Finlepsin may be available in the countries listed below.
Carbamazepine is reported as an ingredient of Finlepsin in the following countries:
International Drug Name Search
Fluracil may be available in the countries listed below.
Fluorouracil is reported as an ingredient of Fluracil in the following countries:
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Fluoxone may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxone in the following countries:
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Ufexil may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ufexil in the following countries:
Ciprofloxacin lactate (a derivative of Ciprofloxacin) is reported as an ingredient of Ufexil in the following countries:
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Aprecap may be available in the countries listed below.
Aprepitant is reported as an ingredient of Aprecap in the following countries:
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Fluoxetina Kern Pharma may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetina Kern Pharma in the following countries:
International Drug Name Search
Rec.INN
M01AX04
0013539-59-8
C16-H20-N4-O2
300
Analgesic, antipyretic and anti-inflammatory agent
Non-steroidal anti-inflammatory drug, NSAID
1H-Pyrazolo[1,2-a][1,2,4]benzotriazine-1,3(2H)-dione, 5-(dimethylamino)-9-methyl-2-propyl-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Tosufloxacin Tosilate may be available in the countries listed below.
Tosufloxacin Tosilate (JAN) is also known as Tosufloxacin (Rec.INN)
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Flogovital N.F. may be available in the countries listed below.
Nimesulide is reported as an ingredient of Flogovital N.F. in the following countries:
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Flurbiprofen Sodium may be available in the countries listed below.
Flurbiprofen Sodium (BANM) is known as Flurbiprofen in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
F-Din may be available in the countries listed below.
Mometasone 17-(2-furoate) (a derivative of Mometasone) is reported as an ingredient of F-Din in the following countries:
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Fenilefrina ALM may be available in the countries listed below.
Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Fenilefrina ALM in the following countries:
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Debenal may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Debenal in the following countries:
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Duclazide may be available in the countries listed below.
Gliclazide is reported as an ingredient of Duclazide in the following countries:
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DHC® Continus® prolonged release tablets 60 mg, 90 mg, 120 mg.
Dihydrocodeine tartrate 60 mg, 90 mg, 120 mg.
Prolonged release tablet.
White capsule shaped tablets, 60 mg are marked DHC 60, 90 mg are marked DHC 90 and 120 mg are marked DHC 120.
For the relief of severe pain in cancer and other chronic conditions.
Adults and children over 12 years: 60 mg - 120 mg every 12 hours.
Elderly: Dosage should be reduced.
Children 12 years or under: Not recommended.
Method of administration
Oral.
Hypersensitivity to dihydrocodeine or any of the tablet constituents; respiratory depression; obstructive airways disease; paralytic ileus; head injury; raised intracranial pressure; acute alcoholism. As dihydrocodeine may cause the release of histamine, it should not be given during an asthma attack and should be given with caution to asthmatics.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Dosage should be reduced in the elderly, in hypothyroidism, chronic hepatic disease and renal insufficiency.
Dihydrocodeine should be administered with caution to patients with a history of opioid abuse, biliary tract disorders, prostatic hypertrophy, pancreatitis, constipation, obstructive bowel disorder and severe cor pulmonale.
Dihydrocodeine has a recognised abuse and addiction profile similar to other opioids. Tolerance to analgesic effects may develop upon repeated administration.
The risk-benefit of continued use should be assessed regularly by the prescriber, and in particular the prescriber should take care to avoid any unnecessary increase in dosage especially where there is evidence of a previous history of drug dependence or abuse.
DHC Continus tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed tablets may lead to a rapid release and absorption of a potential overdose of dihydrocodeine (see Section 4.9).
Other central nervous system depressants, including sedatives or hypnotics, phenothiazines, other tranquillisers and alcohol, may result in respiratory depression or sedation. Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors or within two weeks of such therapy.
There is little published evidence on safety in human pregnancy but dihydrocodeine has been used for many years without apparent ill effects. Dihydrocodeine has not been reported to be excreted in breast milk. However, it is advisable that dihydrocodeine only be administered to breast-feeding mothers if considered essential.
Dihydrocodeine may cause drowsiness and, if affected, patients should not drive or operate machinery.
Common adverse drug reactions seen during therapy are constipation, nausea, vomiting, headache, somnolence, pruritus and rash.
Uncommon adverse reactions are urinary retention, ureteric or biliary spasm, dry mouth, mood changes, blurred vision, sweating, decreased libido, flushing, abdominal pain, hypotension, paraesthesia, confusion, dizziness, hallucinations, urticaria, paralytic ileus and respiratory depression.
Dependence may occur. Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is stopped.
Prolonged use of a painkiller for headaches can make them worse.
Acute overdosage with dihydrocodeine can be manifested by somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis, non-cardiac pulmonary oedema, bradycardia, hypotension and respiratory depression or apnoea.
Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.
In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response, or by an infusion. An infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient's clinical state. Intramuscular naloxone is an alternative in the event that IV access is not possible.
As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.
Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to dihydrocodeine overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on dihydrocodeine. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.
Additional/other considerations:
• Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations but there is no evidence to support this.
•DHC Continus tablets will continue to release and add to the dihydrocodeine load for up to 12 hours after administration and the management of overdosage should be modified accordingly. Gastric contents may therefore need to be emptied, as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.
Dihydrocodeine is a semisynthetic narcotic analgesic with a potency between morphine and codeine. It acts on opioid receptors in the brain to reduce the patient's perception of pain and improve the psychological reaction to pain by reducing the associated anxiety.
Dihydrocodeine is well absorbed from the gastrointestinal tract following administration of DHC Continus tablets and plasma levels are maintained throughout the twelve hour dosing interval.
Like other phenanthrene derivatives, dihydrocodeine is mainly metabolised in the liver with the resultant metabolites being excreted mainly in the urine. Metabolism of dihydrocodeine includes o-demethylation, n-demethylation and 6-keto reduction.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Lactose (anhydrous)
Hydroxyethylcellulose
Cetostearyl alcohol
Magnesium stearate
Purified talc
Purified water
None known.
Three years.
Do not store above 25°C.
Polypropylene containers with polyethylene lids (56 tablets)
None stated.
Napp Pharmaceuticals Limited
Cambridge Science Park
Milton Road
Cambridge
CB4 0GW
PL 16950/0019 - 0021
|
|
|
|
February 2007
POM
® The Napp device, DHC and DHC CONTINUS are Registered Trade Marks
© Napp Pharmaceuticals Ltd 2007.
Fluvoxaminemaleaat PCH may be available in the countries listed below.
Fluvoxamine maleate (a derivative of Fluvoxamine) is reported as an ingredient of Fluvoxaminemaleaat PCH in the following countries:
International Drug Name Search
Lorazepam MK may be available in the countries listed below.
Lorazepam is reported as an ingredient of Lorazepam MK in the following countries:
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Ketoplus may be available in the countries listed below.
Ketoprofen is reported as an ingredient of Ketoplus in the following countries:
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Perioxidin may be available in the countries listed below.
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Perioxidin in the following countries:
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Generic Name: benzocaine (Oral route, Oromucosal route)
BEN-zoe-kane
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Anesthetic, Local
Chemical Class: Amino Ester
Benzocaine lozenges are used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.
This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.
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:
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.
No information is available on the relationship of age to the effects of benzocaine lozenges in the pediatric population. Safety and efficacy have not been established in children below 5 years of age.
No information is available on the relationship of age to the effects of benzocaine in geriatric patients.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
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:
This section provides information on the proper use of a number of products that contain benzocaine. It may not be specific to Baby Orajel. Please read with care.
Use this medicine exactly as directed by your doctor. Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.
This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present.
Do not use this medicine for more than 2 days without checking first with your doctor.
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.
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.
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.
If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.
Call your doctor right away if you start to have a severe sore throat or sore throat that occurs with a high fever, headache, nausea, or vomiting. These maybe signs of an infection.
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:
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: Baby Orajel 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.
In some countries, this medicine may only be approved for veterinary use.
Tilmicosin is reported as an ingredient of Pulmotil in the following countries:
Tilmicosin phosphate (a derivative of Tilmicosin) is reported as an ingredient of Pulmotil in the following countries:
International Drug Name Search
Facimin may be available in the countries listed below.
Oxymetazoline hydrochloride (a derivative of Oxymetazoline) is reported as an ingredient of Facimin in the following countries:
International Drug Name Search
Nichoflam may be available in the countries listed below.
Diclofenac potassium salt (a derivative of Diclofenac) is reported as an ingredient of Nichoflam in the following countries:
International Drug Name Search
Fosicomb may be available in the countries listed below.
Fosinopril sodium salt (a derivative of Fosinopril) is reported as an ingredient of Fosicomb in the following countries:
Hydrochlorothiazide is reported as an ingredient of Fosicomb in the following countries:
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Mapin may be available in the countries listed below.
Naloxone hydrochloride (a derivative of Naloxone) is reported as an ingredient of Mapin in the following countries:
International Drug Name Search
In the US, Forane (isoflurane systemic) is a member of the drug class general anesthetics and is used to treat Anesthesia.
US matches:
Isoflurane is reported as an ingredient of Forane in the following countries:
International Drug Name Search
Fabolergic may be available in the countries listed below.
Diphenhydramine hydrochloride (a derivative of Diphenhydramine) is reported as an ingredient of Fabolergic in the following countries:
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Fenobarbital Cevallos may be available in the countries listed below.
Phenobarbital is reported as an ingredient of Fenobarbital Cevallos in the following countries:
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Floraquin may be available in the countries listed below.
Diiodohydroxyquinoline is reported as an ingredient of Floraquin in the following countries:
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se-TIR-i-zeen hye-droe-KLOR-ide, soo-doe-e-FED-rin hye-droe-KLOR-ide
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antihistamine/Decongestant Combination
Pharmacologic Class: Cetirizine
Chemical Class: Cetirizine
Cetirizine and pseudoephedrine is a combination of an antihistamine and a decongestant used to treat the symptoms of seasonal or yearly allergies. Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Decongestants produce a narrowing of blood vessels. This leads to clearing of nasal congestion, but it may also cause an increase in blood pressure in patients who have high blood pressure.
cetirizine and pseudoephedrine is available without a prescription.
Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .
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 cetirizine and pseudoephedrine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to cetirizine and pseudoephedrine 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.
Use is not recommended in infants and children up to 12 years of age. In children 12 years of age and older, cetirizine and pseudoephedrine is not expected to cause different side effects or problems than it does in adults.
Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cetirizine and pseudoephedrine in the elderly with use in other age groups.
| 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. |
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.
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 cetirizine and pseudoephedrine, 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 cetirizine and pseudoephedrine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using cetirizine and pseudoephedrine 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.
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.
The presence of other medical problems may affect the use of cetirizine and pseudoephedrine. Make sure you tell your doctor if you have any other medical problems, especially:
The dose of cetirizine and pseudoephedrine 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 cetirizine and pseudoephedrine. 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.
Swallow the extended-release tablet whole. Do not crush, break, or chew before swallowing.
If you miss a dose of cetirizine and pseudoephedrine, 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.
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.
The antihistamine in cetirizine and pseudoephedrine will add to the effects of alcohol and other CNS depressants including tricyclic antidepressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are other antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Examples of Tricyclic antidepressants are amitriptyline [e.g. Elavil], amoxapine [e.g. Asendin], clomipramine [e.g. Anafranil], desipramine [e.g. Pertofrane], doxepine [e.g. Sinequan], imipramine [e.g. Tofranil], nortriptyline [e.g. Aventyl], protriptyline [Vivactil], trimipramine [e.g. Surmontil]. Check with your doctor before taking any of the above while you are taking cetirizine and pseudoephedrine.
The antihistamine in cetirizine and pseudoephedrine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to cetirizine and pseudoephedrine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
Antihistamines may cause dryness of the mouth, nose, and throat. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
The decongestant in cetirizine and pseudoephedrine may cause some people to be nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of cetirizine and pseudoephedrine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.
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.
Get emergency help immediately if any of the following symptoms of overdose occur:
Check with your doctor as soon as possible if any of the following side effects occur:
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:
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: cetirizine and pseudoephedrine 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.
Carbonex may be available in the countries listed below.
Magnesium Hydroxide is reported as an ingredient of Carbonex in the following countries:
International Drug Name Search
Flurbic may be available in the countries listed below.
Flurbiprofen is reported as an ingredient of Flurbic in the following countries:
International Drug Name Search
Anasilpiel may be available in the countries listed below.
Neomycin undecylenate (a derivative of Neomycin) is reported as an ingredient of Anasilpiel in the following countries:
Triamcinolone 16α,17α-acetonide (a derivative of Triamcinolone) is reported as an ingredient of Anasilpiel in the following countries:
International Drug Name Search
Flogol may be available in the countries listed below.
Etofenamate is reported as an ingredient of Flogol in the following countries:
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Flecainide sometimes produces new irregular heartbeats (arrhythmias), which can be life-threatening.
Treating and preventing various types of irregular heartbeat that lead to life-threatening heart rhythm disturbances.
Flecainide is an antiarrhythmic. It works by stabilizing the heart rhythm when the heart is beating too fast or in an irregular rhythm.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Flecainide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Flecainide. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Flecainide 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.
Use Flecainide as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Flecainide.
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:
Blurred vision; constipation; difficulty focusing; dizziness; faintness; headache; nausea; seeing spots; stomach discomfort; tiredness; unsteadiness; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty breathing; fainting; fast heartbeat; heart attack; life-threatening irregular heartbeat; lightheadedness; pounding in the chest; seizures; tremor; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Flecainide side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; nausea; seizures; slow heartbeat; vomiting.
Store Flecainide 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 Flecainide out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Flecainide. 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.
Fada Diclofenac may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Fada Diclofenac in the following countries:
International Drug Name Search
D.F.N. may be available in the countries listed below.
Diclofenac diethylamine (a derivative of Diclofenac) is reported as an ingredient of D.F.N. in the following countries:
International Drug Name Search
Floril N.F. may be available in the countries listed below.
Naphazoline hydrochloride (a derivative of Naphazoline) is reported as an ingredient of Floril N.F. in the following countries:
International Drug Name Search
Tamsulozin Stichting may be available in the countries listed below.
Tamsulosin is reported as an ingredient of Tamsulozin Stichting in the following countries:
International Drug Name Search
Metronidazol-Rotexmedica may be available in the countries listed below.
Metronidazole is reported as an ingredient of Metronidazol-Rotexmedica in the following countries:
International Drug Name Search
Fada Cefepime may be available in the countries listed below.
Cefepime is reported as an ingredient of Fada Cefepime in the following countries:
International Drug Name Search
Rec.INN
0000583-03-9
C11-H16-O
164
Choleretic
Benzenemethanol, α-butyl-
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Virmen Topico may be available in the countries listed below.
Aciclovir is reported as an ingredient of Virmen Topico in the following countries:
International Drug Name Search
Ferro sanol gyn may be available in the countries listed below.
Ferrous Glycine Sulfate is reported as an ingredient of Ferro sanol gyn in the following countries:
Folic Acid is reported as an ingredient of Ferro sanol gyn in the following countries:
International Drug Name Search
Topiramate 100mg Film-Coated Tablets
Each tablet contains 100mg of Topiramate.
Excipient: Also contains 0.53mg soya lecithin (E322).
For a full list of excipients, see section 6.1.
Film-Coated Tablets
Topiramate 100mg Film-Coated Tablets are yellow, round, biconvex tablets with 10mm diameter and engraved with the marking “V4”.
Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.
Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome.
Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. Topiramate is not intended for acute treatment.
General
It is recommended that therapy be initiated at a low dose followed by titration to an effective dose. Dose and titration rate should be guided by clinical response.
Topiramate is available in film-coated tablets and it is recommended that the film-coated tablets not be broken.
It is not necessary to monitor topiramate plasma concentrations to optimize therapy with topiramate. On rare occasions, the addition of topiramate to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and carbamazepine to adjunctive therapy with topiramate may require adjustment of the dose of topiramate.
Topiramate can be taken without regard to meals.
In patients with or without a history of seizures or epilepsy, antiepileptic drugs including topiramate should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency. In clinical trials, daily dosages were decreased in weekly intervals by 50-100 mg in adults with epilepsy and by 25-50 mg in adults receiving topiramate at doses up to 100 mg/day for migraine prophylaxis. In paediatric clinical trials, topiramate was gradually withdrawn over a 2-8 week period.
Monotherapy epilepsy
General
When concomitant antiepileptic drugs (AEDs) are withdrawn to achieve monotherapy with topiramate, consideration should be given to the effects this may have on seizure control. Unless safety concerns require an abrupt withdrawal of the concomitant AED, a gradual discontinuation at the rate of approximately one-third of the concomitant AED dose every 2 weeks is recommended.
When enzyme inducing medicinal products are withdrawn, topiramate levels will increase. A decrease in topiramate dosage may be required if clinically indicated.
Adults
Dose and titration should be guided by clinical response. Titration should begin at 25 mg nightly for 1 week. The dosage should then be increased at 1- or 2-week intervals by increments of 25 or 50 mg/day, administered in two divided doses. If the patient is unable to tolerate the titration regimen, smaller increments or longer intervals between increments can be used.
The recommended initial target dose for topiramate monotherapy in adults is 100 mg/day to 200 mg/day in 2 divided doses. The maximum recommended daily dose is 500 mg/day in 2 divided doses. Some patients with refractory forms of epilepsy have tolerated topiramate monotherapy at doses of 1,000 mg/day. These dosing recommendations apply to all adults including the elderly in the absence of underlying renal disease.
Paediatric population (children over 6 years of age)
Dose and titration rate in children should be guided by clinical outcome. Treatment of children over 6 years of age should begin at 0.5 to 1 mg/kg nightly for the first week. The dosage should then be increased at 1 or 2 week intervals by increments of 0.5 to 1 mg/kg/day, administered in two divided doses. If the child is unable to tolerate the titration regimen, smaller increments or longer intervals between dose increments can be used.
The recommended initial target dose range for topiramate monotherapy in children over 6 years of age is 100 mg/day depending on clinical response, (this is about 2.0 mg/kg/day in children 6-16 years).
Adjunctive therapy epilepsy (partial onset seizures with or without secondary generalization, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome)
Adults
Therapy should begin at 25-50 mg nightly for one week. Use of lower initial doses has been reported, but has not been studied systematically. Subsequently, at weekly or bi-weekly intervals, the dose should be increased by 25-50 mg/day and taken in two divided doses. Some patients may achieve efficacy with once-a-day dosing.
In clinical trials as adjunctive therapy, 200 mg was the lowest effective dose. The usual daily dose is 200-400 mg in two divided doses.
These dosing recommendations apply to all adults, including the elderly, in the absence of underlying renal disease (see section 4.4).
Paediatric population (children aged 2 years and above)
The recommended total daily dose of topiramate as adjunctive therapy is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response.
Daily doses up to 30 mg/kg/day have been studied and were generally well tolerated.
Migraine
Adults
The recommended total daily dose of topiramate for prophylaxis of migraine headache is 100 mg/day administered in two divided doses. Titration should begin at 25 mg nightly for 1 week. The dosage should then be increased in increments of 25 mg/day administered at 1-week intervals. If the patient is unable to tolerate the titration regimen, longer intervals between dose adjustments can be used.
Some patients may experience a benefit at a total daily dose of 50 mg/day. Patients have received a total daily dose up to 200 mg/day. This dose may be benefit in some patients, nevertheless, caution is advised due to an increase incidence of side effects
Paediatric population
Topiramate is not recommended for treatment or prevention of migraine in children due to insufficient data on safety and efficacy.
General dosing recommendations for topiramate in special patient populations
Renal impairment
In patients with impaired renal function (CLCR
In patients with end-stage renal failure, since topiramate is removed from plasma by haemodialysis, a supplemental dose of topiramate equal to approximately one-half the daily dose should be administered on haemodialysis days. The supplemental dose should be administered in divided doses at the beginning and completion of the haemodialysis procedure. The supplemental dose may differ based on the characteristics of the dialysis equipment being used.
Hepatic impairment
In patients with moderate to severe hepatic impairment topiramate should be administered with caution as the clearance of topiramate is decreased.
Elderly
No dose adjustment is required in the elderly population providing renal function is intact.
Hypersensitivity to the active substance or to any of the excipients.
Migraine prophylaxis in pregnancy and in women of childbearing potential if not using effective methods of contraception
In situations where rapid withdrawal of topiramate is medically required, appropriate monitoring is recommended (see section 4.2 for further details).
As with other anti-epileptic drugs, some patients may experience an increase in seizure frequency or the onset of new types of seizures with topiramate. These phenomena may be the consequence of an overdose, a decrease in plasma concentrations of concomitantly used anti-epileptics, progress of the disease, or a paradoxical effect.
Adequate hydration while using topiramate is very important. Hydration can reduce the risk of nephrolithiasis (see below). Proper hydration prior to and during activities such as exercise or exposure to warm temperatures may reduce the risk of heat-related adverse reactions (see section 4.8).
Oligohydrosis (decreased sweating) has been reported in association with the use of topiramate. Decreased sweating and rise in body temperature may occur especially in young children exposed to high ambient temperature.
Mood disturbances/depression
An increased incidence of mood disturbances and depression has been observed during topiramate treatment.
Suicide/suicide ideation
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo-controlled trials of anti-epileptic drugs has shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for topiramate.
In double blind clinical trials, suicide related events (SREs) (suicidal ideation, suicide attempts and suicide) occurred at a frequency of 0.5 % in topiramate treated patients (46 out of 8,652 patients treated) and at a nearly 3 fold higher incidence than those treated with placebo (0.2 %; 8 out of 4,045 patients treated).
Patients therefore should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Nephrolithiasis
Some patients, especially those with a predisposition to nephrolithiasis, may be at increased risk for renal stone formation and associated signs and symptoms such as renal colic, renal pain or flank pain.
Risk factors for nephrolithiasis include prior stone formation, a family history of nephrolithiasis and hypercalciuria. None of these risk factors can reliably predict stone formation during topiramate treatment. In addition, patients taking other medicinal products associated with nephrolithiasis may be at increased risk.
Decreased hepatic function
In hepatically-impaired patients, topiramate should be administered with caution as the clearance of topiramate may be decreased.
Acute myopia and secondary angle closure glaucoma
A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperaemia (redness) and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in paediatric patients as well as adults. Treatment includes discontinuation of topiramate, as rapidly as possible in the judgment of the treating physician, and appropriate measures to reduce intraocular pressure. These measures generally result in a decrease in intraocular pressure.
Elevated intraocular pressure of any aetiology, if left untreated, can lead to serious sequelae including permanent vision loss.
A determination should be made whether patients with history of eye disorders should be treated with topiramate.
Metabolic acidosis
Hyperchloremic, non-anion gap, metabolic acidosis (i.e. decreased serum bicarbonate below the normal reference range in the absence of respiratory alkalosis) is associated with topiramate treatment. Depending on underlying conditions, appropriate evaluation including measurement of serum bicarbonate levels is recommended with topiramate therapy. If signs or symptoms are present (e.g. Kussmaul's deep breathing, dyspnoea, anorexia, nausea, vomiting, excessive tiredness, tachycardia or arrhythmia), indicative of metabolic acidosis, measurement of serum bicarbonate is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering).
This decrease in serum bicarbonate is due to the inhibitory effect of topiramate on renal carbonic anhydrase. Generally, the decrease in bicarbonate occurs early in treatment although it can occur at any time during treatment. These decreases are usually mild to moderate (average decrease of 4 mmol/l at doses of 100 mg/day or above in adults and at approximately 6 mg/kg/day in paediatric patients). Rarely, patients have experienced decreases to values below 10 mmol/l. Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhoea, surgery, ketogenic diet, or certain medicinal products) may be additive to the bicarbonate lowering effects of topiramate.
Chronic metabolic acidosis increases the risk of renal stone formation and may potentially lead to osteopenia.
Chronic metabolic acidosis in paediatric patients can reduce growth rates. The effect of topiramate on bone-related sequelae has not been systematically investigated in paediatric or adult populations.
Depending on underlying conditions, appropriate evaluation including serum bicarbonate levels is recommended with topiramate therapy. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering).
Topiramate should be used with caution in patients with conditions or treatments that represent a risk factor for the appearance of metabolic acidosis.
Nutritional supplementation
Some patients may experience weight loss whilst on treatment with topiramate. It is recommended that patients on topiramate treatment should be monitored for weight loss. A dietary supplement or increased food intake may be considered if the patient is losing weight while on topiramate.
Lecithin
Topiramate 50 mg, 100 mg and 200 mg film-coated tablets contain lecithin (contains soya oil). Patients that are allergic to peanuts or soya should not use this medicinal product.
Impairment of cognitive function
Cognitive impairment in epilepsy is multifactorial and may be due to the underlying aetiology, due to the epilepsy or due to the anti epileptic treatment.
There have been reports in the literature of impairment of cognitive function in adults on topiramate therapy which required reduction in dosage or discontinuation of treatment. However, studies regarding cognitive outcomes in children treated with topiramate are insufficient and its effect in this regard still needs to be elucidated.
Effects of topiramate on other antiepileptic medicinal products
The addition of topiramate to other antiepileptic drugs (phenytoin, carbamazepine, valproic acid, phenobarbital, primidone) has no effect on their steady-state plasma concentrations, except in the occasional patient, where the addition of topiramate to phenytoin may result in an increase of plasma concentrations of phenytoin. This is possibly due to inhibition of a specific enzyme polymorphic isoform (CYP2C19). Consequently, any patient on phenytoin showing clinical signs or symptoms of toxicity should have phenytoin levels monitored.
A pharmacokinetic interaction study of patients with epilepsy indicated the addition of topiramate to lamotrigine had no effect on steady state plasma concentration of lamotrigine at topiramate doses of 100 to 400 mg/day. In addition, there was no change in steady state plasma concentration of topiramate during or after removal of lamotrigine treatment (mean dose of 327 mg/day).
Topiramate inhibits the enzyme CYP 2C19 and may interfere with other substances metabolized via this enzyme (e.g., diazepam, imipramin, moclobemide, proguanil, omeprazol).
Effects of other antiepileptic medicinal products on topiramate
Phenytoin and carbamazepine decrease the plasma concentration of topimarate. The addition or withdrawal of phenytoin or carbamazepine to topiramate therapy may require an adjustment in dosage of the latter. This should be done by titrating to clinical effect. The addition or withdrawal of valproic acid does not produce clinically significant changes in plasma concentrations of topiramate and, therefore, does not warrant dosage adjustment of topiramate. The results of these interactions are summarized below:
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Other medicinal product interactions
Digoxin
In a single-dose study, serum digoxin area under plasma concentration curve (AUC) decreased 12 % due to concomitant administration of topiramate. The clinical relevance of this observation has not been established. When topiramate is added or withdrawn in patients on digoxin therapy, careful attention should be given to the routine monitoring of serum digoxin.
CNS depressants
Concomitant administration of topiramate and alcohol or other CNS depressant medicinal products has not been evaluated in clinical studies. It is recommended that topiramate not be used concomitantly with alcohol or other CNS depressant medicinal products.
St John's Wort (Hypericum perforatum)
A risk of decreased plasma concentrations resulting in a loss of efficacy could be observed with co-administration of topiramate and St John's Wort. There have been no clinical studies evaluating this potential interaction.
Oral contraceptives
In a pharmacokinetic interaction study in healthy volunteers with a concomitantly administered combination oral contraceptive product containing 1 mg norethindrone (NET) plus 35 μg ethinyl estradiol (EE), topiramate given in the absence of other medications at doses of 50 to 200 mg/day was not associated with statistically significant changes in mean exposure (AUC) to either component of the oral contraceptive. In another study, exposure to EE was statistically significantly decreased at doses of 200, 400, and 800 mg/day (18 %, 21 %, and 30 %, respectively) when given as adjunctive therapy in epilepsy patients taking valproic acid. In both studies, topiramate (50-200 mg/day in healthy volunteers and 200-800 mg/day in epilepsy patients) did not significantly affect exposure to NET. Although there was a dose dependent decrease in EE exposure for doses between 200-800 mg/day (in epilepsy patients), there was no significant dose dependent change in EE exposure for doses of 50-200 mg/day (in healthy volunteers). The clinical significance of the changes observed is not known. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with topiramate. Patients taking estrogen containing contraceptives should be asked to report any change in their bleeding patterns. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding.
Lithium
In healthy volunteers, there was an observed reduction (18 % for AUC) in systemic exposure for lithium during concomitant administration with topiramate 200 mg/day. In patients with bipolar disorder, the pharmacokinetics of lithium were unaffected during treatment with topiramate at doses of 200 mg/day; however, there was an observed increase in systemic exposure (26 % for AUC) following topiramate doses of up to 600 mg/day. Lithium levels should be monitored when co-administered with topiramate.
Risperidone
Drug-drug interaction studies conducted under single dose conditions in healthy volunteers and multiple dose conditions in patients with bipolar disorder, yielded similar results. When administered concomitantly with topiramate at escalating doses of 100, 250 and 400 mg/day there was a reduction in risperidone (administered at doses ranging from 1 to 6 mg/day) systemic exposure (16 % and 33 % for steady-state AUC at the 250 and 400 mg/day doses, respectively). However, differences in AUC for the total active moiety between treatment with risperidone alone and combination treatment with topiramate were not statistically significant. Minimal alterations in the pharmacokinetics of the total active moiety (risperidone plus 9-hydroxyrisperidone) and no alterations for 9-hydroxyrisperidone were observed. There were no significant changes in the systemic exposure of the risperidone total active moiety or of topiramate. When topiramate was added to existing risperidone (1-6 mg/day) treatment, adverse events were reported more frequently than prior to topiramate (250-400 mg/day) introduction (90 % and 54 % respectively). The most frequently reported AE's when topiramate was added to risperidone treatment were: somnolence (27 % and 12 %), paraesthesia (22 % and 0 %) and nausea (18 % and 9 % respectively).
Hydrochlorothiazide (HCTZ)
A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of HCTZ (25 mg q24h) and topiramate (96 mg q12h) when administered alone and concomitantly. The results of this study indicate that topiramate Cmax increased by 27 % and AUC increased by 29 % when HCTZ was added to topiramate. The clinical significance of this change is unknown. The addition of HCTZ to topiramate therapy may require an adjustment of the topiramate dose. The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate. Clinical laboratory results indicated decreases in serum potassium after topiramate or HCTZ administration, which were greater when HCTZ and topiramate were administered in combination.
Metformin
A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of metformin and topiramate in plasma when metformin was given alone and when metformin and topiramate were given simultaneously. The results of this study indicated that metformin mean Cmax and mean AUC0-12h increased by 18 % and 25 %, respectively, while mean CL/F decreased 20 % when metformin was co-administered with topiramate. Topiramate did not affect metformin tmax. The clinical significance of the effect of topiramate on metformin pharmacokinetics is unclear. Oral plasma clearance of topiramate appears to be reduced when administered with metformin. The extent of change in the clearance is unknown. The clinical significance of the effect of metformin on topiramate pharmacokinetics is unclear.
When topiramate is added or withdrawn in patients on metformin therapy, careful attention should be given to the routine monitoring for adequate control of their diabetic disease state.
Pioglitazone
A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly. A 15 % decrease in the AUCmax,ss was observed. This finding was not statistically significant. In addition, a 13 % and 16 % decrease in Cmax,ss and AUCmax,ss and AUC
Glyburide
A drug-drug interaction study conducted in patients with type 2 diabetes evaluated the steady-state pharmacokinetics of glyburide (5 mg/day) alone and concomitantly with topiramate (150 mg/day). There was a 25 % reduction in glyburide AUC24 during topiramate administration. Systemic exposure of the active metabolites, 4-trans-hydroxy-glyburide (M1) and 3-cis-hydroxyglyburide (M2), were also reduced by 13 % and 15 %, respectively. The steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide.
When topiramate is added to glyburide therapy or glyburide is added to topiramate therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state.
Other forms of interactions
Agents predisposing to nephrolithiasis
Topiramate, when used concomitantly with other agents predisposing to nephrolithiasis, may increase the risk of nephrolithiasis. While using topiramate, agents like these should be avoided since they may create a physiological environment that increases the risk of renal stone formation.
Valproic acid
Concomitant administration of topiramate and valproic acid has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either medicinal product alone. In most cases, symptoms and signs abated with discontinuation of either medicinal product. This adverse reaction is not due to a pharmacokinetic interaction. An association of hyperammonemia with topiramate monotherapy or concomitant treatment with other anti-epileptics has not been established.
Additional pharmacokinetic drug interaction studies
Clinical studies have been conducted to assess the potential pharmacokinetic drug interaction between topiramate and other agents. The changes in Cmax or AUC as a result of the interactions are summarized below. The second column (concomitant drug concentration) describes what happens to the concentration of the concomitant drug listed in the first column when topiramate is added. The third column (topiramate concentration) describes how the coadministration of a drug listed in the first column modifies the concentration of topiramate.
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Topiramate was teratogenic in mice, rats and rabbits. In rats, topiramate crosses the placental barrier.
There are no adequate and well-controlled studies with topiramate in pregnant women.
Pregnancy registry data suggest that there may be an association between the use of topiramate during pregnancy and congenital malformations (e.g., craniofacial defects, such as cleft lip/palate, hypospadias, and anomalies involving various body systems). This has been reported with topiramate monotherapy and topiramate as part of a polytherapy regimen. This data should be interpreted with caution, as more data is needed to identify increased risks for malformations.
In addition, data from these registries and other studies suggest that, compared with monotherapy, there may be an increased risk of teratogenic effects associated with the use of anti-epileptic drugs in combination therapy.
It is recommended that women of child bearing potential use adequate contraception.
Animal studies have shown excretion of topiramate in milk. The excretion of topiramate in human milk has not been evaluated in controlled studies. Limited observations in patients suggest an extensive excretion of topiramate into breast milk. Since many medicinal products are excreted into human milk, a decision must be made whether to suspend breast-feeding or to discontinue/ abstain from topiramate therapy taking into account the importance of the medicinal product to the mother (section 4.4).
Indication Epilepsy
During pregnancy, topiramate should be prescribed after fully informing the woman of the known risks of uncontrolled epilepsy to the pregnancy and the potential risks of the medicinal product to the foetus.
Indication Migraine Prophylaxis
Topiramate is contraindicated in pregnancy, and in women of childbearing potential if an effective method of contraception is not used (see section 4.3 and 4.5 Interactions with oral contraceptives).
Topiramate acts on the central nervous system and may produce drowsiness, dizziness or other related symptoms. It may also cause visual disturbances and/or blurred vision. These adverse reactions could potentially be dangerous in patients driving a vehicle or operating machinery, particularly until such time as the individual patient's experience with the medicinal products established.
No studies on the effects on the ability to drive and use machines have been performed.
The safety of topiramate was evaluated from a clinical trial database consisting of 4,111 patients (3,182 on topiramate and 929 on placebo) who participated in 20 double-blind trials and 2,847 patients who participated in 34 open-label trials, respectively, for topiramate as adjunctive treatment of primary generalized tonic-clonic seizures, partial onset seizures, seizures associated with Lennox-Gastaut syndrome, monotherapy for newly or recently diagnosed epilepsy or migraine prophylaxis. The majority of ADRs were mild to moderate in severity. ADRs identified in clinical trials, and during post-marketing experience (as indicated by “*”) are listed by their incidence in clinical trials in Table 1. Assigned frequencies are as follows:
Very common
Common
Uncommon
Rare
Not known cannot be estimated from the available data
The most common ADRs (those with an incidence of >5 % and greater than that observed in placebo in at least 1 indication in double-blind controlled studies with topiramate) include: anorexia, decreased appetite, bradyphrenia, depression, expressive language disorder, insomnia, coordination abnormal, disturbance in attention, dizziness, dysarthria, dysgeusia, hypoesthesia, lethargy, memory impairment, nystagmus, paresthesia, somnolence, tremor, diplopia, vision blurred, diarrhoea, nausea, fatigue, irritability, and weight decreased.
Paediatric population
ADRs reported more frequently (
• decreased appetite
• increased appetite
• acidosis hyperchloraemic
• hypokalaemia
• abnormal behaviour
• aggression
• apathy
• initial insomnia
• suicidal ideation
• disturbance in attention
• lethargy
• circadian rhythm sleep disorder
• poor quality sleep
• lacrimation increased
• sinus bradycardia
• feeling abnormal
• gait disturbance.
ADRs that were reported in children but not in adults in double-blind controlled studies include:
• eosinophilia
• psychomotor hyperactivity
• vertigo
• vomiting
• hyperthermia
• pyrexia
• learning disability.
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