Isosorbide mononitrate 20mg tablets (Aurobindo Pharma Ltd)

1. Name Of The Medicinal Product

Monomil 20 mg Tablets

Carmil 20 mg Tablets

Isosorbide Mononitrate 20 mg tablets.

2. Qualitative And Quantitative Composition

Isosorbide-5-mononitrate Ph. Eur. 20 mg/tablet.

3. Pharmaceutical Form

Tablets

White to off-white, round flat tablets with 'I15' embossing on one side.

4.1 Therapeutic Indications

For the prophylaxis of angina pectoris

As adjunctive therapy in congestive heart failure not responding to cardiac glycosides or diuretics.

4.2 Posology And Method Of Administration

Adults: One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day. For patients not already receiving prophylactic nitrate therapy it is recommended that the initial dose of isosorbide mononitrate be 20mg twice a day. The dosage may be increased to 120mg per day. The lowest effective dose should be used.

Children: The safety and efficacy of Isosorbide Mononitrate 20mg tablets in children has not been established.

Elderly: There is no evidence to suggest that an adjustment of the dosage is necessary.

Treatment with Isosorbide mononitrate tablets, as with any other nitrate, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually (see section 4.4)

4.3 Contraindications

Isosorbide mononitrate tablets should not be used in cases of acute myocardial infarction with low filling pressures, acute circulatory failure (shock, vascular collapse), or very low blood pressure, hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intra-cranial pressure e.g. following a head trauma and including cerebral haemorrhage.

This product should not be given to patients with a known sensitivity to isosorbide mononitrate, the listed ingredients or other nitrates.

Isosorbide mononitrate Tablets should not be used in patients with marked anaemia, severe hypotension, closed angle glaucoma or hypovolaemia.

Phosphodiesterase type-5 inhibitors (e.g. sildenafil, tadalafil and vardenafil) have been shown to potentiate the hypotensive effects of nitrates, and their co-administration with nitrates or nitric oxide donors is therefore contraindicated (see section 4.5)

4.4 Special Warnings And Precautions For Use

Isosorbide mononitrate Tablets should be used with caution in patients who have recent history of myocardial infarction, or who are suffering from hypothyroidism, hypothermia, malnutrition and severe liver or renal disease.

Symptoms of circulatory collapse may arise after first dose, particularly in patients with labile circulation.

This product may give rise to postural hypotension and syncope in some patients. Severe postural hypotension with light-headedness and dizziness is frequently observed after the consumption of alcohol.

Hypotension induced by nitrates may be accompanied by paradoxical bradycardia and increased angina.

Isosorbide mononitrate Tablets contain lactose and therefore should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

In the event of an acute angina attack, a sublingual treatment such as a GTN spray or tablet should be used instead of Isosorbide mononitrate Tablets.

If the tablets are not taken as indicated (see section 4.2), tolerance to the medication could develop. The lowest effective dose should be used.

Treatment with Isosorbide mononitrate, as with any other nitrate, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually (see section 4.2)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concurrent administration of drugs with blood pressure lowering properties, e.g. beta-blockers, calcium channel blockers, vasodilators, alprostadil, aldesleukin, angiotensin II receptor antagonists etc. and/or alcohol may potentiate the hypotensive effects of Isosorbide mononitrate Tablets. This may occur with neuroleptics and tricyclic antidepressants.

Any blood pressure lowering effect of Isosorbide mononitrate tablets will be increased if used together with phosphodiesterase type-5- inhibitors, which are used for erectile dysfunction (see special warning and contraindications). This may lead to life threatening cardiovascular complications. Patients who are on Isosorbide mononitrate therapy therefore must not use phosphodiesterase type-5 inhibitors.

Reports suggest that concomitant administration of Isosorbide mononitrate tablets may increase the blood levels of dihydroergotamine and its hypertensive effects.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy and lactation and use during pregnancy and lactation is not recommended unless considered essential by the patient's physician.

4.7 Effects On Ability To Drive And Use Machines

Dizziness, tiredness or blurred vision might occur at the start of the treatment. The patient should therefore be advised that if affected, they should not drive or operate machinery. This effect may be increased by alcohol.

4.8 Undesirable Effects

A very common (>10% of patients) adverse reaction to Isosorbide mononitrate Tablets is throbbing headache. The incidence of headache diminishes gradually with time and continued use.

At the start of therapy or when the dosage is increased, hypotension and/or light-headedness in the upright position are commonly observed (i.e. in 1-10% of patients). These symptoms may be associated with dizziness, drowsiness, reflex tachycardia and a feeling of weakness.

Infrequently (i.e. in less than 1% patients) nausea, vomiting, flushing and allergic skin reactions (e. g. rash) may occur sometimes severely. In single cases exfoliative dermatitis may occur.

Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness pallor and excessive perspiration. Uncommonly collapse may occur (sometimes accompanied by bradyarrhythmia and syncope). Uncommonly severe hypotension may lead to enhanced angina symptoms.

A few reports of heartburn most likely due to a nitrate induced sphincter relaxation have been reported.

Tachycardia and paroxysmal bradycardia have been reported.

4.9 Overdose

Symptoms and signs: Headache, hypotension, nausea, vomiting, sweating, tachycardia, vertigo, restlessness, warm flushed skin, blurred vision and syncope. A rise in intracranial pressure with confusion and neurological deficits can sometimes occur. Methaemoglobinaemia (cyanosis, hypoxaemia, restlessness, respiratory depression, convulsions, cardiac arrhythmias, circulatory failure, raised intracranial pressure) occurs rarely.

Management:

Consider oral activated charcoal if ingestion of a potentially toxic amount has occurred within 1 hour. Observe for at least 12 hours after the overdose. Monitor blood pressure and pulse. Correct hypotension by raising the foot of the bed and /or by expanding the intravascular volume. Other measures as indicated by the patient's clinical condition. If severe hypotension persists despite the above measures consider use of inotropes.

If methaemoglobinaemia (symptoms or >30% methaemoglobin), IV administration of methylene blue 1-2mg/kg body-weight. If therapy fails with second dose after 1 hour or contraindicated, consider red blood cell concentrates or exchange transfusion. In case of cerebral convulsions, diazepam or clonazepam IV, or if therapy fails, phenobarbital, phenytoin or propofol anaesthesia.

5.1 Pharmacodynamic Properties

ATC code: C01D A14 Vasodilatator used in cardiac diseases

Isosorbide mononitrate is an organic nitrate, which, in common with other cardioactive nitrates, is a vasodilator. It produces decreased left and right ventricular end-diastolic pressures to a greater extent than the decrease in systemic arterial pressure, thereby reducing afterload and especially the preload of the heart.

Isosorbide mononitrate influences the oxygen supply to ischaemic myocardium by causing the redistribution of blood flow along collateral channels and from epicardial to endocardial regions by selective dilation of large epicardial vessels.

It reduces the requirements of the myocardium for oxygen by increasing venous capacitance, causing a pooling of blood in peripheral veins, thereby reducing ventricular volume and heart wall distension.

5.2 Pharmacokinetic Properties

Isosorbide 5—mononitrate is rapidly absorbed and peak plasma levels occur approx. 1 hour following oral dosing.

Isosorbide-5-mononitrate is completely bioavailable after oral doses and is not subject to pre-systemic elimination processes.

Isosorbide-5-mononitrate is eliminated from the plasma with a half-life of about 5.1 hours. It is metabolised to Isosrbide-5-mn-2-glucoronide, which has a half-life of approximately 2.5 hours. As well as being excreted unchanged in the urine.

After multiple oral dosing plasma concentrations are similar to those that can be predicted from single dose kinetic parameters.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity, oncogenicity and toxicity to reproduction.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Microcrystalline cellulose Ph. Eur., Lactose Monohydrate Ph. Eur., Colloidal Anhydrous Silica Ph. Eur., Maize starch Ph. Eur., Talc Ph. Eur., and Magnesium stearate Ph. Eur.

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25ºC.

6.5 Nature And Contents Of Container

PVC/Aluminium foil blisters on a cardboard carton.

Each sheet of blisters contains 10 tablets and there are six sheets of ten tablets per carton (60's pack).

Each strip of blister contains 14 tablets and there are four such strips per carton (56's pack).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Milpharm Limited,

Ares,

Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

8. Marketing Authorisation Number(S)

PL 16363/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

21^st September 1998

10. Date Of Revision Of The Text

16/10/2007

Salofalk 1.5g gastro-resistant prolonged release granules

Salofalk 1.5g

gastro-resistant prolonged release granules

mesalazine

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Salofalk 1.5g granules are and what they are used for

2. Before you take Salofalk 1.5g granules

3. How to take Salofalk 1.5g granules

4. Possible side effects

5. How to store Salofalk 1.5g granules

6. Further information

WHAT SALOFALK 1.5g GRANULES ARE AND WHAT THEY ARE USED FOR

Salofalk granules contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.

Salofalk 1.5g granules are used for:

• the treatment of acute episodes of an inflammatory disease of the large intestine (colon), known by doctors as ulcerative colitis.

BEFORE YOU TAKE SALOFALK 1.5g GRANULES

Do not take Salofalk granules

• If you are or have been told you are allergic (hypersensitive) to salicylic acid, to salicylates such as Aspirin or to any of the other ingredients of Salofalk 1.5g granules (these are listed in section 6, Further information)


• If you have a serious liver and/or kidney disease


• If you have a stomach or duodenal ulcer


• If you have a tendency to bleed easily or you have ever been told that there is a problem with the clotting of your blood

Take special care with Salofalk granules.

Before you start taking this medicine you should tell your doctor

• If you have a history of problems with your lungs, particularly if you suffer from bronchial asthma


• If you have a history of allergy to sulphasalazine, a substance related to mesalazine


• If you suffer with problems of your liver


• If you suffer with problems of your kidney

Further precautions

During treatment your doctor may want to keep you under close medical supervision, where you will have regular blood and urine tests.

Using other medicines

Please tell your doctor if you take or use any of the medicines mentioned below as the effects of these medicines may change (interactions):

• 
  Certain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood)


• 
  Glucocorticoids (certain steroid-like anti-inflammatory agents, such as prednisolone)


• 
  Sulphonyl ureas (substances used to control your blood sugar, such as glibenclamide)


• 
  Methotrexate (an agent used to treat leukaemia or immune disorders)


• 
  Probenecid/sulphinpyrazone (agents used to treat gout)


• 
  Spironolactone/frusemide (agents used to treat heart problems)


• 
  Rifampicin (substance used against tuberculosis)


• 
  Medicines containing azathioprine or 6-mercaptopurine (used to treat immune disorders)


• 
  Lactulose (substance used for treating constipation) or other preparations that can change the acidity of your stools

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It may still be all right for you to use Salofalk granules and your doctor will be able to decide what is suitable for you.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You should only use Salofalk granules during pregnancy if your doctor tells you to.

Salofalk granules should not be used during breast-feeding as the drug and its metabolite may pass into breast milk.

Driving and using machines

There are no effects on the ability to drive and use machines.

Important information about some of the ingredients of Salofalk 1.5g granules

This medicine contains the sweetening agent aspartame. Aspartame is a source of phenylalanine and may be harmful if you suffer from phenylketonuria. One sachet of Salofalk 1.5g granules contains the equivalent to 1.68 mg phenylalanine.

HOW TO TAKE SALOFALK 1.5g GRANULES

Always take Salofalk granules exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

Method of administration

Salofalk granules are for oral use only.

Salofalk granules should not be chewed. You should take the Salofalk granules by placing the granules directly on the tongue and then swallowing them with plenty of liquid without chewing.

Dosage

Adults and the elderly

Unless otherwise prescribed by your doctor, the normal dosage for the treatment of acute episodes of ulcerative colitis is:

1-2 sachets of Salofalk 1.5g granules once daily preferably in the morning (equivalent to 1.5-3 g mesalazine per day) depending on the clinical requirements in the individual case.

Children

There is only limited documentation for an effect in children (age 6-18 years).

Children 6 years of age and older

Please ask your doctor about the precise dosage of Salofalk granules for your child.

In acute episodes: to be determined individually, starting with 30-50 mg mesalazine per kg body weight per day that should be given once daily preferably in the morning or in divided doses. The maximum dose is 75 mg mesalazine per kg body weight per day. The total dose should not exceed the maximum adult dose.

It is generally recommended that half the adult dose should be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.

Due to their high content in active substance, Salofalk 1.5g granules are therefore not suitable for children weighing less than 40 kg. Please use Salofalk 500mg granules or 1000mg instead.

Duration of treatment

How long you will use the medicine depends upon your condition. Your doctor will decide how long you are to continue the medication.

You should follow the treatment with Salofalk granules regularly and consistently both during the acute episode of inflammation and also as long-term treatment, because this is the only way to achieve the desired therapeutic effect.

If you think that the effect of Salofalk granules is too strong or too weak, talk to your doctor.

If you take more Salofalk granules than you should

Contact a doctor if you are in doubt, so he or she can decide what to do.

If you use too much Salofalk granules on one occasion, just take your next dose as prescribed. Do not use a smaller amount.

If you forget to take Salofalk granules

Do not take a larger than normal dose of Salofalk granules next time, but continue treatment at the prescribed dosage.

If you stop taking Salofalk granules

Do not stop taking this product until you have talked to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Salofalk granules can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after taking this medicine, you should contact your doctor immediately:

• 
  Allergic skin rash
  


• 
  Fever
  


• 
  Breathing difficulties
  

If you experience the following serious side effects, stop taking the medicine and contact your doctor immediately:

If you experience a serious reduction of your general health condition with fever, and/or sore throat and mouth, please report to your doctor immediately. The symptoms might derive from a reduction in the number of white blood cells in your blood (agranulocytosis). This may increase your chances of suffering from a serious infection.

A blood test will be taken to check possible reduction of white blood cells.

It is important to inform your doctor about your medicine.

The following side effects have also been reported:

Rare side effects (that affect less than 1 in 1,000 patients):

• Abdominal pain, diarrhoea, wind, nausea and vomiting


• Headache, dizziness

Very rare side effects (that affect less than 1 in 10,000 patients):

• Changes in kidney function, sometimes with swollen limbs or flank pain because of renal disorders


• Chest pain, breathlessness or swollen limbs because of heart disorders


• Severe abdominal pain because of acute inflammation of the pancreas


• Severe breathlessness because of allergic inflammation of the lung


• Severe diarrhoea and abdominal pain because of allergic inflammation of the intestine


• Skin rash or inflammation


• Muscle and joint pain


• Fever, sore throat, or malaise because of blood count changes


• Jaundice or abdominal pain because of liver and bile flow disorders


• Hair loss and the development of baldness


• Numbness and tingling in the hands and feet (peripheral neuropathy)


• Reversible decrease in semen production

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE SALOFALK 1.5g GRANULES

Keep out of the reach and sight of children.

Do not use Salofalk granules after the expiry date which is stated on the carton and the sachet. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Salofalk 1.5g granules contain

The active substance in Salofalk 1.5g granules is mesalazine and one sachet of Salofalk 1.5g granules contains 1.5 g mesalazine.

The other ingredients are aspartame (E 951); carmellose sodium; cellulose, microcrystalline; citric acid, anhydrous; silica, colloidal anhydrous; hypromellose; magnesium stearate; methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100); methylcellulose; polyacrylate dispersion 40 per cent (Eudragit NE 40 D containing 2 per cent nonoxynol 100); povidone K 25; simeticone; sorbic acid; talc; titanium dioxide (E 171); triethyl citrate; vanilla custard flavour (containing propylene glycol).

What Salofalk 1.5g granules look like and contents of the pack

Salofalk 1.5g granules are rod-shaped or round, grey-white granules.

Salofalk 1.5g granules are available in packs of 20, 30, 35, 45, 50, 60, 70, 90, 100 and 150 sachets.

Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

DR. FALK PHARMA GmbH

Leinenweberstr. 5

79108 Freiburg

Germany

Tel.:+49 (0) 761/1514-0

Fax.:+49 (0) 761/1514-321

E-mail:zentrale@drfalkpharma.de

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark, Finland, Germany, Great Britain, Greece, Ireland, The Netherlands, Norway, Portugal, Slovenia, Sweden and Spain: Salofalk.

Belgium, Luxembourg: Colitofalk.

Austria: Mesagran.

This leaflet was last approved in May 2010

PL 08637/0016

1042810

GB/06.10

Sudal-12 Tannate

Generic Name: chlorpheniramine and pseudoephedrine (klor fen EER a meen and soo doe e FED rin)

Brand Names: AccuHist Drops, Allerest Maximum Strength, Brexin L.A., Colfed-A, D-Amine-SR, Dayquil Allergy, Deconamine, Dicel, Dicel Chewables, Dura-Tap/PD, Durafed, Duratuss DA, Dynahist-ER Pediatric, Genaphed Plus, Histade, Histex, Kronofed-A, Kronofed-A-Jr, LoHist-D, Mintex, Neutrahist Drops, Re2+30, Rescon-Ed, Suclor, SudaHist, Sudal-12 Chewable, Sudal-12 Tannate, Sudogest Cold & Allergy, SudoGest Sinus & Allergy, Tavist-DA, Triaminic Cold and Allergy, Triaminic Softchew Cold and Allergy, Triaminic Softchews Allergy Runny Nose and Congestion

What is Sudal-12 Tannate (chlorpheniramine and pseudoephedrine)?

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

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine and pseudoephedrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sudal-12 Tannate (chlorpheniramine and pseudoephedrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

What should I discuss with my healthcare provider before taking Sudal-12 Tannate (chlorpheniramine and pseudoephedrine)?

Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have:

• 
  

  severe or uncontrolled high blood pressure;

  
  


• 
  

  severe coronary artery disease;

  
  


• 
  

  narrow angle glaucoma;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  if you are unable to urinate; or

  
  


• 
  

  if you are having an asthma attack.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• kidney disease;


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  circulation problems;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  a seizure disorder such as epilepsy;

  
  


• 
  

  asthma, emphysema or chronic bronchitis; or

  
  


• 
  

  urination problems or an enlarged prostate.

  
  

FDA pregnancy category C. It is not known whether chlorpheniramine and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether chlorpheniramine and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Sudal-12 Tannate (chlorpheniramine and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

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

If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking Sudal-12 Tannate (chlorpheniramine and pseudoephedrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Sudal-12 Tannate (chlorpheniramine and pseudoephedrine) side effects

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

• 
  

  fast or pounding heartbeats;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness; or

  
  


• 
  

  seizure (black-out or convulsions).

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry nose or mouth;

  
  


• 
  

  nausea, stomach pain, constipation, loss of appetite;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  feeling restless or excited (especially in children).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

What other drugs will affect Sudal-12 Tannate (chlorpheniramine and pseudoephedrine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

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

• 
  

  mecamylamine (Inversine);

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  reserpine;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with chlorpheniramine and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Sudal-12 Tannate resources

• Sudal-12 Tannate Side Effects (in more detail)
• Sudal-12 Tannate Use in Pregnancy & Breastfeeding
• Drug Images
• Sudal-12 Tannate Drug Interactions
• Sudal-12 Tannate Support Group
• 0 Reviews for Sudal-12 Tannate - Add your own review/rating

• AccuHist Drops Prescribing Information (FDA)


• Biohist LA Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Deconamine MedFacts Consumer Leaflet (Wolters Kluwer)


• Deconamine SR Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Duotan Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• QDALL 24-Hour Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Sudal-12 Tannate with other medications

• Hay Fever
• Sinusitis

Where can I get more information?

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

See also: Sudal-12 Tannate side effects (in more detail)

Jimaixin

Jimaixin may be available in the countries listed below.

Ingredient matches for Jimaixin

Erythropoietin

Erythropoietin is reported as an ingredient of Jimaixin in the following countries:

• China

International Drug Name Search

Congestant

Pronunciation: klor-fen-IHR-ah-meen /a-seet-a-MIN-oh-fen
Generic Name: Chlorpheniramine/Acetaminophen
Brand Name: Examples include Congestant and Coricidin HBP Cold/Flu

Congestant is used for:

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

Congestant is an antihistamine and analgesic combination. Chlorpheniramine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. Acetaminophen works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Congestant if:

• you are allergic to any ingredient in Congestant


• you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (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 Congestant:

Some medical conditions may interact with Congestant. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day


• if you have a fast, slow, or irregular heartbeat; or liver problems (eg, hepatitis) or kidney problems


• if you have a history of asthma; lung problems (eg, emphysema); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate; seizures; or an overactive thyroid

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

• Furazolidone, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Congestant may be increased


• Anticoagulants (eg, warfarin) because the risk of side effects, such as bleeding, may be increased by Congestant


• Hydantoins (eg, phenytoin) because side effects may be increased by Congestant


• Isoniazid because side effects of Congestant may be increased

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

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

• Congestant may be taken with or without food.


• If you miss a dose of Congestant, 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 Congestant.

Important safety information:

• Congestant may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Congestant. Using Congestant alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


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


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Congestant may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Congestant or other pain relievers/fever reducers. Alcohol use combined with Congestant may increase your risk for liver damage.


• Congestant contains acetaminophen. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen. If it does or if you are uncertain, contact your doctor or pharmacist.


• Congestant may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Congestant. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• If you are scheduled for allergy skin testing, do not take Congestant for several days before the test because it may decrease your response to the skin tests.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Congestant.


• Use Congestant with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Congestant in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Congestant, discuss with your doctor the benefits and risks of using Congestant during pregnancy. It is unknown if Congestant is excreted in breast milk. Do not breast-feed while taking Congestant.

Possible side effects of Congestant:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

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

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; unusual fatigue; vision changes; yellowing of the skin or eyes.

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: Congestant side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Congestant:

Store Congestant 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 Congestant out of the reach of children and away from pets.

General information:

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


• Congestant 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 Congestant. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Congestant resources

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

• Coricidin Consumer Overview

Compare Congestant with other medications

• Cold Symptoms
• Hay Fever
• Influenza
• Rhinorrhea

Children's Triacting

Generic Name: acetaminophen and dextromethorphan (a SEET a MIN oh fen and DEX troe me THOR fan)

Brand Names: Children's Triacting, Triaminic Cough & Sore Throat, Triaminic Cough & Sore Throat Softchews, Tylenol Cough and Sore Throat Daytime

What is Children's Triacting (acetaminophen and dextromethorphan)?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

The combination of acetaminophen and dextromethorphan is used to treat cough and pain or fever caused by the common cold or flu.

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

Acetaminophen and dextromethorphan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Children's Triacting (acetaminophen and dextromethorphan)?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking Children's Triacting (acetaminophen and dextromethorphan)?

Do not take this medication if you are allergic to acetaminophen or dextromethorphan. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

It is not known whether acetaminophen and dextromethorphan will harm an unborn baby. Do not use cold or cough medicine without medical advice if you are pregnant. It is not known whether acetaminophen and dextromethorphan will harm an unborn baby. Do not use cold or cough medicine without medical advice if you are pregnant.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Children's Triacting (acetaminophen and dextromethorphan)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and dextromethorphan. You may need to stop using the medicine for a short time. Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Since cough or cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include dizziness, drowsiness, feeling restless or nervous, diarrhea, loss of appetite, seizure (convulsions), or coma.

What should I avoid while taking Children's Triacting (acetaminophen and dextromethorphan)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough medicine can increase your risk of unpleasant side effects.

Children's Triacting (acetaminophen and dextromethorphan) side effects

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

• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  slow, shallow breathing;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  upset stomach.

  
  


• 
  

  mild loss of appetite; or

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Children's Triacting (acetaminophen and dextromethorphan)?

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

• 
  

  celecoxib (Celebrex);

  
  


• 
  

  cinacalcet (Sensipar);

  
  


• 
  

  darifenacin (Enablex);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid;

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  ranolazine (Ranexa);

  
  


• 
  

  ritonavir (Norvir, Kaletra);

  
  


• 
  

  sibutramine (Meridia);

  
  


• 
  

  terbinafine (Lamisil);

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  gout medication such as probenecid (Benemid);

  
  


• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), bupropion (Wellbutrin, Zyban, Aplenzin), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

  
  

This list is not complete and other drugs may interact with acetaminophen and dextromethorphan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Children's Triacting resources

• Children's Triacting Use in Pregnancy & Breastfeeding
• Children's Triacting Drug Interactions
• 0 Reviews for Children's Triacting - Add your own review/rating

Compare Children's Triacting with other medications

• Cold Symptoms
• Cough
• Pain

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and dextromethorphan.

Ergotamine and Caffeine

Dosage Form: tablets

Rev. 11/04

Rx Only

Warning

Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate and caffeine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (See also CONTRAINDICATIONS and WARNINGS sections)

DESCRIPTION:

Ergotamine Tartrate and Caffeine Tablets USP

ergotamine tartrate USP . . . . . . . . . . . . . . . . . .1 mg

caffeine USP . . . . . . . . . . . . . . . . . . . . . . . . . . .100 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, sugar, and tartaric acid. Polishing and Film Coating Solutions may contain the following: FD&C Blue Lake #2, FD&C Yellow Lake #6, hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide. The printing ink contains: amide resin, black pigment, natural resin, and wax.

Ergotamine and Caffeine - Clinical Pharmacology

Ergotamine is an alpha adrenergic blocking agent with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels and produces depression of central vasomotor centers. The compound also has the properties of serotonin antagonism. In comparison to hydrogenated ergotamine, the adrenergic blocking actions are less pronounced and vasoconstrictive actions are greater.

Caffeine, also a cranial vasoconstrictor, is added to further enhance the vasoconstrictive effect without the necessity of increasing ergotamine dosage.

Many migraine patients experience excessive nausea and vomiting during attacks, making it impossible for them to retain any oral medication. In such cases, therefore, the only practical means of medication is through the rectal route where medication may reach the cranial vessels directly, evading the splanchnic vasculature and the liver.

Pharmacokinetics: Interactions

Pharmacokinetic interactions (increased blood levels of ergotamine) have been reported in patients treated orally with ergotamine and macrolide antibiotics (e.g., troleandomycin, clarithromycin, erythromycin), and in patients treated orally with ergotamine and protease inhibitors (e.g. ritonavir) presumably due to inhibition of cytochrome P450 3A metabolism of ergotamine (see CONTRAINDICATIONS). Ergotamine has also been shown to be an inhibitor of cytochrome P450 3A catalyzed reactions. No pharmacokinetic interactions involving other cytochrome P450 isoenzymes are known.

Indications and Usage for Ergotamine and Caffeine

Ergotamine Tartrate and Caffeine

Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”.

Contraindications

Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities (see PRECAUTIONS: Drug Interactions), with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine tartrate and caffeine was coadministered, at least one resulting in death. Because of the increased risk for ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drug and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole) (see WARNINGS: CYP 3A4 Inhibitors).

Ergotamine tartrate and caffeine may cause fetal harm when administered to pregnant women. Ergotamine tartrate and caffeine is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus.

Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function and sepsis.

Hypersensitivity to any of the components.

Warnings

CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors)

Coadministration of ergotamine with potent CYP 3A4 inhibitors such as protease inhibitors or macrolide antibiotics has been associated with serious adverse events, for this reason, these drugs should not be given concomitantly with ergotamine (see CONTRAINDICATIONS). While these reactions have not been reported with less potent CYP 3A4 inhibitors, there is a potential risk for serious toxicity including vasospasm when these drugs are used with ergotamine. Examples of less potent CYP 3A4 inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP3A4 of other agents being considered for concomitant use with ergotamine.

Fibrotic Complications

There have been a few reports of patients on ergotamine tartrate and caffeine therapy developing retroperitoneal and/or pleuropulmonary fibrosis. There have also been rare reports of fibrotic thickening of the aortic, mitral, tricuspid, and/or pulmonary valves with long-term continuous use of ergotamine tartrate and caffeine. Ergotamine tartrate should not be used for chronic daily administration (see DOSAGE AND ADMINISTRATION).

Precautions

General

Although signs and symptoms of ergotism rarely develop even after long term intermittent use of the rectally administered drug, care should be exercised to remain within the limits of recommended dosage.

Ergotism is manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia. Ergotamine induces vasoconstriction by a direct action on vascular smooth muscle. In chronic intoxication with ergot derivatives, headache, intermittent claudication, muscle pains, numbness, coldness and pallor of the digits may occur. If the condition is allowed to progress untreated, gangrene can result.

While most cases of ergotism associated with ergotamine treatment result from frank overdosage, some cases have involved apparent hypersensitivity. There are few reports of ergotism among patients taking doses within the recommended limits or for brief periods of time. In rare instances, patients, particularly those who have used the medication indiscriminately over long periods of time, may display withdrawal symptoms consisting of rebound headache upon discontinuation of the drug.

Rare cases of solitary rectal or anal ulcer have occurred from abuse of ergotamine suppositories usually in higher than recommended doses or with continual use at the recommended dose for many years. Spontaneous healing occurs within usually 4-8 weeks after drug withdrawal.

Information for Patients

Patients should be advised that two tablets of ergotamine tartrate and caffeine should be taken at the first sign of a migraine headache. No more than 6 tablets should be taken for any single migraine attack. No more than 10 tablets should be taken during any 7-day period. Administration of ergotamine tartrate and caffeine tablets should not exceed the dosing guidelines and should be used for chronic daily administration (see DOSAGE AND ADMINISTRATION). Ergotamine tartrate and caffeine should be used only for migraine headaches. It is not effective for other types of headaches and it lacks analgesic properties. Patients should be advised to report to the physician immediately any of the following: numbness or tingling in the fingers and toes, muscle pain in the arms and legs, weakness in the legs, pain in the chest or temporary speeding or slowing of the heart rate, swelling or itching.

Drug Interactions

CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors)

See CONTRAINDICATIONS and WARNINGS.

Ergotamine tartrate and caffeine should not be administered with other vasoconstrictors. Use with sympathominetics (pressor agents) may cause extreme elevation of blood pressure. The beta-blocker Inderal (propranolol) has been reported to potentiate the vasoconstrictive action of ergotamine tartrate and caffeine by blocking the vasodilating property of epinephrine. Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy.

The blood levels of ergotamine-containing drugs are reported to be elevated by the concomitant administration of macrolide antibiotics and vasospastic reactions have been reported with therapeutic doses of the ergotamine-containing drugs when coadministered with those antibiotics.

Pregnancy

Teratogenic Effects

Pregnancy Category X: There are no studies on the placental transfer or teratogenicity of the combined products of ergotamine tartrate and caffeine. Caffeine is known to cross the placenta and has been shown to be teratogenic in animals. Ergotamine crosses the placenta in small amounts, although it does not appear to be embryotoxic in this quantity. However, prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone leading to reduced myometrial and placental blood flow may have contributed to fetal growth retardation observed in animals (see CONTRAINDICATIONS).

Nonteratogenic Effects

Ergotamine tartrate and caffeine is contraindicated in pregnancy due to the oxytocic effects of ergotamine (see CONTRAINDICATIONS).

Labor and Delivery

Ergotamine tartrate and caffeine is contraindicated in labor and delivery due to its oxytocic effect which is maximal in the third trimester (see CONTRAINDICATIONS).

Nursing Mothers

Ergot drugs are known to inhibit prolactin but there are no reports of decreased lactation with ergotamine tartrate and caffeine. Ergotamine is excreted in breast milk and may cause symptoms of vomiting, diarrhea, weak pulse and unstable blood pressure in nursing infants. Because of the potential for serious adverse reactions in nursing infants from ergotamine tartrate and caffeine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS:

Cardiovascular: Vasoconstrictive complications of a serious nature may occur at times. These include ischemia, cyanosis, absence of pulse, cold extremities, gangrene, precordial distress and pain, EKG changes and muscle pains. Although these effects occur most commonly with long-term therapy at relatively high doses, they have also been reported with short-term or normal doses. Other cardiovascular adverse effects include transient tachycardia or bradycardia and hypertension.

Gastrointestinal: Nausea and vomiting; rectal or anal ulcer (from overuse of suppositories).

Neurological: paresthesias, numbness, weakness, and vertigo.

Allergic: Localized edema and itching.

Fibrotic Complications: (see WARNINGS).

Drug Abuse and Dependence

There have been reports of drug abuse and psychological dependence in patients on ergotamine tartrate and caffeine therapy. Due to chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages with long-term use to avoid ergotism (see PRECAUTIONS).

Overdosage

The toxic effects of an acute overdosage of ergotamine tartrate and caffeine are due primarily to the ergotamine component. The amount of caffeine is such that its toxic effects will be overshadowed by those of ergotamine. Symptoms include vomiting, numbness, tingling, pain and cyanosis of the extremities associated with diminished or absent peripheral pulses, hypertension or hypotension, drowsiness, stupor, coma, convulsion and shock. A case has been reported of reversible bilateral papillitis with ring scotomata in a patient who received five times the recommended daily adult dose over a period of 14 days.

Treatment consists of removal of the offending drug by induction of emesis. Maintenance of adequate pulmonary ventilation, correction of hypotension, and control of convulsions and blood pressure are important considerations. Treatment of peripheral vasospasm should consist of warmth, but not heat, and protection of the ischemic limbs. Vasodilators may be beneficial but caution must be exercised to avoid aggravating an already existent hypotension.

Ergotamine and Caffeine Dosage and Administration

Procedure: For the best results, dosage should start at the first sign of an attack.

Adults: Take 2 tablets at the start of attack; 1 additional tablet every ½ hour, if needed for full relief (maximum 6 tablets per attack, 10 per week).

Early Administration Gives Maximum Effectiveness.

Maximum Adult Dosage: Six tablets is the maximum dose for an individual attack.

Total weekly dosage should not exceed 10 tablets. Ergotamine tartrate and caffeine-tablets should not be used for chronic daily administration.

In carefully selected patients, with due consideration of maximum dosage recommendations, administration of the drug at bedtime may be an appropriate short-term preventive measure.

How is Ergotamine and Caffeine Supplied

Ergotamine Tartrate and Caffeine Tablets USP, 1 mg/100 mg are round, film coated buff colored tablet; printed "WW 120" in black ink and are available in:

 

Bottles of 30 tablets.

 

Bottles of 100 tablets.

 

Bottles of 500 tablets.

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured By:

West-ward Pharmaceutical Corp.

Eatontown, NJ 07724

Revised November 2004

ERGOTAMINE  ergotamine tartrate and caffeine  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0143-2120 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Ergotamine Tartrate (Ergotamine) Active 1 MILLIGRAM  In 1 TABLET Caffeine (Caffeine) Active 100 MILLIGRAM  In 1 TABLET Corn Starch Inactive   Sugar 6x Powder Inactive   Mannito Inactive   Compressible Sugar Inactive   Microcrystalline Cellulose Inactive   Colloidal Silicon Dioxide Inactive   Sodium Starch Glycolate Inactive   Magnesium Inactive   FD&C Blue Lake #2 Inactive   FD&C Yellow Lake #6 Inactive   hydroxypropyl Inactive   methylcellulose Inactive   polyethylerne gylcol titanium dioxide Inactive   amide resin Inactive   black pigment Inactive   natural resin Inactive   wax Inactive

Product Characteristics Color WHITE (WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code WW;120 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0143-2120-30 30 TABLET In 1 BOTTLE, PLASTIC None 2 0143-2120-01 100 TABLET In 1 BOTTLE, PLASTIC None 3 0143-2120-05 500 TABLET In 1 BOTTLE, PLASTIC None

Revised: 01/2008West-ward Pharmaceutical Corp.

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