Alipid may be available in the countries listed below.
Atorvastatin calcium (a derivative of Atorvastatin) is reported as an ingredient of Alipid in the following countries:
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Colesolvin may be available in the countries listed below.
Policosanol is reported as an ingredient of Colesolvin in the following countries:
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Generic Name: estradiol (Transdermal route)
es-tra-DYE-ol
Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible .
Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible.
Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible .
Unopposed estrogens increase the risk of endometrial cancer. Adding a progestin will reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Diagnostic measures should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) using estrogen alone have been reported. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) using estrogens combined with progestins have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported in women receiving estrogen alone or estrogen combined with progestins. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible. Breast budding and breast masses in prepubertal females and gynecomastia and breast masses in prepubertal males have been reported following unintentional secondary exposure. Patients should strictly adhere to recommended instructions for use .
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Endocrine-Metabolic Agent
Pharmacologic Class: Estrogen
Estradiol transdermal spray is used to treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen.
Estradiol is an estrogen hormone. The hormone from the spray is absorbed through your skin into your body. It works by preventing symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ("hot flashes") in women during menopause.
This medicine 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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Use of estradiol transdermal spray is not indicated in the pediatric population. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of estradiol transdermal spray have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have breast cancer, stroke, or dementia, which may require caution in patients receiving estradiol transdermal spray.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | X | Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. |
Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
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 receiving this medicine, 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 this medicine 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.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain estradiol. It may not be specific to Vivelle-Dot. Please read with care.
It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.
This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, breast, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.
This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
Wash your hands with soap and water before and after using this medicine.
To use the spray:
The spray contains alcohol and is flammable. Avoid using it near an open flame or while smoking.
The dose of this medicine 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 this medicine. 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.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Do not use Evamist® spray if it has been more than 12 hours since you missed your last dose.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise.
It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using large doses of this medicine over a long period of time may increase your risk of heart attack, stroke, blood clots, dementia, breast cancer, or uterine cancer. Talk with your doctor about this risk. If you still have your uterus (womb), ask your doctor if you should also use a progestin medicine.
Your risk of heart disease or stroke from this medicine is higher if you smoke. Your risk is also increased if you have diabetes or high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine.
This medicine may also increase your risk of certain types of cancer. Talk to your doctor if you have concerns about this risk.
Using this medicine alone may increase your risk of getting cancer of the uterus (womb). Check with your doctor right away if you have unusual vaginal bleeding while you are using this medicine.
Stop using this medicine and check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Check with your child's doctor right away if your child starts to have the following symptoms: nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to this medicine.
Do not allow your pets to lick or touch the arm where this medicine was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have the following symptoms: nipple or breast enlargement, swelling of the vulva, or any signs of illness.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines or drink grapefruit juice unless you discuss it with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.
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:
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.
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Tizanidine hydrochloride is a centrally acting α2-adrenergic agonist. Tizanidine hydrochloride is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine’s molecular formula is C9H8CIN5S•HCl, its molecular weight is 290.2 and its structural formula is:
Tizanidine is supplied as 2 and 4 mg tablets for oral administration. Tizanidine hydrochloride tablets are composed of the active ingredient, Tizanidine hydrochloride (2.288 mg equivalent to 2 mg Tizanidine base and 4.576 mg equivalent to 4 mg Tizanidine base), and the inactive ingredients, colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose and stearic acid.
Tizanidine is an agonist at α2-adrenergic receptor sites and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. In animal models, Tizanidine has no direct effect on skeletal muscle fibers or the neuromuscular junction, and no major effect on monosynaptic spinal reflexes. The effects of Tizanidine are greatest on polysynaptic pathways. The overall effect of these actions is thought to reduce facilitation of spinal motor neurons.
The imidazoline chemical structure of Tizanidine is related to that of the anti-hypertensive drug clonidine and other α2-adrenergic agonists. Pharmacological studies in animals show similarities between the two compounds, but Tizanidine was found to have one-tenth to one-fiftieth (1/50) of the potency of clonidine in lowering blood pressure.
Following oral administration, Tizanidine is essentially completely absorbed. The absolute oral bioavailability of Tizanidine is approximately 40% (CV = 24%), due to extensive first-pass hepatic metabolism. Tizanidine is extensively distributed throughout the body with a mean steady state volume of distribution of 2.4 L/kg (CV = 21%) following intravenous administration in healthy adult volunteers. Tizanidine is approximately 30% bound to plasma proteins.
Tizanidine has linear pharmacokinetics over a dose of 1 mg to 20 mg. Tizanidine has a half-life of approximately 2.5 hours (CV=33%). Approximately 95% of an administered dose is metabolized. The primary cytochrome P450 isoenzyme involved in Tizanidine metabolism is CYP1A2. Tizanidine metabolites are not known to be active; their half-lives range from 20 to 40 hours.
Following single and multiple oral dosing of 14C-Tizanidine, an average of 60% and 20% of total radioactivity was recovered in the urine and feces, respectively.
A single dose of two 4 mg tablets was administered under fed and fasting conditions in an open label, four period, randomized crossover study in 96 human volunteers, of whom 81 were eligible for the statistical analysis.
Following oral administration of the tablet (in the fasted state), Tizanidine has peak plasma concentrations occurring 1 hour after dosing with a half-life of approximately 2 hours.
When two 4 mg tablets are administered with food the mean maximal plasma concentration is increased by approximately 30% and the median time to peak plasma concentration is increased by 25 minutes, to 1 hour and 25 minutes.
Figure 1: Mean Tizanidine Concentration vs. Time Profiles for Tizanidine Tablets (2 x 4 mg) Under Fasted and Fed Conditions.
Age Effects: No specific pharmacokinetic study was conducted to investigate age effects. Cross study comparison of pharmacokinetic data following single dose administration of 6 mg Tizanidine showed that younger subjects cleared the drug four times faster than the elderly subjects. Tizanidine has not been evaluated in children (see PRECAUTIONS).
Hepatic Impairment: The influence of hepatic impairment on the pharmacokinetics of Tizanidine has not been evaluated. Because Tizanidine is extensively metabolized in the liver, hepatic impairment would be expected to have significant effects on pharmacokinetics of Tizanidine. Tizanidine should ordinarily be avoided or used with extreme caution in this patient population (see WARNINGS).
Renal Impairment: Tizanidine clearance is reduced by more than 50% in elderly patients with renal insufficiency (creatinine clearance < 25 mL/min) compared to healthy elderly subjects; this would be expected to lead to a longer duration of clinical effect. Tizanidine should be used with caution in renally impaired patients (see PRECAUTIONS).
Gender Effects: No specific pharmacokinetic study was conducted to investigate gender effects. Retrospective analysis of pharmacokinetic data, however, following single and multiple dose administration of 4 mg Tizanidine showed that gender had no effect on the pharmacokinetics of Tizanidine.
Race Effects: Pharmacokinetic differences due to race have not been studied.
Fluvoxamine: The effect of fluvoxamine on the pharmacokinetics of Tizanidine was studied in 10 healthy subjects. The Cmax, AUC, and half-life of Tizanidine increased by 12-fold, 33-fold, and 3-fold, respectively. These changes resulted in significant decreases in blood pressure, increased drowsiness, and psychomotor impairment (see CONTRAINDICATIONS and WARNINGS).
Ciprofloxacin: The effect of ciprofloxacin on the pharmacokinetics of Tizanidine was studied in 10 healthy subjects. The Cmax and AUC of Tizanidine increased by 7-fold and 10-fold, respectively. These changes resulted in significant decreases in blood pressure, increased drowsiness, and psychomotor impairment (see CONTRAINDICATIONSand WARNINGS).
CYP1A2 Inhibitors: The interaction between Tizanidine and either fluvoxamine or ciprofloxacin is most likely due to inhibition of CYP1A2 by fluvoxamine or ciprofloxacin. Although there have been no clinical studies evaluating the effects of other CYP1A2 inhibitors on Tizanidine, other CYP1A2 inhibitors, such as zileuton, other fluoroquinolones, antiarrythmics (amiodarone, mexiletine, propafenone and verapamil), cimetidine, famotidine, oral contraceptives, acyclovir and ticlopidine, may also lead to substantial increases in Tizanidine blood concentrations (see WARNINGS).
Oral Contraceptives: No specific pharmacokinetic study was conducted to investigate interaction between oral contraceptives and Tizanidine. Retrospective analysis of population pharmacokinetic data following single and multiple dose administration of 4 mg Tizanidine, however, showed that women concurrently taking oral contraceptives had 50% lower clearance of Tizanidine compared to women not on oral contraceptives (see PRECAUTIONS).
Tizanidine’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 drug 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 Tizanidine.
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 Tizanidine compared to placebo was detected at 1, 2 and 3 hours after treatment. Figure 2 below shows a comparison of the mean change in muscle tone from baseline as measured by the Ashworth scale. The greatest reduction in muscle tone was 1 to 2 hours after treatment. By 6 hours after treatment, muscle tone in the 8 and 16 mg Tizanidine groups was indistinguishable from muscle tone in placebo treated patients. Within a given patient, improvement in muscle tone was correlated with plasma concentration. Plasma concentrations were variable from patient to patient at a given dose. Although 16 mg produced a larger effect, adverse 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.
Figure 2: Single Dose Study - Mean Change in Muscle Tone from Baseline as Measured by the Ashworth Scale ± 95% Confidence Interval (A Negative Ashworth Score Signifies an Improvement in Muscle Tone from Baseline)
In a multiple dose study, 118 patients with spasticity secondary to spinal cord injury were randomized to either placebo or Tizanidine. 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 dose for 4 additional weeks (i.e., maintenance phase). Throughout the 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 Tizanidine 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 Tizanidine treated patients on measures of activities of daily living. Figure 3 below shows a comparison of the mean change in muscle tone from baseline as measured by the Ashworth scale.
Figure 3: Multiple Dose Study - Mean Change in Muscle Tone 0.5-2.5 Hours after Dosing as Measured by the Ashworth Scale ± 95% Confidence Interval (A Negative Ashworth Score Signifies an Improvement in Muscle Tone from Baseline)
Tizanidine tablets is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with Tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).
Concomitant use of Tizanidine with fluvoxamine or with ciprofloxacin, potent inhibitors of CYP1A2, is contraindicated. Significant alterations of pharmacokinetic parameters of Tizanidine including increased AUC, t1/2, Cmax, increased oral bioavailability and decreased plasma clearance have been observed with concomitant administration of either fluvoxamine or ciprofloxacin. This pharmacokinetic interaction can result in potentially serious adverse events (see WARNINGS and CLINICAL PHARMACOLOGY, Drug Interactions).
Tizanidine is contraindicated in patients with known hypersensitivity to Tizanidine or its ingredients.
Clinical experience with long-term use of Tizanidine at doses of 8 mg to 16 mg single doses or total daily doses of 24 mg to 36 mg (see DOSAGE AND ADMINISTRATION) is limited. In safety studies, approximately 75 patients have been exposed to individual doses of 12 mg or more for at least one year or more and approximately 80 patients have been exposed to total daily doses of 30 mg/day to 36 mg/day for at least one year or more. There is essentially no long-term experience with single, daytime 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 (see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS).
Tizanidine is an α2-adrenergic agonist (like clonidine) and can produce hypotension. In a single dose study where blood pressure was monitored closely after dosing, two-thirds of patients treated with 8 mg of Tizanidine had a 20% reduction in either the diastolic or systolic BP. The reduction was seen within 1 hour after dosing, peaked 2 to 3 hours after dosing and was associated, at times, with bradycardia, orthostatic hypotension, lightheadedness/dizziness and rarely syncope. The hypotensive effect is dose related and has been measured following single doses of ≥ 2 mg.
The chance of significant hypotension may possibly be minimized by titration of the dose and by focusing attention on signs and symptoms of hypotension prior to dose advancement. In addition, patients moving from a supine to a fixed upright position may be at increased risk for hypotension and orthostatic effects.
Caution is advised when Tizanidine is to be used in patients receiving concurrent antihypertensive therapy and should not be used with other α2-adrenergic agonists.
Clinically significant hypotension (decreases in both systolic and diastolic pressure) has been reported with concomitant administration of either fluvoxamine or ciprofloxacin and single doses of 4 mg of Tizanidine. Therefore, concomitant use of Tizanidine with fluvoxamine or with ciprofloxacin, potent inhibitors of CYP1A2, is contraindicated (see CONTRAINDICATIONSand CLINICAL PHARMACOLOGY, Drug Interactions).
Tizanidine occasionally causes liver injury, most often hepatocellular in type. In controlled clinical studies, approximately 5% of patients treated with Tizanidine had elevations of liver function tests (ALT/SGPT, AST/SGOT) to greater than 3 times the upper limit of normal (or 2 times if baseline levels were elevated) compared to 0.4% in the control patients. Most cases resolved rapidly upon drug withdrawal with no reported residual problems. In occasional symptomatic cases, nausea, vomiting, anorexia and jaundice have been reported. Based upon post-marketing experience, death associated with liver failure has been a rare occurrence reported in patients treated with Tizanidine.
Monitoring of aminotransferase levels is recommended during the first 6 months of treatment (e.g., baseline, 1, 3 and 6 months) and periodically thereafter, based on clinical status. Because of the potential toxic hepatic effect of Tizanidine, the drug should ordinarily be avoided or used with extreme caution in patients with impaired hepatic function.
In the multiple dose, controlled clinical studies, 48% of patients receiving any dose of Tizanidine 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, when asked, reported that they were drowsy during the 6 hour study. This compares to 76% of the patients on 8 mg and 35% of the patients on placebo. Patients began noting this effect 30 minutes following dosing. The effect peaked 1.5 hours following dosing. Of the patients who received a single 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 Tizanidine.
In the multiple dose studies, the prevalence of patients with sedation peaked following the first week of titration and then remained stable for the duration of the maintenance phase of the study.
Tizanidine 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. 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 Tizanidine.
The influence of hepatic impairment on the pharmacokinetics of Tizanidine has not been evaluated. Because Tizanidine is extensively metabolized in the liver, hepatic impairment would be expected to have significant effects on the pharmacokinetics of Tizanidine. Tizanidine should ordinarily be avoided or used with extreme caution in patients with hepatic impairment (see also WARNINGS, Risk of Liver Injury).
In a pharmacokinetic study, Tizanidine serum concentration was significantly increased (Cmax 12-fold, AUC 33-fold) when the drug was given concomitantly with fluvoxamine. Potentiated hypotensive and sedative effects were observed. Fluvoxamine and Tizanidine should not be used together (see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY, Drug Interactions).
In a pharmacokinetic study, Tizanidine serum concentration was significantly increased (Cmax 7-fold, AUC 10-fold) when the drug was given concomitantly with ciprofloxacin. Potentiated hypotensive and sedative effects were observed. Ciprofloxacin and Tizanidine should not be used together (see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY, Drug Interactions).
Because of potential drug interactions, concomitant use of Tizanidine with other CYP1A2 inhibitors, such as zileuton, other fluoroquinolones, antiarrythmics (amiodarone, mexiletine, propafenone, and verapamil), cimetidine, famotidine, oral contraceptives, acyclovir and ticlopidine (see CLINICAL PHARMACOLOGY, Drug Interactions) should ordinarily be avoided. If their use is clinically necessary, they should be used with caution.
Prolongation of the QT interval and bradycardia were noted in chronic toxicity studies in dogs at doses equal to the maximum human dose on a mg/m2 basis. ECG evaluation was not performed in the controlled clinical studies. Reduction in pulse rate has been noted in association with decreases in blood pressure in the single dose controlled study (see WARNINGS).
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/m2 basis. There have been no reports of corneal opacities or retinal degeneration in the clinical studies.
Tizanidine should be used with caution in patients with renal insufficiency (creatinine clearance < 25 mL/min), as clearance is reduced by more than 50%. In these patients, during titration, the individual doses should be reduced. If higher 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 overdose.
Because drug interaction studies of Tizanidine with oral contraceptives have shown that concomitant use may reduce the clearance of Tizanidine by as much as 50%, concomitant use of Tizanidine with oral contraceptives should ordinarily be avoided (see CLINICAL PHARMACOLOGY, Drug Interactions). However, if concomitant use is clinically necessary, the starting dose and subsequent titration rate of Tizanidine should be reduced.
If therapy needs to be discontinued, particularly in patients who have been receiving high doses for long periods, the dose should be decreased slowly to minimize the risk of withdrawal and rebound hypertension, tachycardia, and hypertonia.
Patients should be advised of the limited clinical experience with Tizanidine both in regard to duration of use and the higher doses required to reduce muscle tone (see WARNINGS).
Because of the possibility of Tizanidine lowering blood pressure, patients should be warned about the risk of clinically significant orthostatic hypotension (see WARNINGS).
Because of the possibility of sedation, patients should be warned about performing activities requiring alertness, such as driving a vehicle or operating machinery (see WARNINGS). Patients should also be instructed that the sedation may be additive when Tizanidine is taken in conjunction with drugs (baclofen, benzodiazepines) or substances (e.g., alcohol) that act as CNS depressants.
Patients should be advised of the change in the absorption profile of Tizanidine if taken with food and the potential changes in efficacy and adverse effect profiles that may result (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
Patients should be advised not to stop Tizanidine suddenly as rebound hypertension and tachycardia may occur (see PRECAUTIONS, Discontinuing Therapy).
Tizanidine 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.
Because of the potential for the increased risk of serious adverse reactions including severe lowering of blood pressure and sedation when Tizanidine and either fluvoxamine or ciprofloxacin are used together, Tizanidine should not be used with either fluvoxamine or ciprofloxacin. Because of the potential for interaction with other CYP1A2 inhibitors, patients should be instructed to inform their physicians and pharmacists when any medication is added or removed from their regimen.
In vitro studies of cytochrome P450 isoenzymes using human liver microsomes indicate that neither Tizanidine nor the major metabolites are likely to affect the metabolism of other drugs metabolized by cytochrome P450 isoenzymes.
The effect of fluvoxamine on the pharmacokinetics of a single 4 mg dose of Tizanidine was studied in 10 healthy subjects. The Cmax, AUC, and half-life of Tizanidine increased by 12-fold, 33-fold, and 3-fold, respectively. These changes resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment (see CONTRAINDICATIONS and WARNINGS).
The effect of ciprofloxacin on the pharmacokinetics of a single 4 mg dose of Tizanidine was studied in 10 healthy subjects. The Cmax and AUC of Tizanidine increased by 7-fold and 10-fold, respectively. These changes resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment (see CONTRAINDICATIONS and WARNINGS).
The interaction between Tizanidine and either fluvoxamine or ciprofloxacin is most likely due to inhibition of CYP1A2 by fluvoxamine or ciprofloxacin. Although there have been no clinical studies evaluating the effects of other CYP1A2 inhibitors on Tizanidine, other CYP1A2 inhibitors, including zileuton, other fluroquinolones, antiarrythmics (amiodarone, mexiletine, propafenone, and verapamil), cimetidine and famotidine, oral contraceptives, acyclovir, and ticlopidine may also lead to substantial increases in Tizanidine blood concentrations. Concomitant use of Tizanidine with CYP1A2 inhibitors should ordinarily be avoided. If their use is clinically necessary, they should be used with caution (see WARNINGS).
Tizanidine delayed the Tmax of acetaminophen by 16 minutes. Acetaminophen did not affect the pharmacokinetics of Tizanidine.
Alcohol increased the AUC of Tizanidine by approximately 20% while also increasing its Cmax by approximately 15%. This was associated with an increase in side effects of Tizanidine. The CNS depressant effects of Tizanidine and alcohol are additive.
No specific pharmacokinetic study was conducted to investigate interaction between oral contraceptives and Tizanidine, but retrospective analysis of population pharmacokinetic data following single and multiple dose administration of 4 mg Tizanidine showed that women concurrently taking oral contraceptives had 50% lower clearance of Tizanidine than women not on oral contraceptives.
No evidence for carcinogenicity was seen in two dietary studies in rodents. Tizanidine 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/m2 basis. Tizanidine 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/m2 basis. There was no statistically significant increase in tumors in either species.
Tizanidine was not mutagenic or clastogenic in the following in vitro assays: the bacterial Ames test and the mammalian gene mutation test and chromosomal aberration test in Chinese hamster cells. It was also negative in the following in vivo assays: the bone marrow micronucleus test in mice, the bone marrow micronucleus and cytogenicity test in Chinese hamsters, the dominant lethal mutagenicity test in mice, and the unscheduled DNA synthesis (UDS) test in mice.
Tizanidine did not affect fertility in male rats at doses of 10 mg/kg, approximately 2.7 times the maximum recommended human dose on a mg/m2 basis, and in females at doses of 3 mg/kg, approximately equal to the maximum recommended human dose on a mg/m2 basis; fertility was reduced in males receiving 30 mg/kg (8 times the maximum recommended human dose on a mg/m2 basis) and in females receiving 10 mg/kg (2.7 times the maximum recommended human dose on a mg/m2 basis). At these doses, maternal behavioral effects and clinical signs were observed including marked sedation, weight loss, and ataxia.
Reproduction studies performed in rats at a dose of 3 mg/kg, equal to the maximum recommended human dose on a mg/m2 basis, and in rabbits at 30 mg/kg, 16 times the maximum recommended human dose on a mg/m2 basis, did not show evidence of teratogenicity. Tizanidine at doses that are equal to and up to 8 times the maximum recommended human dose on a mg/m2 basis increased gestation duration in rats. Prenatal and postnatal pup loss was increased and developmental retardation occurred. Post-implantation loss was increased in rabbits at doses of 1 mg/kg or greater, equal to or greater than 0.5 times the maximum recommended human dose on a mg/m2 basis. Tizanidine has not been studied in pregnant women. Tizanidine should be given to pregnant women only if clearly needed.
The effect of Tizanidine on labor and delivery in humans is unknown.
It is not known whether Tizanidine is excreted in human milk, although as a lipid soluble drug, it might be expected to pass into breast milk.
Tizanidine should be used with caution in elderly patients because clearance is decreased four-fold.
There are no adequate and well-controlled studies to document the safety and efficacy of Tizanidine in children.
In multiple dose, placebo-controlled clinical studies, 264 patients were treated with Tizanidine and 261 with placebo. Adverse events, including severe adverse events, were more frequently reported with Tizanidine than with placebo.
Forty-five of 264 (17%) patients receiving Tizanidine and 13 of 261 (5%) of 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 of Tizanidine 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%).
In multiple dose, placebo-controlled clinical studies involving 264 patients with spasticity, the most frequent 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.
The events cited reflect experience gained under closely monitored conditions of clinical studies in a highly selected patient population. In actual clinical practice or in other clinical studies, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ. Table 1 lists treatment emergent signs and symptoms that were reported in greater than 2% of patients in three multiple dose, placebo-controlled studies who received Tizanidine where the frequency in the Tizanidine group was at least as common as in the placebo group. These events are not necessarily related to Tizanidine treatment. For comparison purposes, the corresponding frequency of the event (per 100 patients) among placebo treated patients is also provided.
| ||
| Event | Placebo N=261 % | Tizanidine Hydrochloride N=264 % |
| Dry Mouth | 10 | 49 |
| Somnolence | 10 | 48 |
| Asthenia* | 16 | 41 |
| Dizziness | 4 | 16 |
| UTI | 7 | 10 |
| Infection | 5 | 6 |
| Constipation | 1 | 4 |
| Liver function tests abnormal | 1 | 3 |
| Vomiting | 0 | 3 |
| Speech disorder | 0 | 3 |
| Amblyopia (blurred vision) | <1 | 3 |
| Urinary frequency | 2 | 3 |
| Flu symptom | 2 | 3 |
| SGPT/ALT increased | <1 | 3 |
| Dyskinesia | 0 | 3 |
| Nervousness | <1 | 3 |
| Pharyngitis | 1 | 3 |
| Rhinitis | 2 | 3 |
In the single dose, placebo-controlled study involving 142 patients with spasticity, the patients were specifically asked if they had experienced any of the four most common adverse events: dry mouth, somnolence (drowsiness), asthenia (weakness, fatigue and/or tiredness) and dizziness. In addition, hypotension and bradycardia were observed. The occurrence of these adverse events is summarized in Table 2. Other events were, in general, reported at a rate of 2% or less.
| |||
| Event | Placebo N=48 % | Tizanidine Hydrochloride, N=45 % | Tizanidine Hydrochloride, N=49 % |
Somnolence Dry mouth Asthenia* Dizziness Hypotension Bradycardia | 31 35 40 4 0 0 | 78 76 67 22 16 2 | 92 88 78 45 33 10 |
Tizanidine was administered to 1,385 patients in additional clinical studies where adverse event information was available. The conditions and duration of exposure varied greatly, and included (in overlapping categories) double-blind and open-label studies, uncontrolled and controlled studies, inpatient and outpatient studies, and titration studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.
In the tabulations that follow, reported adverse events were classified using a standard COSTART-based dictionary terminology. The frequencies presented, therefore, represent the proportion of the 1,385 patients exposed to Tizanidine who experienced an event of the type cited on at least one occasion while receiving Tizanidine. All reported events are included except those already listed in Table 1. If the COSTART term for an event was so general as to be uninformative, it was replaced by a more informative term. It is important to emphasize that, although the events reported occurred during treatment with Tizanidine, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled studies appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare adverse events are those occurring in fewer than 1/1,000 patients.
Body as a Whole:Frequent: fever; Infrequent: allergic reaction, moniliasis, malaise, abscess, neck pain, sepsis, cellulitis, death, overdose; Rare: carcinoma, congenital anomaly, suicide attempt.
Cardiovascular System: Infrequent: vasodilatation, postural hypotension, syncope, migraine, arrhythmia; Rare: angina pectoris, coronary artery disorder, heart failure, myocardial infarct, phlebitis, pulmonary embolus, ventricular extrasystoles, ventricular tachycardia.
Digestive System: Frequent: abdomen pain, diarrhea, dyspepsia; Infrequent: dysphagia, cholelithiasis, fecal impaction, flatulence, gastrointestinal hemorrhage, hepatitis, melena; Rare: gastroenteritis, hematemesis, hepatoma, intestinal obstruction, liver damage.
Hemic and Lymphatic System: Infrequent: ecchymosis, hypercholesteremia, anemia, hyperlipemia, leukopenia, leukocytosis, sepsis; Rare: petechia, purpura, thrombocythemia, thrombocytopenia.
Metabolic and Nutritional System: Infrequent: edema, hypothyroidism, weight loss; Rare: adrenal cortex insufficiency, hyperglycemia, hypokalemia, hyponatremia, hypoproteinemia, respiratory acidosis.
Musculoskeletal System: Frequent: myasthenia, back pain; Infrequent: pathological fracture, arthralgia, arthritis, bursitis.
Nervous System: Frequent: depression, anxiety, paresthesia; Infrequent: tremor, emotional lability, convulsion, paralysis, thinking abnormal, vertigo, abnormal dreams, agitation, depersonalization, euphoria, migraine, stupor, dysautonomia, neuralgia; Rare: dementia, hemiplegia, neuropathy.
Respiratory System: Infrequent: sinusitis, pneumonia, bronchitis; Rare: asthma.
Skin and Appendages: Frequent: rash, sweating, skin ulcer; Infrequent: pruritus, dry skin, acne, alopecia, urticaria; Rare: exfoliative dermatitis, herpes simplex, herpes zoster, skin carcinoma.
Special Senses: Infrequent: ear pain, tinnitus, deafness, glaucoma, conjunctivitis, eye pain, optic neuritis, otitis media, retinal hemorrhage, visual field defect; Rare: iritis, keratitis, optic atrophy.
Urogenital System: Infrequent: urinary urgency, cystitis, menorrhagia, pyelonephritis, urinary retention, kidney calculus, uterine fibroids enlarged, vaginal moniliasis, vaginitis; Rare: albuminuria, glycosuria, hematuria, metrorrhagia.
Abuse potential was not evaluated in human studies. Rats were able to distinguish Tizanidine from saline in a standard discrimination paradigm, after training, but failed to generalize the effects of morphine, cocaine, diazepam or phenobarbital to Tizanidine. Monkeys were shown to self-administer Tizanidine in a dose-dependent manner, and abrupt cessation of Tizanidine produced transient signs of withdrawal at doses > 35 times the maximum recommended human dose on a mg/m2 basis. These transient withdrawal signs (increased locomotion, body twitching, and aversive behavior toward the observer) were not reversed by naloxone administration.
Tizanidine is closely related to clonidine, which is often abused in combination with narcotics and is known to cause symptoms of rebound upon abrupt withdrawal. Three cases of rebound symptoms on sudden withdrawal of Tizanidine have been reported. The case reports suggest that these patients were also misusing narcotics. Withdrawal symptoms included hypertension, tachycardia, hypertonia, tremor, and anxiety. As with clonidine, withdrawal is expected to be more likely in cases where high doses are used, especially for prolonged periods.
A review of the safety surveillance database revealed cases of intentional and accidental Tizanidine overdose. Some of the cases resulted in fatality and many of the intentional overdoses were with multiple drugs including CNS depressants. The clinical manifestations of Tizanidine overdose were consistent with its known pharmacology. In the majority of cases a decrease in sensorium was observed including lethargy, somnolence, confusion and coma. Depressed cardiac function are also observed including most often bradycardia and hypotension. Respiratory depression is another common feature of Tizanidine overdose.
Should overdose occur, basic steps to ensure the adequacy of an airway and the monitoring of cardiovascular and respiratory systems should be undertaken. In general, symptoms resolve within one to three days following discontinuation of Tizanidine and administration of appropriate therapy. Due to the similar mechanism of action, symptoms and management of Tizanidine overdose are similar to those following clonidine overdose. For the most recent information concerning the management of overdose, contact a poison control center.
A single dose of 8 mg of Tizanidine reduces muscle tone in patients with spasticity for a period of several hours. The effect peaks at approximately 1 to 2 hours and dissipates between 3 to 6 hours. Effects are dose-related.
Although single doses of less than 8 mg have not been demonstrated to be effective in controlled clinical studies, the dose-related nature of Tizanidine’s common adverse events make it prudent to begin treatment with single oral doses of 4 mg. Increase the dose gradually (2 mg to 4 mg steps) to optimum effect (satisfactory reduction of muscle tone at a tolerated dose).
The dose can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours. The total daily dose should not exceed 36 mg.
Experience with single doses exceeding 8 mg and daily doses exceeding 24 mg is limited. There is essentially no experience with repeated, single, daytime doses greater
Pyassan may be available in the countries listed below.
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Generic Name: varicella virus (chickenpox) vaccine (VAR i SEL a VYE rus vax EEN)
Brand Names: Varivax
Varicella (commonly known as chickenpox) is a common childhood disease that causes fever, skin rash, and a breakout of fluid-filled blisters on the skin. Most people who receive this vaccine will not get chickenpox, or will get only a mild case and will recover faster.
Chickenpox is usually mild, but it can be serious or even fatal in young infants and in adults. It can lead to severe skin infection, breathing problems, brain damage, or death. A person who has had chickenpox can develop herpes zoster (also called shingles) later in life, which causes severe nerve pain, and hearing or vision problems, which may last for months or years.
Chickenpox is spread from person to person through the air, or by coming into contact with the fluid from a chickenpox blister.
Varicella virus vaccine is for use in adults and children who are at least 12 months old.
This vaccine works by exposing you to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.
Like any vaccine, the varicella virus vaccine may not provide protection from disease in every person.
The varicella vaccine is given in a series of shots. The first shot is usually given to a child who is 12 to 15 months old. The booster shot is then given at 4 to 6 years of age, or at least 3 months after the first dose.
If you are at least 13 years old and you have never had chickenpox or received this vaccine, you should receive two varicella virus vaccines at least 28 days apart.
Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.
Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.
You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.
Do not give salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others to a child under 18 for at least 6 weeks after he or she has received varicella vaccine. A serious condition called Reye's Syndrome has been reported in young people with chickenpox who take aspirin or salicylates.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
You should also not receive this vaccine if you have:
active tuberculosis infection that is not being treated;
a history of Guillain-Barré syndrome;
a chronic disease such as asthma or other breathing disorder, diabetes, kidney disease, or blood cell disorder such as anemia;
if you or someone in your household has severe immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving certain medicines such as steroids, chemotherapy or radiation;
if you are under 18 years old and have recently taken aspirin or other similar medicines such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others;
if you have recently received a stem cell transplant; or
if you are pregnant.
Before receiving varicella virus (Chickenpox) vaccine, talk to your doctor if you have:
thrombocytopenia purpura (easy bruising or bleeding);
active tuberculosis infection; or
if you have received an immune globulin or other blood product within the past year.
You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.
This vaccine is given as an injection (shot) under the skin. You will receive this injection in a doctor's office or other clinic setting.
The varicella vaccine is given in a series of shots. The first shot is usually given to a child who is 12 to 15 months old. The booster shot is then given at 4 to 6 years of age, or at least 3 months after the first dose.
If you are at least 13 years old and you have never had chickenpox or received this vaccine, you should receive two varicella virus vaccines at least 28 days apart.
Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.
Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.
It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.
This vaccine can cause false results on a skin test for tuberculosis. Tell any doctor who treats you if you have received a varicella virus vaccine within the past 4 to 6 weeks.
Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.
Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.
An overdose of this vaccine is unlikely to occur.
Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Call your doctor at once if you have any of these serious side effects:
cough, tight feeling in your chest, breathing problems;
seizure (black-out or convulsions);
easy bruising or bleeding, unusual weakness;
behavior changes; or
high fever (within a few hours or a few weeks after the vaccine).
Less serious side effects include:
redness, pain, or swelling where the shot was given;
low fever;
mild skin rash;
runny or stuffy nose, cough, sore throat;
headache, tired feeling;
sleep problems (insomnia);
joint or muscle pain; or
nausea, vomiting, stomach pain, diarrhea.
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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Usual Adult Dose for Varicella-Zoster -- Prophylaxis:
Two doses of 0.5 mL subcutaneously, 4 to 8 weeks apart
Usual Pediatric Dose for Varicella-Zoster -- Prophylaxis:
>= 1 year to 12 years: 0.5 mL subcutaneously once.
>= 13 years: Two doses of 0.5 mL subcutaneously, 4 to 8 weeks apart
Do not use salicylates (aspirin or aspirin containing products) for at least six weeks after receiving the vaccine. A serious condition called Reye's Syndrome has been reported in patients with chicken pox taking salicylates.
Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:
an oral, nasal, inhaled, or injectable steroid medicine;
medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).
If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.
There may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: varicella virus (chickenpox) vaccine side effects (in more detail)
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Treating and preventing symptoms of hay fever, other allergies, and colds. It may also be used for other conditions as determined by your doctor.
Brompheniramine 12-Hour Sustained-Release Tablets are an antihistamine. It works by blocking the action of histamine, a chemical released during allergic reactions.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Brompheniramine 12-Hour Sustained-Release 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 Brompheniramine 12-Hour Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Brompheniramine 12-Hour Sustained-Release 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 Brompheniramine 12-Hour Sustained-Release 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 Brompheniramine 12-Hour Sustained-Release 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:
Dizziness; drowsiness; dry mouth, throat, and nose; thickening of mucus in nose or throat.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; fever; mental or mood changes; shortness of breath; sore throat; unusual bleeding or bruising; unusual tiredness or weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Brompheniramine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bizarre behavior; constipation; enlarged pupils; excitement; flushing; hallucinations; seizures; severe dizziness; severe drowsiness.
Store Brompheniramine 12-Hour Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Brompheniramine 12-Hour Sustained-Release Tablets out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Brompheniramine 12-Hour Sustained-Release 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.
