Monday, 8 October 2012

chlorpheniramine and pseudoephedrine


Generic Name: chlorpheniramine and pseudoephedrine (klor fen EER a meen and soo doe e FED rin)

Brand names: AccuHist Drops, Allerest Maximum Strength, Brexin L.A., Colfed-A, D-Amine-SR, Dayquil Allergy, Deconamine, Dicel, Dicel Chewables, Dura-Tap/PD, Durafed, Duratuss DA, Dynahist-ER Pediatric, Genaphed Plus, Histade, Histex, Kronofed-A, Kronofed-A-Jr, LoHist-D, Mintex, Neutrahist Drops, Re2+30, Rescon-Ed, Suclor, SudaHist, Sudal-12 Chewable, Sudal-12 Tannate, Sudogest Cold & Allergy, SudoGest Sinus & Allergy, Tavist-DA, Triaminic Cold and Allergy, Triaminic Softchew Cold and Allergy, Triaminic Softchews Allergy Runny Nose and Congestion, ...show all 89 brand names.


What is chlorpheniramine and pseudoephedrine?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of chlorpheniramine and pseudoephedrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.


Chlorpheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about chlorpheniramine and pseudoephedrine?


There are many brands and forms of this medication available and not all brands are listed on this leaflet.


Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.


What should I discuss with my healthcare provider before taking chlorpheniramine and pseudoephedrine?


Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have:

  • severe or uncontrolled high blood pressure;




  • severe coronary artery disease;




  • narrow angle glaucoma;




  • a stomach ulcer;




  • if you are unable to urinate; or




  • if you are having an asthma attack.



Ask a doctor or pharmacist if it is safe for you to take this medication if you have:


  • kidney disease;

  • liver disease;


  • diabetes;




  • glaucoma;




  • circulation problems;




  • heart disease or high blood pressure;




  • overactive thyroid;




  • a seizure disorder such as epilepsy;




  • asthma, emphysema or chronic bronchitis; or




  • urination problems or an enlarged prostate.




FDA pregnancy category C. It is not known whether chlorpheniramine and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether chlorpheniramine and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.


How should I take chlorpheniramine and pseudoephedrine?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.


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.


Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.


This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.


If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since cold medicine 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 take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.


What should I avoid while taking chlorpheniramine and pseudoephedrine?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Chlorpheniramine and pseudoephedrine side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeats;




  • confusion, hallucinations, unusual thoughts or behavior;




  • severe dizziness, anxiety, restless feeling, nervousness;




  • urinating less than usual or not at all;




  • easy bruising or bleeding, unusual weakness; or




  • seizure (black-out or convulsions).



Less serious side effects may include:



  • blurred vision;




  • dry nose or mouth;




  • nausea, stomach pain, constipation, loss of appetite;




  • dizziness, drowsiness;




  • problems with memory or concentration;




  • ringing in your ears; or




  • feeling restless or excited (especially in children).



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.


Chlorpheniramine and pseudoephedrine Dosing Information


Usual Adult Dose for Allergic Rhinitis:

Chlorpheniramine-pseudoephedrine 2 mg-15 mg oral tablet, chewable:
2 tablets orally every 4 to 6 hours.

Chlorpheniramine-pseudoephedrine 2 mg-30 mg oral tablet, chewable:
2 tablets orally every 4 to 6 hours not to exceed 4 doses per day.

Chlorpheniramine-pseudoephedrine 4 mg-30 mg oral tablet, chewable, extended release:
1 to 2 tablets orally every 12 hours.

Chlorpheniramine-pseudoephedrine 5 mg-75 mg/5 mL oral suspension, extended release:
10 to 20 mL orally every 12 hours not to exceed 40 mL daily.

Chlorpheniramine-pseudoephedrine tannate 4 mg-30 mg oral tablet, chewable, extended release:
1 to 2 tablets orally every 12 hours.

Usual Adult Dose for Sinusitis:

Chlorpheniramine-pseudoephedrine 2 mg-15 mg oral tablet, chewable:
2 tablets orally every 4 to 6 hours.

Chlorpheniramine-pseudoephedrine 2 mg-30 mg oral tablet, chewable:
2 tablets orally every 4 to 6 hours not to exceed 4 doses per day.

Chlorpheniramine-pseudoephedrine 4 mg-30 mg oral tablet, chewable, extended release:
1 to 2 tablets orally every 12 hours.

Chlorpheniramine-pseudoephedrine 5 mg-75 mg/5 mL oral suspension, extended release:
10 to 20 mL orally every 12 hours not to exceed 40 mL daily.

Chlorpheniramine-pseudoephedrine tannate 4 mg-30 mg oral tablet, chewable, extended release:
1 to 2 tablets orally every 12 hours.

Usual Pediatric Dose for Allergic Rhinitis:

Chlorpheniramine-pseudoephedrine 0.8 mg-9 mg/mL oral liquid:
6 to 12 months: 0.5 mL orally four times daily not to exceed 4 doses per day.
1 to 2 years: 0.75 mL orally four times daily not to exceed 4 doses per day.
2 to 3 years: 1 mL orally four times daily not to exceed 4 doses per day.

Chlorpheniramine-pseudoephedrine 2 mg-15 mg oral tablet, chewable:
6 to 11 years: 1 tablet orally every 4 to 6 hours.
12 years or older: 2 tablets orally every 4 to 6 hours.

Chlorpheniramine-pseudoephedrine 2 mg-30 mg oral tablet, chewable
6 to 11 years: 1 tablet orally every 4 to 6 hours not to exceed 4 doses per day.
12 years or older: 2 tablets orally every 4 to 6 hours not to exceed 4 doses per day.

Chlorpheniramine-pseudoephedrine 4 mg-30 mg oral tablet, chewable, extended release:
2 to 5 years: 1/2 tablet orally every 12 hours.
6 to 11 years: 1/2 to 1 tablet orally every 12 hours.
12 years or older: 1 to 2 tablets orally every 12 hours.

Chlorpheniramine-pseudoephedrine 5 mg-75 mg/5 mL oral suspension, extended release:
2 to 5 years: 2.5 to 5 mL orally every 12 hours not to exceed 10 mL daily.
6 to 11 years: 5 to 10 mL orally every 12 hours not to exceed 20 mL daily.
12 years or older: 10 to 20 mL orally every 12 hours not to exceed 40 mL daily.

Chlorpheniramine-pseudoephedrine tannate 4 mg-30 mg oral tablet, chewable, extended release:
2 to 5 years: 1/2 tablet orally every 12 hours.
6 to 11 years: 1/2 to 1 tablet orally every 12 hours.
12 years or older: 1 to 2 tablets orally every 12 hours.

Usual Pediatric Dose for Sinusitis:

Chlorpheniramine-pseudoephedrine 0.8 mg-9 mg/mL oral liquid:
6 to 12 months: 0.5 mL orally four times daily not to exceed 4 doses per day.
1 to 2 years: 0.75 mL orally four times daily not to exceed 4 doses per day.
2 to 3 years: 1 mL orally four times daily not to exceed 4 doses per day.

Chlorpheniramine-pseudoephedrine 2 mg-15 mg oral tablet, chewable:
6 to 11 years: 1 tablet orally every 4 to 6 hours.
12 years or older: 2 tablets orally every 4 to 6 hours.

Chlorpheniramine-pseudoephedrine 2 mg-30 mg oral tablet, chewable
6 to 11 years: 1 tablet orally every 4 to 6 hours not to exceed 4 doses per day.
12 years or older: 2 tablets orally every 4 to 6 hours not to exceed 4 doses per day.

Chlorpheniramine-pseudoephedrine 4 mg-30 mg oral tablet, chewable, extended release:
2 to 5 years: 1/2 tablet orally every 12 hours.
6 to 11 years: 1/2 to 1 tablet orally every 12 hours.
12 years or older: 1 to 2 tablets orally every 12 hours.

Chlorpheniramine-pseudoephedrine 5 mg-75 mg/5 mL oral suspension, extended release:
2 to 5 years: 2.5 to 5 mL orally every 12 hours not to exceed 10 mL daily.
6 to 11 years: 5 to 10 mL orally every 12 hours not to exceed 20 mL daily.
12 years or older: 10 to 20 mL orally every 12 hours not to exceed 40 mL daily.

Chlorpheniramine-pseudoephedrine tannate 4 mg-30 mg oral tablet, chewable, extended release:
2 to 5 years: 1/2 tablet orally every 12 hours.
6 to 11 years: 1/2 to 1 tablet orally every 12 hours.
12 years or older: 1 to 2 tablets orally every 12 hours.


What other drugs will affect chlorpheniramine and pseudoephedrine?


Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

Tell your doctor about all other medications you use, especially:



  • mecamylamine (Inversine);




  • methyldopa (Aldomet);




  • reserpine;




  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;




  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or




  • an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others.



This list is not complete and other drugs may interact with chlorpheniramine and pseudoephedrine. 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.



More chlorpheniramine and pseudoephedrine resources


  • Chlorpheniramine and pseudoephedrine Side Effects (in more detail)
  • Chlorpheniramine and pseudoephedrine Use in Pregnancy & Breastfeeding
  • Drug Images
  • Chlorpheniramine and pseudoephedrine Drug Interactions
  • Chlorpheniramine and pseudoephedrine Support Group
  • 11 Reviews for Chlorpheniramine and pseudoephedrine - Add your own review/rating


Compare chlorpheniramine and pseudoephedrine with other medications


  • Hay Fever
  • Sinusitis


Where can I get more information?


  • Your pharmacist can provide more information about chlorpheniramine and pseudoephedrine.

See also: chlorpheniramine and pseudoephedrine side effects (in more detail)


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Sunday, 7 October 2012

Endo-Mectin





Dosage Form: FOR ANIMAL USE ONLY
Endo-Mectin®

Ivermectin 1% Sterile Solution

Injection for Cattle and Swine


ANADA 200-437, Approved by the FDA


A Parasiticide for the Treatment and Control of Internal and External Parasites of Cattle and Swine.


Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.



INTRODUCTION


Endo-Mectin® (ivermectin) Injection is an injectable parasiticide for cattle and swine. One low-volume dose effectively treats and controls the following internal and external parasites that may impair the health of cattle and swine: gastrointestinal roundworms (including inhibited Ostertagia ostertagi in cattle), lungworms, grubs, sucking lice, and mange mites of cattle; and gastrointestinal roundworms, lungworms, lice, and mange mites of swine. Ivermectin's convenience, broad-spectrum efficacy and safety margin make Endo-Mectin® Injection a unique product for parasite control of cattle and swine.



PRODUCT DESCRIPTION


Ivermectin is derived from the avermectins, a family of potent, broadspectrum antiparasitic agents isolated from fermentation of Streptomyces vermitilis.


Endo-Mectin® Injection is a clear, ready-to-use, sterile solution containing 1% ivermectin, 40% glycerol formal, and propylene glycol q.s. ad 100%. Endo-Mectin® Injection is formulated to deliver the recommended dose level of 200 mcg ivermectin/kilogram of body weight in cattle when given subcutaneously at the rate of 1 mL/110 lb (50 kg). In Swine, Endo-Mectin® Injection is formulated to deliver the recommended dose level of 300 mcg ivermectin/kilogram body weight when given subcutaneously in the neck at the rate of 1 mL per 75 lb (33 kg).



MODE OF ACTION


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 channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).


The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.



INDICATIONS



Cattle: Endo-Mectin® Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice, and mange mites in cattle:


Gastrointestinal Roundworms (adults and fourth-stage larvae):

Ostertagia ostertagi (including inhibited O. ostertagi)

O. lyrata

Haemonchus placei

Trichostrongylus axei

T. colubriformis

Cooperia oncophora

C. punctata

C. pectinata

Oesophagostomum radiatum

Bunostomum phlebotomum

Nematodirus helvetianus (adults only)

N. spathiger (adults only)


Lungworms (adults and fourth-stage larvae):

Dictyocaulus viviparus


Cattle Grubs (parasitic stages):

Hypoderma bovis

H. lineatum


Sucking Lice:

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus


Mites (scabies):

Psoroptes ovis (syn. P. communis var. bovis)

Sarcoptes scabiei var. bovis



Persistent Activity


Ivermectin injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostrongylus axei and Cooperia punctata for 21 days after treatment; Haemonchus placei and Cooperia oncophora for 14 days after treatment.



Swine: Endo-Mectin® Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice, and mange mites in swine:


Gastrointestinal Roundworms:

Large roundworm, Ascaris sum

(adults and fourth-stage larvae)

Red stomach worm, Hyostrongylus rubidus

(adults and fourth-stage larvae)

Nodular worm, Oesophagostomum spp.

(adults and fourth-stage larvae)

Threadworm, Strongyloides ransomi (adults)


Somatic Roundworm Larvae:

Threadworm, Strongyloides ransomi (somatic larvae)

Sows must be treated at least seven days before farrowing to prevent

infection in piglets.


Lungworms:

Metastrongylus spp. (adults)


Lice:

Haematopinus suis


Mange Mites:

Sarcoptes scabiei var. suis



DOSAGE



Cattle: Endo-Mectin® Injection should be given only by subcutaneous injection under the loose skin in front of or behind the shoulder at the recommended dose level of 200 mcg of ivermectin per kilogram of body weight. Each mL of Endo-Mectin® Injection contains 10 mg of ivermectin, sufficient to treat 110 lb (50 kg) of body weight (maximum 10 mL per injection site).






















Body Weight (lb)Dose Volume (mL)
2202
3303
4404
5505
6606
7707
8808
9909
110010

Swine: Endo-Mectin® Injection should be given only by subcutaneous injection in the neck of swine at the recommended dose level of 300 mcg of ivermectin per kilogram (2.2 lb) of body weight. Each mL of Endo-Mectin® Injection contains 10 mg of ivermectin, sufficient to treat 75 lb of body weight.





























Body Weight (lb)Dose Volume (mL)
Growing Pigs191/4
381/2
751
1502
Breeding Animals2253
[Sows, Gilts, and Boars]3004
3755
4506

ADMINISTRATION



Cattle: Endo-Mectin® Injection is to be given subcutaneously only, to reduce risk of potentially fatal clostridial infection of the injection site. Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16-gauge, 1/2 to 3/4 inch needle is suggested. Inject under the loose skin in front of or behind the shoulder (see illustration).



When using the 250, 500 or 1000 mL pack size, use only automatic syringe equipment. Use sterile equipment and sanitize the injection site by applying a suitable disinfectant. Clean, properly disinfected needles should be used to reduce the potential for injection site infections. No special handling or protective clothing is necessary.


Swine: Endo-Mectin® (ivermectin) Injection is to be given subcutaneously in the neck. Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16- or 18-gauge needle is suggested for sows and boars, while an 18- or 20-gauge needle may be appropriate for young animals. Inject under the skin, immediately behind the ear (see illustration).



When using the 100, 250, 500 or 1000 mL pack size, use only automatic syringe equipment. As with any injection, sterile equipment should be used. The injection site should be cleaned and disinfected with alcohol before injection. The rubber stopper should also be disinfected with alcohol to prevent contamination of the contents. Mild and transient pain reactions may be seen in some swine following subcutaneous administration.



Recommended Treatment Program



Swine: At the time of initiating any parasite control program, it is important to treat all breeding animals in the herd. After the initial treatment, use Endo-Mectin® Injection regularly as follows:



BREEDING ANIMALS



Sows: Treat prior to farrowing, preferably 7-14 days before, to minimize infection of piglets.



Gilts: Treat 7-14 days prior to breeding. Treat 7-14 days prior to farrowing.



Boars: Frequency and need for treatments are dependent upon exposure. Treat at least two times a year.



FEEDER PIGS


(Weaners/Growers/Finishers)


All weaner/feeder pigs should be treated before placement in clean quarters. Pigs exposed to contaminated soil or pasture may need retreatment if reinfection occurs.


NOTE:


(1) Endo-Mectin® Injection has a persistent drug level sufficient to control mite infestations throughout the egg to adult life cycle. However, since the ivermectin effect is not immediate, care must be taken to prevent reinfestation from exposure to untreated animals or contaminated facilities. Generally, pigs should not be moved to clean quarters or exposed to uninfested pigs for approximately one week after treatment. Sows should be treated at least one week before farrowing to minimize transfer of mites to newborn baby pigs.


(2) Louse eggs are unaffected by Endo-Mectin® Injection and may require up to three weeks to hatch. Louse infestations developing from hatching eggs may require retreatment.


(3) Consult a veterinarian for aid in the diagnosis and control of internal and external parasites of swine.



Special Minor Use



Reindeer: For the treatment and control of warbles (Oedemagena tarandi) in reindeer, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. Follow use directions for cattle as described under ADMINISTRATION.



American Bison: For the treatment and control of grubs (Hypoderma bovis) in American bison, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. Follow use directions for cattle as described under ADMINISTRATION.


RESIDUE INFORMATION: Do not treat reindeer or American bison within 8 weeks (56 days) of slaughter.


WARNING


NOT FOR USE IN HUMANS.


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 adverse effects, obtain an MSDS or for assistance, contact Aspen Veterinary Resources, Ltd. at 1-816-415-4324.


RESIDUE INFORMATION: Do not treat cattle within 35 days of slaughter. 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.


Do not treat swine within 18 days of slaughter.



PRECAUTIONS


Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions have disappeared without treatment. For cattle, divide doses greater than 10 mL between two injection sites to reduce occasional discomfort or site reaction.


Use sterile equipment and sanitize the injection site by applying a suitable disinfectant. Clean, properly disinfected needles should be used to reduce the potential for injection site infections.


Observe cattle for injection site reactions. Reactions may be due to clostridial infection and should be aggressively treated with appropriate antibiotics. If injection site infections are suspected, consult your veterinarian.


This product is not for intravenous or intramuscular use.Protect product from light.


Endo-Mectin® Injection for Cattle and Swine has been developed specifically for use in cattle, swine, reindeer, and American bison only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.



When to Treat Cattle with Grubs


Endo-Mectin® Injection effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. Destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions including the possibility of fatalities. Killing Hypoderma lineatum when it is in the tissue surrounding the esophagus (gullet) may cause salivation and bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. These reactions are not specific to treatment with Endo-Mectin® Injection, but can occur with any successful treatment of grubs. Cattle should be treated either before or after these stages of grub development. Consult your veterinarian concerning the proper time for treatment.


Cattle treated with Endo-Mectin® Injection after the end of the heel fly season may be retreated with Endo-Mectin® Injection during the winter for internal parasites, mange mites, or sucking lice without danger of grub-related reactions. A planned parasite control program is recommended.



STORAGE


Store at 15 - 30 °C (59 to 86 °F).



ENVIRONMENTAL SAFETY


Studies indicate that when ivermectin comes in contact with soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish and certain aquatic organisms. Do not permit water runoff from feedlots to enter lakes, streams, or ponds. Do not contaminate water by direct application or by 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 of 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-dependent insects.



HOW SUPPLIED


Endo-Mectin® Injection for Cattle and Swine is available in five ready-to-use pack sizes:


The 50 mL pack is a multiple-dose, rubber-capped bottle. Each bottle contains sufficient solution to treat 10 head of 550 lb (250 kg) cattle or 100 head of 38 lb (17.3 kg) swine.


The 100 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 20 head of 550 lb (250 kg) cattle or 200 head of 38 lb (17.3 kg) swine.


The 250 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 50 head of 550 lb (250 kg) cattle or 500 head of 38 lb (17.3 kg) swine.


The 500 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle or 1000 head of 38 lb (17.3 kg) swine.


The 1000 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 200 head of 550 lb (250 kg) cattle or 2000 head of 38 lb (17.3 kg) swine.


Restricted Drug - California. Use Only as Directed.


Made in the UK.


Norbrook Laboratories Limited,


Newry, Co. Down, Northern Ireland.


MANUFACTURED FOR:

Aspen Veterinary Resources,® Ltd.

Liberty, MO 64068, USA


All rights reserved.

024628I03



Principal Display Panel



Principal Display Panel - 500 ml Label


ANADA 200-437 Approved by the FDA


Endo-Mectin®


Ivermectin 1% Sterile Solution


Injection for Cattle and Swine


NET CONTENTS:


500 mL


Aspen®


VETERENARY RESOURCES,® Ltd.




Principal Display Panel - 500 ml Carton


ANADA 200-437 Approved by the FDA


Endo-Mectin®


Ivermectin 1% Sterile Solution


Injection for Cattle and Swine


A Parasiticide for the Treatment and Control of Internal and External Parasites of Cattle and Swine.


NET CONTENTS:


500 mL


Aspen®


VETERENARY RESOURCES,® Ltd.










Endo-Mectin FOR CATTLE AND SWINE 
ivermectin  injection, solution










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)46066-027
Route of AdministrationSUBCUTANEOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ivermectin (ivermectin)ivermectin10 mg  in 1 mL






Inactive Ingredients
Ingredient NameStrength
propylene glycol 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






























Packaging
#NDCPackage DescriptionMultilevel Packaging
146066-027-011 VIAL In 1 CARTONcontains a VIAL, PLASTIC
150 mL In 1 VIAL, PLASTICThis package is contained within the CARTON (46066-027-01)
246066-027-041 VIAL In 1 CARTONcontains a VIAL, PLASTIC
2250 mL In 1 VIAL, PLASTICThis package is contained within the CARTON (46066-027-04)
346066-027-051 VIAL In 1 CARTONcontains a VIAL, PLASTIC
3500 mL In 1 VIAL, PLASTICThis package is contained within the CARTON (46066-027-05)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20043705/01/2007


Labeler - Aspen Veterinary (627265361)

Registrant - Norbrook Laboratories Limited (214580029)









Establishment
NameAddressID/FEIOperations
Armagh Road232880554MANUFACTURE, ANALYSIS









Establishment
NameAddressID/FEIOperations
Carnbane Industrial Estate211218325MANUFACTURE
Revised: 04/2010Aspen Veterinary



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Wednesday, 3 October 2012

Cardizem CD 24-Hour Sustained-Release Beads Capsules


Pronunciation: dil-TYE-a-zem
Generic Name: Diltiazem
Brand Name: Examples include Cardizem CD and Cartia XT


Cardizem CD 24-Hour Sustained-Release Beads Capsules are used for:

Treating high blood pressure and chronic stable angina (chest pain). It may be used alone or in combination with other medicines. It may also be used for other conditions as determined by your doctor.


Cardizem CD 24-Hour Sustained-Release Beads Capsules are a calcium channel blocker. It works by relaxing (dilating) your blood vessels, lowering blood pressure, and decreasing heart rate, which lowers the workload of the heart. It also dilates coronary arteries, which increases blood flow to the heart.


Do NOT use Cardizem CD 24-Hour Sustained-Release Beads Capsules if:


  • you are allergic to any ingredient in Cardizem CD 24-Hour Sustained-Release Beads Capsules

  • you have certain heart problems (eg, sick sinus syndrome, second- or third-degree heart block) and do not have a pacemaker, you have very low blood pressure, or you have fluid buildup in the lungs during or soon after a heart attack

  • you are taking erythromycin

Contact your doctor or health care provider right away if any of these apply to you.



Before using Cardizem CD 24-Hour Sustained-Release Beads Capsules:


Some medical conditions may interact with Cardizem CD 24-Hour Sustained-Release Beads Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have heart failure, a recent heart attack with lung congestion, heart block, a very slow heart rate, or other heart problems; low blood pressure; certain stomach or intestine problems (eg, narrowing); liver disease; or kidney problems

  • if you are taking other medicines for high blood pressure or heart conditions

Some MEDICINES MAY INTERACT with Cardizem CD 24-Hour Sustained-Release Beads Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Antiarrhythmics (eg, amiodarone, dronedarone), cimetidine, clonidine, HIV protease inhibitors (eg, atazanavir, indinavir), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Cardizem CD 24-Hour Sustained-Release Beads Capsules's side effects, such as heart rhythm problems

  • Moricizine or rifamycins (eg, rifampin) because they may decrease Cardizem CD 24-Hour Sustained-Release Beads Capsules's effectiveness

  • Benzodiazepines (eg, alprazolam), beta-blockers (eg, propranolol), buspirone, carbamazepine, cilostazol, cisapride, colchicine, corticosteroids (eg, hydrocortisone), cyclosporine, digoxin, everolimus, fentanyl, HMG-CoA reductase inhibitors (eg, simvastatin), hydantoins (eg, phenytoin), lurasidone, macrolide antibiotics (eg, erythromycin), macrolide immunosuppressants (eg, tacrolimus), nifedipine, quinidine, ranolazine, theophylline, or vasopressin antagonists (eg, tolvaptan) because the risk of their side effects, some potentially life-threatening, may be increased by Cardizem CD 24-Hour Sustained-Release Beads Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cardizem CD 24-Hour Sustained-Release Beads Capsules 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.


How to use Cardizem CD 24-Hour Sustained-Release Beads Capsules:


Use Cardizem CD 24-Hour Sustained-Release Beads Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Cardizem CD 24-Hour Sustained-Release Beads Capsules by mouth with or without food.

  • Swallow Cardizem CD 24-Hour Sustained-Release Beads Capsules whole. Do not open, break, crush, or chew before swallowing.

  • Taking Cardizem CD 24-Hour Sustained-Release Beads Capsules at the same time each day will help you remember to take it.

  • Continue to take Cardizem CD 24-Hour Sustained-Release Beads Capsules even if you feel well. Do not miss any doses.

  • If you miss a dose of Cardizem CD 24-Hour Sustained-Release Beads Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cardizem CD 24-Hour Sustained-Release Beads Capsules.



Important safety information:


  • Cardizem CD 24-Hour Sustained-Release Beads Capsules may cause dizziness, lightheadedness, or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Cardizem CD 24-Hour Sustained-Release Beads Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Cardizem CD 24-Hour Sustained-Release Beads Capsules may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Cardizem CD 24-Hour Sustained-Release Beads Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Cardizem CD 24-Hour Sustained-Release Beads Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.

  • Do not suddenly stop taking Cardizem CD 24-Hour Sustained-Release Beads Capsules. Your condition may get worse if you suddenly stop taking it. If you need to stop Cardizem CD 24-Hour Sustained-Release Beads Capsules or add a new medicine, your doctor will gradually lower your dose.

  • Tell your doctor or dentist that you take Cardizem CD 24-Hour Sustained-Release Beads Capsules before you receive any medical or dental care, emergency care, or surgery.

  • Be sure to have your blood pressure checked regularly while taking Cardizem CD 24-Hour Sustained-Release Beads Capsules.

  • Lab tests, including blood pressure, electrocardiogram (ECG), and heart rate, may be performed while you use Cardizem CD 24-Hour Sustained-Release Beads Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Cardizem CD 24-Hour Sustained-Release Beads Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially swelling of the ankles, feet, or hands; dizziness; and slow heartbeat.

  • Cardizem CD 24-Hour Sustained-Release Beads Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Cardizem CD 24-Hour Sustained-Release Beads Capsules while you are pregnant. Cardizem CD 24-Hour Sustained-Release Beads Capsules are found in breast milk. Do not breast-feed while taking Cardizem CD 24-Hour Sustained-Release Beads Capsules.


Possible side effects of Cardizem CD 24-Hour Sustained-Release Beads Capsules:


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; facial flushing; headache; lightheadedness; tiredness; weakness.



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; unusual hoarseness); chest pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes; personality changes; reddened, blistered, or swollen skin; severe or persistent dizziness, lightheadedness, nausea, or vomiting; shortness of breath; sudden weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); tender, bleeding, or swollen gums; unusual bleeding or bruising; unusual or persistent tiredness or weakness; vision changes.



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: Cardizem CD side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; difficulty breathing, especially when lying down; dizziness; drowsiness; fainting; lightheadedness, especially when standing; loss of consciousness; nausea; nervousness; slurred speech; unusual weakness; very slow heart rate.


Proper storage of Cardizem CD 24-Hour Sustained-Release Beads Capsules:

Store Cardizem CD 24-Hour Sustained-Release Beads Capsules 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 Cardizem CD 24-Hour Sustained-Release Beads Capsules out of the reach of children and away from pets.


General information:


  • If you have any questions about Cardizem CD 24-Hour Sustained-Release Beads Capsules, please talk with your doctor, pharmacist, or other health care provider.

  • Cardizem CD 24-Hour Sustained-Release Beads Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cardizem CD 24-Hour Sustained-Release Beads Capsules. 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.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cardizem CD resources


  • Cardizem CD Side Effects (in more detail)
  • Cardizem CD Use in Pregnancy & Breastfeeding
  • Drug Images
  • Cardizem CD Drug Interactions
  • Cardizem CD Support Group
  • 4 Reviews for Cardizem CD - Add your own review/rating


Compare Cardizem CD with other medications


  • Angina Pectoris Prophylaxis
  • Atrial Fibrillation
  • Atrial Flutter
  • Heart Failure
  • High Blood Pressure
  • Raynaud's Syndrome
  • Supraventricular Tachycardia

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