Saturday, March 31, 2012

Ketaset Injection





Dosage Form: FOR ANIMAL USE ONLY
Ketaset®

KETAMINE HYDROCHLORIDE

INJECTION, USP

Veterinary Injection For Intramuscular Use in Cats

and Subhuman Primates Only



CAUTION


Federal law restricts this drug to use by or on the order of a licensed veterinarian.



Ketaset Injection Description


KETASET (ketamine hydrochloride injection, USP) is a rapid-acting, nonnarcotic, nonbarbiturate agent for anesthetic use in cats and for restraint in subhuman primates. It is chemically designated dl 2-(o-chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride and is supplied as a slightly acid (pH 3.5 to 5.5) solution for intramuscular injection in a concentration containing the equivalent of 100 mg ketamine base per milliliter and contains not more than 0.1 mg/mL benzethonium chloride as a preservative.



ACTION


KETASET is a rapid-acting agent whose pharmacological action is characterized by profound analgesia, normal pharyngeal-laryngeal reflexes, mild cardiac stimulation and respiratory depression. Skeletal muscle tone is variable and may be normal, enhanced or diminished. The anesthetic state produced does not fit into the conventional classification of stages of anesthesia, but instead KETASET produces a state of unconsciousness which has been termed "dissociative" anesthesia in that it appears to selectively interrupt association pathways to the brain before producing somesthetic sensory blockade.


In contrast to other anesthetics, protective reflexes, such as coughing and swallowing are maintained under KETASET anesthesia. The degree of muscle tone is dependent upon level of dose; therefore, variations in body temperature may occur. At low dosage levels there may be an increase in muscle tone and a concomitant slight increase in body temperature. However, at high dosage levels there is some diminution in muscle tone and a resultant decrease in body temperature, to the point where supplemental heat may be advisable.


In cats, there is usually some transient cardiovascular stimulation, increased cardiac output with slight increase in mean systolic pressure with little or no change in total peripheral resistance. At higher doses the respiratory rate is usually decreased.


The assurance of a patent airway is greatly enhanced by virtue of maintained pharyngeal-laryngeal reflexes. Although some salivation is occasionally noted, the persistence of the swallowing reflex aids in minimizing the hazards associated with ptyalism. Salivation may be effectively controlled with atropine sulfate in dosages of 0.04 mg/kg (0.02 mg/lb) in cats and 0.01 to 0.05 mg/kg (0.005 to 0.025 mg/lb) in subhuman primates.


Other reflexes, e.g., corneal, pedal, etc., are maintained during KETASET anesthesia, and should not be used as criteria for judging depth of anesthesia. The eyes normally remain open with the pupils dilated. It is suggested that a bland ophthalmic ointment be applied to the cornea if anesthesia is to be prolonged.


Following administration of recommended doses, cats become ataxic in about 5 minutes with anesthesia usually lasting from 30 to 45 minutes at higher doses. At the lower doses, complete recovery usually occurs in 4 to 5 hours but with higher doses recovery time is more prolonged and may be as long as 24 hours.


In studies involving 14 species of subhuman primates represented by at least 10 anesthetic episodes for each species, the median time to restraint ranged from 1.5 [Aotus trivirgatus (night monkey) and Cebus capucinus (white-throated capuchin)] to 5.3 minutes [Macaca nemestrina (pig-tailed macaque)]. The median duration of restraint ranged between 20 and 55 minutes in all but five of the species studied. Total time from injection to end of restraint ranged from 43 [Saimiri sciureus (squirrel monkey)] to 183 minutes [Macaca nemestrina (pig-tailed macaque)] after injection. Recovery is generally smooth and uneventful. The duration is dose related.


By single intramuscular injection, KETASET usually has a wide margin of safety in cats and subhuman primates. In cats, cases of prolonged recovery and death have been reported.



INDICATIONS


KETASET may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.



Contraindications


KETASET is contraindicated in cats and subhuman primates suffering from renal or hepatic insufficiency.


KETASET is detoxified by the liver and excreted by the kidneys; therefore, any preexistent hepatic or renal pathology or impairment of function can be expected to result in prolonged anesthesia; related fatalities have been reported.



Precautions


In cats, doses in excess of 50 mg/kg during any single procedure should not be used. The maximum recommended dose in subhuman primates is 40 mg/kg.


To reduce the incidence of emergence reactions, animals should not be stimulated by sound or handling during the recovery period. However, this does not preclude the monitoring of vital signs.


Apnea, respiratory arrest, cardiac arrest and death have occasionally been reported with ketamine used alone, and more frequently when used in conjunction with sedatives or other anesthetics. Close monitoring of patients is strongly advised during induction, maintenance and recovery from anesthesia.


Color of solution may vary from colorless to very slightly yellowish and may darken upon prolonged exposure to light. This darkening does not affect potency. Do not use if precipitate appears.



Adverse Reactions


Respiratory depression may occur following administration of high doses of KETASET (ketamine hydrochloride injection, USP). If at any time respiration becomes excessively depressed and the animal becomes cyanotic, resuscitative measures should be instituted promptly. Adequate pulmonary ventilation using either oxygen or room air is recommended as a resuscitative measure.


Adverse reactions reported have included emesis, salivation, vocalization, erratic recovery and prolonged recovery, spastic jerking movements, convulsions, muscular tremors, hypertonicity, opisthotonos, dyspnea and cardiac arrest. In the cat, myoclonic jerking and/or mild tonic convulsions can be controlled by ultrashortacting barbiturates which should be given to effect. The barbiturates should be administered intravenously at a dose level of one-sixth to one-fourth the usual dose for the product being used. Acepromazine may also be used. However, recent information indicates that some phenothiazine derivatives may potentiate the toxic effects of organic phosphate compounds such as found in flea collars and certain anthelmintics. A study has indicated that ketamine hydrochloride alone does not potentiate the toxic effects of organic phosphate compounds.



ADMINISTRATION AND DOSAGE


KETASET is well tolerated by cats and subhuman primates when administered by intramuscular injection.


Fasting prior to induction of anesthesia or restraint with KETASET is not essential; however, when preparing for elective surgery, it is advisable to withhold food for at least six hours prior to administration of KETASET.


Anesthesia may be of shorter duration in immature cats. Restraint in subhuman primate neonates (less than 24 hours of age) is difficult to achieve.


As with other anesthetic agents, the individual response to KETASET is somewhat varied depending upon the dose, general condition and age of the subject so that dosage recommendations cannot be absolutely fixed.



Dosage


Cats

A dose of 11 mg/kg (5 mg/lb) is recommended to produce restraint. Dosages from 22 to 33 mg/kg (10 to 15 mg/lb) produce anesthesia that is suitable for diagnostic or minor surgical procedures that do not require skeletal muscle relaxation.


Subhuman Primates

The recommended restraint dosages of KETASET for the following species are: Cercocebus torquatus (white-collared mangabey), Papio cynocephalus (yellow baboon), Pantroglodytes verus (chimpanzee), Papio anubis (olive baboon), Pongo pygmaeus (orangutan), Macaca nemestrina (pigtailed macaque) 5 to 7.5 mg/kg; Presbytis entellus (entellus langur) 3 to 5 mg/kg; Gorilla gorilla gorilla (gorilla) 7 to 10 mg/kg; Aotus trivirgatus (night monkey) 10 to 12 mg/kg; Macaca mulatta (rhesus monkey) 5 to 10 mg/kg; Cebus capucinus (white-throated capuchin) 13 to 15 mg/kg; and Macaca fascicularis (crab-eating macaque), Macaca radiata (bonnet macaque) and Saimiri sciureus (squirrel monkey) 12 to 15 mg/kg.


A single intramuscular injection produces restraint suitable for TB testing; radiography, physical examination or blood collection.



STORAGE INFORMATION


Store at or below 25°C (77°F). Protect from light.



How is Ketaset Injection Supplied


KETASET (ketamine hydrochloride injection, USP) is supplied as the hydrochloride in concentrations equivalent to ketamine base.


Each 10 mL vial contains 100 mg/mL.


NDC 0856-2013-01 — 10 mL — vial



Clinical Studies


KETASET has been clinically studied in subhuman primates in addition to those species listed under Administration and Dosage. Dosages for restraint in these additional species, based on limited clinical data, are: Cercopithecus aethiops (grivet), Papio papio (guinea baboon) 10 to 12 mg/kg; Erythrocebus patas patas (patas monkey) 3 to 5 mg/kg; Hylobates lar (white-handed gibbon) 5 to 10 mg/kg; Lemur catta (ringtailed lemur) 7.5 to 10 mg/kg; Macaca fuscata (Japanese macaque) 5 mg/kg; Macaca speciosa (stumptailed macaque) and Miopithecus talapoin (mangrove monkey) 5 to 7.5 mg/kg; and Symphalangus syndactylus (siamangs) 5 to 7 mg/kg.



Fort Dodge Animal Health

Fort Dodge, Iowa 50501 USA


01109


Rev. April 2009


4409C


NADA 45-290, Approved by FDA



PRINCIPAL DISPLAY PANEL - 1000 mg Carton


NDC 0856-2013-01


Ketaset® CIII

KETAMINE HCl

INJECTION, USP


FORT DODGE®


Equivalent to


1000 mg/10 mL

(100 mg/mL)


Ketamine


CAUTION: Federal law restricts

this drug to use by or on the

order of a licensed veterinarian.


NADA 45-290

Approved by FDA










KETASET 
ketamine hydrochloride  injection










Product Information
Product TypePRESCRIPTION ANIMAL DRUGNDC Product Code (Source)0856-2013
Route of AdministrationINTRAMUSCULARDEA ScheduleCIII    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ketamine hydrochloride (ketamine)ketamine100 mg  in 1 mL






Inactive Ingredients
Ingredient NameStrength
benzethonium chloride0.1 mg  in 1 mL


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10856-2013-0110 mL In 1 VIALNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA04529012/23/1970


Labeler - FDAH, Division of Wyeth (149957656)

Registrant - Pfizer Inc. (001326495)
Revised: 01/2011FDAH, Division of Wyeth

Tapazole


Generic Name: methimazole (Oral route)

meth-IM-a-zole

Commonly used brand name(s)

In the U.S.


  • Tapazole

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antithyroid Agent


Chemical Class: Thionamide


Uses For Tapazole


Methimazole is used to treat hyperthyroidism, a condition where the thyroid gland produces too much thyroid hormone. It is also used before thyroid surgery or radioactive iodine treatment.


Methimazole is an antithyroid medicine. It works by making it harder for the body to use iodine to make thyroid hormone. It does not block the effects of a thyroid hormone that was made by the body before its use was begun.


This medicine is available only with your doctor's prescription.


Before Using Tapazole


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methimazole in children.


Geriatric


No information is available on the relationship of age to the effects of methimazole in geriatric patients.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acenocoumarol

  • Anisindione

  • Dicumarol

  • Phenindione

  • Phenprocoumon

  • Warfarin

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Blood or bone marrow problems (e.g., agranulocytosis, aplastic anemia, thrombocytopenia)—Use with caution. May make these conditions worse.

  • Liver disease—Effects may be increased because of slower removal of the medicine from the body.

Proper Use of Tapazole


Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.


This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, if you are taking more than one dose a day, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 3 doses a day, the doses should be spaced about 8 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your doctor.


Food in your stomach may change the amount of methimazole that is able to enter the bloodstream. To make sure that you always get the same effects, try to take methimazole at the same time in relation to meals every day. That is, always take it with meals or always take it on an empty stomach.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For treatment of hyperthyroidism (overactive thyroid):
      • Adults—At first, 15 to 60 milligrams (mg) daily, divided into 3 equal doses and given every 8 hours. The maintenance dose is 5 to 15 mg daily.

      • Children—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.4 mg per kilogram (kg) of body weight per day, divided into 3 equal doses and given every 8 hours. The maintenance dose is 0.2 mg/kg of body weight per day.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Tapazole


It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.


Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.


Methimazole can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:


  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.

  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

  • Avoid contact sports or other situations where bruising or injury could occur.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.


While you are being treated with methimazole, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Methimazole may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take or have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.


Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking methimazole together with medicines used during surgery may increase the risk of side effects.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


Tapazole Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Black, tarry stools

  • chest pain

  • chills

  • cough

  • fever

  • painful or difficult urination

  • shortness of breath

  • sore throat

  • sores, ulcers, or white spots on the lips or in the mouth

  • swollen glands

  • unusual bleeding or bruising

  • unusual tiredness or weakness

Rare
  • Backache

  • increase or decrease in urination

  • swelling of the feet or lower legs

Incidence not known
  • Abdominal or stomach pain

  • bleeding gums

  • bleeding under the skin

  • blood in the urine or stools

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • cough or hoarseness

  • dark urine

  • difficulty with moving

  • fever with or without chills

  • general feeling of discomfort, illness, or weakness

  • general feeling of tiredness or weakness

  • headache

  • joint pain

  • light-colored stools

  • loss of appetite and weight

  • lower back or side pain

  • muscle aching or cramping

  • muscle pain or stiffness

  • nausea and vomiting

  • numbness or tingling of the hands, feet, or face

  • pinpoint red spots on the skin

  • soreness of the muscles

  • sores, ulcers, or white spots on the lips or in the mouth

  • swollen joints

  • swollen salivary glands

  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

  • tightness in the chest

  • upper right abdominal pain

  • wheezing

  • yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Cloudy or bloody urine

  • cracks in the skin

  • high blood pressure

  • loss of heat from the body

  • red, swollen skin

  • scaly skin

  • sensation of pins and needles

  • stabbing pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Incidence not known
  • Abnormal loss of hair

  • dizziness or lightheadedness

  • feeling of constant movement of self or surroundings

  • heartburn

  • hives or welts

  • itching

  • loss of taste

  • pain or discomfort in the chest, upper stomach, or throat

  • redness of the skin

  • sensation of spinning

  • skin rash

  • sleepiness

  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tapazole side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Tapazole resources


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


  • Tapazole Prescribing Information (FDA)

  • Tapazole MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tapazole Concise Consumer Information (Cerner Multum)

  • Tapazole Monograph (AHFS DI)

  • Methimazole Prescribing Information (FDA)

  • Methimazole Professional Patient Advice (Wolters Kluwer)



Compare Tapazole with other medications


  • Hyperthyroidism


Friday, March 30, 2012

Torecan


Generic Name: thiethylperazine (Oral route, Intramuscular route, Rectal route)

thye-eth-il-PER-a-zeen

Commonly used brand name(s)

In the U.S.


  • Torecan

Available Dosage Forms:


  • Suppository

  • Tablet

  • Solution

Therapeutic Class: Antiemetic


Pharmacologic Class: Phenothiazine


Chemical Class: Piperazine (class)


Uses For Torecan


Thiethylperazine is a phenothiazine medicine. It is used to treat nausea and vomiting.


This medicine is available only with your doctor's prescription.


Before Using Torecan


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Children are usually more sensitive than adults to the effects of phenothiazine medicines such as thiethylperazine. Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, especially those with severe illness or dehydration.


Geriatric


Elderly patients are usually more sensitive to the effects of phenothiazine medicines such as thiethylperazine. Confusion; difficult or painful urination; dizziness; drowsiness; feeling faint; or dryness of mouth, nose, or throat may be more likely to occur in elderly patients. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients. In addition, uncontrolled movements may be more likely to occur in elderly patients taking thiethylperazine.


Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Cisapride

  • Grepafloxacin

  • Sparfloxacin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Fentanyl

  • Gatifloxacin

  • Ibutilide

  • Isradipine

  • Levorphanol

  • Methadone

  • Metrizamide

  • Morphine

  • Morphine Sulfate Liposome

  • Moxifloxacin

  • Octreotide

  • Oxycodone

  • Pentamidine

  • Procarbazine

  • Tramadol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Belladonna

  • Belladonna Alkaloids

  • Betel Nut

  • Evening Primrose

  • Meperidine

  • Phenylalanine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Alcohol abuse—This medicine, if taken together with alcohol, may lower the blood pressure and cause CNS depressant effects, such as severe drowsiness

  • Asthma attack or

  • Other lung diseases—Thiethylperazine may cause secretions to become thick so that it might be difficult to cough them up, for example, during an asthma attack

  • Blood disease or

  • Heart or blood vessel disease—This medicine may cause more serious conditions to develop

  • Difficult urination or

  • Enlarged prostate—This medicine may cause urinary problems to get worse

  • Glaucoma—This medicine may cause an increase in inner eye pressure

  • Liver disease—Thiethylperazine may accumulate in the body, increasing the chance of side effects, such as muscle spasms

  • Parkinson's disease or

  • Seizure disorders—The chance of thiethylperazine causing seizures or uncontrolled movements is greater when these conditions are present

Proper Use of Torecan


Thiethylperazine is used only to relieve or prevent nausea and vomiting. Use it only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.


For patients taking this medicine by mouth:


  • This medicine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.

For patients using the suppository form of this medicine :


  • To insert suppository: First, remove foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum. If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

  • Wash your hands with soap and water.

Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For nausea and vomiting:
    • For oral dosage form (tablets):
      • Adults—10 milligrams (mg) one to three times a day.

      • Children—Use and dose must be determined by your doctor.


    • For injection dosage form:
      • Adults—10 mg one to three times a day, injected into a muscle.

      • Children—Use and dose must be determined by your doctor.


    • For rectal dosage form (suppositories):
      • Adults—10 mg one to three times a day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Torecan


If you are going to be taking this medicine for a long time, your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. This will allow your dosage to be changed if necessary to meet your needs.


Thiethylperazine will add to the effects of alcohol and other CNS depressants (medicines that cause you to feel drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .


This medicine may cause some people to have blurred vision or to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well.


Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.


When using thiethylperazine on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin or other salicylates at the same time (as for arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by this medicine.


Thiethylperazine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.


Torecan Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Less common or rare
  • Abdominal or stomach pains

  • aching muscles and joints

  • blurred vision, change in color vision, or difficulty in seeing at night

  • confusion (especially in the elderly)

  • convulsions (seizures)

  • difficulty in speaking or swallowing

  • fast heartbeat

  • fever and chills

  • inability to move eyes

  • lip smacking or puckering

  • loss of balance control

  • mask-like face

  • muscle spasms (especially of face, neck, and back)

  • nausea, vomiting, or diarrhea

  • nightmares (continuing)

  • nosebleeds

  • puffing of cheeks

  • rapid or fine, worm-like movements of tongue

  • shuffling walk

  • skin itching (severe)

  • sore throat and fever

  • stiffness of arms or legs

  • swelling of arms, hands, and face

  • tic-like or twitching movements

  • trembling and shaking of hands and fingers

  • twisting movements of body

  • uncontrolled chewing movements

  • uncontrolled movements of arms or legs

  • unusual bleeding or bruising

  • unusual excitement, nervousness, restlessness, or irritability

  • unusual tiredness or weakness

  • weakness of arms and legs

  • yellow eyes or skin

Symptoms of overdose
  • Confusion (severe)

  • convulsions (seizures)

  • dizziness (severe)

  • drowsiness (severe)

  • dry mouth (severe)

  • hyperextension of neck and trunk

  • inability to move eyes

  • loss of consciousness

  • spasms of face and neck

  • stuffy nose

  • troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Dizziness

  • drowsiness

Less common or rare
  • Constipation

  • dizziness or lightheadedness, especially when getting up from a lying or sitting position

  • dryness of mouth, nose and throat

  • fainting

  • fever

  • headache

  • ringing or buzzing in ears

  • skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Torecan side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Torecan resources


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


  • Torecan Prescribing Information (FDA)

  • Torecan Concise Consumer Information (Cerner Multum)



Compare Torecan with other medications


  • Nausea/Vomiting


Thursday, March 29, 2012

Tagamet



Generic Name: Cimetidine
Class: Histamine H2-Antagonists
VA Class: GA301
CAS Number: 51481-61-9

Introduction

Histamine H2 receptor antagonist.b


Uses for Tagamet


Duodenal Ulcer


Short-term treatment of active duodenal ulcer (endoscopically or radiographically confirmed).a b


Maintainence of healing and reduction in recurrence of duodenal ulcer.a b


Pathologic GI Hypersecretory Conditions


Long-term treatment of Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis.a b


Gastric Ulcer


Short-term treatment of active benign gastric ulcer.a b


Gastroesophageal Reflux (GERD)


Short-term treatment of erosive esophagitis (endoscopically diagnosed) in patients with GERD.118


Treatment of symptomatic GERD.105 106 123 288


Self-medication as initial therapy to achieve acid suppression, control symptoms, and prevent complications of less severe symptomatic GERD.288


Upper GI Bleeding


Prevention of upper GI bleeding resulting from stress-related mucosal damage (erosive esophagitis, stress ulcers) in critically ill patients.118 142 143 144 145 146 147 152 153 154 155 156 157 161 162 163 164 165 166 170 171 172 173 174 175 176 177 179 188 191


Treatment of upper GI bleeding secondary to hepatic failure, esophagitis, duodenal or gastric ulcers when hemorrhage is not caused by major blood vessel erosion.b


Heartburn (pyrosis), Acid Indigestion (hyperchlorhydria), or Sour Stomach


Short-term self-medication for relief of heartburn symptoms in adults and adolescents≥12 years of age.c


Short-term self-medication for prevention of heartburn symptoms associated with acid indigestion (hyperchlorhydria) and sour stomach brought on by ingestion of certain foods and beverages in adults and children ≥12 years of age.c


Allergic Conditions and Urticarias124 125 126 127 128 129 130 131 132 133 134 135 136 137


Tagamet Dosage and Administration


Administration


Administer orally, IV, or IM.118


Administer by IM or slow IV injection, or by intermittent or continuous IV infusion in hospitalized patients with pathological GI hypersecretory conditions or intractable duodenal ulcer, or when oral therapy is not feasible.118


Oral Administration


Administer with or without food; administration with food may delay and slightly decrease absorption, but achieves maximum antisecretory effect when stomach is no longer protected by food buffering effect. Administer oral tablets with water.b


Antacids may be given as necessary for pain relief, but not at the same time.a b


For duodenal ulcer treatment, administration once daily at bedtime is the regimen of choice because of a high healing rate, maximal pain relief, decreased drug interaction potential, and maximal compliance.117 118 119


For gastric ulcer treatment, administration once daily at bedtime is the regimen of choice because of convenience and decreased drug interaction potential.118


For gastroesophageal reflux, once-daily dosing is not considered appropriate.288


IM Administration


May be administered undiluted.a b


Intermittent Direct IV Injection


Dilution

Dilute 300 mg to 20 mL with 0.9% sodium chloride injection or other compatible IV solution before direct IV injection (see Compatibility under Stability).118


Rate of Administration

Inject over ≥5 minutes.118


Intermittent IV infusion


Reconstitution

Reconstitute ADD-Vantage vials according to manufacturer’s directions.118


Dilution

Dilute 300 mg in at least 50 mL of 0.9% sodium chloride injection or 5% dextrose injection or other compatible IV solution (see Compatibility under Stability).118


No additional dilution required for commercially available infusion solution (300 mg cimetidine in 50 mL of 0.9% sodium chloride injection).a


Rate of Administration

Over 15–20 minutes.118


Continuous IV Infusion


Dilution

Dilute 900 mg in 100–1000 mL of a compatible IV solution (see Compatibility under Stability).a b


Rate of Administration

Over 24 hours.a b


Adjust rate to individual patient requirements.a b


Volume <250 mL: use controlled-infusion device (e.g., pump).a b


Dosage


Dosage of cimetidine hydrochloride expressed in terms of cimetidine.118


Pediatric Patients


20–40 mg/kg daily in divided doses has been used in a limited number of children when potential benefits are thought to outweigh the possible risks.118


Heartburn, Acid Indigestion, or Sour Stomach

Heartburn Relief (Self-medication)

Oral

Adolescents ≥12 years of age: 200 mg once or twice daily, or as directed by a clinician.268


Prevention of Heartburn (Self-medication)

Oral

Adolescents ≥12 years of age: 200 mg once or twice daily or as directed by a clinician; administer immediately (or up to 30 minutes) before ingestion of causative food or beverage.c


Adults


General Parenteral Dosage

Parenteral dosage regimens for GERD have not been established.a


General parenteral dosage (in hospitalized patients with pathologic hypersecretory conditions or intractable ulcer, or for short-term use when oral therapy is not feasible):a


IM

300 mg every 6–8 hours.118


Intermittent Direct IV Injection

300 mg every 6–8 hours.118


300 mg more frequently if increased daily dosage is necessary (i.e., single doses not >300 mg), up to 2400 mg daily.118


Intermittent IV Infusion

300 mg every 6–8 hours.118


300 mg more frequently if increased daily dosage is necessary (i.e., single doses not >300 mg), up to 2400 mg daily.118


Continuous IV infusion

900 mg over 24 hours (37.5 mg/hour).a b See Pathologic GI Hypersecretory Conditions under Dosage: Adults.


For more rapid increase in gastric pH, a loading dose of 150 mg may be given as an intermittent infusion before continuous infusion.a b


Duodenal Ulcer

Treatment of Active Duodenal Ulcer

Oral

Dosage of choice: 800 mg once daily at bedtime.117 118 119


Patients with ulcer >1 cm in diameter who are heavy smokers (i.e., ≥1 pack daily) when rapid healing (e.g., within 4 weeks) is considered important:118 1.6 g daily at bedtime.117 118 119


Administer for 4–6 weeks unless healing is confirmed earlier.117 118 If not healed or symptoms continue after 4 weeks, additional 2–4 weeks of full dosage therapy may be beneficial.118 More than 6–8 weeks at full dosage is rarely needed.118


Healing of active duodenal ulcers may occur in 2 weeks in some, and occurs within 4 weeks in most patients.117 118 119 120 121 122


Other regimens (no apparent rationale for these other than familiarity of use) that have been used:117 118 300 mg 4 times daily with meals and at bedtime; 200 mg 3 times daily and 400 mg at bedtime; 400 mg twice daily in the morning and at bedtime.b


Maintenance of Healing of Duodenal Ulcer

Oral

400 mg daily at bedtime.118 Efficacy not increased by higher dosages or more frequent administration.b


Pathologic GI Hypersecretory Conditions

Zollinger-Ellison Syndrome

Oral

300 mg 4 times daily with meals and at bedtime.118


Higher doses administered more frequently may be necessary;a b adjust dosage according to response and tolerance but in general, do not exceed 2400 mg daily.a


Continue as long as necessary.118


Continuous IV Infusion

Mean infused dose of 160 mg/hour (range: 40-600 mg/hour) in one study.a


Gastric Ulcer

Oral

Preferred regimen: 800 mg once daily at bedtime.118


Alternative regimen: 300 mg 4 times daily, with meals and at bedtime.118


Monitor to ensure rapid progress to complete healing.a b


Studies limited to 6 weeks, efficacy for >8 weeks not established.118


GERD

Once daily (at bedtime) not considered appropriate therapy.288


Treatment of Symptomatic GERD

Oral

300 mg 4 times daily has been used.105 106 123


Treatment of Erosive Esophagitis

Oral

800 mg twice daily or 400 mg 4 times daily (e.g., before meals and at bedtime) for up to 12 weeks.118


Upper GI Bleeding

Prevention of Upper GI Bleeding

Continuous IV Infusion

50 mg/hour; loading dose not required.118


Safety and efficacy of therapy beyond 7 days has not been established.118


Alternative dosage: Some clinicians recommend 300-mg IV loading dose over 5–20 minutes, then continuous IV infusion at 37.5–50 mg/hour; titrate with 25-mg/hour increments up to 100 mg/hour based on gastric pH (e.g., to maintain a pH of at least 3.5–4).118 143 144 173 174 176 188


Intermittent IV doses may be less effective in preventing upper GI bleeding than continuous IV infusion.155 172 173 174 175 176 177 178 188 189 191


Treatment of Upper GI Bleeding

Oral

1–2 g daily in 4 divided doses has been used.b


IV

1–2 g daily in 4 divided doses has been used.b


Heartburn, Acid Indigestion, or Sour Stomach

Heartburn (Self-medication)

Oral

200 mg once or twice daily, or as directed by clinician.268


Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Prevention of Heartburn (Self-medication)

Oral

200 mg once or twice daily or as directed by a clinician; administer immediately (or up to 30 minutes) before ingestion of causative food or beverage.c


Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Prescribing Limits


Pediatric Patients


Heartburn, Acid Indigestion, or Sour Stomach

Heartburn (Self-Medication)

Oral

Adolescents ≥12 years of age: Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Prevention of Heartburn (Self-medication)

Oral

Adolescents ≥12 years of age: Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Adults


General Parenteral Dosage

General parenteral dosage (hospitalized patients with pathologic hypersecretory conditions or intractable duodenal ulcer, or short-term use when oral therapy is not feasible):


Direct IV injection

Maximum 2.4 g daily.a


Maximum 300 mg per dose.a


Maximum concentration 300 mg/20 mL.a


Maximum injection rate: 20 mL over not less than 5 minutes (4 mL per minute).a


Intermittent IV Infusion

Maximum 2.4 g daily.a


Maximum 300 mg per dose.a


Maximum concentration 300 mg/50 mL.a


Maximum infusion rate: 15–20 minutes.a


GERD

Short-term Treatment of Erosive Esophagitis

Oral

Safety and efficacy beyond 12 weeks of administration have not been established.a


Heartburn, Acid Indigestion, or Sour Stomach

Heartburn Relief (Self-medication)

Oral

Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Prevention of Heartburn (Self-medication)

Oral

Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Duodenal Ulcer

Intermittent Direct IV Injecton

Maximum 2.4 g daily.a


Intermittent IV Infusion

Maximum 2.4 g daily.a


Gastric Ulcer

Short-term treatment of Active Benign Gastric Ulcer

Oral

Safety and efficacy beyond 8 weeks have not been established.118


Intermittent Direct IV Injection

Maximum 2.4 g daily.a


Intermittent IV Infusion

Maximum 2.4 g daily.a


Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)

Oral

Maximum usually 2.4 g daily.118


Intermittent Direct IV Injection

Maximum 2.4 g daily.a


Intermittent IV Infusion

Maximum 2.4 g daily.a


Upper GI Bleeding

Prevention of Upper GI Bleeding

Continuous IV Infusion

Safety and efficacy beyond 7 days have not been established.a


Special Populations


Renal Impairment


Severe (Clcr< 30 mL/minute)

Oral

300 mg every 12 hours.118


Accumulation may occur; use lowest frequency of dosing compatible with adequate response.118


Increase frequency to every 8 hours or more frequently (with caution) if required.118


Presence of hepatic impairment may require further dosage reduction.118


Direct IV Injection

300 mg every 12 hours.118


Accumulation may occur; use lowest frequency compatible with adequate response.118


Increase frequency to every 8 hours or more frequently (with caution) if required118


Presence of hepatic impairment may require further dosage reduction.118


Continuous IV Infusion

Prevention of Upper GI Bleeding: One-half recommended dosage (i.e., 25 mg/hour).118


Hemodialysis

Decreases blood levels; administer at the end of hemodialysis and every 12 hours during interdialysis.b


Hepatic Impairment


May require further dosage reduction in the presence of severe renal impairment.118


Cautions for Tagamet


Contraindications



  • Known hypersensitivity to cimetidine or any ingredient in the formulation.118



Warnings/Precautions


General Precautions


Cardiovascular Effects

Rapid IV administration associated rarely with hypotension, cardiac arrhythmias; avoid.a b


Gastric Malignancy

Response to cimetidine does not preclude presence of gastric malignancy.118


CNS Effects

Reversible confusional states reported, especially in geriatric (i.e., ≥50 years) and severely ill (e.g., hepatic or renal disease, organic brain syndrome) patients.118 b Usually occurs within 2–3 days after initiating cimetidine and resolves within 3–4 days after discontinuance.118 b


Respiratory Effects

Administration of H2-receptor antagonists has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).302 303


Specific Populations


Pregnancy

Category B.a


Pregnant women should consult a clinician before using for self-medication.268


Lactation

Distributed into milk.118 Generally, do not nurse during therapy with cimetidine.118


Nursing women should consult a clinician before using for self-medication.268


Pediatric Use

Safety and efficacy not established in children <16 years of age; do not use unless potential benefits outweigh risks.118


Safety and efficacy for self-medication not established in children <12 years of age; do not use unless directed by a clinician.c


Renal Impairment

Dosage adjustments necessary in patients with severe renal impairment.118 (See Renal Impairment under Dosage and Administration.)


Hepatic Impairment

Further dosage adjustments may be necessary in presence of severe renal impairment.118 (See Hepatic Impairment under Dosage and Administration.)


Immunocompromised Patients

Increased possibility of Strongyloides stercoralis hyperinfection with decreased gastric acidity.118 269 270


Common Adverse Effects


Headache,118 144 dizziness, somnolence, diarrhea.118


With ≥1 month of therapy: gynecomastia.118 b


With IM therapy: transient pain at injection site.118


Interactions for Tagamet


Inhibits hepatic microsomal enzyme systems, decreases hepatic metabolism of some drugs.118 If necessary, adjust dosage of hepatically metabolized drugs when cimetidine therapy is initiated or discontinued.b


Specific Drugs
















































Drug



Interaction



Comments



Alcohol



Possible increased blood alcohol concentrations,256 257 258 259 260 261 263 264 265 psychomotor impairment256 257 258 259 260 261 267



Potential for psychomotor impairment controversial, 256 257 258 259 260 261 267 but use caution during performance of hazardous tasks requiring mental alertness, physical coordination257 258 261



Antacidsb



Decreased cimetidine absorptionb



Administer 1 hour before or after cimetidine in the fasting state, or 1 hour after cimetidine is taken with food.a b



Benzodiazepines118



Potential for delayed elimination, increased blood concentrations of certain benzodiazepines (e.g., diazepam, chlordiazepoxide, triazolam)118



Adjust dosage if needed b



Calcium-channel blockers (e.g., nifedipine)a



Potential for delayed elimination, increased blood concentrations of nifedipine118



Adjust dosage if needed b



Ketoconazole118



Absorption of ketoconazole may be affected by altered gastric pH118



Administer ≥2 hours before cimetidine118



Lidocaine118



Potential for delayed elimination, increased blood concentrations of lidocaine118



Adverse effects reported, adjust dosage if needed b



Metronidazole118



Potential for delayed elimination, increased blood concentrations of metronidazole118



Adjust dosage if neededb



Myelosuppressive drugs (e.g., alkylating agents [e.g., carmustine], antimetabolites) and/or therapies (radiation)b



May potentiate myelosuppressionb



 



Phenytoin118



Potential for delayed elimination, increased blood concentrations of phenytoin118



Adverse effects reported, adjust dosage if needed b



Propranolol118



Potential for delayed elimination, increased blood concentrations of propranolol118



Adjust dosage if needed b



Theophylline118



Potential for delayed elimination, increased blood concentrations of theophylline118



Adverse effects reported, adjust dosage if needed b



Triamterene108



Potential for delayed elimination, increased blood concentrations of triamterene118



Consider potential of clinically important interaction108



Tricyclic Antidepressants118



Potential for delayed elimination, increased blood concentrations of certain tricyclic antidepressants118



Adjust dosage if neededb



Warfarin118



Potential for delayed elimination, increased blood concentrations of warfarin118



Monitor PT, adjust dosage if neededb


Tagamet Pharmacokinetics


Absorption


Bioavailability


Oral: 60–70%.b


Onset


≥70% decrease in basal acid secretion within 45 minutes after single 300- or 400-mg IV dose in healthy males.100


Duration
















































Dosage Regimen



Effect On Acid Secretion



Comments



Oral: 800 mg at bedtime in duodenal ulcer patients118



Mean hourly nocturnal secretion decreased by 85% over 8 hours.118



No effect on daytime acid secretion118



Oral: 1600 mg at bedtime in duodenal ulcer patients 118



Mean hourly nocturnal secretion decreased by 100% over 8 hours, 35% decrease for additional 5 hours.118



Moderate (<60%) 24-hour suppression118



Oral: 400 mg twice daily in duodenal ulcer pateints118



Nocturnal secretion decreased by 47–83% over 6–8 hours 118



Moderate (<60%) 24-hour suppression118



Oral: 300 mg 4 times daily in duodenal ulcer patients118



Nocturnal secretion decreased by 54% over 9 hours118



Moderate (<60%) 24-hour suppression118



Oral: Single 300-mg dose within 1 hour after meal in duodenal ulcer patientsa



Food-stimulated secretion decreased by 50% for 1 hour, then 75% for 2 hours.a



 



Oral: 300-mg dose at breakfast in duodenal ulcer patientsa



Continued suppression for 4 hours, with partial suppression after luncha



Effect enhanced and maintained by additional 300-mg dose with luncha



Oral: 300-mg dose with foodb



Mean gastric pH 3.5–4 at 1 hour, 5.5–6.1 at 4 hoursb



 



Oral: Single dose 300 mg with fooda



Mean gastric pH: 3.5, 3.1, 3.8, 6.1 at hour 1, 2, 3, 4, respectivelya



Placebo mean gastric pH: 2.6, 1.6, 1.9, 2.2 at hour 1, 2, 3, 4, respectivelya



Oral: 300–400 mg in fasting state in duodenal ulcer patientsb



Anacidity for up to 8 hoursb



 



Oral: 300 mg in duodenal ulcer patientsb



Basal gastric acid output decreased by 90% for 4 hoursb



Meal-stimulated acid secretion by 66% for 3 hoursb



IV continuous infusion: mean dosage of 160 mg/hour (range:40-600 mg/hour) in pathologic hypersecretory conditionsb



Maintained secretion at ≤10 mEq/hourb



 



IV continuous infusion (37.5 mg/hour or 900 mg daily) in patients with active or healed duodenal or gastric ulcerb



Maintained gastric pH at >4 for >50% of the time at steady-state.b



 



Intermittent injection: (300 mg every 6 hours or 1200 mg daily) in patients with active or healed duodenal or gastric ulcerb



Maintained gastric pH at >4 for >50% of the time at steady-state.b



 



IV: Single 300- or 400-mg dose in healthy males



≥70% decrease in basal acid secretion maintained for 4–4.5 hours100



 


Food


Delays, slightly decreases absorption.b However, administration with meals achieves maximum blood concentrations and antisecretory effect when stomach is no longer protected by food buffering effect.b


Distribution


Extent


Widely distributed throughout the body.b


Distributed into human milk.b


Crosses the placenta in animals.b


Plasma Protein Binding


15–20%.b


Elimination


Metabolism


Metabolized to sulfoxide (major metabolite) and 5-hydroxymethyl derivatives in liver.a b More extensively metabolized after oral than parenteral administration.a


Elimination Route


Excreted principally in urine.a b Single oral dose: 48% (unchanged) excreted in urine over 24 hours.a IV or IM: about 75% (unchanged) excreted in urine within 24 hours.a Single IV dose of radiolabeled cimetidine: 80–90% (50–73% unchanged, remainder as metabolites) excreted in urine over 24 hours.b About 10% excreted in feces.b


Half-life


2 hours.a


After IV administration in children 4.1–15 years of age: Apparent biphasic decline of plasma cimetidine and cimetidine sulfoxide concentrations with half-lives of 1.4 and 2.6 hours, respectively.102


Special Populations


2.9 hours in patients with Clcr 20–50 mL/minute.b 3.7 hours in patients with Clcr <20 mL/minute.b 5 hours in anephric patients.b


Stability


Storage


Oral


Liquid and Tablets

Tight, light-resistant containers at 15–30°C.b


Parenteral


Injection

15–30°C.b Protect from light.b Do not refrigerate.b Stable in most IV solutions for at least 3 days at room temperature in concentrations of 1.2–5 mg/mL,b but use within 48 hours when diluted as directed.118 b


Injection for IV infusion only

15–30°C.b Protect from excessive heat; brief exposure up to 40°C does not adversely affect stability.b Stable through the labeled expiration date when stored as recommended.118


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Parenteral


Solution CompatibilityHID


































Compatible



Amino acids 3.5, 5.5, or 8.5% with electrolytes



Amino acids 5.5 or 8.5%



Dextrose 5% with Ascor-B-Sol



Dextrose 5% and Electrolyte #48



Dextrose 5% and Electrolyte #75



Dextrose 5% in Ringer’s injection, lactated



Dextrose 5% in sodium chloride 0.2, 0.45, or 0.9%



Dextrose 10% in sodium chloride 0.9%



Dextrose 5% in water



Dextrose 10% in water



Dextrose 5% in water with vitamins



Fructose 5% and Electrolyte #48



Fructose 5% and Electrolyte #75



Invert sugar 5% in water



Invert sugar 10% in water



Ionosol B in dextrose 5% in water



Ionosol MB in dextrose 5% in water



Ionosol T in dextrose 5% in water



Mannitol 10% in water



Normosol M, 900 cal



Normosol M in dextrose 5% in water



Normosol M and Surbex T in dextrose 5% in water



Normosol R



Normosol R, pH 7.4



Normosol R in dextrose 5% in water



Plasma-Lyte 56 in dextrose 5% in water



Plasma-Lyte M in dextrose 5% in water



Ringer’s injection



Ringer’s injection, lactated



Sodium bicarbonate 5%



Sodium chloride 0.9%


Drug Compatibility















































Admixture CompatibilityHID

Compatible



Acetazolamide sodium



Amikacin sulfate



Aminophylline



Atracurium besylate



Cefoxitin sodium



Chlorothiazide sodium



Ciprofloxacin



Clindamycin phosphate



Colistimethate sodium



Dexamethasone sodium phosphate



Digoxin



Epinephrine HCl



Erythromycin lactobionate



Ethacrynate sodium



Flumazenil



Furosemide



Gentamicin sulfate



Insulin, regular



Isoproterenol HCl



Lidocaine HCl



Lincomycin HCl



Meropenem



Metaraminol bitartrate



Methylprednisolone sodium succinate



Midazolam HCl



Norepinephrine bitartrate



Penicillin G potassium



Phytonadione



Polymyxin B sulfate



Potassium chloride



Protamine sulfate



Quinidine gluconate



Sodium nitroprusside



Tacrolimus



Vancomycin HCl



Verapamil HCl



Vitamin B complex



Vitamin B complex with C



Incompatible



Amphotericin B



Variable



Ampicillin sodium



Cefazolin sodium



Metoclopramide HCl









































































Y-Site CompatibilityHID

Compatible



Acyclovir sodium



Amifostine



Aminophylline



Anakinra



Anidulafungin



Atracurium besylate



Aztreonam



Bivalirudin



Cisplatin



Cladribine



Clarithromycin



Cyclophosphamide



Cytarabine



Dexmedetomidine HCl



Diltiazem HCl



Docetaxel



Doxorubicin HCl



Doxorubicin HCl liposome injection



Enalaprilat



Esmolol HCl



Etoposide phosphate



Fenoldopam mesylate



Filgrastim



Fluconazole



Fludarabine phosphate



Foscarnet sodium



Gallium nitrate



Gemcitabine HCl



Granisetron HCl



Haloperidol lactate



Heparin sodium



Hetastarch in lactated electrolyte injection (Hextend)



Hetastarch in sodium chloride 0.9%



Idarubicin HCl



Inamrinone lactate



Labetalol HCl



Levofloxacin



Linezolid



Melphalan HCl



Meropenem



Methotrexate sodium



Midazolam HCl



Milrinone lactate



Nicardipine HCl



Ondansetron HCl



Oxaliplatin



Paclitaxel



Pancuronium bromide



Pemetrexed disodium



Piperacillin sodium–tazobactam sodium



Propofol



Remifentanil HCl



Sargramostim



Tacrolimus



Teniposide



Theophylline



Thiotepa



Topotecan HCl



Vecuronium bromide



Vinorelbine tartrate



Zidovudine



Incompatible



Allopurinol sodium



Amphotericin B cholesteryl sulfate complex



Amsacrine



Cefepime HCl



Indomethacin sodium trihydrate



Lansoprazole



Warfarin sodium


ActionsActions



  • Inhibits basal and stimulated gastric acid secretion.b




  • Competitively inhibits histamine at parietal cell H2 receptors.b




  • Weak antiandrogenic effect.b



Advice to Patients



  • Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.289




  • Importance of taking antacids on an empty stomach 1 hour before or 1 hour after oral administration of cimetidine, or 1 hour after the drug is taken with food,b but not at same time as oral cimetidine.a b




  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.289




  • Before self-medication, importance of consulting clinician if taking warfarin, theophylline, or phenytoin.268




  • Importance of following dosage instructions when cimetidine is administered for self-medication, unless otherwise directed by a clinician.c




  • Importance of promptly informing clinician of persistent abdominal pain or difficulty swallowing.268




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



Preparations


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


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name











































Cimetidine

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Solution



300 mg/mL*



Cimetidine Hydrochloride Oral Solution



Actavis, Duramed, Endo, Hi-Tech, Morton Grove, Pharmaceutical Associates, Teva



Tagamet (with parabens, povidone, and propylene glycol)



GlaxoSmithKline



Tablets, film-coated



200 mg*



Tagamet HB 200



GlaxoSmithKline



Tagamet HB (with povidone)



GlaxoSmithKline



300 mg*



Tagamet (with povidone and propylene glycol)



GlaxoSmithKline



400 mg*



Tagamet Tiltab (with povidone and propylene glycol)



GlaxoSmithKline



800 mg*



Tagamet Tiltab (with povidone and propylene glycol; scored)



GlaxoSmithKline


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name



















Cimetidine Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Solution



300 mg (of cimetidine) per 5 mL*



Tagamet HCl (with alcohol 2.8% parabens and propylene glycol)



GlaxoSmithKline



Parenteral



Injection



150 mg (of cimetidine) per mL



Cimetidine Hydrochloride Injection



Endo, Hospira, Sicor