OSIMAX - Alendronate

Uses :
OSIMAX is used to prevent and treat certain types of bone loss (osteoporosis).It belongs to a class of medications called bisphosphonates, and they decrease the activity of cells which break down bone. Maintaining strong bones by slowing bone loss helps to reduce the risk of fractures. Your risk of developing osteoporosis is greater as you age, after menopause due to the lack of natural estrogen hormones , and if you are taking corticosteroid medications(e.g.,prednisone) for long periods.

What is osteoporosis ?
Simply stated, osteoporosis is a thinning and weakening of the bones that happens to all of us as we get older. If this deterioration in our bones goes untreated , our skeleton eventually will become extremely fragile, and some bones will be likely to break or fracture with very little trauma.
Although the process of bone loss begins gradually when we are in our mid to late thirties, it is so slow that it may take many years before we become aware of it. Women, generally, are at greater risk of developing osteoporosis than men develop. This is because, following the menopause,women experience a rapid loss of bone from the skeleton due to the decrease in estrogen production.
Bone loss is usually a painless process until a fracture occurs. Thus,women often are unaware that they have osteoporosis until it is brought to their attention ,suddenly,with an unexpected and painful fracture, when they are in their fifties, sixties, or seventies. The most common way that a woman may discover that she has osteoporosis is when she breaks her wrist or hip following a minor fall. Other women, as they grow older , may find themselves losing height or developing a hunched back(“ dowager’s hump”) or find that their clothes no longer fit properly. This occurs when the vertebrae– the bones that make up the spine- become so weak that a simple daily movement such as coughing or lifting may cause them to collapse. This , too, can be extremely painful. Osteoporotic fractures, particularly those of the hip and spine, often lead to significant pain and disability. Although a fracture of the wrist often will heal with little residual deformity, a patient may not make a complete recovery from a fractured hip or spine. The resulting disability may affect the individual’s ability to work and care for her family and may be so severe that she becomes dependent on family members or community caregivers.
After the menopause, almost all women are at increased risk of osteoporosis, although certain lifestyle, hereditary, or medical factors may increase your risk of developing osteoporosis and the lifestyle changes that you can make to reduce this risk. If necessary, your physician will discuss with you further options that are available to you to prevent and treat osteoporosis.

Who is at risk of developing osteoporosis?
It is a fact of life that, as we grow older, our bones become thinner and weaker. In theory, therefore , we are all at risk of developing osteoporosis . Certain factors may accelerate this process, however, and it is important that we become aware of them.

Menopause:
Women are at greater risk of developing osteoporosis than men. Of course, this does not mean that every woman will get osteoporosis , simply that osteoporosis occurs with greater frequency in women.
After the menopause, the ovaries stop producing the female hormone, estrogen. Estrogen is important for maintaining bone strength. Without estrogen, bone loses calcium- one of its most important components. If you have had a particularly early menopause (before the age of 45, for example), your bones will have lost the important benefits of estrogen much earlier than usual, and it is likely that you are at an increased risk of developing osteoporosis.
The amount of estrogen in your body may also decrease due to reasons other than the menopause. If, for example, you have had a hysterectomy, and if your ovaries were removed, you are likely to have a very low estrogen level, and your risk of osteoporosis may be higher than normal.
Women whose periods have stopped for a long time, for any reason other than pregnancy, may have weaker bones as a result of having a deficiency of estrogen during that time. If you are still having regular periods, your ovaries probably are producing enough estrogen.

Smoking / Alcohol:
We all know about the health risks associated with smoking and a high alcohol intake. In addition to all the other problems that they can cause, smoking and a regular high alcohol intake can also interfere with the body’s ability to maintain normal, healthy bones.
Smoking speeds up the rate at which you lose bone, which makes you much more likely to suffer from osteoporosis.
The strength of our bones is determined partly by the physical demands places on the skeleton. Similar to the way in which our muscles weaken if they are not used, bones need a certain amount of exercise to stay strong and healthy. People who are confined to bed or a wheelchair, or who lead a particularly inactive lifestyle, have a higher risk of developing.

Diet:
We are what we eat! To a certain extend this is true, particularly with regard to the maintenance of healthy bones.An inadequate intake of calcium in the diet deprives the body of the raw materials it needs to maintain bone mass and strength. Anyone who is nutritionally deficient or who has a low dietary intake of calcium-rich foods, such as dairy products and fresh vegetables, may be at increased risk of developing osteoporosis. In addition, as we grow older, the amount of calcium that our body needs changes. For example, a higher calcium intake is recommended for children, adolescents,women who are breast-feeding, and postmenopausal women.
As we grow older we should be more conscious about what we eat. This is because, as we age, the the ability of our digestive system to absorb the important vitamins and minerals contained in the food that we eat is reduced. Therefore, it is often easy for older persons to become malnourished, even if they think that they are eating properly.

Family History:
If your mother or grandmother suffered from osteoporosis, then you are more likely to be at an increased risk of developing the disease. How you find out if you have osteoporosis in your family ? First, your relative may have been diagnosed with osteoporosis by a physician. Because osteoporosis may be present for many years without any obvious signs or symptoms, you may have a relative who has characteristic signs of osteoporosis, such as broken bones following minor trauma, a hunched back, or height loss.

Medical History:
Some medical problems, for example, an overactive thyroid gland, liver disease, or anorexia nervosa, can cause osteoporosis. In addition, certain medications, such as steroids, when used for a long time can have a detrimental effect on bones. Steroids often are used in the long-term treatment of asthma and conditions like rheumatoid arthritis. If you have been taking steroids, you should discuss this with your physician.

Previous Fracture:
A previous broken bone, particularly of the hip, wrist, or spine, that has resulted from minor trauma may be an indication that your bones are already weak. If this is the case , the likelihood of breaking additional bones, or possibly the same bone, could be increased. Your physician will advise you on how to try to lower your chances of having more fractures.

Low Body Weight
Women who are unusually slender may be at increased risk of osteoporosis.This is because their skeleton is small to begin with. Once the bones start to thin and weaken after the menopause, they will reach a stage at which they fracture more easily than the bones in women who have a normal build.

How to take this Medication
Follow these instructions very closely to maximize the amount of drug absorbed and reduce the risk of injury to your esophagus. This medicine comes with a patient information leaflet. Read it carefully. Ask your doctor or pharmacist any questions you may have about this medicine. Take this medication by mouth once a day, after getting up for the day and before taking your first food, beverage or other medication. Take it with a full glass (6-8 oz. or 180-240 ml) of plain water. Swallow the tablet whole. Do not chew or suck on it. Then stay fully upright ( sitting, standing or walking ) for at least 30 minutes and do not lie down until after your first food of the day. Wait at least 30 minutes after taking the medication before you eat or drink anything other than plain water. Do not take this medication at bedtime or before rising for the day. It may not be absorbed and you may have side effects. Other medications, vitamins, antacids, coffee , tea , soda , mineral water and food can decrease the absorption of OSIMAX. Do not take these for at least 30 minutes after taking OSIMAX . Use this medication regulary to get the most benefit from it. Remember to use it at the same time each morning.

Indications
- Treatment and prevention of osteoporosis in postmenopausal women
- Treatment of glucocorticoid- induced osteoporosis in men and women receiving glucocorticoid in a daily dosage equivalent to 7.5 mg or greater of prednisone .
- Treatment of page’s disease of bone in men & women
Contraindications
- Abnormalities of the esophagus which delay esophageal emptying
- Inability to stand or sit upright for at least 30 minutes
- Hypersensitivity to any component of this product
- Hypocalcemia

Side Effects
Stomach pain,constipation,gas,or nausea may occur. If these effects persist or worsen,notify your doctor or pharmacist promptly.Tell your doctor immediately if any of these unlikely but serious side effects occur: an increase in muscle or bone pain, black stools,vomit that looks like coffee grounds. This medication may infrequently cause serious irritation and ulcers for the esophagus. If you notice any of the following unlikely but very serious side effects, stop taking OSIMAX and consult your doctor or pharmacist immediately: new or worsening heartburn, chest pain, trouble or painful swallowing. A serious allergic reaction to this drug is unlikely , but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include : rash, itching,swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions
Before taking OSIMAX , tell your doctor or pharmacist if you are allergic to it ; or to other bisphosphonates ; or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have : disorders of the esophagus (e.g. esophageal stricture or achalasia ), inability to stand or sit upright for at least 30 minutes, low calcium levels, severe kidney disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of : trouble swallowing, stomach/intestinal disorders(e.g., ulcers). This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:corticosteroids(e.g.,prednisone), hormone replacement (e.g., estrogens, progestins),nonsteroidal anti-inflammatory drugs (NSAIDs such as aspirin, ibuprofen). Do not start or stop any medicine without doctor or pharmacist approval.

Patient Information
These are the important things you must do to help make sure you will benefit from OSIMAX :
1- After getting up for the day , swallow your OSIMAX tablet with a full glass (6-8oz) of plain water only.
Not mineral water
Not coffee or tea
Not juice
2- After swallowing your OSIMAX tablet do not lie down – stay fully upright (sitting or standing) for at least 30 minutes and until after your first food of the day. Do not chew or suck on a tablet of OSIMAX . This will help the OSIMAX tablet reach your stomach quickly and help reduce the potential for irritation of your esophagus .
3- After swallowing your OSIMAX tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day, including antacids, calcium supplement and vitamins . OSIMAX is effective only if taken when your stomach is empty.
4- Do not take OSIMAX at bedtime or before getting up for the day.
5- If you have difficulty or pain upon swallowing ,chest pain, or new or worsening heartburn, stop taking OSIMAX and call your doctor.
6- Take one OSIMAX tablet once a day, every day.
7- It is important that you continue taking OSIMAX for as long as your doctor prescribes it. OSIMAX can treat your osteoporosis or help you from getting osteoporosis only if you continue to take it.
8- If you miss a dose do not take it later in the day. Continue your usual schedule of tablet once a day the next morning.

OSIMAX works by :
• Reducing the activity of the cells that cause bone loss
• Decreasing the faster rate of bone loss that occurs after menopause or with use of corticosteroid medications.
• Increasing the amount of bone in most patients.

These effects are seen as soon as three months after therapy with OSIMAX has begun. The effects continue as long as you keep taking OSIMAX. The density of bone is maintained or increased and the bone is less likely to fracture.

Who should not take OSIMAX?
Patients with :
• Certain disorders of the esophagus( the tube that connects your mouth with your stomach )
• Inability to stand or sit upright for at least 30 minutes
• Low levels of calcium in their blood
• Severe kidney disease
• Allergy to OSIMAX
Patients who are :
• Pregnant or Nursing
If you are pregnant or nursing , you should not be taking OSIMAX. Talk to your doctor.
Some patients may develop severe digestive reactions including irritation, inflammation or ulceration ( occasionally with bleeding ) of the esophagus.These reactions can cause chest pain. Heartburn or difficulty or pain upon swallowing. This may occur especially if patients do not drink a full glass of water with OSIMAX and/or if they lie down in less than 30 minutes or before their first food of the day. Esophageal reactions may worsen if patients continue to take OSIMAX after developing symptoms suggesting irritation of the esophagus.Side effects usually have been mild. They generally have not caused patients to stop taking OSIMAX. Some patients treated with OSIMAX experienced abdominal (stomach) pain. This is the most commonly reported side effect.
Bone, muscle or joint pain, headache, or an altered sense of taste were also experienced by some patients. Rarely, a rash (occasionally made worse by sunlight) or eye pain have occurred. Allergic reactions such as hives or, rarely, swelling of the face , lips, tongue and/ or throat which may cause difficulty in breathing or swallowing have also been reported . Mouth ulcers have occurred when the tablet was chewed or dissolved in the mouth. Anytime you have a medical problem you think may be related to OSIMAX , talk to your doctor.

How can osteoporosis be treated or prevented ?
• Medication
Your doctor has prescribed OSIMAX. OSIMAX acts specially on your bones. OSIMAX is not a hormone and does not have the benefits and risks of estrogen (hormone replacement therapy used in postmenopausal women) elsewhere in your body. In postmenopausal women, either OSIMAX or estrogen may be used to treat or prevent osteoporosis.
• Lifestyle changes
In addition to OSIMAX, your doctor may recommend one or more of the following lifestyle changes:
• Stop smoking. Smoking appears to increase the risk of osteoporosis.
• Reduce the use of alcohol. Too much alcohol appears to increase the risk of osteoporosis and injuries that may cause fractures.
• Exercise regularly. Like muscles, bones need exercise to stay strong and healthy. Exercise must be safe to prevent injuries including fractures.You should consult your doctor before you begin any exercise program.
• Eat a balanced diet. Adequate dietary calcium is important. Your doctor can advise you whether you need to change your diet or take any dietary supplements such as calcium or vitamin D.
This medication was prescribed for your particular condition. Do not use if for another condition or give the drug to others. Keep OSIMAX and all medicines out of the reach of children . If you suspect that more than the prescribed dose of this medicine has been taken, drink a full glass of milk and contact your local poison control center or emergency room immediately. Do not induce vomiting . Do not lie down.

Dosage Form
Tablets 10mg