Bronchicum may be available in the countries listed below.
Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Bronchicum in the following countries:
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Zazole® Vaginal Suppositories (terconazole vaginal suppositories, 80 mg) are white to off-white suppositories for intravaginal administration containing 80 mg of the antifungal agent terconazole, cis - 1 - [p - [[2 - (2,4 - Dichlorophenyl) - 2 - (1H - 1,2,4 - triazol - 1 - ylmethyl) - 1,3 - dioxolan - 4 - yl]methoxy]phenyl] - 4 - Isopropylpiperazine, in triglycerides derived from coconut and/or palm kernel oil (a base of hydrogenated vegetable oils) and butylated hydroxyanisole. The structural formula of terconazole is as follows:
Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.
Following intravaginal administration of terconazole in humans, absorption ranged from 5-8% in three hysterectomized subjects and 12-16% in two non-hysterectomized subjects with tubal ligations.
Following oral (30 mg) administration of 14C-labeled terconazole, the harmonic half-life of elimination from the blood for the parent terconazole was 6.9 hours (range 4.0-11.3). Terconazole is extensively metabolized; the plasma AUC for terconazole compared to the AUC for total radioactivity was 0.6%. Total radioactivity was eliminated from the blood with a harmonic half-life of 52.2 hours (range 44-60). Excretion of radioactivity was both by renal (32-56%) and fecal (47-52%) routes.
In vitro, terconazole is highly protein bound (94.9%) and the degree of binding is independent of drug concentration.
Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% and 0.8% creams under conditions of filtered artificial ultraviolet light.
Photosensitivity reactions have not been observed in U.S. and foreign clinical trials in patients who were treated with Zazole® Vaginal Suppositories.
Terconazole exhibits fungicidal activity in vitro against Candida albicans. Antifungal activity has also been demonstrated against other fungi. The MIC values of terconazole against most Lactobacillus spp. typically found in the human vagina were ≥128 mcg/mL; therefore these beneficial bacteria were not affected by drug treatment.
The exact pharmacologic mode of action of terconazole is uncertain; however, it may exert its antifungal activity by the disruption of normal fungal cell membrane permeability. No resistance to terconazole has developed during successive passages of C. albicans.
Zazole® Vaginal Suppositories are indicated for the local treatment of vulvovaginal candidiasis (monilasis). As Zazole® Vaginal Suppositories are effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
Patients known to be hypersensitive to terconazole or to any of the components of the suppositories.
None.
Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills, or flu-like symptoms are reported during use.
The base contained in the suppository formulation may interact with certain rubber or latex products, such as those used in vaginal contraceptive diaphragms, therefore concurrent use is not recommended.
If there is lack of response to terconazole, appropriate microbiologic studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.
The therapeutic effect of this product is not affected by oral contraceptive usage.
Studies to determine the carcinogenic potential of terconazole have not been performed.
Terconazole was not mutagenic when tested in vitro for induction of microbial point mutations (Ames test), or for inducing cellular transformation, or in vivo for chromosome breaks (micronucleus test) or dominant lethal mutations in mouse germ cells.
No impairment of fertility occurred when female rats were administered terconazole orally up to 40 mg/kg/day for a three month period.
There was no evidence of teratogencity when terconazole was administered orally up to 40 mg/kg/day (25× the recommended intravaginal human dose of the suppository formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats.
Dosages at or below 10 mg/kg/day produced no embryotoxicity; however, there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20-40 mg/kg. In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight. There was also delay in ossification and an increased incidence of skeletal variants.
The no-effect dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 17 times the mean peak plasma level (0.010 mcg/mL) seen in normal subjects after intravaginal administration of terconazole vaginal suppositories. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes. Since terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.
It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from terconazole, 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 efficacy in children have not been established.
Clinical studies of terconazole 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.
During controlled clinical studies conducted in the United States, 284 patients with vulvovaginal candidiasis were treated with terconazole vaginal suppositories 80 mg.
Based on comparative analyses with placebo (295 patients), the adverse experiences considered adverse reactions most likely related to terconazole vaginal suppositories 80 mg were headache (30.3% vs. 20.7% with placebo) and pain of the female genitalia (4.2% vs. 0.7% with placebo). Adverse reactions that were reported but were not statistically significantly different from placebo were burning (15.2% vs. 11.2% with placebo) and body pain (3.9% vs. 1.7% with placebo). Fever (2.8% v. 1.4% with placebo) and chills (1.8% vs. 0.7% with placebo) have also been reported. The therapy-related dropout rate was 3.5% and the placebo therapy-related dropout rate was 2.7%. The adverse drug experience on terconazole most frequently causing discontinuation was burning (2.5% vs. 1.4% with placebo) and pruritus (1.8% vs. 1.4% with placebo).
Overdose of terconazole in humans has not been reported to date. In the rat, the oral LD 50 values were found to be 1741 and 849 mg/kg for the male and female, respectively.
The oral LD 50 values for the male and female dog were 1280 and ≥ 640 mg/kg, respectively.
One Zazole® Vaginal Suppository (terconazole vaginal suppositories 80 mg) should be administered intravaginally once daily at bedtime for three consecutive days.
Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of terconazole vaginal suppositories is not affected by menstruation.
Zazole® Vaginal Suppositories (terconazole vaginal suppositories 80 mg are available in 2.5 g, elliptically shaped white to off-white suppositories in packages of three with a vaginal applicator.
NDC 0462-0348-03
Store at 20°-25° C (68°-77° F) [see USP Controlled Room Temperature].
PharmaDerm®
a division of ALTANA Inc
Duluth, GA 30096 USA
www.pharmaderm.com
IF8384A
R12/05
#34
--------------------
Zazole®Vaginal Suppositories (terconazole vaginal suppositories, 80 mg)
Three oval suppositories, for use inside the vagina only.
Designed to be inserted into the vagina.
HOW TO USE:
Place one suppository into the vagina each night at bedtime, for 3 nights, as directed by your doctor. The Zazole® Vaginal Suppository is self-lubricating and may be inserted with or without the applicator.
NOTE: Store the suppositories at at 20°-25° C (68°-77° F) [see USP Controlled Room Temperature]. See end flap for lot number and expiration date.
A WORD ABOUT YEAST INFECTIONS
Why do yeast infections occur?
Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive tract, and vagina.
Sometimes the natural balance of the vagina becomes upset. This may lead to rapid growth of Candida, which results in a yeast infection. Symptoms of a yeast infection include itching, burning, redness, and an abnormal discharge. Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope.
How can I prevent yeast infections?
Certain factors may increase your chance of developing a yeast infection. These factors don't actually cause the problem, but they may create a situation that allows the yeast to grow rapidly.
Controlling these factors can help eliminate yeast infections and may prevent them from coming back.
Some other helpful tips:
PharmaDerm®
a division of ALTANA Inc
Duluth, GA 30096 USA
www.pharmaderm.com
R12/05
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Generic Name: acetaminophen and hydrocodone (a SEET a MIN oh fen and hye droe KOE done)
Brand Names: Anexsia, Co-Gesic, Hycet, Liquicet, Lorcet 10/650, Lorcet Plus, Lortab 10/500, Lortab 2.5/500, Lortab 5/500, Lortab 7.5/500, Lortab Elixir, Maxidone, Norco, Polygesic, Stagesic, Vicodin, Vicodin ES, Vicodin HP, Xodol, Zamicet, Zolvit, Zydone
Hydrocodone is in a group of drugs called narcotic pain relievers.
Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.
The combination of acetaminophen and hydrocodone is used to relieve moderate to severe pain.
Acetaminophen and hydrocodone may also be used for purposes not listed in this medication guide.
To make sure you can safely take acetaminophen and hydrocodone, tell your doctor if you have any of these other conditions:
asthma, COPD, sleep apnea, or other breathing disorders;
liver or kidney disease;
a history of head injury or brain tumor;
low blood pressure;
a stomach or intestinal disorder;
underactive thyroid;
Addison's disease or other adrenal gland disorder;
curvature of the spine;
mental illness; or
a history of drug or alcohol addiction.
One acetaminophen and hydrocodone tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.
Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Acetaminophen can cause false results with certain lab tests for glucose (sugar) in the urine. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.
If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and hydrocodone. You may need to stop using the medicine for a short time.
Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.
Since acetaminophen and hydrocodone is taken 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing
shallow breathing, slow heartbeat;
feeling light-headed, fainting;
confusion, fear, unusual thoughts or behavior;
seizure (convulsions);
problems with urination; or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
anxiety, dizziness, drowsiness;
mild nausea, vomiting, upset stomach, constipation;
headache, mood changes;
blurred vision;
ringing in your ears; or
dry mouth.
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 about all other medicines you use, especially:
an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;
an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).
This list is not complete and other drugs may interact with acetaminophen and hydrocodone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Maxidone side effects (in more detail)
Co-Quinapril EG may be available in the countries listed below.
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In the US, Covera-HS (verapamil systemic) is a member of the following drug classes: calcium channel blocking agents, group IV antiarrhythmics and is used to treat Angina, Arrhythmia, Bipolar Disorder, Cluster Headaches, High Blood Pressure, Idiopathic Hypertrophic Subaortic Stenosis, Migraine Prevention, Nocturnal Leg Cramps and Supraventricular Tachycardia.
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DAN-troe-leen
Dantrolene has a potential for hepatotoxicity and symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels of the drug. Risk of hepatic injury appears to be greater in patients taking a higher dosage (800 mg or more per day), in females, in patients over 35 years of age, and in patients taking other medication(s) in addition to dantrolene. Monitor hepatic function including frequent determination of SGOT or SGPT during therapy. Discontinue therapy after 45 days if no observable benefit is derived from therapy .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Skeletal Muscle Relaxant, Direct Acting
Dantrolene is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by certain medical problems such as multiple sclerosis (MS), cerebral palsy, stroke, or injury to the spine. Dantrolene does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition. Dantrolene acts directly on the muscles to produce its relaxant effects.
Dantrolene is also used to prevent or treat a medical problem called malignant hyperthermia that may occur in some patients during or following surgery or anesthesia. Malignant hyperthermia consists of a group of symptoms including very high fever, fast and irregular heartbeat, and breathing problems. It is believed that the tendency to develop malignant hyperthermia is inherited.
dantrolene 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 dantrolene, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to dantrolene 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.
Appropriate studies have not been performed on the relationship of age to the effects of dantrolene in children below 5 years of age. Safety and efficacy have not been established.
No information is available on the relationship of age to the effects of dantrolene in geriatric patients.
| 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. |
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.
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 dantrolene, 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 dantrolene with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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 dantrolene. Make sure you tell your doctor if you have any other medical problems, especially:
Dantrolene may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.
Take dantrolene only as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered.
The dose of dantrolene 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 dantrolene. 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 dantrolene, 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.
If you will be taking dantrolene for a long time (e.g., several months at a time), your doctor should check your progress at regular visits. Blood tests will be needed to check for unwanted effects.
dantrolene will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using dantrolene.
dantrolene may cause drowsiness, dizziness or lightheadedness, vision problems, or muscle weakness in some people. Make sure you know how you react to dantrolene before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert, well-coordinated, and able to see well.
dantrolene may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
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. Serious side effects are very rare when dantrolene is taken for a short time, for example, when it is used for a few days before, during, or after surgery or anesthesia to prevent or treat malignant hyperthermia. However, serious side effects may occur, especially when the medicine is taken for a long time.
Check with your doctor immediately 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.
See also: dantrolene side effects (in more detail)
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.
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Cinkamin may be available in the countries listed below.
Amikacin is reported as an ingredient of Cinkamin in the following countries:
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Itraconazole 100mg Capsules, Hard
Itraconazole capsules are indicated for the treatment of fungal infections of the vagina, skin, mouth, eyes, nails and internal organs.
The active substance is itraconazole, a member of the following pharmaco-therapeutic class of drugs: Antimycotic for systemic use, triazole derivatives.
Itraconazole is very effective against a variety of infections caused by yeasts and fungi.
It has great affinity for highly keratinized tissues such as skin and nails, as well as for the vaginal wall lining.
Therapeutic levels of itraconazole remain in the skin for two to four weeks following the end of treatment, depending on its duration.
In vaginal tissue, itraconazole can be found for a period of two to three days, again depending on the duration of treatment.
Children should not be given itraconazole, except for exceptional situations as assessed by the doctor.
Please inform your doctor if you:
The dose may have to be adjusted if you:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Examples of drugs that should never be taken with itraconazole include:
Certain drugs can drastically decrease the action of itraconazole. This is particularly true of certain drugs used to treat epilepsy (carbamazepine, phenytoin and phenobarbital) and tuberculosis (rifampicin, riphabutin and isoniazid).
Inform your doctor if you are taking any of these drugs so that proper measures may be taken.
Examples of drug combinations that may require adjusting the dose of itraconazole or of the other drugs:
Proper absorption of itraconazole by the human body requires an adequate level of acidity. Therefore, drugs that inhibit stomach acid must not be taken for a period of two hours preceding itraconazole. For the same reason, if you are taking medication to decrease the formation of stomach acids, take itraconazole with a cola drink.
Bear in mind that these instructions may also apply to medication you took before or may take after.
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Itraconazole capsules if you are pregnant. Women of childbearing age who may become pregnant must use proper contraception to ensure they do not get pregnant while under treatment with itraconazole.
Contraception should be used through the first normal menstrual cycle following termination of itraconazole treatment, as the drug can remain in the system for some time.
Ask your doctor or pharmacist for advice before taking any medicine.
Inform your doctor if you are breast-feeding and are prescribed Itraconazole capsules, as small amounts of the drug may be present in milk.
For maximum drug absorption itraconazole should be taken immediately following a meal.
No studies on the effects on the ability to drive and use machines have been performed.
This medicine contains the sugar sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take Itraconazole capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Itraconazole must be taken immediately following a meal for optimum absorption. Capsules should be swallowed with a small amount of water.
The number of capsules and the duration of treatment will depend on the fungus and on the location of infection. Your doctor will tell you exactly what dose to take.
The following table lists some of the more frequent dosages:
For nail infections, depending on your specific requirements, your doctor may opt for continuous or pulse treatment:
Drug effects are not immediate.
In skin infections, lesions normally disappear a few weeks after treatment is suspended. This is characteristic of fungus lesions as the drug will eliminate the fungus but the lesions will remain until new skin grows.
Nail lesions will disappear six to nine months after treatment, as the drug will eliminate the fungus but new nail growth takes several months.
Do not worry if you see no improvement during the treatment. The drug will remain in your nails for several months and is doing its job.
Suspend treatment as soon as your doctor tells you to, even if you see no visible signs of improvement.
For infections of internal organs higher doses and longer treatment times may be required.
Do not forget to take your medication.
Follow these instructions unless your doctor tells you otherwise. Your doctor will tell you how long you should take Itraconazole capsules.
Do not interrupt treatment before being advised to do so by your doctor or cure may not be complete.
Immediately consult your doctor or pharmacist if you take more Itraconazole capsules than you should.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Itraconazole capsules can cause side effects, although not everybody gets them.
The following side effects can occur:
Common (affects 1 to 10 users in 100):
Uncommon (affects 1 to 10 users in 1,000):
Very rare (affects less than 1 user in 10,000):
Not known (frequency cannot be estimated from the available data):
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Itraconazole capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Itraconazole capsules is presented in the form of hard gelatin capsules containing micro-granules.
The active substance is itraconazole. Each capsule contains 100mg of itraconazole (I.N.N.).
The other ingredients are:
Capsule contents: sugar spheres (maize starch and sucrose), poloxamer 188 and hypromellose
Capsule shell: indigo carmine (E 132), quinoline yellow (E 104), titanium dioxide (E 171) and gelatin.
Itraconazole capsules are opaque green and are available in blister packs of 15
This leaflet was last revised in: June 2009
LICPL007
Brumeton Colloidale S may be available in the countries listed below.
Betamethasone is reported as an ingredient of Brumeton Colloidale S in the following countries:
Sulfacetamide sodium salt (a derivative of Sulfacetamide) is reported as an ingredient of Brumeton Colloidale S in the following countries:
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Patriot Insecticide Ear Tag may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Dimpylate is reported as an ingredient of Patriot Insecticide Ear Tag in the following countries:
International Drug Name Search
Bercetina may be available in the countries listed below.
Flunarizine dihydrochloride (a derivative of Flunarizine) is reported as an ingredient of Bercetina in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
In the US, Bromocriptine (bromocriptine systemic) is a member of the following drug classes: dopaminergic antiparkinsonism agents, prolactin inhibitors and is used to treat Acromegaly, Diabetes - Type 2, Hyperprolactinemia and Parkinson's Disease.
US matches:
Rec.INN
G02CB01,N04BC01
0025614-03-3
C32-H40-Br-N5-O5
654
Prolactin inhibitor
Treatment of Parkinson's disease: Dopaminergic
Ergotaman-3',6',18-trione, 2-bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpropyl)-, (5'α)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Calcianta may be available in the countries listed below.
Nifedipine is reported as an ingredient of Calcianta in the following countries:
International Drug Name Search
Xazal may be available in the countries listed below.
Levocetirizine dihydrochloride (a derivative of Levocetirizine) is reported as an ingredient of Xazal in the following countries:
International Drug Name Search
Generic Name: sodium fluoride (Oral route, Dental route, Oromucosal route)
SOE-dee-um FLOOR-ide
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Cariostatic
Fluoride has been found to be helpful in reducing the number of cavities in the teeth. It is usually present naturally in drinking water. However, some areas of the country do not have a high enough level in the water to prevent cavities. To make up for this, extra fluoride may be added to the diet. Some children may require both dietary fluoride and topical fluoride treatments by the dentist. Use of a fluoride toothpaste or rinse may be helpful as well.
Taking extra oral fluoride does not replace good dental habits. These include eating a good diet, brushing and flossing the teeth often, and having regular dental checkups.
Fluoride may also be used for other conditions as determined by your doctor.
This medicine is available only with a prescription.
For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.
People get needed fluoride from fish, including the bones, tea, and drinking water that has fluoride added to it. Food that is cooked in water containing fluoride or in Teflon-coated pans also provides fluoride. However, foods cooked in aluminum pans provide less fluoride.
The daily amount of fluoride needed is defined in several different ways.
There is no RDA or RNI for fluoride. Daily recommended intakes for fluoride are generally defined as follows:
Remember:
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.
Problems in children have not been reported with intake of normal daily recommended amounts. Doses of sodium fluoride that are too large or are taken for a long time may cause bone problems and teeth discoloration in children.
Problems in older adults have not been reported with intake of normal daily recommended amounts. Older people are more likely to have joint pain, kidney problems, or stomach ulcers which may be made worse by taking large doses of sodium fluoride. You should check with your health care professional.
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
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:
This section provides information on the proper use of a number of products that contain sodium fluoride. It may not be specific to Fluoridex Daily Defense. Please read with care.
Take this medicine only as directed by your health care professional. Do not take more of it and do not take it more often than ordered. Taking too much fluoride over a period of time may cause unwanted effects.
For individuals taking the chewable tablet form of this medicine:
For individuals taking the oral liquid form of this medicine:
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.
The level of fluoride present in the water is different in different parts of the U.S. If you move to another area, check with a health care professional in the new area as soon as possible to see if this medicine is still needed or if the dose needs to be changed. Also, check with your health care professional if you change infant feeding habits (e.g., breast-feeding to infant formula), drinking water (e.g., city water to nonfluoridated bottled water), or filtration (e.g., tap water to filtered tap water).
Do not take calcium supplements or aluminum hydroxide–containing products and sodium fluoride at the same time. It is best to space doses of these two products 2 hours apart, to get the full benefit from each medicine.
Inform your health care professional as soon as possible if you notice white, brown, or black spots on the teeth. These are signs of too much fluoride in children when it is given during periods of tooth development.
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:
Sodium fluoride in drinking water or taken as a supplement does not usually cause any side effects. However, taking an overdose of fluoride may cause serious problems.
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:
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.
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