Solaraze

DRUG DESCRIPTION

Solaraze® (diclofenac sodium) Gel, 3%, contains the active ingredient,
diclofenac sodium, in a clear, transparent, colorless to slightly yellow gel
base. Diclofenac sodium is a white to slightly yellow crystalline powder. It
is freely soluble in methanol, soluble in ethanol, sparingly soluble in water,
slightly soluble in acetone, and partially insoluble in ether. The chemical
name for diclofenac sodium is:

Sodium [o-(2,6-dichloranilino) phenyl] acetate

Diclofenac sodium has a molecular weight of 318.13.

The CAS number is CAS-15307-79-6. The structural formula is represented below:

Solaraze® Gel also contains benzyl alcohol, hyaluronate sodium, polyethylene
glycol monomethyl ether, and purified water.

1 g of Solaraze® (diclofenac sodium) Gel contains 30 mg of the active substance,
diclofenac sodium.

What are the possible side effects of diclofenac topical (Flector Patch, Solaraze, Voltaren Topical)?

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.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• chest pain, weakness,...

Read All Potential Side Effects and See Pictures of Solaraze »

What are the precautions when taking diclofenac sodium (Solaraze)?

Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver...

Read All Potential Precautions of Solaraze »

Solaraze Consumer (continued)

SIDE EFFECTS: Rash, scaling, dry skin, or itching may occur at application site. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: eye redness/itching, headache, shortness of breath, muscle pain, swelling at application site.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, easy bruising/bleeding, unexplained stiff neck, signs of infection (e.g., fever, persistent sore throat), persistent/severe headache, swelling hands/feet, sudden/unexplained weight gain, vision changes, hearing changes (e.g., ringing in the ears), mental/mood changes (e.g., depression), fast/pounding heartbeat, fainting.

Other medications similar to this medication may infrequently cause serious bleeding from the stomach or intestines. Also, related drugs rarely have caused blood clots to form, resulting in heart attacks and strokes. If you notice any of the following rare but very serious side effects, stop using this medication and seek immediate medical attention: black/bloody stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest pain, sudden vision changes, weakness on one side of the body, slurred speech.

This drug may rarely cause serious (possibly fatal) liver problems. Stop using diclofenac and tell your doctor immediately if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, unusual/extreme tiredness, severe stomach/abdomen pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, stomach/intestine problems (e.g., bleeding, ulcers), heart disease (e.g., heart failure, history of heart attack), high blood pressure, stroke, swelling (edema, water retention), poorly controlled diabetes, a severe loss of body water (dehydration), blood disorders (e.g., anemia, bleeding/clotting problems), asthma, growths in the nose (nasal polyps).

Before having surgery, tell your doctor or dentist that you are using this medication.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

Your condition may get worse when exposed to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Wear protective clothing when outdoors. Ask your doctor whether you should use sunscreen along with this medication.

Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and kidney effects.

During the first 6 months of pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and problems with normal labor/delivery. Discuss the risks and benefits with your doctor.

Based on information from related drugs, this medication may pass into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Solaraze Patient Information Including Side Effects

Brand Names: Flector Patch, Solaraze, Voltaren Topical

Generic Name: diclofenac topical (Pronunciation: dye KLOE fen ak)

• What is diclofenac topical (Solaraze)?


• What are the possible side effects of diclofenac topical (Solaraze)?


• What is the most important information I should know about diclofenac topical (Solaraze)?


• What should I discuss with my healthcare provider before using diclofenac topical (Solaraze)?


• How should I use diclofenac topical (Solaraze)?


• What happens if I miss a dose (Solaraze)?


• What happens if I overdose (Solaraze)?


• What should I avoid while using diclofenac topical (Solaraze)?


• What other drugs will affect diclofenac topical (Solaraze)?


• Where can I get more information?

What is diclofenac topical (Solaraze)?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.

Diclofenac topical skin patch (Flector Patch) is used to treat pain caused by minor sprains, strains, or bruising.

Diclofenac topical 1% gel (Voltaren Topical) is used to treat joint pain in the hands, wrists, elbows, knees, ankles, or feet caused by osteoarthritis. This medication may not be effective in treating arthritis pain elsewhere in the body.

Diclofenac topical 3% (Solaraze) gel is used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the body.

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

What are the possible side effects of diclofenac topical (Solaraze)?

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.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;


• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;


• swelling or rapid weight gain;


• urinating less than usual or not at all;


• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);


• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or


• bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

• dryness, itching, peeling, or scaling of treated skin; or


• fever, chills, sore throat, body aches or other flu symptoms.

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 is the most important information I should know about diclofenac topical (Solaraze)?

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have a history of stomach ulcer or bleeding, liver or kidney disease, high blood pressure, or congestive heart failure.

While the risk of absorbing diclofenac topical into your bloodstream is low, all non-steroidal anti-inflammatory drugs (NSAIDs) can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use diclofenac topical just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are using an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Related Drug Centers

• Flector Patch


• Voltaren Gel


• Solaraze

Sulfamylon Cream

DRUG DESCRIPTION

SULFAMYLON Cream (mafenide acetate cream) is a soft, white, nonstaining, water-miscible, anti-infective cream for topical administration to burn wounds.

SULFAMYLON Cream (mafenide acetate cream) spreads, easily, and can be washed off readily with water.
It has a slight acetic odor. Each gram of SULFAMYLON Cream (mafenide acetate cream) contains mafenide
acetate equivalent to 85 mg of the base. The cream vehicle consists of cetyl
alcohol, steryl alcohol, cetyl esters wax, polyoxyl 40 stearate, polyoxyl 8
stearate, glycerin, and water, with methylparaben, propylparaben, sodium metabisulfite,
and edetate disodium as preservatives.

Chemically, mafenide acetate is α-Amino-p-toluenesulonamide mono acetate and has the following structural formula:

What are the possible side effects of mafenide (Sulfamylon)?

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.

Tell your caregivers right away if you have a serious side effect such as:

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;


• chest pain, fast or pounding heartbeats, headache, confusion;


• nausea, vomiting, stomach pain, appetite changes, muscle weakness, bone pain, and weight loss;


• rapid breathing, gasping, or...

Read All Potential Side Effects and See Pictures of Sulfamylon Cream »

What are the precautions when taking mafenide acetate cream (Sulfamylon Cream)?

Before using mafenide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung problems (e.g., asthma), kidney disease, metabolism problems (e.g., glucose-6-phosphate dehydrogenase deficiency-G6PD), blood disorders.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Sulfamylon Cream »

Sulfamylon Cream Consumer (continued)

SIDE EFFECTS: Pain, burning, or redness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blisters, fast breathing, nausea, vomiting, diarrhea, headache, change in alertness, shaking (tremors), seizures.

Tell your doctor immediately if any of these rare but very serious side effects occur: weakness, dark urine, stomach/abdominal pain, arm/leg/back pain, fast heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using mafenide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung problems (e.g., asthma), kidney disease, metabolism problems (e.g., glucose-6-phosphate dehydrogenase deficiency-G6PD), blood disorders.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Sulfamylon Cream Patient Information Including Side Effects

Brand Names: Sulfamylon

Generic Name: mafenide topical (Pronunciation: MAF en ide)

• What is mafenide (Sulfamylon Cream)?


• What are the possible side effects of mafenide (Sulfamylon Cream)?


• What is the most important information I should know about mafenide (Sulfamylon Cream)?


• What should I discuss with my health care provider before receiving mafenide (Sulfamylon Cream)?


• How is mafenide used (Sulfamylon Cream)?


• What happens if I miss a dose (Sulfamylon Cream)?


• What happens if I overdose (Sulfamylon Cream)?


• What should I avoid while being treated with mafenide (Sulfamylon Cream)?


• What other drugs will affect mafenide (Sulfamylon Cream)?


• Where can I get more information?

What is mafenide (Sulfamylon Cream)?

Mafenide is an antibiotic that fights bacteria in the body.

Mafenide topical (for the skin) is used to prevent infection in severe burn wounds.

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

What are the possible side effects of mafenide (Sulfamylon Cream)?

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.

Tell your caregivers right away if you have a serious side effect such as:

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;


• chest pain, fast or pounding heartbeats, headache, confusion;


• nausea, vomiting, stomach pain, appetite changes, muscle weakness, bone pain, and weight loss;


• rapid breathing, gasping, or feeling short of breath; or


• severe skin rash, bruising, severe tingling, numbness, or pain.

Less serious side effects may include:

• mild skin rash, redness, or itching; or


• pain or burning of treated skin areas.

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 is the most important information I should know about mafenide (Sulfamylon Cream)?

You should not receive this medication if you are allergic to mafenide.

Before being treated with mafenide, tell your doctor if you are allergic to any drugs (especially sulfa drugs), or if you have kidney disease or glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Before you are treated with mafenide topical, tell your doctor if you are pregnant or breast-feeding.

Tell your caregivers right away if you have a serious side effect such as pale or yellowed skin, dark colored urine, fever, confusion or weakness, chest pain, fast or pounding heartbeats, confusion, vomiting, appetite changes, muscle weakness, bone pain, rapid breathing, gasping, or feeling short of breath, or severe skin rash with bruising, severe tingling, numbness, or pain.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are being treated with mafenide.

Related Drug Centers

• Sulfamylon


• Sulfamylon Cream

Stelazine

DRUG DESCRIPTION

Tablets: Each round, blue, film-coated tablet contains trifluoperazine
hydrochloride equivalent to trifluoperazine as follows: 1 mg imprinted SKF and
S03; 2 mg imprinted SKF and S04; 5 mg imprinted SKF and S06; 10 mg imprinted
SKF and S07. Inactive ingredients consist of cellulose, croscarmellose sodium,
FD&C Blue No. 2, FD&C Yellow No. 6, FD&C Red No. 40, gelatin, iron
oxide, lactose, magnesium stearate, talc, titanium dioxide and trace amounts
of other inactive ingredients.

Multi-Dose Vials, 10 mL (2 mg/mL)—Each mL contains, in aqueous solution,
trifluoperazine, 2 mg, as the hydrochloride; sodium tartrate, 4.75 mg; sodium
biphosphate, 11.6 mg; sodium saccharin, 0.3 mg; benzyl alcohol, 0.75%, as preservative.

Concentrate—Each mL of clear, yellow, banana-vanilla-flavored liquid
contains 10 mg of trifluoperazine as the hydrochloride. Inactive ingredients
consist of D&C Yellow No. 10, FD&C Yellow No. 6, flavor, sodium benzoate,
sodium bisulfite, sucrose and water.

N.B.: The Concentrate is for use in schizophrenia when oral medication is preferred and other oral forms are considered impractical.

What are the possible side effects of trifluoperazine (Stelazine)?

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...

Read All Potential Side Effects and See Pictures of Stelazine »

What are the precautions when taking trifluoperazine (Stelazine)?

See also Warning section.

Before taking trifluoperazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (such as chlorpromazine, perphenazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used in a patient who is unconscious or intoxicated with alcohol/narcotics/other drugs that cause drowsiness/slowed breathing.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, heart problems (such as mitral valve insufficiency, abnormal heart rhythm, angina), low blood pressure, blockage of the...

Read All Potential Precautions of Stelazine »

Stelazine Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, dry mouth, blurred vision, tiredness, constipation, weight gain, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This drug may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe another medication to decrease these side effects. Tell your doctor immediately if you notice any of the following side effects: feelings of anxiety/agitation/jitteriness, drooling/trouble swallowing, restlessness/constant need to move, shaking (tremor), shuffling walk, stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up), mask-like expression of the face.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: difficulty urinating, sunburn-like rash (sun sensitivity), decreased cough reflex, swelling of the feet/ankles, butterfly-shaped rash on nose and cheeks, joint/muscle pain, skin discoloration, eye/vision changes, feeling unusually cold or hot, muscle weakness.

Infrequently, this medication may cause face/muscle twitching and uncontrollable movements (tardive dyskinesia). In some cases, this condition may be permanent. Tell your doctor immediately if you develop any uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, chewing, or unusual arm/leg movements.

In rare cases, trifluoperazine may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and seek immediate medical attention, or permanent problems could occur.

Tell your doctor immediately if any of these rare but serious side effects occur: signs of liver problems (such as yellowing eyes/skin, dark urine, persistent nausea, vomiting, stomach/abdominal pain), signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, signs of anemia (such as severe tiredness, fast breathing, pale skin, fast heartbeat), mental/mood changes (such as worsening psychosis, unresponsive/catatonic state).

Seek immediate medical attention if any of these rare but serious side effects occur: slowed breathing, chest pain, seizures.

This drug may rarely cause a serious (sometimes fatal) nervous system problem (neuroleptic malignant syndrome-NMS). Seek immediate medical attention if you notice any of the following side effects: fever, stiff muscles, increased sweating, fast/irregular heartbeat, sudden mental/mood changes (such as confusion, loss of consciousness), change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking trifluoperazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (such as chlorpromazine, perphenazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used in a patient who is unconscious or intoxicated with alcohol/narcotics/other drugs that cause drowsiness/slowed breathing.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, heart problems (such as mitral valve insufficiency, abnormal heart rhythm, angina), low blood pressure, blockage of the intestines, glaucoma, seizures, enlarged prostate, breathing problems (such as severe asthma, emphysema, lung infections), blood disorders (such as bone marrow depression, low red/white/platelet blood cell counts), low levels of calcium in the blood, loss of too much body water (dehydration), breast cancer, brain disorder/tumor/injury, exposure to organophosphate insecticides, pheochromocytoma, drug/alcohol/substance abuse, Parkinson's disease.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery or imaging procedures (such as certain X-rays, CT scans) requiring the use of contrast dye (such as metrizamide), tell your doctor or dentist that you are using this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication may decrease your ability to sweat, making you more likely to get heat stroke. Avoid activities that may cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). When the weather is hot, drink plenty of fluids and dress lightly. If you become overheated, promptly seek cooler shelter and stop exercising. Seek immediate medical attention if you develop a fever, mental/mood changes, headache, or dizziness.

Children with acute illnesses (such as a viral infection, dehydration) are at increased risk for serious muscle problems during trifluoperazine treatment. Consult the doctor for more details.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, uncontrollable movements, and anticholinergic effects (such as constipation, difficulty urinating, and blurred vision).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk, and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Stelazine Patient Information Including Side Effects

Brand Names: Stelazine

Generic Name: trifluoperazine (Pronunciation: trye floo oh PER a zeen)

• What is trifluoperazine (Stelazine)?


• What are the possible side effects of trifluoperazine (Stelazine)?


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


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


• How should I take trifluoperazine (Stelazine)?


• What happens if I miss a dose (Stelazine)?


• What happens if I overdose (Stelazine)?


• What should I avoid while taking trifluoperazine (Stelazine)?


• What other drugs will affect trifluoperazine (Stelazine)?


• Where can I get more information?

What is trifluoperazine (Stelazine)?

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 are the possible side effects of trifluoperazine (Stelazine)?

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

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.

Related Drug Centers

• Stelazine

Ferrlecit

DRUG DESCRIPTION

Ferrlecit® (sodium ferric gluconate complex in sucrose injection), an iron
replacement product, is a stable macromolecular complex with an apparent molecular
weight on gel chromatography of 289,000 – 440,000 daltons. The macromolecular
complex is negatively charged at alkaline pH and is present in solution with
sodium cations. The product has a deep red color indicative of ferric oxide
linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt.

The structural formula is considered to be [NaFe₂O₃(C₆H₁₁O₇)(C₁₂H₂₂O₁₁)5]n≈200•

Each sterile, single-use ampule or vial of 5 mL of Ferrlecit for intravenous
injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt
of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately
20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7 - 9.7.

Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.

What are the precautions when taking sodium ferric gluconate (Ferrlecit)?

Consult your...

Read All Potential Precautions of Ferrlecit »

Ferrlecit Consumer (continued)

SIDE EFFECTS: Consult your pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.

Streptase

(Generic versions may still be available.)

DRUG DESCRIPTION

Streptase®, Streptokinase, is a sterile, purified preparation of a bacterial protein elaborated by group C (beta) -hemolytic streptococci. It is supplied as a lyophilized white powder containing 25 mg cross-linked gelatin polypeptides, 25 mg sodium L-glutamate, sodium hydroxide to adjust pH, and 100 mg Albumin (Human) per vial or infusion bottle as stabilizers. The preparation contains no preservatives and is intended for intravenous and intracoronary administration.

Selseb

DRUG DESCRIPTION

A liquid antiseborrheic, antifungal preparation for topical application.

Each gram of Selseb Shampoo contains 22.5 mg selenium sulfide, urea, zinc pyrithione, purified water, edetate disodium, prppylene glycol, diazolidinyl urea, methylparaben, propylparaben, hypromellose, ammonium lauryl sulfate, titanium dioxide, caprylic/capric trigiyceride, D&C yellow #8, FD&C red #40, chromium oxide greens, citric acid, sodium citrate, cocamidopropyl betaine, lauramide DEA, magnesium aluminum silicate and fragrance.

Sucraid

DRUG DESCRIPTION

Sucraid® (sacrosidase) oral solution is an enzyme replacement therapy for
the treatment of the genetically determined sucrase deficiency, which is part
of congenital sucrase-isomaltase deficiency (CSID).

Sucraid® (sacrosidase oral solution) is a pale yellow, clear solution with a pleasant sweet taste.
Each milliliter (mL) of Sucraid (sacrosidase oral solution) ® contains 8,500 International Units (I.U)
of the enzyme sacrosidase, the active ingredient. The chemical name of this
enzyme is ß,D-fructofuranoside fructohydrolase. The enzyme is derived
from baker's yeast (saccharomyces cerevisiae). It has been reported that
the primary amino acid structure of this protein consists of 513 amino acids
with an apparent molecular weight of 100,000 g/mole for the glycosolated monomer
(range 66,000-116,000 g/mole). Reports also suggest that the protein exists
in solution as a monomer, dimmer, tetramer, and octomer ranging from 100,000
g/mole to 800,000 g/mole. It has an isoelectric point of 4 (pl=4.093).

Sucraid® (sacrosidase oral solution) also contains 50% glycerol in an aqueous solution. Glycerol (glycerin)
in the amount consumed in the recommended doses of Sucraid® (sacrosidase oral solution) has no expected
toxicity.

This enzyme preparation is fully soluble with water, milk, and infant formula

(DO NOT HEAT SOLUTIONS CONTAINING Sucraid® (sacrosidase oral solution) ). Do not put Sucraid (sacrosidase oral solution) ® in
warm or hot liquids.

What are the possible side effects of sacrosidase (Sucraid)?

Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• stomach pain;


• nausea, vomiting;


• diarrhea, constipation;


• sleep problems (insomnia);


• headache;


• nervous feeling; or


• increased thirst and dry, hot skin.

Some of these may be symptoms of your condition...

Read All Potential Side Effects and See Pictures of Sucraid »

Sucraid Patient Information Including Side Effects

Brand Names: Sucraid

Generic Name: sacrosidase (Pronunciation: sak ROE si dase)

• What is sacrosidase (Sucraid)?


• What are the possible side effects of sacrosidase (Sucraid)?


• What is the most important information I should know about sacrosidase (Sucraid)?


• What should I discuss with my health care provider before taking sacrosidase (Sucraid)?


• How should I take sacrosidase (Sucraid)?


• What happens if I miss a dose (Sucraid)?


• What happens if I overdose (Sucraid)?


• What should I avoid while taking sacrosidase (Sucraid)?


• What other drugs will affect sacrosidase (Sucraid)?


• Where can I get more information?

What is sacrosidase (Sucraid)?

Sacrosidase is a yeast-based enzyme that replaces an enzyme called sucrase which is normally produced in the body. Sucrase helps the body breakdown and process certain sugars during digestion.

In people who lack the sucrase enzyme, sugar can pass into the intestines where it can interact with bacteria. This can cause bloating, gas, stomach pain, nausea, and vomiting.

Sacrosidase is used to treat sucrase deficiency that occurs in people with congenital sucrase-isomaltase deficiency (CSID).

CSID is a genetic enzyme deficiency and sacrosidase will not cure this condition.

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

What are the possible side effects of sacrosidase (Sucraid)?

Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• stomach pain;


• nausea, vomiting;


• diarrhea, constipation;


• sleep problems (insomnia);


• headache;


• nervous feeling; or


• increased thirst and dry, hot skin.

Some of these may be symptoms of your condition and not actual side effects of sacrosidase.

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 is the most important information I should know about sacrosidase (Sucraid)?

Sacrosidase is used to treat sucrase deficiency that occurs in people with congenital sucrase-isomaltase deficiency (CSID). CSID is a genetic enzyme deficiency and sacrosidase will not cure this condition.

You should not use this medication if you are allergic to yeast, yeast products, glycerin (glycerol), or papain (Accuzyme, Ethezyme, Gladase, Kovia, and others).

Before using sacrosidase, tell your doctor if you have diabetes. Sacrosidase changes the way your body absorbs sugar and your glucose levels may change. Your doctor will tell you if any of your medication doses need to be changed.

This medication sometimes causes an allergic reaction. Before you start the medication, your doctor may recommend a sacrosidase skin test to make sure you are not allergic to the medication.

Sacrosidase is usually taken with each meal or snack. It is best to take one half of the dose when you start eating and take the other half during your meal or snack.

Measure your dose using the scoop provided with this medication.

Sacrosidase liquid should be mixed with 2 to 4 ounces of water, milk, or baby formula that is no hotter than room temperature. Do not mix with warm or hot liquids or the medication will not be as effective.

Do not mix sacrosidase with fruit juice or drink fruit juice when taking the medication.

You may need to avoid eating a lot of starch (found mainly in rice, potatoes, corn, pasta, and bread). Follow your doctor's instructions about any special diet while you are taking sacrosidase.

Related Drug Centers

• Sucraid