Prodasone may be available in the countries listed below.
Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Prodasone in the following countries:
International Drug Name Search
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP is a sterile antimicrobial and anti-inflammatory ointment for ophthalmic use.
Each Gram Contains: ACTIVES: Neomycin sulfate (equivalent to 3.5 mg neomycin base), Polymyxin B Sulfate equivalent to 10,000 polymyxin B units, Bacitracin Zinc equivalent to 400 bacitracin units, Hydrocortisone 10 mg (1%); INACTIVES: White Petrolatum, Mineral Oil.
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 mcg of neomycin standard per mg, 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 mg, calculated on an anhydrous basis.
The structural formulae are:
Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg.
The structural formula is:
Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone.
Its structural formula is:
Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body’s defense mechanism against infection, concomitant antimicrobial drugs may be used when this inhibition is considered to be clinically significant in a particular case.
When a decision to administer both a corticosteroid and antimicrobials is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of all drugs is administered. When each type of drug is in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.
The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.
The anti-infective components in neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment are included to provide action against specific organisms susceptible to it. Neomycin sulfate and polymyxin B sulfate are active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against Serratia marcescens (see INDICATIONS AND USAGE).
Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see CLINICAL PHARMACOLOGY: Microbiology).
The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.
Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
This product is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.
NOT FOR INJECTION INTO THE EYE. Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing. Prolonged use of corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.
Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.
If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma.
The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs.
Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.
Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).
The initial prescription and renewal of the medication order beyond 8 grams should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.
The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.
If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS).
There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).
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.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.
Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).
If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.
Keep tightly closed when not in use. Keep out of the reach of children.
Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg /mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.
Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity attributable to oral administration of corticosteroids. Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids. Studies to determine mutagenicity with hydrocortisone have revealed negative results.
Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet. Long-term animal studies have not been performed to evaluate the effect on fertility of topical corticosteroids.
Pregnancy Category C. Corticosteroids have been found 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. Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment, 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 in pediatric patients have not been established.
Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. The exact incidence is not known.
Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.
The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
The development of secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.
Local irritation on instillation has also been reported.
Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.
Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS: above.
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP is supplied in a tube with ophthalmic tip applicator in the following size:
3.5 g - Prod. No. 03934.
DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.
FOR OPHTHALMIC USE ONLY
Store between 15° - 30°C (59°- 86°F).
KEEP OUT OF REACH OF CHILDREN.
Rx only
Revised November 2007
Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated
9113800 (Folded)
9113900 (Flat)
NDC 0904-2995-38
Cortomycin Ophthalmic Ointment
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment USP (Sterile)
Net wt. 3.5 gram
Rx only
FOR OPHTHALMIC USE ONLY.
| CORTOMYCIN neomycin sulfate and polymyxin b sulfate, bacitracin zinc and hydrocortisone ointment | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA064068 | 10/30/1995 | |
| Labeler - Major Pharmaceuticals (191427277) |
| Registrant - Bausch & Lomb Incorporated (196603781) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bausch & Lomb Incorporated | 807927397 | MANUFACTURE | |
Generic Name: sodium chloride (Ophthalmic route)
SOE-dee-um KLOR-ide
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Osmotherapy Agent
Hypertonic sodium chloride solution for the eye is used to draw water out of a swollen cornea. The extra water in the cornea can cause your vision to be poor. You may also see halos or rings around point light sources. The cornea is the clear cover over the colored part of your eye.
This medicine is available only with your doctor's prescription.
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:
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.
Although there is no specific information comparing use of hypertonic sodium chloride in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.
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. There is no specific information comparing use of hypertonic sodium chloride in the elderly with use in other age groups.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
This section provides information on the proper use of a number of products that contain sodium chloride. It may not be specific to AK-NaCl. Please read with care.
To use:
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.
If you miss a dose of this medicine, take 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. Do not double doses.
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Use only under the advice and supervision of a doctor.
If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if your symptoms continue for more than 3 days or become worse, check with your doctor.
Importance of not contaminating the product. Do not touch the tip of the container to the eye or any surface.
Do not use if the solution changes color or becomes cloudy.
Replace cap after each use. Store container upright.
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:
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.
Codeine Linctus BP
Codeine Phosphate BP 15mg/5ml dose.
Linctus.
Codeine is indicated in adults for relief of the symptoms of dry or irritating coughs.
Oral.
Recommended doses
Adults: one 5ml spoonful
The elderly: Use with caution, not exceeding the recommended adult dose.
Paediatric population
Codeine should not be used for the treatment of children under the age of 18 years.
Dosage schedule
The dose may be repeated after four hours if required, but not more than 4 doses in any 24 hours.
Contraindicated:
In cases of liver disease and respiratory depression.
In patients with raised intracranial pressure or head injury.
During an acute asthmatic attack
Hypersensitivity to codeine or to any of the other ingredients.
Concurrent use of monoamine oxidase inhibitors or within 2 weeks discontinuation of their use.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Use with caution in patients with large bowel disease, renal impairment or a history of asthma. Prolonged use could aggravate irritable bowel syndrome.
Use with caution in the elderly, as codeine may induce faecal impaction, producing incontinence, spurious diarrhoea, abdominal pain and, rarely, colonic obstruction.
Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the caucasian population may be ultra-rapid metabolisers.
Precautions/warnings to be declared on labels:
Do not exceed the stated dose.
Keep all medicines away from children.
Use with caution if elderly.
Do not take during pregnancy except on a doctor's advice.
Antagonism of the effects of metoclopramide; codeine phosphate has the opposing effect on gastro-intestinal activity. Opioid analgesics can antagonise the gastrointestinal effects of domperidone
May cause delayed absorption of flecainide and mexiletine, and potentiation of the effects of hypnotics and anxiolytics.
When used with monoamine-oxidase inhibitors this may cause CNS excitation and hypertension, the effects can occur up to two weeks after stopping MAOI'S.
The effects of alcohol may be enhanced and codeine phosphate can be absorbed by light kaolin.
Opioid analgesics may potentiate the depressant effects of anaesthetics, tricyclic antidepressants and antipsychotics.
The product should not be used during pregnancy unless considered necessary by the physician.
Opioid administration near term may cause respiratory depression in the newborn.
At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.
However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.
If symptoms of opioid toxicity develop in either the mother or the infant, then all codine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.
Using the dose recommended, codeine linctus is not considered to be a hazard, however the use of codeine phosphate may cause sedation, dizziness and nausea. If affected driving or operating of machinery would not be advised.
Use may result in tolerance and dependence, sedation, dizziness, nausea and constipation.
Prolonged use could aggravate irritable bowel syndrome. use with caution in the elderly, as codeine may induce faecal impaction, producing incontinence, spurious diarrhoea; abdominal pain and, rarely, colonic obstruction.
Due to the histamine releasing effect, reactions such as urticaria and pruritus occur in some individuals.
Following large doses of codeine, respiratory depression, hypotension with circulatory failure and deepening coma, excitement, and in children convulsions may occur.
Death may occur due to respiratory failure.
Toxic doses vary considerably with the individual addicts may tolerate large doses.
Treatment of overdose should consist of aspiration and gastric lavage together with supportive therapy such as replacement of fluids and electrolytes.
Naloxone may be given to counteract respiratory depression.
Codeine depresses the cough reflex, partly by a direct effect on a cough centre in the medulla; the exact mechanism is not entirely clear. It has been suggested that the usual doses of opioids produce their major effect on the patients subjective reactions to the cough, rather than on the frequency and intensity of coughing.
Codeine phosphate is absorbed from the gastro-intestinal tract, it is metabolised by O- and N-Demethylation in the liver to morphine and norcodeine. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid.
Ingestion of codeine phosphate produces peak plasma - codeine concentrations in about one hour. The plasma half-life has been reported to be between 2½ and 4 hours after ingestion.
None.
Citric Acid Monohydrate BP, Purified Water BP, Lemon Oil Terpeneless BP, Chloroform BP, Ethanol (96%) BP, Benzoic Acid Solution BP, Invert Syrup BP, Quinoline Yellow Solution Compound, Syrup BP.
Codeine phosphate is incompatible with bromides, iodides and salts of heavy metals.
It is incompatible with phenobarbitone sodium, forming a codeine-phenobarbitone complex.
100ml: 24 months unopened
200ml: 24 months unopened
500ml: 24 months unopened
2000 ml: 24 months unopened
Protect from light.
Store below 25°C.
100ml: Amber glass bottle with polypropylene cap or white 28mm child-resistant cap with tamper evident band and EPE/Saranex liner.
200ml: Amber glass bottle with polypropylene cap or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.
500ml: Amber glass bottle with plastic cap and saranex/epe liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.
2000ml: Amber glass bottle with plastic cap and saranex/epe liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.
None.
L.C.M. LIMITED
Linthwaite Laboratories
Huddersfield
HD7 5QH
PL 12965/0009
21.7.1993
09/12/2010
Generic Name: codeine and phenylephrine (KOE deen and FEN il EFF rin)
Brand Names: Ala-Hist AC, Notuss-PE
Codeine is a narcotic cough suppressant.
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of codeine and phenylephrine is used to treat cough and nasal congestion caused by the common cold.
Codeine will not treat a cough that is caused by smoking, asthma, or emphysema.
Codeine and phenylephrine may also be used for other purposes not listed in this medication guide.
You should not use codeine and phenylephrine if you are allergic to it, or if you have severe or uncontrolled high blood pressure, severe coronary artery disease, ischemic heart disease (reduced circulation of blood to the heart), or if you are breast-feeding a baby.
Before taking this medication, tell your doctor if you have heart disease or high blood pressure, asthma or other breathing disorder, diabetes, a thyroid disorder, an enlarged prostate, or problems with urination.
severe or uncontrolled high blood pressure;
severe coronary artery disease;
ischemic heart disease (reduced circulation of blood to the heart); or
if you are breast-feeding a baby.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take codeine and phenylephrine:
heart disease or high blood pressure;
asthma, COPD, emphysema, or other breathing disorder;
diabetes;
a thyroid disorder; or
enlarged prostate, urination problems.
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. Follow the directions on your prescription label. Cold medicine is usually taken for only a short time until your symptoms clear up.
Measure liquid 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.
Keep track of how much of this medicine has been used from the bottle. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.
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, dizziness, fast or uneven heart rate, fainting, or seizure (convulsions).
fast or pounding heartbeat;
feeling like you might pass out;
chest tightness or congestion;
easy bruising or bleeding, unusual weakness;
severe dizziness, anxiety, restless feeling, or nervousness;
seizure (convulsions); or
painful or difficult urination.
Less serious side effects may include:
dizziness, drowsiness, headache;
dry mouth, nose, or throat;
nausea, vomiting, diarrhea, constipation;
increased sweating or urination;
feeling excited or restless;
sleep problems (insomnia);
blurred vision, dry eyes;
ringing in your ears; or
mild skin rash or itching.
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 pain medication, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by codeine and phenylephrine.
Tell your doctor about all other medicines you use, especially:
medicines to treat high blood pressure;
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
an antidepressant 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 codeine and phenylephrine. 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.
See also: Ala-Hist AC side effects (in more detail)
Generic Name: cyanocobalamin (oral) (sye AN oh koe BAL a min)
Brand Names: B-12 Resin, Vitamin B-12, Vitamin B12
Cyanocobalamin is a man-made form of vitamin B12. Vitamin B12 is important for growth, cell reproduction, blood formation, and protein and tissue synthesis.
Cyanocobalamin is used to treat vitamin B12 deficiency in people with pernicious anemia and other conditions.
Cyanocobalamin may also be used for purposes other than those listed in this medication guide.
To treat pernicious anemia, you will have to use this medication on a regular basis for the rest of your life. Not using the medication can lead to irreversible nerve damage in your spinal cord.
Pernicious anemia is also treated with folic acid to help maintain red blood cells. However, folic acid will not treat Vitamin B12 deficiency and will not prevent possible damage to the spinal cord. Take all of your medications as directed.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take oral cyanocobalamin:
any type of infection;
iron or folic acid deficiency;
kidney or liver disease; or
if you are receiving any medication or treatment that affects bone marrow.
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
The sublingual tablet should be placed under your tongue where it will dissolve.
To be sure this medication is helping your condition, your blood will need to be tested every 3 to 6 months. This will help your doctor determine the correct dose and how long to treat you with cyanocobalamin. Do not miss any scheduled appointments.
To treat pernicious anemia, you will have to use this medication on a regular basis for the rest of your life. Not using the medication can lead to irreversible nerve damage in your spinal cord.
Pernicious anemia is also treated with folic acid to help maintain red blood cells. However, folic acid will not treat Vitamin B12 deficiency and will not prevent possible damage to the spinal cord. Take all of your medications as directed.
See also: Cyanocobalamin dosage (in more detail)
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
chest pain;
feeling short of breath, even with mild exertion;
swelling, rapid weight gain; or
unusual warmth, redness, or pain in an arm or leg.
Less serious side effects may include:
headache, dizziness, weakness;
nausea, upset stomach, diarrhea;
numbness or tingling;
fever;
joint pain;
swollen tongue;
swelling; or
itching or rash.
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 Adult Dose for Pernicious Anemia:
Parenteral:
Initial dose: 100 mcg intramuscularly once a day for 7 days. If there is clinical improvement and a reticulocyte response, 100 mcg intramuscularly once every other day for 7 days, then once every 3 to 4 days for another 2 to 3 weeks is recommended. Most patients require monthly injections of 100 to 1000 mcg intramuscularly for life.
Nasal Spray or Gel:
Alternatively, cyanocobalamin (Nascobal) nasal spray or nasal gel 500 mcg intranasally to one nostril once a week may be administered to patients with pernicious anemia who require maintenance of normal hematologic status following intramuscular vitamin B12 and who have no nervous system involvement. However, if the patient is not adequately maintained with cyanocobalamin nasal, intramuscular vitamin B12 administration must be resumed.
Usual Adult Dose for B12 Nutritional Deficiency:
Oral: 25 to 250 mcg once a day.
Nasal Spray or Gel:
(Nascobal) 500 mcg intranasally in one nostril once a week
(CaloMist) 25 mcg in each nostril once a day (total dose 50 mcg). May be increased to 50 mcg in each nostril once a day.
Usual Adult Dose for Schilling Test:
1 mcg radiolabeled cyanocobalamin orally once after urinary voiding. A 24-hour urinary collection is immediately begun. At 2 hours an injection of cyanocobalamin 1,000 mcg intramuscularly is given to "flush" the patient of absorbed radiolabeled drug. The percentage of radiolabeled B12 excreted in the urine is a measure of how much labeled drug was absorbed. Normally 7% or more of a dose is excreted in 24 hours (
Usual Pediatric Dose for Pernicious Anemia:
Neonates and Infants: Intramuscular or Subcutaneous: 0.2 mcg/kg for 2 days, followed by 1000 mcg/day for 2 to 7 days; maintenance: 100 mcg/month.
Children: Intramuscular or Subcutaneous: 30 to 50 mcg/day for 2 or more weeks (to a total dose of 1000 mcg), then follow with 100 mcg/month.
Usual Pediatric Dose for B12 Nutritional Deficiency:
Intramuscular or Subcutaneous: Initial: 0.2 mcg/kg for 2 days followed by 1000 mcg/day for 2 to 7 days followed by 100 mcg/week for a month or 100 mcg/day for 10 to 15 days (total dose of 1 to 1.5 mg), then once or twice weekly for several months. May taper to 60 mcg every month. For malabsorptive causes of B12 deficiency, monthly maintenance doses of 100 mcg have been recommended.
Before taking cyanocobalamin, tell your doctor if you are taking any of the following medications:
antibiotics;
methotrexate (Rheumatrex);
pyrimethamine (Daraprim);
colchicine; or
if you drank a lot of alcohol within the past 2 weeks.
This list is not complete and there may be other drugs that can interact with cyanocobalamin. 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.
See also: cyanocobalamin side effects (in more detail)
Generic Name: tolnaftate topical (toll NAF tate)
Brand Names: Absorbine Athletes Foot, Absorbine Jr. Antifungal, Aftate For Athletes Foot, Blis-To-Sol, Desenex Spray, Fungatin, Fungi-Guard, Genaspor, Hongos, NP 27, Podactin, T-Athlete, Tinactin, Tinaspore, Ting
Tolnaftate topical is an antifungal medication. Tolnaftate topical prevents fungus from growing on the skin.
Tolnaftate topical is used to treat skin infections such as athlete's foot, jock itch, and ringworm infections. Tolnaftate is also used, along with other antifungals, to treat infections of the nails, scalp, palms, and soles of the feet. The powder and powder aerosol may be used to prevent athlete's foot.
Tolnaftate 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 tolnaftate 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 gel, cream, lotion, spray, or powder twice daily as directed for 2 to 6 weeks.
If the infection does not clear up in 10 days 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 the next regularly scheduled dose, skip the dose you missed and apply only the regular amount of tolnaftate topical. Do not use a double dose unless otherwise directed by your doctor.
An overdose of tolnaftate topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that tolnaftate 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 tolnaftate topical use are not expected to occur. Stop using tolnaftate 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.
Other skin medications may affect the absorption or effectiveness of tolnaftate topical. Avoid using other topicals at the same time except under the direction of a doctor.
See also: Aftate For Athletes Foot side effects (in more detail)
