Zanaflex

Item	Count		Retail	Price	Order
Zanaflex 2 mg	30	tablets	$149.70	$124.75
Zanaflex 2 mg	90	tablets	$240.90	$200.75
Zanaflex 4 mg	30	tablets	$175.20	$146.00
Zanaflex 4 mg	90	tablets	$305.70	$254.75

BEFORE USING :

INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. Inform your doctor and pharmacist of any other medical conditions, allergies, pregnancy, or breast-feeding.

DIRECTIONS :

Follow the directions for using zanaflex provided by your doctor. STORE zanaflex at room temperature, away from heat and light. IF YOU MISS A DOSE OF zanaflex , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.

CAUTIONS :

BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using zanaflex . zanaflex MAY CAUSE DROWSINESS. Using zanaflex alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Ask your doctor or pharmacist if you have questions about which medicines cause drowsiness. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using zanaflex during pregnancy.

zanaflex Possible side effects :

SIDE EFFECTS, that may go away during treatment, include drowsiness, dry mouth, flushing, or dizziness. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience increased muscle weakness; trouble urinating or lack of bladder control; or change in emotions, mood, or behavior. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

DRUG INTERACTIONS :

Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other.

IF YOU TAKE TOO MUCH :

If overdose is suspected, contact your local poison control center or emergency room immediately.

ADDITIONAL INFORMATION :

Do Not Share zanaflex with others for whom it was not prescribed. Do Not Use zanaflex for other health conditions. KEEP zanaflex out of the reach of children. If using zanaflex for an extended period of time, obtain refills before your supply runs out.

MORE ABOUT ZANAFLEX (tizanidine hydrochloride)

DESCRIPTION

ZANAFLEX (tizanidine hydrochloride) works centrally in the brain by effecting adrenergic nerve receptors. Zanaflex is a white to off-white, fine crystalline powder, odorless or with a faint characteristic odor.

OVERVIEW

Zanaflex is a muscle relaxer. Zanaflex is a prescription medication that is now available for your purchase online. You should never take more than one Zanaflex at a time. Driving can be dangerous when using Zanaflex because it is a muscle relaxer and you could become tired or groggy.

Zanaflex is most often used to treat muscle pain, muscle cramps and muscle spasms. Those who have muscle disorders or muscle problems are the number one users of Zanaflex around the world. If you have had an injury to you arm, leg, back or neck and you experience muscle spasms then Zanaflex can help your muscles relax.

CLINICAL PHARMACOLOGY

Mechanism of Action

Zanaflex is a stimulant at the adrenergic receptor sites of the brain. Zanaflex presumably reduces spasticity by increasing inhibition of motor neurons. In animal models, Zanaflex has no direct effect on skeletal muscle.

Pharmacokinetics

Following oral administration, Zanaflex is essentially completely absorbed and has a half-life of approximately 2.5 hours. Following administration of Zanaflex, peak plasma concentrations occurred at 1.5 hours after dosing. Food increases C max by approximately one-third and shortens time to peak concentration by approximately 40 minutes, but the extent of Zanaflex absorption is not affected. Zanaflex has linear pharmacokinetics over a dose of 1 to 20 mg. The absolute oral bioavailability of Zanaflex is approximately 40% (CV = 24%), due to extensive first-pass metabolism in the liver; approximately 95% of an administered dose is metabolized. Zanaflex metabolites are not known to be active; their half-lives range from 20 to 40 hours. Zanaflex is widely distributed throughout the body; mean steady state volume of distribution is 2.4 L/kg (CV = 21%) following intravenous administration in healthy adult volunteers.

Special Populations

Age Effects: No specific pharmacokinetic study was conducted to investigate age effects on Zanaflex. Cross study comparison of pharmacokinetic data following single dose administration of 6 mg Zanaflex showed that younger subjects cleared the drug four times faster than the elderly subjects. Zanaflex has not been evaluated in children.

Hepatic Impairment: Pharmacokinetic differences in Zanaflex due to hepatic impairment have not been studied.

Kidney Impairment: Zanaflex clearance is reduced by more than 50% in elderly patients with kidney insufficiency compared to healthy elderly subjects; this would be expected to lead to a longer duration of clinical effect. Zanaflex should be used with caution in renally impaired patients.

Gender Effects: No specific pharmacokinetic study was conducted to investigate gender effects on Zanaflex. Retrospective analysis of pharmacokinetic data, however, following single and multiple dose administration of 4 mg Zanaflex showed that gender had no effect on the pharmacokinetics of Zanaflex.

Race Effects: Pharmacokinetic differences due to race with Zanaflex have not been studied.

Drug Interactions-Oral Contraceptives: No specific pharmacokinetic study was conducted to investigate interaction between oral contraceptives and Zanaflex. Retrospective analysis of population pharmacokinetic data following single and multiple dose administration of 4 mg Zanaflex, however, showed that women concurrently taking oral contraceptives had 50% lower clearance of Zanaflex compared to women not on oral contraceptives.

CLINICAL STUDIES

Zanaflex 's capacity to reduce increased muscle tone associated with spasticity was demonstrated in two adequate and well controlled studies in patients with multiple sclerosis or spinal cord injury.

In one study, patients with multiple sclerosis were randomized to receive single oral doses of Zanaflex or placebo. Patients and assessors were blind to treatment assignment and efforts were made to reduce the likelihood that assessors would become aware indirectly of treatment assignment (e.g., they did not provide direct care to patients and were prohibited from asking questions about side effects). In all, 140 patients received either placebo, 8 mg or 16 mg of Zanaflex.

Response was assessed by physical examination; muscle tone was rated on a 5 point scale (Ashworth score), with a score of 0 used to describe normal muscle tone. A score of 1 indicated a slight spastic catch while a score of 2 indicated more marked muscle resistance. A score of 3 was used to describe considerable increase in tone, making passive movement difficult. A muscle immobilized by spasticity was given a score of 4. Spasm counts were also collected.

Assessments were made at 1, 2, 3 and 6 hours after treatment. A statistically significant reduction of the Ashworth score for Zanaflex compared to placebo was detected at 1, 2 and 3 hours after treatment. The greatest reduction in muscle tone was 1 to 2 hours after Zanaflex treatment. By 6 hours after treatment, muscle tone in the 8 and 16 mg Zanaflex groups was indistinguishable from muscle tone in placebo treated patients. Within a given patient, improvement in muscle tone was correlated with Zanaflex plasma concentration. Zanaflex plasma concentrations were variable from patient to patient at a given dose. Although 16 mg of Zanaflex produced a larger effect, adverse Zanaflex events including hypotension were more common and more severe than in the 8 mg group. There were no differences in the number of spasms occurring in each group.

In a multiple dose study, 118 patients with spasticity secondary to spinal cord injury were randomized to either placebo or Zanaflex. Steps similar to those taken in the first study were employed to ensure the integrity of blinding.

Patients were titrated over 3 weeks up to a maximum tolerated dose or 36 mg daily given in three unequal doses (e.g., 10 mg given in the morning and afternoon and 16 mg given at night). Patients were then maintained on their maximally tolerated Zanaflex dose for 4 additional weeks (i.e., maintenance phase). Throughout the Zanaflex maintenance phase, muscle tone was assessed on the Ashworth scale within a period of 2.5 hours following either the morning or afternoon dose. The number of daytime spasms was recorded daily by patients.

At endpoint (the protocol-specified time of outcome assessment), there was a statistically significant reduction in muscle tone and frequency of spasms in the Zanaflex treated group compared to placebo. The reduction in muscle tone was not associated with a reduction in muscle strength (a desirable outcome) but also did not lead to any consistent advantage of Zanaflex treated patients on measures of activities of daily living.

INDICATIONS AND USAGE

Zanaflex is a short-acting drug for the management of muscle spasticity. Because of the short duration of effect, treatment with Zanaflex should be reserved for those daily activities and times when relief of spasticity is most important.

CONTRAINDICATIONS

Zanaflex is contraindicated in patients with known hypersensitivity to Zanaflex or its ingredients.

WARNINGS

Limited data base for chronic use of single doses of Zanaflex above 8 mg and multiple Zanaflex doses above 24 mg per day

Clinical experience with long-term use of Zanaflex at doses of 8 to 16 mg single doses or total daily doses of 24 to 36 mg is limited. Approximately 75 patients have been exposed to individual Zanaflex doses of 12 mg or more for at least one year or more and approximately 80 patients have been exposed to total daily Zanaflex doses of 30 to 36 mg/day for at least one year or more. There is essentially no long-term experience with single, daytime Zanaflex doses of 16 mg. Because long-term clinical study experience at high doses is limited, only those adverse events with a relatively high incidence are likely to have been identified.

Hypotension

Zanaflex is an (alpha) 2 -adrenergic agonist (like clonidine) and can produce hypotension. In a single dose Zanaflex study where blood pressure was monitored closely after dosing, two-thirds of patients treated with 8 mg of Zanaflex had a 20% reduction in either the diastolic or systolic BP.

The chance of significant hypotension with Zanaflex may possibly be minimized by titration of the dose and by focusing attention on signs and symptoms of hypotension prior to Zanaflex dose advancement. In addition, patients moving from a supine to a fixed upright position may be at increased risk for hypotension and orthostatic effects.

Risk of Liver Injury

Zanaflex occasionally causes liver injury. In occasional symptomatic cases, nausea, vomiting, anorexia and jaundice have been reported. In post-marketing experience, three deaths associated with liver failure have been reported in patients treated with Zanaflex. In one case, a 49 year-old male developed jaundice and liver enlargement following 2 months of Zanaflex treatment, primarily at 6 mg three times per day. Treatment was discontinued and the patient died in hepatic coma 10 days later. There was no explanation, other than a reaction to Zanaflex, to explain the liver injury. In the two other cases, patients were taking other drugs with known potential for liver toxicity. One patient, treated with Zanaflex at a dose of 4 mg/day, was also on carbamazepine when he developed jaundice after 2 months of treatment; this patient died with pneumonia about 20 days later. Another patient, treated with Zanaflex for 11 days, was also treated with dantrolene for about 2 weeks prior to developing fatal hepatic failure.

Sedation

In the multiple Zanaflex dose, controlled clinical studies, 48% of patients receiving any dose of Zanaflex reported sedation as an adverse event. In 10% of these cases, the sedation was rated as severe compared to <1% in the placebo treated patients. Sedation may interfere with everyday activity.

The effect appears to be dose related. In a single dose study, 92% of the patients receiving 16 mg of Zanaflex, when asked, reported that they were drowsy during the 6 hour study. This compares to 76% of the patients on 8 mg of Zanaflex and 35% of the patients on placebo. Patients began noting this effect 30 minutes following Zanaflex dosing. The effect peaked 1.5 hours following dosing. Of the patients who received a single Zanaflex dose of 16 mg, 51% continued to report drowsiness 6 hours following dosing compared to 13% in the patients receiving placebo or 8 mg of Zanaflex.

Hallucinosis/Psychotic-Like Symptoms

Zanaflex use has been associated with hallucinations. Formed, visual hallucinations or delusions have been reported in 5 of 170 patients (3%) in two North American controlled clinical studies. These 5 cases occurred within the first 6 weeks of Zanaflex treatment. Most of the patients were aware that the events were unreal. One patient developed psychoses in association with the hallucinations. One patient among these 5 continued to have problems for at least 2 weeks following discontinuation of Zanaflex.

PRECAUTIONS

Cardiovascular

Reduction in pulse rate has been noted in association with decreases in blood pressure in the single dose Zanaflex controlled study.

Ophthalmic

Zanaflex Dose-related retinal degeneration and corneal opacities have been found in animal studies at doses equivalent to approximately the maximum recommended dose on a mg/m 2 basis. There have been no reports of corneal opacities or retinal degeneration in the clinical studies.

Use in Kidney Impaired Patients

Zanaflex should be used with caution in patients with kidney insufficiency as clearance is reduced by more than 50%. In these patients, during titration, the individual Zanaflex doses should be reduced. If higher Zanaflex doses are required, individual doses rather than dosing frequency should be increased. These patients should be monitored closely for the onset or increase in severity of the common adverse events (dry mouth, somnolence, asthenia and dizziness) as indicators of potential Zanaflex overdose.

Use in Women Taking Oral Contraceptives

Zanaflex should be used with caution in women taking oral contraceptives, as clearance of Zanaflex is reduced by approximately 50% in such patients. In these patients, during Zanaflex titration, the individual doses should be reduced.

Information for Patients

Because of the possibility of Zanaflex lowering blood pressure, patients should be warned about the risk of clinically significant orthostatic hypotension.

Because of the possibility of sedation with Zanaflex, patients should be warned about performing activities requiring alertness, such as driving a vehicle or operating machinery. Patients should also be instructed that the sedation may be additive when Zanaflex is taken in conjunction with drugs (baclofen, benzodiazepines) or substances (e.g., alcohol) that act as CNS depressants.

Zanaflex should be used with caution where spasticity is utilized to sustain posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.

Drug Interactions

Alcohol: Alcohol increased the AUC of Zanaflex by approximately 20% while also increasing its C max by approximately 15%. This was associated with an increase in side effects of Zanaflex. The CNS depressant effects of Zanaflex and alcohol are additive.

Oral Contraceptives: No specific pharmacokinetic study was conducted to investigate interaction between oral contraceptives and Zanaflex, but retrospective analysis of population pharmacokinetic data following single and multiple dose administration of 4 mg Zanaflex showed that women concurrently taking oral contraceptives had 50% lower clearance of Zanaflex than women not on oral contraceptives.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence for carcinogenicity was seen in two dietary studies in rodents. Zanaflex was administered to mice for 78 weeks at doses up to 16 mg/kg, which is equivalent to 2 times the maximum recommended human dose on a mg/m 2 basis. Zanaflex was also administered to rats for 104 weeks at doses up to 9 mg/kg, which is equivalent to 2.5 times the maximum recommended human dose on a mg/m 2 basis. There was no statistically significant increase in tumors in either species.

Labor and Delivery

The effect of Zanaflex on labor and delivery in humans is unknown.

Nursing Mothers

It is not known whether Zanaflex is excreted in human milk, although as a lipid soluble drug, it might be expected to pass into breast milk.

Geriatric Use

Zanaflex should be used with caution in elderly patients because clearance is decreased four-fold.

Pediatric Use

There are no adequate and well-controlled studies to document the safety and efficacy of Zanaflex in children.

Adverse Reactions

In multiple dose, placebo-controlled clinical studies, 264 patients were treated with Zanaflex and 261 with placebo. Adverse events, including severe adverse events, were more frequently reported with Zanaflex than with placebo.

Common Adverse Events Leading to Discontinuation

Forty-five of 264 (17%) patients receiving Zanaflex and 13 of 261 (5%) patients receiving placebo in three multiple dose, placebo-controlled clinical studies discontinued treatment for adverse events. When patients withdrew from the study, they frequently had more than one reason for discontinuing. The adverse events most frequently leading to withdrawal Zanaflex treated patients in the controlled clinical studies were asthenia (weakness, fatigue and/or tiredness) (3%), somnolence (3%), dry mouth (3%), increased spasm or tone (2%) and dizziness (2%).

Most Frequent Adverse Clinical Events Seen in Association With the Use of Zanaflex

In multiple dose, placebo-controlled clinical studies involving 264 patients with spasticity, the most frequent adverse Zanaflex related adverse events were dry mouth, somnolence/sedation, asthenia (weakness, fatigue and/or tiredness), and dizziness. Three-quarters of the patients rated the events as mild to moderate and one-quarter of the patients rated the events as being severe. These events appeared to be dose related.

Adverse Events Reported in Controlled Studies

DRUG ABUSE AND DEPENDENCE

Abuse potential of Zanaflex was not evaluated in human studies.

OVERDOSAGE

Should Zanaflex overdosage occur, basic steps to ensure the adequacy of an airway and the monitoring of cardiovascular and respiratory systems should be undertaken. For the most recent information concerning the management of overdose, contact a poison control center.

DOSAGE AND ADMINISTRATION

A single oral dose of 8 mg of Zanaflex reduces muscle tone in patients with spasticity for a period of several hours. The effect of Zanaflex peaks at approximately 1 to 2 hours and dissipates between 3 to 6 hours. Zanaflex effects are dose-related.

Although single doses of less than 8 mg of Zanaflex have not been demonstrated to be effective in controlled clinical studies, the dose-related nature of Zanaflex's common adverse events make it prudent to begin treatment with single oral doses of 4 mg. Increase the Zanaflex dose gradually (2 to 4 mg steps) to optimum effect (satisfactory reduction of muscle tone at a tolerated dose).

The Zanaflex dose can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours. The total daily Zanaflex dose should not exceed 36 mg.

Experience with single doses exceeding 8 mg of Zanaflex and daily doses exceeding 24 mg is limited. There is essentially no experience with repeated, single, daytime doses greater than 12 mg of Zanaflex or total daily doses greater than 36 mg.

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