Boniva Drug Description

BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1diphosphonic acid, monosodium salt, monohydrate with the molecular formula C₉H₂₂NO₇P₂Na•H₂O and a molecular weight of 359.24. Ibandronate sodium is a white- to off-white powder. It Pro Agra is freely soluble in water and practically insoluble in organic solvents. Ibandronate sodium has the following structural formula:

BONIVA (ibandronate sodium) is available as a white, oblong, 2.5 mg film-coated tablet for daily oral administration or as a white, oblong, 150 mg film-coated tablet for once-monthly oral administration. One 2.5 mg film-coated tablet contains 2.813 mg ibandronate monosodium monohydrate, equivalent to 2.5 mg free acid. One 150 mg film-coated tablet contains 168.75 mg ibandronate monosodium monohydrate, equivalent to 150 mg free acid. BONIVA (ibandronate sodium) also contains the following inactive ingredients: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, colloidal silicon dioxide, and purified water. The tablet film coating contains hypromellose, titanium dioxide, talc, polyethylene glycol 6000, and purified water.

SIDE EFFECTS:Stomach upset, diarrhea, pain in arms/legs, or mild flu-like symptoms (e.g., fatigue, muscle ache) may occur. If any of these effects persist or worsen, notify 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: increased or severe bone/joint/muscle pain, jaw pain, vision changes.

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

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 ibandronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (e.g., alendronate, etidronate, pamidronate, risedronate); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have the following conditions: low blood calcium levels (hypocalcemia), inability to sit upright or stand for 60 minutes, severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: disorders of the esophagus (e.g., esophageal stricture or achalasia), difficult or painful swallowing, kidney problems, stomach/intestinal disorders (e.g., ulcers).

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 ibandronate 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 ibandronate.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

BONIVA

Indication

BONIVA is a prescription medicine used to treat or prevent osteoporosis in Tadapox women after menopause. BONIVA helps increase bone mass and helps reduce the chance of having a spinal fracture (break).

It is not known how long BONIVA works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if BONIVA is still right for you.

Important Safety Information

You should not take BONIVA if you have certain problems with your esophagus (the tube that connects your mouth and stomach), low blood calcium, cannot sit or stand for at least 60 minutes, or are allergic to BONIVA or any of its ingredients.

BONIVA can cause serious side effects including problems with the esophagus, low blood calcium, bone, joint or muscle pain, severe jaw bone problems, and unusual thigh bone fractures.

Before starting BONIVA, tell your doctor if you have problems with swallowing, stomach or digestive problems, have low blood calcium, plan to have dental surgery or teeth removed or have kidney problems.

Stop taking BONIVA and tell your doctor right away if you have pain or trouble swallowing, chest pain, or severe or continuing heartburn, as these may be signs of serious upper digestive problems. Call your doctor immediately if jaw problems, hip, groin, or thigh pain develop, or if you have symptoms of low blood calcium such as spasms, twitching, cramps in your muscles, or numbness or tingling in your fingers, toes, or around your mouth.

Follow the dosing instructions for once-monthly BONIVA carefully.

The most common side effects are back pain, heartburn, stomach area pain, pain in your arms and legs, diarrhea, headache, muscle pain, and flu-like symptoms.

Talk to your doctor for more information or if you have questions about your treatment.

What is the most important information I should know about BONIVA?

BONIVA can cause serious side effects including:

• Esophagus problems
• Low calcium levels in your blood (hypocalcemia)
• Bone, joint or muscle pain
• Severe jaw bone problems (osteonecrosis)
• Unusual thigh bone fractures

• Esophagus problems.
  Some people who take BONIVA may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed.
  • It is important that you take BONIVA exactly as prescribed to help lower your chance of getting esophagus problems (see How to Take BONIVA).
  • Stop taking BONIVA and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow.
• Low calcium levels in your blood (hypocalcemia).
  BONIVA may lower the calcium levels in your blood. If you have low blood calcium before you start taking BONIVA, it may get worse during treatment. Your low blood calcium must be treated before you take BONIVA. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
  • Spasms, twitches, or cramps in your muscles
  • Numbness or tingling in your fingers, toes, or around your mouth
  Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take BONIVA. Take calcium and vitamin D as your doctor tells you to.
• Bone, joint, or muscle pain.
  Some people who take BONIVA develop severe bone, joint, or muscle pain.
• Severe jaw bone problems (osteonecrosis).
  Severe jaw bone problems may happen when you take BONIVA. Your doctor may examine your mouth before you start BONIVA. Your doctor may tell you to see your dentist before you start BONIVA. It is important for you to practice good mouth care during treatment with BONIVA.
• Unusual thigh bone fractures.
  Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.

Call your doctor right away if you have any of these side effects.