Generic Name: alendronate and cholecalciferol (a LEN dro nayt and KOL e cal SIF er ol)
Brand Names: Fosamax Plus D

What is alendronate and cholecalciferol?

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

Cholecalciferol is form of vitamin D, and is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Alendronate and cholecalciferol is used to treat and prevent osteoporosis.

Alendronate and cholecalciferol may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about alendronate and cholecalciferol?

Do not take an alendronate and cholecalciferol tablet if you cannot sit upright or stand for at least 30 minutes. This medicine can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking the medicine.

Take the alendronate and cholecalciferol tablet first thing in the morning, at least 30 minutes 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 an alendronate and cholecalciferol tablet.

For at least the first 30 minutes after taking this medicine, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to alendronate 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.

Alendronate and cholecalciferol is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

What should I discuss with my healthcare provider before taking alendronate and cholecalciferol?

Do not take an alendronate and cholecalciferol tablet if you cannot sit upright or stand for at least 30 minutes. This medicine can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking the medicine.

Before using alendronate and cholecalciferol, tell your doctor if you have:

• low blood calcium (hypocalcemia);

• a cancer such as sarcoidosis, leukemia, lymphoma;

• a vitamin D deficiency;

• kidney disease; or

• an ulcer in your stomach or esophagus.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take alendronate and cholecalciferol.

Some people using medicines similar to alendronate 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 dental surgery or pre-existing dental problems.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take alendronate and cholecalciferol?

Take this medication exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor.

Alendronate and cholecalciferol tablets are taken once each week. Choose the day of the week that best fits your schedule. Every week, take one alendronate and cholecalciferol tablet on your chosen day.

Take the alendronate and cholecalciferol tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.

Take the tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking this medicine. Do not crush, chew, or suck the tablet. Swallow the pill whole.

After taking an alendronate and cholecalciferol tablet, carefully follow these instructions:

• Do not lie down or recline for at least 30 minutes after taking alendronate and cholecalciferol.
• Do not eat or drink anything other than plain water.
• Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking alendronate and cholecalciferol. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. Do not miss any scheduled appointments.

Alendronate and cholecalciferol is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

If you forget to take alendronate and cholecalciferol on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take take two (2) tablets in one day.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking alendronate and cholecalciferol?

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking alendronate and cholecalciferol. Do not lie down for at least 30 minutes after you take this medicine.

Alendronate and cholecalciferol side effects

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 this medicine 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.

Less serious side effects may include:

• mild heartburn, nausea, or stomach upset;

• diarrhea, gas, or constipation;

• mild joint or back pain; or

• headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect alendronate and cholecalciferol?

Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs alendronate and cholecalciferol. If you use these other medicines, do not that take them for at least 30 minutes after taking an alendronate and cholecalciferol tablet.

Before using alendronate and cholecalciferol, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

There may be other drugs that can interact with alendronate and cholecalciferol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about alendronate and cholecalciferol.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.03. Revision Date: 4/12/2009 4:45:47 PM.

Generic name: Saquinavir
Brand names: Invirase, Fortovase

Why is Fortovase prescribed?

Fortovase is used in the treatment of advanced human immunodeficiency virus (HIV) infection. HIV causes the immune system to break down so that it can no longer fight off other infections. This leads to the fatal disease known as acquired immune deficiency syndrome (AIDS).

Fortovase belongs to a class of HIV drugs called protease inhibitors, which work by interfering with an important step in the virus’s reproductive cycle. Fortovase is used in combination with other HIV drugs called nucleoside analogues (zidovudine or zalcitabine, for example). The combination produces an increase in the immune system’s vital CD4 cells (white blood cells) and reduces the amount of virus in the bloodstream. Fortovase should not be used by itself.

The active ingredient in Invirase is saquinavir mesylate, and although it’s similar to the active ingredient in Fortovase, the two drugs are not interchangeable (see “Most important fact about Fortovase”). However, the drug information provided here about Fortovase also applies to Invirase.

Most important fact about Fortovase

Fortovase will not cure an HIV infection. You will continue to face the possibility of complications, including opportunistic infections (rare infections that develop only when the immune system falters, such as certain types of pneumonia, tuberculosis, and fungal infections). Therefore, it is important that you remain under the care of a doctor and keep all your follow-up appointments.

Although they contain a similar ingredient, Fortovase and Invirase are not interchangeable. When using saquinavir as the sole protease inhibitor in a combination drug regimen, Fortovase is the recommended brand. Invirase may be used only if it is combined with ritonavir. Any switch from Invirase to Fortovase or vice versa should be made only under the supervision of your doctor.

How should you take Fortovase?

Take Fortovase exactly as prescribed by your doctor. Do not share Fortovase with anyone and do not exceed your recommended dosage. Take Fortovase with a meal or within 2 hours afterwards. This allows the drug to be properly absorbed by your body. Your doctor will perform laboratory tests before you start therapy with Fortovase and at regular intervals during your therapy to see how you are reacting to the medication.

• If you miss a dose…
  Take it as soon as possible. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take a double dose.

• Storage instructions…
  Store Fortovase in the refrigerator in a tightly closed bottle. The capsules should be used within 3 months if they’ve been allowed to reach room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Fortovase.

• Side effects may include:
  Abdominal discomfort and pain, appetite disturbance, depression, diarrhea, dizziness, fatigue, gas, headache, indigestion, mouth sores, muscle and bone pain, nausea, numbness in the arms and legs, tingling or “pins and needles” sensation, vomiting, weakness

Why should Fortovase not be prescribed?

You should not use Fortovase if you have severe liver impairment. Also, you should not take certain medications while using Fortovase (see “Possible food and drug interactions when taking Fortovase”).

If you suffer an allergic reaction to Fortovase or any of its components, you will not be able to use Fortovase.

Invirase may be used only when it’s combined with ritonavir; it cannot be added to regimens that don’t contain Norvir.

Special warnings about Fortovase

Fortovase may increase blood sugar levels. If you have diabetes, be sure to let the doctor know. Your dosage of diabetes medication may need adjustment.

Fortovase may aggravate mild-to-moderate liver problems and should be used with caution if you have such liver disorders as hepatitis or cirrhosis. Also use the drug with caution if you have severe kidney problems.

Fortovase may cause bleeding in people with hemophilia type A or B.

Patients taking protease inhibitors such as Fortovase sometimes undergo a redistribution of body fat, gaining weight around the waist, developing a pad of fat on the upper back, and losing weight in the arms and legs. The long-term health effects of these changes are still unknown.

High cholesterol and triglyceride levels have been observed in people taking Fortovase or Invirase combined with ritonavir. If you’re taking Fortovase combination, the doctor will do periodic blood tests to check for problems.

This medication does not reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Therefore, you should continue to avoid practices that could give HIV to others.

Possible food and drug interactions when taking Fortovase

Combining certain medications with Fortovase could cause serious or life-threatening reactions. The following drugs should never be used while you’re taking Fortovase:

Amiodarone
Astemizole
Bepridil
Certain migraine drugs, including dihydroergotamine and ergotamine
Cisapride
Flecainide
Midazolam
Pimozide
Propafenone
Quinidine
Terfenadine
Triazolam

The manufacturer also warns against combining Fortovase with the following:

Cholesterol-lowering drugs known as statins, such as atorvastatin, lovastatin, and simvastatin
Garlic
Rifampin
St. John’s wort

If Fortovase is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Fortovase with the following:

Antidepressants known as tricyclics, such as amitriptyline and imipramine
Carbamazepine
Calcium channel blockers, including diltiazem, nicardipine, and verapamil
Delavirdine
Dexamethasone
Erectile dysfunction medications such as sildenafil, tadalafil, and vardenafil
Efavirenz
Immunosuppressants such as cyclosporine, sirolimus, and tacrolimus
Lidocaine
Methadone
Nevirapine
Oral contraceptives
Other protease inhibitors such as indinavir, nelfinavir, and ritonavir
Phenobarbital
Phenytoin
Rifabutin
Sedatives such as alprazolam, clorazepate, and diazepam
Warfarin

Be sure to tell your doctor and pharmacist about all the medications (both prescription and over-the-counter) that you are presently taking. Alert them, too, whenever you stop taking a medication.

Special information if you are pregnant or breastfeeding

The effects of Fortovase during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, tell your doctor immediately. Do not breastfeed. HIV appears in breast milk and can be passed to a nursing infant.

Recommended dosage for Fortovase

ADULTS AND CHILDREN 16 YEARS AND OLDER

Fortovase Combined with Other Anti-HIV Drugs

The recommended dosage is 1,200 milligrams (six 200-milligram capsules), taken 3 times a day with a meal or within 2 hours afterwards. Daily doses lower than 1,200 milligrams 3 times a day are not recommended, since they will not have the same antiviral activity. You should also be taking zidovudine, zalcitabine, or another antiviral drug as directed.

Invirase Combined with Ritonavir

The recommended dosage is 1,000 milligrams (five 200-milligram capsules) taken 2 times a day with a meal or within 2 hours afterwards. Ritonavir should be taken at the same time as Invirase. Daily doses lower than 1,000 milligrams (along with 100 milligrams of ritonavir) 2 times a day are not recommended, since they will not have the same antiviral activity.

CHILDREN LESS THAN 16 YEARS OLD

Fortovase and Invirase have not been studied in children younger than 16 years old.

Overdosage

There have been no reports of Fortovase poisoning. However, any medication taken in excess can have serious consequences. If you suspect an overdose, seek emergency medical treatment immediately.

Generic name: Alendronate sodium
Brand names: Fosamax

Why is Fosamax prescribed?

Fosamax is prescribed for the prevention and treatment of osteoporosis, the brittle bone disease, in postmenopausal women. It is also used to increase bone mass in men with osteoporosis, and is prescribed for both men and women who have developed a form of osteoporosis sometimes caused by steroid medications such as prednisone. This drug can also be used to relieve Paget’s disease of bone, a painful condition that weakens and deforms the bones.

Most important fact about Fosamax

For Fosamax to be effective, you must take the tablets without food or other medications, exactly as directed.

How should you take Fosamax?

Fosamax is effective only when each tablet or bottle of oral solution is taken with a full glass of plain water first thing in the morning, at least 30 minutes before the first food, beverage, or other medication. If you can wait longer before eating or drinking, the medication will be absorbed better. Do not lie down after taking Fosamax until at least 30 minutes have passed and you’ve had something to eat.

Avoid chewing or sucking on the tablet; it can cause mouth sores.

You should take calcium and vitamin D supplements if you don’t get enough in your diet. Avoid smoking and alcohol. Weight-bearing exercise can also strengthen bones.

• If you miss a dose…
  If you are taking Fosamax on a daily basis, do not take a missed dose later in the day, Instead, skip it and go back to your regular schedule the next morning.

If you are taking Fosamax once a week, take 1 tablet or 1 bottle of oral solution the morning after you remember, then return to your original once-weekly schedule on the chosen day. Do not take 2 doses on the same day.

• Storage instructions…
  Keep the container tightly closed and store at room temperature. Do not freeze the oral solution.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue using Fosamax.

• Side effects may include:
  Abdominal pain, acid regurgitation, bone and joint pain, constipation, diarrhea, gas, indigestion, muscle pain, nausea

Why should Fosamax not be prescribed?

You should not take Fosamax if the calcium level in your blood is low. Avoid Fosamax if it causes an allergic reaction.

You will not be able to take Fosamax if you are unable to stand or sit upright for at least 30 minutes. You must also avoid the drug if your esophagus is not working properly due to strictures or achalasia (a swallowing disorder).

If you’re prone to swallowing air or choking when you drink something, you should not use the oral solution.

Special warnings about Fosamax

Fosamax is not recommended for women on hormone replacement therapy, or for women with kidney problems.

Be sure to tell your doctor if you have trouble swallowing or have any digestive problems, including heartburn or ulcers. Fosamax may cause problems in your esophagus such as inflammation, ulcers, bleeding, and in rare cases, blockage or perforation.

Arthritis of the joints (primarily in the jaw) has been reported in patients taking Fosamax. If you experience jaw pain, contact your doctor or dentist.

Fosamax may cause bone, joint, and/or muscle pain. If you develop these symptoms, talk to your doctor. Most pain stops when the drug is discontinued, but don’t stop taking it without consulting your doctor first.

Possible food and drug interactions when taking Fosamax

Combining aspirin with a Fosamax dose of more than 10 milligrams per day will increase the likelihood of stomach upset.

Calcium supplements, antacids, and some other oral medications will interfere with the absorption of Fosamax, so wait at least 30 minutes after taking Fosamax before you take anything else.

Special information if you are pregnant or breastfeeding

The effects of Fosamax during pregnancy and breastfeeding have not been adequately studied. If you are pregnant or plan to become pregnant, notify your doctor immediately. It is not known whether Fosamax appears in breast milk. The drug is not recommended for nursing mothers.

Recommended dosage for Fosamax

TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS

The usual dose of Fosamax is one 10-milligram tablet once a day, or one 70-milligram tablet or bottle of oral solution once a week. The usual dose of Fosamax Plus D is one 70-milligram tablet once a week. Treatment may continue for years.

PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS

The usual dose is one 5-milligram tablet once a day or one 35-milligram tablet once a week.

OSTEOPOROSIS IN MEN

The usual dose is one 10-milligram tablet once a day, or one 70-milligram tablet or bottle of oral solution once a week. The usual dose of Fosamax Plus D is one 70-milligram tablet once a week.

STEROID-INDUCED OSTEOPOROSIS

The usual dose is one 5-milligram tablet once a day, except for postmenopausal women not taking estrogen, who should take one 10-milligram tablet once daily.

PAGET’S DISEASE

The usual dose is 40 milligrams once a day for 6 months.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

• Symptoms of Fosamax overdose may include:
  Heartburn, inflammation of the esophagus or stomach, ulcer, upset stomach

Generic Name: Alendronate (a-LEN-droe-nate)
Brand Name: Fosamax

Fosamax Solution is used for:

Treating and preventing osteoporosis in certain patients. It may also be used for other conditions as determined by your doctor.

Fosamax Solution is a bisphosphonate. It works by slowing bone loss.

Do NOT use Fosamax Solution if:

• you are allergic to any ingredient in Fosamax Solution
• you have certain esophagus problems (eg, narrowing, blockage)
• you are unable to stand or sit upright for at least 30 minutes
• you have low blood calcium levels or severe kidney problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fosamax Solution:

Some medical conditions may interact with Fosamax Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of stomach or bowel problems (eg, inflammation, ulcer), esophagus problems (eg, heartburn, reflux disease, severe irritation), or kidney problems, or if you have difficult or painful swallowing
• if you are bedridden or have a history of aspiration
• if you have low blood vitamin D levels, cancer, anemia, blood clotting problems, an infection, or calcium metabolism problems
• if you have poor dental hygiene, other dental problems, or you will be having a dental procedure
• if you smoke or drink alcohol
• if you take a corticosteroid (eg, prednisone), or you have had or will be having chemotherapy or radiation treatment
• if you have a mental disorder or other condition that may decrease your ability to follow the dosing instructions for Fosamax Solution

Some MEDICINES MAY INTERACT with Fosamax Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of side effects, such as esophagus or stomach irritation, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fosamax Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fosamax Solution:

Use Fosamax Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Fosamax Solution. Talk to your pharmacist if you have questions about this information.
• Be sure you understand how much of Fosamax Solution to take for your dose.
• Take Fosamax Solution by mouth on an empty stomach in the morning at least 30 minutes before your first food, drink, or other medicine of the day. Do NOT take Fosamax Solution at bedtime or before you get out of bed in the morning.
• Drink at least 2 oz (1/4 cup) of plain water after you take Fosamax Solution. Do not take Fosamax Solution with mineral water, coffee, tea, or juice. Do not lie down for 30 minutes after taking Fosamax Solution and until you eat your first food of the day.
• Fosamax Solution is usually taken 1 time each week. Be sure you understand how to take Fosamax Solution. Contact your doctor or pharmacist if you have any questions.
• Continue to use Fosamax Solution even if you feel well. Do not miss any doses.
• If you miss a dose of Fosamax Solution, do not take it later in the day. Take it the morning after you remember, and then go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fosamax Solution.

Important safety information:

• Fosamax Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Fosamax Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Talk with your doctor before you drink alcohol, smoke, or use other tobacco products while taking Fosamax Solution.
• Follow the diet and exercise program given to you by your health care provider. Talk to your doctor about whether you should take a calcium and vitamin D supplement while you use Fosamax Solution.
• Talk to your doctor about the use of weight-bearing exercises to help prevent weak bones.
• Fosamax Solution may cause jaw bone problems in some patients. Your risk may be greater if you have cancer, poor dental hygiene, or certain other conditions (eg, anemia, blood clotting problems, dental problems, infection). You risk may also be greater if you use certain medicines or therapies (eg, chemotherapy, corticosteroids, radiation). Talk to your doctor about having a dental exam before you start to use Fosamax Solution. Ask your doctor any questions you may have about dental treatment while you use Fosamax Solution.
• Proper dental care is important while you are taking Fosamax Solution. Brush and floss your teeth and visit the dentist regularly.
• Fosamax Solution may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Fosamax Solution. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Tell your doctor or dentist that you take Fosamax Solution before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including bone density and blood calcium levels, may be performed while you use Fosamax Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Fosamax Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fosamax Solution while you are pregnant. It is not known if Fosamax Solution is found in breast milk. If you are or will be breast-feeding while you use Fosamax Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fosamax Solution:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bone, muscle, or joint pain; constipation; diarrhea; dizziness; feeling bloated or full; flu-like symptoms at the start of treatment; gas; headache; mild stomach pain; nausea; taste changes; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; chest pain; coughing or vomiting blood; difficult or painful swallowing; mouth sores; new, worsening, or severe heartburn; red, swollen, blistered, or peeling skin; severe bone, muscle, or joint pain; severe or persistent sore throat or stomach pain; swelling of the hands, legs, or joints; swelling or pain in the jaw.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Drink a full glass (8 oz/240 mL) of milk. Do not lie down for at least 30 minutes or as directed by your doctor. Do not try to vomit. Symptoms may include painful swallowing; severe heartburn; stomach pain or upset.

Proper storage of Fosamax Solution:

Store Fosamax Solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fosamax Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Fosamax Solution, please talk with your doctor, pharmacist, or other health care provider.
• Fosamax Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fosamax Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: calcitonin nasal (kal si TOE nin)
Brand Names: Fortical, Miacalcin Nasal

What is calcitonin nasal?

Calcitonin is a man-made form of a hormone that occurs naturally in the thyroid gland.

Calcitonin nasal is used to treat osteoporosis in women who have been in menopause for at least 5 years.

Calcitonin nasal may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about calcitonin nasal?

To make sure you are not allergic to this medication, your doctor may perform an allergy skin test before your first dose of calcitonin nasal.

Before using calcitonin nasal, tell your doctor if you have any nasal or sinus problems such as nasal deformities, a chronic infection, or nasal pain.

Avoid using any other nasal sprays or medicines at the same time you use calcitonin nasal unless your doctor has told you to.

Call your doctor at once if you have any type of severe irritation of your nose, or if you feel light-headed or faint.

Less serious nasal irritation is more likely to occur, such as minor bleeding, redness, itching, tenderness, dryness, crusting, scabs, or nasal congestion.

To be sure this medication is not causing harmful side effects to the inside of your nose, your doctor may want to check your nasal passages on a regular basis. Do not miss any scheduled visits to your doctor.

What should I discuss with my healthcare provider before using calcitonin nasal?

Do not use this medication if you are allergic to salmon calcitonin.

Before using calcitonin nasal, tell your doctor if you have any nasal or sinus problems such as nasal deformities, a chronic infection, or nasal pain.

FDA pregnancy category C. It is not known whether calcitonin nasal is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether calcitonin nasal passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use calcitonin nasal?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

To make sure you are not allergic to this medication, your doctor may perform an allergy skin test before your first dose of calcitonin nasal.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Store unopened calcitonin nasal in the refrigerator but do not allow it to freeze. Once you put the bottle and pump assembly together, you may keep the medicine at room temperature, away from light and heat. Keep the bottle upright while stored. Throw away any unused medicine after 35 days.

Before your first use of the assembled bottle and pump, you must prime the spray. Allow the medicine to reach room temperature before priming.

To prime calcitonin nasal, spray the medicine into the air and away from your face, until a fine mist appears. You will need to prime the pump only before your first use of the newly assembled bottle.

Calcitonin nasal is usually given as one spray per day into only one of your nostrils. Use the other nostril the next day and continue alternating back and forth for each daily dose.

Before each use, gently blow your nose to clear your nostrils.

Hold the nasal spray upright with your first and second fingers on each side of the pump and your thumb on the bottom of the bottle.

Gently insert the sprayer tip into the nostril but not far into your nose. Bend your head forward to aim the spray toward the back of your nose. Pump the spray unit firmly to spray the medicine into your nostril. You do not need to sniff or inhale deeply.

Calcitonin nasal spray delivers a fine mist into the nose. Even if you do not feel the spray while using it, the medication is still being absorbed by your nasal passages.

Avoid blowing your nose for several minutes after using this medication.

Each bottle contains 30 doses of calcitonin nasal. Throw away the medicine after 30 uses, even if there is still medicine left in the bottle.

To be sure this medication is not causing harmful side effects to the inside of your nose, your doctor may want to check your nasal passages on a regular basis. Do not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of calcitonin nasal is not likely to produce life-threatening side effects.

What should I avoid while using calcitonin nasal?

Avoid using any other nasal sprays or nasal medications at the same time you use calcitonin nasal unless your doctor has told you to.

Calcitonin nasal side effects

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. Call your doctor at once if you have any of these serious side effects:

• feeling light-headed, fainting; or

• severe nasal irritation.

Less serious side effects may include:

• bleeding from your nose;

• runny or stuffy nose;

• dryness, itching, tenderness, or general discomfort of your nose;

• crusting, scabs, or sores inside your nose;

• redness in or around your nose;

• warmth, redness, or tingly feeling under your skin;

• headache;

• back pain; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect calcitonin nasal?

There may be other drugs that can interact with calcitonin nasal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about calcitonin nasal.

• Remember, keep this and all other medicines out of the reach of children. Never share your medicines with others and only use this medication for the condition prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.1. Revision Date: 12/30/2009 11:52:17 AM.

Generic Name: Calcitonin-Salmon (KAL-si-TOE-nin SA-mon)
Brand Name: Examples include Fortical and Miacalcin

Fortical Spray is used for:

Treating osteoporosis (fragile or brittle bones) in certain women who have been past menopause for more than 5 years. It should be used along with adequate calcium and vitamin D intake. It may also be used for other conditions as determined by your doctor.

Fortical Spray is a polypeptide hormone. It works by stopping bone loss and increasing the density or strength of bone.

Do NOT use Fortical Spray if:

• you are allergic to any ingredient in Fortical Spray

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fortical Spray:

Some medical conditions may interact with Fortical Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Fortical Spray. However, no specific interactions with Fortical Spray are known at this time.

Ask your health care provider if Fortical Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fortical Spray:

Use Fortical Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Fortical Spray. Talk to your pharmacist if you have questions about this information.
• Before priming the pump and using a new bottle, allow the medicine to reach room temperature.
• The pump must be primed before the first use of each new bottle. To prime the pump, hold the bottle upright and press the 2 white side arms toward the bottle until a faint spray is seen. Only prime the pump before the first use of a new bottle.
• Use Fortical Spray in only 1 nostril each day. Alternate nostrils every day.
• To use Fortical Spray, hold your head in the upright position. Place the nozzle of the pump into the nostril and press the pump firmly towards the bottle. It is not necessary to inhale while spraying Fortical Spray.
• Keep track of how many doses you use from the bottle. Do not use more than 30 doses from one bottle, even if the bottle does not appear to be empty. After 30 doses, the pump may not deliver the correct amount of medicine with each spray.
• If you miss a dose of Fortical Spray, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fortical Spray.

Important safety information:

• Follow the diet program given to you by your health care provider. Fortical Spray works better if used along with calcium and vitamin D. Ask your doctor about appropriate calcium and vitamin D supplements.
• Fortical Spray may infrequently cause flushing. Check with your doctor if you develop flushing that is persistent or severe.
• Lab tests, including urine tests and nasal examinations, may be performed while you use Fortical Spray. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Fortical Spray with caution in the ELDERLY; they may be more sensitive to its effects, especially runny nose or nasal irritation or redness.
• Fortical Spray should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fortical Spray while you are pregnant. It is not known if Fortical Spray is found in breast milk. Do not breast-feed while using Fortical Spray.

Possible side effects of Fortical Spray:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back or joint pain; headache; runny nose; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); nasal irritation, soreness, or pain; nosebleeds; sores in nose.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Fortical Spray:

Store new, unassembled nasal spray bottles in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Protect from freezing. Store bottles that are in use at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in an upright position. Read the extra patient leaflet or ask your pharmacist to find out how long you can use Fortical Spray after it has been opened. Keep Fortical Spray out of the reach of children and away from pets.

General information:

• If you have any questions about Fortical Spray, please talk with your doctor, pharmacist, or other health care provider.
• Fortical Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fortical Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic name: Calcitonin-salmon
Brand names: Fortical Nasal Spray

Why is Fortical Nasal Spray prescribed?

Fortical Nasal Spray works like the hormone calcitonin, which reduces the rate of calcium loss from bones. Fortical Nasal Spray is indicated to treat bone weakening (osteoporosis) in women going through menopause for more than 5 years. Fortical Nasal Spray not only helps to stop osteoporosis, it may also reverse the disease and increase bone strength. Fortical Nasal Spray helps make bones stronger and less likely to break.

Most important fact about Fortical Nasal Spray

Although no allergic reactions have been reported with Fortical Nasal Spray, the generic ingredient calcitonin-salmon has been reported to cause serious allergic reactions such as shock, difficulty breathing, wheezing, and swelling of the throat or tongue. Seek medical attention immediately if you develop symptoms of an allergic reaction.

How should you take Fortical Nasal Spray?

Before taking the first dose, allow the bottle to reach room temperature. Remove the protective cap and clip from the bottle of Fortical Nasal Spray. Hold the bottle upright and depress the two white side arms of the pump toward the bottle at least 5 times until a full spray is produced. To use the spray, the nozzle should be carefully placed into the nostril with the head in the upright position and the pump firmly depressed toward the bottle.

• If you miss a dose…
  If you missed a dose take it as soon as you remember. Never take 2 doses at once.

• Storage instructions…
  Store the unopened medication in the refrigerator. Do not freeze. You can keep the bottle at room temperature for 30 days. Make sure it stands upright.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Fortical Nasal Spray.

• Side effects may include:
  Back pain, dizziness, dry nose with crusting, headache, nosebleeds, nasal irritation, runny nose

Why should Fortical Nasal Spray not be prescribed?

You should not take Fortical Nasal Spray if you are allergic to calcitonin-salmon.

Special warnings about Fortical Nasal Spray

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Fortical Nasal Spray. Also, talk to your doctor about your complete medical history, especially if you are nursing or will be having surgery.

Special information if you are pregnant or breastfeeding

The effects of Fortical Nasal Spray during pregnancy and breastfeeding are unknown. Talk with your doctor before taking Fortical Nasal Spray if you are pregnant, plan to become pregnant, or are breastfeeding.

Recommended dosage for Fortical Nasal Spray

ADULTS

The usual dose of Fortical Nasal Spray is 1 spray per day into your nostril, alternating nostrils daily.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

Generic Name: Metformin (met-FOR-min)
Brand Name: Examples include Fortomet and Glucophage XR

Fortomet Extended-Release Tablets are used for:

Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Fortomet Extended-Release Tablets are a biguanide antidiabetic. It works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.

Do NOT use Fortomet Extended-Release Tablets if:

• you are allergic to any ingredient in Fortomet Extended-Release Tablets
• you have congestive heart failure that is treated by medicine
• you have a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (eg, diabetic ketoacidosis), or severe dehydration
• you have had a stroke or a recent heart attack, or you are in shock
• you are 80 years old or older and have not had a kidney function test
• you will be having surgery or certain lab procedures

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fortomet Extended-Release Tablets:

Some medical conditions may interact with Fortomet Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of heart problems (eg, heart failure), lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, or lactic acidosis
• if you have vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B₁₂ levels, or anemia, or if you are dehydrated
• if you have an infection, fever, recent injury, or moderate to severe burns
• if you drink alcohol or have a history of alcohol abuse
• if you will be having surgery or certain lab procedures
• if you are taking a beta-blocker (eg, propranolol)

Some MEDICINES MAY INTERACT with Fortomet Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), insulin, isoniazid, nicotinic acid, phenothiazine (eg, chlorpromazine), phenytoin, sulfonylureas (eg, glipizide), sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high or low blood sugar may be increased
• Amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin because they may increase the risk of Fortomet Extended-Release Tablets’s side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fortomet Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fortomet Extended-Release Tablets:

Use Fortomet Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Fortomet Extended-Release Tablets. Talk to your pharmacist if you have questions about this information.
• Take Fortomet Extended-Release Tablets by mouth with the evening meal unless your doctor tells you otherwise.
• Swallow Fortomet Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Take Fortomet Extended-Release Tablets on a regular schedule to get the most benefit from it. Taking Fortomet Extended-Release Tablets at the same time each day will help you remember to take it.
• Continue to take Fortomet Extended-Release Tablets even if you feel well. Do not miss any doses.
• If you miss a dose of Fortomet Extended-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fortomet Extended-Release Tablets.

Important safety information:

• Fortomet Extended-Release Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Fortomet Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Follow the diet and exercise program given to you by your health care provider.
• Do not drink large amounts of alcohol while you use Fortomet Extended-Release Tablets. Talk to your doctor or health care provider before you drink alcohol while you use Fortomet Extended-Release Tablets.
• Tell your doctor or dentist that you take Fortomet Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Be careful not to become dehydrated, especially during hot weather or while you are being active. Dehydration may increase the risk of Fortomet Extended-Release Tablets’s side effects.
• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
• You may notice undissolved parts of Fortomet Extended-Release Tablets in your stool. This is normal and not a cause for concern.
• Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Fortomet Extended-Release Tablets exactly as prescribed, tell your doctor.
• Fortomet Extended-Release Tablets does not usually cause low blood sugar. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take Fortomet Extended-Release Tablets along with certain medicines for diabetes (eg, sulfonylureas, insulin). It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
• Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar closely and tell your doctor right away.
• Fortomet Extended-Release Tablets may commonly cause stomach upset, indigestion, nausea, vomiting, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis.
• Lab tests, including kidney function, fasting blood glucose, hemoglobin A_1c, and blood counts, may be performed while you use Fortomet Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Fortomet Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in the elderly.
• Fortomet Extended-Release Tablets should not be used in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fortomet Extended-Release Tablets while you are pregnant. It is not known if Fortomet Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Fortomet Extended-Release Tablets.

When used for long periods of time, Fortomet Extended-Release Tablets may not work as well. If your blood sugar has been under control and then becomes hard to manage, contact your doctor. Do not change the dose of your medicine without checking with your doctor.

Possible side effects of Fortomet Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; gas; headache; indigestion; nausea; stomach pain or upset; temporary metallic taste; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; dizziness or lightheadedness; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; muscle pain or weakness; slow or irregular heartbeat; unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include dizziness or lightheadedness; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or tenderness; slow or irregular heartbeat; unusual drowsiness; unusual stomach discomfort; unusual weakness or tiredness.

Proper storage of Fortomet Extended-Release Tablets:

Store Fortomet Extended-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fortomet Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Fortomet Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Fortomet Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fortomet Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: teriparatide (Subcutaneous route)

ter-i-PAR-a-tide

Commonly used brand name(s):

In the U.S.

• Forteo

Available Dosage Forms:

• Solution

Therapeutic Class: Calcium Regulator

Pharmacologic Class: Parathyroid

Uses For Forteo

Teriparatide is a synthetic form of the natural human parathyroid hormone and is used by injection to treat osteoporosis. Teriparatide forms new bone, increases bone mineral density and bone strength, and as a result reduces the chance of getting a fracture (broken bone). Teriparatide can be used by men or postmenopausal women with osteoporosis who are at high risk for having fractures. Teriparatide can be used by people who have had a fracture related to osteoporosis, or who have multiple risk factors for fracture, or who cannot use other osteoporosis treatments.

Teriparatide has been used by injection into a vein as a test to help diagnose problems of the parathyroid gland. This test determines whether you have hypoparathyroidism or a type of pseudohypoparathyroidism.

This product, for use as a test to help diagnose problems of the parathyroid gland, was withdrawn from the U.S. market in January 1997.

Before Using Forteo

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of teriparatide in the pediatric population. Safety and efficacy have not been established. Use in children or young adults is not recommended due to possible effects on growing bones .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of teriparatide in the elderly .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alkaline phosphatase (an enzyme in the blood), elevated levels or
• Bone cancer, or history of or
• Hypercalcemia (high calcium in the blood) or
• Metabolic bone disease or
• Paget’s disease (bone disease) or
• Radiation therapy of bones, history of—Should not use in these conditions.

• Urolithiasis (kidney stone), active or recent—May make this condition worse.

Proper Use of Forteo

If you are injecting this medicine yourself, use it exactly as directed by your doctor. Special patient instructions will come with the medicine. Read the directions carefully before using the medicine. Make sure you understand:

• Where to give the injection.
• How to give the injection.
• How long the injection is stable.

If you have any questions, check with your health care professional.

Do not use the medicine if you see solid particles in the liquid.

Do not use the medicine beyond the expiration date on the package.

For the first few doses, inject the medicine where you can sit or lie down right away in case you get dizzy.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For subcutaneous injection dosage form:
  • For osteoporosis:
    • Adults—20 micrograms (mcg) once daily, injected under the skin on the thigh or abdominal (gut) wall.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Throw away the teriparatide pen at 28 days after the first injection, even if there is still medicine in it. Do not use the medicine if it has been frozen.

Precautions While Using Forteo

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not inject this medicine into a vein or muscle.

This medicine may cause lightheadedness or fast heartbeats. If this happens, sit or lie down until you feel better. If you do not feel better, call your health care provider before continuing treatment.

Forteo Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal pain
• confusion
• constipation
• depression
• dry mouth
• headache
• incoherent speech
• increased urination
• loss of appetite
• metallic taste
• muscle weakness
• nausea
• thirst
• unusual tiredness
• vomiting
• weight loss

Less common

• Arm, back, or jaw pain
• chest pain or discomfort
• chest tightness or heaviness
• cough
• difficult or labored breathing
• fainting
• fast or irregular heartbeat
• fever or chills
• nausea
• shortness of breath
• sneezing
• sore throat
• sweating
• tightness in the chest
• wheezing

Incidence not known

• Hives or welts
• itching
• redness of the skin
• skin rash
• swelling or puffiness of the mouth and face

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• belching
• blurred vision
• body aches or pain
• congestion
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• dizziness
• heartburn
• hoarseness
• indigestion
• lack or loss of strength
• muscle pain or stiffness
• muscle spasm
• nervousness
• pain in the joints
• pounding in the ears
• runny nose
• tender, swollen glands in the neck
• trouble with swallowing
• voice changes

Less common

• Abdominal or stomach cramps
• back pain
• discomfort
• discouragement
• feeling of constant movement of self or surroundings
• feeling sad or empty
• indigestion
• irritability
• lack of appetite
• leg cramps
• loss of interest or pleasure
• neck pain
• rash
• sensation of spinning
• sleeplessness
• swollen mouth and tongue
• tiredness
• tooth disorder
• trouble concentrating
• trouble sleeping
• unpleasant taste
• urge to have bowel movement

Rare

• Pain at the place of injection during or following the injection
• tingling feeling in the hands and feet
• urge for bowel movement

Incidence not known

• Bruising at the injection site
• flushing
• minor bleeding at the injection site
• unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Generic Name: Multivitamins with Minerals (MUL-ti-VYE-ta-mins/MIN-er-als)
Brand Name: Examples include Centrum and Formula B Plus

Formula B Plus is used for:

Treating or preventing low levels of vitamins and minerals in the body. It may also be used for other conditions as determined by your doctor.

Formula B Plus is a vitamin and mineral supplement. It works by providing extra vitamins and minerals to the body when you do not get enough from your diet.

Do NOT use Formula B Plus if:

• you are allergic to any ingredient in Formula B Plus

Contact your doctor or health care provider right away if this applies to you.

Before using Formula B Plus:

Some medical conditions may interact with Formula B Plus. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have anemia, liver problems, or metabolism problems

Some MEDICINES MAY INTERACT with Formula B Plus. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acitretin or anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Formula B Plus
• Levodopa or penicillamine because their effectiveness may be decreased by Formula B Plus

This may not be a complete list of all interactions that may occur. Ask your health care provider if Formula B Plus may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Formula B Plus:

Use Formula B Plus as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Formula B Plus by mouth with or without food.
• If you are also taking a bisphosphonate (eg, alendronate), take Formula B Plus at least 2 hours after you take the bisphosphonate.
• If you are also taking a quinolone antibiotic (eg, ciprofloxacin) or tetracycline antibiotic (eg, minocycline), ask your doctor or pharmacist how to take them with Formula B Plus.
• If you miss a dose of Formula B Plus for 1 or more days, there is no cause for concern. If your doctor recommends that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use Formula B Plus.

Important safety information:

• Do not take large doses of vitamins while you use Formula B Plus unless your doctor tells you to.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Formula B Plus while you are pregnant. It is not known if Formula B Plus is found in breast milk. If you are or will be breast-feeding while you use Formula B Plus, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Formula B Plus:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Formula B Plus:

Store Formula B Plus at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Formula B Plus out of the reach of children and away from pets.

General information:

• If you have any questions about Formula B Plus, please talk with your doctor, pharmacist, or other health care provider.
• Formula B Plus is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Formula B Plus. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.