Diprolene Ointment

DRUG DESCRIPTION

DIPROLENE® (augmented betamethasone dipropionate ointment) Ointment contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.

Chemically, betamethasone dipropionate is 9-fluoro-11b , 17,21-trihydroxy-16b -methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C₂₈H₃₇FO₇., a molecular weight of 504.6 and the following structural formula:

It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol.

Each gram of DIPROLENE Ointment 0.05% contains 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a vehicle of propylene glycol, propylene glycol stearate, white wax, and white petrolatum.

What are the possible side effects of betamethasone 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.

Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing betamethasone topical through your skin or gums:

• blurred vision, or seeing halos around lights;


• uneven heartbeats;


• mood changes;


• sleep problems (insomnia);


• weight gain, puffiness in your face; or

...

Read All Potential Side Effects and See Pictures of Diprolene Ointment »

What are the precautions when taking betamethasone dipropionate (Diprolene Ointment)?

Before using betamethasone, 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, 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: poor blood circulation, immune system problems, certain skin conditions if using the gel (rosacea, perioral dermatitis).

Do not use if there is an infection or sore present in the area to be treated.

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...

Read All Potential Precautions of Diprolene Ointment »

Diprolene Ointment Consumer (continued)

SIDE EFFECTS: Burning, itching, irritation, or dryness at the application site may occur when this medication is first applied to the skin. This should disappear in a few days as your body adjusts to the medication. 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 promptly if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, extreme/unwanted hair growth, "hair bumps" (folliculitis).

Skin infections can become worse when this medication is used. Notify your doctor if redness, swelling, or irritation does not improve.

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 betamethasone, 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, 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: poor blood circulation, immune system problems, certain skin conditions if using the gel (rosacea, perioral dermatitis).

Do not use if there is an infection or sore present in the area to be treated.

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.

Diprolene Ointment Patient Information Including Side Effects

Brand Names: Alphatrex, Beta-Val, Diprolene, Diprolene AF, Diprosone, Luxiq

Generic Name: betamethasone topical (Pronunciation: bay ta METH a sone)

• What is betamethasone topical (Diprolene Ointment)?


• What are the possible side effects of betamethasone topical?


• What is the most important information I should know about betamethasone topical?


• What should I discuss with my healthcare provider before using betamethasone topical?


• How should I use betamethasone topical?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid while using betamethasone topical?


• What other drugs will affect betamethasone topical?


• Where can I get more information?

What is betamethasone topical (Diprolene Ointment)?

Betamethasone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Betamethasone topical is used to treat the inflammation caused by a number of conditions such as allergic reactions, eczema, and psoriasis. The dental paste form of betamethasone is used to treat mouth ulcers.

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

What are the possible side effects of betamethasone 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.

Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing betamethasone topical through your skin or gums:

• blurred vision, or seeing halos around lights;


• uneven heartbeats;


• mood changes;


• sleep problems (insomnia);


• weight gain, puffiness in your face; or


• feeling tired.

Less serious side effects may include:

• skin redness, burning, itching, or peeling;


• thinning of your skin; or


• blistering skin; or


• stretch marks.

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 betamethasone topical?

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.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with betamethasone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of betamethasone topical.

Betamethasone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

Related Drug Centers

• Diprolene Lotion


• Diprolene Ointment

RiaSTAP

DRUG DESCRIPTION

RiaSTAP (fibrinogen concentrate human for intravenous use) is a heat-treated, lyophilized  fibrinogen (coagulation factor I) powder made from pooled human plasma.

Each vial contains 900 to 1300 mg  fibrinogen, 400 to 700 mg human albumin,
375 to 660 mg L-arginine hydrochloride, 200 to 350 mg sodium chloride and 50
to 100 mg sodium citrate. Sodium hydroxide and hydrochloric acid may have been
used to adjust the pH.

All plasma used in the manufacture of RiaSTAP (fibrinogen concentrate human for intravenous use) is tested using FDA-licensed
serological assays for hepatitis B surface antigen and antibodies to HIV-1/2
and HCV. Additionally, the plasma is tested with FDA-licensed Nucleic Acid Testing
(NAT) for HCV and HIV-1 and found to be non-reactive (negative). For HBV, an
investigational NAT procedure is used; however, the signifcance of a negative
result has not been established. In addition, the plasma has been tested by
NAT for HAV and B19V. Only plasma that passed virus screening is used for production,
and the limit for B19V in the fractionation pool is set not to exceed 10⁴
IU of B19V DNA per mL.

RiaSTAP (fibrinogen concentrate human for intravenous use) is manufactured from cryoprecipitate into a glycine precipitate, which
is then further purifed by multiple precipitation/adsorption steps. The manufacturing
process has been demonstrated to reduce the risk of virus transmission in an
additive manner: cryoprecipitation, Al(OH)₃  adsorption/glycine
precipitation/Al(OH)₃ adsorption, heat treatment (+60ºC for 20 hours
in an aqueous solution), and two subsequent glycine precipitation steps (initial
and main glycine precipitation steps). These steps have been validated independently
in a series of in vitro experiments for their capacity to inactivate
and/or remove both enveloped and non-enveloped viruses. Table 1 shows the virus
clearance during the manufacturing process for RiaSTAP (fibrinogen concentrate human for intravenous use) , expressed as the mean
log₁₀ reduction factor (LRF).

Table 1: Cumulative (Log₁₀) Virus Inactivation/Reduction
in RiaSTAP (fibrinogen concentrate human for intravenous use)

Manufacturing Step	Virus Reduction Factor (log10)
	Enveloped viruses					Non-enveloped viruses
	HIV	BVDV	WNV	HSV-1	PRV	H AV	CPV	B19V*
Cryoprecipitation	n.d.	n.d.	n.d.		1.6†	2.4	2.8	n.d.
Al(OH)3 adsorption/ glycine precipitation/ Al(OH)3 adsorption	(2.8)‡	(1.5)‡	n.d.	(0.9)‡				n.d.
Heat Treatment	≥ 5.7	≥ 9.1	≥ 8.3	≥ 8.1		≥ 4.3	1.6	≥ 4.5*
Glycine precipitation (two subsequent steps)	3.9	2.1	n.d.	1.0		(1.0)‡	(1.6)‡	n.d.
Cumulative virus reduction (log10)	≥ 9.6	≥ 11.2	≥ 8.3	≥ 9 .1	1.6	≥ 6.7	4.4	≥ 4.5
BVDV, bovine viral diarrhea virus, model for HCV WNV,West Nile virus HSV-1, herpes simplex virus type 1 CPV, canine parvovirus, model for B19V *B19V, human parvovirus B19, the virus elimination studies for parvovirus B19 employed a novel experimental infectivity assay utilizing clone of cell line UT7 that contains erythropoietic progeny cells. Virus titer was determined using an mmunofuorescence-based detection method. † PRV as HSV-1 a herpes virus – is reduced by cryoprecipitation by 1.6 log10 ‡ Not included in the calculation of the cumulative virus reduction factor n.d., not done

What are the possible side effects of fibrinogen (RiaSTAP)?

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any other serious side effect, such as:

• sudden numbness or weakness, especially on one side of the body;


• sudden headache, confusion, problems with vision, speech, or balance;


• sudden cough, rapid breathing, fast heart rate;

...

Read All Potential Side Effects and See Pictures of RiaSTAP »

RiaSTAP Patient Information Including Side Effects

Brand Names: RiaSTAP

Generic Name: fibrinogen (Pronunciation: fye BRIN oh gen)

• What is fibrinogen (RiaSTAP)?


• What are the possible side effects of fibrinogen (RiaSTAP)?


• What is the most important information I should know about fibrinogen (RiaSTAP)?


• What should I discuss with my health care provider before using fibrinogen (RiaSTAP)?


• How should I use fibrinogen (RiaSTAP)?


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


• What happens if I overdose (RiaSTAP)?


• What should I avoid while taking fibrinogen (RiaSTAP)?


• What other drugs will affect fibrinogen (RiaSTAP)?


• Where can I get more information?

What is fibrinogen (RiaSTAP)?

Fibrinogen is a man-made form of a protein that occurs naturally in the body and helps the blood clot.

Fibrinogen is used to treat bleeding episodes in people who have a congenital fibrinogen deficiency.

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

What are the possible side effects of fibrinogen (RiaSTAP)?

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any other serious side effect, such as:

• sudden numbness or weakness, especially on one side of the body;


• sudden headache, confusion, problems with vision, speech, or balance;


• sudden cough, rapid breathing, fast heart rate;


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


• pain or swelling in one or both legs.

Less serious side effects may include:

• fever


• chills;


• nausea; or


• vomiting.

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 fibrinogen (RiaSTAP)?

You should not use this medication if you have ever had an allergic reaction to it, or if you have ever had any life-threatening allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using fibrinogen, tell your doctor if you have a history of stroke or blood clot.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not mix the medicine until you are ready to give the injection.

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.

Other serious side effects may include sudden numbness or weakness, chest pain, confusion, pain or swelling in your one or both legs, and problems with vision, speech, or balance.

Fibrinogen is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Related Drug Centers

• RiaSTAP

Dantrium Capsules

DRUG DESCRIPTION

The chemical formula of Dantrium (dantrolene sodium) is hydrated 1-[[[5-(4- nitrophenyl)-2-furanyl]methylene]amino]-2, 4-imidazolidinedione sodium salt. It is an orange powder, slightly soluble in water, but due to its slightly acidic nature the solubility increases somewhat in alkaline solution. The anhydrous salt has a molecular weight of 336. The hydrated salt contains approximately 15% water (3-½ moles) and has a molecular weight of 399. The structural formula for the hydrated salt is:

Dantrium is supplied in capsules of 25 mg, 50 mg, and 100 mg.

Inactive Ingredients: Each capsule contains edible black ink, FD&C
Yellow No. 6, gelatin, lactose, magnesium stearate, starch, synthetic iron oxide
red, synthetic iron oxide yellow, talc, and titanium dioxide.

What are the possible side effects of dantrolene (Dantrium)?

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

Call your doctor at once if you have a serious side effect such as:

• severe diarrhea or constipation;


• weak or shallow breathing;


• pale skin, easy bruising or bleeding;


• trouble swallowing, especially if it causes choking;


• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing...

Read All Potential Side Effects and See Pictures of Dantrium Capsules »

What are the precautions when taking dantrolene sodium capsules (Dantrium Capsules)?

Before taking dantrolene, 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: liver problems (e.g., hepatitis, cirrhosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., chronic obstructive pulmonary disease-COPD), heart problems.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure...

Read All Potential Precautions of Dantrium Capsules »

Dantrium Capsules Consumer (continued)

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, weakness, tiredness, nausea, and diarrhea may occur as your body adjusts to this medication and usually lessen after several days. Headache, constipation, slurred speech, and drooling may also 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: sunburn (sun sensitivity), vision changes, black/tarry stools, vomit that looks like coffee grounds, mental/mood changes, trouble swallowing, problems with urination, severe/persistent constipation, seizures, fast heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (e.g., fever, chills, persistent sore throat), chest pain, swelling of the ankles/feet, trouble breathing.

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 dantrolene, 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: liver problems (e.g., hepatitis, cirrhosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., chronic obstructive pulmonary disease-COPD), heart problems.

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. Limit alcoholic beverages.

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.

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

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

This drug 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.

Dantrium Capsules Patient Information Including Side Effects

Brand Names: Dantrium

Generic Name: dantrolene (oral) (Pronunciation: DAN troe leen)

• What is dantrolene (Dantrium Capsules)?


• What are the possible side effects of dantrolene (Dantrium Capsules)?


• What is the most important information I should know about dantrolene (Dantrium Capsules)?


• What should I discuss with my healthcare provider before taking dantrolene (Dantrium Capsules)?


• How should I take dantrolene (Dantrium Capsules)?


• What happens if I miss a dose (Dantrium Capsules)?


• What happens if I overdose (Dantrium Capsules)?


• What should I avoid while taking dantrolene (Dantrium Capsules)?


• What other drugs will affect dantrolene (Dantrium Capsules)?


• Where can I get more information?

What is dantrolene (Dantrium Capsules)?

Dantrolene is a muscle relaxant.

Dantrolene is used to treat muscle spasticity (stiffness and spasms) caused by conditions such as a spinal cord injury, stroke, cerebral palsy, or multiple sclerosis.

Dantrolene is also used to prevent muscle stiffness and spasms caused by malignant hyperthermia (a rapid rise in body temperature) that can occur during surgery with certain types of anesthesia.

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

What are the possible side effects of dantrolene (Dantrium Capsules)?

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

Call your doctor at once if you have a serious side effect such as:

• severe diarrhea or constipation;


• weak or shallow breathing;


• pale skin, easy bruising or bleeding;


• trouble swallowing, especially if it causes choking;


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


• black, bloody, or tarry stools;


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


• seizure (black-out or convulsions); or


• urinating less than usual or not at all.

Less serious side effects may include:

• drowsiness, dizziness, weakness, tired feeling;


• mild diarrhea or constipation;


• mild nausea, vomiting, stomach pain;


• problems with speech, balance, or walking;


• headache, confusion, vision problems;


• sleep problems (insomnia);


• sweating, drooling; or


• urinating more than usual.

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 dantrolene (Dantrium Capsules)?

You should not take this medication if you are allergic to dantrolene, or if you have liver disease such as hepatitis or cirrhosis.

You may be more likely to develop liver problems while taking dantrolene if you are a woman, or if you are older than 35. Talk with your doctor about your individual risk.

Do not use dantrolene at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone.

Before taking dantrolene, tell your doctor if you have a history of liver disease, a breathing disorder such as COPD, heart disease, or a history of heart attack.

Dantrolene 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.

Dantrolene can cause muscle weakness, which can affect your ability to swallow. Use caution to prevent choking while you are eating meals. Talk with your doctor if you are unable to eat because of this side effect.

Avoid drinking alcohol. It can increase some of the side effects of dantrolene.

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

Related Drug Centers

• Dantrium Capsules

Orbivan

DRUG DESCRIPTION

ORBIVAN™ Butalbital, Acetaminophen and Caffeine Capsules, USP are supplied
in hard-gelatin capsule form for oral administration.

Each capsule contains the following active ingredients:

Butalbital, USP	50 mg
Acetaminophen, USP	300 mg
Caffeine, USP	40 mg

Inactive Ingredients: sodium lauryl sulfate, talc, microcrystalline
cellulose, stearic acid, D&C yellow #10, FD&C red#40, titanium dioxide,
FD&C blue #1, FD&C yellow #6, gelatin.

Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting
barbiturate of molecular weight 212.25. It has the following structural formula:

Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic
and antipyretic of molecular weight 151.16. It has the following structural
formula:

Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of
molecular weight 194.19. It has the following structural formula:

Medrol

DRUG DESCRIPTION

MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water.

The chemical name for methylprednisolone is pregna - 1,4 - diene - 3,20-dione,
11, 17, 21-trihydroxy-6-methyl-, (6α, 11β)-and the molecular weight
is 374.48. The structural for-mula is represented below:

Each MEDROL (methylprednisolone) Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg
or 32 mg of methylprednisolone.

Inactive ingredients:

2 mg
Calcium Stearate

Corn Starch

Erythrosine Sodium

Lactose

Mineral Oil

Sorbic Acid

Sucrose

4 and 16 mg

Calcium Stearate

Corn Starch

Lactose

Mineral Oil

Sorbic Acid

Sucrose

8 and 32 mg

Calcium Stearate

Corn Starch

F D & C Yellow No. 6

Lactose

Mineral Oil

Sorbic Acid

Sucrose

What are the possible side effects of methylprednisolone (Medrol, Medrol Dosepak, MethylPREDNISolone Dose Pack)?

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

Call your doctor at once if you have any of these serious side effects:

• problems with your vision;


• swelling, rapid weight gain, feeling short of breath;


• severe depression, unusual thoughts or behavior, seizure (convulsions);


• bloody or tarry stools, coughing up blood;

...

Read All Potential Side Effects and See Pictures of Medrol »

What are the precautions when taking methylprednisolone (Medrol)?

Before taking 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: untreated active fungal infections.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, history of blood clots, brittle bones (osteoporosis), high blood pressure, certain heart problems (such as congestive heart failure), diabetes, certain eye diseases (such as cataracts, herpes infection,...

Read All Potential Precautions of Medrol »

Medrol Consumer (continued)

SIDE EFFECTS: Stomach upset, headache, dizziness, menstrual period changes, trouble sleeping, or weight gain 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: bone/joint pain, easy bruising/bleeding, black stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, increased thirst/urination, fast/pounding/irregular heartbeat, shortness of breath, swelling of the ankles/feet, persistent weight gain, puffy face, unusual hair growth, thinning skin, slow wound healing, signs of infection (such as persistent fever/cough/sore throat, painful urination, eye pain/discharge), muscle weakness/pain, mental/mood changes (such as mood swings, depression, agitation), vision changes, seizures, unusual skin growths.

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 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: untreated active fungal infections.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, history of blood clots, brittle bones (osteoporosis), high blood pressure, certain heart problems (such as congestive heart failure), diabetes, certain eye diseases (such as cataracts, herpes infection, glaucoma), kidney disease, current infections (such as tuberculosis, threadworm), severe liver disease (cirrhosis), certain mental/mood conditions (such as psychosis, depression), seizures, stomach/intestinal problems (such as diverticulitis, ulcer, ulcerative colitis), thyroid problems (both underactive and overactive conditions), untreated mineral problems (such as low potassium or calcium).

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

This medication may mask signs of infection or put you at greater risk of developing very serious infections. Report any injuries or signs of infection (e.g., persistent sore throat/cough/fever, pain during urination, muscle aches) that occur while taking this medication or within 12 months after stopping it.

Using corticosteroid medications for a long time 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 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

Do not have immunizations, vaccinations, or skin tests while you are using this drug unless specifically directed by your doctor. Avoid contact with people who have recently received oral polio vaccine.

Avoid exposure to chickenpox or measles infection while taking this medication. If you are exposed to these infections, seek immediate medical attention.

If you have a history of ulcers or take large doses of aspirin or other arthritis medication, limit alcoholic beverages while taking this drug. Alcohol may increase the risk of stomach/intestinal bleeding.

If you have diabetes, this drug may increase your blood sugar levels. Check your blood glucose levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms such as increased thirst and urination. 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 osteoporosis. Talk with your doctor about ways to prevent bone loss.

This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

This medication should be used only when clearly needed during pregnancy. There have been rare reports of harm to an unborn baby when corticosteroids are used during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk and is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Medrol Patient Information Including Side Effects

Brand Names: Medrol, Medrol Dosepak, MethylPREDNISolone Dose Pack

Generic Name: methylprednisolone (Pronunciation: METH il pred NIS oh lone)

• What is methylprednisolone (Medrol)?


• What are the possible side effects of methylprednisolone (Medrol)?


• What is the most important information I should know about methylprednisolone (Medrol)?


• What should I discuss with my healthcare provider before taking methylprednisolone (Medrol)?


• How should I take methylprednisolone (Medrol)?


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


• What happens if I overdose (Medrol)?


• What should I avoid while taking methylprednisolone (Medrol)?


• What other drugs will affect methylprednisolone (Medrol)?


• Where can I get more information?

What is methylprednisolone (Medrol)?

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

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

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

What are the possible side effects of methylprednisolone (Medrol)?

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

Call your doctor at once if you have any of these serious side effects:

• problems with your vision;


• swelling, rapid weight gain, feeling short of breath;


• severe depression, unusual thoughts or behavior, seizure (convulsions);


• bloody or tarry stools, coughing up blood;


• pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);


• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or


• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

• sleep problems (insomnia), mood changes;


• acne, dry skin, thinning skin, bruising or discoloration;


• slow wound healing;


• increased sweating;


• headache, dizziness, spinning sensation;


• nausea, stomach pain, bloating; or


• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about methylprednisolone (Medrol)?

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

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

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

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

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

Do not receive a "live" vaccine while you are taking methylprednisolone. Vaccines may not work as well while you are taking a steroid.

Do not stop using methylprednisolone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

Related Drug Centers

• Medrol

Rimso-50

DRUG DESCRIPTION

RIMSO-50® brand of dimethyl sulfoxide (DMSO) 50% w/w Aqueous Solution for
intravesical instillation. Each mL contains 0.54 gm dimethyl sulfoxide. Intravesical
instillation for the treatment of interstitial cystitis. NOT FOR I.M. OR I.V.
INJECTION. Rx ONLY.

The active component of RIMSO-50® solution is dimethyl sulfoxide which
has the empirical formula C₂H₆OS. Dimethyl sulfoxide is
a clear, colorless and essentially odorless liquid which is miscible with water
and most organic solvents. Other physical characteristics include: molecular
weight 78.13, melting point 18.3° C, and a specifc gravity of 1.096.

What are the possible side effects of dimethyl sulfoxide (Rimso-50)?

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 if you feel severe discomfort or irritation when the medication is inserted or while you are holding it in your bladder. This discomfort may become less noticeable over time with repeat treatments.

You may notice a garlic- or onion-like taste in your mouth while you are receiving dimethyl sulfoxide. This effect may last for several hours after you...

Read All Potential Side Effects and See Pictures of Rimso-50 »

What are the precautions when taking dmso (Rimso-50)?

Before using dimethyl sulfoxide, 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: cancer of the urinary tract.

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...

Read All Potential Precautions of Rimso-50 »

Rimso-50 Consumer (continued)

SIDE EFFECTS: Bladder pain and discomfort may occur. A garlic-like taste in the mouth may be noticed within minutes of placing this medication in the bladder. This taste may last several hours, and an odor on the breath or from the skin may be noticed for up to 3 days following use of this medication. 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 rare but very serious side effects occur: vision changes.

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 dimethyl sulfoxide, 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: cancer of the urinary tract.

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.

Rimso-50 Patient Information Including Side Effects

Brand Names: Rimso-50

Generic Name: dimethyl sulfoxide (Pronunciation: dye METH il sul FOX ide)

• What is dimethyl sulfoxide (Rimso-50)?


• What are the possible side effects of dimethyl sulfoxide (Rimso-50)?


• What is the most important information I should know about dimethyl sulfoxide (Rimso-50)?


• What should I discuss with my health care provider before I receive dimethyl sulfoxide (Rimso-50)?


• How is dimethyl sulfoxide given (Rimso-50)?


• What happens if I miss a dose (Rimso-50)?


• What happens if I overdose (Rimso-50)?


• What should I avoid while receiving dimethyl sulfoxide (Rimso-50)?


• What other drugs will affect dimethyl sulfoxide (Rimso-50)?


• Where can I get more information?

What is dimethyl sulfoxide (Rimso-50)?

Dimethyl sulfoxide is used to treat pain and swelling associated with bladder or urinary conditions including cystitis (bladder inflammation or irritation).

This medication will not treat a bacterial or fungal infection of the bladder.

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

What are the possible side effects of dimethyl sulfoxide (Rimso-50)?

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 if you feel severe discomfort or irritation when the medication is inserted or while you are holding it in your bladder. This discomfort may become less noticeable over time with repeat treatments.

You may notice a garlic- or onion-like taste in your mouth while you are receiving dimethyl sulfoxide. This effect may last for several hours after you receive the medication, and you may also sense these odors on your breath or skin. This is a normal side effect of dimethyl sulfoxide and is not cause for concern.

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 dimethyl sulfoxide (Rimso-50)?

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

Before you receive dimethyl sulfoxide, tell your doctor if you have cancer of your bladder or kidneys. You may not be able to use this medication, or you may need a dose adjustment or special tests during treatment.

Dimethyl sulfoxide will not treat a bacterial or fungal infection of the bladder.

This medication should be used only when clearly needed during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

You may notice a garlic- or onion-like taste in your mouth while you are receiving dimethyl sulfoxide. This effect may last for several hours after you receive the medication, and you may also sense these odors on your breath or skin. This is a normal side effect of dimethyl sulfoxide and is not cause for alarm.

Related Drug Centers

• Rimso-50

Zenate Prenatal

DRUG DESCRIPTION

ADVANCED FORMULA ZENATE®
Prenatal Multivitamin/ Mineral Supplement Tablets

WARNING Accidental overdose of iron-containing products is a leading cause of fetal poisoning in children under six. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

 

Each film-coated tablet contains:

Vitamins:
A*	3000 I.U.
D (as cholecalciferol)	400 I.U.
E (as dl-alpha tocopheryl acetate)	10 I.U.
C (ascorbic acid)	70 mg
Folic Acid	1 mg
B1 (as thiamine mononitrate)	1.5 mg
B2 (riboflavin)	1.6 mg
B6 (as pyridoxine hydrochloride)	2.2 mg
B12 (cyanocobalamin)	2.2 µg
Niacin (as niacinamide)	17mg
Minerals:
Calcium (from calcium carbonate)	200 mg
Iodine (from potassium iodide)	175 µg
Iron (from ferrous fumarate)	65 mg
Magnesium (from magnesium oxide)	100 mg
Zinc (from zinc oxide)	15 mg

* Input as retinyl palmitate and beta-carotene

Inactive Ingredients:
Amorphous Precipitated Silica, Aqueous Shellac, Croscarmellose Sodium, Crospovidone, Hydrogenated Soybean Oil, Hydrogenated Castor Oil, Hydroxypropyl Cellulose, Hydroxylpropyl Methylcellulose, Magnesium Stearate, Polyethylene Glycol, Polysorbate 80, Powdered Cellulose, Pregelatinized Starch and Titanium Dioxide.