking, fail to swallow with recommended water, or continue taking with symptoms. Caution with active upper gastrointestinal problems. Rare reports of gastric/duodenal ulcers, some severe. Musculoskeletal: Atypical fractures (low-energy subtrochanteric and proximal femoral shaft) have been reported, some stress fractures. Prodromal pain may occur. Evaluate for causes and risk factors (e.g., vitamin D deficiency, malabsorption, glucocorticoid use). Consider interruption of alendronate therapy based on benefit/risk. Severe and incapacitating bone, joint, and/or muscle pain reported with bisphosphonates, including JAMP Alendronate / Vitamin D3. Osteonecrosis: Osteonecrosis of the jaw (ONJ) reported, often following tooth extractions, especially in cancer patients on IV bisphosphonates, chemotherapy, and corticosteroids. Also in patients on oral bisphosphonates for postmenopausal osteoporosis. Dental examination with preventive dentistry recommended before treatment in patients with risk factors (cancer, poor dental health, infection, diabetes, smoking, heavy alcohol use). Manage ONJ with antibiotic therapy and/or oral surgery; discontinuation of bisphosphonate therapy considered based on benefit/risk. Dental surgery may exacerbate ONJ. Cases of osteonecrosis of the external auditory canal (cholesteatoma) reported. Ophthalmologic: Ocular disturbances (conjunctivitis, uveitis, episcleritis, scleritis) reported. Refer to ophthalmologist for non-uncomplicated conjunctivitis. Treatment may need discontinuation if ocular inflammatory symptoms observed. Renal: Contraindicated in severe renal insufficiency (creatinine clearance < 0.58 mL/s [< 35 mL/min]).