In the US, Xolegel (ketoconazole topical) is a member of the drug class topical antifungals and is used to treat Cutaneous Candidiasis, Dandruff, Seborrheic Dermatitis, Tinea Corporis, Tinea Cruris, Tinea Pedis and Tinea Versicolor.
US matches:
Ketoconazole is reported as an ingredient of Xolegel in the following countries:
International Drug Name Search
Diamorphine Hydrochloride 500mg for Injection
Each ampoule contains 500mg of diamorphine hydrochloride
For full list of excipients, see section 6.1.
A white to off-white, sterile, freeze dried powder of Diamorphine Hydrochloride BP for reconstitution for injection.
Diamorphine may be used in the treatment of severe pain associated with surgical procedures, myocardial infarction or pain in the terminally ill and for the relief of dyspnoea in acute pulmonary oedema.
Diamorphine may be given by the intramuscular, intravenous or subcutaneous routes. Glucose intravenous infusion is the preferred diluent, particularly when the drug is administered by a continuous infusion pump over 24 to 48 hours, although it is also compatible with sodium chloride intravenous infusion.
The dose should be suited to the individual patient.
Adults:
Acute pain, 5mg repeated every four hours if necessary (up to 10mg for heavier, well muscled patients) by subcutaneous or intramuscular injection. By slow intravenous injection, one quarter to one half the corresponding intramuscular dose.
Chronic pain, 5-10mg regularly every four hours by subcutaneous or intramuscular injection. The dose may be increased according to individual needs.
Myocardial infarction, 5mg by slow intravenous injection (1mg/minute) followed by a further 2.5mg to 5mg if necessary.
Acute pulmonary oedema, 2.5mg to 5mg by slow intravenous injection (1mg/minute).
Children and Elderly:
As diamorphine has a respiratory depressant effect, care should be taken when giving the drug to the very young and the elderly and a lower starting dose than normal is recommended.
Hepatic impairment:
A reduction in dosage should be considered in hepatic impairment.
Renal impairment:
The dosage should be reduced in moderate to severe renal impairment.
Debilitated patients:
A reduction in dosage should be considered in debilitated patients.
For concomitant illnesses/conditions where dose reduction may be appropriate see 4.4 Special Warnings and Precautions for Use.
Acute respiratory depression.
Known hypersensitivity to diamorphine or morphine.
Phaeochromocytoma (endogenous release of histamine may stimulate catecholamine release).
Biliary colic (see also biliary tract disorders, 4.4 Special Warnings and Precautions).
Coma. Raised intracranial pressure. Head injuries, as there is an increased risk of respiratory depression that may lead to elevation of CSF pressure. The sedation and pupillary changes produced may interfere with accurate monitoring of the patient
Acute alcoholism.
Diamorphine is also contra-indicated where there is a risk of paralytic ileus, or in acute diarrhoeal conditions associated with antibiotic-induced pseudomembranous colitis or diarrhoea caused by poisoning (until the toxic material has been eliminated).
Repeated administration of diamorphine may lead to dependence and tolerance developing. Abrupt withdrawal in patients who have developed dependence may precipitate a withdrawal syndrome. Great caution should be exercised in patients with a known tendency or history of drug abuse.
Morphine-like opioids should either be avoided in patients with biliary tract disorders or they should be given with an antispasmodic (use in biliary colic is a contraindication see 4.3 Contraindications).
Diamorphine should be given in reduced doses or with caution to patients with asthma or decreased respiratory reserve (including kyphoscoliosis, emphysema, severe obesity, cor pulmonale). Avoid use during an acute asthma attack (see 4.3 Contraindications).
Use with caution or in reduced doses in patients with toxic psychosis, CNS depression, myxoedema, prostatic hypertrophy or urethral stricture, severe inflammatory or obstructive bowel disorders, hypotension, shock, convulsive disorders, adrenal insufficiency or debilitated patients.
Care should be exercised in treating the elderly, children or debilitated patients and those with hepatic or renal impairment (see 4.2 Posology for dosage recommendations).
Palliative care - in the control of pain in terminal illness, these conditions should not necessarily be a deterrent to use.
Alcohol: Alcohol may enhance the sedative and hypotensive effects of diamorphine.
Anti-arrhythmics: Diamorphine may delay the absorption of mexiletine.
Antidepressants, anxiolytics, hypnotics: Severe CNS excitation or depression (hypertension or hypotension) has been reported with the concomitant use of monoamine oxidase inhibitors (MAOIs) and pethidine. It is therefore possible that a similar interaction may occur with other opioid analgesics - avoid concomitant use and for two weeks after stopping MAOIs.
The depressant effects of diamorphine may be exaggerated and prolonged by tricyclic antidepressants, anxiolytics and hypnotics.
Antivirals: Plasma concentration of opioid analgesics (except methadone) is possibly increased by ritinovir.
Opioids potentiate the effects of CNS depressants including tricyclic antidepressants, anxiolytics and hypnotics.
Antipsychotics: enhanced sedative and hypotensive effect.
Antidiarrhoeal and antiperistaltic agents (such as loperamide and kaolin): concurrent use may increase the risk of severe constipation.
Antimuscarinics: The risk of severe constipation and/or urinary retention is increased by administration of antimuscarinic drugs (e.g. atropine).
Motility stimulants: There may be antagonism of the gastrointestinal effects of domperidone and metoclopramide.
Cimetidine inhibits metabolism of opioid analgesics.
Safety has not been established in pregnancy.
Administration during labour may cause respiratory depression in the neonate and gastric stasis during labour, increasing the risk of inhalation pneumonia. Babies born to diamorphine-dependant mothers have been reported to suffer withdrawal symptoms.
Diamorphine should not be given to women who are breast-feeding as there is limited information available on diamorphine in breast milk.
Diamorphine causes drowsiness and mental clouding. If affected patients should not drive or use machines.
The most serious hazard of therapy is respiratory (see also 4.9 Overdose).
The most common side effects are sedation, nausea and vomiting, constipation and sweating. Tolerance generally develops with long-term use, but not to constipation. Other side effects include the following:
Anaphylaxis: Anaphylactic reactions following intravenous injection have been reported rarely.
Cardiovascular: orthostatic hypotension, facial flushing, palpitations, tachycardia, bradycardia.
Central Nervous System: dizziness, vertigo, mental clouding, confusion (with large doses), hallucinations, headache, mood changes including dysphoria and euphoria.
Gastrointestinal: dry mouth, biliary spasm.
Disorders of the eye: blurred or double vision or other changes in vision, miosis.
Sexual dysfunction: long term use may lead to a reversible decrease in libido or potency.
Skin: rash, pruritus, urticaria.
Urinary: urinary retention, difficulty with micturition, ureteric spasm, antidiuretic effect. Tolerance develops to the effects of opioids on the bladder.
The euphoric activity of diamorphine has led to its abuse and physical and psychological dependence may occur (see also 4.4 Special Warnings and Precautions for use).
a) Symptoms
The triad of respiratory depression, coma and constricted pupils is considered indicative of opioid overdosage with dilatation of the pupils occurring as hypoxia develops.
Pulmonary oedema after overdosage is a common cause of fatalities among diamorphine addicts.
Other opioid overdose symptoms include cold, clammy skin, hypotension, bradycardia, circulatory failure, muscle flaccidity, severe weakness, severe nervousness or restlessness, confusion, severe dizziness, severe drowsiness, hallucinations, convulsions (especially in infants and children), rhabdomyolysis progressing to renal failure.
b) Treatment
Respiration and circulation should be maintained and the specific opioid antagonist, naloxone is indicated if coma or bradypnoea are present, using one of the recommended dosage regimens. Oxygen and assisted ventilation should be administered if necessary.
Diamorphine is a narcotic analgesic which acts primarily on the central nervous system and smooth muscle. It is predominantly a central nervous system depressant but it has stimulant actions resulting in nausea, vomiting and miosis.
Diamorphine is a potent opiate analgesic which has a more rapid onset of activity than morphine as the first metabolite, monoacetylmorphine, more readily crosses the blood brain barrier. In man, diamorphine has a half life of two to three minutes. Its first metabolite, monoacetylmorphine, is more slowly hydrolysed in the blood to be concentrated mainly in skeletal muscle, kidney, lung, liver and spleen. Monoacetylmorphine is metabolised to morphine. Morphine forms conjugates with glucuronic acid. The majority of the drug is excreted via the kidney as glucuronides and to a much lesser extent as morphine. About 7-10% is eliminated via the biliary system into the faeces.
Diamorphine does not bind to protein. However, morphine is about 35% bound to human plasma proteins, mainly to albumin. The analgesic effect lasts approximately three to four hours.
There are no additional pre-cliical data of relevance to the prescriber.
Water for Injections (Not detectable in the finished product).
Physical incompatibility has been reported with mineral acids and alkalis and with chlorocresol. Mixtures of diamorphine with cyclizine, haloperidol or dexamethasone may result in precipitation. Mixtures of diamorphine and metoclopramide may become discoloured and should be discarded. Specialised references should be consulted for specific compatibility information.
Three years from date of manufacture
Do not store above 25°C.
Keep container in the outer carton.
5ml Neutral glass ampoules, PhEur. Type 1. Ampoules are packed into cartons of 5, 10 or 50.
The solution should be used immediately after preparation.
Wockhardt UK Limited
Ash Road North
Wrexham
LL13 9UF
UK
PL 29831/0060
27/04/2007
27/04/2007
Treating symptoms of the common cold, flu, or hayfever, and other upper respiratory allergies such as cough, runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes. S-T Forte 2 Liquid may also be used for other conditions as determined by your doctor.
S-T Forte 2 Liquid is a narcotic antitussive (cough suppressant) and antihistamine combination. The antitussive (hydrocodone) works by suppressing the cough center in the brain. The antihistamine (chlorpheniramine) works by blocking the action of histamine, which reduces the symptoms of an allergic reaction such as itch, watery eyes and runny nose.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with S-T Forte 2 Liquid. 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 S-T Forte 2 Liquid. 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 S-T Forte 2 Liquid 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 S-T Forte 2 Liquid 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 S-T Forte 2 Liquid.
When used for long periods of time or at high doses, S-T Forte 2 Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if S-T Forte 2 Liquid stops working well. Do not take more than prescribed.
Some people who use S-T Forte 2 Liquid for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. The early sign of addiction is medicine ineffectiveness. Dependence is not an issue in terminal illness where pain relief is more important. If using S-T Forte 2 Liquid for an extended period of time, do not suddenly stop taking S-T Forte 2 Liquid without your doctor's approval. If you suddenly stop taking S-T Forte 2 Liquid, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever; runny nose or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping this medication.
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:
Constipation; dizziness; drowsiness; dry mouth, throat, or nose; excitement; nausea; stomach upset; thickening or mucus in nose or throat.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; flushing or redness of face; rapid or pounding heartbeat.
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: S-T Forte 2 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 agitation; coma; confusion; deep sleep or loss of consciousness; difficulty breathing; diminished mental alertness; hallucinations; hot or cold skin; large and unchanging pupils; sedation; seizures; shaking; sleeplessness; slowed breathing; slow heartbeat.
Store S-T Forte 2 Liquid 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 S-T Forte 2 Liquid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about S-T Forte 2 Liquid. 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.
Ferrum Hausmann may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ferrous Fumarate is reported as an ingredient of Ferrum Hausmann in the following countries:
Iron Dextran is reported as an ingredient of Ferrum Hausmann in the following countries:
Iron Polymaltose is reported as an ingredient of Ferrum Hausmann in the following countries:
International Drug Name Search
Carbolitium may be available in the countries listed below.
Lithium carbonate (a derivative of Lithium) is reported as an ingredient of Carbolitium in the following countries:
International Drug Name Search
DUODOPA intestinal gel
Levodopa 20mg/ml, carbidopa monohydrate 5mg/ml
Duodopa contains a combination of levodopa and carbidopa for treatment of Parkinson’s disease.
Levodopa is transformed in the body to dopamine, a substance present in the brain and in the spinal cord where it assists in the transfer of impulses between the nerve cells. Too little dopamine can give symptoms like those in Parkinson’s disease, e.g. tremor, rigidity, slow movements, difficulty keeping one’s balance. The treatment with levodopa increases the amount of dopamine and hence reduces these symptoms.
Carbidopa is added to improve the effect and reduce the undesirable effects of levodopa.
Duodopa is a gel that is administered with a pump via a tube directly into the duodenum (the first part of the gut). This means that the two active ingredients are supplied continuously in small doses. Consequently, the content of drug in the blood becomes more constant and the risk of symptoms such as movement disorders is reduced.
If you are pregnant or think you may be pregnant, tell your doctor.
You should not breast-feed while under treatment with Duodopa.
Duodopa can cause somnolence (drowsiness) and/or sudden sleep episodes. You should therefore refrain from driving a car or engaging in activities such as operating machines where impaired alertness may put you, or others, at risk of serious injury or death until you are certain that you are not affected in this way.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those which are not prescribed.
It is particularly important for you to tell your doctor if you are already taking iron tablets or certain medicines used for the treatment of depression, schizophrenia, tuberculosis (TB), high blood pressure, tremor (muscle twitches) or epilepsy. Your doctor may wish to change you to a different medicine or adjust the dose of Duodopa.
Always take Duodopa exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.
Usually, a larger morning dose is administered with the pump (bolus dose) to quickly reach the correct blood level. After that a lower maintenance dose is given. If needed, extra doses may be given. The dose is different for each patient and may need regular fine-tuning.
Do not change the dosage or discontinue the treatment without consulting your doctor. Abrupt interruption of treatment may result in complications.
If you have taken too large a dose of Duodopa, always contact a doctor or hospital.
Like all medicines, Duodopa can have side effects.
If you experience any of these side effects, contact your doctor as soon as you can. Many of the side effects can be relieved by adjusting the dose.
The following very common complications have been reported for the tube system: dislocation of the intestinal tube to the stomach (which leads to an irregular response to treatment); local infection around the tube through the abdominal wall; and stomach pain. If any problem occurs with the pump or the tube system, please contact your doctor.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Do not use Duodopa after the expiry date printed on the carton. Used cassettes should not be re-used but returned to your nearest pharmacy.
Store at 2ºC - 8ºC (in a refrigerator). Duodopa is sensitive to light, so always keep the cassettes in the outer carton, and close it carefully.
The drug cassettes are for single use only and should not be used for longer than one day (up to 16 hours) even if some intestinal gel remains.
Keep Duodopa out of the reach and sight of children.
The active ingredients in Duodopa are levodopa and carbidopa (as monohydrate). The other ingredients are carmellose sodium and purified water. 1 ml of intestinal gel contains 20 mg levodopa and 5 mg carbidopa (as monohydrate). One cassette (100 ml) of Duodopa intestinal gel contains 2000 mg levodopa and 500 mg carbidopa (as monohydrate).
The other ingredients are carmellose sodium and purified water.
and also by
Duodopa is distributed in the UK by
and in Ireland by
This leaflet was last approved in October 2008
DOMPERIDONE 1MG/ML ORAL SUSPENSION
The name of your medicine is Domperidone 1mg/ml Oral Suspension (called domperidone in this leaflet). The active ingredient in this medicine is called domperidone. This belongs to a group of medicines called ‘dopamine antagonists’.
Domperidone works by helping to move food faster through your food pipe (oesophagus), stomach and gut. This is so that it does not stay in the same place for too long. It also helps stop food flowing the wrong way back up your food pipe.
Adults
Children
Do not take domperidone if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking domperidone.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking domperidone. Do this even if they have applied in the past.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without a prescription, including herbal medicines. This is because domperidone can affect the way some other medicines work. Also, some medicines can affect the way domperidone works.
In particular, tell your doctor if you are taking any of the following:
Talk to your doctor or pharmacist before taking domperidone if:
You may feel sleepy, confused or have less control over your movements while taking domperidone. If this happens, do not drive or use any tools or machines.
This medicine contains sorbitol. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking domperidone.
Always take Domperidone Oral Suspension exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
Your doctor may tell you to take a lower dose or to take the medicine less often.
Your doctor will decide how long you will need to take this medicine.
If you take domperidone for more than 4 weeks your doctor may wish to see you again. This is to check if you need to keep taking the treatment.
Like all medicines, domperidone can have side effects, although not everybody gets them.
Rare (affects less than 1 in 1,000 people)
Very rare (affects less than 1 in 10,000 people)
Talk to your doctor or pharmacist if any of the side effects get serious or last longer than a few days, or if you notice any side effects not listed in this leaflet.
Domperidone 1mg/ml Oral Suspension contains domperidone (the active ingredient). It also contains sorbitol, microcrystalline cellulose and carmellose sodium, methylhydroxybenzoate, propylhydroxybenzoate, sodium saccharin, polysorbate 20, sodium hydroxide and water.
Each pack contains a 200 millilitre bottle of a white coloured liquid suspension.
Marketing Authorisation Holder is:
Manufacturer is:
This leaflet was last revised in: September 2008
‘Winthrop’ is a registered trademark. ©2008 Winthrop Pharmaceuticals.
2020635.06
