Josamine may be available in the countries listed below.
Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Josamine in the following countries:
International Drug Name Search
Treating and preventing breathing problems in patients who have asthma or certain airway diseases. It may also be used for other conditions as determined by your doctor.
Levalbuterol Aerosol is a sympathomimetic (beta-agonist) bronchodilator. It works by relaxing the smooth muscle in the airway, which allows air to flow in and out of the lungs more easily.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Levalbuterol Aerosol. 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 Levalbuterol Aerosol. 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 Levalbuterol Aerosol 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 Levalbuterol Aerosol 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 Levalbuterol Aerosol.
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:
Dizziness; dry mouth; nervousness; runny or stuffy nose; sore or dry throat; tremor.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; new or worsening wheezing, coughing, or trouble breathing; severe headache or dizziness; severe or persistent trouble sleeping; sudden shortness of breath; unusual hoarseness.
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: Levalbuterol 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; dizziness; fast or irregular heartbeat; seizures; severe or persistent dizziness or headache; severe or persistent nervousness, tremor, or trouble sleeping.
Store Levalbuterol Aerosol upright between 68 and 77 degrees F (20 and 25 degrees C). Store with the mouthpiece down. Do not freeze. Avoid temperatures above 120 degrees F (48 degrees C). Store away from heat and direct sunlight. Keep Levalbuterol Aerosol out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Levalbuterol Aerosol. 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.
Preventing hepatitis A and B infections.
Twinrix is a vaccine. It works by stimulating the body to produce antibodies against hepatitis A and B.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Twinrix. 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 Twinrix. However, no specific interactions with Twinrix are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Twinrix 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 Twinrix 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 Twinrix.
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; fatigue; fever; headache; nausea; pain, redness, or swelling at the injection site; tiredness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; fast 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: Twinrix 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.
Twinrix is usually handled and stored by a health care provider. If you are using Twinrix at home, store Twinrix as directed by your pharmacist or health care provider. Keep Twinrix out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Twinrix. 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.
Li-Liquid 509mg/5ml Oral Syrup
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Solution for oral administration
• Treatment of mania and hypomania
• Treatment of recurrent bipolar depression, where the use of alternative anti-depressants has been ineffective
• Prophylactic treatment of recurrent affective disorders
• Control of aggressive or self mutilating behaviour
Treatment should be directed to stabilise manic depressive illness rather than to establish early control of acute episodes.
For oral administration only.
A simple treatment schedule has been evolved which except for some minor variations should be followed whether using Li-Liquid therapeutically or prophylactically. The minor variations to this schedule depend on the elements of the illness being treated and these are described later.
Adults:
1. In patients of average weight (70Kg) an initial total daily dose of 1018 - 3054mg Lithium citrate (equivalent to 400 - 1200mg Lithium carbonate which is 10-30ml of liquid) should be given in divided doses, in the morning and in the evening.
When changing between lithium preparations, serum lithium levels should first be checked, then Li-liquid therapy commenced at a daily dose as close as possible to that of the other form of lithium. As bioavailability varies from product to product (particularly with regard to slow release preparations) a change of product should be regarded as initiation of new treatment.
2. Four to five days after starting treatment (and never longer than one week) a blood sample should be taken for the estimation of serum lithium level.
3. The objective is to adjust the Li-liquid dose so as to maintain the serum lithium level permanently within the diurnal range of 0.5 - 1.5mmol/L. Blood samples for measurement of serum lithium concentration should be taken before a dose is due and not less than 12 hours after the previous dose. 'Target' serum lithium concentration at 12 hours should be 0.5 - 0.8 mmol/L. Serum lithium levels should be monitored weekly until stabilisation is achieved. Levels of more than 1.5mmol/L must be avoided.
4. Lithium therapy should not be initiated unless adequate facilities for routine monitoring of serum concentrations are available. Following stabilisation of serum lithium levels, the period between subsequent estimations can be increased gradually but should not normally exceed three months. Additional measurements should be made following alteration of dosage, on development of intercurrent disease, signs of manic or depressive relapse, following significant changes in sodium or fluid intake, or if signs of lithium toxicity occur.
5. Whilst a high proportion of acutely ill patients may respond within three to seven days after the commencement of therapy with Li-Liquid, it should be continued through any recurrence of the affective disturbance. This is important as the full prophylactic effect may not occur for 6 to 12 months after the initiation of therapy.
6. In patients who show a positive response to therapy with Li-Liquid, treatment is likely to be long term. Careful clinical appraisal of the patient should be exercised throughout medication (see precautions).
Prophylactic treatment of recurrent affective disorders: It is recommended that the described treatment schedule is followed.
Treatment of acute mania, hypomania and recurrent bipolar depression: It is likely that a higher than normal intake of Li-Liquid may be necessary during an acute phase. As soon as control of mania or depression is achieved, the serum lithium level should be determined and it may be necessary, dependent on the results, to lower the dose of Li-Liquid and to re-stabilise serum lithium levels.
Elderly: In elderly patients or those below 50 Kg in weight, it is recommended that a starting dose of 509mg lithium citrate (equivalent to 200mg lithium carbonate which is 5ml of liquid) is taken in divided doses, in the morning and in the evening. Elderly patients may be more sensitive to undesirable effects of lithium and may also require lower doses in order to maintain normal serum lithium levels. It follows therefore that long term patients often require a reduction in dosage over a period of years.
Children and adolescents: Not recommended.
Do not use in patients with a history of hypersensitivity to lithium, renal insufficiency, cardiovascular insufficiency and untreated hypothyroidism.
Lithium should not be given to patients with low body sodium levels, including, for example, dehydrated patients, those on low sodium diets or those with Addison's disease.
Do not use in patients who are breastfeeding.
Hypersensitivity to any of the excipients.
When considering therapy with Li-Liquid, it is necessary to ascertain whether patients are receiving lithium in any other form. If so, check serum levels before proceeding.
Lithium therapy may lower the seizure threshold and increase the risks of neurological adverse effects following electroconvulsive therapy (ECT). If ECT is administered to patients on lithium therapy, lithium levels should checked beforehand to ensure that they are moderate (around 0.4-1 mmol/l) and a low electrical dose at the first treatment should be considered.
It is important to ensure that renal function is normal, if necessary a creatinine clearance test or other renal function test should be performed.
Cardiac and thyroid function should be assessed before commencing lithium treatment. Histological changes (including tubulointerstitial nephropathy) have been reported after long-term treatment with lithium.(see section 4.8)
Patients should be euthyroid before the initiation of lithium therapy.
Renal function, cardiac function and thyroid function should be re-assessed periodically.
Patients should be warned to report if polyuria or polydipsia develops. Nausea, vomiting, diarrhoea, intercurrent infection, fluid deprivation (e.g. excessive sweating, severe dieting) and drugs likely to upset electrolyte balance, such as diuretics, may all reduce lithium excretion and thereby precipitate intoxication; lithium dosage should be closely monitored and a reduction of dosage may be required. Treatment should be discontinued during any intercurrent infection and should only be reinstituted after the patient's physical health has returned to normal.
Caution should be exercised to ensure that diet and fluid intake are normal in order to maintain a stable electrolyte balance. This may be of special importance in very hot weather or work environment.
Use with care in elderly patients as lithium excretion may also be reduced. They may exhibit adverse reactions at serum levels ordinarily tolerated by younger patients.
Patients should be warned of the symptoms of impending toxication (see Section 4.8), of the urgency of immediate action should these symptoms appear, and also of the need to maintain a constant and adequate salt and water intake.
Treatment should be discontinued immediately on the first signs of toxicity (see Section 4.8). Acute renal failure has been reported rarely with lithium toxicity.
Patients with bipolar disorder may experience worsening of their depressive symptoms and/or the emergence of suicidal ideation and behaviours (suicidality) whether or not they are taking medications for bipolar disorder. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes.
Patients (and caregivers of patients) should be alerted about the need to monitor for any worsening of their condition and/or the emergence of suicidal ideation/behaviours or thoughts of harming themselves and to seek medical advice immediately if these symptoms present. .
Excipients in the Formulation
Li -lithium 509mg/5ml Oral Syrup contains methyl and propyl hydroxybenzoates (preservatives) which may cause allergic reactions (possibly delayed).
The medicine contains 1.7g of glucose in each 5ml. When taken according to dosage recommendations, the maximum dose supplies up to 10.2g of glucose.
It also contains 0.4g of sorbitol. When taken according to dosage recommendations, the maximum dose supplies up to 2.2g of sorbitol. It is unsuitable for those with an hereditary fructose intolerance.
The flavour contains a small amount of ethanol (alcohol), less than 100mg per dose.
If one of the following drugs is initiated, lithium dosage should either be adjusted or concomitant treatment stopped, as appropriate.
Interactions which increase lithium concentrations
• Metronidazole
• Non-steroidal anti-inflammatory drugs (monitor serum lithium concentrations more frequently if NSAID therapy is initiated or discontinued)
• ACE inhibitors
• Angiotensin II receptor antagonists.
• Diuretics should be prescribed with extreme caution and careful monitoring. Similar precautions should be exercised on diuretic withdrawal. Note that thiazides show a paradoxical antidiuretic effect resulting in possible water retention and lithium intoxication. If a thiazide diuretic has to be prescribed for a lithium-treated patient, lithium dosage should first be reduced and the patient re-stabilised with frequent monitoring.
• Other drugs affecting electrolyte balance, e.g. steroids, may alter lithium excretion and therefore should be avoided.
• Tetracyclines
Interactions which decrease serum lithium concentrations
• urea
• xanthines
• sodium bicarbonate containing products
• Diuretics (carbonic anhydrase inhibitors)
Interactions causing neurotoxicity
• Neuroleptics (particularly haloperidol at higher dosages), flupentixol, diazepam, thioridazine, fluphenazin, chlorpromazine and clozapine may lead in rare cases to neurotoxicity in the form of confusion, disorientation, lethargy, tremor, extrapyramidal symptoms and myoclonus.
• Methyldopa
• Selective Serotonin Re-uptake Inhibitors (e.g. fluvoxamine and fluoxetine) as this combination may precipitate a serotonergic syndrome.
• Calcium channel blockers may lead to a risk of neurotoxicity in the form of ataxia, confusion and somnolence, reversible after discontinuation of the drug. Lithium concentrations may be increased.
• Carbamazepine may lead to dizziness, somnolence, confusion and cerebellar symptoms.
• Tricyclic antidepressants
• Lithium may prolong the effects of neuromuscular blocking agents. There have been reports of interaction between lithium and phenytoin, indometacin and other prostaglandin-synthetase inhibitors.
Drugs which prolong QT interval
• Use with drugs that prolong QT interval is not recommended
Other
• Raised plasma levels of ADH may occur during treatment.
Lithium therapy should not be used during pregnancy, especially during the first trimester, unless considered essential. There is epidemiological evidence that lithium may be harmful to the foetus in human pregnancy. Lithium crosses the placental barrier. In animal studies lithium has been reported to interfere with fertility, gestation and foetal development. An increase in cardiac and other abnormalities, especially Ebstein anomaly, have been reported. Therefore, a pre-natal diagnosis such as ultrasound and electrocardiogram examination is strongly recommended. In certain cases where a severe risk to the patient could exist if treatment were stopped, lithium has been continued during pregnancy.
It is advisable that women treated with lithium should adopt adequate contraceptive methods. It is strongly recommended that lithium be discontinued before a planned pregnancy. If it is considered essential to maintain treatment with Li-Liquid during pregnancy, serum lithium levels should be monitored closely since renal function changes gradually during pregnancy and suddenly at parturition, requiring dosage adjustments. It is recommended that administration of Li-Liquid be discontinued shortly before delivery and recommenced a few days post-partum.
Babies may show signs of lithium toxicity necessitating fluid therapy in the neonatal period. Babies born with low serum concentrations may have a flaccid appearance which returns to normal without any treatment. Lithium is secreted in breast milk, therefore bottle feeding is recommended. (See section 4.3 Contraindications).
Lithium may impair alertness. Patients should be warned of these risks, and advised not to drive or operate machinery until their susceptibilities are known.
Side effects are usually related to serum lithium concentration and are less common in patients with plasma lithium concentrations below 1.0 mmol/L.
Initial therapy:
Fine tremor of the hands, polyuria and thirst and nausea may occur.
Body as a whole:
Peripheral oedema, muscle weakness, arthralgia, myalgia
Cardiovascular:
Reported cardiovascular effects are cardiac arrhythmia, bradycardia, sinus node dysfunction, peripheral circulatory collapse, hypotension, oedema, Raynaud's phenomenon and ECG changes, such as reversible flattening or inversion of T-waves and QT prolongation, cardiomyopathy.
CNS:
Ataxia, peripheral sensorimotor neuropathy, hyperactive deep tendon reflexes, extrapyramidal symptoms, seizures, slurred speech, dizziness, nystagmus, stupor, coma, pseudotumor cerebri, myasthenia gravis, vertigo, giddiness, dazed feeling, memory impairment.
Dermatological:
Alopecia, acne, folliculitis, pruritus, exacerbation or occurrence of psoriasis, allergic rashes, acneiform eruptions, papular skin disorder, cutaneous ulcers.
Endocrine:
Euthyroid goitre, hypothyroidism, hyperthyroidism, hyperparathyroidism, thyrotoxicosis. Lithium induced hypothyroidism may be managed successfully with concomitant thyroxine.
Gastro-intestinal:
Anorexia, nausea, vomiting, diarrhoea, gastritis, excessive salivation, dry mouth, abdominal discomfort, gastritis.
Haematological:
Leukocytosis
Metabolic and Nutritional:
Hyperglycaemia, hypercalcaemia, hypermagnesaemia, weight gain
Renal:
Polydipsia and/or polyuria, symptoms of nephrogenic diabetes insipidus, histological renal changes with interstitial fibrosis after long term treatment. High serum concentrations of lithium including episodes of acute lithium toxicity may aggravate these changes. The minimum clinically effective dose of lithium should always be used. In patients who develop polyuria and/or polydipsia, renal function should be monitored, e.g. with measurement of blood urea, serum creatinine and urinary protein levels in addition to the routine serum lithium assessment.
Reproductive:
Sexual dysfunction
Senses:
Scotomata, dysgeusia, blurred vision.
Rare cases of nephrotic syndrome, speech disorder, confusion, impaired consciousness, myoclony and abnormal reflex have been reported.
If any of the above symptoms appear, treatment should be stopped immediately and arrangements made for serum lithium measurement.
Any overdose in a patient who has been taking chronic lithium therapy should be regarded as potentially serious. A single acute overdose usually carries low risk and patients tend to show mild symptoms only, irrespective of their serum lithium concentration. However more severe symptoms may occur after a delay if lithium elimination is reduced because of renal impairment, particularly if a slow-release preparation has been taken. The fatal dose, in a single overdose, is probably over 5g.
If an acute overdose has been taken by a patient on chronic lithium therapy, this can lead to serious toxicity occurring even after a modest overdose as the extravascular tissues are already saturated with lithium.
Lithium toxicity can also occur in chronic accumulation for the following reasons:
Acute or chronic overdosage.
Dehydration e.g. due to intercurrent illness.
Deteriorating renal function.
Drug interactions, most commonly involving a thiazide diuretic or a non-steroidal anti-inflammatory drug (NSAID).
In patients with a raised lithium concentration, the risk of toxicity is greater in those with the following underlying medical conditions: hypertension; diabetes; congestive heart failure; chronic renal failure; schizophrenia; Addison's disease.
Symptoms
The onset of symptoms may be delayed, with peak effects not occurring for as long as 24 hours, especially in patients who are not receiving chronic lithium therapy or following the use of a sustained release preparation.
Mild: Nausea, diarrhoea, blurred vision, polyuria, light headedness, fine resting tremor, muscular weakness and drowsiness.
Moderate: Increasing confusion, blackouts, fasciculation and increased deep tendon reflexes, myoclonic twitches and jerks, choreoathetoid movements, urinary or faecal incontinence, increasing restlessness followed by stupor. Hypernatraemia.
Severe: Coma, convulsions, cerebellar signs, cardiac dysrhythmias including sino-atrial block, sinus and junctional bradycardia and first degree heart block. Hypotension or rarely hypertension, circulatory collapse and renal failure.
Management
There is no specific antidote to lithium poisoning. In the event of accumulation, lithium should be stopped and serum estimation should be carried out every 6 hours.
Under no circumstances should a diuretic be used. Osmotic diuresis (mannitol or urea infusion) or alkalinisation of the urine (sodium lactate or sodium bicarbonate infusion) should be initiated. Particular attention should be paid to maintenance of fluid and electrolyte balance and adequate renal function. Where convulsions are present, diazepam may be used. All patients should be observed for a minimum of 24 hours. ECG should be monitored in symptomatic patients. Steps should be taken to correct hypotension.
Consider gastric lavage for non-sustained-release preparations if more than 4 g has been ingested by an adult within one hour or definite ingestion of a significant amount by a child. Slow-release tablets do not disintegrate in the stomach and most are too large to pass up a lavage tube. Gut decontamination is not useful for chronic accumulation. Whole bowel irrigation may be helpful in patients ingesting large quantities of a slow-release preparation.
Note: Activated charcoal does not adsorb lithium.
Peritoneal or haemodialysis is the treatment of choice for severe poisoning and should be considered in all patients with marked neurological or cardic features. If the serum lithium level is over 4.0 mmol/l, in an acute overdose (not in addition to chronic use), if there is a deterioration in the patient's condition, or if the serum lithium concentration is not falling at a rate corresponding to a half-life of under 30 hours. This should be continued until there is no lithium in the serum or dialysis fluid. Serum lithium levels should be monitored for at least a further week to take account of any possible rebound in serum lithium levels as a result of delayed diffusion from the body tissues.
In cases of acute on chronic overdose or in cases of chronic lithium toxicity if the lithium concentration is >4.0 mmol/L, discuss with your local poisons service.
Note: Clinical improvement generally takes longer than reduction of serum lithium concentrations regardless of the method used.
ATC Code: N05A N01
Although lithium is a simple ion it can exert a profound effect on both human behaviour and early embryonic development. Manic depressive psychosis, characterised by dramatic savings in mood can be effectively controlled.
Little is known about the way the lithium ion can modify neurotransmission within the CNS. Many of the proposed mechanisms have suggested an inhibitory effect on components of various neurotransmitter signalling pathways, such as cyclic AMP formation, cyclic GMP formation, G-proteins or inositol phosphate metabolism.
Lithium is rapidly and completely absorbed from the gastrointestinal tract when taken in solution as one of its salts.
Peak plasma concentrations are obtained about 0.75 hours after ingestion of Li-Liquid. Lithium is reported to have a plasma half life of about 7 to 20 hours during the daytime. Lithium is excreted by the kidneys. There is a narrow margin between the therapeutic and the toxic plasma concentration. Therefore, not only is individual titration of lithium dosage essential to ensure constant plasma concentrations for the patient involved, but the conditions under which the blood samples are taken for monitoring must be carefully controlled. In practice a blood sample drawn 12 hours after the last dose of lithium in a patient who has been taking his daily lithium requirement at the scheduled hours during the past 48 hours is measured. Under such conditions the usual therapeutic plasma concentrations of lithium are 0.6 - 1.25 mmol/L, with a reported effective range of 0.5 - 1.5mmol/L
There is epidemiological evidence that lithium may be harmful to the foetus in human pregnancy. Therefore it is recommended that lithium be discontinued or if the lithium is necessary, the levels in the patient should be monitored closely.
Lithium is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.
Citric acid monohydrate, saccharin sodium, sorbitol solution, syrup liquid glucose, propylene glycol, methyl and propyl hydroxybenzoate, colouring E104, cherry flavour (containing ethanol and propylene glycol) and purified water
None known
24 months
6 months opened
Store above 4°C and protect from light.
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Keep out of the reach of children.
Rosemont Pharmaceuticals Ltd
Rosemont House
Yorkdale Industrial Park
Braithwaite Street
Leeds
LS11 9XE
UK
PL 00427/0074
27 January 1992
6th July 2011.
Carbimazole 20mg tablets
Each tablet contains 20mg of carbimazole
For a full list of excipients see section 6.1
Tablet
Pale pink, uncoated, round, biconvex tablets marked with LINK C20 on one side and a scoreline on the reverse.
Carbimazole is an anti-thyroid agent. It is indicated in all conditions where reduction of thyroid function is required.
Such conditions are:
1. Hyperthyroidism.
2. Preparation for thyroidectomy in hyperthyroidism.
3. Therapy prior to and post radio-iodine treatment.
Carbimazole should only be administered if hyperthyroidism has been confirmed by laboratory tests.
Adult:
The initial dose is in the range 20mg to 60mg, taken as two to three divided doses. The dose should be titrated against thyroid function until the patient is euthyroid in order to reduce the risk of over-treatment and resultant hypothyroidism.
Subsequent therapy may then be administered in one of two ways.
Maintenance regimen: Final dosage is usually in the range 5mg to 15mg per day, which may be taken as a single daily dose. Therapy should be continued for at least six months and up to eighteen months. Serial thyroid function monitoring is recommended, together with appropriate dosage modification in order to maintain a euthyroid state.
Blocking-replacement regimen: dosage is maintained at the initial level, i.e. 20mg to 60mg per day, and supplemental L-thyroxine, 50mcg to 150mcg per day, is administered concomitantly, in order to prevent hypothyroidism. Therapy should be continued for at least six months and up to eighteen months. Where a single dosage of less than 20mg is recommended, it is intended that carbimazole 5mg tablets should be taken.
Elderly:
No special dosage regimen is required, but care should be taken to observe the contraindications and warnings as it has been reported that the risk of a fatal outcome to neutrophil dyscrasia may be greater in the elderly (aged 65 or over).
Children:
The usual initial daily dose is 15mg per day adjusted according to response.
Carbimazole 20mg tablets are contraindicated in patients with a previous history of adverse reactions to carbimazole or to any of the excipients listed in section 6.1 List of Excipients.
Serious, pre-existing haematological conditions, severe hepatic insufficiency.
As fatal cases of agranulocytosis with carbimazole have been reported and early treatment of agranulocytosis is essential, it is important that patients should always be warned about the onset of sore throats, bruising or bleeding, mouth ulcers, fever, malaise and should be instructed to stop the drug and to seek medical advice immediately.
In such patients white blood cell counts should be performed, particularly where there is any clinical evidence of infection. Following the onset of any signs and symptoms of hepatic disorder (pain in the upper abdomen, anorexia, general pruritus) in patients, the drug should be stopped and liver function tests performed immediately. Early withdrawal of the drug will increase the chance of complete recovery.
Carbimazole tablets should be used with caution in patients with mild-moderate hepatic insufficiency. If abnormal liver function is discovered, the treatment should be stopped. The half-life may be prolonged due to the liver disorder.
Carbimazole should be stopped temporarily at the time of administration of radio-iodine (to avoid thyroid crisis).
Patients unable to comply with the instructions for use or who cannot be monitored regularly should not be treated with Carbimazole.
Regular full blood count checks should be carried out in patients who may be confused or have a poor memory.
Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Precaution should be taken in patients with intrathoracic goitre, which may worsen during initial treatment with Carbimazole. Tracheal obstruction may occur due to intrathoracic goitre.
The use of carbimazole in non-pregnant women of childbearing potential should be based on individual risk/benefit assessment (see section 4.6).
There is a risk of cross-allergy between carbimazole, the active metabolite thiamazole (methimazole) and propylthiouracil.
Little is known about interactions. Particular care is required in case of concurrent administration of medication capable of inducing agranulocytosis. Since carbimazole is a vitamin K antagonist, the effect of anticoagulants could be intensified. The serum levels of theophylline can increase and toxicity may develop if hyperthyroidic patients are treated with antithyroid medications without reducing the theophylline dosage.
Carbimazole crosses the placenta but, provided the mother's dose is within the standard range and her thyroid status is monitored; there is no evidence of neonatal thyroid abnormalities. Studies have shown that the incidence of congenital malformations is greater in the children of mothers whose hyperthyroidism has remained untreated than in those who have been treated with carbimazole.
However, very rare cases of congenital malformations have been observed following the use of carbimazole or its active metabolite methimazole during pregnancy.
A causal relationship of these malformations, especially choanal atresia and aplasia cutis congenital (congential scalp defects), to transplacental exposure to carbimazole and methimazole cannot be excluded.
Therefore the use of carbimazole in non-pregnant women of childbearing potential should be based on individual risk/benefit assessment (see section 4.4 Special warnings and precautions for use).
Cases of renal, skull, cardiovascular congenital defects, exomphalos, gastrointestinal malformation, umbilical malformation and duodenal atresia have also been reported. Therefore, carbimazole should be used in pregnancy only when propylthiouracil is not suitable.
If carbamazole is used in pregnancy, the dose of carbimazole tablets must be regulated by the patient's clinical condition. The lowest dose possible should be used, and this can often be discontinued three or four weeks before term, in order to reduce the risk of neonatal complications.
The blocking-replacement regimen should not be used during pregnancy since very little thyroxine crosses the placenta in the last trimester.
Carbimazole is excreted in milk and if treatment is continued during lactation the patient should not continue to breast-feed her baby.
The effect on the ability to drive and use machines is not known.
Adverse reactions usually occur in the first eight weeks of treatment. The most common minor reactions are nausea, headache, arthralgia, mild gastrointestinal disturbance, skin rashes and pruritus. These reactions are usually self-limiting and may not require withdrawal of the drug.
Blood and lymphatic system disorders
Bone marrow depression including neutropenia, eosinophilia, leucopenia, agranulocytosis has been reported. Fatalities with carbimazole-induced agranulocytosis have been reported.
Rare cases of pancytopenia/aplastic anaemia and isolated thrombocytopenia have also been reported. Additionally, very rare cases of haemolytic anaemia have been reported.
Patients should always be warned about the onset of sore throats, bruising or bleeding, mouth ulcers, fever, malaise and should be instructed to stop the drug and to seek medical advice immediately. In such patients, white blood cell counts should be performed immediately particularly where there is any clinical evidence of infection.
Nervous system disorders
Headache
Gastrointestinal system disorders
Nausea, mild gastrointestinal disturbance.
Loss of sense of taste has been observed.
General disorders and administration site conditions
Fever, Malaise
Hepato-biliary system disorders
Hepatic disorders, including abnormal liver function tests, hepatitis, cholestatic hepatitis, cholestatic jaundice and most commonly jaundice, have been reported; in these cases carbimazole tablets should be withdrawn.
Injury, poisoning and procedural complications
Bruising
Skin and subcutaneous tissue disorders
Skin rashes, pruritus, urticaria. Hair loss has been occasionally reported.
Musculoskeletal system disorders
Isolated cases of myopathy have been reported. Patients experiencing myalgia after the intake of Carbimazole should have their creatine phosphokinase levels monitored.
Hypersensitivity and allergic reaction
Angioedema and multi-system hypersensitivity reactions such as cutaneous vasculitis, liver, lung and renal effects occur.
Vascular Disorders
Bleeding
No symptoms are likely from a single large dose and so no specific treatment is indicated.
ATC Code: H03B B01 - a thyroid reducing agent.
Carbimazole, a thionamide, is a pro-drug which undergoes rapid and virtually complete metabolism to the active metabolite, thiamazole, also known as Methimazole. The method of action is believed to be inhibition of the organification of iodide and the coupling of iodothyronine residues which in turn suppress the synthesis of thyroid hormones.
Carbimazole is rapidly metabolised to thiamazole. The mean peak plasma concentration of thiamazole is reported to occur one hour after a single dose of thiamazole.
After oral ingestion, peak plasma concentrations of thiamazole, the active moiety, occur at 1 to 2 hours. The total volume of distribution of thiamazole is 0.5l/kg. Thiamazole is concentrated in the thyroid gland. This intrathyroidal concentration of thiamazole has the effect of prolonging the activity of carbimazole. However, thiamazole has a shorter half-life in hyperthyroid patients than in normal controls and so more frequent initial doses are required while the hyperthyroidism is active.
Thiamazole is moderately bound to plasma proteins.
Carbimazole has a half-life of 5.3 to 5.4 hours. It is possible that the plasma half-life may also be prolonged by renal or hepatic disease. See Section 4.2. Posology and method of administration.
Thiamazole crosses the placenta and appears in breast milk. The plasma:milk ratio approaches unity.
Over 90% of orally administered carbimazole is excreted in the urine as thiamazole or its metabolites. The remainder appears in faeces. There is 10% enterohepatic circulation.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
Anhydrous lactose,
Croscarmellose sodium
Iron oxide (red) (E172)
Magnesium stearate
None known
36 months
Do not store above 25°C. Store the blisters in the original package.
The tablets are supplied in white, opaque 250 micron thermoformed PVC blister packs sealed with 20 micron lacquered aluminium foil containing 28, 56, 100 or 112 tablets (not all pack sizes may be marketed).
The heatseal coating lacquer of the aluminium foil consists of a PVC/PVAC co-polymer and polymethacrylate, with the outer side being a heat resistant lacquer based on polyester.
No special requirements.
Archimedes Pharma UK Ltd
250 South Oak Way
Green Park
Reading
Berkshire
RG2 6UG
UK
PL 12406/0020
08/05/2008
08/05/2008
Treating certain skin conditions and muscle/skin conditions (dermatomyositis). It may also be used for certain problems with the penis (Peyronie disease) or other conditions as determined by your doctor.
Potaba Powder is an antifibrotic in the vitamin B family. It works by increasing the oxygen supply in tissues, which helps prevent the formation of fibrous tissue.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Potaba 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 Potaba 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 Potaba 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 Potaba 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 Potaba Powder.
All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; loss of appetite; nausea.
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: Potaba 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 fever, chills, or sore throat; inflammation of the skin; severe or persistent nausea; vomiting; yellowing of the eyes or skin.
Store Potaba Powder 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 Potaba Powder out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Potaba 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.
Generic Name: fluoride topical (FLOR ide TOP i kal)
Brand names: ACT Fluoride Rinse, ACT Kids Fluoride Rinse, ACT Restoring Mouthwash Cinnamon, ACT Restoring Mouthwash Mint, ACT Restoring Mouthwash Spearmint, ACT Restoring Mouthwash Vanilla Mint, Control Rx, Denta 5000 Plus, Dentagel, Ethedent, Fluoridex, Fluoridex Daily Defense, Fluoridex Daily Defense Enhanced Whitening, Fluorigard, Fluorinse, Gel-Kam, Gel-Kam Dental Therapy Pak, Gel-Kam Dentinbloc, Gel-Kam Sensitivity Therapy, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, Nafrinse Solution, NaFrinse Weekly, Neutracare Gel, Neutragard, Neutragard Advanced, Neutral Sodium Fluoride Rinse, Omnii Gel, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Phos-Flur, Prevident, Prevident 500 Plus Boost, PreviDent 5000 Booster, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop, Thera-Flur-N, ...show all 53 brand names.
Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.
Fluoride topical is used as a medication to prevent tooth decay in patients that have a low level of fluoride topical in their drinking water. Fluoride topical is also used to prevent tooth decay in patients who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.
Fluoride may also be used for other purposes not listed in this medication guide.
Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.
Overdose symptoms may result if you swallow large amounts of fluoride while using it.
Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.
If you have gum disease, some forms of fluoride topical may be irritating to your gums. Talk to your dentist or doctor if you have bothersome mouth irritation while using fluoride topical.
Use this medication exactly as directed on the label, or as it was prescribed by your dentist or doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Fluoride topical should be used immediately after brushing or flossing your teeth. For best results, use the medication just before bedtime, unless your doctor tells you otherwise.
Swish this medication in your mouth without swallowing. Then spit it out.
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.
Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).
Overdose symptoms may result if you swallow large amounts of fluoride while using it.
discolored teeth;
weakened tooth enamel; or
any changes in the appearance of your teeth.
Less serious side effects may include:
stomach upset;
headache; or
weakness.
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.
Usual Adult Dose for Prevention of Dental Caries:
Apply a small amount of fluoride toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute.
After use, expectorate.
For best results, do not eat, drink, or rinse for 30 minutes.
Use twice daily as your normal dentifrice or as directed by your dental professional.
Usual Pediatric Dose for Prevention of Dental Caries:
Less than 6 years of age: Do not use unless recommended by a dentist or physician.
Age 6 to 17:
Apply a small amount of fluoride toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute.
Expectorate after use and rinse mouth thoroughly.
Use twice daily as your normal dentifrice or as directed by your dental professional.
It is not likely that other drugs you take orally or inject will have an effect on topically applied fluoride. But many drugs can interact with each other. 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.
