DMSA

Dosage Form: Injection

Rx ONLY

DIAGNOSTIC - FOR INTRAVENOUS USE

DMSA Description

Each vial contains a sterile, pyrogen-free freeze-dried mixture of 1.0 mg dimercaptosuccinic acid, 0.42 mg stannous chloride dihydrate [0.38 mg (minimum) stannous chloride dihydrate (SnCl2•2H2O) and 0.46 mg (maximum) total tin expressed as stannous chloride dihydrate (SnCl2•2H2O)], 0.70 mg ascorbic acid, and 50.0 mg inositol. After freeze-drying, vials are sealed under a nitrogen atmosphere with a rubber closure. Sodium hydroxide and hydrochloric acid have been used for pH adjustment. When sterile, oxidant-free, pyrogen-free sodium pertechnetate Tc99m injection in isotonic saline is combined with the vial contents, following the instructions provided with the kit, a complex is formed. After 10 minutes incubation the reconstituted solution is ready for intravenous injection.

Chemical Name: meso-2,3-dimercaptosuccinic acid

The succimer component of DMSA consists of more than 90% meso isomer and less than 10% d,l isomer.

PHYSICAL CHARACTERISTICS

Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hours1. The principal photon that is useful for detection and imaging studies is listed in Table 1.

Table 1. Principal Radiation Emission Data1

Radiation	Mean % / Disintegration	Mean Energy (keV)
Gamma 2	89.07	140.5

1

Kocher, David C., "Radioactive Decay Data Tables," DOE/TIC-11026,108 (1981).

EXTERNAL RADIATION

The specific gamma ray constant for technetium Tc99m is 0.78 R/hr-mCi at 1 cm. The first half value layer is 0.017 cm of Pb. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.

Table 2. Radiation Attenuation by Lead Shielding

Shield Thickness (Pb) cm	Coefficient of Attenuation
0.02	0.5
0.08	0.1
0.16	0.01
0.25	0.001
0.33	0.0001

To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.

Table 3. Physical Decay Chart: Tc99m, half-life 6.02 hours

Hours	Fraction Remaining	Hours	Fraction Remaining
* Calibration Time
0*	1.000	7	0.447
1	0.891	8	0.398
2	0.794	9	0.355
3	0.708	10	0.316
4	0.631	11	0.282
5	0.562	12	0.251
6	0.501

DMSA - Clinical Pharmacology

After intravenous administration, technetium Tc99m succimer injection is distributed in the plasma, apparently bound to plasma proteins. There is negligible activity in the red blood cells. The activity is cleared from the plasma with a half-time of about 60 minutes and concentrates in the renal cortex. Approximately 16% of the activity is excreted in the urine within two hours. At six hours about 20% of the dose is concentrated in each kidney.

Indications and Usage for DMSA

DMSA is to be used as an aid in the scintigraphic evaluation of renal parenchymal disorders.

Contraindications

None known.

Warnings

None.

Precautions

General

As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers.

DMSA should be used between 10 minutes and 4 hours following reconstitution (see "Preparation" section). Any unused portion should be discarded after that time.

Some patients with advanced renal failure may exhibit poor renal intake of Tc99m DMSA. It has been reported that satisfactory images may be obtained in some of these patients by delaying imaging for up to 24 hours.

The contents of the kit vials are intended only for use in the preparation of DMSA Injection and are not to be directly administered to the patient.

The contents of the kit vials are not radioactive. However, after Tc99m is added, adequate shielding of the final preparation must be maintained.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether technetium Tc99m succimer injection affects fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with technetium Tc99m succimer injection. It is also not known whether technetium Tc99m succimer injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Technetium Tc99m succimer injection should be administered to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of child bearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers

Technetium Tc99m is excreted in human milk during lactation; therefore, formula feedings should be substituted for breast feedings.

Pediatric Use

Safety and effectiveness in pedriatric patients have not been established

Geriatric Use

Clinical studies of DMSA did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

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.

Adverse Reactions

Rare instances of syncope, fever, nausea and maculopapular skin rash have been reported.

DMSA Dosage and Administration

The suggested dose range for slow I.V. administration to be employed in the average patient (70 kg) for renal parenchymal imaging is 74-222 MBq, 2-6 mCi technetium Tc99m succimer injection.

The product must be used between 10 minutes to 4 hours following preparation (see "Preparation" section). Acceptable renal images may be obtained beginning 1 to 2 hours post injection. Any unused portion should be discarded after that time.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Do not use after the expiration date stated on the label. The components of the kit are supplied sterile and pyrogen-free. Aseptic procedures normally employed in making additions and withdrawals from sterile, pyrogen-free containers should be used during addition of sodium pertechnetate Tc99m injection solutions and during the withdrawal of doses for patient administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

RADIATION DOSIMETRY

The estimated absorbed radiation doses2,3 to an average adult (70 kg) are shown in Table 4.

Table 4. Absorbed Radiation Dose

Tissue	mGy / 222 MBq	rads / 6 mCi
Bladder Wall	4.2	0.42
Kidneys (total)	37.8	3.78
Renal Cortices	51.0	5.10
Liver	1.9	0.19
Bone Marrow	1.3	0.13
Ovaries	0.8	0.08
Testes	0.4	0.04
Total Body	0.9	0.09

2

Method of Calculation: A schema for Absorbed-Dose Calculations for Biologically Distributed Radionuclides, Supplement No. 1, MIRD Pamphlet No. 1, J. Nucl. Med., p. 7, 1968.

3

Biological Data: Arnold, R.W; Subramanian, G.; McAfee, J.G.; Blair, R.J.; Thomas, F.D.; Comparison of Tc99m complexes for renal imaging, J. Nucl. Med., 16, pp. 357-367, 1975.

How is DMSA Supplied

Kit Contents

5

Vials containing a freeze-dried mixture of 1.0 mg dimercaptosuccinic acid, 0.42 mg stannous chloride dihydrate [0.38 mg (minimum) stannous chloride dihydrate (SnCl2•2H2O) and 0.46 mg (maximum) total tin expressed as stannous chloride dihydrate (SnCl2•2H2O)], 0.70 mg ascorbic acid, and 50.0 mg inositol.

5

Labels

1

Package Insert

NDC 017156-525-01

Storage

Store the kit at 2°-8°C (36°-46°F) and protect from light.

Preparation

The following directions must be carefully followed for optimum preparation of technetium Tc99m succimer injection:

Note: Use aseptic procedures throughout and take precautions to minimize radiation exposure by the use of suitable shielding. Waterproof gloves should be worn during the preparation procedure.

1. Place one of the vials in a suitable shielding container and swab the closure with a bacteriostatic swab.


2. Using a 10 mL sterile syringe, inject an appropriate amount (see notes 1 and 2) of the eluate from a Tc99m generator into the shielded vial. Before removing the syringe from the vial withdraw an equivalent volume of nitrogen from the space above the solution to normalize the pressure in the vial.


3. Carefully invert the vial a few times until the powder is completely dissolved.


4. Assay the total activity, complete the label provided and attach to the vial.


5. Incubate the vial for at least 10 minutes at room temperature.


6. Use the preparation between 10 minutes and 4 hours following reconstitution.

Note:

1. Not more than 1.48 GBq, 40 mCi technetium-99m in a volume of 1-6 mL should be added to the vial.


2. Before reconstitution, the eluate may be adjusted to the correct radioactive concentration by dilution with preservative-free, non-bacteriostatic saline for injection.


3. The use of technetium-99m solution complying with the specifications prescribed by the USP Monograph on Sodium Pertechnetate (99mTc) injection will yield a preparation of an appropriate quality.


4. It is recommended that with proper shielding and equipment, the final formulation be tested for radiochemical purity. If radiochemical purity is not adequate, discard the finished drug.

DISPOSAL

Any unused portion of the Tc99m-labeled kit must be stored and disposed of in accordance with the conditions of NRC radioactive materials license pursuant to 10 CFR Parts 20 and 35 or equivalent conditions pursuant to Agreement state regulation, or other regulatory agency authorized to license the use of radionuclides.

The unlabeled residual materials may be discarded in ordinary trash, provided that the vials and syringes read background with an appropriate low-range survey meter. It is suggested that all identification labels be destroyed before discarding.

This reagent kit is approved for use by persons licensed by the Illinois Emergency Management Agency pursuant to 32 Ill. Code Adm. Section, Section 330.260(a) and 335.4010 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, or an Agreement State.

Manufactured for:

GE Healthcare

Medi-Physics, Inc.

3350 North Ridge Avenue

Arlington Heights, IL 60004

1-800-633-4123 (Toll Free)

By:

GE Healthcare Ltd.

Little Chalfont, HP7 9NA, UK

GE and the GE Monogram are trademarks of General Electric Company.

43-4349H

L/2331/04

Revised February 2006

DMSA  dimercaptosuccinic acid  injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17156-525 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Dimercaptocuccinic Acid (Dimercaptocuccinic Acid) Active 1 MILLIGRAM  In 1 VIAL Stannous Chloride Dihydrate Inactive 4.2 MICROGRAM  In 1 VIAL ascorbic acid Inactive 0.70 MILLIGRAM  In 1 VIAL inositol Inactive 50.0 MILLIGRAM  In 1 VIAL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17156-525-01 5 VIAL In 1 BOX contains a VIAL 1 1 VIAL In 1 VIAL This package is contained within the BOX (17156-525-01)

Revised: 08/2007GE Healthcare

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eribulin Intravenous

er-i-BUE-lin MES-i-late

Commonly used brand name(s)

In the U.S.

• Halaven

Available Dosage Forms:

• Solution

Pharmacologic Class: Eribulin

Uses For eribulin

Eribulin belongs to the group of medicines called antineoplastics (cancer medicines). It is used to treat metastatic (cancer that has already spread) breast cancer. eribulin is used in patients who have already received at least two types of cancer medicines.

Eribulin interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by eribulin, other side effects may occur. Some of these may be serious and must be reported to your doctor right away. Some unwanted effects may not be serious but may cause concern. Some of the unwanted effects do not occur until months or years after the medicine is used.

Before you begin treatment with eribulin, you and your doctor should talk about the benefits of eribulin as well as the risks.

eribulin is to be administered only by or under the immediate supervision of your doctor.

Before Using eribulin

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 eribulin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to eribulin 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 eribulin injection 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 eribulin injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 eribulin. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (e.g., cytopenia, neutropenia) or


• Congestive heart failure or


• Heart rhythm problems (e.g., arrhythmias, QT prolongation) or


• Mineral imbalance (e.g., low magnesium or potassium in the blood) or


• Nerve problems (e.g., peripheral neuropathy)—Use with caution. May make these conditions worse. or

• Heart rhythm problem (e.g., congenital long QT syndrome)—Eribulin injection should not be given in patients with this condition.

• Kidney disease or


• Liver disease—Use with caution. You may require a lower dose of eribulin. Talk with your doctor if you have concerns about this.

Proper Use of eribulin

A nurse or other trained health professional will give you eribulin in a hospital or cancer treatment center. eribulin is given through a needle placed in one of your veins.

eribulin is usually given on Day 1 and Day 8 of a 21-day cycle of treatment. This 2-day treatment is given again every 21 days until your body responds to the medicine or you and your doctor decide to stop the treatment. Each treatment usually takes about 2 to 5 minutes.

eribulin comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using eribulin

It is very important that your doctor check your progress closely to make sure that eribulin is working properly. Blood tests may be needed to check for unwanted effects.

Using eribulin while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Eribulin 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.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

eribulin can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

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.

eribulin 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 or nurse immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bladder pain


• bloating or swelling of the face, arms, hands, lower legs, or feet


• bloody or cloudy urine


• body aches or pain


• burning, numbness, tingling, or painful sensations


• chills


• convulsions


• cough


• decreased urine


• decreased weight


• difficult or labored breathing


• difficult, burning, or painful urination


• dry mouth


• ear congestion


• fever


• frequent urge to urinate


• headache


• increased thirst


• irregular heartbeat


• loss of appetite


• loss of voice


• lower back or side pain


• mood changes


• muscle pain or cramps


• nasal congestion


• nausea or vomiting


• numbness or tingling in the hands, feet, or lips


• pale skin


• rapid weight gain


• runny nose


• shortness of breath


• sneezing


• sore throat


• tightness in the chest


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unsteadiness or awkwardness


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• weakness in the arms, hands, legs, or feet


• wheezing

Incidence not known

• Fainting


• irregular heartbeat, recurrent

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

• Acid or sour stomach


• back pain


• belching


• bone pain


• change in taste


• cracked lips


• depression


• diarrhea


• difficulty having a bowel movement (stool)


• difficulty with moving


• difficulty with swallowing


• dizziness


• hair loss or thinning of the hair


• heartburn


• indigestion


• lack or loss of strength


• loss of taste


• muscle spasm or weakness


• muscle stiffness


• pain in the arms or legs


• pain in the joints


• rash


• sleeplessness


• sores, ulcers, or white spots on the lips, tongue, or inside the mouth


• stomach discomfort, upset, or pain


• swelling or inflammation of the mouth


• trouble sleeping


• unable to sleep


• watering of the eyes


• weight loss

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: eribulin Intravenous 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 eribulin Intravenous resources

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

Compare eribulin Intravenous with other medications

• Breast Cancer
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narcotic analgesic - for surgery and obstetrics Parenteral

Class Name: narcotic analgesic (

FOR SURGERY AND OBSTETRICS (Parenteral route)

Uses For This Medicine

Narcotic analgesics are given to relieve pain before and during surgery (including dental surgery) or during labor and delivery. These medicines may also be given before or together with an anesthetic (either a general anesthetic or a local anesthetic), even when the patient is not in pain, to help the anesthetic work better.

When a narcotic analgesic is used for surgery or obstetrics (labor and delivery), it will be given by or under the immediate supervision of a medical doctor or dentist, or by a specially trained nurse, in the doctor's office or in a hospital.

The following information applies only to these special uses of narcotic analgesics. If you are taking or receiving a narcotic analgesic to relieve pain after surgery, or for any other reason, ask your health care professional for additional information about the medicine and its use.

These medicines are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, fentanyl by injection is used in certain patients with the following medical conditions:

• Pain, during surgery, neonatal

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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 younger than 2 years of age may be especially sensitive to the effects of narcotic analgesics. This may increase the chance of side effects.

Geriatric

Elderly people are especially sensitive to the effects of narcotic analgesics. This may increase the chance of side effects.

Pregnancy

Although studies on birth defects have not been done in pregnant women, these medicines have not been reported to cause birth defects. However, in animal studies, many narcotics have caused birth defects or other unwanted effects when they were given for a long time in amounts that were large enough to cause harmful effects in the mother.

Use of a narcotic during labor and delivery sometimes causes drowsiness or breathing problems in the newborn baby. If this happens, your health care professional can give the baby another medicine that will overcome these effects. Narcotics are usually not used during the delivery of a premature baby.

Breast Feeding

Some narcotics have been shown to pass into the breast milk. However, these medicines have not been reported to cause problems in nursing babies.

Interactions with Medicines

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

• Acecainide


• Ajmaline


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Aprindine


• Astemizole


• Azimilide


• Bepridil


• Bretylium


• Brofaromine


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Cisapride


• Citalopram


• Clarithromycin


• Clorgyline


• Desipramine


• Dibenzepin


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Dronedarone


• Droperidol


• Ebastine


• Encainide


• Erythromycin


• Flecainide


• Fluconazole


• Flucytosine


• Fluoxetine


• Fluvoxamine


• Foscarnet


• Furazolidone


• Halofantrine


• Haloperidol


• Hydroquinidine


• Ibutilide


• Imipramine


• Iproniazid


• Isocarboxazid


• Isradipine


• Itraconazole


• Lazabemide


• Lidoflazine


• Linezolid


• Lorcainide


• Mefloquine


• Mesoridazine


• Methdilazine


• Mexiletine


• Mibefradil


• Moclobemide


• Naltrexone


• Nialamide


• Nicardipine


• Nortriptyline


• Octreotide


• Olanzapine


• Pargyline


• Pentamidine


• Phenelzine


• Pimozide


• Pirmenol


• Prajmaline


• Primaquine


• Probucol


• Procainamide


• Procarbazine


• Propafenone


• Protriptyline


• Quinidine


• Rasagiline


• Risperidone


• Selegiline


• Sematilide


• Sertindole


• Sertraline


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Tedisamil


• Telavancin


• Terfenadine


• Thioridazine


• Tiapride


• Toloxatone


• Tranylcypromine


• Trimeprazine


• Trimethoprim


• Trimipramine


• Vasopressin


• Zimeldine


• Ziprasidone


• Zolmitriptan


• Zotepine

Using medicines in this class 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.

• Acebutolol


• Acetazolamide


• Acetophenazine


• Adinazolam


• Alfentanil


• Almotriptan


• Alphaprodine


• Alprazolam


• Alprenolol


• Amiloride


• Amiodarone


• Amitriptyline


• Amlodipine


• Amobarbital


• Amoxapine


• Amprenavir


• Anileridine


• Aprepitant


• Aprobarbital


• Aripiprazole


• Arsenic Trioxide


• Asenapine


• Atazanavir


• Atenolol


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bepridil


• Betaxolol


• Bevantolol


• Bisoprolol


• Brofaromine


• Bromazepam


• Bromperidol


• Brotizolam


• Bucindolol


• Bumetanide


• Buprenorphine


• Buspirone


• Butabarbital


• Butalbital


• Butorphanol


• Canrenoate


• Carbamazepine


• Carisoprodol


• Carteolol


• Carvedilol


• Castor Oil


• Celiprolol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorprothixene


• Chlorthalidone


• Chlorzoxazone


• Cimetidine


• Citalopram


• Clarithromycin


• Clobazam


• Clomipramine


• Clonazepam


• Clopamide


• Clorazepate


• Clorgyline


• Clovoxamine


• Clozapine


• Codeine


• Cyclobenzaprine


• Cyclothiazide


• Dantrolene


• Desflurane


• Desipramine


• Desvenlafaxine


• Dexmedetomidine


• Dezocine


• Diazepam


• Difenoxin


• Digoxin


• Dihydrocodeine


• Diltiazem


• Diphenhydramine


• Diphenoxylate


• Docusate


• Dofetilide


• Dothiepin


• Doxepin


• Doxylamine


• Droperidol


• Duloxetine


• Eletriptan


• Enflurane


• Erythromycin


• Escitalopram


• Esmolol


• Estazolam


• Eszopiclone


• Ethacrynic Acid


• Ethchlorvynol


• Ethopropazine


• Etozolin


• Felodipine


• Femoxetine


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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 medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your 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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Abdominal problems or


• Brain tumor or


• Head injury or


• Gallbladder disease or


• Heart disease or


• Kidney disease or


• Liver disease or


• Lung disease or


• Prostate disease or


• Thyroid disease or


• Urinary tract disease—Narcotic analgesics may make these conditions or the symptoms of these conditions worse.

Proper Use of This Medicine

The dose of narcotic analgesic will be different for different patients. Your health care professional will decide on the right amount for you, depending on:

• Your age;


• Your general physical condition;


• The reason you are receiving the narcotic analgesic; and


• Other medicines you are taking or will receive before or after the narcotic analgesic is given.

Precautions While Using This Medicine

For patients going home within a few hours after surgery:

• Narcotic analgesics and other medicines that may be given with them during surgery may cause some people to feel drowsy, tired, or weak for up to a few days after they have been given. Therefore, for at least 24 hours (or longer if necessary) after receiving this medicine, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.


• Unless otherwise directed by your medical doctor or dentist, do not drink alcoholic beverages or take other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) for about 24 hours after you have received this medicine. To do so may add to the effects of the narcotic analgesic. 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; and muscle relaxants.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Before you leave the hospital or doctor's office, your health care professional will closely follow the effects of this medicine. However, some effects may continue, or may not be noticed until later.

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

More common

• Dizziness, light-headedness, or feeling faint


• drowsiness


• nausea or vomiting


• unusual tiredness or weakness

Less common or rare

• Blurred or double vision or other vision problems


• confusion


• constipation


• convulsions (seizures)


• difficult or painful urination


• mental depression


• shortness of breath, trouble in breathing, tightness in the chest, or wheezing


• skin rash, hives, or itching


• unusual excitement

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.

The information contained in the Thomson Healthcare (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 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 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 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 HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

Boots NicAssist Fruit Fresh 4 mg Gum

1. Name Of The Medicinal Product

Nicorette Freshfruit 4 mg Gum

Boots NicAssist Fruit Fresh 4 mg Gum

2. Qualitative And Quantitative Composition

Chewing Gum containing 4mg nicotine, as nicotine resinate.

For excipients, see 6.1.

3. Pharmaceutical Form

Medicated Chewing Gum

A square, coated, crème coloured piece of gum

4. Clinical Particulars

4.1 Therapeutic Indications

Nicorette Freshfruit 4 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

Nicorette Freshfruit 4 mg Gum is indicated in pregnant and lactating women making a quit attempt.

4.2 Posology And Method Of Administration

Adults and Children over 12 years of age

Nicorette Freshfruit 4 mg Gum should be chewed slowly according to the instructions.

The strength of gum to be used will depend on the smoking habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is indicated. If more than 20 cigarettes per day are smoked, 4 mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.

Nicorette Freshfruit 4 mg Gum should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur.

Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Gum and as soon as they are able, reduce the number of gums used until they have stopped completely.

Smokers aiming to reduce cigarettes should use Nicorette Freshfruit 4 mg Gum, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible.

As soon as they are ready smokers should aim to quit smoking completely.

Maximum daily dose: 15 pieces per day.

When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing Nicorette Freshfruit 4 mg Gum are recommended to contact their pharmacist or doctor for advice.

For those using the 4mg gum, switching to the 2 mg gum may be helpful when stopping treatment or reducing the number of gums used each day.

The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.

4.3 Contraindications

Hypersensitivity to nicotine or any component of the chewing gum.

Nicorette Freshfruit 4 mg Gum is contraindicated in children under the age of 12 years.

4.4 Special Warnings And Precautions For Use

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.

Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Freshfruit 4 mg Gum presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Freshfruit 4 mg Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Renal or hepatic impairment: Nicorette Freshfruit 4 mg Gum should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Freshfruit 4 mg Gum should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.

Excipients: Nicorette Freshfruit 4 mg Gum also contains butylated hydroxy toluene (E321); this may cause irritation to the mucous membranes.

Denture warning: Smokers who wear dentures may experience difficulty in chewing Nicorette Freshfruit 4 mg Gum. The chewing gum may stick to, and may in rare cases damage dentures.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking cessation during pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable Nicorette Freshfruit 4 mg Gum may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the fetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Nicorette Freshfruit 4 mg Gum may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Freshfruit 4 mg Gum has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3-4 weeks after start of treatment.

Excessive consumption of Nicorette Freshfruit 4 mg Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping.

Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation.

Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4mg nicotine gum is used; slower chewing and the use of the 2mg nicotine gum (if necessary more frequently) will usually overcome this problem.

The chewing gum may stick to, and may in rare cases damage dentures.

Reported adverse events associated with Nicorette 2mg and 4mg gum include:

Body System	Incidence*	Reported adverse event
Nervous system disorders:	Very common:	Headache
	Common:	Dizziness
Cardiac disorders:	Uncommon:	Palpitations
	Very rare:	Reversible atrial fibrillation
Gastrointestinal disorders:	Very common:	Gastrointestinal discomfort, hiccups, nausea
	Common:	Vomiting
Skin and subcutaneous tissue disorders:	Uncommon:	Erythema, urticaria
General disorders and administration site conditions:	Very common:	Sore mouth or throat, jaw-muscle ache
	Rare:	Allergic reactions including angioedema

* Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Drugs used in nicotine dependence

ATC code: N07B A01

The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette Freshfruit 4 mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.

Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation weight gain is common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt.

5.2 Pharmacokinetic Properties

Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5 – 7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.

5.3 Preclinical Safety Data

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product which have not been considered in other relevant sections of this Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Core Gum

Chewing gum base, containing butylated hydroxy toluene (E321)

Xylitol

Peppermint oil

Sodium carbonate, anhydrous

Acesulfame Potassium

Levomenthol

Magnesium oxide, light

Quinoline yellow Al-Lake (E104)

Talc

Sub-coating

Tuttifrutti QL84441

Hypromellose

Sucralose

Polysorbate 80

Purified water

Coating

Xylitol

Acacia

Titanium dioxide (E171)

Tuttifrutti QL84441

Quinoline yellow Al-lake (E104)

Carnauba wax

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 Years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

PVC/PVDC/Al Blister packed strips each containing 15 pieces supplied in packs of 15, 30, 105 and 210 pieces.

Blister packed strips each containing 6 pieces supplied in packs of 12 pieces.

Blister packed strips each containing 10 pieces supplied in packs of 10 pieces.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Dispose of Nicorette Gum sensibly.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0137

9. Date Of First Authorisation/Renewal Of The Authorisation

18/07/2006

10. Date Of Revision Of The Text

27 September 2011

Hyperammonemia Medications

Drugs associated with Hyperammonemia

The following drugs and medications are in some way related to, or used in the treatment of Hyperammonemia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Ammonul

Carbaglu

Leukodystrophy Medications

There are currently no drugs listed for "Leukodystrophy".

Definition of Leukodystrophy: Type of dysmyelinating disease, hereditary, peripheral nervous system unaffected in some disorders Specific diseases: adrenoleukodystrophy, metachromatic leukodystrophy, spongy degeneration (Canavan), globoid cell (Krabbe) leukodystrophy, Alexander disease, Pelizaeus-Merzbacher disease, Cockayne syndrome.

Learn more about Leukodystrophy

Medical Encyclopedia:

• Krabbe disease

Drug List:

MuGard

Generic Name:
Brand Name: MuGard

MuGard is used for:

Treating sores and ulcers in the mouth caused by various conditions (eg, radiation, chemotherapy, canker sores, surgery, poorly fitting dentures).

MuGard is a mucoadhesive. It works by forming a protective coating over the inside of the mouth.

Do NOT use MuGard if:

• you are allergic to any ingredient in MuGard

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

Before using MuGard:

Some medical conditions may interact with MuGard. 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

Some MEDICINES MAY INTERACT with MuGard. However, no specific interactions with MuGard are known at this time.

Ask your health care provider if MuGard 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 MuGard:

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

• Use a measuring device marked for medicine dosing. Your doctor will tell you how much of MuGard to use. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Gently pour the prescribed amount of medicine into the mouth. Rinse the entire mouth for 1 minute or longer, if possible.


• If rinsing is not possible or is too painful, spread MuGard throughout the mouth by gently rotating your head.


• Be sure that all parts of the mouth have been covered by MuGard.


• Check with your doctor to see if you should spit MuGard out or swallow it after rinsing.


• Do not eat or drink for at least 1 hour after you use MuGard.


• If you miss a dose of MuGard, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use MuGard.

Important safety information:

• Do not dilute MuGard before using it.


• It is important to practice good oral hygiene as directed by your doctor or dentist while you are using MuGard. Talk with your doctor or dentist if you have questions about good oral hygiene.


• Use MuGard with caution in the ELDERLY; safety and effectiveness in the elderly have not been confirmed.


• MuGard 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 MuGard while you are pregnant. It is not known if MuGard is found in breast milk. If you are or will be breast-feeding while you use MuGard, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of MuGard:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with MuGard. 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).

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.

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.

Proper storage of MuGard:

Store MuGard at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store tightly closed and away from heat and light. Do not use MuGard past the expiration date on the bottle. Keep MuGard out of the reach of children and away from pets.

General information:

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


• MuGard 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 MuGard. 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.

Merck & Co., Inc.

Address Merck & Co., Inc., 1 Merck Access Drive Whitehouse Station, NJ 08889 Contact Details Phone: (908) 423-1000 Website: http://www.merck.com/ Careers: http://www.merck.com/careers/ Patient Assistance Program: http://www.merck.com/merckhelps/

Cotab AX

Pronunciation: KLOR-fen-IR-a-meen/KOE-deen
Generic Name: Chlorpheniramine/Codeine
Brand Name: Examples include Cotab A and Cotab AX

Cotab AX is used for:

Relieving runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Cotab AX is an antihistamine and narcotic cough suppressant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Cotab AX if:

• you are allergic to any ingredient in Cotab AX or any other codeine- or morphine-related medicine (eg, oxycodone)


• you have severe high blood pressure, severe heart blood vessel disease, angle-closure glaucoma, or peptic ulcers


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


• you are taking sodium oxybate (GHB) or 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 Cotab AX:

Some medical conditions may interact with Cotab AX. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following

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


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


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


• if you have heart blood vessel problems, irregular heartbeat, or any other heart problems (eg, cor pulmonale)


• if you have a history of high blood pressure; diabetes; liver or kidney problems; stroke; glaucoma or increased pressure in the eye; a blockage of your bladder, stomach, or bowels; ulcers; trouble urinating; an enlarged prostate or other prostate problems; or thyroid problems


• if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea, slow or irregular breathing), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)


• if you are dehydrated, have very poor health, have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery


• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior


• if you are taking medicine for high blood pressure or depression

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

• Anticholinergics (eg, scopolamine) because a serious bowel motility problem (paralytic ileus) may occur


• Cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Cotab AX's side effects


• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Cotab AX's effectiveness


• Narcotic pain medicines (eg, hydrocodone) because the risk of their side effects may be increased by Cotab AX

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

Use Cotab AX as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Cotab AX by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Cotab AX 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 Cotab AX.

Important safety information:

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


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Cotab AX; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Cotab AX may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not use Cotab AX for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Cotab AX has chlorpheniramine in it. Before you start any new medicine, check the label to see if it has chlorpheniramine 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 cough or other symptoms persist for more than 5 days or come back, or if you also have fever, rash, or persistent headache, check with your doctor.


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


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


• Tell your doctor or dentist that you take Cotab AX before you receive any medical or dental care, emergency care, or surgery.


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


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


• Cotab AX should not be used in CHILDREN younger than 6 years old; 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 using Cotab AX while you are pregnant. Do not take Cotab AX if you are in the third trimester of pregnancy. It is not known if Cotab AX is found in breast milk. Do not breast-feed while taking Cotab AX.

When used for long periods of time or at high doses, Cotab AX may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Cotab AX stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Cotab AX. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Cotab AX, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; trouble sleeping.

Possible side effects of Cotab AX:

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; thickening of mucus secretions; upset stomach; vomiting.

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); blurred vision, double vision, or other vision changes; confusion; difficulty urinating or inability to urinate; fast, slow, or irregular heartbeat; loss of coordination; mood or mental changes; nervousness; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; trouble sleeping; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness.

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: Cotab AX 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; chest pain; cold or clammy skin; confusion; difficult or very slow breathing; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Cotab AX:

Store Cotab AX 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 Cotab AX out of the reach of children and away from pets.

General information:

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


• Cotab AX 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 Cotab AX. 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.

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