Nicorette Citrus 4mg Gum

1. Name Of The Medicinal Product

Nicorette^® Citrus 4 mg Gum

2. Qualitative And Quantitative Composition

Chewing Gum containing 4 mg nicotine

3. Pharmaceutical Form

Chewing Gum

4. Clinical Particulars

4.1 Therapeutic Indications

Nicorette Citrus 4 mg Gum is for the relief of nicotine withdrawal symptoms as an aid to smoking cessation.

4.2 Posology And Method Of Administration

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

Adults

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

The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Not more than 15 pieces of the chewing gum may be used each day. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.

• Smoking should be stopped completely.

• Nicorette Citrus 4 mg Gum should be chewed as directed whenever there is an urge to smoke to maintain complete abstinence from smoking.

• Sufficient gums should be used each day, usually 8-12, up to a maximum of 15.

• Continue use for up to three months to break the habit of smoking, then gradually reduce gum use. When daily use is 1-2 gums, use should be stopped. Any spare gum should be retained, as craving may suddenly return.

• For those using the 4 mg nicotine gum, the 2 mg nicotine gum will be helpful during withdrawal from treatment.

Children

Not for use by persons under age 18 except on the advice of a doctor.

4.3 Contraindications

Nicotine in any form is contra-indicated in pregnancy and lactation (see section 4.6).

4.4 Special Warnings And Precautions For Use

Smokers who wear dentures may experience difficulty in chewing Nicorette Citrus 4 mg Gum.

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

Swallowed nicotine may exacerbate symptoms in patients suffering from gastritis or peptic ulcers.

Allergic reactions such as angioedema and urticaria and ulcerative stomatitis have been reported.

The cardiovascular effects of nicotine may be deleterious to patients with a history of cardiovascular disease (especially angina, cardiac arrhythmias or a myocardial infarction within the last 3 months). Nicorette Citrus 4 mg Gum presents a lesser hazard, however, than smoking, which introduces carbon monoxide as an additional toxic factor.

Nicotine gum should be used with caution in patients with diabetes mellitus, hyperthyroidism or pheochromocytoma, since nicotine causes the release of catecholamines from the adrenal medulla.

The label will state 'Not for use by persons under age 18 except on the advice of a doctor.'

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Nicorette crosses the placenta and is excreted in breast milk; thus it may be a hazard to the foetus or infant.

Patients should be advised to give up smoking without the use of nicotine replacement therapy. Should this fail medical assessment of the risk/benefit ratio of nicotine gum use should be made

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Nicorette Citrus 4 mg Gum in the recommended dose has not been found to cause any serious adverse effects. Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation. Excessive swallowing of dissolved nicotine may, at first, cause hiccuping.

Excessive consumption of Nicorette Citrus 4 mg Gum by patients who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches (as may be experienced by such a patient if tobacco is inhaled).

Common (>1/100)	CNS:	Dizziness, headache
Gastro-intestinal:	Nausea, gastro-intestinal discomfort, hiccups
Local:	Sore mouth or throat. Jaw muscle ache. The gum may stick to, and may, in rare cases damage dentures
Uncommon (1/100-1/1000)	Circulatory:	Palpitation
Dermatological:	Erythema, urticaria
Local:	Stomatitis
Rare (<1/1000)	Cardiovascular:	Atrial fibrillation
Other:	Allergic reactions such as angioedema

Some symptoms, such as dizziness, headache and sleep disturbances may be related to withdrawal symptoms associated with abstinence from smoking. Increased frequency of aphthous ulcer may occur after abstinence from smoking.

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

4.9 Overdose

Overdosage may occur if many gums are taken simultaneously or in rapid succession. The consequences of an overdose are most likely to be minimised by the early nausea and vomiting known to occur with excessive nicotine intake. Nicotine is also subject to a significant first-pass metabolism.

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

Management of an overdose

All nicotine intake should cease immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

5.2 Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Chewing gum base

Xylitol

Sodium carbonate, anhydrous

Blood orange flavour

Magnesium oxide, light

Quinoline yellow (E104)

Talcum

Nitrogen, food grade

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 30^oC

6.5 Nature And Contents Of Container

Blister packed strips each containing 15 pieces supplied in packs of 15, 30 and 105 pieces. Pack containing blister strip of 6 pieces

6.6 Special Precautions For Disposal And Other Handling

See section 4.2

7. Marketing Authorisation Holder

Pharmacia Limited.

Davy Avenue

Milton Keynes

MK5 8PH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00032/0295

9. Date Of First Authorisation/Renewal Of The Authorisation

1 May 2001 / 1^st January 2002

10. Date Of Revision Of The Text

8 March 2002

Legal Category

GSL.

chloramphenicol/polymyxin B and hydrocortisone ophthalmic

Generic Name: chloramphenicol/polymyxin B and hydrocortisone ophthalmic (klor am FEN i kole, paw lee MIX in and hye droe KOR ti sone)

Brand Names: Ophthocort

What is chloramphenicol/polymyxin B and hydrocortisone ophthalmic?

Chloramphenicol and polymyxin B are antibiotics. They are used to treat bacterial infections.

Hydrocortisone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.

Chloramphenicol/polymyxin B and hydrocortisone ophthalmic is used to treat bacterial infections of the eyes.

Chloramphenicol/polymyxin B and hydrocortisone ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about chloramphenicol/polymyxin B and hydrocortisone ophthalmic?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the tube opening to any surface, including your eyes or hands. The tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Who should not use chloramphenicol/polymyxin B and hydrocortisone ophthalmic?

Do not use chloramphenicol/polymyxin B and hydrocortisone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only. It is not known whether chloramphenicol/polymyxin B and hydrocortisone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is not known whether chloramphenicol/polymyxin B and hydrocortisone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use chloramphenicol/polymyxin B and hydrocortisone ophthalmic?

Use chloramphenicol, polymyxin B, and hydrocortisone ophthalmic ointment exactly as directed by your doctor.

Wash your hands before and after using your ointment.

To apply the ointment:

• 
  

  Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.

  
  

Do not touch the tube opening to any surface, including your eyes or hands. The tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Store chloramphenicol/polymyxin B and hydrocortisone ophthalmic at room temperature away from moisture and heat. Keep the tube properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the ointment has been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using chloramphenicol/polymyxin B and hydrocortisone ophthalmic?

Do not touch the tube opening to any surface, including your eyes or hands. The tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Chloramphenicol/polymyxin B and hydrocortisone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

Chloramphenicol/polymyxin B and hydrocortisone ophthalmic side effects

Serious side effects are not expected with this medication. Rarely, prolonged use of chloramphenicol medications has damaged bone marrow. Call your doctor if you experience extreme fatigue or unusual bleeding or bruising.

More commonly, some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur. Continue to use chloramphenicol/polymyxin B and hydrocortisone ophthalmic and talk to your doctor about any side effects you experience.

What other drugs will affect chloramphenicol/polymyxin B and hydrocortisone ophthalmic?

Avoid other eye medications unless they are approved by your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).

Drugs other than those listed here may also interact with chloramphenicol/polymyxin B and hydrocortisone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More chloramphenicol/polymyxin B and hydrocortisone ophthalmic resources

• Chloramphenicol/polymyxin B and hydrocortisone ophthalmic Drug Interactions
• Chloramphenicol/polymyxin B and hydrocortisone ophthalmic Support Group
• 0 Reviews for Chloramphenicol/polymyxin B and hydrocortisone - Add your own review/rating

Compare chloramphenicol/polymyxin B and hydrocortisone ophthalmic with other medications

• Conjunctivitis, Bacterial

Where can I get more information?

• Your pharmacist has additional information about chloramphenicol/polymyxin B and hydrocortisone ophthalmic written for health professionals that you may read.

What does my medication look like?

Chloramphenicol/polymyxin B and hydrocortisone ophthalmic is available with a prescription under the brand name Ophthocort in an ointment formulation. Other brand or generic formulations of this medication may also be available. Ask your pharmacist any questions you have about this medication, especially if it is unfamiliar to you.

Cetirizine Tablets

Dosage Form: tablet
Cetirizine Hydrochloride Tablets

Drug Facts:

Active ingredient (in each tablet)  

Cetirizine HCl 5 mg

Purpose: Antihistamine

Uses

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

• trouble swallowing


• dizziness or loss of consciousness


• swelling of tongue


• trouble speaking


• swelling in or around mouth


• drooling


• wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

   • to prevent hives from any known cause such as:

• foods


• insect stings


• medicines


• latex or rubber gloves

because this product will not stop hives from occuring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

• liver or kidney disease. Your doctor should determine if you need a different dose.


• hives that are an unusual color, look bruised or blistered


• hives that do not itch

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

• drowsiness may occur


• avoid alcoholic drinks


• alcohol, sedatives, and tranquilizers may increase drowsiness


• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• an allergic reaction to this product occurs. Seek medical help right away.


• symptoms do not improve after 3 days of treatment


• the hives have lasted more than 6 weeks

If pregnant or breast-feeding:

• If breast-feeding: not recommended


• If pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 6 years and over	1 to 2 tablets once daily depending upon   severity of symptoms; do not take more than   2 tablets in 24 hours.
adults 65 years and over	1 tablet once a day; do not take more than 1   tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

• store between 20° to 25°C (68° to 77°F)

Inactive ingredients colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

call 1-269-544-2299 weekdays

Manufactured by :

TORRENT PHARMACEUTICALS LTD.

Indrad-382 721, Dist. Mehsana, INDIA.

PRINCIPAL DISPLAY PANEL

NDC 13668-029-04

Cetirizine HCl Tablets 5 mg

Antihistamine

Hives Relief

24 Hour Relief of Itching Due to Hives

500 Tablets 5 mg each

Tamper Evident:

Do not use if imprinted inner safety seal is torn or missing.

CETIRIZINE HYDROCHLORIDE   cetirizine hydrochloride  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 13668-029 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE   STARCH, CORN   HYPROMELLOSE 2910 (6 CPS)   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   POLYETHYLENE GLYCOL 400   POVIDONE K30   TALC   TITANIUM DIOXIDE

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (rounded-off,rectangular shaped, film coated tablet) Size 7mm Flavor Imprint Code 5;29 Contains

Packaging # NDC Package Description Multilevel Packaging 1 13668-029-06 30 TABLET In 1 BOTTLE None 2 13668-029-02 100 TABLET In 1 BOTTLE None 3 13668-029-03 250 TABLET In 1 BOTTLE None 4 13668-029-04 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079191	04/15/2010

Labeler - Torrent Pharmaceuticals Limited (916488547)

Revised: 07/2010Torrent Pharmaceuticals Limited

More Cetirizine Tablets resources

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

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• Hay Fever
• Urticaria

Profen LA

Generic Name: guaifenesin and phenylpropanolamine (gwye FEN e sin/fen ill proe pa NOLE a meen)

Brand Names: Ami-Tex LA, Banex-LA, Coldloc-LA, Dayquil Sinus Pressure and Congestion, Despec, Entex LA, Exgest LA, G-Vent, Guaifenex PPA 75, Guaivent, Guiatex LA, Naldecon-EX Pediatric, Nasahist LA, Phentex-LA, Phenylfenesin LA, Poly-Vent, Profen LA, Stamoist LA, Triaminic Expectorant, Vanex-LA

What is Profen LA (guaifenesin and phenylpropanolamine)?

Guaifenesin is an expectorant. It is used to break up congestion and mucous to make breathing easier. Guaifenesin thins mucous, increases lubrication of the respiratory tract (lungs, nose and throat), and increases the removal of mucous.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries), which reduces swelling of mucous membranes in areas such as the nose and sinuses.

Guaifenesin and phenylpropanolamine is used to treat the symptoms of the common cold and of infections of the sinuses, lungs, and throat.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Guaifenesin and phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Profen LA (guaifenesin and phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Drink plenty of extra fluids while taking this medication. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed.

Who should not take Profen LA (guaifenesin and phenylpropanolamine)?

Do not take guaifenesin and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  high blood pressure or any other type of heart disease,

  
  


• 
  

  diabetes,

  
  


• 
  

  a peripheral vascular disorder (poor circulation),

  
  


• 
  

  glaucoma or increased pressure in the eyes,

  
  


• 
  

  an overactive thyroid, or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

You may not be able to take guaifenesin and phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Guaifenesin and phenylpropanolamine is in the FDA pregnancy category C. This means that it is not known whether guaifenesin and phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from guaifenesin and phenylpropanolamine. You may require a lower dose of this medication. Guaifenesin and phenylpropanolamine has not been approved for use by children younger than 6 years of age.

How should I take Profen LA (guaifenesin and phenylpropanolamine)?

Take guaifenesin and phenylpropanolamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Increasing fluid intake during the day may help relieve congestion. Take guaifenesin and phenylpropanolamine with food if it causes stomach upset. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed. Store guaifenesin and phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a guaifenesin and phenylpropanolamine overdose include vomiting, high blood pressure (headache, redness of face, blurred vision), an irregular heartbeat, and numbness of the fingers or toes.

What should I avoid while taking Profen LA (guaifenesin and phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Guaifenesin and phenylpropanolamine may cause dizziness. If you experience dizziness, avoid these activities.

Profen LA (guaifenesin and phenylpropanolamine) side effects

No serious side effects from guaifenesin and phenylpropanolamine are expected. Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take guaifenesin and phenylpropanolamine and talk to your doctor if you experience

• 
  

  dizziness or headache;

  
  


• 
  

  nervousness, restlessness, or insomnia;

  
  


• 
  

  nausea or stomach upset; or

  
  


• 
  

  difficulty urinating.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Profen LA (guaifenesin and phenylpropanolamine)?

Do not take guaifenesin and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Heart medications such as methyldopa (Aldomet), reserpine (Serpalan, Serpasil), and guanethidine (Ismelin) may have decreased effects. Talk to your doctor before taking guaifenesin and phenylpropanolamine if you are taking any of these medications.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking guaifenesin and phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain guaifenesin, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Drugs other than those listed here may also interact with guaifenesin and phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Profen LA resources

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

Compare Profen LA with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist has additional information about guaifenesin and phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Guaifenesin and phenylpropanolamine is available with a prescription under several brand names. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 
  

  Entex LA, 400 mg of guaifenesin and 75 mg of phenylpropanolamine--orange, scored tablets

  
  


• 
  

  Exgest LA, 400 mg of guaifenesin and 75 mg of phenylpropanolamine--white, oval-shaped, scored, long-acting tablets with blue speckles

  
  


• 
  

  Dura-Vent, 600 mg of guaifenesin and 75 mg of phenylpropanolamine--white, scored tablets

  
  

See also: Profen LA side effects (in more detail)

Sotalol Hydrochloride AF

Generic Name: sotalol AF (SO tuh lol AF)

Brand Names: Betapace AF, Sotalol Hydrochloride AF

What is Sotalol Hydrochloride AF (sotalol AF)?

Sotalol AF is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Sotalol AF is used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Sotalol AF is used in people with atrial fibrillation or atrial flutter.

Another form of this medicine, called sotalol, is used to treat heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Sotalol is used in people with ventricular tachycardia or ventricular fibrillation. Sotalol (Betapace and Sorine) is not used for the same conditions that sotalol AF (Betapace AF) is used for.

Sotalol AF may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sotalol Hydrochloride AF (sotalol AF)?

You should not use this medication if you are allergic to sotalol AF, or if you have asthma, certain serious heart conditions, a history of "Long QT syndrome," severe kidney disease, low levels of potassium in your blood, or uncontrolled congestive heart failure.

Before taking sotalol AF, tell your doctor if you have breathing problems, a history of heart disease or congestive heart failure, diabetes, kidney disease, a thyroid disorder, an electrolyte imbalance, or if you have recently had a heart attack.

Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

You will receive your first few doses of sotalol AF in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Do not skip doses or stop taking sotalol AF without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using sotalol AF. You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before taking Sotalol Hydrochloride AF (sotalol AF)?

Do not use this medication if you are allergic to sotalol AF, or if you have:

• 
  

  asthma;

  
  


• 
  

  certain heart conditions, especially "AV block" or "sick sinus syndrome" (unless you have a pacemaker);

  
  


• 
  

  a history of "Long QT syndrome";

  
  


• 
  

  severe kidney disease;

  
  


• 
  

  low levels of potassium in your blood (hypokalemia); or

  
  


• 
  

  severe or uncontrolled congestive heart failure.

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take sotalol AF:

• 
  

  breathing problems such as bronchitis or emphysema;

  
  


• 
  

  a history of heart disease or congestive heart failure;

  
  


• 
  

  diabetes;

  
  


• 
  

  kidney disease;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  an electrolyte imbalance such as low levels of potassium or magnesium in your blood; or

  
  


• 
  

  if you have recently had a heart attack.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Sotalol AF can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Sotalol Hydrochloride AF (sotalol AF)?

You will receive your first few doses of sotalol AF in a hospital setting where your heart can be monitored, in case the medication causes serious side effects.

Sotalol AF comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take sotalol AF exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Take this medication with a full glass of water.

Take sotalol AF at the same time every day.

Do not skip doses or stop taking sotalol AF without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Your heart and kidney function will also need to be tested. Do not miss any follow-up visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using sotalol AF.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using sotalol AF. You may need to stop using the medicine for a short time.

Store sotalol AF at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Call your doctor if you miss more than two doses of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include swelling, hunger, weakness, confusion, sweating, slow or fast heartbeats, chest pain, feeling short of breath, fainting, and seizure (convulsions).

What should I avoid while taking Sotalol Hydrochloride AF (sotalol AF)?

Do not take an antacid within 2 hours before or after taking sotalol AF. Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb sotalol AF.

Sotalol Hydrochloride AF (sotalol AF) 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. Call your doctor at once if you have any of these serious side effects:

• 
  

  fast or pounding heartbeat, chest pain, shortness of breath;

  
  


• 
  

  feeling light-headed, fainting;

  
  


• 
  

  slow heartbeat;

  
  


• 
  

  unusual sweating, increased thirst; or

  
  


• 
  

  swelling, rapid weight gain.

  
  

Less serious side effects may include:

• 
  

  mild diarrhea, nausea, vomiting;

  
  


• 
  

  headache;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  tired feeling.

  
  

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 Sotalol Hydrochloride AF (sotalol AF)?

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

• 
  

  clonidine (Catapres);

  
  


• 
  

  digoxin (digitalis, Digitek, Lanoxicaps, Lanoxin);

  
  


• 
  

  reserpine;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  drugs that can affect heart rhythm, such as cisapride (Propulsid), droperidol (Inapsine), methadone (Methadose), pentamidine (NebuPent, Pentam);

  
  


• 
  

  any other heart rhythm medications, especially amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan), quinidine (Cardioquin, Quinaglute), sotalol (Betapace);

  
  


• 
  

  antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), telithromycin (Ketek);

  
  


• 
  

  medicines to treat psychiatric disorder, such as pimozide (Orap), haloperidol (Haldol), thioridazine (Mellaril);

  
  


• 
  

  a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), and others;

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others;

  
  


• 
  

  a diabetes medication such as insulin, glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), metformin (Glucophage);

  
  


• 
  

  a calcium channel blocker such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

  
  


• 
  

  medicine for asthma or other breathing disorders, such as albuterol (Ventolin, Proventil), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Theo-Dur, Theolair).

  
  

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

More Sotalol Hydrochloride AF resources

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

• Sotalol Prescribing Information (FDA)


• Betapace Prescribing Information (FDA)


• Betapace MedFacts Consumer Leaflet (Wolters Kluwer)


• Betapace Advanced Consumer (Micromedex) - Includes Dosage Information


• Betapace AF Prescribing Information (FDA)


• Betapace AF MedFacts Consumer Leaflet (Wolters Kluwer)


• Sorine Prescribing Information (FDA)


• Sotalol Hydrochloride Monograph (AHFS DI)

Compare Sotalol Hydrochloride AF with other medications

• Atrial Fibrillation
• Atrial Flutter

Where can I get more information?

• Your pharmacist can provide more information about sotalol AF.

See also: Sotalol Hydrochloride AF side effects (in more detail)

Cortisporin-TC otic

Generic Name: colistin, hydrocortisone, neomycin, and thonzonium (otic) (koe LIS tin, HYE droe KOR ti sone, NEE oh MYE sin, thon ZOE nee um)

Brand Names: Coly Mycin S, Coly-Mycin S, Cortisporin-TC

What is colistin, hydrocortisone, neomycin, and thonzonium?

Colistin and neomycin are antibiotics that fight bacteria.

Hydrocortisone is in a class of drugs called steroids. Hydrocortisone prevents the release of substances in the body that cause inflammation.

Thonzonium is a wetting agent.

The combination of colistin, hydrocortisone, neomycin, and thonzonium otic (for the ears) is used to treat ear infections caused by bacteria.

This medication will not treat a viral infection such as herpes or shingles.

Colistin, hydrocortisone, neomycin, and thonzonium otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about colistin, hydrocortisone, neomycin, and thonzonium?

You should not use colistin, hydrocortisone, neomycin, and thonzonium if you are allergic to any of the drugs contained in this combination, or if you have a ruptured ear drum..

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing. Stop using this medication and call your doctor at once if you have a skin rash, redness, swelling, itching, dryness, or scaling.

What should I discuss with my health care provider before using colistin, hydrocortisone, neomycin, and thonzonium?

You should not use colistin, hydrocortisone, neomycin, and thonzonium if you are allergic to any of the drugs contained in this combination, or if you have a ruptured ear drum.. FDA pregnancy category C. It is not known whether colistin, hydrocortisone, neomycin, and thonzonium ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydrocortisone and colistin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use colistin, hydrocortisone, neomycin, and thonzonium?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Before using this medication, clean and dry your ear canal with sterile cotton.

Shake the ear drops well just before you measure a dose.

The usual dose of this medication is 5 drops into the affected ear every 6 to 8 hours. If you are using this medicine on a child, use only 4 drops per affected ear.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes.

As an alternative to dropping the medicine into your ear, you may insert a small piece of cotton into the ear canal and then drop the medicine directly onto the cotton to soak it. Leave the cotton in the ear and keep it moist by adding more of the medication every 4 hours. Replace the cotton at least every 24 hours. Follow your doctor's instructions about the use of cotton with this medication.

Wipe the ear dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include hearing problems, or urinating less than usual.

What should I avoid while using colistin, hydrocortisone, neomycin, and thonzonium?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using this medication.

Colistin, hydrocortisone, neomycin, and thonzonium 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:

• 
  

  skin rash, redness, swelling, itching, dryness, or scaling;

  
  


• 
  

  hearing loss; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

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

What other drugs will affect colistin, hydrocortisone, neomycin, and thonzonium?

There may be other drugs that can interact with colistin, hydrocortisone, neomycin, and thonzonium. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Cortisporin-TC resources

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

Compare Cortisporin-TC with other medications

• Acute Otitis Externa
• Chronic Otitis Media
• Otitis Externa
• Otitis Media

Where can I get more information?

• Your pharmacist can provide more information about colistin, hydrocortisone, neomycin, and thonzonium otic.

See also: Cortisporin-TC side effects (in more detail)

Amisulpride 200mg tablets

1. Name Of The Medicinal Product

Amisulpride 200mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 200mg Amisulpride

3. Pharmaceutical Form

Tablet

White to off-white round tablets with break line on one side and 'MAM 200' on other.

4. Clinical Particulars

4.1 Therapeutic Indications

Amisulpride 200mg Tablets are indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.

4.2 Posology And Method Of Administration

For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used. No specific titration is required when initiating the treatment with amisulpride. Doses should be adjusted according to individual response.

For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms.

Maintenance treatment should be established individually with the minimally effective dose.

For patients characterised by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually.

Amisulpride can be administered once daily at oral doses up to 300 mg, higher doses should be administered bid.

Elderly:

Amisulpride should be used with particular caution because of a possible risk of hypotension or sedation.

Children:

Amisulpride is contra-indicated in children under 15 years of age as its safety has not yet been established.

Renal insufficiency:

Amisulpride is eliminated by the renal route. In renal insufficiency, the dose should be reduced to half in patients with creatinine clearance (CR_CL) between 30-60 ml/min and to a third in patients with CR_CL between 10-30 ml/min.

As there is no experience in patients with severe renal impairment (CR_CL < 10 ml/min) particular care is recommended in these patients.

Hepatic insufficiency:

Since the drug is weakly metabolised a dosage reduction should not be necessary.

4.3 Contraindications

• Hypersensitivity to the active ingredient or to other ingredients of the drug

• Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer

• Phaeochromocytoma

• Children under 15 years of age

• Pregnancy or lactation

• Women of childbearing potential unless using adequate contraception

• Combination with the following medication which could induce torsades de pointes:

- Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide#

- Class III antiarrhythmic agents such as amiodarone, sotalol

- Other medications such as bepridil, cisapride, sultopride, thioridazine, IV erythromycin, IV vincamine, Halofantrine, pentamidine, sparfloxacin

This list is not exhaustive

• Combination with levodopa

4.4 Special Warnings And Precautions For Use

As with other neuroleptics, Neuroleptic Malignant Syndrome, characterized by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated CPK, may occur. In the event of hyperthermia, particularly with high daily doses, all antipsychotic drugs including Amisulpride should be discontinued.

Amisulpride is eliminated by the renal route. In cases of severe renal insufficiency, the dose should be decreased and intermittent treatment should be considered (see 4.2 Posology and method of administration).

Amisulpride may lower the seizure threshold. Therefore patients with a history of epilepsy should be closely monitored during Amisulpride therapy.

In elderly patients, Amisulpride, like other neuroleptics, should be used with particular caution because of a possible risk of hypotension or sedation.

As with other antidopaminergic agents, caution should be also exercised when prescribing Amisulpride to patients with Parkinson's disease since it may cause worsening of the disease. Amisulpride should be used only if neuroleptic treatment cannot be avoided.

Acute withdrawal symptoms including nausea, vomiting and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisa, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal is advisable.

Prolongation of the QT interval

Amisulpride induces a dose-dependent prolongation of the QT interval. This effect, known to potentiate the risk of serious ventricular arrhythmias such as torsades de pointes is enhanced by the pre-existence of bradycardia, hypokalaemia, congenital or acquired long QT interval.

Hypokalaemia should be corrected.

Before any administration, and if possible according to the patient's clinical status, it is recommended to monitor factors which could favour the occurrence of this rhythm disorder:

- bradycardia less than 55 bpm,

- hypokalaemia,

- congenital prolongation of the QT interval.

- on-going treatment with a medication likely to produce pronounced bradycardia (< 55 bpm), hypokalaemia, decreased intracardiac conduction, or prolongation of the QTc interval (see 4.5 Interaction with other medicinal products and other forms of interaction).

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Amisulpride and preventive measures undertaken

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

COMBINATIONS WHICH ARE CONTRAINDICATED

Medications which could induce torsades de pointes:

- Class Ia antiarrhythmic agents such as quinidine, dispyramide, procainamide

- Class III antiarrhythmic agents such as amiodarone, sotalol

- Other medications such as bepridil, cisapride, sultopride, thioridazine, IV erythromycin, IV vincamine, Halofantrine, pentamidine, sparfloxacin

This list is not exhaustive

Levodopa: reciprocal antagonism of effects between levodopa and neuroleptics.

COMBINATIONS WHICH ARE NOT RECOMMENDED

Amusulpride may enhance the central effects of alcohol

COMBINATIONS WHICH REQUIRE PRECAUTIONS FOR USE

Medications which enhance the risk of torsades de pointes:

- Bradycardia-inducing medications such as beta-blockers, bradycardia-inducing calcium channel blockers such as diltiazem and verapamil, clonidine, guanfacine; digitalis

- Medications which induce hypokalaemia: hypokalaemic diuretics, stimulant laxatives, IV amphotericin B, glucocortocoids, tetracosactides

- Neuroleptics such as pimozide, haloperidon; imipramine, antidepressants; lithium

COMBINATIONS TO BE TAKEN INTO ACCOUNT

CNS depressants including narcotics, anaesthetics, analgesics, sedative H1 antihistamines, barbiturates, benzodiazepines and other anxiolytic drugs, clonidine and derivatives

Antihypertensive drugs and other hypotensive medications

Dopamine agonists (eg: levodopa) since it may attenuate their action

4.6 Pregnancy And Lactation

Neonates exposed to antipsychotics including Amisulpride tablets during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.

4.7 Effects On Ability To Drive And Use Machines

Even used as recommended, amisulpride may affect reaction time so that the ability to drive vehicles or operate machinery can be impaired.

4.8 Undesirable Effects

The following adverse effects have been observed in controlled clinical trials. It should be noted that in some instances it can be difficult to differentiate adverse events from symptoms of the underlying disease.

Common adverse effects (5-10 %):

insomnia, anxiety, agitation

Less common adverse effects (0.1-5 %):

somnolence

gastrointestinal disorders such as constipation, nausea, vomiting, dry mouth.

In common with other neuroleptics:

Amisulpride causes an increase in plasma prolactin levels which is reversible after drug discontinuation. This may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, orgasmic dysfunction and impotence.

Weight gain may occur under therapy with amisulpride.

Acute dystonia (spasm torticolis, oculogyric crisis, trismus) may appear. This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent.

Extrapyramidal symptoms may occur: tremor, rigidity, hypokinesia, hypersalivation, akathisia. These symptoms are generally mild at optimal dosages and partially reversible without discontinuation of amisulpride upon administration of antiparkinsonian medication.

The incidence of extrapyramidal symptoms which is dose related, remains very low in the treatment of patients with predominantly negative symptoms with doses of 50-300mg/day.

Tardive dyskinesia characterised by rhythmic, involuntary movements primarily of the tongue and/or face have been reported, usually after long term administration.

Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms.

Hypotension and bradycardia have been reported occasionally.

Cases of QT prolongation and very rare cases of torsades de pointes have been reported.

Allergic reactions, elevation of hepatic enzymes, mainly transaminases and cases of seizures have been very rarely reported.

Very rare cases of Neuroleptic Malignant Syndrome have been reported (see special warnings and special precautions for use).

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown

Pregnancy, puerperium and perinatal conditions:

Drug withdrawal syndrome neonatal (see 4.6) / not known

4.9 Overdose

Experience with amisulpride in overdosage is limited. Exaggeration of the known pharmacological effects of the drug have been reported. These include drowsiness and sedation, coma, hypotension and extrapyramidal symptoms.

In cases of acute overdosage, the possibility of multiple drug intake should be considered.

Since amisulpride is weakly dialysed, hemodialysis should not be used to eliminate the drug.

There is no specific antidote to amisulpride. Appropriate supportive measures should therefore be instituted with close supervision of vital functions including continuous cardiac monitoring due to risk of prolongation of the QT interval.

If severe extrapyramidal symptoms occur, anticholinergic agents should be administered.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Amisulpride binds selectively with a high affinity to human dopaminergic D₂/D₃ receptor subtypes whereas it is devoid of affinity for D₁, D₄ and D₅ receptor subtypes.

Unlike classical and atypical neuroleptics, amisulpride has no affinity for serotonic, α-adrenergic, histamine H₁ and cholinergic receptors. In addition, amisulpride does not bind to sigma sites.

In animal studies, at high doses, amisulpride blocks dopamine receptors located in the limbic structure in preference to those in the striatum.

At low doses it preferentially blocks pre-synaptic D₂/D₃ receptors, producing dopamine release responsible for its disinhibitory effects.

This pharmacological profile explains the clinical efficacy of amisulpride against both negative and positive symptoms of schizopheria.

5.2 Pharmacokinetic Properties

In man, amisulpride shows two absorption peaks: one which is attained rapidly, one hour post-dose and a second between 3 and 4 hours after administration. Corresponding plasma concentrations are 39 ± 3 and 54 ± 4 ng/ml after a 50mg dose.

The volume of distribution is 5.8 l/kg, plasma protein binding is low (16%) and no drug interactions are suspected.

Absolute bioavailability is 48%. Amisulpride is weakly metabolised: two inactive metabolites, accounting for approximately 4% of the dose, have been identified. There is no accumulation of amisulpride and its pharmacokinetics remain unchanged after the administration of repeated doses. The elimination half-life of amisulpride is approximately 12 hours after an oral dose.

Amisulpride is eliminated unchanged in the urine. Fifty percent of an intravenous dose is excreted via the urine, of which 90% is eliminated in the first 24 hours. Renal clearance is in the order of 20 l/h or 330 ml/min.

A carbohydrate rich meal (containing 68% fluids) significantly decreases the AUCs, Tmax and Cmax of amisulpride but no changes were seen after a high fat meal. However, the significance of these findings in routine clinical use is not known.

Hepatic insufficiency: since the drug is weakly metabolised a dosage reduction should not be necessary in patients with hepatic insufficiency.

Renal insufficiency: The elimination half-life is unchanged in patients with renal insufficiency while systemic clearance is reduced by a factor of 2.5 to 3. The AUC of amisulpride in mild renal failure increased two fold and almost tenfold in moderate renal failure (see chapter 4.2). Experience is however limited and there is no data with doses greater than 50 mg.

Amisulpride is very weakly dialysed.

Limited pharmacokinetic data in elderly subjects (> 65 years) show that a 10-30 % rise occurs in Cmax, T1/2 and AUC after a single oral dose of 50 mg. No data are available after repeat dosing.

5.3 Preclinical Safety Data

An overall review of the completed safety studies indicates that amisulpride is devoid of any general, organ-specific, teratogenic, mutagenic or carcinogenic risk. Changes observed in rats and dogs at doses below the maximum tolerated dose are either pharmacological effects or are devoid of major toxicological significance under these conditions. Compared with the maximum recommended dosages in man, maximum tolerated doses are 2 and 7 times greater in the rat (200 mg/kg/d) and dog (120 mg/kg/d) respectively in terms of AUC. No carcinogenic risk, relevant to man, was identified in the rat at up to 1.5 to 4.5 times the expected human AUC.

A mouse carcinogenicity study (120 mg/kg/d) and reproductive studies (160, 300 and 500 mg/kg/d respectively in rat, rabbit and mouse) were performed. The exposure of the animals to amisulpride during these latter studies was not evaluated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Each tablet contains the following excipients:

Maize starch

Lactose monohydrate

Methylcellulose 400cP

Colloidal silica anhydrous

Magnesium stearate

6.2 Incompatibilities

None

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Do not store above 25°C. Store in original package.

6.5 Nature And Contents Of Container

The tablets are packed in blisters constituted from a PVC and aluminium foil.

6.6 Special Precautions For Disposal And Other Handling

None

No Data Held

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 16363/0147

9. Date Of First Authorisation/Renewal Of The Authorisation

14 May 2004

10. Date Of Revision Of The Text

October 2011