Spironolactone Tablets 25mg, 50mg, 100mg

Spironolactone 25mg, 50mg and 100mg tablets

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.

Index

• 
  1 What Spironolactone tablets are and what they are used for
  


• 
  2 Before you take
  


• 
  3 How to take
  


• 
  4 Possible side effects
  


• 
  5 How to store
  


• 
  6 Further information
  

What Spironolactone tablets are and what they are used for

Spironolactone tablets belong to a group of medicines called potassium-sparing diuretics (water tablets), which help you lose excess fluid from your body. They may be used for:

• congestive heart failure


• nephrotic syndrome (a kidney disorder)


• liver cirrhosis with fluid retention (oedema) and swelling of the abdomen (ascites)


• a cancerous disease with swelling of the abdomen (malignant ascites)


• diagnosis and treatment of primary aldosteronism (a condition where excess hormone is produced).

Before you take

Do not take Spironolactone tablets and tell your doctor if you:

• are allergic (hypersensitive) to spironolactone or any of the other ingredients in Spironolactone tablets (see section 6)


• have diabetes with or without kidney problems


• have Addison’s disease (weakness, loss of energy, low blood pressure and dark pigmentation of the skin)


• have kidney problems which may be severe or worsening


• have high blood levels of potassium


• are not passing urine.

Check with your doctor or pharmacist before taking Spironolactone tablets if you have:

• a diet high in potassium


• 
  low blood levels of sodium


• 
  liver cirrhosis
  


• been passing small amounts of urine


• a severe illness


• or have ever had too much acid in the body


• an inherited disorder of the red blood pigment haemoglobin causing skin blisters, abdominal pain and nervous system disorders (porphyria)


• abnormal periods or swollen breasts.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

• blood pressure lowering medicines (antihypertensives) such as ACE inhibitors (e.g. captopril or enalapril) and angiotensin-II receptor antagonists (such as valsartan or losartan)


• chlorpropamide (used in diabetes)


• digoxin (used in some heart conditions)


• ciclosporin or tacrolimus (used to prevent organ transplant rejection, treat rheumatoid arthritis, eczema or psoriasis)


• fludrocortisone (a corticosteroid)


• warfarin (used to thin the blood)


• other potassium-sparing diuretics (water tablets)


• lithium (used for some mental illnesses)


• non-steroidal anti-inflammatory drugs (NSAIDs) such as indometacin and mefenamic acid


• aspirin (to reduce pain, inflammation and high temperature)


• potassium supplements (potassium salts)


• noradrenaline (norepinephrine) (used for low blood pressure or heart problems)


• an anaesthetic


• carbenoxolone (an ulcer healing drug).

Pregnancy and breast-feeding

If you are pregnant or planning to become pregnant, speak to your doctor before taking this medicine. Spironolactone tablets should not be taken if you are breast-feeding.

Driving and using machines

Spironolactone tablets may cause dizziness or drowsiness. Make sure you are not affected before you drive or operate machinery.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.

Tests

Your doctor may want to carry out tests to monitor the levels of fluid and chemicals in your body, especially if you are elderly or have impaired liver or kidney function.

Diabetic and liver function tests

If you are to have liver function tests, you are to be tested for diabetes or need to have other tests related to diabetes, tell your doctor that you are taking Spironolactone tablets. Spironolactone tablets may need to be stopped at least three days before a diabetes test.

How to take

Always take Spironolactone tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with water and preferably with food.

Doses:

• 
  Adults
  
  • 
    Congestive heart failure – 100mg a day. The maintenance dose is 25-200mg a day. In difficult or severe cases, up to a maximum of 400mg a day may be taken.
  
  
  • 
    Nephrotic syndrome – 100-200mg a day.
  
  
  • 
    Liver cirrhosis with fluid retention and swelling of the abdomen - 100-400mg a day. Your doctor will decide on the best maintenance dose for you.
  
  
  • 
    A cancerous disease with swelling of the abdomen – 100-200mg a day. Your doctor will decide on the best maintenance dose for you. In severe cases, up to a maximum of 400mg a day may be taken.
  
  
  • 
    Primary aldosteronism diagnosis –
    Long test: 400mg a day for 3-4 weeks.
    Short test: 400mg a day for 4 days.
    
  
  
  • 
    Primary aldosteronism treatment - 100-400mg a day in preparation for surgery. If surgery is not to be carried out, your doctor will decide on the best maintenance dose for you.
  
  

• 
  Elderly
  
  Your doctor will decide on the best dose for you. If you have severely impaired liver or kidney function, your doctor may prescribe a different dose.
  

• 
  Children
  
  
  
  Usual starting dose is 3mg per kg of bodyweight a day, to be taken in divided doses. Your doctor will adjust the dose depending on the response to treatment. If necessary, the tablets may be crushed and dispersed in food or drink.
  

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include drowsiness, mental confusion, feeling or being sick, dizziness, diarrhoea, decreased blood levels of sodium, increased blood levels of potassium (symptoms include ‘pins and needles’ or tingling, unusual tiredness or weakness, muscular weakness, paralysis with a loss of muscle tone, muscle spasm).

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

Possible side effects

Like all medicines, Spironolactone tablets can cause side effects, although not everybody gets them.

Stop taking Spironolactone and contact your doctor at once if you develop high blood levels of potassium (muscle twitching or weakness, irregular heart beat, unusual tiredness or weakness, paralysis with or without loss of muscle tone, circulatory failure), especially if you have impaired kidney function or a diet high in potassium.

Contact your doctor immediately if you notice signs of an allergic reaction (hypersensitivity) such as swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, shock, collapse, skin rash or itching.

Tell your doctor or pharmacist if you notice any of the following side effects, they get worse or if you notice anything not listed.

• 
  Blood: increase in blood levels of nitrogen or urea especially in those with impaired kidney function, altered numbers and types of blood cells. If you notice increased bruising, nosebleeds, sore throats or infections, you should tell your doctor who may want you to have a blood test.


• 
  Metabolism and nutrition: low blood levels of sodium, changes in the levels of chemicals in the body.


• 
  Nervous system: lack of muscle control or coordination, drowsiness, dizziness, headache, clumsiness.


• 
  Psychiatric: tiredness.


• 
  Liver: a poisonous effect on the liver.


• 
  Stomach and intestines: inflammation of the stomach lining, bleeding in the stomach, stomach or intestinal ulcers, stomach cramps, diarrhoea, being sick.


• 
  Skin: skin rashes including pale or red irregular raised patches with severe itching (hives), hair loss.


• 
  Muscle and bone: bone softening due to vitamin D deficiency.


• 
  Kidneys: acute kidney failure particularly in those who already have impaired kidney function.


• 
  Reproductive system: enlarged breasts in men, changes in voice pitch, reduced sexual potency in men, decreased sexual ability, breast tenderness and increased hair growth in females, irregular periods, sweating.

Tell your doctor or pharmacist if you notice any of the above side effects, they get worse or if you notice anything not listed.

How to store Spironolactone tablets

Keep out of the reach and sight of children.

Do not store above 25 °C.

Store in the original package.

Keep container in the outer carton.

Do not use Spironolactone tablets after the expiry date which is stated on the label/carton/bottle. The expiry date refers to the last day of that month.

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 Spironolactone tablets contain

• The active substance (the ingredient that makes the tablets work) is spironolactone. Each tablet contains either 25mg, 50mg or 100mg of the active substance.


• The other ingredients are lactose, magnesium stearate, maize starch, microcrystalline cellulose, peppermint flavour, polyvidone, sodium starch glycollate, purified water, iron oxide red (E172), iron oxide yellow (E172), methylhydroxypropylcellulose (E5) (E464), propylene glycol, titanium dioxide (E171).

What Spironolactone tablets look like and contents of the pack

Spironolactone tablets are buff, circular, biconvex film-coated tablets.

Pack size is 28.

Marketing Authorisation Holder and Manufacturer

Actavis

Barnstaple

EX32 8NS

UK

This leaflet was last revised in March 2008.

If you would like a leaflet with larger text, please contact 01271 311257.

Actavis

Barnstaple

EX32 8NS

UK

Benicar

Benicar is a brand name of olmesartan, approved by the FDA in the following formulation(s):

BENICAR (olmesartan medoxomil - tablet; oral)

• 
  Manufacturer: DAIICHI SANKYO
  
  Approval date: April 25, 2002
  
  Strength(s): 20MG, 40MG ^[RLD], 5MG
  

Has a generic version of Benicar been approved?

No. There is currently no therapeutically equivalent version of Benicar available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Benicar. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Angiotensin II antagosist 1-biphenylmethylimidazole compounds and their therapeutic use
  Patent 5,616,599
  Issued: April 1, 1997
  Inventor(s): Yanagisawa; Hiroaki & Fujimoto; Koichi & Amemiya; Yoshiya & Shimoji; Yasuo & Kanazaki; Takuro & Koike; Hiroyuki & Sada; Toshio
  Assignee(s): Sankyo Company, Limited
  Compounds of the following formula (I) or the formula (I).sub.p : ##STR1## wherein R.sup.1 is alkyl or alkenyl; R.sup.2 and R.sup.3 are hydrogen, alkyl, alkenyl, cycloalkyl, aralkyl, aryl, or aryl fused to cycloalkyl; R.sup.4 is hydrogen, alkyl, alkanoyl, alkenoyl, arylcarbonyl, alkoxycarbonyl, tetrahydropyranyl, tetrahydrothiopyranyl, tetrahydrothienyl, tetrahydrofuryl, a group of formula --SiR.sup.a R.sup.b R.sup.c, in which R.sup.a, R.sup.b and R.sup.c are alkyl or aryl, alkoxymethyl, (alkoxyalkoxy)methyl, haloalkoxymethyl, aralkyl, aryl or alkanoyloxymethoxycarbonyl; R.sup.5 is carboxy or --CONR.sup.8 R.sup.9, wherein R.sup.8 and R.sup.9 hydrogens or alkyl, or R.sup.8 and R.sup.9 together form alkylene; R.sup.6 is hydrogen, alkyl, alkoxy or halogen; R.sup.7 is carboxy or tetrazol-5-yl; R.sub.p.sup.1 is hydrogen, alkyl, cycloalkyl or alkanoyl; R.sub.p.sup.2 is a single bond, alkylene or alkylidene; R.sub.p.sup.3 and R.sub.p.sup.4 are each hydrogen or alkyl; R.sub.p.sup.6 is carboxy or tetrazol-5-yl; and X.sub.p is oxygen or sulfur; and pharmaceutically acceptable salts and esters thereof. The compounds are AII receptor antagonists and thus have hypotensive activity and can be used for the treatment and prophylaxis of hypertension. The compounds may be prepared by reacting a biphenylmethyl compound with an imidazole compound.
  
  Patent expiration dates:
  
  
  • April 25, 2016
    
    ✓ 
    Patent use: USE AS AN ANTIHYPERTENSIVE AGENT
    ✓ 
    Drug substance
    ✓ 
    Drug product
  
  
  
  • October 25, 2016
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Pharmaceutical composition
  Patent 6,878,703
  Issued: April 12, 2005
  Inventor(s): Sada; Toshio & Mizuno; Makoto
  Assignee(s): Sankyo Company, Limited
  A pharmaceutical composition comprises an angiotensin II receptor antagonist selected from among compounds having the following formula (I), a pharmacologically acceptable salt thereof, a pharmacologically acceptable ester thereof and a pharmacologically acceptable salt of such ester, and one or more diuretics: The pharmaceutical composition of the present invention has an excellent hypotensive effect and low toxicity, and therefore is useful as a medicament for preventing or treating hypertension or heart disease.
  
  Patent expiration dates:
  
  
  • November 19, 2021
    
    ✓ 
    Patent use: TREATMENT OF HYPERTENSION
    ✓ 
    Sponsor has requested patent be delisted
  
  
  
  • May 19, 2022
    
    ✓ 
    Pediatric exclusivity
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • February 4, 2013 - NEW PATIENT POPULATION
  
  
  • August 4, 2013 - PEDIATRIC EXCLUSIVITY
  
  

See also...

• Benicar Consumer Information (Drugs.com)
• Benicar Consumer Information (Wolters Kluwer)
• Benicar Consumer Information (Cerner Multum)
• Benicar Advanced Consumer Information (Micromedex)
• Olmesartan Consumer Information (Wolters Kluwer)
• Olmesartan Consumer Information (Cerner Multum)
• Olmesartan Advanced Consumer Information (Micromedex)
• Olmesartan medoxomil Advanced Consumer Information (Micromedex)
• Olmesartan Medoxomil AHFS DI Monographs (ASHP)

Sterile Potassium Chloride Concentrate BP 15% w / v, 1.5g in 10ml

1. Name Of The Medicinal Product

Sterile Potassium Chloride Concentrate BP 15% w/v, 1.5g in 10ml

2. Qualitative And Quantitative Composition

Each 10ml contains 1.5g of Potassium Chloride BP

3. Pharmaceutical Form

Clear, colourless, sterile, aqueous solution intended for parenteral administration to human beings.

4. Clinical Particulars

4.1 Therapeutic Indications

For use in patients requiring supplemental potassium therapy.

4.2 Posology And Method Of Administration

Route of administration: Intravenous, after dilution.

BEFORE ADMINSTERING STERILE POTASSIUM CHLORIDE CONCENTRATE BP

1.) This solution must be diluted with not less than 50 times its volume of sodium chloride solution or other suitable diluent.

2.) The solution should be carefully mixed with the infusion fluid.

During administration:

1) The diluted injection should be administered by slow intravenous infusion at a maximal rate of

20mmol of potassium per hour.

2) The ECG should be monitored continuously.

The goal of potassium replacement therapy is to elevate the plasma concentration of the ion to within the normal range.

Dose per hour: The maximal rate of intravenous infusion is 20mmol/hour.

Dose per day: Since the normal dietary intake of potassium is 50 to 100mmol daily, it is rare that a larger amount is required during potassium replacement therapy.

4.3 Contraindications

1.) Sterile Potassium Chloride Concentrate BP should never be used undiluted.

2.) Hyperkalaemia.

4.4 Special Warnings And Precautions For Use

The diluted solution should always be given slowly as high blood concentrations of potassium may cause serious cardiac toxicity.

Particular care is required when administering potassium to patients with renal or adrenal insufficiency, cardiac disease or extensive tissue destruction as may occur with severe bums. In cases of renal insufficiency due to severe dehydration, excretory function should be restored by correction of the fluid deficit in order to ensure adequate urinary excretion of potassium before its parenteral administration. Where renal insufficiency is accompanied by either inadequate urinary excretion of potassium or defective cellular uptake of potassium, administration of standard doses of potassium could result in life-threatening hyperkalaemia.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use of other drugs containing potassium or agents having the potential for hyperkalaemia, such as potassium-sparing diuretics, may lead to accumulation of potassium.

4.6 Pregnancy And Lactation

Potassium chloride should only be used during pregnancy or lactation only if considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

Nil.

4.8 Undesirable Effects

Excessive intake of potassium may cause hyperkalaemia, with paraesthesia, muscle weakness, paralysis, hypotension, cardiac arrhythmias and cardiac arrest.

4.9 Overdose

All drugs containing potassium should be withdrawn and potassium-sparing diuretics discontinued. Infusions of glucose alone or with insulin, or sodium bicarbonate solution may be used to reduce serum potassium concentrations. Intravenous administration of calcium gluconate may be used to treat cardiac toxicity. Mild hyperkalaemia may be treated with sodium polystyrene sulphonate, a cation-exchange resin administered by mouth or as an enema. If the above measures fail, haemodialysis or peritoneal dialysis may be required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Active ion transport by the sodium-potassium ATP ASE carrier maintains a high gradient of potassium across the plasma membrane. Intracellular concentrations of potassium are about 150 mEqper litre while the plasma concentration is in the range of 3.5 to 5 mEq per litre, although there is a modest variation from one cell type to another.

Potassium plays a vital physiological role in maintenance of normal electrical excitability of nerve and muscle. it is also important in the genesis and correction of imbalances of acid-base metabolism.

In acute hypokalaemia, parenteral administration of potassium chloride promptly corrects the deficit in plasma potassium concentration and restores normal physiological function to potassium-dependent systems.

5.2 Pharmacokinetic Properties

Potassium is an essential dietary constituent and is readily absorbed from the gastro-intestinal tract.

Accumulation of potassium by cells occurs via an energy-dependent mechanism that extrudes sodium. Active ion transport systems maintain a high gradient of potassium across the plasma membrane, resulting in plasma concentrations of about 3.5 to 5 mEq per litre and intracellular concentrations of approximately 150 mEq per litre.

Potassium is excreted mainly by the kidneys. It is freely filtered at the glomerulus and is mainly absorbed in the proximal tubules, so that by the time the tubular fluid reaches the late distal tubules, it contains less than 10% of the amount of potassium in the original glomerular filtrate. Normally, considerable amounts of potassium are secreted into the distal tubules and secretory transport is extremely important for the control of plasma potassium concentration.

As a consequence of the large volume of distribution and the rapid response of the kidney, intracellular and extracellular concentrations of potassium are normally maintained within relatively narrow limits. However, when potassium is administered as a drug, the factors that govern the rate and extent of its distribution are of critical importance. Although administration of potassium will not significantly increase the total body content of the ion, it may easily raise the extracellular concentration excessively. Because it is the extracellular concentration of potassium that determines life-threatening toxicity, awareness of the transient concentration achieved in plasma should govern the use of potassium therapy.

5.3 Preclinical Safety Data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Water for Injections BP

6.2 Incompatibilities

Incompatibilities have been reported with dobutamine hydrochloride, amphotericin, amikacin sulphate and fixed oil emulsions.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Keep in the outer carton.

Do not store above 25°C.

6.5 Nature And Contents Of Container

10ml hermetically sealed translucent plastic ampoules, polypropylene Ph.Eur., packed in cardboard cartons to

contain 10,20, 50 and 100 ampoules.

6.6 Special Precautions For Disposal And Other Handling

Use as directed by the physician.

Warning: Dilute before use with not less than 50 times its volume of Sodium

Chloride Injection or another suitable diluent.

Discard if cloudy or deposit present.

If only part used, discard the remaining solution.

Keep out of reach of children.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

Antigen Internation Ltd

Roscrea,

Co. Tipperary,

Ireland.

8. Marketing Authorisation Number(S)

PL 02848/0154

9. Date Of First Authorisation/Renewal Of The Authorisation

28/05/1997

10. Date Of Revision Of The Text

August 2001

Unguentum Ichthyoli

Unguentum Ichthyoli may be available in the countries listed below.

Ingredient matches for Unguentum Ichthyoli

Ichthammol

Ichthammol is reported as an ingredient of Unguentum Ichthyoli in the following countries:

• Latvia

International Drug Name Search

Ibukem

Ibukem may be available in the countries listed below.

Ingredient matches for Ibukem

Ibuprofen

Ibuprofen is reported as an ingredient of Ibukem in the following countries:

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International Drug Name Search

Zarontin

Generic Name: ethosuximide (ETH oh SUX i mide)

Brand Names: Zarontin

What is Zarontin (ethosuximide)?

Ethosuximide is an anti-epileptic medication, also called an anticonvulsant.

Ethosuximide is used alone or in combination with other medications to treat absence seizures (also called "petit mal" seizures) in adults and children.

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

What is the most important information I should know about Zarontin (ethosuximide)?

Ethosuximide can cause a decrease in many types of blood cells (white cells, red cells, platelets). Call your doctor at once if you have any unusual bleeding, weakness, or any signs of infection, even if these symptoms first occur after you have been using the medication for several months.

Ethosuximide may also cause liver damage. Call your doctor if you have symptoms such as loss of appetite, stomach pain, or jaundice (yellowing of the skin or eyes).

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

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

Do not stop using ethosuximide without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using ethosuximide suddenly. You will need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking ethosuximide.

Wear a medical alert tag or carry an ID card stating that you take ethosuximide. Any medical care provider who treats you should know that you take seizure medication.

What should I discuss with my healthcare provider before taking Zarontin (ethosuximide)?

You should not use this medication if you are allergic to ethosuximide or to other seizure medications.

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

• 
  

  lupus;

  
  


• 
  

  liver disease;

  
  


• 
  

  kidney disease; or

  
  


• 
  

  a history of depression, mood problems, or suicidal thoughts or actions.

  
  

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

It is not known whether ethosuximide is harmful to an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Follow your doctor's instructions about taking ethosuximide while you are pregnant. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of ethosuximide on the baby. Ethosuximide passes 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. Ethosuximide should not be given to a child younger than 3 years old.

How should I take Zarontin (ethosuximide)?

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

Your doctor may occasionally change your dose to make sure you get the best results.

Ethosuximide can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your kidney and liver function may also need to be tested. Visit your doctor regularly.

Call your doctor at once if you have any unusual bleeding, weakness, or any signs of infection, including flu-like symptoms. These symptoms may first develop even after you have been using the medication for several months. Do not stop using ethosuximide without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using ethosuximide suddenly. You may need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking ethosuximide.

Wear a medical alert tag or carry an ID card stating that you take ethosuximide. Any medical care provider who treats you should know that you take seizure medication.

Use ethosuximide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, extreme drowsiness, and weak or shallow breathing.

What should I avoid while taking Zarontin (ethosuximide)?

Do not drink alcohol. It can increase certain side effects of ethosuximide. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Zarontin (ethosuximide) 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.

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

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

• 
  

  fever, chills, flu symptoms, sore throat, swollen glands, feeling very weak;

  
  


• 
  

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

  
  


• 
  

  joint pain or swelling with mild fever, muscle aches, chest pain when breathing;

  
  


• 
  

  patchy skin color, red spots, or a butterfly shaped skin rash over your cheeks and nose (worsens in sunlight);

  
  


• 
  

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

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior, extreme fear;

  
  


• 
  

  severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling; or

  
  


• 
  

  worsening of seizures.

  
  

Less serious side effects may include:

• 
  

  upset stomach, mild nausea, stomach cramps, diarrhea, weight loss;

  
  


• 
  

  swelling in your tongue or gums;

  
  


• 
  

  headache, dizziness, drowsiness, feeling tired;

  
  


• 
  

  lack of balance or coordination; or

  
  


• 
  

  unusual vaginal bleeding.

  
  

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 Zarontin (ethosuximide)?

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

Before taking ethosuximide, tell your doctor about all other seizure medications you use, especially:

• 
  

  phenobarbital (Solfoton);

  
  


• 
  

  phenytoin (Dilantin); or

  
  


• 
  

  valproic acid (Depakene, Stavzor).

  
  

This list is not complete and other drugs may interact with ethosuximide. 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 Zarontin resources

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

• Zarontin Prescribing Information (FDA)


• Zarontin MedFacts Consumer Leaflet (Wolters Kluwer)


• Zarontin Monograph (AHFS DI)


• Zarontin Advanced Consumer (Micromedex) - Includes Dosage Information


• Ethosuximide Prescribing Information (FDA)


• Ethosuximide Professional Patient Advice (Wolters Kluwer)

Compare Zarontin with other medications

• Seizures

Where can I get more information?

• Your pharmacist can provide more information about ethosuximide.

See also: Zarontin side effects (in more detail)

Pielograf

Pielograf may be available in the countries listed below.

Ingredient matches for Pielograf

Diatrizoic acid

Diatrizoic acid meglumine and sodium salt (a derivative of Diatrizoic acid) is reported as an ingredient of Pielograf in the following countries:

• Colombia


• Spain

International Drug Name Search

Revlimid

Pronunciation: LEN-a-LID-oh-mide
Generic Name: Lenalidomide
Brand Name: Revlimid

Revlimid may cause severe birth defects or death of the fetus if used during pregnancy. Revlimid is similar to thalidomide, which causes life-threatening birth defects.

Females who are able to become pregnant and who take Revlimid:

• must not become pregnant;


• must avoid sexual contact with men or use at least 2 forms of effective birth control for 4 weeks before starting Revlimid, while taking Revlimid, during dose interruptions, and for 4 weeks after stopping Revlimid;


• must have a negative pregnancy test 10 to 14 days before starting Revlimid and again within 24 hours before starting Revlimid; and


• must have a pregnancy test every week for the first 4 weeks after starting Revlimid and then every 2 to 4 weeks thereafter while using Revlimid.

Women who experience abnormal menstrual bleeding, miss their menstrual period, become pregnant, or suspect for any reason they may be pregnant while taking Revlimid must stop taking it and contact their doctor immediately.

Males who take Revlimid must either:

• avoid sexual contact with women who are pregnant or could become pregnant while taking Revlimid and for 4 weeks after stopping Revlimid; OR


• use a latex condom during sexual contact with women who are pregnant or could become pregnant for as long as they are taking Revlimid and for 4 weeks after stopping Revlimid, even if they have had a successful vasectomy.

Men who have unprotected sexual contact with a woman who is pregnant or may become pregnant or who think for any reason that their sexual partner may be pregnant should contact their doctor immediately.

All patients who take Revlimid:

• It is not known if Revlimid passes into semen. Female partners of men taking Revlimid should call their doctor if they become pregnant.


• All patients must receive and understand all oral and written warnings about the risks of using Revlimid.


• All patients must be able to follow the instructions for using Revlimid and for using effective birth control methods if they are sexually active.


• Revlimid may cause an increased risk of blood clots in the veins and lungs. Call your doctor right away if you experience shortness of breath; chest pain; or pain, redness, tenderness, or swelling in the arms or legs.


• Revlimid often lowers the number of white blood cells and platelets in the blood. Call your doctor right away if you experience unusual bleeding or bruising, fever, chills, or sore throat.


• Blood counts should be checked each week for the first 8 weeks after starting Revlimid and at least once per month thereafter. If low blood counts develop, it may be necessary to lower the dose or stop treatment. Sometimes blood transfusions and treatment with other medicines may be necessary. Keep all doctor and lab appointments while using Revlimid.

Revlimid is used for:

Treating anemia in patients who have certain types of myelodysplastic syndrome (MDS). It is also used along with dexamethasone to treat a certain type of cancer (multiple myeloma) in certain patients.

Revlimid is an immunomodulatory medicine. Exactly how it works is not known.

Do NOT use Revlimid if:

• you are allergic to any ingredient in Revlimid


• you are pregnant, planning to become pregnant, could become pregnant, or become pregnant during treatment with Revlimid


• you have had a severe allergic reaction (eg, rash; hives; hoarseness; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) or a severe rash (eg, red, swollen, blistered, or peeling skin) from Revlimid or thalidomide in the past

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

Before using Revlimid:

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

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


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


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


• if you have a tumor, cancer, kidney problems, certain hereditary problems (glucose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption), low white blood cell levels, or low platelet counts or if you receive dialysis


• if you have an infection, blood electrolyte problems, high blood pressure, or a history of blood clots or heart problems (eg, irregular heartbeat, heart attack)

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

• Erythropoietic agents (eg, erythropoietin), estrogens (eg, estrogen, estradiol), progestins (eg, medroxyprogesterone), or medicines that contain estrogens or progestins (eg, birth control pills) because the risk of developing blood clots may be increased


• Digoxin because the risk of its side effects may be increased by Revlimid

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

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

• Revlimid comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Revlimid refilled.


• Revlimid can only be prescribed and dispensed through a special program. Make sure you understand all warnings and instructions for using Revlimid. Ask your doctor or pharmacist if you have any questions about this program or the use of Revlimid.


• Take Revlimid by mouth with or without food.


• Swallow Revlimid whole with water. Do not break, crush, or chew before swallowing.


• Women who are able to become pregnant (including those who have started menopause within the last 24 months) must use at least 2 methods of effective birth control while taking Revlimid, unless they are not sexually active. These birth control methods must be used for at least 4 weeks before starting Revlimid, while taking Revlimid, during dose interruptions, and for 4 weeks after stopping Revlimid. Talk with your doctor about which methods of effective birth control may be appropriate for you.


• Men who take Revlimid must always use a latex condom during any sexual contact with a woman who is pregnant or could become pregnant. Do this for as long as you are taking Revlimid and for 4 weeks after you stop taking it. This includes men who have had a vasectomy.


• Do not open the capsules or handle them more than needed. If you touch a broken capsule or the medicine inside of the capsule, wash the area with soap and water.


• If you miss a dose of Revlimid and it has been less than 12 hours since the missed dose, take it as soon as you remember. If it has been more than 12 hours since the missed 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 Revlimid.

Important safety information:

• Revlimid may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Revlimid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Revlimid may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Revlimid may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Revlimid may increase the risk of blood clots in certain patients. Tell your doctor at once if you notice shortness of breath; chest pain; or pain, redness, tenderness, or swelling of an arm or leg.


• Patients with cancer who take Revlimid have a risk of developing a serious and possibly fatal condition called tumor lysis syndrome (TLS). Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness.


• Do not donate semen, sperm, or blood while taking Revlimid or within 4 weeks after stopping Revlimid.


• If you are using a hormonal contraceptive (eg, birth control pills) to prevent pregnancy, inform your doctor if you also take an HIV protease inhibitor (eg, ritonavir); griseofulvin, rifampin, rifabutin, penicillin, amoxicillin, ampicillin, or other antibiotic medicines; St. John's wort; modafinil; phenytoin; or carbamazepine. These medicines may decrease the effectiveness of hormonal contraceptives.


• Lab tests, including pregnancy tests and complete blood cell counts, may be performed while you use Revlimid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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


• Revlimid should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Use of Revlimid during pregnancy may cause severe birth defects and death of the fetus. If you think you may be pregnant, miss your menstrual period, experience unusual menstrual bleeding, or stop using birth control, contact your doctor right away. If you become pregnant while using Revlimid, consult an obstetrician/gynecologist experienced in reproductive toxicity. It is not known if Revlimid is found in breast milk. Do not breast-feed while taking Revlimid.

Possible side effects of Revlimid:

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:

Back pain; constipation; cough; diarrhea; dizziness; dry mouth or skin; headache; increased sweating or night sweats; loss of appetite; mild stomach pain; nausea; sluggishness; stuffy or runny nose; taste changes; tiredness; trouble sleeping; vomiting; weakness.

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

Severe allergic reactions (rash; hives; hoarseness; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stools or vomit; burning, numbness, or tingling; chest pain; confusion; dark urine; depression; difficulty swallowing; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; joint pain; muscle pain, weakness, or cramps; one-sided weakness; pain, numbness, tingling, tenderness, redness, or swelling of the arms or legs; painful or difficult urination; red, swollen, blistered, or peeling skin; reduces senses of touch; severe or persistent headache, dizziness, or stomach pain; severe tiredness or weakness; shortness of breath; slurred speech; swelling of the hands, ankles, or feet; tremor; unusual bruising or bleeding; vision problems.

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: Revlimid 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.

Proper storage of Revlimid:

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

General information:

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


• Revlimid 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 Revlimid. 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 Revlimid resources

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

• Revlimid Prescribing Information (FDA)


• Revlimid Consumer Overview


• Revlimid Monograph (AHFS DI)


• Revlimid Advanced Consumer (Micromedex) - Includes Dosage Information


• Lenalidomide Professional Patient Advice (Wolters Kluwer)

Compare Revlimid with other medications

• Anemia
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Flotac

Flotac may be available in the countries listed below.

Ingredient matches for Flotac

Diclofenac

Diclofenac resinate (a derivative of Diclofenac) is reported as an ingredient of Flotac in the following countries:

• Brazil


• Chile


• Colombia


• Mexico


• Peru


• Venezuela

International Drug Name Search

Siligas Tabletas

Siligas Tabletas may be available in the countries listed below.

Ingredient matches for Siligas Tabletas

Simeticone

Simeticone is reported as an ingredient of Siligas Tabletas in the following countries:

• Colombia

International Drug Name Search

Sterile Dopamine Concentrate BP Selectajet (International Medication Systems)

1. Name Of The Medicinal Product

Sterile Dopamine Concentrate BP Selectajet

2. Qualitative And Quantitative Composition

Dopamine Hydrochloride 40 mg/ml

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

For the correction of haemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicaemia, cardiac surgery, renal failure and chronic cardiac decompensation as in congestive failure.

4.2 Posology And Method Of Administration

Adults, elderly and children over 12 years old:

Begin infusion at between 1 - 5 mcg/kg/min. Increase dose by 1 - 5 mcg/kg/min, as required every 10 - 30 minutes, up to 20 - 50 mcg/kg/min. Most patients can be maintained at 20mcg/kg/min or less. Doses in excess of 50mcg/kg/min have been used in advanced states of circulatory decompensation.

Patients with severe refractory chronic congestive heart failure should be started on 0.5 - 2mcg/kg/min and the dose increased by 1 - 3 mcg/kg/min as urinary output increases.

ECG, blood pressure and urine output should be monitored. Cardiac output and pulmonary wedge pressure should be monitored if possible.

Children under 12 years:

The safety and efficacy of dopamine in children has not been established.

4.3 Contraindications

Dopamine should not be used in patients with phaeochromocytoma, uncorrected tachyarrhythmias, or ventricular fibrillation.

4.4 Special Warnings And Precautions For Use

Correct hypovolaemia, before administering dopamine if possible.

Administer dilute solution through as large a vein as possible, to minimise the risk of extravasation. A metering chamber or device should be used to accurately control dosage in drops/minute.

Dopamine infusion should be withdrawn gradually, to avoid unnecessary hypotension.

Patients with a history of occlusive vascular disease (e.g. atherosclerosis, arterial embolism, Raynaud's disease, cold injury, diabetic endarteritis and Buerger's disease) should be closely monitored for any changes in colour or temperature of the skin in the extremities. If ischaemia occurs and is thought to be the result of vasoconstriction, the benefits of continued dopamine infusion should be weighed against the risk of possible necrosis. This condition may be reversed by either decreasing the rate or discontinuing the infusion. IV administration of phentolamine mesylate 5-10 mg may reverse the ischaemia.

If excessive vasoconstriction (as indicated by a disproportionate rise in diastolic pressure and a marked decrease in pulse pressure) is observed, the infusion rate should be decreased or suspended and the patient observed closely.

As the effect of dopamine on impaired renal and hepatic function is not known, close monitoring is advised.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The action of dopamine is potentiated by monoamine oxidase inhibitors (MAOI's). In patients who have received MAOI's within the previous 2-3 weeks, the initial dopamine dose should be no greater than 10% of the usual dose.

The concurrent administration of dopamine in patients with a chronic use of selegiline (given for Parkinson disease) should be avoided.

The concurrent administration of cyclopropane or halogenated hydrocarbon anaesthetics may cause ventricular arrhythmias.

The cardiac effects of dopamine are antagonised by beta-adrenergic blocking agents such as propranolol and metoprolol.

The ergot alkaloids should be avoided because of the possibility of excessive vasoconstriction. Tricyclic antidepressants and guanethidine may potentiate the pressor response to dopamine.

Hypotension and bradycardia have been observed in patients receiving phenytoin.

Dopamine may increase the effect of diuretic agents.

Peripheral vasoconstriction may be antagonised by alpha-adrenergic blocking agents, such as phentolamine. Other vasodilators may also be useful in patients with heart failure, allowing greater inotropic and renal effects without the associated vasoconstriction. Care must be taken to avoid hypotension.

4.6 Pregnancy And Lactation

The use of any drug in pregnant women or women of child-bearing potential requires that the expected benefit be carefully weighed against the possible risk to mother and child. Animal studies have shown no evidence of teratogenic effect. It is not known whether dopamine crosses the placenta or enters breast milk.

4.7 Effects On Ability To Drive And Use Machines

This drug is intended for use in life threatening situations.

4.8 Undesirable Effects

Extravasation of dopamine into the tissues may cause local necrosis. The area should be infiltrated with 5-10mg phentolamine in 10-15mL saline.

The most frequent adverse reactions include ectopic beats, nausea, vomiting, tachycardia, anginal pain, palpitations, dyspnoea, headache, hypotension, hypertension and vasoconstriction. Other less frequent adverse reactions are aberrant ventricular conduction, bradycardia, piloerection, mydriasis, widened QRS complex, azotaemia, elevated blood pressure and diabetes insipidus. Peripheral ischaemic gangrene in patients with pre-existing vascular disease. Fatal ventricular arrhythmias have been reported on rare occasions.

4.9 Overdose

In case of accidental overdosage, as evidenced by excessive blood pressure elevation, reduce the rate of administration or temporarily discontinue dopamine until the patients condition stabilises. Since the duration of action of dopamine is quite short, no additional measures are usually necessary. If these measures fail to stabilise the patient's condition, use of the short-acting alpha- adrenergic blocking agent such as phentolamine should be considered.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code: C01CA 04; adrenergic and dopaminergic agents

Dopamine is a catecholamine. It is an agonist for specific dopamine receptors in the CNS, renal and other vascular beds (vasodilation) and for b₁ adrenoceptors in the heart (positive inotrope). At high doses it activates a-adrenoceptors (vasoconstriction).

5.2 Pharmacokinetic Properties

The half life of an iv bolus of dopamine is about 2 minutes, thus it is given by continuous infusion. Steady state is reached within 5 - 10 minutes. On termination of the infusion, dopamine is cleared from the plasma with a half life of about 9 minutes.

Dopamine is widely distributed throughout the body, but does not cross the blood/brain barrier. Dopamine like all catecholamines is metabolised by monoamine oxidase (MAO) and catechol-O-methyl transerase (COMT), in the liver, kidney and plasma. A small amount of unchanged drug plus its main metabolites, homovanillic acid ⁽HVA) and 3,4-dihydroxyphenyl acetic acid (DOPAC) are excreted in the urine.

5.3 Preclinical Safety Data

The LD₅₀ values for IV dopamine hydrochloride have been determined as 290 mg/kg in mice and 38.8 mg/kg in rats; the animals suffered massive internal bleeding and pulmonary congestion.

Subacute toxicity tests in rats revealed prostatic hypertrophy with associated bladder distension and hydronephrosis. In animals given higher doses (570 mg/kg daily) weights of heart, kidneys and lung were significantly higher than in controls, the weight of the spleen was significantly lower. Dogs given dopamine continuously for two weeks suffered intractable vomiting. Subsequent examination showed an increase in weight of the adrenal glands in all animals and an increase in weight of the prostate gland in dogs given the higher doses, some of which also had small areas of myocardial necrosis.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium bisulphite

Water for Injection

6.2 Incompatibilities

Do not add dopamine to any alkaline diluent solution e.g. sodium bicarbonate, since the drug is inactivated by these solutions.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C. Keep vial in the outer carton.

6.5 Nature And Contents Of Container

The solution is contained in a USP type I glass vial with an elastomeric closure which meets all the relevant USP specifications. The product is available as 5 ml, 10 ml and 20ml.

6.6 Special Precautions For Disposal And Other Handling

Dopamine must be diluted before use. Appropriate diluents include 5% dextrose, sodium chloride 0.9% or compound sodium lactate. Incompatible with sodium bicarbonate or any other alkali solution.

Dopamine is stable for about 24 hours in sodium chloride or dextrose. It should be used as soon as possible after mixing.

The container is specially designed for use with the IMS Select-A-Jet injector.

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

7. Marketing Authorisation Holder

International Medication Systems (UK) Ltd.

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

8. Marketing Authorisation Number(S)

PL 03265/0027

9. Date Of First Authorisation/Renewal Of The Authorisation

16^th July 1979 / 24^th August 2001

10. Date Of Revision Of The Text

Approved: March 2009

Antalyre

Antalyre may be available in the countries listed below.

Ingredient matches for Antalyre

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Antalyre in the following countries:

• France

International Drug Name Search

Captopril comp. AbZ

Captopril comp. AbZ may be available in the countries listed below.

Ingredient matches for Captopril comp. AbZ

Captopril

Captopril is reported as an ingredient of Captopril comp. AbZ in the following countries:

• Germany

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Captopril comp. AbZ in the following countries:

• Germany

International Drug Name Search

Sterile Potassium Chloride Concentrate 20% (hameln)

1. Name Of The Medicinal Product

Sterile Potassium Chloride Concentrate 20%.

2. Qualitative And Quantitative Composition

20% of Potassium Chloride in 5ml.

3. Pharmaceutical Form

Sterile Injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Sterile Potassium Chloride Concentrate 20% is used as a source of the potassium cation for the treatment or prevention of potassium depletion in patients for whom dietary measures or oral medication are inadequate. Potassium salts may also be used cautiously in those taking digoxin where potassium depletion may cause arrhythmias. Sterile Potassium Chloride Concentrate 20% must be administered by slow I.V, as a dilute solution.

4.2 Posology And Method Of Administration

Adults (including elderly) and Children:

Sterile Potassium Chloride Concentrate 20% must be diluted by adding to a large volume of intravenous fluid before use. For example, 10mls diluted with not less than 700mls 0.9% Sodium Chloride Intravenous Infusion BP, or other suitable diluent, and mixed well.

Dosage depends on the serum ionogram value and the acid-base state. A potassium deficiency is calculated according to the formula:

MMOL Potassium = KG BW x 0.2 x 2 x (4.5 – actual serum potassium (MMOL)).

(The extracellular volume is calculated from the body weight in kg x 0.2).

The maximum dosage is 20 MMOL potassium per hour.

It is recommended not to exceed 2-3 MMOL potassium per kg body weight in 24 hours.

4.3 Contraindications

Hyperkalaemia, hyperchloraemia, impaired renal function with oliguria, anuria or azotaemia, Addison's disease, acute dehydration and heat cramps.

4.4 Special Warnings And Precautions For Use

Sterile Potassium Chloride Concentrate 20% must not be injected undiluted.

Plasma potassium concentration must be measured at regular intervals to avoid the development of hyperkalaemia, especially in patients with renal impairment.

ECG monitoring facilities should be available.

Initial potassium replacement therapy should not involve glucose infusions, because glucose may cause a further decrease in the plasma potassium concentration.

Potassium supplements should be administered with caution in patients with cardiac disease and in patients who are receiving potassium sparing diuretics or other medications which may increase plasma potassium levels.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Potassium sparing diuretics:

Potassium supplements should not be administered with potassium- sparing diuretics (such as amiloride, spironolactone and triamterene), particularly in patients with impaired renal function. Any patients on this combination require close monitoring in order to diagnose a potential hyperkalaemic condition as soon as possible.

Angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists:

Patients taking ACE-inhibitors or angiotensin II receptor antagonists, especially those with impaired renal function, should be closely monitored, as the potassium sparing effect in combination with potassium infusion may result in hyperkalaemia.

Ciclosporin:

Concurrent use of ciclosporin may increase the risk of hyperkalaemia.

Glucose Infusion:

Concomitant use of glucose infusions in hypokalaemic patients may cause a further decrease in plasma potassium concentrations.

4.6 Pregnancy And Lactation

Sterile Potassium Chloride Concentrate 20%, may be used during pregnancy and lactation under the supervision of the prescribing physician.

4.7 Effects On Ability To Drive And Use Machines

Not known.

4.8 Undesirable Effects

Pain at the injection site and phlebitis may occur during IV administration of solutions containing 30 MMOL potassium or more per litre.

Hyperkalaemia is the most common and serious hazard of potassium therapy.

4.9 Overdose

Clinical signs and symptoms of potassium overdosage include: Paraesthesia of the extremities, listlessness, mental confusion, weakness or heaviness of the legs, flaccid paralysis, cold skin, grey pallor, peripheral vascular collapse, fall in blood pressure, cardiac arrhythmias and heart block. Extremely high plasma potassium concentrations (8-11 MMOL/litre) may cause death from cardiac depression, arrhythmias or arrest.

Cardiac arrhythmias or a serum concentration above 6.5 MMOL/litre, require immediate attention and may be treated by intravenous injection over 1-5 minutes of 10 – 20 ml of 10% Calcium Gluconate Injection B.P. with E.C.G. monitoring. Serum concentrations may be reduced by infusion of 300 – 500 mls per hour of 10%-25% glucose solutions containing up to 10 units of insulin for each 20 g of glucose, or by the infusion of sodium bicarbonate solution.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Potassium is the major cation of intracellular fluid and is essential for maintenance of acid-base balance, isotonicity and the electrodynamic characteristics of the cell. Potassium chloride is used as a source of the potassium cation for treatment or prevention of potassium depletion in patients in whom dietary measures are inadequate. Potassium chloride may also be used cautiously to abolish arrhythmias or cardiac glycoside toxicity precipitated by a loss of potassium.

5.2 Pharmacokinetic Properties

Potassium chloride is generally readily absorbed from the gastro-intestinal tract. Potassium is excreted mainly by the kidneys; it is secreted in the distal tubules which are also the site of sodium-potassium exchange. The capacity of the kidneys to conserve potassium is poor and urinary excretion of potassium continues even when there is severe depletion. Tubular secretion of potassium is influenced by several factors, including chloride ion concentration, hydrogen ion exchange, acid-base equilibrium and adrenal hormones. Some potassium is excreted in the faeces and small amounts may also be excreted in saliva, sweat, bile and pancreatic juice.

5.3 Preclinical Safety Data

No further information other than that which is included in the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Water for Injections Ph. Eur.

6.2 Incompatibilities

The compatibility of the large volume IV fluid intended for dilution should be checked before use.

6.3 Shelf Life

36 Months.

6.4 Special Precautions For Storage

Protect from light and store at less than 25°C.

6.5 Nature And Contents Of Container

5 and 10ml clear glass ampoules, hermetically sealed under flame at the gauging point. The ampoules are packed in cartons to contain 10 ampoules.

6.6 Special Precautions For Disposal And Other Handling

Use as directed by a physician.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

hameln pharmaceuticals ltd

Gloucester

UK

8. Marketing Authorisation Number(S)

PL 01502/0015R

9. Date Of First Authorisation/Renewal Of The Authorisation

30^th August 2001

10. Date Of Revision Of The Text

30/12/2008

Gineflor

Gineflor may be available in the countries listed below.

Ingredient matches for Gineflor

Ibuprofen

Ibuprofen isobutanolamine (a derivative of Ibuprofen) is reported as an ingredient of Gineflor in the following countries:

• Italy

International Drug Name Search

devil's claw

Generic Name: devil's claw (DEH vilz CLAW)

Brand Names:

What is devil's claw?

The use of devil's claw in cultural and traditional settings may differ from concepts accepted by current Western medicine. When considering the use of herbal supplements, consultation with a primary health care professional is advisable. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial, and coordination of treatment among all health care providers involved may be advantageous.

Devil's claw is also known as Harpagophytum procumbens, grapple plant, and wood spider.

Devil's claw has been used most commonly for rheumatism, arthritis, gout, muscle pain, and other degenerative disorders of the musculoskeletal system. Devil's claw has also been used orally for liver and gallbladder complaints, stomach complaints, loss of appetite, and pain relief and topically as an ointment for skin injuries and disorders.

Devil's claw has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of devil's claw may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. There have been instances where herbal/health supplements have been sold which were contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Devil's claw may also have uses other than those listed in this product guide.

What is the most important information I should know about devil's claw?

Do not take devil's claw without first talking to your doctor if you have a stomach or intestinal ulcer, diabetes, high or low blood pressure or other heart problems, or if you are taking any medicines to prevent or treat these conditions.

Devil's claw has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of devil's claw may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. There have been instances where herbal/health supplements have been sold which were contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

What should I discuss with my healthcare provider before taking devil's claw?

Do not take devil's claw without first talking to your doctor if you have a stomach or intestinal ulcer, diabetes, high or low blood pressure or other heart problems, or if you are taking any medicines to prevent or treat these conditions.

Before taking devil's claw, talk to your doctor, pharmacist, or health care professional if you have allergies (especially to plants), have any medical condition, or if you take other medicines or other herbal/health supplements. Devil's claw may not be recommended in some situations.

Do not take devil's claw without first talking to your doctor if you are pregnant or could become pregnant. It is not known whether devil's claw will be harmful an unborn baby. Do not take devil's claw without first talking to your doctor if you are breast-feeding a baby. It is not known whether devil's claw will be harmful a nursing infant. There is no information available regarding the use of devil's claw by children. Do not give any herbal/health supplement to a child without first talking to the child's doctor.

How should I take devil's claw?

The use of devil's claw in cultural and traditional settings may differ from concepts accepted by current Western medicine. When considering the use of herbal supplements, consultation with a primary health care professional is advisable. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial, and coordination of treatment among all health care providers involved may be advantageous.

If you choose to take devil's claw, use it as directed on the package or as directed by your doctor, pharmacist, or other health care provider.

Standardized extracts, tinctures, and solid formulations of herbal/health supplements may provide a more reliable dose of the product.

Take the pill forms of devil's claw with a full glass of water.

To ensure the correct dose, measure the liquid forms of devil's claw with a dropper or a dose-measuring spoon or cup.

Some forms of devil's claw can be brewed to form a tea for drinking.

Topical forms of devil's claw are intended for external use only. Do not use different formulations (e.g., tablets, liquids, teas, and others) of devil's claw at the same time, unless specifically directed to do so by a health care professional. Using different formulations together increases the risk of an overdose of devil's claw.

Store devil's claw as directed on the package. In general, devil's claw should be protected from light.

What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra devil's claw 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.

What should I avoid while taking devil's claw?

Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.

Devil's claw side effects

Although rare, allergic reactions to devil's claw may occur. Stop taking devil's claw and seek emergency medical attention if you experience symptoms of a serious allergic reaction including difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives.

Other less serious side effects have also been reported infrequently. Talk to your doctor, pharmacist, or health care provider if you experience

• 
  

  headache,

  
  


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  ringing in the ears,

  
  


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  loss of appetite, or

  
  


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  loss of taste.

  
  

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 devil's claw?

Interactions between devil's claw and other prescription or over-the-counter medicines or herbal/health supplements have not been reported. Talk to your doctor, pharmacist, or health care professional before taking devil's claw if you are taking any other medicines, vitamins, minerals, or supplements.

More devil's claw resources

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

• Devil's Claw Natural MedFacts for Professionals (Wolters Kluwer)


• Devil's Claw Natural MedFacts for Consumers (Wolters Kluwer)


• Devil's Claw MedFacts Consumer Leaflet (Wolters Kluwer)

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Where can I get more information?

• Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

See also: devil's claw side effects (in more detail)

Tocainide

In the US, Tocainide (tocainide systemic) is a member of the drug class group I antiarrhythmics and is used to treat Arrhythmia.

US matches:

• Tocainide

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

C01BB03

CAS registry number (Chemical Abstracts Service)

0041708-72-9

Chemical Formula

C11-H16-N2-O

Molecular Weight

192

Therapeutic Category

Antiarrhythmic agent

Chemical Name

Propanamide, 2-amino-N-(2,6-dimethylphenyl)-

Foreign Names

• Tocainidum (Latin)
• Tocainid (German)
• Tocaïnide (French)
• Tocainida (Spanish)

Generic Names

• Tocainide (OS: BAN, USAN)
• Tocainide Hydrochloride (OS: BANM)
• APX (IS)
• W 36095 (IS)
• Tocainide Hydrochloride (PH: USP 32)

Brand Name

• Tocainide Yimin Pharm
  Yimin, China

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Insulin Resistance Syndrome (Metabolic Syndrome) Medications

Definition of Insulin Resistance Syndrome: Many people with noninsulin-dependent diabetes produce enough insulin, but their bodies do not respond to the action of insulin. This may happen because the person is overweight and has too many fat cells, which do not respond well to insulin. Also, as people age, their body cells lose some of the ability to respond to insulin. Insulin resistance is also linked to high blood pressure and high levels of fat in the blood. Another kind of insulin resistance may happen in some people who take insulin injections. They may have to take very high doses of insulin every day

Drugs associated with Insulin Resistance Syndrome

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

See sub-topics

Topics under Insulin Resistance Syndrome

• Glucagonoma (2 drugs)

Learn more about Insulin Resistance Syndrome (Metabolic Syndrome)

Medical Encyclopedia:

• Metabolic syndrome

Drug List:

Fortomet-Extended-Release-Tablets

Glucophage

Glucophage-Xr-Extended-Release-Tablets

Glumetza

Humulin-R

Humulin-R-Concentrated

Iletin-Ii-Regular-Pork

Insulin-Purified-Regular-Pork

Novolin-R

Novolin-R-Innolet

Novolin-R-Penfill

Relion-Novolin-R

Riomet

Velosulin-Br