Etomidate

Etomidate Injection

2 mg/mL

Rx only

Etomidate Description

Etomidate Injection is a sterile, nonpyrogenic solution. Each milliliter contains Etomidate, 2 mg, propylene glycol 35% v/v. The pH is 6.0 (4.0 to 7.0).

It is intended for the induction of general anesthesia by intravenous injection.

The drug Etomidate is chemically identified as (R)-(+)-ethyl-1-(1-phenylethyl)-1H-imidazole -5-carboxylate and has the following structural formula:

Molecular formula: C14H16N2O2

Molecular weight: 244.29

Etomidate - Clinical Pharmacology

Etomidate is a hypnotic drug without analgesic activity. Intravenous injection of Etomidate produces hypnosis characterized by a rapid onset of action, usually within one minute. Duration of hypnosis is dose dependent but relatively brief, usually three to five minutes when an average dose of 0.3 mg/kg is employed. Immediate recovery from anesthesia (as assessed by awakening time, time needed to follow simple commands and time to perform simple tests after anesthesia as well as they were performed before anesthesia), based upon data derived from short operative procedures where intravenous Etomidate was used for both induction and maintenance of anesthesia, is about as rapid as, or slightly faster than, immediate recovery after similar use of thiopental. These same data revealed that the immediate recovery period will usually be shortened in adult patients by the intravenous administration of approximately 0.1 mg of intravenous fentanyl, one or two minutes before induction of anesthesia, probably because less Etomidate is generally required under these circumstances (consult the package insert for fentanyl before using).

The most characteristic effect of intravenous Etomidate on the respiratory system is a slight elevation in arterial carbon dioxide tension (PaCO2). See also ADVERSE REACTIONS.

Reduced cortisol plasma levels have been reported with induction doses of 0.3 mg/kg Etomidate. These persist for approximately 6 to 8 hours and appear to be unresponsive to ACTH administration.

The intravenous administration of up to 0.6 mg/kg of Etomidate to patients with severe cardiovascular disease has little or no effect on myocardial metabolism, cardiac output, peripheral circulation or pulmonary circulation. The hemodynamic effects of Etomidate have in most cases been qualitatively similar to those of thiopental sodium, except that the heart rate tended to increase by a moderate amount following administration of thiopental under conditions where there was little or no change in heart rate following administration of Etomidate. However, clinical data indicates that Etomidate administration in geriatric patients, particularly those with hypertension, may result in decreases in heart rate, cardiac index, and mean arterial blood pressure. There are insufficient data concerning use of Etomidate in patients with recent severe trauma or hypovolemia to predict cardiovascular response under such circumstances.

Clinical experience and special studies to date suggest that standard does of intravenous Etomidate ordinarily neither elevate plasma histamine nor cause signs of histamine release.

Limited clinical experience, as well as animal studies, suggests that inadvertent intra-arterial injection of Etomidate, unlike thiobarbiturates, will not usually be followed by necrosis of tissue distal to the injection site. Intra-arterial injection of Etomidate is, however, not recommended.

Etomidate induction is associated with a transient 20 to 30% decrease in cerebral blood flow. This reduction in blood flow appears to be uniform in the absence of intracranial space occupying lesions. As with other intravenous induction agents, reduction in cerebral oxygen utilization is roughly proportional to the reduction in cerebral blood flow. In patients with and without intracranial space occupying lesions, Etomidate induction is usually followed by a moderate lowering of intracranial pressure, lasting several minutes. All of these studies provided for avoidance of hypercapnia. Information concerning regional cerebral perfusion in patients with intracranial space occupying lesions is too limited to permit definitive conclusions.

Preliminary data suggests that Etomidate will usually lower intraocular pressure moderately.

Etomidate is rapidly metabolized in the liver. Minimal hypnotic plasma levels of unchanged drug are equal to or higher than 0.23 mcg/mL; they decrease rapidly up to 30 minutes following injection and thereafter more slowly with a half-life value of about 75 minutes. Approximately 75% of the administered dose is excreted in the urine during the first day after injection. The chief metabolite is R-(+)-1-(1-phenylethyl)-1H-imidazole-5-carboxylate acid, resulting from hydrolysis of Etomidate, and accounts for about 80% of the urinary excretion. Limited pharmacokinetic data in patients with cirrhosis and esophageal varices suggest that the volume of distribution and elimination half-life of Etomidate are approximately double that seen in healthy subjects.

(Reference: H. Van Beem, et. al., Anaesthesia 38 (Supp 38:61-62, July 1983).

In clinical studies, elderly patients demonstrated decreased initial distribution volumes and total clearance of Etomidate. Protein binding of Etomidate to serum albumin was also significantly decreased in these individuals.

Reduced plasma cortisol and aldosterone levels have been reported following induction doses of Etomidate. These results persist for approximately 6 to 8 hours and appear to be unresponsive to ACTH stimulation. This probably represents blockage of 11 beta-hydroxylation within the adrenal cortex.

(References: 1. R.J. Fragen, et. al., Anesthesiology 61:652-656, 1984. 2. R.L. Wagner & P.F. White, Anesthesiology 61:647-651, 1984. 3. F.H. DeJong, et. al., Clin. Endocrinology and Metabolism 59:(6):1143-1147, 1984, and three additional drafts of Metabolic Studies, all submitted to NDA 18-228 on April 1, 1985).

Indications and Usage for Etomidate

Etomidate injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of Etomidate, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS).

Intravenous Etomidate is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.

Contraindications

Etomidate is contraindicated in patients who have shown hypersensitivity to it.

Warnings

INTRAVENOUS Etomidate SHOULD BE ADMINISTERED ONLY BY PERSONS TRAINED IN THE ADMINISTRATION OF GENERAL ANESTHETICS AND IN THE MANAGEMENT OF COMPLICATIONS ENCOUNTERED DURING THE CONDUCT OF GENERAL ANESTHESIA.

BECAUSE OF THE HAZARDS OF PROLONGED SUPPRESSION OF ENDOGENOUS CORTISOL AND ALDOSTERONE PRODUCTION, THIS FORMULATION IS NOT INTENDED FOR ADMINISTRATION BY PROLONGED INFUSION.

Precautions

Do not administer unless solution is clear and container is undamaged. Discard unused portion (see DOSAGE AND ADMINISTRATION).

1. Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenesis or mutagenesis studies have been carried out on Etomidate. The results of reproduction studies showed no impairment of fertility in male and female rats when Etomidate was given prior to pregnancy at 0.31, 1.25 and 5 mg/kg (approximately 1X, 4X, and 16X human dosage).

2. Pregnancy Category C

Etomidate has been shown to have an embryocidal effect in rats when given in doses 1 and 4 times the human dose. There are no adequate and well-controlled studies in pregnant women. Etomidate should be used during pregnancy only if the potential benefit justifies the potential risks to the fetus. Etomidate has not been shown to be teratogenic in animals. Reproduction studies with Etomidate have been shown to:

Decrease pup survival at 0.3 and 5 mg/kg in rats (approximately 1X and 16X human dosage) and at 1.5 and 4.5 mg/kg in rabbits (approximately 5X and 15X human dosage).  No clear dose-related pattern was observed.

Increase slightly the number of stillborn fetuses in rats at 0.3 and 1.25 mg/kg (approximately 1X and 4X human dosage).

Cause maternal toxicity with deaths of 6/20 rats at 5 mg/kg (approximately 16X human dosage) and 6/20 rabbits at 4.5 mg/kg (approximately 15X human dosage).

3. Labor and Delivery

There are insufficient data to support use of intravenous Etomidate in obstetrics, including Caesarean section deliveries. Therefore, such use is not recommended.

4. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Etomidate is administered to a nursing mother.

5. Pediatric Use

There are inadequate data to make dosage recommendations for induction of anesthesia in pediatric patients below the age of ten (10) years; therefore, such use in not recommended (see also DOSAGE AND ADMINISTRATION).

6. Geriatric Use

Clinical data indicates that Etomidate may induce cardiac depression in elderly patients, particularly those with hypertension (see CLINICAL PHARMACOLOGY and OTHER ADVERSE OBSERVATIONS, Circulatory System.).

Elderly patients may require lower doses of Etomidate than younger patients. Age-related differences in pharmacokinetic parameters have been observed in clinical studies (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.

7. Plasma Cortisol Levels

Induction doses of Etomidate have been associated with reduction in plasma cortisol and aldosterone concentrations (see CLINICAL PHARMACOLOGY). These have not been associated with changes in vital signs or evidence of increased mortality; however, where concern exists for patients undergoing severe stress, exogenous replacement should be considered.

Adverse Reactions

The most frequent adverse reactions associated with use of intravenous Etomidate are transient venous pain on injection and transient skeletal muscle movements, including myoclonus:

1. Transient venous pain was observed immediately following intravenous injection of Etomidate in about 20% of the patients, with considerable difference in the reported incidence (1.2% to 42%). This pain is usually described as mild to moderate in severity but it is occasionally judged disturbing. The observation of venous pain is not associated with a more than usual incidence of thrombosis of thrombophlebitis at the injection site. Pain also appears to be less frequently noted when larger, more proximal arm veins are employed and it appears to be more frequently noted when smaller more distal, hand or wrist veins are employed.


2. Transient skeletal muscle movements were noted following use of intravenous Etomidate in about 32% of the patients, with considerable difference in the reported incidence (22.7% to 63%). Most of these observations were judged mild to moderate in severity but some were judged disturbing. The incidence of disturbing movements was less when 0.1 mg fentanyl was given immediately before induction. These movements have been classified as myoclonic in the majority of cases (74%), but averting movements (7%), tonic movements (10%), and eye movements (9%) have also been reported. No exact classification is available, but these movements may also be placed into three groups by location:

a. Most movements are bilateral. The arms, legs, shoulders, neck, chest wall, trunk and all four extremities have been described in some cases, with one or more of these muscle groups predominating in each individual case. Results of electroencephalographic studies suggest that these muscle movements are a manifestation of disinhibition of cortical activity; cortical electroencephalograms, taken during periods when these muscle movements were observed, have failed to reveal seizure activity.

b. Other movements are described as either unilateral or having a predominance of activity of one side over the other. These movements sometimes resemble a localized response to some stimuli, such as venous pain on injection, in the lightly anesthetized patient (averting movements). Any muscle group or groups may be involved, but a predominance of movement of the arm in which the intravenous infusion is started is frequently noted.

c. Still other movements probably represent a mixture of the first two types.

Skeletal muscle movements appear to be more frequent in patients who also manifest venous pain on injection.

OTHER ADVERSE OBSERVATIONS

Respiratory System:

Hyperventilation, hypoventilation, apnea of short duration (5 to 90 seconds with spontaneous recovery), laryngospasm, hiccup and snoring suggestive of partial upper airway obstruction have been observed in some patients. These conditions were managed by conventional countermeasures.

Circulatory System:

Hypertension, hypotension, tachycardia, bradycardia and other arrhythmias have occasionally been observed during induction and maintenance of anesthesia. One case of severe hypotension and tachycardia, judged to be anaphylactoid in character, have been reported.

(Reference: M. Sold and A. Rothhammer, Anaesthesist 34:208-210, 1985. Submitted to NDA 18-228 on 16 May 1985).

Geriatric patients, particularly those with hypertension, may be at increased risk for the development of cardiac depression following Etomidate administration (see CLINICAL PHARMACOLOGY).

Gastrointestinal System:

Postoperative nausea and/or vomiting following induction of anesthesia with Etomidate is probably no more frequent than the general incidence. When Etomidate was used for both induction and maintenance of anesthesia in short procedures such as dilation and curettage, or when insufficient analgesia was provided, the incidence of postoperative nausea and/or vomiting was higher than that noted in control patients who received thiopental.

Overdosage

Overdosage may occur from too rapid or repeated injections. Too rapid injection may be followed by a fall in blood pressure. No adverse cardiovascular or respiratory effects attributable to Etomidate overdose have been reported.

In the event of suspected or apparent overdosage, the drug should be discontinued, a patent airway established (intubate, if necessary) or maintained and oxygen administered with assisted ventilation, if necessary.

The LD50 of Etomidate administered intravenously to rats is 20.4 mg/kg.

Etomidate Dosage and Administration

Etomidate injection is intended for administration only by the intravenous route (see CLINICAL PHARMACOLOGY). The dose for induction of anesthesia in adult patients and in children above the age of ten (10) years will vary between 0.2 and 0.6 mg/kg of body weight, and it must be individualized in each case. The usual dose for induction in these patients is 0.3 mg/kg, injected over a period of 30 to 60 seconds. There are inadequate data to make dosage recommendations for induction of anesthesia in patients below the age of ten (10) years; therefore, such use is not recommended. Geriatric patients may require reduced doses of Etomidate.

Smaller increments of intravenous Etomidate may be administered to adult patients during short operative procedures to supplement subpotent anesthetic agents, such as nitrous oxide. The dosage employed under these circumstances, although usually smaller than the original induction dose, must be individualized. There are insufficient data to support this use of Etomidate for longer adult procedures or for any procedures in pediatric patients; therefore, such use is not recommended. The use of intravenous fentanyl and other neuroactive drugs employed during the conduct of anesthesia may alter the Etomidate dosage requirements. Consult the prescribing information for all other such drugs before using.

Premedication:

Etomidate injection is compatible with commonly administered pre-anesthetic medications, which may be employed as indicated. See also CLINICAL PHARMACOLOGY, ADVERSE REACTIONS, and dosage recommendations for maintenance of anesthesia.

Etomidate hypnosis does not significantly alter the usual dosage requirements of neuromuscular blocking agents employed for endotracheal intubation or other purposes shortly after induction of anesthesia.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand.

How is Etomidate Supplied

Etomidate Injection 20 mg/10 mL is supplied as follows:

NDC Number                                 Packaging

0069 - 0006 - 01                      Carton of 10 x 10 mL Single-dose vials

Etomidate Injection 40 mg/20 mL is supplied as follows:

NDC Number                                 Packaging

0069 - 0006 - 03                      Carton of 10 x 20 mL Single-dose vials

Store at 20º to 25º C (68º to 77º F). [see USP Controlled Room Temperature].

Discard unused portion.

Rx Only

Made in India

Distributed by

Pfizer Labs

Division of Pfizer Inc

New York, NY 10017

May 2011

1016382

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 mg

NDC 0069-0006-02

10 mL Single Dose Vial

Etomidate injection

20 mg/10 mL

(2 mg/mL)

For Intravenous Use

Discard Unused Portion

Rx only

NDC 0069-0006-01

Contains 10 of NDC 0069-0006-02

Rx only

10 x 10 mL Single Dose Vials

Etomidate injection

20 mg/10 mL

(2 mg/mL)

For Intravenous Use

Pfizer Injectables

40 mg

NDC 0069-0006-04

20 mL Single Dose Vial

Etomidate injection

40 mg/20 mL

(2 mg/mL)

For Intravenous Use

Discard Unused Portion

Rx only

Pfizer Injectables

NDC 0069-0006-03

Contains 10 of NDC 0069-0006-04

Rx only

10 x 20 mL Single Dose Vials

Etomidate injection

40 mg/20 mL

(2 mg/mL)

For Intravenous Use

Pfizer Injectables

Etomidate  Etomidate  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0069-0006 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Etomidate (Etomidate) Etomidate 2 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0069-0006-01 10 VIAL In 1 CARTON contains a VIAL (0069-0006-02) 1 0069-0006-02 10 mL In 1 VIAL This package is contained within the CARTON (0069-0006-01) 2 0069-0006-03 10 VIAL In 1 CARTON contains a VIAL (0069-0006-04) 2 0069-0006-04 20 mL In 1 VIAL This package is contained within the CARTON (0069-0006-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078289	02/03/2012

Labeler - Pfizer Laboratories Div Pfizer Inc. (134489525)

Registrant - AGILA SPECIALTIES PRIVATE LIMITED (650548014)

Establishment
Name	Address	ID/FEI	Operations
AGILA SPECIALTIES PRIVATE LIMITED		676199117	Analysis, Manufacture, Sterilize, Pack

Revised: 02/2012Pfizer Laboratories Div Pfizer Inc.

Aphthasol

Generic Name: amlexanox (Mucous membrane, oral route)

am-LEX-a-nox

Commonly used brand name(s)

In the U.S.

• Aphthasol

Available Dosage Forms:

• Paste

Therapeutic Class: Protectant, Dental

Uses For Aphthasol

Amlexanox is used as a paste in the mouth to treat aphthous ulcers (canker sores).

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

Before Using Aphthasol

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

There is no specific information comparing use of amlexanox in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of amlexanox in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Immune system problems—It is not known if this medicine will work properly in patients with these problems

Proper Use of Aphthasol

How to use this medicine:

• Apply this medicine to the canker sore as soon as you notice it.


• Squeeze a small amount of the paste (about 1/4 inch) onto your fingertip. Using gentle pressure, dab the paste onto each sore in your mouth.


• Wash your hands immediately after using amlexanox paste.


• Keep using the medicine until the sore is healed. However, if it is not healed after 10 days, check with your doctor.


• Do not get any of the paste in your eyes. If any gets in your eyes, wash them out with water right away.

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 mucosal-local dosage form (oral paste):
  
  • For treatment of canker sores:
    
    • Adults—Apply to each canker sore in the mouth four times a day, after you brush your teeth after breakfast, lunch, dinner, and at bedtime.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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.

Aphthasol 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.

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:

Less common or rare

• Burning, stinging, or pain at place medicine is applied


• inflammation of mucous membranes


• diarrhea


• nausea

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: Aphthasol 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 Aphthasol resources

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

• Aphthasol Monograph (AHFS DI)


• Aphthasol MedFacts Consumer Leaflet (Wolters Kluwer)


• Aphthasol Consumer Overview

Compare Aphthasol with other medications

• Aphthous Stomatitis, Recurrent

Zide

Generic Name: hydrochlorothiazide (Oral route)

hye-droe-klor-oh-THYE-a-zide

Commonly used brand name(s)

In the U.S.

• Aquazide H


• Hydrocot


• Microzide


• Zide

Available Dosage Forms:

• Tablet


• Capsule


• Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Diuretic

Chemical Class: Thiazide

Uses For Zide

Hydrochlorothiazide is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Hydrochlorothiazide is also used to treat fluid retention (edema) that is caused by congestive heart failure, severe liver disease (cirrhosis), kidney disease, or treatment with a steroid or hormone medicine.

Hydrochlorothiazide is a thiazide diuretic (water pill). It is used to help reduce the amount of water in the body by increasing the flow of urine. It may also be used for other conditions as determined by your doctor.

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

Before Using Zide

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 have not been performed on the relationship of age to the effects of hydrochlorothiazide capsules or tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrochlorothiazide capsules in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving hydrochlorothiazide capsules.

No information is available on the relationship of age to the effects of hydrochlorothiazide tablets in geriatric patients. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving hydrochlorothiazide tablets.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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.

• Dofetilide

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.

• Acetyldigoxin


• Arsenic Trioxide


• Deslanoside


• Digitalis


• Digitoxin


• Digoxin


• Droperidol


• Flecainide


• Ketanserin


• Levomethadyl


• Lithium


• Metildigoxin


• Ouabain


• Proscillaridin


• Sotalol

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.

• Alacepril


• Apazone


• Aspirin


• Benazepril


• Bepridil


• Bromfenac


• Captopril


• Carbamazepine


• Celecoxib


• Chlorpropamide


• Cholestyramine


• Cilazapril


• Cyclophosphamide


• Delapril


• Diclofenac


• Diflunisal


• Enalaprilat


• Enalapril Maleate


• Etodolac


• Fenoprofen


• Flurbiprofen


• Fosinopril


• Ginkgo


• Glipizide


• Gossypol


• Ibuprofen


• Ibuprofen Lysine


• Imidapril


• Indomethacin


• Ketoprofen


• Ketorolac


• Licorice


• Lisinopril


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Moexipril


• Nabumetone


• Naproxen


• Nepafenac


• Oxaprozin


• Pentopril


• Perindopril


• Piroxicam


• Quinapril


• Ramipril


• Salicylic Acid


• Salsalate


• Spirapril


• Sulindac


• Temocapril


• Tolmetin


• Topiramate


• Trandolapril


• Zofenopril

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:

• Anuria (not able to urinate) or


• Sulfa drug allergy (e.g., sulfamethoxazole/trimethoprim, Bactrim®, Septra®)—Should not be used in patients with these conditions.

• Asthma or


• Diabetes or


• Electrolyte imbalance (e.g., hypercalcemia, hypokalemia, hyponatremia, hypomagnesemia) or


• Gout or


• Hypercholesterolemia (high cholesterol in the blood) or


• Hyperuricemia (high uric acid in the blood) or


• Hypoglycemia (low blood sugar) or


• Liver disease or


• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of hydrochlorothiazide

This section provides information on the proper use of a number of products that contain hydrochlorothiazide. It may not be specific to Zide. Please read with care.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt) or potassium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to receive it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

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 fluid retention (edema):
  
  • For oral dosage form (tablets):
    
    • Adults—The usual dose is 25 to 100 milligrams (mg) daily as a single or divided dose. Your doctor may want you to take this dose every other day or on 3 to 5 days each week.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor.
    
    
  
  


• For high blood pressure:
  
  • For oral dosage form (capsule):
    
    • Adults—At first, 12. 5 milligrams (mg) or one capsule once a day. Your doctor may want you to take this alone or together with other blood pressure medicines. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 25 milligrams (mg) once a day. Your doctor may increase your dose as needed and may be taken as a single dose or divided into two doses.
    
    
    • Children—Dose is based on body weight and 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.

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

Precautions While Using Zide

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

Check with your doctor right away if you have any of the following symptoms while taking this medicine: convulsions or seizures; decreased urine; drowsiness; dry mouth; excessive thirst; increased heart rate or pulse; muscle pains or cramps; nausea or vomiting; or unusual tiredness or weakness. These may be symptoms of a condition called hypokalemia or potassium loss.

Stop using this medicine and check with your doctor immediately if you have blurred vision, difficulty in reading, eye pain, or any other change in vision during or after treatment. This could be a sign of a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause some people to become dizzy. Do not drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Drinking alcoholic beverages may also make the dizziness worse. While you are taking this medicine, be careful to limit the amount of alcohol you drink.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests (e.g., tests for parathyroid function) may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Zide 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:

Incidence not known

• Abdominal or stomach pain


• back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• blood in the urine or stools


• bloody urine


• blue lips and fingernails


• blurred vision


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


• chest pain


• chills


• clay-colored stools


• cloudy urine


• cold sweats


• confusion


• constipation


• cough or hoarseness


• coughing that sometimes produces a pink frothy sputum


• coughing up blood


• cracks in the skin


• darkened urine


• decrease in urine output or decrease in urine-concentrating ability


• decreased frequency or amount of urine


• diarrhea


• difficult, fast, or noisy breathing, sometimes with wheezing


• difficulty with breathing


• difficulty with swallowing


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


• dry mouth


• fast or irregular heartbeat


• fever


• flushed, dry skin


• fruit-like breath odor


• general body swelling


• general feeling of discomfort or illness


• general feeling of tiredness or weakness


• greatly decreased frequency of urination or amount of urine


• headache


• hives


• increased blood pressure


• increased hunger


• increased sweating


• increased thirst


• increased urination


• indigestion


• itching


• joint pain, stiffness, or swelling


• loss of appetite


• loss of heat from the body


• lower back or side pain


• muscle cramps or pain


• nausea or vomiting


• nosebleeds


• numbness, tingling, pain, or weakness in the hands or feet


• pain in the joints or muscles


• painful or difficult urination


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale skin


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rash


• red, irritated eyes


• red skin lesions, often with a purple center


• red, swollen skin


• redness, soreness, or itching skin


• scaly skin


• seizures


• shortness of breath


• sore throat


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


• sores, welting, or blisters


• sugar in the urine


• swelling of the face, fingers, legs, ankles, feet, or lower legs


• swollen or painful glands


• tenderness of salivary glands


• thickening of bronchial secretions


• tightness in the chest


• trembling


• troubled breathing


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight loss


• vomiting of blood


• weakness and heaviness of the legs


• weight gain


• wheezing


• yellow eyes or skin

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

• Cramping


• decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• feeling of constant movement of self or surroundings


• hair loss or thinning of the hair


• inability to have or keep an erection


• increased sensitivity of the skin to sunlight


• loss in sexual ability, desire, drive, or performance


• muscle spasm


• pinpoint red or purple spots on the skin


• redness or other discoloration of the skin


• restlessness


• sensation of spinning


• severe sunburn


• weakness

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: Zide 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 Zide resources

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

Compare Zide with other medications

• Diabetes Insipidus
• Edema
• High Blood Pressure
• Nephrocalcinosis
• Osteoporosis

Diamorphine Injection BP 5mg (Wockhardt UK Ltd)

1. Name Of The Medicinal Product

Diamorphine Hydrochloride 5mg for Injection

2. Qualitative And Quantitative Composition

Each ampoule contains 5mg of Diamorphine Hydrochloride.

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

A white to off-white, sterile, freeze dried powder of Diamorphine Hydrochloride BP for reconstitution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Diamorphine may be used in the treatment of severe pain associated with surgical procedures, myocardial infarction or pain in the terminally ill and for the relief of dyspnoea in acute pulmonary oedema.

4.2 Posology And Method Of Administration

Diamorphine may be given by the intramuscular, intravenous or subcutaneous routes. Glucose intravenous infusion is the preferred diluent, particularly when the drug is administered by a continuous infusion pump over 24 to 48 hours, although it is also compatible with sodium chloride intravenous infusion.

The dose should be suited to the individual patient.

Adults:

Acute pain, 5mg repeated every four hours if necessary (up to 10mg for heavier, well muscled patients) by subcutaneous or intramuscular injection. By slow intravenous injection, one quarter to one half the corresponding intramuscular dose.

Chronic pain, 5-10mg regularly every four hours by subcutaneous or intramuscular injection. The dose may be increased according to individual needs.

Myocardial infarction, 5mg by slow intravenous injection (1mg/minute) followed by a further 2.5mg to 5mg if necessary.

Acute pulmonary oedema, 2.5mg to 5mg by slow intravenous injection (1mg/minute).

Children and Elderly:

As diamorphine has a respiratory depressant effect, care should be taken when giving the drug to the very young and the elderly and a lower starting dose than normal is recommended.

Hepatic impairment:

A reduction in dosage should be considered in hepatic impairment.

Renal impairment:

The dosage should be reduced in moderate to severe renal impairment.

Debilitated patients:

A reduction in dosage should be considered in debilitated patients.

For concomitant illnesses/conditions where dose reduction may be appropriate see 4.4 Special Warnings and Precautions for Use.

4.3 Contraindications

Acute respiratory depression.

Known hypersensitivity to diamorphine or morphine.

Phaeochromocytoma (endogenous release of histamine may stimulate catecholamine release).

Biliary colic (see also biliary tract disorders, 4.4 Special Warnings and Precautions).

Coma. Raised intracranial pressure. Head injuries, as there is an increased risk of respiratory depression that may lead to elevation of CSF pressure. The sedation and pupillary changes produced may interfere with accurate monitoring of the patient

Acute alcoholism.

Diamorphine is also contra-indicated where there is a risk of paralytic ileus, or in acute diarrhoeal conditions associated with antibiotic-induced pseudomembranous colitis or diarrhoea caused by poisoning (until the toxic material has been eliminated).

4.4 Special Warnings And Precautions For Use

Repeated administration of diamorphine may lead to dependence and tolerance developing. Abrupt withdrawal in patients who have developed dependence may precipitate a withdrawal syndrome. Great caution should be exercised in patients with a known tendency or history of drug abuse.

Morphine-like opioids should either be avoided in patients with biliary tract disorders or they should be given with an antispasmodic (use in biliary colic is a contraindication see 4.3 Contraindications).

Diamorphine should be given in reduced doses or with caution to patients with asthma or decreased respiratory reserve (including kyphoscoliosis, emphysema, severe obesity, cor pulmonale). Avoid use during an acute asthma attack (see 4.3 Contraindications).

Use with caution or in reduced doses in patients with toxic psychosis, CNS depression, myxoedema, prostatic hypertrophy or urethral stricture, severe inflammatory or obstructive bowel disorders, hypotension, shock, convulsive disorders, adrenal insufficiency or debilitated patients.

Care should be exercised in treating the elderly, children or debilitated patients and those with hepatic or renal impairment (see 4.2 Posology for dosage recommendations).

Palliative care - in the control of pain in terminal illness, these conditions should not necessarily be a deterrent to use.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Alcohol: Alcohol may enhance the sedative and hypotensive effects of diamorphine.

Anti-arrhythmics: Diamorphine may delay the absorption of mexiletine.

Antidepressants, anxiolytics, hypnotics: Severe CNS excitation or depression (hypertension or hypotension) has been reported with the concomitant use of monoamine oxidase inhibitors (MAOIs) and pethidine. It is therefore possible that a similar interaction may occur with other opioid analgesics - avoid concomitant use and for two weeks after stopping MAOIs.

The depressant effects of diamorphine may be exaggerated and prolonged by tricyclic antidepressants, anxiolytics and hypnotics.

Antivirals: Plasma concentration of opioid analgesics (except methadone) is possibly increased by ritinovir.

Opioids potentiate the effects of CNS depressants including tricyclic antidepressants, anxiolytics and hypnotics.

Antipsychotics: enhanced sedative and hypotensive effect.

Antidiarrhoeal and antiperistaltic agents (such as loperamide and kaolin): concurrent use may increase the risk of severe constipation.

Antimuscarinics: The risk of severe constipation and/or urinary retention is increased by administration of antimuscarinic drugs (e.g. atropine).

Motility stimulants: There may be antagonism of the gastrointestinal effects of domperidone and metoclopramide.

Cimetidine inhibits metabolism of opioid analgesics.

4.6 Pregnancy And Lactation

Safety has not been established in pregnancy.

Administration during labour may cause respiratory depression in the neonate and gastric stasis during labour, increasing the risk of inhalation pneumonia. Babies born to diamorphine-dependant mothers have been reported to suffer withdrawal symptoms.

Diamorphine should not be given to women who are breast-feeding as there is limited information available on diamorphine in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Diamorphine causes drowsiness and mental clouding. If affected patients should not drive or use machines.

4.8 Undesirable Effects

The most serious hazard of therapy is respiratory (see also 4.9 Overdose). The most common side effects are sedation, nausea and vomiting, constipation and sweating. Tolerance generally develops with long-term use, but not to constipation. Other side effects include the following:

Anaphylaxis: Anaphylactic reactions following intravenous injection have been reported rarely.

Cardiovascular: orthostatic hypotension, facial flushing, palpitations, tachycardia, bradycardia.

Central Nervous System: dizziness, vertigo, mental clouding, confusion (with large doses), hallucinations, headache, mood changes including dysphoria and euphoria.

Gastrointestinal: dry mouth, biliary spasm.

Disorders of the eye: blurred or double vision or other changes in vision, miosis.

Sexual dysfunction: long term use may lead to a reversible decrease in libido or potency.

Skin: rash, pruritus, urticaria.

Urinary: urinary retention, difficulty with micturition, ureteric spasm, antidiuretic effect. Tolerance develops to the effects of opioids on the bladder.

The euphoric activity of diamorphine has led to its abuse and physical and psychological dependence may occur (see also 4.4 Special Warnings and Precautions for use).

4.9 Overdose

a) Symptoms

The triad of respiratory depression, coma and constricted pupils is considered indicative of opioid overdosage with dilatation of the pupils occurring as hypoxia develops.

Pulmonary oedema after overdosage is a common cause of fatalities among diamorphine addicts.

Other opioid overdose symptoms include cold, clammy skin, hypotension, bradycardia, circulatory failure, muscle flaccidity, severe weakness, severe nervousness or restlessness, confusion, severe dizziness, severe drowsiness, hallucinations, convulsions (especially in infants and children), rhabdomyolysis progressing to renal failure.

b) Treatment

Respiration and circulation should be maintained and the specific opioid antagonist, naloxone is indicated if coma or bradypnoea are present, using one of the recommended dosage regimens. Oxygen and assisted ventilation should be administered if necessary.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Diamorphine is a narcotic analgesic which acts primarily on the central nervous system and smooth muscle. It is predominantly a central nervous system depressant but it has stimulant actions resulting in nausea, vomiting and miosis.

5.2 Pharmacokinetic Properties

Diamorphine is a potent opiate analgesic which has a more rapid onset of activity than morphine as the first metabolite, monoacetylmorphine, more readily crosses the blood brain barrier. In man, diamorphine has a half life of two to three minutes. Its first metabolite, monoacetylmorphine, is more slowly hydrolysed in the blood to be concentrated mainly in skeletal muscle, kidney, lung, liver and spleen. Monoacetylmorphine is metabolised to morphine. Morphine forms conjugates with glucuronic acid. The majority of the drug is excreted via the kidney as glucuronides and to a much lesser extent as morphine. About 7-10% is eliminated via the biliary system into the faeces.

Diamorphine does not bind to protein. However, morphine is about 35% bound to human plasma proteins, mainly to albumin. The analgesic effect lasts approximately three to four hours.

5.3 Preclinical Safety Data

There are no additional pre-cliical data of relevance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Water for Injections (Not detectable in the finished product).

6.2 Incompatibilities

Physical incompatibility has been reported with mineral acids and alkalis and with chlorocresol. Mixtures of diamorphine with cyclizine, haloperidol or dexamethasone may result in precipitation. Mixtures of diamorphine and metoclopramide may become discoloured and should be discarded. Specialised references should be consulted for specific compatibility information.

6.3 Shelf Life

Three years from date of manufacture

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep container in the outer carton.

6.5 Nature And Contents Of Container

2ml Neutral glass ampoules, PhEur. Type 1. Ampoules are packed into cartons of 5, 10 or 50.

6.6 Special Precautions For Disposal And Other Handling

The solution should be used immediately after preparation.

7. Marketing Authorisation Holder

Wockhardt UK Limited

Ash Road North

Wrexham

LL13 9UF

UK

8. Marketing Authorisation Number(S)

PL 29831/0062

9. Date Of First Authorisation/Renewal Of The Authorisation

27/04/2007

10. Date Of Revision Of The Text

Lortuss LQ Liquid

Pronunciation: dox-IL-a-meen/SOO-doe-e-FED-rin
Generic Name: Doxylamine/Pseudoephedrine
Brand Name: Lortuss LQ

Lortuss LQ Liquid is used for:

Relieving symptoms of sinus congestion, runny nose, itching of the nose and throat, itchy or watery eyes, and sneezing due to colds, hay fever, and allergies. It may also be used for other conditions as determined by your doctor.

Lortuss LQ Liquid is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine and reducing symptoms such as watery eyes and sneezing. The decongestant relieves nasal congestion by causing vasoconstriction and shrinkage of the nasal mucous membranes and promoting drainage.

Do NOT use Lortuss LQ Liquid if:

• you are allergic to any ingredient in Lortuss LQ Liquid


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you use any product containing diphenhydramine


• you take droxidopa, sodium oxybate (GHB), or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Lortuss LQ Liquid:

Some medical conditions may interact with Lortuss LQ Liquid. 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 a history of adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, cor pulmonale; fast, slow, or irregular heartbeat; heart disease), high blood pressure, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, seizures, or thyroid problems


• if you have a history of asthma or other breathing problems, chronic cough, lung problems (eg, chronic bronchitis, emphysema), chronic obstructive pulmonary disease (COPD), or sleep apnea


• if you have a blockage of your bladder, stomach, or bowels; ulcers; trouble sleeping; an enlarged prostate or other prostate problems; or trouble urinating

Some MEDICINES MAY INTERACT with Lortuss LQ Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or a heart attack may be increased


• Beta-blockers (eg, propranolol), furazolidone, linezolid, MAOIs (eg, phenelzine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Lortuss LQ Liquid's side effects


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Lortuss LQ Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Lortuss LQ Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lortuss LQ Liquid 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 Lortuss LQ Liquid:

Use Lortuss LQ Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Lortuss LQ Liquid may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Lortuss LQ Liquid and you are taking it regularly, 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 Lortuss LQ Liquid.

Important safety information:

• Lortuss LQ Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Lortuss LQ Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Lortuss LQ Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not drink alcohol while you are using Lortuss LQ Liquid.


• If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take Lortuss LQ Liquid.


• Do not take diet or appetite control medicines while you are taking Lortuss LQ Liquid without checking with your doctor.


• Lortuss LQ Liquid has a decongestant and an antihistamine in it. Before you start any new medicine, check the label to see if it has a decongestant or antihistamine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 7 days; if they get worse; if they occur along with a fever, rash, or persistent headache; or if new symptoms occur, check with your doctor.


• Lortuss LQ Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Lortuss LQ Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Lortuss LQ Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Lortuss LQ Liquid for a few days before the tests.


• Tell your doctor or dentist that you take Lortuss LQ Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Lortuss LQ Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Lortuss LQ Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Lortuss LQ Liquid should not be used in CHILDREN younger than 6 years; safety and effectiveness in these 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 Lortuss LQ Liquid while you are pregnant. It is not known if Lortuss LQ Liquid is found in breast milk. Do not breast-feed while taking Lortuss LQ Liquid.

Possible side effects of Lortuss LQ Liquid:

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; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes; persistent trouble sleeping; restlessness; seizures; severe dizziness, drowsiness, lightheadedness, or headache; tremor.

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: Lortuss LQ 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 blurred vision; confusion; hallucinations; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Lortuss LQ Liquid:

Store Lortuss LQ Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lortuss LQ Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Lortuss LQ Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Lortuss LQ Liquid is 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 Lortuss LQ Liquid. 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 Lortuss LQ resources

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

Compare Lortuss LQ with other medications

• Cough and Nasal Congestion

Fe Caps Controlled-Release Capsules

Pronunciation: FER-us SUL-fate
Generic Name: Ferrous Sulfate
Brand Name: Examples include Fe Caps and Slow Fe

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years old. Keep this product out of the reach of children. In case of an accidental overdose, call a doctor or poison control center right away.

Fe Caps Controlled-Release Capsules are used for:

Preventing or treating low levels of iron in the blood. It may also be used for other conditions as determined by your doctor.

Fe Caps Controlled-Release Capsules are an essential body mineral. It works by replacing iron in your body if your body does not produce enough on its own.

Do NOT use Fe Caps Controlled-Release Capsules if:

• you are allergic to any ingredient in Fe Caps Controlled-Release Capsules


• you have high levels of iron in your blood

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

Before using Fe Caps Controlled-Release Capsules:

Some medical conditions may interact with Fe Caps Controlled-Release 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 inflammation of the intestines, Crohn disease, digestive problems, ulcers, anemia, or a blood disease (eg, porphyria, thalassemia)


• if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Fe Caps Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Doxycycline, mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Fe Caps Controlled-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fe Caps Controlled-Release 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 Fe Caps Controlled-Release Capsules:

Use Fe Caps Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Fe Caps Controlled-Release Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Swallow Fe Caps Controlled-Release Capsules whole. Do not break, crush, or chew before swallowing.


• Take Fe Caps Controlled-Release Capsules with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Fe Caps Controlled-Release Capsules.


• If you are also taking an antacid, a bisphosphonate (eg, alendronate), a cephalosporin (eg, cephalexin), methyldopa, penicillamine, a quinolone (eg, ciprofloxacin), or a tetracycline (eg, minocycline) along with Fe Caps Controlled-Release Capsules, you may need to space the doses several hours apart. Ask your doctor or pharmacist how much time is needed between doses of Fe Caps Controlled-Release Capsules and your other medicines.


• Certain foods and drinks may decrease the amount of Fe Caps Controlled-Release Capsules that works in your body. Ask your doctor or pharmacist how you should take Fe Caps Controlled-Release Capsules if you consume whole grain breads or cereal, dairy products, coffee, or tea.


• If you miss a dose of Fe Caps Controlled-Release 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 Fe Caps Controlled-Release Capsules.

Important safety information:

• Do not take large doses of vitamins while you use Fe Caps Controlled-Release Capsules unless your doctor tells you to.


• Do NOT take more than the recommended dose or take for longer than 6 months without checking with your doctor.


• Fe Caps Controlled-Release Capsules has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.


• Lab tests, including complete blood cell counts and blood iron levels, may be performed while you use Fe Caps Controlled-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Fe Caps Controlled-Release 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 using Fe Caps Controlled-Release Capsules while you are pregnant. Fe Caps Controlled-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Fe Caps Controlled-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fe Caps Controlled-Release 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; darkened or green stools; diarrhea; nausea; stomach upset.

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); black, tarry stools; blood or streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.

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: Fe Caps 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 difficulty breathing; loss of consciousness; seizures; severe nausea; stomach pain; tarry stools; unusual tiredness; vomiting; weak, fast heartbeat.

Proper storage of Fe Caps Controlled-Release Capsules:

Store Fe Caps Controlled-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fe Caps Controlled-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Fe Caps Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Fe Caps Controlled-Release 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 Fe Caps Controlled-Release 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 Fe Caps resources

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

Compare Fe Caps with other medications

• Anemia Associated with Chronic Renal Failure
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• Vitamin/Mineral Supplementation and Deficiency
• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Vanatrip

Generic Name: amitriptyline (a mee TRIP ti leen)

Brand Names: Vanatrip

What is Vanatrip (amitriptyline)?

Amitriptyline is a tricyclic antidepressant. Amitriptyline affects chemicals in the brain that may become unbalanced.

Amitriptyline is used to treat symptoms of depression.

Amitriptyline may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Vanatrip (amitriptyline)?

Do not use this medication if you are allergic to amitriptyline, or if you have recently had a heart attack. Do not use amitriptyline if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before taking Vanatrip (amitriptyline)?

You should not use this medication if you are allergic to amitriptyline, or if you have recently had a heart attack. Do not use amitriptyline 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.

To make sure you can safely take amitriptyline, tell your doctor if you have any of these other conditions:

• 
  

  heart disease;

  
  


• 
  

  a history of heart attack, stroke, or seizures;

  
  


• 
  

  bipolar disorder (manic-depression);

  
  


• 
  

  schizophrenia or other mental illness;

  
  


• 
  

  diabetes (amitriptyline may raise or lower blood sugar);

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  glaucoma; or

  
  


• 
  

  problems with urination.

  
  

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. It is not known whether amitriptyline will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Amitriptyline can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using amitriptyline. Do not give this medication to anyone under 12 years old without medical advice.

How should I take Vanatrip (amitriptyline)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

If you need surgery, tell the surgeon ahead of time that you are using amitriptyline. You may need to stop using the medicine for a short time. Do not stop using amitriptyline suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using amitriptyline. It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment. Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

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. An overdose of amitriptyline can be fatal.

Overdose symptoms may include uneven heartbeats, extreme drowsiness, confusion, agitation, vomiting, hallucinations, feeling hot or cold, muscle stiffness, seizure (convulsions), or fainting.

What should I avoid while taking Vanatrip (amitriptyline)?

Do not drink alcohol. It can cause dangerous side effects when taken together with amitriptyline. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid exposure to sunlight or tanning beds. Amitriptyline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Vanatrip (amitriptyline) 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.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  pounding heartbeats or fluttering in your chest;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  confusion, hallucinations, seizures (convulsions);

  
  


• 
  

  restless muscle movements in your eyes, tongue, jaw, or neck, uncontrollable shaking or tremor;

  
  


• 
  

  extreme thirst with headache, nausea, vomiting, and weakness;

  
  


• 
  

  numbness, burning pain, or tingly feeling;

  
  


• 
  

  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, constipation, diarrhea, loss of appetite;

  
  


• 
  

  dry mouth, unpleasant taste;

  
  


• 
  

  feeling dizzy, drowsy, or tired;

  
  


• 
  

  trouble concentrating;

  
  


• 
  

  nightmares;

  
  


• 
  

  blurred vision, headache, ringing in your ears;

  
  


• 
  

  breast swelling (in men or women); or

  
  


• 
  

  decreased sex drive, impotence, or difficulty having an orgasm.

  
  

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.

What other drugs will affect Vanatrip (amitriptyline)?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by amitriptyline. Tell your doctor if you regularly use any of these medicines, or any other antidepressants.

Before taking amitriptyline, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

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

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  methimazole (Tapazole);

  
  


• 
  

  nicardipine (Cardene);

  
  


• 
  

  ropinirole (Requip);

  
  


• 
  

  ticlopidine (Ticlid);

  
  


• 
  

  an antibiotic such as terbinafine (Lamisil);

  
  


• 
  

  anti-malaria medication such as chloroquine (Arelan) or pyrimethamine (Daraprim), or quinine (Qualaquin);

  
  


• 
  

  HIV or AIDS medicine such as delavirdine (Rescriptor) or ritonavir (Norvir, Kaletra);

  
  


• 
  

  medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril);

  
  


• 
  

  a heart rhythm medication such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), ibutilide (Corvert), or sotalol (Betapace); or

  
  


• 
  

  a heart rhythm medication such as disopyramide (Norpace), dronedarone (Multaq), flecainide (Tambocor), mexiletine (Mexitil), procainamide (Pronestyl), propafenone (Rythmol), or quinidine (Quin-G).

  
  

This list is not complete and there are many other drugs that can interact with amitriptyline. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Vanatrip resources

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

• Vanatrip Advanced Consumer (Micromedex) - Includes Dosage Information


• Amitriptyline Prescribing Information (FDA)


• Amitriptyline MedFacts Consumer Leaflet (Wolters Kluwer)


• Amitriptyline Hydrochloride Monograph (AHFS DI)


• Elavil Consumer Overview

Compare Vanatrip with other medications

• Anxiety and Stress
• Burning Mouth Syndrome
• Cyclic Vomiting Syndrome
• Depression
• Dysautonomia
• Dysthymia
• Fibromyalgia
• Hyperhidrosis
• Insomnia
• Interstitial Cystitis
• Migraine Prevention
• Neurotic Depression
• Pain
• Post Traumatic Stress Disorder
• Reflex Sympathetic Dystrophy Syndrome
• Somatoform Pain Disorder
• Urinary Incontinence
• Vulvodynia

Where can I get more information?

• Your pharmacist can provide more information about amitriptyline.

See also: Vanatrip side effects (in more detail)