Sulpirid Milinda may be available in the countries listed below.
Ingredient matches for Sulpirid Milinda
Sulpiride
Sulpiride is reported as an ingredient of Sulpirid Milinda in the following countries:
- Germany
International Drug Name Search
Tuesday, October 25, 2016
Amobantes
Amobantes may be available in the countries listed below.
Ingredient matches for Amobantes
Eszopiclone
Zopiclone is reported as an ingredient of Amobantes in the following countries:
- Japan
International Drug Name Search
Eperbel-S
Generic Name: belladonna, ergotamine, and phenobarbital (bel uh DON uh, er GOT uh meen, and feen oh BAR bit al)
Brand Names: Bel-Phen-Ergot, Bellamine, Bellamor, Bellaphen-S, Bellaspas, Bellergal-S, Duragal-S, Eperbel-S, Spastrin
What is Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Belladonna is a naturally occurring mixture that produces many effects in the body. It reduces spasms within the stomach and intestines, the bladder, and the biliary (liver) system. Belladonna also reduces the secretions of many organs, which helps control conditions such as excess stomach acid.
Ergotamine narrows the blood vessels involved in circulation to the head. Ergotamine can also alter blood flow patterns involved in vascular headaches, such as migraines.
Phenobarbital is a barbiturate that reduces brain and nervous system activity.
The combination of belladonna, ergotamine, and phenobarbital is used to treat symptoms of menopause including hot flashes, sweating, increased heart rate, dizziness, restlessness, headache, anxiety, and trouble sleeping.
Belladonna, ergotamine, and phenobarbital may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Do not use this medication if you have a history of stroke or blood clots, or if you have glaucoma, heart disease, liver disease, kidney disease, porphyria, or high blood pressure. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. This medication contains phenobarbital, which may be habit-forming. You may have withdrawal symptoms when you stop using this medication after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to gradually reduce the dose. Avoid drinking alcohol, which can increase some of the side effects of belladonna, ergotamine, and phenobarbital.
Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by belladonna, ergotamine, and phenobarbital.
This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
What should I discuss with my health care provider before taking Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Do not use this medication if you have:
narrow-angle glaucoma;
heart disease;
liver disease;
kidney disease;
porphyria;
a history of circulation problems, stroke, or blood clots;
high blood pressure; or
if you are pregnant or breast-feeding.
Before using belladonna, ergotamine, and phenobarbital, tell your doctor if you have:
a stomach problem called pyloric obstruction; or
angina (chest pain).
If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.
FDA pregnancy category X. This medication can cause birth defects. Do not use belladonna, ergotamine, and phenobarbital if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. This medication can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. This medication contains phenobarbital, which may be habit-forming. You may have withdrawal symptoms when you stop using this medication after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to gradually reduce the dose.
How should I take Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.
To be sure this medication is helping your condition, your doctor may need to check your progress on a regular basis. It is important that you not miss any scheduled visits to your doctor.
Do not stop using this medication without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store this medicine at room temperature away from moisture and heat.
What happens if I miss a dose?
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 the next regularly scheduled time. 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. Symptoms of a belladonna, ergotamine, and phenobarbital overdose may include extremely dry mouth, nausea, vomiting, stomach pain, problems with vision, numbness or pain, blue fingers or toes, cold feeling, extreme drowsiness, confusion, feeling light-headed, fainting, or seizure (convulsions).
What should I avoid while taking Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Avoid drinking alcohol, which can increase some of the side effects of belladonna, ergotamine, and phenobarbital.
Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by belladonna, ergotamine, and phenobarbital.
This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Eperbel-S (belladonna, ergotamine, and phenobarbital) 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.
Other less serious side effects are more likely to occur, such as:
blurred vision;
dry mouth;
warmth or tingly feeling;
drowsiness; or
changes in behavior (in children).
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.
What other drugs will affect Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Before taking this medication, tell your doctor if you are using any of the following drugs:
a blood thinner such as warfarin (Coumadin);
birth control pills;
erythromycin (E-Mycin, Ery-Tab, Erythrocin, E.E.S.); or
troleandomycin (Tao).
If you are using any of these drugs, you may not be able to use belladonna, ergotamine, and phenobarbital, or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect belladonna, ergotamine, and phenobarbital. 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.
More Eperbel-S resources
- Eperbel-S Use in Pregnancy & Breastfeeding
- Eperbel-S Drug Interactions
- Eperbel-S Support Group
- 0 Reviews for Eperbel-S - Add your own review/rating
- Bellamine S MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Eperbel-S with other medications
- Hot Flashes
- Menopausal Disorders
- Perimenopausal Symptoms
- Postmenopausal Symptoms
Where can I get more information?
- Your pharmacist has more information about belladonna, ergotamine, and phenobarbital written for health professionals that you may read.
What does my medication look like?
Belladonna, ergotamine, and phenobarbital is available with a prescription under the brand names Bellergal, Bellamine, Bellaspas, Duragal-S, and Spastrin. Other brand or generic forms may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Monday, October 24, 2016
Cocaine Hydrochloride Topical Solution
Dosage Form: topical solution
COCAINE HYDROCHLORIDE
Topical Solution
CII
Rx only
| NOT FOR INJECTION OR OPHTHALMIC USE. |
Cocaine Hydrochloride Topical Solution Description
Each mL contains:
Cocaine hydrochloride 40 mg or 100 mg As aqueous solution.
The topical solution contains the following inactive ingredients: citric acid, D&C Yellow No. 10, FD&C Green No. 3, sodium benzoate, and water.
NOTE (for Glass Bottle): External surface of unopened bottle may be sterilized by ethylene oxide only. Do not steam autoclave.
Cocaine hydrochloride USP is a crystalline, granular, or powder substance having a saline, slightly bitter taste that numbs tongue and lips. Cocaine hydrochloride is a local anesthetic.
Cocaine Hydrochloride Topical Solution - Clinical Pharmacology
Cocaine blocks the initiation or conduction of the nerve impulse following local application, thereby effecting local anesthetic action. Cocaine is absorbed from all sites of application, including mucous membranes and the gastrointestinal mucosa. Cocaine is degraded by plasma esterses, with the half-life in the plasma being approximately one hour.
Indications and Usage for Cocaine Hydrochloride Topical Solution
Cocaine Hydrochloride Topical Solution is indicated for the introduction of local (topical) anesthesia of accessible mucous membranes of the oral, laryngeal and nasal cavities.
Contraindications
Cocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to the drug or to the components of the topical solution.
Warnings
RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHEN ANY LOCAL ANESTHETIC IS USED.
Carcinogenesis, Mutagenesis
Long-term studies to determine the carcinogenic and mutagenic potential of cocaine are not available.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Animal reproduction studies have not been conducted with cocaine. It is also not known whether cocaine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cocaine should be given to a pregnant woman only if needed.
Precautions
The safety and effectiveness of Cocaine Hydrochloride Topical Solution depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Standard textbooks should be consulted for specific techniques and precautions for various anesthetic procedures.
The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status.
Cocaine Hydrochloride Topical Solution should be used with caution in patients with severely traumatized mucosa and sepsis in the region of the proposed application. Use with caution in persons with known drug sensitivities.
Adverse Reactions
Adverse reactions may be due to high plasma levels as a result of excessive and rapid absorption of the drug. Reactions are systemic in nature and involve the central nervous system and/or the cardiovascular system. A small number of reactions may result from hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.
CNS reactions are excitatory and/or depressant, and may be characterized by nervousness, restlessness and excitement. Tremors and eventually clonic-tonic convulsions may result. Emesis may occur. Central stimulation is followed by depression, with death resulting from respiratory failure.
Small doses of cocaine slow the heart rate, but after moderate doses, the rate is increased due to central sympathetic stimulation.
Cocaine is pyrogenic, augmenting heat production in stimulating muscular activity and causing vasoconstriction which decreases heat loss. Cocaine is known to interfere with the uptake of norepinephrine by adrenergic nerve terminals, producing sensitization to catecholamines, causing vasoconstriction and mydriasis.
Cocaine causes sloughing of the corneal epithelium, causing clouding, pitting, and occasionally ulceration of the cornea. The drug is not meant for ophthalmic use.
Overdosage
The fatal dose of cocaine has been approximated at 1.2 g., although severe toxic effects have been reported from doses as low as 20 mg.
Symptoms
The symptoms of cocaine poisoning are referable to the CNS, namely the patient becomes excited, restless, garrulous, anxious and confused. Enhanced reflexes, headache, rapid pulse, irregular respiration, chills, rise in body temperature, mydriasis, exophthalmos, nausea, vomiting and abdominal pain are noticed. In severe overdoses, delirium, Cheyne-Stokes respiration, convulsions, unconsciousness, and death from respiratory arrest result. Acute poisoning by cocaine is rapid in developing.
Treatment
The specific treatment of acute cocaine poisoning is the intravenous administration of a short-acting barbiturate or diazepam. Artificial respiration may be necessary. It is important to limit absorption of the drug. If entrance of the drug into circulation can be checked, and respiratory exchange maintained, the prognosis is favorable since cocaine is eliminated fairly rapidly.
Cocaine Hydrochloride Topical Solution Dosage and Administration
The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Cocaine Hydrochloride Topical Solution can be administered by means of cotton applicators or packs, instilled into a cavity, or as a spray.
How is Cocaine Hydrochloride Topical Solution Supplied
4% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.
NDC 0527-1728-74: Unit-of-Use Glass Bottle filled to contain 4 mL, one 4 mL bottle per carton.
NDC 0527-1728-73: Multi-Dose Bottle of 10 mL.
10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.
NDC 0527-1729-74: Unit-of-Use Glass Bottle filled to contain 4 mL, one 4 mL bottle per carton.
NDC 0527-1729-73: Multi-Dose Bottle of 10 mL.
DEA Order Form Required.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Avoid freezing.
Keep out of reach of children.
Rev. 03/08
Manufactured
By
Cody Laboratories, Inc.
Cody, WY 82414
For
Lannett Company, Inc.
Philadelphia, PA 19136
PRINCIPAL DISPLAY PANEL - 4 mL/4% label
NDC 0527-1728-74
Unit of Use 4 mL
LANNETT
Dispense with confidence
Rx Only
4%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains Cocaine HCl 40 mg
NOT FOR INJECTION
OR OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 4 mL/4% box
NDC 0527-1728-74
LANNETT
Dispense with Confidence
Unit-of Use
4 mL
4%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains:
Cocaine Hydrochloride
40 mg
Rx Only
NOT FOR
INJECTION OR
OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 10 mL/4% label
NDC 0527-1728-73
Multi-Dose 10 mL
LANNETT
Dispense with confidence
Rx Only
4%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains Cocaine HCl 40 mg
NOT FOR INJECTION
OR OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 10 mL/4% box
NDC 0527-1728-73
LANNETT
Dispense with Confidence
Multi-Dose
10 mL
4%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains:
Cocaine Hydrochloride
40 mg
Rx Only
NOT FOR
INJECTION OR
OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 4 mL/10% label
NDC 0527-1729-74
Unit of Use 4 mL
LANNETT
Dispense with confidence
Rx Only
10%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains Cocaine HCl 100 mg
NOT FOR INJECTION
OR OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 4 mL/10% box
NDC 0527-1729-74
LANNETT
Dispense with Confidence
Unit-of Use
4 mL
10%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains:
Cocaine Hydrochloride
100 mg
Rx Only
NOT FOR
INJECTION OR
OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 10 mL/10% label
NDC 0527-1729-73
Multi-Dose 10 mL
LANNETT
Dispense with confidence
Rx Only
10%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains Cocaine HCl 100 mg
NOT FOR INJECTION
OR OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 10 mL/10% box
NDC 0527-1729-73
LANNETT
Dispense with Confidence
Multi-Dose
10 mL
10%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains:
Cocaine Hydrochloride
100 mg
Rx Only
NOT FOR
INJECTION OR
OPHTHALMIC USE
| COCAINE HYDROCHLORIDE cocaine hydrochloride solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved other | 12/01/2008 | ||
| COCAINE HYDROCHLORIDE cocaine hydrochloride solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved other | 12/01/2008 | ||
| Labeler - Lannett Company, Inc. (002277481) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Cody Laboratories, Inc. | 028153216 | ANALYSIS, MANUFACTURE | |
More Cocaine Hydrochloride Topical Solution resources
- Cocaine Hydrochloride Topical Solution Side Effects (in more detail)
- Cocaine Hydrochloride Topical Solution Use in Pregnancy & Breastfeeding
- Cocaine Hydrochloride Topical Solution Drug Interactions
- Cocaine Hydrochloride Topical Solution Support Group
- 0 Reviews for Cocaine Hydrochloride Topical - Add your own review/rating
Compare Cocaine Hydrochloride Topical Solution with other medications
- Local Anesthesia
Minims Fluorescein Sodium
Minims Fluorescein Sodium may be available in the countries listed below.
Ingredient matches for Minims Fluorescein Sodium
Fluorescein
Fluorescein sodium (a derivative of Fluorescein) is reported as an ingredient of Minims Fluorescein Sodium in the following countries:
- Finland
- Hong Kong
- Netherlands
- New Zealand
- Oman
- South Africa
International Drug Name Search
Eserine
Generic Name: physostigmine (Ophthalmic route)
fye-soe-STIG-meen
Commonly used brand name(s)
In the U.S.
- Eserine
- Isopto Eserine
Available Dosage Forms:
- Ointment
- Solution
Therapeutic Class: Antiglaucoma
Pharmacologic Class: Cholinesterase Inhibitor
Uses For Eserine
Physostigmine is used to treat certain types of glaucoma.
This medicine is available only with your doctor's prescription.
Before Using Eserine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Although there is no specific information comparing use of this medicine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.
Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing use of physostigmine in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Succinylcholine
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Eye disease or problems (other)—Physostigmine may make the condition worse
Proper Use of physostigmine
This section provides information on the proper use of a number of products that contain physostigmine. It may not be specific to Eserine. Please read with care.
To use the ophthalmic solution (eye drops) form of this medicine:
- Do not use if the solution becomes discolored.
- First, wash your hands. With the middle finger, apply pressure to the inside corner of the eye (and continue to apply pressure for 1 or 2 minutes after the medicine has been placed in the eye). Tilt the head back and with the index finger of the same hand, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed.
- Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
- To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.
To use the ointment form of this medicine:
- First, wash your hands. Pull the lower eyelid away from the eye to form a pouch. Squeeze a thin strip of ointment into the pouch. A 1-cm (approximately 1/3-inch) strip of ointment is usually enough unless otherwise directed by your doctor. Gently close the eyes and keep them closed for 1 or 2 minutes to allow the medicine to be absorbed.
- Immediately after using the eye ointment, wash your hands to remove any medicine that may be on them.
- To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.
Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For glaucoma:
- For ophthalmic ointment dosage form:
- Adults and children—Use in each eye one to three times a day.
- For ophthalmic solution (eye drops) dosage form:
- Adults and children—One drop in each eye up to four times a day.
- For ophthalmic ointment dosage form:
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Precautions While Using Eserine
Your doctor should check your eye pressure at regular visits.
For a short time after you apply this medicine, your vision may be blurred or there may be a change in your near or distant vision, especially at night. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well .
Eserine Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Symptoms of too much medicine being absorbed into the body
- Increased sweating
- loss of bladder control
- muscle weakness
- nausea, vomiting, diarrhea, or stomach cramps or pain
- shortness of breath, tightness in chest, or wheezing
- slow or irregular heartbeat
- unusual tiredness or weakness
- watering of mouth
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Blurred vision or change in near or distant vision
- eye pain
- Burning, redness, stinging, or other eye irritation
- headache or browache
- twitching of eyelids
- watering of eyes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
More Eserine resources
- Eserine Drug Interactions
- 0 Reviews for Eserine - Add your own review/rating
Compare Eserine with other medications
- Glaucoma
Friday, October 21, 2016
Cortomycin
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution USP is a sterile antibacterial and anti-inflammatory solution for otic use.
Each mL Contains: ACTIVES: Neomycin Sulfate equivalent to 3.5 mg neomycin base, Polymyxin B Sulfate equivalent to 10,000 polymyxin B units, Hydrocortisone 10 mg (1%). INACTIVES: Propylene Glycol, Hydrochloric Acid, Potassium Metabisulfite, Cupric Sulfate, Glycerin, Purified Water. The pH range is 2.0 to 4.5.
Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin standard per milligram, calculated on an anhydrous basis. The structural formulae are:
Polymyxin b Sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are:
Hydrocortisone, 11β, 17, 21 - trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is:
C21H30O5 Mol. Wt. 362.47
Clinical Pharmacology
Corticoids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body’s defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.
The anti-infective components in the combination are included to provide action against specific organisms susceptible to them. Neomycin sulfate and polymyxin B sulfate together are considered active against the following microorganisms: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae.
The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.
Indications and Usage
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.
Contraindications
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components. This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (for example, herpes simplex virus or varicella zoster virus).
Warnings
Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk of ototoxicity is greater with prolonged use; therefore, duration of therapy should be limited to 10 consecutive days (see PRECAUTIONS: General).
Patients being treated with eardrops containing neomycin should be under close clinical observation. Due to its acidity which may cause burning and stinging, neomycin and polymyxin B sulfates and hydrocortisone otic solution should not be used in any patients with a perforated tympanic membrane.
Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known. Discontinue this product promptly if sensitization or irritation occurs.
When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances, including neomycin. The manifestation of sensitization to neomycin is usually a low-grade reddening with swelling, dry scaling and itching; it may be manifest simply as a failure to heal. Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. These symptoms regress quickly on withdrawing the medication. Neomycin-containing applications should be avoided for the patient thereafter.
Contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Precautions
General
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.
If the infection is not improved after 1 week, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed.
Treatment should not be continued for longer than 10 days.
Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin; paromomycin; streptomycin; and possibly, gentamicin.
Information for patients
Avoid contaminating bottle tip with material from the ear, fingers or other source. This caution is necessary if the sterility of the drops is to be preserved.
If sensitization or irritation occurs, discontinue use immediately and contact your physician.
Do not use in the eyes.
Laboratory tests
Systemic effects of excessive levels of hydrocortisone may include a reduction in the number of circulating eosinophils and a decrease in urinary excretion of 17-hydroxycorticosteroids.
Carcinogenesis, mutagenesis, impairment of fertility
Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of corticosteroids.
Pregnancy
Teratogenic effects
Pregnancy Category C: Corticosteroids have been shown to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a concentration of 15% on days 10 to 13 of gestation. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers
Hydrocortisone appears in human milk following oral administration of the drug. Since systemic absorption of hydrocortisone may occur when applied topically, caution should be exercised when neomycin and polymyxin B sulfates and hydrocortisone otic solution is used by a nursing woman.
Pediatric use
The safety and effectiveness of neomycin and polymyxin B sulfates and hydrocortisone otic solution in otitis externa have been established in the pediatric age group 2 years to 16 years of age. There is inadequate data to establish safety and effectiveness in otitis externa for pediatric patients under 2 years of age 1.
- 1
Jones, RN, Milazzo J, Seidlin, M. Ofloxacin Otic Solution for Treatment of Otitis Externa in Children and Adults. Arch Otolaryngol Head Neck Surg. 1997; 123; 1193-1200.
Geriatric use
Clinical studies of neomycin and polymyxin B sulfates and hydrocortisone otic solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Adverse Reactions
Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general population. 2 In another study, the incidence was found to be approximately 1%.3
The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Stinging and burning have been reported when this product has gained access to the middle ear.
- 2
Leyden JJ. Kligman AM. Contact dermatitis to neomycin sulfate. JAMA 1979; 242: 276-1278.
- 3
Prystowsky SD, Allen AM, Smith RW, Nonomura JH, Odum RB, Akers WA. Allergic contact hypersensitivity to nickel, neomycin, ethylenediamine, and benzocaine: relationships between age, sex, history of exposure, and reactivity to standard patch tests and use tests in general population. Arch Dermatol 1979; 115:959-962.
Dosage and Administration
Therapy with this product should be limited to 10 consecutive days. The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.
For adults, four drops of the solution should be instilled into the affected ear 3 or 4 times daily. For infants and children, three drops are suggested because of the smaller capacity of the ear canal.
The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the solution. This wick should be kept moist by adding further solution every 4 hours. The wick should be replaced at least once every 24 hours.
How Supplied
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution USP is supplied in a white plastic dropper bottle in the following size:
10 mL - Prod. No. 10009
STERILE OTIC SOLUTION
Rx only
FOR USE IN THE EARS ONLY
NOT FOR USE IN THE EYES
Storage
Store between 15°-30°C (59°- 86°F).
Securely tighten cap between uses.
DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT
Manufacturer Information
Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated
Revised February 2008
9072201 (Folded)
9072101 (Flat)
Prod. No. 10009
Principle Display Panel
| Cortomycin neomycin and polymyxin b sulfates and hydrocortisone solution/ drops | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA064053 | 06/01/2004 | |
| Labeler - Major Pharmaceuticals (191427277) |
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