gadodiamide Intravenous

gad-oh-DYE-a-mide

Intravenous route(Solution)

Gadodiamide is not for intrathecal use. Inadvertent intrathecal use has caused convulsions, coma, and sensory and motor neurologic deficits. Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced MRI. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Do not administer to patients with chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m(2)) or acute kidney injury. Screen all patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes), perform lab testing to estimate the GFR. For patients with the highest NSF risk, do not exceed recommended dose and allow a sufficient time period for elimination prior to readministration .

Commonly used brand name(s)

In the U.S.

• Omniscan

Available Dosage Forms:

• Solution

Therapeutic Class: Radiological Non-Ionic Contrast Media

Uses For gadodiamide

Gadodiamide is a magnetic resonance imaging (MRI) contrast agent. Contrast agents are used to help create a clear picture of the body during MRI scans. MRI scans are a special kind of diagnostic procedure. They use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve ionizing radiation. Gadodiamide is a gadolinium-based contrast agent (GBCA).

Gadodiamide is given by injection before MRI to help diagnose problems in the brain, spine, chest, stomach, hip area, and other parts of your body.

gadodiamide is to be used only by or under the direct supervision of a doctor.

Before Using gadodiamide

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 gadodiamide, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gadodiamide in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

• Asthma or allergies, history of or


• Infection, severe or


• Kidney problems, mild to moderate or


• Seizures, history of—Use with caution. May cause side effects to become worse.

• Diabetes or


• Hypertension (high blood pressure)—Use with caution. May increase risk for kidney problems.

• Kidney problems, severe (recent or long-term)—Should not be used in patients with this condition.

Proper Use of gadodiamide

A doctor or other trained health professional will give you gadodiamide. gadodiamide is given through a needle placed in one of your veins just before you have an MRI scan.

Precautions While Using gadodiamide

Check with your doctor right away if you or your child have burning or itching of the skin; red or dark patches on the skin; skin swelling, hardening, or tightening; joint stiffness; limited range of motion in the arms and legs; pain that is deep in the hip bone or ribs; or muscle weakness. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).

gadodiamide may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have cold, clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.

Make sure your doctor knows that you or your child have used gadodiamide. gadodiamide may affect the results of certain medical tests (e.g., serum iron or calcium).

gadodiamide 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:

Less common or rare

• Agitation


• bloody, black, or tarry stools


• blurred vision


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


• change in consciousness


• changes in skin color


• chest pain or discomfort


• clumsiness or unsteadiness


• confusion


• cough


• decreased urine output


• depression


• difficult or labored breathing


• difficulty controlling your bladder or bowels


• difficulty swallowing


• difficulty walking


• dilated neck veins


• dizziness


• extreme fatigue


• fainting


• fast, slow, or irregular heartbeat


• feeling faint, dizzy, or lightheaded


• feeling of warmth or heat


• feeling sad or depressed


• feeling unusually cold


• flushing or redness of the skin, especially on the face and neck


• forgetful


• general feeling of discomfort or illness


• headache


• headache, severe and throbbing


• hives


• hostility


• irregular breathing


• irritability


• itching


• lethargy


• loss of bladder control


• loss of consciousness


• muscle cramps


• muscle twitching


• nausea


• numbness or tingling in your arms, legs, or face


• pain or discomfort in the arms, jaw, back, or neck


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


• rapid weight gain


• redness of the face, neck, arms, and occasionally, upper chest


• seizures


• shakiness and unsteady walk


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


• shivering


• shortness of breath


• skin rash


• slurred speech or problems swallowing


• stupor


• sudden sweating


• sweating


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


• tenderness


• tightness in the chest


• total body jerking


• trembling or shaking of the hands or feet


• troubled breathing


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual tiredness or weakness


• vomiting


• weight gain


• wheezing

Incidence not known

• Burning or itching of the skin


• joint stiffness


• limited range of motion in the arms and legs


• muscle weakness


• pain that is deep in the hip bone or ribs


• partial or slight paralysis


• red or dark patches on the skin


• skin swelling, hardening, or tightening

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

• Abdominal or stomach pain


• bad, unusual, or unpleasant (after) taste


• belching


• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• bloated or full feeling


• change in taste


• changes in vision


• continuing ringing or buzzing or other unexplained noise in the ears


• diarrhea


• difficulty with moving


• dry mouth


• excess air or gas in the stomach


• hearing loss


• hives or welts


• increased sweating


• joint pain


• muscle pains or stiffness


• redness of the skin


• runny nose


• sneezing


• stuffy nose


• swollen joints

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: gadodiamide 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 gadodiamide Intravenous resources

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

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• CNS Magnetic Resonance Imaging
• Vascular Magnetic Resonance Imaging

abarelix Intramuscular, Injection

a-ba-REL-ix, SOE-dee-um KLOR-ide

Intramuscular routeKit

Immediate-onset systemic allergic reactions, some resulting in hypotension and syncope, have occurred after administration of abarelix. These immediate-onset reactions have been reported to occur following any administration of abarelix , including after the initial dose. The cumulative risk of such a reaction increases with the duration of treatment. Following each injection of abarelix, patients should be observed for at least 30 minutes in the office and in the event of an allergic reaction, managed appropriately.

Abarelix is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.

The effectiveness of abarelix in suppressing serum testosterone to castrate levels decreases with continued dosing in some patients. Effectiveness beyond 12 months has not been established. Treatment failure can be detected by measuring serum total testosterone concentrations just prior to administration on Day 29 and every 8 weeks thereafter .

• PLENAXIS™
  
  • Only physicians who have enrolled in the Plenaxis™ PLUS Program (Plenaxis™ User Safety Program), based on their attestation of qualifications and acceptance of prescribing responsibilities, may prescribe Plenaxis™ .
  
  

Immediate-onset systemic allergic reactions, some resulting in hypotension and syncope, have occurred after administration of abarelix. These reactions can occur after any dose, and patients should be observed for at least 30 minutes following each injection and managed appropriately if an allergic reaction occurs. Measure serum total testosterone concentrations to assess effectiveness and detect treatment failure. Only physicians who have enrolled in the PLENAXIS(TM) PLUS Program may prescribe PLENAXIS(TM) .

Commonly used brand name(s):

In the U.S.

• Plenaxis

Available Dosage Forms:

• Powder for Suspension


• Solution

Uses For abarelix

Abarelix is a type of medicine called a gonadotropin-releasing hormone (GnRH) antagonist that lowers the male hormone testosterone in your blood. Testosterone makes most prostate cancers grow. Other ways to treat your prostate cancer are taking other hormone medicines to lower testosterone or surgery to remove your testicles. Abarelix is used when these other ways to treat prostate cancer cannot be used or are refused.

Abarelix is to be given only under the supervision of your doctor. It is to be injected into your buttocks.

abarelix was available only with your doctor's prescription.

abarelix was withdrawn from the U.S. market in May 2005, and is available only to patients who are currently receiving the medicine.

Before Using abarelix

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 abarelix, the following should be considered:

It is very important that you read the Patient Information for abarelix before you start getting injections. You will need to sign the last page if you agree with treatment with abarelix. If you have any questions about this ask your doctor.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to abarelix 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

Studies on abarelix have only been done in adult patients, and there is no specific information comparing the use of abarelix in children with other age groups. Abarelix is not for use in children.

Geriatric

abarelix has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Abarelix

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.

Sodium Chloride

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

Interactions with Medicines

Using abarelix 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.

• Amiodarone


• Quinidine


• Sotalol

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

• Osteoporosis or


• QT prolongation (rare heart condition)—abarelix may make these conditions become worse.

Proper Use of abarelix

Abarelix is only prescribed by doctors who are part of Plenaxis PLUS Program (Plenaxis User Safety Program) that is run by the pharmaceutical (drug) company that makes the medicine.

Abarelix is given as an injection (shot) in your buttocks. Your doctor or nurse will give you the injection. It is important that you keep your appointment with your doctor's office when your injection is due. If you are unable to keep your appointment, contact your doctor's office to be rescheduled as soon as possible. It is very important that you follow the schedule that your doctor planned for your treatment.

You must always wait in your doctor's office for at least 30 minutes after getting each abarelix injection (shot). If a serious or life-threatening allergic reaction happens it is usually soon after getting an abarelix injection. Tell your doctor right away if you feel warm, faint or lightheaded or if you have chest tightness, shortness of breath, redness of your skin, or swelling of your face, eyelids, tongue, or throat. These could be signs of an allergic reaction.

Abarelix is only used for treating advanced symptomatic prostate cancer when a patient cannot have or refuses other treatments for prostate cancer

Dosing

The dose of abarelix 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 abarelix. 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 parenteral dosage form (injection):
  
  • For advanced prostate cancer:
    
    • Adults—100 milligrams (mg) in the muscle (buttock) on Day 1, 15, 29 (week 4), and every 4 weeks thereafter.
    
    
  
  

Precautions While Using abarelix

It is very important that your doctor check you at regular visits. Your doctor will also want to do regular blood tests about every 8 weeks to check your testosterone level to see if abarelix is working for you. If you weigh more than 225 pounds there may be a greater chance that abarelix may stop working. Your doctor may also want to do blood tests to check your liver function before and during treatment with abarelix.

abarelix may cause loss in bone mineral density with extended treatment. Loss in bone mineral density can lead to the thinning of bones (osteoporosis). If you have any questions about this ask your doctor.

abarelix can cause a change in heart rhythm called prolongation of the QTc interval. This condition may change the way your heart beats and can cause fainting and serious side effects in some patients. Contact your doctor right away if you have any of these symptoms or any questions about this.

abarelix 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:

Less common

• Fainting or loss of consciousness


• fast or irregular breathing


• itching


• skin rash


• swelling of the eyes or eyelids


• tightness in the chest and/or wheezing


• trouble with breathing

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

More common

• Back pain


• bladder pain


• breast enlargement


• breast pain


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


• bloody or cloudy urine


• body aches or pain


• burning while urinating


• chills


• cough


• decrease in frequency of urination


• decrease in urine volume


• diarrhea


• difficult, burning, or painful urination


• difficulty having a bowel movement (stool)


• difficulty in passing urine (dribbling)


• dizziness


• ear congestion


• feeling of warmth


• fever


• frequent urge to urinate


• headache


• loss of voice


• lower back or side pain


• nasal congestion


• nausea


• nipple enlargement


• pain


• rapid weight gain


• redness of the face, neck, arms, and occasionally, upper chest


• runny nose


• sneezing


• sore throat


• sweating


• tingling of the hands or feet


• trouble in holding or releasing urine


• trouble with sleeping


• unusual tiredness or weakness


• unusual weight gain or loss

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

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.

More abarelix Intramuscular, Injection resources

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

Compare abarelix Intramuscular, Injection with other medications

• Prostate Cancer

Beechams Cold & Flu Hot Lemon and Honey

1. Name Of The Medicinal Product

Beechams Hot Lemon and Honey

or

Beechams Warmers Lemon and Honey

or

Beechams Cold & Flu Hot Lemon and Honey

2. Qualitative And Quantitative Composition

Active Constituents	mg / 6 g powder
Paracetamol	600.00
Ascorbic Acid	40.00
Phenylephrine Hydrochloride	10.00

3. Pharmaceutical Form

Powder

4. Clinical Particulars

4.1 Therapeutic Indications

The relief of symptoms of influenza, feverishness, chills and feverish colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain, and acute nasal catarrh.

4.2 Posology And Method Of Administration

Directions for use

Empty contents of sachet into beaker. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.

Recommended Dose and Dosage Schedule

Adults (including elderly) and children aged 12 years and over:

One sachet to be taken every four hours, if necessary, up to a maximum of six sachets in any 24 hours.

Do not take continuously for more than 7 days without medical advice.

Not to be given to children under 12 years of age except on medical advice

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

Concomitant use of other sympathomimetic decongestants

Phaeochromocytoma

Closed angle glaucoma

Hypertensive patients or those taking or have taken in the last two weeks monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers(see section 4.5). Hepatic or renal impairment, diabetes, hyperthyroidism and cardiovascular disease.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Medical advice should be sought before taking this product in patients with these conditions:

• An enlargement of the prostate gland

• Occulusive Vascular disease (e.g. Raynaud's Phenomenon)

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Do not exceed the stated dose.

Patients should be advised not to take other paracetamol-containing or any other cold, flu or decongestant products concurrently.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Special label warnings

Do not take with other flu, cold or decongestant products. Do not take with any other paracetamol-containing products.

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Special leaflet warnings

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.

Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported

Monoamine oxidase inhibitors (including moclobemide)	Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications).
Sympathomimetic amines	Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.
Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa)	Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased.
Tricyclic antidepressants (e.g. amitriptyline)	May increase the risk of cardiovascular side effects with phenylephrine.
Ergot alkaloids	(ergotamine and methylsergide) increased risk of ergotism
Digoxin and cardiac glycosides	Increase the risk of irregular heartbeat or heart attack

4.6 Pregnancy And Lactation

Due to the phenylephrine content this product should not be used in pregnancy or whilst breast-feeding without medical advice. Phenylephrine may be excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness.

4.8 Undesirable Effects

Paracetamol

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Body System	Undesirable effect
Blood and lymphatic system disorders	Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol
Immune system disorders	Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis
Respiratory, thoracic and mediastinal disorders	Bromchospasm *
Hepatobiliary disorders	Hepatic dysfunction

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Phenylephrine

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.

Body System	Undesirable effect
Psychiatric disorders	Nervousness, irritability, restlessness, and excitability
Nervous system disorders	Headache, dizziness, insomnia
Cardiac disorders	Increased blood pressure
Gastrointestinal disorders	Nausea, Vomiting.

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.

Eye disorders	Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma
Cardiac disorders	Tachycardia, palpitations
Skin and subcutaneous disorders	Allergic reactions (e.g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions – including that cross-sensitivity may occur with other sympathomimetics
Renal and urinary disorders	Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors:

If the patient

a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b, Regularly consumes ethanol in excess of recommended amounts.

Or

c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms:

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management:

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

Phenylephrine

Symptoms and signs

Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.

Treatment

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.

Ascorbic acid

Symptoms and signs

High doses of ascorbic acid (>3000 mg) may cause transient osmotic diarrhoea and gastrointestinal effects such as nausea and abdominal discomfort. Effects of overdose of ascorbic acid would be subsumed by severe liver toxicity caused by paracetamol overdose.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol provides the analgesic and antipyretic actions.

Phenylephrine Hydrochloride is a sympathomimetic agent and provides relief from nasal congestion due to its vasoconstrictor action.

Ascorbic Acid is commonly included in combination cold products to compensate for vitamin C losses that may occur in the initial stages of acute viral infections, including the common cold.

5.2 Pharmacokinetic Properties

Paracetamol - Is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucuronide and sulphate conjugates.

Ascorbic Acid - Is readily absorbed from the GI tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic acid in excess of the body's needs is eliminated in the urine as metabolites.

Phenylephrine Hydrochloride - Due to irregular absorption and first pass metabolism by monoamine oxidase in the gut and liver, phenylephrine has reduced bioavailability from the gastrointestinal tract. It is excreted in the urine almost entirely as the sulphate conjugate.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose Ph Eur, Sodium citrate Ph Eur, Citric acid Ph Eur, Maize starch Ph Eur, Sodium cyclamate NF, Saccharin sodium BP, Lemon flavour, Honey Flav-o-lok, Honey flavour, Caramel SCS (E150).

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

The product is packed in laminate sachets comprising paper / polythene / aluminium foil / polythene. Five or ten sachets may be contained in a box board carton.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Beecham Group Plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as GlaxoSmithKline Consumer Healthcare

Brentford

TW8 9GS

U.K.

8. Marketing Authorisation Number(S)

PL 00079/0283

9. Date Of First Authorisation/Renewal Of The Authorisation

18.12.91 / 10.11.97

10. Date Of Revision Of The Text

July 2011

Miochol-E

Dosage Form: intraocular solution
Miochol®-E

acetylcholine chloride

intraocular solution

1:100 with Electrolyte

Diluent

Rx only

Prescribing Information

Miochol-E Description

Miochol®-E (acetylcholine chloride intraocular solution) is a parasympathomimetic preparation for intraocular use. It is packaged in a blister pack containing one vial and one ampoule. The vial contains 20 mg acetylcholine chloride and 56 mg mannitol. The accompanying ampoule contains 2 mL of a modified diluent of sodium acetate trihydrate, potassium chloride, magnesium chloride hexa-hydrate, calcium chloride dihydrate and sterile water for injection.

The reconstituted liquid will be a sterile isotonic solution (275–330 milliosmoles/Kg) containing 20 mg acetylcholine chloride (1:100 solution) and 2.8% mannitol. The pH range is 5.0–8.2. Mannitol is used in the process of lyophilizing acetylcholine chloride, and is not considered an active ingredient.

The chemical name for acetylcholine chloride, C7H16ClNO2, is Ethanaminium, 2-(acetyloxy)-N,N,N-trimethyl-, chloride and is represented by the following chemical structure:

Miochol-E - Clinical Pharmacology

Acetylcholine is a naturally occurring neurohormone which mediates nerve impulse transmission at all cholinergic sites involving somatic and autonomic nerves. After release from the nerve ending, acetylcholine is rapidly inactivated by the enzyme acetylcholinesterase by hydrolysis to acetic acid and choline.

Direct application of acetylcholine to the iris will cause rapid miosis of short duration. Topical ocular instillation of acetylcholine to the intact eye causes no discernible response as cholinesterase destroys the molecule more rapidly than it can penetrate the cornea.

Indications and Usage for Miochol-E

To obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid miosis may be required.

Contraindications

Miochol®-E (acetylcholine chloride intraocular solution) is contraindicated in persons with a known hypersensitivity to any component of this product.

Warnings

DO NOT GAS STERILIZE. If blister or peelable backing is damaged or broken, sterility of the enclosed vial and ampoule cannot be assured. Open under aseptic conditions only.

Precautions

General

If miosis is to be obtained quickly with Miochol®-E (acetylcholine chloride intraocular solution), anatomical hindrances to miosis, such as anterior or posterior synechiae, must be released, prior to administration of Miochol-E. During cataract surgery, use Miochol-E only after delivery of the lens.

Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution which is not clear and colorless. Discard any solution that has not been used.

Drug Interactions

Although clinical studies with acetylcholine chloride and animal studies with acetylcholine or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with topical nonsteroidal anti-inflammatory agents.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Infrequent cases of corneal edema, corneal clouding, and corneal decompensation have been reported with the use of intraocular acetylcholine.

Adverse reactions have been reported rarely which are indicative of systemic absorption. These include bradycardia, hypotension, flushing, breathing difficulties and sweating.

Overdosage

Atropine sulfate (0.5 to 1 mg) should be given intramuscularly or intravenously and should be readily available to counteract possible overdosage. Epinephrine (0.1 to 1 mg subcutaneously) is also of value in overcoming severe cardiovascular or bronchoconstrictor responses.

Miochol-E Dosage and Administration

Miochol®-E (acetylcholine chloride intraocular solution) is instilled into the anterior chamber before or after securing one or more sutures.

Instillation should be gentle and parallel to the iris face and tangential to pupil border.

If there are no mechanical hindrances, the pupil starts to constrict in seconds and the peripheral iris is drawn away from the angle of the anterior chamber. Any anatomical hindrance to miosis must be released to permit the desired effect of the drug. In most cases, 0.5 to 2 mL produces satisfactory miosis. Note that the syringe filter supplied with Miochol-E has a priming volume of 0.6 mL (approximately).

In cataract surgery, use Miochol-E only after delivery of the lens.

Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution which is not clear and colorless. Discard any solution that has not been used.

DIRECTIONS FOR PREPARING MIOCHOL®-E:

STERILE UNLESS PACKAGE OPEN OR BROKEN

1. Inspect the unopened blister, vial and ampoule to ensure that they are all intact. Peel open the blister under a sterile field. Maintain sterility of the outer containers of the vial and ampoule during preparation of solution.


2. Aseptically attach a sterile 18–20 gauge, beveled needle to the luer tip of a sterile disposable syringe with a twisting motion to assure a secure fit.


3. Break open the ampoule containing the diluent. The One Point Cut (OPC) ampoule must be opened as follows: Hold the bottom part of the ampoule with the thumb pointing to the colored dot. Grasp the top of the ampoule with the other hand, positioning the thumb at the colored dot, and press back to break at the existing cut under the dot.


4. Remove the needle protector and withdraw the diluent from the ampoule into the syringe. Discard the ampoule.


5. Remove and discard the cap from the top of the vial.


6. Insert the needle through the center of the vial stopper, and transfer the diluent from the syringe to the vial. Shake gently to dissolve the powder.


7. Slowly withdraw the solution from the vial through the needle into the syringe. Discard the needle.


8. Aseptically open the syringe filter pouch, and attach the filter onto the luer tip of the syringe with a twisting motion to assure a secure fit.


9. Aseptically attach a sterile blunt tip irrigation cannula to the male luer of the filter prior to intraocular irrigation

Discard the filter appropriately after use.

Do not reuse the syringe filter.

Do not aspirate and inject through the same filter.

How is Miochol-E Supplied

Miochol®-E (acetylcholine chloride intraocular solution)............................NDC 24208-539-20

One blister pack containing the following components:

• Vial of 20 mg acetylcholine chloride powder for intraocular solution


• Ampoule of 2 mL diluent

One 0.2 micron sterile filter

• Priming volume 0.6 mL (approximately)

Store at 4°–25°C (39°–77°F).

KEEP FROM FREEZING.

REV: MARCH 2007              T2007-10

MIOCHOL is a registered trademark of Bausch & Lomb Incorporated.

Distributed by:

Bausch & Lomb Incorporated

Rochester, NY 14609

© Bausch & Lomb Incorporated

9214900                 AB53920

2074024 US

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 24208-539-20

Miochol-E

acetylcholine chloride

intraocular solution

1:100 with Electrolyte

Diluent

Rx Only

Sterile

Bausch & Lomb

MIOCHOL E  acetylcholine chloride  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24208-539

Packaging # NDC Package Description Multilevel Packaging 1 24208-539-20 1 KIT In 1 BLISTER PACK None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 VIAL   2 mL Part 2 1 AMPULE   2 mL

Part 1 of 2 MIOCHOL E  acetylcholine chloride  solution

Product Information       Route of Administration INTRAOCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETYLCHOLINE CHLORIDE (ACETYLCHOLINE) ACETYLCHOLINE CHLORIDE 20 mg  in 2 mL

Inactive Ingredients Ingredient Name Strength MANNITOL 56 mg  in 2 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 2 mL In 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020213 09/22/1993

Part 2 of 2 DILUENT  diluent  solution

Product Information       Route of Administration INTRAOCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength No Active Ingredients Found

Inactive Ingredients Ingredient Name Strength CALCIUM CHLORIDE   MAGNESIUM CHLORIDE   POTASSIUM CHLORIDE   SODIUM ACETATE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 2 mL In 1 AMPULE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020213 09/22/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020213	09/22/1993

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Operations
Norvatis Pharma Stein AG		488152505	MANUFACTURE

Revised: 01/2011Bausch & Lomb Incorporated

More Miochol-E resources

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

• Miochol-E system pak

Compare Miochol-E with other medications

• Production of Miosis

carbetapentane and chlorpheniramine

Generic Name: carbetapentane and chlorpheniramine (kar BET a PEN tane and KLOR fen IR a meen)

Brand Names: C-Tanna 12, Tannate 12 S, Tannic-12 S, Trionate, Tussi-12, Tussi-12S, Tussizone-12 RF, Tustan 12S

What is carbetapentane and chlorpheniramine?

Carbetapentane is a cough suppressant.

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

The combination of carbetapentane and chlorpheniramine is used to treat runny nose, sneezing, watery eyes, and cough caused by allergies, the common cold, or the flu.

This medication will not treat a cough that is caused by smoking, asthma, or emphysema.

Carbetapentane and chlorpheniramine may also be used for other purposes not listed in this medication guide.

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

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Before using this medication, tell your doctor if you have heart disease, high blood pressure, emphysema, chronic bronchitis, a seizure disorder, glaucoma, kidney disease, a thyroid disorder, enlarged prostate, problems with urination, or any drug or food allergies.

Avoid drinking alcohol while you are taking carbetapentane and chlorpheniramine.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or cough suppressant.

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

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. You should not use this medication if you are allergic to carbetapentane or chlorpheniramine, or to other antihistamines.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  heart disease, high blood pressure;

  
  


• 
  

  emphysema, chronic bronchitis, or other breathing problems;

  
  


• 
  

  glaucoma;

  
  


• 
  

  kidney disease;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  an enlarged prostate;

  
  


• 
  

  problems with urination; or

  
  


• 
  

  if you are allergic to yellow food dye.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take carbetapentane and chlorpheniramine?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cough and cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Drink plenty of fluids to help loosen mucus congestion while you are taking this medication.

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

Talk with your doctor if your symptoms do not improve, or if they get worse after using this medication. Store the medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking carbetapentane and chlorpheniramine?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by carbetapentane and chlorpheniramine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications. Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an carbetapentane and chlorpheniramine.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or cough suppressant.

Carbetapentane and chlorpheniramine side effects

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

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  confusion, unusual thoughts or behavior, seizure (convulsions);

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

  slow, shallow breathing.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dry mouth, nose, or eyes; or

  
  


• 
  

  nausea, stomach pain, constipation, loss of appetite.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect carbetapentane and chlorpheniramine?

Many drugs can interact with carbetapentane and chlorpheniramine. Below is just a partial list. Tell your doctor if you are using:

• 
  

  an antidepressant;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome; or

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol).

  
  

This list is not complete and there may be other drugs that can interact with carbetapentane and chlorpheniramine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More carbetapentane and chlorpheniramine resources

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

Compare carbetapentane and chlorpheniramine with other medications

• Cold Symptoms

Where can I get more information?

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

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

warfarin

WAR-far-in

Oral route(Tablet)

Warfarin can cause major or fatal bleeding. Regular monitoring of INR should be performed on all treated patients. Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy. Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding .

Commonly used brand name(s)

In the U.S.

• Coumadin


• Jantoven

Available Dosage Forms:

• Tablet

Therapeutic Class: Anticoagulant

Chemical Class: Coumarin (class)

Uses For warfarin

Warfarin is an anticoagulant. It is used to decrease the clotting ability of the blood and to help prevent harmful clots from forming in the blood vessels. It is often used to prevent or treat deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and cause a condition called pulmonary embolism. Warfarin is also used to prevent or treat blood clots that are caused by certain heart conditions or open-heart surgery. It may be used after a heart attack to prevent blood clots from forming. Although it will not dissolve blood clots that have already formed, warfarin may keep the clots from becoming larger and causing more serious problems.

warfarin is available only with your doctor's prescription.

Before Using warfarin

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 warfarin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to warfarin 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 warfarin 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 warfarin in the elderly. However, elderly patients may require caution and an adjustment in the dose, especially those who are at risk of bleeding.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking warfarin, 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 warfarin 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.

• Tamoxifen

Using warfarin 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.

• Abciximab


• Acenocoumarol


• Alteplase, Recombinant


• Amiodarone


• Anistreplase


• Aprepitant


• Aspirin


• Bivalirudin


• Capecitabine


• Carboplatin


• Celecoxib


• Chamomile


• Citalopram


• Clopidogrel


• Cyclophosphamide


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desvenlafaxine


• Dipyridamole


• Doxorubicin


• Dronedarone


• Drotrecogin Alfa


• Enoxaparin


• Eptifibatide


• Escitalopram


• Etoposide


• Etravirine


• Fenofibrate


• Fenofibric Acid


• Fish Oil


• Fluconazole


• Fluorouracil


• Fluoxetine


• Fluvoxamine


• Garlic


• Ginkgo


• Imatinib


• Infliximab


• Influenza Virus Vaccine


• Ketoprofen


• Leflunomide


• Lepirudin


• Levofloxacin


• Lycium


• Marijuana


• Mechlorethamine


• Methotrexate


• Methyl Salicylate


• Metronidazole


• Milnacipran


• Moxifloxacin


• Nandrolone


• Naproxen


• Noscapine


• Oxandrolone


• Papaya


• Paroxetine


• Phenindione


• Phenprocoumon


• Prasugrel


• Procarbazine


• Proguanil


• Reteplase, Recombinant


• Rivaroxaban


• Ropinirole


• Sertraline


• Simvastatin


• Sitaxsentan


• St John's Wort


• Streptokinase


• Sulfamethoxazole


• Sulfisoxazole


• Tan-Shen


• Tenecteplase


• Testosterone


• Ticlopidine


• Tinzaparin


• Tirofiban


• Torsemide


• Urokinase


• Valproic Acid


• Venlafaxine


• Vilazodone


• Vincristine


• Vindesine


• Voriconazole

Using warfarin 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.

• Acarbose


• Acemetacin


• Acetaminophen


• Allopurinol


• Aminoglutethimide


• Amitriptyline


• Amoxicillin


• Amprenavir


• Apazone


• Argatroban


• Atovaquone


• Avocado


• Azathioprine


• Azithromycin


• Bee Pollen


• Benorilate


• Benzbromarone


• Black Tea


• Bosentan


• Bromfenac


• Butabarbital


• Butalbital


• Carbamazepine


• Carbimazole


• Cefamandole


• Cefazolin


• Chitosan


• Chloral Hydrate


• Cholestyramine


• Choline Magnesium Trisalicylate


• Chondroitin


• Cimetidine


• Ciprofloxacin


• Cisapride


• Clarithromycin


• Coenzyme Q10


• Colesevelam


• Curcumin


• Cyclosporine


• Danazol


• Darunavir


• Desogestrel


• Dexamethasone


• Dexlansoprazole


• Dextrothyroxine


• Dicloxacillin


• Dienogest


• Diflunisal


• Disopyramide


• Disulfiram


• Dong Quai


• Doxepin


• Drospirenone


• Duloxetine


• Enoxacin


• Erlotinib


• Erythromycin


• Esomeprazole


• Estradiol Cypionate


• Estradiol Valerate


• Eterobarb


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Exenatide


• Felbamate


• Fluoxymesterone


• Fluvastatin


• Gefitinib


• Gemcitabine


• Gemfibrozil


• Ginger


• Ginseng


• Glucagon


• Glucosamine


• Glyburide


• Green Tea


• Griseofulvin


• Heparin


• Ifosfamide


• Indomethacin


• Indoprofen


• Isoniazid


• Isoxicam


• Itraconazole


• Ivermectin


• Ketoconazole


• Lactulose


• Lansoprazole


• Levamisole


• Levonorgestrel


• Levothyroxine


• Liothyronine


• Lopinavir


• Lornoxicam


• Medroxyprogesterone Acetate


• Melatonin


• Meloxicam


• Menthol


• Mephobarbital


• Mercaptopurine


• Mesalamine


• Mesna


• Mestranol


• Methimazole


• Methylprednisolone


• Methyltestosterone


• Methylthiouracil


• Miconazole


• Mitotane


• Moricizine


• Nafcillin


• Nalidixic Acid


• Nelfinavir


• Nevirapine


• Niacin


• Nilutamide


• Nimesulide


• Norelgestromin


• Norethindrone


• Norfloxacin


• Norgestimate


• Norgestrel


• Ofloxacin


• Omeprazole


• Orlistat


• Oxyphenbutazone


• Pantoprazole


• Phenobarbital


• Phenylbutazone


• Phytonadione


• Piracetam


• Polyacrylamide


• Potassium Iodide


• Prednisone


• Primidone


• Propafenone


• Propoxyphene


• Propylthiouracil


• Quetiapine


• Ranitidine


• Rifabutin


• Rifampin


• Rifapentine


• Ritonavir


• Rofecoxib


• Rosuvastatin


• Roxithromycin


• Salicylamide


• Salicylic Acid


• Salsalate


• Saquinavir


• Secobarbital


• Sodium Salicylate


• Sodium Thiosalicylate


• Sorafenib


• Soybean


• Soy Isoflavones


• Soy Protein


• Stanozolol


• Sucralfate


• Sulfasalazine


• Sulfinpyrazone


• Sulindac


• Telithromycin


• Tenidap


• Terbinafine


• Thyroglobulin


• Thyroid


• Tibolone


• Ticlopidine


• Tigecycline


• Tolterodine


• Tramadol


• Trastuzumab


• Trolamine Salicylate


• Valdecoxib


• Vancomycin


• Vemurafenib


• Vitamin A


• Vitamin E


• Vorinostat


• Zafirlukast


• Zileuton

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 warfarin 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 warfarin, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry Juice


• Pomegranate

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

• Enteral Nutrition


• High Protein Food


• Noni Juice


• Vitamin K Containing Food

Other Medical Problems

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

• Alcohol abuse, history of or


• Mental disorders (e.g., psychosis or senility)—Patients with these conditions or those who cannot cooperate should not be given warfarin.

• Blood disease or bleeding problems or


• Heart infection or


• Hypertension (high blood pressure) or


• Spinal anesthesia, recent or


• Stomach or intestinal ulcer, active or


• Stroke or


• Surgery, recent or scheduled (e.g., surgery of the eye, brain, or spine) or


• Threatened miscarriage—Should not be used in patients with any of these conditions. The risk of bleeding from warfarin may be increased.

• Catheter insertion or


• Congestive heart failure or


• Deep venous thrombosis, heparin-induced or


• Diabetes or


• Falls or blows to the body or head or


• Infection or


• Kidney disease or


• Liver disease or


• Major surgery, any type or


• Protein C deficiency (rare hereditary disease), known or suspected or


• Thrombocytopenia, heparin-induced or


• Trauma—Use with caution. warfarin may increase your risk of having serious problems.

Proper Use of warfarin

Your doctor will tell you how much of warfarin to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.

Carefully follow your doctor's instructions about any special diet. warfarin works best when you eat about the same amount of vitamin K in your food every day. Avoid big changes in how much vitamin K you eat. Some foods that have a high amount of vitamin K are asparagus, broccoli, brussels sprouts, cabbage, green leafy vegetables (such as collards, turnip greens, mustard greens, spinach, and salad greens), plums, rhubarb, and certain vegetable oils (such as soybean oil and canola oil).

Do not drink alcohol while you are using warfarin. Also avoid drinking cranberry juice or eating cranberry products.

You may take the tablets on a full or empty stomach.

warfarin should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of warfarin 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 warfarin. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage form (tablets):
  
  • For prevention or treatment of blood clots:
    
    • Adult—At first, 2 to 5 milligrams (mg) per day. Your doctor will then adjust your dose up to a maximum of 10 mg per day depending on your condition.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of warfarin, 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 warfarin

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests, such as INR, are needed to check for proper dosage and unwanted side effects. Be sure to keep all appointments.

Using warfarin 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.

Do not stop taking any of your medicines or start any new medicines unless they have been discussed with your doctor. Keep a list of your medicines with you at all times. This includes prescription medicines, nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.

Do not take other medicines that also contain warfarin. Using too much warfarin may cause serious bleeding problems.

Make sure any doctor or dentist who treats you knows that you are using warfarin. You may need to stop using warfarin several days before having surgery or medical tests.

Check with your doctor immediately if you start to have diarrhea, fever, or any signs of infection.

warfarin may cause skin necrosis or gangrene. Call your doctor right away if you have a pain, color change, or temperature change to any area of your body. Also, call your doctor right away if you have a pain in your toes and they look purple or dark in color. These could be signs of a serious medical problem.

warfarin may increase your chance of bleeding. Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.

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.

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.

It is recommended that you carry identification that says you are using warfarin. If you have any questions about what kind of identification to carry, check with your doctor.

warfarin 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:

Less common

• Abdominal or stomach pain with cramping


• bleeding gums


• blood in the urine


• bloody stools


• blurred vision


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


• chest pain or discomfort


• confusion


• coughing up blood


• difficulty with breathing or swallowing


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


• excessive bruising


• headache


• increased menstrual flow or vaginal bleeding


• nosebleeds


• paralysis


• peeling of the skin


• prolonged bleeding from cuts


• red or black, tarry stools


• red or dark brown urine


• shortness of breath


• sweating


• unexplained swelling


• unusual tiredness or weakness

Rare

• Arm, back, or jaw pain


• blue-green to black skin discoloration


• blue or purple toes


• change in consciousness


• chest tightness or heaviness


• chills


• clay-colored stools


• diarrhea


• dizziness


• fainting or loss of consciousness


• fast or irregular breathing


• fast or irregular heartbeat


• fever


• itching


• light-colored stools


• loss of appetite


• nausea and vomiting


• pain in the toes


• pain, redness, or sloughing of the skin


• pale skin


• skin blisters


• skin rash


• small red or purple spots on the skin


• stomach pain


• swelling of the eyes or eyelids


• tightness in the chest or wheezing


• troubled breathing with exertion


• unpleasant breath odor


• unusual bleeding or bruising


• upper right abdominal or stomach pain


• vomiting of blood


• yellow eyes and skin

Incidence not known

• Painful or prolonged erection of the penis

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

• Joint pain


• muscle pain

Rare

• Bloated


• change in taste, or bad, unusual, or unpleasant (after) taste


• cold intolerance


• excess air or gas in the stomach or intestines


• full feeling


• general feeling of discomfort or illness


• hair loss or thinning of the hair


• hives or welts


• lack or loss of strength


• pain


• passing gas


• red, sore, or itching skin


• sores, welting, or blisters


• unusual drowsiness, dullness, or feeling of sluggishness

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: warfarin side effects (in more detail)

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More warfarin resources

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

• Warfarin Prescribing Information (FDA)


• Warfarin MedFacts Consumer Leaflet (Wolters Kluwer)


• Coumadin Prescribing Information (FDA)


• Coumadin Monograph (AHFS DI)


• Coumadin Consumer Overview


• Jantoven Prescribing Information (FDA)

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