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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Friday, 28 September 2012

Telavancin Hydrochloride


Class: Glycopeptides
ATC Class: J01XA03
VA Class: AM900
Chemical Name: Vancomycin, N3″-[2-(decylamino)ethyl}-29-{[(phosphono-methyl)-amino]-methyl}-hydrochloride
Molecular Formula: C80H106C12N11O27P • xHCl (where x=1 to 3)
CAS Number: 380636-75-9
Brands: Vibativ


  • Fetal Risk


  • Women of childbearing potential should have a serum pregnancy test to exclude pregnancy prior to administration of telavancin.1




  • Avoid use of telavancin during pregnancy unless potential benefits to the woman outweigh potential risks to the fetus.1




  • Concerns about potential adverse developmental outcomes in humans based on adverse developmental outcomes observed in 3 animal species given telavancin at clinically relevant doses during the period of organogenesis.1 (See Pregnancy under Cautions.)



REMS:


FDA approved a REMS for telavancin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of telavancin and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().



Introduction

Antibacterial; lipoglycopeptide; synthetic derivative of vancomycin.1 2 3 4 5


Uses for Telavancin Hydrochloride


Skin and Skin Structure Infections


Treatment of complicated skin and skin structure infections caused by susceptible Staphylococcus aureus (including methicillin-resistant S. aureus [MRSA; also known as oxacillin-resistant S. aureus or ORSA]), Streptococcus pyogenes (group A β-hemolytic streptococci), S. agalactiae (group B streptococci), S. anginosus group (includes S. anginosus, S. intermedius, S. constellatus), or Enterococcus faecalis (vancomycin-susceptible strains only).1


Indicated only for treatment of certain infections caused by certain gram-positive bacteria; if documented or presumed pathogens include gram-negative or anaerobic bacteria, concomitant use of another anti-infective may be clinically indicated.1


Telavancin Hydrochloride Dosage and Administration


Administration


Administer by IV infusion.1


IV Infusion


Must be reconstituted and then further diluted prior to administration.1


Should not be admixed or added to solutions containing other drugs.1


If the same IV line is used for sequential infusion of other drugs, flush the IV line with 0.9% sodium chloride injection, 5% dextrose injection, or lactated Ringer's injection before and after the telavancin infusion.1


Reconstitution

Reconstitute vials containing 250 or 750 mg of telavancin with 15 or 45 mL, respectively, of 5% dextrose injection, sterile water for injection, or 0.9% sodium chloride injection to provide a solution containing 15 mg/mL.1


Discard vial if the vacuum is insufficient to pull diluent into vial.1


Mix thoroughly and ensure that drug has dissolved completely.1 Usually reconstitutes in <2 minutes, but reconstitution may take up to 20 minutes.1


Dilution

For doses of 150–800 mg, withdraw correct dose from the reconstituted vial and add to 100–250 mL of appropriate IV infusion fluid (i.e., 0.9% sodium chloride injection, 5% dextrose injection, lactated Ringer's injection).1


For doses <150 mg or >800 mg, withdraw correct dose from the reconstituted vial and add to a volume of appropriate IV infusion fluid (i.e., 0.9% sodium chloride injection, 5% dextrose injection, lactated Ringer's injection) that results in a final concentration of 0.6–8 mg/mL.1


Rate of Administration

Administer by IV infusion over 1 hour.1 Avoid rapid IV infusion.1 (See Infusion Reactions under Cautions.)


Dosage


Available as telavancin hydrochloride; dosage is expressed in terms of telavancin.1


Adults


Skin and Skin Structure Infections

IV

10 mg/kg once every 24 hours for 7–14 days.1


Duration of therapy based on severity and location of infection and patient's clinical and bacteriologic response.1


Special Populations


Hepatic Impairment


Dosage adjustment not needed in adults with mild to moderate hepatic impairment.1 8


Renal Impairment


Reduce dosage in adults with Clcr 10–50 mL/minute.1 Data insufficient to make dosage recommendations for adults with end-stage renal disease (Clcr <10 mL/minute), including those undergoing hemodialysis.1











Table 1. Telavancin Dosage for Adults with Renal Impairment1

Clcr Calculated Using Cockcroft-Gault Formula (mL/minute)



Telavancin Dosage



>50



10 mg/kg once every 24 hours



30–50



7.5 mg/kg once every 24 hours



10 to <30



10 mg/kg once every 48 hours


Geriatric Patients


Select dosage with caution because of age-related decreases in renal function.1 (See Geriatric Use under Cautions.)


Cautions for Telavancin Hydrochloride


Contraindications



  • Manufacturer states none known.1



Warnings/Precautions


Warnings


Fetal/Neonatal Morbidity

Adverse developmental outcomes reported in 3 animal species given telavancin at clinically relevant doses during the period of organogenesis.1


Exclude pregnancy (negative serum pregnancy test) prior to initiation of telavancin in females of childbearing potential (i.e., those who have not had complete absence of menses for ≥24 months, medically confirmed menopause or primary ovarian failure, hysterectomy, bilateral oophorectomy, or tubal ligation).1


Use effective contraception to prevent pregnancy during treatment.1


Avoid use of telavancin during pregnancy unless potential benefits to the woman outweigh potential risks to the fetus.1 (See Pregnancy under Cautions.)


FDA required and approved a Risk Evaluation and Mitigation Strategy (REMS) for telavancin;17 goal of the telavancin REMS is to avoid unintended telavancin exposure in pregnant women by educating health-care providers and patients about potential risk of fetal developmental toxicity and recommended measures to exclude and prevent pregnancy.17 The REMS requires that a telavancin medication guide be provided to patient each time the drug is dispensed and outlines a communication plan requiring initial and periodic communications from manufacturer to certain targeted groups of prescribers and pharmacists.17


Nephrotoxicity

Renal impairment reported in patients receiving telavancin.1 In patients with normal baseline Scr concentrations, increased Scr (1.5 times baseline) reported more frequently in telavancin-treated patients than in vancomycin-treated patients.1


Adverse renal effects more likely in patients with conditions known to increase the risk of renal impairment (e.g., preexisting renal disease, diabetes mellitus, CHF, hypertension) and in those receiving concomitant therapy with an agent that affects renal function (e.g., NSAIAs, certain diuretics, ACE inhibitors).1


Monitor renal function (i.e., Scr, Clcr).1 Perform renal function tests prior to initiation of telavancin, every 48–72 hours during therapy (more frequently if indicated), and at end of therapy.1


If renal function decreases, weigh benefits of continuing telavancin versus discontinuing the drug and initiating an alternative anti-infective.1


Infusion Reactions

Rapid IV administration of glycopeptide anti-infectives (including telavancin) can result in a reaction referred to as the “red-man syndrome.”1 Flushing of the upper body, urticaria, pruritus, or rash may occur.1


To reduce risk of infusion-related reactions, give IV infusion over 1 hour.1 If an infusion reaction occurs, the reaction may cease if the infusion is discontinued or slowed.1


Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms, including fungi.1 Monitor carefully; institute appropriate therapy if superinfection occurs.1


Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 12 13 14 15 16 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives and may range in severity from mild diarrhea to fatal colitis.1 Hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1


Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 12 13 14 15 16 Obtain a careful medical history since CDAD may occur as late as ≥2 months after anti-infective therapy is discontinued.1


If CDAD is suspected or confirmed, anti-infectives not directed against C. difficile may need to be discontinued.1 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.1 12 13 14 15 16


Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of telavancin and other antibacterials, use only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.1


When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1


If documented or presumed pathogens include gram-negative or anaerobic bacteria, concomitant use of an anti-infective active against such bacteria may be clinically indicated.1 (See Uses.)


Cardiovascular Effects

Prolongation of the QTc interval reported.1 Caution advised if used with drugs known to prolong QT interval.1


Avoid use in individuals with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy; such individuals not included in telavancin clinical trials.1


Hematologic Effects

Does not interfere with coagulation and has no effect on platelet aggregation.1 Increased risk of bleeding not observed in clinical trials.1 Evidence of hypercoagulability not observed; healthy adults receiving telavancin have normal levels of D-dimer and fibrin degradation products.1


Interferes with certain tests used to monitor coagulation (i.e., PT, INR, aPTT, activated clotting time, tests based on factor Xa).1 (See Specific Drugs and Laboratory Tests under Interactions.)


Specific Populations


Pregnancy

Category C.1 Pregnancy registry at 888-658-4228.1


In reproduction studies in rats, rabbits, and minipigs, there was evidence that telavancin has the potential to cause limb and skeletal malformations and reduced fetal weight.1


Has not been evaluated in pregnant women, but animal data raise concerns about potential adverse developmental outcomes in humans.1 Avoid use during pregnancy unless potential benefits to the patient outweigh potential risks to the fetus.1 (See Fetal/Neonatal Morbidity under Cautions.)


Lactation

Not known whether telavancin is distributed into milk in humans.1 Use with caution.1


Pediatric Use

Safety and efficacy not established in children or adolescents <18 years of age.1


Geriatric Use

In clinical studies evaluating telavancin for treatment of complicated skin and skin structure infections, the drug appeared to be less effective in adults ≥65 years of age relative to adults <65 years of age.1


No overall differences in frequency of treatment-emergent adverse events compared with younger adults; however, incidence of adverse events indicating renal impairment was higher in geriatric adults than in younger adults.1


Substantially eliminated by kidneys; select dosage with caution since geriatric patients are more likely to have decreased renal function.1


Hepatic Impairment

Pharmacokinetics not altered in adults with moderate hepatic impairment (Child-Pugh class B);1 8 pharmacokinetics not evaluated in those with severe hepatic impairment (Child-Pugh class C).1 Dosage adjustment not needed in adults with mild to moderate hepatic impairment.1 8


Renal Impairment

In clinical studies evaluating telavancin for treatment of complicated skin and skin structure infections, the drug appeared to be less effective in adults with Clcr ≤50 mL/minute relative to those with Clcr >50 mL/minute.1 Consider possible reduced effectiveness when selecting an anti-infective for adults with baseline moderate or severe renal impairment (Clcr ≤50 mL/minute).1


Risk of adverse renal effects may be greater in patients with preexisting renal impairment or risk factors for renal dysfunction.1 (See Nephrotoxicity under Cautions.)


Reduce dosage in adults with Clcr 10–50 mL/minute.1 (See Renal Impairment under Dosage and Administration.)


Hydroxypropyl-β-cyclodextrin (an inactive ingredient in the formulation) may accumulate in individuals with renal impairment.1 If renal toxicity is suspected, consider an alternative anti-infective.1


Common Adverse Effects


GI effects (taste disturbance,1 2 3 nausea,1 2 3 vomiting,1 2 3 constipation2 ), headache,2 3 insomnia,2 3 foamy urine.1 2


Interactions for Telavancin Hydrochloride


Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes


Inhibits CYP 3A4/5.1


Specific Drugs and Laboratory Tests







































Drug or Test



Interaction



Comments



Aminoglycosides (amikacin, gentamicin)



Gentamicin: In vitro evidence of synergistic antibacterial effects against MRSA6


Amikacin or gentamicin: No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1



Aztreonam



No effect on pharmacokinetics of either drug1 9


No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1



Dosage adjustments not needed1



Carbapenems (imipenem, meropenem)



Meropenem: In vitro evidence of synergistic antibacterial effects against MRSA6


Imipenem or meropenem: No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1



Cephalosporins



Cefepime or ceftriaxone: In vitro evidence of synergistic antibacterial effects against MRSA6


Cefepime or ceftriaxone: No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1



Co-trimoxazole



No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1



Fluoroquinolones



Ciprofloxacin: In vitro evidence of synergistic antibacterial effects against MRSA6


Ciprofloxacin: No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1



Midazolam



No effect on pharmacokinetics of either drug1 7



Penicillins



Piperacillin and tazobactam: No effect on pharmacokinetics of either drug1 9


Oxacillin or piperacillin and tazobactam: No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1



Piperacillin and tazobactam: Dosage adjustments not needed1



Rifampin



In vitro evidence of synergistic antibacterial effects against MRSA6


No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1



Tests, coagulation



Telavancin interferes with PT, INR, aPTT, activated clotting time, and tests based on factor Xa if blood samples are drawn 0–18 hours after a dose of the anti-infective1


Does not affect thrombin time, whole blood (Lee-White) clotting time, ex vivo platelet aggregation, chromogenic factor Xa assay, functional (chromogenic) factor X assay, bleeding time, or tests for D-dimer or fibrin degradation products1



Draw blood samples for PT, INR, aPTT, activated clotting time, and tests based on factor Xa just before a telavancin dose1



Tests, urine protein



Telavancin interferes with urine qualitative dipstick protein assays and quantitative dye methods used to measure urine protein (e.g., pyrogallol red-molybdate);1 does not affect microalbumin assays1



Use microalbumin assays to monitor urinary protein excretion in patients receiving telavancin1


Telavancin Hydrochloride Pharmacokinetics


Absorption


Plasma Concentrations


In healthy young adults, pharmacokinetics are linear following single IV doses of 5–12.5 mg/kg or multiple IV doses of 7.5–15 mg/kg given once daily for up to 7 days.1


Steady-state concentrations achieved by day 3 of once-daily dosage.1


Special Populations


AUC increased in patients with renal impairment.1


Distribution


Extent


Concentration in skin blister fluid is 40% of plasma concentrations after administration of 7.5 mg/kg once daily for 3 days.1


Not known whether telavancin is distributed into milk in humans.1


Plasma Protein Binding


90%, primarily albumin.1 Protein binding not affected by renal or hepatic impairment.1


Elimination


Metabolism


Metabolic pathway not elucidated to date.1 Three hydroxylated metabolites identified; the major metabolite is THRX-651540.1


Not metabolized by CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 3A4, 3A5, or 4A11.1


Elimination Route


Approximately 76% of a dose recovered in urine; <1% of dose recovered in feces.1


In adults with end-stage renal disease, approximately 5.9% of a dose is removed by 4 hours of hemodialysis.1 In vitro date indicate telavancin may be removed by continuous venovenous hemofiltration (CVVH).1


Half-life


Approximately 8 hours in adults.1


Special Populations


Pharmacokinetics not altered in geriatric individuals based solely on age.1


Pharmacokinetics altered by decreased renal function.1


No clinically important change in pharmacokinetics in adults with moderate hepatic impairment (Child-Pugh class B).1 8 Not evaluated in adults with severe hepatic impairment (Child-Pugh class C).1


Stability


Storage


Parenteral


Powder for Injection

2–8°C; may be exposed to temperatures up to 25°C.1 Avoid excessive heat.1


Following reconstitution and further dilution, administer within 4 hours when stored at room temperature or within 72 hours when stored at 2–8°C.1


Actions



  • Lipoglycopeptide antibacterial.1 2 3 4 5 Synthetic derivative of vancomycin.1 2 3 4 5




  • Usually bactericidal in action.1 Inhibits bacterial cell wall synthesis by inhibiting peptidoglycan synthesis and blocking the transglycosylation step.1 4 Binds to the bacterial membrane and disrupts membrane barrier function.1 4




  • Active against some gram-positive bacteria, including Staphylococcus aureus (including methicillin-resistant S. aureus [MRSA; also known as oxacillin-resistant S. aureus or ORSA]),1 2 3 5 11 Streptococcus pyogenes (group A β-hemolytic streptococci),1 S. agalactiae (group B streptococci),1 S. anginosus group (includes S. anginosus, S. intermedius, S. constellatus),1 and Enterococcus faecalis (vancomycin-susceptible strains only).1 5




  • Some vancomycin-resistant enterococci have reduced susceptibility to telavancin.1 5 Cross-resistance between telavancin and other anti-infectives not reported to date.1



Advice to Patients



  • Telavancin medication guide must be provided to patient each time the drug is dispensed;17 importance of patient reading the medication guide prior to initiating telavancin therapy and each time the prescription is refilled.1




  • Advise patients that antibacterials (including telavancin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1




  • Importance of completing full course of therapy, even if feeling better after a few days.1




  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with telavancin or other antibacterials in the future.1




  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.1




  • Advise patients about the common adverse effects reported with telavancin (e.g., taste disturbance, nausea, vomiting, headache, foamy urine) and importance of informing a clinician if any unusual symptom develops or if any known symptom persists or worsens.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Advise women of childbearing potential about potential risk of fetal harm if telavancin is used during pregnancy.1 (See Pregnancy under Cautions.)




  • Importance of excluding pregnancy with a serum pregnancy test before starting telavancin.1 Advise women of childbearing potential to use effective contraception to prevent pregnancy during telavancin therapy and to notify a clinician if pregnancy occurs during telavancin therapy.1 (See Pregnancy under Cautions.)




  • Importance of informing patients of other important precautionary information.1 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


















Telavancin Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



For injection, for IV infusion



250 mg (of telavancin)



Vibativ



Theravance



750 mg (of telavancin)



Vibativ



Theravance



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Theravance. Vibativ (telavancin) for injection prescribing information. South San Francisco, CA; 2009 Sep.



2. Stryjewski ME, Graham DR, Wilson SE et al. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clin Infect Dis. 2008; 46:1683-93. [PubMed 18444791]



3. Stryjewski ME, Chu VH, O'Riordan WD et al. Telavancin versus standard therapy for treatment of complicated skin and skin structure infections caused by gram-positive bacteria: FAST 2 study. Antimicrob Agents Chemother. 2006; 50:862-7. [PubMed 16495243]



4. Shaw JP, Seroogy J, Kaniga K et al. Pharmacokinetics, serum inhibitory and bactericidal activity, and safety of telavancin in healthy subjects. Antimicrob Agents Chemother. 2005; 49:195-201. [PubMed 15616296]



5. Dunbar LM, Tang DM, Manausa RM. A review of telavancin in the treatment of complicated skin and skin structure infections (cSSSI). Ther Clin Risk Manag. 2008; 4:235-44. [PubMed 18728713]



6. Lin G, Pankuch GA, Ednie LM et al. Antistaphylococcal activity of telavancin tested alone and in combination by time-kill assay. Antimicrob Agents Chemother. 2010; :.



7. Wong SL, Goldberg MR, Ballow CH et al. Effect of Telavancin on the pharmacokinetics of the cytochrome P450 3A probe substrate midazolam: a randomized, double-blind, crossover study in healthy subjects. Pharmacotherapy. 2010; 30:136-43. [PubMed 20099988]



8. Goldberg MR, Wong SL, Shaw JP et al. Lack of effect of moderate hepatic impairment on the pharmacokinetics of telavancin. Pharmacotherapy. 2010; 30:35-42. [PubMed 20030471]



9. Wong SL, Sörgel F, Kinzig M et al. Lack of pharmacokinetic drug interactions following concomitant administration of telavancin with aztreonam or piperacillin/tazobactam in healthy participants. J Clin Pharmacol. 2009; 49:816-23. [PubMed 19443680]



11. Kosowska-Shick K, Clark C, Pankuch GA et al. Activity of telavancin against staphylococci and enterococci determined by MIC and resistance selection studies. Antimicrob Agents Chemother. 2009; 53:4217-24. [PubMed 19620338]



12. Johnson S, Gerding DN. Clostridium difficile-associated diarrhea. Clin Infect Dis. 1998; 26:1027-36. [IDIS 407733] [PubMed 9597221]



13. Gerding DN, Johnson S, Peterson LR et al for the Society for Healthcare Epidemiology of America. Position paper on Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol. 1995; 16:459-77. [PubMed 7594392]



14. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50. [IDIS 386628] [PubMed 9149180]



15. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]



16. Wilcox MH. Treatment of Clostridium difficile infection. J Antimicrob Chemother. 1998; 41(Suppl C):41-6. [IDIS 407246] [PubMed 9630373]



17. NDA 22-110 Vibativ (telavancin) risk evaluation and mitigation strategy (REMS). From FDA website.



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