There are currently no drugs listed for "Adhesive Arachnoiditis".
Definition of Adhesive Arachnoiditis: Adhesive Arachnoiditis is an incurable inflammatory condition affecting the middle (arachnoid) layer of the meninges (which are the membranes surrounding the spinal cord).
Micromedex Care Notes:
Generic Name: chlorpheniramine, carbetapentane, ephedrine, and phenylephrine (klor feh NEER a meen., kar be ta PEN tane, eh FEH drin, and feh nill EH frin)
Brand names: Rentamine, Rynatuss, Tuss Tan, ...show all 10 brand names.
Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.
Carbetapentane is a cough suppressant. It suppresses an area in the brain that causes coughing.
Ephedrine and phenylephrine are decongestants. They constrict blood vessels (veins and arteries). This reduces the blood flow and allows nasal passages to open up.
Chlorpheniramine, carbetapentane, ephedrine, and phenylephrine is used to treat nasal congestion, sinusitis (inflammation of the sinuses), and coughs associated with allergies, hay fever, and the common cold.
Chlorpheniramine, carbetapentane, ephedrine, and phenylephrine may also be used for purposes other than those listed in this medication guide.
Do not take more of this medication than is recommended. If your symptoms do not improve or if they worsen, talk to your doctor.
Before taking this medication, tell your doctor if you have
diabetes,
glaucoma,
heart disease or high blood pressure,
thyroid disease,
emphysema or chronic bronchitis, or
difficulty urinating or have an enlarged prostate.
You may not be able to take chlorpheniramine, carbetapentane, ephedrine, and phenylephrine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Take chlorpheniramine, carbetapentane, ephedrine, and phenylephrine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Do not take chlorpheniramine, carbetapentane, ephedrine, and phenylephrine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.
Symptoms of a chlorpheniramine, carbetapentane, ephedrine, and phenylephrine overdose include dry mouth, large pupils, flushing, nausea and vomiting, hyperactivity, and hallucinations.
Chlorpheniramine, carbetapentane, ephedrine, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine, carbetapentane, ephedrine, and phenylephrine is taken with any of these medications.
Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine, carbetapentane, ephedrine, and phenylephrine and talk to your doctor or try another similar medication if you experience
dryness of the eyes, nose, and mouth;
drowsiness or dizziness;
blurred vision;
difficulty urinating; or
excitation in children.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking chlorpheniramine, carbetapentane, ephedrine, and phenylephrine without first talking to your pharmacist or doctor. Other medications may also contain chlorpheniramine, carbetapentane, ephedrine, phenylephrine, or other similar drugs, and you may accidentally take too much of these medicines.
Chlorpheniramine, carbetapentane, ephedrine, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine, carbetapentane, ephedrine, and phenylephrine is taken with any of these medications.
Drugs other than those listed here may also interact with chlorpheniramine, carbetapentane, ephedrine, and phenylephrine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
See also: chlorpheniramine, carbetapentane, ephedrine, and phenylephrine side effects (in more detail)
Generic Name: chlorpheniramine, dihydrocodeine, and pseudoephedrine (klor fen EER a meen, dye hye droe KOE deen, soo doe e FED rin)
Brand Names: Dihydro-CP, Hydro-Tussin DHC
Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Dihydrocodeine is a narcotic cough suppressant similar to codeine. Dihydrocodeine affects the signals in the brain that trigger cough reflex.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of chlorpheniramine, dihydrocodeine, and pseudoephedrine is used to treat cough, sneezing, itching, watery eyes, runny nose, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.
Chlorpheniramine, dihydrocodeine, and pseudoephedrine may also be used for purposes not listed in this medication guide.
Before you take chlorpheniramine, dihydrocodeine, and pseudoephedrine, tell your doctor about all of your medical conditions and other medicines you use.
severe or uncontrolled high blood pressure;
severe coronary artery disease;
narrow-angle glaucoma;
a stomach ulcer;
a bowel obstruction called paralytic ileus;
bladder obstruction or other urination problems;
overactive thyroid; or
asthma, pneumonia, or other breathing problems.
To make sure you can safely take chlorpheniramine, dihydrocodeine, and pseudoephedrine, tell your doctor if you have any of these other conditions:
kidney or liver disease;
curvature of the spine;
heart disease or high blood pressure;
enlarged prostate or urination problems;
diabetes;
glaucoma;
a thyroid disorder;
COPD other breathing disorder;
a history of head injury or brain tumor;
epilepsy or other seizure disorder;
low blood pressure;
gallbladder disease;
Addison's disease or other adrenal gland disorders;
mental illness; or
a history of drug or alcohol addiction.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Cough or cold medicine is usually taken for only a short time until your symptoms clear up.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include extreme dizziness or drowsiness, confusion, feeling restless or nervous, cold and clammy skin, warmth or tingly feeling, nausea, vomiting, slow or shallow breathing, slow heart rate, pinpoint pupils, seizure (convulsions), or fainting.
Avoid becoming overheated or dehydrated during exercise and in hot weather.
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeats;
weak or shallow breathing, slow heartbeat;
severe dizziness, fainting, anxiety, restless feeling, nervousness, or tremor;
confusion, hallucinations, unusual thoughts or behavior;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
urinating less than usual or not at all; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
blurred vision;
dry mouth;
nausea, vomiting, stomach pain, constipation, mild loss of appetite;
mild dizziness, drowsiness;
problems with memory or concentration;
ringing in your ears;
warmth, redness, or tingling under your skin;
feeling restless or excited (especially in children);
sleep problems (insomnia); or
skin rash or itching.
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.
Tell your doctor about all other medicines you use, especially:
methyldopa (Aldomet);
cimetidine (Tagamet);
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
zidovudine (Retrovir, AZT);
aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others;
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
a diuretic (water pill), or blood pressure medication;
medication to treat irritable bowel syndrome;
medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril); or
seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).
This list is not complete and other drugs may interact with chlorpheniramine, dihydrocodeine, and pseudoephedrine. 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.
See also: Hydro-Tussin DHC side effects (in more detail)
Digoxin Injection BP 500 micrograms/2ml.
Each 2ml of solution contains 500 micrograms of Digoxin BP
Clear, colourless, sterile solution, intended for parenteral administration to human beings.
Digoxin is indicated in the management of chronic cardiac failure. The therapeutic benefit of digoxin is greater in patients with ventricular dilatation.
Digoxin is specifically indicated where cardiac failure is accompanied by atrial fibrillation.
Digoxin is indicated in the management of certain supraventricular arrhythmias, particularly atrial fibrillation and flutter, where its major beneficial effect is to reduce the ventricular rate.
Digoxin injection is indicated when emergency parenteral digitilisation is required in patients who have not been given cardiac glycosides within the preceding two weeks.
Digoxin Injection BP is for administration by slow intravenous infusion (see Dilution below).
The dose of Digoxin for each patient has to be tailored individually according to age, lean body weight and renal function. Suggested doses are intended only as an initial guide.
Emergency parenteral digitalisation (in patients who have not been given cardiac glycosides within the preceding two weeks):
Adults: 500 to 1,000 micrograms (0.5 to 1.0mg) depending on age, lean body weight and renal function.
The loading dose should be administered in divided doses with approximately half of the total dose given as the first dose and further fractions of the total dose given at intervals of 4 - 8 hours, assessing the clinical response before giving each additional dose. Each dose should be given by intravenous infusion (see Dilution) over a period of 10 - 20 minutes.
- Maintenance Dose:
The maintenance dosage should be based upon the percentage of the peak body stores lost each day through elimination. The following formula has had wide clinical use:
Ccr is creatinine clearance corrected to 70 kg body weight or 1.73 m2 body surface area.
If only serum creatinine (Scr) concentrations are available, a Ccr (corrected to 70 kg body weight) may be estimated in men as
NOTE: Where serum creatinine values are obtained in micromol/L these may be converted to mg/100 ml (mg %) as follows:
Where 113.12 is the molecular weight of creatinine.
For women, this result should be multiplied by 0.85.
NOTE: These formulae cannot be used for creatinine clearance in children.
In practice, this will mean that most patients will be maintained on 0.125 to 0. 25 mg digoxin daily; however in those who show increased sensitivity to the adverse effects of digoxin, a dosage of 62.5 microgram (0.0625 mg) daily or less may suffice. Conversely, some patients may require a higher dose.
Neonates, infants & children up to 10 years of age (if cardiac glycosides have not been given in the preceding two weeks):
In the newborn, particularly in the premature infant, renal clearance of digoxin is diminished and suitable dose reductions must be observed, over and above general dosage instructions.
Beyond the immediate newborn period, children generally require proportionally larger doses than adults on the basis of body weight or body surface area, as indicated in the schedule below. Children over 10 years of age require adult dosages in proportion to their body weight.
Parenteral Loading:
The Parenteral loading dose should be administered according to the following schedule:
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The loading dose should be administered in divided doses with approximately half the total dose given as the first dose and further fractions of the total dose given at intervals of 4 - 8 hours, assessing the clinical response before giving each additional dose. Each dose should be given by intravenous infusion (see Dilution) over a period of 10 - 20 minutes.
Note: In patients who have received a cardiac glycoside within the preceding two weeks, it should be expected that the optimum loading doses of digoxin will be less than those recommended above.
-Maintenance Dose:
The maintenance dose should be administered in accordance with the following schedule:
Preterm neonates:
daily dose = 20% of 24-hour loading dose (intravenous or oral)
Term neonates and children up to 10 years:
daily dose = 25% of 24-hour loading dose (intravenous or oral)
These dosage schedules are meant as guidelines and careful clinical observation and monitoring of serum digoxin levels (see Monitoring) should be used as a basis for adjustment of dosage in these paediatric patient groups.
Elderly patients: In the elderly, the tendency towards impaired renal function and a low lean body mass affects the pharmacokinetics of digoxin so that high serum digoxin levels and associated toxicity can occur unless reduced doses are used. Serum levels should be checked regularly, and hypokalaemia should be avoided.
Dosage in renal impairment or with concurrent Diuretic therapy: See (Precautions & Interactions).
Dilution: Digoxin Injection BP may be diluted with the following solutions:
Sodium Chloride Intravenous Infusion BP 0.9% w/v
Glucose Intravenous Infusion BP 5.0% w/v
Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion BP When diluted in the ratio of 1 to 250 (i.e. one 2ml ampoule containing 500 micrograms digoxin added to 500ml of infusion solution), Digoxin Injection B.P. is known to be compatible with the above mentioned infusion solutions and stable for up to 48 hours at room temperature (20 - 25°C).
Dilution should be carried out either under full aseptic conditions or immediately prior to use. Any unused solution should be discarded.
Monitoring: Serum digoxin concentrations may be expressed in Conventional Units of ng/ml or in SI units of nM/L (Multiply ng/ml by 1.28 to convert to nM/L).
Serum digoxin concentration can be determined by radioimmunoassay. Blood samples for digoxin assay should be taken at least 6 hours after the last dose to allow for distribution.
Several post hoc analyses of heart failure patients in the Digitalis Investigation Group trial suggest that the optimal trough digoxin serum level may be 0.5 ng/mL (0.64 nanomol/L) to 1.0 ng/mL (1.28 nanomol/L).
Digoxin toxicity is more commonly associated with serum digoxin concentration greater than 2 ng/mL. However, toxicity may occur with lower digoxin serum concentrations.
When deciding whether symptoms are due to digoxin toxicity, the patient's clinical state together with the serum potassium level and thyroid function are important factors to be considered.
Other glycosides, including digoxin metabolites can interfere with the available assays and one should be cautious of values that are not compatible with the clinical state of the patient.
Digoxin is contra-indicated in intermittent complete heart block or second degree atrioventricular block, especially if there is a history of Stokes-Adams attacks.
Digoxin is contra-indicated in arrhythmias caused by cardiac glycoside intoxication.
Digoxin is contra-indicated in supraventricular arrhythmias associated with an accessory atrioventricular pathway, as in the Wolff-Parkinson-White syndrome unless the electrophysiological characteristics of the accessory pathway and any possible deleterious effect of digoxin on these characteristics have been evaluated. If an accessory pathway is known or suspected to be present and there is no history of previous supraventricular arrhythmias, digoxin is contra-indicated.
Digoxin is contra-indicated in ventricular tachycardia or ventricular fibrillation
Digoxin is contra-indicated in hypertrophic obstructive cardiomyopathy, unless there is concomitant atrial fibrillation and heart failure, but even then caution should be exercised if digoxin is to be used.
Digoxin is contra-indicated in patients known to be hypersensitive to digoxin or other digitalis glycosides or to any component of the preparation.
Digoxin intoxication produces a variety of cardiac dysrhythmias, some of which can resemble those for which the product was intended. Atrial tachycardia with intermittent AV block, although not the commonest dysrhythmia resulting from digoxin overdosage, requires particular care as the irregular rhythm clinically resembles atrial fibrillation.
In some cases of sinoatrial disorder (i.e. Sick Sinus Syndrome) digoxin may cause or exacerbate sinus bradycardia or cause sinoatrial block.
Determination of the serum digoxin concentration may be very helpful in making a decision to continue digoxin therapy, but toxic doses of other glycosides may cross-react in the assay and wrongly suggest apparently satisfactory measurements. Observations during the temporary withholding of digoxin might be more appropriate.
If cardiac glycosides have been taken in the preceding two weeks, the recommendations for initial dosing of a patient should be reconsidered and a reduced dose is advised.
The dosage recommendations should be reconsidered if patients are elderly or if there are other reasons for the renal clearance of digoxin being reduced. A reduction in both initial and maintenance doses should be considered.
Hypokalaemia sensitises the myocardium to the actions of cardiac glycosides.
Hypoxia, Hypomagnesemia and marked hypercalcemia increase myocardial sensitivity to cardiac glycosides.
Rapid intravenous injection can cause vaso-constriction producing hypertension and/or reduced coronary flow. A slow injection rate is therefore important in hypertensive heart failure and acute myocardial infarction.
Administering digoxin to a patient with thyroid disease requires care. Initial and maintenance doses of digoxin should be reduced when thyroid function is subnormal. In hyperthyroidism there is relative digoxin resistance and the dose may have to be increased. During the course of treatment of thyrotoxicosis, dosage should be reduced as the thyrotoxicosis comes under control.
Patients with malabsorption syndrome or gastro-intestinal reconstructions may require larger doses of digoxin.
The risk of provoking dangerous arrhythmias with direct current cardioversion is greatly increased in the presence of digitalis toxicity and is in proportion to the cardioversion energy used.
For elective direct current cardioversion of a patient who is taking digoxin, the drug should be withheld for 24 hours before cardioversion is performed. In emergencies, such as cardiac arrest, the lowest effective energy should be applied when attempting cardioversion.
Direct current cardioversion is inappropriate in the treatment of arrhythmias thought to be caused by cardiac glycosides.
Many beneficial effects of digoxin on arrhythmias result from a degree of atrioventricular conduction blockade. However, when incomplete atrioventricular block already exists the effects of a rapid progression in the block should be anticipated. In complete heart block the idioventricular escape rhythm may be suppressed.
The administration of digoxin in the period immediately following myocardial infarction is not contra-indicated. However, the use of inotropic drugs in some patients in this setting may result in undesirable increases in myocardial oxygen demand and ischaemia, and some retrospective follow-up studies have suggested digoxin to be associated with an increased risk of death. However, the possibility of arrhythmias arising in patients who may be hypokalaemic after myocardial infarction and are likely to be cardiologically unstable must be borne in mind. The limitations imposed thereafter on direct current cardioversion must also be remembered.
Treatment with digoxin should generally be avoided in patients with heart failure associated with cardiac amyloidosis. However, if alternative treatments are not appropriate, digoxin can be used with caution to control the ventricular rate in patients with cardiac amyloidosis and atrial fibrillation.
Digoxin can rarely precipitate vasoconstriction and therefore should be avoided in patients with myocarditis.
Patients with beri beri heart disease may fail to respond adequately to digoxin if the underlying thiamine deficiency is not treated concomitantly. There is also some published information indicating that digoxin may inhibit the uptake of thiamine in myocytes in beri beri heart disease.
Digoxin should not be used in constrictive pericarditis unless it is used to control the ventricular rate in atrial fibrillation or to improve systolic dysfunction.
Digoxin improves exercise tolerance in patients with impaired left ventricular systolic dysfunction and normal sinus rhythm. This may or may not be associated with an improved haemodynamic profile. However, the benefit of patients with supraventricular arrhythmias is most evident at rest, less evident with exercise.
In patients receiving diuretics and an ACE inhibitor, or diuretics alone, the withdrawal of digoxin has been shown to result in clinical deterioration.
The use of therapeutic doses of digoxin may cause prolongation of the PR interval and depression of the ST segment on the electrocardiogram.
Digoxin may produce false positive ST-T changes on the electrocardiogram during exercise testing. These electrophysiologic effects reflect an expected effect of the drug and are not indicative of toxicity.
Patients receiving digoxin should have their serum electrolytes and renal function (serum creatinine concentration) assessed periodically; the frequency of assessments will depend on the clinical setting.
Although many patients with chronic congestive cardiac failure benefit from acute administration of digoxin, there are some in whom it does not lead to constant, marked or lasting haemodynamic improvement. It is therefore important to evaluate the response of each patient individually when digoxin is continued long-term.
The intramuscular route is painful and is associated with muscle necrosis. This route cannot be recommended.
Patients with severe respiratory disease may have an increased myocardial sensitivity to digitalis glycosides.
These may arise from effects on the renal excretion, tissue binding, plasma protein binding and distribution within the body, gut absorptive capacity and sensitivity to digoxin. The best precaution is to consider the possibility of an interaction whenever concomitant therapy is contemplated and to check on serum digoxin concentration when any doubt exists.
Digoxin, in association with beta-adrenoceptor blocking drugs, may increase atrio-ventricular conduction time.
Agents causing hypokalaemia or intracellular potassium deficiency may cause increased sensitivity to digoxin; they include diuretics, lithium salts, corticosteroids and carbenoxolone.
Patients receiving Digoxin are more susceptible to the effects of suxamethonium-exacerbated hyperkalaemia.
Calcium, particularly if administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients.
Serum levels of digoxin may be INCREASED by concomitant administration of the following:
Alprazolam, amiodarone, flecainide, gentamicin, indometacin, itraconazole, prazosin, propafenone, quinidine, quinine, spironolactone, macrolide antibiotics (e.g. erythromycin and clarithromycin), tetracycline (and possibly other antibiotics), trimethoprim, propantheline, atorvastatin, ciclosporin, epoprostenol (transient) and carvedilol.
Serum levels of digoxin may be REDUCED by concomitant administration of the following: Adrenaline (epinephrine), antacids, kaolin-pectin, some bulk laxatives, colestyramine, acarbose, salbutamol, sulfasalazine, neomycin, rifampicin, some cytostatics, phenytoin, metoclopramide, penicillamine and the herbal remedy St John's wort (Hypericum perforatum).
Calcium channel blocking agents may either increase or cause no change in serum digoxin levels. Verapamil, felodipine and tiapamil increase serum digoxin levels. Nifedipine and diltiazem may increase or have no effect on serum digoxin levels. Isradipine causes no change in serum digoxin levels. Angiotensin converting enzyme (ACE) inhibitors may also increase or cause no change in serum digoxin concentrations.
Milrinone does not alter steady-state serum digoxin levels.
Digoxin is a substrate of P-glycoprotein. Thus, inhibitors of P-glycoprotein may increase blood concentrations of digoxin by enhancing its absorption and/or by reducing its renal clearance (See 5.2 Pharmacokinetic Properties).
No data are available on whether or not digoxin has teratogenic effects.
There is no information available on the effect of digoxin on human fertility.
The use of digoxin in pregnancy is not contra-indicated, although the dosage and control may be less predictable in pregnant than in non-pregnant women with some requiring an increased dosage of digoxin during pregnancy. As with all drugs, use of digoxin should be considered only when the expected clinical benefit to the mother outweighs any possible risk to the foetus.
Despite extensive antenatal exposure to digitalis preparations, no significant adverse effects have been observed in the foetus or neonate when maternal serum digoxin concentrations are maintained within the normal range. Although it has been speculated that a direct effect of digoxin on the myometrium may result in relative prematurity and low birth weight, a contributing role of the underlying cardiac disease cannot be excluded. Maternally administered digoxin has been successfully used to treat foetal tachycardia and congestive heart failure.
Adverse foetal effects have been reported in mothers with digitalis toxicity.
Although digoxin is excreted in breast milk, the quantities are minute and breast feeding is not contra-indicated.
Since central nervous system and visual disturbances have been reported in patients receiving Digoxin, patients should exercise caution before driving, using machinery or participating in dangerous activities.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (
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The symptoms and signs of toxicity are generally similar to those described in the Undesirable Effects section but may be more frequent and can be more severe.
Signs and symptoms of digoxin toxicity become more frequent with levels above 2.0 nanograms/mL (2.56 nanomol/L) although there is considerable interindividual variation. However, in deciding whether a patient's symptoms are due to digoxin, the clinical state, together with serum electrolyte levels and thyroid function are important factors (see Dosage and Administration).
Adults
In adults without heart disease, clinical observation suggests that an overdose of digoxin of 10 to 15 mg was the dose resulting in death of half of the patients.
Cardiac manifestations
Cardiac manifestations are the most frequent and serious sign of both acute and chronic toxicity. Peak cardiac effects generally occur 3 to 6 hours following overdosage and may persist for the ensuing 24 hours or longer. Digoxin toxicity may result in almost any type of arrhythmia. Multiple rhythm disturbances in the same patient are common. These include paroxysmal atrial tachycardia with variable atrioventricular (AV) block, accelerated junctional rhythm, slow atrial fibrillation (with very little variation in the ventricular rate) and bi directional ventricular tachycardia.
Premature ventricular contractions (PVCs) are often the earliest and most common arrhythmia. Bigeminy or trigeminy also occur frequently.
Sinus bradycardia and other bradyarrhythmias are very common.
First, second, third degree heart blocks and AV dissociation are also common.
Early toxicity may only be manifested by prolongation of the PR interval.
Ventricular tachycardia may also be a manifestation of toxicity.
Cardiac arrest from asystole or ventricular fibrillation due to digoxin toxicity is usually fatal.
Hypokalaemia may contribute to toxicity (see Warnings and Precautions).
Non-cardiac manifestations
Acute massive digoxin overdosage can result in mild to pronounced hyperkalaemia due to inhibition of the sodium-potassium (Na+-K+) pump.
Gastrointestinal symptoms are very common in both acute and chronic toxicity. The symptoms precede cardiac manifestations in approximately half of the patients in most literature reports. Anorexia, nausea and vomiting have been reported with an incidence up to 80%. These symptoms usually present early in the course of an overdose.
Neurologic and visual manifestations occur in both acute and chronic toxicity. Dizziness, various CNS disturbances, fatigue and malaise are very common. The most frequent visual disturbance is an aberration of colour vision (predominance of yellow green). These neurological and visual symptoms may persist even after other signs of toxicity have resolved.
In chronic toxicity, non-specific extracardiac symptoms, such as malaise and weakness, may predominate.
Children
In children aged 1 to 3 years without heart disease, clinical observation suggests that an overdose of digoxin of 6 to 10 mg was the dose resulting in death in half of the patients.
Most manifestations of toxicity in children occur during or shortly after the loading phase with digoxin.
Cardiac manifestations
The same arrhythmias or combination of arrhythmias that occur in adults can occur in children. Sinus tachycardia, supraventricular tachycardia, and rapid atrial fibrillation are seen less frequently in the paediatric population.
Paediatric patients are more likely to present with an AV conduction disturbance or a sinus bradycardia.
Ventricular ectopy is less common, however in massive overdose, ventricular ectopy, ventricular tachycardia and ventricular fibrillation have been reported.
Any arrhythmia or alteration in cardiac conduction that develops in a child taking digoxin should be assumed to be caused by digoxin, until further evaluation proves otherwise.
Extracardiac manifestations
The frequent extracardiac manifestations similar to those seen in adults are gastrointestinal, CNS and visual. However, nausea and vomiting are not frequent in infants and small children.
In addition to the undesirable effects seen with recommended doses, weight loss in older age groups and failure to thrive in infants, abdominal pain due to mesenteric artery ischaemia, drowsiness and behavioural disturbances including psychotic manifestations have been reported in overdose.
Treatment
After recent ingestion, such as accidental or deliberate self-poisoning, the load available for absorption may be reduced by gastric lavage.
Patients with massive digitalis ingestion should receive large doses of activated charcoal to prevent absorption and bind digoxin in the gut during enteroenteric recirculation.
If more than 25 mg of digoxin was ingested by an adult without heart disease, death or progressive toxicity responsive only to digoxin-binding Fab antibody fragments resulted. If more than 10 mg of digoxin was ingested by a child aged 1 to 3 years without heart disease, the outcome was uniformly fatal when Fab fragment treatment was not given.
Hypokalaemia should be corrected. In cases where a large amount of Digoxin has been ingested, hyperkalaemia may be present due to release of potassium from skeletal muscle. Before administering potassium in digoxin overdose the serum potassium level must be known.
Bradyarrhythmias may respond to atropine but temporary cardiac pacing may be required. Ventricular arrhythmias may respond to lignocaine or phenytoin.
Dialysis is not particularly effective in removing digoxin from the body in potentially life-threatening toxicity.
Rapid reversal of the complications that are associated with serious poisoning by digoxin, digitoxin and related glycosides has followed intravenous administration of digoxin-specific antibody fragments (Fab) when other therapies have failed.
Mode of Action:-
Digoxin increases contractility of the myocardium by direct activity.This effect is proportional to dose in the lower range and some effect is achieved with quite low dosing; it occurs even in normal myocardium although it is then entirely without physiological benefit. The primary action of digoxin is specifically to inhibit adenosine triphosphatase, and thus sodium-potassium (Na+-K+) exchange activity, the altered ionic distribution across the membrane resulting in an augmented calcium ion influx and thus an increase in the availability of calcium at the time of excitation-contraction coupling. The potency of digoxin may therefore appear considerably enhanced when the extracellular potassium concentration is low, with hyperkalaemia having the opposite effect.
Digoxin exerts the same fundamental effect of inhibition of the Na+-K+ exchange mechanism on cells of the autonomic nervous system, stimulating them to exert indirect cardiac activity. Increases in efferent vagal impulses result in reduced sympathetic tone and diminished impulse conduction rate through the atria and atrioventricular node. Thus, the major beneficial effect of digoxin is reduction of ventricular rate.
Indirect cardiac contractility changes also result from changes in venous compliance brought about by the altered autonomic activity and by direct venous stimulation. The interplay between direct and indirect activity governs the total circulatory response, which is not identical for all subjects. In the presence of certain supraventricular arrhythmias, the neurogenically mediated slowing of AV conduction is paramount.
The degree of neurohormonal activation occurring in patients with heart failure is associated with clinical deterioration and an increased risk of death. Digoxin reduces activation of both the sympathetic nervous system and the (renin-angiotensin) system independently of its inotropic actions, and may thus favourably influence survival. Whether this is achieved via direct sympathoinhibitory effects or by re-sensitising baroreflex mechanisms remains unclear.
Absorption
Intravenous administration of a loading dose produces an appreciable pharmacological effect within 5 to 30 minutes; this reaches a maximum in 1 to 5 hours.
Distribution
The initial distribution of digoxin from the central to the peripheral compartment generally lasts from 6 to 8 hours. This is followed by a more gradual decline in serum digoxin concentration, which is dependent upon digoxin elimination from the body. The volume of distribution is large (Vdss = 510 litres in healthy volunteers), indicating digoxin to be extensively bound to body tissues. The highest digoxin concentrations are seen in the heart, liver and kidney that in the heart averaging 30- fold that in the systemic circulation. Although the concentration in skeletal muscle is far lower, this store cannot be overlooked since skeletal muscle represents 40% of total body weight. Of the small proportion of digoxin circulating in plasma, approximately 25% is bound to protein.
Elimination
The major route of elimination is renal excretion of the unchanged drug.
Digoxin is a substrate for P-glycoprotein. As an efflux protein on the apical membrane of enterocytes, P-glycoprotein may limit the absorption of digoxin. P-glycoprotein in renal proximal tubules appears to be an important factor in the renal elimination of digoxin (See 4.5 Interaction with other medicinal products and other forms of interaction).
Following intravenous administration to healthy volunteers, between 60 and 75% of a digoxin dose is recovered unchanged in the urine over a 6 day follow-up period. Total body clearance of digoxin has been shown to be directly related to renal function, and percent daily loss is thus a function of creatinine clearance, which in turn may be estimated from a stable serum creatinine. The total and renal clearances of digoxin have been found to be 193 ± 25 ml/min and 152 ± 24 mil/min in a healthy control population.
In a small percentage of individuals, orally administered digoxin is converted to cardioinactivate reduction products (digoxin reduction products or DRPs) by colonic bacteria in the gastrointestinal tract. In these subjects over 40% of the dose may be excreted as DRPs in the urine. Renal clearances of the two main metabolites, dihydrodigoxin and digoxygenin, have been found to be 79 ± 13 ml/min and 100 ± 26 ml/min respectively. In the majority of cases however, the major route of digoxin elimination is renal excretion of the unchanged drug.
The terminal elimination half life of digoxin in patients with normal renal function is 30 to 40 hours. It will be prolonged in patients with impaired renal function, and in anuric patients will be of the order of 100 hours.
In the newborn period, renal clearance of digoxin is diminished and suitable dosage adjustments must be observed. This is specially pronounced in the premature infant since renal clearance reflects maturation of renal function. Digoxin clearance has been found to be 65.6 ± 30 ml/min/1.73m2 at 3 months, compared to only 32 ± 7 ml/min/1.73 m2 at 1 week. Beyond the immediate newborn period, children generally require proportionally larger doses than adults on the basis of body weight and body surface area.
Since most of the drug is bound to the tissues rather than circulating in the blood, digoxin is not effectively removed from the body during cardiopulmonary by-pass. Furthermore, only about 3% of a digoxin dose is removed from the body during five hours of haemodialysis.
No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.
Ethanol B.P.
Propylene Glycol BP
Citric Acid Monohydrate BP
Disodium Hydrogen Phosphate BP
Water for Injections BP
Not applicable.
Unopened: 4 years
After reconstitution: not applicable
After first opening: 4 years*
*If only part of an ampoule is used, discard the remaining solution.
Store below 25°C.
Protect from light.
2ml, clear one point cut (OPC) glass ampoules, glass type 1 Ph.Eur. borosilicate glass, packed in cardboard cartons to contain 10 x 2ml ampoules.
For slow intravenous infusion.
Use as directed by the physician.
Keep out of reach of children.
If only part used, discard the remaining solution.
Antigen International Ltd.,
Roscrea,
Co. Tipperary,
Ireland.
PL 02848/5934R.
24/1/91.
01/02/2011
Generic Name: romidepsin (ROE mi DEP sin)
Brand Names: Istodax
Romidepsin blocks certain enzymes in the body and interferes with the growth of tumor cells.
Romidepsin is used to treat T-cell lymphoma affecting the skin (cutaneous T-cell lymphoma, or CTCL).
Romidepsin is usually given after other medications have been tried without successful treatment of symptoms.
Romidepsin may also be used for other purposes not listed in this medication guide.
Before you receive romidepsin, tell your doctor if you have an electrolyte imbalance, a personal or family history of "Long QT syndrome," heart disease, kidney disease, or liver disease.
Call your doctor if you have a serious side effect such as severe nausea or vomiting, chest pain, fast or uneven heartbeats, feeling short of breath, fever, chills, flu symptoms, pale skin, easy bruising or bleeding, muscle cramps, confusion, pain or burning when you urinate, or worsening of your CTCL skin symptoms.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive this medication:
an electrolyte imbalance (such as high or low levels of potassium or magnesium in your blood);
a personal or family history of "Long QT syndrome";
heart disease;
Romidepsin is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.
Romidepsin is usually given every 7 days for 3 weeks. This treatment cycle may be repeated 28 days after your first dose. Your doctor will determine how long to treat you with romidepsin.
Romidepsin can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.
Call your doctor for instructions if you miss an appointment for your romidepsin injection.
Symptoms of a romidepsin overdose are not known.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
severe nausea or vomiting;
chest pain, fast or uneven heartbeats, feeling short of breath;
fever, chills, body aches, flu symptoms, sores in your mouth and throat;
pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
low magnesium (depression, muscle cramps, feeling tired or irritable, severe or ongoing diarrhea);
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
pain or burning when you urinate; or
worsening of CTCL skin symptoms.
Less serious side effects may include:
nausea, vomiting, loss of appetite;
diarrhea, constipation;
tired feeling; or
mild itching.
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.
Many drugs can interact with romidepsin. Below is just a partial list. Tell your doctor if you are using:
dexamethasone (Decadron, Hexadrol);
isoniazid (for treating tuberculosis);
St. John's wort;
an antibiotic such as clarithromycin (Biaxin), erythromycin (Ery-Tab, Erythrocin), levofloxacin (Levaquin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), telithromycin (Ketek);
antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), voriconazole (Vfend);
an antidepressant such as amitriptylline (Elavil, Vanatrip), nefazodone;
anti-malaria medication;
a barbiturate such as phenobarbital (Solfoton);
a blood thinner such as warfarin (Coumadin);
heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan);
heart rhythm medicine such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), quinidine (Quinidex, Quin-Release Quin-G), and others;
HIV or AIDS medications such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir);
medicines used to prevent organ transplant rejection;
medicine to prevent or treat nausea and vomiting, such as droperidol (Inapsine) or ondansetron (Zofran);
medicines to treat a psychiatric disorder, such as clozapine (FazaClo, Clozaril), haloperidol (Haldol), or pimozide (Orap);
migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig);
narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose); or
seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), and others.
See also: Istodax side effects (in more detail)
Dietary management of age-related macular degeneration in certain patients. It should only be used under the direction and supervision of a doctor.
Macutek Smooth Dissolve Tablets is a medical food. It works by providing vitamins to meet nutritional requirements.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Macutek Smooth Dissolve Tablets. 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 Macutek Smooth Dissolve Tablets. However, no specific interactions with Macutek Smooth Dissolve Tablets are known at this time.
Ask your health care provider if Macutek Smooth Dissolve Tablets 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 Macutek Smooth Dissolve Tablets 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 Macutek Smooth Dissolve Tablets.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea, nausea, stomach upset, or cramping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Macutek Smooth Dissolve Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Macutek Smooth Dissolve Tablets out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Macutek Smooth Dissolve Tablets. 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.
hye-al-ure-ON-i-dase
In the U.S.
Available Dosage Forms:
Therapeutic Class: Tissue Permeability Modifier
Pharmacologic Class: Enzyme
Hyaluronidase is a natural substance found in the body. Hyaluronidase is collected from either cows or pigs. It is cleaned up to remove animal substances. Hyaluronidase is a spreading substance. Hyaluronidase is used with other drugs given under the skin to improve their uptake by the body. This method of drug delivery is only used when the drug cannot be given by injection into a vein.
hyaluronidase is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For hyaluronidase, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to hyaluronidase or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
hyaluronidase has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.
hyaluronidase has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking hyaluronidase, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using hyaluronidase with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of hyaluronidase. Make sure you tell your doctor if you have any other medical problems.
The dose of hyaluronidase will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of hyaluronidase. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Store in the refrigerator. Do not freeze.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Some people may be allergic to hyaluronidase. Tell your doctor if you develop red or itching skin or if you have trouble breathing after you receive hyaluronidase.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: hyaluronidase Subcutaneous, Injection side effects (in more detail)
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