Urogliss may be available in the countries listed below.
Chlorhexidine dihydrochloride (a derivative of Chlorhexidine) is reported as an ingredient of Urogliss in the following countries:
Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Urogliss in the following countries:
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Caluniatin S may be available in the countries listed below.
Kallidinogenase is reported as an ingredient of Caluniatin S in the following countries:
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Generic Name: miconazole topical (my CON a zole)
Brand Names: Aloe Vesta, Aloe Vesta 2 in 1 Antifungal, Baza, Cruex Prescription Strength, Desenex Prescription Strength, Fungoid, Fungoid Kit, Micatin, Micatin Cooling Action, Micatin Foot Powder, Micatin Foot Powder Deodorant, Micatin Jock Itch, Micatin Liquid Foot, Mitrazol, Monistat Derm, Ony-Clear, Zeasorb-AF
Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin.
Miconazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections.
Miconazole topical may also be used for purposes other than those listed in this medication guide.
Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).
Do not use miconazole topical if you have had an allergic reaction to it in the past.
Wash your hands before and after using this medication.
Clean and dry the affected area. Apply the cream, lotion, spray, or powder once or twice daily as directed for 2 to 4 weeks.
If the infection does not clear up in 2 weeks (or 4 weeks for athlete's foot), or if it appears to get worse, see your doctor.
Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.
Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of miconazole topical. Do not use a double dose unless otherwise directed by your doctor.
An overdose of miconazole topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that miconazole topical has been ingested, contact an emergency room or a poison control center.
Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.
Serious side effects of miconazole topical use are not expected. Stop using miconazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of miconazole topical.
See also: Ony-Clear side effects (in more detail)
Bepreve® (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.
Instill one drop of Bepreve into the affected eye(s) twice a day (BID).
Topical ophthalmic solution containing bepotastine besilate 1.5%.
Bepreve is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see Adverse Reactions(6.2)]
To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.
Patients should be advised not to wear a contact lens if their eye is red. Bepreve should not be used to treat contact lens-related irritation.
Bepreve should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of Bepreve. The preservative in Bepreve, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Bepreve.
Bepreve is for topical ophthalmic use only.
The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.
The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2‑5% of subjects were eye irritation, headache, and nasopharyngitis.
Hypersensitivity reactions have been reported rarely [two (2) possibly related cases for an incidence of 0.00006%] during the post-marketing use of Bepreve®. Because this reaction is reported voluntarily from a population of unknown size, the actual incidence cannot be verified. The hypersensitivity reactions include itching, body rash, and swelling of lips, tongue and/or throat.
Pregnancy Category C: Teratogenicity studies have been performed in animals. Bepotastine besilate was not found to be teratogenic in rats during organogenesis and fetal development at oral doses up to 200 mg/kg/day (representing a systemic concentration approximately 3,300 times that anticipated for topical ocular use in humans), but did show some potential for causing skeletal abnormalities at 1,000 mg/kg/day. There were no teratogenic effects seen in rabbits at oral doses up to 500 mg/kg/day given during organogenesis and fetal development (>13,000 times the dose in humans on a mg/kg basis). Evidence of infertility was seen in rats given oral bepotastine besilate 1,000 mg/kg/day however, no evidence of infertility was observed in rats given 200 mg/kg/day (approximately 3,300 times the topical ocular use in humans). The concentration of radiolabeled bepotastine besilate was similar in fetal liver and maternal blood plasma following a single 3 mg/kg oral dose. The concentration in other fetal tissues was one-third to one-tenth the concentration in maternal blood plasma.
An increase in stillborns and decreased growth and development were observed in pups born from rats given oral doses of 1,000 mg/kg/day during perinatal and lactation periods. There were no observed effects in rats treated with 100 mg/kg/day.
There are no adequate and well-controlled studies of bepotastine besilate in pregnant women. Because animal reproduction studies are not always predictive of human response, Bepreve (bepotastine besilate ophthalmic solution) 1.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Following a single 3 mg/kg oral dose of radiolabeled bepotastine besilate to nursing rats 11 days after delivery, the maximum concentration of radioactivity in milk was 0.40 μg eq/mL 1 hour after administration; at 48 hours after administration the concentration was below detection limits. The milk concentration was higher than the maternal blood plasma concentration at each time of measurement.
It is not known if bepotastine besilate is excreted in human milk. Caution should be exercised when Bepreve (bepotastine besilate ophthalmic solution) 1.5% is administered to a nursing woman.
Safety and efficacy of Bepreve (bepotastine besilate ophthalmic solution) 1.5% have not been established in pediatric patients under 2 years of age. Efficacy in pediatric patients under 10 years of age was extrapolated from clinical trials conducted in pediatric patients greater than 10 years of age and from adults.
No overall difference in safety or effectiveness has been observed between elderly and younger patients.
Bepreve (bepotastine besilate ophthalmic solution) 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of Bepreve contains 15 mg bepotastine besilate.
Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is:
Bepotastine besilate is a white or pale yellowish crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. Bepreve ophthalmic solution is supplied as a sterile, aqueous 1.5% solution, with a pH of 6.8.
The osmolality of Bepreve (bepotastine besilate ophthalmic solution) 1.5% is approximately 290 mOsm/kg.
Each mL of Bepreve (bepotastine besilate ophthalmic solution) 1.5% contains:
Active: Bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine)
Preservative: benzalkonium chloride 0.005%
Inactives: monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP.
Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.
Absorption: The extent of systemic exposure to bepotastine following topical ophthalmic administration of bepotastine besilate 1% and 1.5% ophthalmic solutions was evaluated in 12 healthy adults. Following one drop of 1% or 1.5% bepotastine besilate ophthalmic solution to both eyes four time daily (QID) for seven days, bepotastine plasma concentrations peaked at approximately one to two hours post-instillation. Maximum plasma concentration for the 1% and 1.5% strengths were 5.1 ± 2.5 ng/mL and 7.3 ± 1.9 ng/mL, respectively. Plasma concentration at 24 hours post-instillation were below the quantifiable limit (2ng/mL) in 11/12 subjects in the two dose groups.
Distribution: The extent of protein binding of bepotastine is approximately 55% and independent of bepotastine concentration.
Metabolism: In vitro metabolism studies with human liver microsomes demonstrated that bepotastine is minimally metabolized by CYP450 isozymes.
In vitro studies demonstrated that bepotastine besilate does not inhibit the metabolism of various cytochrome P450 substrate via inhibition of CYP3A4, CYP2C9, and CYP2C19. The effect of bepotastine besilate on the metabolism of substrates of CYP1A2, CYP2C8, CYP2D6 was not studied. Bepotastine besilate has a low potential for drug interaction via inhibition of CYP3A4, CYP2C9, and CYP2C19.
Excretion: The main route of elimination of bepotastine besilate is urinary excretion (with approximately 75-90% excreted unchanged in urine).
Long-term dietary studies in mice and rats were conducted to evaluate the carcinogenic potential of bepotastine besilate. Bepotastine besilate did not significantly induce neoplasms in mice receiving a nominal dose of up to 200 mg/kg/day for 21 months or rats receiving a nominal dose of up to 97 mg/kg/day for 24 months. These dose levels represent systemic exposures approximating 350 and 200 times that achieved with human topical ocular use.
The no observable adverse effect levels for bepotastine besilate based on nominal dose levels in carcinogenicity tests were 18.7 to 19.9 mg/kg/day in mice and 9.6 to 9.8 mg/kg/day in rats (representing exposure margins of approximately 60 and 20 times the systemic exposure anticipated for topical use in humans).
There was no evidence of genotoxicity in the Ames test, in CHO cells (chromosome aberrations), in mouse hepatocytes (unscheduled DNA synthesis), or in the mouse micronucleus test.
When oral bepotastine was administered to male and female rats at doses up to 1,000 mg/kg/day, there was a slight reduction in fertility index and surviving fetuses. Infertility was not seen in rats given 200 mg/kg/day oral bepotastine besilate (approximately 3,300 times the systemic concentration anticipated for topical ocular use in humans).
Clinical efficacy was evaluated in 2 conjunctival allergen challenge (CAC) studies (237 patients). Bepreve (bepotastine besilate ophthalmic solution) 1.5% was more effective than its vehicle for relieving ocular itching induced by an ocular allergen challenge, both at a CAC 15 minutes post-dosing and a CAC 8 hours post dosing of Bepreve.
The safety of Bepreve was evaluated in a randomized clinical study of 861 subjects over a period of 6 weeks.
Bepreve (bepotastine besilate ophthalmic solution) 1.5% is supplied in a white low density polyethylene plastic squeeze bottle with a white controlled dropper tip and a white polypropylene cap in the following sizes:
5 mL (NDC 67425-007-50); 10 mL (NDC 67425-007-75)
STORAGE
Store at 15º – 25ºC (59º – 77ºF).
For topical ophthalmic administration only.
Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.
Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that Bepreve should not be used to treat contact lens-related irritation.
Patients should also be advised to remove contact lenses prior to instillation of Bepreve. The preservative in Bepreve, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Bepreve.
Rx Only
Manufactured for: ISTA Pharmaceuticals®, Inc.
Irvine, CA 92618
By: Bausch & Lomb Incorporated
Tampa, FL 33637
Under license from:
Senju Pharmaceutical Co., Ltd.
Osaka, Japan 541-0046
® and ™ marks owned by ISTA Pharmaceuticals, Inc.
U.S. Patents: 6,307,052; 6,780,877
©2012 ISTA Pharmaceuticals, Inc.
18.1 Container Label
Bepreve™
(bepotastine besilate ophthalmic solution) 1.5%
Sterile 10 mL NDC 67425-007-75
For topical application in the eye.
Store at 15°-25°C (59°-77°F)
Rx only
Manufactured for:
ISTA Pharmaceuticals®, Inc.
Irvine, CA 92618
By:
Bausch & Lomb Incorporated
Tampa, FL 33637
9149401
JA52109
18.2 Carton Label
NDC 67425-007-75
Bepreve™
(bepotastine besilate ophthalmic solution) 1.5%
Sterile 10 mL
Rx only
Each mL Contains:
Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine).
Preservative: benzalkonium chloride 0.005%.
Inactives: monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP.
Manufactured for:
ISTA Pharmaceuticals®, Inc.
Irvine, CA 92618
By:
Bausch & Lomb Incorporated
Tampa, FL 33637
Under license from:
Senju Pharmaceutical Co., Ltd.
Osaka, Japan 541-0046
This product is sterile when manufactured and should be dispensed in the original unopened container. Instruct patient on precautions to avoid contamination.
For topical applicationin the eye.
Usual dosage:
Instill one drop into the affected eye(s) twice a day.
See accompanying prescribing information.
Store at 15º –25ºC (59º–77ºF)
9149501
JA52109
Lot
Exp
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA022288 | 09/08/2009 | |
| Labeler - Ista Pharmaceuticals, Inc (957212350) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| ISTA PHARMACEUTICALS, INC. | 957212350 | ANALYSIS | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| BAUSCH & LOMB PHARMACEUTICALS, INC | 807927397 | MANUFACTURE | |
Chloral (hydrate de) may be available in the countries listed below.
Chloral (hydrate de) (DCF) is known as Chloral Hydrate in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
In the US, Filgrastim (filgrastim systemic) is a member of the drug class colony stimulating factors and is used to treat Aplastic Anemia, Bone Marrow Transplantation, Myelodysplastic Syndrome, Neutropenia, Neutropenia Associated with AIDS or Zidovudine, Neutropenia Associated with Chemotherapy, Peripheral Progenitor Cell Transplantation and Sepsis.
US matches:
Rec.INN
L03AA02
0121181-53-1
C845-H1339-N223-O243-S9
18798
Immunomodulator
Colony stimulating factor, granulocyte, G-CSF
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Cefazolin-Fresenius Vials may be available in the countries listed below.
Cefazolin sodium salt (a derivative of Cefazolin) is reported as an ingredient of Cefazolin-Fresenius Vials in the following countries:
International Drug Name Search
DOT Plus may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Dinitolmide is reported as an ingredient of DOT Plus in the following countries:
Ethopabate is reported as an ingredient of DOT Plus in the following countries:
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Candid-CL may be available in the countries listed below.
Clindamycin is reported as an ingredient of Candid-CL in the following countries:
Clotrimazole is reported as an ingredient of Candid-CL in the following countries:
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Barnix may be available in the countries listed below.
Barnidipine hydrochloride (a derivative of Barnidipine) is reported as an ingredient of Barnix in the following countries:
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Gabapentine-EG may be available in the countries listed below.
Gabapentin is reported as an ingredient of Gabapentine-EG in the following countries:
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Anaesthesin may be available in the countries listed below.
Benzocaine is reported as an ingredient of Anaesthesin in the following countries:
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Oxybutynin Chloride (USAN) is known as Oxybutynin in the US.
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Glossary
| USAN | United States Adopted Name |
