Pecasolin may be available in the countries listed below.
Lincomycin hydrochloride monohydrate (a derivative of Lincomycin) is reported as an ingredient of Pecasolin in the following countries:
International Drug Name Search
In the US, Zartan is a member of the drug class first generation cephalosporins and is used to treat Acne, Bacterial Endocarditis Prevention, Bacterial Infection, Bladder Infection, Bone infection, Kidney Infections, Otitis Media, Pharyngitis, Prostatitis, Skin Infection and Upper Respiratory Tract Infection.
Losartan is reported as an ingredient of Zartan in the following countries:
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Zartan in the following countries:
International Drug Name Search
Axofin may be available in the countries listed below.
Doxofylline is reported as an ingredient of Axofin in the following countries:
International Drug Name Search
Zitrol XR may be available in the countries listed below.
Glipizide is reported as an ingredient of Zitrol XR in the following countries:
International Drug Name Search
Treating swelling, itching, redness, and irritation of the eyes and eyelids. It may also be used in the ear canal to treat inflammation of the outer ear. It may also be used to treat other conditions as determined by your doctor.
Dexasol Drops are a corticosteroid. It works by decreasing inflammation, which helps to relieve symptoms such as redness, swelling, itching, warmth, and pain.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Dexasol Drops. 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 Dexasol Drops. Because little, if any, of Dexasol Drops are absorbed into the blood, the risk of it interacting with another medicine is low.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Dexasol Drops 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 Dexasol Drops 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 Dexasol Drops.
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:
Blurring of vision; increased pressure in the eye.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cataracts; changes in vision; continued or worsening itching or swelling; continuing blurred vision; discharge from eyes; eye pain; glaucoma; vision problems.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Dexasol 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. Dexasol Drops may be harmful if swallowed.
Store Dexasol Drops tightly closed at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from heat, moisture, and light. Do not store in the bathroom. Keep Dexasol Drops out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Dexasol Drops. 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.
Arelix ACE may be available in the countries listed below.
Piretanide is reported as an ingredient of Arelix ACE in the following countries:
Ramipril is reported as an ingredient of Arelix ACE in the following countries:
International Drug Name Search
Isoniazid may cause severe and sometimes fatal liver problems (eg, hepatitis). The risk of liver problems is greater in patients older than 35 years old. It may also be increased by daily use of alcohol, long-term liver problems or unsanitary injectable drug use. Women, especially those who are black, are Hispanic, or have just had a baby, may also be at increased risk. Hepatitis can develop at any time during treatment but usually occurs during the first 3 months. Your doctor will monitor your liver function and discuss your progress every month.
Contact your doctor right away if you develop unusual fatigue, weakness or fever that lasts longer than 3 days, general feeling of discomfort, loss of appetite, nausea, vomiting, numbness or tingling of the hands or feet, dark urine, yellowing of the skin or eyes, or stomach pain or tenderness.
Patients with active liver problems should not use Isoniazid.
Treating or preventing tuberculosis (TB). If you are using Isoniazid to treat TB, it should always be used along with another medicine.
Isoniazid is an antibacterial. It works by killing TB bacteria.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Isoniazid. 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 Isoniazid. 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 Isoniazid 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 Isoniazid 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 Isoniazid.
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:
Mild stomach upset.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chills or fever; dark urine; general feeling of discomfort; increased thirst or urination; joint pain or swelling; loss of appetite; memory problems; mental or mood changes; nausea; seizures; stomach pain or tenderness; symptoms of low vitamin B6 levels (eg, confusion, cracks in the corners of the mouth, irritability, mouth redness or soreness, scaly rash); tingling or numbness in the hands or feet; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; 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: Isoniazid 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 blurred vision; dizziness; hallucinations; loss of consciousness; nausea; seizures; slurred speech; symptoms of high blood sugar (eg, confusion, increased thirst or urination, rapid breathing, unusual drowsiness); very slow breathing; vomiting.
Store Isoniazid between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Isoniazid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Isoniazid. 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.
Ranbaxy Cefaclor may be available in the countries listed below.
Cefaclor is reported as an ingredient of Ranbaxy Cefaclor in the following countries:
International Drug Name Search
Altezerod may be available in the countries listed below.
Tegaserod is reported as an ingredient of Altezerod in the following countries:
International Drug Name Search
Flixonase may be available in the countries listed below.
UK matches:
Fluticasone is reported as an ingredient of Flixonase in the following countries:
Fluticasone propionate (a derivative of Fluticasone) is reported as an ingredient of Flixonase in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Arbit may be available in the countries listed below.
Irbesartan is reported as an ingredient of Arbit in the following countries:
International Drug Name Search
Apyrene may be available in the countries listed below.
Paracetamol is reported as an ingredient of Apyrene in the following countries:
International Drug Name Search
Ardeytropin may be available in the countries listed below.
Tryptophan is reported as an ingredient of Ardeytropin in the following countries:
International Drug Name Search
Piriton Syrup
Each 5 ml of syrup contains 2mg of chlorphenamine maleate
Syrup
Colourless syrup
Piriton Syrup is indicated for symptomatic control of all allergic conditions responsive to antihistamines, including hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergy, drug and serum reactions, insect bites.
Also indicated for the symptomatic relief of itch associated with chickenpox.
Oral administration only
Do not exceed the stated dose or frequency of dosing
Adults and children 12 years and over: 10ml (4mg) every 4 to 6 hourly. Maximum daily dose: 60ml (24mg) in any 24 hours.
Elderly: The elderly are more likely to experience neurological anticholinergic effects. Consideration should be given to using a lower daily dose (e.g. a maximum of 12 mg in any 24 hours).
Children aged 6 - 12 years: 5ml (2mg) every 4 to 6 hourly. Maximum daily dose: 30ml (12mg) in any 24 hours.
Children aged 2 - 6 years: 2.5ml (1mg) every 4 to 6 hourly. Maximum daily dose: 15ml (6mg) in any 24 hours.
Children aged 1 - 2 years: 2.5ml (1mg) twice daily. The minimum interval between the doses should be 4 hours. Maximum daily dose: 5ml (2mg) in any 24 hours.
Not recommended for children below 1 year
Piriton Syrup is contra-indicated in patients who are hypersensitive to antihistamines or to any of the syrup ingredients.
The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). Piriton Syrup is therefore contra-indicated in patients who have been treated with MAOIs within the last fourteen days.
Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis or asthma; hepatic impairment. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. Increased energy, restlessness, nervousness).
The effects of alcohol may be increased and therefore concurrent use should be avoided.
Should not be used with other antihistamine containing products, including antihistamine containing cough and cold medicines.
Piriton syrup contains 6.3% v/v ethanol. Harmful for those suffering from alcoholism. To be taken into account in pregnant and breast feeding women, children and high risk groups such as patients with liver disease or epilepsy.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Piriton Syrup contains 2.36 g of sucrose per 5 ml. This should be taken into account in patients with diabetes mellitus.
Long term use increases the risk of dental caries and it is essential that adequate dental hygiene is maintained.
Methyl, ethyl and propyl hydroxybenzoates (E218, E214 and E216) may cause allergic reactions (possibly delayed).
Keep out of the reach and sight of children.
Concurrent use of chlorphenamine and hypnotics or anxiolytics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines.
Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity.
The anticholinergic effects of chlorphenamine are intensified by MAOIs (see Contra-indications).
Pregnancy
There are no adequate data from the use of chlorphenamine in pregnant women. The potential risk for humans is unknown, Use during the third trimester may result in reactions in the newborn or premature neonates. Not to be used during pregnancy unless considered essential by a physician.
Lactation
Chlorphenamine maleate and other antihistamines may inhibit lactation and may be secreted in breast milk. Not to be used during lactation unless considered essential by a physician.
The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients' ability to drive and use machinery.
Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). Adverse reactions which have been observed in clinical trails and which are considered to be common (occurring in
Blood and lymphatic system disorders
Unknown: haemolytic anaemia, blood dyscrasias
Immune system disorders:
Unknown: allergic reaction, angioedema, anaphylactic reactions
Metabolism and nutritional disorders:
Unknown: anorexia
Psychiatric disorders:
Unknown: confusion*, excitation*, irritability*, nightmares*, depression
Nervous system disorders*:
Very common: sedation, somnolence
Common: disturbance in attention, abnormal coordination, dizziness, headache
Eye disorders:
Common: blurred vision
Ear and labyrinth disorders
Unknown: tinnitus
Cardiac disorders:
Unknown: palpitations, tachycardia, arrythmias
Vascular disorders:
Unknown: Hypotension
Respiratory, thoracic and Mediastinal disorders:
Unknown: thickening of bronchial secretions
Gastrointestinal disorders:
Common: nausea, dry mouth
Unknown: vomiting, abdominal pain, diarrhoea, dyspepsia
Hepatobiliary disorders:
Unknown: hepatitis including jaundice
Skin and subcutaneous disorders:
Unknown: exfoliative dermatitis, rash, urticaria, photosensitivity,
Musculoskeletal and connective tissue disorders:
Unknown: muscular twitching, muscle weakness.
Renal and Urinary disorders:
Unknown: Urinary retention
General disorders and administration site conditions:
Common: fatigue
Unknown: chest tightness
*Children and the elderly are more susceptible to neurological anticholinergic effects and paradoxical excitation (eg increased energy, restlessness, nervousness)
Symptoms and signs
The estimated lethal dose of chlorphenamine is 25 to 50mg/kg body weight. Symptoms and signs include sedation, paradoxical excitation of the CNS, toxic psychosis, convulsions, apnoea, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment
Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. If overdosage is by the oral route, treatment with activated charcoal should be considered provided there are no contraindications for use and the overdose has been taken recently (treatment is most effective if given within an hour of ingestion.) Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with i.v. diazepam. Haemoperfusion may be used in severe cases.
ATC Code R06AB02
Chlorphenamine is a potent antihistamine (H1-antagonist).
Antihistamines diminish or abolish the actions of histamine in the body by competative reversible blockade of histamine H1-receptor sites on tissues. Chlorphenamine also has anticholinergic activity.
Antihistamines act to prevent the release of histamine, prostaglandins and leukotrines and have been shown to prevent the migration of inflammatory mediators. The actions of chlorphenmine include inhibition of histamine on smooth muscle, cappillary permeability and hence reduction of oedma and wheal in hypersneitivity reactions such as allergy and anaphylaxis.
Chlorphenamine is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours.
Chlorphenamine is metabolised to the monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine.
No additional data of relevance.
Syrup
Glycerol
Ethanol
Tingle flavour
Peppermint oil
Nipasept
Purified Water
None known
3 years.
Store below 25ºC. Protect from light
Amber glass bottle containing 150ml Piriton Syrup. Supplied with a measuring spoon
or
Amber plastic bottle containing 150ml Piriton Syrup. Supplied with a measuring spoon
For detailed instructions for use refer to the Patient Information Leaflet in every pack.
Stafford Miller Limited
980 Great West Road
Brentford
Middlesex TW8 9GS
UNITED KINGDOM
Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK.
PL 00036/0088
14 February 1997/28 April 2000
24/05/2010
Preventing or treating low blood potassium levels when the amount of potassium in the diet is inadequate. Low potassium levels may also be caused by some diseases, severe or prolonged episodes of vomiting or diarrhea, or by certain medicines (eg, diuretics). Symptoms of low potassium levels include weakness, fatigue, or weakening of reflexes.
Gen-K Powder is an electrolyte that is needed for normal functioning of cells, nerve conduction, muscle contraction, kidney function, and acid-base balance.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Gen-K Powder. 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 Gen-K Powder. 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 Gen-K Powder 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 Gen-K Powder 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 Gen-K Powder.
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:
Diarrhea; nausea; stomach discomfort; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bleeding in the stomach; chest pain; heart problems; irregular heartbeat; numbness or tingling in the hands or feet; stomach pain; vomit that looks like coffee grounds; weak or heavy legs.
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: Gen-K 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 chest pain; fast, slow, or irregular heartbeat; limp muscles; listlessness; muscle weakness or paralysis; slow or difficult breathing.
Store Gen-K Powder at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Gen-K Powder out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Gen-K Powder. 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.
Amoxicilina + Ácido Clavulânico Hikma may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Amoxicilina + Ácido Clavulânico Hikma in the following countries:
Clavulanic Acid is reported as an ingredient of Amoxicilina + Ácido Clavulânico Hikma in the following countries:
International Drug Name Search
Déprényl may be available in the countries listed below.
Selegiline hydrochloride (a derivative of Selegiline) is reported as an ingredient of Déprényl in the following countries:
International Drug Name Search
Managing hyperhomocysteinemia or to supplement the diet. It may also be used to treat other conditions as determined by your doctor.
Cerefolin is a vitamin combination. It provides nutritional supplementation for certain nutritional requirements.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Cerefolin. 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 Cerefolin. 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 Cerefolin 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 Cerefolin 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 Cerefolin.
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:
Drowsiness; feeling of swelling of the entire body; mild diarrhea; numbness or tingling.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
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: Cerefolin 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.
Store Cerefolin at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from heat, moisture, and light. Do not store in the bathroom. Keep Cerefolin out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Cerefolin. 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.
Hespercorbin may be available in the countries listed below.
Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Hespercorbin in the following countries:
International Drug Name Search
Andolex-C may be available in the countries listed below.
Benzydamine hydrochloride (a derivative of Benzydamine) is reported as an ingredient of Andolex-C in the following countries:
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Andolex-C in the following countries:
International Drug Name Search
Falzy may be available in the countries listed below.
Felbinac is reported as an ingredient of Falzy in the following countries:
International Drug Name Search
Arandal may be available in the countries listed below.
Allylestrenol is reported as an ingredient of Arandal in the following countries:
International Drug Name Search
Ara II may be available in the countries listed below.
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Ara II in the following countries:
International Drug Name Search
Akineton Retard may be available in the countries listed below.
Biperiden is reported as an ingredient of Akineton Retard in the following countries:
International Drug Name Search
Alben may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Albendazole is reported as an ingredient of Alben in the following countries:
International Drug Name Search
Narcan néonatal may be available in the countries listed below.
Naloxone hydrochloride (a derivative of Naloxone) is reported as an ingredient of Narcan néonatal in the following countries:
International Drug Name Search
Agiserc may be available in the countries listed below.
Betahistine is reported as an ingredient of Agiserc in the following countries:
International Drug Name Search
Aciclovir Pensa may be available in the countries listed below.
Aciclovir is reported as an ingredient of Aciclovir Pensa in the following countries:
International Drug Name Search
Bicalutamida Delta Farma may be available in the countries listed below.
Bicalutamide is reported as an ingredient of Bicalutamida Delta Farma in the following countries:
International Drug Name Search
Amenflox may be available in the countries listed below.
Gatifloxacin is reported as an ingredient of Amenflox in the following countries:
International Drug Name Search
Generic Name: charcoal (CHAR coal)
Brand Names: Actidose-Aqua, Activated Charcoal, Charcoal Plus DS, EZChar, Insta-Char, Liqui-Char, Optimum Charcoal
Charcoal is used to treat stomach pain caused by excess gas, diarrhea, or indigestion.
Charcoal also is used to relieve itching related to kidney dialysis treatment and to treat poisoning or drug overdose.
Charcoal may also be used for other purposes not listed in this medication guide.
Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease, or any type of serious illness.
In a poisoning or overdose situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.
If possible, before you receive charcoal, tell your doctor if you are allergic to any drugs, or if you have:
liver disease;
kidney disease; or
any type of serious illness.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
In a poisoning or overdose situation, it may not be possible to tell your caregivers that you are pregnant or breast-feeding before you are treated with charcoal. However, make sure any doctor caring for your pregnancy or your baby knows that you have received the medication.
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.
Charcoal is usually taken after meals or at the first sign of stomach discomfort.
Stop taking charcoal and call your doctor if your diarrhea lasts longer than 2 days or you also have a fever.
Since charcoal is often taken only when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
An overdose of charcoal is not likely to cause life-threatening symptoms.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
There may be other drugs that can interact with charcoal. 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.
See also: Insta-Char side effects (in more detail)
Acido Folico Omega may be available in the countries listed below.
Folic Acid is reported as an ingredient of Acido Folico Omega in the following countries:
International Drug Name Search
Ametil may be available in the countries listed below.
Prochlorperazine maleate (a derivative of Prochlorperazine) is reported as an ingredient of Ametil in the following countries:
International Drug Name Search
HALDOL 2 mg/ml oral liquid
Each ml of liquid contains haloperidol 2mg
Oral solution
For excipients, see 6.1.
Adults:
• Schizophrenia: treatment of symptoms and prevention of relapse
• Other psychoses: especially paranoid
• Mania and hypomania
• Mental or behavioural problems such as aggression, hyperactivity and self mutilation in the mentally retarded and in patients with organic brain damage
• As an adjunct to short term management of moderate to severe psychomotor agitation, excitement, violent or dangerously impulsive behaviour
• Intractable hiccup
• Gilles de la Tourette syndrome and severe tics
Children:
• Childhood behavioural disorders, especially when associated with hyperactivity and aggression
• Gilles de la Tourette syndrome
• Childhood schizophrenia.
For oral administration.
Since this product is not intended for administration in multiples of 5 ml, the quantities given are expressed per ml.
Dosage for all indications should be individually determined and is best initiated and titrated under close clinical supervision. To determine the initial dose, consideration should be given to the patient's age, severity of symptoms and previous response to other neuroleptic drugs.
Patients who are elderly or debilitated or those with previously reported adverse reactions to neuroleptic drugs may require less Haldol. The normal starting dose should be halved, followed by a gradual titration to achieve optimal response.
Haldol liquid should be used at the minimum dose that is clinically effective.
Adults:
Schizophrenia, psychoses, mania and hypomania, mental or behavioural problems, psychomotor agitation, excitement, violent or dangerously impulsive behaviour, organic brain damage
Initial dose:
Moderate symptomatology 1.5-3.0 mg bd or tds
Severe symptomatology/resistant patients 3.0-5.0mg bd or tds
The same starting doses may be employed in adolescents and resitant schizophrenics who may require up to 30 mg/day.
Maintenance dosage:
Once satisfactory control of symptoms has been achieved, dosage should be gradually reduced to the lowest effective maintenance dose, often as low as 5 or 10 mg/day. Too rapid a dosage reduction should be avoided.
Restlessness or agitation in the elderly
Initial dose 1.5-3.0 mg bd or tds. Titrated as required, to attain an effective maintenance dose(1.5 – 30mg daily).
Gilles de la Tourette syndrome, severe tics, intractable hiccup
Starting dose 1.5 mg tds adjusted according to response. A daily maintenance dose of 10 mg may be required in Gilles de la Tourette syndrome.
Children:
Childhood behavioural disorders/schizophrenia
Total daily maintenance dose of 0.025-0.05 mg/kg/day. Half the dose should be given in the morning and the other half in the evening, up to a maximum of 10 mg daily.
Gilles de la Tourette syndrome
Oral maintenance doses of up to 10 mg/day in most patients.
Comatose states, CNS depression, Parkinson's disease, known hypersensitivity to haloperidol, lesions of basal ganglia.
In common with other neuroleptics, haloperidol has the potential to cause rare prolongation of the QT interval. Use of haloperidol is therefore contra-indicated in patients with clinically significant cardiac disorders e.g. recent acute myocardial infarction, uncompensated heart failure, arrhythmias treated with class IA and III antiarrhythmic medicinal products, QTc interval prolongation, history of ventricular arrhythmia or torsades de pointes clinically significant bradycardia, second or third degree heart block and uncorrected hypokalaemia. Haloperidol should not be used concomitantly with other QT prolonging drugs (see section 4.5, Interactions)
Cases of sudden death have been reported in psychiatric patients receiving antipsychotic drugs, including haloperidol.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
Haldol is not licensed for the treatment of dementia-related behavioural disturbances.
Cardiovascular effects
Very rare reports of QT prolongation and/or ventricular arrhythmias, in addition to rare reports of sudden death, have been reported with haloperidol. They may occur more frequently with high doses and in predisposed patients.
The risk-benefit of haloperidol treatment should be fully assessed before treatment is commenced and patients with risk factors for ventricular arrhythmias such as cardiac disease, family history of sudden death and/or QT prolongation; uncorrected electrolyte disturbances; subarachnoid haemorrhage, starvation or alcohol abuse should be monitored carefully (ECGs and potassium levels), particularly during the initial phase of treatment to obtain steady plasma levels. The risk of QT prolongation and/or ventricular arrhythmias may be increased with higher doses (see Sections 4.8 and 4.9) or with parenteral use, particularly intravenous administration. ECG monitoring should be performed for QT interval prolongation and for serious cardiac dysrhythmias if Haldol is administered intravenously.
Haloperidol should be used with caution in patients known to be slow metabolisers of CYP2D6, and during use of cytochrome P450 inhibitors. Concomitant use of antipsychotics should be avoided. (See Section 4.5)
Baseline ECG is recommended prior to treatment in all patients, especially in the elderly and patients with a positive personal or family history of cardiac disease or abnormal findings on cardiac clinical examination. During therapy, the need for ECG monitoring (e.g. at dose escalation) should be assessed on an individual basis. Whilst on therapy, the dose should be reduced if QT is prolonged, and haloperidol should be discontinued if the QTc exceeds 500 ms.
Periodic electrolyte monitoring is recommended, especially for patients taking diuretics, or during intercurrent illness.
An approximately 3-fold increase risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Haloperidol should be used with caution in patients with risk factors for stroke.
Neuroleptic malignant syndrome
In common with other antipsychotic drugs, Haldol has been associated with neuroleptic malignant syndrome: a rare idiosyncratic response characterised by hyperthermia, generalised muscle rigidity, autonomic instability, altered consciousness. Hyperthermia is often an early sign of this syndrome. Antipsychotic treatment should be withdrawn immediately and appropriate supportive therapy and careful monitoring instituted.
Tardive dyskinesia
As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or after drug discontinuation. The syndrome is mainly characterised by rhythmic involuntary movements of the tongue, face, mouth or jaw. The manifestations may be permanent in some patients. The syndrome may be masked when treatment is reinstituted, when the dosage is increased or when a switch is made to a different antipsychotic drug. Treatment should be discontinued as soon as possible.
Extrapyramidal symptoms
In common with all neuroleptics, extrapyramidal symptoms may occur, e.g. tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia.
Antiparkinson drugs of the anticholinergic type may be prescribed as required, but should not be prescribed routinely as a preventive measure. If concomitant antiparkinson medication is required, it may have to be continued after stopping Haldol if its excretion is faster than that of Haldol in order to avoid the development or aggravation of extrapyramidal symptoms. The physician should keep in mind the possible increase in intraocular pressure when anticholinergic drugs, including antiparkinson agents, are administered concomitantly with Haldol.
Seizures/Convulsions
It has been reported that seizures can be triggered by Haldol. Caution is advised in patients suffering from epilepsy and in conditions predisposing to convulsions (e.g., alcohol withdrawal and brain damage).
Hepatobiliary concerns
As Haldol is metabolised by the liver, caution is advised in patients with liver disease. Isolated cases of liver function abnormalities or hepatitis, most often cholestatic, have been reported.
Endocrine system concerns
Thyroxin may facilitate Haldol toxicity. Antipsychotic therapy in patients with hyperthyroidism should be used only with great caution and must always be accompanied by therapy to achieve a euthyroid state.
Hormonal effects of antipsychotic neuroleptic drugs include hyperprolactinaemia, which may cause galactorrhoea, gynaecomastia and oligo- or amenorrhoea. Very rare cases of hypoglycaemia and of Syndrome of Inappropriate ADH Secretion have been reported.
Venous thromboembolism
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Haldol and preventive measures undertaken.
Additional considerations
In schizophrenia, the response to antipsychotic drug treatment may be delayed. Also, if drugs are withdrawn, recurrence of symptoms may not become apparent for several weeks or months. Acute withdrawal symptoms including nausea, vomiting and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic drugs. Relapse may also occur and gradual withdrawal is advisable.
As with all antipsychotic agents, Haldol should not be used alone where depression is predominant. It may be combined with antidepressants to treat those conditions in which depression and psychosis coexist.
Caution is advised in patients with renal failure and phaeochromocytoma.
Concomitant use of haloperidol with drugs known to prolong the QT interval may increase the risk of ventricular arrhythmias, including torsade de pointes. Therefore concomitant use of these products is not recommended (see section 4.3-Contraindications).
Examples include certain antiarrhythmics, such as those of Class 1A (such as quinidine, disopyramide and procainamide) and class III (such as amiodarone, sotalol and dofetilide), certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV), tricyclic antidepressants (such as amitriptyline), certain tetracyclic antidepressants (such as maprotiline), other neuroleptics (e.g. phenothiazines, pimozide and sertindole), certain antihistamines (such as terfenadine), cisapride, bretylium and certain antimalarials such as quinine and mefloquine. This list is not comprehensive.
Concurrent use of drugs causing electrolyte imbalance may increase the risk of ventricular arrhythmias and is not recommended (see section 4.4-Special Warnings and Precautions for Use). Diuretics, in particular those causing hypokalaemia, should be avoided but, if necessary, potassium-sparing diuretics are preferred.
Haloperidol is metabolised by several routes, including glucuronidation and the cytochrome P450 enzyme system (particularly CYP 3A4 or CYP 2D6). Inhibition of these routes of metabolism by another drug or a decrease in CYP 2D6 enzyme activity may result in increased haloperidol concentrations and an increased risk of adverse events, including QT-prolongation. In pharmacokinetic studies, mild to moderately increased haloperidol concentrations have been reported when haloperidol was given concomitantly with drugs characterised as substrates or inhibitors of CYP 3A4 or CYP 2D6 isozymes, such as, itraconazole, buspirone, venlafaxine, alprazolam, fluvoxamine, quinidine, fluoxetine, sertraline, chlorpromazine, and promethazine. A decrease in CYP2D6 enzyme activity may result in increased haloperidol concentrations. Increases in QTc and extrapyramidal symptoms have been observed when haloperidol was given with a combination of the metabolic inhibitors ketoconazole (400 mg/day) and paroxetine (20 mg/day). It may be necessary to reduce the haloperidol dosage.
Effect of Other Drugs on Haloperidol
When prolonged treatment with enzyme-inducing drugs such as carbamazepine, phenobarbital, rifampicin is added to Haldol therapy, this results in a significant reduction of haloperidol plasma levels. Therefore, during combination treatment, the Haldol dose should be adjusted, when necessary. After stopping such drugs, it may be necessary to reduce the dosage of Haldol.
Sodium valproate, a drug known to inhibit glucuronidation, does not affect haloperidol plasma concentrations.
Effect of Haloperidol on Other Drugs
In common with all neuroleptics, Haldol can increase the central nervous system depression produced by other CNS-depressant drugs, including alcohol, hypnotics, sedatives or strong analgesics. An enhanced CNS effect, when combined with methyldopa, has also been reported.
Haldol may antagonise the action of adrenaline and other sympathomimetic agents and reverse the blood-pressure-lowering effects of adrenergic-blocking agents such as guanethidine.
Haldol may impair the antiparkinson effects of levodopa.
Haloperidol is an inhibitor of CYP 2D6. Haldol inhibits the metabolism of tricyclic antidepressants, thereby increasing plasma levels of these drugs.
Other Forms of Interaction
In rare cases, an encephalopathy-like syndrome has been reported in combination with lithium and haloperidol. It remains controversial whether these cases represent a distinct clinical entity or whether they are in fact cases of NMS and/or lithium toxicity. Signs of encephalopathy-like syndrome include confusion, disorientation, headache, disturbances of balance and drowsiness. One report showing symptomless EEG abnormalities on the combination has suggested that EEG monitoring might be advisable. When lithium and haloperidol therapy are used concomitantly, haloperidol should be given in the lowest effective dose and lithium levels should be monitored and kept below 1 mmol/l. If symptoms of encephalopathy-like syndrome occur, therapy should be stopped immediately.
Antagonism of the effect of the anticoagulant phenindione has been reported.
The dosage of anticonvulsants may need to be increased to take account of the lowered seizure threshold.
The safety of haloperidol in pregnancy has not been established. There is some evidence of harmful effects in some but not all animal studies. Neonates exposed to antipsychotic drugs (including haloperidol) during the third trimester of pregnancy are at risk of adverse effects including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
There have been a number of reports of birth defects following foetal exposure to haloperidol for which a causal role for haloperidol cannot be excluded.. Haldol should be used during pregnancy only if the anticipated benefit outweighs the risk and the administered dose and duration of treatment should be as low and as short as possible.
Haloperidol is excreted in breast milk. There have been isolated cases of extrapyramidal symptoms in breast-fed children. If the use of Haldol is essential, the benefits of breast feeding should be balanced against its potential risks.
Some degree of sedation or impairment of alertness may occur, particularly with higher doses and at the start of treatment, and may be potentiated by alcohol or other CNS depressants. Patients should be advised not to undertake activities requiring alertness such as driving or operating machinery during treatment, until their susceptibility is known.
The data provided below covers all haloperidol formulations including the Haldol Decanoate formulations.
The safety of Haldol was evaluated in 284 haloperidol-treated subjects who participated in 3 placebo-controlled, and in 1295 haloperidol-treated subjects who participated in sixteen double-blind active comparator-controlled clinical trials. The safety of Haldol decanoate was evaluated in 410 subjects who participated in 3 comparator trials (one comparing haloperidol vs. fluphenazine and two comparing the decanoate formulation to the oral formulation), 9 open label trials and 1 dose responsive trial. Based on pooled safety data from these clinical trials, the most commonly reported (% incidence) Adverse Drug Reactions (ADRs) were: Extrapyramidal disorder (34), Insomnia (19), Agitation (15), Hyperkinesia (13), Headache (12), Psychotic disorder (9), Depression (8), Weight increased (8), Orthostatic hypotension (7) and Somnolence (5).
Including the above mentioned ADRs, the following ADRs have been observed from clinical trials and post-marketing experiences reported with the use of Haldol and Haldol decanoate. Frequencies displayed use the following convention:
Very common (
|
| ||||
| |||||
|
|
|
|
| |
|
|
| |||
|
|
| |||
|
|
| |||
|
| ||||
|
|
|
| ||
|
|
|
|
| |
|
|
| |||
|
|
| |||
|
| ||||
|
|
|
| ||
|
| ||||
|
|
|
| ||
|
|
|
| ||
|
|
| |||
|
| ||||
|
| ||||
|
|
|
|
| |
|
|
| |||
|
|
|
Additional Information
Cardiac effects such as QT-interval prolongation, torsade de pointes, ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia), and cardiac arrest have been reported. These effects may occur more frequently with high doses, and in predisposed patients.
Toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported in patients taking haloperidol. The true incidence of these reports is not known.
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown.
Symptoms:
In general, the manifestations of haloperidol overdosage are an extension of its pharmacological actions. The most prominent of which would be severe extrapyramidal symptoms, hypotension and psychic indifference with a transition to sleep. The risk of ventricular arrhythmias possibly associated with QT-prolongation should be considered. The patient may appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state. Paradoxically hypertension rather than hypotension may occur. Convulsions may also occur.
Treatment:
There is no specific antidote to haloperidol. A patent airway should be established and maintained with mechanically assisted ventilation if necessary. In view of isolated reports of arrhythmia ECG monitoring is strongly advised. Hypotension and circulatory collapse should be treated by plasma volume expansion and other appropriate measures. Adrenaline should not be used. The patient should be monitored carefully for 24 hours or longer, body temperature and adequate fluid intake should be maintained.
In cases of severe extrapyramidal symptoms, appropriate anti-Parkinson medication should be administered.
Haloperidol acts as a central dopamine receptor antagonist. It also has some anticholinergic activity and binds to opiate receptors. It also acts at peripheral dopamine receptors.
Haloperidol is absorbed rapidly with a bioavailability of 38-86% (mean 58%) after oral solution. Variable bioavailability is likely to be due to interindividual differences in gastro-intestinal absorption and extent of first-pass metabolism.
Haloperidol is rapidly distributed to extravascular tissues especially liver and adipose tissue. It is approximately 92% bound to plasma proteins.
Haloperidol is extensively metabolised by oxidative dealkylation and ultimately conjugated with glycine. Half-life is approximately 20 hours.
Only limited data are available, however these show no specific hazards apart from decreased fertility, limited teratogenicity as well as embryo-toxic effects in rodents.
Haloperidol has been shown to block the cardiac hERG channel in several published studies in vitro. In a number of in vivo studies intravenous administration of haloperidol in some animal models has caused significant QTc prolongation, at doses around 0.3 mg/kg i.v., giving Cmax plasma levels 3 to 7 times higher than the effective human plasma concentrations of 4 to 20 ng/ml. These intravenous doses which prolonged QTc did not cause arrhythmias. In some studies higher intravenous doses of 1 to 5 mg/kg haloperidol i.v. caused QTc prolongation and/or ventricular arrhythmias at Cmax plasma levels 19 to 68 times higher than the effective human plasma concentrations.
Lactic acid
Methyl parahydroxybenzoate
Purified water
None known.
5 years.
Do not store above 25°C.
Do not refrigerate or freeze
Bottle:
Amber glass (Type III, Ph.Eur); 100 ml
Closure:
Aluminium screw-cap, tamper resistant, coated on the inner side with polyvinylchloride.
OR
Child resistant, polypropylene screw-cap with low density polyethylene insert.
Dosing Device:
A blunt ended 2.5ml plastic dosing pipette with minor graduations of 0.25ml
|
|
Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
PL 00242/0035R
7 June 1989/30 March 2005
16 Nov 2011
POM
