AddressKing Pharmaceuticals, Inc., 501 Fifth Street Bristol, Tennessee 37620 Contact DetailsPhone: (800) 776-3637Website: http://www.kingpharm.com Careers: http://www.kingpharm.com/Careers... |
Thursday, 28 June 2012
King Pharmaceuticals, Inc.
Day & Night Nurse Capsules
1. Name Of The Medicinal Product
Day & Night Nurse Capsules
2. Qualitative And Quantitative Composition
Day Nurse Capsules
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Night Nurse Capsules
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For excipients, see 6.1.
3. Pharmaceutical Form
Capsule, hard
The Day capsule has an orange cap and yellow body printed 'Day Nurse' in black ink on the cap and the body.
The Night capsule has an green cap and white body printed 'Night Nurse' in black ink on the cap and the body.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of colds, chills and influenza during the day.
For the symptomatic relief of colds, chills and influenza at night.
4.2 Posology And Method Of Administration
For oral administration.
Do not exceed the stated dose
Should not be used with other paracetamol-containing products; decongestants antihistamine containing products (including those used on the skin) or cough and cold medicines.
Not to be given to children under 12 years of age
Day Capsules
Adults and children aged 12 years and over
Two capsules every four hours, up to a maximum of three doses in any 24 hour period. Minimum dosing interval: 4 hours
Night Capsules
Adults and children aged 12 years and over
Two capsules just before bedtime. Only one dose should be taken at night. Allow at least 4 hours between taking last dose of Day capsules and the dose of Night capsules.
Elderly
There is no specific requirement for dosage reduction in the elderly. However. the product should not be taken by elderly patients with confusion. The elderly may be more susceptible to adverse effects including confusion and paradoxical excitation with this medicine.
Do not use for longer than 3 days without medical advice.
4.3 Contraindications
Hypersensitivity to any of the ingredients and hyperexcitability.
Not to be used by patients taking monoamine oxidase inhibitors (MAOIs) or for two weeks after stopping the MAOI drug.
Avoid in patients with cardiovascular disease, hypertension, diabetes, epilepsy, hyperthyroidism, phaeochromocytoma, closed angle glaucoma, prostatic enlargement, severe liver or kidney disease and in patients with asthma, chronic bronchitis and bronchiectasis.
4.4 Special Warnings And Precautions For Use
Contains paracetamol.
Do not exceed the stated dose.
The night capsule may cause drowsiness. If affected, do not drive or operate machinery. Alcohol should be avoided.
If symptoms persist, consult your doctor.
Do not take with any other paracetamol-containing products.
Keep all medicines safely away from children.
Special label warnings
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Do not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products.
Special leaflet warnings
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment. May diminish the antihypertensive effects of hypotensive drugs and increase the possibility of arrhythmias in digitalised patients. May enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.
Promethazine may potentiate the action of alcohol and other centrally-acting depressants, hypnotics and anxiolytics. MAOIs may enhance the antimuscarinic effects of antihistamines. Antihistamines have an added antimuscarinic effect with other antimuscarinic drugs including tricyclic antidepressants. Promethazine may interfere with immunologic urine pregnancy tests to produce false results.
4.6 Pregnancy And Lactation
The use of the product during pregnancy or when breast feeding should be avoided.
In view of the possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, the use of the product during pregnancy should be avoided. The safety of pseudoephedrine and pholcodine during lactation has not been established and therefore the product should not be used during this period.
4.7 Effects On Ability To Drive And Use Machines
The night capsule may cause drowsiness. If affected do not drive or operate machinery.
4.8 Undesirable Effects
May cause nausea, vomiting, diarrhoea or constipation, epigastric pain, headache, tinnitus, irritability, nightmares, anorexia, difficulty in micturition, tachycardia, tremors and skin rashes. Drowsiness, dizziness, psychomotor impairment, antimuscarinic effects (such as urinary retention, dry mouth, blurred vision), disorientation, restlessness. There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol. Hypersensitivity reactions including rash and photosensitivity reactions have been reported.
Pholcodine has been associated with immune system disorders: hypersensitivity reactions, anaphylaxis.
4.9 Overdose
Paracetamol
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors:
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts.
Or
c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management:
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Pseudoephedrine Hydrocholride
Symptoms:
As with other sympathomimetics pseudoephedrine overdose will result in symptoms due to central nervous system and cardiovascular stimulation e.g. excitement, irritability, restlessness, tremor, hallucinations, hypertension, palpitations,arrhythmias and difficulty with micturition. In severe cases, psychosis, convulsions, coma and hypertensive crisis may occur. Serum potassium levels may be low due to extracellular to intracellular shifts in potassium.
Management:
Treatment should consist of standard supportive measures. Beta-blockers should reverse the cardiovascular complications and the hypokalaemia.
Promethazine Hydrochloride
Symptoms:
Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children. Coma or excitement may precede their occurrence. Cardiorespiratory depression is uncommon.
Management:
Treatment is supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anti-convulsants.
Dextromethorphan/Pholcodine
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms:
Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.
Management:
This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life, so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol - an analgesic and antipyretic.
Pseudoephedrine - a sympathomimetic agent with both direct and indirect effects on adrenergic receptors.
Pholcodine – an antitussive with little analgesic activity.
Promethazine hydrochloride – an antihistamine with anticholinergic activity.
Dextromethorphan hydrobromide - an antitussive.
5.2 Pharmacokinetic Properties
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after oral administration. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic concentrations. Paracetamol is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10% as glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half life varies from about 1 to 4 hours.
Pseudoephedrine is absorbed from the gastrointestinal tract. It is resistant to metabolism and is excreted largely unchanged in the urine. It has a half life of several hours but elimination is enhanced and half life shortened in acid urine.
Pholcodine is rapidly absorbed after oral administration and maximum plasma concentrations are attained at about 4-8 hours. The elimination half life ranges from 32 to 43 hours. The drug has a large volume of distribution and is only 23.5% protein bound. Pholcodine is metabolised in the liver but undergoes little conjugation with glucuronide and sulphate.
Promethazine hydrochloride is readily absorbed from the gastrointestinal tract, but undergoes extensive first pass metabolism in the liver, with only 25% of the oral dose reaching the systemic circulation unchanged. After oral therapy therapeutic effects are identifiable at 15-30 minutes and peak plasma concentrations at 2 to 3 hours. Estimates of terminal half life in blood plasma are in the range of 4-6 hours. It is extensively plasma protein bound. It is eliminated mainly as metabolites, predominantly by the faecal (via biliary) route, with < 1% of the parent compound and ca. 10% as the sulphoxide metabolite being excreted in the urine over a 72 hour period.
Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted as demethylated metabolites including dextrorphan, and as a minor proportion of unchanged dextromethorphan. In a small proportion of individuals, metabolism proceeds more slowly and dextromethorphan predominates in blood and urine.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Day Nurse Capsules
Sodium lauryl sulphate
Sodium starch glycollate
Magnesium stearate (E572)
Hard gelatin capsule
Quinoline yellow (E104)
Allura red (E 129)
Titanium dioxide (E171)
Printing Ink: Opacode black
(containing: shellac, iron oxide black (E172), propylene glycol)
Night Nurse Capsules
Lactose monohydrate
Dimeticone
Colloidal anhydrous silica
Gelatin
Patent blue V (E131)
Quinoline yellow (E104)
Titanium dioxide (E171).
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Do not store above 25°C. Store in the original package.
6.5 Nature And Contents Of Container
Blisters: 250 μm PVC/40gsm PVDC blister tray with 30 μm aluminium foil lid. Each tray holds 6 Day Nurse capsules and 2 Night Nurse capsules.
Pack size: 24 capsules (3 trays) comprising 18 Day Nurse capsules and 6 Night Nurse capsules.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Beecham Group plc
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.
8. Marketing Authorisation Number(S)
PL 00079/0387
9. Date Of First Authorisation/Renewal Of The Authorisation
18th July 2002
10. Date Of Revision Of The Text
11/11/2010
Wednesday, 27 June 2012
Non-ionic iodinated contrast media
A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.
See also
Medical conditions associated with non-ionic iodinated contrast media:
- Angiocardiography
- Aortography
- Arthrography
- Body Imaging
- Cerebral Arteriography
- Computed Tomography
- Coronary Arteriography
- Cystourethrography
- Digital Subtraction Angiography
- Endoscopy or Radiology Premedication
- Gastrointestinal Tract Examination
- Head Imaging
- Hysterosalpingography
- Intra-arterial Digital Subtraction Angiography
- Intravenous Digital Subtraction Angiography
- Intravenous Urography
- Left Ventriculography
- Myelography
- Pediatric Angiocardiography
- Peripheral Angiography
- Peripheral Arteriography
- Renal Arteriography
- Urography
- Venography
- Visceral Arteriography
Drug List:
Tuesday, 26 June 2012
Amicar
Amicar (aminocaproic acid) is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis.
Its chemical structure is:
Amicar is soluble in water, acid, and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform.
Amicar (aminocaproic acid) Oral Solution for oral administration, contains 0.25 g/mL of aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%, edetate disodium 0.30% as preservatives and the following inactive ingredients: sodium saccharin, sorbitol solution, citric acid anhydrous, natural and artificial raspberry flavor and an artificial bitterness modifier.
Each Amicar (aminocaproic acid) Tablet, for oral administration contains 500 mg or 1000 mg of aminocaproic acid and the following inactive ingredients: povidone, crospovidone, stearic acid, and magnesium stearate.
Amicar - Clinical Pharmacology
The fibrinolysis-inhibitory effects of Amicar appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity.
In adults, oral absorption appears to be a zero-order process with an absorption rate of 5.2 g/hr. The mean lag time in absorption is 10 minutes. After a single oral dose of 5 g, absorption was complete (F=1). Mean ± SD peak plasma concentrations (164 ± 28 mcg/mL) were reached within 1.2 ± 0.45 hours.
After oral administration, the apparent volume of distribution was estimated to be 23.1 ± 6.6 L (mean ± SD). Correspondingly, the volume of distribution after intravenous administration has been reported to be 30.0 ± 8.2 L. After prolonged administration, Amicar has been found to distribute throughout extravascular and intravascular compartments of the body, penetrating human red blood cells as well as other tissue cells.
Renal excretion is the primary route of elimination. Sixty-five percent of the dose is recovered in the urine as unchanged drug and 11% of the dose appears as the metabolite adipic acid. Renal clearance (116 mL/min) approximates endogenous creatinine clearance. The total body clearance is 169 mL/min. The terminal elimination half-life for Amicar is approximately 2 hours.
Indications and Usage for Amicar
Amicar is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required.
Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.
Urinary fibrinolysis, usualIy a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.)
Contraindications
Amicar should not be used when there is evidence of an active intravascular clotting process.
When there is uncertainty as to whether the cause of bleeding is primary fibrinolysis or disseminated intravascular coagulation (DIC), this distinction must be made before administering Amicar.
The following tests can be applied to differentiate the two conditions:
- Platelet count is usually decreased in DIC but normal in primary fibrinolysis.
- Protamine paracoagulation test is positive in DIC; a precipitate forms when protamine sulfate is dropped into citrated plasma. The test is negative in the presence of primary fibrinolysis.
- The euglobulin clot Iysis test is abnormal in primary fibrinolysis but normal in DIC.
Amicar must not be used in the presence of DIC without concomitant heparin.
Warnings
In patients with upper urinary tract bleeding, Amicar administration has been known to cause intrarenal obstruction in the form of glomerular capillary thrombosis or clots in the renal pelvis and ureters. For this reason, Amicar should not be used in hematuria of upper urinary tract origin, unless the possible benefits outweigh the risk.
Subendocardial hemorrhages have been observed in dogs given intravenous infusions of 0.2 times the maximum human therapeutic dose of Amicar and in monkeys given 8 times the maximum human therapeutic dose of Amicar.
Fatty degeneration of the myocardium has been reported in dogs given intravenous doses of Amicar at 0.8 to 3.3 times the maximum human therapeutic dose and in monkeys given intravenous doses of Amicar at 6 times the maximum human therapeutic dose.
Rarely, skeletal muscle weakness with necrosis of muscle fibers has been reported following prolonged administration. Clinical presentation may range from mild myalgias with weakness and fatigue to a severe proximal myopathy with rhabdomyolysis, myoglobinuria, and acute renal failure. Muscle enzymes, especially creatine phosphokinase (CPK) are elevated. CPK levels should be monitored in patients on long-term therapy. Amicar administration should be stopped if a rise in CPK is noted. Resolution follows discontinuation of Amicar; however, the syndrome may recur if Amicar is restarted.
The possibility of cardiac muscle damage should also be considered when skeletal myopathy occurs. One case of cardiac and hepatic lesions observed in man has been reported. The patient received 2 g of aminocaproic acid every 6 hours for a total dose of 26 g. Death was due to continued cerebrovascular hemorrhage. Necrotic changes in the heart and liver were noted at autopsy.
Precautions
General
Amicar inhibits both the action of plasminogen activators and to a lesser degree, plasmin activity. The drug should NOT be administered without a definite diagnosis and/or laboratory finding indicative of hyperfibrinolysis (hyperplasminemia).1
Inhibition of fibrinolysis by aminocaproic acid may theoretically result in clotting or thrombosis. However, there is no definite evidence that administration of aminocaproic acid has been responsible for the few reported cases of intravascular clotting which followed this treatment. Rather, it appears that such intravascular clotting was most likely due to the patient's preexisting clinical condition, e.g., the presence of DIC. It has been postulated that extravascular clots formed in vivo may not undergo spontaneous Iysis as do normal clots.
Reports have appeared in the literature of an increased incidence of certain neurological deficits such as hydrocephalus, cerebral ischemia, or cerebral vasospasm associated with the use of antifibrinolytic agents in the treatment of subarachnoid hemorrhage (SAH). All of these events have also been described as part of the natural course of SAH, or as a consequence of diagnostic procedures such as angiography. Drug relatedness remains unclear.
Aminocaproic acid should not be administered with Factor IX Complex concentrates or Anti-Inhibitor Coagulant concentrates, as the risk of thrombosis may be increased.
Laboratory Tests
The use of Amicar should be accompanied by tests designed to determine the amount of fibrinolysis present. There are presently available: (a) general tests such as those for the determination of the Iysis of a clot of blood or plasma; and (b) more specific tests for the study of various phases of the fibrinolytic mechanisms. These latter tests include both semiquantitative and quantitative techniques for the determination of profibrinolysin, fibrinolysin, and antifibrinolysin.
Drug Laboratory Test Interactions
Prolongation of the template bleeding time has been reported during continuous intravenous infusion of Amicar at dosages exceeding 24 g/day. Platelet function studies in these patients have not demonstrated any significant platelet dysfunction. However, in vitro studies have shown that at high concentrations (7.4 mMol/L or 0.97 mg/mL and greater) aminocaproic acid inhibits ADP and collagen-induced platelet aggregation, the release of ATP and serotonin, and the binding of fibrinogen to the platelets in a concentration-response manner. Following a 10 g bolus of Amicar, transient peak plasma concentrations of 4.6 mMol/L or 0.60 mg/mL have been obtained. The concentration of Amicar necessary to maintain inhibition of fibrinolysis is 0.99 mMol/L or 0.13 mg/mL. Administration of a 5 g bolus followed by 1 to 1.25 g/hr should achieve and sustain plasma levels of 0.13 mg/mL. Thus, concentrations which have been obtained in vivo clinically in patients with normal renal function are considerably lower than the in vitro concentrations found to induce abnormalities in platelet function tests. However, higher plasma concentrations of Amicar may occur in patients with severe renal failure.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate the carcinogenic potential of Amicar and studies to evaluate its mutagenic potential have not been conducted. Dietary administration of an equivalent of the maximum human therapeutic dose of Amicar to rats of both sexes impaired fertility as evidenced by decreased implantations, litter sizes and number of pups born.
Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with Amicar. It is also not known whether Amicar can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Amicar should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Amicar is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Adverse Reactions
Amicar is generally well tolerated. The following adverse experiences have been reported:
General: Edema, headache, malaise.
Hypersensitivity Reactions: Allergic and anaphylactoid reactions, anaphylaxis.
Cardiovascular: Bradycardia, hypotension, peripheral ischemia, thrombosis.
Gastrointestinal: Abdominal pain, diarrhea, nausea, vomiting.
Hematologic: Agranulocytosis, coagulation disorder, leukopenia, thrombocytopenia.
Musculoskeletal: CPK increased, muscle weakness, myalgia, myopathy (see WARNINGS), myositis, rhabdomyolysis.
Neurologic: Confusion, convulsions, delirium, dizziness, hallucinations, intracranial hypertension, stroke, syncope.
Respiratory: Dyspnea, nasal congestion, pulmonary embolism.
Skin: Pruritis, rash.
Special Senses: Tinnitus, vision decreased, watery eyes.
Urogenital: BUN increased, renal failure. There have been some reports of dry ejaculation during the period of Amicar treatment. These have been reported to date only in hemophilia patients who received the drug after undergoing dental surgical procedures. However, this symptom resolved in all patients within 24 to 48 hours of completion of therapy.
Overdosage
A few cases of acute overdosage with Amicar administered intravenously have been reported. The effects have ranged from no reaction to transient hypotension to severe acute renal failure leading to death. One patient with a history of brain tumor and seizures experienced seizures after receiving an 8 gram bolus injection of Amicar. The single dose of Amicar causing symptoms of overdosage or considered to be life-threatening is unknown. Patients have tolerated doses as high as 100 grams while acute renal failure has been reported following a dose of 12 grams.
The intravenous and oral LD50 of Amicar were 3.0 and 12.0 g/kg, respectively, in the mouse and 3.2 and 16.4 g/kg, respectively, in the rat. An intravenous infusion dose of 2.3 g/kg was lethal in the dog. On intravenous administration, tonic-clonic convulsions were observed in dogs and mice.
No treatment for overdosage is known, although evidence exists that Amicar is removed by hemodialysis and may be removed by peritoneal dialysis. Pharmacokinetic studies have shown that total body clearance of Amicar is markedly decreased in patients with severe renal failure.
Amicar Dosage and Administration
An identical dosage regimen may be followed by administering Amicar Tablets or Amicar Oral Solution as follows:
For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 5 Amicar 1000 mg Tablets or 10 Amicar 500 mg Tablets (5 g) or 20 milliliter of Amicar Oral Solution (5 g) be administered during the first hour of treatment, followed by a continuing rate of 1 Amicar 1000 mg Tablet or 2 Amicar 500 mg Tablets (1 g) or 5 milliliter of Amicar Oral Solution (1.25 g) per hour. This method of treatment would ordinarily be continued for about 8 hours or until the bleeding situation has been controlled.
HOW SUPPLIED:
Amicar®
(aminocaproic acid)
Amicar Oral Solution, 0.25 g/mL
Each mL of raspberry-flavored oral solution contains 0.25 g/mL of aminocaproic acid.
16 Fl. Oz. (473 mL) Bottle – NDC 66479-023-56
Store Between 15°-30°C (59°-86°F); Dispense in Tight Containers; Do Not Freeze.
Amicar 500 mg Tablets
Each round, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 10 on the right, contains 500 mg of aminocaproic acid.
Bottle of 100 – NDC 66479-021-82
Store Between 15°-30°C (59°-86°F); Dispense in Tight Containers.
Amicar 1000 mg Tablets
Each oblong, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 20 on the right, contains 1000 mg of aminocaproic acid.
Bottle of 100 – NDC 66479-022-82
Store Between 15°-30°C (59°-86°F); Dispense in Tight Containers.
REFERENCE
1 Stefanini M, Dameshek W: The Hemorrhagic Disorders, Ed. 2, New York, Grune and Stratton; 1962:510-514.
Marketed by
XANODYNE® PHARMACEUTICALS, INC.
Newport, KY 41071
Rev. 09/08
Code 909A00
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Revised: 12/2008XANODYNE PHARMACEUTICALS, INC.
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Compare Amicar with other medications
- Fibrinolytic Bleeding
Friday, 22 June 2012
Mental Retardation Medications
There are currently no drugs listed for "Mental Retardation".
Definition of Mental Retardation: Mental retardation is described as below-average general intellectual function with associated deficits in adaptive behavior that occurs before age 18.
Learn more about Mental Retardation
Medical Encyclopedia:
- Fragile X syndrome
- Krabbe disease
- Mental retardation
- Polydactyly
- Prader-Willi syndrome
- Trisomy 13
- Trisomy 18
- Tuberous sclerosis
Drug List:
Lyflex 5mg / 5ml Oral Solution
1. Name Of The Medicinal Product
Lyflex 5mg/5ml Oral Solution
2. Qualitative And Quantitative Composition
Each 5ml of oral solution contains 5mg Baclofen.
For excipients see Section 6.1
3. Pharmaceutical Form
Oral Solution
Clear yellowish liquid with an odour and flavour of raspberry
4. Clinical Particulars
4.1 Therapeutic Indications
Baclofen is indicated for the relief of voluntary muscle spasticity resulting from disorders such as: multiple sclerosis, other spinal lesions, e.g. tumours of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, traumatic partial section of the cord.
Baclofen Oral Solution is also indicated in adults and children for the relief of spasticity of voluntary muscle arising from e.g. cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury.
Patient selection is important when initiating treatment with Baclofen Oral Solution; it is likely to be of most benefit in patients whose spasticity constitutes a handicap to activities and/or physiotherapy. Treatment should not be commenced until the spastic state has become stabilised.
Paediatric population:
Baclofen is indicated in patients 0 to <18 years for the symptomatic treatment of spasticity of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease.
Baclofen is also indicated for the symptomatic treatment of muscle spasms occurring in spinal cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin such as multiple sclerosis, spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord.
4.2 Posology And Method Of Administration
Baclofen Oral Solution is particularly suitable for children or those adults who are unable to take tablets. Dosage titration can be achieved more precisely with the oral solution.
Before initiating treatment with Baclofen Oral Solution it is advisable to assess realistically the overall extent of clinical improvement that the patient may be expected to achieve with treatment. Careful titration of dosage is essential (particularly in the elderly) until the patient is stabilised. If too high a dose is used initially or if increases in dosage are too rapid side effects may occur. This is particularly relevant if the patient is ambulant in order to minimise muscle weakness in the unaffected limbs or where spasticity is necessary for support.
Adults:
It is recommended that treatment is started with a gradually increasing dosage regimen as follows. However this may be adjusted to meet individual patient requirements:
5mg three times a day for three days
10mg three times a day for three days
15mg three times a day for three days
20mg three times a day for three days
Satisfactory control of symptoms is usually obtained with doses of up to 60mg daily, but a careful adjustment is often necessary to meet the requirements of each individual patient. The dose may be increased slowly if required, but a maximum daily dose of more than 100mg is not advised unless the patient is in hospital under careful medical supervision. Small frequent doses may prove better in some cases than larger spaced doses. Also some patients benefit from the use of Baclofen Oral Solution only at night to counteract painful flexor spasm. Similarly a single dose given approximately 1 hour prior to performance of specific tasks such as washing, dressing, shaving, physiotherapy, will often improve mobility.
Once the maximum recommended dose has been reached, if the therapeutic effect is not apparent within 6 weeks consideration should be made by the physician as to whether to continue treatment with Baclofen Oral Solution .
Elderly:
Elderly patients may be more susceptible to side effects, particularly in the early stages of starting treatment with Baclofen Oral Solution. Small doses should therefore be used at the start of treatment, the dose being titrated gradually against the response, under careful supervision. There is no evidence that the eventual average maximum dose differs from that in younger patients.
Paediatric population (0 to <18 years):
Treatment should usually be started with a very low dose (corresponding to approximately 0.3 mg/kg a day), in 2-4 divided doses (preferably in 4 divided doses).
The dosage should be raised cautiously, at about 1 week intervals, until it becomes sufficient for the child's individual requirements. The usual daily dose for maintenance therapy ranges between 0.75 and 2 mg/kg body weight. The total daily dose should not exceed a maximum of 40 mg/day in children below 8 years of age. In children over 8 years of age a maximum daily dose of 60 mg/day may be given.
Patients with impaired renal function:
In patients with impaired renal function or undergoing chronic haemodialysis, a particularly low dosage of Baclofen should be selected i.e. approx. 5mg daily.
Patients with spastic states of cerebral origin:
Unwanted effects are more likely to occur in these patients. It is therefore recommended that a very cautious dosage schedule be adopted and that patients be kept under appropriate surveillance.
4.3 Contraindications
Hypersensitivity to baclofen or any of the ingredients of the oral solution, peptic ulceration.
4.4 Special Warnings And Precautions For Use
Psychotic disorders, schizophrenia, depressive or manic disorders, confusional states or Parkinson's disease may be exacerbated by treatment with baclofen. Patients suffering from these conditions should therefore be treated cautiously and kept under close surveillance.
Baclofen may also exacerbate epileptic manifestations but can be used provided appropriate supervision and adequate anticonvulsive therapy are maintained. Baclofen should be used with extreme care in patients already receiving antihypertensive therapy, (see Interactions).
Baclofen should be used with caution in patients suffering from cerebrovascular accidents or from respiratory, hepatic or renal impairment.
During treatment with baclofen, neurogenic disturbances affecting emptying of the bladder may show an improvement. In patients with pre-existing sphincter hypertonia, acute retention of urine may occur; the drug should be used with caution in such cases.
There is very limited clinical data on the use of Baclofen in children under the age of one year. Use in this patient population should be based on the physician's consideration of individual benefit and risk of therapy.
This medicine contains sorbitol. Patients with rare hereditary problems should not take this medicine. Calorific value 2.6kcal/g sorbitol”.
Abrupt withdrawal:
Anxiety and confusional states, hallucinations, psychotic, manic or paranoid states, convulsions (status epilepticus), dyskinesia, tachycardia, hyperthermia and as rebound phenomenon temporary aggravation of spasticity have been reported with abrupt withdrawal of baclofen, especially after long term medication. Treatment should always, (unless serious adverse effects occur), be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks.
Since in rare instances elevated SGOT, alkaline phosphatase and glucose levels in serum have been recorded, appropriate laboratory tests should be performed in patients with liver diseases or diabetes mellitus in order to ensure that no drug induced changes in these underlying diseases have occurred.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Where baclofen is taken concomitantly with other drugs acting on the CNS with synthetic opiates or with alcohol, increased sedation may occur.
The risk of respiratory depression is also increased. Careful monitoring of respiratory and cardiovascular functions is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
During concurrent treatment with tricyclic antidepressants, the effect of baclofen may be potentiated, resulting in pronounced muscular hypotonia.
Since concomitant treatment with baclofen and anti-hypertensives is likely to increase the fall in blood pressure, the dosage of antihypertensive medication should be adjusted accordingly. Hypotension has been reported in one patient receiving morphine and intrathecal baclofen.
Drugs which may produce renal insufficiency e.g. ibuprofen may reduce baclofen excretion leading to toxic effects. In patients with Parkinson's disease receiving treatment with baclofen and levodopa plus carbidopa, there have been reports of mental confusion, hallucinations, nausea and agitation.
4.6 Pregnancy And Lactation
During pregnancy, especially in the first 3 months, baclofen should only be used if its use is of vital necessity. The benefits of the treatment for the mother must be carefully weighed against the possible risks for the child. Baclofen crosses the placental barrier.
In mothers taking baclofen in therapeutic doses, the active substance passes into the breast milk, but in quantities so small that no undesirable effects on the infant would be expected.
4.7 Effects On Ability To Drive And Use Machines
The patient's reactions may be adversely affected by baclofen induced sedation or decreased alertness. Patients should therefore exercise due caution. Operating equipment or machinery may be hazardous.
4.8 Undesirable Effects
Unwanted effects occur mainly at the start of treatment, if the dosage is raised too rapidly, if large doses are employed, or in elderly patients. They are often transitory and can be attenuated or eliminated by reducing the dosage; they are seldom severe enough to necessitate withdrawal of the medication.
Should nausea persist following a reduction in dosage, it is recommended that baclofen be ingested with food or a milk beverage.
In patients with a case history of psychiatric illness or with cerebrovascular disorders (e.g. stroke) as well as in elderly patients, adverse reactions may assume a more serious form.
Central nervous system:
Frequent (>10%): particularly at the start of treatment daytime sedation, drowsiness, and nausea.
Occasional (> 1%,<10%): respiratory depression, light-headedness, lassitude, exhaustion, mental confusion, dizziness, headache, insomnia, euphoria, depression, muscular weakness, ataxia, tremor, hallucinations, nightmares, myalgia, nystagmus, dry mouth.
Rare (> 0.001%,<1%): paraesthesia, dysarthria. Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients.
Sense organs:
Occasional (> 1%,<10%): accommodation disorders, visual disturbance.
Rare (> 0.001%,<1%): dysgeusia.
Gastro-intestinal tract:
Frequent (>10%): nausea.
Occasional (> 1%,<10%): mild gastro-intestinal disturbances constipation, diarrhoea, retching and vomiting.
Rare (> 0.001%,<1%): abdominal pain
Cardiovascular system:
Occasional (> 1%,<10%): hypotension, diminished cardiovascular function.
Urogenital system:
Frequent (>10%): frequency of micturition, enuresis, dysuria.
Rare (> 0.001%,<1%): urinary retention, impotence.
Liver:
Rare (> 0.001%,<1%): disorders of hepatic function.
Skin:
Occasional (> 1%,<10%): hyperhydrosis, skin rash.
General disorders and administration site conditions:
Very rare: hypothermia.
Certain patients have shown increased spasticity as a paradoxical reaction to the medication.
An undesirable degree of muscular hypotonia – making it more difficult for patients to walk or fend for themselves – may occur and can usually be relieved by re-adjusting the dosage (i.e. by reducing the doses given during the day and possibly increasing the evening dose).
The excipient sorbitol may have a mild laxative effect when taken in large amounts and hydroxybenzoates may cause allergic reactions which may be possibly delayed
4.9 Overdose
Symptoms:
Prominent features of overdosage are signs of central nervous depression: drowsiness, impairment of consciousness, respiratory depression, coma. Also liable to occur are: confusion, hallucinations, agitation, accommodation disorders, absent pupillary reflex; generalised muscular hypotonia, myoclonia, hyporeflexia or areflexia; convulsions; peripheral vasodilatation, hypotension, bradycardia; hypothermia; nausea, vomiting, diarrhoea, hypersalivation; elevated LDH, SGOT and AP values.
A deterioration in the condition may occur if various substances or drugs acting on the central nervous system (e.g. alcohol, diazepam, tricyclic antidepressants) have been taken at the same time.
Treatment:
No specific antidote is known.
Elimination of the drug from the gastro-intestinal tract (induction of vomiting, gastric lavage; comatose patients should be intubated prior to gastric lavage), administration of activated charcoal; if necessary, saline aperient; in respiratory depression, administration of artificial respiration, also measures in support of cardiovascular functions. Since the drug is excreted chiefly via the kidneys, generous quantities of fluid should be given, possibly together with a diuretic. In the event of convulsions diazepam should be administered cautiously i.v.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Baclofen is an antispastic agent acting at the spinal level. It is a gamma-aminobutyric acid (GABA) derivative, with a similar chemical structure, but differing in action.
Baclofen depresses monosynaptic and polysynaptic reflex transmission, probably by stimulating the GABA beta receptors, this stimulation in turn inhibiting the release of the excitatory amino acids glutamate and aspartate. Neuromuscular transmission is unaffected by baclofen.
The major benefits of baclofen stem from its ability to reduce painful flexor spasms and spontaneous clonus thereby facilitating the mobility of the patient, increasing their independence and helping rehabilitation.
Baclofen also exerts an antinociceptive effect. General well being is often improved and sedation is less often a problem than with centrally acting drugs.
Baclofen stimulates gastric acid secretion.
5.2 Pharmacokinetic Properties
Absorption:
Baclofen is rapidly and completely absorbed from the gastro-intestinal tract. No significant difference between the liquid and tablet formulations is observed in respect of tmax, cmax and bioavailability.
Following oral administration of single doses (10-30mg) peak plasma concentrations are reached after 0.5 to 3.0 hours and the areas under the serum concentration curves are proportional to the dose.
Distribution:
The volume of distribution of baclofen is 0.7 l/kg and the protein binding rate is approximately 30%. In cerebrospinal fluid active substance concentrations are approximately 8.5 times lower than in the plasma.
Biotransformation:
Baclofen is metabolised to only a minor extent. Deamination yields the main metabolite, β-(p-chlorophenyl)-4-hydroxybutyric acid, which is pharmacologically inactive.
Elimination / excretion:
The plasma elimination half-life of baclofen averages 3 to 4 hours. The serum protein binding rate is approximately 30%.
Baclofen is eliminated largely in unchanged form. Within 72 hours, about 75% of the dose is excreted via the kidneys with about 5% of this amount as metabolites.
Elderly:
The pharmacokinetics of baclofen in elderly patients are virtually the same as in young subjects. The peak plasma concentrations of baclofen in elderly patients are slightly lower and occur later than in healthy young subjects but the AUCs are similar in the two groups.
5.3 Preclinical Safety Data
Baclofen increases the incidence of omphaloceles (ventral hernias) in the foetuses of rats given approximately 13 times the maximum oral dose (on a mg/kg basis) recommended for human use. This was not seen in mice or rabbits.
A dose related increase in the incidence of ovarian cysts, and a less marked increase in enlarged and/or haemorrhagic adrenals have been observed in female rats treated for 2 years. The clinical relevance of these findings is not known.
Experimental evidence to date suggests that baclofen does not possess either carcinogenic or mutagenic properties.
6. Pharmaceutical Particulars
6.1 List Of Excipients
70% Sorbitol Solution
Methyl hydroxybenzoate,
Propyl hydroxybenzoate,
Raspberry flavour (contains propylene glycol),
Carmellose Sodium,
Purified water.
Baclofen Oral Solution is sugar free.
6.2 Incompatibilities
None known.
6.3 Shelf Life
24 months
Once opened use within 56 days of first opening
Baclofen Oral Solution may be diluted with purified water. The shelf life of the diluted solution is 14 days when stored not above 25ºC.
6.4 Special Precautions For Storage
Do not store above 25ºC
Store in the original container
Do not refrigerate or freeze
6.5 Nature And Contents Of Container
Pharmaceutical grade type III amber glass bottle with child resistant and tamper evident polypropylene faced cap with an EPE liner
6.6 Special Precautions For Disposal And Other Handling
There is no specific instruction for use/handling.
7. Marketing Authorisation Holder
Chemidex Pharma Limited,
Egham Business Village,
Crabtree Road,
Egham,
Surrey,
TW20 8RB
8. Marketing Authorisation Number(S)
PL 17736 / 0061
9. Date Of First Authorisation/Renewal Of The Authorisation
24 May 2004
10. Date Of Revision Of The Text
May 2011
Monday, 18 June 2012
Mallory-Weiss Syndrome Medications
There are currently no drugs listed for "Mallory-Weiss Syndrome". See Esophageal Disease.
Definition of Mallory-Weiss Syndrome: Mucosal gastric tear, only 10% are purely oesophageal: most are at GE junction or proximal stomach, M greater than F, associated with retching, EtOH, massive haematemesis, abdominal pain.
Drug List:
Saturday, 9 June 2012
Konakion MM Paediatric Ampoules 2mg / 0.2ml
UK
Roche
Konakion MM Paediatric 2 mg/0.2 ml
solution for injection or oral administration
Phytomenadione (vitamin K1)
Please read all of this leaflet carefully before your baby or child is given this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask the doctor, nurse or midwife.
- This medicine has been prescribed for your child. Do not pass it on to others. It may harm them even if their symptoms are the same.
- If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell the doctor, nurse or midwife.
In this leaflet:
- 1. What Konakion MM Paediatric is and what it is used for
- 2. Before your baby or child is given Konakion MM Paediatric
- 3. How Konakion MM Paediatric is given
- 4. Possible side effects
- 5. How Konakion MM Paediatric is stored
- 6. Further information
What Konakion MM Paediatric is and what it is used for
Konakion MM Paediatric contains a medicine called phytomenadione. This is a man-made vitamin called vitamin K1. Konakion MM Paediatric is used for the following:
- Babies who do not have enough vitamin K in their bodies. Giving Konakion MM Paediatric prevents and treats bleeding caused by a lack of vitamin K. This is called ‘vitamin K deficiency bleeding’ (VKDB). This is a serious, but rare condition. All newborn babies are given vitamin K1 with their parent’s permission.
- Babies and young children who may have had too much of certain medicines to thin their blood (called anticoagulants). Konakion MM Paediatric is normally used to treat these children after advice from a specialist haematologist (blood doctor).
Konakion MM Paediatric works by helping your body make blood clotting factors. These blood clotting factors help stop bleeding.
Before your baby or child is given Konakion MM Paediatric
Your child must not be given Konakion MM Paediatric if they are allergic (hypersensitive) to:
- Phytomenadione or any of the other ingredients of Konakion MM Paediatric (listed in Section 6: Further information).
If you are not sure if this applies to your child, talk to the doctor, nurse or midwife before they are given Konakion MM Paediatric.
Take special care with Konakion MM Paediatric
Check with your doctor, nurse or midwife before your child has Konakion if:
- They have a problem with the flow of bile in their body (cholestatic disease). Bile is important in helping the body to use some vitamins.
Taking other medicines
Please tell your doctor, nurse or midwife if your child is taking or has recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Konakion MM Paediatric can affect the way some medicines work. Also some other medicines may affect the way Konakion MM Paediatric works.
In particular, tell your doctor, nurse or midwife if your baby or child is taking medicines to stop their blood clotting (anticoagulants).
Important information about some of the ingredients of Konakion MM Paediatric
Konakion MM Paediatric is essentially ‘sodium free’ as it contains less than 1 millimole sodium (2.64 mg in each millilitre).
How Konakion MM Paediatric is given
Konakion MM Paediatric can be given to your child by injection into a vein or muscle or by mouth (orally). How it is given will depend upon what the medicine is being used for and whether your baby was born prematurely. The doctor will decide how much Konakion MM Paediatric your child needs.
Prevention of vitamin K deficiency bleeding
Healthy babies delivered at or nearly full term
These babies will be given either:
- A single injection (1 mg) either at birth or soon after, or
- By mouth (oral) a first dose (2 mg) at birth or soon after. This is followed by a second 2 mg dose after 4 to 7 days which you will be asked to give to your baby yourself.
Further doses:
- Babies who are given vitamin K by mouth and who are breast-fed (not given formula milk) may need more doses of vitamin K by mouth.
- If further doses are needed the next dose should be given at 1 month of age (2 mg).
- This may be followed by doses every month until your baby starts to have some formula milk or solid food.
- Bottle-fed babies given the two doses of vitamin K by mouth do not need any more doses of vitamin K. This is because it is included in formula milk.
The instructions ‘How to give your baby Konakion MM Paediatric by mouth’ are given later in this section (section 3).
Premature babies or full term babies at special risk of bleeding
- These babies will be given Konakion MM Paediatric as an injection at birth or soon after.
- More injections may be given later if your baby is still at risk of bleeding.
Treatment of vitamin K deficiency bleeding (VKDB)
- These babies will be given Konakion MM Paediatric as an injection (usually 1 mg).
- More injections may be given later if your baby is still at risk of bleeding. Some babies may also need a blood transfusion.
Treatment of too much blood thinning medicine
Treatment of children who have had too much blood thinning medicine is usually decided by a haematologist (blood doctor).
- Konakion MM Paediatric will be given by injection into one of your child’s veins (IV injection).
- The doctor will usually check your child’s blood for the levels of clotting factors. This check will be made 2 to 6 hours after giving Konakion MM Paediatric.
- If your child still does not have enough blood clotting factors, the doctor may give additional doses of Konakion MM Paediatric.
How to give your baby Konakion MM Paediatric by mouth
If your baby was given Konakion MM Paediatric by mouth at birth, you will be asked to give your baby another 2 mg dose. You will give them this by mouth 4 to 7 days after birth.
If your baby is having breast milk and no formula milk you may be asked to give your baby 2 mg doses once a month (by mouth).
The pictures in this leaflet show you how to give the doses to your baby by mouth, using the dispenser provided in the pack. If you are not sure, or have any worries about doing this talk to your health visitor, midwife, doctor or pharmacist.
- Picture 1 shows the ampoule (the small glass container) and the dispenser. The part of the dispenser which can be moved in and out is called the plunger.
- Shake the ampoule until the liquid is in the bottom of the ampoule. Do not use it if it looks cloudy
- Hold the bottom part of the ampoule between the thumb and first finger of one hand. Make sure the spot is facing towards your thumb (see Picture 2).
- Hold the top of the ampoule between the thumb and first finger of your other hand. Snap the top off by pushing away from the side with the spot (see Picture 2).
- 3. Put the dispenser into the ampoule. The tip of the dispenser should touch the bottom of the ampoule (see Picture 3). Pull the plunger up slowly to pull the medicine into the dispenser until it is level with the second mark (2 mg) on the side of the dispenser.
The dispenser is designed to draw up the right dose from the ampoule. There may be some liquid left over in the ampoule even after the right dose has been removed. This is OK. Do not give your baby any extra liquid.
- 4. Put the dispenser into your baby's mouth as shown in Picture 4. Gently push the plunger in, to give your baby the medicine.
If your baby gets more Konakion MM Paediatric than they should
If your baby has had more Konakion MM Paediatric than they should, talk to a doctor, nurse or midwife. The following effects may happen to your baby; jaundice (signs of which are yellowing of the skin or the whites of the eyes), tummy ache, constipation, soft stools (poo), seeming unwell, being agitated (upset), a rash and changes to how well their liver works (shown up by blood tests).
If you forget to give your baby Konakion MM Paediatric
- If you forget to give your baby their dose of Konakion MM Paediatric by mouth, talk to your health visitor, midwife or doctor about when to give the next dose.
- Do not give your baby a double dose to make up for a forgotten dose.
If someone else takes your baby’s Konakion MM Paediatric by mistake, they should talk to a doctor.
If you have any further questions on the use of this medicine, ask your doctor, nurse or midwife.
Possible side effects
Like all medicines, Konakion MM Paediatric can cause side effects, although not everyone gets them.
The following side effects may happen with this medicine:
Allergic reactions
The signs may include:
- Swelling of your baby or child’s throat, face, lips and mouth. This may make it difficult for them to breathe or swallow.
- Sudden swelling of your baby or child’s hands, feet and ankles.
If your baby or child has an allergic reaction, tell a doctor straight away.
A reaction where the injection was given
Rarely this may be severe. Signs include redness, swelling, pain and it may cause a scar.
If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or midwife.
How Konakion MM Paediatric is stored
- Konakion MM Paediatric ampoules should be stored in their original packaging to protect them from light.
- Konakion MM Paediatric should be stored at a temperature below 25°C.
- Keep out of the reach and sight of children.
- Do not use Konakion MM Paediatric after the expiry date printed on the pack.
- Do not throw away any whole left over ampoules. Instead, return them to your pharmacist so that they can be disposed of carefully. Only keep them if your doctor tells you to.
Further information
What Konakion MM Paediatric contains
The active substance in Konakion MM Paediatric 2 mg/0.2 ml is vitamin K1 (phytomenadione). Each 0.2 ml of liquid medicine contains 2 mg vitamin K1.
Other ingredients are glycocholic acid, sodium hydroxide, lecithin, hydrochloric acid and water for injections.
What Konakion MM Paediatric looks like and contents of the pack
Konakion MM Paediatric is a slightly opalescent, pale yellow liquid (‘solution for injection or oral administration’).
Konakion MM Paediatric is supplied in amber coloured glass ampoules in packs of 1, 5 or 10 with plastic oral dispensers. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder and Manufacturer is:
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
This leaflet was last approved in April 2008.
This information is intended for medical or healthcare professionals only:
The tear-off portion above is intended for the patient
Date of preparation of leaflet April 2008.
Konakion-MM-PIL-UTP-0712- 2mg-2ml.doc
Friday, 8 June 2012
Inflaren K
Inflaren K may be available in the countries listed below.
Ingredient matches for Inflaren K
Diclofenac
Diclofenac potassium salt (a derivative of Diclofenac) is reported as an ingredient of Inflaren K in the following countries:
- Brazil
International Drug Name Search
Thursday, 7 June 2012
ibandronate
Generic Name: ibandronate (eye BAN dro nate)
Brand names: Boniva, Bondronat
What is ibandronate?
Ibandronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Ibandronate slows bone loss while increasing bone mass, which may prevent bone fractures.
Ibandronate is used to treat or prevent osteoporosis in women after menopause.
Ibandronate may also be used for purposes not listed in this medication guide.
What is the most important information I should know about ibandronate?
Do not take an ibandronate tablet if you cannot sit upright or stand for at least one full hour. Ibandronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 60 minutes after taking this medication.
Take the ibandronate tablet first thing in the morning, at least 1 hour (60 minutes) before you eat or drink anything or take any other medicine.
Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an ibandronate tablet.
For at least the first 60 minutes after taking an ibandronate tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.
Some people using medicines similar to ibandronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using ibandronate. You may need to stop using the medicine for a short time.
Talk with your doctor about the risks and benefits of using this medication.
What should I discuss with my healthcare provider before using ibandronate?
You should not use this medication if you are allergic to ibandronate, or if you have severe kidney disease, low blood levels of calcium (hypocalcemia), or a problem with your esophagus (the tube that connects your mouth and stomach).
Do not take an ibandronate tablet if you cannot sit upright or stand for at least one full hour. Ibandronate can cause serious problems in the stomach or esophagus. You will need to stay upright for at least 60 minutes after taking this medication.
To make sure you can safely take ibandronate, tell your doctor if you have any of these other conditions:
a vitamin D deficiency;
kidney disease;
an ulcer in your stomach or esophagus; or
trouble swallowing.
Some people using medicines similar to ibandronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.
You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.
FDA pregnancy category C. It is not known whether ibandronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether ibandronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I use ibandronate?
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Ibandronate tablets are taken either once each day or once each month. Ibandronate intravenous solution is given as an injection into one of your veins once every three (3) months. A healthcare provider will give you this injection. Ibandronate tablets can be taken at home.
Take the ibandronate tablet first thing in the morning, at least 1 hour (60 minutes) before you eat or drink anything or take any other medicine. If you take an ibandronate tablet only once a month, take it on the same day each month and always first thing in the morning.
Take each ibandronate tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an ibandronate tablet. Do not crush, chew, or suck the ibandronate tablet. Swallow the pill whole.
After taking an ibandronate tablet, carefully follow these instructions:
Do not lie down or recline for at least 60 minutes after taking ibandronate.
Do not eat or drink anything other than plain water.
Do not take any other medicines including vitamins, calcium, or antacids for at least 60 minutes after taking ibandronate. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.
To be sure this medication is helping your condition, your bone mineral density will need to be tested often. Visit your doctor regularly.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using ibandronate. You may need to stop using the medicine for a short time.
Ibandronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
If you take ibandronate tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.
If you take ibandronate tablets once a month: If you forget to take ibandronate on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular monthly schedule on your chosen dose day. If your next scheduled dose is less than 7 days away, wait until then to take the medicine and skip the missed dose. Do not take two (2) tablets in one week.
If you receive ibandronate injections every 3 months: Call your doctor for instructions if you miss an appointment for your injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.
Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.
What should I avoid while taking ibandronate?
Do not take any other medicines including vitamins, calcium, or antacids for at least 60 minutes before or after taking an ibandronate tablet.
Avoid milk and other dairy products for at least 60 minutes after taking ibandronate (except in the case of overdose as stated above).
Ibandronate side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using ibandronate and call your doctor at once if you have any of these serious side effects:
chest pain;
difficulty or pain when swallowing;
pain or burning under the ribs or in the back;
new or worsening heartburn;
severe joint, bone, or muscle pain;
new or unusual pain in your thigh or hip; or
jaw pain, numbness, or swelling.
Less serious side effects may include:
back pain, headache;
redness or swelling of your eyes;
diarrhea;
flu symptoms;
redness or swelling where the medicine was injected;
nausea or upset stomach; or
pain in your arms or legs.
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.
Ibandronate Dosing Information
Usual Adult Dose for Osteoporosis:
2.5 mg orally once daily
150 mg orally once monthly on the same day each month
3 mg by bolus intravenous injection over 15 to 30 seconds every three months.
Oral ibandronate should be administered with 6 to 8 ounces of plain water at least 60 minutes before the first food, beverage or medication of the day. Beverages other than water, food, and certain medications reduce the absorption of ibandronate. Plain water is the only drink that should be taken with ibandronate. Some mineral waters may have a higher concentration of calcium and therefore should not be used.
Patients should remain upright (standing or sitting) for at least 60 minutes following administration of oral ibandronate.
Usual Adult Dose for Prevention of Osteoporosis:
2.5 mg orally once daily
150 mg orally once monthly on the same day each month
3 mg by bolus intravenous injection over 15 to 30 seconds every three months.
Oral ibandronate should be administered with 6 to 8 ounces of plain water at least 60 minutes before the first food, beverage or medication of the day. Beverages other than water, food, and certain medications reduce the absorption of ibandronate. Plain water is the only drink that should be taken with ibandronate. Some mineral waters may have a higher concentration of calcium and therefore should not be used.
Patients should remain upright (standing or sitting) for at least 60 minutes following administration of oral ibandronate.
What other drugs will affect ibandronate?
Tell your doctor about all other medicines you use, especially aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as:
celecoxib (Celebrex);
diclofenac (Voltaren);
diflunisal (Dolobid);
ibuprofen (Motrin, Advil);
indomethacin (Indocin);
ketoprofen (Orudis)
ketorolac (Toradol);
naproxen (Aleve, Naprosyn); or
piroxicam (Feldene), and others.
This list is not complete and other drugs may interact with ibandronate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More ibandronate resources
- Ibandronate Side Effects (in more detail)
- Ibandronate Use in Pregnancy & Breastfeeding
- Ibandronate Drug Interactions
- Ibandronate Support Group
- 13 Reviews for Ibandronate - Add your own review/rating
- ibandronate Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information
- Ibandronate MedFacts Consumer Leaflet (Wolters Kluwer)
- Boniva Monograph (AHFS DI)
- Boniva Prescribing Information (FDA)
- Boniva Advanced Consumer (Micromedex) - Includes Dosage Information
- Boniva Consumer Overview
Compare ibandronate with other medications
- Osteoporosis
- Prevention of Osteoporosis
Where can I get more information?
- Your pharmacist can provide more information about ibandronate.
See also: ibandronate side effects (in more detail)
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