Calpol Sugar Free Infant Suspension Sachets

1. Name Of The Medicinal Product

CALPOL Sugar Free Infant Suspension Sachets

2. Qualitative And Quantitative Composition

Calpol Sugar Free Infant Suspension Sachets contains 120 mg Paracetamol in each 5 ml.

Excipients: maltitol liquid ((E965), contains 2.72 g of maltitol in each 5 ml) , sorbitol liquid (E420), methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216) and carmoisine (E122). See section 4.4 for further information.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral Suspension.

A pink strawberry flavoured suspension

4. Clinical Particulars

4.1 Therapeutic Indications

Calpol Sugar Free Infant Suspension Sachets is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds & influenza, aches and pains and post-immunisation fever.

4.2 Posology And Method Of Administration

Age : 2 – 3 months	Dose
1. Post-vaccination fever	2.5 ml (small end of spoon) If necessary, after 4-6 hours, give a second 2.5 ml dose
2. Other causes of Pain and Fever - if your baby weighs over 4 kg and was born after 37 weeks
• Do not give to babies less than 2 months of age. • Do not give more than 2 doses. • Leave at least 4 hours between doses. • If further doses are needed, talk to your doctor or pharmacist.

Children aged 3 months – 6 years:

Child's Age	How Much	How often (in 24 hours)
3 – 6 months	One 2.5 ml spoonful (small end)	4 times
6 – 24 months	One 5 ml spoonful (large end)	4 times
2 – 4 years	One 5 ml spoonful (large end) and one 2.5 ml spoonful (small end)	4 times
4 – 6 years	Two 5 ml spoonfuls (large end)	4 times
• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

It is important to massage the sachet for before use.

The Elderly:

In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.

4.3 Contraindications

Calpol Sugar Free Infant Suspension Sachets is contra-indicated in patients with known hypersensitivity to paracetamol, or any of the other components.

4.4 Special Warnings And Precautions For Use

Calpol Sugar Free Infant Suspension Sachets should be used with caution in severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Concomitant use of other paracetamol-containing products should be avoided.

Due to the presence of maltitol liquid (E965) and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance should not take this medicine.

Maltitol may have a mild laxative effect. Each 5 ml spoonful of this product contains 2.72 g of maltitol. Calorific value 2.3 kcal/g maltitol.

Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed).

Carmoisine (E122) may cause allergic reactions.

The label contains the following statements:

Contains paracetamol.

Do not give this medicine with any other paracetamol containing products.

For oral use only

Never give more medicine than shown in the table.

Do not overfill the spoon.

Always use the spoon supplied with the pack.

Do not give to babies less than 2 months of age.

For infants 2-3 months no more than 2 doses should be given.

Do not give more than 4 doses in any 24 hour period.

Leave at least 4 hours between doses.

Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product.

Keep out of the reach and sight of children.

Massage contents of sachet before opening.

Do not exceed the stated dose.

If symptoms persist consult your doctor.

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

Immediate medical advice should be sought in the event of an overdose, even if the child seems well. (label)

Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage. (leaflet)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

The use of drugs that induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of the doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare.Very rarely hypersensitivity and anaphylatic reactions including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Most reports of adverse reactions to paracetamol relate to overdose with the drug.

Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.

Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.

4.9 Overdose

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

Risk Factors:

If the patient

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

OR

b) Regularly consumes ethanol in excess of recommended amounts

OR

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

Symptoms

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

Management

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

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has only weak anti-inflammatory effects.

ATC Code: NO2 BE01 – Other analgesics and antipyretics.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses. Drug is widely distributed throughout most body fluids. Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours almost entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity for glucuronidation of the drug than do adults. In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.

5.3 Preclinical Safety Data

Mutagenicity

There are no studies relating to the mutagenic potential of Calpol Sugar Free Infant Suspension Sachets.

In vivo mutagenicity tests of paracetamol in mammals are limited and show conflicting results. Therefore, there is insufficient information to determine whether paracetamol poses a mutagenic risk to man.

Paracetamol has been found to be non-mutagenic in bacterial mutagenicity assays, although a clear clastogenic effect has been observed in mammalian cells in vitro following exposure to paracetamol (3 and 10 mM for 2h).

Carcinogenicity

There are no studies to the carcinogenic potential of Calpol Sugar Free Infant Suspension Sachets.

There is inadequate evidence to determine the carcinogenic potential of paracetamol in humans. A positive association between the use of paracetamol and cancer of the ureter (but not of other sites in the urinary tract) was observed in a case-control study in which approximate lifetime consumption of paracetamol (whether acute or chronic) was estimated. However, other similar studies have failed to demonstrate a statistically significant association between paracetamol and cancer of the urinary tract, or paracetamol and renal cell carcinoma.

There is limited evidence for the carcinogenicity of paracetamol in experimental animals. Liver cell tumours can be detected in rats following chronic feeding of 500 mg/kg/day paracetamol.

Teratogenicity

There is no information relating to the teratogenic potential of Calpol Sugar Free Infant Suspension Sachets. In humans, paracetamol crosses the placenta and attains concentrations in the foetal circulation similar to those in the maternal circulation. Intermittent maternal ingestion of therapeutic doses of paracetamol are not associated with teratogenic effects in humans.

Paracetamol has been found to be foetotoxic to cultured rat embryo.

Fertility

There is no information relating to the effects of Calpol Sugar Free Infant Suspension Sachets on fertility. A significant decrease in testicular weight was observed when male Sprague-Dawley rats were given daily high doses of paracetamol (500 mg/kg/body weight/day) orally for 70 days.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maltitol liquid

Sorbitol liquid (non crystallising) (E420)

Glycerol

Dispersible cellulose

Xanthan gum

Ethyl parahydroxybenzoate (E214)

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Polysorbate 80

Strawberry flavour

Carmoisine (E122)

Purified water

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

5 ml sachet composed of a laminate made of paper/PE/Aluminium/Surlyn. Pack sizes 12 or 20 sachets. A spoon with a 5 ml and 2.5 ml measure is supplied with this pack.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0155

9. Date Of First Authorisation/Renewal Of The Authorisation

26/02/2007- 25/02/2009

10. Date Of Revision Of The Text

6^th June 2011

LEGAL STATUS

GSL for sachets

Tricitrates

Generic Name: citric acid, potassium citrate, and sodium citrate (SIT rik AS id, poe TASS ee um, and SOE dee um SIT rayt)

Brand Names: Cytra-3, Polycitra, Polycitra-LC, Tricitrates

What is Tricitrates (citric acid, potassium citrate, and sodium citrate)?

Citric acid and sodium citrate are alkalinizing agents that make the urine less acidic.

Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.

The combination of citric acid, potassium citrate, and sodium citrate is used to prevent gout or kidney stones, or metabolic acidosis in people with kidney problems.

Citric acid, potassium citrate, and sodium citrate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Tricitrates (citric acid, potassium citrate, and sodium citrate)?

You should not use this medication if you have severe kidney disease, severe heart damage (such as from a prior heart attack), Addison's disease (an adrenal gland disorder), high levels of potassium or sodium in your blood, or if you are severely dehydrated.

You should not take citric acid, potassium citrate, and sodium citrate tablets if you have problems with your esophagus, stomach, or intestines that make it difficult for you to swallow or digest pills.

Before you take citric acid, potassium citrate, and sodium citrate, tell your doctor about all your medical conditions, especially kidney disease, heart disease, high blood pressure, a history of heart attack, urinary problems, diabetes, swelling (edema), urination problems, stomach ulcer or chronic diarrhea (such as ulcerative colitis, Crohn's disease), or if you are on a low-salt diet.

Also tell your doctor about all other medications you use, including antacids, heart or blood pressure medications, or a diuretic (water pill).

To be sure this medication is helping your condition, your blood and urine may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. Follow your doctor's instructions carefully and do not miss any scheduled appointments.

Serious side effects of citric acid, potassium citrate, and sodium citrate include numbness or tingly feeling, swelling or rapid weight gain, muscle twitching or cramps, fast or slow heart rate, confusion, or mood changes, bloody or tarry stools, severe stomach pain, ongoing diarrhea, or seizure (convulsions).

What should I discuss with my healthcare provider before taking Tricitrates (citric acid, potassium citrate, and sodium citrate)?

You should not use this medication if you are allergic to it, or if you have:

• 
  

  severe kidney disease;

  
  


• 
  

  severe heart damage (such as from a prior heart attack);

  
  


• 
  

  Addison's disease (an adrenal gland disorder);

  
  


• 
  

  high levels of potassium in your blood (hyperkalemia);

  
  


• 
  

  high levels of sodium in your blood (hypernatremia); or

  
  


• 
  

  if you are severely dehydrated.

  
  

You should not take citric acid, potassium citrate, and sodium citrate tablets if you have problems with your esophagus, stomach, or intestines that make it difficult for you to swallow or digest pills.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take citric acid, potassium citrate, and sodium citrate, tell your doctor if you have:

• kidney disease;


• 
  

  low levels of calcium in your blood (hypocalcemia);

  
  


• 
  

  congestive heart failure, heart rhythm problems, or history of heart attack;

  
  


• 
  

  other heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a peptic ulcer in your stomach;

  
  


• 
  

  swelling of your hands or feet, or in your lungs (pulmonary edema);

  
  


• 
  

  toxemia of pregnancy;

  
  


• 
  

  urination problems (or if you are unable to urinate);

  
  


• 
  

  chronic diarrhea (such as irritable bowel disease, ulcerative colitis, Crohn's disease); or

  
  


• 
  

  if you are on a low-salt diet.

  
  

It is not known whether this medication is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Tricitrates (citric acid, potassium citrate, and sodium citrate)?

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

Citric acid, potassium citrate, and sodium citrate should be taken after meals to help prevent stomach or intestinal side effects. You may also need to take the medicine at bedtime. Follow your doctor's instructions.

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

The liquid medicine should be mixed with at lease 4 ounces of water or juice. Drink this mixture slowly and then add a little more water to the same glass, swirl gently and drink right away. You may chill the mixed medicine to make it taste better, but do not allow it to freeze. Your treatment may include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.

To be sure this medication is helping your condition, your blood and urine may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. Follow your doctor's instructions carefully and do not miss any scheduled appointments.

Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse. Store citric acid, potassium citrate, and sodium citrate at room temperature away from moisture, heat, or freezing. Keep the medication in a closed container.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 2 hours late in taking your medicine, wait until your next scheduled time to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include muscle cramps or twitching, slow heart rate, and seizure (convulsions).

What should I avoid while taking Tricitrates (citric acid, potassium citrate, and sodium citrate)?

Avoid using antacids without your doctor's advice, including household baking soda (sodium bicarbonate). Antacids that contain aluminum or sodium can interact with citric acid, potassium citrate, and sodium citrate, causing a serious electrolyte imbalance or aluminum toxicity.

Avoid taking potassium supplements or using other foods or products that contain potassium without first asking your doctor. Salt substitutes or low-salt dietary products often contain potassium. If you take certain products together you may accidentally get too much potassium. Read the label of any other medicine you are using to see if it contains potassium.

Avoid eating foods that are high in salt, or using extra table salt on your meals.

It is very important to follow any diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.

Tricitrates (citric acid, potassium citrate, and sodium citrate) 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:

• 
  

  swelling, rapid weight gain;

  
  


• 
  

  numbness or tingly feeling in your hands or feet, or around your mouth;

  
  


• 
  

  muscle twitching or pain, leg pain or cramps;

  
  


• 
  

  fast, slow, or uneven heart rate;

  
  


• 
  

  unusual weakness, rapid and shallow breathing, dizziness, confusion, or mood changes;

  
  


• 
  

  feeling restless, nervous, or irritable;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  severe stomach pain, ongoing diarrhea or vomiting; or

  
  


• 
  

  seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  nausea, or vomiting, stomach pain;

  
  


• 
  

  mild or occasional diarrhea; or

  
  


• 
  

  mild stomach pain.

  
  

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 Tricitrates (citric acid, potassium citrate, and sodium citrate)?

The following drugs can interact with citric acid, potassium citrate, and sodium citrate. Tell your doctor if you are using any of these:

• 
  

  eplerenone (Inspra);

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  drospirenone (Angelique, Yasmin, Yaz);

  
  


• 
  

  lithium (Eskalith, LithoBid);

  
  


• 
  

  quinidine (Quinaglute, Quinidex, Quin-Release);

  
  


• 
  

  candesartan (Atacand), losartan (Cozaar, Hyzaar), valsartan (Diovan), or telmisartan (Micardis);

  
  


• 
  

  cold or allergy medicine (decongestants), diet pills, ADHD medication;

  
  


• 
  

  salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Tricosal, and others;

  
  


• 
  

  a vitamin, mineral supplement, or medication that contains potassium;

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);

  
  


• 
  

  a diuretic (water pill) such as amiloride (Midamor), spironolactone (Aldactone, Aldactazide), or triamterene (Dyrenium); or

  
  


• 
  

  an antacid that contains aluminum or sodium, including Alka-Seltzer, Maalox, Mylanta, Di-Gel, Gelusil, Alamag Plus, Rulox Plus, Tempo, and others.

  
  

This list is not complete and there may be other drugs that can interact with citric acid, potassium citrate, and sodium citrate. 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 Tricitrates resources

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

• Tricitrates Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Tricitrates with other medications

• Metabolic Acidosis
• Urinary Alkalinization

Where can I get more information?

• Your pharmacist can provide more information about citric acid, potassium citrate, and sodium citrate.

See also: Tricitrates side effects (in more detail)

Lamictal

Generic Name: lamotrigine (Oral route)

la-MOE-tri-jeen

Oral route(Tablet;Tablet, Chewable;Tablet, Disintegrating;Tablet, Extended Release)

Serious, life-threatening rashes requiring hospitalization and discontinuation of treatment have been caused by lamotrigine in adults and children. The rate of serious rash is greater in pediatric patients than in adults. The risk of rash may also be increased by coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), exceeding the recommended initial dose of lamotrigine, or exceeding the recommended dose escalation for lamotrigine. Nearly all cases of life-threatening rashes associated with lamotrigine have occurred within 2 to 8 weeks of treatment initiation. Benign rashes also occur; however, it is not possible to predict which rashes prove to be serious or life-threatening. Lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related .

Commonly used brand name(s)

In the U.S.

• Lamictal


• Lamictal CD


• Lamictal XR

Available Dosage Forms:

• Tablet, Extended Release


• Tablet


• Tablet, Chewable

Therapeutic Class: Anticonvulsant

Chemical Class: Phenyltriazine

Uses For Lamictal

Lamotrigine is used alone or together with other medicines to help control certain types of seizures (e.g., partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome) in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it. It can also be used in the treatment of bipolar disorder (manic-depressive illness) in adults older than 18 years of age.

This medicine is available only with your doctor's prescription.

Before Using Lamictal

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lamotrigine chewable tablets, disintegrating tablets, or tablets in children with certain types of seizures older than 2 years of age. However, safety and efficacy have not been established in children less than 2 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of lamotrigine extended-release tablets in children with partial seizures younger than 13 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of lamotrigine chewable tablets, disintegrating tablets, or tablets in children with bipolar disorder. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of lamotrigine have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of lamotrigine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving lamotrigine.

Pregnancy

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

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ezogabine


• Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine


• Desogestrel


• Dienogest


• Drospirenone


• Escitalopram


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Ginkgo


• Levonorgestrel


• Lopinavir


• Medroxyprogesterone Acetate


• Mestranol


• Methsuximide


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Oxcarbazepine


• Phenobarbital


• Primidone


• Rifampin


• Risperidone


• Ritonavir


• Rufinamide


• Sertraline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Blood or bone marrow problems or


• Depression—May make these conditions worse.

• Heart disease—It is not clear if patients who have problems with heart rhythms will have increased problems while taking lamotrigine.

• Kidney disease or


• Liver disease—Higher blood levels of lamotrigine may occur, which may increase the chance of unwanted effects; your doctor may need to change your dose.

• Thalassemia—Lamotrigine may cause your body to stop making or to make fewer red blood cells.

Proper Use of lamotrigine

This section provides information on the proper use of a number of products that contain lamotrigine. It may not be specific to Lamictal. Please read with care.

Take lamotrigine only as directed by your doctor to help your condition as much as possible and to decrease the chance of unwanted effects. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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

Lamotrigine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

If you are taking the chewable dispersible tablets, they may be swallowed whole, chewed, and swallowed, or dispersed in a small amount of liquid and swallowed. If the tablets are chewed, they should be followed with a small amount of water or diluted fruit juice to aid in swallowing. To break up these tablets, add the tablets in enough water or diluted fruit juice to cover the tablets (about a teaspoonful), wait until the tablets are completely dispersed (about 1 minute), then swirl the solution and swallow it immediately.

If you are taking the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet into your tongue and moved around in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

Swallow the extended-release tablets whole. Do not break, crush, or chew it.

Use only the brand of this medicine that your doctor prescribed. Different brands and dosage forms may not work the same way.

This medicine can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage forms (chewable dispersible tablets, disintegrating tablets, or tablets):
  
  • For treatment of bipolar disorder:
    
    • Adults not taking valproic acid (Depakote®) and not taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 25 milligrams (mg) of lamotrigine once a day for two weeks, then a total of 50 mg divided into two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 200 mg a day.
    
    
    • Adults taking valproic acid (Depakote®)—At first, 25 mg of lamotrigine once every other day for two weeks, then 25 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 100 mg a day.
    
    
    • Adults not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 50 mg of lamotrigine once a day for two weeks, then a total of 100 mg divided into two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.
    
    
    • Adults who are discontinuing valproic acid (Depakote®) or discontinuing carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—Dose will be determined by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For treatment of epilepsy:
    
    • Adults and teenagers not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 50 milligrams (mg) of lamotrigine once a day for two weeks, then a total of 100 mg divided into two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 500 mg a day.
    
    
    • Adults and teenagers not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 25 mg of lamotrigine once a day for two weeks, then 50 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 375 mg a day.
    
    
    • Adults and teenagers taking valproic acid (Depakote®) and also taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 25 mg of lamotrigine once every other day for two weeks, then 25 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.
    
    
    • Adults who are discontinuing valproic acid (Depakote®) or discontinuing carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—Dose will be determined by your doctor.
    
    
    • Children 2 to 12 years of age:
      
      • Children not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)— At first, 0.6 milligrams (mg) per kilogram (kg) (0.27 mg per pound) of body weight of lamotrigine once a day for two weeks, then 1.2 mg/kg (0.54 mg per pound) of body weight divided into two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.
      
      
      • Children not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)— At first, 0.3 milligrams (mg) per kilogram (kg) (0.14 mg per pound) of body weight of lamotrigine once a day for two weeks, then 0.6 mg/kg (0.27 mg per pound) of body weight divided into two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 300 mg a day.
      
      
      • Children taking valproic acid (Depakote®) and also taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)— At first, 0.15 mg per kg (0.07 mg per pound) of body weight of lamotrigine given in one dose or two smaller doses each day for two weeks, then 0.3 mg/kg (0.136 mg per pound) of body weight given in one dose or two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 200 mg a day.
      
      
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage form (extended-release tablet):
  
  • For seizures:
    
    • Adults and teenagers older than 13 years of age not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 50 milligrams (mg) of lamotrigine once a day for two weeks, then 100 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 600 mg a day.
    
    
    • Adults and teenagers older than 13 years of age not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), and/or primidone (Mysoline®)—At first, 25 mg of lamotrigine once a day for two weeks, then 50 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.
    
    
    • Adults and teenagers older than 13 years of age taking valproic acid (Depakote®)—At first, 25 mg of lamotrigine once every other day for two weeks, then 25 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 250 mg a day.
    
    
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Lamictal

It is important that your doctor check the progress of you or your child at regular visits, especially during the first few months of your treatment with lamotrigine. This will allow your doctor to change your dose, if necessary, and will help reduce any unwanted effects.

It is important to tell your doctor if you become pregnant while using this medicine. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

You should not start or stop using birth control pills or other female hormonal products while you are taking this medicine until you have consulted your doctor.

Tell your doctor right away if you have unusual changes in your menstrual cycle such as breakthrough bleeding while taking lamotrigine and birth control pills or other female hormonal products.

This medicine may increase the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; ; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Lamotrigine may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, or drowsiness. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to see well. If these reactions are especially bothersome, check with your doctor.

Skin rash may be a sign of a serious unwanted effect. Check with your doctor immediately if you or your child develop a rash, fever, flu-like symptoms, or swollen glands, or if your seizures becomes worse.

Lamotrigine may cause serious allergic reactions affecting multiple body organs (e.g., liver or kidney). Check with your doctor right away if you or your child have the following symptoms: fever, dark urine, headache, hives, muscle pain or stiffness, stomach pain, unusual tiredness, or yellow eyes or skin.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Check with your doctor right away if you or your child start to have a stiff neck, confusion, drowsiness, fever, chills, headache, nausea or vomiting, rash, or sensitivity to light. These could be symptoms of a rare and serious condition called aseptic meningitis.

Do not stop taking lamotrigine without first checking with your doctor. Stopping this medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Lamictal Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blurred vision


• changes in vision


• clumsiness or unsteadiness


• double vision


• poor coordination


• skin rash

Less common

• Anxiety


• chest pain


• confusion


• continuous, uncontrolled back and forth or rolling eye movements


• depression


• increase in seizures


• infection


• irritability

Rare

• Blistering, peeling, or loosening of the skin


• chills


• dark-colored urine


• fever


• flu-like symptoms


• itching


• memory loss


• muscle cramps, pain, or weakness


• red or irritated eyes


• small red or purple spots on the skin


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swelling of the face, mouth, hands, or feet


• swollen lymph nodes


• trouble with breathing


• unusual bleeding or bruising


• unusual tiredness or weakness


• yellow eyes or skin

Incidence not known

• Back, leg, or stomach pains


• bleeding gums


• bloating


• blood in the urine


• bloody, black or tarry stools


• bluish lips or skin


• bruising


• constipation


• cough or hoarseness


• coughing or vomiting blood


• difficulty with breathing


• difficulty with swallowing


• fainting


• fast heartbeat


• general body swelling


• general feeling of discomfort or illness


• general feeling of tiredness or weakness


• heartburn


• high fever


• lightheadedness


• loss of appetite


• loss of balance control


• lower back or side pain


• mask-like face


• muscle spasms


• nosebleeds


• not breathing


• pain or burning in the throat


• painful or difficult urination


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale skin


• persistent bleeding or oozing from puncture sites, mouth, or nose


• rapid, shallow breathing


• redness, soreness, or itching skin


• shortness of breath


• shuffling walk


• slowed movement


• slurred speech


• sores, welting, or blisters


• stiffness of the arms and legs


• swollen or painful glands


• tic-like (jerky) movements


• tightness in the chest


• unexplained bleeding or bruising


• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Clumsiness or unsteadiness (severe)


• coma


• continuous, uncontrolled back and forth or rolling eye movements (severe)


• dizziness (severe)


• drowsiness (severe)


• dryness of the mouth (severe)


• headache (severe)


• increased heart rate


• slurred speech (severe)

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

More common

• Dizziness


• drowsiness


• headache


• nausea


• vomiting

Less common

• Diarrhea


• indigestion


• loss of strength


• menstrual pain


• pain


• runny nose


• trembling or shaking


• trouble with sleeping


• unusual weight loss

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Lamictal side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Lamictal resources

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

• Lamictal Prescribing Information (FDA)


• Lamictal Consumer Overview


• Lamictal Monograph (AHFS DI)


• Lamictal MedFacts Consumer Leaflet (Wolters Kluwer)


• Lamictal ODT Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Lamictal XR Prescribing Information (FDA)


• Lamictal XR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Lamotrigine Prescribing Information (FDA)


• Lamotrigine Professional Patient Advice (Wolters Kluwer)

Compare Lamictal with other medications

• Bipolar Disorder
• Schizoaffective Disorder
• Seizure Prevention

Stahist AD

Pronunciation: klor-SYE-klih-zeen/SOO-doe-e-FED-rin
Generic Name: Chlorcyclizine/Pseudoephedrine
Brand Name: Stahist AD

Stahist AD is used for:

Relieving symptoms of sinus congestion; pressure; runny nose; itching of the nose or throat; itchy, watery eyes; and sneezing due to colds, hay fever, or allergies. It may also be used for other conditions as determined by your doctor.

Stahist AD is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.

Do NOT use Stahist AD if:

• you are allergic to any ingredient in Stahist AD


• you have severe or uncontrolled high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


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


• you take droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Stahist AD:

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

• if you are pregnant, plan 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 history of adrenal gland problems (eg, adrenal gland tumor); heart problems (eg, cor pulmonale; fast, slow, or irregular heartbeat; heart disease); high blood pressure; diabetes; blood vessel problems; stroke; glaucoma or increased pressure in the eye; seizures; thyroid problems; or trouble sleeping


• if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, chronic bronchitis, emphysema); chronic cough; or sleep apnea


• if you have a blockage of your bladder, stomach, or bowels; ulcers; an enlarged prostate or other prostate problems; or trouble urinating


• if you are taking medicine for high blood pressure

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

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), furazolidone, linezolid, MAOIs (eg, phenelzine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Stahist AD's side effects


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Stahist AD


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Stahist AD

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

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

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


• If you miss a dose of Stahist AD and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

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


• Do not drink alcohol while you are using Stahist AD.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Stahist AD; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you are taking Stahist AD without checking with your doctor.


• Before you start any new medicine, check the label to see if it has a decongestant or an antihistamine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or take Stahist AD for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 7 days, if they get worse, if they occur along with a fever, or if new symptoms occur, check with your doctor.


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


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


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


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


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


• Stahist AD should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Stahist AD while you are pregnant. Stahist AD may be found in breast milk. Do not breast-feed while taking Stahist AD.

Possible side effects of Stahist AD:

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:

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

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

Severe allergic reactions (rash; hives; itching, difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, nervousness); persistent trouble sleeping; restlessness; seizures; severe or persistent dizziness, drowsiness, light-headedness, or headache; tremor; vision changes (eg, blurred vision).

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: Stahist AD side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Stahist AD:

Store Stahist AD 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 Stahist AD out of the reach of children and away from pets.

General information:

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


• Stahist AD 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 Stahist AD. 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 Stahist AD resources

• Stahist AD Side Effects (in more detail)
• Stahist AD Use in Pregnancy & Breastfeeding
• Stahist AD Drug Interactions
• Stahist AD Support Group
• 0 Reviews · Be the first to review/rate this drug

Librax

Generic Name: chlordiazepoxide hydrochloride and clidinium bromide

Dosage Form: capsule
Librax®

(chlordiazepoxide HCl)

(clidinium bromide)

CAPSULES

to control emotional

and somatic factors

in gastrointestinal disorders

Librax Description

Librax combines in a single capsule formulation the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide, both exclusive developments of Roche research.

Each Librax capsule contains 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains corn starch, lactose and talc. Gelatin capsule shells may contain methyl and propyl parabens and potassium sorbate, with the following dye systems: D&C Yellow No. 10 and either FD&C Blue No. 1 or FD&C Green No. 3.

Chlordiazepoxide hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds.

Chlordiazepoxide hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of chlordiazepoxide hydrochloride is as follows:

Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally clidinium bromide is:

Animal Pharmacology

Chlordiazepoxide hydrochloride has been studied extensively in many species of animals and these studies are suggestive of action on the limbic system of the brain, which recent evidence indicates is involved in emotional responses.

Hostile monkeys were made tame by oral drug doses which did not cause sedation. Chlordiazepoxide hydrochloride revealed a "taming" action with the elimination of fear and aggression. The taming effect of chlordiazepoxide hydrochloride was further demonstrated in rats made vicious by lesions in the septal area of the brain. The drug dosage which effectively blocked the vicious reaction was well below the dose which caused sedation in these animals.

The oral LD50 of single doses of chlordiazepoxide hydrochloride, calculated according to the method of Miller and Tainter, is 720 ± 51 mg/kg as determined in mice observed over a period of 5 days following dosage.

Clidinium bromide is an effective anticholinergic agent with activity approximating that of atropine sulfate against acetylcholine-induced spasms in isolated intestinal strips. On oral administration in mice it proved an effective antisialagogue in preventing pilocarpine-induced salivation. Spontaneous intestinal motility in both rats and dogs is reduced following oral dosing with 0.1 to 0.25 mg/kg. Potent cholinergic ganglionic blocking effects (vagal) are produced with intravenous usage in anesthetized dogs.

Oral doses of 2.5 mg/kg to dogs produced signs of nasal dryness and slight pupillary dilation. In two other species, monkeys and rabbits, doses of 5 mg/kg, po, given three times daily for 5 days did not produce apparent secretory or visual changes.

The oral LD50 of single doses of clidinium bromide is 860 ± 57 mg/kg as determined in mice observed over a period of 5 days following dosage; the calculations were made according to the method of Miller and Tainter.

Effects on Reproduction

Reproduction studies in rats fed chlordiazepoxide hydrochloride, 10, 20 and 80 mg/kg daily, and bred through one or two matings showed no congenital anomalies, nor were there adverse effects on lactation of the dams or growth of the newborn. However, in another study at 100 mg/kg daily there was noted a significant decrease in the fertilization rate and a marked decrease in the viability and body weight of offspring which may be attributable to sedative activity, thus resulting in lack of interest in mating and lessened maternal nursing and care of the young. One neonate in each of the first and second matings in the rat reproduction study at the 100 mg/kg dose exhibited major skeletal defects. Further studies are in progress to determine the significance of these findings.

Two series of reproduction experiments with clidinium bromide were carried out in rats, employing dosages of 2.5 and 10 mg/kg daily in each experiment. In the first experiment clidinium bromide was administered for a 9-week interval prior to mating; no untoward effect on fertilization or gestation was noted. The offspring were taken by caesarean section and did not show a significant incidence of congenital anomalies when compared to control animals. In the second experiment adult animals were given clidinium bromide for 10 days prior to and through two mating cycles. No significant effects were observed on fertility, gestation, viability of offspring or lactation, as compared to control animals, nor was there a significant incidence of congenital anomalies in the offspring derived from these experiments.

A reproduction study of Librax was carried out in rats through two successive matings. Oral daily doses were administered in two concentrations: 2.5 mg/kg chlordiazepoxide hydrochloride with 1.25 mg/kg clidinium bromide or 25 mg/kg chlordiazepoxide hydrochloride with 12.5 mg/kg clidinium bromide. In the first mating no significant differences were noted between the control or the treated groups, with the exception of a slight decrease in the number of animals surviving during lactation among those receiving the highest dosage. As with all anticholinergic drugs, an inhibiting effect on lactation may occur. In the second mating similar results were obtained except for a slight decrease in the number of pregnant females and in the percentage of offspring surviving until weaning. No congenital anomalies were observed in both matings in either the control or treated groups. Additional animal reproduction studies are in progress.

INDICATIONS AND USAGE

Based on a review of this drug by the National Academy of Sciences — National Research Council and/or other information, FDA has classified the indications as follows:

"Possibly" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

Final classification of the less-than-effective indications requires further investigation.

Contraindications

Librax is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide.

Warnings

As in the case of other preparations containing CNS-acting drugs, patients receiving Librax should be cautioned about possible combined effects with alcohol and other CNS depressants. For the same reason, they should be cautioned against hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle.

Usage In Pregnancy

An Increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested In several studies. Because use of these drugs Is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of Institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.

As with all anticholinergic drugs, an inhibiting effect on lactation may occur (see Animal Pharmacology).

Overdosage

Manifestations of chlordiazepoxide hydrochloride overdosage include somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following chlordiazepoxide hydrochloride overdosage.

While the signs and symptoms of Librax overdosage may be produced by either of its components, usually such symptoms will be overshadowed by the anticholinergic actions of clidinium bromide. The symptoms of overdosage of clidinium bromide are excessive dryness of mouth, blurring of vision, urinary hesitancy and constipation.

General supportive measures should be employed, along with immediate gastric lavage. Administer physostigmine 0.5 to 2 mg at a rate of no more than 1 mg per minute. This may be repeated in 1 to 4 mg doses if arrhythmias, convulsions or deep coma recur. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol. Methylphenidate or caffeine and sodium benzoate may be given to combat CNS-depressive effects. Dialysis is of limited value. Should excitation occur, barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE section).

Precautions

In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion (not more than 2 Librax capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Librax and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed — particularly when the known potentiating compounds such as the MAO inhibitors and phenothiazines are to be used. The usual precautions in treating patients with impaired renal or hepatic function should be observed.

Paradoxical reactions to chlordiazepoxide hydrochloride, eg, excitement, stimulation and acute rage, have been reported in psychiatric patients and should be watched for during Librax therapy. The usual precautions are indicated when chlordiazepoxide hydrochloride is used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary. Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide hydrochloride.

Information for Patients

To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Librax. These effects can usually be avoided with proper dosage adjustment, although they have occasionally been observed even at the lower dosage ranges. Dosing in geriatric subjects should be initiated cautiously (no more than 2 capsules per day) and increased gradually if needed and tolerated (see DOSAGE AND ADMINISTRATION). Librax is contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction (see CONTRAINDICATIONS).

Adverse Reactions

No side effects or manifestations not seen with either compound alone have been reported with the administration of Librax. However, since Librax contains chlordiazepoxide hydrochloride and clidinium bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded.

When chlordiazepoxide hydrochloride has been used alone the necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients — particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported.

Other adverse reactions reported during therapy with chlordiazepoxide hydrochloride include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after chlordiazepoxide hydrochloride treatment.

Blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction have occasionally been reported during therapy with chlordiazepoxide hydrochloride. When chlordiazepoxide hydrochloride treatment is protracted, periodic blood counts and liver function tests are advisable.

Adverse effects reported with use of Librax are those typical of anticolinergic agents, ie, dryness of the mouth, blurring of vision, urinary hesitancy and constipation. Constipation has occurred most often when Librax therapy has been combined with other spasmolytic agents and/or a low residue diet.

Drug Abuse and Dependence

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving chlordiazepoxide or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

Librax Dosage and Administration

Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Librax varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime.

Geriatric Dosing

Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Librax capsules per day, to be increased gradually as needed and tolerated.

How is Librax Supplied

Librax is available in green capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 100 (NDC 0187-4100-10).

Manufactured by:

Legacy Pharmaceuticals Puerto Rico, LLC

Humacao, Puerto Rico 00791

Manufactured for:

VALEANT®

Pharmaceuticals North America

One Enterprise, Aliso Viejo, CA 92656 USA

02-4100-EX-00

Rev. March 09

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

NDC 0187-4100-10

Rx Only

Librax®

(chlordiazepoxide HCl)

(clidinium bromide)

Each capsule

contains 5 mg

chlordiazepoxide

HCl and 2.5 mg

clidinium bromide.

VALEANT®

100 Capsules

Librax  chlordiazepoxide hydrochloride and clidinium bromide  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0187-4100 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlordiazepoxide Hydrochloride (Chlordiazepoxide) Chlordiazepoxide Hydrochloride 5 mg Clidinium Bromide (Clidinium Bromide) Clidinium Bromide 2.5 mg

Inactive Ingredients Ingredient Name Strength Starch, Corn   Lactose   Talc   D&C Yellow No. 10   FD&C Blue No. 1   FD&C Green No. 3

Product Characteristics Color GREEN Score no score Shape CAPSULE Size 14mm Flavor Imprint Code OPI;409 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0187-4100-10 100 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA012750	09/01/1966

Labeler - Valeant Pharmaceuticals International (042230623)

Establishment
Name	Address	ID/FEI	Operations
Legacy Pharmaceuticals		026611520	MANUFACTURE

Revised: 09/2010Valeant Pharmaceuticals International

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