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Stieva-A Cream Forte

30/06/10

Generic Name: tretinoin (Topical route)

TRET-i-noin

Oral routeCapsule, Liquid Filled

Experienced Physician and Institution
- Patients with acute promyelocytic leukemia (APL) are at high risk in general and can have severe adverse reactions to tretinoin. tretinoin should therefore be administered only to patients with APL under the strict supervision of a physician who is experienced in the management of patients with acute leukemia and ni a facility with laboratory and supportive services sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity, including respiratory compromise. Use of tretinoin requires that the physician concludes that the possible benefit to the patient outweighs the following known adverse effects of the therapy.
Retinoic Acid-APL Syndrome
- About 25% of patients with APL treated with tretinoin have experienced a syndrome called the retinoic acid-APL (RA-APL) syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal and multi-organ failure. This syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension. It has been observed with or without concomitant leukocytosis. Endotracheal intubation and mechanical ventilation have been required in some cases due to progressive hypoxemia, and several patients have expired with multi-organ failure. The syndrome generally occurs during the first month of treatment, with some cases reported following the first dose of tretinoin.
- The management of the syndrome has not been defined rigorously, but high-dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality. At the first signs suggestive of the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), high-dose steroids (dexamethasone 10 mg intravenously administered every 12 hours for 3 days or until the resolution of symptoms) should be immediately initiated, irrespective of the leukocyte count. The majority of patients do not require termination of tretinoin therapy during treatment of the RA-APL syndrome. However, in cases of moderate and severe RA-APL syndrome, temporary interruption of tretinoin therapy should be considered.
Leukocytosis at Presentation and Rapidly Evolving Leukocytosis During Tretinoin Treatment
- During tretinoin treatment about 40% of patients will develop rapidly evolving leukocytosis. Patients who present with high WBC at diagnosis (greater than 5×10(9)/L) have an increased risk of a further rapid increase in WBC counts. Rapidly evolving leukocytosis is associated with a higher risk of life-threatening complications.
- If signs and symptoms of the RA-APL syndrome are present together with leukocytosis, treatment with high-dose steroids should be initiated immediately. Some investigators routinely add chemotherapy to tretinoin treatment in the case of patients presenting with a WBC count of greater than 5×10(9)/L or in the case of a rapid increase in WBC count for patients leukopenic at start of treatment, and have reported a lower incidence of the RA-APL syndrome. Consideration could be given to adding full-dose chemotherapy (including an anthracycline if not contraindicated) to the tretinoin therapy on day 1 or 2 for patients presenting with a WBC count of greater than 5×10(9)/L, or immediately, for patients presenting with a WBC count of less than 5×10(9)/L, if the WBC count reaches greater than or equal to 6×10(9)/L by day 5, or greater than or equal to 10×10(9)/L by day 10, or greater than or equal to 15×10(9)/L by day 28.
Teratogenic Effects. Pregnancy Category D
- There is a high risk that a severely deformed infant will result if tretinoin is administered during pregnancy. If, nonetheless, it is determined that tretinoin represents the best available treatment for a pregnant woman or a woman of childbearing potential, it must be assured that the patient has received full information and warnings of the risk to the fetus if she were to be pregnant and of the risk of possible contraception failure and has been instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy, and has acknowledged her understanding of the need for using dual contraception, unless abstinence in the chosen method.
- Within 1 week prior to the institution of tretinoin therapy, the patient should have blood or urine collected for a serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL. When possible, tretinoin therapy should be delayed until a negative result from this test is obtained. When a delay is not possible, the patient should be placed on two reliable forms of contraception. Pregnancy testing and contraception counseling should be repeated monthly throughout the period of tretinoin treatment.

Patients with acute promyelocytic leukemia (APL) can have severe adverse reactions to tretinoin including retinoic acid-APL (RA-APL) syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal and multi-organ failure. High-dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality. Patients can also develop rapidly evolving leukocytosis during therapy which can lead to an increased risk of life-threatening complications. There is a high risk that a severely deformed infant will result if tretinoin is administered during pregnancy. Pregnancy testing is necessary prior to initiation of treatment in women of childbearing potential and the patient must be instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy. Pregnancy testing and contraception counseling should be repeated monthly throughout the period of tretinoin treatment .

Commonly used brand name(s):

In the U.S.

Atralin
Avita
Refissa
Renova
Retin-A
Retin-A Micro
Tretin-X

In Canada

Rejuva-A
Stieva-A Cream
Stieva-A Cream Forte
Stieva-A Gel
Stieva-A Solution
Vitamin A Acid

Available Dosage Forms:

Gel/Jelly
Solution
Liquid
Cream

Therapeutic Class: Dermatological Agent

Chemical Class: Retinoid

Uses For Stieva-A Cream Forte

Tretinoin is used to treat acne. It works partly by keeping skin pores clear.

One of the tretinoin creams is used to treat fine wrinkles, dark spots, or rough skin on the face caused by damaging rays of the sun. It works by lightening the skin, replacing older skin with newer skin, and by slowing down the way the body removes skin cells that may have been harmed by the sun. Tretinoin works best when used within a skin care program that includes protecting the treated skin from the sun. However, it does not completely or permanently erase these skin problems or greatly improve more obvious changes in the skin, such as deep wrinkles caused by sun or the natural aging process.

Tretinoin may also be used to treat other skin diseases as determined by your doctor.

Tretinoin is available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, tretinoin is used in certain patients with the following medical conditions:

Keratosis follicularis (skin disorder of small, red bumps)
Verruca plana (flat warts)

Before Using Stieva-A Cream Forte

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups. Children are unlikely to have skin problems due to the sun. In older children treated for acne, tretinoin is not expected to cause different side effects or problems than it does in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of tretinoin in patients 50 years of age and older with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aminocaproic Acid
Aprotinin
Tetracycline
Tranexamic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Fluconazole
Ketoconazole
Voriconazole

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 tretinoin

This section provides information on the proper use of a number of products that contain tretinoin. It may not be specific to Stieva-A Cream Forte. Please read with care.

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause irritation of the skin.

Do not apply this medicine to windburned or sunburned skin or on open wounds.

Do not use this medicine in or around the eyes or lips, or inside of the nose. Spread the medicine away from these areas when applying. If the medicine accidentally gets on these areas, wash with water at once.

This medicine usually comes with patient directions. Read them carefully before using the medicine.

Before applying tretinoin, wash the skin with a mild soap or cleanser and warm water by using the tips of your fingers. Then gently pat dry. Do not scrub your face with a sponge or washcloth. Wait 20 to 30 minutes before applying this medicine to make sure the skin is completely dry. Applying tretinoin to wet skin can irritate the skin.

To use the cream or gel form of this medicine:

Apply just enough medicine to very lightly cover the affected areas, and rub in gently but well. A pea-sized amount is enough to cover the whole face.

To use the solution form of this medicine:

Using your fingertips, a gauze pad, or a cotton swab, apply enough tretinoin solution to cover the affected areas. If you use a gauze pad or a cotton swab for applying the medicine, avoid getting it too wet. This will help prevent the medicine from running into areas not intended for treatment.

After applying the medicine, wash your hands to remove any medicine that might remain on them.

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 topical dosage forms (cream, gel, or solution):
- For acne:
  - Adults and teenagers—Apply to the affected area(s) of the skin once a day, at bedtime.
For cream dosage form (brand name Renova only):
- For fine wrinkles, dark spots, or rough skin caused by the sun:
  - Adults up to 50 years of age—Apply to the affected area(s) of the skin once a day, at bedtime.
  - Adults 50 years of age and older—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

The gel product is flammable and should be kept away from fire or excessive heat.

Precautions While Using Stieva-A Cream Forte

During the first 3 weeks you are using tretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. It may take longer than 12 weeks before you notice full improvement of your acne, even if you use the medicine every day. Check with your health care professional at any time skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks.

You should avoid washing the skin treated with tretinoin for at least 1 hour after applying it.

Avoid using any topical medicine on the same area within 1 hour before or after using tretinoin. Otherwise, tretinoin may not work properly or skin irritation might occur.

Unless your doctor tells you otherwise, it is especially important to avoid using the following skin products on the same area as tretinoin:

Any other topical acne product or skin product containing a peeling agent (such as benzoyl peroxide, resorcinol, salicylic acid, or sulfur)
Hair products that are irritating, such as permanents or hair removal products
Skin products that cause sensitivity to the sun, such as those containing spices or limes
Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions
Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers

Using these products along with tretinoin may cause mild to severe irritation of the skin. Although skin irritation can occur, some doctors sometimes allow benzoyl peroxide to be used with tretinoin to treat acne. Usually tretinoin is applied at night so that it does not cause a problem with any other topical products that you might use during the day. Check with your doctor before using topical medicines with tretinoin.

During the first 6 months of use, avoid overexposing the treated areas to sunlight, wind, or cold weather. The skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks. However, you should not stop using this medicine unless the skin irritation becomes too severe. Do not use a sunlamp .

To help tretinoin work properly, regularly use sunscreen or sunblocking lotions with a sun protection factor (SPF) of at least 15. Also, wear protective clothing and hats, and apply creams, lotions, or moisturizers often.

Check with your doctor at any time your skin becomes too dry and irritated. Your health care professional can help you choose the right skin products for you to reduce skin dryness and irritation and may include the following:

For patients using tretinoin for the treatment of acne:
- Regular use of water-based creams or lotions helps to reduce skin irritation or dryness that may be caused by the use of tretinoin.
For patients using tretinoin for the treatment of fine wrinkling, dark spots, and rough skin caused by the sun:
- This medicine should be used as part of an ongoing program to avoid further damage to your skin from the sun. This program includes staying out of the sun when possible or wearing proper clothing or hats to protect your skin from sunlight.
- Regular use of oil-based creams or lotions helps to reduce skin irritation or dryness caused by the use of tretinoin.

Stieva-A Cream Forte Side Effects

In some animal studies, tretinoin has been shown to cause skin tumors to develop faster when the treated area is exposed to ultraviolet light (sunlight or artificial sunlight from a sunlamp). Other studies have not shown the same result and more studies need to be done. It is not known if tretinoin causes skin tumors to develop faster in humans.

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 as soon as possible if any of the following side effects occur:

More common

Burning feeling or stinging skin (severe)
lightening of skin of treated area, unexpected
peeling of skin (severe)
redness of skin (severe)
unusual dryness of skin (severe)

Rare

Darkening of treated 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:

More common

Burning feeling, stinging, or tingling of skin (mild)—lasting for a short time after first applying the medicine
chapping or slight peeling of skin (mild)
redness of skin (mild)
unusual dryness of skin (mild)
unusually warm skin (mild)

The side effects will go away after you stop using tretinoin. On the rare chance that your skin color changes, this effect may last for several months before your skin color returns to normal.

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.

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Stieva-A Gel

30/06/10

Generic Name: tretinoin (Topical route)

TRET-i-noin

Oral routeCapsule, Liquid Filled

Experienced Physician and Institution
- Patients with acute promyelocytic leukemia (APL) are at high risk in general and can have severe adverse reactions to tretinoin. tretinoin should therefore be administered only to patients with APL under the strict supervision of a physician who is experienced in the management of patients with acute leukemia and ni a facility with laboratory and supportive services sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity, including respiratory compromise. Use of tretinoin requires that the physician concludes that the possible benefit to the patient outweighs the following known adverse effects of the therapy.
Retinoic Acid-APL Syndrome
- About 25% of patients with APL treated with tretinoin have experienced a syndrome called the retinoic acid-APL (RA-APL) syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal and multi-organ failure. This syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension. It has been observed with or without concomitant leukocytosis. Endotracheal intubation and mechanical ventilation have been required in some cases due to progressive hypoxemia, and several patients have expired with multi-organ failure. The syndrome generally occurs during the first month of treatment, with some cases reported following the first dose of tretinoin.
- The management of the syndrome has not been defined rigorously, but high-dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality. At the first signs suggestive of the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), high-dose steroids (dexamethasone 10 mg intravenously administered every 12 hours for 3 days or until the resolution of symptoms) should be immediately initiated, irrespective of the leukocyte count. The majority of patients do not require termination of tretinoin therapy during treatment of the RA-APL syndrome. However, in cases of moderate and severe RA-APL syndrome, temporary interruption of tretinoin therapy should be considered.
Leukocytosis at Presentation and Rapidly Evolving Leukocytosis During Tretinoin Treatment
- During tretinoin treatment about 40% of patients will develop rapidly evolving leukocytosis. Patients who present with high WBC at diagnosis (greater than 5×10(9)/L) have an increased risk of a further rapid increase in WBC counts. Rapidly evolving leukocytosis is associated with a higher risk of life-threatening complications.
- If signs and symptoms of the RA-APL syndrome are present together with leukocytosis, treatment with high-dose steroids should be initiated immediately. Some investigators routinely add chemotherapy to tretinoin treatment in the case of patients presenting with a WBC count of greater than 5×10(9)/L or in the case of a rapid increase in WBC count for patients leukopenic at start of treatment, and have reported a lower incidence of the RA-APL syndrome. Consideration could be given to adding full-dose chemotherapy (including an anthracycline if not contraindicated) to the tretinoin therapy on day 1 or 2 for patients presenting with a WBC count of greater than 5×10(9)/L, or immediately, for patients presenting with a WBC count of less than 5×10(9)/L, if the WBC count reaches greater than or equal to 6×10(9)/L by day 5, or greater than or equal to 10×10(9)/L by day 10, or greater than or equal to 15×10(9)/L by day 28.
Teratogenic Effects. Pregnancy Category D
- There is a high risk that a severely deformed infant will result if tretinoin is administered during pregnancy. If, nonetheless, it is determined that tretinoin represents the best available treatment for a pregnant woman or a woman of childbearing potential, it must be assured that the patient has received full information and warnings of the risk to the fetus if she were to be pregnant and of the risk of possible contraception failure and has been instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy, and has acknowledged her understanding of the need for using dual contraception, unless abstinence in the chosen method.
- Within 1 week prior to the institution of tretinoin therapy, the patient should have blood or urine collected for a serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL. When possible, tretinoin therapy should be delayed until a negative result from this test is obtained. When a delay is not possible, the patient should be placed on two reliable forms of contraception. Pregnancy testing and contraception counseling should be repeated monthly throughout the period of tretinoin treatment.

Commonly used brand name(s):

In the U.S.

Atralin
Avita
Refissa
Renova
Retin-A
Retin-A Micro
Tretin-X

In Canada

Rejuva-A
Stieva-A Cream
Stieva-A Cream Forte
Stieva-A Gel
Stieva-A Solution
Vitamin A Acid

Available Dosage Forms:

Gel/Jelly
Solution
Liquid
Cream

Therapeutic Class: Dermatological Agent

Chemical Class: Retinoid

Uses For Stieva-A Gel

Tretinoin is used to treat acne. It works partly by keeping skin pores clear.

Tretinoin may also be used to treat other skin diseases as determined by your doctor.

Tretinoin is available only with your doctor’s prescription.

Keratosis follicularis (skin disorder of small, red bumps)
Verruca plana (flat warts)

Before Using Stieva-A Gel

Allergies

Pediatric

Geriatric

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Interactions with Medicines

Aminocaproic Acid
Aprotinin
Tetracycline
Tranexamic Acid

Fluconazole
Ketoconazole
Voriconazole

Interactions with Food/Tobacco/Alcohol

Proper Use of tretinoin

This section provides information on the proper use of a number of products that contain tretinoin. It may not be specific to Stieva-A Gel. Please read with care.

Do not apply this medicine to windburned or sunburned skin or on open wounds.

This medicine usually comes with patient directions. Read them carefully before using the medicine.

To use the cream or gel form of this medicine:

Apply just enough medicine to very lightly cover the affected areas, and rub in gently but well. A pea-sized amount is enough to cover the whole face.

To use the solution form of this medicine:

Using your fingertips, a gauze pad, or a cotton swab, apply enough tretinoin solution to cover the affected areas. If you use a gauze pad or a cotton swab for applying the medicine, avoid getting it too wet. This will help prevent the medicine from running into areas not intended for treatment.

After applying the medicine, wash your hands to remove any medicine that might remain on them.

Dosing

For topical dosage forms (cream, gel, or solution):
- For acne:
  - Adults and teenagers—Apply to the affected area(s) of the skin once a day, at bedtime.
For cream dosage form (brand name Renova only):
- For fine wrinkles, dark spots, or rough skin caused by the sun:
  - Adults up to 50 years of age—Apply to the affected area(s) of the skin once a day, at bedtime.
  - Adults 50 years of age and older—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

The gel product is flammable and should be kept away from fire or excessive heat.

Precautions While Using Stieva-A Gel

You should avoid washing the skin treated with tretinoin for at least 1 hour after applying it.

Avoid using any topical medicine on the same area within 1 hour before or after using tretinoin. Otherwise, tretinoin may not work properly or skin irritation might occur.

Unless your doctor tells you otherwise, it is especially important to avoid using the following skin products on the same area as tretinoin:

Any other topical acne product or skin product containing a peeling agent (such as benzoyl peroxide, resorcinol, salicylic acid, or sulfur)
Hair products that are irritating, such as permanents or hair removal products
Skin products that cause sensitivity to the sun, such as those containing spices or limes
Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions
Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers

For patients using tretinoin for the treatment of acne:
- Regular use of water-based creams or lotions helps to reduce skin irritation or dryness that may be caused by the use of tretinoin.
For patients using tretinoin for the treatment of fine wrinkling, dark spots, and rough skin caused by the sun:
- This medicine should be used as part of an ongoing program to avoid further damage to your skin from the sun. This program includes staying out of the sun when possible or wearing proper clothing or hats to protect your skin from sunlight.
- Regular use of oil-based creams or lotions helps to reduce skin irritation or dryness caused by the use of tretinoin.

Stieva-A Gel 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 as soon as possible if any of the following side effects occur:

More common

Burning feeling or stinging skin (severe)
lightening of skin of treated area, unexpected
peeling of skin (severe)
redness of skin (severe)
unusual dryness of skin (severe)

Rare

Darkening of treated skin

More common

Burning feeling, stinging, or tingling of skin (mild)—lasting for a short time after first applying the medicine
chapping or slight peeling of skin (mild)
redness of skin (mild)
unusual dryness of skin (mild)
unusually warm skin (mild)

The side effects will go away after you stop using tretinoin. On the rare chance that your skin color changes, this effect may last for several months before your skin color returns to normal.

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.

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Sterapred

30/06/10

Generic Name: prednisone (PRED ni sone)
Brand Names: Meticorten, Sterapred, Sterapred DS

What is Sterapred (prednisone)?

Prednisone is in a class of drugs called steroids. Prednisone prevents the release of substances in the body that cause inflammation.

Prednisone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

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

What is the most important information I should know about Sterapred (prednisone)?

You should not use this medication if you are allergic to prednisone, or if you have a fungal infection anywhere in your body.

Before taking prednisone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a “live” vaccine while you are taking prednisone. Vaccines may not work as well while you are taking a steroid.

What should I discuss with my healthcare provider before taking Sterapred (prednisone)?

You should not use this medication if you are allergic to prednisone, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take prednisone:

liver disease (such as cirrhosis);
kidney disease;
a thyroid disorder;
diabetes;
a history of malaria;
tuberculosis;
osteoporosis;
a muscle disorder such as myasthenia gravis;
glaucoma or cataracts;
herpes infection of the eyes;
stomach ulcers, ulcerative colitis, or diverticulitis;
depression or mental illness;
congestive heart failure; or
high blood pressure

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

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I take Sterapred (prednisone)?

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

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

Measure the liquid form of prednisone with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using prednisone.

Do not stop using prednisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking steroid medication. Store prednisone at room temperature away from moisture and heat.

What happens if I miss a dose?

If you miss a dose or forget to take your medicine, contact your doctor or pharmacist for instructions.

What happens if I overdose?

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

A single large dose of prednisone is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking Sterapred (prednisone)?

Do not receive a “live” vaccine while you are being treated with prednisone. Vaccines may not work as well while you are taking a steroid.

Avoid drinking alcohol while you are taking prednisone.

Sterapred (prednisone) 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:

problems with your vision;
swelling, rapid weight gain, feeling short of breath;
severe depression, unusual thoughts or behavior, seizure (convulsions);
bloody or tarry stools, coughing up blood;
pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

sleep problems (insomnia), mood changes;
acne, dry skin, thinning skin, bruising or discoloration;
slow wound healing;
increased sweating;
headache, dizziness, spinning sensation;
nausea, stomach pain, bloating; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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 Sterapred (prednisone)?

There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:

aspirin (taken on a daily basis or at high doses);
a diuretic (water pill);
a blood thinner such as warfarin (Coumadin);
cyclosporine (Gengraf, Neoral, Sandimmune);
insulin or diabetes medications you take by mouth;
ketoconazole (Nizoral);
rifampin (Rifadin, Rifater, Rifamate, Rimactane); or
seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

This list is not complete and there may be other drugs that can interact with prednisone. 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 prednisone.

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.

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Sterapred DS

30/06/10

Generic Name: prednisone (PRED ni sone)
Brand Names: Meticorten, Sterapred, Sterapred DS

What is Sterapred DS (prednisone)?

Prednisone is in a class of drugs called steroids. Prednisone prevents the release of substances in the body that cause inflammation.

Prednisone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

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

What is the most important information I should know about Sterapred DS (prednisone)?

You should not use this medication if you are allergic to prednisone, or if you have a fungal infection anywhere in your body.

Do not receive a “live” vaccine while you are taking prednisone. Vaccines may not work as well while you are taking a steroid.

What should I discuss with my healthcare provider before taking Sterapred DS (prednisone)?

You should not use this medication if you are allergic to prednisone, or if you have a fungal infection anywhere in your body.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take prednisone:

liver disease (such as cirrhosis);
kidney disease;
a thyroid disorder;
diabetes;
a history of malaria;
tuberculosis;
osteoporosis;
a muscle disorder such as myasthenia gravis;
glaucoma or cataracts;
herpes infection of the eyes;
stomach ulcers, ulcerative colitis, or diverticulitis;
depression or mental illness;
congestive heart failure; or
high blood pressure

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I take Sterapred DS (prednisone)?

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Measure the liquid form of prednisone with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using prednisone.

What happens if I miss a dose?

If you miss a dose or forget to take your medicine, contact your doctor or pharmacist for instructions.

What happens if I overdose?

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

What should I avoid while taking Sterapred DS (prednisone)?

Do not receive a “live” vaccine while you are being treated with prednisone. Vaccines may not work as well while you are taking a steroid.

Avoid drinking alcohol while you are taking prednisone.

Sterapred DS (prednisone) side effects

problems with your vision;
swelling, rapid weight gain, feeling short of breath;
severe depression, unusual thoughts or behavior, seizure (convulsions);
bloody or tarry stools, coughing up blood;
pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

sleep problems (insomnia), mood changes;
acne, dry skin, thinning skin, bruising or discoloration;
slow wound healing;
increased sweating;
headache, dizziness, spinning sensation;
nausea, stomach pain, bloating; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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 Sterapred DS (prednisone)?

There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:

aspirin (taken on a daily basis or at high doses);
a diuretic (water pill);
a blood thinner such as warfarin (Coumadin);
cyclosporine (Gengraf, Neoral, Sandimmune);
insulin or diabetes medications you take by mouth;
ketoconazole (Nizoral);
rifampin (Rifadin, Rifater, Rifamate, Rimactane); or
seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

Where can I get more information?

Your pharmacist can provide more information about prednisone.

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.

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Sterile Saline Diluent Tip-Lok Syringe

30/06/10

Generic Name: sodium chloride (Injection route)

SOE-dee-um KLOR-ide

Commonly used brand name(s):

In the U.S.

Sterile Saline Diluent Tip-Lok Syringe
Syrex

Available Dosage Forms:

Solution

Therapeutic Class: Parenteral Electrolyte, Sodium

Uses For Sterile Saline Diluent Tip-Lok Syringe

Sodium chloride as a 20% solution is given by injection into the uterus to cause abortion. It is to be administered only by or under the immediate care of your doctor.

Before Using Sterile Saline Diluent Tip-Lok Syringe

Allergies

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

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

Proper Use of sodium chloride

This section provides information on the proper use of a number of products that contain sodium chloride. It may not be specific to Sterile Saline Diluent Tip-Lok Syringe. Please read with care.

During the procedure, you will be awake and asked questions about how you are doing by the health care team. This helps them to react quickly to any problems you might have and to keep side effects to a minimum.

Dosing

Precautions While Using Sterile Saline Diluent Tip-Lok Syringe

Do not have sexual intercourse and avoid using tampons or douches for 2 to 3 weeks after the abortion to allow your body time to heal. This will also help protect you from getting an infection of the vagina or uterus.

Spotting (or slight bleeding from the uterus) is normal after the abortion. This may continue for 2 weeks. Heavier spotting or uterine bleeding should be reported to your health care professional.

Contraception should be considered for the near future because you may ovulate before your first menstrual period. Your first menstrual period will occur 4 to 6 weeks after the abortion.

Sterile Saline Diluent Tip-Lok Syringe 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:

Less common

Excessive blood loss
fever

Rare

Anxiety
burning pain in lower abdomen
chest pain, severe
chills
confusion
convulsions (seizures)
coughing
dizziness
feeling of heat
feeling of warmth in lips and tongue
headache (severe or dull)
nervousness
numbness of the fingertips
pain in lower back, pelvis, or stomach
ringing in the ears
shortness of breath
sweating
thirst (sudden) or salty taste
unconsciousness
vision problems
weakness

After the procedure is completed, some side effects may occur that need medical attention. Check with your doctor if you notice any of the following side effects:

Abdominal cramping
bad smelling discharge from vagina
bleeding at place of injection
chills or shivering
fever
increase in bleeding from the uterus
pain in lower abdomen
passing of pieces of tissue from the uterus
redness at place of injection

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.

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Sterile Talc

30/06/10

Dosage Form: Powder

Prescribing Information
NDC 63256-200-05
Cat. # 1690

For Intrapleural Administration Only

Sterile Talc Description

Sterile Talc Powder is a sclerosing agent intended for intrapleural administration supplied in a single use 100 mL brown glass bottle, sealed with a gray, 20 mm stopper and covered with a flip-off seal. Each bottle contains a minimum of 5.0 g of Talc USP (Ultra 2000 Talc), either white or off-white to light gray, asbestos-free and brucite-free grade of talc of controlled particle size. The composition of the talc is ≥ 95% talc as hydrated magnesium silicate. The empirical formula of talc is Mg3 Si4 010 (OH)2 with a molecular weight of 379.3. Associated naturally occurring minerals include chlorite (hydrated aluminum and magnesium silicate.), dolomite (calcium and magnesium carbonate), calcite (calcium carbonate) and quartz. Talc is practically insoluble in water and in dilute solutions of acids and alkali hydroxides. The finished product has been sterilized by gamma irradiation.

Sterile Talc – Clinical Pharmacology

Mechanism of Action

The therapeutic action of talc instilled into the pleural cavity is believed to result from induction of an inflammatory reaction. This reaction promotes adherence of the visceral and parietal pleura, obliterating the pleural space and preventing reaccumulation of pleural fluid.

The extent of systemic absorption of talc after intrapleural administration has not been adequately studied. Systemic exposure could be affected by the integrity of the pleural surface, and therefore could be increased if talc is administered immediately following lung resection or biopsy.

Clinical Studies

The data demonstrating safety and efficacy of talc slurry administered via chest tube for the treatment of patients with malignant pleural effusions are from the published medical literature. The following prospective, randomized studies were designed to evaluate the risk of recurrence of malignant pleural effusions in patients with a variety of solid tumors. The studies compared talc slurry, instilled into the pleural cavity via chest tube, versus a concurrent control. In all studies, after maximal drainage of the pleural effusion, the investigator administered talc slurry via chest tube. Chest films documented response (defined as lack of recurrence of fluid for a period of time). Studies differed on the timing of the efficacy assessment. Zimmer et al. did not specify the time required evaluations. Ong et al. specified the assessment at one month. Sorensen et al. specified the assessment at 3-4 months. The remaining studies assessed response at the completion of the follow-up period.

Randomized Controlled Trials Using Talc Slurry as a Sclerosing Agent
* Two-sided p-value based on Fisher’s exact test
a Patients were evaluable if chest x-rays were done to assess response per protocol.
The Sorensen study excluded patients if incomplete lung re-expansion was noted post drainage.
b Data per procedure (33 procedures in 29 evaluable patients, 3 patients with bilateral effusions).
c Plus lidocaine 1%, 20 mL.
d Plus lidocaine 1%, 10 mL.
REFERENCE	TREATMENT	RESPONSE RATE EVALUABLE PTS* p value*	RESPONSE RATE ALL PTS* p value*
Sorensen et al. Eur J Respir Dis. 1984: 65(2):131-5	Talc Slurry 10g /250ml NS vs. Chest tube drainage alone	100% (9/9) vs. 58% (7/12) p=0.04	64% (9/14) vs. 41% (7/17) p=0.29
Noppen et al. Acta Clin Belg 1997; 52(4):258-62	Talc Slurry 5g/50-ml NS vs. Bleomycin 1mg/kg/50ml NS	79% (11/14) vs. 75% (9/12) p=1.00	79% (11/14) vs. 75% (9/12) p=1.00
Zimmer PW et al. Chest 1997; 112(2):430-434	Talc Slurry 5g/50 ml NSc vs. Bleomycin 60U/50 ml NSc	90% (17/19b) vs. 79% (11/14 b) p=0.63	Not Given
Ong KC et al. Respirology 2000; 5:99-103	Talc Slurry 5g/150ml NSd vs. Bleomycin 1U/kg/150 ml NSd	89% (16/18) vs. 70% (14/20) p=0.24	64% (16/25) vs. 56% (14/25) p=0.77
Yim AP et al. Ann Thorax Surg 1996; 62:1655-8	Talc Slurry 5g/50ml NS, lidocaine 2% 10 ml vs. Talc Insufflation 5g powder	90%(26/29) vs. 96% (27/28) p=0.61	90% (26/29) vs. 96% (27/28) p=0.61

In single-arm studies of malignant pleural effusions from the published literature, variously defined “success” rates using talc slurry pleurodesis ranged from 75% to 100%.

Indications and Usage for Sterile Talc

Sterile Talc Powder, administered intrapleurally via chest tube, is indicated as a sclerosing agent to decrease the recurrence of malignant pleural effusions in symptomatic patients.

Contraindications

None known

Warnings

None

Precautions

1. Future procedures: The possibility of the future diagnostic and therapeutic procedures involving the hemithorax to be treated must be considered prior to administering Sterile Talc Powder. Sclerosis of the pleural space may preclude subsequent diagnostic procedures of the pleura on the treated side. Talc sclerosis may complicate or preclude future ipsilateral lung resective surgery, including pneumonectomy for transplantation purposes.

2. Use in potentially curable disease: Talc has no known antineoplastic activity and should not be used alone for potentially curable malignancies where systemic therapy would be more appropriate, e.g., a malignant effusion secondary to a potentially curable lymphoma.

3. Pulmonary complications: Acute Pneumonitis and Acute Respiratory Distress Syndrome (ARDS) have been reported in association with intrapleural talc administration. Three of the case reports of ARDS have occurred after treatment with a relatively large talc dose (10 g) administered via intrapleural chest tube instillation. One patient died one month post treatment and two patients recovered without further sequelae.

DRUG INTERACTIONS

It is not known whether the effectiveness of a second sclerosing agent after prior talc pleurodesis would be diminished by the absorptive properties of talc.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies on the carcinogenicity of talc have been performed using non-standard designs which prevent firm conclusions on its carcinogenicity. With single intraperitoneal administration to mice at 20 mg and observation for at least 6 months or 4 weekly doses administered intraperitoneally at 25 mg/dose to rats with observation for at least 84 weeks, tumor incidence was not increased. In these studies the talc and its asbestos content were not characterized.

Genotoxicity was tested in cultures of rat pleural mesothelial cells (RPMC) as unscheduled DNA synthesis (UDS) and sister chromatid exchanges (SCEs). None of the talc samples (which were asbestos-free) induced enhancement of UDS or SCEs in treated cultures. No information is available on impairment of fertility in animals by talc.

Pregnancy: Pregnancy Category B. An oral administration study has been performed in the rabbit at 900 mg/kg. Approximately 5 fold higher than a human dose on mg/m2 basis, and has revealed no evidence of teratogenicity due to talc. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy unless the benefit outweighs the risk.

Pediatric Use: The safety and efficacy of Sterile Talc Powder in pediatric patients have not been established.

Geriatric use: The estimated mean and median ages of patients treated with talc slurry from clinical studies (single-arm or randomized) were 60 and 62 years, respectively. No analyses to specifically evaluate the safety and efficacy in the geriatric population have been reported.

Adverse Reactions

Intrathoracic administration of talc slurry has been described in medical literature reports involving more that 2000 patients. Patients with malignant pleural effusions were treated with talc via poudrage or slurry. In general, with respect to reported adverse experiences, it is difficult to distinguish the effects of talc from the effects of the procedure(s) associated with its administration. The most often reported adverse experiences to intrapleurally-administered talc were fever and pain.

Infection: Complications reported include empyema.

Respiratory: Complications reported include hypoxemia, dyspnea, unilateral pulmonary edema, pneumonia, ARDS, brochopleural fistula, hemoptysis and pulmonary emboli.

Cardiovascular: Complications reported included tachycardia, myocardial infarction, hypotension, hypovolemia and asystolic arrest

Delivery Procedure: Adverse reactions due to the delivery procedure and the chest tube may include: pain, infection at the site of thoracostomy or thoracoscopy, localized bleeding, and subcutaneous emphysema.

Chronic Toxicity: Since patients in clinical studies had a limited life expectancy, data on chronic toxicity are limited

Overdosage

No definite relationship between dose and toxicity has been established. Excessive talc may be partially removed with saline lavage.

Sterile Talc Dosage and Administration

Sterile Talc Powder should be administered after adequate drainage of the effusion. The success of the pleurodesis appears to be related to the completeness of the drainage of the pleural fluid, as well as the full re-expansion of the lung, both of which will promote symphysis of the pleural surfaces.

The recommended dose is 5 g, dissolved in 50 – 100 ml Sodium Chloride Injection, USP. Although the optimal dose for effective pleurodesis is unknown, 5 g was the dose most frequently reported in the published literature.

Talc Preparation

Prepare the talc slurry using aseptic technique in an appropriate laminar flow hood. Remove talc container from packaging. Remove protective flip-off seal.

Each brown bottle contains 5 g of Sterilized Talc Powder. To dispense the contents:

Using a 16 gauge needle attached to a 60-mL LuerLok syringe, measure and draw up 50 mL of Sodium Chloride Injection, USP. Vent the talc bottle using a needle. Slowing inject the 50 mL of Sodium Chloride Injection, USP into the bottle. For doses more than 5 g, repeat this procedure with a second bottle.
Swirl the bottle(s) to disperse the talc powder and continue swirling to avoid settling of the talc in the slurry. Each bottle will contain 5 g Sterile Talc Powder dispersed in 50 mL of Sodium Chloride Injection, USP.
Divide the content of each bottle into two 60 mL irrigation syringes by withdrawing 25 mL of the slurry into each syringe with continuous swirling. QS each syringe with Sodium Chloride Injection, USP to a total volume of 50 mL in each syringe. Draw air into each syringe to the 60 mL mark to serve as a headspace for mixing prior to administration.
When appropriately labeled, each syringe contains 2.5 g of Sterile Talc in 50 mL of Sodium Chloride Injection, USP with an air headspace of 10 mL. Once the slurry has been made, use within 12 hours or discard and prepare fresh slurry. Label the syringes appropriately noting the expiration date and time, with the statement “For Pleurodesis Only – NOT FOR IV ADMINISTRATION,” the identity of the patient intended to receive this material and a cautionary statement to SHAKE WELL before use.
Prior to administration, completely and continuously agitate the syringes to evenly redisperse the talc and avoid settlement. Immediately prior to administration, vent the 10mL air headspace from each syringe.
Attach the adapter and place a syringe tip on the adapter. Maintain continuous agitation of the syringes.

NOTICE: Shake well before installation. Each 25 ml of prepared slurry in the syringe contains 1.25 g of talc. NOT FOR IV ADMINISTRATION.

Administration

Administer the talc slurry through the chest tube by gently applying pressure to syringe plunger and empty the contents of the syringe into the chest cavity. After application, discard the empty syringe according to general hospital procedures. After the talc slurry has been administered through the chest tube into the pleural cavity, the chest tube may be flushed with 10- 25 mL sodium chloride solution to ensure that the complete dose of talc is delivered.

Following introduction of the talc slurry, the chest drainage tube is clamped, and the patient is asked to move, at 20 to 30 minute intervals, from supine to alternating decubitus positions, so that over a period of about 2 hours the talc is distributed within the chest cavity. Recent evidence suggests that this step may not be necessary.

At the end of this period, the chest drainage tube is unclamped, and the excess saline is removed by the routine continual external suction on the tube.

How is Sterile Talc Supplied

NDC 63256-200-05 Sterile Talc Powder is supplied in a 100 mL brown glass bottle containing 5 g of talc. The sterile bottle is closed with a gray stopper and covered with a flip-off seal.

Storage: Store at Room Temperature (18-25°C). Protect against sunlight.

DISTRIBUTED BY: Bryan Corporation. Woburn, MA 01801

Version: Original Sep 2003

TALC
talc aerosol, powder

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	63256-200
Route of Administration	INTRAPLEURAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
Talc (Talc)	Active	5 GRAM In 1 CANISTER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	63256-200-05	1 CANISTER In 1 CANISTER	None

Revised: 10/2006Bryan Corporation

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Sterile Water for Injection

30/06/10

Dosage Form: injection

Sterile Water for Injection, USP
in VIAFLEX Plastic Container
For Drug Diluent Use Only

Sterile Water for Injection Description

Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5 (5.0 to 7.0). The osmolarity is 0.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Sterile Water for Injection – Clinical Pharmacology

Sterile Water for Injection, USP is used for fluid replacement only after suitable additives are introduced to approximate isotonicity and to serve as a vehicle for suitable medications.

Indications and Usage for Sterile Water for Injection

Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions.

Contraindications

Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is contraindicated for intravenous administration without additives.

Warnings

Do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute.

Precautions

Do not administer unless solution is clear and seal is intact.

Adverse Reactions

The administration of a suitable admixture of prescribed additives may be associated with adverse reactions because of the solution or the technique of administration including febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Sterile Water for Injection Dosage and Administration

Following suitable admixture of prescribed additives, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. See directions accompanying additive drug.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Do not store an unused portion of Sterile Water for Injection, USP. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

How is Sterile Water for Injection Supplied

Sterile Water for Injection, USP is supplied in VIAFLEX plastic containers as follows:

1000 mL

2B0304

NDC 0338-0013-04

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER

Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

To Open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. See following directions.

Preparation for Administration After Rendering Isotonic

1. Suspend container from eyelet support.

2. Remove plastic protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

Warning: Additives may be incompatible.

To add medication before administration

1. Prepare medication site.

2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.

3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during administration

1. Close clamp on the set.

2. Prepare medication site.

3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.

4. Remove container from IV pole and/or turn to an upright position.

5. Evacuate both ports by squeezing them while container is in the upright position.

6. Mix solution and medication thoroughly.

7. Return container to in use position and continue administration.

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

7-19-31-347 Rev. September 2002

BAXTER, VIAFLEX, and PL 146 are trademarks of Baxter International Inc.

PACKAGE LABEL.PRINCIPLE DISPLAY PANEL

Sterile Water Container Label

LOT EXP

2B0304

NDC 0338-0013-04

STERILE WATER

Sterile Water for Injection USP

FOR DRUG DILUENT USE ONLY

1000mL

NO ANTIMICROBIAL OR OTHER SUBSTANCE HAS BEEN ADDED

pH 5.5 (5.0 TO 7.0) STERILE NONPYROGENIC SINGLE

DOSE CONTAINER ADMINISTER INTRAVENOUSLY ONLY AFTER

RENDERING APPROXIMATELY ISOTONIC WITH SUITABLE SOLUTE

ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST

IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC

TECHNIQUE MIX THOROUGHLY DO NO STORE DOSAGE

INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE

DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG

WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE

FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT

USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN

MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C)

UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT

VIAFLEX PLUS CONTAINER PL 146 PLASTIC

BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF

BAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION 1-800-933-0303

BAXTER

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN THE USA

Sterile Water Carton Label

2B0304X 14-1000 ML UNITS

VIAFLEX® CONTAINER

STERILE WATER FOR INJ., USP

EXP

XXXXX

SECONDARY BAR CODE

(17) XXXXX (10) XXXXX

LOT

XXXXX

PRIMARY BAR CODE

(01) 50303380013048

NOTE: Lot and Exp. Date added at time of printing.

Secondary bar code human readable is variable and will be

added at time of printing. The parenthesis are not

encoded in actual bar code.

STERILE WATER
water injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0338-0013
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (WATER)	WATER	100 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0338-0013-04	1000 mL In 1 BAG	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA018632	06/30/1982

Labeler - BAXTER HEALTHCARE CORPORATION (005083209)

Establishment
Name	Address	ID/FEI	Operations
BAXTER HEALTHCARE CORPORATION		059140764	MANUFACTURE

Revised: 12/2009BAXTER HEALTHCARE CORPORATION

Professional,S

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Stelazine

30/06/10

Generic Name: trifluoperazine (trye floo oh PER a zeen)
Brand Names: Stelazine

What is Stelazine (trifluoperazine)?

Trifluoperazine is an anti-psychotic medication in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain.

Trifluoperazine is used to treat anxiety or psychotic disorders such as schizophrenia.

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

What is the most important information I should know about Stelazine (trifluoperazine)?

Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects. Trifluoperazine is not for use in psychotic conditions related to dementia. Trifluoperazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not use trifluoperazine if you have liver disease, brain damage, bone marrow depression, a blood cell disorder (such as low platelets or low red or white blood cell counts), or if you are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to trifluoperazine or other phenothiazines.

Before you take trifluoperazine, tell your doctor if you have heart disease, high blood pressure, angina (chest pain), severe asthma or breathing problems, glaucoma, a history of seizures, adrenal gland tumor, Parkinson’s disease, enlarged prostate or urination problems, low levels of calcium in your blood, past or present breast cancer, or if you have ever had a serious side effect while using trifluoperazine or similar medicines.

Before taking trifluoperazine, tell your doctor about all other medications you use.

What should I discuss with my healthcare provider before taking oral Stelazine (trifluoperazine)?

Trifluoperazine is not for use in psychotic conditions related to dementia. Trifluoperazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not use trifluoperazine if you have liver disease, brain damage, bone marrow depression, a blood cell disorder (such as low platelets or low red or white blood cell counts), or if you are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to trifluoperazine or other phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Adgan, Pentazine, Phenergan), or thioridazine (Mellaril).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take trifluoperazine, tell your doctor if you have:

heart disease high blood pressure, or angina (chest pain);
severe asthma, emphysema, or other breathing problem;
glaucoma;
a history of seizures;
adrenal gland tumor (pheochromocytoma);
Parkinson’s disease;
enlarged prostate or urination problems;
low levels of calcium in your blood (hypocalcemia);
past or present breast cancer; or
if you have ever had a serious side effect while using trifluoperazine or another phenothiazine.

Tell your doctor if you will be exposed to extreme heat or cold, or to insecticide poisons while you are taking trifluoperazine.

It is not known whether trifluoperazine will harm an unborn baby. Trifluoperazine may cause side effects in a newborn if the mother takes the medication during pregnancy. Do not take this medication without first talking to your doctor if you are pregnant. Tell your doctor if you become pregnant while taking trifluoperazine. Trifluoperazine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Talk with your doctor before giving this medication to a child who has been ill with a fever or flu symptoms.

How should I take Stelazine (trifluoperazine)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Call your doctor if your symptoms do not improve, or if they get worse while taking trifluoperazine.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using trifluoperazine.

If you need to have an x-ray or CT scan of your spinal column using a dye that is injected into a vein, you may need to temporarily stop taking trifluoperazine. Be sure the doctor knows ahead of time that you are using this medication.

Do not stop using trifluoperazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms such as nausea, vomiting, dizziness, or feeling shaky. Talk to your doctor about how to avoid withdrawal symptoms when you stop using trifluoperazine.

Store trifluoperazine at room temperature away from moisture, heat, and light.

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, wait until then to take the medicine and skip the missed dose. Do not take 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. Overdose symptoms may include dry mouth, constipation, bloating or stomach cramps, extreme drowsiness or feeling restless and agitated, changes in heart rate, fever, fainting, and seizure (convulsions).

What should I avoid while taking Stelazine (trifluoperazine)?

Trifluoperazine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Avoid drinking alcohol. It can increase some of the side effects of trifluoperazine. Avoid exposure to sunlight or tanning beds. Trifluoperazine can make your skin more sensitive to sunlight, and a sunburn may result. Wear sunscreen (SPF 15 or higher) and protective clothing if you must be outdoors.

Stelazine (trifluoperazine) 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 trifluoperazine and call your doctor at once if you have a serious side effect such as:

twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
feeling restless, jittery, or agitated;
high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;
feeling like you might pass out;
decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;
seizure (black-out or convulsions);
nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);
urinating less than usual or not at all;
pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;
joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or
slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

dizziness, drowsiness, anxiety;
sleep problems (insomnia);
blurred vision, headache;
dry mouth, stuffy nose;
constipation;
breast swelling or discharge;
a missed menstrual period;
weight gain, swelling in your hands or feet;
mild itching or skin rash; or
impotence, trouble having an orgasm.

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 Stelazine (trifluoperazine)?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with trifluoperazine and cause medical problems or increase side effects. Tell your doctor if you regularly use any of these medicines, or any other anti-psychotic medications.

Also tell your doctor if you are taking any of the following medicines:

atropine (Atreza, Sal-Tropine);
lithium (Eskalith, Lithobid);
phenytoin (Dilantin);
an antibiotic;
birth control pills or hormone replacement estrogens;
a blood thinner such as warfarin (Coumadin);
certain asthma medications or bronchodilators;
a diuretic (water pill);
drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);
incontinence medications;
insulin or diabetes medications you take by mouth;
medication for nausea, vomiting, or motion sickness;
medications to treat or prevent malaria;
medications used for general anesthesia;
medicines used to prevent organ transplant rejection;
numbing medicine such as lidocaine or Novocain;
a stimulant or ADHD medication;
ulcer or irritable bowel medications; or
medicines to treat Parkinson’s disease, restless leg syndrome, or pituitary gland tumor (prolactinoma).

This list is not complete and there are many other medicines that can interact with trifluoperazine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about trifluoperazine.

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.

Concise,S

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Stemetic

30/06/10

Generic Name: trimethobenzamide (Intramuscular route)

trye-meth-oh-BENZ-a-mide

Commonly used brand name(s):

In the U.S.

Arrestin
Benzacot
Stemetic
Ticon
Tigan
Tribenzagan

Available Dosage Forms:

Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Anticholinergic

Uses For Stemetic

Trimethobenzamide is used to treat nausea and vomiting .

This medicine is available only with your doctor’s prescription .

Before Using Stemetic

Allergies

Pediatric

No information is available on the relationship of age to the effects of intramuscular trimethobenzamide in the pediatric population. However, because of this medication’s toxicity, use in children is contraindicated. Intramuscular trimethobenzamide should never be used in children .

Geriatric

No information is available on whether the risk of trimethobenzamide-induced adverse effects is increased in the elderly. However, because of this medication’s toxicity, it should be used with caution, after less toxic alternatives have been considered and/or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy .

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of trimethobenzamide

This section provides information on the proper use of a number of products that contain trimethobenzamide. It may not be specific to Stemetic. Please read with care.

Trimethobenzamide is only used to relieve or prevent nausea and vomiting. A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your muscles .

Your doctor may only give you a few doses of this medicine until your condition improves, and then may switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor .

Precautions While Using Stemetic

Trimethobenzamide will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicines or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using trimethobenzamide .

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert .

Stemetic 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:

Rare

Body spasm, with head and heels bent backward and body bowed forward
convulsions (seizures)
depression
shakiness or tremors
skin rash
sore throat or fever
unusual tiredness
vomiting (severe or continuing)
yellow eyes or skin

More common

Drowsiness

Less common

Blurred vision
diarrhea
dizziness
headache
muscle cramps

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.

Advanced,S

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Stemetil

30/06/10

Generic Name: meclizine, buclizine, and cyclizine (Oral route, Parenteral route)

Commonly used brand name(s):

In the U.S.

Antivert
Antivert/25
Antivert/50
Atarax
Compazine
Permitil
Prolixin
Torecan
Trilafon
Vistaril
Xyzal
Zyrtec

In Canada

Moditen Hydrochloride
Pms-Hydroxyzine
Pms-Perphenazine
Stemetil
Trilafon Concentrate

Available Dosage Forms:

Tablet
Capsule
Liquid
Solution
Elixir
Tablet, Chewable
Capsule, Liquid Filled
Syrup
Capsule, Extended Release
Suspension

Uses For Stemetil

Buclizine, cyclizine, and meclizine are used to prevent and treat nausea, vomiting, and dizziness associated with motion sickness, and vertigo (dizziness caused by other medical problems).

Some of these preparations are available only with your doctor’s prescription. Others are available without a prescription; however, your doctor may have special instructions on the proper dose of the medicine for your medical condition.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, some of these medicines are used in certain patients to prevent the following medical conditions:

Nausea and vomiting following surgery
Nausea and vomiting following cancer radiation treatment

Before Using Stemetil

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

There is no specific information comparing use of buclizine, cyclizine, and meclizine in children with use in other age groups. However, children may be especially sensitive to the anticholinergic effects (e.g., dryness of mouth, nose, and throat) of these medicines.

Geriatric

There is no specific information comparing use of buclizine, cyclizine, and meclizine in the elderly with use in other age groups. Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. However, older people may be especially sensitive to the anticholinergic effects (e.g., constipation; difficult urination; dryness of mouth, nose, and throat) of these medicines.

Pregnancy

These medicines have not been shown to cause birth defects or other problems in humans. However, studies in animals have shown that buclizine, cyclizine, and meclizine given in doses many times the usual human dose cause birth defects, such as cleft palate.

Breast Feeding

Although these medicines may pass into breast milk, they have not been reported to cause problems in nursing babies. However, since these medicines tend to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some patients.

Interactions with Medicines

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Arsenic Trioxide
Bepridil
Cisapride
Dofetilide
Droperidol
Grepafloxacin
Levomethadyl
Mesoridazine
Metoclopramide
Pimozide
Sparfloxacin
Terfenadine
Thioridazine
Venlafaxine
Ziprasidone

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Ajmaline
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Aprindine
Arsenic Trioxide
Astemizole
Azimilide
Bretylium
Chloral Hydrate
Chloroquine
Chlorpromazine
Clarithromycin
Desipramine
Dibenzepin
Disopyramide
Dofetilide
Dolasetron
Doxepin
Droperidol
Encainide
Enflurane
Erythromycin
Fentanyl
Flecainide
Fluconazole
Fluoxetine
Foscarnet
Gatifloxacin
Gemifloxacin
Halofantrine
Haloperidol
Halothane
Hydromorphone
Hydroquinidine
Ibutilide
Imipramine
Isoflurane
Isradipine
Levofloxacin
Levomethadyl
Levorphanol
Lidoflazine
Lithium
Lorcainide
Mefloquine
Methadone
Metrizamide
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nortriptyline
Octreotide
Oxycodone
Paliperidone
Pentamidine
Pimozide
Pirmenol
Prajmaline
Probucol
Procainamide
Procarbazine
Prochlorperazine
Propafenone
Quetiapine
Quinidine
Risperidone
Sematilide
Sertindole
Sotalol
Spiramycin
Sulfamethoxazole
Sultopride
Tapentadol
Tedisamil
Telithromycin
Tramadol
Trifluoperazine
Trimethoprim
Trimipramine
Vasopressin
Ziprasidone
Zolmitriptan
Zolpidem
Zotepine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of meclizine, buclizine, and cyclizine

This section provides information on the proper use of a number of products that contain meclizine, buclizine, and cyclizine. It may not be specific to Stemetil. Please read with care.

This medicine is used to relieve or prevent the symptoms of motion sickness or vertigo (dizziness caused by other medical problems). Take it only as directed. Do not take more of it or take it more often than stated on the label or ordered by your doctor. To do so may increase the chance of side effects.

Dosing

The dose medicines in this class 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 these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

For buclizine
For oral dosage form (chewable tablets):
- To prevent motion sickness:
  - Adults and teenagers—The usual dose is 50 milligrams (mg) thirty minutes before travel. The dose may be repeated every four to six hours if needed. Not more than 150 mg should be taken in one day.
  - Children—Dose must be determined by your doctor.

For cyclizine
For oral dosage form (tablets):
- To prevent and treat motion sickness:
  - Adults and teenagers—The usual dose is 50 milligrams (mg) thirty minutes before travel. The dose may be repeated every four to six hours if needed. Not more than 200 mg should be taken in one day.
  - Children 6 to 12 years of age—The usual dose is 25 mg thirty minutes before travel. The dose may be repeated every six to eight hours if needed. Not more than 75 mg should be taken in one day.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.
For injection dosage form:
- To prevent and treat motion sickness:
  - Adults and teenagers—The usual dose is 50 mg injected into a muscle every four to six hours as needed.
  - Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 mg per kilogram (0.45 mg per pound) of body weight injected into a muscle three times a day as needed.

For meclizine
For oral dosage forms (tablets and chewable tablets):
- To prevent and treat motion sickness:
  - Adults and children 12 years of age or older—The usual dose is 25 to 50 milligrams (mg) one hour before travel. The dose may be repeated every twenty-four hours as needed.
  - Children up to 12 years of age—Use and dose must be determined by your doctor.
- To prevent and treat vertigo (dizziness):
  - Adults and children 12 years of age or older—The usual dose is 25 to 100 mg a day as needed, divided into smaller doses.
  - Children up to 12 years of age—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

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Stemetil

Tell the doctor in charge that you are taking this medicine before you have any skin tests for allergies. The results of the test may be affected by this medicine.

Buclizine, cyclizine, or meclizine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people to become drowsy or less alert than they are normally Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Buclizine, cyclizine, and meclizine may cause dryness of the mouth. For temporary relief use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Stemetil 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.

More common

Drowsiness

Less common or rare

Blurred or double vision
constipation
diarrhea
difficult or painful urination
dizziness
dryness of mouth, nose, and throat
fast heartbeat
headache
loss of appetite
nervousness, restlessness, or trouble in sleeping
skin rash
upset stomach

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. Buclizine, cyclizine, and meclizine are similar, so any of the above side effects may occur with any of these medicines.

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.

Advanced,S

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30/06/10

Uses For Stieva-A Cream Forte

Before Using Stieva-A Cream Forte

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of tretinoin

Dosing

Missed Dose

Storage

Precautions While Using Stieva-A Cream Forte

Stieva-A Cream Forte Side Effects

30/06/10

Uses For Stieva-A Gel

Before Using Stieva-A Gel

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of tretinoin

Dosing

Missed Dose

Storage

Precautions While Using Stieva-A Gel

Stieva-A Gel Side Effects

30/06/10

What is Sterapred (prednisone)?

What is the most important information I should know about Sterapred (prednisone)?

What should I discuss with my healthcare provider before taking Sterapred (prednisone)?

How should I take Sterapred (prednisone)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Sterapred (prednisone)?

Sterapred (prednisone) side effects

What other drugs will affect Sterapred (prednisone)?

Where can I get more information?

30/06/10

What is Sterapred DS (prednisone)?

What is the most important information I should know about Sterapred DS (prednisone)?

What should I discuss with my healthcare provider before taking Sterapred DS (prednisone)?

How should I take Sterapred DS (prednisone)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Sterapred DS (prednisone)?

Sterapred DS (prednisone) side effects

What other drugs will affect Sterapred DS (prednisone)?

Where can I get more information?

30/06/10

Uses For Sterile Saline Diluent Tip-Lok Syringe

Before Using Sterile Saline Diluent Tip-Lok Syringe

Allergies

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of sodium chloride

Dosing

Precautions While Using Sterile Saline Diluent Tip-Lok Syringe

Sterile Saline Diluent Tip-Lok Syringe Side Effects

30/06/10

Sterile Talc Description

Sterile Talc – Clinical Pharmacology

Mechanism of Action

Clinical Studies

Indications and Usage for Sterile Talc

Contraindications

Warnings