Skelid

DRUG DESCRIPTION

SKELID (tiludronate) is a bisphosphonate characterized by a (4-chlorophenylthio) group on the carbon atom of the basic P-C-P structure common to all bisphosphonates. Its generic name is tiludronate disodium. Tiludronate disodium is the hydrated hemihydrate form of the disodium salt of tiludronic acid. Its chemical name is [[(4-Chlorophenyl) thio]methylene]bis[phosphonic acid], disodium salt, and its structural formula is as follows:

SKELID®
  (tiludronate disodium)  Structural Formula Illustration

SKELID tablets for oral administration contain 240 mg tiludronate disodium, which is the molar equivalent of 200 mg tiludronic acid. SKELID (tiludronate) tablets also contain sodium lauryl sulfate, hydroxypropyl methylcellulose 2910, crospovidone, magnesium stearate, and lactose monohydrate.

What are the possible side effects of tiludronate (Skelid)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tiludronate and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • difficulty or pain when swallowing;
  • pain or burning under the ribs or in the back;
  • new or worsening heartburn;
  • severe joint, bone, or muscle pain; or
  • jaw pain, numbness, or...

Read All Potential Side Effects and See Pictures of Skelid »

What are the precautions when taking tiludronate (Skelid)?

Before taking tiludronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate, etidronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, inability to sit upright or stand for at least 30 minutes, difficult/painful swallowing, esophagus problems (such as heartburn, narrowing of the esophagus), stomach/intestinal problems (such as ulcers), low level of calcium in the blood.

Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems...

Read All Potential Precautions of Skelid »


Skelid Consumer (continued)

SIDE EFFECTS: Nausea or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: new or worsening bone/joint/muscle pain, jaw pain, eye/vision problems.

This medication may infrequently cause irritation and ulcers in your stomach or esophagus. Seek immediate medical attention if any of these serious side effects occur: new/severe/worsening heartburn, chest pain, difficult/painful swallowing, stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking tiludronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate, etidronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, inability to sit upright or stand for at least 30 minutes, difficult/painful swallowing, esophagus problems (such as heartburn, narrowing of the esophagus), stomach/intestinal problems (such as ulcers), low level of calcium in the blood.

Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. If you develop jaw pain, tell your doctor and dentist immediately.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking tiludronate before your surgery. Ask for specific instructions about stopping or starting this medication.

Caution is advised if you are pregnant or planning to become pregnant in the future. This medication may stay in your body for many years. Its effects on an unborn baby are not known. Discuss the risks and benefits with your doctor before starting treatment with this medication.

It is not known if this medication passes into breast milk, and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.


Skelid Patient Information Including Side Effects

Brand Names: Skelid

Generic Name: tiludronate (Pronunciation: til UD ro nayt)

  • What is tiludronate (Skelid)?
  • What are the possible side effects of tiludronate (Skelid)?
  • What is the most important information I should know about tiludronate (Skelid)?
  • What should I discuss with my healthcare provider before taking tiludronate (Skelid)?
  • How should I take tiludronate (Skelid)?
  • What happens if I miss a dose (Skelid)?
  • What happens if I overdose (Skelid)?
  • What should I avoid while taking tiludronate (Skelid)?
  • What other drugs will affect tiludronate (Skelid)?
  • Where can I get more information?

What is tiludronate (Skelid)?

Tiludronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Tiludronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Tiludronate is used to treat Paget's disease of bone.

Tiludronate may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of tiludronate (Skelid)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tiludronate and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • difficulty or pain when swallowing;
  • pain or burning under the ribs or in the back;
  • new or worsening heartburn;
  • severe joint, bone, or muscle pain; or
  • jaw pain, numbness, or swelling.

Continue using tiludronate and talk with your doctor if you have any of these less serious side effects:

  • mild heartburn or stomach upset;
  • diarrhea, gas, or constipation;
  • mild joint or back pain; or
  • headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What is the most important information I should know about tiludronate (Skelid)?

Take tiludronate on an empty stomach, at least 2 hours before or 2 hours after eating.

Your doctor may ask you to take the medicine first thing in the morning, before you eat or drink anything or take any other medicine.

Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a tiludronate tablet.

Wait at least 2 hours after taking tiludronate before you eat or take other medicines including vitamins, calcium, or antacids. Do not take tiludronate if it has been less than 2 hours since your last meal or other medication.

Some people using medicines similar to tiludronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

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