Beprosone may be available in the countries listed below.
Betamethasone 17α,21-dipropionate (a derivative of Betamethasone) is reported as an ingredient of Beprosone in the following countries:
International Drug Name Search
Treating mild to moderate Crohn disease and maintaining remission for up to 3 months. It may also be used for other conditions as determined by your doctor.
Budesonide Sustained-Release Capsules are a corticosteroid. It works by decreasing inflammation.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Budesonide Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Budesonide Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Budesonide Sustained-Release 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.
Use Budesonide Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Budesonide Sustained-Release 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:
Back pain; changes in menstrual cycle; dizziness; gas; headache; indigestion; nausea; nervousness; pain; respiratory tract infection; stomach pain; tiredness; tremor; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); acne; change in mood or behavior; chest pain; confusion; severe headache; sudden increase in weight; swelling of the ankles; unusual bruising; vision changes.
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.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Budesonide Sustained-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Budesonide Sustained-Release Capsules out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Budesonide Sustained-Release 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.
Generic Name: brompheniramine, dextromethorphan, and pseudoephedrine (brom fen EER a meen, dex troe me THOR fan, soo doe e FED rin)
Brand Names: Allanhist PDX Drops, Anaplex DM, Anaplex DMX, Andehist DM NR Syrup, Brom Tann, Brometane DX, Bromfed DM, Bromhist PDX, Bromhist-DM Drops, Bromophed-DX, Bromph DM, Bromplex DM, BroveX PSB DM, BroveX PSE DM, Carbofed DM Syrup, Dallergy DM, EndaCof-DM, Histacol BD Drops, Myphetane DX Cough, PBM Allergy, Pediahist DM Drops, ProHist DM, Q-Tapp DM, Resperal-DM Drops, Robitussin Allergy & Cough, Sildec DM
Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of brompheniramine, dextromethorphan, and pseudoephedrine is used to treat sneezing, runny or stuffy nose, cough, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.
Brompheniramine, dextromethorphan, and pseudoephedrine may also be used for other purposes not listed in this medication guide.
Ask a doctor or pharmacist if it is safe for you to take brompheniramine, dextromethorphan, and pseudoephedrine if you have:
diabetes;
glaucoma;
heart disease or high blood pressure;
diabetes;
a thyroid disorder;
emphysema or chronic bronchitis;
an enlarged prostate; or
problems with urination.
Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
Since cough and cold medicine is usually taken only as needed, you may not 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, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeat;
slow, shallow breathing;
confusion, hallucinations, unusual thoughts or behavior;
severe dizziness, anxiety, restless feeling, or nervousness;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
urinating less than usual or not at all.
Less serious side effects may include:
dry mouth;
nausea, stomach pain, constipation, mild loss of appetite, upset stomach;
blurred vision;
warmth, tingling, or redness under your skin;
sleep problems (insomnia);
restless or excitability (especially in children);
skin rash or itching;
dizziness, drowsiness, or headache;
problems with memory or concentration; or
ringing in your ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor if you regularly use other medicines that make you sleepy (such as sleeping pills, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by brompheniramine.
Tell your doctor about all other medications you use, especially:
a diuretic (water pill), or blood pressure medicine;
medication to treat irritable bowel syndrome;
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), darifenacin (Enablex), or tolterodine (Detrol);
aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This list is not complete and there may be other drugs that can interact with brompheniramine, dextromethorphan, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Generic Name: botulism immune globulin (BOT ue lizm im MYOON GLOB yoo lin)
Brand Names: BabyBIG
Botulism immune globulin is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection caused by botulism toxin type A and B.
Botulism immune globulin is used to treat infant botulism caused by toxin type A or B. This medication is used in children who are younger than 1 year old.
Botulism immune globulin may also be used for other purposes not listed in this medication guide.
Before your baby receives botulism immune globulin, tell your doctor if the baby has kidney disease, diabetes, a life-threatening infection, or if the baby is dehydrated, or has recently received any vaccinations.
Botulism immune globulin can be harmful to the kidneys, and these effects are increased when this medication is used together with other drugs that can harm the kidneys. Before your baby is treated with botulism immune globulin, tell your doctor if the baby is receiving chemotherapy, medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain medicines, or any IV antibiotics.
To be sure this medication is not causing harmful effects, your baby may need blood tests. Do not miss any follow-up appointments after treatment with botulism immune globulin.
If your baby has certain conditions, he or she may need a dose adjustment or special tests to safely use this medication. Before your baby receives botulism immune globulin, tell your doctor if the baby has:
diabetes;
a life-threatening infection;
if the baby is dehydrated; or
if the baby has recently received any vaccinations.
To best participate in the care of your baby while he or she is being treated with botulism immune globulin, carefully follow all instructions provided by your baby's caregivers.
Botulism immune globulin is given as an injection through a needle placed into a vein. Your baby will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take over an hour to complete.
To be sure this medication is not causing harmful effects, your baby may need blood tests.
Since botulism immune globulin is usually given as a single IV infusion, your baby is not likely be on a daily dosing schedule.
Since botulism immune globulin is given in a controlled medical setting by a healthcare professional, an overdose is not likely to occur.
If your baby was recently vaccinated before treatment with botulism immune globulin, he or she may need to be vaccinated again to be fully protected. Follow your doctor's instructions.
trouble breathing, blue lips, pale skin;
urinating less than usual, fewer wet diapers than usual;
fever with headache, neck stiffness, sleepiness, sensitivity to light, vomiting;
trouble swallowing, noisy breathing, slow breathing;
vomiting, diarrhea, more wet diapers than usual; or
feeding problems, white patches in the mouth.
Less serious side effects may include:
mild skin rash or redness on the baby's face, chest, back, or stomach;
fussiness, excessive crying; or
stuffy nose, cough, chills.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Pediatric Dose for Botulism:
Less than one year of age with infant botulism caused by toxin type A or B:
2 mL/kg (100 mg/kg), given as a single intravenous infusion as soon as the clinical diagnosis of infant botulism is made. Add 2 mL sterile water for injection to the 100 mg vial, resulting in 50 mg/mL solution. Infusion should begin within 2 hours after reconstitution is complete and should be concluded within 4 hours of reconstitution. The infusion should begin slowly. Administration should start at 0.5 mL per kg body weight per hr (25 mg/kg/hr). If no untoward reactions occur after 15 minutes, the rate may be increased to the maximum infusion rate of 1 mL/kg/hr (50 mg/kg/hr). At the recommended rates, infusion of the indicated dose should take 127.5 minutes total elapsed time.
Botulism immune globulin can be harmful to the kidneys, and these effects are increased when this medication is used together with other drugs that can harm the kidneys. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.
Before your baby is treated with botulism immune globulin, tell your doctor about all other medications your baby is receiving, especially:
chemotherapy;
medicines to treat a bowel disorder;
medication to prevent organ transplant rejection;
antiviral medications;
pain or arthritis medicines, including aspirin or ibuprofen (Advil, Motrin); or
any IV antibiotics.
This list is not complete and there may be other drugs that can interact with botulism immune globulin. 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.
In some countries, this medicine may only be approved for veterinary use.
Oxytocin is reported as an ingredient of Vetocin in the following countries:
International Drug Name Search
Treating chronic hepatitis C virus (HCV) infection in certain patients. It must be used in combination with peginterferon and ribavirin.
Boceprevir is a hepatitis C protease inhibitor. It reduces the amount of HCV in the body by preventing the spread of the HCV within the body.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Boceprevir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Boceprevir. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Boceprevir 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.
Use Boceprevir as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Boceprevir.
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:
Change in taste; decreased appetite; diarrhea; dizziness; dry mouth; dry skin; hair loss; headache; irritability; joint pain; nausea; tiredness; trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark, tarry, or bloody stools; fainting; fast or irregular heartbeat; feeling cold, especially in the hands or feet; fever, chills, or sore throat; pale skin; severe or persistent dizziness; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness.
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: Boceprevir side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Boceprevir in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Boceprevir may also be stored at room temperature up to 77 degrees F (25 degrees C) for 3 months. Keep Boceprevir in the original container. Avoid exposure to excessive heat. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Boceprevir out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Boceprevir. 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.
Celestone is a brand name of betamethasone, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Celestone available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Celestone. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Celestone.
Topical Gel: clindamycin (1%) as clindamycin phosphate, benzoyl peroxide (5%)
For Dermatological Use Only - Not for Ophthalmic Use
*SAMPLE. NO RECONSTITUTION NECESSARY*
BenzaClin® Topical Gel contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.
Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below:
Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7 - chloro - 6,7,8 - trideoxy - 6 - (1 - methyl - trans - 4 - propyl - L - 2 - pyrrolidinecarboxamido) - 1 - thio - L - threo - alpha - D - galacto - octopyranoside 2-(dihydrogen phosphate).
BenzaClin Topical Gel also contains benzoyl peroxide, for topical use.
Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula:
Benzoyl peroxide has a molecular weight of 242.23.
Each gram of BenzaClin Topical Gel contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water.
An in vitro percutaneous penetration study comparing BenzaClin Topical Gel and topical 1% clindamycin gel alone, demonstrated there was no statistical difference in penetration between the two drugs. Mean systemic bioavailability of topical clindamycin in BenzaClin Topical Gel is suggested to be less than 1%.
Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Less than 2% of the dose enters systemic circulation as benzoic acid. It is suggested that the lipophilic nature of benzoyl peroxide acts to concentrate the compound into the lipid-rich sebaceous follicle.
The pharmacokinetics (plasma and urine) of clindamycin from BenzaClin Topical Gel was studied in male and female patients (n=13) with acne vulgaris. BenzaClin Topical Gel (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Quantifiable (>LOQ=1ng/mL) clindamycin plasma concentrations were obtained in six of thirteen subjects (46.2%) on Day 1 and twelve of thirteen subjects (92.3%) on Day 5. Peak plasma concentrations (Cmax) of clindamycin ranged from 1.47 ng/mL to 2.77 ng/mL on Day 1 and 1.43 ng/mL to 7.18 ng/mL on Day 5. The AUC (0-12h) ranged from 2.74 ng.h/mL to 12.86 ng.h/mL on Day 1 and 11.4 ng.h/mL to 69.7 ng.h/mL on Day 5.
The amount of clindamycin excreted in the urine during the 12 hour dosing interval increased from a mean (SD) of 5745 (3130) ng on Day 1 to 12069 (7660) ng on Day 5. The mean % (SD) of the administered dose that was excreted in the urine ranged from 0.03% (0.02) to 0.08% (0.04).
A comparison of the single (Day 1) and multiple (Day 5) dose plasma and urinary concentrations of clindamycin indicates that there is accumulation of clindamycin following multiple dosing of BenzaClin Topical Gel. The degree of accumulation calculated from the plasma and urinary excretion data was ~2-fold.
The clindamycin and benzoyl peroxide components individually have been shown to have in vitro activity against Propionibacterium acnes an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical trials with this product.
In two adequate and well controlled clinical studies of 758 patients, 214 used BenzaClin, 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. BenzaClin applied twice daily for 10 weeks was significantly more effective than vehicle in the treatment of moderate to moderately severe facial acne vulgaris. Patients were evaluated and acne lesions counted at each clinical visit; weeks 2, 4, 6, 8 and 10. The primary efficacy measures were the lesion counts and the investigator's global assessment evaluated at week 10. Patients were instructed to wash the face with a mild soap, using only the hands. Fifteen minutes after the face was thoroughly dry, application was made to the entire face. Non-medicated make-up could be applied at one hour after the BenzaClin application. If a moisturizer was required, the patients were provided a moisturizer to be used as needed. Patients were instructed to avoid sun exposure. Percent reductions in lesion counts after treatment for 10 weeks in these two studies are shown below:
| BenzaClin | Benzoyl peroxide | Clindamycin | Vehicle |
|---|---|---|---|
| n=120 | n=120 | n=120 | n=120 |
| Mean percent reduction in inflammatory lesion counts | |||
| 46% | 32% | 16% | + 3% |
| Mean percent reduction in non-inflammatory lesion counts | |||
| 22% | 22% | 9% | +1% |
| Mean percent reduction in total lesion counts | |||
| 36% | 28% | 15% | 0.2% |
| BenzaClin | Benzoyl peroxide | Clindamycin | Vehicle |
|---|---|---|---|
| n=95 | n=95 | n=49 | n=48 |
| Mean percent reduction in inflammatory lesion counts | |||
| 63% | 53% | 45% | 42% |
| Mean percent reduction in non-inflammatory lesion counts | |||
| 54% | 50% | 39% | 36% |
| Mean percent reduction in total lesion counts | |||
| 58% | 52% | 42% | 39% |
The BenzaClin group showed greater overall improvement than the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator.
BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris.
BenzaClin Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTS IN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA, BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUS COLITIS) HAVE BEEN REPORTED WITH THE USE OF TOPICAL AND SYSTEMIC CLINDAMYCIN. STUDIES INDICATE A TOXIN(S) PRODUCED BY CLOSTRIDIA IS ONE PRIMARY CAUSE OF ANTIBIOTIC-ASSOCIATED COLITIS. THE COLITIS IS USUALLY CHARACTERIZED BY SEVERE PERSISTENT DIARRHEA AND SEVERE ABDOMINAL CRAMPS AND MAY BE ASSOCIATED WITH THE PASSAGE OF BLOOD AND MUCUS. ENDOSCOPIC EXAMINATION MAY REVEAL PSEUDOMEMBRANOUS COLITIS. STOOL CULTURE FOR Clostridium Difficile AND STOOL ASSAY FOR C. difficile TOXIN MAY BE HELPFUL DIAGNOSTICALLY. WHEN SIGNIFICANT DIARRHEA OCCURS, THE DRUG SHOULD BE DISCONTINUED. LARGE BOWEL ENDOSCOPY SHOULD BE CONSIDERED TO ESTABLISH A DEFINITIVE DIAGNOSIS IN CASES OF SEVERE DIARRHEA. ANTIPERISTALTIC AGENTS SUCH AS OPIATES AND DIPHENOXYLATE WITH ATROPINE MAY PROLONG AND/OR WORSEN THE CONDITION. DIARRHEA, COLITIS, AND PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITH CLINDAMYCIN.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
For dermatological use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.
The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi. If this occurs, discontinue use of this medication and take appropriate measures.
Avoid contact with eyes and mucous membranes.
Clindamycin and erythromycin containing products should not be used in combination. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.
Patients using BenzaClin Topical Gel should receive the following information and instructions:
Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. The clinical significance of this is unknown.
Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced skin tumors in transgenic Tg.AC mice in a study using 20 weeks of topical treatment.
In a 52 week dermal photocarcinogenicity study in hairless mice, the median time to onset of skin tumor formation was decreased and the number of tumors per mouse increased following chronic concurrent topical administration of BenzaClin Topical Gel with exposure to ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation).
In a 2-year dermal carcinogenicity study in rats, treatment with BenzaClin Topical Gel at doses of 100, 500 and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats. The incidence of keratoacanthoma at the treated site of males treated with 2000 mg/kg/day (8 times the highest recommended adult human dose of 2.5 g BenzaClin Topical Gel, based on mg/m2) was statistically significantly higher than that in the sham- and vehicle-controls.
Genotoxicity studies were not conducted with BenzaClin Topical Gel. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test. Clindamycin phosphate sulfoxide, an oxidative degradation product of clindamycin phosphate and benzoyl peroxide, was not clastogenic in a mouse micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Studies have not been performed with BenzaClin Topical Gel or benzoyl peroxide to evaluate the effect on fertility. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g BenzaClin Topical Gel, based on mg/m2) revealed no effects on fertility or mating ability.
Animal reproductive/developmental toxicity studies have not been conducted with BenzaClin Topical Gel or benzoyl peroxide. Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity.
There are no well-controlled trials in pregnant women treated with BenzaClin Topical Gel. It also is not known whether BenzaClin Topical Gel can cause fetal harm when administered to a pregnant woman.
It is not known whether BenzaClin Topical Gel is excreted in human milk after topical application. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.
During clinical trials, the most frequently reported adverse event in the BenzaClin treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the BenzaClin and vehicle groups.
| BenzaClin | Vehicle | |
|---|---|---|
| n = 420 | n = 168 | |
| Application site reaction | 13 (3%) | 1 (<1%) |
| Dry skin | 50 (12%) | 10 (6%) |
| Pruritus | 8 (2%) | 1 (<1%) |
| Peeling | 9 (2%) | - |
| Erythema | 6 (1%) | 1 (<1%) |
| Sunburn | 5 (1%) | - |
The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.
Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
BenzaClin Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.
BenzaClin Topical Gel is supplied in 6 gram plastic jars.
Store at room temperature 25°C (77°F).
Do not freeze. Refrigeration is not required. Keep tightly closed. Keep out of the reach of children.
Prescribing Information as of June 2010.
Dermik Laboratories
a business of sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
©2010 sanofi-aventis U.S. LLC
PRINCIPAL DISPLAY PANEL - 6 g Jar Label
0066-0494-06
Rx ONLY 50095578
50084131C
BenzaClin®
(Clindamycin and Benzoyl Peroxide) gel 1%/5%
FOR TOPICAL USE ONLY
No Reconstitution Necessary
PHYSICIAN SAMPLE—NOT TO BE SOLD
ONE 6g Jar
Peel Here
| BenzaClin clindamycin phosphate and benzoyl peroxide gel | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA050756 | 06/01/2009 | |
| Labeler - Dermik Laboratories (824676584) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sanofi-Aventis Canada Inc. | 251046934 | MANUFACTURE, ANALYSIS, LABEL, PACK | |
Dual Lax Extra Strong Coated Tablets
Lanes Modern Herbals Laxative Coated Tablets
Boots Alternatives Laxative Coated Tablets
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Excipients: Sucrose (92mg/tablet), sodium propyl parahydroxybenzoate E217 and sodium methyl parahydroxybenzoate E219.
For a full list of excipients, see section 6.1.
Coated tablet.
Brown circular biconvex sugar coated tablet.
For the relief of temporary constipation.
For oral use.
Adults and children aged 12 and over: Swallow 1 or 2 tablets with water at night.
Not recommended for children under 12 years old.
Children under 12 years old.
Hypersensitivity to the active substances or to any of the excipients.
Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory colon diseases (e.g. Crohn's disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration state with water and electrolyte depletion.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This product contains sodium propyl parahydroxybenzoate (E217) and sodium methyl parahydroxybenzoate (E219) and should not be used by patients who are allergic to these ingredients.
Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, corticosteroids or liquorice root, have to consult a doctor before taking senna leaves or cascara concomitantly.
Like all laxatives, senna leaves should not be taken by patients suffering from faecal impaction and undiagnosed, acute or persistent gastro-intestinal complaints, e.g. abdominal pain, nausea and vomiting, unless advised by a doctor, because these symptoms can be signs of potential or existing intestinal blockage (ileus).
If laxatives are needed every day the cause of the constipation should be investigated. Long-term use of laxatives should be avoided.
If stimulant laxatives are taken for longer than a brief period of treatment, this may lead to impaired function of the intestine and dependence on laxatives. Senna leaf or cascara preparations should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents.
When senna leaf or cascara preparations are administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces.
Patients with kidney disorders should be aware of possible electrolyte imbalance.
If symptoms worsen or do not improve after 7 days, contact a doctor.
Hypokalaemia (resulting from long-term laxative abuse) potentiates the action of cardiac glycosides and interacts with antiarrhythmic medicinal products, with medicinal products, which induce reversion to sinus rhythm (e.g. quinidine) and with medicinal products inducing QT-prolongation. Concomitant use with other medicinal products inducing hypokalaemia (e.g. diuretics, corticosteroids and liquorice root) may enhance electrolyte imbalance.
Pregnancy
There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage.
However, as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g. aloe-emodin, emodin, frangulin, chrysophanol and physcion, use is not recommended during pregnancy.
Lactation
Use during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk.
After administration of other anthranoids, active metabolites, such as rhein, are excreted in breast milk in small amounts. A laxative effect in breast fed babies has not been reported.
This product has no influence on the ability to drive and use machines.
Hypersensitivity reactions (pruritus, urticaria, local or generalised exanthema) may occur.
Senna leaves and cascara may produce abdominal pain and spasm and passage of liquid stools, in particular in patients with irritable colon. However, these symptoms may also occur generally as a consequence of individual overdose. In such cases dose reduction is necessary.
Chronic use may lead to disorders in water equilibrium and electrolyte metabolism and may result in albuminuria and haematuria.
Furthermore, chronic use may cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually recedes when the patient stops taking the preparation.
Red-brown (pH dependent) discolouration of urine by metabolites, which is not clinically significant, may occur during the treatment.
If other adverse reactions not mentioned above occur, a doctor or a pharmacist should be consulted.
The major symptoms of overdose/abuse are griping pain and severe diarrhoea with consequent losses of fluid and electrolytes, which should be replaced. Diarrhoea may especially cause potassium depletion, which may lead to cardiac disorders and muscular asthenia, particularly where cardiac glycosides, diuretics, corticosteroids or liquorice root are being taken at the same time.
Treatment should be supportive with generous amounts of fluid. Electrolytes, especially potassium, should be monitored. This is especially important in the elderly.
Chronic ingested overdoses of anthranoid containing medicinal products may lead to toxic hepatitis.
Pharmaco-therapeutic group: contact laxatives
ATC-code: A 06 AB
1,8-dihydroxyanthracene derivatives possess a laxative effect. The β-Ο-linked glycosides (sennosides) are not absorbed in the upper gut; they are converted by bacteria of the large intestine into the active metabolite (rhein anthrone).
Cascarosides A and B are mixed anthrone-C- and O-glycosides, Cascarosides C, D, E and F are 8-O-β-D-glucosides, which are largely not split by human digestive enzymes in the upper gut and therefore not absorbed to a large extent. They are converted by the bacteria of the large intestine into the active metabolites (mainly emodin-9-anthrone).
There are two different mechanisms of action:
1. stimulation of the motility of the large intestine resulting in accelerated colonic transit.
2. influence on secretion processes by two concomitant mechanisms viz. inhibition of absorption of water and electrolytes (Na+, Cl-) into the colonic epithelial cells (antiabsorptive effect) and increase of the leakiness of the tight junctions and stimulation of secretion of water and electrolytes into the lumen of the colon (secretagogue effect) resulting in enhanced concentrations of fluid and electrolytes in the lumen of the colon.
Defaecation takes place after a delay of 6 - 12 hours due to the time taken for transport to the colon and metabolisation into the active compound
The β-Ο-linked glycosides (sennosides) are neither absorbed in the upper gut nor split by human digestive enzymes. They are converted by the bacteria of the large intestine into the active metabolite (rhein anthrone). Aglyca are absorbed in the upper gut. Animal experiments with radio-labeled rhein anthrone administered directly into the caecum demonstrated absorption < 10%. In contact with oxygen, rhein anthrone is oxidised into rhein and sennidins, which can be found in the blood, mainly in the form of glucuronides and sulphates. After oral administration of sennosides, 3 - 6% of the metabolites are excreted in urine; some are excreted in bile
Most of the sennosides (ca. 90%) are excreted in faeces as polymers (polyquinones) together with 2 - 6% of unchanged sennosides, sennidins, rhein anthrone and rhein. In human pharmacokinetic studies with senna pods powder (20 mg sennosides), administered orally for 7 days, a maximum concentration of 100 ng rhein/ml was found in the blood. An accumulation of rhein was not observed. Active metabolites, e.g. rhein, pass in small amounts into breast milk. Animal experiments demonstrated that placental passage of rhein is low
The β-0-linked glycosides (cascarosides) are not split by human digestive enzymes and therefore not absorbed in the upper gut to a large extent. They are converted by the bacteria of the large intestine into the active metabolite (mainly emodin-9-anthrone). The absorbed anthraquinone aglycones are transformed into their corresponding glucuronides and sulphate derivatives.
It is not known to what extent aloe-emodin-9-anthrone is absorbed. However, in the case of senna, animal experiments with radio-labeled rhein-anthrone administered directly into the caecum show that only a very small proportion (less than 10%) of rhein-anthrone is absorbed.
After administration of other anthranoids, active metabolites, such as rhein, pass in small amounts into breast milk. Animal experiments demonstrated that placental-passage of rhein is low.
Senna
There are no new, systematic preclinical tests for senna leaves or preparations thereof. Data derive from investigations with senna pods. Since the spectrum of constituents of senna leaf and fruit is comparable these data can be transferred to senna leaves. Most data refer to extracts of senna pods containing 1.4 to 3.5% of anthranoids, corresponding to 0.9 to 2.3% of potential rhein, 0.05 to 0.15% of potential aloe-emodin and 0.001 to 0.006% of potential emodin or isolated active constituents, e.g. rhein or sennosides A and B. The acute toxicity of senna pods, specified extracts thereof, as well as of sennosides in rats and mice was low after oral treatment.
As a result of investigations with parenteral application in mice, extracts are supposed to possess a higher toxicity than purified glycosides, possibly due to the content of aglyca.
In a 90-day rat study, senna pods were administered at dose levels from 100 mg/kg up to 1,500 mg/kg. The tested drug contained 1.83 % sennosides A-D, 1.6 % potential rhein, 0.11 % potential aloe-emodin and 0.014 % potential emodin. In all groups epithelial hyperplasia of the large intestine of minor degree was found and was reversible within the 8-week recovery period. The hyperplastic lesions of the forestomach epithelium were reversible as well. Dose-dependent tubular basophilia and epithelial hypertrophy of the kidneys were seen at a dose of, or greater than 300 mg/kg per day without functional affection. These changes were also reversible. Storage of a brown tubular pigment led to a dark discoloration of the renal surface and still remained to a lesser degree after the recovery period. No alterations were seen in the colonic nervous plexus. A no-observable-effect-level (NOEL) could not be obtained in this study.
A 104-week study on rats of both genders did not reveal any carcinogenic effects with the same senna pods preparation at oral dosages of up to 300 mg/kg.
In addition a specified senna extract given orally for 2 years was not carcinogenic in male or female rats. The extract investigated contained approximately 40.8% of anthranoids from which 35% were sennosides, corresponding to about 25.2% of potential rhein, 2.3% of potential aloe-emodin and 0.007% of potential emodin and 142 ppm free aloe-emodin and 9 ppm free emodin.
Further 2-year studies on male and female rats and mice with emodin gave no evidence of carcinogenic activity for male rats and female mice, and equivocal evidence for female rats and male mice.
Sennosides displayed no specific toxicity when tested at doses up to 500 mg/kg in dogs for 4 weeks and up to 100 mg/kg in rats for 6 months.
There was no evidence of any embryolethal, teratogenic or foetotoxic actions in rats or rabbits after oral treatment with sennosides. Furthermore, there was no effect on the postnatal development of young rats, on rearing behaviour of dams or on male and female fertility in rats. Data for herbal preparations are not available.
An extract and aloe-emodin were mutagenic in in vitro tests, sennoside A, B and rhein gave negative results. Comprehensive in vivo examinations of a defined extract of senna pods were negative.
Laxative use as a risk factor in colorectal cancer (CRC) was investigated in some clinical trials. Some studies revealed a risk for CRC associated with the use of anthraquinone-containing laxatives, some studies did not. However, a risk was also revealed for constipation itself and underlying dietary habits. Further investigations are needed to assess the carcinogenic risk definitely
Cascara
There are no recent studies on single dose toxicity, on repeated dose toxicity, or on reproductive toxicity.
Experimental data, mainly in vitro tests showed a genotoxic risk of several anthranoids in the Salmonella/ microsome assay, aloe-emodin, emodin, chrysophanol and physcion were weakly mutagenic. No mutagenic effects were observed in the V79-HGPRT mutation assay and in the unscheduled DNA synthesis (UDS) assay for chrysophanol and physcion. Emodin was highly mutagenic in the V79-HGPRT mutation assay. In the UDS assay emodin was a string inducer of UDS in primary hepatocytes. Aloe-emodin showed a significant increase in net grains/nucleus. Emodin was also tested with respect to its transforming activity in C3H/M2 mouse fibroblasts in vitro. In the in vitro Salmonella/microsome mutagen test and the deoxyribonucleic acid (DNA) repair test of primary rat hepatocytes emodin and frangulin showed a dose-dependent increase in the mutation rate or the induction of DNA repair.
However, in vivo studies of other anthranoid-containing herbal substance (senna) in rat hepatocytes (chromosome aberration test, mouse spot test, in vivo/in vitro UDS (unscheduled DNA synthesis) showed no evidence of any genetic effects.
In in vivo studies (micronucleus assay in bone marrow cells of NMRI mice; chromosome aberration assay in bone marrow cells of Wistar rats; mouse spot test [DBA/2J x NMRI]) no indication of a mutagenic activity of aloe emodin was found.
Further 2-year studies on male and female rats and mice with emodin gave no evidence of carcinogenic activity for male rats and female mice, and equivocal evidence for female rats and male mice.
Dietary exposure of rats to high doses of the anthraquinone glycosides of cascara for 56 successive days did not cause appearance of aberrant crypti foci (ACF) or increase of incidence of ACF induced by 1,2-dimethyl-hydrazine (DMH). However, in rats treated with both DMH and the highest dose of glycosides, the average number of aberrant crypts per focus, considered a consistent predictor of tumour outcome, was higher than in rats given DMH alone.
Rats were treated with azoyxmethane (AOM) and 140 and 420 mg/kg cascara (alone or in combination) for 13 weeks. Cascara did not induce the development of colonic aberrant crypti foci (ACF) and tumours and did not modify the number of AOM-induced ACF and tumours in both doses.
Laxative use as a risk factor in colorectal cancer (CRC) was investigated in some clinical trials. Some studies revealed a risk for CRC associated with the use of anthraquinone-containing laxatives, some studies did not. However, a risk was also revealed for constipation itself and underlying dietary habits. Further investigations are needed to assess the carcinogenic risk definitely.
Core:
Calcium Phosphate E341
Magnesium Stearate E572
Maize Starch, Pregelatinised
Silicon Dioxide E551
Sodium Starch Glycolate
Stearic Acid E570
Coating:
Acacia, Spray-Dried E414
Calcium Carbonate E170
Carnauba Wax E903
Mastercote Brown SP0830 (containing Red and Black Iron Oxide E172, hydrochloric acid E507, sodium propyl parahydroxybenzoate (E217) and sodium methyl parahydroxybenzoate (E219))
Opaseal (Polyvinyl Acetate Phthalate, Ethyl Acetate, Stearic Acid)
Talc E553b
Sucrose
Titanium Dioxide E171
Yellow Beeswax E901
Not applicable.
3 years (bottles)
2 years (blisters)
Keep out of the reach and sight of children.
Do not store above 25ºC.
14 tablets and 60 tablets packaged into PVDC-aluminium/polyethylene laminate blister packs.
100 tablets are packaged into amber glass bottles (USP type III glass) fitted with white HDPE tamper evident caps.
Not all pack sizes may be marketed.
No special requirements.
G. R. Lane Health Products Limited
Sisson Road
Gloucester
GL2 0GR
United Kingdom
Tel: +44 (0)1452 524012
Fax: +44 (0)1452 507930
Email: info@laneshealth.com
PL 1074/5015R
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November 2008.
