Free Article Directory New Zealand: September 2016

Friday, September 30, 2016

Efudex

Generic Name: fluorouracil topical (flore oh YER a sill)

Brand Names: Carac, Efudex, Efudex Occlusion Pack, Fluoroplex

What is Efudex (fluorouracil topical)?

Fluorouracil interferes with the growth of skin cells. Fluorouracil works by causing the death of cells which are growing fastest, such as abnormal skin cells.

Fluorouracil topical is used to treat scaly overgrowths of skin (actinic or solar keratoses). Fluorouracil topical may also be used in the treatment of superficial basal cell carcinoma.

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

What is the most important information I should know about Efudex (fluorouracil topical)?

Do not use fluorouracil topical on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using fluorouracil topical. Fluorouracil topical is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when fluorouracil topical was applied to mucous membrane areas by pregnant women. Do not use fluorouracil topical if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with fluorouracil topical.

Fluorouracil topical is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.

Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with fluorouracil topical. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating.

What should I discuss with my healthcare provider before using Efudex (fluorouracil topical)?

Before using fluorouracil topical, tell your doctor if you:

have ever had an allergic reaction to another form of fluorouracil topical (Carac, Efudex, Fluoroplex) or injectable fluorouracil (Adrucil, 5-FU); or

have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

You may not be able to use fluorouracil topical, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Fluorouracil topical is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when fluorouracil topical was applied to mucous membrane areas by pregnant women. Do not use fluorouracil topical if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with fluorouracil topical. It is not known whether fluorouracil topical passes into breast milk. Do not use fluorouracil topical without first talking to your doctor if you are breast-feeding a baby. The safety and effectiveness of fluorouracil topical in patients younger than 18 years of age have not been established.

How should I use Efudex (fluorouracil topical)?

Use fluorouracil topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Clean the area where you will apply fluorouracil topical. Rinse well and dry the area with a towel and wait ten minutes before applying the medication.

Wash your hands before and immediately after applying this medication, unless it is being used to treat a hand condition.

Apply fluorouracil topical to the affected area with the finger tips or a non-metal applicator, smoothing it gently onto the affected skin. Use enough to cover the entire area with a thin film.

Fluorouracil topical should not be applied on the eyelids or in the eyes, nose, or mouth. Use caution when applying fluorouracil topical around the eyes, nose, or mouth. Do not use fluorouracil topical on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using fluorouracil topical.

Do not cover the area after applying fluorouracil topical. This could cause too much medicine to be absorbed by the body and could be harmful. If a covering is needed, ask your doctor if a porous gauze dressing may be used.

A moisturizer or sun screen may be applied 2 hours after fluorouracil topical has been applied. Do not use any other skin products including creams, lotions, medications, or cosmetics unless instructed by your doctor.

The reaction of the skin treated with fluorouracil topical may be unsightly during treatment, and sometimes, for several weeks after completion of therapy.

Store fluorouracil topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not apply a double dose of this medication.

What happens if I overdose?

An overdose of fluorouracil topical is unlikely to occur. If you do suspect an overdose, or if fluorouracil topical has been ingested, call a poison control center or an emergency room for advice.

What should I avoid while using Efudex (fluorouracil topical)?

Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with fluorouracil topical. They may interfere with the treatment or increase irritation of the skin. Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with fluorouracil topical. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating.

Efudex (fluorouracil topical) side effects

Serious side effects are not likely to occur. Stop using fluorouracil topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Fluorouracil topical may cause skin irritation, dryness, scaling or peeling (exfoliation), rash, and other local reactions. Eye irritation has also been reported. If these side effects are excessive or worsen with continued treatment, contact your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Efudex (fluorouracil topical)?

Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with fluorouracil topical. They may interfere with treatment or increase irritation to the skin.

Drugs other than those listed here may also interact with fluorouracil topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Efudex resources

Efudex Side Effects (in more detail)
Efudex Use in Pregnancy & Breastfeeding
Efudex Support Group
9 Reviews for Efudex - Add your own review/rating

Efudex Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Efudex Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Efudex Prescribing Information (FDA)

Carac Prescribing Information (FDA)

Fluoroplex Prescribing Information (FDA)

Compare Efudex with other medications

Actinic Keratosis
Basal Cell Carcinoma
Skin Cancer

Where can I get more information?

Your pharmacist has additional information about fluorouracil topical written for health professionals that you may read.

See also: Efudex side effects (in more detail)

Zonnic

Zonnic may be available in the countries listed below.

Ingredient matches for Zonnic

Nicotine

Nicotine is reported as an ingredient of Zonnic in the following countries:

Sweden

International Drug Name Search

Pilo

Pilo may be available in the countries listed below.

Ingredient matches for Pilo

Pilocarpine

Pilocarpine is reported as an ingredient of Pilo in the following countries:

Tunisia

Pilocarpine hydrochloride (a derivative of Pilocarpine) is reported as an ingredient of Pilo in the following countries:

Belgium

France

International Drug Name Search

Thursday, September 29, 2016

Moxonidine Ratiopharm

Moxonidine Ratiopharm may be available in the countries listed below.

Ingredient matches for Moxonidine Ratiopharm

Moxonidine

Moxonidine is reported as an ingredient of Moxonidine Ratiopharm in the following countries:

France

International Drug Name Search

Ampyra

Ampyra is a brand name of dalfampridine, approved by the FDA in the following formulation(s):

AMPYRA (dalfampridine - tablet, extended release; oral)

Manufacturer: ACORDA

Approval date: January 22, 2010

Strength(s): 10MG ^[RLD]

Has a generic version of Ampyra been approved?

No. There is currently no therapeutically equivalent version of Ampyra available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ampyra. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Formulations and their use in the treatment of neurological diseases
Patent 5,370,879
Issued: December 6, 1994
Inventor(s): Masterson; Joseph G. & Myers; Michael
Assignee(s): Elan Corporation, plc
Pharmaceutical formulations comprise a mono- or di-aminopyridine active agent for administration on a once- or twice-daily basis for use in the treatment of neurological diseases, in particular multiple sclerosis and Alzheimer's disease. The formulations, which are suitable for oral or percutaneous administration of the active agent, include the active agent in a carrier effective to permit release of the mono- or di-aminopyridine at a rate allowing controlled absorption thereof over, on the average, not less than a 12 hour period and at a rate sufficient to achieve therapeutically effective blood levels over a period of 12-24 hours following administration.
Patent expiration dates:
- December 6, 2011
  ✓
  Drug product

Formulations and their use in the treatment of neurological diseases
Patent 5,540,938
Issued: July 30, 1996
Inventor(s): Masterson; Joseph G. & Myers; Michael
Assignee(s): Elan Corporation, plc
Pharmaceutical formulations comprise a mono- or di-aminopyridine active agent for administration on a once- or twice-daily basis for use in the treatment of neurological diseases, in particular multiple sclerosis and Alzheimer's disease. The formulations, which are suitable for oral or percutaneous administration of the active agent, include the active agent in a carrier effective to permit release of the mono- or di-aminopyridine at a rate allowing controlled absorption thereof over, on the average, not less than a 12 hour period and at a rate sufficient to achieve therapeutically effective blood levels over a period of 12-24 hours following administration.
Patent expiration dates:
- July 30, 2013
  ✓
  Patent use: IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)

Sustained release aminopyridine composition
Patent 8,007,826
Issued: August 30, 2011
Inventor(s): Blight; Andrew R. & Cohen; Ron
Assignee(s): Acorda Therapeutics, Inc.
A pharmaceutical composition which comprises a therapeutically effective amount of a aminopyridine dispersed in a release matrix, including, for example, a composition that can be formulated into a stable, sustained-release oral dosage formulation, such as a tablet which provides, upon administration to a patient, a therapeutically effective plasma level of the aminopyridine for a period of at least 12 hours, preferably 24 hours or more and the use of the composition to treat various neurological diseases.
Patent expiration dates:
- May 26, 2027
  ✓
  Patent use: IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- January 22, 2015 - NEW CHEMICAL ENTITY
- January 22, 2017 - ORPHAN DRUG EXCLUSIVITY

What is flutamide?

Flutamide is an antiandrogen. It works in the body to prevent the actions of androgens (male hormones).

Flutamide is used in the treatment of prostate cancer.

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

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

In rare cases, flutamide has caused severe liver damage resulting in death or hospitalization. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, "flu-like" symptoms, yellow skin or eyes, itching, clay-colored stools, or dark urine. These symptoms may be early signs of liver damage.

Your doctor will need to monitor your liver function with blood tests before starting treatment with flutamide, every month for the first 4 months of treatment, and periodically thereafter.

Do not stop taking this medication without first talking to your doctor.

What should I discuss with my healthcare provider before taking flutamide?

Before taking flutamide, tell your doctor if you

smoke,

have liver disease,

have glucose-6-phosphate dehydrogenase deficiency, or

have hemoglobin M deficiency.

You may not be able to take flutamide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Flutamide is not indicated for use by women. Flutamide is in the FDA pregnancy category D. This means that it is known to harm an unborn baby. Do not take flutamide if you are pregnant. Flutamide is not indicated for use by women. It is not known whether flutamide passes into breast milk. Do not take flutamide without first talking to your doctor if you are breast-feeding.

How should I take flutamide?

Take flutamide exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Take each dose with a full glass of water.

Flutamide is usually taken three times a day (every 8 hours). Follow your doctor's instructions.

Your doctor will need to monitor your liver function with blood tests before starting treatment with flutamide, every month for the first 4 months of treatment, and periodically thereafter.

Do not stop taking this medication without first talking to your doctor. Store flutamide at room temperature away from moisture and heat.

See also: Eulexin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a flutamide overdose include decreased activity, slow breathing, dizziness, watering eyes, upraised body hair, decreased appetite, vomiting, and sedation.

What should I avoid while taking flutamide?

There are no restrictions on foods, beverages, or activities while taking flutamide. Follow any special instructions given by your doctor.

Flutamide side effects

Stop taking flutamide and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take flutamide and talk to your doctor if you experience

hot flashes,

diarrhea,

skin rash,

increased skin sensitivity to sunlight,

loss of sex drive,

impotence,

lowered sperm count,

enlarged breasts,

amber or greenish discoloration of the urine,

rectal bleeding or inflammation, or

blood in the urine.

What other drugs will affect flutamide?

Before taking flutamide, tell your doctor if you are taking warfarin (Coumadin). Flutamide may interact with warfarin, and the interaction could lead to bleeding.

Drugs other than those listed here may also interact with flutamide. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Eulexin resources

Eulexin Side Effects (in more detail)
Eulexin Dosage
Eulexin Use in Pregnancy & Breastfeeding
Drug Images
Eulexin Drug Interactions
Eulexin Support Group
0 Reviews for Eulexin - Add your own review/rating

Eulexin Prescribing Information (FDA)

Eulexin Monograph (AHFS DI)

Eulexin Advanced Consumer (Micromedex) - Includes Dosage Information

Flutamide Prescribing Information (FDA)

Flutamide Professional Patient Advice (Wolters Kluwer)

Flutamide MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Eulexin with other medications

Hirsutism
Prostate Cancer

Where can I get more information?

Your pharmacist has additional information about flutamide written for health professionals that you may read.

See also: Eulexin side effects (in more detail)

Wednesday, September 28, 2016

ticarcillin and clavulanate Intravenous

tye-kar-SIL-in dye-SOE-dee-um, KLAV-ue-la-nate poe-TAS-ee-um

Commonly used brand name(s)

In the U.S.

Timentin

Timentin Novaplus

Available Dosage Forms:

Powder for Solution

Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: Ticarcillin

Uses For ticarcillin and clavulanate

Ticarcillin and clavulanate combination is used to treat bacterial infections in many different parts of the body.

Ticarcillin and clavulanate combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria or preventing their growth. However, ticarcillin and clavulanate will not work for colds, flu, or other virus infections.

ticarcillin and clavulanate is available only with your doctor's prescription.

Before Using ticarcillin and clavulanate

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 ticarcillin and clavulanate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ticarcillin and clavulanate 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ticarcillin and clavulanate combination in children. However, safety and efficacy have not been established in infants below 3 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ticarcillin and clavulanate combination in the elderly. However, elderly patients are more likely to have age-related kidney or heart problems, which may require an adjustment in the dose for patients receiving ticarcillin and clavulanate combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

Proper Use of ticarcillin and clavulanate

A nurse or other trained health professional will give you ticarcillin and clavulanate. ticarcillin and clavulanate is given through a needle placed in one of your veins.

Precautions While Using ticarcillin and clavulanate

Your doctor will check your progress closely while you are receiving ticarcillin and clavulanate. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

ticarcillin and clavulanate may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive ticarcillin and clavulanate.

Ticarcillin and clavulanate combination may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you have any medical tests, tell the doctor in charge that you are taking ticarcillin and clavulanate. The results of some tests may be affected by ticarcillin and clavulanate.

Ticarcillin and clavulanate combination may decrease the effects of some oral contraceptives (birth control pills). To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills (e.g. condoms, a diaphragm, or a contraceptive foam or jelly) while using ticarcillin and clavulanate.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

ticarcillin and clavulanate 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 or nurse immediately if any of the following side effects occur:

Rare

Blood in the urine

frequent urination

lower abdominal cramping

painful urination

Incidence not known

Abdominal or stomach cramps, pain, or tenderness

black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

bloating

changes in skin color

chest pain or discomfort

chills

clay-colored stools

convulsions

cough

dark urine

diarrhea

diarrhea, watery and severe, which may also be bloody

dizziness

fast heartbeat

fever

general tiredness and weakness

headache

increased thirst

irritability

itching

joint or muscle pain

loss of appetite

lower back or side pain

muscle twitching

nausea or vomiting

pain, tenderness, or swelling of the foot or leg

pinpoint red spots on the skin

rash

red skin lesions, often with a purple center

red, irritated eyes

restlessness

seizures

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling or inflammation of the mouth

swollen glands

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight loss

upper right abdominal pain

vomiting of blood

yellow eyes or skin

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:

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

change in taste or bad unusual or unpleasant (after) taste

difficulty with moving

excess air or gas in the stomach or intestines

full feeling

heartburn

muscle aching, cramping, or stiffness

passing gas

swollen joints

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.

More ticarcillin and clavulanate Intravenous resources

Ticarcillin and clavulanate Intravenous Use in Pregnancy & Breastfeeding
Ticarcillin and clavulanate Intravenous Drug Interactions
Ticarcillin and clavulanate Intravenous Support Group
0 Reviews for Ticarcillin and clavulanate Intravenous - Add your own review/rating

Compare ticarcillin and clavulanate Intravenous with other medications

Aspiration Pneumonia
Bacteremia
Bacterial Infection
Bone infection
Deep Neck Infection
Endometritis
Febrile Neutropenia
Intraabdominal Infection
Joint Infection
Kidney Infections
Pelvic Inflammatory Disease
Peritonitis
Pneumonia
Pneumonia with Cystic Fibrosis
Septicemia
Skin Infection
Urinary Tract Infection

Mexyl

Mexyl may be available in the countries listed below.

Ingredient matches for Mexyl

Hexamidine

Hexamidine diisetionate (a derivative of Hexamidine) is reported as an ingredient of Mexyl in the following countries:

Peru

International Drug Name Search

Fosamax Plus D

Generic Name: alendronate and cholecalciferol (a LEN dro nate 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 a 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 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.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate and cholecalciferol. You may need to stop using the medicine for a short time.

Talk with your doctor about the risks and benefits of using this medication.

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

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

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.

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.

Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether alendronate and cholecalciferol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. 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 exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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. Visit your doctor regularly.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate and cholecalciferol. You may need to stop using the medicine for a short time.

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 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 two (2) tablets in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. 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 alendronate and cholecalciferol and call your doctor at once if you have a serious side effect such as:

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;

new or unusual pain in your thigh or hip; 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. 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 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), ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with alendronate and cholecalciferol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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Osteoporosis

Where can I get more information?

Your pharmacist can provide more information about alendronate and cholecalciferol.

See also: Fosamax Plus D side effects (in more detail)

Sodium Chloride Inhalation Solution

Sodium Chloride Inhalation Solution 0.9% 3 mL

PRODUCT CODE 0378-6985-01

Sodium Chloride

Inhalation Solution

USP

0.9% 3 mL

For Respiratory Therapy

Not for parenteral administration.

3 mL, 100 Vials

Sterile

Unit-Dose Vial

Sodium Chloride Inhalation Solution USP

0.9% 3 mL

Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy.

No bacteriostatic agent or other preservative added.

INDICATIONS: Contents of these vials are for use in respiratory therapy and for tracheal lavage.

WARNING: Not for injection or in preparations to be used for injection.

DIRECTIONS FOR USE: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume.

Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup.

HOW SUPPLIED: Single-use plastic vials containing 3 mL or 5 mL solutions supplied in cartons of 100 vials and 15 mL solution supplied in cartons of 50 vials.

PRODUCT CODE 0378-6985-01 Sodium Chloride Inhalation Solution USP 0.9%, 3 mL

PRODUCT CODE 0378-6986-01 Sodium Chloride Inhalation Solution USP 0.9%, 5 mL

PRODUCT CODE 0378-6987-89 Sodium Chloride Inhalation Solution USP 0.9%, 15 mL

Internal contents sterile. External surface of vial not sterile.

STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).

Rx Only

Manufactured by: Catalent, Woodstock, IL 60098 Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505

DYM:6985:100C:R2

Sodium Chloride Inhalation Solution 0.9% 5 mL

PRODUCT CODE 0378-6986-01

Sodium Chloride

Inhalation Solution

USP

0.9% 5 mL

For Respiratory Therapy

Not for parenteral administration.

5 mL, 100 Vials

Sterile

Unit-Dose Vial

Sodium Chloride Inhalation Solution USP

0.9% 5 mL

Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy.

No bacteriostatic agent or other preservative added.

INDICATIONS: Contents of these vials are for use in respiratory therapy and for tracheal lavage.

WARNING: Not for injection or in preparations to be used for injection.

DIRECTIONS FOR USE: To verify container integrity, squeeze the vial before use.

Twist cap completely off vial, invert and squeeze prescribed volume.

Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup.

HOW SUPPLIED: Single-use plastic vials containing 3 mL or 5 mL solutions supplied in cartons of 100 vials and 15 mL solution supplied in cartons of 50 vials.

Internal contents sterile. External surface of vial not sterile.

STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).

Rx Only

Manufactured by: Catalent, Woodstock, IL 60098 Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505

DYM:6986:100C:R2

Sodium Chloride Inhalation Solution 0.9% 15 mL

PRODUCT CODE 0378-6987-89

Sodium Chloride

Inhalation Solution

USP

0.9% 15 mL

For Respiratory Therapy

Not for parenteral administration.

15 mL, 50 Vials

Sterile

Unit-Dose Vial

Sodium Chloride Inhalation Solution USP

0.9% 15 mL