YAZ

Generic Name: drospirenone and ethinyl estradiol (Oral route)

droe-SPYE-re-none, ETH-i-nil es-tra-DYE-ol

Oral route(Tablet)

Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Women who are over 35 years of age and smoke should not use oral contraceptives .

Commonly used brand name(s)

In the U.S.

• Gianvi


• Loryna


• Ocella


• Syeda


• Vestura


• Yasmin


• YAZ


• Yaz 28


• Zarah

Available Dosage Forms:

• Tablet

Therapeutic Class: Monophasic Contraceptive Combination

Pharmacologic Class: Progestin

Uses For YAZ

Drospirenone and ethinyl estradiol combination is used as an oral contraceptive. Oral contraceptives are known also as the Pill, OCs, BCs, BC tablets, or birth control pills. This medicine usually contains two types of hormones, estrogens and progestins and, when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented. Although oral contraceptives have other effects that help prevent a pregnancy from occurring, this is the main action.

This medicine is also used to treat premenstrual dysphoric disorder (PMDD). PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may experience severe emotional and physical symptoms 10 to 14 days before their menstrual flow starts .

No contraceptive method is 100 percent effective. Discuss with your health care professional your options for birth control .

Drospirenone and ethinyl estradiol combination is also used to treat acne in women at least 14 years of age, who have already started menstruating and choose to use a birth control pill to prevent pregnancy .

This medicine is available only with your doctor's prescription.

Before Using YAZ

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine is not intended for use in children or teenagers who have not yet started menstruating. This medicine is frequently used for birth control in teenage females and has not been shown to cause different side effects or problems than it does in adults. Some teenagers may need extra information on the importance of taking this medication exactly as prescribed.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Drospirenone

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Ethinyl Estradiol

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Boceprevir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Boceprevir


• Felbamate


• Isotretinoin


• Paclitaxel


• Paclitaxel Protein-Bound


• Theophylline


• Tizanidine


• Tranexamic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam


• Amoxicillin


• Ampicillin


• Amprenavir


• Aprepitant


• Atazanavir


• Bacampicillin


• Betamethasone


• Bexarotene


• Bosentan


• Carbamazepine


• Colesevelam


• Cyclosporine


• Darunavir


• Delavirdine


• Doxycycline


• Efavirenz


• Etravirine


• Fosamprenavir


• Fosaprepitant


• Fosphenytoin


• Ginseng


• Griseofulvin


• Lamotrigine


• Licorice


• Minocycline


• Modafinil


• Mycophenolate Mofetil


• Mycophenolic Acid


• Nelfinavir


• Nevirapine


• Oxcarbazepine


• Oxytetracycline


• Phenobarbital


• Phenytoin


• Pioglitazone


• Prednisolone


• Primidone


• Rifabutin


• Rifampin


• Rifapentine


• Ritonavir


• Roflumilast


• Rosuvastatin


• Rufinamide


• Selegiline


• St John's Wort


• Telaprevir


• Tetracycline


• Tipranavir


• Topiramate


• Troglitazone


• Troleandomycin


• Valdecoxib


• Voriconazole


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine


• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal changes in menstrual or uterine bleeding or


• Fibroid tumors of the uterus—Oral contraceptives usually improve these female conditions but sometimes they can make them worse or make the diagnosis of these problems more difficult.

• Adrenal insufficiency or


• Liver problems or


• Kidney problems—These conditions may increase the risk of retaining too much potassium in the blood.

• Blood clots (or history of) or


• Heart or circulation disease or


• Stroke (or history of)—If these conditions are already present, oral contraceptives may have a greater chance of causing blood clots or circulation problems, especially in women who smoke tobacco. Otherwise, oral contraceptives may help prevent circulation and heart disease if you are healthy and do not smoke.

• Cancer, including breast cancer (or history of or family history of)—Oral contraceptives may worsen some cancers, especially when breast, cervical, or uterine cancers already exist. Use of oral contraceptives is not recommended if you have any of these conditions. If you have a family history of breast disease, oral contraceptives may still be a good choice but you may need to be tested more often.

• Gallbladder disease or gallstones (or history of) or


• High blood cholesterol or


• High blood potassium or


• Liver disease (or history of, including jaundice during pregnancy) or


• Mental depression (or history of)—Oral contraceptives may make these conditions worse or, rarely, cause them to occur again. Oral contraceptives may still be a good choice but you may need to be tested more often.

• High blood pressure (hypertension) or


• Migraine headaches—Oral contraceptives may cause fluid build-up and may cause these conditions to become worse; however, some people have fewer migraine headaches when they use oral contraceptives.

Proper Use of drospirenone and ethinyl estradiol

This section provides information on the proper use of a number of products that contain drospirenone and ethinyl estradiol. It may not be specific to YAZ. Please read with care.

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of oral contraceptives. Read this paper carefully and ask your health care professional if you need additional information or explanation.

When you begin to use oral contraceptives, your body will require at least 7 days to adjust before a pregnancy will be prevented. You will need to use an additional birth control method for at least 7 days. Some doctors recommend using an additional method of birth control for the first cycle (or 3 weeks) to ensure full protection. Follow the advice of your doctor or other health care professional.

Try to take the doses no more than 24 hours apart to reduce the possibility of side effects and to prevent pregnancy. Since one of the most important factors in the proper use of oral contraceptives is taking every dose exactly on schedule, you should never let your tablet supply run out. When possible, try to keep an extra month's supply of tablets on hand and replace it monthly.

It is very important that you keep the tablets in their original container and take the tablets in the same order that they appear in the container. The containers help you keep track of which tablets to take next. Different colored tablets in the same package contain different amounts of hormones or are placebos (tablets that do not contain hormones). The effectiveness of the medicine is reduced if the tablets are taken out of order.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on Sunday after your period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even when you miss a dose. Do not change your schedule on your own. If the schedule that you have been put on is not convenient, check with your doctor about changing schedules. For Sunday start you need to use another form of birth control for the first 7 days.

For Yasmin(R) and Yaz(R), begin next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule .

• For oral dosage form (tablets):
  
  • For contraception or treatment of acne:
    
    • Adults and teenagers (after menarche) — Yasmin(R), 1 yellow tablet by mouth every day for 21 consecutive days followed by 1 white (inert) tablet daily for 7 days per menstrual cycle
    
    
    • Adults and teenagers (after menarche)— Yaz(R), 1 pink tablet by mouth every day for 24 consecutive days followed by 1 white (inert) tablet daily for 4 days per menstrual cycle
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using YAZ

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.

This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor .

Tell the medical doctor or dentist in charge that you are taking this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue taking this medicine .

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier. If this should occur:

• Continue on your regular dosing schedule.


• The bleeding usually stops within 1 week.


• Check with your doctor if the bleeding continues for more than 1 week.


• After you have been taking oral contraceptives on schedule and for more than 3 months and bleeding continues, check with your doctor.

Missed menstrual periods may occur:

• If you have not taken the medicine exactly as scheduled. Pregnancy must be considered as a possibility.


• If the medicine is not the right strength or type for your needs.


• If you stop taking oral contraceptives, especially if you have taken oral contraceptives for 2 or more years.

Check with your doctor if you miss any menstrual periods so that the cause may be determined.

If you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.

If you are scheduled for any laboratory tests, tell your doctor that you are taking birth control pills.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .

YAZ Side Effects

Healthy women who do not smoke cigarettes have almost no chance of having a severe side effect from taking oral contraceptives. For most women, more problems occur because of pregnancy than will occur from taking oral contraceptives. But for some women who have special health problems, oral contraceptives can cause some unwanted effects. Some of these unwanted effects include benign (not cancerous) liver tumors, liver cancer, or blood clots or related problems, such as a stroke. Although these effects are very rare, they can be serious enough to cause death. You may want to discuss these effects with your doctor.

Smoking cigarettes during the use of oral contraceptives has been found to greatly increase the chances of these serious side effects occurring. To reduce the risk of serious side effects, do not smoke cigarettes while you are taking oral contraceptives.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Abdominal or stomach pain (sudden, severe, or continuing)


• anxiety


• burning pain in lower abdomen


• changes in skin color


• chill


• convulsions


• coughing up blood


• feeling of heat


• feeling of warmth in lips and tongue


• fever


• headache (severe or sudden)


• loss of coordination (sudden)


• loss of vision or change in vision (sudden)


• nervousness


• numbness of the fingertips


• pain in lower back, pelvis, or stomach


• pains in chest, groin, or leg (especially in calf of leg)


• ringing in the ears


• shortness of breath (sudden or unexplained)


• slurring of speech (sudden)


• sudden loss of consciousness


• swelling of foot or leg


• weakness, numbness, or pain in arm or leg (unexplained)

Check with your doctor as soon as possible if any of the following side effects occur:

More common—usually less common after the first 3 months of oral contraceptive use

• Changes in the uterine bleeding pattern at menses or between menses, such as decreased bleeding at menses, breakthrough bleeding or spotting between periods, prolonged bleeding at menses, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes.

Less common

• Headaches or migraines (although headaches may lessen in many users, in others, they may increase in number or become worse)


• increased blood pressure


• vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge

RareFor women who smoke tobacco

• Pains in stomach, side, or abdomen


• yellow eyes or skin

For women with a history of breast disease

• Lumps in breast

• Mental depression


• swelling, pain, or tenderness in upper abdominal area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal cramping or bloating


• acne (usually less common after first 3 months and may improve if acne already exists)


• breast pain, tenderness, or swelling


• dizziness


• nausea


• swelling of ankles and feet


• unusual tiredness or weakness


• vomiting

Less common

• Brown, blotchy spots on exposed skin


• gain or loss of body or facial hair


• increased or decreased interest in sexual intercourse


• weight gain or loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: YAZ side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More YAZ resources

• YAZ Side Effects (in more detail)
• YAZ Use in Pregnancy & Breastfeeding
• YAZ Drug Interactions
• YAZ Support Group
• 237 Reviews for YAZ - Add your own review/rating

• YAZ MedFacts Consumer Leaflet (Wolters Kluwer)


• Gianvi Prescribing Information (FDA)


• Loryna Prescribing Information (FDA)


• Ocella Prescribing Information (FDA)


• Syeda Prescribing Information (FDA)


• Yasmin Prescribing Information (FDA)


• Yasmin Consumer Overview


• Yasmin MedFacts Consumer Leaflet (Wolters Kluwer)


• Yaz Prescribing Information (FDA)


• Yaz Consumer Overview


• Zarah Prescribing Information (FDA)

Compare YAZ with other medications

• Acne
• Birth Control
• Menstrual Disorders
• Premenstrual Dysphoric Disorder

Topicort

desoximetasone

Dosage Form: cream, gel
Topicort® (Desoximetasone)

Cream 0.05%, Cream 0.25%, Gel 0.05%

For topical use only. Not for ophthalmic use.

Rx only

Topicort Description

Topicort® LP (desoximetasone) Cream 0.05%; Topicort® (desoximetasone) Cream 0.25%; and Topicort® (desoximetasone) Gel 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Each gram of Topicort® LP Cream 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of white petrolatum, purified water, isopropyl myristate, lanolin alcohols, mineral oil, cetostearyl alcohol, and edetate disodium.

Each gram of Topicort® Cream 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of white petrolatum, purified water, isopropyl myristate, lanolin alcohols, mineral oil, and cetostearyl alcohol.

Each gram of Topicort® Gel 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of purified water, docusate sodium, edetate disodium, isopropyl myristate, carbomer 940, trolamine, and SDAG-3 95% alcohol.

The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-.

Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2.

The structural formula is:

Topicort - Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Pharmacokinetic studies in men with Topicort® (desoximetasone) Cream 0.25% with tagged desoximetasone showed a total of 5.2% ± 2.9% excretion in urine (4.1% ± 2.3%) and feces (1.1% ± 0.6%) and no detectable level (limit of sensitivity: 0.005 µg/mL) in the blood when it was applied topically on the back followed by occlusion for 24 hours. Seven days after application, no further radioactivity was detected in urine or feces. The half-life of the material was 15 ± 2 hours (for urine) and 17 ± 2 hours (for feces) between the third and fifth trial day.

Indications and Usage for Topicort

Topicort® LP (desoximetasone) Cream 0.05%; Topicort® (desoximetasone) Cream 0.25%; and Topicort® (desoximetasone) Gel 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

Topicort® LP (desoximetasone) Cream 0.05%; Topicort® (desoximetasone) Cream 0.25%; and Topicort® (desoximetasone) Gel 0.05% are not for ophthalmic use.

Keep out of reach of children.

Precautions

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS - Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.


2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.


3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.


4. Patients should report any signs of local adverse reactions, especially under occlusive dressings.


5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

The following tests may be helpful in evaluating the hypothalamic-pituitary-adrenal (HPA) axis suppression:

 

Urinary free cortisol test

 

ACTH stimulation test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Desoximetasone did not show potential for mutagenic activity in vitro in the Ames microbial mutagen test with or without metabolic activation.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 3 to 30 times the human dose of Topicort® (desoximetasone) Cream 0.25% and 15 to 150 times the human dose of Topicort® LP (desoximetasone) Cream 0.05%, or Topicort® (desoximetasone) Gel 0.05%. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, Topicort® LP Cream 0.05%, Topicort® Cream 0.25%, or Topicort® Gel 0.05%, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning	Hypertrichosis	Maceration of the skin
Itching	Acneiform eruptions	Secondary infection
Irritation	Hypopigmentation	Skin atrophy
Dryness	Perioral dermatitis	Striae
Folliculitis	Allergic contact dermatitis	Miliaria

In controlled clinical studies the incidence of adverse reactions were low (0.8%) for Topicort® (desoximetasone) Cream 0.25%, and included burning, folliculitis, and folliculo-pustular lesions. The incidence of adverse reactions were also 0.8% for Topicort® LP (desoximetasone) Cream 0.05% and included pruritus, erythema, vesiculation, and burning sensation.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Topicort Dosage and Administration

Apply a thin film of Topicort® LP (desoximetasone) Cream 0.05%, Topicort® (desoximetasone) Cream 0.25%, and Topicort® (desoximetasone) Gel 0.05% to the affected skin areas twice daily. Rub in gently.

How is Topicort Supplied

Topicort® LP (desoximetasone) Cream 0.05% is supplied in 5 gram tubes for physician samples, 15 gram, 60 gram, 100 gram tubes and 300 gram carton (3 x 100 gram tubes).

Topicort® (desoximetasone) Cream 0.25% is supplied in 5 gram tubes for physician samples, 15 gram, 60 gram, 100 gram tubes and 200 gram carton (2 x 100 g tubes).

Topicort® (desoximetasone) Gel 0.05% is supplied in 5 gram tubes for physician samples, 15 gram and 60 gram tubes.

Store at controlled room temperature 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Topicort® and TaroPharma® are trademarks of Taro Pharmaceuticals U.S.A., Inc. and/or its affiliates.

Revised June 2009

PK-5834-1

PRINCIPAL DISPLAY PANEL - 0.05%, 15g carton

NDC 51672-5205-1

15 g

Rx only

0.05%

CREAM

Topicort®LP

Desoximetasone Cream USP, 0.05%

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Keep this and all medication out of the reach of children.

TaroPharma™

PRINCIPAL DISPLAY PANEL - 0.25%, 15g carton

NDC 51672-5204-1

15 g

Rx only

0.25%

CREAM

Topicort®

Desoximetasone Cream USP, 0.25%

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Keep this and all medication out of the reach of children.

TaroPharma™

PRINCIPAL DISPLAY PANEL - 0.05%, 15g carton

NDC 51672-5202-1

15 g

Rx only

0.05%

GEL

Topicort®

Desoximetasone Gel USP, 0.05%

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Keep this and all medication out of the reach of children.

TaroPharma™

Topicort  desoximetasone  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51672-5205 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength desoximetasone (desoximetasone) desoximetasone 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength petrolatum   water   isopropyl myristate   mineral oil   cetostearyl alcohol   edetate disodium

Product Characteristics Color WHITE (white to off-white) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51672-5205-5 5 g In 1 TUBE None 2 51672-5205-1 1 TUBE In 1 CARTON contains a TUBE 2 15 g In 1 TUBE This package is contained within the CARTON (51672-5205-1) 3 51672-5205-3 1 TUBE In 1 CARTON contains a TUBE 3 60 g In 1 TUBE This package is contained within the CARTON (51672-5205-3) 4 51672-5205-7 1 TUBE In 1 CARTON contains a TUBE 4 100 g In 1 TUBE This package is contained within the CARTON (51672-5205-7) 5 51672-5205-8 3 TUBE In 1 CARTON contains a TUBE 5 100 g In 1 TUBE This package is contained within the CARTON (51672-5205-8)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073193	07/14/1998

Topicort  desoximetasone  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51672-5204 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength desoximetasone (desoximetasone) desoximetasone 2.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength petrolatum   water   isopropyl myristate   mineral oil   cetostearyl alcohol

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51672-5204-5 5 g In 1 TUBE None 2 51672-5204-1 1 TUBE In 1 CARTON contains a TUBE 2 15 g In 1 TUBE This package is contained within the CARTON (51672-5204-1) 3 51672-5204-3 1 TUBE In 1 CARTON contains a TUBE 3 60 g In 1 TUBE This package is contained within the CARTON (51672-5204-3) 4 51672-5204-7 1 TUBE In 1 CARTON contains a TUBE 4 100 g In 1 TUBE This package is contained within the CARTON (51672-5204-7) 5 51672-5204-9 2 TUBE In 1 CARTON contains a TUBE 5 100 g In 1 TUBE This package is contained within the CARTON (51672-5204-9)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073193	07/14/1998

Topicort  desoximetasone  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51672-5202 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength desoximetasone (desoximetasone) desoximetasone 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength water   docusate sodium   edetate disodium   isopropyl myristate   carbomer homopolymer type c   trolamine

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51672-5202-5 5 g In 1 TUBE None 2 51672-5202-1 1 TUBE In 1 CARTON contains a TUBE 2 15 g In 1 TUBE This package is contained within the CARTON (51672-5202-1) 3 51672-5202-3 1 TUBE In 1 CARTON contains a TUBE 3 60 g In 1 TUBE This package is contained within the CARTON (51672-5202-3)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074904	07/14/1998

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Operations
Taro Pharmaceuticals, Inc.		206263295	MANUFACTURE

Revised: 10/2009Taro Pharmaceuticals U.S.A., Inc.

More Topicort resources

• Topicort Side Effects (in more detail)
• Topicort Use in Pregnancy & Breastfeeding
• Topicort Drug Interactions
• Topicort Support Group
• 3 Reviews for Topicort - Add your own review/rating

• Topicort Concise Consumer Information (Cerner Multum)


• Topicort Monograph (AHFS DI)


• Topicort Advanced Consumer (Micromedex) - Includes Dosage Information


• Topicort Cream MedFacts Consumer Leaflet (Wolters Kluwer)

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Minocycline Capsules

Pronunciation: MIN-oh-SYE-kleen
Generic Name: Minocycline
Brand Name: Minocin Kit

Minocycline Capsules is used for:

Treating certain infections. It may also be used with other medicines to treat severe acne. It may also be used for other conditions as determined by your doctor.

Minocycline Capsules is a tetracycline antibiotic. It works by slowing the growth of certain bacteria and allowing the body's immune system to kill them.

Do NOT use Minocycline Capsules if:

• you are allergic to any ingredient in Minocycline Capsules or to another tetracycline (eg, doxycycline)


• you are taking acitretin, isotretinoin, a live oral typhoid vaccine, methoxyflurane, or a penicillin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Minocycline Capsules:

Some medical conditions may interact with Minocycline Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have asthma, kidney or liver problems, or an autoimmune disorder (eg, lupus)

Some MEDICINES MAY INTERACT with Minocycline Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aluminum salts (eg, aluminum carbonate) or cimetidine because they may decrease Minocycline Capsules's effectiveness


• Acitretin, anticoagulants (eg, warfarin), digoxin, ergot alkaloids (eg, ergotamine), isotretinoin, methotrexate, methoxyflurane, or theophyllines because the risk of their side effects may be increased by Minocycline Capsules


• Live oral typhoid vaccine, oral contraceptives (birth control pills), or penicillins (eg, amoxicillin) because their effectiveness may be decreased by Minocycline Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Minocycline Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Minocycline Capsules:

Use Minocycline Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Minocycline Capsules. Talk to your pharmacist if you have questions about this information.


• Take Minocycline Capsules by mouth with or without food.


• Swallow Minocycline Capsules whole. Do not break, crush, or chew before swallowing.


• Take Minocycline Capsules with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Minocycline Capsules.


• Minocycline Capsules comes with calming wipes to help calm dry, red, and irritated skin associated with acne and its treatment.


• Do not take an antacid that has aluminum, calcium, or magnesium in it; bismuth salts (eg, bismuth subsalicylate); colestipol; iron salts (eg, iron sulfate); urinary alkalinizers (eg, sodium bicarbonate); sucralfate; vitamins or minerals; quinapril; didanosine; or zinc salts (eg, zinc sulfate) within 2 to 3 hours before or after taking Minocycline Capsules. Check with your doctor or pharmacist if you have any questions.


• To clear up your infection completely, take Minocycline Capsules for the full course of treatment. Keep taking it even if you feel better in a few days.


• Minocycline Capsules works best if it is taken at the same time each day.


• If you miss a dose of Minocycline Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Minocycline Capsules.

Important safety information:

• Minocycline Capsules may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Minocycline Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Minocycline Capsules only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Minocycline Capsules for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Minocycline Capsules may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Minocycline Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Minocycline Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Minocycline Capsules. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Tell your doctor or dentist that you take Minocycline Capsules before you receive any medical or dental care, emergency care, or surgery.


• Minocycline Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Minocycline Capsules.


• Lab tests may be performed while you use Minocycline Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Minocycline Capsules with caution in the ELDERLY; they may be more sensitive to its effects.


• Use Minocycline Capsules with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.


• Minocycline Capsules should not be used in CHILDREN younger than 8 years old; safety and effectiveness in these children have not been confirmed. Using Minocycline Capsules in CHILDREN younger than 8 years old or in women during the last half of pregnancy may cause a permanent change in the tooth coloring of the child.


• PREGNANCY and BREAST-FEEDING: Minocycline Capsules has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Minocycline Capsules while you are pregnant. Minocycline Capsules is found in breast milk. Do not breast-feed while taking Minocycline Capsules.

Possible side effects of Minocycline Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; indigestion; lightheadedness; loss of appetite; nausea; sore mouth, throat, or tongue; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; blurred vision; change in the amount of urine produced; fever, chills, or sore throat; hearing problems; joint pain; muscle pain or weakness; rectal or genital irritation; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent headache; severe, watery diarrhea; severe skin reaction to the sun; stomach pain or cramps; swollen glands; symptoms of pancreatitis (eg, severe stomach or back pain with or without nausea or vomiting); trouble swallowing; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge; white patches in the mouth; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness, nausea, or vomiting.

Proper storage of Minocycline Capsules:

Store Minocycline Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Minocycline Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Minocycline Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Minocycline Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Minocycline Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Minocycline resources

• Minocycline Use in Pregnancy & Breastfeeding
• Drug Images
• Minocycline Drug Interactions
• Minocycline Support Group
• 84 Reviews for Minocycline - Add your own review/rating

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• Rosacea
• Skin and Structure Infection
• Skin Infection

Hydrocodone/Potassium Guaiacolsulfonate Liquid

Pronunciation: hye-droe-KOE-done/poe-TASS-ee-um gwye-a-kole-SUL-foe-nate
Generic Name: Hydrocodone/Potassium Guaiacolsulfonate
Brand Name: Examples include Entuss and Mintuss NX

Hydrocodone/Potassium Guaiacolsulfonate Liquid is used for:

Relieving cough and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Hydrocodone/Potassium Guaiacolsulfonate Liquid is a cough suppressant and expectorant combination. It works by loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Hydrocodone/Potassium Guaiacolsulfonate Liquid if:

• you are allergic to any ingredient in Hydrocodone/Potassium Guaiacolsulfonate Liquid or any other codeine or morphine-related medicine (eg, oxycodone)


• you are taking sodium oxybate (GHB)


• you have increased pressure in the brain, trouble breathing, or diarrhea due to antibiotic use

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hydrocodone/Potassium Guaiacolsulfonate Liquid:

Some medical conditions may interact with Hydrocodone/Potassium Guaiacolsulfonate Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, stroke, adrenal gland problems, or an underactive thyroid


• if you have a history of stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery


• if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus


• if you have recently had any head injury, brain injury or tumor, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Hydrocodone/Potassium Guaiacolsulfonate Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cimetidine because it may increase the risk of Hydrocodone/Potassium Guaiacolsulfonate Liquid's side effects


• Barbiturates (eg, phenobarbital) or sodium oxybate (GHB) because the risk of severe drowsiness or breathing problems may be increased


• Naltrexone because it may decrease Hydrocodone/Potassium Guaiacolsulfonate Liquid's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydrocodone/Potassium Guaiacolsulfonate Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hydrocodone/Potassium Guaiacolsulfonate Liquid:

Use Hydrocodone/Potassium Guaiacolsulfonate Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Hydrocodone/Potassium Guaiacolsulfonate Liquid by mouth with or without food.


• Drinking extra fluids while you are taking Hydrocodone/Potassium Guaiacolsulfonate Liquid is recommended. Check with your doctor for instructions.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Hydrocodone/Potassium Guaiacolsulfonate Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hydrocodone/Potassium Guaiacolsulfonate Liquid.

Important safety information:

• Hydrocodone/Potassium Guaiacolsulfonate Liquid may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Hydrocodone/Potassium Guaiacolsulfonate Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Tell your doctor or dentist that you take Hydrocodone/Potassium Guaiacolsulfonate Liquid before you receive any medical or dental care, emergency care, or surgery.


• Hydrocodone/Potassium Guaiacolsulfonate Liquid may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Hydrocodone/Potassium Guaiacolsulfonate Liquid.


• Use Hydrocodone/Potassium Guaiacolsulfonate Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Hydrocodone/Potassium Guaiacolsulfonate Liquid should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydrocodone/Potassium Guaiacolsulfonate Liquid while you are pregnant. It is not known if Hydrocodone/Potassium Guaiacolsulfonate Liquid is found in breast milk. Do not breast-feed while taking Hydrocodone/Potassium Guaiacolsulfonate Liquid.

When used for long periods of time or at high doses, Hydrocodone/Potassium Guaiacolsulfonate Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Hydrocodone/Potassium Guaiacolsulfonate Liquid stops working well. Do not take more than prescribed.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Hydrocodone/Potassium Guaiacolsulfonate Liquid. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Hydrocodone/Potassium Guaiacolsulfonate Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Hydrocodone/Potassium Guaiacolsulfonate Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; change in amount of urine; difficulty urinating; hearing change or loss; mental or mood changes; severe drowsiness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Hydrocodone/Potassium Guaiacolsulfonate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Hydrocodone/Potassium Guaiacolsulfonate Liquid:

Store Hydrocodone/Potassium Guaiacolsulfonate Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hydrocodone/Potassium Guaiacolsulfonate Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Hydrocodone/Potassium Guaiacolsulfonate Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Hydrocodone/Potassium Guaiacolsulfonate Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Hydrocodone/Potassium Guaiacolsulfonate Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Hydrocodone/Potassium Guaiacolsulfonate resources

• Hydrocodone/Potassium Guaiacolsulfonate Side Effects (in more detail)
• Hydrocodone/Potassium Guaiacolsulfonate Use in Pregnancy & Breastfeeding
• Hydrocodone/Potassium Guaiacolsulfonate Drug Interactions
• Hydrocodone/Potassium Guaiacolsulfonate Support Group
• 0 Reviews · Be the first to review/rate this drug

Tridesilon Cream

Pronunciation: DES-oh-nide
Generic Name: Desonide
Brand Name: Examples include DesOwen and Tridesilon

Tridesilon Cream is used for:

Treating mild to moderate itching, redness, and swelling caused by certain skin conditions.

Tridesilon Cream is a topical corticosteroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation).

Do NOT use Tridesilon Cream if:

• you are allergic to any ingredient in Tridesilon Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tridesilon Cream:

Some medical conditions may interact with Tridesilon Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin


• if you have measles, tuberculosis (TB), chickenpox, shingles, or a positive TB skin test, or if you have recently had a vaccination


• if you are taking an oral corticosteroid (eg, prednisone)

Some MEDICINES MAY INTERACT with Tridesilon Cream. Because little, if any, of Tridesilon Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Tridesilon Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tridesilon Cream:

Use Tridesilon Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply a thin film of Tridesilon Cream to the affected area(s) as directed by your doctor. Gently rub the medicine in until it is evenly distributed.


• Wash your hands immediately after applying Tridesilon Cream, unless your hands are part of the treated area.


• Do not cover the treated area(s) with bandages or other dressings unless advised to do so by your health care provider.


• If you miss a dose of Tridesilon Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tridesilon Cream.

Important safety information:

• Tridesilon Cream is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, flush right away with cool tap water.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Do not apply Tridesilon Cream over large areas of the body, to open wounds, or to scraped, infected, or burned skin without first checking with your doctor.


• Do not use Tridesilon Cream for other skin conditions at a later time.


• Overuse of topical products may worsen your condition.


• If Tridesilon Cream was prescribed to treat the diaper area of a child, avoid using tight-fitting diapers or plastic pants.


• Check with your doctor before you receive any vaccine while you are using Tridesilon Cream.


• Tridesilon Cream has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or you are not sure, check with your doctor or pharmacist.


• Tell your doctor or dentist that you take Tridesilon Cream before you receive any medical or dental care, emergency care, or surgery.


• Contact your doctor if you have a cut or sore that does not heal.


• Serious side effects may occur if too much of Tridesilon Cream is absorbed through the skin. This may be more likely to occur if you use Tridesilon Cream over a larger area of the body. It may also be more likely if you wrap or bandage the area after you apply Tridesilon Cream. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Tridesilon Cream.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tridesilon Cream while you are pregnant. It is not known if Tridesilon Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use Tridesilon Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tridesilon Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild, temporary stinging or burning when first applied.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; inflamed hair follicles; inflammation around the mouth; severe or persistent burning, irritation, redness, or swelling of the skin; thinning, softening, or discoloration of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tridesilon side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision or other vision changes; muscle weakness; severe or persistent headache; symptoms of high blood sugar (eg, increased thirst or urination, confusion, unusual drowsiness); unusual weight gain, especially in the face.

Proper storage of Tridesilon Cream:

Store Tridesilon Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tridesilon Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Tridesilon Cream, please talk with your doctor, pharmacist, or other health care provider.


• Tridesilon Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tridesilon Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Pethidine Injection BP 50mg / ml

1. Name Of The Medicinal Product

Pethidine Injection B.P. 50mg/ml, 1ml & 2ml.

2. Qualitative And Quantitative Composition

Each 1ml of solution contains 50mg of Pethidine Hydrochloride B.P.

3. Pharmaceutical Form

Clear, colourless, sterile solution intended for parenteral administration to human beings.

4. Clinical Particulars

4.1 Therapeutic Indications

Pethidine hydrochloride may be used as an analgesic for the relief of moderate to severe pain including: obstetric analgesia; pre-operative medication and analgesia during anaesthesia; post-operative analgesia.

4.2 Posology And Method Of Administration

Pethidine Injection may be administered by subcutaneous, intramuscular or slow intravenous injection.

Adults: The following single doses may be used and should not usually be repeated more frequently than four hourly; Subcutaneous or intramuscular injection: 25 - 100mg. Intravenous injection: 25 - 50mg.

Elderly or debilitated patients: The initial dose should not exceed 25mg, because of the particular sensitivity among elderly or debilitated patients to the central depressant effects of pethidine.

Children: The usual single dose is 0.5 to 2mg/kg body weight by intramuscular injection. If necessary, this dose may be repeated, allowing a minimum of four hours between doses. Use of a small graduated syringe is recommended for the accurate administration of dosages in children. In the absence of graduated syringes, the solution should be diluted with Water for Injections before measuring the dose.

4.3 Contraindications

History of hypersensitivity to pethidine. Coma. Respiratory depression or obstructive airways disease. Use in patients receiving monoamine oxidase inhibitors or within two weeks following their withdrawal.

4.4 Special Warnings And Precautions For Use

If the intravenous route is being used, pethidine should be given slowly in order to reduce the risk of adverse reactions.

Extreme care is required when administering pethidine to patients with reduced respiratory function.

Pethidine should only be used with caution and in reduced dosage in neonates and premature infants, elderly and debilitated patients and in patients with head injuries, severe hepatic or renal impairment, biliary tract disorders, hypothyroidism, adrenocortical insufficiency, shock, prostatic hypertrophy and supraventricular tachycardia.

Caution is also required in patients with acute alcoholism, raised intracranial pressure or convulsive disorders.

Repeated administration of pethidine may produce physical and psychological dependence of the morphine type, with the development of withdrawal symptoms on abrupt cessation of therapy or on administration of a narcotic antagonist. Repeated administration may also induce tolerance, with a tendency to increase the dose in order to obtain the desired effect.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The central depressant effects of pethidine may be potentiated by the concurrent use of other central nervous system depressants including anxiolytics, hypnotics, antidepressants, other analgesics, alcohol and general anaesthetics; respiratory depression, hypotension and profound sedation or coma may result.

Severe hypotension may occur when pethidine is administered to patients whose ability to maintain blood pressure has been compromised by a depleted blood volume or by the administration of drugs such as phenothiazine.

Cimetidine inhibits metabolism of pethidine and therefore increases plasma concentration.

Very severe reactions including coma, respiratory depression, cyanosis and hypotension have occurred in patients administered monoamine inhibitors (MAOIs). Pethidine should not be administered to patients taking MAOIs or to those who have taken MAOIs within 14 days (see Special Warnings and Precautions for Use). The interaction of pethidine with MAOIs may result in Serotonin syndrome.

Use of pethidine in prolonged increasing dosage or concomitantly with anticholinergics may result in neurotoxicity in patients with renal failure, cancer or sickle cell anaemia.

4.6 Pregnancy And Lactation

Pethidine crosses the placenta and is excreted in breast milk. This should be borne in mind when considering its use in patients during pregnancy or breast feeding. Administration during labour may cause respiratory depression in the newborn.

4.7 Effects On Ability To Drive And Use Machines

Pethidine may impair the mental and/or physical abilities required for driving or for operating machinery; patients should be advised accordingly and warned not to drive or to operate machines if affected.

4.8 Undesirable Effects

The most serious adverse effects of pethidine are respiratory depression and hypotension. Rapid intravenous administration of pethidine increases the incidence of these effects and may result in serious respiratory depression and hypotension with tachycardia.

The most frequently observed adverse effects include lightheadedness, dizziness, sedation, nausea, vomiting and sweating.

Other adverse effects include;

Nervous System: Euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, convulsions, hallucinations, visual disturbances. Increased risk of delirium in elderly patients.

Gastrointestinal: Dry mouth, constipation, biliary tract spasm.

Cardiovascular: Flushing of the face, tachycardia, bradycardia, palpitation, hypotension, syncope.

Genitourinary: Urinary retention.

Allergic: Pruritus, urticaria, other skin rashes, wheal and flare over the vein with intravenous injection.

Other: Pain at the injection site and local tissue irritation.

4.9 Overdose

Signs of acute overdosage may include convulsions, respiratory depression, hypotension, shock and coma.

Primary attention should be directed at correcting respiratory failure and shock. A patent airway should be established and assisted or controlled ventilation should be provided. Naloxone is a specific antidote used to counteract respiratory depression and coma resulting from opioid overdosage. Intravenous fluids and other supportive measures may be required in the management of shock. An anticonvulsant may be required if seizures occur.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Like other opioids, pethidine binds to opioid receptors and exerts its principal pharmacological actions on the central nervous system where its analgesic and sedative effects are of particular therapeutic value. The respiratory depression produced by pethidine can be antagonised by naloxone and nalorphine.

Pethidine has a spasmogenic effect on certain smooth muscles which is qualitatively similar to that of morphine. In equianalgesic doses, pethidine appears to cause less constipation and biliary tract spasm than does morphine.

Pethidine, like other opioids, dilates resistance and capacitance vessels and may thereby decrease the capacity of the cardiovascular system to respond to gravitational shifts. In therapeutic doses, the effects of pethidine on the cardiovascular system are generally not of clinical significance, especially when the patient is recumbent. However, rapid intravenous administration, or administration of pethidine to patients with depleted blood volume or in other situations where ability to maintain blood pressure has been compromised, may result in severe hypotension.

5.2 Pharmacokinetic Properties

Pethidine hydrochloride is well absorbed by all recommended routes of administration. It is metabolised in the liver by hydrolysis. Following intravenous injection, a rapid decline in plasma concentration occurs due to distribution and this is followed by a slower phase with a half-time of approximately 3 hours. In patients with cirrhosis, the half-life is increased to 6 hours.

Approximately 60% of pethidine in plasma is protein-bound. Older patients have decreased binding to plasma proteins and have higher concentrations in plasma, both of which may account for their increased response to therapeutic doses.

Pethidine is metabolised in the liver by hydrolysis to pethidinic acid or by demethylation to norpethidine and hydrolysis to norpethidinic acid, followed by conjugation with glucoronic acid. About 1/3 of administered pethidine may be accounted for in the urine as N-demethylated derivatives. The accumulation of norpethidine may result in toxicity. The T½ of norpethidine is reported to be up to 20 hours.

5.3 Preclinical Safety Data

No further relevant information other than that which is included with other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Hydroxide B.P. Dilute Hydrochloric Acid B.P. Water for Injections B.P.

6.2 Incompatibilities

There was loss of clarity when intravenous solutions of pethidine hydrochloride were mixed with those of aminophylline, amylobarbitone sodium, heparin sodium, methicillin sodium, morphine sulphate, nitrofurantoin sodium, pentobarbitone sodium, phenobarbitone sodium, phenytoin sodium, sodium bicarbonate, sodium iodide, sulphadiazine sodium, sulphafurazole diethanolamine or thiopentone sodium.

6.3 Shelf Life

4 years.

If only part used, discard the remaining solution.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep in outer carton.

6.5 Nature And Contents Of Container

1ml and 2ml clear glass ampoules, glass type 1 Ph. Eur. packed in cardboard cartons to contain 10 x 1ml or 10 x 2ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

CD (2) For S/C., I/M., or I/V injection. Use as directed by the physician.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

Antigen International Ltd.,

Roscrea,

Co. Tipperary,

Ireland.

8. Marketing Authorisation Number(S)

PL 02848/0016R.

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 10/05/82

Date of renewal: 13/03/97

10. Date Of Revision Of The Text

April 2008