Myfortic

mycophenolic acid

Dosage Form: tablet, delayed release
Myfortic®

(mycophenolic acid*)

delayed-release tablets

*as mycophenolate sodium

Rx only

Prescribing Information

WARNING

Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma and other neoplasms. Only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should use Myfortic® (mycophenolic acid). Patients receiving Myfortic should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Female users of childbearing potential must use contraception. Use of Myfortic® during pregnancy is associated with increased risks of pregnancy loss and congenital malformations.

DESCRIPTION

Myfortic® (mycophenolic acid) delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Myfortic is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt.

Its empirical formula is C17H19O6Na. The molecular weight is 342.32 and the structural formula is

Myfortic, as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1 N hydrochloric acid.

Myfortic is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose anhydrous, magnesium stearate, povidone (K-30), and starch. The enteric coating of the tablet consists of hypromellose phthalate, titanium dioxide, iron oxide yellow, and indigotine (180 mg) or iron oxide red (360 mg).

CLINICAL PHARMACOLOGY

Mechanism of Action

MPA is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation to DNA. Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines, whereas other cell types can utilize salvage pathways, MPA has potent cytostatic effects on lymphocytes.

Mycophenolate sodium has been shown to prevent the occurrence of acute rejection in rat models of kidney and heart allotransplantation. Mycophenolate sodium also decreases antibody production in mice.

Pharmacokinetics

Absorption

In-vitro studies demonstrated that the enteric-coated Myfortic® (mycophenolic acid) tablet does not release MPA under acidic conditions (pH <5) as in the stomach but is highly soluble in neutral pH conditions as in the intestine. Following Myfortic oral administration without food in several pharmacokinetic studies conducted in renal transplant patients, consistent with its enteric-coated formulation, the median delay (Tlag) in the rise of MPA concentration ranged between 0.25 and 1.25 hours and the median time to maximum concentration (Tmax) of MPA ranged between 1.5 and 2.75 hours. In comparison, following the administration of mycophenolate mofetil, the median Tmax ranged between 0.5 and 1.0 hours. In stable renal transplant patients on cyclosporine, USP (MODIFIED) based immunosuppression, gastrointestinal absorption and absolute bioavailability of MPA following the administration of Myfortic delayed-release tablet was 93% and 72%, respectively. Myfortic pharmacokinetics is dose proportional over the dose range of 360 to 2160 mg.

Distribution

The mean (± SD) volume of distribution at steady state and elimination phase for MPA is 54 (± 25) L and 112 (± 48) L, respectively. MPA is highly protein bound to albumin, >98%. The protein binding of mycophenolic acid glucuronide (MPAG) is 82%. The free MPA concentration may increase under conditions of decreased protein binding (uremia, hepatic failure, and hypoalbuminemia).

Metabolism

MPA is metabolized principally by glucuronyl transferase to glucuronidated metabolites. The phenolic glucuronide of MPA, mycophenolic acid glucuronide (MPAG), is the predominant metabolite of MPA and does not manifest pharmacological activity. The acyl glucuronide is a minor metabolite and has comparable pharmacological activity to MPA. In stable renal transplant patients on cyclosporine, USP (MODIFIED) based immunosuppression, approximately 28% of the oral Myfortic dose was converted to MPAG by presystemic metabolism. The AUC ratio of MPA:MPAG:acyl glucuronide is approximately 1:24:0.28 at steady state. The mean clearance of MPA was 140 (± 30) mL/min.

Elimination

The majority of MPA dose administered is eliminated in the urine primarily as MPAG (>60%) and approximately 3% as unchanged MPA following Myfortic administration to stable renal transplant patients. The mean renal clearance of MPAG was 15.5 (± 5.9) mL/min. MPAG is also secreted in the bile and available for deconjugation by gut flora. MPA resulting from the deconjugation may then be reabsorbed and produce a second peak of MPA approximately 6–8 hours after Myfortic dosing. The mean elimination half-life of MPA and MPAG ranged between 8 and 16 hours, and 13 and 17 hours, respectively.

Food Effect

Compared to the fasting state, administration of Myfortic 720 mg with a high-fat meal (55 g fat, 1000 calories) had no effect on the systemic exposure (AUC) of MPA. However, there was a 33% decrease in the maximal concentration (Cmax), a 3.5-hour delay in the Tlag (range, -6 to 18 hours), and 5.0-hour delay in the Tmax (range, -9 to 20 hours) of MPA. To avoid the variability in MPA absorption between doses, Myfortic should be taken on an empty stomach (see DOSAGE AND ADMINISTRATION and PRECAUTIONS, Information for Patients).

Pharmacokinetics in Renal Transplant Patients

The mean pharmacokinetic parameters for MPA following the administration of Myfortic in renal transplant patients on cyclosporine, USP (MODIFIED) based immunosuppression are shown in Table 1. Single-dose Myfortic pharmacokinetics predicts multiple-dose pharmacokinetics. However, in the early posttransplant period, mean MPA AUC and Cmax were approximately one-half of those measured 6 months posttransplant.

After near equimolar dosing of Myfortic 720 mg BID and mycophenolate mofetil 1000 mg BID (739 mg as MPA) in both the single- and multiple-dose cross-over trials, mean systemic MPA exposure (AUC) was similar.

Table 1 Mean ± SD Pharmacokinetic Parameters for MPA Following the Oral Administration of Myfortic® to Renal Transplant Patients on Cyclosporine, USP (MODIFIED) Based Immunosuppression

Study Patient	Myfortic® Dosing	n	Dose (mg)	Tmax* (hr)	Cmax (µg/mL)	AUC0-12hr (µg*hr/mL)
Adult	Single	24	720	2 (0.8 – 8)	26.1 ± 12.0	66.5 ± 22.6**
Pediatric***	Single	10	450 /m2	2.5 (1.5 – 24)	36.3 ± 20.9	74.3 ± 22.5**
Adult	Multiple x 6 days, BID	10	720	2 (1.5 – 3.0)	37.0 ± 13.3	67.9 ± 20.3
Adult	Multiple x 28 days, BID	36	720	2.5 (1.5 – 8)	31.2 ± 18.1	71.2 ± 26.3
Adult	Chronic, multiple dose, BID
	2 weeks posttransplant	12	720	1.8 (1.0 – 5.3)	15.0 ± 10.7	28.6 ± 11.5
	3 months posttransplant	12	720	2 (0.5 – 2.5)	26.2 ± 12.7	52.3 ± 17.4
	6 months posttransplant	12	720	2 (0 – 3)	24.1 ± 9.6	57.2 ± 15.3
Adult	Chronic, multiple dose, BID	18	720	1.5 (0 – 6)	18.9 ± 7.9	57.4 ± 15.0
*median (range), ** AUC0-∞, *** age range of 5-16 years

Special Populations

Renal Insufficiency: No specific pharmacokinetic studies in individuals with renal impairment were conducted with Myfortic. However, based on studies of renal impairment with mycophenolate mofetil, MPA exposure is not expected to be appreciably increased over the range of normal to severely impaired renal function following Myfortic administration. In contrast, MPAG exposure would be increased markedly with decreased renal function; MPAG exposure being approximately 8-fold higher in the setting of anuria. Although dialysis may be used to remove the inactive metabolite MPAG, it would not be expected to remove clinically significant amounts of the active moiety MPA. This is in large part due to the high plasma protein binding of MPA.

Hepatic Insufficiency: No specific pharmacokinetic studies in individuals with hepatic impairment were conducted with Myfortic. In a single dose (mycophenolate mofetil 1000 mg) study of 18 volunteers with alcoholic cirrhosis and 6 healthy volunteers, hepatic MPA glucuronidation processes appeared to be relatively unaffected by hepatic parenchymal disease when the pharmacokinetic parameters of healthy volunteers and alcoholic cirrhosis patients within this study were compared. However, it should be noted that for unexplained reasons, the healthy volunteers in this study had about a 50% lower AUC compared to healthy volunteers in other studies, thus making comparison between volunteers with alcoholic cirrhosis and health volunteers difficult. Effects of hepatic disease on this process probably depend on the particular disease. Hepatic disease, such as primary biliary cirrhosis, with other etiologies may show a different effect.

Pediatrics: Limited data are available on the use of Myfortic at a dose of 450 mg/m2 body surface area in children. The mean MPA pharmacokinetic parameters for stable pediatric renal transplant patients, 5–16 years, on cyclosporine, USP (MODIFIED) are shown in Table 1. At the same dose administered based on body surface area, the respective mean Cmax and AUC of MPA determined in children were higher by 33% and 18% than those determined for adults. The clinical impact of the increase in MPA exposure is not known.

Gender: There are no significant gender differences in Myfortic pharmacokinetics.

Elderly: Pharmacokinetics in the elderly have not been formally studied.

CLINICAL STUDIES

The safety and efficacy of Myfortic® (mycophenolic acid) in combination with cyclosporine, USP (MODIFIED) and corticosteroids for the prevention of organ rejection was assessed in two multicenter, randomized, double-blind trials in de novo and maintenance renal transplant patients compared to mycophenolate mofetil.

The de novo study was conducted in 423 renal transplant patients (ages 18-75 years) in Austria, Canada, Germany, Hungary, Italy, Norway, Spain, UK and USA. Cadaveric donor specimens accounted for 84% of randomized patients. Patients were administered either Myfortic 1.44 g/day or mycophenolate mofetil 2 g/day within 48 hours posttransplant for 12 months in combination with cyclosporine, USP (MODIFIED) and corticosteroids. Forty-one percent of patients received antibody therapy as induction treatment. Treatment failure was defined as the first occurrence of biopsy-proven acute rejection, graft loss, death or lost to follow-up at 6 months. The incidence of treatment failure was similar in Myfortic- and mycophenolate mofetil-treated patients at 6 and 12 months (Table 2). The cumulative incidence of graft loss, death and lost to follow-up at 12 months is also given in Table 2.

Table 2 Treatment Failure in de novo Renal Transplant Patients (Percent of Patients) at 6 and 12 Months of Treatment when Administered in Combination with Cyclosporine* and Corticosteroids

	Myfortic® 1.44 g/day (n=213)	mycophenolate mofetil 2 g/day (n=210)
6 Months	n (%)	n (%)
Treatment failure#	55 (25.8)	55 (26.2)
Biopsy-proven acute rejection	46 (21.6)	48 (22.9)
Graft loss	7 (3.3)	9 (4.3)
Death	1 (0.5)	2 (1.0)
Lost to follow-up**	3 (1.4)	0
12 Months	n (%)	n (%)
Graft loss or death or lost to follow-up***	20 (9.4)	18 (8.6)
Treatment failure	61 (28.6)	59 (28.1)
Biopsy-proven acute rejection	48 (22.5)	51 (24.3)
Graft loss	9 (4.2)	9 (4.3)
Death	2 (0.9)	5 (2.4)
Lost to follow-up**	5 (2.3)	0
*USP (MODIFIED) **Lost to follow-up indicates patients who were lost to follow-up without prior biopsy-proven acute rejection, graft loss or death ***Lost to follow-up indicates patients who were lost to follow-up without prior graft loss or death (9 Myfortic patients and 4 mycophenolate mofetil patients) #95% confidence interval of the difference in treatment failure at 6 months (Myfortic – mycophenolate mofetil) is (-8.7%, 8.0%).

The maintenance study was conducted in 322 renal transplant patients (ages 18–75 years), who were at least 6 months posttransplant receiving 2 g/day mycophenolate mofetil in combination with cyclosporine USP (MODIFIED), with or without corticosteroids for at least two weeks prior to entry in the study. Patients were randomized to Myfortic 1.44 g/day or mycophenolate mofetil 2 g/day for 12 months. The study was conducted in Austria, Belgium, Canada, Germany, Italy, Spain, and USA. Treatment failure was defined as the first occurrence of biopsy-proven acute rejection, graft loss, death, or lost to follow-up at 6 and 12 months. The incidences of treatment failure at 6 and 12 months were similar between Myfortic- and mycophenolate mofetil-treated patients (Table 3). The cumulative incidence of graft loss, death and lost to follow-up at 12 months is also given in Table 3.

Table 3 Treatment Failure in Maintenance Transplant Patients (Percent of Patients) at 6 and 12 Months of Treatment when Administered in Combination with Cyclosporine* and with or without Corticosteroids

	Myfortic® 1.44 g/day (n = 159)	mycophenolate mofetil 2 g/day (n = 163)
6 Months	n (%)	n (%)
Treatment failure#	7 (4.4)	11 (6.7)
Biopsy-proven acute rejection	2 (1.3)	2 (1.2)
Graft loss	0	1 (0.6)
Death	0	1 (0.6)
Lost to follow-up**	5 (3.1)	7 (4.3)
12 Months	n (%)	n (%)
Graft loss or death or lost to follow-up***	10 (6.3)	17 (10.4)
Treatment failure	12 (7.5)	20 (12.3)
Biopsy-proven acute rejection	2 (1.3)	5 (3.1)
Graft loss	0	1 (0.6)
Death	2 (1.3)	4 (2.5)
Lost to follow-up**	8 (5.0)	10 (6.1)
*USP (MODIFIED) **Lost to follow-up indicates patients who were lost to follow-up without prior biopsy-proven acute rejection, graft loss, or death ***Lost to follow-up indicates patients who were lost to follow-up without prior graft loss or death (8 Myfortic patients and 12 mycophenolate mofetil patients) #95% confidence interval of the difference in treatment failure at 6 months (Myfortic – mycophenolate mofetil) is (-7.4%, 2.7%).

The safety and efficacy of Myfortic has not been studied in hepatic or cardiac transplant trials.

INDICATIONS AND USAGE

Myfortic® (mycophenolic acid) delayed-release tablets are indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.

CONTRAINDICATIONS

Myfortic® (mycophenolic acid) is contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or to any of its excipients.

WARNINGS (SEE BOXED WARNING)

Lymphoma and Other Malignancies

Patients receiving immunosuppressive regimens involving combinations of drugs, including Myfortic® (mycophenolic acid), as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see ADVERSE REACTIONS). The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.

The rates for lymphoproliferative disease or lymphoma in Myfortic-treated patients were comparable to the mycophenolate mofetil group in the de novo and maintenance studies (see ADVERSE REACTIONS). As usual for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.

Infections

Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, fatal infections, and sepsis. Fatal infections can occur in patients receiving immunosuppressive therapy (see ADVERSE REACTIONS).

Polyomavirus Infections

Patients receiving immunosuppressants, including Myfortic are at increased risk for opportunistic infections, including Polyomavirus infections. Polyomavirus infections in transplant patients may have serious, and sometimes, fatal outcomes. These include cases of JC virus associated progressive multifocal leukoencephalopathy (PML) and Polyomavirus associated nephropathy (PVAN) especially due to BK virus infection which have been observed in patients receiving Myfortic.

PVAN, especially due to BK virus infection, is associated with serious outcomes, including deteriorating renal function and renal graft loss (see ADVERSE REACTIONS). Patient monitoring may help detect patients at risk for PVAN.

Cases of PML, have been reported in patients treated with MPA derivatives which include mycophenolate mofetil (MMF) and mycophenolate sodium (see ADVERSE REACTIONS). PML, which is sometimes fatal, commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies and ataxia. Risk factors for PML include treatment with immunosuppressant therapies and impairment of immune function. In immunosuppressed patients, physicians should consider PML in the differential diagnosis in patients reporting neurological symptoms and consultation with a neurologist should be considered as clinically indicated.

Reduction in immunosuppression should be considered for patients who develop evidence of PML or PVAN. Physicians should also consider the risk that reduced immunosuppression represents to the functioning allograft.

Blood Dyscrasias Including Pure Red Cell Aplasia

Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolic acid (MPA) derivatives in combination with other immunosuppressive agents. The mechanism for MPA derivatives induced PRCA is unknown; the relative contribution of other immunosuppressants and their combinations in an immunosuppressive regimen is also unknown. In some cases PRCA was found to be reversible with dose reduction or cessation of therapy with MPA derivatives. In transplant patients, however, reduced immunosuppression may place the graft at risk. Changes to Myfortic therapy should only be undertaken under appropriate supervision in transplant recipients in order to minimize the risk of graft rejection (see ADVERSE REACTIONS, Postmarketing Experience).

Patients receiving Myfortic should be monitored for blood dyscrasias (e.g. neutropenia or anemia (see PRECAUTIONS, Laboratory Tests). The development of neutropenia may be related to Myfortic itself, concomitant medications, viral infections, or some combination of these events. If blood dyscrasias occur (e.g. neutropenia (ANC <1.3x103/ µL or anemia)), dosing with Myfortic should be interrupted or the dose reduced, appropriate diagnostic tests performed, and the patient managed appropriately (see DOSAGE AND ADMINISTRATION).

Patients receiving Myfortic should be instructed to immediately report any evidence of infection, unexpected bruising, bleeding, or any other manifestation of bone marrow suppression.

Concomitant Use

Myfortic has been administered in combination with the following agents in clinical trials: antithymocyte/lymphocyte immunoglobulin, muromonab-CD3, basiliximab, daclizumab, cyclosporine, and corticosteroids. The efficacy and safety of Myfortic in combination with other immunosuppression agents have not been determined.

Pregnancy: Teratogenic Effects: Pregnancy Category D

Mycophenolate mofetil (MMF) can cause fetal harm when administered to a pregnant woman. Following oral or IV administration, MMF is metabolized to mycophenolic acid (MPA), the active ingredient in Myfortic and the active form of the drug. Use of Myfortic during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. In the National Transplantation Pregnancy Registry (NTPR), there were data on 33 MMF-exposed pregnancies in 24 transplant patients; there were 15 spontaneous abortions (45%) and 18 live-born infants. Four of these 18 infants had structural malformations (22%). In postmarketing data (collected from 1995 to 2007) on 77 women exposed to systemic MMF during pregnancy, 25 had spontaneous abortions and 14 had a malformed infant or fetus. Six of 14 malformed offspring had ear abnormalities. Because these postmarketing data are reported voluntarily, it is not always possible to reliably estimate the frequency of particular adverse outcomes. These malformations are similar to findings in animal reproductive toxicology studies. For comparison, the background rate for congenital anomalies in the United States is about 3%, and NTPR data show a rate of 4-5% among babies born to organ transplant patients using other immunosuppressive drugs.

In a teratology study performed with mycophenolate sodium in rats, at a dose as low as 1 mg/kg, malformations in the offspring were observed, including anophthalmia, exencephaly and umbilical hernia. The systemic exposure at this dose represents 0.05 times the clinical exposure at the dose of 1.44 g/day Myfortic. In teratology studies in rabbits, fetal resorptions and malformations occurred from 80 mg/kg/day, in the absence of maternal toxicity (dose levels are equivalent to about 0.8 times the recommended clinical dose, corrected for BSA). There are no relevant qualitative or quantitative differences in the teratogenic potential of mycophenolate sodium and mycophenolate mofetil.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. In certain situations, the patient and her healthcare practitioner may decide that the maternal benefits outweigh the risks to the fetus. Women using Myfortic at any time during pregnancy should be encouraged to enroll in the National Transplantation Pregnancy Registry.

Pregnancy Exposure Prevention

Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 1 week prior to beginning therapy. Myfortic therapy should not be initiated until a negative pregnancy test report is obtained.

Women of childbearing potential (including pubertal girls and perimenopausal women) taking Myfortic must receive contraceptive counseling and use effective contraception. The patient should begin using her two chosen methods of contraception 4 weeks prior to starting Myfortic therapy, unless abstinence is the chosen method. She should continue contraceptive use during therapy and for 6 weeks after stopping Myfortic. Patients should be aware that Myfortic reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness (see PRECAUTIONS, Information for Patients and PRECAUTIONS, Drug Interactions, Oral Contraceptives).

 

PRECAUTIONS

General

Gastrointestinal bleeding (requiring hospitalization) has been reported in de novo renal transplant patients (1.0%) and maintenance patients (1.3%) treated with Myfortic® (mycophenolic acid) (up to 12 months). Intestinal perforations, gastrointestinal hemorrhage, gastric ulcers and duodenal ulcers have rarely been observed. Most patients receiving Myfortic were also receiving other drugs known to be associated with these complications. Patients with active peptic ulcer disease were excluded from enrollment in studies with Myfortic. Because MPA derivatives have been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, hemorrhage, and perforation, Myfortic should be administered with caution in patients with active serious digestive system disease (see ADVERSE REACTIONS).

Subjects with severe chronic renal impairment (GFR <25 mL/min/1.73 m2) may present higher plasma MPA and MPAG AUCs relative to subjects with lesser degrees of renal impairment or normal healthy volunteers. No data are available on the safety of long-term exposure to these levels of MPAG.

In the de novo study, 18.3% of Myfortic patients versus 16.7% in the mycophenolate mofetil group experienced delayed graft function (DGF). Although patients with DGF experienced a higher incidence of certain adverse events (anemia, leukopenia, and hyperkalemia) than patients without DGF, these events in DGF patients were not more frequent in patients receiving Myfortic compared to mycophenolate mofetil. No dose adjustment is recommended for these patients; however, such patients should be carefully observed (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

In view of the significant reduction in the AUC of MPA by cholestyramine when administered with mycophenolate mofetil, caution should be used in the concomitant administration of Myfortic with drugs that interfere with enterohepatic recirculation because of the potential to reduce the efficacy (see PRECAUTIONS, Drug Interactions).

On theoretical grounds, because Myfortic is an IMPDH Inhibitor, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.

During treatment with Myfortic, the use of live attenuated vaccines should be avoided and patients should be advised that vaccinations may be less effective (see PRECAUTIONS, Drug Interactions, Live Vaccines).

Information for Patients

• It is recommended that Myfortic be administered on an empty stomach, one hour before or two hours after food intake (see DOSAGE AND ADMINISTRATION).
  


• In order to maintain the integrity of the enteric coating of the tablet, patients should be instructed not to crush, chew, or cut Myfortic tablets and to swallow the tablets whole.
  


• Give patients complete dosage instructions and inform them about the increased risk of lymphoproliferative disease and certain other malignancies.
  


• Inform patients that they need repeated appropriate laboratory tests while they are taking Myfortic.
  


• Inform women of childbearing potential that use of Myfortic in pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of birth defects, and that they must use effective contraception.
  


• Discuss pregnancy plans with female patients of childbearing potential.
  


• Any female of childbearing potential must use highly effective (two methods) contraception 4 weeks prior to starting Myfortic therapy and continue contraception until 6 weeks after stopping Myfortic treatment, unless abstinence is the chosen method (see WARNINGS, Pregnancy).
  


• A patient who is planning a pregnancy should not use Myfortic unless she can not be successfully treated with other immunosuppressant drugs. Risks and benefits of Myfortic and alternative immunosuppressants should be discussed with the patient.

Laboratory Tests

Complete blood count should be performed weekly during the first month, twice monthly for the second and the third month of treatment, then monthly through the first year. If neutropenia develops (ANC <1.3×103/µL), dosing with Myfortic should be interrupted or the dose reduced, appropriate tests performed, and the patient managed accordingly (see WARNINGS).

Drug Interactions

The following drug interaction studies have been conducted with Myfortic:

Gastroprotective agents

Antacids with magnesium and aluminum hydroxides:

Absorption of a single dose of Myfortic was decreased when administered to 12 stable renal transplant patients also taking magnesium-aluminum-containing antacids (30 mL): the mean Cmax and AUC(0-t) values for MPA were 25% and 37% lower, respectively, than when Myfortic was administered alone under fasting conditions. It is recommended that Myfortic and antacids not be administered simultaneously.

Proton Pump inhibitors:

In a study conducted in 12 healthy volunteers, the pharmacokinetics of MPA were observed to be similar when a single dose of 720 mg Myfortic was administered alone and following concomitant administration of Myfortic and pantoprazole, which was administered at a dose of 40 mg BID for 4 days.

Cyclosporine: When studied in stable renal transplant patients, cyclosporine, USP (MODIFIED) pharmacokinetics were unaffected by steady-state dosing of Myfortic.

The following recommendations are derived from drug interaction studies conducted following the administration of mycophenolate mofetil:

Acyclovir/Ganciclovir: May be taken with Myfortic; however, during the period of treatment, physicians should monitor blood cell counts. Both acyclovir/ganciclovir and MPAG concentrations are increased in the presence of renal impairment, their coexistence may compete for tubular secretion and further increase in the concentrations of the two.

Azathioprine/Mycophenolate Mofetil: Given that azathioprine and mycophenolate mofetil inhibit purine metabolism, it is recommended that Myfortic not be administered concomitantly with azathioprine or mycophenolate mofetil.

Cholestyramine and Drugs that Bind Bile Acids: These drugs interrupt enterohepatic recirculation and reduce MPA exposure when coadministered with mycophenolate mofetil. Therefore, do not administer Myfortic with cholestyramine or other agents that may interfere with enterohepatic recirculation or drugs that may bind bile acids, for example bile acid sequestrates or oral activated charcoal, because of the potential to reduce the efficacy of Myfortic.

Oral Contraceptives: Given the different metabolism of Myfortic and oral contraceptives, no drug interaction between these two classes of drug is expected. However, in a drug-drug interaction study, mean levonorgesterol AUC was decreased by 15% when coadministered with mycophenolate mofetil. Therefore, it is recommended that oral contraceptives are coadministered with Myfortic with caution and additional birth control methods be considered (see PRECAUTIONS, Pregnancy).

Live Vaccines: During treatment with Myfortic, the use of live attenuated vaccines should be avoided and patients should be advised that vaccinations may be less effective. Influenza vaccination may be of value. Prescribers should refer to national guidelines for influenza vaccination (see PRECAUTIONS, General).

Drugs that alter the gastrointestinal flora may interact with Myfortic by disrupting enterohepatic recirculation. Interference of MPAG hydrolysis may lead to less MPA available for absorption.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 104-week oral carcinogenicity study in rats, mycophenolate sodium was not tumorigenic at daily doses up to 9 mg/kg, the highest dose tested. This dose resulted in approximately 0.6-1.2 times the systemic exposure (based upon plasma AUC) observed in renal transplant patients at the recommended dose of 1.44 g/day. Similar results were observed in a parallel study in rats performed with mycophenolate mofetil. In a 104-week oral carcinogenicity study in mice, mycophenolate mofetil was not tumorigenic at a daily dose level as high as 180 mg/kg (which corresponds to 0.6 times the proposed mycophenolate sodium therapeutic dose based upon body surface area).

The genotoxic potential of mycophenolate sodium was determined in five assays. Mycophenolate sodium was genotoxic in the mouse lymphoma/thymidine kinase assay, the micronucleus test in V79 Chinese hamster cells, and the in-vivo mouse micronucleus assay. Mycophenolate sodium was not genotoxic in the bacterial mutation assay (Salmonella typhimurium TA 1535, 97a, 98, 100, & 102) or the chromosomal aberration assay in human lymphocytes. Mycophenolate mofetil generated similar genotoxic activity. The genotoxic activity of MPA is probably due to the depletion of the nucleotide pool required for DNA synthesis as a result of the pharmacodynamic mode of action of MPA (inhibition of nucleotide synthesis).

Mycophenolate sodium had no effect on male rat fertility at daily oral doses as high as 18 mg/kg and exhibited no testicular or spermatogenic effects at daily oral doses of 20 mg/kg for 13 weeks (approximately two-fold the therapeutic systemic exposure of MPA). No effects on female fertility were seen up to a daily dose of 20 mg/kg, which was approximately three-fold higher than the recommended therapeutic dose based upon systemic exposure.

Pregnancy

Teratogenic Effects: Pregnancy Category D. (See WARNINGS.)

Nursing Mothers

It is not known whether MPA is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from MPA, a decision should be made whether to discontinue the drug or to discontinue nursing while on treatment or within 6 weeks after stopping therapy, taking into account the importance of the drug to the mother.

Pediatric Use

De novo Renal Transplant

The safety and effectiveness of Myfortic in de novo pediatric renal transplant patients have not been established.

Stable Renal Transplant

There are no pharmacokinetic data available for pediatric patients <5 years. The safety and effectiveness of Myfortic have been established in the age group 5-16 years in stable pediatric renal transplant patients. Use of Myfortic in this age group is supported by evidence from adequate and well-controlled studies of Myfortic in stable adult renal transplant patients. Limited pharmacokinetic data are available for stable pediatric renal transplant patients in the age group 5-16 years. Pediatric doses for patients with BSA <1.19 m2 cannot be accurately administered using currently available formulations of Myfortic tablets (see CLINICAL PHARMACOLOGY, Special Populations and DOSAGE AND ADMINISTRATION).

Geriatric Use

Patients ≥65 years may generally be at increased risk of adverse drug reactions due to immunosuppression. Clinical studies of Myfortic did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

The incidence of adverse events for Myfortic® (mycophenolic acid) was determined in randomized, comparative, active-controlled, double-blind, double-dummy trials in prevention of acute rejection in de novo and maintenance kidney transplant patients.

The principal adverse reactions associated with the administration of Myfortic include constipation, nausea, and urinary tract infection in de novo patients and nausea, diarrhea and nasopharyngitis in maintenance patients.

Adverse events reported in ≥20% of patients receiving Myfortic or mycophenolate mofetil in the 12-month de novo renal study and maintenance renal study, when used in combination with cyclosporine, USP (MODIFIED) and corticosteroids, are listed in Table 4. Adverse event rates were similar between Myfortic and mycophenolate mofetil in both de novo and maintenance patients.

Table 4 Adverse Events (%) in Controlled de novo and Maintenance Renal Studies Reported in ≥20% of Patients

	de novo Renal Study		Maintenance Renal Study
	Myfortic®  1.44 g/day (n=213)	mycophenolate mofetil 2 g/day (n=210)	Myfortic® 1.44 g/day (n=159)	mycophenolate mofetil 2 g/day (n=163)
Blood and Lymphatic System Disorders
Anemia	21.6	21.9	–	–
Leukopenia	19.2	20.5	–	–
Gastrointestinal System Disorders
Constipation	38.0	39.5	–	–
Nausea	29.1	27.1	24.5	19.0
Diarrhea	23.5	24.8	21.4	24.5
Vomiting	23.0	20.0	–	–
Dyspepsia	22.5	19.0	–	–
Infections and Infestations
Urinary Tract Infection	29.1	33.3	–	–
CMV Infection	20.2	18.1	–	–
Nervous System Disorder
Insomnia	23.5	23.8	–	–
Surgical and Medical Procedure
Postoperative Pain	23.9	18.6	–	–

Table 5 summarizes the incidence of opportunistic infections in de novo and maintenance transplant patients, which were similar in both treatment groups.

Table 5 Viral and Fungal Infections (%) Reported Over 0-12 Months

	de novo Renal Study		Maintenance Renal Study
	Myfortic® 1.44 g/day (n = 213)	mycophenolate mofetil 2 g/day (n = 210)	Myfortic® 1.44 g/day (n = 159)	mycophenolate mofetil 2 g/day (n = 163)
	(%)	(%)	(%)	(%)
Any Cytomegalovirus

Valtrex

Generic Name: valacyclovir (Oral route)

val-ay-SYE-kloe-vir

Commonly used brand name(s)

In the U.S.

• Valtrex

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

Uses For Valtrex

Valacyclovir is used to treat herpes virus infections, including herpes labialis (also known as cold sores), herpes zoster (also known as shingles), and herpes simplex (also known as genital herpes) in adults. It is also used to treat chickenpox and cold sores in children.

In your body, valacyclovir becomes the anti-herpes medicine, acyclovir. Although valacyclovir will not cure shingles or genital herpes, it does help relieve the pain and discomfort and helps the sores heal faster.

Valacyclovir is available only with your doctor's prescription.

Before Using Valtrex

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:

Allergies

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of valacyclovir in children below 12 years of age with cold sores, and children below 2 years of age with chickenpox. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of valacyclovir in the elderly. However, elderly patients are more likely to have age-related kidney disease, which may require an adjustment in the dose of patients receiving valacyclovir.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking 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 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.

• Mycophenolate Mofetil


• Mycophenolic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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:

• Advanced human immunodeficiency virus (HIV) infection or


• Bone marrow transplantation or


• Kidney transplantation—Patients with these medical problems may have an increased risk of severe side effects.

• Kidney disease—The effects may be increased because of slower removal of this medicine from the body.

Proper Use of Valtrex

Valacyclovir works best if it is used within 48 hours after the first symptoms of shingles or genital herpes (e.g., pain, burning, or blisters) begin to appear. For recurrent outbreaks of genital herpes, valacyclovir works best if it is used within 24 hours after the symptoms begin to appear.

If you are taking valacyclovir for the treatment of chickenpox, it is best to start taking valacyclovir as soon as possible after the first sign of the chickenpox rash appears, usually within one day.

Valacyclovir may be taken with meals or on an empty stomach.

If you are using the oral suspension, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.

To help clear up your infection, keep taking valacyclovir for the full time of treatment, even if your symptoms begin to clear up after a few days. Do not miss any doses. However, do not use this medicine more often or for a longer time than your doctor ordered.

Dosing

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.

• For oral dosage form (tablets):
  
  • For treatment of chickenpox:
    
    • Adults and children below 2 years of age—Use and dose must be determined by your doctor.
    
    
    • Children 2 to 18 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 milligrams (mg) per kilogram (kg) of body weight, taken three times a day for 5 days. However, the dose is usually not more than 1000 mg three times a day.
    
    
  
  
  • For treatment of cold sores:
    
    • Adults—2000 milligrams (mg) every 12 hours for one day.
    
    
    • Children 12 years of age and above—2000 milligrams (mg) every 12 hours for one day.
    
    
    • Children below 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For treatment of genital herpes, first outbreak:
    
    • Adults—1000 milligrams (mg) two times a day for ten days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For treatment of genital herpes, recurrent outbreaks:
    
    • Adults—500 milligrams (mg) two times a day for three days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To prevent recurrent outbreaks of genital herpes:
    
    • Adults—500 milligrams (mg) or 1000 mg once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For treatment of shingles:
    
    • Adults—1000 milligrams (mg) three times a day for seven days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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.

Storage

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.

Precautions While Using Valtrex

If you or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

The areas affected by genital herpes, chickenpox, or shingles should be kept as clean and dry as possible. Also, wear loose-fitting clothing to avoid irritating the sores (blisters).

It is important to remember that this medicine will not keep you from spreading herpes to others.

Herpes infection of the genitals can be caught from or spread to your partner during any sexual activity. Even though you may get herpes if your partner has no symptoms, the infection is more likely to be spread if sores are present. This is true until the sores are completely healed and the scabs have fallen off. Therefore, it is best to avoid any sexual activity if either you or your sexual partner has any symptoms of herpes. The use of a latex condom (“rubber") may help prevent the spread of herpes. However, spermicidal (sperm-killing) jelly or a diaphragm will probably not help.

Valtrex Side Effects

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:

More common

• Discouragement


• feeling sad or empty


• irritability


• lack of appetite


• loss of interest or pleasure


• tiredness


• trouble concentrating


• trouble sleeping

Rare

• Black, tarry stools


• chest pain


• chills


• cough


• decreased frequency or output of urine


• fever


• flu-like symptoms


• headache


• lower back or side pain


• reduced mental alertness


• shortness of breath


• yellow eyes or skin

Incidence not known

• Actions that are out of control


• agitation


• anxiety


• back, leg, or stomach pains


• bleeding gums


• blood in urine or stools


• blurred vision


• change in consciousness


• change in mental status


• changes in behavior, especially in interactions with other people


• changes in patterns and rhythms of speech


• dark or bloody urine


• difficult or labored breathing


• difficulty speaking


• difficulty swallowing


• dizziness


• drowsiness


• dry mouth


• fast, pounding, or irregular heartbeat or pulse


• feeling that others are watching you or controlling your behavior


• feeling that others can hear your thoughts


• feeling, seeing, or hearing things that are not there


• general tiredness and weakness


• hyperventilation


• increased thirst


• itching


• lightheadedness when getting up from a lying or sitting position


• light-colored stools


• loss of consciousness


• mood or mental changes


• nausea and vomiting


• nervousness


• pale color of skin


• pinpoint red spots on the skin


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• redness of the skin


• restlessness


• seeing, hearing, or feeling things that are not there


• seizures


• severe mood or mental changes


• shakiness and unsteady walk


• shakiness in the legs, arms, hands, or feet


• skin rash


• slurred speech


• sores, ulcers, or white spots on the lips or in the mouth


• stiff neck


• swelling of the face, fingers, or lower legs


• swollen or painful glands


• talking, feeling, and acting with excitement


• tightness in the chest


• trembling or shaking of the hands or feet


• trouble in speaking


• troubled breathing


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual behavior


• unusual bleeding or bruising


• unusual tiredness or weakness


• upper right abdominal pain


• vomiting


• weight gain


• wheezing

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:

More common

• Body aches or pain


• cramps


• difficulty in moving


• ear congestion


• heavy bleeding


• loss of voice


• muscle aches


• muscle pain or stiffness


• nasal congestion


• pain


• pain in joints


• sneezing


• sore throat


• stuffy or runny nose

Less common

• Constipation


• diarrhea

Incidence not known

• Blistering, peeling, or loosening of the skin


• hair loss or thinning of the hair


• hives or welts


• increased sensitivity of skin to sunlight


• red, irritated eyes


• redness or other discoloration of the skin


• severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Valtrex side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Valtrex resources

• Valtrex Side Effects (in more detail)
• Valtrex Use in Pregnancy & Breastfeeding
• Drug Images
• Valtrex Drug Interactions
• Valtrex Support Group
• 56 Reviews for Valtrex - Add your own review/rating

• Valtrex Prescribing Information (FDA)


• Valtrex Consumer Overview


• Valtrex Monograph (AHFS DI)


• Valtrex MedFacts Consumer Leaflet (Wolters Kluwer)


• Valacyclovir Prescribing Information (FDA)

Compare Valtrex with other medications

• Cold Sores
• Cytomegalovirus Infection
• Herpes Simplex, Mucocutaneous/Immunocompetent Host
• Herpes Simplex, Mucocutaneous/Immunocompromised Host
• Herpes Simplex, Suppression
• Herpes Zoster
• Multiple Sclerosis
• Varicella-Zoster

amsacrine Intravenous

AM-sa-kreen

Available Dosage Forms:

• Injectable

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Uses For amsacrine

Amsacrine belongs to the general group of medicines known as antineoplastics. It is used to treat acute adult leukemia.

Amsacrine interferes with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by amsacrine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Before you begin treatment with amsacrine, you and your doctor should talk about the good amsacrine will do as well as the risks of using it.

Amsacrine is to be administered only by or under the supervision of your doctor.

Before Using amsacrine

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 amsacrine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to amsacrine 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.

Pediatric

Studies on amsacrine have been done only in adult patients, and there is no specific information comparing use of amsacrine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of amsacrine in the elderly with use in other age groups.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking amsacrine, 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 amsacrine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using amsacrine 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.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• St John's Wort


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of amsacrine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow depression or


• Infection—There may be an increased risk of infections or worsening infections because of the body's reduced ability to fight them

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body


• Heart rhythm problems—Patients who have problems with heart rhythms may have increased problems while taking amsacrine


• Kidney disease or


• Liver disease—Effects of amsacrine may be increased because of its slower removal from the body

Proper Use of amsacrine

Amsacrine often causes nausea and vomiting. However, it is very important that you continue to receive the medication, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing

The dose of amsacrine 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 amsacrine. 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.

Precautions While Using amsacrine

It is very important that your doctor check your progress at regular visits to make sure that amsacrine is working properly and to check for unwanted effects.

While you are being treated with amsacrine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Amsacrine may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine, since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Amsacrine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

If amsacrine accidentally leaks out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

amsacrine Side Effects

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:

More common

• Accumulation of pus or swollen, red, tender area of infection around the rectum


• Black tarry stools


• blood in urine or stools


• cough or hoarseness


• fever or chills


• lower back or side pain


• painful or difficult urination


• pinpoint red spots on skin


• sores, ulcers, or white spots on lips, tongue, or inside mouth


• unusual bleeding or bruising


• unusual tiredness or weakness

Less common

• Abdominal pain or tenderness


• blurred vision


• confusion


• dark urine


• diarrhea


• dizziness, faintness, or light-headedness


• fast, pounding, or irregular heartbeat or pulse


• fever


• itching


• nausea


• palpitations


• convulsions (seizures)


• vomiting or vomiting of blood or material that looks like coffee grounds


• yellow eyes or skin

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:

More Common

• Burning, crawling, numbness, prickling, “pins and needles”, or tingling feelings


• headache

Less common

• Bleeding gums


• difficulty swallowing


• hives


• loss of appetite


• loss of strength or energy


• muscle or bone pain


• pain or redness at site of injection


• rash


• redness and swelling of gums

amsacrine often causes a temporary loss of hair. After treatment with amsacrine has ended, normal hair growth should return.

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

zafirlukast

Generic Name: zafirlukast (za FIR loo kast)

Brand Names: Accolate

What is zafirlukast?

Zafirlukast is a leukotriene (loo-koe-TRY-een) inhibitor. Leukotrienes are chemicals your body releases when you breathe in an allergen (such as pollen). These chemicals cause swelling in your lungs and tightening of the muscles around your airways, which can result in asthma symptoms.

Zafirlukast is used to for chronic treatment of asthma, and to prevent asthma attacks in adults and children as young as 5 years old.

Do not give this medication to a child without a doctor's advice.

Zafirlukast may also be used for purposes not listed in this medication guide.

What is the most important information I should know about zafirlukast?

Zafirlukast will not work fast enough to treat an asthma attack that has already begun. Use only a fast-acting inhalation medicine to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after several weeks of treatment.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

What should I discuss with my healthcare provider before taking zafirlukast?

You should not use this medication if you are allergic to zafirlukast, or if you have liver disease (including cirrhosis).

To make sure you can safely take zafirlukast, tell your doctor if you have liver disease.

The chewable tablet form of this medication may contain up to 0.842 milligrams of phenylalanine. Talk to your doctor before using this form of zafirlukast if you have phenylketonuria (PKU).

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Zafirlukast can pass into breast milk and may harm a nursing baby. Do not breast-feed while you are taking zafirlukast.

How should I take zafirlukast?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Zafirlukast is usually taken twice daily. Follow your doctor's instructions.

Take zafirlukast on an empty stomach, at least 1 hour before or 2 hours after a meal. Zafirlukast will not work fast enough to treat an asthma attack that has already begun. Use only a fast-acting inhalation medicine to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after several weeks of treatment.

Asthma is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice, even if you have no asthma symptoms.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

Store at room temperature away from moisture and heat.

See also: Zafirlukast dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include skin rash and upset stomach.

What should I avoid while taking zafirlukast?

Avoid situations or activities that may trigger an asthma attack.

Zafirlukast side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  worsening asthma symptoms;

  
  


• 
  

  new or worsening cough, fever, trouble breathing;

  
  


• 
  

  mood or behavior changes, anxiety, depression, sleep problems (insomnia);

  
  


• 
  

  skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or

  
  


• 
  

  nausea, pain in your upper stomach, loss of appetite, flu symptoms, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  diarrhea, stomach pain;

  
  


• 
  

  weakness;

  
  


• 
  

  dizziness;

  
  


• 
  

  muscle pain; or

  
  


• 
  

  sore throat, cold symptoms.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Zafirlukast Dosing Information

Usual Adult Dose for Asthma -- Maintenance:

20 mg orally twice a day, 1 hour before or 2 hours after meals.

Usual Pediatric Dose for Asthma -- Maintenance:

5 years to 11 years:

10 mg orally twice a day, 1 hour before or 2 hours after meals.

12 years or older:

20 mg orally twice a day, 1 hour before or 2 hours after meals.

What other drugs will affect zafirlukast?

Tell your doctor about all other medicines you use, especially:

• 
  

  aspirin;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  tolbutamide (Orinase);

  
  


• 
  

  erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole);

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

  
  


• 
  

  carbamazepine (Carbatrol, Equetro, Tegretol); or

  
  


• 
  

  phenytoin (Dilantin).

  
  

This list is not complete and other drugs may interact with zafirlukast. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More zafirlukast resources

• Zafirlukast Side Effects (in more detail)
• Zafirlukast Dosage
• Zafirlukast Use in Pregnancy & Breastfeeding
• Drug Images
• Zafirlukast Drug Interactions
• Zafirlukast Support Group
• 3 Reviews for Zafirlukast - Add your own review/rating

• zafirlukast Advanced Consumer (Micromedex) - Includes Dosage Information


• Zafirlukast Prescribing Information (FDA)


• Zafirlukast Professional Patient Advice (Wolters Kluwer)


• Zafirlukast Monograph (AHFS DI)


• Zafirlukast MedFacts Consumer Leaflet (Wolters Kluwer)


• Accolate Prescribing Information (FDA)

Compare zafirlukast with other medications

• Asthma, Maintenance

Where can I get more information?

• Your pharmacist can provide more information about zafirlukast.

See also: zafirlukast side effects (in more detail)

Flexeril

Generic Name: cyclobenzaprine (Oral route)

sye-kloe-BEN-za-preen

Commonly used brand name(s)

In the U.S.

• Amrix


• Fexmid


• Flexeril


• FusePaq Tabradol

Available Dosage Forms:

• Capsule, Extended Release


• Tablet


• Suspension

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Uses For Flexeril

Cyclobenzaprine is used to help relax certain muscles in your body. It helps relieve the pain, stiffness, and discomfort caused by strains, sprains, or injuries to your muscles. However, this medicine does not take the place of rest, exercise or physical therapy, or other treatment that your doctor may recommend for your medical problem. Cyclobenzaprine acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of this medicine's side effects.

Cyclobenzaprine may also be used for other conditions as determined by your doctor.

Cyclobenzaprine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, cyclobenzaprine is used in certain patients with fibromyalgia syndrome (also called fibrositis or fibrositis syndrome).

Before Using Flexeril

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:

Allergies

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.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of cyclobenzaprine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cyclobenzaprine tablets in the elderly with use in other age groups.

Because of the possibility of higher blood levels in the elderly as compared to younger adults, use of cyclobenzaprine extended-release capsules is not recommended in the elderly .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brofaromine


• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Lazabemide


• Linezolid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• Tranylcypromine

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.

• Duloxetine


• Tramadol

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.

• Escitalopram


• Fluoxetine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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:

• Glaucoma or


• Problems with urination—Cyclobenzaprine can make your condition worse.

• Heart or blood vessel disease or


• Overactive thyroid—The chance of side effects may be increased.

• Liver disease—Higher blood levels of cyclobenzaprine may occur, increasing the chance of side effects .

Proper Use of cyclobenzaprine

This section provides information on the proper use of a number of products that contain cyclobenzaprine. It may not be specific to Flexeril. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. To do so may increase the chance of serious side effects.

Dosing

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.

• For relaxing stiff muscles:
  
  • For the oral dosage form (tablets):
    
    • Adults and teenagers 15 years of age and older—The usual dose is 10 milligrams (mg) three times a day. The largest amount should be no more than 60 mg (six 10-mg tablets) a day.
    
    
    • Children and teenagers up to 15 years of age—Dose must be determined by your doctor.
    
    
  
  
  • For the oral dosage form (extended-release capsules):
    
    • Adults—The usual dose is 15 mg once a day. Some patients may require up to 30 mg (one 30 mg capsule or two 15 mg capsules) per day.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  

Missed Dose

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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Flexeril

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

You should NOT use the extended-release capsules if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days .

This medicine may cause some people to have blurred vision or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and able to see well.

Cyclobenzaprine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If your condition does not improve within two or three weeks, or if it becomes worse, check with your doctor .

Flexeril Side Effects

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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

• Changes in the skin color of the face


• fast or irregular breathing


• large swellings that look like hives on the face, eyelids, mouth, lips, and/or tongue


• puffiness or swelling of the eyelids or the area around the eyes


• shortness of breath, troubled breathing, tightness in chest, and/or wheezing


• skin rash, hives, or itching

Check with your doctor immediately if any of the following side effects occur:

Rare

• Fainting

Symptoms of overdose

• Convulsions (seizures)


• drowsiness (severe)


• dry, hot, flushed skin


• fast or irregular heartbeat


• hallucinations (seeing, hearing, or feeling things that are not there)


• increase or decrease in body temperature


• troubled breathing


• unexplained muscle stiffness


• unusual nervousness or restlessness (severe)


• vomiting (occurring together with other symptoms of overdose)

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Clumsiness or unsteadiness


• confusion


• mental depression or other mood or mental changes


• problems in urinating


• ringing or buzzing in the ears


• skin rash, hives, or itching occurring without other symptoms of an allergic reaction listed above


• unusual thoughts or dreams


• yellow eyes or skin

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:

More common

• Blurred vision


• dizziness or lightheadedness


• drowsiness


• dryness of mouth

Less common or rare

• Bloated feeling or gas, indigestion, nausea or vomiting, or stomach cramps or pain


• constipation


• diarrhea


• excitement or nervousness


• frequent urination


• general feeling of discomfort or illness


• headache


• muscle twitching


• numbness, tingling, pain, or weakness in hands or feet


• pounding heartbeat


• problems in speaking


• trembling


• trouble in sleeping


• unpleasant taste or other taste changes


• unusual muscle weakness


• unusual tiredness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Flexeril side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Flexeril resources

• Flexeril Side Effects (in more detail)
• Flexeril Use in Pregnancy & Breastfeeding
• Drug Images
• Flexeril Drug Interactions
• Flexeril Support Group
• 92 Reviews for Flexeril - Add your own review/rating

• Flexeril Prescribing Information (FDA)


• Flexeril Consumer Overview


• Flexeril Monograph (AHFS DI)


• Flexeril MedFacts Consumer Leaflet (Wolters Kluwer)


• Cyclobenzaprine Prescribing Information (FDA)


• Amrix Prescribing Information (FDA)


• Amrix Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Fexmid Prescribing Information (FDA)

Compare Flexeril with other medications

• Fibromyalgia
• Migraine
• Muscle Spasm
• Sciatica
• Temporomandibular Joint Disorder