Micro-K for Liquid Suspension

(Generic versions may still be available.)

DRUG DESCRIPTION

Micro-K LS is an oral dosage form of microencapsulated potassium chloride. Each packet contains 1.5 g of potassium chloride, USP, equivalent to 20 mEqand of Potassium Chloride Extended Release Formulation for Liquid Suspension

of potassium. Micro-K LS is comprised of specially formulated granules. After reconstitution with 2-6 fluid ounces of water and 1 minute of stirring, the suspension is odorless and tasteless.

Each crystal of potassium chloride (KCl) is microencapsulated with an insoluble polymeric coating which functions as a semipermeable membrane; it allows for the controlled release of potassium and chloride ions over an 8- to 10-hour period. The controlled release of K⁺ ions by the microcapsular membrane is intended to reduce the likelihood of a high localized concentration of potassium chloride at any point on the mucosa of the gastrointestinal tract. Fluids pass through the membrane and gradually dissolve the potassium chloride within the microcapsules. The resulting potassium chloride solution slowly diffuses outward through the membrane.

Micro-K LS is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.

Inactive ingredients: docusate sodium, ethylcellulose, povidone, silicon dioxide, sucrose, and another ingredient.

What are the precautions when taking potassium chloride extended release formulation for liquid suspension (Micro-K for Liquid Suspension)?

Before taking potassium, 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: high potassium blood levels, severe kidney disease (e.g., chronic kidney failure, inability to make urine), untreated underactive adrenal gland, sudden loss of body fluids (acute dehydration), severe conditions of tissue breakdown (e.g., severe burns, traumatic injury).

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

Read All Potential Precautions of Micro-K for Liquid Suspension »

Micro-K for Liquid Suspension Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, gas, stomach upset, or diarrhea may occur. See How to Use for ways to reduce stomach upset. 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.

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 taking potassium, 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: high potassium blood levels, severe kidney disease (e.g., chronic kidney failure, inability to make urine), untreated underactive adrenal gland, sudden loss of body fluids (acute dehydration), severe conditions of tissue breakdown (e.g., severe burns, traumatic injury).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, certain types of heart disease (e.g., atrioventricular block), stomach ulcers.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to the effects of this drug.

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

Potassium passes into breast milk. Consult your doctor before breast-feeding.

Myobloc

DRUG DESCRIPTION

MYOBLOC ® (rimabotulinumtoxinB) injection is a sterile liquid formulation
of a purified neurotoxin that acts at the neuromuscular junction to produce
flaccid paralysis. The neurotoxin is produced by fermentation of the bacterium
Clostridium botulinum type B (Bean strain) and exists in noncovalent
association with hemagglutinin and nonhemagglutinin proteins as a neurotoxin
complex. The neurotoxin complex is recovered from the fermentation process and
purified through a series of precipitation and chromatography steps.

MYOBLOC (botulinum toxin type b) is provided as a clear and colorless to light-yellow sterile injectable solution in 3.5-mL glass vials. Each single-use vial of formulated MYOBLOC contains 5,000 Units of botulinum toxin type B per milliliter in 0.05% human serum albumin, 0.01 M sodium succinate, and 0.1 M sodium chloride at approximately pH 5.6.

One unit of MYOBLOC (botulinum toxin type b) corresponds to the calculated median lethal intraperitoneal
dose (LD50) in mice. The method for performing the assay is specific to Solstice
Neurosciences' manufacture of MYOBLOC (botulinum toxin type b) . Due to differences in specific details
such as the vehicle, dilution scheme and laboratory protocols for various mouse
LD50 assays, units of biological activity of MYOBLOC (botulinum toxin type b) cannot be compared to or
converted into units of any other botulinum toxin or any toxin assessed with
any other specific assay method. Therefore, differences in species sensitivities
to different botulinum neurotoxin serotypes preclude extrapolation of animal
dose-activity relationships to human dose estimates. The specific activity of
MYOBLOC (botulinum toxin type b) ranges between 70 to 130 Units/ng.

What are the possible side effects of botulinum toxin type B (Myobloc)?

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.

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these serious side effects, some of which can occur up to several...

Read All Potential Side Effects and See Pictures of Myobloc »

What are the precautions when taking botulinum toxin type b (Myobloc)?

Before using this medication, 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 your medical history, especially of: bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, signs of infection near the injection site, muscle/nerve disorders such as Lou Gehrig's disease (ALS) or myasthenia gravis, seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia).

This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do...

Read All Potential Precautions of Myobloc »

Myobloc Consumer (continued)

SIDE EFFECTS: Because this medication is given at the site of your condition, most of the side effects occur close to where the medication is injected. Redness, bruising, infection, and pain at the injection site may occur.

Dizziness, mild difficulty swallowing, respiratory infections such as cold or flu, pain, nausea, headache, and muscle weakness may occur when this medication is used to relax muscles. Double vision, drooping or swollen eyelid, eye irritation, dry eyes, tearing, reduced blinking, and increased sensitivity to light may also occur.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly. You may require protective eye drops/ointments, an eye patch, or other treatment.

When this medication is used to prevent migraines, side effects such as headache, neck pain, and drooping eyelid may occur.

When this medication is used for excessive sweating, side effects such as non-underarm sweating, respiratory infections such as cold or flu, headache, fever, neck or back pain, and anxiety 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.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: itching/swelling (especially of the face/tongue/throat), rash, 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 medication, 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 your medical history, especially of: bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, signs of infection near the injection site, muscle/nerve disorders such as Lou Gehrig's disease (ALS) or myasthenia gravis, seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia).

This drug may make cause muscle weakness, droopy eyelids, or 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. Limit alcoholic beverages.

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

Caution is advised if using this drug in children for muscle spasms, because they may be more sensitive to its possible side effects (such as difficulty breathing or swallowing). See Warning section. Discuss the risks and benefits with the doctor.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Use for the cosmetic treatment of wrinkles is not recommended during pregnancy.

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

Myobloc Patient Information Including Side Effects

Brand Names: Myobloc

Generic Name: botulinum toxin type B (Pronunciation: BOT ue LYE num TOX in type B)

• What is this drug (Myobloc)?


• What are the possible side effects of botulinum toxin type B (Myobloc)?


• What is the most important information I should know about botulinum toxin type B (Myobloc)?


• What should I discuss with my healthcare provider before I receive botulinum toxin type B (Myobloc)?


• How is botulinum toxin type B given (Myobloc)?


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


• What happens if I overdose (Myobloc)?


• What should I avoid after receiving botulinum toxin type B (Myobloc)?


• What other drugs will affect botulinum toxin type B (Myobloc)?


• Where can I get more information?

What is this drug (Myobloc)?

Botulinum toxin type B is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

Botulinum toxin type B is used to treat cervical dystonia (severe spasms in the neck muscles).

Botulinum toxin type B may also be used for other purposes not listed in this medication guide.

What are the possible side effects of botulinum toxin type B (Myobloc)?

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.

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an injection:

• trouble breathing, talking, or swallowing;


• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);


• loss of bladder control; or


• chest pain.

Less serious side effects may include:

• dry mouth, nausea, upset stomach;


• pain where the injection was given;


• headache, back or joint pain;


• cough, runny nose, throat, flu symptoms;


• pain or stiffness in your neck;


• dizziness, drowsiness, anxiety; or


• muscle weakness near where the medicine was injected.

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 botulinum toxin type B (Myobloc)?

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection.

Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

You should not receive this medication if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.

Before receiving a botulinum toxin injection, tell your doctor if you have ALS ( Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

Related Drug Centers

• Myobloc

MiraLAX

DRUG DESCRIPTION

A white powder for reconstitution. MiraLax (polyethylene glycol 3350, NF) is a synthetic polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. The chemical formula is HO(C₂H₄O)_n H in which n represents the average number of oxyethylene groups. Below 55° C it is a free flowing white powder freely soluble in water.

MiraLax (polyethylene glycol 3350 - otc) is an osmotic agent for the treatment of constipation.

What are the possible side effects of polyethylene glycol 3350 (GlycoLax, MiraLax)?

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 taking polyethylene glycol 3350 and call your doctor at once if you have any of these serious side effects:

• severe or bloody diarrhea;


• bleeding from your rectum;


• blood in your stools; or


• severe and worsening stomach pain, cramping, or bloating.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of MiraLAX »

What are the precautions when taking polyethylene glycol 3350 - otc (MiraLAX)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to polyethylene glycol; 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: certain stomach/intestinal problems (bowel obstruction).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: persistent nausea/vomiting/abdominal pain, other stomach/intestinal problems (irritable bowel syndrome), kidney disease.

Caution is advised when using this drug in the elderly because...

Read All Potential Precautions of MiraLAX »

MiraLAX Consumer (continued)

SIDE EFFECTS: Nausea, abdominal cramping, or gas may occur. If any of these effects persist or worsen, tell 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.

Inform your doctor immediately if you have excessive number of bowel movements, persistent diarrhea, or rectal bleeding while using this medication.

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 taking this medication, tell your doctor or pharmacist if you are allergic to polyethylene glycol; 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: certain stomach/intestinal problems (bowel obstruction).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: persistent nausea/vomiting/abdominal pain, other stomach/intestinal problems (irritable bowel syndrome), kidney disease.

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

During pregnancy, this medication should be used only when clearly needed. 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.

MiraLAX Patient Information Including Side Effects

Brand Names: GlycoLax, MiraLax

Generic Name: polyethylene glycol 3350 (Pronunciation: pol ee ETH il een GLYE kol)

• What is polyethylene glycol 3350 (MiraLAX)?


• What are the possible side effects of polyethylene glycol 3350 (MiraLAX)?


• What is the most important information I should know about polyethylene glycol 3350 (MiraLAX)?


• What should I discuss with my healthcare provider before taking polyethylene glycol 3350 (MiraLAX)?


• How should I take polyethylene glycol 3350 (MiraLAX)?


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


• What happens if I overdose (MiraLAX)?


• What should I avoid while taking polyethylene glycol 3350 (MiraLAX)?


• What other drugs will affect polyethylene glycol 3350 (MiraLAX)?


• Where can I get more information?

What is polyethylene glycol 3350 (MiraLAX)?

Polyethylene glycol 3350 is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements.

Polyethylene glycol 3350 is used as a laxative to treat occasional constipation or irregular bowel movements.

Polyethylene glycol 3350 may also be used for other purposes not listed in this medication guide.

What are the possible side effects of polyethylene glycol 3350 (MiraLAX)?

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 taking polyethylene glycol 3350 and call your doctor at once if you have any of these serious side effects:

• severe or bloody diarrhea;


• bleeding from your rectum;


• blood in your stools; or


• severe and worsening stomach pain, cramping, or bloating.

Less serious side effects may include:

• bloating, gas, upset stomach;


• dizziness; or


• increased sweating.

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 polyethylene glycol 3350 (MiraLAX)?

Do not use this medication if you are allergic to polyethylene glycol, or if you have a bowel obstruction or intestinal blockage. If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol 3350.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

Before taking polyethylene glycol 3350, tell your doctor if you are allergic to any drugs, or if you have ulcerative colitis, irritable bowel syndrome, kidney disease, nausea or vomiting with severe stomach pain, or if you have had a sudden change in bowel habits that has lasted 2 weeks or longer.

Polyethylene glycol 3350 should produce a bowel movement within 1 to 3 days of using the medication. Polyethylene glycol 3350 normally causes loose or even watery stools.

Do not use polyethylene glycol 3350 more than once per day. Call your doctor if you are still constipated or irregular after using this medication for 7 days in a row.

Related Drug Centers

• MiraLAX

Zonalon

DRUG DESCRIPTION

Zonalon (doxepin hydrochloride) Cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride (equivalent to 44.3 mg of doxepin).

Doxepin hydrochloride is one of a class of agents known as dibenzoxepin tricyclic
antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[b,e]oxepin-Δ^11(6H),γ-
propylaminehydrochloride. Doxepin hydrochloride has an empirical formula of
C₁₉H₂₁NO•HCl and a molecular weight of 316.

Zonalon (doxepin) Cream also contains sorbitol, cetyl alcohol, isopropyl myristate, glyceryl stearate, PEG-100 stearate, petrolatum, benzyl alcohol, titanium dioxide and purified water.

What are the precautions when taking doxepin (Zonalon)?

Before using doxepin, tell your doctor or pharmacist if you are allergic to it, or to other tricyclic antidepressants (e.g., amitriptyline); 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: certain eye problem (narrow-angle glaucoma), problems urinating (e.g., due to enlarged prostate).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., bronchitis, emphysema), long-term constipation, long-term heartburn, diabetes, eating...

Read All Potential Precautions of Zonalon »

Zonalon Consumer (continued)

SIDE EFFECTS: Burning/stinging at the application site, drowsiness, dizziness, dry mouth, blurred vision, or changes in taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

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: severe constipation, loss of coordination, ringing in the ears, persistent heartburn, mental/mood changes (e.g., agitation, confusion, depression), muscle weakness/spasms, numbness/tingling of the hands/feet, restlessness, decreased sexual ability/interest, trouble urinating, swelling of the hands/feet, weight gain.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), pain/redness/swelling of arms or legs, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

Seek immediate medical attention if any of these rare but very serious side effects occur: slurred speech, fast/irregular heartbeat, vision changes, fainting, weakness on one side of the body, seizures.

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 doxepin, tell your doctor or pharmacist if you are allergic to it, or to other tricyclic antidepressants (e.g., amitriptyline); 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: certain eye problem (narrow-angle glaucoma), problems urinating (e.g., due to enlarged prostate).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., bronchitis, emphysema), long-term constipation, long-term heartburn, diabetes, eating disorders (e.g., bulimia), certain eye problem (open-angle glaucoma), heart problems (e.g., irregular heartbeat), kidney problems, liver problems, overactive thyroid (hyperthyroidism), personal or family history of mental/mood conditions (e.g., bipolar disorder, psychosis, suicide), seizures, conditions that may increase your risk of seizures (e.g., other brain disease, alcohol withdrawal).

Doxepin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using doxepin, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using doxepin safely.

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. Limit alcoholic beverages.

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

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

If you have diabetes, this drug may make your blood sugar levels harder to control. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high or low blood sugar such as fast heartbeat, increased thirst/urination, shakiness, unusual sweating, or 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 its side effects, especially dizziness, drowsiness, confusion, and difficulty urinating.

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

This medication passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Mycelex

DRUG DESCRIPTION

Each Mycelex® Troche contains 10 mg clotrimazole [1 -(o-chloro-a,a-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth.

Structural Formula:

Chemical Formula: C₂₂H₁₇CIN₂

The troche dosage form is a large, slowly dissolving tablet (lozenge) containing 10 mg of clotrimazole dispersed in dextrose, microcrystalline cellulose, povidone, and magnesium stearate.

What are the possible side effects of clotrimazole (Mycelex Troche)?

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

Side effects are not likely to occur with clotrimazole. Continue to take clotrimazole and talk to your doctor if you experience

• nausea or stomach upset,


• vomiting,


• itching, or


• an unpleasant sensation in the mouth.

Side effects other than those listed here may also occur. Talk to your...

Read All Potential Side Effects and See Pictures of Mycelex »

What are the precautions when taking clotrimazole (Mycelex)?

Before taking clotrimazole lozenges, tell your doctor or pharmacist if you are allergic to clotrimazole; or to other azole antifungal drugs (e.g., ketoconazole); 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: liver disease.

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

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

Read All Potential Precautions of Mycelex »

Mycelex Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, mild itching, or an unpleasant sensation in the 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.

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 taking clotrimazole lozenges, tell your doctor or pharmacist if you are allergic to clotrimazole; or to other azole antifungal drugs (e.g., ketoconazole); 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: liver disease.

During pregnancy, this medication should be used only when clearly needed. 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.

Mycelex Patient Information Including Side Effects

Brand Names: Mycelex Troche

Generic Name: clotrimazole (Pronunciation: kloe TRIM a zole)

• What is clotrimazole (Mycelex)?


• What are the possible side effects of clotrimazole (Mycelex)?


• What is the most important information I should know about clotrimazole (Mycelex)?


• What should I discuss with my healthcare provider before taking clotrimazole (Mycelex)?


• How should I take clotrimazole (Mycelex)?


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


• What happens if I overdose (Mycelex)?


• What should I avoid while taking clotrimazole (Mycelex)?


• What other drugs will affect clotrimazole (Mycelex)?


• Where can I get more information?

What is clotrimazole (Mycelex)?

Clotrimazole is an antifungal medication. It is like an antibiotic but is used to treat yeast (fungal) infections.

Oral clotrimazole is used to treat and prevent yeast infections of the mouth and throat.

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

What are the possible side effects of clotrimazole (Mycelex)?

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

Side effects are not likely to occur with clotrimazole. Continue to take clotrimazole and talk to your doctor if you experience

• nausea or stomach upset,


• vomiting,


• itching, or


• an unpleasant sensation in the mouth.

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 clotrimazole (Mycelex)?

Take all of the clotrimazole that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Related Drug Centers

• Mycelex

Prosed DS

DRUG DESCRIPTION

PROSED®/DS is a dark blue, round, sugar coated tablet for oral administration.
Each tablet contains: Methenamine 81.6mg, Phenyl Salicylate 36.2 mg, Methylene
Blue 10.8 mg, Benzoic Acid 9.0 mg and Hyoscyamine Sulfate 0.12 mg.

METHENAMINE (Hexamethylenetetramine) exists as colorless, lustrous crystals
or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble
in water; soluble in alcohol and in chloroform.

PHENYL SALICYLATE (2-hydroxybenzoic acid phenyl ester) exists as white
crystals with a melting point of 40-43°C. It is very slightly soluble in water
and freely soluble in alcohol.

METHYLENE BLUE (methylthionine chloride) exists as dark green crystals.
It is soluble in water and in chloroform; sparingly soluble in alcohol.

BENZOIC ACID (benzenecarboxylic acid) exists as white crystals, scales
or needles. It has a slight odor and is slightly soluble in water; freely soluble
in alcohol, in chloroform and in ether.

HYOSCYAMINE SULFATE (l-tropyl tropate) is an alkaloid of belladonna.
It exists as a white crystalline powder. Its solutions are alkaline to litmus
and affected by light. It is slightly soluble in water; freely soluble in alcohol;
sparingly soluble in ether.

Inactive Ingredients

PROSED®/DS tablets contain the inactive ingredients Calcium Sulfate, Carnauba Wax, Dicalcium Phosphate, FD&C Blue #2 Lake, FD&C Red #40 Lake, FD&C Yellow

#6 Lake, Gelatin, Hypromellose, Kaolin, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Pharmaceutical Glaze, Polyethylene Glycol, Polyvinylpyrrolidone, Sugar and Titanium Dioxide.

Ponstel

DRUG DESCRIPTION

Ponstel® (mefenamic acid) is a member of the fenamate group of nonsteroidal
anti- inflammatory drugs (NSAIDs). Each blue-banded, ivory capsule contains
250 mg of mefenamic acid for oral administration. Mefenamic acid is a white
to greyish-white, odorless, microcrystalline powder with a melting point of
230°-231°C and water solubility of 0.004% at pH 7.1. The chemical name
is N-2,3-xylylanthranilic acid. The molecular weight is 241.29. Its molecular
formula is C₁₅H₁₅NO₂ and the structural formula
of mefenamic acid is:

Each capsule also contains lactose, NF. The capsule shell and/or band contains citric acid, USP; D&C yellow No. 10; FD&C blue No. 1; FD&C red No. 3; FD&C yellow No. 6; gelatin, NF; glycerol monooleate; silicon dioxide, NF; sodium benzoate, NF; sodium lauryl sulfate, NF; titanium dioxide, USP.

What are the possible side effects of mefenamic acid (Ponstel)?

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 taking mefenamic acid and seek medical attention or 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;


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


• urinating less than usual or not...

Read All Potential Side Effects and See Pictures of Ponstel »

What are the precautions when taking mefenamic acid (Ponstel)?

Before taking mefenamic acid, 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, 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, severe kidney disease, recent heart bypass surgery (CABG), active bleeding/sores in stomach/intestines (ulcer, gastrointestinal bleeding).

Before using this medication, tell...

Read All Potential Precautions of Ponstel »

Ponstel Consumer (continued)

SIDE EFFECTS: See also Warning section.

Upset stomach, nausea, heartburn, dizziness, drowsiness, diarrhea, and headache 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, persistent/severe headache, hearing changes (e.g., ringing in the ears), fast/pounding heartbeat, mental/mood changes, stomach pain, difficult/painful swallowing, swelling of the ankles/feet/hands, sudden/unexplained weight gain, vision changes.

Stop taking mefenamic acid and tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), unexplained stiff neck, change in the amount/color of urine.

This drug may rarely cause serious, possibly fatal liver disease. If you notice any of the following rare but very serious side effects, stop taking mefenamic acid and consult your doctor or pharmacist immediately: persistent nausea/vomiting, severe stomach/abdominal pain, extreme/unusual tiredness, weakness, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, stop taking mefenamic acid and immediately seek medical attention if you notice any of the following symptoms of a serious allergic reaction: rash/blisters, 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 taking mefenamic acid, 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, 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, severe kidney disease, recent heart bypass surgery (CABG), active bleeding/sores in stomach/intestines (ulcer, gastrointestinal bleeding).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, bleeding/clotting problems, blood disorders (e.g., anemia), high blood pressure, a severe loss of body water (dehydration), diabetes, heart disease (e.g., congestive heart failure, history of heart attack), kidney disease, liver disease, growths in the nose (nasal polyps), obesity, tobacco use, history of stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn), stroke, swelling of the ankles/feet/hands.

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

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.

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

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

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially stomach 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 interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Ponstel Patient Information Including Side Effects

Brand Names: Ponstel

Generic Name: mefenamic acid (Pronunciation: me fe NAM ik)

• What is mefenamic acid (Ponstel)?


• What are the possible side effects of mefenamic acid (Ponstel)?


• What is the most important information I should know about mefenamic acid (Ponstel)?


• What should I discuss with my healthcare provider before taking mefenamic acid (Ponstel)?


• How should I take mefenamic acid (Ponstel)?


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


• What happens if I overdose (Ponstel)?


• What should I avoid while taking mefenamic acid (Ponstel)?


• What other drugs will affect mefenamic acid (Ponstel)?


• Where can I get more information?

What is mefenamic acid (Ponstel)?

Mefenamic acid is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Mefenamic acid works by reducing hormones that cause inflammation and pain in the body.

Mefenamic acid is used to treat pain or inflammation caused by arthritis. It is also used to treat menstrual pain.

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

What are the possible side effects of mefenamic acid (Ponstel)?

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 taking mefenamic acid and seek medical attention or 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;


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


• urinating less than usual or not at all;


• pain, burning, or bleeding when you urinate;


• 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:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;


• dizziness, headache, nervousness;


• skin itching or rash;


• dry mouth;


• increased sweating, runny nose;


• blurred vision; or


• ringing in your ears.

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 mefenamic acid (Ponstel)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine 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 taking mefenamic acid. 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

• Ponstel

Kuvan

DRUG DESCRIPTION

Sapropterin dihydrochloride, the active pharmaceutical ingredient in Kuvan (saproterin dihydrochloride tablets) Tablets, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to light yellow crystals or crystalline powder.

The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2-
dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the
molecular formula is C₉H₁₅N₅O₃·2HCl
with a molecular weight of 314.17.

Sapropterin dihydrochloride has the following structural formula:

Each Kuvan Tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Tablets are round, off-white to light yellow, mottled, and debossed with “177”. Each tablet contains the following inactive ingredients: ascorbic acid (USP), crospovidone (NF), dibasic calcium phosphate (USP), D-mannitol (USP), riboflavin (USP), and sodium stearyl fumarate (NF).

What are the possible side effects of sapropterin (Kuvan)?

If sapropterin is not controlling your condition properly, you may have symptoms such as behavior changes, numbness or tingling, or problems with speech, vision, or balance. Call your doctor right away if you have any of these symptoms.

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 the serious side effects below:

• seizure (convulsions);


• chest pain or...

Read All Potential Side Effects and See Pictures of Kuvan »

Kuvan Patient Information Including Side Effects

Brand Names: Kuvan

Generic Name: sapropterin (Pronunciation: SAP roe TER in)

• What is sapropterin (Kuvan)?


• What are the possible side effects of sapropterin (Kuvan)?


• What is the most important information I should know about sapropterin (Kuvan)?


• What should I discuss with my health care provider before taking sapropterin (Kuvan)?


• How should I take sapropterin (Kuvan)?


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


• What happens if I overdose (Kuvan)?


• What should I avoid while taking sapropterin (Kuvan)?


• What other drugs will affect sapropterin (Kuvan)?


• Where can I get more information?

What is sapropterin (Kuvan)?

Sapropterin is a synthetic form of a natural salt that contributes to the function of a certain enzyme in the body. In people with a condition called phenylketonuria (PKU), this enzyme is lacking or missing in the body. Without the enzyme, phenylalanine levels can become elevated and cause a variety of neurologic symptoms.

Sapropterin is used to help the body activate the enzyme needed to control blood levels of phenylalanine. This medication is used in people with PKU.

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

What are the possible side effects of sapropterin (Kuvan)?

If sapropterin is not controlling your condition properly, you may have symptoms such as behavior changes, numbness or tingling, or problems with speech, vision, or balance. Call your doctor right away if you have any of these symptoms.

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 the serious side effects below:

• seizure (convulsions);


• chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling;


• easy bruising or bleeding;


• fever, chills, body aches, flu symptoms;


• swelling in your hands or feet;


• pain or burning when you urinate;


• weakness or fainting;


• black, bloody, or tarry stools; or


• coughing up blood or vomit that looks like coffee grounds.

Less serious side effects may include:

• nausea, vomiting, stomach pain, diarrhea;


• runny or stuffy nose, cough;


• headache, feeling agitated;


• dizziness; or


• joint pain.

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 sapropterin (Kuvan)?

Before using sapropterin, tell your doctor if you are allergic to any drugs, or if you have liver disease, a history of stomach ulcer or bleeding, or a seizure disorder.

Also tell your doctor about any medications you use, especially levodopa (Larodopa, Altamet, Parcopa, Sinemet), methotrexate (Rheumatrex, Trexall), or any medication to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra).

To be sure sapropterin is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Sapropterin is only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to help control your condition.

If sapropterin is not controlling your condition properly, you may have symptoms such as behavior changes, numbness or tingling, or problems with speech, vision, or balance. Call your doctor if you have any of these symptoms.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using sapropterin.

Related Drug Centers

• Kuvan

Proquad

DRUG DESCRIPTION

ProQuad (measles mumps rubella varicella vaccine live) * is a combined attenuated live virus vaccine containing measles, mumps, rubella, and varicella viruses. ProQuad (measles mumps rubella varicella vaccine live) is a sterile lyophilized preparation of (1) the components of M-M-R*ll (Measles, Mumps and Rubella Virus Vaccine Live): Measles Virus Vaccine Live, a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps vims propagated in chick embryo cell culture; Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts; and (2) Varicella Virus Vaccine Live (Oka/Merck), the Oka/Merck strain of varicella-zoster virus propagated in MRC-5 cells. The cells, virus pools, bovine serum, and human albumin used in manufacturing are all tested to provide assurance that the final product is free of potential adventitious agents.

ProQuad (measles mumps rubella varicella vaccine live) , when reconstituted as directed, is a sterile preparation for subcutaneous
administration. Each 0.5-mL dose contains not less than 3.00 log₁₀
TCID50 (50% tissue culture infectious dose) of measles virus; 4.30 log₁₀
TCID₅₀ of mumps virus; 3.00 log₁₀ TCID₅₀ of
rubella virus; and a minimum of 3.99 log₁₀ PFU (plaque-forming units)
of Oka/Merck varicella virus.

Each 0.5-mL dose of the vaccine contains no more than 21 mg of sucrose, 11 mg of hydrolyzed gelatin, 2.4 mg of sodium chloride, 1.8 mg of sorbitol, 0.40 mg of monosodium L-glutamate, 0.34 mg of sodium phosphate dibasic, 0.31 mg of human albumin, 0.17 mg of sodium bicarbonate, 72 meg of potassium phosphate monobasic, 60 meg of potassium chloride; 36 meg of potassium phosphate dibasic; residual components of MRC-5 cells including DNA and protein; < 16 meg of neomycin, bovine calf serum (0.5 meg), and other buffer and media ingredients. The product contains no preservative.

What are the possible side effects of this vaccine (ProQuad)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine...

Read All Potential Side Effects and See Pictures of Proquad »

What are the precautions when taking measles mumps rubella varicella vaccine live (Proquad)?

Before your child receives this product, tell the doctor or pharmacist if your child is allergic to it; or to eggs; or if your child has any other allergies. This product may contain inactive ingredients (such as neomycin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this product, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness (such as untreated tuberculosis), bleeding/blood clotting problems (such as hemophilia, low platelets), blood cancer (such as leukemia, lymphoma), immune system problems (such as HIV infection), scheduled organ transplant, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

There is a small risk...

Read All Potential Precautions of Proquad »

Proquad Consumer (continued)

SIDE EFFECTS: Pain/redness/swelling at the injection site, fever, rash, and fussiness may occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.

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

Tell the doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, joint pain/stiffness, seizures with fever.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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 the doctor or pharmacist.

Contact the doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before your child receives this product, tell the doctor or pharmacist if your child is allergic to it; or to eggs; or if your child has any other allergies. This product may contain inactive ingredients (such as neomycin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this product, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness (such as untreated tuberculosis), bleeding/blood clotting problems (such as hemophilia, low platelets), blood cancer (such as leukemia, lymphoma), immune system problems (such as HIV infection), scheduled organ transplant, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

There is a small risk that your child may expose others to infection with chickenpox for up to 6 weeks after your child has been vaccinated. If possible, your child should avoid being in the same room with newborn babies (especially if born prematurely), pregnant women who have not had chickenpox, and people with immune system problems.

This medication must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy for at least 3 months after vaccination.

This medication may pass into breast milk. However, it is unlikely to harm a nursing infant. Consult the doctor before breast-feeding.

Proquad Patient Information Including Side Effects

Brand Names: ProQuad

Generic Name: measles, mumps, rubella and varicella virus vaccine (Pronunciation: MEE zels, MUMPS, roo BEL a, var i SEL a)

• What is measles, mumps, rubella, and varicella virus vaccine (Proquad)?


• What are the possible side effects of this vaccine (Proquad)?


• What is the most important information I should know about this vaccine (Proquad)?


• What should I discuss with my healthcare provider before receiving this vaccine (Proquad)?


• How is this vaccine given (Proquad)?


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


• What happens if I overdose (Proquad)?


• What should I avoid before or after receiving this vaccine (Proquad)?


• What other drugs will affect measles, mumps, rubella and varicella virus vaccine (Proquad)?


• Where can I get more information?

What is measles, mumps, rubella, and varicella virus vaccine (Proquad)?

Measles, mumps, rubella, and varicella are serious diseases caused by viruses. They are spread from person to person through the air.

Measles virus can cause minor symptoms such as skin rash, cough, runny nose, eye irritation, or mild fever. It can also cause more serious symptoms such as ear infection, pneumonia, seizures, permanent brain damage, or death.

Mumps virus causes fever, headache, and swollen glands, but more serious symptoms include hearing loss, and painful swelling of the testicles or ovaries. Mumps can cause breathing problems or meningitis, and these infections can be fatal.

Rubella virus (also called German Measles) causes skin rash, mild fever, and joint pain. Becoming infected with rubella during pregnancy can result in a miscarriage or serious birth defects.

Varicella (commonly known as chickenpox) is a common childhood disease that causes fever, skin rash, and a breakout of fluid-filled blisters on the skin. Most people who receive this vaccine will not get chickenpox, or will get only a mild case and will recover faster.

Chickenpox is usually mild, but it can be serious or even fatal in young infants and in adults. It can lead to severe skin infection, breathing problems, brain damage, or death. A person who has had chickenpox can develop herpes zoster (also called shingles) later in life, which causes severe nerve pain, and hearing or vision problems, which may last for months or years.

Measles, mumps, rubella, and varicella are spread from person to person.

The measles, mumps, rubella, and varicella vaccine is used to help prevent these diseases in children.

This vaccine works by exposing your child to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Measles, mumps, rubella, and varicella vaccine is for use in children between the ages of 12 months and 12 years old.

Like any vaccine, the measles, mumps, rubella, and varicella vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Proquad)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has 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 your child has any of these serious side effects:

• problems with hearing or vision;


• extreme drowsiness, fainting;


• fussiness, irritability, crying for an hour or longer;


• easy bruising or bleeding, unusual weakness;


• seizure (black-out or convulsions); or


• high fever (within a few hours or a few days after the vaccine).

Less serious side effects include:

• redness, pain, swelling, or a lump where the shot was given;


• headache, dizziness;


• low fever;


• joint or muscle pain; or


• nausea, vomiting, diarrhea.

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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What is the most important information I should know about this vaccine (Proquad)?

The measles, mumps, rubella , and varicella vaccine is usually given only once when the child is between 12 months and 12 years old. If a booster dose is needed, At least 3 months should pass between the first and second doses of this vaccine.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Do not give your child salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others for at least 6 weeks after receiving this vaccine. A serious condition called Reye's Syndrome has been reported in patients with chickenpox who take aspirin or salicylates.

Related Drug Centers

• Proquad

Derma-Smoothe Scalp/FS

DRUG DESCRIPTION

Derma-Smoothe/FS® Topical Oil contains fluocinolone acetonide {(6a, 11b, 16a)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Derma-Smoothe/FS® 0.01%, fluocinolone acetonide for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older and as fluocinone acetonide oil, 0.01%for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C₂₄ H₃₀ F₂ O₆. It has the following structural formula:

Fluocinolone acetonide in Derma-Smoothe/FS® (fluocinolone acetonide) has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each gram of Derma-Smoothe/FS® contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF and fragrances.

Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

What are the possible side effects of fluocinolone topical oil (Derma-Smoothe/FS)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing fluocinolone topical oil through your skin, such as:

• blurred vision, headache;


• thinning skin, easy bruising;


• mood changes;


• weight gain, puffiness in your face; or

...

Read All Potential Side Effects and See Pictures of Derma-Smoothe Scalp/FS »

What are the precautions when taking fluocinolone acetonide (Derma-Smoothe Scalp/FS)?

Before using fluocinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as peanuts), 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.

Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when this medication is used. Notify your doctor promptly if redness, swelling, or irritation does not improve.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to...

Read All Potential Precautions of Derma-Smoothe Scalp/FS »

Derma-Smoothe Scalp/FS Consumer (continued)

SIDE EFFECTS: Stinging, burning, irritation, dryness, or redness at the application site may occur. Acne, excessive hair growth, "hair bumps" (folliculitis), skin thinning/discoloration, or stretch marks may also 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.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

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 fluocinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as peanuts), 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.

Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when this medication is used. Notify your doctor promptly if redness, swelling, or irritation does not improve.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

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

It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

Derma-Smoothe Scalp/FS Patient Information Including Side Effects

Brand Names: Derma-Smoothe/FS

Generic Name: fluocinolone topical (oil) (Pronunciation: floo oh SIN oh lone TOP i kal)

• What is fluocinolone topical oil (Derma-Smoothe Scalp/FS)?


• What are the possible side effects of fluocinolone topical oil (Derma-Smoothe Scalp/FS)?


• What is the most important information I should know about fluocinolone topical oil (Derma-Smoothe Scalp/FS)?


• What should I discuss with my healthcare provider before using fluocinolone topical oil (Derma-Smoothe Scalp/FS)?


• How should I use fluocinolone topical oil (Derma-Smoothe Scalp/FS)?


• What happens if I miss a dose (Derma-Smoothe Scalp/FS)?


• What happens if I overdose (Derma-Smoothe Scalp/FS)?


• What should I avoid while using fluocinolone topical oil (Derma-Smoothe Scalp/FS)?


• What other drugs will affect fluocinolone topical oil (Derma-Smoothe Scalp/FS)?


• Where can I get more information?

What is fluocinolone topical oil (Derma-Smoothe Scalp/FS)?

Fluocinolone topical (for the skin) is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Fluocinolone body oil is used to treat atopic dermatitis (a form of eczema). Fluocinolone scalp oil is used to treat scalp psoriasis.

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

What are the possible side effects of fluocinolone topical oil (Derma-Smoothe Scalp/FS)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing fluocinolone topical oil through your skin, such as:

• blurred vision, headache;


• thinning skin, easy bruising;


• mood changes;


• weight gain, puffiness in your face; or


• muscle weakness, feeling tired.

Less serious side effects may include:

• mild skin itching, burning, dryness, or other irritation;


• temporary hair loss;


• swollen hair follicles;


• blisters, pimples, or crusting of treated skin;


• changes in color of treated skin;


• skin rash or irritation around your mouth;


• fever, cough, sore throat, runny or stuffy nose; or


• red spots or the appearance of tiny veins (especially around your nose, cheeks, or chin).

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 fluocinolone topical oil (Derma-Smoothe Scalp/FS)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

This medication contains peanut oil. Tell your doctor if you have a peanut allergy.

Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve after 2 weeks of use, if it gets worse, or if you develop signs of a skin infection.

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