Sumycin

DRUG DESCRIPTION

Sumycin for oral administration contains tetracycline, an antibiotic isolated
from Streptomyces aureofaciens. Tetracycline is described chemically
as 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a-octa- hydro-3, 6, 10, 12, 12a-pentahydroxy-6-methyl-1,
11-dioxo-2-nap- thacenecarboxamide; its structural formula is:

Sumycin '250' and Sumycin '500' Tablets (Tetracycline Hydrochloride Tablets)
are available for oral administration as tablets providing 250 mg and 500 mg
tetracycline hydrochloride, respectively. Inactive ingredients: colorants (D&C
Red No. 30 Aluminum lake, titanium dioxide), hypromellose, anhydrous lactose,
magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch,
stearic acid. In addition, 250 mg contains methylene chloride hydroxypropyl
cellulose, triacetin, and 500 mg contains polyethylene glycol, polyparaben,
methylparaben, sodium citrate, potassium sorbate, propylparaben, and xanthan
gum.

What are the possible side effects of tetracycline (Ala-Tet, Sumycin)?

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

• severe headache, dizziness, blurred vision;


• fever, chills, body aches, flu symptoms;


• severe blistering, peeling, and red skin rash;


• urinating less than usual or not at all;


• pale or yellowed skin, dark colored...

Read All Potential Side Effects and See Pictures of Sumycin »

What are the precautions when taking tetracycline (Sumycin)?

Before taking tetracycline, tell your doctor or pharmacist if you are allergic to it; or to other tetracyclines (e.g., doxycycline, minocycline), or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD).

This drug 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. Limit alcoholic beverages.

This medication may make you more sensitive to the...

Read All Potential Precautions of Sumycin »

Sumycin Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, loss of appetite, mouth sores, black hairy tongue, sore throat, dizziness, headache, or rectal discomfort 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: sunburn (sun sensitivity), nail discoloration, muscle pain, difficult or painful swallowing, change in the amount of urine, brown/gray tooth discoloration, numbness/tingling of the hands/feet, unusual fatigue, new signs of infection (e.g., persistent sore throat, fever, chills).

Tell your doctor immediately if any of these rare but very serious side effects occur: hearing changes (e.g., ringing in the ears, decreased hearing), persistent or severe headache, vision changes (e.g., blurred vision), easy bruising/bleeding, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped.. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool..

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

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, skin lesions/sores, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, new or worsening swelling/pain in the joints, chest pain, fast/irregular heartbeat.

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 tetracycline, tell your doctor or pharmacist if you are allergic to it; or to other tetracyclines (e.g., doxycycline, minocycline), or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD).

This drug 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. Limit alcoholic beverages.

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.

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

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

This medication should not be used in children younger than 8 years of age because it may cause permanent tooth discoloration and other problems. Tooth discoloration has also occurred in older children and young adults. Consult your doctor for more information.

This medication is not recommended for use during pregnancy because of possible harm to an unborn baby. Women of child-bearing age should use effective birth control while taking this medication. Consult your doctor for more details.

This medication passes into breast milk in very small amounts. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Sumycin Patient Information Including Side Effects

Brand Names: Ala-Tet, Sumycin

Generic Name: tetracycline (Pronunciation: TET tra SYE kleen)

• What is tetracycline (Sumycin)?


• What are the possible side effects of tetracycline (Sumycin)?


• What is the most important information I should know about tetracycline (Sumycin)?


• What should I discuss with my healthcare provider before taking tetracycline (Sumycin)?


• How should I take tetracycline (Sumycin)?


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


• What happens if I overdose (Sumycin)?


• What should I avoid while taking tetracycline (Sumycin)?


• What other drugs will affect tetracycline (Sumycin)?


• Where can I get more information?

What is tetracycline (Sumycin)?

Tetracycline is an antibiotic that fights bacteria in the body.

Tetracycline is used to treat many different bacterial infections, such as urinary tract infections, acne, gonorrhea, chlamydia, and others.

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

What are the possible side effects of tetracycline (Sumycin)?

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

• severe headache, dizziness, blurred vision;


• fever, chills, body aches, flu symptoms;


• severe blistering, peeling, and red skin rash;


• urinating less than usual or not at all;


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


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


• loss of appetite, jaundice (yellowing of the skin or eyes); or


• easy bruising or bleeding, unusual weakness.

Less serious side effects may include:

• sores or swelling in your rectal or genital area;


• mild nausea, vomiting, diarrhea, or stomach upset;


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


• swollen tongue, trouble swallowing; or


• vaginal itching or discharge.

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 tetracycline (Sumycin)?

Do not use this medication if you are pregnant. It could cause harm to the unborn baby, including permanent discoloration of the teeth later in life. Tetracycline can make birth control pills less effective. Use a second method of birth control while you are taking tetracycline to keep from getting pregnant.

Tetracycline passes into breast milk and may affect bone and tooth development in a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Do not give tetracycline to a child younger than 8 years old. Tetracycline can cause permanent yellowing or graying of the teeth, and it can affect a child's growth.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Tetracycline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking tetracycline. These products can make tetracycline less effective.

Throw away any unused tetracycline when it expires or when it is no longer needed. Do not take any tetracycline after the expiration date on the label has passed. Expired tetracycline can cause a dangerous syndrome resulting in damage to the kidneys.

Related Drug Centers

• Sumycin

Renova 0.02%

DRUG DESCRIPTION

RENOVA (tretinoin cream) 0.02% contains the active ingredient tretinoin in
a cream base. Tretinoin is a yellow- to light-orange crystalline powder having
a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly
soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically
insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical
name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1 -cyclonexen-1
-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-ret
inoic acid and has a molecular weight of 300.44. The structural formula is represented
below.

Tretinoin is available as RENOVA (tretinoin cream) at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, fragrance, methylparaben, propylparaben purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20: and xanthan gum.

What are the possible side effects of tretinoin topical?

Stop using this medication and 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.

Less serious side effects may include burning, warmth, stinging, tingling, itching, redness, swelling, dryness, peeling, irritation, or discolored skin.

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...

Read All Potential Side Effects and See Pictures of Renova 0.02% »

Renova 0.02% Patient Information Including Side Effects

Brand Names: Altinac, Atralin, Avita, Renova, Retin A Micro Gel, Retin-A, Tretin-X

Generic Name: tretinoin topical (Pronunciation: TRET in oin)

• What is tretinoin topical (Renova 0.02%)?


• What are the possible side effects of tretinoin topical?


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


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


• How should I use tretinoin topical?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid while using tretinoin topical?


• What other drugs will affect tretinoin topical?


• Where can I get more information?

What is tretinoin topical (Renova 0.02%)?

Tretinoin is a topical (applied to the skin) form of vitamin A that helps the skin renew itself.

The Retin-A and Avita brands of tretinoin are used to treat acne. The Renova brand of tretinoin is used to reduce the appearance of fine wrinkles and mottled skin discoloration, and to make rough facial skin feel smoother.

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

What are the possible side effects of tretinoin topical?

Stop using this medication and 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.

Less serious side effects may include burning, warmth, stinging, tingling, itching, redness, swelling, dryness, peeling, irritation, or discolored skin.

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 tretinoin topical?

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Tretinoin topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use tretinoin topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using this medication in wounds or on areas of eczema. Wait until these conditions have healed before using tretinoin topical.

Use this medication for as many days as it has been prescribed for you even if you think it is not working. It may take weeks or months of use before you notice improvement in your skin. If you are using tretinoin topical to treat acne, your condition may get slightly worse for a short time when you first start using the medication. Call your doctor if skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks.

Related Drug Centers

• Atralin


• Renova 0.02%


• Renova


• Retin-A Micro

Tripedia

DRUG DESCRIPTION

Tripedia®, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP), for intramuscular use, is a sterile preparation of diphtheria and tetanus toxoids adsorbed, with acellular pertussis vaccine in an isotonic sodium chloride solution containing sodium phosphate to control pH. After shaking, the vaccine is a homogeneous white suspension. Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is distributed by Aventis Pasteur Inc. (AvP).

Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium.¹ Clostridium tetani cultures are grown in a peptone-based medium containing a bovine extract. The meat used in this medium is US sourced. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration.

The acellular pertussis vaccine components are isolated from culture fluids of Phase 1 Bordetella pertussis grown in a modified Stainer-Scholte medium.² After purification by salt precipitation, ultracentrifugation, and ultrafiltration, preparations containing varying amounts of both pertussis toxin (PT) and filamentous hemagglutinin (FHA) are combined to obtain a 1:1 ratio and treated with formaldehyde to inactivate PT.

The diphtheria and tetanus toxoids are adsorbed using aluminum potassium sulfate (alum). The adsorbed toxoids are combined with acellular pertussis concentrate, and diluted to a final volume using sterile phosphate-buffered physiological saline.

Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid (both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test), and 46.8 mg of pertussis antigens. This is represented in the final vaccine as approximately 23.4 mg of inactivated PT and 23.4 mg of FHA. The inactivated acellular pertussis component contributes not more than 50 endotoxin units to the endotoxin content of 1 mL of DTaP. The potency of the pertussis components is evaluated by measuring the antibody response to PT and FHA in immunized mice using an ELISA system. The vaccine is formulated without preservatives, but contains a trace amount of thimerosal [(mercury derivative), (≤0.3 mg mercury/dose)] from the manufacturing process. Each 0.5 mL dose also contains, by assay, not more than 0.170 mg of aluminum and not more than 100 mg (0.02%) of residual formaldehyde. The vaccine contains gelatin and polysorbate 80 (Tween-80), which are used in the production of the pertussis concentrate.

Acellular Pertussis Vaccine Concentrates (For Further Manufacturing Use) are produced by The Research Foundation for Microbial Diseases of Osaka University (BIKEN), Osaka, Japan, under United States (US) license, and are combined with diphtheria and tetanus toxoids manufactured by AvP. Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is filled, labeled, packaged, and released by AvP.

When Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is used to reconstitute ActHIB[Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) manufactured by Aventis Pasteur SA] the combination vaccine is TriHIBit. Each single 0.5 mL dose of TriHIBit vaccine for the fourth dose only, is formulated to contain 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid (both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test), 46.8 mg of pertussis antigens (approximately 23.4 mg of inactivated PT and 23.4 mg of FHA), 10 mg of purified Haemophilus influenzae type b capsular polysaccharide conjugated to 24 mg of inactivated tetanus toxoid, and 8.5% sucrose. (Refer to ActHIB vaccine package insert.)

REFERENCES

1. Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 1941;40: 21-32.

2. Aventis Pasteur Inc. , Data on File 072503.

What are the possible side effects of diphtheria, tetanus, and pertussis vaccines (Acel-Imune, Certiva, Daptacel, Infanrix, Tripedia)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine, can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

Get emergency medical help if you...

Read All Potential Side Effects and See Pictures of Tripedia »

Tripedia Patient Information Including Side Effects

Brand Names: Acel-Imune, Certiva, Daptacel, Infanrix, Tripedia

Generic Name: diphtheria, tetanus, and pertussis (DTaP) vaccines (Pronunciation: DIF thee ree ah, TET ah nus, per TUH sis)

• What are diphtheria, tetanus, and pertussis vaccines (Tripedia)?


• What are the possible side effects of diphtheria, tetanus, and pertussis vaccines (Tripedia)?


• What is the most important information I should know about diphtheria, tetanus, and pertussis vaccines (Tripedia)?


• What should I discuss with my healthcare provider before receiving diphtheria, tetanus, and pertussis vaccines (Tripedia)?


• How are diphtheria, tetanus, and pertussis vaccines administered (Tripedia)?


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


• What happens if I overdose (Tripedia)?


• What should I avoid before or after getting diphtheria, tetanus, and pertussis vaccines (Tripedia)?


• What other drugs will affect diphtheria, tetanus, and pertussis vaccines (Tripedia)?


• Where can I get more information?

What are diphtheria, tetanus, and pertussis vaccines (Tripedia)?

Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, and even death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open his mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Pertussis (whooping cough) causes coughing so severe that it is hard for infants to eat, drink, or breathe. These spells can last for weeks. It can lead to pneumonia, seizures (convulsions), brain damage, and death.

Diphtheria and pertussis are spread from person to person. Tetanus enters the body through cuts or wounds. Vaccines for these diseases expose the individual to a small amount of the bacteria, helping the body develop immunity to the disease.

Diphtheria, tetanus, and pertussis vaccine (DTaP) can help prevent these diseases. Most children who are vaccinated with DTaP will be protected throughout childhood.

What are the possible side effects of diphtheria, tetanus, and pertussis vaccines (Tripedia)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine, can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

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 the child has any of the following serious side effects:

• loss of consciousness;


• seizure (black-out or convulsions);


• high fever, over 105 degrees; or


• non-stop crying for 3 hours or more.

Other less serious side effects may be more likely to occur. Talk to your doctor if your child has:

• mild fever;


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


• fussiness for 1-3 days after the shot;


• tiredness or poor appetite for 1-3 days after the shot; or


• vomiting for 1-3 days after the shot.

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.

To help reduce fever and pain, your doctor may recommend giving the child an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil). This may be given at the time of the shot and over the next 24 hours. Your doctor will tell you the correct dose to use. Controlling fever is especially important if the child has a history of seizures.

What is the most important information I should know about diphtheria, tetanus, and pertussis vaccines (Tripedia)?

Children should get 5 doses of DTaP vaccine, one dose at each of the following ages: 2 months, 4 months, 6 months, 15 to 18 months, and 4 to 6 years. The series should be completed before the child's seventh birthday.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

Any child who had a life-threatening allergic reaction after a dose of DTaP should not receive another dose.

Any child who has had encephalitis (brain swelling) or a brain or nervous system disease within 7 days after a dose of DTaP should not receive another dose.

Children with a cold or fever can still be vaccinated. Children who are moderately or severely ill should usually wait until they recover before getting DTaP vaccine.

Related Drug Centers

• Tripedia


• Certiva


• Daptacel

Temovate

DRUG DESCRIPTION

TEMOVATE (clobetasol propionate cream and ointment) Cream and Ointment contain
the active compound clobetasol propionate, a synthetic corticosteroid, for topical
dermatologic use. Ciobetasol, an analog of prednisolone, has a high degree of
glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is {11β,16β)-21 -chioro-9- fluoro-11
-hydroxy-16-methyl-17-(1 -oxopropoxy)-pregna-1,4- diene-3,20-dione, and it has
the following structural formula:

Clobetasol propionate has the empirical formula C₂₅H₃₂CIFO₅
and a molecular weight of 467. It is a white to cream-colored crystalline powder
insoluble in water.

TEMOVATE Cream contains clobetasol propionate 0.5 mg/g in a cream base of propylene glycol, glyceryl monostearate, cetostearyl alcohol, glyceryl stearate, PEG 100 stearale, white wax, chlorocresol, sodium citrate, citric acid monohydrate, and purified water.

TEMOVATE Ointment contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.

What are the possible side effects of clobetasol 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 severe irritation of any treated skin, or if you show signs of absorbing clobetasol topical through your skin, such as:

• blurred vision, or seeing halos around lights;


• mood changes;


• sleep problems (insomnia);


• weight gain, puffiness in your face; or


• muscle...

Read All Potential Side Effects and See Pictures of Temovate »

What are the precautions when taking clobetasol propionate cream and ointment (Temovate)?

Before using clobetasol, 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 (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,...

Read All Potential Precautions of Temovate »

Temovate Consumer (continued)

SIDE EFFECTS: Burning, stinging, itching, dryness, or redness at the application site may occur when 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 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 promptly 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 clobetasol, 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 (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.

Temovate Patient Information Including Side Effects

Brand Names: Clobevate, Clobex, Cormax, Embeline E, Olux, Olux-E, Temovate

Generic Name: clobetasol topical (Pronunciation: kloe BAY ta sol)

• What is clobetasol topical (Temovate)?


• What are the possible side effects of clobetasol topical?


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


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


• How should I use clobetasol topical?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid while using clobetasol topical?


• What other drugs will affect clobetasol topical?


• Where can I get more information?

What is clobetasol topical (Temovate)?

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

Clobetasol topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

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

What are the possible side effects of clobetasol 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 severe irritation of any treated skin, or if you show signs of absorbing clobetasol topical through your skin, such as:

• blurred vision, or seeing halos around lights;


• mood changes;


• sleep problems (insomnia);


• weight gain, puffiness in your face; or


• muscle weakness, feeling tired.

Less serious side effects may include:

• mild skin rash, itching, burning, or redness;


• dry or cracking skin;


• thinning or softening of your skin;


• skin rash or irritation around your mouth;


• swollen hair follicles;


• spider veins;


• changes in color of treated skin;


• blisters, pimples, or crusting of treated 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 clobetasol 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. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

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 clobetasol topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Do not use this medication on a child without a doctor's advice. 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 within 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

Related Drug Centers

• Olux


• Temovate


• Olux-E


• Temovate Gel


• Clobevate


• Clobex Lotion


• Temovate Scalp


• Clobex Shampoo


• Clobex

Thyrolar

DRUG DESCRIPTION

Thyrolar Tablets (Liotrix Tablets, USP) contain triiodothyronine (T₃ liothyronine)
sodium and tetraiodothyronine (T₄levothyroxine) sodium in the amounts listed
in the "How Supplied" section. (T₃ liothyronine sodium is approximately
four times as potent as T₄thyroxine on a microgram for microgram basis.)

The inactive ingredients are calcium phosphate, colloidal silicon dioxide,
corn starch, lactose, and magnesium stearate. The tablets also contain the following
dyes: Thyrolar (liotrix) 1/4 - FD&C Blue #1 and FD&C Red #40; Thyrolar (liotrix) ½
- FD&C Red #40 and D&C Yellow #10; Thyrolar (liotrix) 1 - FD&C Red #40; Thyrolar (liotrix)
2 - FD&C Blue #1, FD&C Red #40, and D&C Yellow #10; Thyrolar (liotrix) 3 -
FD&C Red #40 and D&C Yellow #10.

STRUCTURAL FORMULAS

What are the precautions when taking liotrix (Thyrolar)?

Before taking liotrix, 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: increased thyroid hormones (thyrotoxicosis), a heart attack (acute myocardial infarction), adrenal gland problem (e.g., uncorrected adrenal insufficiency).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., coronary artery disease, irregular heartbeat), high blood pressure, diabetes, other hormone...

Read All Potential Precautions of Thyrolar »

Thyrolar Consumer (continued)

SIDE EFFECTS: Some hair loss may occur during the first few months of starting this drug. This effect is usually temporary as your body adjusts to this medication. If this effect persists or worsens, 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 effects of high thyroid hormone levels occur: diarrhea, bone pain, headache, mental/mood changes (e.g., nervousness, mood swings), shaking (tremor), sensitivity to heat, increased sweating, tiredness.

Seek immediate medical attention if any of these rare but very serious effects of high thyroid hormone levels occur: chest pain, fast/pounding/irregular heartbeat, seizures, swelling of the ankles/feet.

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 liotrix, 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: increased thyroid hormones (thyrotoxicosis), a heart attack (acute myocardial infarction), adrenal gland problem (e.g., uncorrected adrenal insufficiency).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., coronary artery disease, irregular heartbeat), high blood pressure, diabetes, other hormone disorders (e.g., decreased pituitary hormone).

If you have diabetes, this medication 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 of high blood sugar, such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

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

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects on the heart caused by high thyroid hormone level.

Current information shows that this drug may be used during pregnancy. Tell your doctor if you are pregnant or if you become pregnant because your dose may need to be adjusted.

Small amounts of this medication pass into breast milk. Consult your doctor before breast-feeding.

Lindane Lotion

DRUG DESCRIPTION

Lindane Lotion, USP 1%, is an ectoparasiticide and ovicide. In addition to
the active ingredient, lindane, it contains 2-amino-2-methyl- 1-propanol, carrageenan,
cetyl alcohol, cocoa butter, glyceryl monostearate, methylparaben, propylene
glycol, propylparaben, purified water, stearic acid and trolamine to form a
lotion. The pH range is between 6.5 and 8.5. Lindane is the gamma isomer of
1,2,3,4,5,6- hexachlorocyclohexane having the following structural formula:

What are the possible side effects of lindane topical ()?

Stop using lindane topical and seek emergency medical attention if you experience an uncommon but serious side effect such as

• an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives);


• seizures; or


• uncontrollable body shaking.

Other less serious side effects may also occur. Talk to your doctor if you experience

• dizziness or drowsiness;


• itching, burning, dryness, or rash of the skin.

Side effects...

Read All Potential Side Effects and See Pictures of Lindane Lotion »

What are the precautions when taking lindane lotion (Lindane Lotion)?

See also Warning section.

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

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a poorly controlled seizure disorder.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous use of lindane in the past few months, other skin conditions (e.g., psoriasis, dermatitis), HIV infection, history of serious head injury, history of seizures, brain tumors, severe liver...

Read All Potential Precautions of Lindane Lotion »

Lindane Lotion Consumer (continued)

SIDE EFFECTS: See also Warning section.

This medication may cause stinging, burning, or redness of the skin. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because 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 these rare but very serious side effects occur: vomiting, dizziness, drowsiness, seizures.

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: See also Warning section.

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

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a poorly controlled seizure disorder.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous use of lindane in the past few months, other skin conditions (e.g., psoriasis, dermatitis), HIV infection, history of serious head injury, history of seizures, brain tumors, severe liver disease, alcohol abuse, sudden stopping of regular alcohol or sedative use.

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.

Before having an imaging test (e.g., X-rays, CT scan) requiring the use of dye, tell your doctor that you have used this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. If you are pregnant, do not apply lindane shampoo to others unless it is absolutely necessary and you have discussed it with your doctor. Use gloves as directed. (See How to Use section.)

Lindane passes into breast milk and could have undesirable effects on a nursing infant. Your baby should not come into direct contact with your skin while it has lindane on it. In addition, to lessen the chance of exposing your baby to the medication and possible side effects, pump your breast milk and discard it for 24 hours after using lindane. During this time, feed your baby formula or breast milk you stored from before you used lindane lotion.

Lindane Lotion Patient Information Including Side Effects

Brand Names:

Generic Name: lindane topical (Pronunciation: LIN dane)

• What is lindane topical ?


• What are the possible side effects of lindane topical ?


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


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


• How should I use lindane topical ?


• What happens if I miss a dose ?


• What happens if I overdose ?


• What should I avoid while using lindane topical ?


• What other drugs will affect lindane topical ?


• Where can I get more information?

What is lindane topical ?

Lindane is a pediculicide and a scabicide. It affects the nervous system of the parasites.

Lindane topical is used to treat head lice, pubic lice ("crabs"), and scabies.

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

What are the possible side effects of lindane topical ?

Stop using lindane topical and seek emergency medical attention if you experience an uncommon but serious side effect such as

• an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives);


• seizures; or


• uncontrollable body shaking.

Other less serious side effects may also occur. Talk to your doctor if you experience

• dizziness or drowsiness;


• itching, burning, dryness, or rash of the skin.

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 lindane topical ?

Do not apply this medication to the face, eyes, nose, or mouth. Flush with water if you get medication in any of these areas. Seek medical attention if lindane topical is ingested or if irritation is persistent.

Do not use more of this medication than is recommended. Using more than the prescribed amount of lindane topical may cause seizures or other dangerous side effects.

Treat sexual and other close contacts who are also infected. Do not use lindane topical to treat contacts who are not infected in an attempt to prevent infection from occurring.

To prevent reinfection, wash all clothing, hats, bed clothes, bed linens, hair brushes, and combs in hot water with a strong cleanser.

Talk to your doctor before using a second dose of lindane topical. Using lindane topical too soon after the first dose may cause seizures and/or death.

Related Drug Centers

• Lindane Lotion

Akineton

DRUG DESCRIPTION

Each AKINETON tablet for oral administration contains 2 mg biperiden hydrochloride.
Other ingredients may include corn syrup, lactose, magnesium stearate, potato
starch and talc. AKINETON (biperiden) is an anticholinergic agent. Biperiden is a5-Norbornen-2-yl-a-phenyl-1-piperidinepropanol.
It is a white, crystalline, odorless powder, slightly soluble in water and alcohol.
It is stable in air at normal temperatures. Biperiden may be represented by
the following structural formula:

What are the possible side effects of biperiden (Akineton HCl)?

If you experience any of the following serious side effects, stop taking biperiden and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);


• unusual fever;


• fast or irregular heartbeat;


• anxiety, hallucinations, confusion, agitation, hyperactivity, or loss of consciousness;


• seizures;


• a rash; or


• eye pain.

Other, less serious side effects may be more...

Read All Potential Side Effects and See Pictures of Akineton »

What are the precautions when taking biperiden (Akineton)?

Consult your...

Read All Potential Precautions of Akineton »

Akineton Consumer (continued)

SIDE EFFECTS: Consult your pharmacist.

In the US -

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

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

PRECAUTIONS: Consult your pharmacist.

Akineton Patient Information Including Side Effects

Brand Names: Akineton HCl

Generic Name: biperiden (Pronunciation: bye PEAR i den)

• What is biperiden (Akineton)?


• What are the possible side effects of biperiden (Akineton)?


• What is the most important information I should know about biperiden (Akineton)?


• Who should not take biperiden (Akineton)?


• How should I take biperiden (Akineton)?


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


• What happens if I overdose (Akineton)?


• What should I avoid while taking biperiden (Akineton)?


• What other drugs will affect biperiden (Akineton)?


• Where can I get more information?

What is biperiden (Akineton)?

Biperiden reduces the effects of certain naturally occurring chemicals in your body that may become unbalanced as a result of disease (such as Parkinson's disease), drug therapy, or other causes.

Biperiden is used to treat the stiffness, tremors, spasms, and poor muscle control of Parkinson's disease. It is also used to treat and prevent these same muscular conditions when they are caused by drugs such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), and others.

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

What are the possible side effects of biperiden (Akineton)?

If you experience any of the following serious side effects, stop taking biperiden and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);


• unusual fever;


• fast or irregular heartbeat;


• anxiety, hallucinations, confusion, agitation, hyperactivity, or loss of consciousness;


• seizures;


• a rash; or


• eye pain.

Other, less serious side effects may be more likely to occur. Continue to take biperiden and talk to your doctor if you experience

• a dry mouth;


• large pupils or blurred vision;


• drowsiness;


• difficulty urinating or constipation;


• nervousness or anxiety;


• upset stomach; or


• decreased sweating.

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 biperiden (Akineton)?

Use caution when driving, operating machinery, or performing other hazardous activities. Biperiden may cause dizziness or blurred vision. If you experience dizziness or blurred vision, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking biperiden.

Avoid becoming overheated. Biperiden may cause decreased sweating. This could lead to heat stroke in hot weather or with vigorous exercise.

Related Drug Centers

• Akineton