Thursday, October 13, 2016

Senna S


Generic Name: docusate and senna (DOK yoo sate and SEN a)

Brand Names: Doc-Q-Lax, Doculax, Dok Plus, Gentlax S, Peri-Colace, Senna Plus, Senna S, Sennalax-S, Senokot S, SenoSol-SS


What is Senna S (docusate and senna)?

Docusate is a stool softener. It makes bowel movements softer and easier to pass.


Senna is a laxative. It stimulates muscle movement in the intestines.


The combination of docusate and senna is used to treat occasional constipation.


Docusate and senna may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Senna S (docusate and senna)?


Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.


You should not use this medication if you are allergic to docusate and senna, or if you are also taking mineral oil.

Ask a doctor or pharmacist before using docusate and senna if you have nausea, vomiting, stomach pain, a sudden change in bowel habits, or an intestinal disorder (such as Crohn's disease or ulcerative colitis).


Do not use this medication without your doctor's advice if you are pregnant or breast-feeding. Do not take this medication for longer than 7 days in a row. Call your doctor if your constipation does not improve or if it gets worse. Stop taking this docusate and senna and call your doctor at once if you have rectal bleeding, severe stomach pain, nausea and vomiting, or if you do not have a bowel movement. Do not use any other over-the-counter laxatives or other stool softener without first asking your doctor or pharmacist.

What should I discuss with my healthcare provider before using Senna S (docusate and senna)?


You should not use this medication if you are allergic to docusate and senna, or if you are also taking mineral oil.

Ask a doctor or pharmacist about using docusate and senna if you have:



  • nausea or vomiting;




  • stomach pain;




  • a sudden change in bowel habits that lasts for 2 weeks or longer; or




  • if you have an intestinal disorder such as Crohn's disease or ulcerative colitis.




Do not use this medication without your doctor's advice if you are pregnant. It is not known whether docusate and senna passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Ask a doctor before giving this medication to a child younger than 2 years old.

How should I use Senna S (docusate and senna)?


Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.


Take this medication with a full glass of water.

It may be best to take this medication at night or at bedtime. Docusate and senna should cause you to have a bowel movement within 6 to 12 hours.


Do not take this medication for longer than 7 days in a row, unless your doctor tells you to. Call your doctor if your constipation does not improve or if it gets worse after taking docusate and senna. Store docusate and senna at room temperature away from moisture and heat.

What happens if I miss a dose?


Since docusate and senna is taken as needed, you are not likely to be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, or diarrhea.


What should I avoid while using Senna S (docusate and senna)?


Do not use any other over-the-counter laxatives or other stool softener without first asking your doctor or pharmacist. Docusate or senna may be contained in other medicines available over the counter. If you take certain products together you may accidentally take too much of a certain medicine. Read the label of any other medicine you are using to see if it contains docusate or senna.

Senna S (docusate and senna) side effects


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 docusate and senna and call your doctor at once if you have a serious side effect such as:

  • rectal bleeding;




  • severe stomach pain, nausea, vomiting; or




  • no bowel movement.



Less serious side effects may include:



  • gas, bloating;




  • diarrhea; or




  • mild nausea.



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 other drugs will affect Senna S (docusate and senna)?


There may be other drugs that can interact with docusate and senna. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Senna S resources


  • Senna S Side Effects (in more detail)
  • Senna S Use in Pregnancy & Breastfeeding
  • Drug Images
  • Senna S Drug Interactions
  • Senna S Support Group
  • 1 Review for Senna S - Add your own review/rating


  • Senna Plus MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Senna S with other medications


  • Constipation, Acute


Where can I get more information?


  • Your pharmacist can provide more information about docusate and senna.

See also: Senna S side effects (in more detail)


Seb-Prev Cream



sodium sulfacetamide

Dosage Form: cream
SEB-PREV™ CREAM (SODIUM SULFACETAMIDE 10%)

Seb-Prev Cream


(Sodium Sulfacetamide 10%)


Rx Only


FOR DERMATOLOGIC USE ONLY


NOT FOR OPHTHALMIC USE



Seb-Prev Cream Description


Each gram of Seb-Prev™ Cream contains 100 mg of Sulfacetamide Sodium USP in a vehicle consisting of benzyl alcohol, cetyl alcohol, dimethicone, edetate disodium, emulsifying wax, glycerin, isopropyl myristate, monobasic sodium phosphate, PEG-8 stearate, propylene glycol monopalmitostearate, purified water and sodium thiosulfate.


Sulfacetamide sodium is C8H9N2NaO3S•H2O with a molecular weight of 254.24. Chemically, it is Acetamide N-[(4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula:



Sulfacetamide sodium is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform, and in ether.



Seb-Prev Cream - Clinical Pharmacology


Sulfacetamide sodium exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There are no clinical data available on the degree and rate of systemic absorption of Seb-Prev™ Cream when applied to the skin or scalp. However, significant absorption of sulfacetamide sodium through the skin has been reported.


The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sulfacetamide sodium are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.



Indications and Usage for Seb-Prev Cream


Seb-Prev™ Cream is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.



Contraindications


Seb-Prev™ Cream is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.



Warnings


Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sulfacetamide sodium topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.



Precautions



General


Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If Seb-Prev™ Cream produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed.



Information For Patients


Patients should discontinue Seb-Prev™ Cream if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Seb-Prev™ Cream also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop.


For external use only. Avoid contact with eyes and mucous membranes.


Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or poison control center immediately (seeOVERDOSAGE).



Drug Interactions


Seb-Prev™ Cream is incompatible with silver preparations.



Carcinogenesis, Mutagenesis, and Impairment of Fertility


Long-term animal studies for carcinogenic potential have not been performed on Seb-Prev™ Cream to date. Studies on reproduction and fertility also have not been performed. One author detected chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sulfacetamide sodium. The significance of this finding to the topical use of sulfacetamide sodium in the human is unknown.



Pregnancy


Teratogenic effects

Pregnancy Category C


Animal reproduction studies have not been conducted with Seb-Prev™ Cream. It also is not known whether Seb-Prev™ Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Seb-Prev™ Cream should be given to a pregnant woman only if clearly needed.



Nursing Mothers


It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Seb-Prev™ Cream is administered to a nursing woman.



Pediatric Use


Safety and effectiveness in children under the age of 12 years have not been established.



Adverse Reactions


Reports of irritation and hypersensitivity to sulfacetamide sodium are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sulfacetamide sodium, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome has been reported (see WARNINGS).



Overdosage


The oral LD50 of sulfacetamide in mice is 16.5 g/kg. The LD50 for topical administration of sulfacetamide has not been determined. Oral overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. In the event of overdosage, call a physician or poison control center; emergency treatment should be started immediately.


Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of eight to twelve fluid ounces of water. If emesis does not occur within 15 minutes, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Isotonic and one-half isotonic saline are the lavage solutions of choice. Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and, therefore, may be valuable for their action in rapid dilution of bowel content. After emergency treatment, the patient should continue to be medically monitored.


Observe kidney function for up to 1 week and have the patient ingest copious amounts of fluid during this period. Mannitol infusions may be helpful at the first sign of oliguria. Alkalinization of the urine by ingestion of bicarbonate is very helpful in preventing crystallization of sulfa drug in the kidney.



Seb-Prev Cream Dosage and Administration


Seborrheic dermatitis including seborrhea sicca: Apply to affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Repeat application as described for eight to ten days. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of Seb-Prev™ Cream should be reinitiated as at the beginning of treatment.


Secondary cutaneous bacterial infections: Apply to affected areas twice daily for eight to ten days.



How is Seb-Prev Cream Supplied


Seb-Prev™ Cream is available as follows:


30 g tube (NDC 45802-954-94)


60 g tube (NDC 45802-954-96)



Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Do not freeze.


Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration is readily removed by ordinary laundering without bleaches.



MANUFACTURED BY


STIEFEL LABORATORIES, INC.


CORAL GABLES, FL 33134


DISTRIBUTED BY


PERRIGO®


ALLEGAN, MI 49010


Rev. 10/07


82174


: 5L500 RC J1



Principal Display Panel - 30 g Carton


Seb-Prev™ Cream


(Sodium Sulfacetamide 10%)


For Dermatologic Use Only. Not for Ophthalmic Use.


Rx Only


Seb-Prev(tm) Cream - 30 g Carton




Principal Display Panel - 30 g Tube


Seb-Prev™ Cream


(Sodium Sulfacetamide 10%)


For Dermatologic Use Only. Not for Ophthalmic Use.


Rx Only


Seb-Prev(tm) Cream - 30 g Tube




Principal Display Panel - 60 g Carton


Seb-Prev™ Cream


(Sodium Sulfacetamide 10%)


For Dermatologic Use Only. Not for Ophthalmic Use.


Rx Only


Seb-Prev(tm) Cream - 60 g Carton




Principal Display Panel - 60 g Tube


Seb-Prev™ Cream


(Sodium Sulfacetamide 10%)


For Dermatologic Use Only. Not for Ophthalmic Use.


Rx Only


Seb-Prev(tm) Cream - 60 g Tube










PERRIGO SEB PREV 
sodium sulfacetamide  cream










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)45802-954
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFACETAMIDE SODIUM (SULFACETAMIDE)SULFACETAMIDE SODIUM100 mg  in 1 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
145802-954-941 TUBE In 1 CARTONcontains a TUBE
130 g In 1 TUBEThis package is contained within the CARTON (45802-954-94)
245802-954-961 TUBE In 1 CARTONcontains a TUBE
260 g In 1 TUBEThis package is contained within the CARTON (45802-954-96)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/07/2008


Labeler - Perrigo New York Inc (078846912)
Revised: 11/2009Perrigo New York Inc

More Seb-Prev Cream resources


  • Seb-Prev Cream Side Effects (in more detail)
  • Seb-Prev Cream Use in Pregnancy & Breastfeeding
  • Seb-Prev Cream Support Group
  • 0 Reviews for Seb-Prev - Add your own review/rating


Compare Seb-Prev Cream with other medications


  • Seborrheic Dermatitis
  • Secondary Cutaneous Bacterial Infections

Sectral


Pronunciation: A-se-BUE-toe-lol
Generic Name: Acebutolol
Brand Name: Sectral


Sectral is used for:

Treating high blood pressure. It may be used alone or in combination with other medicines. It is also used to treat certain kinds of irregular heartbeat. It may also be used for other conditions as determined by your doctor.


Sectral is a beta-blocker. It works by causing the heart to beat more slowly and regularly.


Do NOT use Sectral if:


  • you are allergic to any ingredient in Sectral

  • you have a very slow heart rate, active heart failure, heart block, shock caused by serious heart problems, or low blood pressure caused by a heart attack

  • you are taking mibefradil

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



Before using Sectral:


Some medical conditions may interact with Sectral. 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 heart failure, other heart problems (eg, slow heart rate, valve disease, ventricular problems), low blood pressure, or blood vessel problems (eg, narrowing of the blood vessels)

  • if you have breathing or lung problems (eg, bronchitis, asthma, chronic obstructive pulmonary disease), diabetes, an overactive thyroid, liver or kidney problems, or adrenal gland problems (eg, pheochromocytoma)

  • if you are currently having a severe allergic reaction or if you have a history of any severe allergic reaction

  • if you will be having surgery

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


  • Digoxin, diltiazem, disopyramide, fingolimod, flecainide, ketanserin, mibefradil, or reserpine because side effects, such as severe low blood pressure or slow heart rate, may occur

  • Mefloquine or verapamil because the risk of serious heart problems may be increased

  • Certain cold medicines, decongestant nasal sprays (eg, oxymetazoline), or diet medicines because severe high blood pressure may occur

  • Clonidine because high blood pressure may occur in some cases, especially if you suddenly stop taking clonidine while taking Sectral

  • Indomethacin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because they may decrease Sectral's effectiveness

  • Flecainide, hydralazine, ketanserin, or quinazolines (eg, alfuzosin) because the risk of their side effects may be increased by Sectral

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sectral 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 Sectral:


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


  • Take Sectral by mouth with or without food.

  • Taking Sectral at the same time each day will help you remember to take it.

  • Continue to take Sectral even if you feel well. Do not miss any doses.

  • If you miss a dose of Sectral, 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 Sectral.



Important safety information:


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

  • Sectral may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.

  • Diabetes patients - Sectral may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Do not suddenly stop taking Sectral. Sharp chest pain, irregular heartbeat, and sometimes a heart attack may occur if you suddenly stop Sectral. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. This should be done even if you only take Sectral for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Sectral again.

  • If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Sectral.

  • If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines, including nasal sprays. Contact your doctor if you have any questions or concerns.

  • If your doctor has instructed you to check your blood pressure and heart rate regularly, be sure to do so.

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

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

  • Sectral should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Sectral while you are pregnant. Sectral is found in breast milk. Do not breast-feed while taking Sectral.


Possible side effects of Sectral:


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; diarrhea; dizziness or lightheadedness; frequent urination; gas; headache; indigestion; mild drowsiness; nausea; sleepiness; sleeplessness; unusual tiredness or 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); chest pain or tightness; dark urine; difficulty breathing, especially when lying down; mental or mood changes; pale stools; persistent muscle or joint pain; persistent nausea or loss of appetite; shortness of breath; swelling of the hands, ankles, or feet; unusually slow heartbeat; 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.


See also: Sectral 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 difficulty breathing, especially when lying down; fainting; lightheadedness, especially when standing; seizures (convulsions); shortness of breath; swelling of ankles; very slow heart rate; weakness; wheezing.


Proper storage of Sectral:

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


General information:


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

  • Sectral 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 summary only. It does not contain all information about Sectral. 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 Sectral resources


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


  • Sectral Prescribing Information (FDA)

  • Sectral Advanced Consumer (Micromedex) - Includes Dosage Information

  • Sectral Concise Consumer Information (Cerner Multum)

  • Sectral Monograph (AHFS DI)

  • Acebutolol Prescribing Information (FDA)



Compare Sectral with other medications


  • High Blood Pressure
  • Premature Ventricular Depolarizations
  • Ventricular Tachycardia

Sebucare


Generic Name: salicylic acid topical (SAL i SIL ik AS id TOP ik al)

Brand Names: Compound W, DermalZone, Dermarest Psoriasis Skin Treatment, Dr Scholl's Callus Removers, Dr Scholl's Clear Away Wart Remover, Dr Scholl's Corn Removers, Duofilm, Freezone Corn Remover, Hydrisalic, Keralyt, Mediplast, Oxy Face Scrub, Propa P.H., Salac, Salex, Scalpicin Scalp Relief, Sebucare, Stri-Dex, Wart-Off Treatment


What is Sebucare (salicylic acid topical)?

Salicylic acid is a keratolytic (peeling agent). Salicylic acid causes shedding of the outer layer of skin.


Salicylic acid topical is used in the treatment of acne, dandruff, corns, and warts.


Salicylic acid topical may also be used for purposes other than those listed here.


What is the most important information I should know about Sebucare (salicylic acid topical)?


Avoid the eyes, mouth, lips, inside the nose, genitals, and anal areas when applying salicylic acid topical. Do not use the wart remover on moles or birthmarks, or warts with hair growing from them, red edges, or unusual color. Also, do not use salicylic acid topical on sunburned, windburned, dry, chapped, irritated, or broken skin; or on open wounds. If medication is applied to any of these areas, wash with water.

What should I discuss with my healthcare provider before using Sebucare (salicylic acid topical)?


Avoid the eyes, mouth, lips, inside the nose, genitals, and anal areas when applying salicylic acid topical. Do not use the wart remover on moles or birthmarks, or warts with hair growing from them, red edges, or unusual color. Also, do not use salicylic acid topical on sunburned, windburned, dry, chapped, irritated, or broken skin; or on open wounds. If medication is applied to any of these areas, wash with water.

Before using salicylic topical, talk to your doctor if you


  • have kidney disease;

  • have liver disease;


  • have diabetes;




  • have poor circulation; or




  • are treating a child.



You may not be able to use salicylic acid topical, or you may require a dosage adjustment or special monitoring during treatment.


It is not known whether salicylic acid topical will be harmful to an unborn baby. Do not use salicylic acid topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. Salicylic acid topical may pass into breast milk and affect a nursing baby. Do not use salicylic acid topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Sebucare (salicylic acid topical)?


Use salicylic acid topical exactly as directed by your healthcare provider or as directed on the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.


Gently clean and dry the affected area. For the treatment of warts and calluses, gentle removal of loose skin with a soft brush, wash cloth, or emery board may be recommended before application of the medication.


Shake the lotion gently before application.

Apply a thin film of the medication to the affected area(s) as directed.


Use the soap and shampoo as directed on the package.


Apply the salicylic acid topical adhesive pads as directed on the package.


It is important to use salicylic acid topical regularly to get the most benefit. Do not stop using the medication if you do not see results immediately. Use the medication for the full amount of time directed.

Talk to your doctor if you experience excessive burning, dryness, or irritation of the skin, or changes in the color of the skin.


Store salicylic acid topical at room temperature away from moisture and heat. Some forms of salicylic acid topical may be flammable, keep away from heat and flame.

What happens if I miss a dose?


Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose.


Do not apply a double dose of the medication.


What happens if I overdose?


An overdose of salicylic acid topical is unlikely to occur. If you do suspect an overdose, or if the medication has been ingested, call a poison control center or emergency room for advice.

What should I avoid while using Sebucare (salicylic acid topical)?


Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.


Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or other peeling agents while using salicylic acid topical.


Sebucare (salicylic acid topical) side effects


Serious side effects are not likely to occur with the use of salicylic acid topical. If you do experience any of the following rare serious side effects, stop using salicylic acid topical and seek emergency medical attention or contact your doctor:

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




  • severe skin irritation.



Other, less serious side effects are more likely to occur. Continue to use salicylic acid topical and talk to your doctor if you experience skin burning; stinging; itching; dryness; redness; peeling; or irritation.


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 other drugs will affect Sebucare (salicylic acid topical)?


Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.


Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or other peeling agents while using salicylic acid topical.


Drugs other than those listed here may also interact with salicylic acid topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.



More Sebucare resources


  • Sebucare Use in Pregnancy & Breastfeeding
  • Sebucare Drug Interactions
  • Sebucare Support Group
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Compare Sebucare with other medications


  • Acne
  • Dermatological Disorders


Where can I get more information?


  • Your pharmacist has additional information about salicylic acid topical written for health professionals that you may read.


Selenos Shampoo



selenium sulfide

Dosage Form: shampoo, suspension
Selenos™ Shampoo

Description


A liquid antiseborrheic, antifungal preparation for topical application. Each gram of Selenos™ Shampoo contains 22.5 mg selenium sulfide, urea, zinc pyrithione, purified water, edetate disodium, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, hydroxypropyl methylcellulose, ammonium lauryl sulfate, titanium dioxide, caprylic/capric triglyceride, D&C yellow #8, FD&C red #40, chromium oxide greens, citric acid, sodium citrate, cocamidopropyl betaine, lauramide DEA, magnesium aluminum silicate and fragrance.



Clinical Pharmacology


Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, reducing corneocyte production.



Pharmacokinetics


The mechanism of action of topically applied selenium sulfide is not yet known.



Indications and Uses


A liquid antiseborrheic, antifungal preparation to treat seborrheic dermatitis of the scalp, dandruff and tinea versicolor. Urea hydrates and is useful for conditions such as dry scalp.



Contraindications


Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.



Warnings


For external use only. Not for ophthalmic use. DO NOT USE ON BROKEN SKIN OR INFLAMED AREAS.

If allergic reaction occurs, discontinue use. Avoid contact with eyes, genital areas and skin folds, as irritation and burning may result. If accidental contact occurs, rinse thoroughly with water after application.



Precautions


This medication is to be used as directed by a physician. Do not use when inflammation or exudation is present as increased absorption may occur.



Carcinogenesis


Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects.



Use in Pregnancy


Category C. Animal reproduction studies have not been conducted with Selenos™ Shampoo. It is also not known whether Selenos™ Shampoo can cause fetal harm when applied to the body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances, Selenos™ Shampoo should not be used by pregnant women.



Nursing Mothers


It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Selenos™ Shampoo is administered to a nursing woman.



Pediatric Use


Safety and effectiveness in children have not been established.



Adverse Reactions


In decreasing order of severity: skin irritation; occasional reports of increase in normal hair loss; discoloration of hair (can be avoided or minimized by thorough rinsing of hair after treatment). As with other shampoos, oiliness or dryness of hair and scalp may occur.



Overdosage


There are no documented reports of serious toxicity in humans resulting from acute ingestion of Selenos™ Shampoo. However, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. Evacuation of the stomach contents should be considered in cases of acute oral ingestion.



Dosage and Administration


For seborrheic dermatitis and dandruff: Generally 2 applications each week for 2 weeks will usually control symptoms. After 2 weeks, shampoo may be used less frequently: weekly, every 2 weeks, every 3 to 4 weeks or as directed by a physician. Do not apply more frequently than necessary to maintain control. For tinea versicolor: Apply to affected areas and lather with a small amount of water. Rinse thoroughly after 10 minutes. Repeat procedure once a day for 7 days or as directed by a physician.



How supplied


Selenos™ Shampoo (Selenium Sulfide 2.25%) is supplied in 180 ml bottles, NDC 51991-472-68.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°F-86°F). See USP Controlled Room Temperature. Protect from freezing.



Warning: Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately.

Do not accept if plastic safety shell has been removed or broken.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.



Manufactured by: Harmony Labs, Inc., Landis, NC 28088

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487


picture








SELENOS  
selenium sulfide  shampoo, suspension










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)51991-472
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Selenium Sulfide (Selenium)Selenium Sulfide0.0225 mg  in 1 mL












































Inactive Ingredients
Ingredient NameStrength
urea 
pyrithione zinc 
water 
edetate disodium 
propylene glycol 
diazolidinyl urea 
methylparaben 
propylparaben 
ammonium lauryl sulfate 
titanium dioxide 
medium-chain triglycerides 
D&C yellow no. 8 
FD&C red no. 40 
chromic oxide 
citric acid monohydrate 
sodium citrate 
cocamidopropyl betaine 
lauric diethanolamide 
magnesium aluminum silicate 
hypromelloses 


















Product Characteristics
ColorORANGE (dark orange)Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
151991-472-68180 mL In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved Drug Other01/01/200709/30/2011


Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Registrant - Harmony Labs, Inc. (105803274)









Establishment
NameAddressID/FEIOperations
Harmony Labs, Inc.105803274MANUFACTURE
Revised: 12/2010Breckenridge Pharmaceutical, Inc.

More Selenos Shampoo resources


  • Selenos Shampoo Side Effects (in more detail)
  • Selenos Shampoo Use in Pregnancy & Breastfeeding
  • Selenos Shampoo Support Group
  • 0 Reviews for Selenos - Add your own review/rating


Compare Selenos Shampoo with other medications


  • Seborrheic Dermatitis
  • Tinea Versicolor

senna



Generic Name: senna (SEN nah)

Brand Names: Black Draught, Dr Caldwell Laxative, Ex-Lax Chocolated, Ex-Lax Maximum Relief Formula, Ex-Lax Regular Strength Pills, Fletchers Castoria, Innerclean, Pedia-Lax, Perdiem Overnight, Senexon, Senna, Senna Lax, Senna Smooth, Senna Soft, Senna-gen, Senokot, Senokot Extra, SenokotXTRA, SenoSol, SenoSol-X


What is Senna (senna)?

Senna is also known as Cassia senna, tinnevelly senna, India senna, Alexandrian senna, and Khartoum senna.


Senna has been used in alternative medicine as an aid to treat constipation.


Not all uses for senna have been approved by the FDA. Senna should not be used in place of medication prescribed for you by your doctor.

Senna is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.


Senna may also be used for other purposes not listed in this product guide.


What is the most important information I should know about Senna (senna)?


Not all uses for senna have been approved by the FDA. Senna should not be used in place of medication prescribed for you by your doctor.

Senna is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.


Use senna as directed on the label, or as your healthcare provider has prescribed. Do not use this product in larger amounts or for longer than recommended.


Call your healthcare provider if your symptoms do not improve, or if they get worse while using senna. Do not use this product for longer than 1 week without the advice of a healthcare provider.

What should I discuss with my health care provider before taking Senna (senna)?


Ask a doctor, pharmacist, herbalist, or other healthcare provider if it is safe for you to use this product if you have:



  • a bowel disorder such as Crohn's disease or ulcerative colitis;




  • heart disease; or




  • stomach pain, nausea, or vomiting.



Before using senna, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use senna if you have any other medical conditions, allergies, or if you take other medicines or herbal/health supplements.


Do not take senna without first talking to your doctor if you are pregnant or could become pregnant. Do not take senna without first talking to your doctor if you are breast-feeding a baby. Some forms of senna are made for use by children. Do not give any herbal/health supplement to a child without the advice of a doctor.

How should I take Senna (senna)?


When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.


If you choose to use senna, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.


Senna is usually taken before bed to produce a bowel movement 6 to 12 hours later when you wake up.


Do not use different forms (such as tablets and liquid) of senna at the same time unless your healthcare provider tells you to. Call your healthcare provider if your symptoms do not improve, or if they get worse while using senna. Do not use this product for longer than 1 week without the advice of a healthcare provider. Store senna at room temperature away from moisture, heat, and light.

What happens if I miss a dose?


Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Senna (senna)?


Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.


Senna (senna) side effects


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 healthcare provider at once if you have a serious side effect such as:

  • severe stomach pain, severe diarrhea, watery diarrhea;




  • weight loss;




  • worsening constipation after you stop taking senna;




  • enlargement of your fingers and toes;




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




  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • stomach cramps, bloating, gas, mild diarrhea;




  • numbness or tingly feeling;




  • joint pain; or




  • discolored urine.



This is not a complete list of side effects and others may occur. Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Senna (senna)?


Do not take senna without the advice of a healthcare provider if you are using any of the following medications:

  • digoxin (Lanoxin);




  • a diuretic (water pill); or




  • a blood thinner such as warfarin (Coumadin).



This list is not complete and other drugs may interact with senna. Tell your healthcare provider about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Senna resources


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


Compare Senna with other medications


  • Bowel Preparation
  • Constipation


Where can I get more information?


  • Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

See also: Senna side effects (in more detail)


Senna



Class: Cathartics and Laxatives
ATC Class: A06AB06
VA Class: GA204
CAS Number: 8013-11-4
Brands: Black Draught, Dr. Caldwell, Dr. Edwards’ Olive, Evac-U-Gen, Ex-Lax, Fletcher’s, Perdiem, Peri-Colace, Senexon, Senna-S, Senokot, Senokot S

Introduction

Stimulant laxative; hydroxymethylanthraquinone derivative occurring naturally in plants as glycosides.a


Uses for Senna


Constipation


Used to relieve occasional constipation.b


Mildest of the stimulant laxatives; less pronounced laxative effect than bisacodyl or the violent purgation produced by castor oil.b


Use of stimulant laxatives for simple constipation is seldom necessary or desirable.b


If a stimulant laxative is used, senna derivatives may be preferred.b


Used to treat constipation that occurs following prolonged bed rest or hospitalization.b


Has been used to treat constipation during pregnancy or the puerperium; bulk-forming laxatives or stool softeners preferred.b


Because senna may be distributed into milk, other laxatives usually are preferred for postpartum constipation.b


Also has been used to treat constipation resulting from diminished colonic motor response in geriatric patients but, because this type of constipation frequently is due to psychological or physical laxative dependence, bulk-forming laxatives preferred.b


Used to treat constipation occurring secondary to idiopathic slowing of transit time, to constipating drugs, or to irritable bowel or spastic colon syndrome.b


Also has been used to treat constipation in patients with neurologic constipation.b


Colonic Evacuation


Used orally to empty the bowel prior to surgery or radiologic, proctoscopic, or endoscopic (e.g., sigmoidoscopic, proctoscopic) procedures.b


Usually supplemented with administration of rectal evacuants (e.g., saline, stimulant, or soapsuds enemas) immediately before radiologic procedures.b


Senna Dosage and Administration


Administration


Oral Administration


Administer orally, in conjunction with adequate fluid intake.b


May be administered 1–2 times daily; however, usually administered as a single dose at bedtime.a


Oral Solution

Shake well before use.c d


Tablets

Swallow tablets with a glass of water;f h i do not crush, break, or chew.h i


Chewable Tablets or Pieces

Chew tablets or allow to dissolve in mouth before swallowing.e


Chew piece(s) before swallowing.g


Dosage


Available as sennosides, standardized senna concentrate, and standardized senna fruit extract; dosage expressed in terms of sennosides.a


Administer as infrequently as possible at the lowest effective dosage level.b Do not use for >1 week unless directed by prescriber.c d


Senna fluidextract: 33.3 mg/mL senna concentrate contains 3 mg sennosides A & B per mL.a m


Pediatric Patients


Constipation

Stimulant laxatives generally avoided in children <6 years of age.b


Oral (Standardized Senna Concentrate)

Children 2–6 years of age: 4.3 mg once daily; maximum 8.6 mg twice daily.j


Children 6–11 years of age: Usually, 8.6–15 mg 1–2 times daily.f g h i j May increase to a maximum 17.2 mg twice daily.j


Alternatively, for children 6–11 years of age: 25 mg (1 maximum strength tablet) 1–2 times daily.i


Alternatively, for children ≥6 years of age: 10 mg as chewable tablet 1–2 times daily.e


Children ≥12 years of age: Usually, 17.2–30 mg 1–2 times daily.e f h j May increase to a maximum 34.4 mg twice daily.j


Alternatively, for children ≥12 years of age: 50 mg (2 maximum strength tablets) 1–2 times daily.i


Oral (Senna Fluidextract Oral Solution)

Children 2–5 years of age: 15–30 mg (5–10 mL) 1–2 times daily.c Do not give concentrate containing alcohol to children <6 years of age unless otherwise directed by prescriber.d


Children 6–15 years of age: 30–45 mg (10–15 mL) 1–2 times daily.c


Children ≥12 years of age: Alternatively, 45–90 mg (15–30 mL) of oral solution (with alcohol) may be administered before or after meals or at bedtime.d May repeat in 6–8 hours if needed.d


Oral (Standardized Senna Fruit Extract Oral Solution)

Children 2–5 years of age: 4.4–6.6 mg (2.5–3.75 mL) once daily.n May increase to a maximum 6.6 mg (3.75 mL) twice daily.n


Children 6–11 years of age: 8.8–13.2 mg (5–7.5 mL) 1–2 times daily.n May increase to a maximum 13.2 mg (7.5 mL) twice daily.n


Children ≥12 years of age: 17.6–26.4 mg (10–15 mL) once daily.n May increase to a maximum 26.4 mg (15 mL) twice daily.n


Oral (Sennosides and Docusate Fixed Combination)

Children 2–5 years of age: 4.3 mg of sennosides and 25 mg of docusate sodium once daily.k May increase to a maximum 8.6 mg of sennosides and 50 mg of docusate sodium twice daily.k


Children 6–11 years of age: 8.6 mg of sennosides and 50 mg of docusate sodium once daily.k May increase to a maximum 17.2 mg of sennosides and 100 mg of docusate sodium twice daily.k


Children ≥12 years of age: 17.2 mg of sennosides and 100 mg of docusate sodium once daily.k May increase to a maximum 34.4 mg of sennosides and 200 mg of docusate sodium twice daily.k


Adults


Constipation

Oral (Standardized Senna Concentrate)

Usually, 17.2–30 mg 1–2 times daily.e f g h j May increase to a maximum 34.4 mg twice daily.j


Alternatively, 50 mg (2 maximum strength tablets) 1–2 times daily.i


Oral (Senna Fluidextract Oral Solution)

45–90 mg (15–30 mL) before or after meals or at bedtime.d May repeat in 6–8 hours if needed.d


Oral (Standardized Senna Fruit Extract Oral Solution)

17.6–26.4 mg (10–15 mL) once daily.n May increase to a maximum 26.4 mg (15 mL) twice daily.n


Oral (Sennosides and Docusate Fixed Combination)

17.2 mg of sennosides and 100 mg of docusate sodium once daily.k May increase to a maximum 34.4 mg of sennosides and 200 mg of docusate sodium twice daily.k


Colonic Evacuation

To prepare for colonic surgery or radiologic, sigmoidoscopic, or proctoscopic procedures, patient should receive a residue-free diet 1 day before the surgery or procedure.a Castor oil may be administered 16 hours before surgery or procedure; and a cleansing rectal enema (e.g., tap water, soap suds, saline laxative, bisacodyl tannex enema) administered on the day of surgery or procedure.a


Oral (Standardized Senna Fruit Extract or Standardized Senna Concentrate)

05–157.5 mg as a single dose 12–14 hours before surgery or procedure.a


Prescribing Limits


Pediatric Patients


Constipation

Do not use for >1 week unless directed by prescriber.c d


Oral (Standardized Senna Concentrate)

Children 2–6 years of age: Maximum 8.6 mg twice daily.j


Children 6–11 years of age: Maximum 17.2 mg twice daily.j


Alternatively, for children 6–11 years of age: Maximum 25 mg (1 maximum strength tablet) 2 times daily.i


Children ≥12 years of age: Maximum 34.4 mg twice daily.j


Alternatively, for children ≥12 years of age: 50 mg (2 maximum strength tablets) 2 times daily.i


Oral (Standardized Senna Fruit Extract Oral Solution)

Children ≥12 years of age: Maximum 26.4 mg (15 mL) twice daily.n


Oral (Sennosides and Docusate Fixed Combination)

Children 2–5 years of age: Maximum 8.6 mg of sennosides and 50 mg of docusate sodium twice daily.k


Children 6–11 years of age: Maximum 17.2 mg of sennosides and 100 mg of docusate sodium twice daily.k


Children ≥12 years of age: Maximum 34.4 mg of sennosides and 200 mg of docusate sodium twice daily.k


Adults


Constipation

Do not use for >1 week unless directed by prescriber.c d


Oral (Standardized Senna Concentrate)

Maximum 34.4 mg twice daily.j


Oral (Standardized Senna Fruit Extract Oral Solution)

Maximum 26.4 mg (15 mL) twice daily.n


Oral (Sennosides and Docusate Fixed Combination)

Maximum 34.4 mg of sennosides and 200 mg of docusate sodium twice daily.k


Special Populations


No special population dosage recommendations at this time.


Cautions for Senna


Contraindications



  • Acute abdominal pain, nausea, vomiting,b c d f j k or other symptoms of appendicitis or undiagnosed abdominal pain.b




  • Intestinal obstruction.b



Warnings/Precautions


Warnings


Laxative Dependence

Habit-forming.b


Potentially serious toxicity with chronic use.b (See Chronic Use or Overdosage under Cautions.)


Chronic Use or Overdosage of Laxatives

Chronic use or overdosage of laxatives may produce persistent diarrhea, hypokalemia, loss of essential nutritional factors, and dehydration.b


Laxative dependence, chronic constipation, and loss of normal bowel function may occur during long-term use.b


Electrolyte disturbances (including hypokalemia, hypocalcemia, metabolic acidosis or alkalosis), abdominal pain, diarrhea, malabsorption, weight loss, and protein-losing enteropathy may occur.b


Electrolyte disturbances may produce vomiting and muscle weakness; rarely, osteomalacia, secondary aldosteronism, and tetany.b


Chronic use may cause pathologic changes including structural damage to the myenteric plexus, severe and permanent interference with colonic motility, and hypertrophy of the muscularis mucosae.b


“Cathartic colon” with atony and dilation of the colon, especially of the right side, has occurred with habitual use (often for several years); often resembles ulcerative colitis.b


Change in Bowel Habits

If a sudden change in bowel habits occurs that last >2 weeks, consult a clinician before using.c e h i g j k


General Precautions


Discoloration of Urine and Colonic Mucosa

May discolor colonic mucosa (melanosis coli); innocuous and reversible.b


May discolor urine pink to red or brown to black.b


Diabetes Mellitus

Standardized senna fruit extract contains large amounts of sugar; consider caloric value in patients with diabetes mellitus.b


Use of Fixed Combinations

When senna is used in fixed combination with docusate sodium, consider the cautions, precautions, and contraindications associated with docusate sodium.


Specific Populations


Pregnancy

Category C.l


Lactation

May be distributed into milk.a b Unlikely to appear in sufficient amounts to affect nursing infants.a b


AAP considers senna compatible with breast-feeding.l


Pediatric Use

Safety and efficacy not established in children <2 years of age.c Avoid use of laxatives in infants and children.b


Common Adverse Effects


Abdominal discomfort, nausea, mild cramps, griping, faintness.b


Interactions for Senna


GI Drug Absorption


By increasing intestinal motility, can potentially decrease transit time of concomitantly administered oral drugs and thereby decrease their absorption.b


Specific Drugs and Laboratory Tests











Drugs and Laboratory Tests



Interaction



Phenolsulfonphthalein (PSP)



Discolors urine; possible apparent increase in urinary excretion of PSPb



Test for estrogen (Kober procedure)



Possible false-positive resultsb



Test for urinary urobilinogen



Possible false-positive resultsb


Senna Pharmacokinetics


Absorption


Bioavailability


Minimal absorption following oral administration.a


Onset


Following oral administration, laxation usually occurs within 6–12 hours; may take 24 hours.a c d e f g h i j k


Distribution


Extent


Distribution not fully characterized; may be distributed into bile, saliva, and colonic mucosa.a


Elimination


Metabolism


Absorbed drug metabolized in the liver.a


Elimination Route


Absorbed drug and its metabolites eliminated in feces via biliary excretion and/or in urine.a


Stability


Storage


Oral


Tablets and Chewable Pieces

20–25°C (may be exposed to 15–30°C);f g h i j protect from moisture.f


Solution

Tight, light-resistant container at ≤40°C.a


ActionsActions



  • Stimulant laxative; primary active cathartic principles are the stereoisomeric glucosides, sennosides A and B.a




  • Precise mechanism of action not known.b




  • Commonly thought that the stimulant laxatives induce defecation by stimulating propulsive peristaltic activity of the intestine through local irritation of the mucosa or through a more selective action on the intramural nerve plexus of intestinal smooth muscle, thus increasing motility.b




  • More recent evidence shows that stimulant laxatives alter fluid and electrolyte absorption, producing net intestinal fluid accumulation and laxation.b




  • Increases concentrations of cyclic 3′,5′-adenosine monophosphate (cAMP) in colonic mucosal cells and may alter the permeability of these cells and mediate active ion secretion, producing net fluid accumulation and laxative action.b




  • Mainly promotes evacuation of the colon.b



Advice to Patients



  • Importance of informing clinicians before use if abdominal pain, nausea, or vomiting is present or if there has been a sudden change in bowel habits that persists over a period of 2 weeks.b c d e f g h i k




  • Importance of discontinuing use and informing clinician if a bowel movement does not occur or rectal bleeding occurs after use.b c d e f g h i j k




  • Importance of not using laxative products for a period longer than 1 week unless directed by a clinician.c d f g h i j k




  • Importance of taking with a glass of water.f h i




  • Advise about risk of laxative abuse and potential serious consequences.b (See Chronic Use or Overdosage under Cautions.)




  • Importance of advising clinicians of preexisting diabetes mellitus since some preparations contain sugar (e.g., standardized senna fruit extract).b




  • Advise patients of a potential discoloration in urine.b




  • Importance of taking 2 hours before or 2 hours after taking other medications.f g h i




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses, including intestinal obstruction.b f g h i




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c d e f g h i j k




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name













Senna Leaf

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Powder*


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name




































































Senna Concentrate, Standardized

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, chewable



10 mg Sennosides



Black Draught



Lee



Evac-U-Gen



Lee



Pieces, chewable



15 mg Sennosides



Ex-Lax Chocolated



Novartis



Tablets



8.6 mg Sennosides*



Dr. Edwards’ Olive



Oakhurst



Senexon



Watson



Senna-Gen



Teva



Sennatural



G&W



Senokot



Purdue Frederick



15 mg Sennosides



Ex-Lax Regular Strength



Novartis



Perdiem



Novartis



17 mg Sennosides



SenokotXTRA



Purdue Frederick



25 mg Sennosides



Ex-Lax Maximum Strength



Novartis


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name























Senna Concentrate, Standardized Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets*



8.6 mg Sennosides with Docusate Sodium 50 mg



Peri-Colace



Purdue



Senna-S



Teva



Senokot S



Purdue Frederick


















Senna Fluidextract

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Solution



3 mg Sennosides per mL (33.3 mg Senna Concentrate per mL)



Dr. Caldwell Senna Laxative (with alcohol 4.9%)



Denison



Fletcher’s (with parabens; alcohol-free)



Mentholatum Company


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name













Senna Fruit Extract, Standardized

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Solution*



8.8 mg Sennosides per 5 mL



Senexon Liquid (with parabens)



Watson



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 01, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



a. AHFS drug information 2007. McEvoy GK, ed. Anthraquinones. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2923-4.



b. AHFS drug information 2007. McEvoy GK, ed. Cathartics and laxatives general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2919-23.



c. The Mentholatum Co., Inc. Fletcher’s laxative for kids patient information. Orchard Park, NY. Undated.



d. Denison. Dr. Caldwell senna laxative patient information. From website: . Accessed 2007 May 28.



e. Lee Pharmaceuticals, Inc. Black draught laxative tablets patient information. From website: . Accessed 2007 June 24.



f. Novartis Consumer Health, Inc. Perdiem overnight relief patient information. From website: . Accessed 2007 May 28.



h. Novartis Consumer Health, Inc. ex-lax regular strength patient information. From website: . Accessed 2007 May 28.



g. Novartis Consumer Health, Inc. ex-lax regular strength chocolate patient information. From website: . Accessed 2007 May 28.



i. Novartis Consumer Health, Inc. ex-lax maximum strength patient information. From website: . Accessed 2007 May 28.



j. Purdue Products L.P. Senokot tablets patient information. From website: . Accessed 2007 May 28.



k. Purdue Products L.P. Senokot-S tablets patient information. From website: . Accessed 2007 May 28.



l. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Phildelphia, PA: Lippincott Williams & Wilkins; 2005:1452-3.



m. Esford J (The Mentholatum Co., Inc., Orchard Park, NY): Personal communication; 2007 June 27.



n. Rugby Laboratories. Senexon Liquid patient information. Duluth, GA: 2005 Sept.



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