Patient Medication Information: uses, side effects, how to take - Didronel Tab 200mg
ABOUT THIS MEDICATION
What the medication is used for:
treatment of symptomatic Paget’s disease of the
bone
short-term (30-90 days) maintenance of blood
calcium levels following treatment with Didronel I.V. Infusion for patients with hypercalcemia of malignancy (i.e. high blood calcium secondary to malignant disease)
What it does:
To understand how the Didronel therapy works, it is important to understand your bone health.
Bone is a living tissue that your body constantly renews. In this normal process, your body breaks down old bone tissue and replaces it with new bone. In Paget’s disease, this process is abnormal and accelerated. Didronel acts on bones by slowing the abnormal and accerelated rate of bone turnover in Paget’s disease.
People with Paget’s disease can experience bone pain, bone deformity and vascular disorder (i.e blood vessel disorder associated with Paget’s disease). In research studies, Didronel therapy improved Paget’s symptoms including the reduction of bone pain in patients with Paget’s disease.
Didronel can also be used to treat hypercalcemia of malignancy or high blood calcium, which is a condition that occurs in 8-20% of patients with malignant diseases. By slowing the rate of bone turnover, Didronel also reduces the release of calcium from the bones to the blood stream, which in turn reduces the blood calcium level to an acceptable level.
When it should not be used:
Didronel is not suitable for everyone. Didronel
should not be used:
- If you have unresolved osteomalacia, which is a condition of inadequate or delayed bone mineralization (formation).
- If you are allergic to Didronel and any of its ingredients (see below).
What the medicinal ingredient is:
Etidronate disodium
What the nonmedicinal ingredients are:
Magnesium stearate, microcrystalline cellulose, and pregelatinized starch.
What dosage forms it comes in:
Didronel 200 mg (etidronate disodium) is a rectangular white tablet with “P&G” on one face and “402” on the other face.
WARNINGS AND PRECAUTIONS
BEFORE you use Didronel talk to your doctor or pharmacist if:
$ You have unresolved osteomalacia, which is a condition of inadequate or delayed bone mineralization (formation).
$ You have problems with your kidneys, stomach or intestines
$ You are pregnant or nursing.
$ You are allergic to Didronel and any of its ingredients
$ You have one of the following risk factors:
cancer; chemotherapy, radiotherapy of the head or neck, treatment with corticosteroids, or dental problems or dental infections. If so, a dental examination and any necessary dental procedures should be considered before you start treatment with Didronel
Be sure to tell your health care providers, including doctors and dentists, about all medicines you are taking, including Didronel.
Patients with Paget’s disease of bone should maintain an adequate intake of calcium and vitamin D.
INTERACTIONS WITH THIS MEDICATION
If taken with some other medicines, the effects Didronel or the effects of other medicines may be changed. Please check with your doctor or pharmacist before taking other medications with Didronel.
Drugs that may interact with Didronel include
corticosteroid, phosphate, calcitonin, furosemide, warfarin or mithramycin.
To maximize the absorption, the following foods and medicines should not be taken within 2 hours of taking Didronel: Antacids, vitamins with mineral supplements such as iron, calcium supplements, laxative containing magnesium and foods, especially food high in calcium, such as milk or milk products.
PROPER USE OF THIS MEDICATION
As with all medications, it is important to take as directed by your doctor.
Usual dose:
For Paget’s disease, the recommended initial dose of Didronel for most patients is 5 mg per kilogram of bodyweight per day, not to exceed a period of 6 months.
For hypercalcemia of malignancy, the recommended dose is 20 mg per kilogram of bodyweight per day for 30 days.
Overdose:
If you take too many tablets on any given day, contact your doctor immediately or go to the nearest emergency department.
Missed Dose:
If you miss a day (or more) of the treatment, do not take 2 tablets the same day. Take 1 tablet on the day you remember and continue with the therapy.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
With any medication, there is some chance of side effects. The most common side effects observed with Didronel are nausea and diarrhea.
Rarely reported side effects include confusion, a burning sensation of the tongue, hair loss, and a sensation of numbness, prickling or tingling.
In patients with Paget’s disease, joint pain or new, increased or returning bone pain may occur. In some patients, the pain resolved while Didronel was continued, but persisted for several months in others. On occasion, Didronel may have to be stopped.
Very rarely patients have reported non-healing jaw wounds while receiving drugs in this class, such as Didronel. Consult your doctor if you experience
persistent pain in your mouth, teeth or jaw, or if your gums or mouth heal poorly.
| IMPORTANT SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / Effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||||
Only if sever e | In all cases | |||||
| Uncommon (less than 1 in 100) | ||||||
| Allergic reactions such as: hives; skin rash; itching | T | |||||
| Rare (less than 1 in 1000) | ||||||
| Worsening of asthma | T | |||||
| Blood disorders with symptoms of bleeding, bruising and increased infection | T | |||||
Skin reactions (rash, sores, blisters) involving mucous membranes | T | |||||
Pain and swelling of the tongue or esophagus (tube connecting the mouth & stomach) | T | |||||
| Very rare (less than 1 | ||||||
| in 10,000) | ||||||
| Worsening of stomach and intestinal ulcers | T | |||||
For any unexpected effects while taking Didronel, contact your doctor or pharmacist. This is not a complete list of side effects.
HOW TO STORE IT
The Didronel therapy should be stored at room temperature (15 - 30°C). Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone:866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Information Division
Marketed Health Products Directorate Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals is available by contacting the sponsor, Procter & Gamble Pharmaceuticals Canada Inc. at:
1-800-565-0814