Lipitor Paranova may be available in the countries listed below.
Atorvastatin calcium (a derivative of Atorvastatin) is reported as an ingredient of Lipitor Paranova in the following countries:
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Donashin may be available in the countries listed below.
Doxazosin mesilate (a derivative of Doxazosin) is reported as an ingredient of Donashin in the following countries:
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Generic Name: betaxolol ophthalmic (bay TAX oh lol off THAL mik)
Brand Names: Betoptic S
Betaxolol is a beta-blocker that reduces pressure inside the eye.
Betaxolol ophthalmic may also be used for other purposes not listed in this medication guide.
Before using this medication, tell your doctor if you have breathing problems such as bronchitis or emphysema, a history of heart disease or congestive heart failure, diabetes, history of stroke, blood clot, or circulation problems, a thyroid disorder, or a muscle disorder such as myasthenia gravis.
Betaxolol ophthalmic is sometimes given together with other eye medications. Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using betaxolol ophthalmic. Do not use the medications at the same time.
asthma, or severe chronic obstructive pulmonary disease (COPD);
slow heartbeats; or
a heart condition called "AV block."
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
breathing problems such as bronchitis or emphysema;
a history of heart disease or congestive heart failure;
diabetes;
history of stroke, blood clot, or circulation problems;
a thyroid disorder; or
a muscle disorder such as myasthenia gravis.
Use betaxolol ophthalmic exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.
To apply the eye drops:
Tilt your head back slightly and pull down your lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.
Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.
Overdose symptoms may include slow heart rate, feeling short of breath, swelling, rapid weight gain, or fainting.
Betaxolol ophthalmic is sometimes given together with other eye medications. Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using betaxolol ophthalmic. Do not use the medications at the same time.
severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;
drainage, crusting, or oozing of your eyes or eyelids;
bronchospasm (wheezing, chest tightness, trouble breathing);
slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
feeling short of breath, even with mild exertion; or
swelling, rapid weight gain.
Less serious side effects may include:
mild burning, stinging, itching, or discomfort of your eyes;
dry eyes, blurred vision;
mildly swollen or puffy eyes;
feeling like something is in your eye;
headache, dizziness, spinning sensation;
depression;
sleep problems (insomnia);
muscle weakness; or
altered sense of taste or smell.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Before using betaxolol ophthalmic, tell your doctor if you are using any of the following drugs:
oral betaxolol (Blocadren);
digoxin (digitalis, Lanoxin);
reserpine;
insulin or diabetes medications you take by mouth;
any other beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others;
a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan); or
medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), or thioridazine (Mellaril).
This list is not complete and there may be other drugs that can interact with betaxolol ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: Betoptic S side effects (in more detail)
Indacin may be available in the countries listed below.
Indometacin is reported as an ingredient of Indacin in the following countries:
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Heptadon may be available in the countries listed below.
Methadone hydrochloride (a derivative of Methadone) is reported as an ingredient of Heptadon in the following countries:
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Trivetrin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadoxine is reported as an ingredient of Trivetrin in the following countries:
Trimethoprim is reported as an ingredient of Trivetrin in the following countries:
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A.A.S. 500 may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of A.A.S. 500 in the following countries:
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Amoxicillin Stada may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicillin Stada in the following countries:
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Cadtre may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Cadtre in the following countries:
Colecalciferol is reported as an ingredient of Cadtre in the following countries:
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Zyncet may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Zyncet in the following countries:
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Estramustin Stada may be available in the countries listed below.
Estramustine 17ß-(disodium phosphate) (a derivative of Estramustine) is reported as an ingredient of Estramustin Stada in the following countries:
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Biltricide® (praziquantel) is a trematodicide provided in tablet form for the oral treatment of schistosome infections and infections due to liver fluke.
Biltricide (praziquantel) is 2-(cyclohexylcarbonyl)-1,2,3,6,7, 11b-hexahydro-4H-pyrazino [2, 1-a] isoquinolin-4-one with the molecular formula; C19H24N2O2. The structural formula is as follows:
Praziquantel is a white to nearly white crystalline powder of bitter taste. The compound is stable under normal conditions and melts at 136-140°C with decomposition. The active substance is hygroscopic. Praziquantel is easily soluble in chloroform and dimethylsulfoxide, soluble in ethanol and very slightly soluble in water.
Biltricide tablets contain 600 mg of praziquantel. Inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, polyethylene glycol, titanium dioxide and hypromellose.
Praziquantel induces a rapid contraction of schistosomes by a specific effect on the permeability of the cell membrane. The drug further causes vacuolization and disintegration of the schistosome tegument.
After oral administration Biltricide is rapidly absorbed (80%), subjected to a first pass effect, metabolized and eliminated by the kidneys. Maximal serum concentration is achieved 1-3 hours after dosing. The half-life of praziquantel in serum is 0.8-1.5 hours.
The pharmacokinetics of praziquantel were studied in 40 patients with Schistosoma mansoni infections with varying degrees of hepatic dysfunction (See table1). In patients with schistosomiasis, the pharmacokinetic parameters did not differ significantly between those with normal hepatic function (Group 1) and those with mild (Child-Pugh class A) hepatic impairment. However, in patients with moderate-to-severe hepatic dysfunction (Child-Pugh class B and C), praziquantel half-life, Cmax, and AUC increased progressively with the degree of hepatic impairment. In Child-Pugh class B, the increases in mean half-life, Cmax, and AUC relative to Group 1 were 1.58-fold, 1.76-fold, and 3.55-fold, respectively. The corresponding increases in Child-Pugh class C patients were 2.82-fold, 4.29-fold, and 15-fold for half-life, Cmax, and AUC.
| Patient Group | Half-life (hr) | Tmax (hr) | Cmax (µg/mL) | AUC (µg/mL* hr) |
| a) p<0.05 compared to Group 1 | ||||
| b) p<0.05 compared to Group 2 | ||||
| c) p<0.05 compared to Group 3 | ||||
| Normal hepatic function (Group 1) | 2.99 ± 1.28 | 1.48 ± 0.74 | 0.83 ± 0.52 | 3.02 ± 0.59 |
| Child-Pugh A (Group 2) | 4.66 ± 2.77 | 1.37 ± 0.61 | 0.93 ± 0.58 | 3.87 ± 2.44 |
| Child-Pugh B (Group 3) | 4.74 ± 2.16a | 2.21 ± 0.78a,b | 1.47 ± 0.74a,b | 10.72 ± 5.53a,b |
| Child-Pugh C (Group 4) | 8.45 ± 2.62a,b,c | 3.2 ± 1.05a,b,c | 3.57 ± 1.30a,b,c | 45.35 ± 17.50a,b,c |
Biltricide is indicated for the treatment of infections due to: all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium), and infections due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini (approval of this indication was based on studies in which the two species were not differentiated).
Biltricide is contraindicated in patients who previously have shown hypersensitivity to the drug or any of the excipients. Since parasite destruction within the eye may cause irreversible lesions, ocular cysticercosis must not be treated with this compound.
Concomitant administration with strong Cytochrome P450 (P450) inducers, such as rifampin, is contraindicated since therapeutically effective blood levels of praziquantel may not be achieved (see PRECAUTIONS/Drug Interactions). In patients receiving rifampin who need immediate treatment for schistosomiasis, alternative agents for schistosomiasis should be considered. However, if treatment with praziquantel is necessary, rifampin should be discontinued 4 weeks before administration of praziquantel. Treatment with rifampin can then be restarted one day after completion of praziquantel treatment (see PRECAUTIONS/Drug Interactions).
Therapeutically effective levels of Biltricide may not be achieved when administered concomitantly with strong P450 inducers, such as rifampin (see CONTRAINDICATIONS).
Approximately 80% of a dose of praziquantel is excreted in the kidneys, almost exclusively (>99%) in the form of metabolites. Excretion might be delayed in patients with impaired renal function, but accumulation of unchanged drug would not be expected. Therefore, dose adjustment for renal impairment is not considered necessary. Nephrotoxic effects of praziquantel or its metabolites are not known.
Caution should be exercised in the administration of the usual recommended dose of praziquantel to hepatosplenic schistosomiasis patients with moderate to severe liver impairment (Child-Pugh class B and C). Reduced metabolism of praziquantel by the liver in these patients may lead to considerably higher and longer lasting plasma concentrations of unmetabolized praziquantel (See CLINICAL PHARMACOLOGY/Special Populations).
Minimal increases in liver enzymes have been reported in some patients.
Patients suffering from cardiac irregularities should be monitored during treatment.
As Biltricide can exacerbate central nervous system pathology due to schistosomiasis, as a general rule this drug should not be administered to individuals reporting a history of epilepsy and/or other signs of potential central nervous systems involvement such as subcutaneous nodules suggestive of cysticercosis.
When schistosomiasis or fluke infection is found to be associated with cerebral cysticercosis it is advised to hospitalize the patient for the duration of treatment.
Patients should be warned not to drive a car and not to operate machinery on the day of Biltricide treatment and the following day.
Concomitant administration of rifampin, a strong P450 inducer, with praziquantel is contraindicated and must be avoided (see CONTRAINDICATIONS). In a crossover study with a 2-week washout period, 10 healthy subjects ingested a single 40 mg/kg dose of praziquantel following pre-treatment with oral rifampin (600 mg daily for 5 days). Plasma praziquantel concentrations were undetectable in 7 out of 10 subjects. When a single 40 mg/kg dose of praziquantel was administered to these healthy subjects two weeks after discontinuation of rifampin, the mean praziquantel AUC and Cmax were 23% and 35% lower, respectively, than when praziquantel was given alone. In patients receiving rifampin, for example, as part of a combination regimen for the treatment of tuberculosis, alternative agents for schistosomiasis should be considered. However, if treatment with praziquantel is necessary, treatment with rifampin should be discontinued 4 weeks before administration of praziquantel. Treatment with rifampin can then be restarted one day after completion of praziquantel treatment.
Concomitant administration of other drugs that increase the activity of drug metabolizing liver enzymes (P450 inducers), for example, antiepileptic drugs (phenytoin, phenobarbital and carbamazepine), and dexamethasone, may also reduce plasma levels of praziquantel. Concomitant administration of drugs that decrease the activity of drug metabolizing liver enzymes (P 450 inhibitors), for example, cimetidine, ketoconazole, itraconazole, erythromycin may increase plasma levels of praziquantel.
Chloroquine, when taken simultaneously, may lead to lower concentrations of praziquantel in blood. The mechanism of this drug-drug interaction is unclear.
Grapefruit juice was reported to produce a 1.6-fold increase in the Cmax and a 1.9-fold increase in the AUC of praziquantel. However, the effect of this exposure increase on the therapeutic effect and safety of praziquantel has not been systematically evaluated.
Mutagenic effects in Salmonella tests found by one laboratory have not been confirmed in the same tested strain by other laboratories. Long term carcinogenicity studies in rats and golden hamsters did not reveal any carcinogenic effect.
Reproduction studies have been performed in rats and rabbits at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to praziquantel. There are, however, no adequate and well-controlled studies in pregnant women. An increase of the abortion rate was found in rats at three times the single human therapeutic dose. While animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Praziquantel appeared in the milk of nursing women at a concentration of about 1/4 that of maternal serum although it is not known, whether a pharmacological effect is likely to occur in children. Women should not nurse on the day of Biltricide treatment and during the subsequent 72 hours.
Safety in children under 4 years of age has not been established.
Clinical studies of praziquantel did not include a sufficient number of subjects ages 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, but greater sensitivity of some older patients cannot be ruled out.
This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, the risk of toxic reactions to this drug may be greater in these patients.
In general Biltricide is very well tolerated. Side effects are usually mild and transient and do not require treatment. The following side effects were observed generally in order of severity: malaise, headache, dizziness, abdominal discomfort with or without nausea, rise in temperature and, rarely, urticaria. Such symptoms can, however, also result from the infection itself. Such side effects may be more frequent and/or serious in patients with a heavy worm burden.
Additional adverse events reported from worldwide post marketing experience and from publications with praziquantel include: abdominal pain, allergic reaction (generalized hypersensitivity) including polyserositis, anorexia, arrhythmia (including bradycardia, ectopic rhythms, ventricular fibrillation, AV blocks), asthenia, bloody diarrhea, convulsion, eosinophilia, myalgia, pruritis, somnolence, vertigo and vomiting.
In rats and mice the acute LD50 was about 2,500 mg/kg. No data are available in humans. In the event of overdose a fast-acting laxative should be given.
The dosage recommended for the treatment of schistosomiasis is: 20 mg/kg bodyweight three times a day as a one day treatment, at intervals of not less than 4 hours and not more than 6 hours. The recommended dose for clonorchiasis and opisthorchiasis is: 25 mg/kg bodyweight three times a day as a one day treatment, at intervals of not less than 4 hours and not more than 6 hours. The tablets should be washed down unchewed with water during meals. Keeping the tablets or segments thereof in the mouth can reveal a bitter taste which can promote gagging or vomiting.
Biltricide is supplied as a 600 mg white to orange tinged, film-coated, oblong tablet with three scores. The tablet is coded with “BAYER” on one side and “LG” on the reverse side. When broken, each of the four segments contains 150 mg of active ingredient so that the dosage can be easily adjusted to the patient’s bodyweight.
Segments are broken off by pressing the score (notch) with thumbnails. If 1/4 of a tablet is required, this is best achieved by breaking the segment from the outer end.
Biltricide is available in bottles of 6 tablets.
| Bottles of 6 | Strength 600 mg | NDC 50419-747-01 |
| Store below 86°F (30°C). |
Manufactured for:
Bayer HealthCare Pharmaceuticals Inc.
Wayne, NJ 07470
Manufactured in Germany
Biltricide is a registered trademark of Bayer Aktiengesellschaft.
Rx Only
04/11
©2011 Bayer HealthCare Pharmaceuticals Inc. Printed in USA
Biltricide 600 mg Tablets Bottle Label
8339661 NDC 50419-747-01
Biltricide®
Tablets
(praziquantel)
600 mg
6 Tablets
Rx Only
| Biltricide praziquantel tablet, film coated | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA018714 | 04/21/2011 | |
| Labeler - Bayer HealthCare Pharmaceuticals Inc. (828111489) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bayer Schering Pharma AG | 341081414 | MANUFACTURE | |
Endocorion may be available in the countries listed below.
Chorionic Gonadotrophin is reported as an ingredient of Endocorion in the following countries:
International Drug Name Search
Prazosin-ratiopharm may be available in the countries listed below.
Prazosin hydrochloride (a derivative of Prazosin) is reported as an ingredient of Prazosin-ratiopharm in the following countries:
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Lysocalmspray may be available in the countries listed below.
Cetrimide is reported as an ingredient of Lysocalmspray in the following countries:
Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Lysocalmspray in the following countries:
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Bimectin (ivermectin) Pour-On applied at the recommended dose level of 500 mcg/kg is indicated for the effective treatment and control of these parasites.
Gastrointestinal Roundworms
Ostertagia ostertagi (adults and L4)
(indcluding inhibited state)
Haemonchus placei (adults and L4)
Trichostrongylus axei (adults and L4)
Cooperia oncophora (adults and L4)
Cooperia punctata (adults and L4)
Cooperia surnabada (adults and L4)
Strongyloides papillosus (adults)
Oesophagostomum radiatum (adults and L4)
Lungworms
Dictyocaulus viviparus (adults and L4)
Cattle Grubs
Hypoderma bovis
Mites
Sarcoptes scabei var. bovis
Lice
Lingonathus vituli
Haematopinus eurysternus
Damalia bovis
Solenopotes capillatus
Horn Flies
Haematobia irritans
Dosage: The dose rate is 1 mL for each 22lb of body weight. The formulation should be applied along the topline in a narrow strip extending from the withers to the tailhead.
Administration: Squeeze-Measure-Pour System (1 Liter Bottle with 25 mL Measuring Cap)
Attach metering cap to the bottle.
Select the correct dose rate by rotating the adjuster cap in either direction to position the dose indicator to the appropriate dose.
Gently squeeze the bottle to fill to level (any excess will return to the bottle) and then tip and apply to animal along the topline.
BackPack (84.5 fl oz/2.5 Liter Pack and 169 fl. oz/5 Liter Pack.
Connect the applicator gun to the backpack as follows: Attach the open end of the draw-off tubing to the dosing equipment. (Because of the solvents used in the formulation, only the Protector Drench Gun from Instrument Supplies Limited, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage).
Replace the shipping cap with the draw-off cap and tighten down.
Attach draw-off tubing to the draw-off cap.
Gently prime the applicator gun, checking for leaks.
Follow the manufacturer's directions for adjusting the dose.
When the interval between uses of the applicator gun is expected to exceed 12 hours, disconnect the gun and draw-off tubing from the product container and empty the product from the gun and tubing back into the product container. To prevent removal of special lubricants from the Protector Drench Gun, the gun and tubing must not be washed.
Free standing 338 fl. oz./10 Liter bottle and 676 fl. oz./20 Liter bottle
Connect the applicator gun to the 338 fl. oz./10 L and 676 fl. oz./20 L bottle as follows: Attach the open end of the draw-off tubing to the dosing equipment. (Because of the solvents used in the formulation, only the Protector Drench Gun from Instrument Supply Limited, or equivalent is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage.)
Replace the shipping cap with the draw-off cap.
Gently prime the applicator gun, checking for leaks.
Follow the manufacturer's directions for adjusting the dose.
When the interval between uses of the applicator gun is expected to exceed 12 hours, disconnect the gun and draw-off tubing from the product container and empty the product from the gun and tubing back into the product container. To prevent removal of special lubricants from the Protector Drench Gun, the gun and tubing must not be washed.
Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channel, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The margin of safety of compounds of this class is attributable to the fact that mammals do not have the glutamate-gated chloride channel, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channel and they do not readily cross the blood-brain barrier.
Studies conducted in the U.S.A. have demonstrated the safety margin of ivermectin. Based on the plasma levels, the topically applied formulation is expected to be at least as well tolerated by breeding animals as is the subcutaneous formulation which had no effect on breeding performance.
Cattle must not be treated within 48 days of slaughter for human consumption. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
WARNING! NOT FOR USE IN HUMANS.
The product should not be applied to self or others because it may be irritating to human skin and eyes and absorbed through the skin. To minimize accidental skin contact, the user should wear a long-sleeved shirt and rubber gloves. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water and seek medical attention.
Keep this and all drugs out of the reach of children.
The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report advers effects, obtain an MSDS or for assistance contact Bimeda, Inc. at 1-888-524-6332.
WARNING! FLAMMABLE!
KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME, AND OTHER SOURCES OF IGNITION.
Studies indicate that when ivermectin comes in contact with soil, it readily and tightly binds too the soil and becomes inactive over time. Free ivermectin may adversely affect fish or certain aquatic organisms. Do not permit cattle to enter lakes, streams, or ponds for at least 6 hours after treatment. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.
As with other avermectins, ivermectin is excreted in the dung or treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependant insects.
Bimectin (ivermectin) Pour-On is available in a 33.8 fl oz/1 liter bottle with a measure-pour system, an 84.5 fl. oz/2.5 Liter, a 169 fl. oz/5 Liter, a 338 fl. oz/10 Liter bottle and a 676 fl. oz./20 Liter bottle intended for use with appropriate automatic dosing equipment.
Bimectin
(ivermectin)
Pour-On for Cattle
Contains 5 mg ivermectin/mL
Parasiticide
Kills: Roundworms (including Brown Stomach Worm), Lungworms, Grubs, Sucking Lice, Biting Lice, Mange Mites, Horn Flies
Net Contents: 169 fl oz (5 Liter)
WARNING! FLAMMABLE! KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME AND OTHER SOURCES OF IGNITION.
WARNING! NOT FOR USE IN HUMANS.
ANADA 200-318, Approved by FDA
Bimeda
| Bimectin POUR-ON ivermectin solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANADA | ANADA200318 | 10/01/2009 | |
| Labeler - Bimeda, Inc. Division of Cross Vetpharm Group (043653216) |
Generic Name: olmesartan (Oral route)
ol-me-SAR-tan me-DOX-oh-mil
Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Cardiovascular Agent
Pharmacologic Class: Angiotensin II Receptor Antagonist
Olmesartan is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure also may increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.
Olmesartan is an angiotensin II receptor blocker. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, olmesartan relaxes blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of olmesartan in children.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olmesartan in the elderly.
| Pregnancy Category | Explanation | |
|---|---|---|
| 1st Trimester | 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. |
| 2nd Trimester | D | Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. |
| 3rd Trimester | D | Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. |
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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines 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.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
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.
In addition to taking this medicine, treatment for your high blood pressure may include weight control and a change in the foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.
Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.
Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.
This medicine may be taken with or without food.
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.
It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.
Dizziness or lightheadedness may occur after the first dose of this medicine, especially if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.
Check with your doctor right away if you or your child become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water, which can lead to low blood pressure.
Dizziness, lightheadedness, or fainting may also occur if you or your child exercise or if the weather is hot. Heavy sweating may cause you to lose too much water or salt, which may cause low blood pressure. Use extra care during exercise or hot weather.
Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.
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 immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose 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: Benicar 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.
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.
brin-ZOE-la-mide
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Antiglaucoma
Pharmacologic Class: Carbonic Anhydrase Inhibitor
Brinzolamide ophthalmic (eye) drops is used to treat increased pressure in the eye caused by open-angle glaucoma or a condition called ocular hypertension. Both eye conditions are caused by high pressure in your eye and can lead to pain from pressure in your eye and then can eventually harm your vision. brinzolamide can help you keep your sight by reducing the pressure in your eye and stopping eye pain.
brinzolamide 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 brinzolamide, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to brinzolamide 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 brinzolamide eye drops in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of brinzolamide eye drops in the elderly.
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 brinzolamide. Make sure you tell your doctor if you have any other medical problems, especially:
Your eye doctor will tell you how much of brinzolamide to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
If you normally wear soft contact lenses, remove them before you use brinzolamide eye drops. Wait at least 15 minutes before putting the contact lenses back in.
To use the eye drops:
If your doctor ordered two different eye drops to be used together, wait at least 10 minutes between the times you apply the medicines. This will help to keep the second medicine from “washing out” the first one.
The dose of brinzolamide 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 brinzolamide. 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 brinzolamide, 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.
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
You may also keep the medicine in the refrigerator. Also, keep the bottle upright when you are not using it.
It is important that your doctor check your progress at regular visits to make sure that brinzolamide is working properly and is not causing unwanted effects.
If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor. These signs may mean that you are allergic to brinzolamide.
Serious allergic reactions may occur while using brinzolamide. Stop using brinzolamide and check with your doctor right away if you have any of the following symptoms: black, tarry stools; blistering, peeling, or loosening of the skin; chills; dark urine; joint or muscle pain; rash; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; unusual bleeding or bruising; unusual tiredness or weakness; or yellow eyes or skin.
If you hurt your eye, develop an eye infection, or need to have an eye surgery, talk with your doctor right away. Your doctor may want you to use a new bottle of the eye drops to help prevent an eye infection or keep an infection from getting worse.
brinzolamide may cause some people to have blurred vision for a short time. Make sure you know how you react to brinzolamide before you drive, use machines, or do anything else that could be dangerous if you cannot see properly. Also, since blurred vision may be a sign of a side effect that needs medical attention, check with your doctor if it continues.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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 immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose 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: brinzolamide Ophthalmic 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.
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.
Nimesulene may be available in the countries listed below.
Nimesulide is reported as an ingredient of Nimesulene in the following countries:
International Drug Name Search
Losartan Stada may be available in the countries listed below.
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Losartan Stada in the following countries:
International Drug Name Search
