In the US, Ultrase (pancrelipase systemic) is a member of the drug class digestive enzymes and is used to treat Chronic Pancreatitis, Cystic Fibrosis and Pancreatic Exocrine Dysfunction.
US matches:
Pancrelipase is reported as an ingredient of Ultrase in the following countries:
International Drug Name Search
Meloxicam Mylan may be available in the countries listed below.
Meloxicam is reported as an ingredient of Meloxicam Mylan in the following countries:
International Drug Name Search
Treating mild ear infections.
Acetic Acid/Aluminum Acetate Solution is an antibacterial. It works by killing sensitive bacteria.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Acetic Acid/Aluminum Acetate Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Acetic Acid/Aluminum Acetate Solution. Because little, if any, of Acetic Acid/Aluminum Acetate Solution is absorbed into the blood, the risk of it interacting with another medicine is low.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetic Acid/Aluminum Acetate Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Acetic Acid/Aluminum Acetate Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Acetic Acid/Aluminum Acetate Solution.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Burning; itching; stinging.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irritation; sensitivity.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Acetic Acid/Aluminum Acetate side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Acetic Acid/Aluminum Acetate Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Protect from freezing. Store away from heat and light. Do not store in the bathroom. Keep Acetic Acid/Aluminum Acetate Solution out of the reach of children and away from pets.
This information is summary only. It does not contain all information about Acetic Acid/Aluminum Acetate Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Bimalong may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfamethoxypyridazine sodium salt (a derivative of Sulfamethoxypyridazine) is reported as an ingredient of Bimalong in the following countries:
International Drug Name Search
Chlokinan may be available in the countries listed below.
Chlormadinone 17α-acetate (a derivative of Chlormadinone) is reported as an ingredient of Chlokinan in the following countries:
International Drug Name Search
Ulzone may be available in the countries listed below.
Omeprazole is reported as an ingredient of Ulzone in the following countries:
International Drug Name Search
Nicorette Freshmint 2mg Gum or NicAssist Minty Fresh 2 mg Gum
Chewing Gum containing 2mg nicotine, as nicotine resinate.
For excipients see section 6.1
Medicated Chewing Gum
Nicorette Freshmint 2 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.
Nicorette Freshmint 2 mg Gum is indicated in pregnant and lactating women making a quit attempt.
Adults and Children over 12 years of age
Nicorette Freshmint 2 mg Gum should be chewed slowly according to the instructions.
The strength of gum to be used will depend on the smoking habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2mg nicotine gum is indicated. If more than 20 cigarettes per day are smoked, 4mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.
Nicorette Freshmint 2mg Gum should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur.
Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Gum and as soon as they are able, reduce the number of gums used until they have stopped completely.
Smokers aiming to reduce cigarettes should use Nicorette Freshmint 2 mg Gum, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible.
As soon as they are ready smokers should aim to quit smoking completely.
Maximum daily dose: 15 pieces per day.
When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing Nicorette Freshmint 2 mg Gum are recommended to contact their pharmacist or doctor for advice.
For those using the 4mg gum, switching to the 2mg gum may be helpful when stopping treatment or reducing the number of gums used each day.
The chewing gums should be used whenever there is an urge to smoke according to the "chew and rest" technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.
Hypersensitivity to nicotine or any component of the chewing gum.
Nicorette Freshmint 2mg Gum is contraindicated in children under the age of 12 years.
Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.
Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Freshmint 2mg Gum presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Freshmint 2mg Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.
Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.
GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.
Renal or hepatic impairment: Nicorette Freshmint 2mg Gum should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.
Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care.
Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Freshmint 2mg Gum should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.
Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.
Excipients: Nicorette Freshmint 2mg Gum also contains butylated hydroxy toluene (E321); this may cause irritation to the mucous membranes.
Denture warning: Smokers who wear dentures may experience difficulty in chewing Nicorette Freshmint 2mg Gum. The chewing gum may stick to, and may in rare cases damage dentures.
No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.
Pregnancy
Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking cessation during pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable Nicorette Freshmint 2mg Gum may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the fetus would not normally be exposed to nicotine.
Lactation
The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.
Not applicable.
Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.
Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.
Nicorette Freshmint 2mg Gum may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Freshmint 2mg Gum has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3-4 weeks after start of treatment.
Excessive consumption of Nicorette Freshmint 2mg Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping.
Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation.
Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4mg nicotine gum is used; slower chewing and the use of the 2mg nicotine gum (if necessary more frequently) will usually overcome this problem.
The chewing gum may stick to, and may in rare cases damage dentures.
Reported adverse events associated with Nicorette 2mg and 4mg gum include:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.
Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.
Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.
Pharmacotherapeutic group: Drugs used in nicotine dependence
ATC code: N07B A01
The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette Freshmint 2mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.
Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation weight gain is common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt.
Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5 - 7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.
Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.
There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product which have not been considered in other relevant sections of this Summary of Product Characteristics.
Core Gum
Polacrilin
Chewing gum base, containing butylated hydroxy toluene (E321)
Xylitol
Peppermint oil
Sodium carbonate, anhydrous
Sodium bicarbonate
Acesulfame Potassium
Levomenthol
Magnesium oxide, light
Talcum
Nitrogen, food grade
Coating
Xylitol
Peppermint oil
Acacia
Titanium dioxide (E171)
Carnauba wax
None relevant
3 Years
Do not store above 25°C
PVC/PVDC/Al Blister packed strips each containing 15 pieces supplied in packs of 15, 30, 105 and 210 pieces.
Blister packed strips each containing 6 pieces supplied in packs of 12 pieces.
Blister packed strips each containing 10 pieces supplied in packs of 10 pieces.
Not all pack sizes may be marketed.
Dispose of Nicorette Gum sensibly.
Any unused product or waste material should be disposed of in accordance with local requirements.
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
UK
PL 15513/0173
21 January 2008
31 January 2012
Prednisolone RPG may be available in the countries listed below.
Prednisolone 21-(sodium 3-sulfobenzoate) (a derivative of Prednisolone) is reported as an ingredient of Prednisolone RPG in the following countries:
International Drug Name Search
Trigoa may be available in the countries listed below.
Ethinylestradiol is reported as an ingredient of Trigoa in the following countries:
Levonorgestrel is reported as an ingredient of Trigoa in the following countries:
International Drug Name Search
Osteofel may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Osteofel in the following countries:
International Drug Name Search
Treating symptoms of advanced prostate cancer. It may also be used for certain conditions as determined by your doctor.
Leuprolide Depot Suspension is a gonadotropin-releasing hormone (GnRH) agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries. This prevents the growth of certain tumors that need these hormones to grow.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Leuprolide Depot Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Leuprolide Depot Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following: Antiarrhythmic medicines (eg, amiodarone, quinidine, sotalol) because they may increase the risk of a certain type of irregular heartbeat (prolonged QT interval)
This may not be a complete list of all interactions that may occur. Ask your health care provider if Leuprolide Depot Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Leuprolide Depot Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Leuprolide Depot Suspension.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; dizziness; hot flashes; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); mild joint or back pain; tiredness; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; burning, numbness, tingling, or weakness; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, nervousness); new or worsening bone pain; paralysis; seizures; severe dizziness or light-headedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of infection (eg, chills, fever); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); unusual bruising or bleeding; urination problems (eg, trouble urinating, inability to urinate, painful urination); vision changes or blurred vision; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Leuprolide side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Leuprolide Depot Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Because the product does not contain a preservative, once mixed, discard the suspension if it is not used right away. Keep Leuprolide Depot Suspension out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Leuprolide Depot Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Treating the symptoms of diarrhea plus bloating, pressure, and cramps from gas.
Loperamide/Simethicone is an antidiarrheal and antiflatulent combination. It works by slowing the movement of bowel contents. It also breaks up gas bubbles to make gas easier to eliminate.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Loperamide/Simethicone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Loperamide/Simethicone. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Loperamide/Simethicone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Loperamide/Simethicone as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Loperamide/Simethicone.
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Loperamide/Simethicone side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; nausea; severe constipation or drowsiness; vomiting.
Store at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Loperamide/Simethicone out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Loperamide/Simethicone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Godamed may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Godamed in the following countries:
Glycine is reported as an ingredient of Godamed in the following countries:
International Drug Name Search
Glycan Udder may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Glycerol is reported as an ingredient of Glycan Udder in the following countries:
Sorbitol is reported as an ingredient of Glycan Udder in the following countries:
International Drug Name Search
Class: Corticosteroids
ATC Class: S03CA04
VA Class: OP300
Chemical Name: 11ß, 17, 21-trihydroxypregn-4-ene-3,20-dione
CAS Number: 50-23-7
Brands: Acetasol HC, Cipro HC, Coly-Mycin, Cortisporin, PediOtic
A corticosteroid secreted by the adrenal cortex.a
Treatment of corticosteroid-responsive ocular inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.b d k
Treatment of chronic anterior uveitis.d k
Treatment of corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.b d k
Commercially available only in fixed combination with anti-infectives; use only when such combination therapy is indicated.d k (See Bacterial Ophthalmic Infections under Uses.)
Used for anti-inflammatory properties in conjunction with appropriate anti-infective therapy in some bacterial infections of the eye;b used in fixed combination with neomycin and polymyxin B sulfates, or with neomycin and polymyxin B sulfates and bacitracin zinc when such combination therapy is indicated.d k If an ophthalmic corticosteroid is used in combination with an ophthalmic anti-infective, weigh benefits against risks.b (See Infections under Cautions.)
Used for anti-inflammatory properties in conjunction with appropriate anti-infective therapy in some cases of bacterial otitis externa; used in fixed combination with acetic acid, ciprofloxacin hydrochloride, colistin sulfate and neomycin sulfate, or neomycin and polymyxin B sulfates when such combination therapy is indicated.b c g h i j l If an otic corticosteroid is used in combination with an otic anti-infective, weigh benefits against risks.b
Apply topically to the eye or ear.a c d g h i j k l
Shake suspension well prior to use.c d g i j
Apply topically to the eye(s) as an ophthalmic ointment or suspension.a d k
Not for injection.d k
Avoid contamination of the preparation container.a b d k
Apply topically to the ear(s) as an otic solution or suspension.b c g h i j l
Not for injection.j Do not instill otic preparations into the eye.c g h i j
Clean and dry ear canal prior to administration.a c g h i l
To avoid dizziness that may result from instilling a cold preparation into the ear, warm the preparation by holding the bottle in the hands for 1–2 minutes prior to administration.j (See Advice to Patients.)
Lie with the affected ear upward prior to drug instillation.c g h i Remain in this position for 5 minutes following drug administration to ease penetration of drops into the ear canal.c g h i
Use sparingly to prevent an accumulation of excess debris in the ear canal.a b
Commercially available only in fixed combination with anti-infectives; available as hydrocortisone or hydrocortisone acetate; dosage of hydrocortisone acetate expressed in terms of the salt.a c d g h i j k l
Children ≥3 years of age: Insert a cotton wick saturated with the solution into the ear canal; keep the wick moist by adding 3 or 4 drops of the drug solution every 4–6 hours.l The wick may be removed after 24 hours, but continue to instill 3 or 4 drops 3 or 4 times daily as long as indicated.l
Children ≥1 year of age: Instill 3 drops into affected ear(s) twice daily for 7 days.j
Pediatric patients: Instill 4 drops into affected ear(s) 3 or 4 times daily for up to 10 days.i Alternatively, a cotton wick saturated with the suspension may be packed into the ear canal; keep the wick moist by adding additional drug every 4 hours; replace the wick at least once every 24 hours.i
Children ≥2 years of age: Instill 3 drops into affected ear(s) 3 or 4 times daily for up to 10 days.c g h Alternatively, a cotton wick saturated with the solution or suspension may be packed into the ear canal; keep the wick moist by adding additional drug every 4 hours; replace the wick at least once every 24 hours.c g h
If improvement does not occur after 2 days, reevaluate the patient.d k
Duration of therapy depends on the type and severity of the disease and response to therapy.a
Gradually taper the dosage when the drug is discontinued to avoid exacerbation of the disease.a
Instill 1 or 2 drops into affected eye(s) every 3–4 hours, or more frequently, as necessary.d
Apply small amount to affected eye(s) every 3–4 hours.k
Insert a cotton wick saturated with the solution into the ear canal; keep the wick moist by adding 3–5 drops of the drug solution every 4–6 hours.l The wick may be removed after 24 hours, but continue to instill 5 drops 3 or 4 times daily as long as indicated.l
Instill 3 drops into affected ear(s) twice daily for 7 days.j
Instill 5 drops into affected ear(s) 3 or 4 times daily for up to 10 days.i Alternatively, a cotton wick saturated with the suspension may be packed into the ear canal; keep the wick moist by adding additional drug every 4 hours; replace the wick at least once every 24 hours.i
Instill 4 drops into affected ear(s) 3 or 4 times daily for up to 10 days.c g h Alternatively, a cotton wick saturated with the solution or suspension may be packed into the ear canal; keep the wick moist by adding additional drug every 4 hours; replace the wick at least once every 24 hours.c g h
Otic preparations: Maximum 10 days of therapy.c g k
Otic preparations: Maximum 10 days of therapy.c g k
No special population dosage recommendations at this time.c d g h i j k l
Known hypersensitivity to hydrocortisone, other corticosteroids, or any ingredient in the formulation.b c d g h i j k l
Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella).b d k
Mycobacterial infection of the eye.b d k
Fungal disease of ocular structures.b d k
Acute, purulent, untreated infections of the eye.b
Known or suspected viral infection (e.g., herpes simplex virus, vaccinia, varicella-zoster virus) of the external ear canal.c g h i j l
Fungal disease of otic structures.b
Acute, purulent, untreated infections of the ear.b
Patients with perforated tympanic membrane.j l (See Perforated Tympanic Membrane under Cautions.)
Risk of glaucoma (with damage to optic nerve), defects in visual acuity and fields of vision, and posterior subcapsular cataract formation with prolonged use of corticosteroids.b d k Use with caution in glaucoma because intraocular pressure (IOP) may increase.b d k
If used for ≥10 days, monitor IOP routinely even though monitoring may be difficult in children and uncooperative patients.b d k
In conditions causing thinning of the cornea and sclera, perforations reported with use of topical corticosteroids.b d k
Use of high-dose corticosteroids may delay healing.b d k Use after cataract surgery may delay healing and increase incidence of bleb formation.b d k
See Contraindications under Cautions.
Prolonged use may suppress the host response and thus increase the risk of secondary ocular infections.b d k
In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.d k
Use of corticosteroids in the treatment of herpes simplex infections other than epithelial herpes simplex keratitis, in which corticosteroids are contraindicated, requires great caution; periodic slit-lamp microscopy is essential.d k
Most manufacturers state that otic preparations should not be used in patients with perforated tympanic membrane.c g h l Ciprofloxacin hydrochloride and hydrocortisone otic suspension is not sterile and is contraindicated in patients with perforated tympanic membrane.j
Some otic preparations may contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.h
Initial prescription or renewal of medication order beyond 8 g of ointment or 20 mL of suspension or solution should be provided only after examination of the patient with the aid of magnification (e.g., slit lamp biomicroscopy, fluorescein staining where appropriate).d k
Reevaluate patient if improvement does not occur after 2 days.d k
Long-term local corticosteroid application associated with development of fungal infections of the cornea. d k Consider possibility of fungal infections in patients with persistent corneal ulceration who have been or who are receiving corticosteroid therapy.d k
When hydrocortisone or hydrocortisone acetate is used in fixed combination with anti-infectives, consider the cautions, precautions, and contraindications associated with the concomitant agent(s).c d g h i j k l
Use of ophthalmic ointments may decrease rate of corneal reepithelialization.b k
Category C.c d g h i j k
Not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.d k
Ophthalmic preparations: Discontinue nursing or the drug.d k
Otic preparations: Caution if used in nursing women.c g h i
Safety and efficacy of ophthalmic administration not established.d k
Safety and efficacy of otic administration of hydrocortisone in fixed combination with acetic acid not established in children <3 years of age.l
Safety and efficacy of otic administration of hydrocortisone in fixed combination with ciprofloxacin hydrochloride, with colistin sulfate and neomycin sulfate, or with neomycin and polymyxin B sulfates, not established in children <2 years of age.c g h j Manufacturer states that no known safety concerns would preclude use of hydrocortisone and ciprofloxacin hydrochloride otic suspension in children ≥1 year of age.j
Ophthalmic therapy: No substantial differences in safety and efficacy relative to younger individuals.d k
Otic therapy: Clinical trials included insufficient numbers of patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; other clinical experience has not identified differences in response.c g h
Ophthalmic administration: Elevated IOP,d k transient stinging or burning,b blurred vision,b local irritation.d k
Otic administration: Headache,j pruritus,j transient stinging or burning.l
Test | Interaction |
|---|---|
Test for adrenal steroids | Possible decrease in urinary excretion of 17-hydroxycorticosteroids from excessive systemic levels of hydrocortisonec g i j |
Corticosteroids are absorbed through the aqueous humor; because only low doses are given, little if any systemic absorption occurs.b
15–25°C.k
20–25°C.d
Hydrocortisone and acetic acid: Tightly closed containers at 15–30°C; do not freeze.l
Hydrocortisone and neomycin and polymyxin B sulfates: 15–25°C.h
Hydrocortisone and ciprofloxacin hydrochloride: <25°C; protect from light and freezing.j
Hydrocortisone acetate, colistin and neomycin sulfates: 20–25°C.i
Hydrocortisone and neomycin and polymyxin B sulfates: 15–25°C.c g
Corticosteroids suppress the inflammatory response to mechanical, chemical, or immunologic agents.b c d g h i k
Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.b
Importance of discontinuing ophthalmic therapy and consulting a clinician if inflammation or pain persists for >48 hours or worsens.k
Importance of learning and adhering to proper ophthalmic administration techniques to avoid contamination of the tip of the container.b
Importance of warning the patient not to share the drug.d k
Importance of informing a clinician if another eye condition (e.g., trauma, surgery, infection) develops during ophthalmic therapy.b
Inform patients to warm the otic suspension by holding the bottle in the hands for 1–2 minutes prior to administration to avoid dizziness resulting from placing a cold preparation into the ear.j
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.c d g h i j k
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b c d g h i j k
Importance of informing patients of other important precautionary information.b c d g h i j k l (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Bulk | Powder |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Otic | Solution | 1% Hydrocortisone and Acetic Acid Glacial 2% (of acetic acid) | Acetasol HC Otic Solution | Actavis |
Hydrocortisone 1% and Acetic Acid 2% Otic Solution (with benzethonium chloride and propylene glycol diacetate) | Taro |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone 1%* | Cortisporin Ophthalmic Ointment | Monarch |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Suspension | Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1% | Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension (with propylene glycol and thimerosal) | Falcon |
Otic | Solution | Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1% | Cortisporin Otic Solution (with potassium metabisulfite and propylene glycol) | Monarch |
Neomycin Sulfate, Polymyxin B Sulfate, and Hydrocortisone Otic Solution | Bausch & Lomb | |||
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution (with potassium metabisulfite and propylene glycol) | Falcon | |||
Suspension | Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1% | Neomycin Sulfate, Polymyxin B Sulfate, and Hydrocortisone Otic Solution | Bausch & Lomb | |
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution (with thimerosal and propylene glycol) | Falcon | |||
PediOtic Suspension (with propylene glycol and thimerosal) | Monarch |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Otic | Suspension | 1% with Ciprofloxacin Hydrochloride 0.2% (of ciprofloxacin) | Cipro HC Otic Drops (with benzyl alcohol 0.9%) | Alcon |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Bulk | Powder |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Otic | Suspension | Colistin Sulfate 0.3% (of colistin), Neomycin Sulfate 0.33% (of neomycin), and Hydrocortisone Acetate 1% | Coly-Mycin S Otic with Neomycin and Hydrocortisone (with thimerosal and thonzonium bromide) | JHP |
Cortisporin-TC Otic Suspension (with thimerosal and thonzonium bromide) | JHP |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone Acetate 1% | Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate Ophthalmic Ointment | Fougera |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Cipro HC 0.2-1% Suspension (ALCON VISION): 10/$135.99 or 30/$382.98
Cortisporin 0.5-0.5-10000 Cream (MONARCH PHARMACEUTICALS): 7/$54.99 or 22/$164.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
a. AHFS drug information 2008. McEvoy GK, ed. Hydrocortisone. Bethesda, MD: American Society of Health-Systems Pharmacists; 2008: 2884–5..
b. AHFS drug information 2008. McEvoy GK, ed. EENT corticosteroids general statement. Bethesda, MD: American Society of Health-Systems Pharmacists; 2008: 2867–9.
c. Monarch Pharmaceuticals. Pediotic (neomycin and polymyxin B sulfates and hydrocortisone) otic suspension prescribing information. Bristol, TN; 2003 Apr.
d. Falcon Pharmaceuticals. Neomycin and polymyxin B sulfates, and hydrocortisone ophthalmic suspension prescribing information. Fort Worth, TX; Undated.
g. Falcon Pharmaceuticals. Neomycin and polymyxin B sulfates, and hydrocortisone otic suspension prescribing information. Fort Worth, TX; 2007 Jun.
h. Monarch Pharmaceuticals. Cortisporin (neomycin and polymyxin B sulfates and hydrocortisone) otic solution prescribing information. Bristol, TN; 2003 Apr.
i. JHP Pharmaceuticals. Coly-Mycin S (colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone acetate) otic solution prescribing information. Rochester, MI; 2008 Feb.
j. Alcon. Cipro HC (ciprofloxacin hydrochloride and hydrocortisone) otic suspension prescribing information. Fort Worth, TX; Undated.
k. Fougera. Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment prescribing information. Melville, NY; 2004 Aug
l. Taro Pharmaceuticals. Hydrocortisone 1% and acetic acid 2% otic solution prescribing information. Hawthorne, NY; 2004 Jun.
Generic Name: citrate (Oral route)
In the U.S.
In Canada
Available Dosage Forms:
Citrates are used to make the urine more alkaline (less acid). This helps prevent certain kinds of kidney stones. Citrates are sometimes used with other medicines to help treat kidney stones that may occur with gout. They are also used to make the blood more alkaline in certain conditions
Citrates are available only with your doctor's prescription.
Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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 citrates in children with use in other age groups, these medicines are not expected to cause different side effects or problems in children than they do 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 citrates in the elderly with use in other age groups.
Studies on effects in pregnancy have not been done in either humans or animals.
Although it is not known whether citrates pass into the breast milk, this medicine has not been reported to cause problems in nursing babies.
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.
The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain citrate. It may not be specific to Liqui-DualCitra. Please read with care.
For patients taking the tablet form of this medicine:
For patients taking the liquid form of this medicine:
For patients taking the crystals form of this medicine:
Take each dose immediately after a meal or within 30 minutes after a meal or bedtime snack. This helps prevent the medicine from causing stomach pain or a laxative effect.
Drink at least a full glass (8 ounces) of water or other liquid (except milk) every hour during the day (about 3 quarts a day), unless otherwise directed by your doctor. This will increase the flow of urine and help prevent kidney stones.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important if you are also taking a diuretic (water pill) or digitalis medicine for your heart.
The dose medicines in this class 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 these medicines. 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.
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
It is important that your doctor check your progress at regular visits. This is to make sure the medicine is working properly and to check for unwanted effects.
Do not eat salty foods or use extra table salt on your food while you are taking citrates. This will help prevent kidney stones and unwanted effects.
Check with your doctor before starting any strenuous physical exercise, especially if you are out of condition and are taking any other medication. Exercise and certain medications may increase the amount of potassium in the blood.
For patients taking potassium citrate–containing medicines:
For patients taking sodium citrate–containing medicines:
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.
Stop taking this medicine and get emergency help immediately if any of the following effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
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.
