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

VePesid

DRUG DESCRIPTION

VePesid® (etoposide) (also commonly known as VP-16) is a semisynthetic derivative
of podophyllotoxin used in the treatment of certain neoplastic diseases. It
is 4'-demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside].
It is very soluble in methanol and chloroform, slightly soluble in ethanol,
and sparingly soluble in water and ether. It is made more miscible with water
by means of organic solvents. It has a molecular weight of 588.56 and a molecular
formula of C₂₉H₃₂O₁₃.

VePesid (etoposide) is administered orally. VePesid (etoposide) is available as 50 mg pink capsules. Each liquid-filled, soft gelatin capsule contains 50 mg of etoposide in a vehicle consisting of citric acid, glycerin, purified water, and polyethylene glycol 400. The soft gelatin capsules contain gelatin, glycerin, sorbitol, purified water, and parabens (ethyl and propyl) with the following dye system: iron oxide (red) and titanium dioxide; the capsules are printed with edible ink.

The structural formula is:

What are the possible side effects of etoposide (VePesid)?

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:

• fever, chills, body aches, flu symptoms;


• white patches or sores inside your mouth or on your lips;


• easy bruising or bleeding, unusual weakness;


• fast heart rate;


• severe nausea and vomiting;


• feeling light-headed, fainting; or


• low...

Read All Potential Side Effects and See Pictures of VePesid »

What are the precautions when taking etoposide (VePesid)?

Before taking etoposide, 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: kidney disease, liver disease, blood problems (e.g., anemia, thrombocytopenia), heart problems.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact...

Read All Potential Precautions of VePesid »

VePesid Consumer (continued)

SIDE EFFECTS: (see also Warning section)

Nausea, vomiting, loss of appetite, strange aftertaste, diarrhea, mouth sores, muscle aches, drowsiness, fatigue, or skin color changes may occur. Nausea and vomiting can be quite severe. In some cases, drug therapy may be necessary to prevent or relieve nausea and vomiting. Changes in diet such as eating several small meals or limiting activity may help decrease some of these effects. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Temporary hair loss may occur. Hair growth should return after treatment has ended.

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.

Etoposide, along with certain other anti-cancer drugs, has been known to cause acute leukemia. This is very rare. Consult your doctor for more details.

Etoposide can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection, such as fever, chills or persistent sore throat.

Tell your doctor immediately if this unlikely side effect occurs: tingling of hands or feet.

Tell your doctor immediately if any of these rare but very serious side effects occur: yellowing of the eyes or skin, tarry or bloody stool, vision changes, abdominal pain, redness or swelling of your veins.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, sweating, chest tightness, fast or irregular heartbeat, skin turning blue, cough, 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 taking etoposide, 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: kidney disease, liver disease, blood problems (e.g., anemia, thrombocytopenia), heart problems.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact sports.

Wash your hands well to prevent the spread of infections.

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

Limit alcoholic beverages as drinking alcohol may increase your chances of bleeding in your stomach or intestines.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.

Caution is advised when using etoposide in children because they may be more sensitive to the allergic effects of this drug.

Etoposide should be used during pregnancy only when clearly needed. It may cause harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Women of child-bearing age should use an effective form of birth control while using this medication. Discuss the use of birth control, the risks, the benefits and any other concerns about using this medication with your doctor.

This medication passes into breast milk. Because of the potential risk to the infant, breast-feeding while using etoposide is not recommended. Consult your doctor before breast-feeding.

VePesid Patient Information Including Side Effects

Brand Names: VePesid

Generic Name: etoposide (oral) (Pronunciation: ee TOW poh side)

• What is etoposide (VePesid)?


• What are the possible side effects of etoposide (VePesid)?


• What is the most important information I should know about etoposide (VePesid)?


• What should I discuss with my healthcare provider before taking etoposide (VePesid)?


• How should I use etoposide (VePesid)?


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


• What happens if I overdose (VePesid)?


• What should I avoid while using etoposide (VePesid)?


• What other drugs will affect etoposide (VePesid)?


• Where can I get more information?

What is etoposide (VePesid)?

Etoposide is a cancer medicine that interferes with the growth of cancer cells and slows their growth and spread in the body.

Etoposide is used to treat cancer of the lung or testicles.

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

What are the possible side effects of etoposide (VePesid)?

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:

• fever, chills, body aches, flu symptoms;


• white patches or sores inside your mouth or on your lips;


• easy bruising or bleeding, unusual weakness;


• fast heart rate;


• severe nausea and vomiting;


• feeling light-headed, fainting; or


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

Other, less serious side effects may be more likely to occur, such as:

• mild nausea, vomiting, stomach pain;


• mild itching or skin rash; or


• temporary hair loss.

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

What is the most important information I should know about etoposide (VePesid)?

Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not break or open an etoposide capsule. The medicine from a broken capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water. If you must handle a broken capsule, ask your doctor or pharmacist how to safely dispose of the capsule.

Etoposide can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Using etoposide may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.

Related Drug Centers

• Vepesid

Sodium Sulfacetamide 10% and Sulfur 5% lotion

DRUG DESCRIPTION

Each mL of Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) as dispensed contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a lotion of 2-bromo-2-nitropropane-1,3-diol, butylparaben, colloidal activated attapulgite, diethanolamine, hydroxyethyl cellulose, iron oxides, lauramide DEA, methylparaben, polyethylene glycol 400 monolaurate, propylene glycol, purified water, simethicone emulsion, sodium chloride, sodium metabisulfite, sodium polynaphthalenesulfonate, talc, xanthan gum, and zinc oxide.

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N'-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.

The structural formula is:

What are the precautions when taking sulfacetamide and sulfur (Sodium Sulfacetamide 10% and Sulfur 5% lotion)?

Before using this product, tell your doctor or pharmacist if you are allergic to sodium sulfacetamide or sulfur; or to sulfa antibiotics (such as sulfamethoxazole); or to other ingredients listed on the product package; 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: kidney problems.

Tell your doctor if there are areas of skin near where this product will be applied that are cracked, broken, or raw. Injured skin may absorb more of this product, and the chance of serious side effects may increase.

Before having surgery, tell your doctor or...

Read All Potential Precautions of Sodium Sulfacetamide 10% and Sulfur 5% lotion »

Sodium Sulfacetamide 10% and Sulfur 5% lotion Consumer (continued)

SIDE EFFECTS: Mild peeling of the top layer of skin is expected. Skin irritation, redness, and scaling may also occur. If any of these effects persist or worsen, stop using this medication and 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.

Rarely, sodium sulfacetamide products applied to the skin may be absorbed and may cause serious side effects. Stop using this product and tell your doctor immediately if any of these rare but serious side effects occur: aching/swollen joints, rash on nose and cheeks, signs of infection (such as fever, persistent sore throat), signs of anemia (such as unusual tiredness/weakness, rapid breathing, fast heartbeat), unusual bleeding/bruising, signs of liver problems (such as dark urine, yellowing eyes/skin, stomach/abdominal pain, persistent nausea, vomiting), mouth sores.

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 this product, tell your doctor or pharmacist if you are allergic to sodium sulfacetamide or sulfur; or to sulfa antibiotics (such as sulfamethoxazole); or to other ingredients listed on the product package; 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: kidney problems.

Tell your doctor if there are areas of skin near where this product will be applied that are cracked, broken, or raw. Injured skin may absorb more of this product, and the chance of serious side effects may increase.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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.

Humulin N

DRUG DESCRIPTION

Humulin is synthesized in a special non-disease-producing laboratory strain
of Escherichia coli bacteria that has been genetically altered to produce
human insulin. Humulin N (insulin human recombinant) [Human insulin (rDNA origin) isophane suspension] is
a crystalline suspension of human insulin with protamine and zinc providing
an intermediate-acting insulin with a slower onset of action and a longer duration
of activity (up to 24 hours) than that of Regular human insulin. The time course
of action of any insulin may vary considerably in different individuals or at
different times in the same individual. As with all insulin preparations, the
duration of action of Humulin N (insulin human recombinant) is dependent on dose, site of injection, blood
supply, temperature, and physical activity. Humulin N (insulin human recombinant) is a sterile suspension
and is for subcutaneous injection only. It should not be used intravenously
or intramuscularly. The concentration of Humulin N (insulin human recombinant) is 100 units/mL (U-100).

What are the possible side effects of insulin isophane?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin isophane. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low...

Read All Potential Side Effects and See Pictures of Humulin N »

What are the precautions when taking insulin (human recombinant) (Humulin N)?

Before using insulin, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; 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.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal/pituitary gland problems, infection (especially with diarrhea or vomiting), kidney disease, liver disease, nerve problems (e.g., diabetic neuropathy), thyroid problems.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery,...

Read All Potential Precautions of Humulin N »

Humulin N Consumer (continued)

SIDE EFFECTS: Injection site reactions (e.g., pain, redness, irritation) may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that 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.

This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories or if you have taken too much insulin. The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, quickly raise your blood sugar level by eating a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist about what you should do if you miss a meal.

Too little insulin can cause symptoms of high blood sugar (hyperglycemia). Symptoms include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 insulin, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; 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.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal/pituitary gland problems, infection (especially with diarrhea or vomiting), kidney disease, liver disease, nerve problems (e.g., diabetic neuropathy), thyroid problems.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. 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.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your medication or how often you test your blood sugar may be required.

Changes in your activity level may affect the amount of insulin you need. Tell your doctor if your insulin needs are changing. Check your blood sugar readings before and after exercise. You may need a snack beforehand.

If traveling across time zones, ask your doctor about how to adjust your insulin schedule. Take extra insulin and supplies with you.

The elderly may be more sensitive to the effects of this drug, especially low blood sugar.

Children may be more sensitive to the effects of this drug, especially low blood sugar.

Tell your doctor if you are pregnant before using this medication. If you are planning pregnancy, discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. Consult your doctor for more details.

This medication does not pass into breast milk. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Humulin N Patient Information Including Side Effects

Brand Names: Humulin N, Humulin N Pen, Novolin N, Novolin N Innolet, Novolin N PenFill, Relion Novolin N

Generic Name: insulin isophane (Pronunciation: IN soo lin EYE soe fane)

• What is insulin isophane (Humulin N)?


• What are the possible side effects of insulin isophane?


• What is the most important information I should know about insulin isophane?


• What should I discuss with my healthcare provider before using insulin isophane?


• How should I use insulin isophane?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid while using insulin isophane?


• What other drugs will affect insulin isophane?


• Where can I get more information?

What is insulin isophane (Humulin N)?

Insulin isophane is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin isophane is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Insulin isophane is used to treat diabetes.

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

What are the possible side effects of insulin isophane?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin isophane. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin isophane.

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 insulin isophane?

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin isophane is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Related Drug Centers

• Humulin N

Nardil

DRUG DESCRIPTION

NARDIL® (phenelzine sulfate) is a potent inhibitor of monoamine oxidase
(MAO). Phenelzine sulfate is a hydrazine derivative. It has a molecular weight
of 234.27 and is chemically described as C₈ H₁₂ N₂
• H₂SO₄. Its chemical structure is shown below:

Molecular weight: 234.27

Each NARDIL (phenelzine) film-coated tablet for oral administration contains phenelzine sulfate equivalent to 15 mg of phenelzine base and the following inactive ingredients: mannitol, USP; croscarmellose sodium, NF; povidone, USP; edetate disodium, USP; magnesium stearate, NF; isopropyl alcohol, USP; purified water, USP; opadry orange Y30-13242A; simethicone emulsion, USP.

What are the possible side effects of phenelzine (Nardil)?

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 new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop using phenelzine and call your doctor at once if...

Read All Potential Side Effects and See Pictures of Nardil »

What are the precautions when taking phenelzine (Nardil)?

Before taking phenelzine, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, liver problems, severe kidney disease.

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

Read All Potential Precautions of Nardil »

Nardil Consumer (continued)

SIDE EFFECTS: See also Warning section.

Dizziness, drowsiness, tiredness, weakness, problems sleeping, constipation, and dry mouth may occur. If any of these effects persist or worsen, notify 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: fainting, mental/mood changes (e.g., agitation, confusion), muscle stiffness/twitching, changes in sexual ability/interest, shaking (tremor), shivering, swollen ankles/legs, unusual weight gain, vision changes (e.g., double/blurred vision).

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: severe stomach/abdominal pain, persistent nausea/vomiting, seizures, dark urine, yellowing eyes/skin.

This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk (See also Drug Interaction section.) Stop taking phenelzine and seek immediate medical attention if any of these serious side effects occur: frequent/severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweating/clammy skin (sometimes with fever), widened pupils, sudden sensitivity to light (photophobia).

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), 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 taking phenelzine, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, liver problems, severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal/family history of mental/mood disorders (e.g., schizophrenia, bipolar disorder), family history of high blood pressure, heart disease (e.g., coronary artery disease, history of chest pain), mild/moderate kidney disease, diabetes, certain nervous system diseases (Parkinson's syndrome, seizures), overactive thyroid (hyperthyroidism).

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

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

Before having surgery or any procedures requiring use of contrast dye (e.g., myelography), tell your doctor or dentist you are on this medication. You may need to stop taking this drug beforehand. Follow your doctor's instructions carefully.

If you have heart disease, this medication may mask chest pain. Avoid strenuous exercise while taking this medication.

If you have diabetes, phenelzine may lower your blood sugar levels. Check your blood sugar regularly, and share the results with your doctor. Tell your doctor immediately if you have symptoms of low blood sugar such as cold sweat, shaking, rapid heart rate, fainting, and hunger. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on blood pressure.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Nardil Patient Information Including Side Effects

Brand Names: Nardil

Generic Name: phenelzine (Pronunciation: FEN el zeen)

• What is phenelzine (Nardil)?


• What are the possible side effects of phenelzine (Nardil)?


• What is the most important information I should know about phenelzine (Nardil)?


• What should I discuss with my doctor before taking phenelzine (Nardil)?


• How should I take phenelzine (Nardil)?


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


• What happens if I overdose (Nardil)?


• What should I avoid while taking phenelzine (Nardil)?


• What other drugs will affect phenelzine (Nardil)?


• Where can I get more information?

What is phenelzine (Nardil)?

Phenelzine is a monoamine oxidase inhibitor (MAOI) that works by increasing the levels of certain chemicals in the brain.

Phenelzine is used to treat symptoms of depression that may include feelings of sadness, fear, anxiety, or worry about physical health (hypochondria). This medication is usually given after other anti-depressants have been tried without successful treatment of symptoms. Phenelzine is not for treating severe depression or bipolar disorder (manic depression).

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

What are the possible side effects of phenelzine (Nardil)?

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 new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

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

• sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, sweating, vision problems, sensitivity to light;


• chest pain, fast or slow heart rate;


• swelling, rapid weight gain;


• agitation, unusual thoughts or behavior; or


• feeling light-headed, fainting.

Less serious side effects may include:

• dizziness;


• feeling weak or drowsy;


• sleep problems (insomnia);


• constipation, upset stomach;


• dry mouth, decreased urination; or


• impotence, difficulty 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 phenelzine (Nardil)?

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with phenelzine. Do not take phenelzine before telling your doctor about all other prescription and over-the-counter medications you use, including vitamins, minerals, and herbal products. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

While you are taking phenelzine, you must not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while taking phenelzine?" section of this leaflet. Eating tyramine while you are taking phenelzine can raise your blood pressure to dangerous levels, causing symptoms that include sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, vision problems, and sensitivity to light. Stop taking phenelzine and call your doctor at once if you have any of these symptoms.

You should become very familiar with the list of foods and medicines you must avoid while you are taking phenelzine.

Phenelzine 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.

Related Drug Centers

• Nardil