Nexus Pharmaceuticals Inc
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Nexus Pharmaceuticals Inc Drugs
ADULTS - T he usual parenteral dose is 25 to 50 mg given subcutaneously or intramuscularly. Intravenously, 5 to 25 mg may be administered slowly, repeated in 5 to 10 minutes, if necessary.
CHILDREN - The usual subcutaneous or intramuscular dose is 0.5 mg/kg of body weight or 16 .7 mg/square meter of body surface every 4 to 6 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Since there is no significant difference in onset of effect after intravenous or intramuscular injection, usually there is no need to use the intravenous route. The drug is quickly effective after either route, with improvement sometimes noticeable a few minutes after injection. In emergency situations, when the condition of the patient is alarming, 1 to 2 mL of the injection normally will provide quick relief. If the parkinsonian effect begins to return, the dose can be repeated.
Because of cumulative action, therapy should be initiated with a low dose which is increased gradually at five or six-day intervals to the smallest amount necessary for optimal relief. Increases should be made in increments of 0.5 mg, to a maximum of 6 mg, or until optimal results are obtained without excessive adverse reactions.
The usual daily dose is 1 to 2 mg, with a range of 0.5 to 6 mg parenterally.
As with any agent used in parkinsonism, dosage must be individualized according to age and weight, and the type of parkinsonism being treated. Generally, older patients, and thin patients cannot tolerate large doses. Most patients with postencephalitic parkinsonism need fairly large doses and tolerate them well. Patients with a poor mental outlook are usually poor candidates for therapy.
In idiopathic parkinsonism, therapy may be initiated with a single daily dose of 0.5 to 1 mg at bedtime. In some patients, this will be adequate; in others 4 to 6 mg a day may be required.
In postencephalitic parkinsonism, therapy may be initiated in most patients with 2 mg a day in one or more doses. In highly sensitive patients, therapy may be initiated with 0.5 mg at bedtime, and increased as necessary.
Some patients experience greatest relief by taking the entire dose at bedtime; others react more favorably to divided doses, two to four times a day. Frequently, one dose a day is sufficient, and divided doses may be unnecessary or undesirable.
The long duration of action of this drug makes it particularly suitable for bedtime medication when its effects may last throughout the night, enabling patients to turn in bed during the night more easily, and to rise in the morning.
When benztropine mesylate is started, do not terminate therapy with other antiparkinsonian agents abruptly. If the other agents are to be reduced or discontinued, it must be done gradually. Many patients obtain greatest relief with combination therapy.
Benztropine mesylate may be used concomitantly with SINEMET* (Carbidopa-Levodopa), or with levodopa, in which case periodic dosage adjustment may be required in order to maintain optimum response.
In treating extrapyramidal disorders due to neuroleptic drugs (e.g., phenothiazines), the recommended dosage is 1 to 4 mg once or twice a day parenterally. Dosage must be individualized according to the need of the patient. Some patients require more than recommended; others do not need as much.
In acute dystonic reaction, 1 to 2 mL of the injection usually relieves the condition quickly.
When extrapyramidal disorders develop soon after initiation of treatment with neuroleptic drugs (e.g., phenothiazines), they are likely to be transient. One to 2 mg of benztropine mesylate two or three times a day usually provides relief within one or two days. After one or two weeks, the drug should be withdrawn to determine the continued need for it. If such disorders recur, benztropine mesylate can be reinstituted.
Certain drug-induced extrapyramidal disorders that develop slowly may not respond to benztropine mesylate.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
2.1 General Information
LEVETIRACETAM injection is for intravenous use only and must be diluted prior to administration. LEVETIRACETAM injection (500 mg/5 mL) should be diluted in 100 mL of a compatible diluent [see Dosage and Administration (2.7)] and administered intravenously as a 15-minute IV infusion.
Product with particulate matter or discoloration should not be used.
Any unused portion of the LEVETIRACETAM injection vial contents should be discarded.
2.2 Initial Exposure to LEVETIRACETAM
LEVETIRACETAM can be initiated with either intravenous or oral administration.
Partial Onset Seizures - In clinical trials of oral LEVETIRACETAM, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown. Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies with LEVETIRACETAM tablets for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy - Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.
2.3 Replacement Therapy
When switching from oral LEVETIRACETAM, the initial total daily intravenous dosage of LEVETIRACETAM should be equivalent to the total daily dosage and frequency of oral LEVETIRACETAM and should be administered as a 15-minute intravenous infusion following dilution in 100 mL of a compatible diluent.
2.4 Switching to Oral Dosing
At the end of the intravenous treatment period, the patient may be switched to LEVETIRACETAM oral administration at the equivalent daily dosage and frequency of the intravenous administration.
2.5 Dosing Instructions
LEVETIRACETAM injection is for intravenous use only and must be diluted prior to administration. One vial of LEVETIRACETAM injection contains 500 mg levetiracetam (500 mg/5mL). See Table 1 for the recommended preparation and administration of LEVETIRACETAM injection to achieve a dose of 500 mg, 1000 mg, or 1500 mg.Table 1 : Preparation and Administration of LEVETIRACETAM Injection Dose Withdraw Volume Volume of Diluent Infusion Time 500 mg 5 mL (5 mL vial) 100 mL 15 minutes 1000 mg 10 mL (two 5 mL vials) 100 mL 15 minutes 1500 mg 15 mL (three 5 mL vials) 100 mL 15 minutes
For example, to prepare a 1000 mg dose, dilute 10 mL of LEVETIRACETAM injection in 100 mL of a compatible diluent [ see Dosage and Administration (2.7)] and administer intravenously as a 15-minute infusion.
2.6 Adult Patients with Impaired Renal Function
LEVETIRACETAM dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 2. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:
1. For female patients
[140-age (years)] x weight (kg)
CLcr= - - - - - - - - - - - - - - - - - - - - - - x 10.85 72 x serum creatinine (mg/dL)
1For female patients
1Following dialysis, a 250 to 500 mg supplemental dose is recommended.Table 2 : Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group
(mg)Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 to 80 500 to 1,000 Every 12 h Moderate 30 to 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis --- 500 to 1,000 1Every 24 h
2.7 Compatibility and Stability
LEVETIRACETAM injection was found to be physically compatible and chemically stable when mixed with the following diluents and antiepileptic drugs for at least 24 hours and stored in polyvinyl chloride (PVC) bags at controlled room temperature 15 to 30°C (59 to 86°F).Diluents
Sodium chloride (0.9%) injection, USP Lactated Ringer’s injection Dextrose 5% injection, USPOther Antiepileptic Drugs
Lorazepam DiazepamValproate sodium
There is no data to support the physical compatibility of LEVETIRACETAM injection with antiepileptic drugs that are not listed above.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of tranexamic acid intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:Serum Creatinine (µmol/L) Tranexamic Acid I.V. Dosage 120 to 250 (1.36 to 2.83 mg/dL) 10 mg/kg BID 250 to 500 (2.83 to 5.66 mg/dL) 10 mg/kg daily >500 (>5.66 mg/dL) 10 mg/kg every 48 hours or 5 mg/kg every 24 hours
For intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to tranexamic acid injection. Tranexamic acid injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
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